Item 9A. Controls and Procedures
Item 9A.
Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Disclosure
Controls and Procedures:
As
of December 31, 2022, under the supervision and with the participation of our principal executive officer and principal financial officer
we have evaluated, the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e)
and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on that evaluation, our principal
executive officer and principal financial officer concluded that our disclosure controls and procedures were effective at the reasonable
assurance level as of December 31, 2022.
Our
disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed in the reports
that we filed or submitted under the Exchange Act is recorded, processed, summarized and reported within time periods specified by the
SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure
that information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to our management,
including principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Management’s
Report on Internal Control over Financial Reporting:
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over
financial reporting is a process designed by, or under the supervision of, our principal executive officer and principal financial officer
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements
for external purposes in accordance with generally accepted accounting principles. Our control over financial reporting includes those
policies and procedures that (1) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions
and dispositions of our assets; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of
financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made
only in accordance with authorizations of our management and directors; and (3) provide reasonable assurance regarding prevention or
timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the consolidated
financial statements.
Because
of inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, any projections of
any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions,
or that the degree of compliance with policies and procedures may deteriorate.
71
Management
assessed the effectiveness of our internal control over financial reporting based on criteria established in “Internal Control—Integrated
Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this assessment,
management has concluded as of December 31, 2022, our internal control over financial reporting was effective, as management did not
identify any deficiencies in internal control over financial reporting that was determined to be a material weakness.
A
material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is
a reasonable possibility that a material misstatement of the annual or interim consolidated financial statements will not be prevented
or detected on a timely basis.
Changes
in Internal Control Over Financial Reporting:
There
was no change in our internal control over financial reporting identified in connection with the evaluation required by paragraph (d)
of Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) that occurred
during the quarter ended December 31, 2022 covered by this report that has materially affected or is reasonably likely to materially affect
our internal control over financial reporting.
Item
9B.
Other Information
None.
Item 9C.
Disclosure Regarding
Foreign Jurisdictions that Prevent Inspections
None
PART
III
Item 10.
Directors, Executive
Officers And Corporate Governance
All
directors hold office for one-year terms until the election and qualification of their successors. Officers are appointed by our board
of directors and serve at the discretion of the board, subject to applicable employment agreements. The following table sets forth information
regarding our executive officers and the members of our board of directors.
Name
Age
Position(s)
Eric Ende
54
Chairman of the Board, Director
Jerome D. Jabbour
48
Chief Executive Officer and President, Director
James J. Ferguson
69
Chief Medical Officer
Thomas J. Hoover
53
Chief Business Officer
Keith A. Kucinski
53
Chief Financial Officer
Hui Liu
55
Chief Technology Officer
Theresa Matkovits
55
Chief Development Officer
Herbert Conrad
90
Director
Kathryn Corzo
62
Director
Natasha Giordano
61
Director
James S. Scibetta
58
Director
Matthew Wikler
73
Director
Management
Jerome
D. Jabbour, JD was appointed Chief Executive Officer in March 2018. He has served as our President since March 2016. Prior to
that he served as our Executive Vice President, Chief Business Officer, General Counsel and Secretary since October 2013 and as one of
our directors from April 2012 until November 2013. Mr. Jabbour is also a Co-founder of Matinas BioPharma. Prior to joining our management
team, he was the Executive Vice President and General Counsel of MediMedia USA, or MediMedia, from 2012 to October 2013, a privately
held diversified healthcare services company. Prior to MediMedia, he was the Senior Vice President, Head of Global Legal Affairs of Wockhardt
Limited (2008-2012), a global pharmaceutical and biotechnology company, and Senior Counsel and Assistant Secretary at Reliant (2004-2008).
Earlier in his career, he held positions as Commercial Counsel at Alpharma, Inc. (2003-2004) and as a Corporate Associate at Lowenstein
Sandler LLP (1999-2003). Mr. Jabbour earned his J.D. from Seton Hall University School of Law in New Jersey and a B.A. in Psychology
from Loyola University in Baltimore.
72
James
J. Ferguson, MD was appointed Chief Medical Officer in February 2019. Prior to joining the Company, he served as the Cardiovascular
and Bone Therapeutic Area Head for U.S. Medical Affairs, at Amgen (NASDAQ: AMGN), multinational biopharmaceutical company, from 2016
to 2019. Prior to Amgen Dr. Ferguson held a number of senior positions at AstraZeneca, a multinational pharmaceutical and biopharmaceutical
company, including Vice President of U.S. Cardiovascular Medical and Scientific External Relations, Therapeutic Area Vice President of
Cardiovascular Global Medical Affairs, U.S. Development Brand Leader for BRILINTA ® , and Senior Director, Clinical Research.
Before joining AstraZeneca he was Vice President of Surgical and Critical Care for The Medicines Company. In addition, Dr. Ferguson had
more than 20 years of academic experience as the Associate Director of Clinical Cardiology Research at the Texas Heart Institute, Co-Director
of the Cardiology Fellowship Training Program at St. Luke’s Episcopal Hospital in Houston, where he was an Associate Professor
of Medicine at Baylor College of Medicine, and a Clinical Assistant Professor at the University of Texas Health Science Center at Houston.
Dr. Ferguson has served on the Editorial Board of numerous peer-reviewed journals and has over 400 publications and book chapters. Dr.
Ferguson received his B.A. (cum Laude) in Biology from Harvard University, his M.D. from the University of Pennsylvania School of Medicine
and completed his post-graduate training at the University of Michigan Medical Center, Ann Arbor, Michigan and Beth Israel Hospital,
Boston, Massachusetts.
Thomas
J. Hoover, MBA has served as Chief Business Officer since December 2021. Prior to joining the Company, Mr. Hoover was the Chief
Business Officer at Millendo Therapeutics, a public, clinical stage biotech, from 2016 to 2021. Prior to joining Millendo, Mr. Hoover
was Vice President of New Product Planning and Corporate Development and Licensing at Sunovion Pharmaceuticals Inc. Mr. Hoover started
his pharmaceutical career at GSK in 2001 working in the Global Commercial Strategy group. Earlier in his career, Mr Hoover worked for
The Boston Consulting Group. Mr. Hoover holds a M.B.A. from the University of North Carolina and a B.A. from Harvard College.
Keith
A. Kucinski, MBA, CPA was appointed Chief Financial Officer in January 2019. He most recently served as Chief Financial Officer
at RemedyOne, a privately held healthcare consulting organization, during 2018. Prior to that, he served as Vice President & Treasurer
at Par Pharmaceutical Companies, Inc., an operating company of Endo International plc, a leading generics and specialty-branded pharmaceutical
company, from 2009 to 2015. In addition, Mr. Kucinski held various roles at Barr Pharmaceuticals, Inc., including Senior Director, Finance
& Corporate Development and Assistant Treasurer & Senior Director, Finance. Mr. Kucinski is a Certified Public Accountant. He
received his Bachelor of Business Administration in Accounting from the University of Notre Dame and an M.B.A. in Finance & Management
from the Leonard N. Stern School of Business at New York University.
Hui
Liu, PhD, MBA has serves as Chief Technology Officer since December 2020. Prior to joining the Company, Dr. Liu was Director
of Formulation and Delivery at Seqirus USA Inc., a privately held global leader in influenza and pandemic response, from 2017 to 2020.
Prior to joining Seqirus, Dr. Liu was Director of CMC at Cellics Therapeutics, Inc., a privately held development stage biopharmaceutical
company, in 2017, and Senior Technical Lead at Alcon Inc. (SIX/NYSE: ALC), a global leader in eye care, from 2015 to 2017. Earlier in
his career, Dr. Liu held positions at Cellics Therapeutics, Inc., a privately held biotech company, and Allergan. Dr. Liu holds a Ph.D.
in polymer chemistry from the University of Michigan, an M.B.A. from the University of Massachusetts, Amherst, and a B.S. from The University
of Science and Technology of China.
Theresa
Matkovits, PhD has served as Chief Development officer since September 2018. She joined the Company after having most recently
served as the Chief Operating Officer of ContraVir Pharmaceuticals (NASDAQ: CTRV) (now Hepion Pharmaceuticals), a clinical stage biopharmaceutical
company, from 2015 to 2018. From 2013 to 2015, Dr. Matkovits served as Global Program Leader at NPS Pharmaceuticals, a specialty pharmaceutical
company that was purchased by Shire in 2015. Prior to her time at NPS, Dr. Matkovits was Vice President, Innovation Leader at The Medicines
Company. Earlier in her career, Dr. Matkovits held a number of global leadership positions at Novartis across Global Development and
the U.S. Commercial Organization, including as Head, Strategic Planning and Operations, U.S. Medical and Drug Regulatory Affairs. Dr.
Matkovits began her career at the Roche Institute of Molecular Biology and Organon where she held positions in clinical development in
women’s health and research in the area of infertility. Dr. Matkovits serves on the Board of Directors of Appili Therapeutics (TSX:
APLI; OTCQX: APLIF) . Dr. Matkovits earned her Ph.D. in Biochemistry and Molecular Biology from the University of Medicine and
Dentistry of NJ.
73
Directors
Eric
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
in October, 2022. Dr. Ende is president of Ende BioMedical Consulting Group, a privately-held consulting company which is focused on
helping life sciences companies raise capital, identify licensing partners, and optimize corporate structure as well as analyzing both
private and public investment opportunities for clients within the life sciences industry, a position he has held since 2009. In addition,
Dr. Ende consulted with Icahn Enterprises in their efforts to appoint board members at Forest Labs, Genzyme, Biogen IDEC, and Amylin.
Dr. Ende served on the board of directors and as a member of the Audit and Risk Management Committee of Genzyme Corp. (NASDAQ: GENZ)
from 2010 until it was acquired by Sanofi (NSYE: SNY) in 2011. Through another activist campaign, Dr. Ende served on the board of directors
of Progenics Pharmaceuticals, Inc., an oncology company, from 2019 until it was acquired by Lantheus Holdings, Inc. in 2020, as Chair
of the Compensation Committee and a member of the Audit and Science Committees. Dr. Ende also serves on the board of directors of Avadel
Pharmaceuticals plc, a biopharmaceutical company, as Chair of the Nomination & Corporate Governance Committee and a member of the
Audit and Compensation Committees. Dr. Ende is currently serving on the Technology Transfer Committee of Mount Sinai Innovation Partners
and served as the Chairman of the Unsecured Creditor’s Committee overseeing the bankruptcy of Egenix, Inc. From 2002 through 2008,
Dr. Ende was the senior biotechnology analyst at Merrill Lynch. From 2000 through 2002, Dr. Ende was the senior biotechnology analyst
at Banc of America Securities and, from 1997 to 2000, he was a biotechnology analyst at Lehman Brothers. Dr. Ende received an MBA in
Finance & Accounting from NYU – Stern Business School in 1997, an MD from Mount Sinai School of Medicine in 1994, and a BS
in Biology and Psychology from Emory University in 1990. We believe Dr. Ende is qualified to serve on our board of directors due to his
industry experience, including as president of Ende BioMedical Consulting Group and as a biotechnology analyst, and his prior public
company board experience.
Jerome
D. Jabbour. See description under “Management.”
Herbert
Conrad served as our Chairman of the Board from July 2013 until October 2022, and as Chairman of the Board of Matinas BioPharma,
Inc. from October 2012 until October 2022. He continues to serve as a member of our Board of Directors today. He also serves on the board
of directors of Celldex Therapeutics, Inc. (NASDAQ: CLDX), biopharmaceutical company focused on the development and commercialization
of immunotherapies and other targeted biologics, and as an Advisor to the Seaver Autism Center at Mount Sinai Hospital. Mr. Conrad was
the President of the U.S. Pharmaceuticals Division of Hoffmann-La Roche, Inc. from 1982 until his retirement in 1993. Prior to that,
he held many positions of increasing responsibility at Roche Pharmaceuticals in the United States. Mr. Conrad previously served on the
board of directors of Arbutus Biopharma Corporation (NASDAQ: ABUS), Pharmasset, Inc. (chairman), Savient Pharmaceuticals, Inc. (NASDAQ:
SVNT), Dura Pharmaceuticals, Inc., UroCor, Inc., GenVec, Inc. (NASDAQ: GNVC) (chairman), Sicor, Inc., Bone Care International, Inc. (chairman),
Sapphire Therapeutics, Inc. (chairman), the medical advisory board of Henry Schein Inc. (NASDAQ: HSIC), and he was a Director and Co-Founder
of Reliant Pharmaceuticals. Pharmasset was acquired by Gilead Sciences, Inc. for $11 billion in 2011 and Reliant was acquired by GlaxoSmithKline
for $1.65 billion in 2007. He received B.S. and M.S. degrees from the Brooklyn College of Pharmacy and an honorary Doctorate in Humane
Letters from Long Island University. We believe Mr. Conrad is qualified to serve on our board of directors due to his extensive expertise
and experience in the life sciences industry and his extensive board experience.
Kathryn
Corzo has served on our board of directors since September 2021 and is currently the Chief Operating Officer of bit.bio. Prior
to bit.bio, Ms. Corzo was a partner at Takeda Ventures, Inc., the corporate investment arm of Takeda Pharmaceutical Company Limited,
and previously Head, Oncology Cell Therapy Development at Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK), a global biopharmaceutical
company, a position she has held since 2020. Prior to joining Takeda, Ms. Corzo held positions of increasing responsibility at Sanofi
Genzyme, a specialty care global business unit of Sanofi, from 2010 to 2019. Prior to joining Sanofi, Ms. Corzo worked at Hoffman –
La Roche, Roche Molecular Systems, Eli Lilly and Syndax from 1989 to 2010, during which time she held roles of increasing seniority in
operations, global clinical development, medical affairs, business development, market access and brand management across multiple therapeutic
products and indications. We believe Ms. Corzo is qualified to serve on our Board of Directors due to her broad experience in the life
sciences industry.
74
Natasha
Giordano . Ms. Giordano has served as a member of our board of directors since September 2020. Ms. Giordano has been President,
Chief Executive Officer and director of PLx Pharma Inc. (NASDAQ: PLXP) since January 2016. Previously, Ms. Giordano served as Chief Executive
Officer of ClearPoint Learning, Inc., a privately held learning and training platform company, from May 2015 through November 2015. She
also served on the ClearPoint board of directors from December 2009 through November 2015. Previously, Ms. Giordano served as the Chief
Executive Officer of Healthcare Corporation of America (NYSE: HCA), a leading healthcare provider, from January 2014 through August 2014.
From June 2009 to August 2012, Ms. Giordano served as Chief Operating Officer and then as Chief Executive Officer, President and a member
of the board of directors of Xanodyne Pharmaceuticals, Inc., a privately-held a branded specialty pharmaceutical company with development
and commercial capabilities focused on pain management and women’s health. Prior to that, she served as President, Americas, for
Cegedim Dendrite (formerly Dendrite International Inc.), a global technology services company, from 2007 to 2008 and as Senior Vice President
of the Global Customer Business Unit of Cegedim Dendrite from 2004 to 2007. Ms. Giordano holds a Bachelor of Science degree in nursing
from Wagner College. We believe Ms. Giordano is qualified to serve as a director due to her extensive experience in commercialization,
general management and knowledge of the pharmaceutical and health care industries.
James
S. Scibetta has served as a member of our board of directors since November 2013. Mr. Scibetta is currently the Chief Executive
Officer of ImmuneID, Inc., a privately held company that leverages existing antibody
responses to rapidly unveil the complexities of the immune system, thereby revealing pathways leading to precise, transformative therapies.
Prior to ImmuneID, Mr. Scibetta was Chief Executive Officer of Maverick Therapeutics, a development stage immune-oncology company,
from 2017 until 2021 when it was acquired by Takeda Pharmaceutical Company Limited. Prior to Maverick, he was President and Chief Financial
Officer of Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX), a specialty pharmaceutical company, a position he has held since October 2015.
Prior to that, Mr. Scibetta was the Chief Financial Officer of Pacira since 2008. Prior to joining Pacira in August 2008, he served as
a consultant to Genzyme Corporation following the sale of Bioenvision Inc. (NASDAQ: BIVN) to Genzyme in 2007. From 2006 to 2007 Mr. Scibetta
was CFO of Bioenvision. From 2001 to 2006, he was Executive Vice President and Chief Financial Officer of Merrimack Pharmaceuticals Inc.
(NASDAQ: MACK). Mr. Scibetta has previously served on the board of directors at the following life sciences companies: Nephros Inc. (NASDAQ:
NEPH), Merrimack Pharmaceuticals and Labopharm Inc. Prior to his executive management experience, Mr. Scibetta spent over a decade in
investment banking where he was responsible for sourcing and executing transactions for a broad base of public and private healthcare
and life sciences companies. Mr. Scibetta received his Bachelor of Science in Physics from Wake Forest University and an MBA from the
University of Michigan. We believe Mr. Scibetta is qualified to serve on our board of directors because of his extensive management experience
in the pharmaceutical industry, his investment banking experience and his experience as a chief financial officer and audit committee
member of several publicly traded companies.
Matthew
A. Wikler has served as a member of our board of directors since January 2018. Dr. Wikler currently serves as the Principal of
Infectious Disease Technology Development Consulting (IDTD Consulting), a privately-held consulting firm, where he provides clinical,
medical and regulatory strategic insight to companies developing new technologies for the treatment and prevention of infectious diseases,
a position he has held since 2015. Prior to that from 2012 to 2015, Dr. Wikler served at The Medicines Company (NASDAQ: MDCO), a biopharmaceutical
company, as VP, New Business Ventures and VP and Medical Director, Infectious Disease Care. Over the course of his career Dr. Wikler
held senior leaderships positions for a number of pharmaceutical companies, including as Chief Development Officer of Rib-X Pharmaceuticals,
Inc., a privately-held biopharmaceutical company developing new antibiotics to provide expanded coverage, safety and convenience for
the treatment of serious and life-threatening infections, President and Chief Executive Officer of IASO Pharma Inc., a privately-held
clinical stage biotechnology company focused on the development of antibacterial and antifungal therapeutics, the Institute for One World
Health, a 501(c)(3) nonprofit drug development organization, Mpex Pharmaceuticals, Inc., a privately-held company focused on developing
and manufacturing therapies for antibiotic resistance with focus on gram-negative organisms, Peninsula Pharmaceuticals, Inc., a privately
held biopharmaceutical company focused on developing and commercializing antibiotics to treat life-threatening infections (acquired by
Johnson & Johnson (NYSE: JNJ)), ViroPharma Incorporated (NASDAQ: VPHM), Bristol-Myers Squibb Company (NYSE:BMY), and Ortho-McNeil
Pharmaceutical (a division of Johnson & Johnson). Dr. Wikler began his career at Smith Kline & French/Smith Kline Beecham where
he held positions of increasing responsibilities over ten years. Dr. Wikler held a variety of positions at the FDA, including the Deputy
Director of the Division of Anti-Infective Drug Products. Dr. Wikler earned a B.A. in Chemistry from Franklin and Marshall College, an
M.D. degree from Temple University School of Medicine, and his M.B.A. from the University of Pennsylvania Wharton School of Business.
He completed his Infectious Diseases Fellowship at the Hospital of the University of Pennsylvania and is a Fellow of the Infectious Diseases
Society of America. We believe Dr. Wikler is qualified to serve on our board of directors because of his extensive management experience
in the pharmaceutical industry and his clinical, drug development and regulatory experience.
75
There
are no family relationships among any of our directors or executive officers.
Scientific
Advisory Board
We
believe in seeking and attracting scientific and clinical leaders in the field of infectious diseases to provide counsel and support
our growth. We have established separate Scientific Advisory Boards for MAT2203 and MAT2501 which consist of individuals who are experts
in their chosen fields and recipients of many academic honors and awards.
Board
Committees
Our
board of directors has three standing committees — an Audit Committee, a Compensation Committee and a Nominating and Corporate
Governance Committee.
Audit
Committee . The Audit Committee oversees and monitors our financial reporting process and internal control system, reviews and
evaluates the audit performed by our registered independent public accountants and reports to the Board any substantive issues found
during the audit. The Audit Committee is directly responsible for the appointment, compensation and oversight of the work of our registered
independent public accountants. The Audit Committee reviews and approves all transactions with affiliated parties. James Scibetta, Herbert
Conrad and Natasha Giordano currently serve as members of the Audit Committee, with Mr. Scibetta serving as its chair. All members of
the Audit Committee have been determined to be financially literate and are considered independent directors as defined under the NYSE
MKT’s listing standards and applicable SEC rules and regulations. Mr. Scibetta qualifies as an audit committee “financial
expert” as that term is defined by SEC regulations. The Audit Committee met four times during 2022. Our Board has adopted an Audit
Committee Charter, which is available for viewing at www.matinasbiopharma.com .
Compensation
Committee . The Compensation Committee provides advice and makes recommendations to the Board in the areas of employee salaries,
benefit programs and director compensation. The Compensation Committee also reviews the compensation of our executive officers, including
our chief executive officer, and makes recommendations in that regard to the Board as a whole. Kathryn Corzo, James Scibetta and Matthew
Wikler currently serve as members of the Compensation Committee, with Mr. Scibetta serving as its chair. All members of the Compensation
Committee are considered independent directors as defined under the NYSE MKT’s listing standards. The Compensation Committee met
six times during 2022. Our Board has adopted a Compensation Committee Charter, which is available for viewing at www.matinasbiopharma.com .
Nominating
and Corporate Governance Committee . The Nominating and Corporate Governance Committee nominates individuals to be elected
to the full Board by our stockholders. The Nominating and Corporate Governance Committee considers recommendations from stockholders
if submitted in a timely manner in accordance with the procedures set forth in our Bylaws and applies the same criteria to all persons
being considered. Herbert Conrad, Kathryn Corzo, Eric Ende, and Natasha Giordano currently serve as members of the Nominating and Corporate
Governance Committee, with Ms. Giordano serving as its chair. All members of the Nominating and Corporate Governance Committee are considered
independent directors as defined under the NYSE MKT’s listing standards. The Nominating and Corporate Governance Committee met
four times during 2022. Our Board has adopted a Nominating and Corporate Governance Charter, which is available for viewing at www.matinasbiopharma.com .
76
Code
of Business Conduct and Ethics
We
have adopted a written code of business conduct and ethics that applies to our directors, officers, and employees, including our principal
executive officer, principal financial and accounting officer, or persons performing similar functions. A copy of the code is posted
on the corporate governance section of our website, which is located at www.matinasbiopharma.com. If we make any substantive amendments
to, or grant waivers from, the code of business conduct and ethics for any officer or director, we will disclose the nature of such amendment
or waiver on our website.
Item 11.
Executive Compensation
Summary
Compensation Table – 2022
The
following table presents information regarding the total compensation awarded to, earned by, or paid to our chief executive officer and
the two most highly compensated executive officers who were serving as executive officers as of December 31, 2022 for services rendered
in all capacities to us for the years ended December 31, 2022 and 2021. These individuals are our named executive officers for 2022.
Name and Principal Position
Year
Salary
($)
Bonus
($)
Option
Awards
($) (1)
All Other Compensation ($)
Total
($)
Jerome D. Jabbour
2022
575,000
306,500
792,707
-
1,674,207
Chief Executive Officer
2021
545,000
250,000
2,898,314
-
3,693,314
James J. Ferguson
2022
450,000
169,920
249,179
-
869,099
Chief Medical Officer
2021
422,300
164,000
1,035,637
-
1,621,937
Theresa Matkovits
2022
412,000
189,000
249,179
-
850,179
Chief Development Officer
2021
378,525
147,000
812,636
-
1,338,161
(1)
Amounts reflect the grant
date fair value of option awards granted in 2022 and 2021 in accordance with Accounting Standards Codification Topic 718. These
amounts do not correspond to the actual value that will be recognized by the named executive officers.
Narrative
Disclosure to Summary Compensation Table
Employment
Agreements with Our Named Executive Officers
Jabbour
On
March 22, 2018, we entered into an employment agreement with Mr. Jabbour, as subsequently amended on March 3, 2023. Under the terms of
Mr. Jabbour’s employment agreement, Mr. Jabbour received a signing bonus of $84,000 and a base salary of $350,000 per year. Mr.
Jabbour’s current salary is $598,000. In addition, Mr. Jabbour is eligible to receive an annual bonus, which is targeted at 50%
of his base salary but which may be adjusted by our Compensation Committee based on his individual performance and our performance as
a whole. Mr. Jabbour is also eligible to receive option grants at the discretion of our Compensation Committee. Mr. Jabbour is eligible
to receive option grants and equity grants at the discretion of our Compensation Committee. If we terminate Mr. Jabbour’s employment
without cause or Mr. Jabbour resigns with good reason (absent a change of control), we are required to pay him severance of up to twelve
months of his base salary plus COBRA benefits for twelve months, and his target annual bonus for the year pro rated to the date of termination.
In addition, the vesting of 50% of his outstanding options issued prior to December 31, 2021 will be accelerated in full upon such termination
and Mr. Jabbour will be provided with an extension through two years after the separation date of the exercise period for his vested
stock options. If we terminate Mr. Jabbour’s employment without cause during the 24-month period immediately following a change
of control or Mr. Jabbour resigns with good reason during the 24-month period immediately following a change of control, we are required
to pay him severance of 18 months of his base salary and 1.5 times his target annual bonus plus 18 months of COBRA benefits. In addition,
his outstanding options will be vested in full and Mr. Jabbour will be provided with an extension through two years after the separation
date of the exercise period for his vested stock options. Mr. Jabbour is also subject to a customary non-disclosure agreement, pursuant
to which Mr. Jabbour has agreed to be subject to a non-compete during the term of his employment and for a period of eighteen months
following termination of his employment.
77
Ferguson
On
February 22, 2019, we entered into an employment agreement with Mr. Ferguson which was effective as of February 25, 2019, as subsequently
amended on March 3, 2023. Under the terms of Mr. Ferguson’s employment agreement, Mr. Ferguson base salary was $375,000 per year,
and is currently $468,000. In addition, Mr. Ferguson is eligible to receive an annual bonus, which is targeted at 35% of his base salary
but which may be adjusted by our Compensation Committee based on his individual performance and our performance as a whole. Mr. Ferguson
is also eligible to receive option grants at the discretion of our Compensation Committee. If we terminate Mr. Ferguson’s employment
without cause or Mr. Ferguson resigns with good reason, we are required to pay him severance of up to twelve months of his base salary
plus benefits. In addition, the vesting of 50% of his outstanding options issued prior to December 31, 2021 will be accelerated in full
upon such termination. If we terminate Mr. Ferguson’s employment without cause during the 12-month period immediately following
a change of control or Mr. Jabbour resigns with good reason during the 12-month period immediately following a change of control, we
are required to pay him severance of 12 months of his base salary and his target annual bonus plus 12 months of COBRA benefits. In addition,
his outstanding options will be vested in full. Mr. Ferguson is also subject to a customary non-disclosure agreement, pursuant to which
Mr. Ferguson has agreed to be subject to a non-compete during the term of his employment and for a period of eighteen months following
termination of his employment.
Matkovits
On
September 25, 2018, we entered into an employment agreement with Ms. Matkovits which was effective as of October 15, 2018, as subsequently
amended on March 3, 2023. Under the terms of Ms. Matkovits’ employment agreement, Ms. Matkovits’s base salary was $350,000
per year, and is currently $430,000. In addition, Ms. Matkovits is eligible to receive an annual bonus, which is targeted at 35% of her
base salary but which may be adjusted by our Compensation Committee based on her individual performance and our performance as a whole.
Ms. Matkovits is also eligible to receive option grants at the discretion of our Compensation Committee. If we terminate Ms. Matkovits’
employment without cause or Ms. Matkovits resigns with good reason, we are required to pay her severance of up to twelve months of his
base salary plus benefits. In addition, the vesting of 50% of her outstanding options issued prior to December 31, 2021 will be accelerated
in full upon such termination. If we terminate Ms. Matkovits’s employment without cause during the 12-month period immediately
following a change of control or Matkovits resigns with good reason during the 12-month period immediately following a change of control,
we are required to pay her severance of 12 months of her base salary and her target annual bonus plus 12 months of COBRA benefits. In
addition, her outstanding options will be vested in full. Ms. Matkovits is also subject to a customary non-disclosure agreement, pursuant
to which Ms. Matkovits has agreed to be subject to a non-compete during the term of her employment and for a period of eighteen months
following termination of her employment.
78
Outstanding
Equity Awards at Fiscal Year-End Table – 2022
The
following table summarizes, for each of the named executive officers, the number of shares of common stock underlying outstanding stock
options held as of December 31, 2022.
Option Awards
Name
Number of
securities
underlying
unexercised
options (#)
exercisable
Number of
securities
underlying
unexercised
options (#)
unexercisable
Option
exercise
price ($)
Option
expiration
date
Jerome D. Jabbour
-
1,988,300
$ 0.53
Dec 19, 2032
449,014
1,209,086
$ 0.92
Dec 13, 2031
766,667
833,333
$ 1.36
Dec 31, 2030
729,167
270,833
$ 2.27
Dec 31, 2029
718,750
31,250
$ 1.08
Feb 10, 2029
1,000,000
-
$ 0.98
Mar 21, 2028
400,000
-
$ 3.32
Feb 20, 2027
350,000
-
$ 0.43
Feb 4, 2026
175,000
-
$ 0.41
Jan 27, 2025
350,000
-
$ 1.28
July 20, 2024
350,000
-
$ 0.94
Oct 3, 2023
James J. Ferguson
-
625,000
$ 0.53
Dec 19, 2032
159,123
428,477
$ 0.92
Dec 13, 2031
275,521
299,479
$ 1.36
Dec 31, 2030
364,584
135,416
$ 2.27
Dec 31, 2029
335,417
14,583
$ 1.09
Feb 24, 2029
Theresa Matkovits
-
625,000
$ 0.53
Dec 19, 2031
135,400
364,600
$ 0.92
Dec 13, 2031
203,646
221,354
$ 1.36
Dec 31, 2030
255,209
94,791
$ 2.27
Dec 31, 2029
335,417
14,583
$ 1.08
Feb 10, 2029
350,000
-
$ 0.79
Oct 14, 2028
2013
Equity Compensation Plan
General
On
August 2, 2013, our Board of Directors adopted the 2013 Equity Compensation Plan pursuant to the terms described herein. The 2013 Equity
Compensation Plan was approved by the stockholders on August 7, 2013. Effective May 8, 2014, upon the approval of our Board of Directors
and our stockholders, we amended and restated our 2013 Equity Compensation Plan, primarily to include “evergreen” provisions,
which provides that the number of shares of common stock available for issuance under the Plan is subject to an automatic annual increase
on January 1 of each year beginning in 2015 equal to 4% of the number of shares of common stock outstanding on December 31 of the preceding
calendar year or a lesser number of shares of common stock determined by the Board of Directors; to amend the definition of “fair
market value”; and to increase the limits on awards under the Plan. The 2013 Equity Compensation Plan, as amended and restated,
is referred to herein as the “2013 Plan.”
The
general purpose of the 2013 Plan is to provide an incentive to our employees, directors, consultants and advisors by enabling them to
share in the future growth of our business. Our Board of Directors believes that the granting of stock options, restricted stock awards,
unrestricted stock awards and similar kinds of equity-based compensation promotes continuity of management and increases incentive and
personal interest in the welfare of our Company by those who are primarily responsible for shaping and carrying out our long range plans
and securing our growth and financial success.
79
Our
Board of Directors believes that the 2013 Plan will advance our interests by enhancing our ability to (a) attract and retain employees,
consultants, directors and advisors who are in a position to make significant contributions to our success; (b) reward our employees,
consultants, directors and advisors for these contributions; and (c) encourage employees, consultants, directors and advisors to take
into account our long-term interests through ownership of our shares.
Description
of the 2013 Equity Compensation Plan
The
following description of the principal terms of the 2013 Plan is a summary and is qualified in its entirety by the full text of the 2013
Plan, which is attached as Exhibit 10.1 hereto.
Administration .
The 2013 Plan will be administered by the Compensation Committee of our Board of Directors, provided that the entire Board of Directors
may act in lieu of the Compensation Committee on any matter, subject to certain requirements set forth in the 2013 Plan. The Compensation
Committee may grant options to purchase shares of our common stock, stock appreciation rights, stock units, restricted shares of our
common stock, performance shares, performance units, incentive bonus awards, other cash-based awards and other stock-based awards. The
Compensation Committee also has broad authority to determine the terms and conditions of each option or other kind of award, and adopt,
amend and rescind rules and regulations for the administration of the 2013 Plan. Subject to applicable law, the Compensation Committee
may authorize one or more reporting persons (as defined in the 2013 Plan) or other officers to make awards (other than awards to reporting
persons, or other officers whom the Compensation Committee has specifically authorized to make awards). No awards may be granted under
the 2013 Plan on or after the ten year anniversary of the adoption of the 2013 Plan by our Board of Directors, but awards granted prior
to such tenth anniversary may extend beyond that date.
Eligibility .
Awards may be granted under the 2013 Plan to any person who is an employee, officer, director, consultant, advisor or other individual
service provider of the Company or any subsidiary, or any person who is determined by the Compensation Committee to be a prospective
employee, officer, director, consultant, advisor or other individual service provider of the Company or any subsidiary.
Shares
Subject to the 2013 Plan . As of March 3, 2023 the aggregate number of shares of common stock available for issuance in connection
with awards granted under the 2013 Plan is 54,293,819 shares, subject to customary adjustments for stock splits, stock dividends or similar
transactions (the “Initial Limit”). Incentive Stock Options may be granted under the 2013 Plan with respect to all of those
shares. The number of shares of common stock available for issuance under the 2013 Plan will automatically increase on January 1st of
each year for a period of ten years, commencing on January 1, 2015, in an amount equal to four percent (4%) of the total number of shares
of common stock outstanding on December 31st of the preceding calendar year (the “Annual Increase”). Notwithstanding the
foregoing, the Board of Directors may act prior to the first day of any calendar year, to provide that there shall be no increase in
the share reserve for such calendar year or that the Annual Increase in the share reserve for such calendar year shall be a lesser number
of shares of common stock than would otherwise occur pursuant to the preceding sentence. The number of shares of common stock which may
be issued in respect of Incentive Stock Options is equal to the Current Limit, and will be increased on each January 1, by the Annual
Increase for such calendar year.
To
the extent that any award under the 2013 Plan payable in shares of common stock is forfeited, cancelled, returned to the Company for
failure to satisfy vesting requirements or upon the occurrence of other forfeiture events, or otherwise terminates without payment being
made thereunder, the shares of common stock covered thereby will be available for future grants under the 2013 Plan. Shares of common
stock that otherwise would have been issued upon the exercise of a stock option or in payment with respect to any other form of award,
that are surrendered in payment or partial payment of taxes required to be withheld with respect to the exercise of such stock option
or the making of such payment, will also be available for future grants under the 2013 Plan.
Terms
and Conditions of Options . Options granted under the 2013 Plan may be either “incentive stock options” that are intended
to meet the requirements of Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”) or “nonqualified
stock options” that do not meet the requirements of Section 422 of the Code. The Compensation Committee will determine the exercise
price of options granted under the 2013 Plan. The exercise price of stock options may not be less than the fair market value, on the
date of grant, per share of our common stock issuable upon exercise of the option (or 110% of fair market value in the case of incentive
options granted to a ten-percent stockholder).
80
If
on the date of grant the common stock is listed on a stock exchange or national market system, the fair market value shall generally
be the closing sale price as of such date, or if there were no trades recorded on such date, then the most recent date preceding such
date on which trades were recorded. If on the date of grant the common stock is traded in an over-the-counter market, the fair market
will generally be the average of the closing bid and asked prices for the shares of common stock as of such date, or, if there are no
closing bid and asked prices for the shares of common stock on such date, then the average of the bid and asked prices for the shares
of common stock on the most recent date preceding such date on which such closing bid and asked prices are available. If the common stock
is not listed on a national securities exchange or national market system or traded in an over-the-counter market, the fair market value
shall be determined by the Compensation Committee in a manner consistent with Section 409A of the Internal Revenue Code of 1986, as amended.
Notwithstanding the foregoing, if on the date of grant the common stock is listed on a stock exchange or is quoted on a national market
system, or is traded in an over-the-counter market, then solely for purposes of determining the exercise price of any grant of a stock
option or the base price of any grant of a stock appreciation right, the Compensation Committee may, in its discretion, base fair market
value on the last sale before or the first sale after the grant, the closing price on the trading day before or the trading day of the
grant, the arithmetic mean of the high and low prices on the trading day before or the trading day of the grant, or any other reasonable
method using actual transactions of the common stock as reported by the exchange or market on which the common stock is traded. In addition,
the determination of fair market value also may be made using any other method permitted under Treasury Regulation section 1.409A-1(b)(5)(iv).
No
option may be exercisable for more than ten years from the date of grant (five years in the case of an incentive stock option granted
to a ten-percent stockholder). Options granted under the 2013 Plan will be exercisable at such time or times as the Compensation Committee
prescribes at the time of grant. No employee may receive incentive stock options that first become exercisable in any calendar year in
an amount exceeding $100,000. The Compensation Committee may, in its discretion, permit a holder of a nonqualified stock option to exercise
the option before it has otherwise become exercisable, in which case the shares of our common stock issued to the recipient will continue
to be subject to the vesting requirements that applied to the option before exercise.
Generally,
the option price may be paid in cash or by bank check, or such other means as the Compensation Committee may accept. As set forth in
an award agreement or otherwise determined by the Compensation Committee, in its sole discretion, at or after grant, payment in full
or part of the exercise price of an option may be made (a) in the form of shares of common stock that have been held by the participant
for such period as the Compensation Committee may deem appropriate for accounting purposes or otherwise, valued at the fair market value
of such shares on the date of exercise; (ii) by surrendering to the Company shares of common stock otherwise receivable on exercise of
the option; (iii) by a cashless exercise program implemented by the Compensation Committee in connection with the 2013 Plan; and/or (iv)
by such other method as may be approved by the Compensation Committee and set forth in an award agreement.
No
option may be transferred other than by will or by the laws of descent and distribution, and during a recipient’s lifetime an option
may be exercised only by the recipient or the recipient’s guardian or legal representative. However, the Compensation Committee
may permit the transfer of a nonqualified stock option, share-settled stock appreciation right, restricted stock award, performance share
or share-settled other stock-based award either (a) by instrument to the participant’s immediate family (as defined in the 2013
Plan), (b) by instrument to an inter vivos or testamentary trust (or other entity) in which the award is to be passed to the participant’s
designated beneficiaries, or (c) by gift to charitable institutions. The Compensation Committee will determine the extent to which a
holder of a stock option may exercise the option following termination of service.
Stock
Appreciation Rights . The Compensation Committee may grant stock appreciation rights independent of or in connection with an option.
The Compensation Committee will determine the terms applicable to stock appreciation rights. The base price of a stock appreciation right
will be determined by the Compensation Committee, but will not be less than 100% of the fair market value of a share of our common stock
with respect to the date of grant of such stock appreciation right. The maximum term of any SAR granted under the 2013 Plan is ten years
from the date of grant. Generally, each SAR stock appreciation right will entitle a participant upon exercise to an amount equal to:
●
the
excess of the fair market value of a share of common stock on the date of exercise of the stock appreciation right over the base
price of such stock appreciation right, multiplied by
●
the
number of shares as to which such stock appreciation right is exercised.
81
Payment
may be made in shares of our common stock, in cash, or partly in common stock and partly in cash, all as determined by the Compensation
Committee.
Restricted
Stock and Stock Units . The Compensation Committee may award restricted common stock and/or stock units under the 2013
Plan. Restricted stock awards consist of shares of stock that are transferred to a participant subject to restrictions that may result
in forfeiture if specified conditions are not satisfied. Stock units confer the right to receive shares of our common stock, cash, or
a combination of shares and cash, at a future date upon or following the attainment of certain conditions specified by the Compensation
Committee. The Compensation Committee will determine the restrictions and conditions applicable to each award of restricted stock or
stock units, which may include performance-based conditions. Dividends with respect to restricted stock may be paid to the holder of
the shares as and when dividends are paid to stockholders or at the times of vesting or other payment of the restricted stock award.
Stock unit awards may be granted with dividend equivalent rights, which may be accumulated and may be deemed reinvested in additional
stock units, as determined by the Compensation Committee in its discretion. If any dividend equivalents are paid while a stock unit award
is subject to restrictions, the dividend equivalents shall be subject to the same restrictions on transferability as the underlying stock
units, unless otherwise set forth in an award agreement. Unless the Compensation Committee determines otherwise, holders of restricted
stock will have the right to vote the shares.
Performance
Shares and Performance Units . The Compensation Committee may award performance shares and/or performance units under the
2013 Plan. Performance shares and performance units are awards which are earned during a specified performance period subject to the
attainment of performance criteria, as established by the Compensation Committee. The Compensation Committee will determine the restrictions
and conditions applicable to each award of performance shares and performance units.
Incentive
Bonus Awards . The Compensation Committee may award Incentive Bonus Awards under the 2013 Plan. Incentive Bonus Awards may be
based upon the attainment of specified levels of Company or subsidiary performance as measured by pre-established, objective performance
criteria determined at the discretion of the Compensation Committee. Incentive Bonus Awards will be paid in cash or common stock, as
set forth in an award agreement.
Other
Stock-Based and Cash-Based Awards . The Compensation Committee may award other types of equity-based or cash-based awards
under the 2013 Plan, including the grant or offer for sale of unrestricted shares of our common stock and payment in cash or otherwise
of amounts based on the value of shares of common stock.
Effect
of Certain Corporate Transactions . The Compensation Committee may, at the time of the grant of an award, provide for the effect
of a change in control (as defined in the 2013 Plan) on any award, including (i) accelerating or extending the time periods for exercising,
vesting in, or realizing gain from any award, (ii) eliminating or modifying the performance or other conditions of an award, (iii) providing
for the cash settlement of an award for an equivalent cash value, as determined by the Compensation Committee, or (iv) such other modification
or adjustment to an award as the Compensation Committee deems appropriate to maintain and protect the rights and interests of participants
upon or following a change in control. The Compensation Committee may, in its discretion and without the need for the consent of any
recipient of an award, also take one or more of the following actions contingent upon the occurrence of a change in control: (a) cause
any or all outstanding options and stock appreciation rights to become immediately exercisable, in whole or in part; (b) cause any other
awards to become non-forfeitable, in whole or in part; (c) cancel any option or stock appreciation right in exchange for a substitute
option; (d) cancel any award of restricted stock, stock units, performance shares or performance units in exchange for a similar award
of the capital stock of any successor corporation; (e) redeem any restricted stock, stock unit, performance share or performance unit
for cash and/or other substitute consideration with a value equal to the fair market value of an unrestricted share of our common stock
on the date of the change in control; (f) cancel any option or stock appreciation right in exchange for cash and/or other substitute
consideration based on the value of our common stock on the date of the change in control , and cancel any option or stock appreciation
right without any payment if its exercise price exceeds the value of our common stock on the date of the change in control; (g) cancel
any stock unit or performance unit held by a participant affected by the change in control in exchange for cash and/or other substitute
consideration with a value equal to the fair market value per share of common stock on the date of the change in control, or (h) make
such other modifications, adjustments or amendments to outstanding awards as the Compensation Committee deems necessary or appropriate.
82
Amendment,
Termination . The Compensation Committee may amend the terms of awards in any manner not inconsistent with the 2013 Plan, provided
that no amendment shall adversely affect the rights of a participant with respect to an outstanding award without the participant’s
consent. In addition, our board of directors may at any time amend, suspend, or terminate the 2013 Plan, provided that (i) no such amendment,
suspension or termination shall materially and adversely affect the rights of any participant under any outstanding award without the
consent of such participant and (ii) to the extent necessary and desirable to comply with any applicable law, regulation, or stock exchange
rule, the 2013 Plan requires us to obtain stockholder consent. Stockholder approval is required for any plan amendment that increases
the number of shares of common stock available for issuance under the 2013 Plan or changes the persons or classes of persons eligible
to receive awards.
Tax
Withholding
The
Company has the power and right to deduct or withhold, or require a participant to remit to the Company, the minimum statutory amount
to satisfy federal, state, and local taxes, domestic or foreign, required by law or regulations to be withheld.
Director
Compensation
We
maintain a policy pursuant to which our non-employee directors receive annualized compensation. The policy provides for the following
compensation amounts payable in cash, or upon election by such non-employee director, in shares of unrestricted common stock: (i) each
non-employee director is entitled to receive an annual fee of $50,000; (ii) the chairman of the board is entitled to receive an additional
annual fee of $25,000; (iii) the vice chair, if one is appointed, is entitled to receive an additional annual fee of $20,000; (iv) the
chair of our audit committee is entitled to receive an annual fee of $15,000 and other members of our audit committee are entitled to
receive $7,500; (v) the chair of our compensation committee is entitled to receive an annual fee of $10,000 and other members of our
compensation committee are entitled to receive $6,000; and (vi) the chair of our nominating and corporate governance committee is entitled
to receive an annual fee of $8,000 and other members are entitled to receive $4,000.
As
of the date of each annual meeting of the shareholders, each non-employee director will receive an option grant to purchase shares of
our common stock valued at $80,000 as determined by the Black Scholes method on the date of grant under our existing equity incentive
plan, or any other equity incentive plan we may adopt in the future, which shall vest in twelve equal monthly installments.
All
fees under the director compensation policy are paid on a quarterly basis in arrears and no per meeting fees are paid. All fees may be
paid in unrestricted shares of common stock at the election of the director. We also reimburse non-employee directors for reasonable
expenses incurred in connection with attending board of director and committee meetings.
Director
Compensation Table – 2022
The
following table summarizes the annual compensation for our non-employee directors during 2022.
Name
Cash Compensation
($)
Option
Awards
($) (1)
Total
($)
Herbert Conrad
90,500
80,000
170,500
Kathryn Corzo
56,000
80,000
136,000
Eric Ende
71,500
80,000
151,500
Natasha Giordano
57,500
80,000
137,500
James S. Scibetta
75,000
80,000
155,000
Matthew Wikler
64,000
80,000
144,000
(1)
Amounts
reflect the grant date fair value of stock awards and option awards granted in 2022 in accordance with Accounting Standards Codification
Topic 718. These amounts do not correspond to the actual value that will be recognized by the directors.
83
Compensation
Committee Interlocks and Insider Participation
The
Compensation Committee of the Board of Directors is currently composed of the following three non-employee directors: Kathryn Corzo,
James Scibetta, Chair, and Matthew Wikler. No member of the Compensation Committee is or was formerly an officer or an employee of the
Company during the last fiscal year. In addition, no executive officer of the Company serves on the compensation committee or board of
directors of a company for which any of the Company’s directors serve as an executive officer. See Item 13.
Item
12.
Security
Ownership Of Certain Beneficial Owners And Management And Related Stockholder Matters.
The
following table sets forth the number of shares of common stock beneficially owned as of March 3, 2023 by:
●
each
of our stockholders who is known by us to beneficially own 5% or more of our common stock;
●
each
of our executive officers;
●
each
of our directors; and
●
all
of our directors and current executive officers as a group.
Beneficial
ownership is determined based on the rules and regulations of the SEC. A person has beneficial ownership of shares if such individual
has the power to vote and/or dispose of shares. This power may be sole or shared and direct or indirect. Applicable percentage ownership
in the following table is based on 217,264,526 shares outstanding as of March 3, 2023. In computing the number of shares beneficially
owned by a person and the percentage ownership of that person, shares of common stock that are subject to options or warrants held by
that person and exercisable as of, or within 60 days of, March 3, 2023 are counted as outstanding. These shares, however, are not counted
as outstanding for the purposes of computing the percentage ownership of any other person(s). Except as may be indicated in the footnotes
to this table and pursuant to applicable community property laws, each person named in the table has sole voting and dispositive power
with respect to the shares of common stock set forth opposite that person’s name. Unless indicated below, the address of each individual
listed below is c/o Matinas BioPharma Holdings, Inc., 1545 Route 206 South, Suite 302, Bedminster, NJ 07921.
Name of Beneficial Owner
Number of Shares Beneficially Owned
Percentage of Shares Beneficially Owned
Directors and Executive Officers
Jerome D. Jabbour (1)
5,743,337
2.6 %
Herbert Conrad (2)
6,006,589
2.7 %
Kathryn Corzo (3)
162,211
* %
Eric Ende (4)
1,192,782
* %
Natasha Giordano (5)
418,138
* %
James Scibetta (6)
1,761,148
* %
Matthew Wikler (7)
1,189,162
* %
James J. Ferguson (8)
1,393,500
* %
Thomas J. Hoover (9)
301,042
* %
Keith A. Kucinski (10)
1,438,230
* %
Hui Liu (11)
454,681
* %
Theresa Matkovits (12)
1,474,980
* %
Directors and Executive Officers as a group (12 persons) (13)
21,535,800
9.3 %
*
Less than 1%
(1)
Includes 5,283,013 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
Does not include 3,725,887 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
84
(2)
Includes 1,312,023 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
Does not include 71,328 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
(3)
Includes 162,211 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023. Does
not include 162,209 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
(4)
Includes 1,048,690 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
Does not include 71,328 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
(5)
Includes 418,138 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023. Does
not include 103,318 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
(6)
Includes 1,111,190 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
Does not include 71,328 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
(7)
Includes 898,690 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023. Does
not include 71,328 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
(8)
Includes 1,393,500 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
Does not include 1,244,100 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
(9)
Includes 301,042 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023. Does
not include 1,023,958 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
(10)
Includes 1,343,730 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
Does not include 1,156,270 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
(11)
Includes 454,681 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023. Does
not include 1,045,319 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
(12)
Includes 1,474,980 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 3, 2023.
Does not include 1,125,020 shares of common stock underlying options that are not exercisable within sixty days of March 3, 2023.
(13)
See notes (1) through (12).
85
Securities
Authorized for Issuance under Equity Compensation Plans
The
following table summarizes information about our equity compensation plans as of December 31, 2022.
Plan Category
Number of Shares
of Common Stock to be Issued upon
Exercise of Outstanding Options
(a)
Weighted-Average
Exercise Price of
Outstanding Options
(b)
Number of Options
Remaining Available for Future Issuance Under Equity Compensation Plans (excluding securities reflected in column (a))
(c)(2)
Equity compensation plans approved by stockholders(1)
34,739,470
$ 1.07
6,183,053
Equity compensation plans not approved by stockholders
—
—
—
Total
34,739,470
$ 1.07
6,183,053
(1)
The
amounts shown in this row include securities under the Matinas BioPharma Holdings, Inc. Amended and Restated 2013 Equity Incentive
Plan (the “2013 Plan”).
(2)
In
accordance with the “evergreen” provision in our 2013 Plan, an additional 8,690,581 shares were automatically made available
for issuance on the first trading day of 2023, which represents 4% of the number of shares outstanding on December 31, 2022; these
shares are excluded from this calculation.
Item
13.
Certain
Relationships, Related Transactions, And Director Independence
Certain
Relationships and Related Party Transactions
Other
than compensation arrangements for our named executive officers and directors, there has been no transaction or series of similar transactions,
since January 1, 2022, to which we were a party or will be a party, in which:
●
the
amounts involved exceeded or will exceed the lesser of (i) $120,000 and (ii) one percent of the average of our total assets at year-end
for the last two completed fiscal years; and
●
any
of our directors, executive officers or holders of more than 5% of our capital stock, or any member of the immediate family of the
foregoing persons, had or will have a direct or indirect material interest.
Indemnification
Agreements
We
entered into indemnification agreements with our directors and executive officers. The indemnification agreements provide for indemnification
against expenses, judgments, fines and penalties actually and reasonably incurred by an indemnitee in connection with threatened, pending
or completed actions, suits or other proceedings, subject to certain limitations. The indemnification agreements also provide for the
advancement of expenses in connection with a proceeding prior to a final, non-appealable judgment or other adjudication, provided that
the indemnitee provides an undertaking to repay to us any amounts advanced if the indemnitee is ultimately found not to be entitled to
indemnification by us. The indemnification agreement set forth procedures for making and responding to a request for indemnification
or advancement of expenses, as well as dispute resolution procedures that apply to any dispute between us and an indemnitee arising under
the Indemnification Agreements.
86
Policies
and Procedures for Related Party Transactions
We
have adopted a policy that our executive officers, directors, nominees for election as a director, beneficial owners of more than 5%
of any class of our common stock, any members of the immediate family of any of the foregoing persons and any firms, corporations or
other entities in which any of the foregoing persons is employed or is a partner or principal or in a similar position or in which such
person has a 5% or greater beneficial ownership interest, which we refer to collectively as related parties, are not permitted to enter
into a transaction with us without the prior consent of our board of directors acting through the audit committee or, in certain circumstances,
the chairman of the audit committee. Any request for us to enter into a transaction with a related party, in which the amount involved
exceeds $100,000 and such related party would have a direct or indirect interest must first be presented to our audit committee, or in
certain circumstances the chairman of our audit committee, for review, consideration and approval. In approving or rejecting any such
proposal, our audit committee, or the chairman of our audit committee, is to consider the material facts of the transaction, including,
but not limited to, whether the transaction is on terms no less favorable than terms generally available to an unaffiliated third party
under the same or similar circumstances, the extent of the benefits to us, the availability of other sources of comparable products or
services and the extent of the related party’s interest in the transaction.
Director
Independence
Based
on information requested from and provided by each of our directors, our board of directors has determined that Messrs. Herbert Conrad,
Eric Ende, James Scibetta, Matthew Wikler and Mses. Kathryn Corzo and Natasha Giordano are “independent directors” as such
term is defined in the rules of the NYSE MKT’s corporate governance requirements and Rule 10A-3 promulgated under the Securities
Exchange Act of 1934, as amended.
Item
14.
Principal
Accounting Fees And Services
The
following table represents aggregate fees billed to the Company for the fiscal years ended December 31, 2022 and 2021, by EisnerAmper
LLP, the Company’s independent registered public accounting firm.
Years Ended December 31,
2022
2021
Audit Fees
$ 265
$ 249
Audit-Related Fees
-
-
Tax Fees
-
-
Total Fees
$ 265
$ 249
Audit
Fees consist of fees billed for professional services rendered for the audit of our annual financial statements, audit of internal
controls over financial reporting, review of our interim consolidated financial statements, comfort and consent letters.
Audit-Related
Fees consist of fees billed for professional services rendered for assurance related services that are reasonably related to the
performance of the audit or review of our financial services.
Tax
Fees are for tax-related services related primarily to tax consulting and tax planning.
The
Audit Committee pre-approves all auditing services and any non-audit services that the independent registered public accounting firm
is permitted to render under Section 10A (h) of the Exchange Act. The Audit Committee may delegate the pre-approval to one of its members,
provided that if such delegation is made, the full Audit Committee must be presented at its next regularly scheduled meeting with any
pre-approval decision made by that member.
87
Part
IV
Item
15.
Exhibits
And Financial Statement Schedules
Exhibit
No.
Description
2.1
Merger Agreement, dated July 11, 2013, by and among the Company, Matinas Merger Sub, Inc., and Matinas BioPharma, Inc. (incorporated by reference to Exhibit 2.1 to Amendment No. 1 to the Company’s Registration Statement on Form S-1 filed with the SEC on February 7, 2014).
2.2
Agreement and Plan of Merger (the “Merger Agreement”) with Aquarius Biotechnologies, Inc., a Delaware corporation (“Aquarius”), Saffron Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of the Company (“Merger Sub”) and J. Carl Craft, as the stockholder representative (incorporated herein by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed with the SEC on January 30, 2015).
3.1
Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to Amendment No. 1 to the Company’s Registration Statement on Form S-1 filed with the SEC on February 7, 2014).
3.2
Bylaws (incorporated by reference to Exhibit 3.2 to Amendment No. 1 to the Company’s Registration Statement on Form S-1 filed with the SEC on February 7, 2014).
3.3
Certificate of Amendment, dated October 29, 2015 to Certificate of Incorporation. (incorporated herein by reference to the Company’s Current Report on Form 8-K filed with the SEC on November 5, 2015).
4.1
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).
4.2
Form of Warrant (incorporated by reference to Exhibit 4.1 to Amendment No. 1 to the Company’s Registration Statement on Form S-1 filed with the SEC on February 7, 2014).
4.3
Form of 2015 Investor Warrant. (incorporated by reference to Exhibit 4.4 to the post-effective amendment No. 1 to Form S-1 filed with the SEC on April 17, 2015).
4.4
Form of 2015 Placement Agent Warrant. (incorporated by reference to Exhibit 4.5 to the post-effective amendment No. 1 to Form S-1 filed with the SEC on April 17, 2015).
4.6
Description of Securities*
10.1
Matinas BioPharma Holdings, Inc. Amended and Restated 2013 Equity Compensation Plan (incorporated herein by reference to Exhibit 10.6 to the Company’s Annual Report on Form 10-K filed on March 31, 2015.) †
10.2
Form of Incentive Stock Option Agreement (incorporated by reference to Exhibit 10.7 to Amendment No. 1 to the Company’s Registration Statement on Form S-1 filed with the SEC on February 7, 2014). †
10.3
Form of Non-Qualified Stock Option Agreement (incorporated by reference to Exhibit 10.8 to Amendment No. 1 to the Company’s Registration Statement on Form S-1 filed with the SEC on February 7, 2014). †
10.4
Form of Indemnification Agreement (incorporated by reference to Exhibit 10.14 to Amendment No. 1 to the Company’s Registration Statement on Form S-1 filed with the SEC on February 7, 2014). †
10.5
Lease, effective as of November 4, 2013, by and between the company and A-K Bedminster Associates, L.P. (incorporated by reference to Exhibit 10.17 to Amendment No. 1 to the Company’s Registration Statement on Form S-1 filed with the SEC on February 7, 2014).
10.6
Amended and Restated Exclusive License Agreement dated as of January 29, 2015, by and between Rutgers, the State University of New Jersey and Aquarius Biotechnologies, Inc. (incorporated herein by reference to Exhibit 10.18 to the Company’s Annual Report on Form 10-K filed on March 31, 2015). +
10.7
Employment Agreement, dated September 1, 2015, between Matinas Biopharma Holdings, Inc. and Raphael J. Mannino. (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). †
10.8
Lease Agreement, dated as of December 15, 2016, by and between CIP II/AR Bridgewater Holdings LLC, and Matinas BioPharma Holdings, Inc. (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on April 28, 2017).
10.9
Employment Agreement, dated March 22, 2018, between the Company and Jerome D. Jabbour (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on March 27, 2018). †
10.10
Employment Agreement, dated October 15, 2018, between Matinas Biopharma Holdings, Inc. and Theresa Matkovits (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on October 15, 2018). †
10.11
Employment Agreement, dated January 3, 2019, between Matinas Biopharma Holdings, Inc. and Keith Kucinski (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on January 3, 2019). †
10.12
Employment Agreement, dated February 25, 2019, between Matinas Biopharma Holdings, Inc. and James J. Ferguson III (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on February 25, 2019). †
88
10.13
At-The-Market Sales Agreement, dated July 2, 2020, between Matinas BioPharma Holdings, Inc. and BTIG, LLC (incorporated herein by reference to Exhibit 1.01 to the Company’s Current Report on Form 8-K filed with the SEC on July 2, 2020).
10.14
Therapeutic Development Award Agreement, dated November 19, 2020, between Matinas BioPharma Holdings, Inc. and the Cystic Fibrosis Foundation (incorporated by reference to Exhibit 10.1 to the Company’s Annual Report on Form 10-K filed on March 29, 2021).
10.15
Employment Agreement, dated December 1, 2020, between Matinas Biopharma Holdings, Inc. and Hui Liu. (incorporated by reference to Exhibit 10.16 to the Company’s Annual Report on Form 10-K filed on March 8, 2022)†*
10.16
Employment Agreement, dated December 6, 2021, between Matinas Biopharma Holdings, Inc. and Thomas Hoover. (incorporated by reference to Exhibit 10.16 to the Company’s Annual Report on Form 10-K filed on March 8, 2022)†*
Consulting Agreement, dated August 8, 2022, by and between the Company and Raphael J. Mannino (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly report on Form 10-Q, filed on November 2, 2022).
10.17
Amendment to Employment Agreement, dated March 3, 2023, between Matinas Biopharma Holdings, Inc. and Jerome Jabbour †*
10.18
Amendment to Employment Agreement, dated March 3, 2023, between Matinas Biopharma Holdings, Inc. and Theresa Matkovits †*
10.19
Amendment to Employment Agreement, dated March 3, 2023, between Matinas Biopharma Holdings, Inc. and Keith Kucinski †*
10.20
Amendment to Employment Agreement, dated March 3, 2023, between Matinas Biopharma Holdings, Inc. and James Ferguson †*
21.1
Subsidiaries Index*
23.1
Consent of EisnerAmper LLP*
31.1
Certification of President and Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
31.2
Certification of Acting Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
32.1
Section 1350 Certifications**
101
The
following financial information from the Annual Report on Form 10-K for the fiscal year ended December 31, 2021, formatted in XBRL
(eXtensible Business Reporting Language), is filed electronically herewith: (i) Consolidated Balance Sheets as of December 31, 2022
and 2021; (ii) Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2022 and 2021; (iii)
Consolidated Statement of Changes in Stockholders’ Equity (Deficit) for the Years Ended December 31, 2022 and 2021; (iv) Consolidated
Statements of Cash Flows for the Years Ended December 31, 2022 and 2021; and (v) Notes to Consolidated Financial Statements.*
104
The
cover page from this Annual Report on Form 10-K, formatted as Inline XBRL.
+
Confidential
treatment has been requested for certain provisions of this Exhibit pursuant to Rule 24b-2 promulgated under the Securities Exchange
Act of 1934, as amended.
†
Indicates
a management contract or compensation plan, contract or arrangement.
*
Filed
herewith.
**
Furnished
herewith.
Item
16.
Form
10-K Summary.
None.
89
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Act, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized, in the city of Bedminster, State of New Jersey on March 15, 2023.
MATINAS
BIOPHARMA HOLDINGS, INC.
By:
/s/
Jerome D. Jabbour
Name:
Jerome
D. Jabbour
Title:
Chief
Executive Officer
By:
/s/
Keith A. Kucinski
Name:
Keith
A. Kucinski
Title:
Chief
Financial Officer
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
Person
Capacity
Date
/s/
Jerome D. Jabbour
Chief
Executive Officer and Director
March
15, 2023
Jerome
D. Jabbour
(Principal
Executive Officer)
/s/
Keith A. Kucinski
Chief
Financial Officer
March
15, 2023
Keith
A. Kucinski
(Principal
Financial and Accounting Officer)
/s/
Eric Ende
Chairman
of the Board
March
15, 2023
Eric
Ende
/s/
Herbert Conrad
Director
March
15, 2023
Herbert
Conrad
/s/
Kathryn Corzo
Director
March
15, 2023
Kathryn
Corzo
/s/
Natasha Giordano
Director
March
15, 2023
Natasha
Giordano
/s/
James S. Scibetta
Director
March
15, 2023
James
S. Scibetta
/s/
Matthew A. Wikler
Director
March
15, 2023
Matthew
A. Wikler
90
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and Stockholders of
Matinas
BioPharma Holdings, Inc.
Opinion
on the Financial Statements
We have audited the accompanying consolidated balance
sheets of Matinas BioPharma Holdings, Inc. and Subsidiaries as of December 31, 2022 and 2021 and the related consolidated statements of
operations and comprehensive loss, changes in stockholders’ equity, and cash flows for each of the years then ended, and the related
notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in
all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of their operations and
their cash flows for each of the years then ended, in conformity with accounting principles generally accepted in the United States of
America.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards
of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements
are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform,
an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal
control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
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: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially
challenging, subjective, or complex judgments. The communication of the critical audit matter 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 matter below, providing a separate opinion
on the critical audit matter or on the accounts or disclosures to which it relates.
Accruals and prepaid balance for research and
development expenses
As disclosed in the consolidated statements of operations,
for the year ended December 31, 2022, the Company incurred significant research and development (“R&D”) expenses, which
amounted to approximately $16.7 million. At December 31, 2022, the Company had accrued $1.2 million for R&D expenses on the consolidated
balance sheet. The Company also recorded prepaid R&D expense of $2.7 million on the consolidated balance sheet. A significant amount
of the Company’s R&D expenses are service fees paid to contract research organizations (“CROs) and contract manufacturing organizations
(“CMOs”). The R&D activities with these CROs and CMOs are documented in contractual agreements and are typically performed
over an extended period. The amounts recorded on the consolidated balance sheet for such R&D contracts represent the Company’s
estimates of the unpaid and prepaid R&D expenses based on facts and circumstances known to the Company at that time, and are dependent
upon the timely and accurate reporting of CROs and CMOs. The amount of R&D expense to be recognized under these agreements based on
the Company’s estimate of the progress of work completed during the financial reporting period and involves judgement and estimation.
We identified management’s estimate of accruals
for R&D expenses as a critical audit matter due to the significance of these expenses to the financial statements and the significant
judgement and estimation required by management in determining the progress or state of completion of clinical studies or services rendered.
As a result, a high degree of auditor judgement and additional testing were required to evaluate audit evidence relating to estimates
made by management.
Addressing the matter involved performing procedures and evaluating audit
evidence in connection with forming our overall opinion on the consolidated financial statements. Our audit procedures related to accruals
for R&D expenses included the following, among others, (i) we obtained an understanding of management’s process and evaluated
the design 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; (ii) we read selected agreements and contract amendments with CROs and CMOs
and evaluating the significant assumptions described above and the methods used in developing the R&D estimates and recalculating
the amounts that were unpaid and prepaid at the balance sheet date, (iii) we confirmed with CROs and CMOs contractual commitments and
amounts completed, paid and unpaid, and (iv) made direct inquiries of the Company research personnel regarding project status, and inspected
invoices received subsequent to year-end and additional documents and correspondence with the CROs and CMOs when used by management to
develop its estimate of R&D expenditures.
/s/
EisnerAmper LLP
We
have served as the Company’s auditor since 2011.
EISNERAMPER
LLP
Iselin,
New Jersey
March
15, 2023
F- 1
Matinas
BioPharma Holdings, Inc.
Consolidated
Balance Sheets
(in
thousands, except for share data)
2022
2021
December 31,
2022
2021
ASSETS:
Current assets:
Cash and cash equivalents
$ 6,830
$ 21,030
Marketable debt securities
21,933
28,592
Restricted cash – security deposit
50
50
Prepaid expenses and other current assets
5,719
1,321
Total current assets
34,532
50,993
Non-current assets:
Leasehold improvements and equipment - net
2,091
1,538
Operating lease right-of-use assets - net
3,613
4,219
Finance lease right-of-use assets - net
30
23
In-process research and development
3,017
3,017
Goodwill
1,336
1,336
Restricted cash - security deposit
200
200
Total non-current assets
10,287
10,333
Total assets
$ 44,819
$ 61,326
LIABILITIES AND STOCKHOLDERS’ EQUITY:
Current liabilities:
Accounts payable
$ 618
$ 937
Accrued expenses and other liabilities
3,099
2,851
Operating lease liabilities - current
562
539
Financing lease liabilities - current
7
21
Total current liabilities
4,286
4,348
Non-current liabilities:
Deferred tax liability
341
341
Operating lease liabilities - net of current portion
3,533
4,140
Financing lease liabilities - net of current portion
22
3
Total non-current liabilities
3,896
4,484
Total liabilities
8,182
8,832
Stockholders’ equity:
Common stock par value $ 0.0001 per share, 500,000,000 shares authorized at December 31, 2022 and 2021, respectively; 217,264,526 and 216,269,450 issued and outstanding as of December 31, 2022 and 2021, respectively
22
22
Additional paid-in capital
190,070
184,251
Accumulated deficit
( 152,631 )
( 131,634 )
Accumulated other comprehensive loss
( 824 )
( 145 )
Total stockholders’ equity
36,637
52,494
Total liabilities and stockholders’ equity
$ 44,819
$ 61,326
The
accompanying notes are an integral part of these consolidated financial statements.
F- 2
Matinas
BioPharma Holdings, Inc.
Consolidated
Statements of Operations and Comprehensive Loss
(in
thousands, except share and per share data)
2022
2021
For the Year Ended December 31,
2022
2021
Revenue:
Contract Revenue
$ 3,188
$ 33
Costs and Expenses:
Research and development
16,678
14,583
General and administrative
11,100
10,185
Total costs and expenses
27,778
24,768
Loss from operations
( 24,590 )
( 24,735 )
Sale of New Jersey net operating loss & tax credits
3,491
1,328
Other income, net
102
124
Net loss
$ ( 20,997 )
$ ( 23,283 )
Preferred stock series B accumulated dividends
-
( 396 )
Net loss attributable to common shareholders
$ ( 20,997 )
$ ( 23,679 )
Net loss attributable to common shareholders per share – basic and diluted
$ ( 0.10 )
$ ( 0.11 )
Weighted average common shares outstanding:
Basic and diluted
216,811,439
210,178,332
Other comprehensive loss, net of tax
Net unrealized loss on securities available-for-sale
( 679 )
( 374 )
Other comprehensive loss, net of tax
( 679 )
( 374 )
Comprehensive loss attributable to shareholders
$ ( 21,676 )
$ ( 23,657 )
The
accompanying notes are an integral part of these consolidated financial statements.
F- 3
Matinas
BioPharma Holdings, Inc.
Consolidated
Statements of Changes in Stockholders’ Equity
(in
thousands, except for share data)
Shares
Amount
Shares
Amount
Capital
Deficit
(Loss)/Income
Equity
Redeemable
Convertible
Preferred Stock B
Common Stock
Additional Paid - in
Accumulated
Accumulated Other Comprehensive
Total Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
(Loss)/Income
Equity
Balance, December 31, 2020
4,361
$ 3,798
200,113,431
$ 20
$ 167,192
$ ( 107,507 )
$ 229
$ 63,732
Stock-based compensation
-
-
-
-
4,192
-
-
4,192
Issuance of common stock as compensation for services
-
-
31,769
-
32
-
-
32
Issuance of common stock in exchange for preferred stock
( 4,361 )
( 3,798 )
8,722,000
1
3,797
-
-
-
Issuance of common stock in public offering, net of stock issuance costs ($ 172,592 )
-
-
3,023,147
1
5,580
-
-
5,581
Issuance of common stock upon exercise of options
-
-
1,076,946
-
1,415
-
-
1,415
Issuance of common stock in exchange for warrants
-
-
114,957
-
-
-
-
-
Issuance of common
stock pursuant to the
Aquarius Merger Agreement
-
-
1,500,000
-
1,200
-
-
1,200
Stock dividends
-
-
1,687,200
-
843
( 844 )
-
( 1 )
Other comprehensive loss
-
-
-
-
-
( 374 )
( 374 )
Net loss
-
-
-
-
-
( 23,283 )
-
( 23,283 )
Balance, December 31, 2021
-
$ -
216,269,450
$ 22
$ 184,251
$ ( 131,634 )
$ ( 145 )
$ 52,494
Balance
-
$ -
216,269,450
$ 22
$ 184,251
$ ( 131,634 )
$ ( 145 )
$ 52,494
Stock-based compensation
-
-
-
-
5,228
-
-
5,228
Issuance of common stock upon exercise of options
-
-
195,076
-
99
-
-
99
Issuance of common stock pursuant to license agreement amendment
-
-
400,000
-
291
-
-
291
Issuance of common stock in exchange for warrants
-
-
400,000
-
201
-
-
201
Other comprehensive loss
-
-
-
-
-
-
( 679 )
( 679 )
Net loss
-
-
-
-
-
( 20,997 )
-
( 20,997 )
Balance, December 31, 2022
-
$ -
217,264,526
$ 22
$ 190,070
$ ( 152,631 )
$ ( 824 )
$ 36,637
Balance
-
$ -
217,264,526
$ 22
$ 190,070
$ ( 152,631 )
$ ( 824 )
$ 36,637
The
accompanying notes are an integral part of these consolidated financial statements.
F- 4
Matinas
BioPharma Holdings, Inc.
Consolidated
Statements of Cash Flows
(in
thousands)
2022
2021
For the Year Ended December 31,
2022
2021
Cash flows from operating activities:
Net loss
$ ( 20,997 )
$ ( 23,283 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
337
244
Loss on disposal of equipment
2
2
Stock-based compensation expense
5,228
4,292
Amortization of operating lease right-of-use assets
542
501
Amortization of finance lease right-of-use assets
19
36
Amortization of bond discount
211
250
Stock issued pursuant to license agreement amendment
291
-
Stock issued pursuant to the Aquarius Merger Agreement charged to Research and Development
-
1,200
Changes in operating assets and liabilities:
Operating lease liabilities
( 520 )
( 460 )
Prepaid expenses and other current assets
( 4,197 )
1,350
Accounts payable
( 321 )
588
Accrued expenses and other liabilities
249
57
Net cash used in operating activities
( 19,156 )
( 15,223 )
Cash flows from investing activities:
Purchases of marketable debt securities
( 9,481 )
( 23,195 )
Proceeds from sales of marketable debt securities
15,250
40,225
Purchases of leasehold improvements and equipment
( 892 )
( 260 )
Net cash provided by investing activities
4,877
16,770
Cash flows from financing activities:
Net proceeds from public offering of common stock
-
5,580
Proceeds from exercise of options
99
1,415
Payments of capital lease liability – principal
( 20 )
( 30 )
Net cash provided by financing activities
79
6,965
Net (decrease)/increase in cash, cash equivalents and restricted cash
( 14,200 )
8,512
Cash, cash equivalents and restricted cash at beginning of period
21,280
12,768
Cash, cash equivalents and restricted cash at end of period
$ 7,080
$ 21,280
Supplemental non-cash financing and investing activities:
Unrealized loss on marketable debt securities
$ ( 679 )
$ ( 374 )
Cash exercise of warrants in prepaid expenses and other current assets
$ ( 201 )
$ -
Right-of-use asset in exchange from liabilities from an operating lease modification
$ ( 64 )
$ -
Right-of-use asset in exchange from liabilities from operating lease
$ -
$ 1,444
Right-of-use asset in exchange from liabilities from finance leases
$ 14
$ -
Stock dividends issued
$ -
$ 844
Preferred stock conversion into common stock - series B
$ -
$ 3,798
The
accompanying notes are an integral part of these consolidated financial statements.
F- 5
Note
1 – Description of Business
Matinas
BioPharma Holdings Inc. (“Holdings”) is a Delaware corporation formed in 2013. Holdings is the parent company of Matinas
BioPharma, Inc. (“BioPharma”), and Matinas BioPharma Nanotechnologies, Inc. (“Nanotechnologies,” formerly known
as Aquarius Biotechnologies, Inc.), its operating subsidiaries (“Nanotechnologies”, and together with “Holdings”
and “BioPharma”, “the Company”). The Company is a clinical-stage biopharmaceutical company with a focus on identifying
and developing novel pharmaceutical products.
Note
2 – Liquidity and Plan of Operations
The
Company has experienced net losses and negative cash flows from operations each period since its inception. Through December 31, 2022,
the Company had an accumulated deficit of $ 152,631 . The Company’s net loss for the years ended December 31, 2022 and 2021 was $ 20,997
and $ 23,283 , respectively.
The
Company has been engaged in developing its lipid nanocrystal (“LNC”) platform delivery technology and a pipeline of associated
product candidates, including MAT2203 and MAT2501, since 2011. To date, the Company has not obtained regulatory approval for any of its
product candidates nor generated any revenue from product sales, and the Company expects to incur significant expenses to complete development
of its product candidates. The Company may never be able to obtain regulatory approval for the marketing of any of its product candidates
in any indication in the United States or internationally and there can be no assurance that the Company will generate revenues or ever
achieve profitability.
If
the Company obtains U.S. Food and Drug Administration (“FDA”) approval for one or more of its product candidates, the Company
expects that its expenses will continue to increase once the Company reaches commercial launch. The Company also expects that its research
and development expenses will continue to increase as it moves forward with additional clinical studies for its current product candidates
and development of additional product candidates. As a result, the Company expects to continue to incur substantial losses for the foreseeable
future, and that these losses will be increasing.
As
of December 31, 2022, the Company had cash and cash equivalents of $ 6,830 , marketable debt securities of $ 21,933 and restricted cash
of $ 250 . The Company believes the cash and cash equivalents and marketable debt securities on hand are sufficient to fund planned operations
into the second quarter of 2024.
Note
3 – Summary of Significant Accounting Policies
Basis
of presentation and principles of consolidation
The
accompanying consolidated financial statements include the consolidated accounts of Holdings and its wholly owned subsidiaries, BioPharma,
and Nanotechnologies. The accompanying consolidated financial statements have been prepared in accordance with accounting principles
generally accepted in the United States (“U.S. GAAP”) and reflect the operations of the Company and its wholly owned subsidiaries.
All intercompany transactions have been eliminated in consolidation.
Financial
impact of events beyond our control
Our
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
pandemic, global supply chain disruptions, global trade disputes and/or political instability. Increases in interest rates, especially
if coupled with reduced government spending and volatility in financial markets, may have the effect of further increasing economic uncertainty
and heightening these risks. Additionally, rising inflation rates may affect us by increasing operating expenses, such as employee-related
costs and clinical trial expenses, negatively impacting our results of operations.
The
Company’s financial results for the year ended December 31, 2022 were not significantly impacted by COVID-19 or other factors beyond
our control, such as those described above. However, the Company cannot predict the impact of any of these factors on future results
or the Company’s ability to raise capital due to a variety of factors, including but not limited to the continued good health of
Company employees, the ability of service providers and suppliers to continue to operate and deliver, the ability of the Company to maintain
operations, and any government and/or public actions taken in response to these factors.
F- 6
Use
of estimates
The
preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenue and
expenses during the reporting period. Actual results could differ from those estimates.
Significant
items subject to such estimates and assumptions include, but are not limited to, the Company’s research and development expenses,
the assessment of the impairment of goodwill and intangible assets, income tax
valuations and the determination of stock-based compensation.
Segment
and geographic information
Operating
segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief
operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views
its operations and manages its business in one operating and reporting segment.
Cash,
cash equivalents and restricted cash
The
Company considers all highly liquid financial instruments with original maturities of three months or less when purchased to be cash
and cash equivalents and all investments with maturities of greater than three months from date of purchase are classified as marketable
debt securities. Cash and cash equivalents consisted of cash in bank checking and savings accounts, money market funds and short-term
U.S. treasury bonds that mature within three months of settlement date. The Company presents restricted cash with cash and cash equivalents
in the Consolidated Statements of Cash Flows. Restricted cash represents funds the Company is required to set aside to cover building
operating leases and other purposes. For a complete disclosure of the Company’s cash, cash equivalents and restricted cash, see
Note 4 – Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities.
Marketable
Debt Securities
Marketable
debt securities, all of which are available-for-sale, consist of U.S. treasury bonds, U.S. government notes, corporate debt securities
and state and municipal bonds. Marketable debt securities are carried at fair value, with unrealized gains and losses reported as accumulated
other comprehensive (loss)/income, except for losses from impairments which are determined to be other-than-temporary. Realized gains
and losses and declines in value judged to be other-than-temporary are included in the determination of net loss and are included in
other income, net. Fair values are based on quoted market prices at the reporting date. Interest and dividends on available-for-sale
securities are included in other income, net. For a complete disclosure of the Company’s marketable debt securities, see Note 4
– Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities.
Concentration
of credit risk
The Company’s financial instruments that are exposed to concentrations
of credit risk consist primarily of cash, cash equivalents, restricted cash and marketable debt securities. The Company’s investment
policy is to invest only in institutions that meet high credit quality standards and establishes limits on the amount and time to maturity
of investments with any individual counterparty. Balances are maintained at U.S. financial institutions and may from time to time exceed
the Federal Deposit Insurance Corporation (“FDIC”) insurance limit of $ 250 per depositor, per insured bank for each account
ownership category. The Company has not experienced any credit losses associated with its balances in such accounts for the years ended
December 31, 2022 and 2021.
Leasehold
improvements and equipment
Leasehold
improvements and equipment are stated at cost less accumulated depreciation and amortization. Depreciation on equipment is computed using
the straight-line method over the estimated useful lives of the assets, which range from three to ten years . Capitalized costs associated
with leasehold improvements are amortized on a straight-line basis over the lesser of the estimated useful life of the asset or the remaining
term of the lease.
F- 7
Goodwill
and other intangible assets
Goodwill
is recorded when consideration paid for an acquired entity exceeds the fair value of the net assets acquired. Goodwill is not amortized
but rather is assessed for impairment at least annually on a reporting unit basis, or more frequently when events and circumstances indicate
the goodwill may be impaired. U.S. GAAP provides that the Company has the option to perform a qualitative assessment to determine whether
it is more-likely-than-not that the fair value of a reporting unit is less than its carrying amount. If the Company determine this is
the case, the Company can perform further analysis to identify and measure the amount of goodwill impairment loss to be recognized, if
any.
A
reporting unit is an operating segment, or one level below an operating segment. Historically, the Company has conducted its business
in a single operating segment and reporting unit. For the years ended December 31, 2022 and 2021, the Company assessed goodwill impairment
by performing a qualitative test for its reporting unit. As part of the qualitative review, the Company considered relevant events and
circumstances, with an emphasis on the fact that the Company’s fair value, as determined by its market capitalization, is well
in excess of its book value. Based on the results of the Company’s assessment, it was determined that it is more-likely-than-not
that its goodwill was not impaired during the years ended December 31, 2022 and 2021.
Indefinite
lived intangible assets are composed of in-process research and development (“IPR&D”) and represent projects acquired
in a business combination that have not reached technological feasibility or that lack regulatory approval at the time of acquisition.
These IPR&D assets are reviewed for impairment annually, or sooner if events or changes in circumstances indicate that the carrying
amount of the asset may not be recoverable, and upon establishment of technological feasibility or regulatory approval. An impairment
loss, if any, is calculated by comparing the fair value of the asset to its carrying value. If the asset’s carrying value exceeds
its fair value, an impairment loss is recorded for the difference and its carrying value is reduced accordingly. Similar to the impairment
test for goodwill, the Company may perform a qualitative review of its indefinite-lived intangible assets for impairment. The Company
used the qualitative approach and concluded that it was more-likely-than-not that its indefinite-lived assets were no t impaired during
the years ended December 31, 2022 and 2021.
Leases
The
Financial Accounting Standards Board (the “FASB”) Accounting Standards Codification (“ASC”) Topic 842, “Leases”,
establishes a right-of-use (“ROU”) model that requires a lessee to recognize a ROU asset and lease liability on the balance
sheet for all leases with a term longer than 12 months. Leases will be classified as either finance or operating, with classification
affecting the pattern and classification of expense recognition in the income statement. Lessor accounting under the new standard is
substantially unchanged. Additional qualitative and quantitative disclosures are also required. For a complete disclosure of the Company’s
leases, see Note 8 – Leases.
Preferred
stock dividends
Subject
to provisions detailed more fully in Note 12 - Stockholders’ Equity, shares of Series B Preferred Stock earned dividends at rates
of 10 % , 15 % and 20 % once per year on the first, second and third anniversary, respectively, of June 19, 2018. The dividends were paid
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.
Income
taxes
Deferred
taxes are provided on a liability method whereby deferred tax assets are recognized for deductible temporary differences and operating
loss and tax credit carry forwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences
are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a
valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets
will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates in the period
that includes the enactment date.
F- 8
The
Company adopted the provisions of ASC 740-10 and has analyzed its filing positions in 2022 and 2021 in jurisdictions where it may be
obligated to file returns. The Company believes that its income tax filing position and deductions will be sustained on audit and does
not anticipate any adjustments that will result in a material change to its financial position. Therefore, no reserves for uncertain
income tax positions have been recorded. The Company’s policy is to recognize interest and/or penalties related to income tax matters
in income tax expense. The Company had no accrual for interest or penalties as of December 31, 2022.
Since
the Company incurred net operating losses in every tax year since inception, the 2014 through 2021 income tax returns are subject to
examination and adjustments by the Internal Revenue Service for at least three years following the year in which the tax attributes are
utilized.
Fair
Value Measurements
As
defined in ASC 820 “Fair Value Measurement”, fair value measurements should be disclosed separately by three levels of the
fair value hierarchy. For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable
inputs (quoted prices in active markets) and minimized the use of unobservable inputs (the Company’s assumptions) when developing
fair value measurements, in accordance with the established fair value hierarchy. For a complete disclosure of the Company’s fair
value measurements, see Note 5 – Fair Value Measurements.
Stock-based
compensation
Stock-based
compensation to employees consist of stock option grants and restricted shares. The Company accounts for stock-based compensation under
the provisions of ASC 718-10, Compensation – Stock Compensation , which requires all share-based payments to employees, non-employees
and directors, including grants of stock options and restricted shares, to be recognized in the consolidated statements of operations
and comprehensive loss based on their fair values on the date of grant over the requisite service period, which is generally the vesting
period of the respective award. Forfeitures are accounted for as they occur. Generally, the Company issues stock option awards with only
service-based vesting conditions and records the expense for these awards using the straight-line method. The Company classifies stock-based
compensation expense in the same manner in which the awards recipient’s payroll or service provider’s costs are classified.
The
Company accounts for equity instruments issued to non-employees in accordance with the provisions of ASC Topic 505, subtopic 50, Equity-Based
Payments to Non-Employees based upon the fair-value of the underlying instrument. The equity instruments, consisting of stock options
granted to consultants, are valued using the Black-Scholes valuation model. The Company calculates the fair value of option grants utilizing
the Black-Scholes pricing model and estimates the fair value of restricted stock based upon the estimated fair value or the common stock.
The
resulting compensation expense for both employee and non-employee awards is generally recognized on a straight-line basis over the requisite
service period of the award.
Basic
and diluted net loss per common share
Net
loss per share information is determined using the two-class method, which includes the weighted-average number of shares of common stock
outstanding during the period and other securities that participate in dividends (a “participating security”). The Company
considered its Preferred Stock to be participating securities because the shares included rights to participate in dividends with the
common stock.
Under
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. The net loss attributable
to common stockholders is calculated by adjusting the net loss of the Company for the accretion on the Preferred Stock. Net losses are
not allocated to preferred stockholders as they do not have an obligation to share in the Company’s net losses. In periods with
net income attributable to common stockholders, the Company would allocate net income first to preferred stockholders based on dividend
rights under the Company’s certificate of incorporation and then to preferred and common stockholders based on ownership interests.
Diluted net loss per share attributable to common stockholders is computed using the more dilutive of (1) the two-class method or (2)
the if-converted method.
F- 9
During
the years ended December 31, 2022 and 2021, diluted earnings per common share is the same as basic earnings per common share because,
as the Company incurred a net loss during each period presented, the potentially dilutive securities from the assumed exercise of all
outstanding stock options and warrants would have an anti-dilutive effect. The reconciliation of the diluted shares as of December 31,
2022 and 2021 are as follows:
Schedule
of Anti-dilutive Securities
As of December 31,
2022
2021
Stock options
34,739
28,184
Warrants
238
988
Total
34,977
29,172
Revenue
recognition
Pursuant
to Topic 606, the Company recognizes revenue to depict the transfer of promised goods or services to a customer in an amount that reflects
the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve this core principle,
Topic 606 outlines a five-step process for recognizing revenue from customer contracts that includes i) identification of the contract
with a customer, ii) identification of the performance obligations in the contract, iii) determining the transaction price, iv) allocating
the transaction price to the separate performance obligations in the contract, and v) recognizing revenue associated with performance
obligations as they are satisfied.
At
contract inception, the Company assesses the goods or services promised within each contract and assess whether each promised good or
service is distinct and determine those that are performance obligations. The Company then recognizes as revenue the amount of the transaction
price that is allocated to the respective performance obligation when the performance obligation is satisfied.
For
the year ended December 31, 2022, the Company’s revenues primarily consist of contract research revenue from the BioNTech Agreement
to evaluate the combination of mRNA formats utilizing the Company’s proprietary LNC Platform. For a complete disclosure of the
Company’s Revenue Recognition, see Note 9 – Revenue Recognition, Collaboration Agreements, and Other Research and Development
Agreements.
On
December 12, 2019, the Company entered into a feasibility study agreement (the “Agreement”) with Genentech, Inc. (“Genentech”).
This feasibility study involves the development of oral formulations using the Company’s LNC Platform, which enables the development
of a wide range of difficult-to-deliver molecules. Under the terms of the Agreement, Genentech paid the Company a total of $ 100 for three
molecules, or approximately $ 33 per molecule, which will be recognized upon the Company fulfilling its obligations for each molecule
under the Agreement. The Agreement has a single performance obligation that is recognized over time as the services are performed. There
are no contract assets associated with this Agreement. As of December 31, 2022, the Company completed the first and second of the three
molecules and the Company recognized $ 33 of Genentech revenue for the years ended December 31, 2021 and 2020, respectively. The Company
is scheduled to complete performance obligation related to the remaining molecule during 2023.
Collaboration
Agreements
The
Company assess whether its collaboration agreements are subject to ASC Topic 808, Collaborative Arrangements (Topic 808) based
on whether they involve joint operating activities and whether both parties have active participation in the arrangement and are exposed
to significant risks and rewards. To the extent that the arrangement falls within the scope of Topic 808, the Company will apply by analogy
the unit of account guidance under Topic 606 to identify distinct performance obligations, and then determine whether a customer relationship
exists for each distinct performance obligation. If the Company determines a performance obligation within the arrangement is with a
customer, the Company applies the guidance in Topic 606. If a portion of a distinct bundle of goods or services within an arrangement
is not with a customer, then the unit of account is not within the scope of Topic 606, and the recognition and measurement of that unit
of account shall be based on analogy to authoritative accounting literature or, if there is no appropriate analogy, a reasonable, rational,
and consistently applied accounting policy election.
F- 10
The
terms of such arrangements typically include payments to the Company for one or more of the following: up-front fees; development and
regulatory payments; product supply services; research and development cost reimbursements; profit-sharing arrangements; and royalties
on certain products if they are successfully commercialized. As part of the accounting for these arrangements, the Company develops assumptions
that require judgment to determine the standalone selling price for each performance obligation identified in the contract. These key
assumptions may include forecasted revenues, clinical development timelines and costs, reimbursement rates for personnel costs, discount
rates and probabilities of technical and regulatory success.
Up-front
License Fees: If the license to the Company’s intellectual property is determined to be distinct from the other performance
obligations identified in the arrangement, the Company would recognize revenues from nonrefundable up-front fees allocated to the license
when the license is transferred to the licensee and the licensee is able to use and benefit from the license, which generally would occur
at or near the inception of the contract. For licenses that are bundled with other promises, the Company would utilize judgment to assess
the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or
at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenues from nonrefundable
up-front fees. The Company will evaluate the measure of progress at the end of each reporting period and, if necessary, adjust the measure
of performance and related revenue recognition.
Research
and Development Milestone Payments: At the inception of each arrangement that includes development milestone payments, the Company
will evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction
price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone
value is included in the transaction price. Milestone payments that are not within the Company’s or the licensee’s control,
such as regulatory approvals, are not considered probable of being achieved until uncertainty associated with the approvals has been
resolved. The transaction price is then allocated to each performance obligation, on a relative standalone selling price basis, for which
the Company will recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent
reporting period, the Company re-evaluates the probability of achieving such development and regulatory milestones and any related variable
consideration constraint, and if necessary, adjust the Company’s estimate of the overall transaction price. Any such adjustments
are recorded on a cumulative catch-up basis.
Research
and Development Cost Reimbursements: The Company’s collaboration arrangements may include promises of future clinical development
and drug safety services, as well as participation on certain joint committees. When such services are provided to a customer or partner,
and they are distinct from the licenses provided to the Company’s collaboration partners, these promises are accounted for as a
separate performance obligation which the Company estimates using internal development costs incurred and projections through the term
of the arrangements. The Company records revenues for these services as the performance obligations are satisfied over time based on
measure of progress. However, if the Company concludes that its collaboration partner is not a customer for those collaborative research
and development activities, it presents such payments as a reduction of research and development expenses.
Research
and Development Arrangement: Under the terms of our research and development agreement with the CFF Agreement, the Company did not
account for this arrangement in accordance with Topic 606. However, the Company has determined that it is a partner under a collaboration
agreement as it shares in the risks and rewards that would be received if the product is successful and commercialized. Therefore the
funds received under the terms of this agreement will be recorded as reimbursements of research and development costs and reduce the
research and development expenses in the Company’s Statements of Operations and Comprehensive Loss. The Company records the reimbursements
for certain materials and other research and development costs associated with the agreement when it is probable that a significant reversal
in the amount of cumulative costs have been recognized. As of December 31, 2022 and 2021, the Company recognized $ 811 and $ 2,179 , respectively,
of reimbursed research and development costs associated with the CFF Agreement. For a complete disclosure of the CFF Agreement, see Note
9 – Collaboration Agreements, Collaboration Agreements, and other Research and Development Agreements.
F- 11
Research
and development expenses
Research
and development expenses primarily consist of costs associated with the preclinical and clinical development of our product candidate
portfolio, including the following:
●
external
research and development expenses incurred under arrangements with third parties, such as contract research organizations (“CROs”)
and other vendors and contract manufacturing organizations (“CMOs”) for the production of drug substance and drug product;
and
●
employee-related
expenses, including salaries, benefits and share-based compensation expense.
Research
and development expenses also include costs of acquired product licenses and related technology rights where there is no alternative
future use, costs of prototypes used in research and development, consultant fees and amounts paid to certain of our collaborative partners.
All
research and development expenses are charged to operations as incurred in accordance with FASB ASC Topic 730, Research and Development.
The Company accounts for non-refundable advance payments for goods and services that will be used in future research and development
activities as expenses when the service has been performed or when the goods have been received, rather than when the payment is made.
Accrued
Research and Development Expenses
As
part of the process of preparing the Company’s financial statements, the Company is required to estimate its accrued expenses.
This process involves reviewing quotations and contracts, identifying services that have been performed on the Company’s behalf
and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced
or otherwise notified of the actual cost. Certain of the Company’s service providers invoice the Company monthly in arrears for
services performed or when contractual milestones are met. The Company makes estimates of its accrued expenses as of each balance sheet
date in its financial statements based on facts and circumstances known to the Company at that time. The Company periodically confirms
the accuracy of its estimates with the service providers and adjust if necessary. The significant estimates in the Company’s accrued
research and development expenses are related to expenses incurred with respect to CROs, CMOs and other vendors in connection with research
and development and manufacturing activities.
The
Company bases its expense related to CROs and CMOs on its estimates of the services received and efforts expended pursuant to quotations
and contracts with such vendors that conduct research and development and manufacturing activities on its behalf. The financial terms
of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances
in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of the applicable
research and development or manufacturing expense. In accruing service fees, the Company estimates the time period over which services
will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level
of effort varies from its estimate, the Company adjust the accrual or prepaid expense accordingly. Although the Company does not expect
its estimates to be materially different from amounts actually incurred, the Company’s understanding of the status and timing of
services performed relative to the actual status and timing of services performed may vary and could result in us reporting amounts that
are too high or too low in any particular period. There have been no material changes in estimates for the periods presented.
Patent
expenses
Legal
fees and other direct costs incurred in obtaining and protecting patents are also expensed as incurred and are included in general and
administrative expenses in the consolidated statements of operations.
Other
comprehensive loss
Other
comprehensive loss consists of net gains/(losses) and unrealized losses on marketable debt securities available-for-sale and is presented
in the Consolidated Statements of Operations and Comprehensive Loss.
F- 12
Recent
accounting pronouncements
There
were no recent accounting pronouncements that impacted the Company or are expected to have a significant effect on its consolidated financial
statements.
Note
4 – Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities
The
Company considers all highly liquid financial instruments with original maturities of three months or less when purchased to be cash
and cash equivalents and all investments with maturities of greater than three months from date of purchase are classified as marketable
debt securities. Cash and cash equivalents consisted of cash in bank checking and savings accounts, money market funds and short-term
U.S. treasury bonds that mature within three months of settlement date.
Cash,
Cash Equivalents and Restricted Cash
The
Company presents restricted cash with cash and cash equivalents in the Consolidated Statements of Cash Flows. Restricted cash at each
of December 31, 2022 and 2021 of $ 250 represents funds the Company is required to set aside as collateral, primarily for one of the Company’s
operating leases and other purposes.
The
following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the Consolidated Balance Sheets to
the total of the amounts in the Consolidated Statements of Cash Flows as of December 31, 2022, December 31, 2021 and December 31, 2020:
Schedule of Cash, Cash Equivalents and Restricted Cash
December 31,
2022
December 31,
2021
December 31,
2020
Cash and cash equivalents
$ 6,830
$ 21,030
$ 12,432
Restricted cash included in current/non-current assets
250
250
336
Cash, cash equivalents and restricted cash in the statement of cash flows
$ 7,080
$ 21,280
$ 12,768
Marketable
Debt Securities
The
Company has classified its investments in marketable debt securities as available-for-sale and as a current asset. The Company’s
investments in marketable debt securities are carried at fair value, with unrealized gains and losses included as a separate component
of stockholders’ equity. Unrealized losses and gains are classified as other comprehensive (loss)/income and costs are determined
on a specific identification basis. Realized gains and losses from marketable debt securities are recorded in other income, net. For
the years ended December 31, 2022 and 2021, the Company recorded unrealized losses of $ 679 and $ 374 , respectively. As of December 31,
2022 and 2021, the Company had net accumulated unrealized losses of $ 824 and $ 145 , respectively.
The
Company’s marketable debt securities for the year ended December 31, 2022 consisted of the following:
Schedule of Marketable Securities
Amortized Cost
Unrealized Gain
Unrealized (Loss)
Fair Value
Amortized Cost
Unrealized
Gain
Unrealized (Loss)
Fair Value
U.S. Treasury Bonds
$ 993
$ —
$ ( 34 )
$ 959
U.S. Government Notes
16,324
—
( 721 )
15,603
Corporate Debt Securities
5,440
—
( 69 )
5,371
Total marketable debt securities
$ 22,757
$ —
$ ( 824 )
$ 21,933
Maturities
of debt securities classified as available-for-sale were as follows at December 31, 2022:
Schedule of Maturities of Debt Securities Available-for-sale
Fair Value
Due within one year
$ 13,240
Due after one year through five years
8,693
$ 21,933
F- 13
The
Company’s marketable debt securities for the year ended December 31, 2021 consisted of the following:
Amortized
Unrealized
Gain
Unrealized (Loss)
Fair
Value
Amortized Cost
Unrealized Gain
Unrealized (Loss)
Fair Value
U.S. Government Notes
$ 19,395
$ 2
$ ( 120 )
$ 19,277
Corporate Debt Securities
9,092
—
( 27 )
9,065
State and Municipal Bonds
250
—
—
250
Total marketable debt securities
$ 28,737
$ 2
$ ( 147 )
$ 28,592
Maturities
of debt securities classified as available-for-sale were as follows at December 31, 2021:
Fair Value
Due within one year
$ 8,257
Due after one year through five years
20,335
$ 28,592
The
Company determined that the unrealized (losses) and gains are temporary as of December 31, 2022 and 2021. Unrealized (losses) and gains
generally are the result of increases in the risk premiums required by market participants rather than an adverse change in cash flows
for a fundamental weakness in the credit quality of the issuer or underlying assets.
Note
5 - Fair Value Measurements
The
Company uses the fair value hierarchy to measure the value of its financial instruments. The fair value hierarchy is based on inputs
to valuation techniques that are used to measure fair value that are either observable or unobservable. Observable inputs reflect assumptions
market participants would use in pricing an asset or liability based on market data obtained from independent sources, while unobservable
inputs reflect a reporting entity’s pricing based upon its own market assumptions. The basis for fair value measurements for each
level within the hierarchy is described below:
●
Level
1 – Quoted prices for identical assets or liabilities in active markets.
●
Level
2 – Quoted prices for identical or similar assets and liabilities in markets that are not active; or other model-derived valuations
whose inputs are directly or indirectly observable or whose significant value drivers are observable.
●
Level
3 – Valuations derived from valuation techniques in which one or more significant inputs to the valuation model are unobservable
and for which assumptions are used based on management estimates.
The
Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent
possible as well as considers counterparty credit risk in its assessment of fair value.
The
carrying amounts of cash equivalents, current portion of restricted cash, prepaid expenses and other current assets, accounts payable,
current portion of lease liabilities and accrued expenses approximate fair value due to the short-term nature of these instruments.
A
summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows:
Schedule of Fair Value Measurement of Assets and Liabilities
Fair Value Hierarchy
December 31, 2022
Total
(Level 1)
(Level 2)
(Level 3)
Assets
Marketable Debt Securities:
U.S. Treasury Bonds
$ 959
$ 959
$ —
$ —
U.S. Government Notes
15,603
—
15,603
—
Corporate Debt Securities
5,371
—
5,371
—
Total
$ 21,933
$ 959
$ 20,974
$ —
F- 14
Fair Value Hierarchy
December 31, 2021
Total
(Level 1)
(Level 2)
(Level 3)
Assets
Marketable Debt Securities:
U.S. Government Notes
$ 19,277
$ —
$ 19,277
$ —
Corporate Debt Securities
9,065
—
9,065
—
State and Municipal Bonds
250
—
250
—
Total
$ 28,592
$ —
$ 28,592
$ —
U.S.
treasury bonds are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices for identical
assets in active markets. Marketable debt securities consisting of U.S. government notes, corporate debt securities and state and municipal
bonds are classified as Level 2 and are valued using quoted market prices in markets that are not active.
Note
6 – Leasehold Improvements and Equipment
Leasehold
improvements and equipment, summarized by major category, consist of the following for the years ended December 31, 2022 and 2021:
Schedule of Leasehold Improvements and Equipment
December 30,
2022
December 31,
2021
Equipment
$ 2,305
$ 1,640
Leasehold improvements
1,155
935
Total
3,460
2,575
Less: accumulated depreciation and amortization
1,369
1,037
Leasehold improvements and equipment, net
$ 2,091
$ 1,538
Depreciation
and amortization expense for the years ended December 31, 2022 and 2021 was $ 337 and $ 244 , respectively. During the years ended December
31, 2022 and 2021, the Company purchased equipment and leasehold improvements of $ 892 and $ 260 , respectively. During the year ended December
31, 2022, the Company recorded an asset write-off of $ 7 , including $ 5 of related accumulated depreciation. During the year ended December
31, 2021, the Company recorded an asset write-off of $ 6 , including $ 4 of related accumulated depreciation.
Note
7 – Accrued Expenses and Other Liabilities
Accrued
expenses and other liabilities, summarized by major category, consist of the following for years ended December 31, 2022 and 2021:
Schedule of Accrued Expenses
2022
2021
As of December 31,
2022
2021
Payroll and incentives
$ 1,705
$ 1,343
Deferred revenue *
721
33
General and administrative expenses
455
195
Research and development expenses
130
381
Other deferred liabilities **
88
899
Total
$ 3,099
$ 2,851
*
At
December 31, 2022, the balance included $ 688 related to an exclusive research collaboration with BioNTech SE (the “BioNTech
Agreement”) and $ 33 is related to a feasibility study agreement with Genentech, Inc. (the “Genentech Agreement”).
Both balances are expected to be recognized by March 31, 2023. At December 31, 2021, the balance of $ 33 was related to the Genentech
Agreement. (See Note 9 – Revenue
Recognition, Collaboration Agreements, and Other research and Development Agreements).
**
At
December 31, 2022 and December 31, 2021, the balances of $ 88 and $ 899 , respectively, related to an award agreement with the Cystic
Fibrosis Foundation (the “CFF Agreement). (See Note 9 – Revenue Recognition, Collaboration Agreements, and Other Research
and Development Agreements).
F- 15
Note
8 – Leases
The
Company has various lease agreements including leases of office space, a laboratory and manufacturing facility, and various equipment.
Some leases include purchase, termination or extension options for one or more years. These options will be included in the lease term
when it is reasonably certain that the option will be exercised. Certain of the Company’s lease agreements contain rent escalation
clauses.
Operating
and finance leases are presented in the Company’s consolidated balance sheets as right-of-use assets from leases, current lease
liabilities and long-term lease liabilities. The assets and liabilities from our leases are recognized at the lease commencement date
based on the present value of remaining lease payments over the lease term using the Company’s incremental borrowing rates or implicit
rates, when readily determinable. Short-term leases, which have an initial term of 12 months or less, are not recorded on the balance
sheet. As the Company’s operating leases do not provide implicit rates, the Company has utilized its incremental borrowing rate,
determined based on the long-term borrowing costs of companies with similar credit profiles, to record its lease obligations. The Company’s
finance leases provide readily determinable implicit rates. For operating leases, the Company recognizes the minimum rental expense on
a straight-line basis based on the fixed components of a lease arrangement. The Company will amortize this expense over the term of the
lease beginning with the lease commencement date.
Operating
lease obligations
On
November 1, 2013, the Company entered into a 7 -year lease for office space in Bedminster, New Jersey which commenced in June 2014 at
a monthly rent of approximately $ 13 , increasing to approximately $ 14 toward the end of the term. The lease was subsequently amended,
including most recently on September 13, 2022 to provide additional space and to extend the term of the lease until June 30, 2029 at
a monthly rent of approximately of approximately $ 20 , increasing to approximately $ 23 toward the end of the term. There is no renewal
option, no security deposit, no residual value or significant restrictions or covenants other than those customary in such arrangements.
Except as expressly provided, all other terms, covenants, conditions and agreements as set forth in the lease will remain unchanged and
in full force and effect.
On
December 15, 2016, the Company entered into a 10-year, 3-month lease of laboratory and manufacturing space in Bridgewater, New Jersey.
The lease began August 2017. The monthly rent started at approximately $ 43 , increasing to approximately $ 64 in the final year. To obtain
the lease, the Company provided an initial security deposit of $ 586 which was subsequently reduced and is currently $ 200 at December
31, 2022.
The
Company incurred lease expense for its operating leases of $ 872 and $ 852 for the years ended December 31, 2022 and 2021. The Company
incurred amortization expense on its operating lease right-of-use assets of $ 542 and $ 501 for the years ended December 31, 2022 and 2021,
respectively.
Finance
Leases
The
Company incurred interest expense on its finance leases of $ 1 and $ 3 for the years ended December 31, 2022 and 2021, respectively. The
Company incurred amortization expense on its finance lease right-of-use assets of $ 19 and $ 36 for the years ended December 31, 2022 and
2021, respectively.
F- 16
The
following table presents information about the amount and timing of liabilities arising from the Company’s operating leases and
finance leases as of December 31, 2022:
Schedule of Maturity of Operating and Finance Leases Liabilities
Maturity of Lease Liabilities
Operating Lease Liabilities
Finance Lease Liabilities
2023
$ 916
$ 10
2024
956
7
2025
998
7
2026
1,040
7
2027
944
7
Thereafter
411
-
Total undiscounted operating lease payments
$ 5,265
$ 38
Less: Imputed interest
1,170
9
Present value of operating lease liabilities
$ 4,095
$ 29
Weighted average remaining lease term in years
5.3
4.5
Weighted average discount rate
9.2 %
11.1 %
The
following table presents information about the amount and timing of liabilities arising from the Company’s operating leases and
finance leases as of December 31, 2021:
Maturity of Lease Liabilities
Operating Lease Liabilities
Finance Lease Liabilities
2022
$ 883
$ 22
2023
922
2
2024
962
-
2025
1,004
-
2026
1,046
-
Thereafter
1,112
-
Total undiscounted operating lease payments
$ 5,929
$ 24
Less: Imputed interest
1,250
-
Present value of operating lease liabilities
$ 4,679
$ 24
Weighted average remaining lease term in years
6.1
0.9
Weighted average discount rate
7.8 %
7.8 %
Note
9 – Revenue Recognition, Collaboration Agreements, and Other Research and Development Agreements
BioNTech
Research Collaboration
On
April 8, 2022, the Company entered into the BioNTech Agreement to evaluate the combination of mRNA formats utilizing the Company’s
proprietary LNC Platform. Under the terms of the BioNTech Agreement, the Company received an exclusivity fee in the amount of $ 2,750 ,
and BioNTech SE will fund certain of the Company’s research expenses to be incurred under the agreement. The parties have also
commenced discussions on a potential option to license (“OTL”) agreement for the Company’s LNC Platform. The term of
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
the effective date and termination of the agreement. As of December 31, 2022, the parties have not executed an OTL agreement.
The
Company assessed the BioNTech Agreement under ASC 808 Collaboration Arrangements and ASC 606 Revenue from Contracts with Customers
(“ASC 606”) and concluded that the contract counterparty, BioNTech SE, is a customer based on the arrangement structure.
The Company identified two material promises to deliver under the contract: (1) grant of an exclusive research license and (2) clinical
research services. However, given the nature of the promises, the license and research services are not considered to be distinct from
each other within the context of the contract. The Company therefore concluded that there is one combined performance obligation for
both the license and research services.
F- 17
The
$ 2,750 license fee was recorded as deferred revenue and is being recognized over the term of the contract performance obligation period,
which the Company has concluded to be 12 months after the execution of the contract. The clinical research services are being invoiced
as service revenue is earned on a monthly basis during the term of the contract.
As
of December 31, 2022, the Company recognized $ 3,188 of contract research revenue from the BioNTech Agreement. For the year ended December
31, 2022 $ 2,063 of the contract research revenue was recognized from the license fee and $ 1,125 was earned from the monthly clinical
research services performed by the Company. As of December 31, 2022, $ 688 of the license fee is included in deferred revenue within accrued
expenses.
Cystic
Fibrosis Foundation Therapeutics Development Award
On
November 19, 2020, the Company entered into an award agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation
(“CFF”), pursuant to which it received a Therapeutics Development Award of up to $ 4,234 (the “Award”) (of which
$ 484 had been previously received) to support the preclinical development (the “Development Program”) of the Company’s
MAT2501 product candidate. On November 19, 2021, the Company and CFF entered into an Amendment to the CFF Agreement which added an additional
milestone payment in the amount of $ 321 .
As
of December 31, 2022, the Company has received $ 3,635 of the $ 4,555 commitment, inclusive of the Amendment’s additional milestone
payment, and the related deferred liability balances of $ 88 and $ 899 is included in accrued expenses at December 31, 2022 and December
31, 2021, respectively. During the fourth quarter of 2022, for financial and technical reasons, the Company determined that it was not
commercially reasonable to continue the development of MAT2501 and instead elected to focus existing resources on other initiatives.
As a result, the Company does not anticipate receiving the balance of the commitment.
Pursuant
to the terms of the CFF Agreement, should the Company ceases to use commercially reasonable efforts directed to the development of MAT2501
in the Field, (an “Interruption”) and fail to resume the development of the Product after receiving from CFF notice of an
Interruption, then the Company must either repay the amount of the Award actually received by the Company, or grant to CFF (1) an exclusive
(even as to the Company), worldwide, perpetual, sublicensable license under technology developed under the Agreement that covers the
Product for use in treating infections in CF patients (the “CF Field”), and (2) a non-exclusive, worldwide license under
certain background intellectual property covering the Product, to the extent necessary to commercialize the Product in the CF Field.
Following discussion with the CFF in early 2023, the Company does not believe it will have to repay any amounts of Awards received by
the Company to date pursuant to the terms of the CFF Agreement. The Company is working together with the CFF to wind up the agreement
according to its terms.
In
the event that the Company chooses to resume development of MAT2501, pursuant to the terms of the Agreement, the Company is obligated
to make royalty payments to CFF contingent upon commercialization of the Product in the Field up to a maximum of five times the Award
or approximately $ 21.2 million (the “Royalty Cap”), payable in three equal annual installments following the first commercial
sale of the Product, the first of which is due within 90 days following the first commercial sale of the Product. The Company may also
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
into a change of control transaction which will be applied against the Royalty Cap. In addition, the Company is also obligated to make
up to two royalty payments to CFF of approximately $ 4.2 million each, due in the calendar years in which specific net sales milestones
are achieved.
The
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
the fixed royalty payments set forth therein, the effective date of any license granted to CFF following an Interruption, or upon earlier
termination of the Agreement. Either CFF or the Company may terminate the agreement for cause, which includes the Company’s material
failure to achieve certain development milestones. The Company’s payment obligations survive the termination of the Agreement.
The
Company concluded that the CFF award is in the scope of ASC 808. Accordingly, as discussed in Note 3, the award amounts received from
CFF upon achievement of certain milestones are recognized as credits to research and development expenses in the period the Development
Program’s expenses are incurred. During the years ended December 31, 2022 and 2021, the Company recognized $ 811 and $ 2,179 , respectively,
as credits to research and development expenses related to the CFF award.
F- 18
Genentech
Feasibility Study Agreement
On
December 12, 2019, the Company entered into the Genentech Agreement which involves the development of oral formulations using the Company’s
LNC Platform. Under the terms of the Genentech Agreement, Genentech paid the Company a total of $100 for the development of three molecules,
or approximately $33 per molecule, which is being recognized upon the Company fulfilling its obligations for each molecule under the
Genentech Agreement . The Company recorded the upfront consideration as deferred revenue, which is included in accrued expenses on the
consolidated balance sheets. As of December 31, 2021, the Company completed its obligations related to the first and second of the three
molecules. During the year ended December 31, 2022, the Company did not complete its obligations related to the remaining molecule but
expects to do so during 2023.
License
Agreement
Through
the acquisition of Aquarius, the Company acquired a license from Rutgers University, The State University of New Jersey (successor
in interest to the University of Medicine and Dentistry of New Jersey) for certain patents related to the LNC Platform (the “License Agreement”). The Second
Amended and Restated Exclusive License Agreement provides for, among other things, the payment of (1) royalties on a tiered basis
between low single digits and the mid-single digits of net sales of products using such licensed technology, (2) a one-time sales
milestone fee of $ 100
when and if sales of products using the licensed technology reach the specified sales threshold and (3) an annual license fee of
$ 50
over the term of the License Agreement. The term of the License Agreement will remain in effect 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 of a licensed product under this agreement, whichever
is later.
Note
10 – Commitments
Employment
agreements
The
Company also has employment agreements with certain employees which require the funding of a specific level of payments, if certain events,
such as a change in control, termination without cause or retirement, occur.
Other
normal business operating agreements
In
addition, in the course of normal business operations, the Company enters into agreements with contract service providers to assist in
the performance of research and development and manufacturing activities. Expenditures to these third parties represent significant costs
in clinical development and may require upfront payments and long-term commitments of cash. Subject to required notice periods and obligations
under binding purchase orders, the Company can elect to discontinue the work under these agreements at any time.
Legal
proceedings
The
Company is not currently a party to any legal proceedings, and the Company is not aware of any claims or actions pending or threatened
against its business. In the future, the Company might from time to time become involved in litigation relating to claims arising from
our ordinary course of business.
Note
11 – Income Taxes
The
Company utilizes the liability method of accounting for deferred income taxes. Under this method, deferred tax liabilities and assets
are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets
and liabilities. A valuation allowance is established against deferred tax assets when, based on the weight of available evidence, it
is more likely than not that some or all of the deferred tax assets will not be realized. The Company’s policy is to record interest
and penalties on uncertain tax positions as income tax expense. As of December 31, 2022 and 2021, the Company does not believe any material
uncertain tax positions were present. Accordingly, interest and penalties have not been accrued due to an uncertain tax position.
F- 19
The
components of the income tax provision are as follows:
Schedule
of Income Tax Provision
Year Ended December 31,
2022
2021
Current expense (benefit):
Federal
$ -
$ -
State
-
-
Foreign
-
-
Total current expense (benefit):
$ -
$ -
Deferred expense (benefit):
Federal
$ -
$ -
State
-
-
Foreign
-
-
Total deferred expense (benefit):
$ -
$ -
Total income tax expense (benefit):
$ -
$ -
Deferred
income taxes reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting
purposes and the amounts used for income tax purposes. A reconciliation of the statutory U.S. federal rate to the Company’s effective
tax rate is as follows:
Schedule
of Effective Income Tax Rate Reconciliation
Year Ended December 31,
2022
2021
Income at U.S. Statutory Rate
21.00 %
21.00 %
State Taxes, net of Federal benefit
7.65 %
1.97 %
Permanent Differences
( 1.25 )%
( 0.82 )%
Tax Credits
2.52 %
2.16 %
Valuation Allowance
( 29.92 )%
( 25.21 )%
Discrete items
0.00 %
0.91 %
Effective
income tax rate
0.00 %
0.00 %
The
Company has no current income taxes payable other than certain state minimum taxes which are included in general and administrative expenses.
Significant
components of the Company’s deferred tax assets (liabilities) for 2022 and 2021 consist of the following:
Schedule
of Deferred Tax Assets and Liabilities
Year Ended December 31,
2022
2021
Share-based Compensation
$ 4,512
$ 3,575
Depreciation and Amortization
( 18 )
166
Accrued Liability
481
377
Net Operating Loss Carry-forwards
21,755
24,076
R&D Credit Carryforwards
3,773
3,207
R&D Section 174 Costs
4,268
-
Other
( 1 )
( 1 )
IPR&D
( 851 )
( 848 )
ROU Asset
( 1,027 )
( 1,186 )
ROU Liability
1,155
1,315
Total Deferred tax assets
$ 34,047
$ 30,681
Valuation allowance
( 34,388 )
( 31,023 )
Net deferred tax asset (liability)
$ ( 341 )
$ ( 341 )
On
March 27, 2020, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law making several changes to the Internal
Revenue Code. The changes include but are not limited to: increasing the limitation on the amount of deductible interest expense, allowing
companies to carryback certain net operating losses, and increasing the amount of net operating loss carryforwards that corporations
can use to offset taxable income. The tax law changes in the Act did not have a material impact on the Company’s income tax provision.
F- 20
In
assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all
of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of
taxable income during the periods in which the temporary differences representing net future deductible amounts become deductible, and
is impacted by the Company’s ability to carryforward losses to years in which the Company has taxable income. Due to the Company’s
history of losses and lack of other positive evidence to support taxable income, the Company has recorded a valuation allowance against
those deferred tax assets that are not expected to be realized. The valuation allowances were $ 34.4 , $ 31.0 and $ 25.2 as of December 31,
2022, 2021 and 2020, respectively, representing increases of $ 3.4 and $ 5.8 for the years ending December 31, 2022 and 2021, respectively.
As
of December 31, 2021, the Company had Federal net operating loss carryforwards of $ 38.1 which will begin to expire in 2032 . In addition,
the Company has federal net operating loss carryforwards of $ 64.5 which have an indefinite carryforward period. The Company also had
federal and state research and development tax credit carryforwards of $ 3.8 . The federal net operating loss and tax credit carryforwards
will expire at various dates beginning in 2032, if not utilized. The difference between the statutory tax rate and the effective tax
rate is primarily attributable to the valuation allowance offsetting deferred tax assets.
Utilization
of the net operating losses and general business tax credits carryforwards may be subject to a substantial limitation under Sections
382 and 383 of the Internal Revenue Code of 1986 due to changes in ownership of the Company that have occurred previously or that could
occur in the future. These ownership changes may limit the amount of net operating losses and general business tax credits carryforwards
that can be utilized annually to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section
382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more
than 50 percentage points over a three-year period. The Company has not completed a study to determine whether it had undergone an ownership
change since the Company’s inception.
Under the Tax Cuts and Jobs Act of 2017, research
and development costs are no longer fully deductible and are required to be capitalized and amortized for U.S. tax purposes effective
January 1, 2022. The mandatory capitalization requirement increases our deferred tax assets.
Sale
of net operating losses (NOLs) & tax credits
The
Company recognized $ 3,491 and $ 1,328 for the years ended December 31, 2022 and 2021, respectively, in connection with the sale of certain
State of New Jersey Net Operating Losses (“NOL”) and Research and Development (“R&D”) tax credits to a third
party under the New Jersey Technology Business Tax Certificate Transfer Program. In addition, the Tax Cuts and Jobs Act, signed into
law on December 22, 2017 imposes significant additional limitations on the deductibility of interest and limits NOL deductions to 80%
of net taxable income for losses arising in taxable years beginning after December 31, 2017 . This NOL limitation was suspended for years
2018 through 2020 as a result of the CARES Act.
Note
12 – Stockholders’ Equity
At-The-Market
Equity Offering
On
July 2, 2020, the Company entered into an At-The-Market (“ATM”) Sales Agreement (the “Sales Agreement”) with
BTIG, LLC (“BTIG”), 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 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 and sold by the Company set forth in the Sales Agreement. BTIG will be paid a 3 % commission on the
gross proceeds from each sale. The Company may terminate the Sales Agreement at any time; BTIG may terminate the Sales Agreement in certain
limited circumstances. During 2021, BTIG sold 3,023,147 shares of the Company’s common stock generating gross proceeds of $ 5,753
and net proceeds of $ 5,580 , after deducting BTIG’s commission on gross proceeds. During 2022, the Company did not sell any shares
of its common stock under the ATM Sales Agreement. At December 31, 2022, the ATM’s available capacity was $ 44,247 .
F- 21
Common
Stock
On
February 8, 2022, the Company issued 400,000 unregistered shares of its common stock to Rutgers, The State University of New Jersey (“Rutgers”),
as partial consideration pursuant to the Second Amended and Restated Exclusive License Agreement between the Company and Rutgers. The
agreement provides for (1) royalties on a tiered basis between low single digits and the mid-single digits of net sales of products using
such licensed technology, (2) a one-time sales milestone fee of $ 100,000 when and if sales of products using the licensed technology
reach the specified sales threshold and (3) an annual license fee of $ 50,000 over the term of the license agreement. There was also a
reduction in the consideration paid to Rutgers in the event of a sublicense to a third party of the exclusive patent rights granted pursuant
to the Agreement. The Company recorded a $ 291 research and development expense related to the issuance of the 400,000 shares based on
the closing price of the Company’s common stock of $ 0.728 on the date of issuance.
On
September 3, 2021, the Company issued 1,500,000 unregistered shares of its common stock pursuant to the Agreement and Plan of Merger
by and among the Company, Saffron Merger Sub, Inc., Aquarius Biotechnologies Inc. (“Aquarius”), and J Carl Craft, as holder
representative, dated January 19, 2015, as subsequently amended on September 3, 2021 (the “Aquarius Merger Agreement”), to
the holders of Aquarius Biotechnologies Inc., as defined in the Aquarius Merger Agreement. The shares were issued in place of certain
milestone payments previously included under the Aquarius Merger Agreement upon the achievement of specified development milestones.
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
of the Company’s common stock of $ 0.80 on the date of issuance.
Preferred
Stock
In
accordance with the Certificate of Incorporation, the Company is authorized to issue 10,000,000 preferred shares at a par value of $ 0.001 .
In connection with a public offering of Series B Preferred Stock, on June 19, 2018, the Company filed the Series B Certificate of Designation
with the Secretary of the State of Delaware to designate the preferences, rights and limitations of the Series B Preferred Stock. Pursuant
to the Series B Certificate of Designation, the Company designated 8,000 shares of the Company’s previously undesignated preferred
shares as Series B Preferred Stock.
Between
January 1 and June 18, 2021, 143
shares of Series B Preferred Stock were converted by shareholders resulting in the issuance of 286,000
shares of common stock. On June 19, 2021, each of the 4,218
remaining shares of Series B Preferred Stock were each automatically converted into 2,000
shares of the Company’s common stock resulting in the issuance of 8,436,000
shares of common stock. No shares or Series B Preferred stock remained outstanding after the automatic conversion. Based on an
accounting of the holders of record of Series B Preferred Stock on June 19, 2021, the Company made dividend payments totaling 1,687,200
shares of common stock.
Warrants
All
warrants issued by the Company are exercisable immediately upon issuance and have a five-year term. The warrants may be exercised at
any time in whole or in part upon payment of the applicable exercise price until expiration. No fractional shares will be issued upon
the exercise of the warrants. The exercise price and the number of shares purchasable upon the exercise of the warrants are subject to
adjustment upon the occurrence of certain events, which include stock dividends, stock splits, combinations and reclassifications of
the Company’s capital stock or other similar changes to the equity structure of the Company. The warrants do not have a redemption
feature. They may be exercised on a cashless basis at the holder’s option.
The
warrants are classified as equity instruments.
F- 22
As
of December 31, 2022, the Company had outstanding warrants to purchase an aggregate of 238,000 shares of common stock at an exercise
price of $ 0.75 per share, and with an expiration date of June 21, 2023. A summary of warrants outstanding as of December 31, 2022 and
2021 is presented below, all of which are fully vested:
Summary
of Shareholders Equity Warrants Outstanding
Shares
Outstanding at December 31, 2020
1,328
Issued
-
Exercised
( 320 )
Expired
( 20 )
Outstanding at December 31, 2021
988 *
Issued
-
Exercised
( 400 )**
Expired
( 350 )
Outstanding at December 31, 2022
238
*
Weighted
average exercise price for outstanding warrants is $ 0.56 .
**
Converted
into 400 thousand shares of common stock.
Note
13 – Accumulated Other Comprehensive Income/(Loss)
The
following table summarizes the changes in accumulated other comprehensive income/(loss) by components during the years ended December
31, 2022 and 2021:
Schedule
of Components of Accumulated Other Comprehensive (Loss)/Income
Net Unrealized Gains/(Losses) on Available-for-Sale Securities
Accumulated Other Comprehensive Income/(Loss)
Balance, December 31, 2020
$ 228
$ 228
Net unrealized loss on securities available-for-sale
( 373 )
( 373 )
Balance, December 31, 2021
$ ( 145 )
$ ( 145 )
Net unrealized loss on securities available-for-sale
( 679 )
( 679 )
Balance, December 31, 2022
$ ( 824 )
$ ( 824 )
All
components of accumulated other comprehensive income/(loss) are net of tax.
Note
14 – Stock-based Compensation
The
Company’s Amended and Restated 2013 Equity Compensation Plan (the “Plan”) provides for the granting of incentive stock
options, nonqualified stock options, restricted stock units, performance units, and stock purchase rights to eligible employees, officers,
non-employee directors and other individual service providers. Options under the Plan may be granted at prices not less than 100% of
the fair value of the shares on the date of grant as determined by the Compensation Committee of the Board of Directors. The Compensation
Committee determines the period over which the options become exercisable subject to certain restrictions as defined in the Plan, with
the current outstanding options generally vesting over three or four years. The term of the options is no longer than ten years . As of
December 31, 2022, the Company had 45,603,238 shares of common stock authorized for issuance under the Plan.
With
the approval of the Board of Directors and a majority of shareholders, effective May 8, 2014, the Plan was amended and restated. The
amendment provides for an automatic increase in the number of shares of common stock available for issuance under the Plan each January
(with Board approval), commencing January 1, 2015 in an amount up to four percent ( 4 %) of the total number of shares of common stock
outstanding on the preceding December 31st.
The
Company recognized stock-based compensation expense (options and restricted share grants) in the following expense categories of its
consolidated statements of operations as follows:
Schedule
of Recognized Stock-Based Compensation
Year Ended December 31,
2022
2021
Research and Development
$ 2,400
$ 1,870
General and Administrative
2,828
2,422
Total
$ 5,228
$ 4,292
F- 23
The
following table contains information about the Company’s stock plan at December 31, 2022:
Schedule
of Equity Compensation Plan by Arrangements
Awards Reserved for Issuance
Awards Issued & Exercised
Awards Available for Grant
2013 Equity Compensation Plan (in thousands)
45,603 *
39,420 **
6,183
*
Increased
by 8,651 thousand on January 1, 2022, representing 4 % of the total number of shares of common stock outstanding on December 31, 2021.
**
Includes
both stock grants and option grants
Stock
Options
The
following table summarizes the Company’ stock option activity and related information for the period from January 1, 2021 to December
31, 2022 (options in thousands):
Schedule
of Stock Option Activity
Number of Options
Weighted Average Exercise Price
Weighted Average Contractual Term in Years
Outstanding at December 31, 2020
22,551
$ 1.26
6.9
Granted
10,976
1.11
Exercised
( 1,077 )
0.60
Forfeited
( 2,824 )
1.08
Expired
( 1,442 )
1.98
Outstanding at December 31, 2021
28,184
$ 1.21
7.2
Granted
8,509
0.56
Exercised
( 195 )
0.51
Forfeited
( 175 )
0.96
Expired
( 1,584 )
1.06
Outstanding at December 31, 2022
34,739
$ 1.07
7.1
The
following table summarizes outstanding options at December 31, 2022, by their exercise price (options in thousands):
Summary
of Outstanding Options
Range of Exercise Prices
Number Outstanding
Weighted Average Exercise Price Per Share
$ 0.41 - $ 0.69
8,390
$ 0.52
$ 0.73 - $ 0.92
9,828
$ 0.86
$ 0.93 - $ 1.28
8,284
$ 1.08
$ 1.36 - $ 3.32
8,237
$ 1.88
34,739
$ 1.07
As
of December 31, 2022, the number of vested shares underlying outstanding options was 19,578,859 at a weighted average exercise price
of $ 1.23 . The aggregate intrinsic value of in-the-money options outstanding as of December 31, 2022 was $ 90 . The aggregate intrinsic
value is calculated as the difference between the Company’s closing stock price of $ 0.50 on December 31, 2022, and the exercise
price of options, multiplied by the number of options. As of December 31, 2022, there was $ 9,997 of total unrecognized share-based compensation.
Such costs are expected to be recognized over a weighted average period of approximately 2.6 years.
F- 24
All
outstanding options expire ten
years from
date of grant. Options granted to employees prior to 2018 vest in equal monthly installments over three years. Beginning in 2018, options
granted to employees vest over four years, with 25 %
of the shares vesting on the first annual anniversary of grant and the remaining shares vesting in 36 equal monthly installments over
the following 3 years.
Restricted
Stock Awards
During
the years ended December 31, 2022 and 2021, the Company granted restricted stock awards for 0 and 31,769 shares of common stock, respectively.
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
to a consulting agreement. The Company values restricted stock awards at the fair market value on the date of grant. The Company recorded
the value of these restricted awards as general and administrative expense of $ 0 and $ 100 in the consolidated statement of operations
for the years ended December 31, 2022 and 2021, respectively.
The
Company recognizes compensation expense for restricted stock awards on a straight-line basis over the applicable service period of the
award. The service period is generally the vesting period, with the exception of awards granted subject to a vendor’s consulting
agreement, whereby the award vesting period and the service period defined pursuant to the terms of the consulting agreement may be different.
The following weighted-average assumptions were used to calculate share-based compensation for the comparative periods presented:
Schedule of Stock Option Awards and Restricted Stock Awards
For the Year Ended December 31,
2022
2021
Volatility
92.1 % - 98.7 %
98.4 %
- 101.6 %
Risk-free interest rate
1.57 % - 4.32 %
0.47 %
- 1.28 %
Dividend yield
0.0 %
0.0 %
Expected life
6.0 years
6.0
years
The
Company does not have sufficient historical information to develop reasonable expectations about future exercise patterns and post-vesting
employment termination behavior. Hence, the Company uses the “simplified method” described in Staff Accounting Bulletin (SAB)
107 to estimated the expected term of share option grants.
The
expected stock price volatility assumption is based the Company’s historical stock price volatility.
Note
15 – Subsequent Events
None
F- 25