−Removed: Controls and Procedures
+Added: and Procedures
of Disclosure Controls and Procedures
42 unchanged sentences
of Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) that occurred
−Removed: during the quarter ended December 31, 2022 covered by this report that has materially affected or is reasonably likely to materially affect
−Removed: our internal control over financial reporting.
−Removed: Other Information
−Removed: Disclosure Regarding
−Removed: Foreign Jurisdictions that Prevent Inspections
−Removed: Directors, Executive
−Removed: Officers And Corporate Governance
+Added: during the quarter ended December 31, 2023 covered by this report that has materially affected or is reasonably likely to materially
+Added: affect our internal control over financial reporting.
+Added: Regarding Foreign Jurisdictions that Prevent Inspections
+Added: Executive Officers And Corporate Governance
directors hold office for one-year terms until the election and qualification of their successors.
3 unchanged sentences
regarding our executive officers and the members of our board of directors.
−Removed: Chairman of the Board, Director
−Removed: Chief Executive Officer and President, Director
−Removed: Chief Medical Officer
−Removed: Chief Business Officer
−Removed: Chief Financial Officer
−Removed: Chief Technology Officer
−Removed: Theresa Matkovits
−Removed: Chief Development Officer
−Removed: Herbert Conrad
−Removed: Kathryn Corzo
−Removed: Natasha Giordano
−Removed: Matthew Wikler
+Added: of the Board, Director
+Added: Executive Officer and President, Director
+Added: Medical Officer
+Added: Business Officer
+Added: Financial Officer
+Added: Technology Officer
+Added: Development Officer
Jabbour, JD was appointed Chief Executive Officer in March 2018.
41 unchanged sentences
Hoover was the Chief
−Removed: Business Officer at Millendo Therapeutics, a public, clinical stage biotech, from 2016 to 2021.
+Added: Business Officer at Millendo Therapeutics (now Tempest Therapeutics (NASDAQ:
+Added: TPST)), a public, clinical stage biotech, from 2016 to 2021.
Prior to joining Millendo, Mr.
−Removed: was Vice President of New Product Planning and Corporate Development and Licensing at Sunovion Pharmaceuticals Inc.
−Removed: Hoover started
−Removed: his pharmaceutical career at GSK in 2001 working in the Global Commercial Strategy group.
−Removed: Earlier in his career, Mr Hoover worked for
−Removed: The Boston Consulting Group.
−Removed: Hoover holds a M.B.A.
−Removed: from the University of North Carolina and a B.A.
+Added: Hoover was Vice President of New Product Planning and Corporate Development and Licensing at Sunovion
+Added: Pharmaceuticals Inc, a global biopharmaceutical company.
+Added: Hoover started his pharmaceutical career at GSK in 2001 working in the Global
+Added: Commercial Strategy group.
+Added: Earlier in his career, Mr Hoover worked for The Boston Consulting Group.
+Added: Hoover holds an M.B.A.
+Added: University of North Carolina and a B.A.
from Harvard College.
28 unchanged sentences
of Science and Technology of China.
−Removed: Matkovits, PhD has served as Chief Development officer since September 2018.
+Added: Matkovits, PhD has served as Chief Development officer since October 2018.
She joined the Company after having most recently
14 unchanged sentences
Matkovits serves on the Board of Directors of Appili Therapeutics (TSX:
−Removed: Matkovits earned her Ph.D.
−Removed: in Biochemistry and Molecular Biology from the University of Medicine and
−Removed: Dentistry of NJ.
+Added: APLIF), and is Chairperson of GoodCap Pharmaceuticals, a privately held pharmaceutical company.
+Added: Matkovits earned her
+Added: in Biochemistry and Molecular Biology from the University of Medicine and Dentistry of NJ.
Ende has served on our board of directors since April 2017 and was selected to be Chairman of the Board of Directors of our Company
103 unchanged sentences
Scibetta has served as a member of our board of directors since November 2013.
−Removed: Scibetta is currently the Chief Executive
−Removed: Officer of ImmuneID, Inc., a privately held company that leverages existing antibody
−Removed: responses to rapidly unveil the complexities of the immune system, thereby revealing pathways leading to precise, transformative therapies.
+Added: Scibetta is currently a senior consultant
+Added: with Rock Springs Capital, an investment firm that manages long-biased, healthcare-focused public equity funds.
+Added: Between 2021 and 2023,
+Added: Scibetta was the Chief Executive Officer of ImmuneID, Inc., a privately held company that
+Added: leverages existing antibody responses to rapidly unveil the complexities of the immune system, thereby revealing pathways leading to
+Added: precise, transformative therapies.
Prior to ImmuneID, Mr.
−Removed: Scibetta was Chief Executive Officer of Maverick Therapeutics, a development stage immune-oncology company,
−Removed: from 2017 until 2021 when it was acquired by Takeda Pharmaceutical Company Limited.
−Removed: Prior to Maverick, he was President and Chief Financial
−Removed: Officer of Pacira Pharmaceuticals, Inc.
−Removed: PCRX), a specialty pharmaceutical company, a position he has held since October 2015.
+Added: Scibetta was Chief Executive Officer of Maverick Therapeutics, a development
+Added: stage immune-oncology company, from 2017 until 2021 when it was acquired by Takeda Pharmaceutical Company Limited.
+Added: Prior to Maverick,
+Added: he was President and Chief Financial Officer of Pacira Pharmaceuticals, Inc.
+Added: PCRX), a specialty pharmaceutical company, a position
+Added: he has held since October 2015.
Prior to that, Mr.
Scibetta was the Chief Financial Officer of Pacira since 2008.
−Removed: Prior to joining Pacira in August 2008, he served as
−Removed: a consultant to Genzyme Corporation following the sale of Bioenvision Inc.
+Added: Prior to joining Pacira
+Added: in August 2008, he served as a consultant to Genzyme Corporation following the sale of Bioenvision Inc.
BIVN) to Genzyme in
From 2006 to 2007 Mr.
−Removed: was CFO of Bioenvision.
−Removed: From 2001 to 2006, he was Executive Vice President and Chief Financial Officer of Merrimack Pharmaceuticals Inc.
−Removed: Scibetta has previously served on the board of directors at the following life sciences companies:
+Added: Scibetta was CFO of Bioenvision.
+Added: From 2001 to 2006, he was Executive Vice President and Chief Financial Officer
+Added: of Merrimack Pharmaceuticals Inc.
+Added: Scibetta has previously served on the board of directors at the following life
+Added: sciences companies:
NEPH), Merrimack Pharmaceuticals and Labopharm Inc.
−Removed: Prior to his executive management experience, Mr.
−Removed: Scibetta spent over a decade in
−Removed: investment banking where he was responsible for sourcing and executing transactions for a broad base of public and private healthcare
−Removed: and life sciences companies.
−Removed: Scibetta received his Bachelor of Science in Physics from Wake Forest University and an MBA from the
−Removed: University of Michigan.
+Added: Prior to his executive management experience,
+Added: Scibetta spent over a decade in investment banking where he was responsible for sourcing and executing transactions for a broad base
+Added: of public and private healthcare and life sciences companies.
+Added: Scibetta received his Bachelor of Science in Physics from Wake Forest
+Added: University and an MBA from the University of Michigan.
We believe Mr.
−Removed: Scibetta is qualified to serve on our board of directors because of his extensive management experience
−Removed: in the pharmaceutical industry, his investment banking experience and his experience as a chief financial officer and audit committee
−Removed: member of several publicly traded companies.
+Added: Scibetta is qualified to serve on our board of directors because
+Added: of his extensive management experience in the pharmaceutical industry, his investment banking experience and his experience as a chief
+Added: financial officer and audit committee member of several publicly traded companies.
Wikler has served as a member of our board of directors since January 2018.
35 unchanged sentences
believe in seeking and attracting scientific and clinical leaders in the field of infectious diseases to provide counsel and support
−Removed: We have established separate Scientific Advisory Boards for MAT2203 and MAT2501 which consist of individuals who are experts
−Removed: in their chosen fields and recipients of many academic honors and awards.
+Added: We have established a Scientific Advisory Board for MAT2203 which consists of individuals who are experts in their chosen
+Added: fields and recipients of many academic honors and awards.
board of directors has three standing committees — an Audit Committee, a Compensation Committee and a Nominating and Corporate
51 unchanged sentences
or waiver on our website.
−Removed: Executive Compensation
+Added: Trading Policy
+Added: have adopted an insider trading policy (the “Trading Policy”) that is designed to promote compliance with federal securities
+Added: laws, rules and regulations, as well as the rules and regulations of the New York Stock Exchange.
+Added: The Trading Policy provides Matinas’s
+Added: standards on trading and causing the trading of our securities or securities of other publicly traded companies while in possession of
+Added: confidential information.
+Added: It prohibits trading in certain circumstances and applies to all of our directors, officers and employees as
+Added: well as independent contractors or consultants who have access to material nonpublic information of Matinas.
+Added: Additionally, our Trading
+Added: Policy imposes special additional trading restrictions applicable to all of our directors and executive officers.
+Added: The Trading Policy
+Added: is annexed to this Annual Report as an exhibit.
Compensation Table – 2023
4 unchanged sentences
Name and Principal Position
+Added: Option Awards
All Other Compensation ($)
3 unchanged sentences
Chief Development Officer
−Removed: Amounts reflect the grant
−Removed: date fair value of option awards granted in 2022 and 2021 in accordance with Accounting Standards Codification Topic 718.
−Removed: amounts do not correspond to the actual value that will be recognized by the named executive officers.
+Added: reflect the grant date fair value of option awards granted in 2023 and 2022 in accordance with Accounting Standards Codification
+Added: These amounts do not correspond to the actual value that will be recognized by the named executive officers.
Disclosure to Summary Compensation Table
368 unchanged sentences
Directors and Executive Officers as a group (12 persons) (13)
−Removed: Includes 5,283,013 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
−Removed: Does not include 3,725,887 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
−Removed: Includes 1,312,023 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
−Removed: Does not include 71,328 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
−Removed: Includes 162,211 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
−Removed: not include 162,209 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
−Removed: Includes 1,048,690 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
−Removed: Does not include 71,328 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
−Removed: Includes 418,138 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
−Removed: not include 103,318 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
−Removed: Includes 1,111,190 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
−Removed: Does not include 71,328 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
−Removed: Includes 898,690 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
−Removed: not include 71,328 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
−Removed: Includes 1,393,500 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
−Removed: Does not include 1,244,100 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
−Removed: Includes 301,042 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
−Removed: not include 1,023,958 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
−Removed: Includes 1,343,730 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
−Removed: Does not include 1,156,270 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
−Removed: Includes 454,681 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
−Removed: not include 1,045,319 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
−Removed: Includes 1,474,980 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
−Removed: Does not include 1,125,020 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
+Added: Includes 6,451,704 shares of common stock issuable upon exercise of options.
+Added: Does not include 5,707,196 shares of common stock underlying
+Added: Includes 1,363,410 shares of common stock issuable upon exercise of options.
+Added: Does not include 182,185 shares of common stock underlying
+Added: Includes 549,186 shares of common stock issuable upon exercise of options.
+Added: Does not include 212,478 shares of common stock underlying
+Added: Includes 1,375,077 shares of common stock issuable upon exercise of options.
+Added: Does not include 182,185 shares of common stock underlying
+Added: Includes 776,515 shares of common stock issuable upon exercise of.
+Added: Does not include 182,185 shares of common stock underlying option.
+Added: Includes 1,287,577 shares of common stock issuable upon exercise of options.
+Added: Does not include 182,185 shares of common stock underlying
+Added: Includes 1,225,077 shares of common stock issuable upon exercise of options.
+Added: Does not include 182,185 shares of common stock underlying
+Added: Includes 1,905,501 shares of common stock issuable upon exercise of options.
+Added: Does not include 1,932,099 shares of common stock underlying
+Added: Includes 691,758 shares of common stock issuable upon exercise of options.
+Added: Does not include 1,643,242 shares of common stock underlying
+Added: Includes 1,815,078 shares of common stock issuable upon exercise of options.
+Added: Does not include 1,684,922 shares of common stock underlying
+Added: Includes 894,770 shares of common stock issuable upon exercise of options.
+Added: Does not include 1,605,230 shares of common stock underlying
+Added: Includes 1,927,578 shares of common stock issuable upon exercise of options.
+Added: Does not include 1,972,422 shares of common stock underlying
See notes (1) through (12).
88 unchanged sentences
Common Stock Specimen (incorporated by reference to Exhibit 4.1 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed March 31, 2017 with the Securities and Exchange Commission).
−Removed: Form of Warrant (incorporated by reference to Exhibit 4.1 to Amendment No.
−Removed: 1 to the Company’s Registration Statement on Form S-1 filed with the SEC on February 7, 2014).
−Removed: Form of 2015 Investor Warrant.
−Removed: (incorporated by reference to Exhibit 4.4 to the post-effective amendment No.
−Removed: 1 to Form S-1 filed with the SEC on April 17, 2015).
−Removed: Form of 2015 Placement Agent Warrant.
−Removed: (incorporated by reference to Exhibit 4.5 to the post-effective amendment No.
−Removed: 1 to Form S-1 filed with the SEC on April 17, 2015).
Description of Securities*
12 unchanged sentences
(incorporated herein by reference to Exhibit 10.18 to the Company’s Annual Report on Form 10-K filed on March 31, 2015).
−Removed: Employment Agreement, dated September 1, 2015, between Matinas Biopharma Holdings, Inc.
−Removed: and Raphael J.
−Removed: (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on September 1, 2015).
Lease Agreement, dated as of December 15, 2016, by and between CIP II/AR Bridgewater Holdings LLC, and Matinas BioPharma Holdings, Inc.
20 unchanged sentences
Amendment to Employment Agreement, dated March 3, 2023, between Matinas Biopharma Holdings, Inc.
−Removed: and Jerome Jabbour †*
+Added: and Jerome Jabbour (incorporated by reference to Exhibit 10.17 to the Company’s Quarterly report on Form 10-K, filed on March 15, 2023)†
Amendment to Employment Agreement, dated March 3, 2023, between Matinas Biopharma Holdings, Inc.
−Removed: and Theresa Matkovits †*
+Added: and Theresa Matkovits (incorporated by reference to Exhibit 10.18 to the Company’s Quarterly report on Form 10-K, filed on March 15, 2023)†
Amendment to Employment Agreement, dated March 3, 2023, between Matinas Biopharma Holdings, Inc.
−Removed: and Keith Kucinski †*
+Added: and Keith Kucinski (incorporated by reference to Exhibit 10.19 to the Company’s Quarterly report on Form 10-K, filed on March 15, 2023)†
Amendment to Employment Agreement, dated March 3, 2023, between Matinas Biopharma Holdings, Inc.
−Removed: and James Ferguson †*
+Added: and James Ferguson (incorporated by reference to Exhibit 10.20 to the Company’s Quarterly report on Form 10-K, filed on March 15, 2023)†
+Added: Matinas BioPharma Holdings Corp.
+Added: Insider Trading Policy*
Subsidiaries Index*
3 unchanged sentences
Section 1350 Certifications**
+Added: Matinas BioPharma Holdings, Inc.
+Added: Compensation Recovery Policy*
following financial information from the Annual Report on Form 10-K for the fiscal year ended December 31, 2023, formatted in XBRL
26 unchanged sentences
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
−Removed: the Board of Directors and Stockholders of
+Added: Board of Directors and Stockholders of
BioPharma Holdings, Inc.
on the Financial Statements
−Removed: We have audited the accompanying consolidated balance
−Removed: sheets of Matinas BioPharma Holdings, Inc.
−Removed: and Subsidiaries as of December 31, 2022 and 2021 and the related consolidated statements of
−Removed: operations and comprehensive loss, changes in stockholders’ equity, and cash flows for each of the years then ended, and the related
−Removed: notes (collectively referred to as the “financial statements”).
−Removed: In our opinion, the financial statements present fairly, in
−Removed: all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of their operations and
−Removed: their cash flows for each of the years then ended, in conformity with accounting principles generally accepted in the United States of
−Removed: Basis for Opinion
−Removed: These financial statements are the responsibility
−Removed: of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s financial statements based on our
−Removed: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
−Removed: and are required to be independent with respect to the Company in accordance with the U.S.
−Removed: federal securities laws and the applicable
−Removed: rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance with the standards
−Removed: of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements
−Removed: are free of material misstatement, whether due to error or fraud.
−Removed: The Company is not required to have, nor were we engaged to perform,
−Removed: an audit of its internal control over financial reporting.
−Removed: As part of our audits, we are required to obtain an understanding of internal
−Removed: control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
−Removed: control over financial reporting.
+Added: have audited the accompanying consolidated balance sheets of Matinas BioPharma Holdings, Inc.
+Added: and Subsidiaries as of December 31, 2023
+Added: and 2022, and the related consolidated statements of operations and comprehensive loss, stockholders’ equity, and cash flows for
+Added: each of the years then ended, and the related notes (collectively referred to as the “financial statements”).
+Added: In our opinion,
+Added: the financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December
+Added: 31, 2023 and 2022, and the results of their operations and their cash flows for each of the years then ended, in conformity with accounting
+Added: principles generally accepted in the United States of America.
+Added: accompanying financial statements have been prepared assuming that the Company will continue as a going concern.
+Added: As discussed in Note
+Added: 2 to the financial statements, the Company has recurring net losses and net cash flow used in operations that raise substantial doubt
+Added: about its ability to continue as a going concern.
+Added: Management’s plans in regard to these matters are also described in Note 2.
+Added: financial statements do not include any adjustments that might result from the outcome of this uncertainty.
+Added: financial statements are the responsibility of the Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s
+Added: financial statements based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board
+Added: (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.
+Added: securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: conducted our audits in accordance with the standards of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain
+Added: reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
+Added: is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
+Added: As part of our audits,
+Added: we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
+Added: on the effectiveness of the Company’s internal control over financial reporting.
Accordingly, we express no such opinion.
−Removed: Our audits included performing procedures to assess
−Removed: the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
−Removed: to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
−Removed: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
−Removed: the overall presentation of the financial statements.
−Removed: 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
−Removed: matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit
−Removed: committee and that:
−Removed: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially
−Removed: challenging, subjective, or complex judgments.
−Removed: The communication of the critical audit matter does not alter in any way our opinion on
−Removed: the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion
−Removed: on the critical audit matter or on the accounts or disclosures to which it relates.
−Removed: Accruals and prepaid balance for research and
−Removed: development expenses
−Removed: As disclosed in the consolidated statements of operations,
−Removed: for the year ended December 31, 2022, the Company incurred significant research and development (“R&D”) expenses, which
−Removed: amounted to approximately $16.7 million.
−Removed: At December 31, 2022, the Company had accrued $1.2 million for R&D expenses on the consolidated
−Removed: balance sheet.
−Removed: The Company also recorded prepaid R&D expense of $2.7 million on the consolidated balance sheet.
−Removed: A significant amount
−Removed: of the Company’s R&D expenses are service fees paid to contract research organizations (“CROs) and contract manufacturing organizations
−Removed: The R&D activities with these CROs and CMOs are documented in contractual agreements and are typically performed
−Removed: over an extended period.
−Removed: The amounts recorded on the consolidated balance sheet for such R&D contracts represent the Company’s
−Removed: estimates of the unpaid and prepaid R&D expenses based on facts and circumstances known to the Company at that time, and are dependent
−Removed: upon the timely and accurate reporting of CROs and CMOs.
−Removed: The amount of R&D expense to be recognized under these agreements based on
−Removed: the Company’s estimate of the progress of work completed during the financial reporting period and involves judgement and estimation.
−Removed: We identified management’s estimate of accruals
−Removed: for R&D expenses as a critical audit matter due to the significance of these expenses to the financial statements and the significant
−Removed: judgement and estimation required by management in determining the progress or state of completion of clinical studies or services rendered.
−Removed: As a result, a high degree of auditor judgement and additional testing were required to evaluate audit evidence relating to estimates
−Removed: made by management.
−Removed: Addressing the matter involved performing procedures and evaluating audit
−Removed: evidence in connection with forming our overall opinion on the consolidated financial statements.
−Removed: Our audit procedures related to accruals
−Removed: for R&D expenses included the following, among others, (i) we obtained an understanding of management’s process and evaluated
−Removed: the design of controls over developing its estimate of accrued and prepaid R&D expenses, including the process of estimating the expenses
+Added: audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
+Added: or fraud, and performing procedures that respond to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding
+Added: the amounts and disclosures in the financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant
+Added: estimates made by management, as well as evaluating the overall presentation of the financial statements.
+Added: We believe that our audits
+Added: provide a reasonable basis for our opinion.
+Added: critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated
+Added: or required to be communicated to the audit committee and that:
+Added: (1) relates to accounts or disclosures that are material to the financial
+Added: statements and (2) involved our especially challenging, subjective, or complex judgments.
+Added: The communication of the critical audit matter
+Added: does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit
+Added: matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: and prepaid balance for research and development expenses
+Added: disclosed in the consolidated statements of operations, for the year ended December 31, 2023, the Company incurred significant research
+Added: and development (“R&D”) expenses, which amounted to approximately $14.5 million.
+Added: At December 31, 2023, the Company had
+Added: accrued approximately $0.9 million for R&D expenses on the consolidated balance sheet.
+Added: The Company also recorded prepaid R&D
+Added: expense of approximately $0.7 million on the consolidated balance sheet.
+Added: A significant amount of the Company’s R&D expenses
+Added: are service fees paid to contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”).
+Added: The R&D activities with these CROs and CMOs are documented in contractual agreements and are typically performed over an extended
+Added: The amounts recorded on the consolidated balance sheet for such R&D contracts represent the Company’s estimates of
+Added: the unpaid and prepaid R&D expenses based on facts and circumstances known to the Company at that time, and are dependent upon the
+Added: timely and accurate reporting of CROs and CMOs.
+Added: The amount of R&D expense to be recognized under these agreements based on the Company’s
+Added: estimate of the progress of work completed during the financial reporting period and involves judgement and estimation.
+Added: identified management’s estimate of accruals and prepaid balances for R&D expenses as a critical audit matter due to the
+Added: significance of these expenses to the financial statements and the significant judgement and estimation required by management in
+Added: determining the progress or state of completion of clinical studies or services rendered.
+Added: As a result, a high degree of auditor
+Added: judgement and additional testing were required to evaluate audit evidence relating to estimates made by management.
+Added: the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the
+Added: consolidated financial statements.
+Added: Our audit procedures related to accruals and prepaid balances for R&D expenses included the
+Added: following, among others, (i) we obtained an understanding of management’s process and evaluated the design and implementation
+Added: of controls over developing its estimate of accrued and prepaid R&D expenses, including the process of estimating the expenses
incurred to date based on the status of the clinical studies;
−Removed: (ii) we read selected agreements and contract amendments with CROs and CMOs
−Removed: and evaluating the significant assumptions described above and the methods used in developing the R&D estimates and recalculating
−Removed: the amounts that were unpaid and prepaid at the balance sheet date, (iii) we confirmed with CROs and CMOs contractual commitments and
−Removed: amounts completed, paid and unpaid, and (iv) made direct inquiries of the Company research personnel regarding project status, and inspected
−Removed: invoices received subsequent to year-end and additional documents and correspondence with the CROs and CMOs when used by management to
−Removed: develop its estimate of R&D expenditures.
+Added: (ii) we read selected agreements and contract amendments with CROs and
+Added: CMOs and evaluating the significant assumptions described above and the methods used in developing the R&D estimates and
+Added: recalculating the amounts that were unpaid and prepaid at the balance sheet date, (iii) we confirmed with certain CROs and CMOs
+Added: contractual commitments and amounts completed, paid and unpaid, and (iv) made direct inquiries of the Company research personnel
+Added: regarding project status, and inspected invoices received subsequent to year-end and additional documents and correspondence with
+Added: the CROs and CMOs when used by management to develop its estimate of R&D expenditures.
EisnerAmper LLP
31 unchanged sentences
Common stock par value $ 0.0001 per share, 500,000,000 shares authorized at December 31, 2023 and 2022, respectively;
−Removed: 217,264,526 and 216,269,450 issued and outstanding as of December 31, 2022 and 2021, respectively
+Added: 217,264,526 issued and outstanding as of December 31, 2023 and 2022, respectively
Additional paid-in capital
16 unchanged sentences
Other income, net
−Removed: Preferred stock series B accumulated dividends
−Removed: Net loss attributable to common shareholders
−Removed: Net loss attributable to common shareholders per share – basic and diluted
+Added: Net loss per share – basic and diluted
Weighted average common shares outstanding:
Basic and diluted
−Removed: Other comprehensive loss, net of tax
−Removed: Net unrealized loss on securities available-for-sale
−Removed: Other comprehensive loss, net of tax
−Removed: Comprehensive loss attributable to shareholders
+Added: Other comprehensive gain/(loss), net of tax
+Added: Unrealized gain/(loss) on securities available-for-sale
+Added: Other comprehensive gain/(loss), net of tax
+Added: Comprehensive loss
accompanying notes are an integral part of these consolidated financial statements.
3 unchanged sentences
(Loss)/Income
−Removed: Preferred Stock B
Additional Paid-in
5 unchanged sentences
Stock-based compensation
−Removed: Issuance of common stock as compensation for services
−Removed: Issuance of common stock in exchange for preferred stock
−Removed: Issuance of common stock in public offering, net of stock issuance costs ($ 172,592 )
Issuance of common stock upon exercise of options
Issuance of common stock in exchange for warrants
−Removed: Issuance of common
−Removed: stock pursuant to the
−Removed: Aquarius Merger Agreement
−Removed: Stock dividends
+Added: Issuance of common stock pursuant to license agreement amendment
Other comprehensive loss
3 unchanged sentences
Stock-based compensation
−Removed: Issuance of common stock upon exercise of options
−Removed: Issuance of common stock pursuant to license agreement amendment
−Removed: Issuance of common stock in exchange for warrants
−Removed: Other comprehensive loss
+Added: Other comprehensive income
Balance, December 31, 2023
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Stock issued pursuant to license agreement amendment
−Removed: Stock issued pursuant to the Aquarius Merger Agreement charged to Research and Development
Changes in operating assets and liabilities:
−Removed: Operating lease liabilities
Prepaid expenses and other current assets
1 unchanged sentence
Accrued expenses and other liabilities
+Added: Operating lease liabilities
Net cash used in operating activities
5 unchanged sentences
Cash flows from financing activities:
−Removed: Net proceeds from public offering of common stock
Proceeds from exercise of options
Payments of capital lease liability – principal
−Removed: Net cash provided by financing activities
−Removed: Net (decrease)/increase in cash, cash equivalents and restricted cash
+Added: Net cash (used in) provided by financing activities
+Added: Net decrease in cash, cash equivalents and restricted cash
Cash, cash equivalents and restricted cash at beginning of period
1 unchanged sentence
Supplemental non-cash financing and investing activities:
−Removed: Unrealized loss on marketable debt securities
+Added: Unrealized gain/(loss) on marketable debt securities
Cash exercise of warrants in prepaid expenses and other current assets
Right-of-use asset in exchange from liabilities from an operating lease modification
−Removed: Right-of-use asset in exchange from liabilities from operating lease
Right-of-use asset in exchange from liabilities from finance leases
−Removed: Stock dividends issued
−Removed: Preferred stock conversion into common stock - series B
accompanying notes are an integral part of these consolidated financial statements.
10 unchanged sentences
and developing novel pharmaceutical products.
−Removed: 2 – Liquidity and Plan of Operations
+Added: 2 – Liquidity, Plan of Operations and Going Concern
Company has experienced net losses and negative cash flows from operations each period since its inception.
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future, and that these losses will be increasing.
−Removed: of December 31, 2022, the Company had cash and cash equivalents of $ 6,830 , marketable debt securities of $ 21,933 and restricted cash
−Removed: The Company believes the cash and cash equivalents and marketable debt securities on hand are sufficient to fund planned operations
−Removed: into the second quarter of 2024.
+Added: of December 31, 2023, the Company had cash and cash equivalents of $ 4,787 , marketable debt securities of $ 8,969 and restricted cash of
+Added: The Company does not believe that the cash and cash equivalents and marketable debt securities on hand are sufficient to fund planned operations beyond the next twelve months from the filing date of these financial statements.
+Added: As a result, substantial doubt exists about the Company’s ability to continue as
+Added: a going concern.
+Added: ability of the Company to continue as a going concern is dependent upon control over its operating expenses, anticipated proceeds from
+Added: future sales of common stock through the At-The-Market Sales Agreement (“Sales Agreement”) with BTIG, LLC.
+Added: and securing additional
+Added: While the Company believes in the viability of this strategy and believes the actions presently being taken by the Company
+Added: provide the opportunity for it to continue as a going concern, there can be no assurance the Company will be successful in its implementation.
+Added: In particular, utilization of the Sales Agreement may not be viable due to market conditions and new financing may not be available on
+Added: acceptable terms, or at all.
+Added: These consolidated financial statements do not include any adjustments related to the recoverability and
+Added: classification of asset amounts or the amounts and classification of liabilities that might be necessary if the Company is unable to
+Added: continue as a going concern.
3 – Summary of Significant Accounting Policies
7 unchanged sentences
impact of events beyond our control
−Removed: financial condition and results of operations may be impacted by factors we may not be able to control, such as the COVID-19 or other
−Removed: pandemic, global supply chain disruptions, global trade disputes and/or political instability.
−Removed: Increases in interest rates, especially
−Removed: if coupled with reduced government spending and volatility in financial markets, may have the effect of further increasing economic uncertainty
−Removed: and heightening these risks.
−Removed: Additionally, rising inflation rates may affect us by increasing operating expenses, such as employee-related
−Removed: costs and clinical trial expenses, negatively impacting our results of operations.
−Removed: Company’s financial results for the year ended December 31, 2022 were not significantly impacted by COVID-19 or other factors beyond
−Removed: our control, such as those described above.
−Removed: However, the Company cannot predict the impact of any of these factors on future results
−Removed: or the Company’s ability to raise capital due to a variety of factors, including but not limited to the continued good health of
−Removed: Company employees, the ability of service providers and suppliers to continue to operate and deliver, the ability of the Company to maintain
−Removed: operations, and any government and/or public actions taken in response to these factors.
+Added: financial condition and results of operations may be impacted by factors we may not be able to control, such as pandemics, global supply
+Added: chain disruptions, global trade disputes and/or political instability.
+Added: Increases in interest rates, especially if coupled with reduced
+Added: government spending and volatility in financial markets, may have the effect of further increasing economic uncertainty and heightening
+Added: Additionally, rising inflation rates may affect us by increasing operating expenses, such as employee-related costs and
+Added: clinical trial expenses, negatively impacting our results of operations.
+Added: Company’s financial results for the year ended December 31, 2023 were not significantly impacted by factors beyond our control,
+Added: such as those described above.
+Added: However, the Company cannot predict the impact of any of these factors on future results or the Company’s
+Added: ability to raise capital due to a variety of factors, including but not limited to the continued good health of Company employees, the
+Added: ability of service providers and suppliers to continue to operate and deliver, the ability of the Company to maintain operations, and
+Added: any government and/or public actions taken in response to these factors.
preparation of consolidated financial statements in conformity with U.S.
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items subject to such estimates and assumptions include, but are not limited to, the Company’s research and development expenses
−Removed: the assessment of the impairment of goodwill and intangible assets, income tax
−Removed: valuations and the determination of stock-based compensation.
+Added: and the assessment of the impairment of goodwill and intangible assets.
and geographic information
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treasury bonds, U.S.
−Removed: government notes, corporate debt securities
−Removed: and state and municipal bonds.
−Removed: Marketable debt securities are carried at fair value, with unrealized gains and losses reported as accumulated
−Removed: other comprehensive (loss)/income, except for losses from impairments which are determined to be other-than-temporary.
−Removed: Realized gains
−Removed: and losses and declines in value judged to be other-than-temporary are included in the determination of net loss and are included in
−Removed: other income, net.
+Added: government notes and corporate debt securities
+Added: are carried at fair value, with unrealized gains and losses reported as accumulated other comprehensive loss, except for losses from
+Added: impairments which are determined to be other-than-temporary.
+Added: Any premium or discount arising at purchase is amortized and/or accreted
+Added: to interest income and/or expense over the life of the instrument.
+Added: The Company reviews its portfolio of available-for-sale debt securities,
+Added: using both qualitative and quantitative factors, to determine if declines in fair value below cost have resulted from a credit-related
+Added: loss or other factors.
+Added: Realized gains and losses and declines in value judged to be other-than-temporary are included in the determination
+Added: of net loss and are included in other income, net.
Fair values are based on quoted market prices at the reporting date.
−Removed: Interest and dividends on available-for-sale
−Removed: securities are included in other income, net.
−Removed: For a complete disclosure of the Company’s marketable debt securities, see Note 4
−Removed: – Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities.
+Added: dividends on available-for-sale securities are included in other income, net.
+Added: For a complete disclosure of the Company’s marketable
+Added: debt securities, see Note 4 – Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities.
Concentration
of credit risk
−Removed: The Company’s financial instruments that are exposed to concentrations
−Removed: of credit risk consist primarily of cash, cash equivalents, restricted cash and marketable debt securities.
−Removed: The Company’s investment
−Removed: policy is to invest only in institutions that meet high credit quality standards and establishes limits on the amount and time to maturity
−Removed: of investments with any individual counterparty.
−Removed: Balances are maintained at U.S.
−Removed: financial institutions and may from time to time exceed
−Removed: the Federal Deposit Insurance Corporation (“FDIC”) insurance limit of $ 250 per depositor, per insured bank for each account
−Removed: ownership category.
−Removed: The Company has not experienced any credit losses associated with its balances in such accounts for the years ended
−Removed: December 31, 2022 and 2021.
+Added: Company’s financial instruments that are exposed to concentrations of credit risk consist primarily of cash, cash equivalents,
+Added: restricted cash and marketable debt securities.
+Added: The Company’s investment policy is to invest only in institutions that meet high
+Added: credit quality standards and establishes limits on the amount and time to maturity of investments with any individual counterparty.
+Added: are maintained at U.S.
+Added: financial institutions and may from time to time exceed the Federal Deposit Insurance Corporation (“FDIC”)
+Added: insurance limit of $ 250 per depositor, per insured bank for each account ownership category.
+Added: The Company has not experienced any credit
+Added: losses associated with its balances in such accounts for the years ended December 31, 2023 and 2022.
improvements and equipment
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term of the lease.
+Added: retirement or sale, the cost of assets disposed of and related accumulated depreciation and amortization is removed from the accounts
+Added: and any resulting gain or loss is included in loss from operations.
+Added: Expenditures for repairs and maintenance are charged to expense as
+Added: For a complete disclosure of the Company’s leasehold improvements and equipment, see Note 6 – Leasehold Improvements
+Added: and Equipment.
and other intangible assets
5 unchanged sentences
it is more-likely-than-not that the fair value of a reporting unit is less than its carrying amount.
−Removed: If the Company determine this is
−Removed: the case, the Company can perform further analysis to identify and measure the amount of goodwill impairment loss to be recognized, if
+Added: If the Company determines this is
+Added: the case, the Company can perform further quantitative analysis to identify and measure the amount of goodwill impairment loss to be
+Added: recognized, if any.
reporting unit is an operating segment, or one level below an operating segment.
1 unchanged sentence
in a single operating segment and reporting unit.
−Removed: For the years ended December 31, 2022 and 2021, the Company assessed goodwill impairment
−Removed: by performing a qualitative test for its reporting unit.
−Removed: As part of the qualitative review, the Company considered relevant events and
−Removed: circumstances, with an emphasis on the fact that the Company’s fair value, as determined by its market capitalization, is well
−Removed: in excess of its book value.
−Removed: Based on the results of the Company’s assessment, it was determined that it is more-likely-than-not
−Removed: that its goodwill was not impaired during the years ended December 31, 2022 and 2021.
+Added: the year ended December 31, 2023, due primarily to there being substantial doubt about the ability of the Company to continue as a going
+Added: concern, the Company assessed goodwill impairment by performing a quantitative analysis for its reporting unit.
+Added: As part of the quantitative
+Added: review, the Company considered whether its fair value, determined as the price a market participant would be willing to pay in a potential
+Added: acquisition of the Company, exceeds its carrying value, including goodwill.
+Added: Based on the results of the Company’s assessment, it
+Added: was determined that its goodwill was not impaired.
+Added: the year ended December 31, 2022, the Company assessed goodwill impairment by performing a qualitative analysis for its reporting unit.
+Added: As part of the qualitative review, the Company considered relevant events and circumstances, with an emphasis on the fact that the Company’s
+Added: fair value, as determined by its market capitalization, was well in excess of its book value.
+Added: Based on the results of the Company’s
+Added: assessment, it was determined that it is more-likely-than-not that its goodwill was not impaired.
lived intangible assets are composed of in-process research and development (“IPR&D”) and represent projects acquired
7 unchanged sentences
Similar to the impairment
−Removed: test for goodwill, the Company may perform a qualitative review of its indefinite-lived intangible assets for impairment.
−Removed: used the qualitative approach and concluded that it was more-likely-than-not that its indefinite-lived assets were no t impaired during
−Removed: the years ended December 31, 2022 and 2021.
+Added: test for goodwill, the Company may perform a qualitative review of its indefinite-lived intangible assets for impairment in order to
+Added: determine the necessity of performing a quantitative analysis to identify and measure the amount of impairment loss to be recognized,
+Added: the year ended December 31, 2023, the Company performed a quantitative analysis, using a discounted cash flow approach to determine fair
+Added: value, and concluded that its indefinite-lived assets were not impaired.
+Added: For the year ended December 31, 2022, the Company used the qualitative
+Added: approach and concluded that it was more-likely-than-not that its indefinite-lived assets were not impaired.
Financial Accounting Standards Board (the “FASB”) Accounting Standards Codification (“ASC”) Topic 842, “Leases”,
8 unchanged sentences
leases, see Note 8 – Leases.
−Removed: stock dividends
−Removed: to provisions detailed more fully in Note 12 - Stockholders’ Equity, shares of Series B Preferred Stock earned dividends at rates
−Removed: of 10 % , 15 % and 20 % once per year on the first, second and third anniversary, respectively, of June 19, 2018.
−Removed: The dividends were paid
−Removed: when earned to the holders of the Series B Preferred Stock in the form of shares of the Company’s common stock and all Series B Preferred Stock were converted in 2021.
taxes are provided on a liability method whereby deferred tax assets are recognized for deductible temporary differences and operating
47 unchanged sentences
loss per share information is determined using the two-class method, which includes the weighted-average number of shares of common stock
−Removed: outstanding during the period and other securities that participate in dividends (a “participating security”).
−Removed: considered its Preferred Stock to be participating securities because the shares included rights to participate in dividends with the
−Removed: common stock.
+Added: outstanding during the period and other securities.
the two-class method, basic net loss per share attributable to common stockholders is computed by dividing the net income attributable
to common stockholders by the weighted-average number of shares of common stock outstanding during the period.
−Removed: The net loss attributable
−Removed: to common stockholders is calculated by adjusting the net loss of the Company for the accretion on the Preferred Stock.
−Removed: Net losses are
−Removed: not allocated to preferred stockholders as they do not have an obligation to share in the Company’s net losses.
−Removed: In periods with
−Removed: net income attributable to common stockholders, the Company would allocate net income first to preferred stockholders based on dividend
−Removed: rights under the Company’s certificate of incorporation and then to preferred and common stockholders based on ownership interests.
−Removed: Diluted net loss per share attributable to common stockholders is computed using the more dilutive of (1) the two-class method or (2)
−Removed: the if-converted method.
+Added: Diluted net loss per share
+Added: attributable to common stockholders is computed using the more dilutive of (1) the two-class method or (2) the if-converted method.
the years ended December 31, 2023 and 2022, diluted earnings per common share is the same as basic earnings per common share because,
17 unchanged sentences
price that is allocated to the respective performance obligation when the performance obligation is satisfied.
−Removed: the year ended December 31, 2022, the Company’s revenues primarily consist of contract research revenue from the BioNTech Agreement
−Removed: to evaluate the combination of mRNA formats utilizing the Company’s proprietary LNC Platform.
−Removed: For a complete disclosure of the
−Removed: Company’s Revenue Recognition, see Note 9 – Revenue Recognition, Collaboration Agreements, and Other Research and Development
+Added: the years ended December 31, 2023 and 2022, the Company’s revenues primarily consist of contract research revenue from the BioNTech
+Added: Agreement to evaluate the combination of mRNA formats utilizing the Company’s proprietary LNC Platform.
+Added: For a complete disclosure
+Added: of the Company’s Revenue Recognition, see Note 9 – Revenue Recognition, Collaboration Agreements, and Other Research and
+Added: Development Agreements.
December 12, 2019, the Company entered into a feasibility study agreement (the “Agreement”) with Genentech, Inc.
7 unchanged sentences
are no contract assets associated with this Agreement.
−Removed: As of December 31, 2022, the Company completed the first and second of the three
−Removed: molecules and the Company recognized $ 33 of Genentech revenue for the years ended December 31, 2021 and 2020, respectively.
−Removed: is scheduled to complete performance obligation related to the remaining molecule during 2023.
+Added: The Company recognized $ 33 and $ 0 of Genentech revenue for the years ended December
+Added: 31, 2023 and 2022, respectively.
+Added: As of December 31, 2023, the Company completed its obligations for all three molecules.
Collaboration
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in the amount of cumulative costs have been recognized.
−Removed: As of December 31, 2022 and 2021, the Company recognized $ 811 and $ 2,179 , respectively,
−Removed: of reimbursed research and development costs associated with the CFF Agreement.
−Removed: For a complete disclosure of the CFF Agreement, see Note
−Removed: 9 – Collaboration Agreements, Collaboration Agreements, and other Research and Development Agreements.
+Added: During the years ended December 31, 2023 and 2022, the Company recognized $ 88
+Added: and $ 811 , respectively, of reimbursed research and development costs associated with the CFF Agreement.
+Added: For a complete disclosure of
+Added: the CFF Agreement, see Note 9 – Collaboration Agreements, Collaboration Agreements, and other Research and Development Agreements.
and development expenses
46 unchanged sentences
accounting pronouncements
−Removed: were no recent accounting pronouncements that impacted the Company or are expected to have a significant effect on its consolidated financial
+Added: November 2023, the FASB issued Accounting Standard Update (“ASU”) No.
+Added: 2023-07, Segment Reporting (Topic 280):
+Added: to Reportable Segment Disclosures (“ASU 2023-07”).
+Added: This ASU requires disclosure of significant segment expenses that
+Added: are regularly provided to the chief operating decision maker (“CODM”), an amount for other segment items with description
+Added: of composition, and disclosure of the title and position of the CODM.
+Added: ASU 2023-17 is effective for annual periods beginning after December
+Added: 31, 2023 and interim periods within fiscal years beginning after December 15, 2024.
+Added: Early adoption is permitted and this ASU should be
+Added: applied retrospectively to each period presented in the financial statements.
+Added: Since the Company views its operations and manages its
+Added: business in one operating and reporting segment, the Company believes this additional disclosure will not have an impact on its consolidated
+Added: financial statements and related disclosures.
+Added: As a result, we intend to adopt the provision of this ASU in the fourth quarter of 2024.
+Added: December 2023, the FASB issued ASU No.
+Added: 2023-09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclousres (“ASU 2023-09”) .
+Added: This ASU requires public business entities on an annual basis to disclose specific categories in a tabular rate reconciliation and provide
+Added: additional information for reconciling items that meet a five percent quantitative threshold.
+Added: Additionally, the ASU requires all entities
+Added: to disclose the amount of income taxed paid disaggregated by federal, state, and foreign taxes, as well as individual jurisdictions where
+Added: income taxes paid are equal to or greater than five percent of total income taxes paid.
+Added: ASU 2023-09 is effective for annual periods beginning
+Added: after December 31, 2024.
+Added: Early adoption is permitted and this ASU should be applied on a prospective basis, a retrospective application
+Added: permitted in the financial statements.
+Added: The Company is currently evaluating the impact of the new standard on our consolidated financial
+Added: statements and related disclosures.
+Added: As a result, we intend to adopt the provisions of this ASU in the fourth quarter of 2025.
4 – Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities
23 unchanged sentences
Realized gains and losses from marketable debt securities are recorded in other income, net.
−Removed: the years ended December 31, 2022 and 2021, the Company recorded unrealized losses of $ 679 and $ 374 , respectively.
−Removed: As of December 31,
−Removed: 2022 and 2021, the Company had net accumulated unrealized losses of $ 824 and $ 145 , respectively.
−Removed: Company’s marketable debt securities for the year ended December 31, 2022 consisted of the following:
−Removed: Schedule of Marketable Securities
−Removed: Amortized Cost
−Removed: Unrealized Gain
−Removed: Unrealized (Loss)
−Removed: Amortized Cost
−Removed: Unrealized (Loss)
+Added: Company did not incur any realized gains and losses during the years ended December 31, 2023 and 2022.
+Added: For the years ended December 31,
+Added: 2023 and 2022, the Company recorded unrealized gains/(losses) of $ 603 and ($ 679 ), respectively.
+Added: As of December 31, 2023 and 2022, the
+Added: Company had net accumulated unrealized losses of $ 221 and $ 824 , respectively.
+Added: following tables summarize the Company’s marketable debt securities as of December 31, 2023:
+Added: of Marketable Debt Securities
Treasury Bonds
Government Notes
−Removed: Corporate Debt Securities
Total marketable debt securities
−Removed: of debt securities classified as available-for-sale were as follows at December 31, 2022:
−Removed: Schedule of Maturities of Debt Securities Available-for-sale
−Removed: Due within one year
−Removed: Due after one year through five years
+Added: debt securities classified as available-for-sale are due to mature within one year of December 31, 2023.
Company’s marketable debt securities for the year ended December 31, 2022 consisted of the following:
−Removed: Unrealized (Loss)
Amortized Cost
−Removed: Unrealized Gain
Unrealized (Loss)
+Added: Treasury Bonds
Government Notes
Corporate Debt Securities
−Removed: State and Municipal Bonds
Total marketable debt securities
of debt securities classified as available-for-sale were as follows at December 31, 2022:
+Added: Schedule of Maturities of Debt Securities Available-for-sale
Due within one year
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Government Notes
−Removed: Corporate Debt Securities
Fair Value Hierarchy
1 unchanged sentence
Marketable Debt Securities:
+Added: Treasury Bonds
Government Notes
Corporate Debt Securities
−Removed: State and Municipal Bonds
treasury bonds are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices for identical
1 unchanged sentence
Marketable debt securities consisting of U.S.
−Removed: government notes, corporate debt securities and state and municipal
−Removed: bonds are classified as Level 2 and are valued using quoted market prices in markets that are not active.
+Added: government notes and corporate debt securities are classified
+Added: as Level 2 and are valued using quoted market prices in markets that are not active.
6 – Leasehold Improvements and Equipment
2 unchanged sentences
Leasehold improvements
+Added: Leasehold improvements and equipment, gross
accumulated depreciation and amortization
12 unchanged sentences
Payroll and incentives
−Removed: Deferred revenue *
General and administrative expenses
Research and development expenses
+Added: Deferred revenue *
Other deferred liabilities **
2 unchanged sentences
(the “Genentech Agreement”).
−Removed: Both balances are expected to be recognized by March 31, 2023.
−Removed: At December 31, 2021, the balance of $ 33 was related to the Genentech
−Removed: (See Note 9 – Revenue
−Removed: Recognition, Collaboration Agreements, and Other research and Development Agreements).
−Removed: December 31, 2022 and December 31, 2021, the balances of $ 88 and $ 899 , respectively, related to an award agreement with the Cystic
−Removed: Fibrosis Foundation (the “CFF Agreement).
−Removed: (See Note 9 – Revenue Recognition, Collaboration Agreements, and Other Research
−Removed: and Development Agreements).
+Added: (See Note 9 – Revenue Recognition, Collaboration Agreements, and Other research and Development Agreements).
+Added: December 31, 2022, the balance of $ 88 was related to an award agreement with the Cystic Fibrosis Foundation (the “CFF Agreement).
+Added: (See Note 9 – Revenue Recognition, Collaboration Agreements, and Other Research and Development Agreements).
Company has various lease agreements including leases of office space, a laboratory and manufacturing facility, and various equipment.
64 unchanged sentences
and BioNTech SE will fund certain of the Company’s research expenses to be incurred under the agreement.
−Removed: The parties have also
−Removed: commenced discussions on a potential option to license (“OTL”) agreement for the Company’s LNC Platform.
−Removed: the agreement begins on the effective date and ends on the earlier of the execution of an OTL agreement by the parties, 12-months after
−Removed: the effective date and termination of the agreement.
−Removed: As of December 31, 2022, the parties have not executed an OTL agreement.
+Added: The term of the agreement
+Added: began on the effective date and expired on April 8, 2023.
Company assessed the BioNTech Agreement under ASC 808 Collaboration Arrangements and ASC 606 Revenue from Contracts with Customers
7 unchanged sentences
both the license and research services.
−Removed: $ 2,750 license fee was recorded as deferred revenue and is being recognized over the term of the contract performance obligation period,
−Removed: which the Company has concluded to be 12 months after the execution of the contract.
−Removed: The clinical research services are being invoiced
−Removed: as service revenue is earned on a monthly basis during the term of the contract.
−Removed: of December 31, 2022, the Company recognized $ 3,188 of contract research revenue from the BioNTech Agreement.
−Removed: For the year ended December
−Removed: 31, 2022 $ 2,063 of the contract research revenue was recognized from the license fee and $ 1,125 was earned from the monthly clinical
−Removed: research services performed by the Company.
−Removed: As of December 31, 2022, $ 688 of the license fee is included in deferred revenue within accrued
+Added: $ 2,750 license fee was recorded as deferred revenue and was recognized over the term of the contract performance obligation period, which
+Added: the Company concluded to be 12 months after the execution of the contract.
+Added: The clinical research services were invoiced as service revenue
+Added: was earned on a monthly basis during the term of the contract.
+Added: the year ended December 31, 2023, $ 688 of the contract research revenue was recognized from the license fee and $ 375 was earned from
+Added: the monthly clinical research services performed by the Company.
+Added: As of December 31, 2023, the Company had recognized all of contract
+Added: research revenue from the BioNTech Agreement.
Fibrosis Foundation Therapeutics Development Award
6 unchanged sentences
of December 31, 2023, the Company has received $ 3,635 of the $ 4,555 commitment, inclusive of the Amendment’s additional milestone
−Removed: payment, and the related deferred liability balances of $ 88 and $ 899 is included in accrued expenses at December 31, 2022 and December
+Added: payment, and a related deferred liability balance of $ 0 and $ 88 is included in accrued expenses at December 31, 2023 and December 31,
2022, respectively.
−Removed: During the fourth quarter of 2022, for financial and technical reasons, the Company determined that it was not
−Removed: commercially reasonable to continue the development of MAT2501 and instead elected to focus existing resources on other initiatives.
−Removed: As a result, the Company does not anticipate receiving the balance of the commitment.
−Removed: to the terms of the CFF Agreement, should the Company ceases to use commercially reasonable efforts directed to the development of MAT2501
−Removed: in the Field, (an “Interruption”) and fail to resume the development of the Product after receiving from CFF notice of an
−Removed: Interruption, then the Company must either repay the amount of the Award actually received by the Company, or grant to CFF (1) an exclusive
−Removed: (even as to the Company), worldwide, perpetual, sublicensable license under technology developed under the Agreement that covers the
−Removed: Product for use in treating infections in CF patients (the “CF Field”), and (2) a non-exclusive, worldwide license under
−Removed: certain background intellectual property covering the Product, to the extent necessary to commercialize the Product in the CF Field.
−Removed: Following discussion with the CFF in early 2023, the Company does not believe it will have to repay any amounts of Awards received by
−Removed: the Company to date pursuant to the terms of the CFF Agreement.
−Removed: The Company is working together with the CFF to wind up the agreement
−Removed: according to its terms.
−Removed: the event that the Company chooses to resume development of MAT2501, pursuant to the terms of the Agreement, the Company is obligated
−Removed: to make royalty payments to CFF contingent upon commercialization of the Product in the Field up to a maximum of five times the Award
−Removed: or approximately $ 21.2 million (the “Royalty Cap”), payable in three equal annual installments following the first commercial
−Removed: sale of the Product, the first of which is due within 90 days following the first commercial sale of the Product.
−Removed: The Company may also
−Removed: be obligated to make a payment to CFF if the Company transfers, sells or licenses the Product in the CF Field, or if the Company enters
−Removed: into a change of control transaction which will be applied against the Royalty Cap.
−Removed: In addition, the Company is also obligated to make
−Removed: up to two royalty payments to CFF of approximately $ 4.2 million each, due in the calendar years in which specific net sales milestones
−Removed: are achieved.
−Removed: term of the Agreement commenced on November 19, 2020 and expires on the earlier of the date on which the Company has paid CFF all of
−Removed: the fixed royalty payments set forth therein, the effective date of any license granted to CFF following an Interruption, or upon earlier
−Removed: termination of the Agreement.
−Removed: Either CFF or the Company may terminate the agreement for cause, which includes the Company’s material
−Removed: failure to achieve certain development milestones.
−Removed: The Company’s payment obligations survive the termination of the Agreement.
−Removed: Company concluded that the CFF award is in the scope of ASC 808.
−Removed: Accordingly, as discussed in Note 3, the award amounts received from
−Removed: CFF upon achievement of certain milestones are recognized as credits to research and development expenses in the period the Development
−Removed: Program’s expenses are incurred.
−Removed: During the years ended December 31, 2022 and 2021, the Company recognized $ 811 and $ 2,179 , respectively,
−Removed: as credits to research and development expenses related to the CFF award.
+Added: During the years ended December 31, 2023 and 2022, the Company recognized $ 88 and $ 811 , respectively, as credits
+Added: to research and development expenses related to the CFF award.
+Added: During the fourth quarter of 2022, for financial and technical reasons,
+Added: the Company determined that it was not commercially reasonable to continue the development of MAT2501 and instead elected to focus existing
+Added: resources on other initiatives.
+Added: As a result, the Company does not anticipate receiving the balance of the commitment and has no further
+Added: obligations to CFF.
Feasibility Study Agreement
−Removed: December 12, 2019, the Company entered into the Genentech Agreement which involves the development of oral formulations using the Company’s
−Removed: LNC Platform.
−Removed: Under the terms of the Genentech Agreement, Genentech paid the Company a total of $100 for the development of three molecules,
−Removed: or approximately $33 per molecule, which is being recognized upon the Company fulfilling its obligations for each molecule under the
−Removed: Genentech Agreement .
−Removed: The Company recorded the upfront consideration as deferred revenue, which is included in accrued expenses on the
−Removed: consolidated balance sheets.
−Removed: As of December 31, 2021, the Company completed its obligations related to the first and second of the three
−Removed: During the year ended December 31, 2022, the Company did not complete its obligations related to the remaining molecule but
−Removed: expects to do so during 2023.
−Removed: the acquisition of Aquarius, the Company acquired a license from Rutgers University, The State University of New Jersey (successor
−Removed: in interest to the University of Medicine and Dentistry of New Jersey) for certain patents related to the LNC Platform (the “License Agreement”).
−Removed: Amended and Restated Exclusive License Agreement provides for, among other things, the payment of (1) royalties on a tiered basis
−Removed: between low single digits and the mid-single digits of net sales of products using such licensed technology, (2) a one-time sales
−Removed: milestone fee of $ 100
−Removed: when and if sales of products using the licensed technology reach the specified sales threshold and (3) an annual license fee of
−Removed: over the term of the License Agreement.
−Removed: The term of the License Agreement will remain in effect until the expiration of the last-to-expire patent rights
−Removed: licensed or seven and one-half years from the date of the first commercial sale of a licensed product under this agreement, whichever
+Added: December 12, 2019, the Company entered into the Genentech Agreement which involves the development of oral formulations using the
+Added: Company’s LNC Platform.
+Added: Under the terms of the Genentech Agreement, Genentech paid the Company a total of $ 100 for the
+Added: development of three molecules, or approximately $ 33 per molecule, which is being recognized upon the Company fulfilling its
+Added: obligations for each molecule under the Genentech Agreement.
+Added: The Company recorded the upfront consideration as deferred revenue,
+Added: which is included in accrued expenses on the consolidated balance sheets.
+Added: As of December 31, 2022, the Company completed its
+Added: obligations related to the first and second of the three molecules.
+Added: During the year ended December 31, 2023, the Company completed
+Added: its obligations related to the remaining molecule.
+Added: the acquisition of Aquarius, the Company acquired a license from Rutgers University, The State University of New Jersey (successor in
+Added: interest to the University of Medicine and Dentistry of New Jersey) for certain patents related to the LNC Platform (the “License
+Added: The Second Amended and Restated Exclusive License Agreement provides for, among other things, the payment of (1) royalties
+Added: on a tiered basis between low single digits and the mid-single digits of net sales of products using such licensed technology, (2) a
+Added: one-time sales milestone fee of $100 when and if sales of products using the licensed technology reach the specified sales threshold
+Added: and (3) an annual license fee of $50 over the term of the License Agreement.
+Added: The term of the License Agreement will remain in effect
+Added: until the expiration of the last-to-expire patent rights licensed or seven and one-half years from the date of the first commercial sale
+Added: of a licensed product under this agreement, whichever is later.
10 – Commitments
+Added: payment rights
+Added: to the terms of the Certificate of Designations of Preferences, Rights and Limitations (the “Certificate of Designations”)
+Added: for our Series A Preferred Stock, the Company may be required to pay royalties of up to $ 35 million per year.
+Added: If and when the Company
+Added: obtains FDA or EMA approval of MAT2203 and/or MAT2501, which we do not expect to occur before 2027, if ever, and/or if the Company generates
+Added: sales of such products, or receives any proceeds from the licensing or other disposition of MAT2203 or MAT2501, the Company will be required
+Added: to pay to certain former holders of its Series A Preferred Stock, in aggregate, a royalty equal to (i) 4.5% of Net Sales (as defined
+Added: in the Certificate of Designations), subject in all cases to a cap of $25 million per calendar year, and (ii) 7.5% of Licensing Proceeds
+Added: (as defined in the Certificate of Designations), subject in all cases to a cap of $10 million per calendar year.
+Added: The Royalty Payment
+Added: Rights will expire when the patents covering the applicable product expire, which is currently expected to be in 2033 .
Company also has employment agreements with certain employees which require the funding of a specific level of payments, if certain events,
43 unchanged sentences
Valuation Allowance
−Removed: Discrete items
−Removed: income tax rate
+Added: Effective income tax
Company has no current income taxes payable other than certain state minimum taxes which are included in general and administrative expenses.
47 unchanged sentences
change since the Company’s inception.
−Removed: Under the Tax Cuts and Jobs Act of 2017, research
−Removed: and development costs are no longer fully deductible and are required to be capitalized and amortized for U.S.
−Removed: tax purposes effective
−Removed: January 1, 2022.
+Added: the Tax Cuts and Jobs Act of 2017, research and development costs are no longer fully deductible and are required to be capitalized and
+Added: amortized for U.S.
+Added: tax purposes effective January 1, 2022.
The mandatory capitalization requirement increases our deferred tax assets.
6 unchanged sentences
of net taxable income for losses arising in taxable years beginning after December 31, 2017.
−Removed: This NOL limitation was suspended for years
−Removed: 2018 through 2020 as a result of the CARES Act.
12 – Stockholders’ Equity
1 unchanged sentence
Equity Offering
−Removed: July 2, 2020, the Company entered into an At-The-Market (“ATM”) Sales Agreement (the “Sales Agreement”) with
−Removed: BTIG, LLC (“BTIG”), pursuant to which the Company may offer and sell, from time to time, through BTIG, as sales agent and/or
−Removed: principal, shares of its common stock having an aggregate offering price of up to $ 50,000 , subject to certain limitations on the amount
−Removed: of common stock that may be offered and sold by the Company set forth in the Sales Agreement.
−Removed: BTIG will be paid a 3 % commission on the
−Removed: gross proceeds from each sale.
−Removed: The Company may terminate the Sales Agreement at any time;
−Removed: BTIG may terminate the Sales Agreement in certain
−Removed: limited circumstances.
−Removed: During 2021, BTIG sold 3,023,147 shares of the Company’s common stock generating gross proceeds of $ 5,753
−Removed: and net proceeds of $ 5,580 , after deducting BTIG’s commission on gross proceeds.
−Removed: During 2022, the Company did not sell any shares
−Removed: of its common stock under the ATM Sales Agreement.
−Removed: At December 31, 2022, the ATM’s available capacity was $ 44,247 .
+Added: July 2, 2020, the Company entered into an At-The-Market Sales Agreement (the “Sales Agreement”) with BTIG, LLC (“BTIG”),
+Added: pursuant to which the Company may offer and sell, from time to time, through BTIG, as sales agent and/or principal, shares of its common
+Added: stock having an aggregate offering price of up to $ 50,000 , subject to certain limitations on the amount of common stock that may be offered
+Added: and sold by the Company set forth in the Sales Agreement.
+Added: BTIG will be paid a 3 % commission on the gross proceeds from each sale.
+Added: Company may terminate the Sales Agreement at any time;
+Added: BTIG may terminate the Sales Agreement in certain limited circumstances.
+Added: did not sell any shares of its common stock under the Sales Agreement during either 2023 or 2022.
+Added: At December 31, 2023, the Sales Agreement’s
+Added: available capacity was $ 44,247 .
February 8, 2022, the Company issued 400,000 unregistered shares of its common stock to Rutgers, The State University of New Jersey (“Rutgers”),
8 unchanged sentences
the closing price of the Company’s common stock of $ 0.728 on the date of issuance.
−Removed: September 3, 2021, the Company issued 1,500,000 unregistered shares of its common stock pursuant to the Agreement and Plan of Merger
−Removed: by and among the Company, Saffron Merger Sub, Inc., Aquarius Biotechnologies Inc.
−Removed: (“Aquarius”), and J Carl Craft, as holder
−Removed: representative, dated January 19, 2015, as subsequently amended on September 3, 2021 (the “Aquarius Merger Agreement”), to
−Removed: the holders of Aquarius Biotechnologies Inc., as defined in the Aquarius Merger Agreement.
−Removed: The shares were issued in place of certain
−Removed: milestone payments previously included under the Aquarius Merger Agreement upon the achievement of specified development milestones.
−Removed: The Company recorded a $ 1,200 research and development expense related to the issuance of the 1,500,000 shares based on the closing price
−Removed: of the Company’s common stock of $ 0.80 on the date of issuance.
accordance with the Certificate of Incorporation, the Company is authorized to issue 10,000,000 preferred shares at a par value of $ 0.001 .
−Removed: In connection with a public offering of Series B Preferred Stock, on June 19, 2018, the Company filed the Series B Certificate of Designation
−Removed: with the Secretary of the State of Delaware to designate the preferences, rights and limitations of the Series B Preferred Stock.
−Removed: to the Series B Certificate of Designation, the Company designated 8,000 shares of the Company’s previously undesignated preferred
−Removed: shares as Series B Preferred Stock.
−Removed: January 1 and June 18, 2021, 143
−Removed: shares of Series B Preferred Stock were converted by shareholders resulting in the issuance of 286,000
−Removed: shares of common stock.
−Removed: On June 19, 2021, each of the 4,218
−Removed: remaining shares of Series B Preferred Stock were each automatically converted into 2,000
−Removed: shares of the Company’s common stock resulting in the issuance of 8,436,000
−Removed: shares of common stock.
−Removed: No shares or Series B Preferred stock remained outstanding after the automatic conversion.
−Removed: accounting of the holders of record of Series B Preferred Stock on June 19, 2021, the Company made dividend payments totaling 1,687,200
−Removed: shares of common stock.
−Removed: warrants issued by the Company are exercisable immediately upon issuance and have a five-year term.
−Removed: The warrants may be exercised at
−Removed: any time in whole or in part upon payment of the applicable exercise price until expiration.
−Removed: No fractional shares will be issued upon
−Removed: the exercise of the warrants.
−Removed: The exercise price and the number of shares purchasable upon the exercise of the warrants are subject to
−Removed: adjustment upon the occurrence of certain events, which include stock dividends, stock splits, combinations and reclassifications of
−Removed: the Company’s capital stock or other similar changes to the equity structure of the Company.
−Removed: The warrants do not have a redemption
−Removed: They may be exercised on a cashless basis at the holder’s option.
−Removed: warrants are classified as equity instruments.
−Removed: of December 31, 2022, the Company had outstanding warrants to purchase an aggregate of 238,000 shares of common stock at an exercise
−Removed: price of $ 0.75 per share, and with an expiration date of June 21, 2023.
−Removed: A summary of warrants outstanding as of December 31, 2022 and
−Removed: 2021 is presented below, all of which are fully vested:
−Removed: of Shareholders Equity Warrants Outstanding
+Added: of December 31, 2023, the Company did not have any outstanding warrants to purchase shares of common stock.
+Added: A summary of warrants outstanding
+Added: as of December 31, 2023 and 2022 is presented below:
+Added: Schedule of Shareholder Equity Warrants Outstanding
Outstanding at December 31, 2021
1 unchanged sentence
Outstanding at December 31, 2023
−Removed: average exercise price for outstanding warrants is $ 0.56 .
−Removed: into 400 thousand shares of common stock.
13 – Accumulated Other Comprehensive Income/(Loss)
1 unchanged sentence
31, 2023 and 2022:
−Removed: of Components of Accumulated Other Comprehensive (Loss)/Income
+Added: Schedule of Components of Accumulated Other Comprehensive (Loss) Income
Net Unrealized Gains/(Losses) on Available-for-Sale Securities
3 unchanged sentences
Balance, December 31, 2022
−Removed: Net unrealized loss on securities available-for-sale
+Added: Net unrealized gain on securities available-for-sale
Balance, December 31, 2023
22 unchanged sentences
following table contains information about the Company’s stock plan at December 31, 2023:
−Removed: of Equity Compensation Plan by Arrangements
+Added: Schedule of Equity Compensation Plan by Arrangements
Awards Reserved for Issuance
2 unchanged sentences
2013 Equity Compensation Plan (in thousands)
−Removed: by 8,651 thousand on January 1, 2022, representing 4 % of the total number of shares of common stock outstanding on December 31, 2021.
+Added: by 8,691 on January 1, 2023, representing 4 % of the total number of shares of common stock outstanding on December 31, 2022.
both stock grants and option grants
5 unchanged sentences
Weighted Average Contractual Term in Years
−Removed: Outstanding at December 31, 2020
+Added: Outstanding at January 1, 2022
Outstanding at December 31, 2022
16 unchanged sentences
Such costs are expected to be recognized over a weighted average period of approximately 2.6 years.
−Removed: outstanding options expire ten
−Removed: date of grant.
−Removed: Options granted to employees prior to 2018 vest in equal monthly installments over three years.
−Removed: Beginning in 2018, options
−Removed: granted to employees vest over four years, with 25 %
−Removed: of the shares vesting on the first annual anniversary of grant and the remaining shares vesting in 36 equal monthly installments over
−Removed: the following 3 years.
−Removed: the years ended December 31, 2022 and 2021, the Company granted restricted stock awards for 0 and 31,769 shares of common stock, respectively.
−Removed: These awards are typically granted to members of the Board of Directors as payment in lieu of cash fees or as payment to a vendor pursuant
−Removed: to a consulting agreement.
−Removed: The Company values restricted stock awards at the fair market value on the date of grant.
−Removed: The Company recorded
−Removed: the value of these restricted awards as general and administrative expense of $ 0 and $ 100 in the consolidated statement of operations
−Removed: for the years ended December 31, 2022 and 2021, respectively.
−Removed: Company recognizes compensation expense for restricted stock awards on a straight-line basis over the applicable service period of the
−Removed: The service period is generally the vesting period, with the exception of awards granted subject to a vendor’s consulting
−Removed: agreement, whereby the award vesting period and the service period defined pursuant to the terms of the consulting agreement may be different.
+Added: outstanding options expire ten years from date of grant.
+Added: Options granted to employees prior to 2018 vest in equal monthly installments
+Added: over three years.
+Added: Beginning in 2018, options granted to employees vest over four years, with 25 % of the shares vesting on the first annual
+Added: anniversary of grant and the remaining shares vesting in 36 equal monthly installments over the following 3 years.
+Added: resulting compensation expense for stock options is generally recognized on a straight-line basis over the requisite service period of
The following weighted-average assumptions were used to calculate share-based compensation for the comparative periods presented:
−Removed: Schedule of Stock Option Awards and Restricted Stock Awards
+Added: Schedule of Compensation Expense for Stock Options
For the Year Ended December 31,
91.2 % - 120.5 %
+Added: 92.1 % - 98.7 %
Risk-free interest rate
6 unchanged sentences
107 to estimated the expected term of share option grants.
−Removed: expected stock price volatility assumption is based the Company’s historical stock price volatility.
+Added: expected stock price volatility assumption is based on the Company’s historical stock price volatility.
15 – Subsequent Events
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.