Item 9A. Controls and Procedures
Item
9A.
Controls
and Procedures
Evaluation
of Disclosure Controls and Procedures
Disclosure
Controls and Procedures:
As
of December 31, 2021, 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, 2021.
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.
69
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.
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, 2021, 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 period ended December 31, 2021 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)
Herbert
Conrad
89
Chairman
of the Board, Director
Jerome
D. Jabbour
47
Chief
Executive Officer and President, Director
James
J. Ferguson
68
Chief
Medical Officer
Thomas
J. Hoover
52
Chief
Business Officer
Keith
A. Kucinski
52
Chief
Financial Officer
Hui
Liu
54
Chief
Technology Officer
Raphael
J. Mannino
74
Chief
Scientific Officer
Theresa
Matkovits
54
Chief
Development Officer
Kathryn
Corzo
61
Director
Eric
Ende
53
Director
Natasha
Giordano
60
Director
James
S. Scibetta
57
Director
Matthew
Wikler
72
Director
70
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 health care 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.
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 US 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, (now Tempest Therapeutics, Inc.) a 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., a global biopharmaceutical company. 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.
71
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.
Raphael
J. Mannino has served as our Chief Scientific Officer since September 2015. From 1990 until August 2015, Dr. Mannino was an Associate
Professor of Pathology and Laboratory Medicine at Rutgers University, New Jersey Medical School. Dr. Mannino founded BioDelivery Sciences,
Inc., and served as its President, Chief Executive Officer and Chief Scientific Officer and a member of its Board of Directors from 1995
to 2000, when it was acquired by BioDelivery Sciences International, Inc. (NASDAQ: BDSI). Dr. Mannino served as BDSI’s Executive
Vice President and Chief Scientific Officer from 2001 to 2009 and a member of its Board of Directors from 2000 to 2007. Dr. Mannino’s
previous experience includes positions as Assistant, then Associate Professor, Albany Medical College (1980 to 1990), and Instructor
then Assistant Professor, Rutgers Medical School (1977 to 1980). His postdoctoral training was from 1973 to 1976 at the Biocenter in
Basel, Switzerland. Dr. Mannino received his Ph.D. in Biological Chemistry in 1973 from the Johns Hopkins University, School of Medicine.
Theresa
Matkovits, PhD has served as Chief Development officer since October 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) and GoodCap Pharmaceuticals, a privately held pharmaceutical company . Dr. Matkovits earned her Ph.D. in Biochemistry
and Molecular Biology from the University of Medicine and Dentistry of NJ.
Directors
Herbert
Conrad has served as our Chairman of the Board since July 2013 and as Chairman of the Board of Matinas BioPharma, Inc. since
October 2012. 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.
72
Jerome
D. Jabbour. See description under “Management.”
Kathryn Corzo, RPh, MBA has served
on our board of directors since November 2021. Ms. Corzo is currently the Chief Operating Officer
of bit.bio Ltd, a privately funded company coding human cells to precision engineer the next generation of medicines, a
position she has held since 2021. Prior to bit.bio, Ms. Corzo was partner at Takeda Ventures, Inc., the corporate investment arm
of Takeda Pharmaceutical Company Limited, and also served as Head, Oncology Cell Therapy Development at Takeda Pharmaceutical Company
Limited (TSE: 4502/NYSE: TAK), a global biopharmaceutical company, a position she held since 2020. Before Takeda, Ms. Corzo was Vice
President, R&D Myeloma Program Leader at Sanofi Genzyme, a specialty care global business unit of Sanofi, from 2010 to 2019. From
1989-2010, Ms. Corzo worked at Hoffman – La Roche, Roche Molecular Systems, Eli Lilly and Syndax, 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. Ms. Corzo holds an MBA from Massachusetts Institute of Technology Sloan School
of Management and a Bachelor of Science in Pharmacy from Massachusetts College of Pharmacy. We believe Ms. Corzo is qualified to serve
on our Board of Directors due to her broad experience in the life sciences industry.
Eric
Ende has served on our board of directors since April 2017. 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 and since January 2022 also serves on the board of NeuBase Therapeutics.
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.
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), a late-stage specialty pharmaceutical company, 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 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.
73
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, a privately held precision immunology company. 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 held since October 2015. Prior to that, Mr. Scibetta was the Chief Financial Officer of Pacira
Biosciences, Inc. (NASDAQ: PCRX), a non-opioid pain management and regenerative health solutions company, 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.
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 cardiovascular medicine as well as infectious diseases
to provide counsel and support our growth. We have established two separate Scientific Advisory Boards for MAT2203 and MAT2501, respectively,
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 four standing committees — an Audit Committee, a Compensation Committee, a Nominating and Corporate Governance
Committee and a Scientific Advisory Committee.
74
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, Eric Ende and Natasha Giordano currently serve as members of the Audit Committee, with James Scibetta, serving as its chairman.
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 2021. 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. Eric Ende, Kathryn Corzo, James Scibetta
and Matthew Wikler currently serve as members of the Compensation Committee, with Eric Ende serving as its chairman. All members of the
Compensation Committee are considered independent directors as defined under the NYSE MKT’s listing standards. The Compensation
Committee met four times during 2021. 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, Eric Ende, and James Scibetta currently serve as members of the Nominating and Corporate Governance
Committee, with Herbert Conrad serving as its chairman. 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 2021. Our Board has adopted a Nominating and Corporate Governance Charter, which is available for viewing at www.matinasbiopharma.com .
Scientific
Advisory Committee . The Board of Directors has established a Scientific Advisory Committee consisting of Dr. Matthew Wikler,
Chair, and Jerome D. Jabbour. The primary function of the Scientific Advisory Committee is to assist the Board in undertaking periodic
reviews of our research and development efforts, and clinical trials, and reporting to the Board about developments and strategy, at
such times as the Committee determines to be appropriate.
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.
75
Item
11.
Executive
Compensation
Summary
Compensation Table – 2021
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, 2021 for services rendered
in all capacities to us for the years ended December 31, 2021 and December 31, 2020. These individuals are our named executive officers
for 2021.
Name
and Principal Position
Year
Salary
($)
Bonus
($)
Option
Awards
($)
(1)
All
Other Compensation ($)
Total
($)
Jerome
D. Jabbour
2021
545,000
250,000
2,898,314
-
3,693,314
Chief
Executive Officer
2020
500,000
250,000
2,180,085
-
2,930,085
James
J. Ferguson
2021
422,300
164,000
1,035,637
1,621,937
Chief
Medical Officer
2020
410,000
150,000
1,090,043
-
1,650,043
Theresa
Matkovits
2021
378,525
147,000
812,636
-
1,338,161
Chief
Development Officer
2020
367,500
122,500
763,030
-
1,253,030
(1) Amounts
reflect the grant date fair value of option awards granted in 2021 and 2020 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. 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. 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 received an option grant to purchase 1,000,000 shares on March 22, 2018 and is also eligible to receive additional
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. In addition, the vesting of 50% of his outstanding options 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 up to 24 months of his base salary and 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.
Ferguson
On
February 22, 2019, we entered into an employment agreement with Mr. Ferguson which was effective as of February 25, 2019. Under the terms
of Mr. Ferguson’s employment agreement, Mr. Ferguson receives a base salary of $375,000 per year. 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 will be accelerated in full upon such termination. 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.
76
Matkovits
On
September 25, 2018, we entered into an employment agreement with Ms. Matkovits which was effective as of October 15, 2018. Under the
terms of Ms. Matkovits’ employment agreement, Ms. Matkovits receives a base salary of $350,000 per year. In addition, Ms. Matkovits
is eligible to receive an annual bonus, which is targeted at 35% of her base salary but which may be adjusted by our Compensation Committee
based on her individual performance and our performance as a whole. Ms. Matkovits is also eligible to receive option grants at the discretion
of our Compensation Committee. If we terminate Ms. Matkovits’ employment without cause or Ms. Matkovits resigns with good reason,
we are required to pay her severance of up to twelve months of his base salary plus benefits. In addition, the vesting of 50% of her
outstanding options will be accelerated in full upon such termination. Ms. Matkovits is also subject to a customary non-disclosure agreement,
pursuant to which Ms. Matkovits has agreed to be subject to a non-compete during the term of her employment and for a period of eighteen
months following termination of his employment.
Outstanding
Equity Awards at Fiscal Year-End Table – 2021
The
following table summarizes, for each of the named executive officers, the number of shares of common stock underlying outstanding stock
options held as of December 31, 2021.
Option
Awards
Name
Number
of
securities
underlying
unexercised
options
(#)
exercisable
Number
of
securities
underlying
unexercised
options
(#)
unexercisable
Option
exercise
price
($)
Option
expiration
date
Jerome
D. Jabbour
-
1,658,100
$ 0.92
Dec
13, 2031
-
1,600,000
$ 1.36
Dec
31, 2030
479,167
520,833
$ 2.27
Dec
31, 2029
531,250
218,750
$ 1.08
Feb
10, 2029
937,500
62,500
$ 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
-
587,600
$ 0.92
Dec
13, 2031
-
575,000
$ 1.36
Dec
31, 2030
239,584
260,416
$ 2.27
Dec
31, 2029
247,917
102,083
$ 1.09
Feb
24, 2029
Theresa
Matkovits
-
500,000
$ 0.92
Dec
13, 2031
-
425,000
$ 1.36
Dec
31, 2030
167,709
182,291
$ 2.27
Dec
31, 2029
247,917
102,083
$ 1.08
Feb
10, 2029
277,084
72,916
$ 0.79
Oct
14, 2028
77
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.
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 February 25, 2022 the aggregate number of shares of common stock available for issuance in connection
with awards granted under the 2013 Plan is 45,603,238 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.
78
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).
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.
79
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.
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.
80
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.
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; (vi) the chair of our nominating and corporate governance committee is entitled
to receive an annual fee of $7,500, increasing to $8,000 on January 1, 2022, and other members are entitled to receive
$4,000; and (vii) the chair of our scientific advisory committee is entitled to receive an annual fee of $7,500, increasing to
$8,000 on January 1, 2022.
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 $80,000 as determined by the Black Scholes method on the date of grant under our existing equity incentive
plan, or any other equity incentive plan we may adopt in the future, which shall vest in twelve equal monthly installments.
All
fees under the director compensation policy are paid on a quarterly basis in arrears and no per meeting fees are paid. All fees may be
paid in unrestricted shares of common stock at the election of the director. We also reimburse non-employee directors for reasonable
expenses incurred in connection with attending board of director and committee meetings.
81
Director
Compensation Table – 2021
The
following table summarizes the annual compensation for our non-employee directors during 2021.
Name
Cash
Compensation
($)
Stock
Awards
($)
(1)
Option
Awards
($) (1)
Total
($)
Herbert
Conrad
90,000
-
80,000
170,000
Kathryn
Corzo
9,283
-
160,000
169,283
Eric
Ende
71,500
-
80,000
151,500
Natasha
Giordano
57,500
-
80,000
137,500
Patrick
G. LePore
66,739
-
-
66,739
James
S. Scibetta
75,000
-
80,000
155,000
Matthew
Wikler
31,750
31,750
80,000
143,500
(1)
Amounts
reflect the grant date fair value of stock awards and option awards granted in 2021 in accordance with Accounting Standards Codification
Topic 718. These amounts do not correspond to the actual value that will be recognized by the directors.
Compensation
Committee Interlocks and Insider Participation
The
Compensation Committee of the Board of Directors is currently composed of the following four non-employee directors: Eric Ende, Chair,
Kathryn Corzo, James Scibetta and Matthew Wikler, with Ms. Corzo replacing Mr. LePore on the committee following the Company’s
last Annual Shareholder meeting. 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. Please 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 February 25, 2022 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 216,864,526 shares outstanding as of February 25, 2022. 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, February 25, 2022 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.
82
Name
of Beneficial Owner
Number
of Shares
Beneficially Owned
Percentage
of Shares
Beneficially Owned
Directors
and Executive Officers
Jerome
D. Jabbour (1)
4,129,074
1.9 %
Herbert
Conrad (2)
5,889,819
2.7 %
Kathryn
Corzo (3)
25,245
* %
Eric
Ende (4)
1,076,012
* %
Natasha
Giordano (5)
197,398
* %
James
Scibetta (6)
1,644,378
* %
Matthew
Wikler (7)
1,070,309
* %
James
J. Ferguson (8)
738,022
* %
Thomas
J. Hoover (9)
-
* %
Keith
A. Kucinski (10)
868,459
* %
Hui
Liu (11)
194,792
* %
Raphael
Mannino (12)
2,839,091
1.3 %
Theresa
Matkovits (13)
913,022
* %
Directors
and Executive Officers as a group (13 persons) (14)
19,585,621
8.6 %
*
Less than 1%
(1)
Includes 3,668,750 shares of common stock issuable upon exercise of options that are exercisable within sixty days of February 25, 2022.
Does not include 3,351,850 shares of common stock underlying options that are not exercisable within sixty days of February 25, 2022.
(2)
Includes 1,195,253 shares of common stock issuable upon exercise of options that are exercisable within sixty days of February 25, 2022.
Does not include 45,441 shares of common stock underlying options that are not exercisable within sixty days of February 25, 2022.
(3)
Includes 25,245 shares of common stock issuable upon exercise of options that are exercisable within sixty days of February 25, 2022.
Does not include 156,518 shares of common stock underlying options that are not exercisable within sixty days of February 25, 2022.
(4)
Includes 931,920 shares of common stock issuable upon exercise of options that are exercisable within sixty days of February 25, 2022.
Does not include 45,441 shares of common stock underlying options that are not exercisable within sixty days of February 25, 2022.
(5)
Includes 197,398 shares of common stock issuable upon exercise of options that are exercisable within sixty days of February 25, 2022.
Does not include 181,401 shares of common stock underlying options that are not exercisable within sixty days of February 25, 2022.
(6)
Includes 994,420 shares of common stock issuable upon exercise of options that are exercisable within sixty days of February 25, 2022.
Does not include 45,441 shares of common stock underlying options that are not exercisable within sixty days of February 25, 2022.
(7)
Includes 779,837 shares of common stock issuable upon exercise of options that are exercisable within sixty days of February 25, 2022.
Does not include 47,524 shares of common stock underlying options that are not exercisable within sixty days of February 25, 2022.
(8)
Includes 738,022 shares of common stock issuable upon exercise of options that are exercisable within sixty days of February 25, 2022.
Does not include 1,274,578 shares of common stock underlying options that are not exercisable within sixty days of February 25, 2022.
(9)
Does not include 850,000 shares of common stock underlying options that are not exercisable within sixty days of February 25, 2022.
83
(10)
Includes 773,959 shares of common stock issuable upon exercise of options that are exercisable within sixty days of February 25, 2022.
Does not include 1,101,041 shares of common stock underlying options that are not exercisable within sixty days of February 25, 2022.
(11)
Includes 194,792 shares of common stock issuable upon exercise of options that are exercisable within sixty days of February 25, 2022.
Does not include 680,208 shares of common stock underlying options that are not exercisable within sixty days of February 25, 2022.
(12)
Includes 919,376 shares of common stock issuable upon exercise of options that are exercisable within sixty days of February 25, 2022.
Does not include 490,624 shares of common stock underlying options that are not exercisable within sixty days of February 25, 2022.
(13)
Includes 913,022 shares of common stock issuable upon exercise of options that are exercisable within sixty days of February 25, 2022.
Does not include 1,061,978 shares of common stock underlying options that are not exercisable within sixty days of February 25, 2022.
(14)
See notes (1) through (13).
Securities
Authorized for Issuance under Equity Compensation Plans
The
following table summarizes information about our equity compensation plans as of December 31, 2021.
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)
28,184,291
$ 1.21
4,282,530
Equity
compensation plans not approved by stockholders
—
—
—
Total
28,184,291
$ 1.21
4,282,530
(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 8,650,778 shares were automatically made available
for issuance on the first trading day of 2022, which represents 4% of the number of shares outstanding on December 31, 2021; 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, 2021, 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.
84
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.
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, 2021 and 2020, by EisnerAmper
LLP, the Company’s independent registered public accounting firm.
Years
Ended December 31,
2021
2020
(in
thousands)
Audit
Fees
$ 249
$ 297
Audit-Related Fees
-
-
Tax
Fees
-
-
Total
Fees
$ 249
$ 297
85
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 and comfort 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.
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).
3.4
Certificate of Designation of Series A Preferred Stock (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed August 1, 2016 with the Securities and Exchange Commission).
3.5
Certificate of Designation of Series B Preferred Stock (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed June 19, 2018 with the Securities and Exchange Commission).
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).
4.5
Form of 2016 Placement Agent Warrant (incorporated by reference to Exhibit 4.7 to the Registration Statement on Form S-1 filed with the SEC on November 2, 2016).
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). †
86
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). †
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. †*
10.16
Employment Agreement, dated December 6, 2021, between Matinas Biopharma Holdings, Inc. and Thomas Hoover. †*
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, 2021
and 2020; (ii) Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2021 and 2020; (iii)
Consolidated Statement of Changes in Stockholders’ Equity (Deficit) for the Years Ended December 31, 2021 and 2020; (iv) Consolidated
Statements of Cash Flows for the Years Ended December 31, 2021 and 2020; 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.
87
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 8, 2022.
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
8, 2022
Jerome
D. Jabbour
(Principal
Executive Officer)
/s/
Keith A. Kucinski
Chief
Financial Officer
March
8, 2022
Keith
A. Kucinski
(Principal
Financial and Accounting Officer)
/s/
Herbert Conrad
Chairman
of the Board
March
8, 2022
Herbert
Conrad
/s/
Kathryn Corzo
Director
March
8, 2022
Kathryn
Corzo
/s/
Eric Ende
Director
March
8, 2022
Eric
Ende
/s/
Natasha Giordano
Director
March
8, 2022
Natasha
Giordano
/s/
James S. Scibetta
Director
March
8, 2022
James
S. Scibetta
/s/
Matthew A. Wikler
Director
March
8, 2022
Matthew
A. Wikler
88
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,
2021 and 2020 and the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity,
and cash flows for each of the years in the two-year period ended December 31, 2021, 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, 2021, and the results of their operations and their cash flows for each of the
years in the two-year period ended December 31, 2021, 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) relate 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
for research and development expenses
As
disclosed in the consolidated statements of operations, for the year ended December 31, 2021, the Company incurred significant research
and development (“R&D”) expenses, which amounted to approximately $14.6 million. At December 31, 2021, the Company had
accrued $1.3 million for R&D expenses on the consolidated balance sheet. A large 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, and
there may be several milestones of the services in one agreement. Therefore, the allocation of the service expenses based on the progress
of the R&D projects and the milestones completed for the appropriate financial reporting period involved 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 subjectivity involved in estimating the progress of the R&D projects and service fees accrued
for the completion of milestones by the CROs and CMOs. As a result, auditor judgement and additional testing were required to perform
procedures and evaluate audit evidence related to the accruals for R&D expenses.
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 the 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 related to the accrual process for R&D
expenses; (ii) we read selected research agreements to evaluate whether the progress and the completion of milestones reported by the
representatives of the CROs and CMOs and the corresponding service fees are based on the respective contractual terms, (iii) we sent
confirmations to CROs and CMOs, on a sample basis, to confirm the amount of the total R&D service fees incurred for the year and
the amounts of outstanding payables under the terms of the contracts, and (iv) we selected projects from the open contract list at year
end and made inquiries of the Company research personnel regarding the project status, and we also inspected invoices received subsequent
to year-end and additional documents and correspondence with the CROs and CMOs, supporting management’s estimate of R&D expenditures.
/s/
EisnerAmper LLP
We
have served as the Company’s auditor since 2011.
EISNERAMPER
LLP
Iselin,
New Jersey
March
8, 2022
F- 1
Matinas
BioPharma Holdings, Inc.
Consolidated
Balance Sheets
2021
2020
December
31,
2021
2020
ASSETS:
Current
assets:
Cash
and cash equivalents
$ 21,029,806
$ 12,432,481
Marketable
securities
28,592,049
46,246,573
Restricted
cash
50,000
136,000
Prepaid
expenses and other current assets
1,321,466
2,739,791
Total
current assets
50,993,321
61,554,845
Non-current
assets:
Leasehold
improvements and equipment - net
1,537,728
1,523,950
Operating
lease right-of-use assets - net
4,218,890
3,276,639
Finance
lease right-of-use assets - net
22,270
58,007
In-process
research and development
3,017,377
3,017,377
Goodwill
1,336,488
1,336,488
Restricted
cash - security deposits
200,000
200,000
Total
non-current assets
10,332,753
9,412,461
Total
assets
$ 61,326,074
$ 70,967,306
LIABILITIES
AND STOCKHOLDERS’ EQUITY:
Current
liabilities:
Accounts
payable
$ 938,270
$ 349,941
Accrued
expenses and other liabilities
2,850,888
2,795,329
Operating
lease liabilities - current
538,546
391,498
Financing
lease liabilities - current
21,039
30,853
Total
current liabilities
4,348,743
3,567,621
Non-current
liabilities:
Deferred
tax liability
341,265
341,265
Operating
lease liabilities - net of current portion
4,140,387
3,304,063
Financing
lease liabilities - net of current portion
2,621
23,660
Total
non-current liabilities
4,484,273
3,668,988
Total
liabilities
8,833,016
7,236,609
Stockholders’
equity:
Series
B Convertible preferred stock, stated value $ 1,000 per share, 8,000 shares authorized as of December 31, 2021 and 2020, respectively;
0 and 4,361 shares issued and outstanding as of December 31, 2021 and 2020, respectively
-
3,797,705
Common
stock par value $ 0.0001 per share, 500,000,000 shares authorized at December 31, 2021 and 2020, respectively; 216,269,450 and 200,113,431
issued and outstanding as of December 31, 2021 and 2020, respectively
21,627
20,010
Additional
paid-in capital
184,251,138
167,192,003
Accumulated
deficit
( 131,634,208 )
( 107,507,193 )
Accumulated
other comprehensive (loss)/income
( 145,499 )
228,172
Total
stockholders’ equity
52,493,058
63,730,697
Total
liabilities and stockholders’ equity
$ 61,326,074
$ 70,967,306
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
2021
2020
For
the Year Ended December 31,
2021
2020
Revenue:
Contract
research revenue
$ 33,333
$ 158,333
Costs
and Expenses:
Research
and development
14,583,283
14,358,918
General
and administrative
10,184,805
10,005,967
Total
costs and expenses
24,768,088
24,364,885
Loss
from operations
( 24,734,755 )
( 24,206,552 )
Sale
of New Jersey net operating loss
1,328,470
1,073,289
Other
income, net
122,870
686,425
Net
loss
$ ( 23,283,415 )
$ ( 22,446,838 )
Preferred
stock series B accumulated dividends
( 395,799 )
( 793,442 )
Net
loss attributable to common shareholders
$ ( 23,679,214 )
$ ( 23,240,280 )
Net
loss attributable to common shareholders per share – basic and diluted
$ ( 0.11 )
$ ( 0.12 )
Weighted
average common shares outstanding:
Basic
and diluted
210,178,332
196,894,628
Other
comprehensive (loss)/income, net of tax
Net
unrealized (loss)/gain on securities available-for-sale
( 373,671 )
237,537
Reclassification
of realized gain on securities available-for-sale to net loss
-
( 8,485 )
Other
comprehensive (loss)/income, net of tax
( 373,671 )
229,052
Comprehensive
loss attributable to shareholders
$ ( 23,657,086 )
$ ( 22,217,786 )
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
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, 2019
4,577
$ 3,985,805
163,156,984
$ 16,315
$ 113,427,897
$ ( 84,377,555 )
$ ( 880 )
$ 33,051,582
Stock-based
compensation
-
-
-
-
4,184,141
-
-
4,184,141
Issuance
of common stock as compensation for services
-
-
379,385
38
390,604
-
-
390,642
Issuance
of common stock in exchange for preferred shares B
( 216 )
( 188,100 )
432,000
43
188,057
-
-
-
Issuance
of common stock in public offering, net of stock issuance costs ($ 3,308,790 )
-
-
32,260,000
3,226
46,700,984
-
-
46,704,210
Issuance
of common stock in exchange for Options
-
-
782,073
79
820,248
-
-
820,327
Issuance
of common stock in exchange for Warrants
-
-
1,737,389
172
797,409
-
-
797,581
Stock
dividends
-
-
1,365,600
137
682,663
( 682,800 )
-
-
Other
comprehensive income
-
-
-
-
-
229,052
229,052
Issuance
of common stock pursuant to the Aquarius Merger
-
-
Issuance
of common stock pursuant to the Aquarius Merger, shares
-
-
Net
loss
-
-
-
-
-
( 22,446,838 )
-
( 22,446,838 )
Balance,
December 31, 2020
4,361
$ 3,797,705
200,113,431
$ 20,010
$ 167,192,003
$ ( 107,507,193 )
$ 228,172
$ 63,730,697
Stock-based
compensation
-
-
-
-
4,192,082
-
-
4,192,082
Issuance
of common stock as compensation for services
-
-
31,769
4
31,748
-
-
31,752
Issuance
of common stock in exchange for preferred shares B
( 4,361 )
( 3,797,705 )
8,722,000
873
3,796,832
-
-
-
Issuance
of common stock in public offering, net of stock issuance costs ($ 172,592 )
-
-
3,023,147
302
5,580,169
-
-
5,580,471
Issuance
of common stock in public offering, net of stock issuance costs
-
-
3,023,147
302
5,580,169
-
-
5,580,471
Issuance
of common stock in exchange for Options
-
-
1,076,946
107
1,415,035
-
-
1,415,142
Issuance
of common stock in exchange for Warrants
-
-
114,957
12
( 12 )
-
-
-
Issuance
of common stock pursuant to the Aquarius Merger
-
-
1,500,000
150
1,199,850
-
-
1,200,000
Stock
dividends
-
-
1,687,200
169
843,431
( 843,600 )
-
-
Other comprehensive
(loss)
-
-
-
-
-
-
( 373,671 )
( 373,671 )
Other
comprehensive income loss
-
-
-
-
-
-
( 373,671 )
( 373,671 )
Net
loss
-
-
-
-
-
( 23,283,415 )
-
( 23,283,415 )
Balance,
December 31, 2021
-
$ -
216,269,450
$ 21,627
$ 184,251,138
$ ( 131,634,208 )
$ ( 145,499 )
$ 52,493,058
The
accompanying notes are an integral part of these consolidated financial statements.
F- 4
Matinas
BioPharma Holdings, Inc.
Consolidated
Statements of Cash Flows
2021
2020
For
the Year Ended December 31,
2021
2020
Cash
flows from operating activities:
Net
loss
$ ( 23,283,415 )
$ ( 22,446,838 )
Adjustments
to reconcile net loss to net cash used in operating activities:
Depreciation
and amortization
244,395
231,058
Loss
on disposal of equipment
2,207
-
Stock-based
compensation expense
4,292,355
4,564,787
Amortization
of operating lease right-of-use assets
501,359
484,568
Amortization
of finance lease right-of-use assets
35,737
58,961
Amortization
of bond discount
250,453
239,831
Realized
gain on sale of marketable securities
-
8,485
Stock
issued pursuant to the Aquarius Merger Agreement charged to Research and Development
1,200,000
-
Changes
in operating assets and liabilities:
Operating
lease liabilities
( 460,239 )
( 423,741 )
Prepaid
expenses and other current assets
1,349,804
( 611,397 )
Accounts
payable
588,329
( 329,369 )
Accrued
expenses and other liabilities
55,560
855,819
Net
cash used in operating activities
( 15,223,455 )
( 17,367,836 )
Cash
flows from investing activities:
Purchases
of marketable securities
( 23,194,600 )
( 72,106,359 )
Proceeds
from sales of marketable securities
40,225,000
31,445,156
Purchases
of leasehold improvements and equipment
( 260,380 )
( 5,749 )
Net
cash provided by/(used in) investing activities
16,770,020
( 40,666,952 )
Cash
flows from financing activities:
Net
proceeds from public offering of common stock
5,580,471
46,704,210
Proceeds
from exercise of warrants
-
797,581
Proceeds
from exercise of options
1,415,142
599,713
Payments
of capital lease liability – principal
( 30,853 )
( 54,673 )
Net
cash provided by financing activities
6,964,760
48,046,831
Net
increase/(decrease) in cash, cash equivalents and restricted cash
8,511,325
( 9,987,957 )
Cash,
cash equivalents and restricted cash at beginning of period
12,768,481
22,756,438
Cash,
cash equivalents and restricted cash at end of period
$ 21,279,806
$ 12,768,481
Supplemental
non-cash financing and investing activities:
Unrealized
(loss)/gain on marketable securities
$ ( 373,671 )
$ 229,052
Cashless
exercise of warrants
$ 12
$ -
Stock
dividends issued
$ 843,600
$ 682,800
Non-cash
prepaid from exercise of options
$ -
$ 220,614
Preferred
stock conversion into common stock - series B
$ 3,797,705
$ 188,100
Unearned
restricted stock grants
$ -
$ 68,521
Right-of-use
asset in exchange from liabilities from operating lease
$ 1,443,610
$ -
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” or “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, 2021,
the Company had an accumulated deficit of approximately $ 131.6
million. The Company’s net loss for
the years ended December 31, 2021 and 2020 were approximately $ 23.3
million and $ 22.4
million, respectively.
The
Company has been engaged in developing LYPDISO (formerly MAT9001) as well as 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.
Assuming
the Company obtains 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.
To
continue to fund operations, during January 2021, the Company sold 3,023,147 shares of common stock under its At-The-Market Sales Agreement
with BTIG, LLC, generating gross proceeds of approximately $ 5.8 million and net proceeds of approximately $ 5.6 million. In addition,
on January 14, 2020, the Company completed an underwritten public offering of 32,600,000 shares of common stock, generating gross cash
proceeds of approximately $ 50.0 million and net proceeds of approximately $ 46.7 million. (See Note 12 – Stockholders’ Equity).
As
of December 31, 2021, the Company had cash and cash equivalents of approximately $ 21.0 million, marketable securities of approximately
$ 28.6 million and restricted cash of approximately $ 0.3 million. The Company believes the cash and cash equivalents and marketable securities
on hand are sufficient to fund planned operations through 2023.
Note
3 – Summary of Significant Accounting Policies
Basis
of presentation and principles of consolidation
The
accompanying audited 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 of America (“U.S. GAAP”) and reflect the operations of the Company and
its wholly owned subsidiaries. All intercompany transactions have been eliminated in consolidation.
F- 6
COVID-19
In
March 2020, the World Health Organization declared COVID-19 a global pandemic. This contagious disease outbreak, which has continued
to spread, and any related adverse public health developments, has adversely affected workforces, economics, and financial markets globally,
potentially leading to an economic downturn.
The
Company has been actively monitoring the COVID-19 pandemic and its impact globally. The financial results for the year ended December
31, 2021 were not significantly impacted by COVID-19. However, the Company cannot predict the impact of the progression of the COVID-19
pandemic 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 suppliers to continue to operate and deliver, the ability of the Company
to maintain operations, any further government and/or public actions taken in response to the pandemic and ultimately the length of the
pandemic.
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, level 3 fair value measurement of financial instruments, income tax
valuations, the determination of stock-based compensation and contingent consideration.
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
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 Securities.
Marketable
Securities
Marketable
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 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 securities, see Note 4 –
Cash, Cash Equivalents, Restricted Cash and Marketable Securities.
F- 7
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 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 are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to
regulatory limits. The Company has not experienced any credit losses associated with its balances in such accounts.
Leasehold
improvements and equipment
Equipment
and leasehold improvements 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.
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, 2021 and 2020, the Company assessed goodwill impairment
by performing a qualitative test for its reporting unit. As part of the qualitative review, the Company considered its cash position
and its ability to obtain additional financing in the near term to meet its operational and strategic goals and substantiate the value
of its business. Based on the results of the Company’s assessment, it was determined that it is more-likely-than-not that the fair
value of the reporting unit is greater than its carrying amount. There were no impairments of goodwill during the years ended December
31, 2021 and 2020. If a nonrecurring fair value measurement for a goodwill impairment was required, sufficient information will be provided
to permit reconciliation of the fair value of the asset categorized within the fair value hierarchy as level 3 to the amounts presented
in the statement of financial position.
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 approach for testing 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 not impaired
during the years ended December 31, 2021 and 2020.
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.
F- 8
Preferred
stock dividends
S ubject
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.
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.
The
Company adopted the provisions of Accounting Standard Codification 740-10 and has analyzed its filing positions in 2021 and 2020 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, 2021.
Since
the Company incurred net operating losses in every tax year since inception, the 2014 through 2020 income tax returns are subject to
examination and adjustments by the IRS 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 that are recognized in the consolidated statement of operations
based on their fair values at the date of grant.
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 amount of stock-based compensation recognized during a period is based on the value of the portion of the awards that are ultimately
expected to vest. The Company accounts for forfeitures as they occur. The term “forfeitures” is distinct from “cancellations”
or “expirations” and represents only the unvested portion of the surrendered stock option or warrant.
The
resulting stock-based 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.
F- 9
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 they 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.
During
the years ended December 31, 2021 and 2020, 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, warrants and conversion of preferred stock, would have an anti-dilutive effect. The reconciliation of the
diluted shares as of December 31, 2021 and 2020 are as follows (in thousands):
Schedule
of Anti-dilutive Securities
As
of December 31,
2021
2020
Stock
options
28,184
22,551
Preferred
Stock and accrued dividend upon conversion
-
8,722
Warrants
988
1,328
Total
29,172
32,601
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 years ended December 31, 2020, the Company’s revenues primarily consist of a research grant to provide research and development
services to the Cystic Fibrosis Foundation (“CFF”). The grant contract has a single performance obligation that is recognized
over time as the services are performed. There are no contract assets or liabilities associated with this grant. The Company had approximately
$ 125 thousand of CFF research grant revenue for the year ended December 31, 2020.
On
December 12, 2019, the Company entered into a feasibility study agreement (the “Agreement”) with Genentech, Inc. (“Genentech”).
This feasibility study will involve the development of oral formulations using the Company’s LNC platform delivery technology,
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 thousand for three molecules, or approximately $ 33 thousand 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 or liabilities associated with this Agreement. As certain Agreement
performance obligations in this agreement were completed, disaggregation of revenue is not required. As of December 31, 2021, the Company
completed the first and second of the three molecules and the Company recognized approximately $ 33 thousand of Genentech revenue for
the years ended December 31, 2021 and 2020, respectively. The Company is scheduled to complete the remaining molecule during 2022.
F- 10
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.
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.
F- 11
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 Income/(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, 2021 and 2020, the Company recognized
approximately $ 2.2 million and $ 0.1 million, 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, License and other Research and Development
Agreements.
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.
F- 12
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 income/(loss)
Other
comprehensive income/(loss) consists of net gains/(losses) and unrealized losses on marketable securities available-for-sale and is presented
in the Consolidated Statements of Operations.
Recently
adopted accounting pronouncements
In
December 2019, the FASB Issued Accounting Standard Update 2019-12, “Income Taxes, (Topic 740): Simplifying the Accounting
for Income Taxes”. This standard removes certain exceptions to the general principles and improves consistent application of and
simplify GAAP for other areas of Topic 740 by clarifying and amending existing guidance. This standard is effective for fiscal years,
and interim periods within those fiscal years, beginning after December 15, 2020. The Company adopted the new standard effective January
1, 2021 with no material impact on the Company’s consolidated financial statements.
Note
4 – Cash, Cash Equivalents, Restricted Cash and Marketable 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
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 represents
funds the Company is required to set aside to cover building 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, 2021, December 31, 2020 and December 31, 2019
(in thousands):
Schedule of Cash, Cash Equivalents and Restricted Cash
December
31,
2021
December
31,
2020
December
31,
2019
Cash
and cash equivalents
$ 21,030
$ 12,432
$ 22,170
Restricted
cash included in current/long term assets
250
336
586
Cash,
cash equivalents and restricted cash in the statements of cash flows
$ 21,280
$ 12,768
$ 22,756
Marketable
Securities
The
Company has classified its investments in marketable securities as available-for-sale and as a current asset. The Company’s investments
in marketable securities are carried at fair value, with unrealized gains and losses included as a separate component of stockholders’
equity. Unrealized gains and losses are classified as other comprehensive (loss)/income and costs are determined on a specific identification
basis. Realized gains and losses from our marketable securities are recorded in other income, net. For the years ended December 31, 2021
and 2020, the Company recorded unrealized (losses)/gains of approximately ($ 374 ) thousand and $ 238 thousand, respectively, and reclassed
approximately $ 0 and $ 9 thousand to net realized loss from operations from the sale of certain securities during 2021 and 2020, respectively.
As of December 31, 2021 and 2020, the Company had net accumulated unrealized losses of approximately $ 145 thousand and net accumulated
unrealized gains of approximately $ 228 thousand, respectively.
F- 13
The
following tables summarizes the Company’s marketable securities for the year ended December 31, 2021 consisted of the following
(in thousands):
Summary of Marketable Securities
Amortized Cost
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 securities
$ 28,737
$ 2
$ ( 147 )
$ 28,592
Maturities
of debt securities classified as available-for-sale were as follows at December 31, 2021 (in thousands):
Schedule of Maturities of Debt Securities Available-for-sale
Fair
Value
Net
Carrying Amount
Due
within one year
$ 8,257
$ 8,310
Due
after one year through five years
20,335
20,402
$ 28,592
$ 28,712
The
following tables summarizes the Company’s marketable securities for the year ended December 31, 2020 consisted of the following
(in thousands):
Amortized Cost
Unrealized Gain
Unrealized (Loss)
Fair Value
Amortized
Cost
Unrealized
Gain
Unrealized
(Loss)
Fair
Value
U.S.
Treasury Bonds
$ 18,293
$ 136
$ —
$ 18,429
U.S.
Government Notes
22,148
82
—
22,230
Corporate
Debt Securities
4,303
3
—
4,306
State
and Municipal Bonds
1,275
7
—
1,282
Total
marketable securities
$ 46,019
$ 228
$ —
$ 46,247
Maturities
of debt securities classified as available-for-sale were as follows at December 31, 2020 (in thousands):
Fair
Value
Net
Carrying Amount
Due
within one year
$ 31,438
$ 31,602
Due
after one year through five years
14,809
14,845
$ 46,247
$ 46,447
The
Company determined that the unrealized (losses) and gains are deemed to be temporary as of December 31, 2021 and 2020. 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. The Company has the ability and intent
to hold these investments until maturity. The Company does not consider the investment in marketable securities to be other-than-temporarily
impaired at December 31, 2021 and 2020.
F- 14
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 certain cash and cash equivalents, current portion of restricted cash, marketable securities, prepaid expenses and
other current assets, accounts payable, current portion of lease liability 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 (in thousands):
Schedule of Fair Value Measurement of Assets and Liabilities
Fair
Value Hierarchy
December
31, 2021
Total
(Level
1)
(Level
2)
(Level
3)
Assets
Marketable
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
$ —
Fair
Value Hierarchy
December
31, 2020
Total
(Level
1)
(Level
2)
(Level
3)
Assets
Marketable
Securities:
U.S.
Treasury Bonds
$ 18,429
$ 18,429
$ —
$ —
U.S.
Government Notes
22,230
—
22,230
—
Corporate
Debt Securities
4,306
—
4,306
—
State
and Municipal Bonds
1,282
—
1,282
—
Total
$ 46,247
$ 18,429
$ 27,818
$ —
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 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.
F- 15
Note
6 – Leasehold Improvements and Equipment
Leasehold
improvements and equipment, summarized by major category, consist of the following for the years ended December 31, 2021 and 2020 (in
thousands):
Schedule of Leasehold Improvements and Equipment
December
30,
2021
December
31,
2020
Equipment
$ 1,640
$ 1,443
Leasehold
improvements
935
878
Total
2,575
2,321
Less:
accumulated depreciation and amortization
1,037
797
Leasehold
improvements and equipment, net
$ 1,538
$ 1,524
Depreciation
and amortization expense for the years ended December 31, 2021 and 2020 was approximately $ 244 thousand and $ 231 thousand, respectively.
During the years ended December 31, 2021 and 2020, the Company purchased equipment and leasehold improvements of approximately $ 260 thousand
and $ 6 thousand, respectively. During the year ended December 31, 2021, the Company recorded an asset write-off of approximately $ 6 thousand,
including $ 4 thousand of related accumulated depreciation. The Company had no asset write-offs during the year ended December 31, 2020.
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, 2021 and 2020 (in
thousands):
Schedule of Accrued Expenses
2021
2020
As
of December 31,
2021
2020
Payroll
and incentives
$ 1,343
$ 1,094
General
and administrative expenses
195
280
Research
and development expenses
381
778
Deferred
revenue and other deferred liabilities *
932
643
Total
$ 2,851
$ 2,795
*
At
December 31, 2021, the balance included approximately $ 899 thousand related to the CFF Agreement’s deferred liability and approximately
$ 33 thousand is deferred revenue related to the Genentech feasibility study agreement. At December 31, 2020, the balance included
approximately $ 577 thousand related to the CFF Agreement’s deferred liability and approximately $ 67 thousand of deferred revenue
related to the Genentech feasibility study agreement.
Note
8 – Leases
The
Company has various lease agreements with terms up to 10 years , 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 are included
in the lease term when it is reasonably certain that the option will be exercised.
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 $ 13,000 , increasing to approximately $ 14,000 per month toward the end of the term.
On
September 23, 2020, the Company entered into an amendment to the Bedminster lease. Pursuant to the amendment, the Company leased an additional
3,034 rentable square feet (“Expansion Premises”). The amendment became effective upon delivery to the Company of the Expansion
Premises, which occurred on August 1, 2021, and extends the term of the lease for seven years from such date. 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.
F- 16
On
December 15, 2016, the Company entered into a 10-year, 3-month lease to consolidate our locations while expanding our laboratory and
manufacturing facilities. The lease began August 2017. The monthly rent will start at approximately $ 43,000 increasing to approximately
$ 64,000 in the final year. To obtain the laboratory and facility site, the Company was obligated to provide an initial security deposit
of $ 586,000 . This deposit was subsequently reduced and is currently $ 200,000 at December 31, 2021.
The
assets and liabilities from operating and finance 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.
The
Company’s operating leases do not provide an implicit rate that can readily be determined. Therefore, the Company uses a discount
rate based on its incremental borrowing rate, which is determined using the average of borrowing rates explicitly stated in the Company’s
finance leases.
The
Company incurred lease expense for its operating leases of approximately $ 852 thousand and $ 814 thousand for the years ended December
31, 2021 and 2020. The Company incurred amortization expense on its operating lease right-of-use assets of approximately $ 501 thousand
and $ 485 thousand for the years ended December 31, 2021 and 2020, respectively.
Finance
Leases
The
Company incurred interest expense on its finance leases of approximately $ 3 thousand and $ 7 thousand for the years ended December 31,
2021 and 2020, respectively. The Company incurred amortization expense on its finance lease right-of-use assets of approximately $ 36
thousand and $ 59 thousand for the years ended December 31, 2021 and 2020, respectively.
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 (in thousands):
Schedule of Maturity of Operating and Finance Leases Liabilities
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 %
The
following table presents information about the amount and timing of liabilities arising from the Company’s operating and finance
leases as of December 31, 2020 (in thousands):
Maturity
of Lease Liabilities
Operating
Lease Liabilities
Finance
Lease Liabilities
2021
$ 685
$ 34
2022
645
19
2023
677
2
2024
710
-
2025
745
-
Thereafter
1,458
-
Total
undiscounted operating lease payments
$ 4,920
$ 55
Less:
Imputed interest
1,224
-
Present
value of operating lease liabilities
$ 3,696
$ 55
Weighted
average remaining lease term in years
6.7
1.7
Weighted
average discount rate
8.4 %
8.1 %
F- 17
Note
9 - Collaboration Agreements, License and Other Research and Development Agreements
Cystic
Fibrosis Foundation Therapeutics Development Award
On
November 19, 2020, the Company entered into an award agreement (the “Agreement”) with CFF, pursuant to which it received
a Therapeutics Development Award of up to $ 4.2 million (the “Award”) (of which $ 484,249 had been previously received) to
support the preclinical development (the “Development Program”) of the Company’s MAT2501 product candidate (the “Product”),
a LNC oral formulation of the broad-spectrum aminoglycoside amikacin, for the treatment of pulmonary non-tubercular mycobacteria infections
and other pulmonary diseases (the “Field”). On November 19, 2021, the Company and CFF entered into an Amendment to the Agreement
which added an additional milestone payment in the amount of $ 321 thousand. The milestone payment was invoiced and the payment was received
in the fourth quarter of 2021.
The
first payment under the Agreement, in the amount of $ 650 thousand, became due upon execution of the Agreement. The Company invoiced the
CFF in November 2020 and payment was subsequently received in February 2021. During 2021, the Company invoiced and received $ 2.5 million
related to Agreement and the related deferred liability balance of $ 899 thousand is included in accrued expense and other current liabilities.
The remainder of the Award will be paid to the Company upon the achievement of certain milestones related to the development program
and progress of the Development Program, as set forth in the Agreement.
If
the Company ceases to use commercially reasonable efforts directed to the development of MAT2501 in the Field, (an “Interruption”)
and fails 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.
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 (5) 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 the two royalty payments of CFF of the 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, 2021 and 2020, the Company recognized $ 2.2 million and $ 0.1
million, respectively, as credits to research and development expenses related to the CFF award. In addition, the Company concluded under
the guidance in ASC 730 that it does not have an obligation to repay funds received once related research and development expenses are
incurred.
F- 18
Genentech
Feasibility Study Agreement
On
December 12, 2019, the Company entered into a feasibility study agreement (the “Agreement”) with Genentech, Inc. (“Genentech”).
This feasibility study agreement will involve the development of oral formulations using the Company’s LNC platform delivery technology,
which enables the development of a wide range of difficult-to-deliver molecules. Under the terms of the Agreement, Genentech shall pay
to the Company a total of $100.0 thousand for three molecules, or approximately $33 thousand per molecule, which will be recognized upon
the Company fulfilling its obligations for each molecule under the Agreement. On December 13, 2019, per Genentech’s request, the
Company billed Genentech for the total $ 100 thousand and recorded the upfront consideration as deferred revenue, which is recorded in
accrued expenses on the consolidated balance sheets, and will recognize it over the term of the contract performance obligation period.
As of December 31, 2021, the Company completed the first and second of the three molecules and the Company recognized approximately $ 33
thousand of Genentech revenue for the years ended December 31, 2021 and 2020, respectively. The Company is scheduled to complete the
remaining molecule during 2022.
Other
Research and development agreements
The
Company has financial obligations resulting from Cooperative Research and Development Agreements (“CRADAs”) entered into
with the with the National Institute of Allergy and Infectious Diseases (“NIH”) as follows:
●
On
February 19, 2016, the Company agreed to provide funds in the amount of $ 200,000 per year under a CRADA to support NIH investigators
in the conduct of clinical research to investigate the safety, efficacy, and pharmacokinetics of LNC platform drug products in patients
with fungal, bacterial, or viral infections. The initial term of the CRADA was three years. On April 16, 2019, the Company renewed
the CRADA for an additional three years with an annual funding commitment of $ 200,000 .
●
On
April 2, 2019, the Company agreed to provide funds in the amount of $ 157,405 per year under a CRADA to support NIH investigators
in the conduct of clinical research to investigate the safety, efficacy, and pharmacokinetics of LNC platform drug products in patients
with fungal, bacterial, or viral infections. The term of the CRADA is three years.
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 the LNC platform delivery technology. 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 $ 100,000
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.
Note
10 – Commitments
Royalty
payment rights
On
September 12, 2016 the Company conducted a final closing of a private placement offering to accredited investors of shares of the Company’s
Series A Preferred Stock. As part of this offer, the investors received royalty payment rights if and when the Company generates sales
of its MAT2203 or MAT2501 product candidates. Pursuant to the terms of the Series A Certificate of Designation, the Company may be required
to pay royalties of up to $ 35 million per year. If and when the Company obtains FDA or the European Medicines Agency (“EMA”)
approval of MAT2203 and/or MAT2501, which the Company does not expect to occur before 2023, if ever, and/or if the Company generates
sales of such products, or the Company receives any proceeds from the licensing or other disposition of MAT2203 or MAT2501, the Company
is required to pay to the holders of the Series A Preferred Stock, subject to certain vesting requirements, in the aggregate, a royalty
(the “Royalty Payment Rights”) equal to (i) 4.5% of Net Sales (as defined in the Series A Certificate of Designation), subject
in all cases to a cap of $ 25 million per calendar year, and (ii) 7.5% of Licensing Proceeds (as defined in the Series A Certificate of
Designation), subject in all cases to a cap of $ 10 million per calendar year. The Royalty Payment Rights will expire when the patents
covering the applicable product expire, which is currently expected to be in 2033 .
F- 19
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 & 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.
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, 2021 and 2020, 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.
The
components of the income tax provision are as follows (in thousands):
Schedule
of Income Tax Provision
Year
Ended December 31,
2021
2020
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):
$ -
$ -
F- 20
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,
2021
2020
Income
at US Statutory Rate
21.00 %
21.00 %
State
Taxes, net of Federal benefit
1.97 %
2.95 %
Permanent
Differences
( 0.82 )%
( 1.28 )%
Tax
Credits
2.16 %
0.75 %
Valuation
Allowance
( 25.21 )%
( 24.53 )%
Discrete
items
0.91 %
1.11 %
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 2021 and 2020 consist of the following (in thousands):
Schedule
of Deferred Tax Assets and Liabilities
Year
Ended December 31,
2021
2020
Share-based
Compensation
$ 3,575
$ 3,220
Depreciation
and Amortization
166
( 119 )
Accrued
Liability
377
307
Net
Operating Loss Carry-forwards
24,076
19,927
R&D
Credit Carryforwards
3,207
2,264
Other
( 1 )
( 10 )
IPR&D
( 848 )
( 848 )
ROU
Asset
( 1,186 )
( 921 )
ROU
Liability
1,315
1,045
Total
Deferred tax assets
$ 30,681
$ 24,865
Valuation
allowance
( 31,023 )
( 25,206 )
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: 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.
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 approximately $ 31.0
million,
$ 25.2 million
and $ 19.7 million as of December 31, 2021, 2020 and 2019, respectively, representing increases of approximately
$ 5.8 million
and $ 5.5 million for the years ending December 31, 2021 and 2020, respectively.
As
of December 31, 2021, the Company had Federal net operating loss carryforwards of approximately $ 38.1 million which will begin to expire
in 2032 . In addition, the Company has federal net operating loss carryforwards of approximately $ 63.3 million which have an indefinite
carryforward period. The Company also had federal and state research and development tax credit carryforwards of approximately $ 3.2 million.
The federal net operating loss and tax credit carryforwards will expire at various dates beginning in 2033, 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.
F- 21
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
Sale
of net operating losses (NOLs)
The
Company recognized approximately $ 1.3
million and $ 1.1
million for the years ended December 31, 2021
and 2020, 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 $ 50,000,000 , 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 approximately $ 5.8 million and net proceeds of approximately $ 5.6 million, after deducting BTIG’s commission on gross proceeds.
During 2020, the Company did not sell any shares of its common stock under the ATM Sales Agreement.
Common
Stock
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 $ 1.2 million 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.
On
January 14, 2020, the Company closed on an underwritten public offering of 32,260,000
shares of its common stock at a purchase price of $ 1.55
per
share. The Company generated gross proceeds of approximately $ 50.0
million
and net proceeds of approximately $ 46.7
million,
after deducting underwriting discounts and commissions and other estimated offering expenses. In addition, the Company granted the underwriters
a 30-day option to purchase up to approximately 4.8 million additional shares of its common stock on the same terms and conditions. No
additional shares of the Company’s common stock were sold pursuant to this option.
F- 22
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 private placement of Series A Preferred Stock, on July 26, 2016, the Company filed the Series A Certificate of Designation
with the Secretary of the State of Delaware to designate the preferences, rights and limitations of the Series A Preferred Stock. Pursuant
to the Series A Certificate of Designation, the Company designated 1,600,000 shares of the Company’s previously undesignated preferred
shares as Series A Preferred Stock. 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.
Series
B Preferred Stock
During
2021 and prior to June 19, 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, all 4,218 remaining shares of Series B Preferred Stock were automatically converted into 2,000
shares of the Company’s common stock resulting in the issuance of 8,436,000 shares of common stock. As of December 31, 2021 and
December 31, 2020, there were 0 and 4,361 shares of Series B Preferred stock outstanding, respectively.
Conversion:
Prior
to the automatic conversion of Series B Preferred Stock on June 19, 2021, and subject to certain ownership limitations, each share of
Series B Preferred Stock was convertible into shares of the Company’s common stock at any time at the option of the holder at an
initial conversion price of $ 0.50 per share subject to adjustment for reverse splits, stock combinations and similar changes as provided
in the Certificate of Designation. Based on the conversion price and number of shares outstanding on June 19, 2021, the Series B Preferred
Stock were converted into 8,436,000 shares of common stock.
Dividends:
Subject
to certain ownership limitations, holders of the Series B Preferred Stock received dividends paid in the Company’s common stock
as follows: (i) a number of shares of common stock equal to 10% of the shares of common stock underlying the Series B Preferred Stock
then held by such holder on June 19, 2019, (ii) a number of shares of common stock equal to 15% of the shares of common stock underlying
the Series B Preferred Stock then held by such holder on June 19, 2020 and (iii) a number of shares of common stock equal to 20% of the
shares of common stock underlying the Series B Preferred Stock then held by such holder on June 19, 2021. Based on an accounting of the
holders of record of Series B Preferred Stock on June 19, 2021 and 2020, the Company made dividend payments totaling 1,687,200 and 1,365,600
shares of common stock, respectively .
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- 23
As
of December 31, 2021, the Company had outstanding warrants to purchase an aggregate of 988,000 shares of common stock at exercise prices
ranging from $ 0.50 to $ 0.75 per share, and with expiration dates between December 31, 2022 and June 21, 2023. A summary of warrants outstanding
as of December 31, 2021 and 2020 is presented below, all of which are fully vested (in thousands):
Summary
of Shareholders Equity Warrants Outstanding
Shares
Outstanding
at December 31, 2019
5,397
Issued
-
Exercised
( 2,549 )
Tendered
-
Expired
( 1,493 )
Outstanding at December
31, 2020
1,328 *
Outstanding
at January 01, 2021
Issued
-
Exercised
( 320 )**
Tendered
-
Expired
( 20 )
Outstanding
at December 31, 2021
988 ***
*
Weighted
average exercise price for outstanding warrants is $ 0.55 .
**
Converted
into approximately 115 thousand shares of common stock.
***
Weighted
average exercise price for outstanding warrants is $ 0.56 .
Note
13 – Accumulated Other Comprehensive (Loss)/Income
The
following table summarizes the changes in accumulated other comprehensive (loss)/income by components during the years ended December
31, 2021 and 2020 (in thousands):
Schedule
of Components of Accumulated Other Comprehensive (Loss)/Income
Net
Unrealized (Losses)/Gains on Available-for-Sale Securities
Accumulated
Other Comprehensive (Loss)/Gain
Balance,
December 31, 2019
$
( 1
)
$
( 1
)
Net
unrealized gain on securities available-for-sale
237
237
Reclassification
of realized gain on securities available-for-sale to net loss
( 8
)
( 8
)
Net
current period other comprehensive gain
229
229
Balance,
December 31, 2020
$
228
$
228
Net
unrealized loss on securities available-for-sale
( 373
)
( 373
)
Net
current period other comprehensive loss
( 374
)
( 374
)
Balance,
December 31, 2021
$
( 146
)
$
( 146
)
All
components of accumulated other comprehensive (loss)/income 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. 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, 2021, the Company had 36,952,460 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.
F- 24
The
Company recognized stock-based compensation expense (options and restricted share grants) in its consolidated statements of operations
as follows (in thousands):
Schedule
of Recognized Stock-Based Compensation
Year
Ended December 31,
2021
2020
Research
and Development
$ 1,870
$ 1,897
General
and Administrative
2,422
2,668
Total
$ 4,292
$ 4,565
The
following table contains information about the Company’s stock plan at December 31, 2020:
Schedule
of Equity Compensation Plan by Arrangements
Awards
Reserved for Issuance
Awards
Issued & Exercised
Awards
Available for Grant
2013
Equity Compensation Plan (in thousands)
36,952
*
32,669
**
4,283
*
Increased
by 8,005 thousand on January 1, 2021, representing 4 % of the total number of shares of common stock outstanding on December 31, 2020.
**
Includes
both stock grants and option grants
The
following table summarizes the Company’ stock option activity and related information for the period from January 1, 2020 to December
31, 2021 (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, 2019
17,529
$ 1.11
6.2
Granted
6,501
$ 1.59
Exercised
( 826 )
0.74
Forfeited
( 72 )
$ 1.11
Cancelled
-
-
Expired
( 581 )
$ 1.25
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
Cancelled
-
-
Expired
( 1,441 )
$ 1.98
Outstanding
at December 31, 2021
28,184
$ 1.21
7.2
The
following table summarizes outstanding options at December 31, 2021, 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
1,935
$ 0.49
$ 0.74 - $ 1.12
15,940
$ 0.93
$ 1.24 - $ 1.61
6,525
$ 1.35
$ 2.27
- $ 3.32
3,784
$ 2.50
28,184
$ 1.21
As
of December 31, 2021, the number of vested shares underlying outstanding options was 14,625,397 at a weighted average exercise price
of $ 1.20 . The aggregate intrinsic value of in-the-money options outstanding as of December 31, 2021 was $ 2.5 million. The aggregate intrinsic
value is calculated as the difference between the Company’s closing stock price of $ 1.01 on December 31, 2021, and the exercise
price of options, multiplied by the number of options. As of December 31, 2021, there was approximately $ 11.7 million of total unrecognized
share-based compensation. Such costs are expected to be recognized over a weighted average period of approximately 2.9 years.
F- 25
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. A portion of options
granted to consultants vests over four years, with the remaining vesting being based upon the achievement of certain performance milestones,
which are tied to either financing or drug development initiatives .
During
the years ended December 31, 2021 and 2020, the Company granted restricted stock awards for 31,769 and 379,385 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 approximately $ 100 thousand and $ 292
thousand in the consolidated statement of operations for the years ended December 31, 2021 and 2020, respectively.
The
Company recognizes compensation expense for stock option awards and 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. Beginning January 1, 2020, stock options issued to consultants are recorded at fair value on the date of grant and
the award is recognized as an expense on a straight-line basis over the requisite service period. 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,
2021
2020
Volatility
98.4 %
- 101.6
%
100.5 %
- 107.4
%
Risk-free
interest rate
0.47 %
- 1.28
%
0.34 %
- 1.74
%
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- 26