4 unchanged sentences
Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures.
−Removed: Tab le o f co ntents
The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions;
2 unchanged sentences
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of December 31, 2024.
−Removed: Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of December 31, 2023, our disclosure controls and procedures were not effective due to the material weakness in internal control over financial reporting described below.
+Added: Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of December 31, 2024, our disclosure controls and procedures were effective.
Management’s Annual Report on Internal Control over Financial Reporting
4 unchanged sentences
Management has assessed the effectiveness of internal control over financial reporting as of December 31, 2024, based on the Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”).
−Removed: Based on this assessment, our management has concluded that our internal control over financial reporting as of December 31, 2023 was not effective due to the material weakness in internal control over financial reporting described below.
+Added: Based on this assessment, our management has concluded that our internal control over financial reporting as of December 31, 2024 was effective.
Material Weakness and Remediation Plan
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
−Removed: In connection with the audit of our financial statements for the year ended December 31, 2023, our management identified a material weakness that resulted from our misinterpretation and application of ASC Topic 740, Income Taxes, in relation to our UK small medium enterprise tax credits, which we historically presented in income tax benefit (expense) rather than as a reduction to research and development expense.
−Removed: The material weakness in our internal control resulted in the restatement of our consolidated financial statements as of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021 included in this report.
−Removed: Management is in the process of designing and implementing a remediation plan intended to address the control deficiency that resulted in the material weakness described above.
−Removed: These remediation efforts are underway and include enhancing the training provided to the individuals operating the income taxation controls.
−Removed: Management will report regularly to the Audit Committee regarding the status of the implementation activities.
+Added: In connection with the review of our unaudited condensed consolidated financial statements for the quarter ended March 31, 2024, we identified a material weakness in relation to accounting for complex transactions.
+Added: The material weakness did not allow us to identify, understand and evaluate the impact of certain key aspects of the accounting for the BioNTech Agreements.
+Added: Our process as designed was inadequate to deal with the complexity of the accounting for the transaction and did not allow for an effective and timely evaluation of key aspects of the agreements and their impact on the consolidated financial statements.
+Added: We have taken steps to remediate the material weakness by (i) implementing structured project plans and project monitoring techniques;
+Added: (ii) the use of summary outputs allowing for earlier review of key judgements, estimates and other factors which impact the financial statements;
+Added: and (iii) enhancing our review process, and controls including building in more time to allow for its effective operation and iv) assessing resourcing needs and capabilities resulting additional resources being added to the finance team.
+Added: We believe this material weakness was remediated at December 31, 2024.
Changes in Internal Control Over Financial Reporting
+Added: In connection with the review of our unaudited condensed consolidated financial statements for the quarter ended March 31, 2024, we identified a material weakness in relation to accounting for complex transactions.
+Added: The material weakness did not allow us to identify, understand and evaluate the impact of certain key aspects of the accounting for the BioNTech Agreements.
+Added: Our process as designed was inadequate to deal with the complexity of the accounting for the transaction and did not allow for an effective and timely evaluation of key aspects of the agreements and their impact on the financial statements.
+Added: We have taken steps to remediate the material weakness by (i) implementing structured project plans and project monitoring techniques;
+Added: (ii) the use of summary outputs allowing for earlier review of key judgements, estimates and other factors which impact the financial statements;
+Added: and (iii) enhancing our review process, and controls including building in more time to allow for its effective operation and (iv) assessing resourcing needs and capabilities.
+Added: We believe this material weakness was remediated at December 31, 2024.
Except as described above, there were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the fourth quarter of our fiscal year ended December 31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
4 unchanged sentences
During the three months ended December 31, 2024, none of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
−Removed: Tab le o f co ntents
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
8 unchanged sentences
Robert Dolski 55 Senior Vice President, Chief Financial Officer
−Removed: Edgar Braendle, M.D.* 64 Senior Vice President, Chief Development Officer
David Brochu 69 Senior Vice President, Chief Technical Officer
+Added: Alex Driggs 49 Senior Vice President, Legal Affairs and General Counsel
+Added: Miranda Neville 50 Senior Vice President, Chief Project Officer
Martin Pulé, MBBS 52 Senior Vice President, Founder, Chief Scientific Officer
2 unchanged sentences
Christopher Vann 60 Senior Vice President, Chief Operating Officer
+Added: Matthias Will, M.D.
+Added: 52 Senior Vice President, Chief Development Officer
Christopher Williams, Ph.D.
1 unchanged sentence
Non-Executive Directors:
−Removed: John Johnson 66 Chairman of the Board of Directors
+Added: Michael Bonney 66 Chairman of the Board of Directors
Joseph Anderson, Ph.D.
6 unchanged sentences
Martin Murphy, Ph.D.
+Added: Ravi Rao, M.D.
William Young, Ph.D.
−Removed: *On March 14, 2024, we announced Dr.
−Removed: Edgar Braendle had tendered his resignation.
Senior Management
Christian Itin, Ph.D.
−Removed: has served as our Chief Executive Officer since 2016 and as a director since 2014.
−Removed: He served as Chairman of our board of directors from 2014 to September 2021.
+Added: has served as our Chief Executive Officer since March 2016 and as a director since October 2014.
+Added: He served as chair of our board of directors from October 2014 to September 2021.
Prior to joining us, Dr.
−Removed: Itin served as chief executive officer and chairman of the board of directors at Cytos Biotechnology Ltd, a biotechnology company, from 2012 until it merged with Kuros Biosurgery Holding Ltd in 2016.
−Removed: From 2016 until 2018, he served as chairman, and from 2018 to 2019 as non-executive director, of Kuros Biosciences Ltd.
+Added: Itin served as chief executive officer and chair of the board of directors at Cytos Biotechnology Ltd, a biotechnology company, from November 2012 until it merged with Kuros Biosurgery Holding Ltd in January 2016.
+Added: From January 2016 until June 2018, he served as chair of the board of directors, and from June 2018 to May 2019 as non-executive director, of Kuros Biosciences Ltd.
+Added: Prior to that, Dr.
Itin served as president, chief executive officer and director of Micromet, Inc., a biopharmaceutical company, from 2006 until it was acquired by Amgen Inc.
2 unchanged sentences
Itin was a co-founder of Zyomyx, a protein chip company.
−Removed: Itin also served as a non-executive director of Kymab Ltd., a privately held biopharmaceutical company, from 2012 until its sale to Sanofi in 2021.
+Added: Itin also served as a non- executive director of Kymab Ltd., a privately held biopharmaceutical company, from 2012 until its sale to Sanofi in April 2021.
Itin received a Diploma in Biology and a Ph.D.
−Removed: in Cell Biology summa cum laude from the University of Basel, Switzerland.
−Removed: In addition, he performed post-doctoral research at the Biocenter of University of Basel and at the Stanford University School of Medicine.
+Added: in Cell Biology from the University of Basel, Switzerland.
+Added: In addition, he also performed post-doctoral research at the Biocenter of University of Basel and at the Stanford University School of Medicine.
We believe that Dr.
Itin is qualified to serve on our board of directors because of his deep knowledge of our company and his extensive experience serving in executive and non-executive leadership positions at other public and private biotechnology companies.
−Removed: Table o f contents
−Removed: Robert Dolski has served as our Chief Financial Officer since August 2023.
−Removed: He previously served as Chief Financial Officer at Checkmate Pharmaceuticals from January 2021, until its acquisition by Regeneron Pharmaceuticals in May 2022, where he was responsible for investor relations, financial strategy and management.
−Removed: He served as Vice President, Finance at Akcea Therapeutics from May 2019, until its acquisition by Ionis Pharmaceuticals in October 2020, where he held similar finance responsibilities and supported the development and commercialization of several rare disease programs.
−Removed: Dolski served as Vice President, Head of Financial Planning and Analysis at Moderna Therapeutics from 2016 to May 2019, as Senior Director, Finance at Forum Pharmaceuticals, Inc., and as Vice President, Finance and Treasury at Human Genome Sciences, Inc., prior to its acquisition by GlaxoSmithKline.
−Removed: Dolski started his career as Director of Finance at Amgen Inc.
−Removed: He holds an MBA from The Wharton School of the University of Pennsylvania and a B.S..degree in civil engineering and strategic management from the University of Pennsylvania.
−Removed: Edgar Braendle, M.D., has served as our Chief Development Officer since July 2021.
−Removed: Prior to joining us, he served as Chief Medical Officer and Global Head of Development at Sumitomo Dainippon Pharma Oncology (“SDPO”) from July 2020 to July 2021, where he was responsible for leading the global oncology development programs.
−Removed: Prior to then, from October 2017 until July 2020, Dr.
−Removed: Braendle served as Executive Vice President, Head of Research and Development and Chief Medical Officer at Boston Biomedical Inc., where he led their discovery research and clinical strategies.
−Removed: He started his industry career at Schering AG.
−Removed: Braendle has a M.D and training in hematologic malignancies and solid tumor oncology, pharmacology and urology at the University of Aachen, University of Bonn, and the University of Ulm in Germany.
−Removed: David Brochu has served as our Senior Vice President, Chief Technical Officer since January 2021, having previously served as our Senior Vice President, Head of Product Delivery from October 2019 to January 2021 and as our Vice President of Technical Operations from March 2019 to October 2019.
+Added: Robert Dolski joined Autolus as Chief Financial Officer in August 2023.
+Added: He previously served as Chief Financial Officer at Checkmate Pharmaceuticals, from January 2021 until its acquisition by Regeneron Pharmaceuticals in May 2022 where he was responsible for investor relations and the Company’s financial strategy and management.
+Added: Prior to that he served as Vice President, Finance at Akcea Therapeutics, from May 2019 until its acquisition by Ionis Pharmaceuticals in October 2020, where he held similar finance responsibilities and supported the development and commercialization of several rare disease programs.
+Added: He previously held senior finance positions at Moderna Therapeutics from June 2016 to May 2019, Forum Pharmaceuticals, Inc., and Human Genome Sciences, Inc., prior to its acquisition by GlaxoSmithKline.
+Added: Dolski started his career at Amgen, Inc.
+Added: He holds an MBA from The Wharton School and a BSc in civil engineering and strategic management from the University of Pennsylvania.
+Added: David Brochu has served as our Senior Vice President, Chief Technical Officer since January 2021.
+Added: Prior to that, he served as our Senior Vice President, Head of Product Delivery from October 2019 to January 2021, and our Vice President of Technical Operations from March 2019 to October 2019.
Brochu previously served as vice president of technical operations and program head at Kedrion USA, leading, its next generation IVIG development and industrialization effort.
Prior to this, he was the vice president of plasma collection operations for Talecris Biotherapeutics (formerly Bayer HealthCare LLC), where he led the operations buildout in the Western United States.
−Removed: He previously held engineering and technical operations leadership roles at Bayer and Warner Lambert in the United States, EU and South America.
+Added: Prior to Talecris, Mr.
+Added: Brochu held engineering and technical operations leadership roles at Bayer and Warner Lambert in the United States, European Union and South America.
Brochu has over 30 years of operational and development experience.
He holds a B.S.
−Removed: degree in chemical engineering from Northeastern University.
−Removed: Martin Pulé, MBBS founded our predecessor company and has served as our Senior Vice President and Chief Scientific Officer since 2014.
−Removed: He also served as a member of our predecessor company’s board of directors from 2014 to 2018.
−Removed: Pulé has served as a clinical senior lecturer in the Department of Hematology at UCL Cancer Institute since 2010 and as an Honorary Consultant in Hematology at UCL Hospital since 2010.
+Added: in chemical engineering from Northeastern University.
+Added: Alex Driggs has served as our Senior Vice President, Legal Affairs and General Counsel since January 2024.
+Added: He joined the Company in August 2018 as Vice President, Legal Affairs and General Counsel.
+Added: Prior to joining Autolus, Mr.
+Added: Driggs served in roles of escalating responsibility at Sucampo Pharmaceuticals between May 2015 and February 2018.As Senior Vice President and General Counsel he oversaw all legal aspects of Sucampo’s acquisition by Mallinckrodt.
+Added: Earlier in his career, he served as Associate General Counsel for Micromet prior to its acquisition by Amgen and, following the acquisition, as Senior Counsel in the licensing transactions group at Amgen.
+Added: Driggs began his legal career as an associate in the Life Sciences and Technology Transactions groups at Cooley LLP.
+Added: He holds a J.D.
+Added: from the New York University School of Law and an A.B.
+Added: in Philosophy from Harvard University.
+Added: Miranda Neville has served as our Chief Project Officer since March 2025, having previously served as the Company’s Senior Vice President, Programme and Portfolio Management from July 2023 to March 2025, VP, Head of Programme and Portfolio Management from January 2023 to June 2023, VP, Global Operations & Delivery from October 2021 to January 2023, Executive Director, Global Head of Engineering from October 2020 to October 2021 and Senior Director, Global Engineering from November 2018 to September 2020.
+Added: Prior to joining Autolus, Ms.
+Added: Neville was a Partner at the consulting firm AllianceBio, where she spent four years supporting several clinical stage CDMO and commercial biopharmaceutical companies.
+Added: She started her career at Human Genome Sciences, Inc., where she spent ten years in a variety of roles including manufacturing, engineering & program management, prior to its acquisition by GlaxoSmithKline.
+Added: Neville holds a B.S.
+Added: in Biology from West Virginia University.
+Added: Martin Pulé, MBBS has served as our Senior Vice President, Founder and Chief Scientific Officer since August 2014.
+Added: He also served as a member of our board of directors from August 2014 to June 2018.
+Added: Pulé has served as a clinical senior lecturer in the Department of Haematology at University College London Cancer Institute since 2010 and been an Honorary Consultant in Haematology at University College London Hospital since 2010.
He entered the T cell engineering field in 2001 as a travelling Fulbright Scholar at the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston, Texas.
−Removed: Pulé holds an M.B.B.S.
−Removed: degree from University College Dublin and is a Fellow of the Royal College of Pathologists.
−Removed: Brent Rice has served as our Senior Vice President, Chief Commercial Officer since December 2021, having previously served as our Vice President, Chief Commercial Officer (US) from June 2020 to December 2021 and as our Vice President, Global Market Access from October 2018 to June 2020.
+Added: Pulé holds an MBBS from University College Dublin and is a Fellow of the Royal College of Pathologists.
+Added: Brent Rice has served as our Senior Vice President, Chief Commercial Officer & Site Head (US) since December 2021, having previously served as our Vice President, Chief Commercial Officer (US) from June 2020 to December 2021 and our Vice President, Global Market Access from October 2018 to June 2020.
Previously, Mr.
−Removed: Rice served as the Head of Managed Markets for Juno Therapeutics from 2017 to 2018, where he was responsible for building its payer, access and reimbursement strategy and capability.
−Removed: Prior to joining Juno Therapeutics, Mr.
−Removed: Rice served with Amgen Inc.
−Removed: from 1999 to 2017 in positions of escalating responsibility, where he supported Amgen’s portfolio of products through partnerships and life cycle management.
−Removed: Rice holds a B.A.
−Removed: degree in Russian Studies from the University of California at Los Angeles and an M.B.A.
+Added: Rice served as the Head of Managed Markets for Juno Therapeutics, from November 2017 to August 2018, where he was responsible for building their Payer, Access and Reimbursement strategy and capability.
+Added: Prior to joining Juno Therapeutics, Brent spent 18 years with Amgen from December 1999 to October 2017 in positions of escalating responsibility, where he was recognized as a strong cross-functional leader supporting Amgen’s portfolio of products through innovative partnerships and life cycle management.
+Added: Brent holds a B.A.
+Added: in Russian Studies from the University of California at Los Angeles and an M.B.A.
from the University of Denver.
−Removed: Alexander Swan has served as our Chief Human Resources Officer since January 2023, having previously served as our Senior Vice President, Human Resources from October 2021 to January 2023 and as our Vice President, Human Resources from May 2018 to October 2021.
−Removed: Prior to joining our company, he was EMEA Head of Human Resources for Kite Pharma, where he was responsible for all aspects of human resources, including talent management, organization development, policy and procedure development and compensation and benefits.
+Added: Alexander Swan has served as our Chief Human Resources Officer since January 2023.
+Added: Swan joined Autolus in May 2018 as our Vice President, Human Resources and was promoted to Senior Vice President, Human Resources in October 2021.
+Added: Prior to joining Autolus, he was EMEA Head of Human Resources for Kite where he was responsible for all aspects of HR, ranging from talent management, organization development, policy and procedure development and compensation and benefits.
Previously Mr.
Swan was involved in a number of start-up companies, including Amryt Pharmaceuticals, Taiho Oncology and Aegerion Pharmaceuticals.
+Added: In these roles, he specialized in start-up strategies and processes for HR.
From 2004 to 2012, Mr.
Swan was responsible for developing and leading all HR associated activities for Celgene in EMEA.
−Removed: He has also held a number of positions within local government and the UK National Health Service, helping strategically with talent acquisition and organization development.
+Added: He has also held a number of positions within local government and NHS, helping strategically with talent acquisition and organization development.
Swan holds a Master’s degree in Law from the University of Leicester and is also a Fellow of the Chartered Institute of Personnel and Development.
−Removed: Table o f contents
−Removed: Christopher Vann has served as our Senior Vice President, Chief Operating Officer since 2016.
−Removed: Prior to joining us, he worked at Hoffmann-La Roche’s Swiss headquarters from 1994 to 2016, most recently serving as its commercial director from 2011 to 2016, where he was primarily responsible for leading the lung cancer commercial team and general management of the Tarceva brand.
−Removed: Vann has significant experience in global lifecycle management of oncology products as well as implementing marketing strategy at a regional and national level.
−Removed: This includes launching several oncology, immunology and transplant products in the United States, United Kingdom, Romania, Russia, South Africa and countries in Asia, including Japan.
+Added: Christopher Vann has served as our Senior Vice President, Chief Operating Officer since October 2016.
+Added: Prior to joining us, he worked at Hoffmann-La Roche’s Swiss headquarters from February 1994 to September 2016, most recently serving as its commercial director from December 2011 to September 2016 where he was primarily responsible for leading the lung cancer commercial team and general management of the Tarceva brand.
+Added: Vann has significant experience of global lifecycle management of oncology products as well as implementing marketing strategy at a regional and national level.
+Added: This includes supporting the launch of several oncology, immunology and transplant products in the United States, United Kingdom, Romania, Russia, South Africa and Asia.
Vann holds a B.S.
−Removed: degree in Toxicology and Pharmacology from the School of Pharmacy, University of London.
+Added: in Toxicology and Pharmacology from the School of Pharmacy, University of London.
+Added: Matthias Will, M.D., has served as our Chief Development Officer since September 2024.
+Added: Previously, he served as Chief Medical Officer at the privately held biotech company, Dren Bio, Inc., During his tenure, Matthias led the expansion of the clinical team and oversaw the submission of two INDs for candidates to potentially treat hematologic cancers.
+Added: Prior to that, he served as Vice President of Clinical Development for CRISPR Therapeutics where he led the development of their allogeneic CAR T programs targeting CD70 in T-cell lymphomas and renal cell carcinoma and the early stage CD70-NK cell program in collaboration with NKarta Inc.
+Added: Previously, Dr.
+Added: Will was in charge of clinical development at CytomX Therapeutics Inc.
+Added: and held roles of increasing responsibility in clinical development at Gilead Sciences, Inc.
+Added: and Novartis Oncology.
+Added: Earlier in his career, he served at McKinsey & Company, where he strategically advised clients in the pharmaceutical industry.
+Added: Will received his Medical Degree from the Hannover Medical School and his training in hematology/oncology at the University of Tȕbingen, Germany.
Christopher Williams, Ph.D.
has served as our Chief Business Officer since January 2024.
−Removed: Prior to this role, he served as Senior Vice President, Corporate Development from October 2021 to February 2024, and as Vice President, Global Head of Business Development from December 2018 to October 2021.
−Removed: Williams was part of the team that founded our predecessor company in 2014 and he initially served as a non-executive director of Autolus Limited.
−Removed: In 2016, he transitioned to establish our business development function as Director, Business Development.
−Removed: He previously worked at UCL Business, where he led the establishment of strategic collaborations, licensing deals, new companies, and financing transactions across a portfolio of cell and gene therapies in oncology and rare diseases.
−Removed: He served as non-executive director of Orchard Therapeutics, a company he founded during his tenure at UCL Business, and has worked in business development roles at Thiologics, Canbex and Eli Lilly.
+Added: Prior to this role, he served as Senior Vice President, Corporate Development from October 2021 until February 2024, and as Vice President, Global Head of Business Development from December 2018 until October 2021.
+Added: Williams was part of the team that founded Autolus Limited, our predecessor entity, in 2014 and he initially served as a non-executive director of Autolus Limited.
+Added: In 2016, he transitioned into the Company to establish our business development function as Director, Business Development.
+Added: Previously, he worked at UCL Business where he led the establishment of strategic collaborations, licensing deals, new companies, and financing transactions across a portfolio of cell and gene therapies in oncology and rare diseases.
+Added: Prior to that, he served as non-executive director of Orchard Therapeutics Limited, another company he founded during his tenure at UCL Business, and has worked in business development roles at Thiologics, Canbex and Eli Lilly.
He has also worked in research roles at GSK, Inpharmatica and Imperial College London.
Williams holds a Ph.D.
−Removed: in Biochemistry from Imperial College London and a B.Sc.
−Removed: degree in Genetics from Cardiff University.
+Added: in Biochemistry from Imperial College London and a BSc in Genetics from Cardiff University.
Non-Executive Directors
−Removed: Johnson was appointed as Chairman of our board of directors in September 2021.
−Removed: Since May 2022, he has served as the Chief Executive Officer and a non-executive director of Reaction Biology, a provider of drug discovery services.
−Removed: Previously, he served as Chief Executive Officer of Strongbridge Biopharma plc, between July 2020 and October 2021, until its acquisition by Xeris Biopharma Holdings.
−Removed: Since October 2021, he has served as a non-executive director for Xeris.
−Removed: He previously served as chairman of Strongbridge’s board of directors from 2015 until November 2019 and Executive Chairman from November 2019 until July 2020.
−Removed: Additionally, he has served as a member of the board of directors of Verastem, Inc.
−Removed: since April 2020, and Axogen, Inc.
−Removed: since July 2021.
−Removed: Johnson served as a board member of Melinta Pharmaceuticals, Inc.
−Removed: through September 2019, having served as Chief Executive Officer from February 2019 through August 2019 and as interim Chief Executive Officer from October 2018 through February 2019.
−Removed: Johnson is the former lead independent director of Sucampo Pharmaceuticals, Inc., from 2016 until 2018, and a former director of Histogenics Corporation, from 2013 until 2019, AVEO Pharmaceuticals, Inc., from 2018 until 2019, and Portola Pharmaceuticals, Inc., from 2014 until 2020.
−Removed: From July 2018 to November 2018, Mr.
−Removed: Johnson served as an interim executive officer of Portola.
−Removed: He is a recognized leader in the biopharmaceutical industry with more than 30 years of experience at leading global organizations, including Johnson & Johnson, Eli Lilly & Company, ImClone, and Pfizer, Inc.
−Removed: Johnson previously served on the board of directors of Pharmaceutical Research and Manufacturers of America (PhRMA), the Health Section Governing Board of Biotechnology Industry Organizations (BIO), and BioNJ, and holds a B.S.
−Removed: degree from East Stroudsburg University of Pennsylvania.
+Added: Michael Bonney has served on our board of directors since April 2024.
+Added: He currently serves as a director of Alnylam Pharmaceuticals, Inc., a role he has held since December 2014.
+Added: He previously served as chair of the board of directors of Alnylam from December 2015 to August 2021 and as its executive chair from August 2021 to January 2023.
+Added: Bonney previously served as the chair of the board of directors of Kaleido Biosciences, Inc., a biotechnology company, from June 2017 until August 2021.
+Added: Between August 2018 and October 2020, he served as Kaleido’s executive chair and served as Kaleido’s Chief Executive Officer from June 2017 until August 2018.
+Added: Bonney was a Partner at Third Rock Ventures, a healthcare venture firm, from January 2016 to July 2016.
+Added: Bonney previously served as the Chief Executive Officer and a member of the board of directors of Cubist Pharmaceuticals, Inc., a biopharmaceutical company (now a wholly owned subsidiary of Merck & Co., Inc.), from June 2003 until his retirement in December 2014.
+Added: From January 2002 to June 2003, he served as Cubist’s President and Chief Operating Officer.
+Added: Bonney previously served as the chair of the board of directors of Magenta Therapeutics, Inc.
+Added: and as a director of Bristol-Myers Squibb Company, Celgene Corporation (which was acquired by Bristol-Myers Squibb), Syros Pharmaceuticals, Inc.
+Added: and Sarepta Therapeutics, Inc.
+Added: Bonney holds a B.A.
+Added: in economics from Bates College.
We believe that Mr.
−Removed: Johnson is qualified to serve on our board of directors because of his extensive experience with life science companies.
+Added: Bonney is qualified to serve on our board of directors because of his experience serving in leadership positions at a wide variety of biotechnology companies.
Joseph Anderson, Ph .
−Removed: has served on our board of directors since 2016.
−Removed: He is a Partner at Sofinnova Partners, an investment firm that he joined in October 2020.
−Removed: He served as the chief executive officer and a member of the board of directors of Arix Bioscience plc, a global life sciences company, from 2016 to 2020.
−Removed: He has founded and managed public equity funds and served as a member of the following boards of directors:
−Removed: Algeta ASA (acquired by Bayer AG) from 2009 to 2013, Amarin plc from October 2009 to 2013, Cytos Biotechnology Ltd, a biotechnology company, from 2012 until it merged with Kuros Biosurgery Holding Ltd in 2016, and Epigenomics AG from 2012 to 2014.
−Removed: He was a partner at Abingworth LLP, an international investment group dedicated to the life sciences and healthcare sectors, from 2004 to 2015.
−Removed: From 1999 to 2003, Dr.
−Removed: Anderson served at First State Investments in London, part of the Commonwealth Bank of Australia, where he was head of global healthcare equities and portfolio manager.
−Removed: He was a pharmaceuticals analyst at the investment bank Dresdner Kleinwort Benson from 1998 to 1999.
+Added: has served on our board of directors since February 2016.
+Added: He is a Partner at Sofinnova Partners, which he joined in October 2020.
+Added: Previously, he was the Chief Executive Officer and a member of the board of directors of Arix Bioscience plc, a global life sciences investment company, where he held similar positions since January 2016.
+Added: He has founded and managed public equity funds and been a member of the following boards of directors:
+Added: Algeta ASA (acquired by Bayer AG) from 2009 to 2013, Amarin plc from October 2009 to 2013, Cytos Biotechnology Ltd, a biotechnology company, from 2012 until it merged with Kuros Biosurgery Holding Ltd in January 2016 and Epigenomics AG from 2012 to 2014.
+Added: He was a partner at Abingworth LLP, an international investment group dedicated to the life sciences and healthcare sectors, from January 2004 through December 2015.
+Added: From October 1999 through December 2003, Dr.
+Added: Anderson was at First State Investments in London, part of the Commonwealth Bank of Australia, where he was the head of global healthcare equities and a portfolio manager.
+Added: Prior to this, he was a pharmaceuticals analyst at the investment bank Dresdner Kleinwort Benson from June 1998 through October 1999.
From 1990 to 1998, Dr.
Anderson established and was head of the strategy unit at The Wellcome Trust, one of the world’s largest medical foundations.
−Removed: He currently serves as a non-executive director of RedX Pharma plc and F2G Limited.
−Removed: Anderson holds a Ph.D.
−Removed: in Biochemistry from the University of Aston and a B.S.
−Removed: degree in Biological Science from Queen Mary College, University of London.
+Added: He currently serves as a non-executive director of F2G Limited and previously served as a non-executive director of RedX Pharma plc between September 2023 and May 2024.
+Added: Anderson holds a Doctor of Philosophy in Biochemistry from the University of Aston and a Bachelor of Science in Biological Science from Queen Mary College, University of London.
We believe that Dr.
−Removed: Anderson is qualified to serve on our board of directors because of his extensive experience with life science companies.
−Removed: Table o f contents
+Added: Anderson is qualified to serve on our board of directors because of his extensive experience serving on boards of directors of various life science companies.
Robert Azelby has served on our board of directors since January 2024.
−Removed: He most recently served as President and Chief Executive Officer of Eliem Therapeutics Inc., between October 2020 and February 2023.
+Added: Azelby served as President and Chief Executive Officer of Eliem Therapeutics, Inc., a biopharmaceutical company, from October 2020 to February 2023.
Prior to Eliem, he served as the Chief Executive Officer of Alder BioPharmaceuticals, Inc.
−Removed: from 2018 until its acquisition by H.
+Added: from June 2018 until its acquisition by H.
Lundbeck A/S in October 2019.
−Removed: Azelby served as Executive Vice President, Chief Commercial Officer of Juno Therapeutics, Inc.
−Removed: from 2015 through its acquisition by Celgene in 2018.
+Added: Azelby previously served as Executive Vice President, Chief Commercial Officer of Juno Therapeutics, Inc.
+Added: from 2015 through its acquisition by Celgene in March 2018.
Earlier, during a 15-year tenure at Amgen, Mr.
Azelby served in commercial roles including Vice President and General Manager of Amgen Oncology, Vice President of Oncology Sales, Vice President of the Commercial Effectiveness Unit and General Manager of Amgen Netherlands.
−Removed: He currently serves on the Board of Directors at ADC Therapeutics SA, since June 2023, and also served on the Board of Directors of Chinook Therapeutics Inc.
+Added: He currently serves as a non-executive director of ADC Therapeutics SA since June 2023, and of Cardinal Health since March 2024.
+Added: Azelby previously served on the Board of Directors of Chinook Therapeutics Inc.
between April and August 2023, Clovis Oncology Inc.
−Removed: from 2018 until July 2023, Eliem Therapeutics Inc.
−Removed: from 2020 until February 2023, Alder BioPharmaceuticals Inc.
−Removed: from 2018 until November 2019, and Immunomedics, Inc.
+Added: from October 2018 until July 2023, Eliem Therapeutics Inc.
+Added: from October 2020 until February 2023, Alder BioPharmaceuticals Inc.
+Added: from June 2018 until November 2019, and Immunomedics, Inc.
from February 2020 to October 2020.
−Removed: He holds a B.A.
−Removed: degree in Economics and Religious Studies from the University of Virginia and an MBA from Harvard Business School.
+Added: He holds a BA in Economics and Religious Studies from the University of Virginia and an MBA from Harvard Business School.
We believe that Mr.
Azelby is qualified to serve on our board of directors because of his broad experience in our industry, his commercial and management background and his track record of effective leadership.
−Removed: Linda Bain has served on our board of directors since 2018.
−Removed: She currently serves as the Chief Operating Officer and Chief Financial Officer of Mariana Oncology, Inc., positions she has held since May 2023.
+Added: Linda Bain has served on our board of directors since June 2018.
+Added: Since May 2023, she has served as the chief operating officer and chief financial officer of Mariana Oncology, a Novartis Company as of May 2024.
She has also served as a non-executive director of Arvinas, Inc.
−Removed: since June 2020 and Hemab Therapeutics since January 2022.
−Removed: Between July 2021 and September 2022, Ms.
−Removed: Bain served as a non-executive director for VBI Vaccines, Inc.
+Added: since June 2020, Hemab Therapeutics since January 2022, and VBI Vaccines, Inc.
+Added: between July 2021 and September 2022.
Prior to joining Mariana Oncology, Ms.
Bain served as the chief financial officer of Codiak BioSciences, Inc.
−Removed: from 2015 to April 2023 and Chief Financial Officer and treasurer of Avalanche Biotechnologies, Inc.
−Removed: from 2014 to 2015.
−Removed: Bain served at Bluebird bio, Inc., a gene therapy biotechnology company, as vice president of finance and business operations from 2011 to 2014, and Chief Accounting Officer and treasurer from 2013 to 2014.
−Removed: From 2008 to 2011, Ms.
+Added: between December 2015 and April 2023 and chief financial officer and treasurer of Avalanche Biotechnologies, Inc.
+Added: from April 2014 until November 2015.
+Added: Previously, Ms.
+Added: Bain served at bluebird bio, Inc., a gene therapy biotechnology company, as vice president of finance and business operations from October 2011 to March 2014, and chief accounting officer and treasurer from June 2013 to March 2014.
+Added: From September 2008 to September 2011, Ms.
Bain served as vice president of finance at Genzyme Corporation.
−Removed: From 2007 to 2008, she served as vice president at Fidelity Investments, and from 2000 to 2007, she held a number of positions at AstraZeneca plc.
+Added: From September 2007 to September 2008, she served as vice president at Fidelity Investments, and from May 2000 to September 2007, she held a number of positions at AstraZeneca plc.
She received her B.S.
3 unchanged sentences
Bain is qualified to serve on our board of directors because of her extensive experience in our industry, her background in accounting and finance and her leadership skills.
−Removed: John Berriman has served on our board of directors since 2014.
−Removed: He has served as chairman of the board of directors of Depixus SAS since 2015, and Autifony Therapeutics Ltd.
−Removed: He previously served as chairman of the board of directors of Confo Therapeutics NV, between 2016 and August 2023, ReNeuron Group plc between 2015 and September 2020, Heptares Therapeutics Ltd from 2007 until its acquisition by Sosei Group in 2015, Algeta ASA from 2004 through its listing on the Oslo Stock Exchange in 2007 (and subsequently served as deputy chairman from 2008 until it was sold to Bayer AG in 2014), and as a director of Micromet, Inc.
−Removed: from 2006 until it was sold to Amgen Inc.
−Removed: From 1997 to 2004, he was a director of Abingworth Management, an international healthcare venture capital firm, where he was involved in founding, financing and serving as a director of several biotechnology companies in Europe and the United States, many of which obtained listings on public stock exchanges.
+Added: John Berriman has served on our board of directors since August 2014.
+Added: He has served as chair of the board of directors of Autifony Therapeutics Ltd since 2011.
+Added: He previously served as chair of the board of directors of Depixus SAS between December 2015 and August 2024, Confo Therapeutics NV between December 2016 and August 2023, ReNeuron Group plc between April 2015 and September 2020, Heptares Therapeutics Ltd from 2007 until it was sold to Sosei Group in February 2015, Algeta ASA from 2004 through its listing on the Oslo Stock Exchange in 2007 (and subsequently served as deputy chair from 2008 until it was sold to Bayer AG in 2014), and as a director of Micromet, Inc.
+Added: from May 2006 until it was sold to Amgen Inc.
+Added: Prior to this, from 1997 to 2004, he was a director of Abingworth Management, an international healthcare venture capital firm, where he was involved in founding, financing and serving as a director of several biotechnology companies in Europe and the United States, many of which obtained listings on public stock exchanges.
Prior to that, Mr.
Berriman spent 14 years with Celltech Group plc and was a member of its board when it listed on the London Stock Exchange in 1994.
−Removed: He holds a M.S.
−Removed: in Chemical Engineering from the University of Cambridge and an M.B.A.
+Added: He holds a Master’s degree in Chemical Engineering from the University of Cambridge and an M.B.A.
from the London Business School.
1 unchanged sentence
Berriman is qualified to serve on our board of directors because of his extensive experience in our industry, including his strategic management and operational experience, his experience serving on public company boards and his experience with public offerings, private investments and mergers.
−Removed: Cynthia Butitta has served on our board of directors since 2018.
−Removed: Butitta served as the executive vice president and chief financial officer of Kite Pharma Inc., a biopharmaceutical company, from 2014 to 2016 and as its chief operating officer from 2014 to 2017.
−Removed: From 2011 to 2012, she served as senior vice president and chief financial officer at NextWave Pharmaceuticals, Inc., a specialty pharmaceutical company.
−Removed: Butitta served as chief operating officer of Telik, Inc., a biopharmaceutical company, from 2001 to 2010 and as its chief financial officer from 1998 to 2010.
+Added: Cynthia Butitta has served on our board of directors since March 2018.
+Added: Butitta served as the executive vice president and chief financial officer of Kite Pharma Inc., a biopharmaceutical company, from January 2014 to May 2016 and as its chief operating officer from March 2014 to September 2017.
+Added: From May 2011 to December 2012, she served as senior vice president and chief financial officer at NextWave Pharmaceuticals, Inc., a specialty pharmaceutical company.
+Added: Prior to that, Ms.
+Added: Butitta served as chief operating officer of Telik, Inc., a biopharmaceutical company, from March 2001 to December 2010 and as its chief financial officer from August 1998 to December 2010.
+Added: Butitta also served as principal accounting officer of Telik, Inc.
+Added: until December 2010.
She has served as a member of the board of directors of UroGen Pharma Ltd.
−Removed: since 2017, Olema Pharmaceuticals Inc.
−Removed: since 2020 and Century Therapeutics since 2021 .
+Added: since October 2017, Olema Pharmaceuticals Inc.
+Added: since August 2020 and Century Therapeutics since February 2021.
Butitta holds a B.S.
−Removed: degree with honors in Business and Accounting from Edgewood College in Madison, Wisconsin and an M.B.A.
+Added: with honors in Business and Accounting from Edgewood College in Madison, Wisconsin and an M.B.A.
in Finance from the University of Wisconsin, Madison.
1 unchanged sentence
Butitta is qualified to serve on our board of directors because of her extensive financial and operational experience within the biotechnology and high-technology industries, as well as her leadership skills.
−Removed: Table o f contents
Robert Iannone, M.D., M.S.C.E.
has served on our board of directors since June 2023.
−Removed: Since May 2019, he has served as Executive Vice President, Global Head of Research & Development of Jazz Pharmaceuticals plc., and also served as its Chief Medical Officer from December 2019 until October 2021.
+Added: Since May 2019, he has served as the Executive Vice President, Global Head of Research and Development at Jazz Pharmaceuticals plc, and as their Chief Medical Officer from December 2019 until October 2021.
From April 2018 until May 2019, Dr.
Iannone served as Head of Research and Development and Chief Medical Officer of Immunomedics, Inc., a biopharmaceutical company.
−Removed: From 2014 to 2018, he served as Senior Vice President and Head of Immuno-oncology, Global Medicines Development, and the Global Products Vice President at AstraZeneca plc.
+Added: Prior to that, from July 2014 to April 2018, Dr.
+Added: Iannone served in the roles of Senior Vice President and Head of Immuno-oncology, Global Medicines Development and the Global Products Vice President at AstraZeneca plc, a global science-led biopharmaceutical company.
From 2004 to 2014, Dr.
−Removed: Iannone held several management roles at Merck & Co., Inc., culminating in his role as Executive Director and Section Head of Oncology Clinical Development.
−Removed: Before joining industry, Dr.
−Removed: Iannone was Assistant Professor of Pediatrics at the University of Pennsylvania School of Medicine.
−Removed: He has served on the board of directors of iTeos Therapeutics, Inc., a clinical-stage biopharmaceutical company, since May 2021, and previously served on the Board of Jounce Therapeutics between January 2020 and its acquisition by Concentra Biosciences in May 2023.
−Removed: He has served on the Cancer Steering Committee of the Foundation for the National Institutes of Health since 2011.
−Removed: Iannone received an B.S.
−Removed: degree from The Catholic University of America, an M.D.
+Added: Iannone served in management roles at Merck Co., Inc., a global biopharmaceutical company, culminating in his role as Executive Director and Section Head of Oncology Clinical Development.
+Added: From 2001 to 2004, he served as Assistant Professor of Pediatrics and from 2004 to 2012 as Adjunct Assistant Professor of Pediatrics at the University of Pennsylvania School of Medicine.
+Added: Iannone has been serving on the board of directors of iTeos Therapeutics, Inc., a clinical-stage biopharmaceutical company, since May 2021, and on the Cancer Steering Committee of the Foundation for the National Institutes of Health since 2011.
+Added: He also served as a director of Jounce Therapeutics, Inc., a clinical-stage immunotherapy company, between January 2020 and its acquisition by Concentra Biosciences in May 2023.
+Added: Iannone received a B.S.
+Added: from The Catholic University of America, an M.D.
from Yale University and an M.S.C.E.
−Removed: from the University of Pennsylvania.
−Removed: He completed his Residency and Chief Residency in Pediatrics and a Fellowship in Pediatric Hematology-Oncology at Johns Hopkins University.
+Added: from University of Pennsylvania and completed his residency in Pediatrics and fellowship in Pediatric Hematology-Oncology at Johns Hopkins University.
We believe that Dr.
1 unchanged sentence
Elisabeth Leiderman, M.D, has served on our board of directors since December 2023.
−Removed: She most recently served as the Chief Financial Officer and Chief Business Officer of Atsena Therapeutics, a clinical-stage gene therapy company focused on reversing and preventing blindness, from November 2022 until November 2023.
−Removed: From September 2020 until October 2022, she served as Chief Financial Officer and Head of Corporate Development for Decibel Therapeutics, a clinical-stage biotechnology company developing novel gene therapeutics for restoration of hearing loss and balance disorders.
−Removed: Before joining Decibel, from January 2020 to August 2020, Dr.
+Added: She has served as the Chief Financial & Corporate Development Officer for Dewpoint Therapeutics since June 2024.
+Added: She previously served as Chief Financial Officer and Chief Business Officer at Atsena Therapeutics, a clinical-stage gene therapy company, between November 2022 and November 2023.
+Added: Before joining Atsena, from September 2020 to October 2022, Dr.
+Added: Leiderman was Chief Financial Officer and Head of Corporate Development at Decibel Therapeutics, a clinical stage biotechnology company developing novel gene therapeutics for restoration of hearing loss and balance disorders.
+Added: From January 2020 to August 2020, Dr.
Leiderman served as Chief Business Officer for Complexa, Inc., a clinical stage biopharmaceutical company focused on life-threatening fibrosis and inflammatory diseases.
−Removed: Prior to Complexa, she served as Senior Vice President, Head of Corporate Development at Fortress Biotech from 2016 to 2019.
−Removed: Leiderman is currently a member of the board of directors and chair of the audit committee of bluebird bio, Inc., a position she has held since October 2021.
+Added: Prior to Complexa, Dr.
+Added: Leiderman was Senior Vice President, Head of Corporate Development at Fortress Biotech from November 2016 to November 2019.
Earlier in her career from 2007 to 2016, Dr.
−Removed: Leiderman developed transaction and capital markets expertise in the healthcare investment banking groups at Nomura, Credit Suisse, Jefferies and UBS.
+Added: Leiderman developed her transaction and capital markets expertise in the healthcare investment banking groups at Nomura, Credit Suisse, Jefferies and UBS.
Leiderman began her career in medical affairs at AstraZeneca, where she analyzed product and industry trends related to the central nervous system.
−Removed: Leiderman holds an M.D.
+Added: Leiderman earned an M.D.
from the Sackler School of Medicine at Tel Aviv University, an M.B.A.
from The Wharton School at the University of Pennsylvania and a B.A.
−Removed: degree from the University of Pennsylvania.
+Added: from The University of Pennsylvania.
We believe that Dr.
1 unchanged sentence
Martin Murphy, Ph.D.
−Removed: has served on our board of directors since 2014.
−Removed: He served as Chair of Syncona Investment Management Limited, part of the global life science company Syncona Ltd., from January 2023 until November 2023 and as the chief executive officer of Syncona Investment Management Limited from 2016 until December 2022, and he founded Syncona Partners LLP and served as its chief executive officer from 2012 to 2016.
−Removed: He was a partner at MVM Life Science Partners LLP, a venture capital company focused on life science and healthcare investments, from 2003 to 2012.
+Added: has served on our board of directors since September 2014.
+Added: He served as Chair of Syncona Investment Management Limited, part of the global life science company Syncona Ltd., from January 2023 until November 2023, as the chief executive officer of Syncona Investment Management Limited from December 2016 until December 2022, and founded Syncona Partners LLP and served as its chief executive officer from May 2012 to December 2016.
+Added: Prior to that, he was a partner at MVM Life Science Partners LLP, a venture capital company focused on life science and healthcare investments, from 2003 to 2012.
During his time at MVM, Dr.
2 unchanged sentences
Murphy worked at 3i Group plc and McKinsey & Company.
+Added: Since January 2025, Dr.
+Added: Murphy has served as a non-executive director of Synairgen plc, a specialist respiratory biotech company listed on the London Stock Exchange.
He has a Ph.D.
2 unchanged sentences
Murphy is qualified to serve on our board of directors because of his extensive experience as an investor, particularly in the life sciences industry.
+Added: Ravi Rao, M.D,.
+Added: has served on our board of directors since April 2024.
+Added: He currently serves as Chief Medical Officer of Sitryx Therapeutics, having joined the company in April 2022.
+Added: He was previously Chief Medical Officer at Oxford Biomedica, between April 2022 and November 2023, and Head of Research and Development and Chief Medical Officer at Swedish Orphan Biovitrum, where he led the development of several medicines in rare diseases across immunology and hematology, between September 2020 and February 2022.
+Added: Before that, he worked at Roche Genentech and GlaxoSmithKline.
+Added: Rao also serves as on the board of directors of DBV Technologies SA.
+Added: Rao is an accredited rheumatologist and was an academic physician-scientist at Imperial College (London).
+Added: He is a Member of the Royal College of Physicians, London and an Honorary Member of the Faculty of Pharmaceutical Medicine.
+Added: He received his MB.
+Added: BChir from Cambridge University and his Ph.D.
+Added: in vascular biology from Imperial College, completing a postdoctoral fellowship at Harvard Medical School.
+Added: We believe that Dr.
+Added: Rao is qualified to serve on our board of directors because of his experience leading the development of drug pipelines at several biopharmaceutical companies
has served on our board of directors since November 2021 and was appointed to our board of directors as Blackstone’s designee pursuant to the terms of the collaboration and financing agreement we entered into with Blackstone in November 2021.
−Removed: He has served as a Senior Advisor to the Blackstone Life Sciences group since 2018, following Blackstone’s acquisition of Clarus Ventures.
−Removed: Young became a Venture Partner with Clarus in 2010 after serving as Chief Executive Officer of Monogram Biosciences, from 1999 until the sale of the company to LabCorp in 2009.
−Removed: Prior to then, he was at Genentech for 19 years, serving in various positions of increasing responsibility, most recently serving as Chief Operating Officer, and was responsible for all of the biotechnology company's development, operations and commercial functions.
−Removed: Prior to Genentech, Mr.
−Removed: Young was at Eli Lilly and Company for 14 years.
−Removed: Young has served as chairman of the board of directors of Nanostring Technologies since 2010 and as a non-executive director of Praxis Precision Medicine since 2016.
−Removed: Previously he served on the board of directors of Theravance Biopharma between 2013 and 2014 and as its lead independent director between 2014 and May 2023, and as a director of Vertex Pharmaceuticals from 2014 until 2020.
−Removed: Young received his B.S degree in chemical engineering from Purdue University, his MBA from Indiana University and an honorary doctorate in engineering from Purdue University.
+Added: He is a Senior Advisor to the Blackstone Life Sciences group since November 2018, following Blackstone’s acquisition of Clarus Ventures.
+Added: Young became a Venture Partner with Clarus in 2010 after serving as CEO of Monogram Biosciences, a leader in personalized medicine, from 1999 through to the sale of the company to LabCorp in 2009.
+Added: Prior to Monogram he was at Genentech since 1980 in positions of increasing responsibility, including COO, responsible for all of the biotechnology company's development, operations and commercial functions.
+Added: Prior to Genentech, Dr.
+Added: Young was at Eli Lilly and Company for fourteen years.
+Added: Young has served as a non-executive director of Praxis Precision Medicine since December 2016, of SFJ Pharma since July 2014 and of Satellite Bio since July 2022.
+Added: He also served as chair of the board of directors of Nanostring Technologies from January 2010 until April 2024, as a non-executive director of Theravance Biopharma between October 2013 and April 2014, and as its lead independent director between April 2014 and May 2023.
+Added: Previously he was chair of the board of directors of Biogen (NASDAQ:
+Added: BIIB) and served on the Board of Directors of BioMarin Pharmaceutical and Vertex Pharmaceuticals.
+Added: Young received his Bachelor's degree in chemical engineering from Purdue University, his MBA from Indiana University and an honorary doctorate in engineering from Purdue University.
In 1993 he was elected to the National Academy of Engineering for his leadership in research, development and manufacturing of recombinant proteins using recombinant DNA technology.
+Added: He is the founder of the Young Institute for the Advanced Manufacturing of Pharmaceuticals at Purdue University and a member of the Institute’s Advisory Counsel.
We believe that Dr.
Young is qualified to serve on our board of directors because of his extensive experience in the life sciences industry.
−Removed: Table o f contents
Board Diversity
The table below provides certain information regarding the diversity of our board of directors as of March 20, 2025.
−Removed: Our 2023 Board Diversity Matrix is included in our Annual Report on Form 20-F, filed with the SEC on March 7, 2023.
+Added: Our 2024 Board Diversity Matrix is included in our Annual Report on Form 10-K, filed with the SEC on March 21, 2024.
Board Diversity Matrix
14 unchanged sentences
If we make any amendment to the Code of Ethics or grant any waivers, including any implicit waiver, from a provision of the Code of Ethics, we will disclose the nature of such amendment or waiver on our website to the extent required by the rules and regulations of the SEC.
−Removed: If a waiver or amendment of the Code of Ethics applies to our principal executive officer, principal financial officer, principal accounting officer or controller and relates to standards promoting any of the values described in Item 16B of Form 20-F, we are required to disclose such waiver or amendment on our website.
+Added: Insider Trading Policy
+Added: Our board of directors has adopted an Insider Trading Policy that governs all transactions involving our securities by directors, officers, employees, consultants, and contractors and is reasonably designed to promote compliance with any insider trading laws, rules and regulations, and listing standards applicable to us.
+Added: A copy of our Insider Trading Policy is filed as Exhibit 19.1 to this Annual Report.
Composition of Our Board of Directors
−Removed: Our board of directors presently has eleven members.
+Added: Our board of directors presently has twelve members.
As a foreign private issuer, under the listing requirements and rules of Nasdaq, we are not required to have independent directors on our board of directors, except that our audit committee is required to consist fully of independent directors, subject to certain phase-in schedules.
However, our board of directors has determined that Drs.
−Removed: Anderson, Iannone, Leiderman and Murphy, Mses.
+Added: Anderson, Iannone, Leiderman, Murphy, Rao and Young, Mses.
Butitta and Bain and Messrs.
−Removed: Azelby, Berriman, Johnson and Young representing ten of our eleven directors, do not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of director and that each of these directors is “independent” as that term is defined under Nasdaq rules.
+Added: Azelby, Berriman, and Bonney representing eleven of our twelve directors, do not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of director and that each of these directors is “independent” as that term is defined under Nasdaq rules.
Pursuant to the BioNTech Letter Agreement, BioNTech received the right to nominate a director to the Company’s board of directors.
5 unchanged sentences
Our directors are divided among the three classes as follows:
−Removed: • Class I, which consists of Joseph Anderson, Martin Murphy and Robert Iannone vacancy, whose terms will expire at our 2025 annual general meeting;
−Removed: • Class II, which consists of John Johnson, Robert Azelby, John Berriman and Elisabeth Leiderman, whose terms will expire at our 2026 annual general meeting;
+Added: • Class I, which consists of Ravi Rao, Joseph Anderson, Martin Murphy and Robert Iannone, whose terms will expire at our 2025 annual general meeting;
+Added: • Class II, which consists of Michael Bonney, Robert Azelby, John Berriman and Elisabeth Leiderman, whose terms will expire at our 2026 annual general meeting;
• Class III, which consists of Christian Itin, Cynthia Butitta, Linda Bain and William Young, whose terms will expire at our 2027 annual general meeting.
−Removed: Table o f contents
Each director shall serve until his or her successor is duly elected and qualified or until his or her earlier death, resignation or removal.
6 unchanged sentences
Bain (chair), Dr.
−Removed: Anderson, Ms.
+Added: Anderson, Mr.
Butitta, and Dr.
16 unchanged sentences
Butitta and Dr.
−Removed: Under SEC and Nasdaq rules, there are heightened independence standards for members of the compensation committee, including a prohibition against the receipt of any compensation from us other than standard board member fees.
+Added: Under the SEC and Nasdaq rules, there are heightened independence standards for members of the compensation committee, including a prohibition against the receipt of any compensation from us other than standard board member fees.
Although foreign private issuers are not required to meet this heightened standard, all of our compensation committee members meet this heightened standard.
12 unchanged sentences
• assessing the functioning of individual members of our board of directors and management and reporting the results of such assessment to the full board of directors.
−Removed: Table o f contents
Research and Development Committee
The research and development committee is composed of Drs.
−Removed: Iannone, Itin and Murphy and Mr.
+Added: Iannone (chair), Itin, Murphy, Rao and Young.
The primary functions of the research and development committee include:
25 unchanged sentences
Accordingly, our shareholders will not have the same protections afforded to shareholders of companies that are subject to all of the corporate governance requirements of Nasdaq.
−Removed: Table o f contents
Executive Compensation
10 unchanged sentences
All such amounts are established and paid in pounds sterling.
−Removed: Name Salary/Fees Annual Bonus Pension
+Added: Name Salary/Fees Annual Bonus Pension Benefit
+Added: All Other Compensation
Christian Itin, Ph.D.
1 unchanged sentence
Chairman of the Board £ 13,327 £ — £ — £ 14,777 £ 28,104
+Added: Michael Bonney*
+Added: Chairman of the Board £ 39,375 £ — £ — £ 349,748 £ 389,123
Joseph Anderson, Ph.D.
Non-Executive Director £ 41,874 £ — £ — £ 147,826 £ 189,700
−Removed: Jay Backstrom, M.D, M.P.H*
+Added: Robert Azelby***
Non-Executive Director £ 36,278 £ — £ — £ 334,882 £ 371,160
4 unchanged sentences
Non-Executive Director £ 42,996 £ — £ — £ 147,826 £ 190,822
−Removed: Kapil Dhingra, M.D.****
−Removed: Non-Executive Director £ 48,581 £ — £ — £ 75,814 £ 124,395
Robert Iannone, M.D., M.S.C.E
4 unchanged sentences
Non-Executive Director £ 36,504 £ — £ — £ 147,826 £ 184,330
+Added: Ravi Rao, M.D.****
+Added: Non-Executive Director £ 28,125 £ — £ — £ 274,606 £ 302,731
William Young, Ph.D.
Non-Executive Director £ 45,252 £ — £ — £ 151,411 £ 196,663
−Removed: Backstrom resigned from the board of directors effective February 28, 2023.
−Removed: Iannone joined the board of directors effective June 15, 2023.
−Removed: Leiderman joined the board of directors effective December 20, 2023.
−Removed: Dhingra resigned from the board of directors effective December 31,2023.
+Added: Bonney joined the board of directors effective April 1, 2024.
+Added: Johnson resigned from the board of directors effective April 1, 2024.
+Added: Azelby joined the board of directors effective January 9, 2024.
+Added: Rao joined the board of directors effective April 1, 2024.
Non-Executive Letters of Appointment
2 unchanged sentences
Non-Executive Director Compensation Policy
−Removed: In April 2023, following market research and advice from its compensation consultant, our board of directors amended our non-executive director compensation policy to increase the retainer fee and equity awards for, respectively, the chair and other non-executive directors.
−Removed: Table o f contents
+Added: In April 2024, following market research and advice from its compensation consultant, our board of directors amended our non-executive director compensation policy to increase the retainer fee for the nominating and governance committee chair and member from £7,000 to £8,000 and £3,500 to £4,000, respectively.
Under this policy, we pay each of our non-executive directors a cash retainer for service on our board of directors and committees of our board of directors.
1 unchanged sentence
These retainers are payable in arrears in twelve equal monthly installments at the end of each calendar month, provided that the amount of such payment will be prorated for any portion of such month that the director is not serving on our board.
−Removed: Non-executive directors residing outside the UK will be paid the applicable amounts converted from pounds sterling into a currency of their request at the time of payment.
+Added: Non-executive directors residing outside the U.K.
+Added: will be paid the applicable amounts converted from pounds sterling into a currency of their request at the time of payment.
We will also reimburse our directors for their reasonable out-of-pocket expenses in connection with attending board and committee meetings.
20 unchanged sentences
In addition, a non-executive director who is initially appointed to serve as chair of the board receives an option to purchase 40,000 of our ADSs on the date of such appointment to chair, which will vest in equal monthly installments through the third anniversary of the grant date.
+Added: Similarly, a non-executive director who, in connection with their initial appointment to the board, is designated to serve as chair of a committee of the board shall receive an option to purchase 25,000 of our ADSs on the date of such appointment, which will vest in equal monthly installments through the third anniversary of the grant date.
Annual Awards
On the date of each of our annual meeting of shareholders, each non-executive director that continues to serve will be granted an option to purchase 80,000 of our ADSs or ordinary shares, which will vest in equal monthly installments through the first anniversary of the grant date.
−Removed: In October 2022, the Compensation Committee of the board approved a one-time increase in the annual equity award grant to non-executive directors, from 80,000 to 105,000 shares, to be awarded at the conclusion of our 2023 Annual General Meeting of Shareholders.
−Removed: Table o f contents
Senior Management Compensation
2 unchanged sentences
For the year ended December 31, 2024, the aggregate compensation accrued or paid to the members of our senior management for services, whether or not a director, in all capacities was $13.0 million.
−Removed: T he amount set aside or accrued by us to provide pension, retirement or similar benefits to members of senior management amounted to a total of $1,108 in the year ended December 31, 2023.
+Added: The amount set aside or accrued by us to provide pension, retirement or similar benefits to members of senior management amounted to a total of $2,829 in the year ended December 31, 2024.
Management Incentive Compensation Plan
−Removed: On May 17, 2016, the board of directors adopted the Management Incentive Compensation Plan.
+Added: In May 2016, the board of directors adopted the Management Incentive Compensation Plan, which it amended in October 2024 to reflect additional management tiers added since the plan's inception.
The Management Incentive Compensation Plan is designed to offer annual incentive compensation to our members of senior management and managers by rewarding the achievement of corporate goals and specifically measured personal goals that are consistent with and support the achievement of the corporate goals.
5 unchanged sentences
For the year ended December 31, 2024 the compensation committee of our board of directors determined that our corporate goals were achieved at a level of 107.5%.
−Removed: Pursuant to the terms of the Management Incentive Compensation Plan, our Chief Executive Officer and executive director received an incentive award of £362,880, based on his target bonus percentage of 60%, an overall goal achievement level of 140%, and his base salary of £432,000.
+Added: Pursuant to the terms of the Management Incentive Compensation Plan, our Chief Executive Officer and executive director will receive an incentive award of £306,504, based on his target bonus percentage of 60%, an overall goal achievement level of 107.5%, and his base salary of £475,200.
Form and Determination of Incentive Awards
Incentive award payments may be made in cash, or, at the discretion of the compensation committee and subject to the approval of our board of directors, through the issuance of equity.
−Removed: An individual’s potential incentive award is calculated by multiplying his or her base salary as of the end of the plan year by the participant’s “target award multiplier,” which is a percentage ranging from 10% to 60%.
+Added: An individual’s potential incentive award is calculated by multiplying their base salary as of the end of the plan year by the participant’s “target award multiplier”, which is a percentage ranging from 5% to 70%.
The resulting amount is then divided between a corporate component and an individual component based on the weighting assigned for the individual’s management level.
4 unchanged sentences
Our board of directors may abolish or alter the Management Incentive Compensation Plan at any time before, during or after a plan year is completed.
−Removed: Table o f contents
Senior Management Employment Arrangements
6 unchanged sentences
Senior Management
−Removed: Christian Itin, Ph.D.
−Removed: 500,000 $ 1.91 3/6/2023 3/6/2033
−Removed: 500,000 $ 2.31 10/12/2023 10/12/2033
−Removed: Robert Dolski 500,000 $ 2.50 7/17/2023 7/17/2033
−Removed: 250,000 $ 2.31 10/12/2023 10/12/2033
−Removed: Edgar Braendle, M.D.
−Removed: 200,000 $ 1.91 3/6/2023 3/6/2033
−Removed: 200,000 $ 2.31 10/12/2023 10/12/2033
−Removed: David Brochu 250,000 $ 1.91 3/6/2023 3/6/2033
−Removed: 250,000 $ 2.31 10/12/2023 10/12/2033
−Removed: Martin Pule, MBBS 150,000 $ 1.91 3/6/2023 3/6/2033
−Removed: 150,000 $ 2.31 10/12/2023 10/12/2033
−Removed: Brent Rice 150,000 $ 1.91 3/6/2023 3/6/2033
−Removed: 150,000 $ 2.31 10/12/2023 10/12/2033
−Removed: Alexander Swan 250,000 $ 1.91 3/6/2023 3/6/2033
+Added: Alex Driggs 200,000 $ 6.11 2/23/2024 2/23/2034
+Added: Christopher Williams, Ph.D.
200,000 $ 6.11 2/23/2024 2/23/2034
−Removed: Christopher Vann 200,000 $ 1.91 3/6/2023 3/6/2033
+Added: Matthias Will, M.D.
800,000 $ 3.63 9/30/2024 9/30/2024
Non-Executive Directors
−Removed: John Johnson 80,000 $ 2.38 6/30/2023 6/30/2033
+Added: Michael Bonney* 120,000 $ 5.68 4/1/2024 4/1/2034
80,000 $ 3.48 6/28/2024 6/28/2034
1 unchanged sentence
80,000 $ 3.48 6/28/2024 6/28/2034
+Added: Robert Azelby** 80,000 $ 6.84 1/9/2024 1/9/2034
80,000 $ 3.48 6/28/2024 6/28/2034
Linda Bain 80,000 $ 3.48 6/28/2024 6/28/2034
−Removed: 25,000 $ 2.38 6/30/2023 6/30/2033
John Berriman 80,000 $ 3.48 6/28/2024 6/28/2034
−Removed: 25,000 $ 2.38 6/30/2023 6/30/2033
Cynthia Butitta 80,000 $ 3.48 6/28/2024 6/28/2034
−Removed: 25,000 $ 2.38 6/30/2023 6/30/2033
−Removed: Table o f contents
−Removed: Name Ordinary Share Underlying Option Exercise Price Grant
−Removed: Non-Executive Directors
−Removed: Kapil Dhingra, M.D.* 80,000 $ 2.38 6/30/2023 6/30/2033
−Removed: 25,000 $ 2.38 6/30/2023 6/30/2033
Robert Iannone, M.D., M.S.C.E.
80,000 $ 3.48 6/28/2024 6/28/2034
−Removed: 25,000 $ 2.38 6/30/2023 6/30/2033
Elisabeth Leiderman, M.D.
2 unchanged sentences
80,000 $ 3.48 6/28/2024 6/28/2034
+Added: Ravi Rao, M.D.*** 80,000 $ 5.68 4/1/2024 4/1/2034
80,000 $ 3.48 6/28/2024 6/28/2034
1 unchanged sentence
80,000 $ 3.48 6/28/2024 6/28/2034
−Removed: 25,000 $ 2.38 6/30/2023 6/30/2033
−Removed: Dhingra resigned from the board of directors effective December 31,2023.
+Added: Bonney joined the board of directors effective April 1, 2024.
+Added: Azelby joined the board of directors effective January 9, 2024.
+Added: Rao joined the board of directors effective April 1, 2024.
As of December 31, 2024, members of our board of directors and senior management held vested share options to purchase an aggregate of 7,119,049 ordinary shares.
4 unchanged sentences
In 2017, our board of directors and shareholders approved the 2017 Plan to provide equity incentives to certain eligible employees and directors, consultants and advisors.
−Removed: The 2017 Plan provided for the grant of potentially tax-favored Enterprise Management Incentives (“EMI”), options to our UK employees and for the grant of options to our U.S.
+Added: The 2017 Plan provided for the grant of potentially tax-favored Enterprise Management Incentives (“EMI”), options to our U.K.
+Added: employees and for the grant of options to our U.S.
The 2017 Plan terminated in connection with our IPO;
12 unchanged sentences
The plan administrator also has the authority to determine which eligible service providers receive awards, grant awards, set the terms and conditions of all awards under the 2018 Plan, including any vesting and vesting acceleration provisions, and designate whether such awards will cover our ordinary shares or ADSs, subject to the conditions and limitations in the 2018 Plan.
−Removed: Table o f contents
Shares Available for Awards
1 unchanged sentence
Additionally, the number of ordinary shares reserved for issuance under the 2018 Plan will automatically increase on October 1st of each year, for a period of not more than ten years, commencing on October 1, 2018 and ending on (and including) October 1, 2027, by an amount equal to the lesser of (i) 4% of the total number of ordinary shares outstanding on September 30 of the same calendar year or (ii) such fewer number of ordinary shares as the board of directors may designate prior to the applicable October 1st date.
−Removed: As of December 31, 2023 , 22,298,243 ordinary shares may be issued under the 2018 Plan, of which 3,833,665 ordinary s hares were available for future grant as of that date.
+Added: As of December 31, 2024, 32,943,013 ordinary shares may be issued under the 2018 Plan, of which 11,464,845 ordinary shares were available for future grant as of that date.
If an award under the 2018 Plan, or any prior equity incentive plan, expires, lapses or is terminated, exchanged for cash, surrendered, repurchased, canceled without having been fully exercised or forfeited, any unused shares subject to the award will, as applicable, become or again be available for new grants under the 2018 Plan.
22 unchanged sentences
In addition, in the event of certain non-reciprocal transactions with our shareholders, the plan administrator will make equitable adjustments to the 2018 Plan and outstanding awards as it deems appropriate to reflect the transaction.
−Removed: Table o f contents
Plan Amendment and Termination
15 unchanged sentences
public company, if we are required to restate our financial results due to our material noncompliance with any financial reporting requirements under the federal securities laws as a result of misconduct, our Chief Executive Officer and Chief Financial Officer may be legally required to reimburse us for any bonus or other incentive-based or equity-based compensation they receive in accordance with the provisions of Section 304 of the Sarbanes-Oxley Act.
−Removed: Additionally, we have implemented a Dodd-Frank Act-compliant clawback policy, as required by SEC rules.
−Removed: Table o f contents
+Added: Additionally, we have implemented a Dodd-Frank Act-compliant clawback policy, as required by the SEC rules.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
−Removed: The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of February 29, 2024 by:
+Added: The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of March 1, 2025 by:
• each beneficial owner of 5% or more of our outstanding ordinary shares;
2 unchanged sentences
Beneficial ownership is determined in accordance with the rules of the SEC.
−Removed: These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to those securities and include ordinary shares that can be acquired within 60 days of February 29, 2024.
+Added: These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to those securities and include ordinary shares that can be acquired within 60 days of March 1, 2025.
These ordinary shares, however, are not included in the computation of the percentage ownership of any other person.
−Removed: Percentage ownership calculations are based on 265,812,217 ordinary shares outstanding (including ordinary shares in the form of ADSs) as of February 29, 2024 .
+Added: Percentage ownership calculations are based on 266,125,337 ordinary shares outstanding (including ordinary shares in the form of ADSs) as of March 1, 2025 .
Except as otherwise indicated, all of the shares reflected in the table are ordinary shares and all persons listed below have sole voting and investment power with respect to the shares beneficially owned by them, subject to applicable community property laws.
The information is not necessarily indicative of beneficial ownership for any other purpose.
−Removed: Except as otherwise indicated, the addresses of the persons listed in the table is c/o Autolus Therapeutics plc, 191 Wood Lane, White City, London W12 7FP, United Kingdom.
+Added: Except as otherwise indicated, the addresses of the persons listed in the table is c/o Autolus Therapeutics plc, 191 Wood Lane, White City, London W12 7FP, U.K.
NAME OF BENEFICIAL OWNER Number of Ordinary Shares Beneficially Owned (#) Percent of Ordinary Shares Beneficially Owned (%)
5% or Greater Shareholders:
−Removed: Syncona Portfolio Limited (1) 33,527,162 12.6 %
BioNTech SE (1) 33,333,333 12.5 %
−Removed: 33,333,333 12.5 %
−Removed: BXLS V - Autobahn L.P (3)
−Removed: 23,750,917 8.9 %
−Removed: Paradigm BioCapital Advisors LP (4)
−Removed: 16,028,002 6.0 %
−Removed: Deep Track Capital, LP (5)
−Removed: 15,619,297 5.9 %
+Added: Syncona Portfolio Limited (2) 30,734,957 11.5 %
+Added: Wellington Management Co.
+Added: LLP (3) 25,345,680 9.5 %
+Added: BXLS V – Autobahn LP (4) 23,750,917 8.9 %
Qatar Investment Authority (5) 15,000,000 5.6 %
−Removed: 15,000,000 5.6 %
PPF Capital Partners Fund B.V.
(6) 14,782,275 5.6 %
+Added: Deep Track Capital, LP (7) 14,218,903 5.3 %
Senior Management and Directors:
2 unchanged sentences
Robert Dolski (9) 281,249 *
−Removed: Edgar Braendle M.D.(10)
David Brochu (10) 869,165 *
+Added: Alex Driggs (11) 259,495 *
+Added: Miranda Neville (12) 209,839 *
Martin Pulé, MBBS (13) 545,032 *
2 unchanged sentences
Christopher Vann (16) 954,291 *
+Added: Matthias Will, M.D.
Christopher Williams, Ph.D.
−Removed: John Johnson (17)
+Added: (18) 489,979 *
+Added: Michael Bonney (19) 89,999 *
Joseph Anderson, Ph.D.
+Added: (20) 228,333 *
Robert Azelby (21) 82,221 *
3 unchanged sentences
Robert Iannone, M.D., M.S.C.E.
+Added: (25) 158,333 *
Elisabeth Leiderman, M.D.
+Added: (26) 84,444 *
Martin Murphy, Ph.D.
+Added: (27) 228,333 *
+Added: Ravi Rao, M.D.
+Added: (28) 77,777 *
William Young, Ph.D.
+Added: (29) 203,333 *
All directors and senior management as a group (22 persons) (30)
1 unchanged sentence
* Represents beneficial ownership of less than one percent.
−Removed: Table o f contents
−Removed: (1) The information shown is based, in part, upon disclosures filed on a Schedule 13G/A on February 14, 2024 by Syncona Portfolio Limited.
−Removed: The number reported consists of (i) 12,180,333 ordinary shares and (ii) 21,346,829 ADSs.
−Removed: Syncona Portfolio Limited is a wholly owned subsidiary of Syncona Holdings Limited, which, in turn, is a wholly controlled subsidiary of Syncona Limited, a publicly-listed company.
−Removed: Each of Syncona Holdings Limited and Syncona Limited may be deemed to have voting and dispositive power over the securities held by Syncona Portfolio Limited.
−Removed: Investment and voting decisions with respect to these securities are made by Syncona Portfolio Limited acting upon the recommendation of an investment committee of Syncona Investment Management Limited, also a subsidiary of Syncona Holdings Limited.
−Removed: The members of this investment committee consist of Roel Bulthuis and Christopher Hollowood.
−Removed: The address for Syncona Portfolio Limited is PO Box 273, Sir William Place, St Peter Port, Guernsey GY1 3RD, Channel Islands.
−Removed: (2) The information shown is based, in part, upon disclosures filed on a Schedule 13D on February 21, 2024 by BioNTech.
+Added: (1) The information shown is based, in part, upon disclosures filed on a Schedule 13D on February 21, 2024 by BioNTech SE, "BioNTech".
The number reported consists of 33,333,333 ADSs.
8 unchanged sentences
The address of the principal business office, Management Board and Supervisory Board of BioNTech is An der Goldgrube 12, D-55131 Mainz, Germany.
+Added: (2) The information shown is based, in part, upon disclosures filed on a Schedule 13G/A on November 14, 2024 by Syncona Portfolio Limited.
+Added: The number reported consists of (i) 12,180,333 ordinary shares and (ii) 18,554,624 ADSs.
+Added: Syncona Portfolio Limited is a wholly owned subsidiary of Syncona Holdings Limited, which, in turn, is a wholly controlled subsidiary of Syncona Limited, a publicly-listed company.
+Added: Each of Syncona Holdings Limited and Syncona Limited may be deemed to have voting and dispositive power over the securities held by Syncona Portfolio Limited.
+Added: Investment and voting decisions with respect to these securities are made by Syncona Portfolio Limited acting upon the recommendation of an investment committee of Syncona Investment Management Limited, also a subsidiary of Syncona Holdings Limited.
+Added: The members of this investment committee consist of Roel Bulthuis and Christopher Hollowood.
+Added: The address for Syncona Portfolio Limited is PO Box 273, Sir William Place, St Peter Port, Guernsey GY1 3RD, Channel Islands.
+Added: It should be noted that Martin Murphy stepped down from chair of Syncona Investment Management Limited (SIML) and therefore the Company has not included Syncona's shareholding in Martin's beneficial ownership calculations.
+Added: (3) The information shown is based, in part, upon disclosures filed on a Schedule 13F on February 14, 2025 and on a Schedule 13G on November 14, 2024 by Wellington Management Co.
+Added: The number consists of 25,345,680 ADSs.
+Added: Wellington Management Company LLP is a wholly owned subsidiary of Wellington Management Group LLP, a publicly-listed company.
+Added: The address of the principal business office of Wellington Management Co.
+Added: LLP is 280 Congress Street, Boston, MA 02210.
(4) The information shown is based, in part, upon disclosures filed on a Schedule 13D/A on December 13, 2022 by Blackstone Inc.
17 unchanged sentences
Schwarzman is c/o Blackstone Inc., 345 Park Avenue, New York, NY 10154.
−Removed: (4) The information shown is based, in part, upon disclosures filed on a Schedule 13G/A on February 14, 2024 by (1) Paradigm BioCapital Advisors LP (the “Adviser”);
−Removed: (2) Paradigm BioCapital Advisors GP LLC (the “GP”);
−Removed: (3) Senai Asefaw, M.D.
−Removed: (“Senai Asefaw”);
−Removed: and (4) Paradigm BioCapital International Fund Ltd.
−Removed: (the “Fund”).
−Removed: The number reported consists of 12,611,335 ADSs.
−Removed: The Fund is a private investment vehicle.
−Removed: The Fund and a separately managed account managed by the Adviser (the “Account”) directly beneficially own 12,611,335 ADSs.
−Removed: In addition Paradigm BioCapital Advisors LP purchased a further 3,416,667 ADSs in February 2024.
−Removed: The Adviser is the investment manager of the Fund and the Account.
−Removed: The GP is the general partner of the Adviser.
−Removed: Senai Asefaw is the managing member of the GP.
−Removed: The Adviser, the GP and Senai Asefaw may be deemed to beneficially own the Ordinary Shares directly beneficially owned by the Fund and the Account.
−Removed: Each Reporting Person disclaims beneficial ownership with respect to any Ordinary Shares other than the Ordinary Shares directly beneficially owned by such Reporting Person.
−Removed: The principal business office of the Reporting Persons is 767 Third Avenue, 17th Floor, New York, NY 10017.
−Removed: (5) The information shown is based, in part, upon disclosures filed on a Schedule 13G/A on February 14, 2024 by Deep Track Capital, LP.
−Removed: The number reported consists of 11,869,297 ADSs.
−Removed: In addition Deep Track Capital, LP purchased a further 3,750,000 ADSs in February 2024.
−Removed: Deep Track Biotechnology Master Fund, Ltd is a wholly owned subsidiary of Deep Track Capital, LP.
−Removed: The address of the principal business office of Deep Track Capital, LP is 200 Greenwich Ave, 3rd Floor, Greenwich, CT 06830.
−Removed: The address of the principal business office of Deep Track Biotechnology Master Fund, Ltd.
−Removed: is c/o Walkers Corporate Limited, 190 Elgin Ave, George Town, KY1-9001, Cayman Islands.
−Removed: Deep Track Capital, LP.
−Removed: and Deep Track Biotechnology Master Fund, Ltd are controlled by its founder, David Kroin.
−Removed: The address of the principal business office of Mr.
−Removed: Kroin is c/o Deep Track Capital, LP, 200 Greenwich Ave, 3rd Floor, Greenwich, CT 06830.
(5) The information shown is based, in part, upon disclosures filed on a Schedule 13G on December 13, 2022 by Qatar Investment Authority.
2 unchanged sentences
Box 23224, Qatar.
−Removed: (7) The information shown is based, in part, upon disclosures filed on a Schedule 13D/A on June 23, 2021 by PPF Capital Partners Fund B.V., PPF Group N.V.
+Added: (6) The information shown is based, in part, upon disclosures filed on a Schedule 13D on October 25, 2024 by PPF Capital Partners Fund B.V., PPF Group N.V.
and Renata Kellnerova.
5 unchanged sentences
Box 177, 160 41 Prague 6, Czech Republic.
−Removed: (8) Consists of (i) 1,066,009 ordinary shares issuable upon conversion of restricted ordinary shares, (ii) 50,000 ordinary shares issuable upon restricted stock units and (iii)) 1,142,492 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (9) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (10) Consists of (i) 79,622 ordinary shares issuable upon conversion of restricted stock units and (ii) 338,540 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (11) Consists of (i) 113,125 ordinary shares issuable upon conversion of restricted stock units and (ii) 405,416 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (12) Consists of (i) 538,677 ordinary shares, (ii) 160,064 ordinary shares issuable upon conversion of restricted ordinary shares, and (iii) 331,907 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (13) Consists of (i) 9,400 ADSs and (ii) 37,907 ordinary shares issuable upon conversion of restricted stock units and (iii) 160,417 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (14) Consists of (i) 38,657 ordinary shares issuable upon conversion of restricted stock units, and (ii) 220,508 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (15) Consists of (i) 112,211 ordinary shares issuable upon conversion of restricted ordinary shares, ii) 40,000 ordinary shares issuable upon conversion of restricted stock units and (iii) 524,581 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (16) Consists of (i) 8,198 ordinary shares issuable upon conversion of restricted ordinary shares, (ii) 19,808 ordinary shares issuable upon conversion of restricted stock units and (iii) 200,515 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (17) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (18) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (19) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (20) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (21) Consists of (i) 62,794 ordinary shares and (ii) 73,537 ordinary shares issuable upon conversion of restricted ordinary shares, and (iii) 155,697 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (22) Consists of (i) 10,000 ADSs and (ii) 187,094 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (23) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (24) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (25) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (26) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: (27) Consists of (i) 19,400 ADSs, (ii) 601,471 ordinary shares, (iii) 1,420,019 ordinary shares issuable upon conversion of restricted ordinary shares, (iv) 379,119 ordinary shares issuable upon conversion of restricted stock units and (v) 4,434,251 ordinary shares underlying options that are vested and exercisable within 60 days of February 29, 2024.
−Removed: Table o f contents
+Added: (7) The information shown is based, in part, upon disclosures filed on a Schedule 13F on February 14, 2025 and on a Schedule 13G/A on November 14, 2024 by Deep Track Capital, LP.
+Added: The number reported consists of 14,218,903 ADSs.
+Added: Deep Track Biotechnology Master Fund, Ltd is a wholly owned subsidiary of Deep Track Capital, LP.
+Added: The address of the principal business office of Deep Track Capital, LP is 200 Greenwich Ave, 3rd Floor, Greenwich, CT 06830.
+Added: The address of the principal business office of Deep Track Biotechnology Master Fund, Ltd.
+Added: is c/o Walkers Corporate Limited, 190 Elgin Ave, George Town, KY1-9001, Cayman Islands.
+Added: Deep Track Capital, LP.
+Added: and Deep Track Biotechnology Master Fund, Ltd are controlled by its founder, David Kroin.
+Added: The address of the principal business office of Mr.
+Added: Kroin is c/o Deep Track Capital, LP, 200 Greenwich Ave, 3rd Floor, Greenwich, CT 06830.
+Added: (8) Consists of (i) 1,066,009 ordinary shares issuable upon conversion of restricted ordinary shares, (ii) 50,000 ordinary shares issuable upon restricted stock units and (iii) 1,786,241 ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (9) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (10) Consists of (i) 113,125 ordinary shares issuable upon conversion of restricted stock units and (ii) 756,040 ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (11) Consists of (i) 18,418 ordinary shares issuable upon conversion of restricted ordinary shares, and (ii) 241,077 ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (12) Consists of (i) 33,720 ordinary shares issuable upon conversion of restricted ordinary shares, and (ii) 176,119 ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (13) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (14) Consists of (i) 9,400 ADSs and (ii) 37,907 ordinary shares issuable upon conversion of restricted stock units and (iii) 342,292 ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (15) Consists of (i) 38,657 ordinary shares issuable upon conversion of restricted stock units, and (ii) 513,215 ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (16) Consists of (i) 112,211 ordinary shares issuable upon conversion of restricted ordinary shares, ii) 40,000 ordinary shares issuable upon conversion of restricted stock units and (iii) 802,080 ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (17) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (18) Consists of (i) 8,198 ordinary shares issuable upon conversion of restricted ordinary shares, (ii) 19,808 ordinary shares issuable upon conversion of restricted stock units and (iii) 461,973 ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (19) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (20) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (21) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (22) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (23) Consists of (i) 62,794 ordinary shares and (ii) 73,537 ordinary shares issuable upon conversion of restricted ordinary shares, and (iii) 244,031 ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (24) Consists of (i) 10,000 ADSs and (ii) 275,428 ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (25) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (26) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (27) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (28) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (29) Consists of ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
+Added: (30) Consists of (i) 19,400 ADSs, (ii) 62,794 ordinary shares, (iii) 1,259,955 ordinary shares issuable upon conversion of restricted ordinary shares, (iv) 351,635 ordinary shares issuable upon conversion of restricted stock units and (v) 7,837,280 ordinary shares underlying options that are vested and exercisable within 60 days of March 1, 2025.
Significant Changes in Percentage Ownership
3 unchanged sentences
Shareholders in the United States
−Removed: As of December 31, 2023, assuming that all of our ordinary shares represented by ADSs are held by residents of the United States other than ADSs held by the entities set forth in the table above and certain other holders that we know to be non-residents of the United States, we estimate that appr oximately 44.1% of our outstanding ordinary shares (including ordinary shares underlying ADSs) were held in the United States by 92 hol ders of record .
+Added: As of December 31, 2024, assuming that all of our ordinary shares represented by ADSs are held by residents of the United States other than ADSs held by the entities set forth in the table above and certain other holders that we know to be non-residents of the United States, we estimate that approximately 56.8% of our outstanding ordinary shares (including ordinary shares underlying ADSs) were held in the United States by 213 holders of record.
The actual number of holders is greater than these numbers of record holders, and includes beneficial owners whose ordinary shares are held in street name by brokers and other nominees.
6 unchanged sentences
20,754,316 (1)
+Added: 11,464,845 (3)
Total 20,754,316 11,464,845
15 unchanged sentences
• persons having authority or responsibility for planning, directing or controlling our activities, including directors and senior management and close members of such individuals’ families;
−Removed: Table o f contents
• enterprise in which a substantial interest in our voting power is owned, directly or indirectly, by any person described above or over which such a person is able to exercise significant influence, including enterprises owned by our directors or major shareholders and enterprises that have a member of key management in common with us.
11 unchanged sentences
“Executive Compensation”
−Removed: License Agreement with Syncona
−Removed: We entered into a license agreement with an investee of Syncona Portfolio Limited on September 2, 2020, a holder of more than 5% of our share capital.
−Removed: The terms of the agreement include a non-refundable license fee, payments based upon achievement of clinical development and regulatory objectives, and royalties on product sales.
−Removed: During the year ended December 31, 2023 , we received $0.4 million arising from the achievement of a development milestone.
−Removed: Consequently, we recognized license revenue of $0.4 million (net of foreign exchange differences).
+Added: Transactions with Entities Affiliated with BioNTech
+Added: On February 6, 2024, we, through our wholly owned subsidiaries, Autolus Limited and Autolus Holdings (UK) Limited entered into a License and Option Agreement (the “License Agreement”) with BioNTech SE (“BioNTech”) pursuant to which we granted to BioNTech an exclusive, worldwide, sublicensable license (the “License”) to certain binders and to exploit products that express in vivo such binders (collectively, the “Binder Licensed Products”).
+Added: In addition to the License, under the License Agreement we granted to BioNTech several time-limited options (the “Options”) to acquire additional rights to specified clinical-stage product candidates, binders and technologies, described in more detail below.
+Added: In the event that all Options are fully exercised, we would be eligible to receive future maximum aggregate payments of up to $582.0 million pursuant to the License Agreement.
+Added: This maximum amount includes the potential milestone payments for the Binder Licensed Products described below, all option exercise fees and potential milestone payments for licenses to optioned products and technologies, and additional payments that BioNTech may pay to us for an increased revenue interest with respect to obe-cel as described below.
+Added: License and Options
+Added: In consideration for the License and the Options, BioNTech has made an initial payment to us of $10.0 million.
+Added: We are eligible to receive milestone payments of up to $32 million in the aggregate upon the achievement of specified clinical development and regulatory milestones for each Binder Licensed Product that achieves such milestones.
+Added: We are also eligible to receive a low single-digit royalty on net sales of Binder Licensed Products, subject to customary reductions, which reductions are subject to specified limits.
+Added: The royalty will be increased if BioNTech, its affiliates or sublicensees commercialize a Binder Licensed Product in an indication and country in which we or our affiliates or licensees also commercialize a product containing the same binders.
+Added: Under the License Agreement, BioNTech is solely responsible for, and has sole decision-making authority with respect to, at its own expense, the exploitation of Binder Licensed Products.
+Added: Under the terms of the License Agreement, we have agreed to grant BioNTech the following time-limited Options:
+Added: • an option to obtain exclusive rights to co-fund development costs of our development-stage programs AUTO1/22 and AUTO6NG, in return for agreed upon economic terms, including an option exercise fee, milestone payments and a profit-sharing arrangement for each such product candidate, with additional options to co-promote or co-commercialize such product candidate.
+Added: The product option for AUTO1/22 was not exercised and has expired as of February 8, 2025;
+Added: • an option to obtain an exclusive worldwide license to exploit products that express certain additional binders in vivo or, with respect to certain binders, in an antibody drug conjugate (the “Binder Option”);
+Added: • an option to obtain a co-exclusive worldwide license to exploit products that express in vivo our modules for activity enhancement, with a non-exclusive right, in certain agreed instances, to exploit products that include our modules for activity enhancement but do not express in vivo such modules (the “Activity Enhancement Option”);
+Added: • an option to obtain a non-exclusive worldwide license to exploit products that contain our safety switches (the “Safety Switch Option” and, together with the Binder Option and the Activity Enhancement Option, the “Technology Options”).
+Added: The option exercise fee for each Technology Option is a low seven-digit amount.
+Added: Each of the Activity Enhancement Option and the Safety Switch Option must be exercised with respect to a given biological target or combination of targets.
+Added: There is a cap on the total option exercise fee if multiple options are exercised with respect to a given target.
+Added: There is also a cap on milestone payments across all agreements entered into as the result of BioNTech exercising one or more of the Technology Options and a cap on the royalty rate payable on any given product for which multiple Options are exercised.
+Added: Obe-cel Product Revenue Interest
+Added: Under the License Agreement, BioNTech has also agreed to financially support the expansion of the clinical development program and planned commercialization of obe-cel.
+Added: In exchange for our grant of rights to future revenues from the sales of obe-cel products, BioNTech made an upfront payment to us of $40 million.
+Added: We will pay BioNTech a low single-digit percentage of annual net sales of obe-cel products, which may be increased up to a mid-single digit percentage in exchange for milestone payments of up to $100 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech's election.
+Added: Manufacturing and Commercial Agreement
+Added: Under the terms of the License Agreement, we have granted BioNTech the option to negotiate a joint manufacturing and commercial services agreement pursuant to which we and they may access and leverage each other’s manufacturing and commercial capabilities, in addition to our commercial site network and infrastructure, with respect to certain of each parties’ CAR T products, including BioNTech’s product candidate BNT211 (the “Manufacturing and Commercial Agreement”).
+Added: Securities Purchase Agreement, Registration Rights Agreement and Letter Agreement
+Added: Concurrently with the execution of the License Agreement, we and BioNTech entered into a Securities Purchase Agreement (the “Purchase Agreement”) pursuant to which we issued and sold 33.3 million ADSs to BioNTech at $6.00 per ADS for aggregate gross proceeds of $200.0 million.
+Added: In the event that we and BioNTech enter into the Manufacturing and Commercial Agreement described above within 18 months of the initial closing under the Purchase Agreement, BioNTech will purchase additional ADSs, not to exceed 15.0 million ADSs, for an aggregate purchase price of up to $20 million.
+Added: The total number of ADSs that may be issued to BioNTech is subject to additional limitations and restrictions.
+Added: BioNTech also has the right to purchase equity securities sold by us in bona fide financing transactions in amounts that are based on BioNTech maintaining specified ownership thresholds following such financing transactions.
2024 Underwritten Offering
2 unchanged sentences
Related party ADSs purchased Total purchase price (in millions)
−Removed: Paradigm BioCapital Advisors LP (1)
+Added: Fidelity Management & Research Company, LLC (1)
5,808,333 $ 34.9
Deep Track Capital, LP (2) 3,750,000 $ 30.0
−Removed: (1) Paradigm BioCapital Advisors LP was a holder of more than 5% of our share capital as of December 31, 2023.
+Added: (1) Fidelity Management & Research Company, LLC was a holder of more than 5% of our share capital as of December 31, 2024.
(2) Deep Track Capital, LP was a holder of more than 5% of our share capital as of December 31, 2024.
3 unchanged sentences
However, the enforceability of the non-competition provisions may be limited under applicable law.
−Removed: Table o f contents
Indemnification Agreements
25 unchanged sentences
Form F-1/A 333-224720 3.1 6/19/18
−Removed: 4.1 Deposit Agreement by and among the registrant, Citibank, N.A., as the Depositary bank and the holders and beneficial owners of A DSs issued thereunder.
+Added: 4.1 Deposit Agreement by and among the registrant, Citibank, N.A., as the Depositary bank and the holders and beneficial owners of ADSs issued thereunder.
Form F-1/A 333-224720 4.1
3 unchanged sentences
001-38547 2.4 3/3/20
−Removed: Table of con tents
4.4 Warrant issued to BXLS V – Autobahn L.P.
7 unchanged sentences
333-224720 10.4 6/19/18
−Removed: Management Incentive Compensation Plan.
−Removed: 333-224720 10.5 6/8/18
Form of Deed of Indemnity between the registrant and each of its members of senior management and directors.
14 unchanged sentences
License and Option Agreement between the registrant and BioNTech SE, dated February 6, 2024.
+Added: 001-38547 10.12
Securities Purchase Agreement between the registrant and BioNTech SE, dated February 6, 2024.
8 unchanged sentences
Form 10-Q 001-38547 10.2 11/9/23
+Added: Capital Contribution Deed, dated September 10, 2024, between Forge Life Sciences Nominee I Limited and Forge Life Sciences Nominee 2 Limited, Autolus Limited and Autolus Therapeutics plc relating to The Nucleus Marshgate, Stevenage.
+Added: Form 10-Q 001-38547 10.1 11/12/24
+Added: Deed of Variation, dated September 10, 2024, between Forge Life Sciences Nominee I Limited and Forge Life Sciences Nominee 2 Limited, Autolus Limited and Autolus Therapeutics plc relating to The Nucleus Marshgate, Stevenage.
+Added: Form 10-Q 001-38547 10.2 11/12/24
+Added: License for Alterations, dated September 10, 2024, between Forge Life Sciences Nominee I Limited and Forge Life Sciences Nominee 2 Limited, Autolus Limited and Autolus Therapeutics plc relating to The Nucleus Marshgate, Stevenage.
+Added: Form 10-Q 001-38547 10.3 11/12/24
+Added: Amended Management Incentive Compensation Plan
+Added: Exclusive Distribution Agreement, effective as of April 25, 2024 , by and between Cardinal Health 105, Inc.
+Added: and Autolus Inc.
+Added: 19.1* Amended and Restated Insider Trading and Window Period Policy
Subsidiaries of the registrant.
23.1* Consent of Ernst & Young LLP, independent registered public accounting firm
−Removed: Table of con tents
Power of Attorney (included on signature page)
4 unchanged sentences
Policy relating to recovery of erroneously awarded compensation, as required by applicable listing standards adopted pursuant to 17 CFR 240.10D-1
+Added: 001-38547 10.12
101.INS* Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
13 unchanged sentences
Form 10-K Summary
−Removed: Table of con tents
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
5 unchanged sentences
POWER OF ATTORNEY
−Removed: We, the undersigned officers and directors of Autolus Therapeutics plc, hereby severally constitute and appoint Christian Itin and Alex Driggs our true and lawful attorneys with full power to any of them, and to each of them singly, to sign for us and in our names in the capacities indicated below to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the U.S.
+Added: We, the undersigned officers and directors of Autolus Therapeutics plc, hereby severally constitute and appoint Christian Itin and Robert Dolski our true and lawful attorneys with full power to any of them, and to each of them singly, to sign for us and in our names in the capacities indicated below to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the U.S.
Securities Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done therewith, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, and either of them, his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
15 unchanged sentences
(Principal Accounting Officer)
−Removed: /s/ John Johnson
+Added: /s/ Michael Bonney
Chairman of the Board of Directors
March 20, 2025
+Added: Michael Bonney
/s/ Joseph Anderson, Ph.D.
21 unchanged sentences
Martin Murphy, Ph.D.
−Removed: /s/ William Young
+Added: /s/ Ravi Rao, M.D.
March 20, 2025
−Removed: William Young
−Removed: Table of con tents
+Added: /s/ William Young, Ph.D.
+Added: March 20, 2025
+Added: William Young, Ph.D.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
2 unchanged sentences
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2024 and 2023
−Removed: Consolidated Statements of Shareholders’ Equity for the years ended December 31, 2023, 2022 and 2021
+Added: Consolidated Statements of Changes in Shareholders’ Equity for the years ended December 31, 2024 and 2023
Consolidated Statements of Cash Flows for the years ended December 31, 2024 and 2023
Notes to Consolidated Financial Statements
−Removed: Table of con tents
Report of Independent Registered Public Accounting Firm
1 unchanged sentence
Opinion on the Financial Statements
−Removed: We have audited the accompanying consolidated balance sheets of Autolus Therapeutics plc (the Company) as of December 31, 2023 and 2022, and the related consolidated statements of operations and comprehensive loss, shareholders’ equity and cash flows for each of the three years in the period ended December 31, 2023 and the related notes (collectively referred to as the “consolidated financial statements”).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of Autolus Therapeutics plc at December 31, 2023 and 2022, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2023, in conformity with U.S.
+Added: We have audited the accompanying consolidated balance sheets of Autolus Therapeutics plc (the “Company”) as of December 31, 2024 and 2023, and the related consolidated statements of comprehensive loss, shareholders’ equity and cash flows for each of the two years in the period ended December 31, 2024 and the related notes (collectively referred to as the “consolidated financial statements”).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2024 and 2023, and the results of their operations and their cash flows for each of the two years in the period ended December 31, 2024, in conformity with U.S.
generally accepted accounting principles.
−Removed: Restatement of 2022 and 2021 Financial Statements
−Removed: As discussed in Note 3 to the consolidated financial statements, the 2022 and 2021 consolidated financial statements have been restated to correct a misstatement.
Basis for Opinion
12 unchanged sentences
We believe that our audits provide a reasonable basis for our opinion.
−Removed: Critical Audit Matter
−Removed: The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that:
−Removed: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments.
−Removed: The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
−Removed: Liabilities related to future royalties and sales milestones
−Removed: Description of the matter As explained in note 11 to the consolidated financial statements, the Company entered into a collaboration agreement with BXLS V- Autobahn L.P (“Blackstone”) in 2021 for the development of certain CAR T therapy products for which the Company received an upfront payment and subsequently certain milestone payments which was initially recognized as a liability.
−Removed: The Company remeasures the liability as the present value of future royalties and sales milestones payable, when significant assumptions associated with the underlying cash flows change.
−Removed: The liability is sensitive to forecasts of future royalties and sales milestones payable, which are based on management estimates which include the probability of success of the clinical trial and regulatory approval (‘POS’) and the estimated selling prices of products in different territories.
−Removed: Auditing the Company's measurement of the liability for future royalties and sales milestones, net is especially challenging because the calculation involves significant management judgement about future events, which are inherently uncertain.
−Removed: In particular, the measurement was sensitive to the Company’s estimates of the timing and likelihood of regulatory approvals and pricing of the products on which royalties will be paid.
−Removed: Table of con tents
−Removed: How we addressed the matter To test the liability related to future royalties and sales milestones, net and the related financial model our audit procedures included among others, meeting with management and its expert to understand the basis for changes in the POS and forecast selling prices.
−Removed: We also evaluated the reasonableness of the POS assumption, with the assistance of a specialist, by assessing analysts’ reports, industry standards and publicly available information for similar products.
−Removed: We evaluated the appropriateness of management’s selling price assumptions by comparing the pricing of the Company’s product with competitor pricing from publicly available information in different market segments.
−Removed: We evaluated the reasonableness of the underlying financial model by performing a roll-forward of the prior year valuation, performing certain sensitivity analysis on the significant assumptions and comparing it to the significant assumptions used by management.
−Removed: We also tested the clerical accuracy of the model.
+Added: Critical Audit Matters
+Added: The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that:
+Added: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments.
+Added: The communication of the critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing a separate opinion on the critical audit matters or on the accounts or disclosures to which they relate.
+Added: Liabilities related to future royalties and milestones, net (the “Liabilities”)
+Added: Description of the matter As explained in note 12 to the consolidated financial statements, the Company entered into a collaboration agreement with BXLS V- Autobahn L.P (“Blackstone”) in 2021 for the development of certain CAR T therapy products for which the Company received an upfront payment and subsequently certain milestone payments which were initially recognized as a liability.
+Added: In 2024, the Company entered into a similar arrangement with BioNTech SE (“BioNTech”), as detailed in note 1 to the consolidated financial statements.
+Added: As disclosed in note 2 to the consolidated financial statements, the Liabilities are remeasured when significant assumptions associated with the underlying cashflows change.
+Added: These assumptions include significant unobservable inputs, such as the probability of success of the clinical trial and regulatory approval (“POS”), patient volumes, and the estimated selling prices of products in different territories.
+Added: Auditing the Company's measurement of the Liabilities was especially challenging, because the measurement involves significant management judgements about future events, which are inherently uncertain.
+Added: In particular, the measurement of the Liabilities was sensitive to the Company’s estimates of POS, patient volumes, and pricing of the products on which royalties will be paid.
+Added: How we addressed the matter To test the measurement of the Liabilities, our audit procedures included among others, meeting with management to understand the basis for changes in the POS, patient volumes, and forecast selling prices.
+Added: We evaluated the POS assumption, with the assistance of our life sciences specialist, by assessing industry benchmarks for similar products and analysts’ reports.
+Added: We evaluated management’s patient volume model, including assessing inputs to the model and the reasonableness of the outputs, with the assistance of our life sciences specialists, by performing procedures such as examining published data from third party sources, reperforming calculations and conducting sensitivity analyses.
+Added: We evaluated management’s selling price assumptions, by comparing them to competitor prices from publicly available information.
+Added: With the assistance of our financial modeling specialists, we evaluated the underlying financial model by performing recalculations and sensitivity analyses on significant assumptions and comparing them to those used by management.
+Added: BioNTech Transaction
+Added: Description of the matter On February 6, 2024, the Company entered into a transaction with BioNTech (“the Transaction”) as detailed in note 1 to the Company’s consolidated financial statements.
+Added: The Transaction included the recording of a liability related to a revenue sharing arrangement, the sale of an intellectual property license and the issuance of new ordinary shares.
+Added: Auditing the Transaction involved complex auditor judgment, since there was significant judgment and subjectivity in management’s accounting assessment, particularly in determining the separate components to account for and the allocation of the Transaction’s proceeds between the components.
+Added: How we addressed the matter To audit the accounting for the Transaction, we read the various Transaction agreements, while considering relevant accounting literature, to evaluate whether management's accounting position considered the relevant facts and terms included in the agreements, including management’s determination of the detachability of the various components and embedded features and whether they should be accounted for separately.
+Added: To assess the value assigned to the liability related to the revenue sharing arrangement, we used our valuation specialists to compare the effective interest rate determined by management against publicly available information for comparable arrangements.
+Added: For the license revenue recognized from the sale of the intellectual property license, we assessed the allocated value by considering whether there were any material rights associated with other options granted as part of the transaction and by comparing their exercise prices to similar options sold separately by the Company.
+Added: For the issuance of ordinary shares we recalculated the amount allocated using publicly available per share values on the date the transaction was announced.
/s/ Ernst & Young LLP
2 unchanged sentences
March 20, 2025
−Removed: Table o f contents
AUTOLUS THERAPEUTICS PLC
1 unchanged sentence
(In thousands, except share and per share amounts)
+Added: Note 2024 2023
Current assets:
Cash and cash equivalents $ 227,380 $ 239,566
+Added: Marketable securities - Available-for-sale debt securities
Restricted cash 1,425 769
+Added: Inventories, net
Prepaid expenses and other current assets 8 67,343 34,967
2 unchanged sentences
Property and equipment, net 9 49,553 34,862
+Added: Intangible assets, net
Prepaid expenses and other non-current assets 170 380
8 unchanged sentences
Operating lease liabilities, current 19 2,998 5,053
+Added: Liabilities related to future royalties and milestones, net - current
Total current liabilities 60,743 44,737
1 unchanged sentence
Operating lease liabilities, non-current 19 49,631 47,914
−Removed: Liability related to future royalties and sales milestones, net
+Added: Liabilities related to future royalties and milestones, net - non-current
12 244,600 170,899
4 unchanged sentences
Ordinary shares, $ 0.000042 par value;
−Removed: 290,909,783 shares authorized at December 31, 2023 and 2022, 174,101,361 and 173,074,510 shares issued and outstanding at December 31, 2023 and 2022
+Added: 490,909,783 shares authorized at December 31, 2024 and 290,909,783 as of December 31, 2023;
+Added: 266,121,689 and 174,101,361 shares issued at December 31, 2024 and 2023, respectively;
+Added: 266,125,337 and 174,158,985 shares outstanding at December 31, 2024 and 2023, respectively
Deferred shares, £ 0.00001 par value;
10 unchanged sentences
The accompanying notes are an integral part of these consolidated financial statements.
−Removed: Table o f contents
AUTOLUS THERAPEUTICS PLC
1 unchanged sentence
(In thousands, except share and per share amounts)
−Removed: (As Restated)
−Removed: (As Restated)
−Removed: Grant income $ — $ 166 $ 823
+Added: Product revenue, net
License revenue 10,120 1,698
+Added: Total revenue, net
+Added: Cost and operating expenses:
+Added: Cost of sales
+Added: Research and development expenses, net
( 138,436 ) ( 130,481 )
−Removed: Operating expenses:
−Removed: Research and development 3
+Added: Selling, general and administrative expenses
( 101,086 ) ( 46,745 )
−Removed: General and administrative ( 46,745 ) ( 31,899 ) ( 31,865 )
Loss on disposal of property and equipment ( 223 ) ( 3,791 )
Impairment of operating lease right-of-use assets and related property and equipment ( 414 ) ( 382 )
−Removed: Total operating expenses, net ( 179,701 ) ( 143,408 ) ( 141,050 )
−Removed: Other income (expense), net 2,861 2,038 ( 145 )
+Added: Loss from operations
+Added: ( 241,426 ) ( 179,701 )
+Added: Other income, net 220 222
+Added: Foreign exchange (losses) gains, net
+Added: ( 989 ) 2,639
Interest income 32,355 13,505
−Removed: Interest expense
+Added: Interest expense, net
( 9,294 ) ( 45,067 )
−Removed: Total other expenses, net ( 28,701 ) ( 5,159 ) ( 988 )
+Added: Total other income (expenses), net
+Added: 22,292 ( 28,701 )
Net loss before income tax ( 219,134 ) ( 208,402 )
−Removed: Income tax benefit (expense)
+Added: Income tax (expense) benefit
( 220,662 ) ( 208,383 )
−Removed: Net loss attributable to ordinary shareholders ( 208,383 ) ( 148,839 ) ( 142,096 )
−Removed: Other comprehensive income (loss):
+Added: Other comprehensive income (loss), net of tax:
Foreign currency exchange translation adjustment 135 9,906
+Added: Unrealized holding losses on available-for-sale debt securities, net of tax of $ 0 and $ 0
+Added: Total other comprehensive income (loss), net of tax
+Added: ( 182 ) 9,906
Total comprehensive loss $ ( 220,844 ) $ ( 198,477 )
4 unchanged sentences
The accompanying notes are an integral part of these consolidated financial statements.
−Removed: Table o f contents
AUTOLUS THERAPEUTICS PLC
−Removed: Consolidated Statements of Shareholders’ Equity
+Added: Consolidated Statements of Changes in Shareholders’ Equity
(In thousands, except share amounts)
2 unchanged sentences
Balance at December 31, 2022 173,074,510 $ 8 34,425 $ — 88,893,548 $ 118 1 $ — $ 1,007,625 $ ( 38,898 ) $ ( 670,179 ) $ 298,674
−Removed: Issuance of ordinary shares, net of issuance costs 38,202,155 1 — — — — — — 228,160 — — 228,161
Share-based compensation expense — — — — — — — — 11,250 — — 11,250
−Removed: Vesting of restricted stock 163,375 — — — — — — — — — — —
−Removed: Exercise of stock options 196,069 — — — — — — — 127 — — 127
−Removed: Issuance of warrants, net of transaction costs — — — — — — — — 9,868 — — 9,868
−Removed: Unrealized loss on foreign currency translation — — — — — — — — — ( 2,709 ) — ( 2,709 )
−Removed: Net loss attributable to ordinary shareholders — — — — — — — — — — ( 142,096 ) ( 142,096 )
−Removed: Balance at December 31, 2021 90,907,830 $ 4 34,425 $ — 88,893,548 $ 118 1 $ — $ 843,108 $ ( 8,570 ) $ ( 521,340 ) $ 313,320
−Removed: Issuance of ordinary shares, net of issuance costs 81,927,012 4 — — — — — — 152,386 — — 152,390
−Removed: Share-based compensation expense — — — — — — — — 12,014 — — 12,014
−Removed: Vesting of restricted stock 76,804 — — — — — — — — — — —
−Removed: Exercise of stock options 162,864 — — — — — — — 117 — — 117
−Removed: Unrealized loss on foreign currency translation — — — — — — — — — ( 30,328 ) — ( 30,328 )
−Removed: Net loss attributable to ordinary shareholders — — — — — — — — — — ( 148,839 ) ( 148,839 )
−Removed: Balance at December 31, 2022 173,074,510 $ 8 34,425 $ — 88,893,548 $ 118 1 $ — $ 1,007,625 $ ( 38,898 ) $ ( 670,179 ) $ 298,674
−Removed: Share-based compensation expense — — — — — — — — 11,250 — — 11,250
Vesting of restricted stock unit awards net of shares withheld to cover tax withholding 1,006,382 — — — — — — — — — — —
2 unchanged sentences
Unrealized gain on foreign currency translation — — — — — — — — — 9,906 — 9,906
−Removed: Net loss attributable to ordinary shareholders
— — — — — — — — — — ( 208,383 ) ( 208,383 )
Balance at Balance at December 31, 2023 174,101,361 $ 8 34,425 $ — 88,893,548 $ 118 1 $ — $ 1,018,902 $ ( 28,992 ) $ ( 878,562 ) $ 111,474
+Added: Issuance of ordinary shares, net of issuance costs of $ 29,360
+Added: 91,666,669 4 — — — — — — 520,613 — — 520,617
+Added: Share-based compensation expense — — — — — — — — 15,475 — — 15,475
+Added: Vesting of restricted stock unit awards net of shares withheld to cover tax withholding 136,824 — — — — — — — — — — —
+Added: Exercise of share options 216,835 — — — — — — — 603 — — 603
+Added: Other comprehensive loss
+Added: — — — — — — — — — ( 182 ) — ( 182 )
+Added: — — — — — — — — — — ( 220,662 ) ( 220,662 )
+Added: Balance at December 31, 2024 266,121,689 $ 12 34,425 $ — 88,893,548 $ 118 1 $ — $ 1,555,593 $ ( 29,174 ) $ ( 1,099,224 ) $ 427,325
The accompanying notes are an integral part of these consolidated financial statements.
−Removed: Table o f contents
AUTOLUS THERAPEUTICS PLC
1 unchanged sentence
(In thousands)
−Removed: 2023 2022 2021
Cash flows from operating activities:
−Removed: Net loss attributable to ordinary shareholders $ ( 208,383 ) $ ( 148,839 ) $ ( 142,096 )
+Added: $ ( 220,662 ) $ ( 208,383 )
Adjustments to reconcile net loss to net cash used in operating activities:
−Removed: Depreciation and amortization 6,565 7,422 8,458
+Added: Depreciation on property and equipment
+Added: Amortization of intangible assets
Loss on disposal of property and equipment 223 3,791
Share-based compensation net of amounts capitalized 15,472 11,204
−Removed: Interest expense accrued on liability related to future royalties and sales milestones, net and cumulative catch-up adjustment
−Removed: 44,999 8,884 1,093
+Added: Interest expense accrued on liabilities related to future royalties and milestones, net
+Added: Accretion of available-for-sale securities
Foreign exchange differences 1,898 ( 7,604 )
Non-cash operating lease expense
−Removed: 4,058 3,432 3,728
−Removed: Loss on lease incentive and reassessment
Loss on termination of operating lease
2 unchanged sentences
Changes in operating assets and liabilities
−Removed: Decrease (increase) in prepaid expenses and other current assets
+Added: (Increase) decrease in prepaid expenses and other current assets
( 33,524 ) 10,695
Decrease in prepaid expenses and other non-current assets
−Removed: 1,726 161 503
−Removed: Decrease (increase) in long-term deposits
−Removed: 937 ( 5 ) 575
−Removed: (Decrease) increase in accounts payable
−Removed: ( 509 ) 22 ( 1,816 )
−Removed: (Decrease) increase in accrued expenses and other liabilities
+Added: Increase in inventories, net
+Added: Decrease in long-term deposits
+Added: Increase (decrease) in accounts payable
1,590 ( 509 )
−Removed: (Decrease) increase in operating lease liability
+Added: Increase in accrued expenses and other liabilities
+Added: Decrease in operating lease liability
( 369 ) ( 13,555 )
1 unchanged sentence
Cash flows from investing activities:
−Removed: Purchases of property and equipment ( 10,986 ) ( 10,841 ) ( 8,857 )
+Added: Acquisition of property and equipment
+Added: ( 22,075 ) ( 10,986 )
+Added: Acquisition of intangibles assets
+Added: Investment in marketable securities:
+Added: available-for-sale debt securities
+Added: ( 359,733 ) —
Net cash used in investing activities ( 394,552 ) ( 10,986 )
Cash flows from financing activities:
−Removed: Proceeds of issuance of ordinary shares — 163,854 245,900
+Added: Proceeds from issuance of ordinary shares
Proceeds from exercise of share options 602 27
−Removed: Proceeds from liability related to future royalties and sales
−Removed: milestones, net
−Removed: — 70,000 50,000
+Added: Proceeds from liabilities related to future royalties and milestones, net
Payments of equity issuance costs ( 29,360 ) ( 910 )
−Removed: Payments of issuance costs related to the liability related to the sale of
−Removed: future royalties and sales milestones, net
−Removed: Net cash (used in) provided by financing activities ( 883 ) 223,610 284,063
+Added: Payments of issuance costs related to the liabilities related to future royalties and milestones, net
+Added: Net cash provided by (used in) financing activities
+Added: 589,554 ( 883 )
Effect of exchange rate changes on cash, cash equivalents and restricted cash ( 261 ) 15,030
−Removed: Net (decrease) increase in cash, cash equivalents and restricted cash ( 142,426 ) 72,085 156,591
+Added: Net decrease in cash, cash equivalents and restricted cash
+Added: ( 11,530 ) ( 142,426 )
Cash, cash equivalents and restricted cash, beginning of period 240,335 382,761
Cash, cash equivalents and restricted cash, end of period $ 228,805 $ 240,335
−Removed: Table o f contents
AUTOLUS THERAPEUTICS PLC
1 unchanged sentence
(In thousands)
−Removed: 2023 2022 2021
Supplemental cash flow information
−Removed: Cash paid for taxes - primarily related to the United States of America
+Added: Cash paid for income taxes
$ ( 2,391 ) $ ( 551 )
+Added: Unrealized gains on marketable securities:
+Added: available-for-sale debt securities
Supplemental non-cash flow information
5 unchanged sentences
Capitalized implementation costs included in accrued expenses
−Removed: $ 564 $ 230 $ 100
Issuance costs included in accounts payable and accrued expenses $ — $ 272
−Removed: Warrants issued in relation to Blackstone Agreements at relative fair
−Removed: $ — $ — $ 9,868
Reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets:
1 unchanged sentence
Restricted cash
+Added: $ 1,425 $ 769
Total cash, cash equivalents and restricted cash
1 unchanged sentence
The accompanying notes are an integral part of these consolidated financial statements.
−Removed: Table o f con tents
AUTOLUS THERAPEUTICS PLC
1 unchanged sentence
Nature of the Business
−Removed: Autolus Therapeutics plc and its subsidiaries (collectively “Autolus” or the “Company”) is a biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer and autoimmune diseases.
−Removed: Using its broad suite of proprietary and modular T cell programming technologies, the Company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and attack and kill these cells.
−Removed: The Company believes its programmed T cell therapies have the potential to be best-in-class and offer cancer patients substantial benefits over the existing standard of care, including the potential for cure in some patients.
+Added: Autolus Therapeutics plc (with its subsidiaries, collectively, “Autolus” or the “Company”) is an early commercial-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer and autoimmune diseases.
+Added: Using its broad suite of proprietary and modular T cell programming technologies, the Company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and attack and kill these cells.
+Added: The Company believes its programmed T cell therapies have the potential to be best-in-class and to offer patients substantial benefits over the existing standard of care, including the potential for cure in some patients.
+Added: On November 8, 2024 Autolus was notified by the U.S.
+Added: Food and Drug Administration (the “FDA”) that its biologics license application (“BLA”) was approved, allowing for the marketing of AUCATZYL (obecabtagene autoleucel, also known as obe-cel) in the US for the treatment of adult patients (18 years and older) with r/r B-ALL.
+Added: Obe-cel is under regulatory review in both the European Union (the “EU”) and the United Kingdom (the “U.K.”) for the treatment of r/r B-ALL, with marketing authorization submissions accepted by the European Medicines Agency (“EMA”) in April 2024, and the U.K.
+Added: Medicines and Healthcare products Regulatory Agency (“MHRA”) in August 2024.
+Added: The Company expects to receive notification of approval status from these authorities in the second half of 2025.
+Added: The commercial launch and first sale of AUCAZTYL in the US occurred in January 2025.
Autolus Therapeutics plc is registered in England and Wales.
Its registered office is The MediaWorks, 191 Wood Lane, London, W12 7FP, United Kingdom.
+Added: The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations.
+Added: The Company’s product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization.
+Added: Although AUCATZYL has been granted marketing approval in the US by the FDA, the Company will continue to incur significant additional costs to commercialize it.
+Added: These efforts will require significant amounts of capital, as well as additional personnel, infrastructure, and compliance capabilities.
+Added: Even if the Company’s product development efforts for obe-cel and its other product candidates are successful, it is uncertain when, if ever, the Company will become profitable.
The Company is a public limited company incorporated under the laws of England and Wales, and qualifies as a “foreign private issuer,” as such term is defined in Rule 405 under the Securities Act of 1933, as amended (the “Securities Act”), and Rule 3b-4 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and, therefore, is not subject to the same requirements that are imposed upon U.S.
5 unchanged sentences
domestic issuers including its officers, directors, and principal shareholders are not subject to the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act.
+Added: BioNTech Agreements
+Added: On February 6, 2024 (the “Execution Date”), the Company concurrently entered into a (i) Securities Purchase Agreement (the “BioNTech Securities Purchase Agreement”), (ii) a Registration Rights Agreement (the “BioNTech Registration Rights Agreement”), (iii) a Letter Agreement (the “BioNTech Letter Agreement”) and (iv) a License and Option Agreement (the “BioNTech License and Option Agreement”), collectively called the “BioNTech Agreements”, with BioNTech.
+Added: The BioNTech Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for these agreements in the aggregate.
+Added: The following descriptions of the BioNTech Agreements do not purport to be complete and are qualified in their entirety by reference to the full text of such agreements.
+Added: (i) BioNTech Securities Purchase Agreement
+Added: Pursuant to the BioNTech Securities Purchase Agreement the Company sold to BioNTech ADSs, each representing one ordinary share with a nominal value of $ 0.000042 per share, of the Company (the “Ordinary Shares”) in a private placement transaction (the “Private Placement”).
+Added: On February 13, 2024, the Company completed the Private Placement of 33,333,333 ADSs (the “Initial ADSs”) , representing 33,333,333 Ordinary Shares at an offering price of $ 6.00 per Initial ADS.
+Added: Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $ 193.8 million.
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
+Added: In the event that BioNTech and the Company enter into a Manufacturing and Commercial Services Agreement (as defined below) within 18 months of the initial closing of the Private Placement, BioNTech will purchase additional ADSs (the “Subsequent ADSs” and, together with the Initial ADSs, the “Private Placement ADSs”), not to exceed 15,000,000 ADSs, for an aggregate purchase price of up to $ 20.0 million.
+Added: The total number of Subsequent ADSs that may be issued is subject to additional limitations and restrictions.
+Added: The BioNTech Securities Purchase Agreement contains customary representations, warranties, and covenants of each of the Company and BioNTech.
+Added: (ii) BioNTech Registration Rights Agreement
+Added: Pursuant to the BioNTech Registration Rights Agreement the Company agreed to file a registration statement with the SEC to register the resale of the Private Placement ADSs.
+Added: (iii) BioNTech Letter Agreement
+Added: The BioNTech Letter Agreement provides BioNTech with certain additional rights and subjects BioNTech’s investment in the Company to certain restrictions.
+Added: BioNTech received the right to nominate a director to the Company’s board of directors.
+Added: If BioNTech acquires beneficial ownership of at least 30 % of the issued and outstanding Ordinary Shares of the Company (including in the form of ADSs) within five years of the Execution Date, BioNTech will have the right to designate an additional director who shall be independent.
+Added: BioNTech’s director nomination rights shall automatically terminate upon BioNTech’s ownership of Ordinary Shares dropping below certain specified percentages.
+Added: Additionally, BioNTech has the right to purchase equity securities sold by the Company in bona fide financing transactions in amounts that are based on BioNTech maintaining specified ownership thresholds following such financing transactions.
+Added: Subject to specified exceptions, BioNTech may not sell the Private Placement ADSs without the Company’s approval for a period of six months following the applicable closing date for such ADSs.
+Added: The BioNTech Letter Agreement terminates upon the earlier of (a) the later of (i) February 6, 2027 and (ii) such time as no securities of the Company are held by BioNTech or its affiliates and (b) the consummation of a change of control transaction involving the Company.
+Added: (iv) BioNTech License and Option Agreement
+Added: License and Options
+Added: The Company, through its wholly owned subsidiaries, Autolus Limited and Autolus Holdings (U.K.) Limited, entered into the BioNTech License and Option Agreement with BioNTech pursuant to which the Company granted to BioNTech:
+Added: • an exclusive, worldwide, sublicensable license (the “Binder License”) to certain binders and to exploit products that express in vivo such binders (collectively, the “Binder Licensed Products”), and
+Added: • several time-limited options (the “Options”) to acquire additional rights to specified clinical-stage product candidates, binders and technologies of the Company, described in more detail below:
+Added: ◦ an option to obtain exclusive rights to co-fund development costs of the Company’s development-stage programs AUTO1/22 and AUTO6NG (“Product Options”), in return for agreed upon economic terms, including an option exercise fee, milestone payments and a profit-sharing arrangement for each such product candidate, with additional options to co-promote or co-commercialize each such product candidate.
+Added: The product option for AUTO1/22 was not exercised and has expired as of February 8, 2025;
+Added: ◦ an option to obtain an exclusive worldwide license to exploit products that express certain additional binders in vivo or, with respect to certain binders, in an antibody drug conjugate (the “Binder Option”);
+Added: ◦ an option to obtain a co-exclusive worldwide license to exploit products that express in vivo the Company’s modules for activity enhancement, with a non-exclusive right, in certain agreed instances, to exploit products that include Company’s modules for activity enhancement but do not express in vivo such modules (the “Activity Enhancement Option”);
+Added: ◦ an option to obtain a non-exclusive worldwide license to exploit products that contain the Company’s safety switches (the “Safety Switch Option” and, together with the Binder Option and the Activity Enhancement Option, the “Technology Options”).
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
+Added: In consideration for the Binder License and the Technology Options, BioNTech made an initial payment to the Company of $ 10.0 million.
+Added: In the event that all Options are fully exercised, the Company would be eligible to receive maximum aggregate payments of up to $ 582.0 million pursuant to the License Agreement.
+Added: This maximum amount includes the potential milestone payments for the Binder Licensed Products described below, all option exercise fees and potential milestone payments for licenses to optioned products and technologies, and additional payments that BioNTech may pay to the Company for an increased revenue interest with respect to the Company’s product candidate obe-cel as described below.
+Added: The option exercise fee for each Technology Option is a low seven-digit amount.
+Added: Each of the Activity Enhancement Option and the Safety Switch Option must be exercised with respect to a given biological target or combination of targets.
+Added: There is a cap on the total option exercise fee if multiple options are exercised with respect to a given target.
+Added: There is also a cap on milestone payments across all agreements entered into as the result of BioNTech exercising one or more of the Technology Options and a cap on the royalty rate payable on any given product for which multiple Options are exercised.
+Added: Obe-cel Product Revenue Interest
+Added: Under the License Agreement, BioNTech has also agreed to financially support the expansion of the clinical development program and planned commercialization of obe-cel (through a revenue sharing arrangement) .
+Added: In exchange for the grant of rights to future revenues from the sales of obe-cel products, BioNTech made an upfront payment to us of $ 40.0 million.
+Added: The Company will pay BioNTech a low single-digit percentage of annual net sales of obe-cel products, including revenues from sales of AUCATZYL, which may be increased up to a mid-single digit percentage in exchange for milestone payments of up to $ 100.0 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech's election.
+Added: The Company expects to make initial payments of the revenue interest to BioNTech in 2025.
+Added: Manufacturing and Commercial Services Agreement
+Added: Under the terms of the BioNTech License and Option Agreement, the Company has agreed to grant BioNTech the option to negotiate a joint manufacturing and commercial services agreement pursuant to which the parties may access and leverage each other’s manufacturing and commercial capabilities, in addition to Autolus’ commercial site network and infrastructure, with respect to certain of each parties’ CAR T products, including BioNTech’s product candidate BNT211 (the “Manufacturing and Commercial Services Agreement” or “MCSA”).
+Added: The MCSA, if entered into, would also grant BioNTech access to the Company’s commercial site network and infrastructure.
+Added: The Company concluded there were four freestanding financial instruments arising from the execution of the BioNTech Agreements, comprising:
+Added: the Initial ADSs representing ordinary shares purchased pursuant to the BioNTech Securities Purchase Agreement;
+Added: the potential Subsequent ADSs representing ordinary shares that may be purchased pursuant to the BioNTech Securities Purchase Agreement;
+Added: the BioNTech License and Option Agreement, and
+Added: The Subsequent ADSs are classified as a forward instrument contingent on the MCSA being executed.
+Added: As of December 31, 2024, the MCSA had not been entered into.
+Added: The forward instrument has an inconsequential market value as the exercise price approximates the Company’s stock price on the last trading day prior to the signing date of the MCSA.
+Added: Consequently, the initial proceeds arising from the purchase of Initial ADSs pursuant to the BioNTech Securities Purchase Agreement will not be separately allocated to this freestanding financial instrument at inception of the BioNTech Agreements.
+Added: Furthermore, as the MCSA has yet to be entered into no consideration will be allocated to this freestanding financial instrument at inception of the BioNTech Agreements.
+Added: Within the BioNTech License and Option Agreement, there are a number of embedded features which have each been assessed for freestanding financial instrument accounting in accordance with Accounting Standards Codification ( “ ASC ” ) 480 – Distinguishing Liabilities from Equity .
+Added: Although these embedded features are separately exercisable, they lack legal detachability and, therefore, the BioNTech License and Option Agreement is accounted for as one freestanding financial instrument.
+Added: However, each embedded feature is assessed for derivative accounting in accordance to ASC 815 – Derivative and Hedging (“ASC 815”) .
+Added: The Company analyzed how it should account for the host contract (i.e., the BioNTech License and Option Agreement) as the Binder License represents an agreement with customer for goods and services and therefore should be accounted for under ASC 606 – Revenue from Contracts with Customers (“ASC 606”) .
+Added: However, as the other embedded features of the BioNTech License and Option Agreement fall under the scope of other topics that specify how to initially measure the contract (i.e., ASC 470 – Debt (“ASC 470”) ), the Company determined that the host contract should not be accounted for and initially measured pursuant to ASC 606.
+Added: Furthermore, the Company determined the host contract (the BioNTech License and Option Agreement) met the scope exception of ASC 815-10-15-59(d) and therefore should not be accounted for as a derivative under ASC 815 but instead be accounted for as a debt financial instrument in accordance with ASC 470.
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
+Added: The four units of accounting were recorded at fair value upon initial recognition and will not be subsequently measured at fair value.
+Added: The Company allocated the total gross proceeds arising from the BioNTech Securities Purchase Agreement (i.e., the Initial ADSs representing ordinary shares), and the BioNTech License and Option Agreement among the four units of accounting on a relative fair value basis at the time of the transaction as follows:
+Added: Units of Accounting Gross proceeds (in millions)
+Added: Initial fair value
+Added: (in millions)
+Added: Allocated consideration based on relative fair value
+Added: (in millions)
+Added: Net allocated consideration based on relative fair value after transaction costs*
+Added: (in millions)
+Added: Initial ADSs, representing ordinary shares
+Added: $ 200.0 $ 200.0 $ 200.0 $ 193.8
+Added: Subsequent ADSs, representing ordinary shares
+Added: $ — $ — $ — $ —
+Added: BioNTech License and Option Agreement
+Added: $ 50.0 $ 50.0 $ 50.0 $ 47.9
+Added: Liabilities related to future royalties and milestones, net ( Obe-cel Product Revenue Interest )
+Added: $ 40.0 $ 40.0 $ 40.0 $ 38.3
+Added: License Revenue (Binder License)
+Added: $ 10.0 $ 10.0 $ 10.0 $ 9.6
+Added: $ — $ — $ — $ —
+Added: Total $ 250.0 $ 250.0 $ 250.0 $ 241.7
+Added: * In addition, the total shared transaction costs of $ 8.3 million, relating to the BioNTech Agreements have been allocated to the four units of accounting on a relative fair value basis.
Summary of Significant Accounting Policies
4 unchanged sentences
Going concern
−Removed: In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the financial statements are issued.
−Removed: As of December 31, 2023, the Company held cash and cash equivalents of $ 239.6 million and a net loss attributable to ordinary shareholders for the year the ended December 31, 2023 of $ 208.4 million.
+Added: In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued.
+Added: Management considers that there are no conditions or events, in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for a period of at least one year from the date the consolidated financial statements are issued.
+Added: The Company has incurred losses o f $ 220.7 million and $ 208.4 million for the years ended December 31, 2024 and 2023, respectively.
As of December 31, 2024, the Company had an accumulated deficit of $ 1,099.2 million .
−Removed: The Company concluded with its existing cash and cash equivalents of $ 239.6 million together with the total aggregate gross proceeds received post year end of $ 600.0 million ($ 250.0 million and $ 350.0 million received from BioNTech SE and an underwritten offering, respectively as further details described in Note 24 - Subsequent events) that it can fund its operations for at least the next twelve months from the date of issuance of these financial statements and as such has prepared the consolidated financial statements on the going concern basis.
+Added: The Company has funded its operations to date primarily with proceeds from the sale of its equity securities, including ADSs, licensing and collaboration arrangements and strategic financing.
As the Company continues to incur losses, the transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support its cost structure.
1 unchanged sentence
Use of estimates
−Removed: The preparation of consolidated financial statements in conformity with U.S.
−Removed: GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of income and expenses during the reporting periods.
−Removed: Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses, share-based compensation including assessing the probability of meeting performance conditions, income taxes, initial fair value of warrants, and accrued interest expense on liability related to future royalties and sales milestones, net and related cumulative catch-up adjustment, initial lease term of the Company's new manufacturing facility (The Nucleus), and incremental borrowing rates related to the Company's leased properties.
+Added: The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of income and expenses during the reporting periods.
+Added: Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses, share-based compensation including assessing the probability of meeting performance conditions, income taxes, initial fair value of warrants, and present value of liabilities related to future royalties and milestones, net including the related interest expense and cumulative catch-up adjustment, lease term of the Company’s manufacturing facility (“The Nucleus ” ), incremental borrowing rates related to the Company ’ s leased properties and allocation of transaction price using the relative standalone selling price.
Estimates are periodically reviewed in light of changes in circumstances, facts and experience.
3 unchanged sentences
Segment Information
−Removed: Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker in deciding how to allocate resources and assess performance.
−Removed: The Company and the Company’s chief operating decision maker, the Company’s Chief Executive Officer, view the Company’s operations and manages its business as a single operating segment, which is the business of developing and commercializing CAR T therapies.
−Removed: Cash and cash equivalents
−Removed: The Company considers cash and cash equivalents in the consolidated financial statements to include cash and highly liquid investments at financial institutions.
−Removed: The Company invests in variety of short-term interest-bearing instruments including money market funds, which are subject to an insignificant risk of changes in value.
−Removed: Cash equivalents are primarily accessible on demand and have a weighted average maturity date of less than 95 days.
−Removed: Restricted Cash
−Removed: The Company's restricted cash consists of cash providing security for corporate credit cards, rental deposits relating to the sub-lease of facilities to third parties and cash deposited with a financial institution for the incorporation of the Company's newly incorporated Swiss subsidiary.
−Removed: The Company has a security deposit relating to entered into a credit card arrangement with one of its financial institutions amounting to $ 0.6 million.
−Removed: In October 2021, the Company entered into two sub-leasing agreements relating to the Enfield facility, which require aggregate rental deposits of $ 0.1 million to be held by the Company.
−Removed: The cash deposited with a financial institution for the incorporation of Company's newly incorporated Swiss subsidiary amounted to $ 0.1 million
+Added: The Company’s chief operating decision maker (the “CODM”), its Chief Executive Officer and Executive Team members, manages the Company’s operations on an integrated basis for the purpose of appropriately allocating resources.
+Added: When evaluating the Company’s financial performance, the CODM reviews total revenue, total expenses and expenses by function and makes decisions using this information on a global basis.
+Added: The Company and the CODM view the Company’s operations and manage its business as a single operating and reportable segment, which is the business of developing and commercializing CAR T therapies.
+Added: Foreign Currency Translation
+Added: The reporting currency of the Company is in U.S.
+Added: The Company has determined that its functional currency of the ultimate parent company, Autolus Therapeutics plc, is British Pound Sterling.
+Added: The functional currency of each subsidiary’s operations is the applicable local currency.
+Added: Monetary assets and liabilities denominated in currencies other than the Company’s functional currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates.
+Added: Non-monetary assets and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the date of the transaction.
+Added: Translation adjustments are not included in determining net income (loss) but are included in foreign currency translation to other comprehensive loss, a component of shareholders’ equity.
+Added: The Company recorded a foreign exchange loss of $ 1.0 million and a foreign exchange gain of $ 2.6 million for the years ended December 31, 2024 and 2023, respectively, which are included in foreign exchange (losses) gains in the consolidated statements of operations and comprehensive loss.
Fair Value Measurements
5 unchanged sentences
• Level 3 — Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability.
−Removed: The carrying amounts reported in the balance sheet for cash and cash equivalents, restricted cash, prepaid expenses and other assets, accounts payable and accrued expenses and other liabilities approximate their fair value because of the short-term nature of these instruments.
−Removed: Concentration of Credit Risk
−Removed: Financial instruments that subject the Company to credit risk consist primarily of cash and cash equivalents and restricted cash.
−Removed: The Company places cash and cash equivalents and restricted cash with established financial institutions with strong credit ratings.
−Removed: The Company holds significant amounts of cash and cash equivalents that are in excess of federally insured limits in various currencies, placed with one or more financial institutions for varying periods according to expected liquidity requirements.
−Removed: The Company's cash and cash equivalents are held with multiple banks and financial institutions.
−Removed: Management monitors the credit rating of those banks and financial institutions on a regular basis.
−Removed: The Company has no significant off-balance-sheet risk or concentration of credit risk, such as foreign exchange contracts, options contracts, or other foreign hedging arrangements.
−Removed: Implementation Costs in a Cloud Computing Arrangement
−Removed: The Company’s cloud computing arrangements primarily comprise hosting arrangements which are service contracts, whereby the Company gains remote access to use enterprise software hosted by the vendor or another third party on an as-needed basis for a period of time in exchange for a subscription fee.
−Removed: Implementation costs for cloud computing arrangements are capitalized if certain criteria are met and consist of internal and external costs directly attributable to developing and configuring cloud computing software for its intended use.
−Removed: These capitalized implementation costs are presented in the consolidated balance sheet in prepaid expenses and other assets, current and non-current, and are generally amortized over the fixed, non-cancellable term of the associated hosting arrangement on a straight-line basis.
+Added: The carrying amounts reported in the consolidated balance sheet for cash and cash equivalents, restricted cash, prepaid expenses and other assets, accounts payable and accrued expenses and other liabilities approximate their fair value because of the short-term nature of these instruments.
+Added: Cash and cash equivalents
+Added: The Company considers all highly liquid investments with a maturity at acquisition date of three months or less to be cash equivalents.
+Added: Cash and cash equivalents comprise cash balances, money market funds, commercial paper, U.K.
+Added: government gilt, debt securities issued by foreign government and US treasury bills.
+Added: Cash equivalents are primarily accessible on demand and have a weighted average maturity date of less than three months.
+Added: Restricted Cash
+Added: The Company's restricted cash consists of cash providing security for corporate credit cards, rental deposits relating to the sub-lease of facilities to third parties and cash deposited with a financial institution for the incorporation of the Company's newly incorporated Swiss subsidiary.
+Added: Marketable securities:
+Added: available for sale debt securities
+Added: The Company invests excess cash balances in marketable debt securities.
+Added: The Company classifies investments in marketable debt securities as available-for-sale.
+Added: Management determines the appropriate classification of its investments in available-for-sale debt securities at the time of purchase and reevaluates such designation as of each reporting date.
+Added: The Company reports available-for-sale debt securities at fair value at each balance sheet date, and includes any unrealized holding gains and losses (the adjustment to fair value) in accumulated other comprehensive income (loss), a component of shareholders’ equity.
+Added: Realized gains and losses are determined using the specific-identification method, and are included in other income, net in the consolidated statements of operations and comprehensive loss.
+Added: Interest income and amortization of premiums and discounts at acquisition are included in Interest income.
+Added: The Company classifies available-for-sale debt securities as current or non-current based on management’s intentions.
AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
−Removed: Property and Equipment
+Added: The Company evaluates securities for impairment at the end of each reporting period.
+Added: Impairment is evaluated considering numerous factors, and their relative significance varies depending on the situation.
+Added: Factors considered include whether a decline in fair value below the amortized cost basis is due to credit-related factors or non-credit-related factors, the financial condition and near-term prospects of the issuer, and the Company's intent and ability to hold the investment to allow for an anticipated recovery in fair value.
+Added: A credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings.
+Added: Any impairment that is not credit- related is recognized in other comprehensive income (loss), net of applicable taxes.
+Added: Inventories, net
+Added: The Company commences capitalization of inventory once regulatory approval is received.
+Added: Until this date, the Company expenses all such costs as incurred as research and development expenses.
+Added: The Company capitalizes material costs, labor and applicable overheads that are incurred in the production of its commercial product.
+Added: Inventory that can be used for either clinical, research or commercial purposes is classified initially as inventory.
+Added: Inventory that is subsequently used in clinical trials or research activities is expensed once it has been used for research and development purposes.
+Added: On November 8, 2024, the Company received FDA approval for AUCATZYL and commenced capitalization of inventory from this date.
+Added: There is no pre-launch inventory recognized on the balance sheet as of December 31, 2024.
+Added: Inventories are measured at the lower of cost or net realizable value, with cost determined using weighted average method for different components of inventory.
+Added: The Company reviews the recoverability of inventory at each reporting period to determine any changes to net realizable value arising from excess, slow-moving or obsolete inventory.
+Added: If net realizable value is lower than cost, the inventory will be written down to net realizable value and an impairment charge will be recognized in cost of sales.
+Added: Accounts receivable
+Added: Accounts receivable are recorded at the invoiced amount and do not bear interest.
+Added: Amounts collected on accounts receivable are included in net cash used by operating activities in the consolidated statements of cash flows.
+Added: Accounts receivable are recorded within prepaid expenses and other current assets on the balance sheet.
+Added: Property and Equipment, net
Property and equipment are recorded at cost and depreciated or amortized using the straight-line method over the estimated useful lives of the respective assets.
14 unchanged sentences
If such asset is considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying value of the asset exceeds the fair value.
−Removed: The Company recognized an impairment of long-lived asset s located in the United Kingdom amounting to $ 0.4 million for the year ended December 31, 2023.
−Removed: The Company did not recognize any impairment of long-lived assets for the year ended December 31, 2022 and 2021 .
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
+Added: Milestone payments made to third parties either on or subsequent to regulatory approval are capitalized as an intangible asset and amortized over the remaining useful life of the product.
+Added: During the year ended December 31, 2024 the Company recognized a license milestone payment $ 12.5 million as an intangible asset due to the technology having alternative future use in research and development projects at the time of the payment.
+Added: The minimum annual royalties have been expensed as incurred.
+Added: Implementation Costs in a Cloud Computing Arrangement
+Added: The Company’s cloud computing arrangements primarily comprise hosting arrangements which are service contracts, whereby the Company gains remote access to use enterprise software hosted by the vendor or another third party on an as-needed basis for a period of time in exchange for a subscription fee.
+Added: Implementation costs for cloud computing arrangements are capitalized if certain criteria are met and consist of internal and external costs directly attributable to developing and configuring cloud computing software for its intended use.
+Added: These capitalized implementation costs are presented in the consolidated balance sheet in prepaid expenses and other assets, current and non-current, and are generally amortized over the fixed, non-cancellable term of the associated hosting arrangement on a straight-line basis.
At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present.
7 unchanged sentences
In accordance with the guidance in Topic 842, Leases (“ASC 842”), components of a lease should be split into three categories:
−Removed: lease components ( e.g.
−Removed: , land, building, etc.) and non-lease components ( e.g.
−Removed: , common area maintenance, consumables, etc).
+Added: lease components (e.g., land, building, etc.) and non-lease components (e.g., common area maintenance, consumables, etc.).
Many of the Company's leases contain variable non-lease components such as maintenance, taxes, insurance, and similar costs for the spaces it occupies.
3 unchanged sentences
The Company determined the underlying lease to be the predominant component, and therefore, the entire agreement was accounted for under ASC 842.
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
The Company identified and assessed the following significant assumptions in recognizing its right-of-use assets and corresponding lease liabilities during the adoption of ASC 842:
4 unchanged sentences
• Since the Company elected to account for the classes of underlying assets and its associated non-lease components as a single combined lease component, all contract consideration was allocated to the combined lease component.
−Removed: Intangible Assets Subject to Amortization
−Removed: The Company’s intangible assets have been related to acquired software licenses with finite lives which are amortized over their useful lives and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable.
−Removed: If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset.
−Removed: If those net undiscounted cash flows do not exceed the carrying amount ( i.e.
−Removed: , the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any.
−Removed: The Company evaluates the useful lives for these intangible assets each reporting period to determine whether events and circumstances warrant a revision in their remaining useful lives.
−Removed: At December 31, 2023 and 2022 these intangible assets were fully amortized.
−Removed: R esearch and Development Costs
−Removed: Research and development (“R&D”) costs are expensed as incurred.
−Removed: R&D expenses consist of costs incurred in performing R&D activities, including salaries, share-based compensation and benefits, depreciation expense, third-party license fees, external costs of outside vendors engaged to conduct clinical development activities, clinical trials, costs to manufacture clinical trial materials and certain tax credits associated with research and development activities.
−Removed: UK Research and Developments Tax Credits
−Removed: As a company that carries out extensive R&D activities, the Company benefits from research and development tax credits in the UK.
−Removed: The Company claims UK research and development tax credits under the regimes for small or medium-sized enterprises (“SME R&D tax credit”), and UK Research and Development Expenditure Credit (“RDEC”), to the extent that the Company's projects are grant funded.
−Removed: The UK research and development tax credits are fully refundable to the Company and are not dependent on current or future taxable income.
−Removed: As a result, the Company records the entire benefit from the UK research and development tax credits as a benefit, which is included in net loss before income tax and accordingly, not reflected as part of the income tax provision.
−Removed: If, in the future, any UK research and development tax credits generated are needed to offset a corporate income tax liability in the UK, that portion would be recorded as a benefit within the income tax provision and any refundable portion not dependent on taxable income would continue to be recorded as a reduction of research and development expenses.
−Removed: The benefits from UK research and development tax credits are recognized in the statements of operations and comprehensive loss as a reduction of research and development expenses and represents the sum of the research and development tax credits recoverable in the UK.
−Removed: The SME regime has been particularly beneficial to the Company, as under such program the trading losses that arise from the Company's qualifying R&D activities can be surrendered for a cash rebate of up to 33.35% of qualifying expenditure incurred prior to April 1, 2023 and decreasing to 18.6% after April 1, 2023.
−Removed: Additionally, the UK Government has enacted further changes to the SME regime on March 4, 2024 which include the introduction of a new rate for R&D intensive companies of 27% (which the Company may qualify for) and comes into effect for expenditures incurred after April 1, 2024.
−Removed: Qualifying expenditures largely comprise of employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects for which the Company do not receive income.
−Removed: A large proportion of costs in relation to the Company's pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by its wholly owned subsidiary Autolus Limited, are eligible for inclusion within these tax credit cash rebate claims.
AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
−Removed: Under the RDEC Program, tax credits for qualifying R&D expenditure incurred prior to April 1, 2023 are granted at a headline rate of 13% and can generate cash rebates of up to 10.5% of qualifying R&D expenditure.
−Removed: The headline rate of RDEC increased to 20% on April 1, 2023 and can generate cash rebates of up to 15% on qualifying R&D expenditure incurred from this date.
−Removed: Amendments to the current SME and RDEC programs that are contained in the Finance Bill currently proceeding through the UK Parliament will take effect from periods on or after April 1, 2024 and will (i) (unless limited exceptions apply) introduce restrictions on the tax relief that can be claimed for expenditure incurred on sub-contracted R&D activities or externally provided workers, where such sub-contracted activities are not carried out in the UK or such workers are not subject to UK payroll taxes, and (ii) merge the SME regime and the RDEC regime into a single scheme which would generate net cash benefit of up to 15% of the qualifying expenditure for profit making companies and up to 16.2% for loss making companies.
−Removed: The Company currently meet the conditions of the SME regime, but also can make claims under the RDEC regime to the extent that our projects are grant funded.
−Removed: In addition, the Company may meet the conditions of the R&D intensive scheme and may be able to make claims under merged SME R&D intensive regime.
−Removed: The Company may not be able to continue in the future to qualify as a small or medium-sized enterprise under the SME Regime, based on size criteria concerning employee headcount, turnover and gross assets.
−Removed: If the Company ceases to qualify under the SME regime, the Company may make a claim under the RDEC regime for periods ending December 31, 2024, or the merged R&D regime from period ending December 31, 2025.
−Removed: It should be noted, however, that the types of qualifying expenditure in respect of which the Company may make claims under the RDEC regime are more restricted than under the SME regime (for example, it may be the case that certain subcontracted costs in respect of which claims may be made under the SME regime do not qualify for relief under the RDEC regime).
−Removed: R&D tax credits of $ 19.5 million, $ 24.6 million and $ 24.0 million were recognized for the years ended December 31, 2023, 2022 and 2021 , respectively, and are recorded as offsets to research and development expense in our consolidated statement of operations and comprehensive loss.
Accrued Research and Development Expenses
5 unchanged sentences
The Company makes judgments and estimates in determining the accrued balance in any accounting period.
−Removed: Share-Based Compensation
−Removed: The Company recognizes share-based compensation expense for equity awards based on the grant date fair value of the award.
−Removed: The Company recognizes share-based compensation expense for awards granted to employees and non-employees that have a graded vesting schedule based on a service condition only on a straight-line basis over the requisite service period for each separately vesting portion of the award as if the award was, in substance, multiple awards (the “graded-vesting attribution method”), based on the estimated grant date fair value for each separately vesting tranche.
−Removed: For equity awards with a graded vesting schedule and a combination of service and performance conditions, the Company recognizes share-based compensation expense using a graded-vesting attribution method over the requisite service period when the achievement of a performance-based milestone is probable, based on the relative satisfaction of the performance condition as of the reporting date.
−Removed: For performance conditions related to regulatory approvals those regulatory approvals are deemed probable when actually achieved.
−Removed: The Company accounts for forfeitures as they occur.
−Removed: The fair value of each share option grant is estimated on the date of grant using the Black-Scholes option pricing model.
−Removed: See Note 14, “ Share-based compensation ” , for the Company’s assumptions used in connection with share option grants made during the periods covered by these consolidated financial s tatements.
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
−Removed: Assumptions used in the option pricing model include the following:
−Removed: ▪ Expected volatility.
−Removed: The Company lacks company-specific historical and implied volatility information for the Company's ADSs for expected terms greater than 5.5 years.
−Removed: Therefore, it uses a combination of the historical volatility of the ADSs and also the expected share volatility based on the historical volatility of publicly traded peer companies and expect to continue to do so until such time as the Company has adequate historical data regarding the volatility of its own traded ADS price.
−Removed: ▪ Expected term .
−Removed: The expected term of the Company’s share options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options.
−Removed: ▪ Risk-free interest rate .
−Removed: The risk-free interest rate is determined by reference to the U.S.
−Removed: Treasury yield curve in effect at the time of grant of the award for time periods that are approximately equal to the expected term of the award.
−Removed: ▪ Expected dividend.
−Removed: Expected dividend yield of zero is based on the fact that the Company has never paid cash dividends on ordinary shares and does not expect to pay any cash dividends in the foreseeable future.
−Removed: ▪ Fair value of ordinary shares.
−Removed: The fair market value of the Company’s ADSs underlying the share option is equal to the closing price of the ADSs on the Nasdaq Global Select Market on the date the grant is approved by the Compensation Committee or delegate of the Compensation Committee.
−Removed: Foreign Currency Translation
−Removed: The Company maintains its accounting records in its functional currency, which is pound sterling.
−Removed: Monetary assets and liabilities denominated in currencies other than the functional currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates.
−Removed: Non-monetary assets and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the date of the transaction.
−Removed: Exchange gains or losses arising from foreign currency transactions are included in the determination of net income (loss) for the respective periods.
−Removed: The Company recorded a foreign exchange gain of $ 2.6 million and $ 1.8 million for the year ended December 31, 2023 and 2022, respectively, and a foreign exchange loss of $ 2.3 million for the years ended December 31, 2021.
−Removed: Foreign exchange gains and losses are included in other income (expense), net in the consolidated statements of operations and comprehensive loss.
−Removed: For financial reporting purposes, the financial statements of the Company have been translated into U.S.
−Removed: Assets and liabilities have been translated at the exchange rates at the balance sheet dates, while revenue and expenses are translated at the average exchange rates over the reporting period and shareholders’ equity amounts are translated based on historical exchange rates as of the date of each transaction.
−Removed: Translation adjustments are not included in determining net income (loss) but are included in foreign exchange adjustment to other comprehensive loss, a component of shareholders’ equity.
−Removed: The Company expenses patent prosecution and related legal costs as they are incurred and classifies such costs as general and administrative expenses in the accompanying statements of operations and comprehensive loss.
−Removed: The Company has received research grants under which it is reimbursed for specific research and development activities.
−Removed: Payments received are recognized as income in the statements of operations and comprehensive loss over the period in which the Company recognizes the related costs.
−Removed: At the time the Company recognizes grant income, it has complied with the conditions attached to it and the receipt of the reimbursement is reasonably assured.
−Removed: The Company has received grants from the UK government, which are repayable under certain circumstances, including breach or noncompliance.
−Removed: For grants with refund provisions, the Company reviews the grant to determine the likelihood of repayment.
−Removed: If the likelihood of repayment of the grant is determined to be remote, then the grant is recognized as grant income.
−Removed: The Company has determined that the likelihood of any repayment events included in its current grants is remote.
−Removed: Interest Income
−Removed: Interest income arises on the Company's cash and cash equivalents including money market funds and short-term deposits.
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
+Added: Liabilities related to future royalties and milestones, net and related interest expense accrued on liabilities related to future royalties and milestones, net and cumulative catch-up adjustment
+Added: The Company accounted for the Blackstone Collaboration Agreement (“Blackstone Collaboration Agreement Liability”) and the BioNTech Obe-cel Product Revenue Interest, (“BioNTech Liability”) as liabilities measured at amortized cost based on an effective interest rate determined at the outset of the arrangement.
+Added: The Blackstone Collaboration Agreement Liability is measured based on the Company's current estimates of the timing and amount of expected future royalty and milestone payments to be paid and the Blackstone Development Payments expected to be received over the estimated term of the agreement.
+Added: Similarly, the BioNTech Liability is measured based on the Company's current estimates of the timing and amount of expected future royalty expected to be paid over the estimated term of the agreement.
+Added: Milestone payments (“BioNTech Milestone Payments”) pursuant to the BioNTech License and Option Agreement are payable upon BioNTech's election, and therefore have not been included in the determination of the effective interest rate or in the measurement of the liability.
+Added: The liabilities are amortized using the effective interest rate, resulting in recognition of interest expense over the estimated term of the agreement.
+Added: Each reporting period the Company assesses the estimated probability, timing and amount of the future expected royalty, milestone payments, over the estimated term.
+Added: If there are changes to the estimates, the Company recognize the impact to the liability’s amortization schedule and the related interest expense using the catch-up method.
+Added: The imputed rate of interest on the unamortized portion of the Blackstone Collaboration Agreement Liability was approximately 15.80 % as of December 31, 2024 and 2023, respectively.
+Added: The imputed rate of interest on the unamortized portion of the BioNTech Liability was approximately 28.70 % as of February 6, 2024, the execution date of the BioNTech Agreements and December 31, 2024 respectively.
+Added: The Company's estimate of the probability, timing and amount of expected future royalties and milestones to be paid by the Company, considers significant unobservable inputs.
+Added: These inputs include regulatory approval, the estimated patient population, estimated selling price, estimated sales volumes, estimated peak sales and sales ramp, timing of the expected launch and its impact on the royalties as well as the overall probability of success.
+Added: Additionally, the transaction costs associated with the liability will be amortized to interest expense over the estimated term of the agreements.
+Added: The carrying amount of the Blackstone Collaboration Agreement Liability and BioNTech Liability is based on the Company's estimate of the future royalties, milestones to be paid to Blackstone by the Company and the expected Blackstone Development Payment to be received over the life of the arrangement as discounted using the initial effective interest rate.
+Added: On a quarterly basis, the Company assesses the amount and timing of expected royalty using a combination of internal projections and forecasts from external sources.
+Added: The excess or deficit of estimated present value of future royalty, milestone payments and the future Blackstone Development Payment received over the carrying amount is recognized as a cumulative catch-up adjustment within interest expense, net using the effective interest rate.
+Added: The Company will recognize the relevant portion of royalties or sales milestones due to Blackstone and BioNTech upon the commercialization of AUCATZYL or other products as a decrease to the applicable liabilities, with a corresponding reduction in cash.
License Revenue
8 unchanged sentences
and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
License Fees and Multiple Element Arrangements
22 unchanged sentences
This includes an assessment of the probability that all or some of the milestone revenue could be reversed when the uncertainty around whether or not the achievement of each milestone is resolved, and the amount of reversal could be significant.
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
GAAP provides factors to consider when assessing whether variable consideration should be constrained.
3 unchanged sentences
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
−Removed: Accounts receivable
−Removed: Accounts receivable are recorded at the invoiced amount and do not bear interest.
−Removed: Amounts collected on accounts receivable are included in net cash used by operating activities in the consolidated statements of cash flows.
−Removed: Accounts receivable are recorded within prepaid expenses and other current assets on the balance sheet.
−Removed: Liability Related to Future Royalties and Sales Milestones, net and related interest expense accrued on liability related to future royalties and sales milestones, net and cumulative catch-up adjustment
−Removed: The Company accounted for the Blackstone Collaboration Agreement (as defined in Note 11, “Liability relating to future royalties and sales milestones, net”) as a liability.
−Removed: The carrying amount of the Blackstone Collaboration Agreement liability is based on the Company’s estimate of the future royalties and sales milestones to be paid to Blackstone and the Blackstone Development Payments (as defined in the Blackstone Collaboration Agreement) to be received over the life of the arrangement as discounted using an effective interest rate.
−Removed: The excess estimated present value of future royalties and sales milestone payments over the initial carrying amount and future Blackstone Development Payments received, is recognized as a cumulative catch-up method within interest expense using the initial effective interest rate.
−Removed: The imputed rate of interest on the unamortized portion of the Blackstone Collaboration Agreement liability was approximately 15.80 % as of December 31, 2023, 2022, and 2021, respectively.
−Removed: At each reporting period, the Company assesses the estimated probability, timing and amount of any future royalty and sales milestone payments to be made by the Company and Blackstone Development Payments to be received from Blackstone over the term.
−Removed: There are a number of factors that could materially affect the probability, amount and timing of royalty and sales milestone payments to be made by the Company and Blackstone Development Payment to be received from Blackstone, most of which are not within the Company’s control.
−Removed: The Blackstone Collaboration Agreement liability is recognized using significant unobservable inputs.
−Removed: These inputs are derived using internal management estimates developed based on third party data and reflect management’s judgements, current market conditions surrounding competing products, and forecasts.
−Removed: The significant unobservable inputs include regulatory approvals, estimated patient populations, estimated selling price, estimated sales, estimated peak sales and sales ramp, timing of the expected launch and its impact on the royalties as well as the overall probability of a success.
−Removed: The Company may use a specialist third party valuation team in the determining the present value of the Blackstone Collaboration Agreement liability at each reporting date.
−Removed: Additionally, the transaction costs associated with the liability will be amortized to accrued interest expense over the estimated term of the agreements.
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
+Added: Cost of sales
+Added: Cost of sales represents production costs including raw materials, employee-related expenses, including salaries, related benefits, travel and share-based compensation expense for employees engaged in commercial manufacturing functions, external manufacturing costs including outsourced professional expenses services, allocated facilities costs, depreciation and other expenses, and other costs incurred in bringing inventories to their location and condition prior to sale.
+Added: Cost of sales may also include costs related to excess or obsolete inventory adjustment charges and amortization expense of intangible assets.
+Added: Research and Development Costs
+Added: Research and development (“R&D”) costs are expensed as incurred.
+Added: R&D expenses consist of costs incurred in performing R&D activities, including salaries, share-based compensation and benefits, depreciation expense, third-party license fees, external costs of outside vendors engaged to conduct clinical development activities, clinical trials, costs to manufacture clinical trial materials and certain tax credits associated with research and development activities.
+Added: Upfront and milestone payments to third parties for in-licensed products or technology which has not yet received regulatory approval and which does not have alternative future use in R&D projects or otherwise are expensed as incurred.
+Added: Research and Developments Tax Credits
+Added: As a company that carries out extensive R&D activities, the Company benefits from research and development tax credits in the U.K.
+Added: The Company claims U.K.
+Added: research and development tax credits under the regimes for small or medium-sized enterprises (“SME R&D tax credit”), and U.K.
+Added: Research and Development Expenditure Credit (“RDEC”), to the extent that the Company's projects are grant funded.
+Added: research and development tax credits are fully refundable to the Company and are not dependent on current or future taxable income.
+Added: As a result, the Company records the entire benefit from the U.K.
+Added: research and development tax credits as a benefit, which is included in net loss before income tax and accordingly, not reflected as part of the income tax provision.
+Added: If, in the future, any U.K.
+Added: research and development tax credits generated are needed to offset a corporate income tax liability in the U.K., that portion would be recorded as a benefit within the income tax provision and any refundable portion not dependent on taxable income would continue to be recorded as a reduction of research and development expenses.
+Added: The Company expenses patent prosecution and related legal costs as they are incurred and classifies such costs as general and administrative expenses in the accompanying statements of operations and comprehensive loss.
+Added: Interest Income
+Added: Interest income arises on the Company's cash and cash equivalents including money market funds, short-term deposits and marketable securities classified as available for sale debt securities.
+Added: Share-Based Compensation
+Added: The Company recognizes share-based compensation expense for equity awards based on the grant date fair value of the award.
+Added: The Company recognizes share-based compensation expense for awards granted to employees and non-employees that have a graded vesting schedule based on a service condition only on a straight-line basis over the requisite service period for each separately vesting portion of the award as if the award was, in substance, multiple awards (the “graded-vesting attribution method”), based on the estimated grant date fair value for each separately vesting tranche.
+Added: For equity awards with a graded vesting schedule and a combination of service and performance conditions, the Company recognizes share-based compensation expense using a graded-vesting attribution method over the requisite service period when the achievement of a performance-based milestone is probable, based on the relative satisfaction of the performance condition as of the reporting date.
+Added: For performance conditions related to regulatory approvals those regulatory approvals are deemed probable when actually achieved.
+Added: The Company has elected to account for forfeitures of stock options when they occur by reversing share-based compensation expense previously recognized, in the period the award is forfeited, for an award that is forfeited before completion of the requisite service period.
+Added: The fair value of each share option grant is estimated on the date of grant using the Black-Scholes option pricing model.
+Added: See Note 15, “ Share-Based Compensation ” , for the Company’s assumptions used in connection with share option grants made during the periods covered by these consolidated financial s tatements.
+Added: Assumptions used in the option pricing model include the following:
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
+Added: • Expected volatility.
+Added: The Company historically lacked company-specific historical and implied volatility information for the Company's ADSs for expected terms greater than 6.08 years.
+Added: Up to June 30, 2024, the Company used a combination of the historical volatility of the ADSs and also the expected share volatility based on the historical volatility of publicly traded peer companies.
+Added: From July 1, 2024, the Company used its own historical regarding the volatility of its own traded ADS price.
+Added: • Expected term.
+Added: The expected term of the Company’s share options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options.
+Added: • Risk-free interest rate.
+Added: The risk-free interest rate is determined by reference to the U.S.
+Added: Treasury yield curve in effect at the time of grant of the award for time periods that are approximately equal to the expected term of the award.
+Added: • Expected dividend.
+Added: Expected dividend yield of zero is based on the fact that the Company has never paid cash dividends on ordinary shares and does not expect to pay any cash dividends in the foreseeable future.
+Added: • Fair value of ordinary shares.
+Added: The fair market value of the Company’s ADSs underlying the share option is equal to the closing price of the ADSs on the Nasdaq Global Select Market on the date the grant is approved by the Compensation Committee or a delegate of the Compensation Committee.
The Company accounts for income taxes under the asset and liability method which includes the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the Company’s financial statements.
9 unchanged sentences
In circumstances where there is sufficient negative evidence indicating that the Company’s deferred tax assets are not more likely than not realizable, the Company establishes a valuation allowance.
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
The Company uses a two-step approach for recognizing and measuring uncertain tax positions.
2 unchanged sentences
Differences between the amount of tax benefits taken or expected to be taken in the Company’s income tax returns and the amount of tax benefits recognized in its financial statements represent the Company’s unrecognized income tax benefits, which it either records as a liability or reduction of deferred tax assets.
−Removed: Un-surrendered UK losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions.
+Added: Un-surrendered U.K.
+Added: losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions.
The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of United Kingdom taxable profits.
2 unchanged sentences
Comprehensive gain or loss is defined to include all changes in equity during a period except those resulting from investments by owners and distributions to owners.
−Removed: Restructuring expenses
−Removed: The Company records costs and liabilities associated with exit and disposal activities in accordance with FASB ASC Topic 420, Exit or Disposal Cost Obligations (“ASC 420”).
−Removed: Such costs are based on estimates of fair value in the period liabilities are incurred.
−Removed: The Company evaluates and adjusts these costs as appropriate for changes in circumstances as additional information becomes available.
−Removed: Refer to Note 22, “Severance Plan”.
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
Net Loss per Share
Basic and diluted net loss per ordinary share is determined by dividing net loss by the weighted average number of ordinary shares outstanding during the period.
−Removed: For all periods presented, the outstanding but unvested restricted shares, unvested restricted stock units (“RSU”), share options and warrants have been excluded from the calculation, due their effects being anti-dilutive in nature.
+Added: For all periods presented, the outstanding but unvested restricted shares, unvested restricted stock units (“RSU”), share options and warrants have been excluded from the calculation, due to their effects being anti-dilutive in nature.
Therefore, the weighted average shares outstanding used to calculate both basic and diluted loss per share are the same for each period presented.
Refer to Note 16, “Net Loss Per Share” .
−Removed: Recently issued accounting pronouncements not yet adopted
−Removed: In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07, Segment Reporting:
−Removed: Improvements to Reportable Segment Disclosures.
−Removed: This ASU modified the disclosure and presentation requirements primarily through enhanced disclosures of significant segment expenses and clarified that single reportable segment entities must apply Topic 280 in its entirety.
−Removed: This guidance is effective for the Company for the year beginning January 1, 2024, with early adoption permitted.
−Removed: The amendments should be applied retrospectively to all prior periods presented in the financial statement.
−Removed: The Company is currently assessing the impact of this guidance on its disclosures.
+Added: Concentration of Credit Risk
+Added: Financial instruments that subject the Company to credit risk consist primarily of cash and cash equivalents, restricted cash and marketable securities:
+Added: available-for-sale debt securities.
+Added: The Company places cash and cash equivalents and restricted cash with established financial institutions with strong credit ratings.
+Added: The Company holds significant amounts of cash and cash equivalents that are in excess of federally insured limits in various currencies, placed with one or more financial institutions for varying periods according to expected liquidity requirements.
+Added: The Company's cash and cash equivalents are held with multiple banks and financial institutions.
+Added: Management monitors the credit rating of those banks and financial institutions on a regular basis.
+Added: The Company has no significant off-balance-sheet risk or concentration of credit risk, such as foreign exchange contracts, options contracts, or other foreign hedging arrangements.
+Added: Recently Issued Accounting Pronouncements
+Added: In January 2025, the FASB issued ASU 2025-01— Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40):
+Added: Clarifying the Effective Date, to clarify the effective date of ASU No.
+Added: 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40):
+Added: Disaggregation of Income Statement Expenses.
+Added: FASB clarified that all public business entities should initially adopt the disclosure requirements in the ASU 2024-04 in the first annual reporting period beginning after December 15, 2026, and interim reporting periods within annual reporting periods beginning after December 15, 2027.
+Added: The Company is currently assessing the effect of this ASU on its consolidated financial statements and related disclosures.
+Added: In November 2024, the FASB issued ASU 2024-03— Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40):
+Added: Disaggregation of Income Statement Expenses, to improve the disclosures about entity’s expenses.
+Added: The amendments apply to all public business entities.
+Added: The ASU is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027 with early adoption permitted.
+Added: The Company is currently assessing the effect of this ASU on its consolidated financial statements and related disclosures.
+Added: In March 2024, the FASB issued ASU 2024-02— Codification Improvements—Amendments to Remove References to the Concepts Statements , that contains amendments to the Codification that remove references to various FASB Concepts Statements.
+Added: This effort facilitates Codification updates for technical corrections such as conforming amendments, clarifications to guidance, simplifications to wording or the structure of guidance, and other minor improvements.
+Added: The amendments are effective for public business entities for fiscal years beginning after December 15, 2024, with early adoption permitted.
+Added: Early application of the amendments in this ASU is permitted for all entities, for any fiscal year or interim period for which financial statements have not yet been issued (or made available for issuance).
+Added: If an entity adopts the amendments in an interim period, it must adopt them as of the beginning of the fiscal year that includes that interim period.
+Added: The Company is currently assessing the effect of this ASU on its consolidated financial statements and related disclosures.
+Added: In March 2024, the FASB issued ASU 2024-01— Compensation—Stock Compensation (Topic 718):
+Added: Scope Application of Profits Interest and Similar Awards, to improve GAAP by adding an illustrative example that includes four fact patterns to demonstrate how an entity should apply the scope guidance in paragraph 718-10-15-3 to determine whether a profits interest award should be accounted for in accordance with Topic 718, Compensation—Stock Compensation.
+Added: For public business entities, the amendments in this ASU are effective for annual periods beginning after December 15, 2024, and interim periods within those annual periods.
+Added: Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance.
+Added: If an entity adopts the amendments in an interim period, it should adopt them as of the beginning of the annual period that includes that interim period.
+Added: The Company does not expect the adoption of ASU 2024-01 to have a material effect on its financial statements and related disclosures.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures.
1 unchanged sentence
This guidance is effective for the Company for the year beginning January 1, 2025, with early adoption permitted.
−Removed: The amendments should be applied on a prospective basis, with retrospective application permitted.
−Removed: The Company is currently assessing the impact of this guidance on its disclosures.
−Removed: Restatement of previously issued consolidated financial statements
−Removed: In connection with the preparation of the Company's consolidated financial statements as of and for the year ended December 31, 2023, the Company discovered that in prior years it incorrectly accounted and presented its U.K SME tax credit in accordance with ASC 740 - Income taxes .
−Removed: The error resulted in an overstatement of both income tax benefit and research and development expense, and therefore total operating expenses, of $ 24.6 million and $ 24.0 million for the years ended December 31, 2022 and 2021, respectively.
+Added: The Company intends to adopt the guidance in the fiscal year beginning January 1, 2025.
+Added: The Company does not expect the adoption of ASU 2023-09 to have a material effect on its financial statements and related disclosures.
AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
−Removed: In accordance with Staff Accounting Bulletin (“SAB”) No.
−Removed: 99, “ Materiality ”, and SAB No.
−Removed: 108, “ Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements ”, the Company evaluated these errors as material to its previously issued consolidated financial statements.
−Removed: As a result, the Company has restated its Consolidated Statement of Operations and Comprehensive Loss.
−Removed: There is no effect on the Company's Consolidated Balance Sheet, Consolidated Statements of Shareholders' Equity, or Consolidated Statements of Cash Flows as of and for the years ended December 31, 2022 or 2021.
−Removed: Furthermore, the error had no effect on the Company's net loss attributable to ordinary shareholders or basic diluted net loss per ordinary share.
−Removed: The following table presents the effect of the restatement adjustments on the Company’s Consolidated Statement of Operations and Comprehensive Loss for the years ended December 31, 2022 and 2021 (in thousands, except share and per share amounts):
−Removed: Year ended December 31, 2022
−Removed: As previously Reported
−Removed: Restatement adjustments
−Removed: Research and development expenses
−Removed: $ ( 141,992 ) $ 24,638 $ ( 117,354 )
−Removed: Total operating expenses, net
−Removed: ( 168,046 ) 24,638 ( 143,408 )
−Removed: Income tax benefit (expense)
−Removed: 24,366 ( 24,638 ) ( 272 )
−Removed: Basic and diluted net loss per ordinary share $ ( 1.57 ) $ — $ ( 1.57 )
−Removed: Year ended December 31, 2021
−Removed: As previously Reported
−Removed: Restatement adjustments
−Removed: Research and development expenses
−Removed: $ ( 134,789 ) $ 23,950 $ ( 110,839 )
−Removed: Total operating expenses, net
−Removed: ( 165,000 ) $ 23,950 $ ( 141,050 )
−Removed: Income tax benefit (expense)
−Removed: 23,892 ( 23,950 ) $ ( 58 )
−Removed: Basic and diluted net loss per ordinary share $ ( 1.97 ) $ — $ ( 1.97 )
−Removed: The Company has also restated its unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the quarterly periods ended March 31, 2022, June 30, 2022, September 30, 2022, March 31, 2023, June 30, 2023 and September 30, 2023.
−Removed: The unaudited Condensed Consolidated Statement Balance Sheet, Condensed Consolidated Statement of Changes in Equity and Condensed Consolidated Statement of Cash Flows for the periods ended March 31, 2022, June 30, 2022, September 30, 2022, March 31, 2023, June 30, 2023 and September 30, 2023 were not affected by the misstatement.
−Removed: Furthermore, the error had no effect on the Company's unaudited net loss attributable to ordinary shareholders or basic or diluted net loss per ordinary share for each of the above mentioned quarterly periods.
−Removed: Refer to Note 25, “Restatement of previously issued quarterly condensed consolidated financial statements (unaudited)” for further details.
+Added: In November 2023, the FASB issued Accounting Standards Update (ASU) 2023-07, Segment Reporting:
+Added: Improvements to Reportable Segment Disclosures.
+Added: This ASU modified the disclosure and presentation requirements primarily through enhanced disclosures of significant segment expenses and clarified that single reportable segment entities must apply Topic 280 in its entirety.
+Added: The amendments should be applied retrospectively to all prior periods presented in the financial statement.
+Added: The Company adopted the guidance in its Annual Report on Form 10-K for the year ended December 31, 2024 and additional disclosures have been included in Note 22.
+Added: Product revenue, net
+Added: On November 8, 2024 the Company was notified by the FDA that the Company’s BLA was approved, allowing for the marketing of AUCATZYL in the US for the treatment of adult patients with r/r B-ALL.
+Added: The Company has not recognized product revenue during the year ended December 31, 2024.
License revenue
−Removed: Revenue comprises of license revenue only for the years ended December 31, 2023, 2022 and 2021:
−Removed: Total revenue by geographical location (in thousands):
+Added: License revenue by geographical location for the years ended December 31, 2024 and 2023 comprised of the following (in thousands):
Year Ended December 31,
−Removed: 2023 2022 2021
License revenue
2 unchanged sentences
Total License revenue $ 10,120 $ 1,698
+Added: License and Option Agreement with BioNTech
+Added: See Note 1 for a description of the BioNTech License and Option Agreement, under which the Company recognized revenue during the year ended December 31, 2024 .
+Added: For further details on the terms and accounting treatment considerations for the BioNTech Agreement, refer to following notes to these consolidated financial statements:
+Added: • Note 1, “Nature of the Business”
+Added: • Note 2, “Summary of Significant Accounting Policies”
+Added: • Note 12, “Liabilities Related to Future Royalties and Milestones, Net”
+Added: • Note 14, “Shareholders’ Equity”
+Added: • Note 20, “Commitments and Contingencies”
+Added: As the BioNTech License and Option Agreement has been accounted for as one freestanding financial instrument with various embedded features, including the Binder License and related transfer of know-how, Technology Options, and Product Options, the Company is required to consider if the embedded features are required to be bifurcated from the host contract and therefore accounted for as a separate derivative.
+Added: The Company concluded the Binder License and related transfer of know-how, Technology Options, and Product Options meet the scope exception set out in ASC 815-10-15-59(d) and therefore not accounted for as derivatives under ASC 815.
+Added: Binder License
+Added: The Company applied ASC 606 to account for the Binder License and related know-how as functional intellectual property.
+Added: The Binder License and related transfer of know-how were not distinct from one another and must be combined as a performance obligation, as BioNTech requires the know-how to derive benefit from the license.
+Added: Based on these determinations, the Company identified one combined distinct performance obligation at the inception of the BioNTech License and Option Agreement.
+Added: The Company further determined the consideration received included in the transaction price at contract inception, is to be allocated to the one combined performance obligation.
+Added: The Company determined that the performance obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and Binder License to BioNTech.
+Added: The Company recognized total license revenue of $ 10.1 million (net of foreign exchange differences), related to the BioNTech License and Option Agreement during the year ended December 31, 2024.
AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
+Added: The Company is eligible to receive milestone payments of up to $ 32.0 million in the aggregate upon the achievement of specified clinical development and regulatory milestones for each Binder Licensed Product that achieves such milestones.
+Added: The Company is also eligible to receive a low single-digit royalty on net sales of Binder Licensed Products, subject to customary reductions, which are subject to specified limits.
+Added: The royalty will be increased if BioNTech, its affiliates or sublicensees commercialize a Binder Licensed Product in an indication and country in which the Company or its affiliates or licensees also commercializes a product containing the same binders.
+Added: Under the BioNTech License and Option Agreement, BioNTech is solely responsible for, and has sole decision-making authority with respect to, at its own expense, the exploitation of Binder Licensed Products.
+Added: Milestone payments and royalty payments are regarded as variable consideration and will be evaluated under the most likely amount method.
+Added: Milestone payments and royalty payments were not included in the transaction price, as these amounts were fully constrained as of December 31, 2024.
+Added: Technology Options
+Added: The Company applied ASC 606, considering particularly the accounting guidance related to any options granted to customers to purchase additional goods or services at a future date as this could provide a material right to the customer.
+Added: A material right is a promise embedded in a current contract that should be accounted for as a separate performance obligation.
+Added: The Company determined the Technology Options were not offered at a significant and incremental discount.
+Added: Accordingly, the Technology Options granted to BioNTech do not represent a material right and, therefore, were not a performance obligation at the outset of the arrangement.
+Added: The Technology Option exercise fee equates to the standalone selling price of the technologies underlying each option and consequently, the transaction price of $ 10.0 million was not allocated to the Technology Options ’ performance obligation.
+Added: No Technology Options were exercised during the year ended December 31, 2024.
+Added: Product Options
+Added: As the Product Options are precluded from being accounted for under ASC 815 due to the scope exception, management considered the terms of the Product Options and concluded that they should be accounted for as a gain contingency under the scope of ASC 450 - Contingencies (“ASC 450”).
+Added: The Product Options, unlike the Technology Options, are 1) still subject to negotiation as to the specific activities to be performed by each party, which will be determined and agreed before the Product Options can be exercised, and 2) have not been exercised upon signature of the BioNTech License and Option Agreement.
+Added: As a result, Product Options are not accounted for under to ASC 606, and no recognition is required under ASC 450, until the Product Options are exercised.
+Added: No Product Options were exercised during the year ended December 31, 2024.
Research, Option and License Agreement with Cabaletta
13 unchanged sentences
The Company recognized total license revenue of $ 1.2 million related to the Cabaletta Agreement for the year ended December 31, 2023.
−Removed: Upon execution of the Cabaletta Agreement, the transaction price included only the $ 1.2 million non-refundable license fee payable to the Company.
−Removed: The Company may receive further payments upon the exercise of the options for licensed targets, the achievement of certain development and sales milestones, as well as royalty payments based on net sales of each product covered by the licensed intellectual property.
−Removed: Research, Option and License Agreement with an Investee of Syncona Portfolio Limited
−Removed: The Company entered into a license agreement with an investee of Syncona Portfolio Limited on September 2, 2020 relating to the Company's RQR8 technology.
−Removed: The terms of the agreement include a non-refundable license fee, payments based upon achievement of clinical development and regulatory objectives, sales milestones payments and royalties on product sales.
−Removed: Upon the execution of the license agreement, the Company made available the RQR8 licensed know-how to investee of Syncona Portfolio Limited for a non-refundable license fee of $ 0.3 million.
−Removed: The Company has no further material performance obligations related to the agreement.
−Removed: The Company identified the following material promises relating to the granting of a non-exclusive license for research, development, manufacturing and commercialization activities as well as the initial transfer of know-how and information to the investee of Syncona Portfolio Limited.
−Removed: The Company determined that the granting of the research license and the initial transfer of know-how were not distinct from one another and must be combined as a performance obligation, as the investee of Syncona Portfolio Limited required the know-how to derive benefit from the license.
−Removed: Based on these determinations, the Company identified one distinct performance obligation at the inception of the contract.
−Removed: Upon execution of the license agreement, the transaction price included only the $ 0.3 million non-refundable license fee payable to the Company.
−Removed: The Company may receive further payments upon the achievement of certain development and sales milestones, as well as royalty payments based on net sales of each product covered by the licensed intellectual property.
−Removed: During the year ended December 31, 2023 , Company received variable consideration arising from the achievement of a development milestone amounting to $ 0.35 million.
−Removed: Consequently, the Company recognized license revenue of $ 0.35 million (net of foreign exchange differences).
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
−Removed: Option and License Agreement with Bristol-Myers Squibb:
−Removed: On October 3, 2022, the Company entered into an Option and License Agreement (the “BMS Agreement”) with Bristol-Myer s Squibb Company (“BMS”), pursuant to which the Company granted to BMS a non-exclusive license to research, develop, manufacture, have manufactured, use, and commercialize products incorporating the Company's RQR8 technology.
−Removed: Upon the execution of the BMS Agreement, the Company made available the RQR8 licensed know-how to BMS for a non-refundable upfront license fee of $ 3.5 million.
−Removed: The Company has no further material performance obligations related to the BMS Agreement, as discussed below.
−Removed: BMS have agreed to pay non-refundable development milestones and low single-digit royalties based on net sales of each product covered by the licensed intellectual property.
−Removed: The Company further granted to BMS the option (the “Target Option”) to expand the rights and licenses granted hereunder to include the research, development, manufacture, use, or commercialization of licensed products up to a predetermined number of licensed targets upon payment of an option exercise fee (“Option Exercise Fee”).
−Removed: The Company identified the following material promises in the arrangement:
−Removed: the granting of a non-exclusive license for research and preclinical development activities as well as the initial transfer of know-how and information to BMS.
−Removed: The Company determined that the Option Exercise Fee was not offered at a significant and incremental discount.
−Removed: Accordingly, the Commercial Option did not represent a material right and, therefore, was not a performance obligation at the outset of the arrangement.
−Removed: The Company determined that the granting of the research license and the initial transfer of know-how were not distinct from one another and must be combined as a performance obligation (the “BMS Combined Performance Obligation”).
−Removed: This is because BMS requires the know-how to derive benefit from the license.
−Removed: Based on these determinations, the Company identified one distinct performance obligation at the inception of the contract:
−Removed: the BMS Combined Performance Obligation.
−Removed: The Company further determined that the up-front payment of $ 3.5 million constituted the entirety of the consideration included in the transaction price at contract inception, which was allocated to the BMS Combined Performance Obligation.
−Removed: The amount of the transaction price allocated to the BMS Combined Performance Obligation is recognized as or when the Company satisfies the performance obligation.
−Removed: The Company determined that the BMS Combined Performance Obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and research license to BMS.
−Removed: Upon execution of the BMS Agreement, the transaction price included only the $ 3.5 million up-front payment owed to the Company.
−Removed: The Company may receive further payments upon the exercise of the Target Option, the achievement of certain milestones, as well as royalty payments that reach low-single digit based on future net sales.
−Removed: The Company received an upfront non-refundable cash payment of $ 3.5 million in November 2022 and recognized license revenue of $ 3.5 million for the year ended December 31, 2022.
−Removed: Research, Option and License Agreement with Moderna
−Removed: On June 22, 2021, the Company entered into a Research, Option and License Agreement (the “Moderna Agreement”) with Mode rnaTX, Inc.
−Removed: (“Moderna”), pursuant to which the Company granted to Moderna an exclusive research license to perform research and pre-clinical development activities relating to target sequences with respect to certain of the Company’s research targets and products.
−Removed: The Company also granted Moderna on a research target-by-research target basis, the right to obtain an exclusive commercial license upon payment of a commercial option fee of $ 2.0 million (the “Commercial Option”).
−Removed: Pursuant to the Moderna Agreement, the Company received an upfront non-refundable cash payment of $ 1.5 million in October 2021 and is entitled to receive development milestones payments per product and in sales milestones payments per product from Moderna if certain clinical, regulatory and sales performance milestones are achieved.
−Removed: The Company is further eligible to receive royalties in the low to mid-single digits on net sales on a product-by-product basis.
−Removed: The Company identified the following material promises in the arrangement:
−Removed: the granting of an exclusive license to research and preclinical development activities as well as the initial transfer of know-how and information to Moderna.
−Removed: The Company determined the Commercial Option fee was not offered at a significant and incremental discount.
−Removed: Accordingly, the Commercial Option did not represent a material right and, therefore, was not a performance obligation at the outset of the arrangement.
−Removed: The Company determined that the granting of the research license and the initial transfer of know-how were not distinct from one another and must be combined as a performance obligation (the “Moderna Combined Performance Obligation”).
−Removed: This is because Moderna requires the know-how to derive benefit from the research license.
−Removed: Based on these determinations, the Company identified one distinct performance obligation at the inception of the contract:
−Removed: the Moderna Combined Performance Obligation.
−Removed: The Company further determined that the up-front payment of $ 1.5 million constituted the entirety of the consideration included in the transaction price at contract inception, which was allocated to the Combined Performance Obligation.
−Removed: The amount of the transaction price allocated to the Moderna Combined Performance Obligation is recognized as or when the Company satisfies the performance obligation.
−Removed: The Company determined that the Moderna Combined Performance Obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and research license to Moderna.
+Added: No license revenue was recognized related to the Cabaletta Agreement for the year ended December 31, 2024.
AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
−Removed: Upon execution of the Agreement, the transaction price included only the $ 1.5 million up-front payment was owed to the Company.
−Removed: The Company may receive further payments upon the exercise of the Commercial Option, the achievement of certain milestones, as detailed above, as well as royalty payments that reach mid-single digits based on future net sales.
−Removed: In September 2022, Moderna exercised its option, pursuant to the terms of the Moderna Agreement, to obtain the commercial license of the Company’s proprietary binders against an undisclosed immuno-oncology target for the development and commercialization of mRNA therapeutics resulting in the Company recognizing $ 2.0 million of license revenue for the year ended December 31, 2022.
−Removed: The future milestones, which represent variable consideration, were evaluated under the most likely amount method, and were not included in the transaction price, because the amounts were fully constrained as of December 31, 2023 and 2022 , respectively.
−Removed: As part of the Company’s evaluation of the constraint, it considered numerous factors, including that receipt of such milestones is outside the Company’s control.
−Removed: Separately, any consideration related to development milestones, sales-based milestones, as well as royalties on net sales upon commercialization by Cabaletta, BMS, Moderna and the investee of Syncona Portfolio Limited, will be recognized when the related sales occur, and therefore, have also been excluded from the transaction price in accordance with the sales-based royalty exception.
−Removed: The Company will re-evaluate the transaction price in each reporting period, as uncertain events are resolved, or as other changes in circumstances occur.
−Removed: For the years ended December 31, 2023, 2022 and 2021, the Company has no t recognized any variable consideration with regards to the development milestones, sales-based milestones which are included in the revenue generating license agreements with Cabaletta, BMS and Moderna.
−Removed: These development milestones are not yet probable and therefore no revenue has been recognized.
+Added: Upon execution of the Cabaletta Agreement, the transaction price included only the $ 1.2 million non-refundable license fee payable to the Company.
+Added: The Company may receive further payments upon the exercise of the options for licensed targets, the achievement of certain development and sales milestones, as well as royalty payments based on net sales of each product covered by the licensed intellectual property.
+Added: The future milestones, which represent variable consideration, will be evaluated under the most likely amount method, and were not included in the transaction price, as these amounts were fully constrained as of December 31, 2024 .
+Added: For the year ended December 31, 2024 and 2023, the Company has not recognized any variable consideration with regards to the development milestones and sales-based milestones with its customers as they are deemed not probable.
For the years ended December 31, 2024 and 2023, the Company has no t recognized any royalty revenue from the license agreements that were executed in the current and prior periods.
−Removed: Interest expense
−Removed: Interest expense consisted of the following (in thousands):
+Added: Interest Expense, Net
+Added: Interest expense, net consisted of the following (in thousands):
Year Ended December 31,
+Added: Interest expense accrued on liabilities related to future royalties and milestones, net (refer to Note 12)
$ 39,510 $ 19,892
−Removed: Interest expense accrued on liability related to future royalties and sales milestones, net (refer to Note 11)
+Added: Cumulative catch-up adjustment arising from the liabilities related to future royalties and milestones, net (refer to Note 12)
( 30,644 ) 25,107
−Removed: Cumulative catch-up adjustment arising from the liability related to future royalties and sales milestones, net (refer to Note 11)
Other interest expense
3 unchanged sentences
December 31, 2024
+Added: Aggregate estimated fair value
Quoted Prices in Active Markets for Identical Assets (Level 1)
1 unchanged sentence
Significant Unobservable Inputs (Level 3)
−Removed: Financial assets
−Removed: Cash and cash equivalents:
+Added: Assets classified as cash equivalents:
Money market funds
$ 113,447 $ 113,447 $ — $ —
+Added: Commercial paper
14,301 — 14,301 —
+Added: Debt Securities issued by Foreign Government
+Added: 54,897 — 54,897 —
+Added: Government Gilts 29,358 — 29,358 —
+Added: US Treasury Bills
+Added: 7,989 7,989 — —
+Added: $ 219,992 $ 121,436 $ 98,556 $ —
+Added: Assets classified as marketable securities:
+Added: available-for-sale debt securities
+Added: Commercial paper
+Added: $ 21,141 $ — $ 21,141 $ —
+Added: Corporate debt securities
+Added: 151,124 — 151,124 —
+Added: Debt Securities issued by Foreign Government
+Added: 72,012 — 72,012 —
+Added: Government Gilts 69,295 — 69,295 —
+Added: US Treasury Bills
+Added: 47,071 47,071 — —
+Added: $ 360,643 $ 47,071 $ 313,572 $ —
+Added: $ 580,635 $ 168,507 $ 412,128 $ —
AUTOLUS THERAPEUTICS PLC
4 unchanged sentences
Significant Unobservable Inputs (Level 3)
−Removed: Financial assets
−Removed: Cash and cash equivalents:
+Added: Assets classified as cash equivalents:
Money market funds
$ 184,635 $ 184,635 $ — $ —
−Removed: Total $ 28,593 $ 28,593 $ — $ —
−Removed: Money market funds are measured at fair value on a recurring basis using quoted prices and are classified as Level 1.
+Added: $ 184,635 $ 184,635 $ — $ —
+Added: The Company estimates the fair value of available-for-sale debt securities using actual trade and indicative prices sourced from third-party providers on a daily basis to estimate the fair value.
+Added: If observed market prices are not available (for example securities with short maturities and infrequent secondary market trades), the securities are priced using a valuation model maximizing observable inputs, including market interest rates.
+Added: As of December 31, 2024 and 2023, the Company did not have non-financial assets measured at fair value on a recurring basis.
+Added: During the years ended December 31, 2024 and 2023, there were no transfers between levels.
+Added: Marketable Securities:
+Added: Available-For-Sale Debt Securities
+Added: As of December 31, 2024, the Company has the following investments in available-for-sale debt securities, which are categorized as marketable securities:
+Added: available-for-sale debt securities on the balance sheet depending on their maturity at acquisition (in thousands):
+Added: December 31, 2024
+Added: Remaining contractual maturity
+Added: Amortized cost Gross unrealized gains
+Added: Gross unrealized losses
+Added: Aggregate estimated fair value
+Added: Marketable securities:
+Added: available-for-sale debt securities:
+Added: Commercial paper
+Added: within 1 year $ 21,145 $ 3 $ ( 7 ) $ 21,141
+Added: Corporate debt securities within 1 year 91,853 5 ( 70 ) 91,788
+Added: Debt Securities issued by Foreign Government within 1 year 72,056 — ( 44 ) 72,012
+Added: Government Gilts within 1 year 69,320 — ( 25 ) 69,295
+Added: US Treasury Bills
+Added: within 1 year 29,663 12 — 29,675
+Added: Corporate debt securities 1 to 5 years 59,530 — ( 194 ) 59,336
+Added: US Treasury Bills
+Added: 1 to 5 years 17,393 7 ( 4 ) 17,396
+Added: $ 360,960 $ 27 $ ( 344 ) $ 360,643
+Added: There were no available-for-sale debt securities as of December 31, 2023.
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
+Added: The number of securities held by the Company and aggregate fair value (in thousands) and in an unrealized loss position as of December 31, 2024 are as follows (in thousands):
+Added: December 31, 2024
+Added: Number of securities held
+Added: Gross unrealized losses
+Added: Fair market value of investments in an unrealized loss position
+Added: Marketable securities:
+Added: available-for-sale debt securities in a continuous loss position for less than 12 months:
+Added: Commercial paper 3 $ ( 6 ) $ 8,944
+Added: Corporate debt securities 41 ( 264 ) 133,078
+Added: Debt Securities issued by Foreign Government 5 ( 45 ) 72,012
+Added: Government Gilts 3 ( 25 ) 69,295
+Added: US Treasury Bills
+Added: 4 ( 4 ) 9,905
+Added: 63 $ ( 355 ) $ 356,957
+Added: The aggregated net unrealized loss on available-for-sale debt securities in the amount of $ 0.3 million has been recognized in accumulated other comprehensive loss in the Company's consolidated balance sheet as of December 31, 2024.
+Added: At December 31, 2024, the Company held 63 marketable securities:
+Added: available-for-sale debt securities out of its total investment portfolio that were in a continuous unrealized loss position.
+Added: As of December 31, 2024, no allowance for expected credit losses has been recognized in relation to securities in an unrealized loss position.
+Added: The related unrealized losses are not severe, have been for a short duration and are due to normal market, exchange rate fluctuations and all securities have an investment-grade credit rating.
+Added: The Company neither intend to sell these investments nor conclude that the Company are more-likely-than-not that it will have to sell them before recovery of their carrying values.
+Added: The Company also believe that it will be able to collect both principal and interest amounts due to the Company at maturity.
+Added: There were no amounts reclassified out of other comprehensive income (loss), net of tax during the year ended December 31, 2024.
+Added: Inventories, Net
+Added: Inventories consisted of the following (in thousands):
+Added: Raw materials
+Added: Work in progress
+Added: Finished goods
+Added: Total inventories, net
+Added: There were no inventory write-downs recorded for the year ended December 31, 2024.
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
Prepaid Expenses and Other Current Assets
3 unchanged sentences
VAT receivable 5,996 2,771
+Added: Accrued interest income 2,566 999
Deferred cost 2,320 1,787
−Removed: Other receivable 1,515 1,435
+Added: Other assets 1,571 —
Lease and lease deposit receivable 930 938
+Added: Other receivable 491 516
Accounts receivable 15 109
−Removed: Other assets — 203
−Removed: Grant income receivable — 2
Total prepaid expenses and other current assets $ 67,343 $ 34,967
8 unchanged sentences
Total property and equipment, net $ 49,553 $ 34,862
−Removed: Depreciation expense recorded for the years ended December 31, 2023, 2022 and 2021 was $ 6.6 million, $ 7.3 million and $ 8.6 million, respectively.
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
+Added: Depreciation expense recorded for the years ended December 31, 2024 and 2023 was $ 7.6 million and $ 6.6 million, respectively.
Intangible Assets, Net
The following table summarizes the carrying amount of the Company's intangible assets, net of accumulated amortization (in thousands):
−Removed: Software licenses $ — $ 258
+Added: Licensed IP rights
accumulated amortization ( 162 ) —
Total intangibles assets, net $ 12,373 $ —
−Removed: Software licenses have an estimated useful life of 3 years.
−Removed: Amortization expense for the years ended December 31, 2023, 2022 and 2021 was nil , $ 65,000 and $ 90,000 , respectively.
+Added: Amortization expense was $ 0.2 million and nil for the year ended December 31, 2024 and 2023, respectively.
+Added: The estimated aggregate amortization expense expected to be recorded in respect of this asset for each of the five years ended 2029 is $ 1.1 million annually.
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
Accrued Expenses and Other Liabilities
Accrued expenses and other liabilities consisted of the following (in thousands):
−Removed: Research and development costs $ 19,825 $ 26,478
Compensation and benefits $ 19,681 $ 14,757
+Added: Research and development costs 13,372 19,825
Professional fees 9,075 4,466
+Added: Other accrued expenditure 6,075 —
Other liabilities 479 533
1 unchanged sentence
Research and development costs have decreased primarily due to a reduction in clinical trials related costs relating to the Company's product candidate obe-cel.
−Removed: Liability related to future royalties and sales milestones, net
+Added: Liabilities Related to Future Royalties and Milestones, Net
+Added: The following table summarizes the carrying amount of the Company's liabilities related to future royalties and milestones, net (in thousands):
+Added: Amount in thousands
+Added: Balance at December 31, 2022
+Added: Interest expense accrued on liabilities related to future royalties and milestones, net
+Added: Cumulative catch-up adjustment
+Added: Balance at December 31, 2023
+Added: Initial recognition of BioNTech liability
+Added: Proceeds from Blackstone Development Payments received
+Added: Interest expense accrued on liabilities related to future royalties and milestones, net
+Added: Cumulative catch-up adjustment
+Added: Balance at December 31, 2024
+Added: The following table summarizes the current versus non-current split of the liabilities related to future royalties and milestones, net (in thousands):
+Added: Current portion of liabilities related to future royalties and milestones, net
+Added: Non-current portion of liabilities related to future royalties and milestones, net
+Added: 244,600 170,899
+Added: Total liabilities related to future royalties and milestones, net
+Added: $ 248,100 $ 170,899
Blackstone Agreements
6 unchanged sentences
The Blackstone Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for these agreements in the aggregate.
−Removed: Blackstone Collaboration Agreement
−Removed: Pursuant to the Blackstone Collaboration Agreement, Blackstone agreed to pay the Company up to $ 150 million to support the c ontinued development of the Company's CD19 CAR T cell investigational therapy product candidate, obecabtagene autoleucel (obe-cel), as well as next generation product therapies of obe-cel in B-cell malignancies.
−Removed: These payments include (i) an upfront payment of $ 50 million and (ii) up to $ 100 million payable based on the achievement of certain specified clinical, manufacturing and regulatory milestones (each such payment, a “Blackstone Development Payment” and collectively, the “Blackstone Development Payments”)
AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
+Added: Blackstone Collaboration Agreement
+Added: Pursuant to the Blackstone Collaboration Agreement, Blackstone agreed to pay the Company up to $ 150 million to support the c ontinued development of obe-cel, as well as next generation product therapies of obe-cel in B-cell malignancies.
+Added: These payments include (i) an upfront payment of $ 50 million and (ii) up to $ 100 million payable based on the achievement of certain specified clinical, manufacturing and regulatory milestones (each such payment, a “Blackstone Development Payment” and collectively, the “Blackstone Development Payments”)
In November 2021, the upfront payment of $ 50 million was paid by Blackstone upon execution of the Blackstone Collaboration Agreement.
−Removed: In December 2022, two Blackstone Development Payments were paid by Blackstone of $ 35 million each as a result of (i) the joint steering committee’s review of Autolus’ interim analysis of pivotal FELIX Phase 2 clinical trial of obe-cel in relapsed/refractory (r/r) adult Acute Lymphoblastic Leukemia (ALL) and (ii) achievement of a pre-agreed manufacturing milestone as a result of completion of planned activities demonstrating the performance and qualification of the Company’s obe-cel’s manufacturing process.
−Removed: The remaining $ 30 million will be payable to the Company on the achievement on certain specified regulatory milestones.
−Removed: The Company considers the achievement of the specified regulatory milestone as probable when actually achieved.
+Added: In December 2022, two Blackstone Development Payments were paid by Blackstone of $ 35 million each as a result of (i) the joint steering committee’s review of Autolus’ interim analysis of pivotal FELIX Phase 2 clinical trial of obe-cel in relapsed/refractory (“r/r”) adult Acute Lymphoblastic Leukemia (“B-ALL”) and (ii) achievement of a pre-agreed manufacturing milestone as a result of completion of planned activities demonstrating the performance and qualification of the Company’s obe-cel’s manufacturing process.
+Added: In December 2024, the remaining $ 30 million Blackstone Development Payment was paid to the Company on the approval of AUCATZYL by the FDA.
+Added: The Company considers the achievement of the specified regulatory milestone as probable when actually achieved (i.e., when the contingency resolves).
In exchange for the Blackstone Development Payments, the Company agreed to make payments to Blackstone (the “Revenue Share Payments”) equal to a mid-single digit royalty, subject to the Aggregate Cap (as defined in the Blackstone Collaboration Agreement) on payments under the Blackstone Collaboration Agreement, based on net sales anywhere in the world of (i) Collaboration Products in B-cell malignancies, (ii) subject to certain conditions set forth in the Blackstone Collaboration Agreement, its CD19 and CD22 CAR T cell investigational therapy product candidate known as AUTO3 in B-cell malignancies, and (iii) certain Collaboration Products to the extent developed or commercialized in indications other than a B-cell malignancy (“Obe-cel Franchise Products”).
1 unchanged sentence
The Company, and all of its subsidiaries have provided, and all of its future subsidiaries will provide, a guaranty to Blackstone of its obligations under the Blackstone Collaboration Agreement.
−Removed: In addition, the Company has granted a security interest in its subsidiary Autolus Limited to Blackstone in (a) intellectual property that is necessary or useful for the development, manufacture, use, commercialization, import, or export of Collaboration Products (the “Autolus IP Collateral”), (b) a segregated and blocked cash collateral account that will be established following regulatory approval of any Collaboration Product, solely for the purpose of receiving remittance of Revenue Share Payments and Sales Milestone Payments and disbursement thereof to Blackstone as provided in the Blackstone Collaboration Agreement, (c) a segregated cash collateral account established solely for the purpose of receiving Blackstone Development Payments and disbursing them for use by the Company in accordance with the terms of the Blackstone Collaboration Agreement, (d) all assets or property of the Company related to or arising from the Collaboration Products in any B-cell malignancy or the obe-cel Franchise Products in any indication other than a B-cell malignancy, and (e) all proceeds and products of each of the foregoing (collectively referred to as the “Collateral”).
−Removed: The security interest will be maintained until the earlier of (i) such time at which cumulative payments made by the Company under the Blackstone Collaboration Agreement equal $ 150 million and (ii) the first commercial sale in the United States of obe-cel or any other Lead Product (as defined in the Blackstone Collaboration Agreement) selected to replace obe-cel following a Program Failure (as defined in the Blackstone Collaboration Agreement) (such time, the “Release Time”).
−Removed: The Blackstone Collaboration Agreement contains negative covenants that restrict the Company from, among other things, (a) granting liens or otherwise encumbering its assets that constitute Collateral, (b) paying dividends or making distributions on account or, or redeeming, retiring or purchasing any capital stock, (c) other than certain permitted licensing transactions, transferring to third parties rights to commercialize any Collaboration Product or the Autolus IP Collateral anywhere in the world and (d) selling, transferring or assigning any rights to receive payments of royalties, returns on net sales, revenue share or other compensation or license fees with respect to a Collaboration Product in a B-cell malignancy and/or obe-cel Franchise Product in any indication other than a B-cell malignancy.
−Removed: Each of the negative covenants is subject to exceptions and carve outs set forth in the Blackstone Collaboration Agreement.
−Removed: The negative covenants will fall away upon the Release Time.
+Added: In addition, the Company granted a security interest in its subsidiary Autolus Limited to Blackstone in certain intellectual property and financial assets of the Company and its subsidiaries.
+Added: The security interest terminated in January 2025 upon the first commercial sale of AUCATZYL in the U.S.
+Added: (such time, the “Release Time”).
+Added: The Blackstone Collaboration Agreement contains certain restrictive negative covenants that also expired upon the Release Time.
Termination of the Blackstone Collaboration Agreement by Blackstone due to certain breaches of the Blackstone Collaboration Agreement or other actions by the Company will require the Company to make liquidated damage payments to Blackstone in excess of the Blackstone Development Payments.
The Company has accounted for the Blackstone Collaboration Agreement as a liability primarily due to the Company's significant continuing involvement in generating the royalty stream.
−Removed: If and when obe-cel is commercialized and royalties or sales milestones become payable, the Company will recognize the portion of royalties paid to Blackstone as a decrease to the Collaboration Agreement liability with a corresponding reduction in cash.
−Removed: The Company concluded the Blackstone Agreements comprised of the following three units of accounting for the consideration received:
−Removed: (i) the Blackstone Collaboration Agreement, (ii) the purchase of ADSs, representing its ordinary shares, and (iii) Blackstone Warrants.
−Removed: The three units of accounting were recorded at relative fair value upon initial recognition and are not subsequently measured at fair value.
+Added: The Company will recognize the relevant portion of royalties or sales milestones due to Blackstone upon the commercialization of AUCATZYL or other products as a decrease to the applicable liabilities, with a corresponding reduction in cash.
+Added: On February 6, 2024, the Company concurrently entered into the BioNTech Agreements.
+Added: For further details on the terms and accounting treatment considerations for these contracts, refer to following notes to these interim condensed consolidated financial statements:
+Added: • Note 1, “Nature of the Business”
+Added: • Note 2, “Summary of Significant Accounting Policies”
+Added: • Note 3, “Revenue”
+Added: • Note 14, “Shareholders’ Equity”
+Added: • Note 20, “Commitment and Contingencies”
+Added: Obe-cel Product Revenue Interest
+Added: Under the BioNTech License and Option Agreement, BioNTech has agreed to financially support the expansion of the clinical development program and planned commercialization of obe-cel.
+Added: In exchange for the grant of rights to future revenues from the sales of obe-cel products, including AUCATZYL, BioNTech made an upfront payment to the Company of $ 40.0 million.
+Added: The Company will pay BioNTech a low single-digit percentage of annual net sales of obe-cel products, which may be increased up to a mid-single digit percentage in exchange for milestone payments of up to $ 100.0 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech's election.
AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
−Removed: During 2021, the Company allocated the initial total gross proceeds arising from the Blackstone Collaboration Agreement and the Blackstone Securities Purchase Agreement along with the issuance of the Blackstone Warrant among the three units of accounting on a relative fair value basis at the time of the transaction as follows:
−Removed: Units of Accounting Gross proceeds (in millions)
−Removed: Initial fair value
−Removed: (in millions)
−Removed: Allocated consideration based on relative fair value
−Removed: (in millions)
−Removed: Net allocated consideration based on relative fair value after transaction costs*
−Removed: (in millions)
−Removed: Liability related to future royalties and sales milestones, net (Blackstone Collaboration Agreement)
−Removed: $ 50.0 $ 49.6 $ 46.4 $ 45.9
−Removed: ADSs, representing ordinary shares 100.0 100.0 93.6 91.6
−Removed: Warrants — 10.7 10.0 9.9
−Removed: Total $ 150.0 $ 160.3 $ 150.0 $ 147.4
−Removed: * In addition, the total shared transaction costs of $ 1.7 million, relating to the Blackstone Agreement have been allocated to the three units of accounting on a relative fair value basis.
−Removed: The Company allocated the consideration and issuance costs on a relative fair value basis to the Collaboration Agreement, securities purchased and warrants issued to Blackstone which resulted in the Blackstone Collaboration Agreement being initially recognized at $ 46.4 million (relative fair value of $ 45.9 million, net of issuance costs).
−Removed: The two Blackstone Development Payments received during the year ended December 31, 2022 were allocated solely to the Blackstone Collaboration Agreement liability.
−Removed: Changes to the Blackstone Collaboration Agreement liability related to future royalties and sales milestones are as follows:
−Removed: Amount in thousands
−Removed: Balance at December 31, 2021 $ 47,016
−Removed: Proceeds from Blackstone Development Payments received
−Removed: Interest expense accrued on liability related to future royalties and sales milestones, net (included interest expense)
−Removed: Cumulative catch-up adjustment (included in interest expense)
−Removed: Balance at December 31, 2022 $ 125,900
−Removed: Interest expense accrued on liability related to future royalties and sales milestones, net (included interest expense)
−Removed: Cumulative catch-up adjustment (included in interest expense)
−Removed: Balance at December 31, 2023
+Added: As the BioNTech License and Option Agreement has been accounted for as one freestanding financial instrument with various embedded features, (e.g.
+Added: the Obe-cel Product Revenue Interest, milestone payments and royalties), the Company is required to consider if these embedded features are required to bifurcated from the host contract and therefore accounted for as a separate derivative.
+Added: The Company determined the host contract to be debt-like and therefore the embedded features were analyzed pursuant to a debt host contract.
+Added: The Company concluded the BioNTech License and Option Agreement (the host contract) should not be accounted as a derivative in accordance with ASC 815-10-15-59(d) but rather as a debt instrument under ASC 470.
+Added: The Company has accounted for the Obe-cel Product Revenue Interest as a liability primarily due to the Company’s significant continuing involvement in generating the royalty stream.
+Added: In February 2024, the Company initially recognized the BioNTech Liability at $ 38.3 million being the face value less debt issuance costs.
+Added: Once the Company commences commercial sales of AUCATZYL that generate royalties, which the Company expect will occur in the first quarter of 2025, the Company will recognize the portion of royalties paid to BioNTech as a decrease to the liability with a corresponding reduction in cash.
+Added: The carrying amount of the BioNTech Liability is based on the Company’s estimate of the future royalties to be paid to BioNTech to be received over the life of the arrangement as discounted using an effective interest rate.
+Added: The excess or deficit of estimated present value of future royalties over the initial carrying amount, is recognized using the cumulative catch-up method within interest expense, net using the initial effective interest rate.
+Added: The imputed rate of interest on the unamortized portion of the BioNTech Liability was approximately 28.70 % as of February 6, 2024 and December 31, 2024,
On November 6, 2021, in connection with the Blackstone Agreement, pursuant to the Blackstone Warrant, the Company issued Blackstone a warrant to purchase up to 3,265,306 ADSs representing 3,265,306 of the Company's ordinary shares, at an exercise price of $ 7.35 per ADS.
2 unchanged sentences
Therefore, the Company has accounted for the Blackstone Warrant as equity-classified instruments (recognized within additional paid-in capital), per ASC 815-40.
−Removed: The assessment considers whether the warrants are freestanding financial instruments, meet the definition of a liability or whether the warrants meet all of the requirements for equity classification, including whether the warrants are indexed to the Company’s own shares, among other conditions for equity classification.
−Removed: On November 6, 2021, the Blackstone Warrant had a relative fair value of approximately $ 10.0 million.
−Removed: As a result, the Company recorded a discount on the Blackstone Collaboration Agreement of $ 3.6 million during the year ended December 31, 2021.
−Removed: In addition, the Company also applied an offset to additional paid-in capital in an amount of $ 6.4 million related to the issuance of the Company’s ordinary shares arising from the Blackstone Securities Purchase Agreement.
−Removed: Refer to Note 13, “ Shareholders' equity ” .
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
+Added: The assessment considered whether the warrants were freestanding financial instruments, met the definition of a liability or whether the warrants met all of the requirements for equity classification, including whether the warrants were indexed to the Company’s own shares, among other conditions for equity classification.
The fair value of each Blackstone Warrant issued was estimated on the date of issuance using the Black-Scholes option pricing model.
17 unchanged sentences
Expected dividend yield 0 %
−Removed: The Company determined the initial fair value of Blackstone Warrant using the Black-Scholes option pricing model to be $ 10.7 million.
+Added: The Company determined the initial fair value of the Blackstone Warrant using the Black-Scholes option pricing model to be $ 10.7 million on November 6, 2021.
+Added: As the Blackstone Warrant is classified as equity, it will not be remeasured at each reporting date.
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
Shareholders’ Equity
Ordinary Shares
−Removed: Each holder of ordinary shares is entitled to one vote per ordinary share and to receive dividends when and if such dividends are recommended by the board of directors and declared by the shareholders.
+Added: Each holder of ordinary shares is entitled to one vote per ordinary share and to receive dividends when and if such dividends are recommended by the Board of Directors (the "Board")and declared by the shareholders.
As of December 31, 2024, the Company has not declared any dividends.
3 unchanged sentences
Each issued share has been fully paid.
−Removed: Initial Public Offering and Impact of Corporate Reorganization
+Added: Restricted Stock Units
+Added: At December 31, 2024, restricted stock unit awards for 3,648 ordinary shares had vested but the underlying shares had not been issued.
+Added: However, these vested restricted stock unit awards have been included in the calculation of the Company’s outstanding shares at December 31, 2024 as they are considered issuable for little or no cash consideration.
+Added: Subsequent to December 31, 2024, all of the underlying ordinary shares were issued.
+Added: Initial Public Offering ("IPO") and Impact of Corporate Reorganization
On June 18, 2018, Autolus Therapeutics Limited re-registered as a public limited company and its name was changed from Autolus Therapeutics Limited to Autolus Therapeutics plc.
2 unchanged sentences
Prior to the Company’s June 2018 reorganization and IPO, the Company had issued series A preferred shares, ordinary B shares, and ordinary C shares to fund its operations and upon the completion of the IPO, the different classes of shares were converted into a single class of ordinary shares on a 3.185 -for-1 basis and created various classes of deferred shares.
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
The following deferred share classes were created:
9 unchanged sentences
This deferred C share has no voting rights.
−Removed: February 2021 Public Offering
−Removed: On February 12, 2021, the Company completed an underwritten public offering of 14,285,715 ADSs representing 14,285,715 ordinary shares at a public offering price of $ 7.00 per ADS.
−Removed: In addition, the underwriters exercised their right to purchase an additional 2,142,857 ADSs representing 2,142,857 ordinary shares, at a public offering price of $ 7.00 per ADS.
−Removed: Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $ 106.9 million.
−Removed: Blackstone Securities Purchase Agreement
−Removed: On November 6, 2021, pursuant to the Securities Purchase Agreement (the “Blackstone Securities Purchase Agreement”), the Company sold 17,985,611 ADSs, representing 17,985,611 ordinary shares, at a private placement price of $ 5.56 per ADS to Blackstone, resulting in gross proceeds of $ 100 million.
−Removed: Aggregate net proceeds to the Company after offering expenses, were $ 98.0 million.
−Removed: Net allocated consideration based on relative fair value after deducting direct and allocated shared transaction costs relating to the issuance of ADSs, were $ 91.6 million.
−Removed: For further details of the Blackstone Agreements, see Note 11, “Liability related to future royalties and sales milestones, net” and Note 12, “Warrants”.
−Removed: December 2022 Public Offering
−Removed: In December 2022, the Company completed an underwritten public offering of 81,927,012 ADSs representing 81,927,012 ordinary shares, which includes the partial exercise by the underwriters to purchase an additional 6,927,012 ADSs, at a public offering price of $ 2.00 per ADS.
+Added: February 2024 Underwritten Offering
+Added: On February 12, 2024, the Company completed an underwritten offering of 58,333,336 ADSs representing 58,333,336 ordinary shares at an offering price of $ 6.00 per ADS.
Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $ 326.8 million .
−Removed: February 2024 Private Placement with BioNTech SE and Underwritten Offering
−Removed: Refer to Note 24, “ Subsequent events ” for further information.
−Removed: Open Market Sale Agreement
−Removed: In September 2020, the Company entered into an Open Market Sale Agreement, or the “Sales Agreement”, with Jefferies LLC, or Jefferies, under which the Company could, at its option, offer and sell ADSs having an aggregate offering price of up to $ 100.0 million from time to time through Jefferies, acting as sales agent.
−Removed: Any such sales made through Jefferies could be made by any method that is deemed an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act, or in other transactions pursuant to an effective shelf registration statement on Form F-3.
−Removed: The Company agreed to pay Jefferies a commission of 3.0 % of the gross proceeds of any sales of ADSs sold pursuant to the Sales Agreement.
−Removed: During the year ended December 31, 2021, the Company issued an aggregate of 3,787,972 ADSs under the Sales Agreement for net proceeds, after underwriting discounts and offering expenses, of $ 29.6 million.
−Removed: There were no similar sales in 2022 and 2023.
−Removed: The Sales Agreement expired in September 2023.
AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
+Added: BioNTech Securities Purchase Agreement
+Added: Concurrently with the execution of the BioNTech License and Option Agreement (see Note 1 and Note 3), the Company and BioNTech entered into the BioNTech Securities Purchase Agreement pursuant to which the Company sold ADSs, each representing one ordinary share, to BioNTech in a Private Placement transaction.
+Added: On February 13, 2024, the Company completed the Private Placement of 33,333,333 ADSs representing 33,333,333 ordinary shares at an offering price of $ 6.00 per ADS.
+Added: Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $ 193.8 million .
+Added: In the event that BioNTech and the Company enter into the MCSA within 18 months of the initial closing of the Private Placement, BioNTech will purchase up to 15,000,000 ADSs for an aggregate purchase price of up to $ 20.0 million, subject to additional limitations and restrictions.
Share-Based Compensation
1 unchanged sentence
The 2017 Plan was set to expire on February 21, 2027.
−Removed: The 2017 Plan provided for the grant of potentially tax-favored Enterprise Management Incentives, or EMI, options to the Company's UK employees and for the grant of options to its U.S.
−Removed: In June 2018, as part of the Company's reorganization and IPO, the Company’s board of directors and shareholders approved the 2018 Equity Incentive Plan, or the 2018 Plan.
+Added: The 2017 Plan provided for the grant of potentially tax-favored Enterprise Management Incentives, or EMI, options to the Company's U.K.
+Added: employees and for the grant of options to its U.S.
+Added: In June 2018, the Company’s the Board and shareholders approved the 2018 Equity Incentive Plan, or the 2018 Plan.
The initial maximum number of ordinary shares that may be issued under the 2018 Plan was 3,281,622 .
2 unchanged sentences
The updated maximum number of ordinary shares that may be issued under the 2018 Plan is 32,943,013 as of December 31, 2024.
+Added: As of December 31, 2024, 11,464,845 ordinary shares were available for future grant.
The total shares issued under the 2018 Plan may be authorized but unissued shares, shares purchased on the open market, treasury shares or ADSs.
1 unchanged sentence
Share options granted under the 2018 Plan and 2017 Plan generally expire ten years from the date of grant.
−Removed: For certain senior members of management and directors, the board of directors has approved an alternative vesting schedule.
+Added: For certain senior members of management and directors, the Board has approved an alternative vesting schedule.
Share Option Valuation
1 unchanged sentence
Year Ended December 31,
−Removed: 2023 2022 2021
Expected option life (years) 3.14 to 6.08
1 unchanged sentence
3.37 % to 4.86 %
−Removed: 0.62 % to 1.34 %
Expected volatility 79.48 % to 83.87 %
83.25 % to 85.51 %
−Removed: 80.05 % to 82.03 %
Expected dividend yield 0 % 0 %
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
Share Options
5 unchanged sentences
Outstanding as of December 31, 2023
+Added: 17,956,385 $ 5.64 8.35 $ 48,968
Granted 4,283,550 4.09 — 62
3 unchanged sentences
Outstanding as of December 31, 2024
+Added: 20,754,316 $ 5.41 7.78 $ 1,536
Exercisable as of December 31, 2024
1 unchanged sentence
Vested and expected to vest as of December 31, 2024
+Added: 20,754,316 $ 5.41 7.78 $ 1,536
(1) Aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of common stock for those options in the money as of December 31, 2024
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
−Removed: The total intrinsic value of options exercised was $ 0.01 million, $ 0.4 million, and $ 1.2 million for the years ended December 31, 2023, 2022, and 2021, respectively.
+Added: The total intrinsic value of options exercised was $ 0.5 million and $ 0.01 million, for the years ended December 31, 2024 and 2023, respectively.
The aggregate intrinsic value of share options is calculated as the difference between the exercise price of the share options and the fair value of the Company’s underlying ordinary shares for those share options that had exercise prices lower than the fair value of the Company’s underlying ordinary shares.
−Removed: The total fair value of share options vested (including performance-based share options) amounted to $ 11.4 million, $ 11.1 million, and $ 13.0 million for the years ended December 31, 2023, 2022 and 2021, respectively.
+Added: The total fair value of share options vested (including performance-based share options) amounted to $ 12.9 million and $ 11.4 million, for the years ended December 31, 2024 and 2023, respectively.
The weighted average grant-date fair value of share options granted was $ 2.96 and $ 1.69 per option for the years ended December 31, 2024 and 2023, respectively.
1 unchanged sentence
Performance based share options
−Removed: During the year ended December 31, 2021, the Company granted 1,602,500 share options with performance conditions related to specified regulatory milestones, of which 222,500 share options with performance conditions were forfeited.
−Removed: During the year ended December 31, 2021, 80,000 of these share options were modified to remove the performance conditions, thereby accelerating the vesting.
−Removed: During the year ended December 31, 2022, the Company did not grant any share options with performance conditions.
−Removed: However, during the year ended December 31, 2022, 222,500 share options with performance conditions were forfeited.
−Removed: In addition, 120,000 performance-based share options were modified during the year ended December 31, 2022 to remove the performance conditions, thereby accelerating the vesting and resulting in associated share-based compensation expen se of $ 0.3 million.
+Added: The Company did not grant share options with a specified regulatory performance condition during the year ended December 31, 2024, 15,000 performance-based share options were forfeited or expired.
+Added: In addition, during the year ended December 31, 2024, 573,850 performance-based share options vested upon the achievement of the relevant regulatory milestone.
During the year ended December 31, 2023, the Company granted 107,600 share options with a specified regulatory performance condition.
1 unchanged sentence
In addition, during the year ended December 31, 2023, 478,750 performance-based share options vested upon the achievement of the relevant regulatory milestone.
−Removed: As of December 31, 2023, 2022 and 2021, a performance condition related to these performance-based share options was deemed probable.
−Removed: As a result, $ 1.0 million, $ 1.1 million and $ 1.4 million share-based compensation expense was recognized for the years ended December 31, 2023, 2022 and 2021, respectively.
−Removed: As at December 31, 2023, the total unrecognized share-based compensation expense related to unvested share options with performance conditions was $ 3.1 million, which the Company expects to recognize over a weighted average vesting period of 2.33 years.
+Added: As of December 31, 2024 and 2023, all the performance condition related to these performance-based share options were met.
+Added: As a result, $ 2.9 million and $ 1.0 million share-based compensation expense was recognized for the years ended December 31, 2024 and 2023, respectively.
Restricted Stock Units
1 unchanged sentence
The fair value of each RSU award is based on the closing price of the Company’s ADSs on the date of grant.
−Removed: Prior to 2021, the Company historically granted RSU awards with service conditions that vest over a three-year service period with 50 % of the award vesting one-and-half years from grant date and the remaining 50 % of the award vesting at the end of the third year.
−Removed: In January 2021, the Company awarded RSU awards that contained a performance condition based on a condition related to a specified clinical milestone.
−Removed: These performance-based RSU awards vest upon achievement of the related performance condition.
In March 2021, the Company awarded RSU awards with service conditions that vest over a four-year service period with 25 % on the first anniversary of the grant date, and the balance vesting quarterly over the remaining three-years .
−Removed: In July 2021, the Company awarded RSU awards with service conditions that vest over a two-year period, with 100 % of the award vesting on the second anniversary of the grant date.
−Removed: In 2022, RSUs awarded during the year typically vest over a four-year service period, with 25 % of the award vesting on the first anniversary of the commencement date and the balance vesting monthly over the remaining three years .
−Removed: However, in September 2022, the Company awarded RSU awards with service conditions that vest over an 11-month period, with 50 % of the award vesting eight months from grant date and the remaining 50 % of the award vesting at the end of the eleventh month.
−Removed: In addition, in December 2022, the Company awarded RSU awards with service conditions that vest over a 15 month period, with 50 % of the award vesting twelve months from grant date and the remaining 50 % of the award vesting at the end of the fifteenth month.
In July 2023, the Company granted 90,000 RSU awards with a performance condition related to a specified regulatory milestone.
−Removed: These performance-based RSU awards vest upon achievement of the related performance condition.
+Added: These performance-based RSU awards have vested upon achievement of the related performance condition.
AUTOLUS THERAPEUTICS PLC
3 unchanged sentences
Unvested and outstanding at December 31, 2023
−Removed: Granted 90,000 2.54
+Added: 116,436 $ 3.43
Vested ( 82,848 ) 3.08
1 unchanged sentence
Unvested and outstanding at December 31, 2024
−Removed: As of December 31, 2023, there was $ 0.1 million of unrecognized share-based compensation expense related to unvested RSUs without performance conditions, which are expected to be recognized over a weighted average period of 1.69 years.
−Removed: The total fair value of share RSU awards vested (including performance-based RSU awards) amounted to $ 1.3 million, $ 1.5 million, and $ 1.5 million for the years ended December 31, 2023, 2022 and 2021, respectively.
+Added: 32,412 $ 4.22
+Added: As of December 31, 2024, there was less than $ 0.1 million of unrecognized share-based compensation expense related to unvested RSUs without performance conditions, which are expected to be recognized over a weighted average period of 1.26 years.
+Added: The total fair value of share RSU awards vested (including performance-based RSU awards) amounted to $ 0.5 million and $ 1.3 million for the years ended December 31, 2024 and 2023, respectively.
Performance-based RSU awards
−Removed: During the year ended December 31, 2021, the Company awarded an aggregate of 1,020,000 RSU awards with a performance condition related to a specified clinical milestone.
−Removed: As of December 31, 2021, the related clinical milestone performance condition was determined to be probable and accordingly, $ 4.4 million of share-based compensation expense was recognized.
−Removed: During the year ended December 31, 2022, 617,500 of these RSU award s vested due to the achievement of a specified clinical milestone resulting in the recognition of $ 1.2 million of share-based compensation expense.
−Removed: A further 60,000 of these RSU award s were modified during the year ended December 31, 2022 by removing the performance condition, thereby accelerating the vesting and resulting in related share-based compensation expense of $ 0.2 million.
−Removed: An aggregate of 152,500 and 222,500 performance based RSU awards with performance conditions were forfeited during the year ended December 31, 2022 and 2021, respectively.
+Added: During the year ended December 31, 2024, the Company did no t grant RSU awards with performance conditions.
During the year ended December 31, 2023, the Company granted 90,000 RSU awards with performance condition related to a specified regulatory milestone.
3 unchanged sentences
During the year ended December 31, 2024, 3,648 RSU awards vested but were not issued as of December 31, 2024, and as such are not included in the Company's outstanding shares at December 31, 2024.
−Removed: 57,524 of these RSU awards were issued in February 2024.
+Added: The shares corresponding to these RSUs awards were issued in January 2025.
Share-based compensation expense
−Removed: Share-based compensation expense recorded as research and development and general and administrative expenses is as follows (in thousands):
+Added: Share-based compensation expense recorded as research and development expenses, selling, general and administrative expenses and cost of sales is as follows (in thousands):
Year Ended December 31,
+Added: Research and development expenses
$ 5,593 $ 6,777
−Removed: Research and development $ 6,732 $ 7,171 $ 5,241
−Removed: General and administrative 4,472 4,849 4,696
+Added: Selling, general and administrative expenses
+Added: Cost of sales
Capitalized to intangible assets, net / property and equipment ( 3 ) ( 46 )
5 unchanged sentences
Year Ended December 31,
−Removed: 2023 2022 2021
Net loss $ ( 220,662 ) $ ( 208,383 )
2 unchanged sentences
Net loss per share - basic and diluted $ ( 0.86 ) $ ( 1.20 )
−Removed: For all periods presented, outstanding but unvested restricted shares, unvested RSUs, share options and warrants have been excluded from the calculation, because their effects would be anti-dilutive.
+Added: For all periods presented, outstanding but unvested RSUs, share options and warrants have been excluded from the calculation, because their effects would be anti-dilutive.
Therefore, the weighted average number of ordinary shares used to calculate both basic and diluted loss per share are the same for all periods presented.
The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:
−Removed: 2023 2022 2021
Unvested RSUs 32,412 116,436
18 unchanged sentences
On a per-product basis, these milestone payments range from £ 1.0 million to £ 18.5 million, depending on which T cell programming modules are used in the product achieving the milestone.
−Removed: The Company considers the regulatory approval and commercial milestones probable when actually achieved.
+Added: On November 8, 2024 the Company was notified by the FDA that the Company’s BLA was approved, allowing for the marketing of AUCATZYL in the US for the treatment of adult patients (18 years and older) with r/r B-ALL.
+Added: Consequently, the Company paid a regulatory milestone payment of £ 10.0 million to UCLB.
Under the terms of the license, the Company has the right to grant sub-licenses to third parties, subject to certain restrictions.
−Removed: If the Company receives any income in connection with such sublicenses, it must pay UCLB a percentage of the income allocable to the value of the sublicensed intellectual property rights ranging from the low twenties to mid-single digits percent, decreasing based on the development expenses incurred by us and the passage of time.
+Added: If the Company receives any income in connection with such sublicenses, it must pay UCLB a percentage of the income allocable to the value of the sublicensed intellectual property rights ranging from the low twenties to mid-single digits percent, decreasing based on the development expenses incurred by the Company and the passage of time.
During the year ended December 31, 2024, $ 0.1 million was payable to UCLB by the Company relating to the income allocable to the value of the sublicensed intellectual property rights.
8 unchanged sentences
In addition, UCLB has the right to negotiate with the Company for the grant of an exclusive license to the Company’s improvements to the T cell programming modules the Company has licensed on terms to be agreed upon at the time.
−Removed: Noile-Immune Biotech Inc.
−Removed: In November 2019, the Company entered into an exclusive license agreement with Noile-Immune Biotech Inc.
−Removed: (“Noile”) under which the Company will have the right to develop CAR T cell therapies incorporating Noile’s PRIME (proliferation-inducing and migration-enhancing) technology.
−Removed: The PRIME technology is designed to improve proliferation and trafficking into solid tumors of both engineered CAR T cells as well as the patient’s own T cells.
−Removed: The Company paid an upfront fee and may be obligated to make additional payments to Noile upon the achievement of development milestones and receipt of regulatory approvals, product sales milestones, as well as royalty payments based on possible future sales resulting from the utilization of the licensed technology.
Miltenyi Biotech B.V.
3 unchanged sentences
The Company recognized $ 0.4 million in aggregate relating to an upfront license payment and milestone payments that were deemed probable during the year ended December 31, 2023.
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
+Added: There were no additional milestone payments deemed probable during the year ended December 31, 2024.
Loss before income tax benefit (expense) is as follows (in thousands):
Year Ended December 31,
−Removed: (As Restated)
−Removed: (As Restated)
−Removed: UK $ ( 209,766 ) $ ( 149,455 ) $ ( 142,736 )
$ ( 221,661 ) $ ( 209,766 )
2 unchanged sentences
$ ( 219,134 ) $ ( 208,402 )
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
The components of income tax benefit (expense) are as follows (in thousands):
Year Ended December 31,
−Removed: (As Restated)
−Removed: (As Restated)
$ ( 1,228 ) $ ( 859 )
State and local
−Removed: ( 5 ) ( 19 ) ( 19 )
Switzerland and Germany
( 459 ) ( 104 )
−Removed: Total current tax benefit (expense)
+Added: Total current tax expense
( 1,703 ) ( 968 )
1 unchanged sentence
State and local
−Removed: ( 15 ) ( 5 ) ( 52 )
Switzerland and Germany
−Removed: Total deferred tax benefit (expense)
−Removed: Total income tax benefit (expense)
+Added: Total deferred tax benefit
+Added: Total income tax (expense) benefit
$ ( 1,528 ) $ 19
−Removed: The Company recorded an income tax benefit (expense) of $ 19.5 thousand, $ 0.3 million and $ 0.1 million, for the years ended December 31, 2023, 2022 and 2021, respectively.
+Added: The Company recorded an income tax expense of $ 1.5 million and income tax benefit of less than $ 0.1 million, for the years ended December 31, 2024 and 2023, respectively.
+Added: Deferred tax assets consisted of the following at December 31, 2024 and 2023 (in thousands):
+Added: Deferred tax assets:
+Added: Other differences $ 18,761 $ 14,834
+Added: Tax losses 136,406 104,534
+Added: Fixed assets 5,069 6,653
+Added: Total deferred tax assets 160,236 126,021
+Added: Valuation allowances ( 156,997 ) ( 122,958 )
+Added: Net deferred tax asset $ 3,239 $ 3,063
+Added: The movements in the deferred tax asset valuation allowance consisted of the following at December 31, 2024 and 2023 (in thousands):
+Added: Valuation allowance as of January 1,
+Added: $ ( 122,958 ) $ ( 95,955 )
+Added: Decrease in valuation allowance through net loss
+Added: ( 36,670 ) ( 21,245 )
+Added: Foreign currency translation adjustments
+Added: 2,631 ( 5,758 )
+Added: Valuation allowance as of December 31,
+Added: $ ( 156,997 ) $ ( 122,958 )
AUTOLUS THERAPEUTICS PLC
2 unchanged sentences
Year Ended December 31,
−Removed: (As Restated)
−Removed: (As Restated)
Net loss before taxes $ ( 219,134 ) $ ( 208,402 )
−Removed: UK statutory tax rate 23.5 % 19.0 % 19.0 %
−Removed: Income tax benefit at UK statutory tax rate ( 48,974 ) ( 28,228 ) ( 26,987 )
+Added: statutory tax rate 25.0 % 23.5 %
+Added: Income tax benefit at U.K.
+Added: statutory tax rate 54,783 48,974
Tax-exempt reimbursable tax credits included within research and development expense 4,934 4,589
5 unchanged sentences
Foreign rate differential 94 26
−Removed: Total income tax benefit (expense)
+Added: Total income tax (expense) benefit
$ ( 1,528 ) $ 19
−Removed: Current income tax benefit 968 485 168
+Added: Current income tax expense
+Added: $ ( 1,703 ) $ ( 968 )
Deferred income tax benefit $ 175 $ 987
Effective rate of income tax 0.7 % — %
−Removed: The Company is headquartered in the United Kingdom and has subsidiaries in the United Kingdom, the United States, Germany and Switzerland.
+Added: The Company is headquartered and has subsidiaries in the United Kingdom.
+Added: Additionally, the Company has subsidiaries in the United States, Germany and Switzerland.
The Company incurs tax losses in the United Kingdom.
−Removed: The UK corporate income tax rate for the year ended December 31, 2023 was 23.5%, and was 19% for the years ended December 31, 2022 and 2021, respectively.
+Added: corporate income tax rate for the year ended December 31, 2024 was 25%, and was 23.5% for the years ended December 31, 2023.
On April 1, 2023, the U.K government increased and enacted the corporate rate from 19% to 25%.
The Company’s subsidiary in the United States has generated taxable profits due to a service agreement between the Company’s subsidiaries in the United States and the United Kingdom.
−Removed: federal corporate income tax rate was 21% for the years ended December 31, 2023, 2022 and 2021, respectively.
−Removed: Deferred tax assets and liabilities consisted of the following at December 31, 2023 and 2022 (in thousands):
−Removed: Deferred tax assets:
−Removed: Other differences $ 14,834 $ 13,576
−Removed: Tax losses 104,534 80,203
−Removed: Fixed assets 6,653 4,252
−Removed: Total deferred tax assets 126,021 98,031
−Removed: Valuation allowances ( 122,958 ) ( 95,955 )
−Removed: Net deferred tax asset $ 3,063 $ 2,076
+Added: federal corporate income tax rate was 21% for the years ended December 31, 2024 and 2023.
Deferred tax assets resulting from loss carryforwards, fixed assets and retirement benefits, with total deferred tax assets increasing by $ 0.2 million in 2024.
2 unchanged sentences
subsidiary entity.
−Removed: At December 31, 2023, the Company had UK trading losses carryforward of $ 418.1 million.
+Added: At December 31, 2024, the Company had U.K.
+Added: trading losses carryforward of $ 545.6 million.
These losses are carried forward indefinitely under local law, but are subject to numerous utilization criteria and restrictions.
2 unchanged sentences
In circumstances where there is sufficient negative evidence indicating that the deferred tax assets are not more likely than not realizable, the Company establishes a valuation allowance.
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
The Company operates in multiple jurisdictions with complex tax and regulatory environment and its tax returns are periodically audited or subjected to review by tax authorities.
3 unchanged sentences
United States
+Added: Research and development U.K.
+Added: The benefits from U.K.
+Added: research and development tax credits are recognized in the statements of operations and comprehensive loss as a reduction of research and development expenses and represents the sum of the research and development tax credits recoverable in the U.K..
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
+Added: The Small Medium Enterprise regime has been particularly beneficial to the Company, as under such program the trading losses that arise from the Company's qualifying R&D activities can be surrendered for a cash rebate of up to 33.35% of qualifying expenditure incurred prior to April 1, 2023 and decreasing to 18.6% after April 1, 2023.
+Added: Government also enacted further changes to the SME regime effective from April 1 2023 (with some amendments effective for accounting periods commencing after April 1 2024) which included the introduction of a new rate for R&D intensive companies of 27% .
+Added: Qualifying expenditures largely comprise employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects for which the Company do not receive income.
+Added: A large proportion of costs in relation to the Company's pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by the Company's wholly owned subsidiary Autolus Limited, are eligible for inclusion within these tax credit cash rebate claims.
+Added: Under the RDEC program, tax credits for qualifying R&D expenditure incurred prior to April 1, 2023 are granted at a headline rate of 13% and can generate cash rebates of up to 10.5% of qualifying R&D expenditure.
+Added: The headline rate of RDEC increased to 20% on April 1, 2023 and can generate cash rebates of up to 15% on qualifying R&D expenditure incurred from this date.
+Added: Amendments to the current SME and RDEC programs contained in the Finance Act 2024 (unless limited exceptions apply) introduce restrictions on the tax relief that can be claimed for expenditure incurred on sub-contracted R&D activities or externally provided workers, where such sub-contracted activities are not carried out in the U.K.
+Added: or such workers are not subject to U.K.
+Added: payroll taxes, and (ii) merge the SME and RDEC programs into a single scheme which would generate net cash benefit of up to 15% of the qualifying expenditure for profit making companies and up to 16.2% for loss making companies.
+Added: These changes take effect from periods commencing after April 1 2024.
+Added: During the year ended December 31, 2024, the Company met the conditions of the SME regime, but it could also make claims under the RDEC regime to the extent that its projects are grant funded.
+Added: In the accounting period to December 2023, based on the relevant tax legislation, the Company considered that it met the conditions of the R&D intensive scheme, and have made a claim on this basis.
+Added: This is subject to agreement by the U.K.
+Added: tax authority who, based on their non-statutory guidance, considers the basis for calculating whether a company meets the intensive criteria includes expenditure which is in conflict with the tax legislation.
+Added: The position is uncertain and the legislation is currently untested in the U.K.
+Added: If the Company's claim is unsuccessful, normal SME relief will be available and there will be a material reduction in the value of the tax credit obtained (18.6% as opposed to 26.97% net benefit).
+Added: From January 2025, the Company does not qualify as a small or medium-sized enterprise under the SME program, based on size criteria concerning employee headcount, turnover and gross assets.
+Added: However, the Company may make a claim under the merged RDEC regime beginning with periods ending December 31, 2025.
+Added: It should be noted, however, that the types of qualifying expenditure in respect of which the Company may make claims under the RDEC regime are more restricted than under the SME regime (for example, it may be the case that certain subcontracted costs in respect of which claims may be made under the SME regime do not qualify for relief under the RDEC regime).
+Added: R&D tax credits of $ 19.7 million and $ 19.5 million were recognized for the years ended December 31, 2024 and 2023, respectively, and are recorded as offsets to research and development expense in the Company's consolidated statement of operations and comprehensive loss.
Operating Leases
−Removed: In September 2017, the Company executed an arrangement with Cell Therapy Catapult Limited to lease a manufacturing suite at the Cell and Gene Therapy Catapult manufacturing center in Stevenage, United Kingdom for a term through May 2021, at which time the Company had the option to renew or terminate the lease.
−Removed: The lease had a six-month rent-free period.
−Removed: In December 2018, the Company executed an additional lease arrangement for additional manufacturing space for a term through September 2023, at which time the Company had the option to renew or terminate the lease.
−Removed: In addition, in May 2020, the Company executed an arrangement with Cell Therapy Catapult Limited to lease a different manufacturing suite at the Cell and Gene Therapy Catapult manufacturing center in Stevenage, United Kingdom for a term through April 2024.
−Removed: In July 2022 the Company and Cell Therapy Catapult Limited mutually agreed:
−Removed: (i) to extend the lease term of a manufacturing suite leased by the Company from April 2024 to February 2025, and (ii) to reduce the lease term of a different manufacturing suite leased by the Company from July 2024 to June 2023.
+Added: Since September 2017, the Company has had an arrangement with Cell Therapy Catapult Limited to lease manufacturing suites at the Cell and Gene Therapy Catapult manufacturing center in Stevenage, United Kingdom.
In March 2023, the Company and Cell Therapy Catapult Limited mutually agreed:
(i) to terminate the lease relating to the leased manufacturing suite which originally had a lease term until February 2025, (ii) to extend the lease term of one of the remaining manufacturing suites from June 2023 to August 2024, and (iii) to extend the lease term of a third manufacturing suite leased by the Company from September 2023 to August 2024.
−Removed: The Company recognized a lease termination loss of $ 0.1 million, which is included in Other income (expense), net on the Consolidated Statement of Operations and Comprehensive Loss for the year ended December 31, 2023, related to the manufacturing suite terminated and exited on March 31, 2023.
+Added: The Company recognized a lease termination loss of $ 0.1 million, which is included in other income, net on the consolidated statement of operations and comprehensive loss for the year ended December 31, 2023, related to the manufacturing suite terminated and exited on March 31, 2023.
In addition, during the year ended December 31, 2023, the Company recognized a loss on disposal on leasehold improvements of $ 3.8 million arising from the manufacturing suite terminated and exited on March 31, 2023.
−Removed: In October 2018, the Company executed an agreement to sublease office space in Rockville, Maryland for a term through October 2021.
−Removed: The Company then terminated the sublease in February 2020 and immediately entered into a five-year lease for the same space with the landlord.
−Removed: As a result of the sublease termination, the Company recognized a $ 0.2 million gain in other (expense) income in March, 2020.
−Removed: The lease related to this facility is classified as an operating lease.
−Removed: The Company is obligated to pay its proportionate share of building operating expenses and real estate taxes in excess of base year amounts.
−Removed: These costs are considered to be variable lease payments and are not included in the determination of the lease’s right-of-use asset or lease liability.
−Removed: In January 2019, the Company executed a lease agreement with Whitewood Media Village GP Limited and Whitewood Media Village Nominee Limited to lease the fifth floor of MediaWorks including laboratory space.
−Removed: The Company has the option to terminate the lease in November 2026.
−Removed: In August 2021, MediaWorks became the Company's main corporate headquarters.
−Removed: In addition to base rent, the Company is obligated to pay its proportionate share of building operating expenses and real estate taxes in excess of base year amounts.
−Removed: These costs are considered to be variable lease payments and are not included in the determination of the lease’s right-of-use asset or lease liability.
−Removed: The lease agreement includes an option to lease additional space.
−Removed: The lease term is nine years and eleven months with an eighteen-month rent free period at the beginning of the lease term.
−Removed: In January 2019, the Company executed a lease agreement to lease additional office and manufacturing space in Rockville, Maryland.
−Removed: The lease agreement required the Company to enter into a lease provided that the landlord completed the required leasehold improvements described in the agreement.
−Removed: The lease commenced in August 2020 for a term through June 2036.
−Removed: In March 2021, the Company announced plans to move the site of its global manufacturing headquarters to the United Kingdom from the United States.
−Removed: As a part of this strategy, the Company entered into a termination agreement with the landlord of its Rockville, Maryland property to terminate the lease for office and manufacturing space.
−Removed: As a result, the Company recognized a $ 2.0 million termination fee gain from the landlord, a $ 2.3 million gain from the removal of the leased right of use asset and corresponding lease liability, and expensed $ 2.4 million of leasehold improvements for the year ended December 31, 2021 within Other income (expense), net.
−Removed: The $ 2.0 million termination fee was received from the landlord in April 2021.
+Added: In August 2024, one of the leased manufacturing suites ended and the Company exited the suite.
+Added: In September 2024, the Company extended the lease term from August 2024 to December 2026 for the remaining manufacturing suite.
AUTOLUS THERAPEUTICS PLC
5 unchanged sentences
These costs are considered to be variable lease payments and are not included in the determination of the lease’s right-of-use asset or lease liability.
−Removed: The Company reduced the right-of-use asset and lease liability based on the contractual option termination date.
−Removed: The Company expensed $ 4.1 million of leasehold improvements from assets under construction as of December 31, 2019 as a result of discontinuing the fit-out of the manufacturing facility.
In March 2021, one of the units was split in two separate units and the Company surrendered one of those units back to the landlord.
−Removed: Upon the surrender of the unit, the Company recognized a $ 0.1 million gain in other (expense) income after recognizing a termination fee of $ 0.2 million.
The Company has no further obligations for the surrendered unit and the right of use asset and lease liability which were recorded for this unit were written off during the year ended December 31, 2021.
1 unchanged sentence
Refer to “Sublease agreements” below for further details .
−Removed: The Company completed an asset impairment analysis of the right-of-use lease concluding the undiscounted cash flows exceeded the carrying value as of December 31, 2023.
−Removed: In September 2021, the Company entered into an arrangement for lease with the landlord, Forge Life Sciences Nominee, an affiliate of the Reef Group, for the design, construction and lease of a new 70,000 square foot commercial manufacturing facility in Stevenage, United Kingdom.
−Removed: Under this arrangement, the landlord leased the facility, which is called The Nucleus, to the Company on agreed terms, upon satisfaction of certain conditions and completion of construction.
−Removed: Since November 2022, the landlord has handed over various portions of the facility to the Company until July 31, 2023.
−Removed: The Company was required to pay a pro-rated license fee for each portion of the facility for which the Company was granted access until the execution of a lease agreement.
−Removed: The Company cumulatively contributed $ 7.5 million as part as of landlord works and tenant contributions towards the lease as of December 31, 2023 resulting in these payments being taken into account in the determination of the right of use asset for this facility.
−Removed: On July 31, 2023, the landlord and its contractors accepted practical completion of The Nucleus.
−Removed: On September 19, 2023, the Company entered into a 20 -year lease agreement with the landlord for The Nucleus.
−Removed: The Company made fit-out costs in other areas of the building and may be required to be removed at the end of the lease term.
−Removed: As a result, as of December 31, 2023, the Company has recognized an estimated Asset Retirement Obligation (“ARO”) amounting to $ 0.2 million.
−Removed: The Company will continue to assess the ARO as more related assets are brought into use.
+Added: The Company completed an asset impairment analysis of the right-of-use lease concluding the undiscounted cash flows exceeded the carrying value as of December 31, 2024 which resulted the recognition of a $ 0.4 million impairment of operating lease right-of-use assets and related property and equipment.
In September 2021, the Company also entered into a lease agreement for 2,762 square feet of laboratory and office space in Gaithersburg, Maryland, with a term until March 2024.
In September 2023, the Company extended the original lease term to March 2027.
+Added: On September 19, 2023, the Company entered into a 20 -year lease agreement with the landlord for The Nucleus.
+Added: The Company made fit-out costs in other areas of the building which may be required to be removed at the end of the lease term.
+Added: On September 10, 2024, the Company completed a variation of the lease for the manufacturing facility, related to additional works at the site.
+Added: The landlord will provide funding for certain specified improvements to the facility (the “Works ” ), which the Company commits to undertake on a mutually agreed schedule.
+Added: Funding received for the Works done are deemed lease incentives in accordance to ASC 842.
+Added: Once the Works are complete, the rental payments under the lease will be increased according to a specified formula for the remainder of the lease term.
+Added: The deed of variation does not affect the lease term, which continues to run for 20 years from September 19, 2023.
The following table shows the lease balance sheet classification of leases for the years ended December 31, 2024 and 2023 (in thousands):
22 unchanged sentences
general and administrative 117 90
+Added: Operating lease costs Operating expenses:
+Added: cost of sales
+Added: Variable costs Operating expenses:
+Added: cost of sales
Total lease costs $ 10,631 $ 9,264
12 unchanged sentences
Present value of lease liabilities $ 52,629
−Removed: Sublease agreements
−Removed: In October 2021, the Company entered into separate two sublease agreements with two third parties for two manufacturing spaces in Enfield which is currently leased by the Company.
−Removed: The annual lease payments to be received for each of subleased units is £ 97,000 and £ 109,000 , over lease terms from October 2021 to February 2029 and October 2026, respectively.
−Removed: In October 2021, the Company received $ 127,000 in rental deposits, arising from the sublease agreements which have been classified as restricted cash as of December 31, 2023 and 2022, respectively.
−Removed: Both sub-leases have been classified as operating leases.
−Removed: The Company recognized the sublease payments on a straight-line basis from the commencement of the sublease agreements.
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
−Removed: The following table shows the sub-lease rental income for the years ended December 31, 2023, 2022 and 2021 (in thousands):
−Removed: Year ended December 31,
−Removed: Sublease rental income
−Removed: Statement of Operations classification 2023 2022 2021
−Removed: Sublease rental income
−Removed: Other income (expense), net
−Removed: $ 241 $ 240 $ 49
−Removed: Total sublease rental income
−Removed: $ 241 $ 240 $ 49
−Removed: Future fixed receipts for non-cancellable operating subleases in effect as of December 31, 2023 are receivable as follows:
−Removed: Operating Leases
−Removed: (in thousands)
−Removed: Total lease payments receivable $ 954
+Added: (1) Includes lease incentives from The Nucleus lease variation amounting to $ 10.2 million and $ 0.9 million, for the year ended December 31, 2025 and 2026, respectively.
Commitments and Contingencies
−Removed: License Agreements
−Removed: The Company has entered into an exclusive license agreement, as amended, with U CLB (Refer to Note 16, “ License Agreements ” ).
−Removed: I n connection with the UCLB license agreement, the Company is required to make annual license payments and may be required to make payments upon the achievement of specified milestones.
−Removed: The Company has estimated the probability of the Company achieving each potential milestone in accordance with ASC 450, Contingencies .
−Removed: In November 2019, the Company entered into an exclusive license agreement with Noile-Immune Biotech Inc.
−Removed: (“Noile”) under which the Company will have the right to develop CAR T cell therapies incorporating Noile’s PRIME (proliferation-inducing and migration-enhancing) technology.
−Removed: The Company may be obligated to make additional payments to Noile upon the achievement of development milestones and receipt of regulatory approvals, product sales milestones, as well as royalty payments based on possible future sales resulting from the utilization of the licensed technology.
−Removed: In July 2022, the Company renegotiated a master services agreement with Adaptive Biotechnologies Corporation (“Adaptive”), under which Adaptive's assay is used to analyze patient samples from relapsed/refractory B Cell Acute Lymphoblastic Leukaemia (rrB-ALL) patients.
−Removed: Under the agreement, the Company is obligated to make specified payments to Adaptive upon the achievement and receipt of certain regulatory approvals and achievement of commercial milestones in connection with the Company's use of the Adaptive assay.
−Removed: During the year ended December 31, 2023, the Company recognized all contractual milestones relating to this contract which were deemed probable.
−Removed: In August 2022, the Company entered into an agreement with Evercore Partners International LLP (“Evercore”) to act as advisors for the Company.
−Removed: The Company is obligated to make specified payments to Evercore upon the achievement of certain strategic transactions involving the Company.
−Removed: The Company became obligated to make a single low- to mid-million dollar payment upon the completion of the BioNTech Collaboration Agreement.
−Removed: (Refer to Note 24 - “Subsequent events”), which will be paid in the first quarter of 2024.
−Removed: In September 2023, the Company entered into a non-exclusive sublicense agreement with Miltenyi Biotech B.V.
−Removed: KG (“Miltenyi”) under which the Company will have the right to develop, manufacture and use Miltenyi's or affiliates' sublicensed products.
−Removed: Under the agreement, the Company is obligated to make specified payments to Miltenyi upon the achievement of certain regulatory and clinical milestones.
−Removed: The Company recognized $ 0.4 million in aggregate relating to an upfront license payment and milestone payments that were deemed probable during the year ended December 31, 2023.
−Removed: In November 2023, the Company entered into an agreement with goetzpartners securities Limited (“goetzpartners”) to act as advisors for the Company.
−Removed: The Company is obligated to make specified payments to goetzpartners upon the achievement of certain strategic transactions involving the Company.
−Removed: The Company became obligated to make a single low to mid million dollar payment upon the completion of the BioNTech Collaboration Agreement (Refer to Note 24 - “Subsequent events”), which was paid in the first quarter of 2024.
+Added: Contractual obligations
+Added: In July 2022, the Company renegotiated a master services agreement (the “Adaptive Master Services Agreement”) with Adaptive Biotechnologies Corporation (“Adaptive”), under which Adaptive's assay is used to analyze patient samples from r/r B-ALL patients.
+Added: During the year ended December 31, 2023, the Company recognized all contractual milestones relating to this contract.
+Added: Under the then-current agreement, the Company would be obligated to make specified payments to Adaptive upon the achievement and receipt of certain regulatory approvals and achievement of commercial milestones in connection with the Company’s use of the Adaptive assay.
+Added: In previous periods, the Company has entered into agreements with certain advisory firms.
+Added: The Company is obligated to make specified payments upon the achievement of certain strategic transactions involving the Company.
+Added: During the year ended December 31, 2024, the Company paid a fee under these agreements.
AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
−Removed: The Company has estimated the probability of the Company achieving each potential milestone in relation to the license agreements with UCLB, Noile, Miltenyi and agreements with Evercore and goetzpartners in accordance with ASC 450, Contingencies .
+Added: The Company has estimated the probability of the Company achieving each potential milestone in relation to the agreements with UCLB, Miltenyi and its agreements with certain advisory firms in accordance with ASC 450.
The Company considers the regulatory approval, commercial milestones and execution of collaboration agreements probable when actually achieved.
−Removed: Furthermore, the Company considers clinical milestones recognizes clinical milestones when deemed probable.
−Removed: The Company concluded that, as of December 31, 2023, there were other no milestones for which the likelihood of achievement was currently probable.
−Removed: Legal Proceedings
−Removed: From time to time, the Company may be a party to litigation or subject to claims incident to the ordinary course of business.
−Removed: Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors.
−Removed: The Company was not a party to any litigation and did not have contingency reserves established for any liabilities as of December 31, 2023.
+Added: Furthermore, the Company recognizes expenses for clinical milestones when their achievement is deemed probable.
+Added: The Company concluded that, as of December 31, 2024, there were no other milestones or contingencies for which the likelihood of achievement was currently probable.
Capital Commitments
−Removed: As of December 31, 2023, the Company’s unconditional purchase obligations for capital expenditure totaled $ 4.3 million and include signed orders for capital equipment and capital expenditure for construction and related expenditure relating to its properties in the United Kingdom and the United States, of which the Company expects to incur $ 0.4 million within one year, and $ 3.9 million within one to four years.
+Added: As of December 31, 2024, the Company’s unconditional purchase obligations for capital expenditure totaled $ 17.5 million and included signed orders for capital equipment and capital expenditure for construction and related expenditure relating primarily to its properties in the United Kingdom.
+Added: The Company expects to incur the full amount of these obligations within one year.
Master Supply Commitments
−Removed: In March 2018, the Company entered into a long-term supply agreement with Miltenyi Biotec GmbH, or Miltenyi, for the supply of Miltenyi’s CliniMACS Prodigy instruments, reagents and disposables for the manufacture of the Company's programmed T cell therapies for preclinical and clinical use and, if approved, for commercial use, as well as support services.
−Removed: The supply agreement sets forth procedures to ensure continuity of supply to the Company of Miltenyi’s products, both during the clinical phase and any future commercial phase of our product candidates.
+Added: In March 2018, the Company entered into a long-term supply agreement with Miltenyi Biotec GmbH, or Miltenyi, for the supply of Miltenyi’s CliniMACS Prodigy instruments, reagents and disposables for the manufacture of the Company's programmed T cell therapies for commercial, preclinical and clinical use as well as support services.
+Added: The supply agreement sets forth procedures to ensure continuity of supply to the Company of Miltenyi’s products, both during the clinical phase and any future commercial phase of the Company's product candidates.
After the initial ten-year term of the agreement, the Company has two separate options to renew the agreement, each for an additional five-year term.
1 unchanged sentence
As of December 31, 2024, the Company’s unconditional purchase obligations for reagents and disposables totaled $ 0.6 million, which the Company expects to incur within one year.
−Removed: Lease payments under operating leases as of December 31, 2023 and information about the Company’s lease arrangements are disclosed in Note 18, “Leases”.
−Removed: Blackstone Strategic Collaboration and Financing Agreement
−Removed: Refer to Note 11, “Liability related to future royalties and sales milestone, net” for further details about the Blackstone Collaboration Agreement .
+Added: Distribution Commitments
+Added: The Company entered into an Exclusive Distribution Agreement, effective as of April 25, 2024 (the “Effective Date”), with Cardinal Health 105, LLC (“Cardinal Health”).
+Added: Pursuant to, and subject to the terms and conditions of, the Exclusive Distribution Agreement, the Company engaged Cardinal Health as its exclusive third-party logistics distribution agent for sales of AUCATZYL in the US.
+Added: The Exclusive Distribution Agreement runs for an initial term of three years following commercial launch and automatically renews for additional terms of one year each, unless either party elects not to renew.
+Added: Under the terms of the Exclusive Distribution Agreement, the Company must pay to Cardinal Health a one-time start-up fee, and a monthly account management fee upon the Company's commercial launch of AUCATZYL, and other fees for various services, including post-launch program implementation, information systems, warehouse operations and financial services.
+Added: BioNTech Agreements
+Added: BioNTech License and Option Agreement - Product Options gain contingency
+Added: As the Product Options within the BioNTech License and Option Agreement were an embedded feature within a freestanding financial instrument, the Company assessed if the Product Options should be accounted for as a derivative under ASC 815.
+Added: However, the Company determined the Product Options met the scope exception for derivative accounting under ASC 815 and therefore should be accounted for a gain contingency under the scope of ASC 450.
+Added: As of December 31, 2024, Product Options were not exercised and therefore no amounts were recognized.
+Added: Refer to Note 12, “Liabilities Related to Future Royalties and Milestone, Net” for further details about the BioNTech's Obe-cel Product Revenue Interest.
+Added: Legal Proceedings
+Added: From time to time, the Company may be a party to litigation or subject to claims incident to the ordinary course of business.
+Added: Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors.
+Added: The Company was not a party to any litigation and did not have contingency reserves established for any liabilities as of December 31, 2024 and 2023.
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
+Added: Indemnification Agreements
+Added: In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification.
+Added: The Company’s exposure under these agreements is unknown because they involve claims that may be made against the Company in the future.
+Added: To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations.
+Added: However, the Company may record charges in the future as a result of these indemnification obligations.
+Added: In accordance with the indemnification agreements entered into with relevant individuals in accordance with the Company’s Articles of Association, the Company has indemnification obligations to its directors, officers and members of senior management for certain events or occurrences, subject to certain limits, while they are serving at the Company’s request in such capacity.
+Added: There have been no claims to date under these indemnification agreements, and the Company has director and officer insurance that may enable it to recover a portion of any amounts paid for future potential claims.
+Added: SME R&D tax credit
+Added: In the accounting period to December 2023, based on the relevant tax legislation, the Company had met the conditions of the R&D intensive scheme, and therefore submitted its corporate tax return on this basis.
+Added: This is subject to agreement by the U.K.
+Added: tax authority who, based on their non-statutory guidance, considers the basis for calculating whether a company meets the intensive criteria includes expenditure which is in conflict with the tax legislation.
+Added: The position is uncertain and the legislation is currently untested in the U.K.
+Added: If the Company's claim is unsuccessful, normal SME relief will be available and there will be a material reduction in the value of the tax credit obtained ( 18.6 % as opposed to 26.97 % net benefit).
+Added: Should the uncertainty be resolved in the Company’s favor, this would result in a gain and accounted for a gain contingency under the scope of ASC 450.
Employee Benefit Plans
−Removed: In the United Kingdom and Switzerland, the Company makes contributions to defined contribution pension schemes on behalf of its employees.
−Removed: The Company expensed $ 2.0 million, $ 1.7 million and $ 1.6 million, in the years ended December 31, 2023, 2022 and 2021, respectively.
+Added: In the United Kingdom, Germany and Switzerland, the Company makes contributions to defined contribution pension schemes on behalf of its employees.
+Added: The Company expensed $ 2.7 million and $ 2.0 million in the years ended December 31, 2024 and 2023, respectively.
In the United States, the Company has established a defined contribution savings plan under Section 401(k) of the Internal Revenue Code.
1 unchanged sentence
employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis.
−Removed: The Company matches employee contributions up to five percent of the employee’s annual salary.
−Removed: The Company expensed $ 0.4 million, $ 0.3 million and $ 0.3 million in contributions in the years ended in the years ended December 31, 2023, 2022 and 2021, respectively.
+Added: The Company matches employee contributions up to four percent of the employee’s annual salary.
+Added: The Company expensed $ 1.0 million and $ 0.4 million in contributions in the years ended December 31, 2024 and 2023, respectively.
The Company pays all administrative fees related to the plan.
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
−Removed: Geographic Information
−Removed: Operations by geographic area
−Removed: Revenue recognized by geographic area are disclosed in Note 4, “ Revenue ” .
−Removed: Major customers
−Removed: During the year ended December 31, 2023, 76 % and 20 % of the Company’s license revenues were generated from Cabaletta, and an investee of Syncona Portfolio Limited, respectively.
+Added: Segment reporting
Long-lived assets
5 unchanged sentences
$ 105,051 $ 95,653
−Removed: For the year ended December 31, 2023, the Company recognized an impairment of long-lived assets relating to the operating lease right-of-use assets and related property and equipment of $ 0.4 million related to a leased property in Stevenage, United Kingdom.
−Removed: There was no impairment recognized for the year ended December 31, 2022.
−Removed: Severance Plan
−Removed: During January 2021 there was a restructuring program executed by the Company leading to a reduction in workforce and resulting in a corresponding severance charge of $ 1.2 million, which has been presented on a proportionate basis within research and development expenses and general and administration expenses.
−Removed: There have been no similar severance charges incurred during the year ended December 31, 2023 and 2022.
+Added: For the year ended December 31, 2024, the Company recognized an impairment of long-lived assets relating to the operating lease right-of-use assets and related property and equipment of $ 0.4 million related to a leased property in Enfield, United Kingdom.
+Added: For the year ended December 31, 2023, the Company recognized an impairment loss on operating lease right-of-use assets and related property and equipment of $ 0.4 million related to a leased property in Stevenage, United Kingdom.
+Added: Revenue recognized by geographic area are disclosed in Note 3, “ Revenue ” .
+Added: AUTOLUS THERAPEUTICS PLC
+Added: Notes to Consolidated Financial Statements — Continued
+Added: Major customers
+Added: During the year ended December 31, 2024, 100 % of the Company’s license revenues were generated from BioNTech.
+Added: For the year ended December 31, 2023, 76 % and 20 % of the Company's license revenues were primarily generated from Cabaletta and an investee of Syncona Portfolio Limited, respectively.
+Added: Segment profit or loss
+Added: The table below is a summary of the segment profit or loss, including significant segment expenses (in thousands):
+Added: License Revenue
+Added: $ 10,120 $ 1,698
+Added: Less operating expenses:
+Added: Research and clinical development
+Added: ( 37,831 ) ( 50,585 )
+Added: Product delivery ( 89,815 ) ( 60,290 )
+Added: Commercial and Medical affairs
+Added: ( 55,219 ) ( 14,955 )
+Added: Support functions ( 66,300 ) ( 48,809 )
+Added: Other segment expenses, net (1)
+Added: ( 2,381 ) ( 6,760 )
+Added: Total operating expenses ( 251,546 ) ( 181,399 )
+Added: Operating loss ( 241,426 ) ( 179,701 )
+Added: Other income, net 220 222
+Added: Foreign exchange (losses) gains ( 989 ) 2,639
+Added: Interest income 32,355 13,505
+Added: Interest expense, net
+Added: ( 9,294 ) ( 45,067 )
+Added: Income tax (expense) benefit ( 1,528 ) 19
+Added: Segment and consolidated net loss $ ( 220,662 ) $ ( 208,383 )
+Added: (1) Other segment expenses, net include U.K.
+Added: research and development tax credits, depreciation, amortization and share-based compensation expenses.
Related Party Transactions
On November 6, 2021, the Company concurrently entered into the Blackstone Agreements.
−Removed: Refer to Note 11, “Liability relating to future royalties and sales milestones, net”, Note 12, “Warrants” and Note 13, "Shareholders Equity”.
+Added: Refer to Note 12, “Liabilities Related to Sales of Future Royalties and Milestones, Net”, Note 13, “Warrants” and Note 14, "Shareholders Equity”.
Subsequent to the execution of the Blackstone Agreements, Blackstone became a related party as Blackstone owns more than 10 % of the Company's outstanding voting securities and is therefore one of the principal owners of the Company.
1 unchanged sentence
William Young was appointed to the Company's board of directors as Blackstone’s designee pursuant to this right.
−Removed: As of December 31, 2023, the carrying amount of the Blackstone Collaboration Agreement liability was $ 170.9 million, which included accrued interest expense and cumulative catch-up adjustment , of $ 45.0 million, $ 8.9 million and $ 1.1 million for the years ended December 31, 2023, 2022, and 2021, respectively.
−Removed: Refer to Note 11, “Liability related to sales of future royalties and sales milestone, net” for further details.
−Removed: Syncona Portfolio Limited
−Removed: Syncona Portfolio Limited is a related party as Syncona Portfolio Limited owns more than 10 % of the Company's outstanding voting securities and is therefore one of the principal owners of the Company.
−Removed: In addition, a member of the Company's board of directors was the chair of the ultimate parent company of Syncona Portfolio Limited until November 2023.
−Removed: In the Company's February 2021 public offering, Syncona Portfolio Limited purchased 3,571,428 ADSs, representing 3,571,428 ordinary shares.
−Removed: This purchase was made through the underwriters at the public offering price.
+Added: As of December 31, 2024, the carrying amount of the Blackstone Collaboration Agreement liability was $ 211.6 million, which included aggregated accrued interest expense and cumulative catch-up adjustment , of $ 10.7 million and $ 45.0 million for the years ended December 31, 2024 and 2023, respectively.
+Added: Refer to Note 12, “Liabilities Related to Sales of Future Royalties and Milestones, Net” for further details.
+Added: BioNTech Agreements
+Added: In February 2024, the Company concurrently entered into the BioNTech Agreements.
+Added: Upon the execution of the BioNTech Agreements, BioNTech became a related party of the Company.
+Added: BioNTech owns more than 10 % of the Company’s outstanding voting securities and is therefore one of the principal owners of the Company.
+Added: In addition, BioNTech has the right to nominate one director to the Board of Directors of the Company which BioNTech has not yet exercised.
+Added: As of December 31, 2024, the carrying amount of the BioNTech Liability was $ 36.5 million which included aggregated accrued interest expense and cumulative catch-up adjustment of $( 1.8 ) million for the year ended December 31, 2024.
+Added: Refer to Note 12, “Liabilities Related to Sales of Future Royalties and Milestones, Net” for further details.
AUTOLUS THERAPEUTICS PLC
Notes to Consolidated Financial Statements — Continued
−Removed: December 2022 public offering
−Removed: In connection with the Company’s December 2022 public offering, certain of the Company's related parties purchased the Company's ADSs from the underwriters at the public offering price of $ 2.00 per ADSs, and on the same terms as other investors in the Company's public offering.
−Removed: The following table summarizes purchases of ADS by the Company's related parties:
−Removed: Related party ADSs purchased Total purchase price (in millions)
−Removed: Syncona Portfolio Limited (1) 14,000,000 $ 28.0
−Removed: Deep Track Capital, LP (2) 15,000,000 30.0
−Removed: Qatar Investment Authority (3) 15,000,000 30.0
−Removed: Armistice Capital, LLC (4) 10,000,000 20.0
−Removed: Entities affiliated with Blackstone (5) 2,500,000 5.0
−Removed: 56,500,000 $ 113.0
−Removed: (1) Syncona Portfolio Limited is a holder of more than 10% of the Company's share capital.
−Removed: (2) In connection with this transaction, Deep Track Capital, LP became a holder of more than 5% of the Company's share capital.
−Removed: (3) In connection with this transaction, Qatar Investment Authority became a holder of more than 5% of the Company's share capital.
−Removed: (4) In connection with this transaction, Armistice Capital, LLC became a holder of more than 5% of the Company's share capital.
−Removed: (5) Entities affiliated with Blackstone collectively hold more than 10% of the Company's share capital.
Investee of Syncona Portfolio Limited
1 unchanged sentence
The terms of the agreement include a non-refundable license fee, payments based upon achievement of clinical development and regulatory objectives, and royalties on product sales.
−Removed: During the year ended December 31, 2023 , Company received variable consideration arising from the achievement of a development milestone amounting to $ 0.4 million.
+Added: During the year ended December 31, 2023 , the Company received variable consideration arising from the achievement of a development milestone amounting to $ 0.4 million.
Consequently, the Company recognized license revenue of $ 0.4 million.
−Removed: The Company did no t recognize any license revenue for the year ended December 31, 2022 and 2021.
+Added: The Company did no t recognize any license revenue for the year ended December 31, 2024.
+Added: 2024 Underwritten Offering
+Added: In connection with our February 2024 underwritten offering, certain of our related parties purchased our ADSs from the underwriters at the public offering price of $ 6.00 per ADSs, and on the same terms as other investors in registered direct offering.
+Added: The following table summarizes purchases of ADS by our related parties:
+Added: Related party ADSs purchased Total purchase price (in millions)
+Added: Fidelity Management & Research Company, LLC (1)
+Added: 5,808,333 $ 34.9
+Added: Deep Track Capital, LP (2) 3,750,000 $ 30.0
+Added: (1) Fidelity Management & Research Company, LLC was a holder of more than 5% of our share capital as of December 31, 2024.
+Added: (2) Deep Track Capital, LP was a holder of more than 5% of our share capital as of December 31, 2024.
Subsequent Events
The Company evaluated subsequent events through March 20, 2025, the date on which these consolidated financial statements were is sued.
−Removed: On February 6, 2024 (the “Execution Date”), the Company, through its wholly owned subsidiaries, Autolus Limited and Autolus Holdings (UK) Limited entered into a License and Option Agreement (the “License Agreement”) with BioNTech SE (“BioNTech”) pursuant to which the Company granted to BioNTech an exclusive, worldwide, sublicensable license (the “License”) to certain binders and to exploit products that express in vivo such binders (collectively, the “Binder Licensed Products”).
−Removed: In addition to the License, under the License Agreement the Company has granted to BioNTech several time-limited options (the “Options”) to acquire additional rights to specified clinical-stage product candidates, binders and technologies of the Company, described in more detail below.
−Removed: In the event that all Options are fully exercised, the Company would be eligible to receive maximum aggregate payments of up to $ 582.0 million pursuant to the License Agreement.
−Removed: This maximum amount includes upfront payments, the potential milestone payments for the Binder Licensed Products described below, all option exercise fees and potential milestone payments for licenses to optioned products and technologies, and additional payments that BioNTech may pay to the Company for an increased revenue interest with respect to the Company’s product candidate obe-cel as described below.
−Removed: License and Options
−Removed: In consideration for the License and the Options, BioNTech made an initial payment to the Company of $ 10.0 million.
−Removed: The Company is eligible to receive milestone payments of up to $ 32 million in the aggregate upon the achievement of specified clinical development and regulatory milestones for each Binder Licensed Product that achieves such milestones.
−Removed: The Company is also eligible to receive a low single-digit royalty on net sales of Binder Licensed Products, subject to customary reductions, which reductions are subject to specified limits.
−Removed: The royalty will be increased if BioNTech, its affiliates or sublicensees commercialize a Binder Licensed Product in an indication and country in which the Company or its affiliates or licensees also commercializes a product containing the same binders.
−Removed: Under the License Agreement, BioNTech is solely responsible for, and has sole decision-making authority with respect to, at its own expense, the exploitation of Binder Licensed Products.
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
−Removed: Under the terms of the License Agreement, the Company has agreed to grant BioNTech the following time-limited Options:
−Removed: • an option to obtain exclusive rights to co-fund development costs of the Company’s development-stage programs AUTO1/22 and AUTO6NG, in return for agreed upon economic terms, including an option exercise fee, milestone payments and a profit-sharing arrangement for each such product candidate, with additional options to co-promote or co-commercialize such product candidate;
−Removed: • an option to obtain an exclusive worldwide license to exploit products that express certain additional binders in vivo or, with respect to certain binders, in an antibody drug conjugate (the “Binder Option”);
−Removed: • an option to obtain a co-exclusive worldwide license to exploit products that express in vivo the Company’s modules for activity enhancement, with a non-exclusive right, in certain agreed instances, to exploit products that include Company’s modules for activity enhancement but do not express in vivo such modules (the “Activity Enhancement Option”);
−Removed: • an option to obtain a non-exclusive worldwide license to exploit products that contain the Company’s safety switches (the “Safety Switch Option” and, together with the Binder Option and the Activity Enhancement Option, the “Technology Options”).
−Removed: The option exercise fee for each Technology Option is a low seven-digit amount.
−Removed: Each of the Activity Enhancement Option and the Safety Switch Option must be exercised with respect to a given biological target or combination of targets.
−Removed: There is a cap on the total option exercise fee if multiple options are exercised with respect to a given target.
−Removed: There is also a cap on milestone payments across all agreements entered into as the result of BioNTech exercising one or more of the Technology Options and a cap on the royalty rate payable on any given product for which multiple Options are exercised.
−Removed: Obe-cel Product Revenue Interest
−Removed: Under the License Agreement, BioNTech has also agreed to financially support the expansion of the clinical development program for, and planned commercialization of obe-cel.
−Removed: In exchange for the grant of rights to future revenues from the sales of obe-cel products, BioNTech made an upfront payment to the Company of $ 40 million.
−Removed: The Company will pay BioNTech a low single-digit percentage of annual net sales of obe-cel products, which may be increased up to a mid-single digit percentage in exchange for milestone payments of up to $ 100 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech's election.
−Removed: Manufacturing and Commercial Agreement
−Removed: Under the terms of the BioNTech License Agreement, the Company has agreed to grant BioNTech the option to negotiate a joint manufacturing and commercial services agreement pursuant to which the parties may access and leverage each other’s manufacturing and commercial capabilities, in addition to Autolus’ commercial site network and infrastructure, with respect to certain of each parties’ CAR T products, including BioNTech’s product candidate BNT211 (the “Manufacturing and Commercial Agreement”).
−Removed: The Manufacturing and Commercial Agreement, if entered into, would also grant BioNTech access to the Company’s commercial site network and infrastructure.
−Removed: Securities Purchase Agreement, Registration Rights Agreement and Letter Agreement
−Removed: Concurrently with the execution of the BioNTech License Agreement, the Company and BioNTech entered into a Securities Purchase Agreement (the “Purchase Agreement”) pursuant to which the Company sold to BioNTech American Depositary Shares (“ADSs”), each representing one ordinary share, with a nominal value of $ 0.000042 per share, of the Company (the “Ordinary Shares”) in a private placement transaction (the “Private Placement”).
−Removed: On February 13, 2024, the Company completed the Private Placement of 33,333,333 ADSs representing 33,333,333 ordinary shares at an offering price of $ 6.00 per ADS.
−Removed: Aggregate gross proceeds to the Company, before underwriting discounts and offering expenses, were $ 200.0 million .
−Removed: In the event that BioNTech and the Company enter into a Manufacturing and Commercial Agreement (as defined above) within 18 months of the Initial Closing, BioNTech will purchase additional ADSs (the “Subsequent ADSs” and, together with the Initial ADSs, the “Private Placement ADSs”), not to exceed 15,000,000 ADSs, for an aggregate purchase price of up to $ 20 million.
−Removed: The total number of Subsequent ADSs that may be issued is subject to additional limitations and restrictions.
−Removed: The Purchase Agreement contains customary representations, warranties, and covenants of each of the Company and BioNTech.
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
−Removed: Concurrently with entry into the Purchase Agreement, the Company and BioNTech entered into a letter agreement (the “Letter Agreement”) providing BioNTech with certain additional rights and subjecting BioNTech’s investment in the Company to certain restrictions.
−Removed: Pursuant to the Letter Agreement, BioNTech received the right to nominate a director to the Company’s board of directors.
−Removed: If BioNTech acquires beneficial ownership of at least 30 % of the issued and outstanding Ordinary Shares of the Company within five years of the Execution Date, BioNTech will have the right to designate an additional director who shall be independent.
−Removed: BioNTech’s director nomination rights under the Letter Agreement shall automatically terminate upon BioNTech’s ownership of Ordinary Shares dropping below certain specified percentages.
−Removed: Additionally, pursuant to the Letter Agreement, BioNTech has the right to purchase equity securities sold by the Company in bona fide financing transactions in amounts that are based on BioNTech maintaining specified ownership thresholds following such financing transactions.
−Removed: Pursuant to the Letter Agreement, subject to specified exceptions, BioNTech may not sell the Private Placement ADSs without the Company’s approval for a period of six months following the applicable closing date for such ADSs.
−Removed: The Letter Agreement terminates upon the earlier of (a) the later of (i) three years from the Execution Date and (ii) such time as no securities of the Company are held by BioNTech or its affiliates and (b) the consummation of a change of control transaction involving the Company.
−Removed: The Company and BioNTech also entered into a registration rights agreement (the “Registration Rights Agreement”) pursuant to which the Company has agreed to file a registration statement with the SEC to register the resale of the Private Placement ADSs.
−Removed: The foregoing descriptions of the License Agreement, the Purchase Agreement, the Registration Rights Agreement and the Letter Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of such agreements.
−Removed: February 2024 Underwritten Offering
−Removed: On February 12, 2024, the Company completed an underwritten offering of 58,333,336 ADSs representing 58,333,336 ordinary shares at an offering price of $ 6.00 per ADS.
−Removed: Aggregate gross proceeds to the Company, before underwriting discounts and offering expenses, were $ 350.0 million .
−Removed: Restatement of previously issued quarterly condensed consolidated financial statements (unaudited)
−Removed: The Company has restated its unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the quarterly periods ended March 31, 2022, June 30, 2022, September 30, 2022, March 31, 2023, June 30, 2023 and September 30, 2023.
−Removed: The unaudited Condensed Consolidated Statement Balance Sheet, Condensed Consolidated Statement of Changes in Equity and Condensed Consolidated Statement of Cash Flows for the periods ended March 31, 2022, June 30, 2022, September 30, 2022, March 31, 2023, June 30, 2023 and September 30, 2023 were not affected by the restatement.
−Removed: Furthermore, the error had no effect on the Company's unaudited net loss to ordinary shareholders or basic or diluted net loss per ordinary share for any of the above mentioned quarterly periods.
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
−Removed: Condensed Consolidated Balance Sheets (Unaudited)
−Removed: (In thousands, except share and per share amounts)
−Removed: Current assets:
−Removed: Cash and cash equivalents $ 343,027 $ 268,558
−Removed: Restricted cash 328 334
−Removed: Prepaid expenses and other current assets 50,530 40,571
−Removed: Total current assets 393,885 309,463
−Removed: Non-current assets:
−Removed: Property and equipment, net 34,667 31,017
−Removed: Prepaid expenses and other non-current assets 465 2,119
−Removed: Operating lease right-of-use assets, net 26,861 17,366
−Removed: Long-term deposits 1,821 1,983
−Removed: Deferred tax asset 2,272 2,000
−Removed: Intangible assets, net — 46
−Removed: Total assets $ 459,971 $ 363,994
−Removed: Liabilities and shareholders' equity
−Removed: Current liabilities:
−Removed: Accounts payable 353 153
−Removed: Accrued expenses and other liabilities 34,463 24,513
−Removed: Operating lease liabilities, current 4,821 4,174
−Removed: Total current liabilities 39,637 28,840
−Removed: Non-current liabilities:
−Removed: Operating lease liabilities, non-current 22,495 15,081
−Removed: Liability related to future royalties and sales milestones, net
−Removed: 130,805 48,806
−Removed: Other long-term payables
−Removed: Total liabilities 193,051 92,851
−Removed: Commitments and contingencies
−Removed: Shareholders' equity:
−Removed: Ordinary shares, $ 0.000042 par value;
−Removed: 290,909,783 and 200,000,000 shares authorized at March 31, 2023 and 2022, 173,074,510 and 90,907,941 shares issued and outstanding at March 31, 2023 and 2022
−Removed: Deferred shares, £ 0.00001 par value;
−Removed: 34,425 shares authorized, issued and outstanding at March 31, 2023 and 2022
−Removed: Deferred B shares, £ 0.00099 par value;
−Removed: 88,893,548 shares authorized, issued and outstanding at March 31, 2023 and 2022
−Removed: Deferred C shares, £ 0.000008 par value;
−Removed: 1 share authorized, issued and outstanding at March 31, 2023 and 2022
−Removed: Additional paid-in capital 1,010,041 845,448
−Removed: Accumulated other comprehensive loss ( 33,257 ) ( 16,025 )
−Removed: Accumulated deficit ( 709,990 ) ( 558,402 )
−Removed: Total shareholders' equity 266,920 271,143
−Removed: Total liabilities and shareholders' equity $ 459,971 $ 363,994
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
−Removed: Condensed Consolidated Balance Sheets (Unaudited)
−Removed: (In thousands, except share and per share amounts)
−Removed: Condensed Consolidated Balance Sheets (Unaudited) 2023 2022
−Removed: Current assets:
−Removed: Cash and cash equivalents $ 307,500 $ 216,437
−Removed: Restricted cash 332 325
−Removed: Prepaid expenses and other current assets 47,533 42,198
−Removed: Total current assets 355,365 258,960
−Removed: Non-current assets:
−Removed: Property and equipment, net 36,857 33,794
−Removed: Prepaid expenses and other non-current assets 295 1,888
−Removed: Operating lease right-of-use assets, net 54,251 15,230
−Removed: Long-term deposits 1,864 1,835
−Removed: Deferred tax asset 2,360 2,244
−Removed: Intangible assets, net — 25
−Removed: Total assets $ 450,992 $ 313,976
−Removed: Liabilities and shareholders' equity
−Removed: Current liabilities:
−Removed: Accounts payable 3,878 162
−Removed: Accrued expenses and other liabilities 30,954 31,360
−Removed: Operating lease liabilities, current 6,231 3,995
−Removed: Total current liabilities 41,063 35,517
−Removed: Non-current liabilities:
−Removed: Operating lease liabilities, non-current 44,707 13,208
−Removed: Liability related to future royalties and sales milestones, net
−Removed: 135,764 50,615
−Removed: Other long-term payables
−Removed: Total liabilities 221,656 99,455
−Removed: Commitments and contingencies
−Removed: Shareholders' equity:
−Removed: Ordinary shares, $ 0.000042 par value;
−Removed: 290,909,783 shares authorized at June 30, 2023 and 2022, 173,680,872 and 90,909,783 shares issued and outstanding at June 30, 202 and 2022
−Removed: Deferred shares, £ 0.00001 par value;
−Removed: 34,425 shares authorized, issued and outstanding at June 30, 2023 and 2022
−Removed: Deferred B shares, £ 0.00099 par value;
−Removed: 88,893,548 shares authorized, issued and outstanding at June 30, 2023 and 2022
−Removed: Deferred C shares, £ 0.000008 par value;
−Removed: 1 share authorized, issued and outstanding at June 30, 2023 and 2022
−Removed: Additional paid-in capital 1,012,709 848,370
−Removed: Accumulated other comprehensive loss ( 27,957 ) ( 33,510 )
−Removed: Accumulated deficit ( 755,542 ) ( 600,461 )
−Removed: Total shareholders' equity 229,336 214,521
−Removed: Total liabilities and shareholders' equity $ 450,992 $ 313,976
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
−Removed: Condensed Consolidated Balance Sheets (Unaudited)
−Removed: (In thousands, except share and per share amounts)
−Removed: Condensed Consolidated Balance Sheets (Unaudited) 2023 2022
−Removed: Current assets:
−Removed: Cash and cash equivalents $ 256,415 $ 163,053
−Removed: Restricted cash 434 315
−Removed: Prepaid expenses and other current assets 51,533 48,943
−Removed: Total current assets 308,382 212,311
−Removed: Non-current assets:
−Removed: Property and equipment, net 34,637 32,474
−Removed: Prepaid expenses and other non-current assets 136 1,718
−Removed: Operating lease right-of-use assets, net 59,403 13,235
−Removed: Long-term deposits 943 1,688
−Removed: Deferred tax asset 2,597 2,396
−Removed: Intangible assets, net — 8
−Removed: Total assets $ 406,098 $ 263,830
−Removed: Liabilities and shareholders' equity
−Removed: Current liabilities:
−Removed: Accounts payable 661 334
−Removed: Accrued expenses and other liabilities 31,388 34,669
−Removed: Operating lease liabilities, current 5,491 3,815
−Removed: Total current liabilities 37,540 38,818
−Removed: Non-current liabilities:
−Removed: Operating lease liabilities, non-current 46,967 11,310
−Removed: Liability related to future royalties and sales milestones, net
−Removed: 140,778 52,443
−Removed: Other long-term payables
−Removed: Total liabilities 225,580 102,676
−Removed: Commitments and contingencies
−Removed: Shareholders' equity:
−Removed: Ordinary shares, $ 0.000042 par value;
−Removed: 290,909,783 shares authorized at September 30, 2023 and 2022, 173,936,794 and 91,132,356 shares issued and outstanding at September 30, 2023 and 2022
−Removed: Deferred shares, £ 0.00001 par value;
−Removed: 34,425 shares authorized, issued and outstanding at September 30, 2023 and 2022
−Removed: Deferred B shares, £ 0.00099 par value;
−Removed: 88,893,548 shares authorized, issued and outstanding at September 30, 2023 and 2022
−Removed: Deferred C shares, £ 0.000008 par value;
−Removed: 1 share authorized, issued and outstanding at September 30, 2023 and 2022
−Removed: Additional paid-in capital 1,015,577 851,824
−Removed: Accumulated other comprehensive loss ( 33,794 ) ( 47,564 )
−Removed: Accumulated deficit ( 801,391 ) ( 643,228 )
−Removed: Total shareholders' equity 180,518 161,154
−Removed: Total liabilities and shareholders' equity $ 406,098 $ 263,830
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
−Removed: Restated Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
−Removed: (In thousands, except share and per share amounts)
−Removed: Three Months Ended March 31, 2023
−Removed: Three Months Ended March 31, 2022
−Removed: As previously reported Impact of adjustment As Restated As previously reported Impact of adjustment As Restated
−Removed: Grant income $ — $ — $ 166 $ 166
−Removed: License revenue 1,292 1,292 — —
−Removed: Operating expenses:
−Removed: Research and development ( 31,344 ) 3,956 ( 27,388 ) ( 33,963 ) 5,598 ( 28,365 )
−Removed: General and administrative ( 9,284 ) ( 9,284 ) ( 7,987 ) ( 7,987 )
−Removed: Loss on disposal of property and equipment ( 3,768 ) ( 3,768 ) — —
−Removed: Total operating expenses, net ( 43,104 ) 3,956 ( 39,148 ) ( 41,784 ) 5,598 ( 36,186 )
−Removed: Other income (expense), net 782 782 860 860
−Removed: Interest income 3,446 3,446 28 28
−Removed: Interest expense
−Removed: ( 4,905 ) ( 4,905 ) ( 1,790 ) ( 1,790 )
−Removed: Total other expenses, net ( 677 ) — ( 677 ) ( 902 ) — ( 902 )
−Removed: Net loss before income tax ( 43,781 ) 3,956 ( 39,825 ) ( 42,686 ) 5,598 ( 37,088 )
−Removed: Income tax benefit
−Removed: 3,970 ( 3,956 ) 14 5,624 ( 5,598 ) 26
−Removed: Net loss attributable to ordinary shareholders ( 39,811 ) — ( 39,811 ) ( 37,062 ) — ( 37,062 )
−Removed: Other comprehensive income (loss):
−Removed: Foreign currency exchange translation adjustment 5,641 5,641 ( 7,455 ) ( 7,455 )
−Removed: Total comprehensive loss $ ( 34,170 ) $ — $ ( 34,170 ) $ ( 44,517 ) $ — $ ( 44,517 )
−Removed: Basic and diluted net loss per ordinary share $ ( 0.23 ) $ — $ ( 0.23 ) $ ( 0.41 ) $ — $ ( 0.41 )
−Removed: Weighted-average basic and diluted ordinary shares 173,825,825 173,825,825 173,825,825 90,914,175 90,914,175 90,914,175
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
−Removed: Restated Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
−Removed: (In thousands, except share and per share amounts)
−Removed: Three Months Ended June 30, 2023
−Removed: Three Months Ended June 30, 2022
−Removed: As previously reported Impact of adjustment As Restated As previously reported Impact of adjustment As Restated
−Removed: Grant income $ — $ — $ — $ —
−Removed: License revenue — — — —
−Removed: Operating expenses:
−Removed: Research and development ( 36,742 ) 3,510 ( 33,232 ) ( 38,212 ) 7,418 ( 30,794 )
−Removed: General and administrative ( 11,122 ) ( 11,122 ) ( 8,269 ) ( 8,269 )
−Removed: Loss on disposal of property and equipment ( 23 ) ( 23 ) — —
−Removed: Total operating expenses, net ( 47,887 ) 3,510 ( 44,377 ) ( 46,481 ) 7,418 ( 39,063 )
−Removed: Other income (expense), net 482 482 ( 1,331 ) ( 1,331 )
−Removed: Interest income 3,403 3,403 89 89
−Removed: Interest expense
−Removed: ( 5,020 ) ( 5,020 ) ( 1,810 ) ( 1,810 )
−Removed: Total other expenses, net ( 1,135 ) — ( 1,135 ) ( 3,052 ) — ( 3,052 )
−Removed: Net loss before income tax ( 49,022 ) 3,510 ( 45,512 ) ( 49,533 ) 7,418 ( 42,115 )
−Removed: Income tax benefit (expense) 3,470 ( 3,510 ) ( 40 ) 7,474 ( 7,418 ) 56
−Removed: Net loss attributable to ordinary shareholders ( 45,552 ) — ( 45,552 ) ( 42,059 ) — ( 42,059 )
−Removed: Other comprehensive income (loss):
−Removed: Foreign currency exchange translation adjustment 5,300 5,300 ( 17,485 ) ( 17,485 )
−Removed: Total comprehensive loss $ ( 40,252 ) $ — $ ( 40,252 ) $ ( 59,544 ) $ — $ ( 59,544 )
−Removed: Basic and diluted net loss per ordinary share $ ( 0.26 ) $ — $ ( 0.26 ) $ ( 0.46 ) $ — $ ( 0.46 )
−Removed: Weighted-average basic and diluted ordinary shares 173,860,491 173,860,491 173,860,491 90,931,964 90,931,964 90,931,964
−Removed: AUTOLUS THERAPEUTICS PLC
−Removed: Notes to Consolidated Financial Statements — Continued
−Removed: Restated Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
−Removed: (In thousands, except share and per share amounts)
−Removed: Three Months Ended September 30, 2023
−Removed: Three Months Ended September 30, 2022
−Removed: As previously reported Impact of adjustment As Restated As previously reported Impact of adjustment As Restated
−Removed: Grant income $ — $ — $ — $ —
−Removed: License revenue 406 406 2,369 2,369
−Removed: Operating expenses:
−Removed: Research and development ( 37,237 ) 4,919 ( 32,318 ) ( 37,632 ) 6,147 ( 31,485 )
−Removed: General and administrative ( 10,611 ) ( 10,611 ) ( 8,231 ) ( 8,231 )
−Removed: Impairment of operating lease right-of-use assets and related property and equipment ( 382 ) ( 382 ) — —
−Removed: Total operating expenses, net ( 47,824 ) 4,919 ( 42,905 ) ( 43,494 ) 6,147 ( 37,347 )
−Removed: Other income (expense), net ( 1,597 ) ( 1,597 ) ( 3,740 ) ( 3,740 )
−Removed: Interest income 3,646 3,646 165 165
−Removed: Interest expense
−Removed: ( 5,014 ) ( 5,014 ) ( 1,850 ) ( 1,850 )
−Removed: Total other expenses, net ( 2,965 ) — ( 2,965 ) ( 5,425 ) — ( 5,425 )
−Removed: Net loss before income tax ( 50,789 ) 4,919 ( 45,870 ) ( 48,919 ) 6,147 ( 42,772 )
−Removed: Income tax benefit
−Removed: 4,940 ( 4,919 ) 21 6,152 ( 6,147 ) 5
−Removed: Net loss attributable to ordinary shareholders ( 45,849 ) — ( 45,849 ) ( 42,767 ) — ( 42,767 )
−Removed: Other comprehensive income (loss):
−Removed: Foreign currency exchange translation adjustment ( 5,837 ) ( 5,837 ) ( 14,054 ) ( 14,054 )
−Removed: Total comprehensive loss $ ( 51,686 ) $ — $ ( 51,686 ) $ ( 56,821 ) $ — $ ( 56,821 )
−Removed: Basic and diluted net loss per ordinary share $ ( 0.26 ) $ — $ ( 0.26 ) $ ( 0.47 ) $ — $ ( 0.47 )
−Removed: Weighted-average basic and diluted ordinary shares 173,984,101 173,984,101 173,984,101 91,240,801 91,240,801 91,240,801
+Added: The Company has concluded that no subsequent event has occurred that requires disclosure.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.