Item 9A. Controls and Procedures
Item
9A.
Controls
and Procedures
Evaluation
of Disclosure Controls and Procedures
Disclosure
Controls and Procedures:
As
of December 31, 2020, 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, 2020.
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.
As
disclosed in our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 9, 2020, management
previously identified a material weakness in our internal controls over financial reporting. Based on management’s evaluation,
this material weakness was remediated as of December 31, 2020.
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, 2020, 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.
The
previously identified material weakness during the year ended December 31, 2019 which has been remediated included not having
designed and implemented a sufficient level of formal financial reporting and operating policies and procedures that define how
transactions should have been initiated, processed, recorded and reported, including presentation and disclosure in the consolidated
financial statements.
Management
implemented its remediation plan by enhancing operational procedures related to purchasing, receiving and recording expenditures,
including consulting with our third-party internal auditors throughout the period while formalizing and testing our review procedures.
Changes
in Internal Control Over Financial Reporting:
There
was no change, except as part of our remediation of the deficiency in internal controls described above, 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 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.
82
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
88
Chairman
of the Board, Director
Jerome
D. Jabbour
46
Chief
Executive Officer and President, Director
James
J. Ferguson
67
Chief
Medical Officer
Keith
A. Kucinski
51
Chief
Financial Officer
Hui
Liu
53
Chief
Technology Officer
Raphael
J. Mannino
73
Chief
Scientific Officer
Theresa
Matkovits
53
Chief
Development Officer
Patrick
G. LePore
65
Vice
Chairman of the Board, Director
Eric
Ende
52
Director
Natasha
Giordano
59
Director
James
S. Scibetta
56
Director
Matthew
Wikler
71
Director
Management
Jerome
D. Jabbour, JD was appointed Chief Executive Officer in March 2018. He has served as our President since March 2016. Prior
to that he served as our Executive Vice President, Chief Business Officer, General Counsel and Secretary since October 2013 and
as one of our directors from April 2012 until November 2013. Mr. Jabbour is also a Co-founder of Matinas BioPharma. Prior to joining
our management team, he was the Executive Vice President and General Counsel of MediMedia USA, or MediMedia, from 2012 to October
2013, a privately held diversified 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), a multinational biopharmaceutical company. 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.
83
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. 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. 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.
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 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 BioSurplus and also serves as an Independent Director of Appili Therapeutics (TSX: APLIF).Dr. Matkovits
was selected to participate in Women in Bio’s Boardroom Ready Program in 2016. Dr. Matkovits earned her Ph.D. in Biochemistry
and Molecular Biology from the University of Medicine and Dentistry of NJ.
Hui
Liu, PhD, MBA was appointed Chief Technology Officer in December 2020. Dr. Liu has over two decades of experience in the
formulation of small molecules, biologics, and gene therapies. He joined the Company from Seqirus, a global leader in influenza
vaccine development and pandemic preparedness, where he served as the Director of Formulation and Delivery from 2017 to 2020.
Prior to his time at Seqirus, Dr. Liu was the CMC Director at Cellics Therapeutics, a privately held biotechnology company based
in San Diego. His early career focused on ophthalmic drug development at two leading eye care companies, Alcon and Allergan plc.
At Alcon, he led multiple CMC teams as the Senior Technical Lead from 2015 to 2017. During his time at Allergan, Dr. Liu played
a critical role in realizing a paradigm shift for standard glaucoma care, focusing on sustained delivery drug development in his
role as a Principal Scientist. Previously, he worked on pigment nanoparticle encapsulation at Hewlett-Packard. 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.
84
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.
Patrick
LePore has served as our Vice Chairman of the Board since September 5, 2018. Mr. LePore served as chairman, chief executive
officer and president of Par Pharmaceuticals, Inc. (NYSE:PRX), an operating company of Endo International plc, a generics and
specialty branded pharmaceutical company, from September 2006 until the company’s acquisition by private equity investor
TPG in November 2012. He remained as chairman of the new company where he led the sale of the company to Endo Pharmaceuticals
(NASDAQ: ENDP). Mr. LePore began his career with Hoffmann LaRoche. Later, he founded Boron LePore and Associates, a medical communications
company, which he took public in 1997 and which was eventually sold to Cardinal Health. He is chairman of the board of directors
of Lannett Company, Inc. (NYSE: LCI), a pharmaceutical company, and is a trustee of Villanova University. He previously served
as a member of the board of directors of PharMerica Corporation (NYSE: PMC) and Innoviva, Inc. (NASDAQ: INVA). Mr. LePore earned
his bachelor’s degree from Villanova University and Master of Business Administration from Fairleigh Dickinson University.
We believe Mr. LePore is qualified to serve on our board of directors due to his executive leadership and significant experience
in the life sciences industry and his public company board experience.
Jerome
D. Jabbour. See description under “Management.”
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. Dr. Ende serves as co-founder, chief executive and chief financial
officer of WellFit Holdings, LLC, a private company focused on developing fitness technologies. 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. 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) since January 2016. Previously, Ms. Giordano served as
the Interim Chief Executive Officer of ClearPoint Learning, Inc., a privately held learning and training platform company, from
May 2015 through November 2015. She also served on the ClearPoint board of directors from December 2009 through November 2015.
Previously, Ms. Giordano served as the Chief Executive Officer of Healthcare Corporation of America (NYSE: HCA), a leading healthcare
provider, from January 2014 through August 2014. From June 2009 to August 2012, Ms. Giordano served as Chief Operating Officer
and then as Chief Executive Officer, President and a member of the board of directors of Xanodyne Pharmaceuticals, Inc., a privately-held
a branded specialty pharmaceutical company with development and commercial capabilities focused on pain management and women’s
health. Prior to that, she served as President, Americas, for Cegedim Dendrite (formerly Dendrite International Inc.), a global
technology services company, from 2007 to 2008 and as Senior Vice President of the Global Customer Business Unit of Cegedim Dendrite
from 2004 to 2007. Ms. Giordano holds a Bachelor of Science degree in nursing from Wagner College. We believe Ms. Giordano is
qualified to serve as a director due to her extensive experience in commercialization, general management and knowledge of the
pharmaceutical and health care industries.
James
S. Scibetta has served as a member of our board of directors since November 2013. He is currently Chief Executive Officer
of Maverick Therapeutics, a development stage immune-oncology company. Prior to Maverick, he was President and Chief Financial
Officer of Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX), a specialty pharmaceutical company, a position he has held since October
2015. Prior to that, Mr. Scibetta was the Chief Financial Officer of Pacira since 2008. Prior to joining Pacira in August 2008,
he served as a consultant to Genzyme Corporation following the sale of Bioenvision Inc. (NASDAQ: BIVN) to Genzyme in 2007. From
2006 to 2007 Mr. Scibetta was CFO of Bioenvision. From 2001 to 2006, he was Executive Vice President and Chief Financial Officer
of Merrimack Pharmaceuticals Inc. (NASDAQ: MACK). Mr. Scibetta has previously served on the board of directors at the following
life sciences companies: Nephros Inc. (NASDAQ: NEPH), Merrimack Pharmaceuticals and Labopharm Inc. Prior to his executive management
experience, Mr. Scibetta spent over a decade in investment banking where he was responsible for sourcing and executing transactions
for a broad base of public and private healthcare and life sciences companies. Mr. Scibetta received his Bachelor of Science in
Physics from Wake Forest University and an MBA from the University of Michigan. We believe Mr. Scibetta is qualified to serve
on our board of directors because of his extensive management experience in the pharmaceutical industry, his investment banking
experience and his experience as a chief financial officer and audit committee member of several publicly traded companies.
85
Matthew
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 superior 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, 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 and regulatory experience in the area of infectious diseases.
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 Board 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.
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 American’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 2020. 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,
Patrick LePore, 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 American’s
listing standards. The Compensation Committee met three times during 2020. Our Board has adopted a Compensation Committee Charter,
which is available for viewing at www.matinasbiopharma.com .
86
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, Patrick LePore 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 American’s listing standards.
The Nominating and Corporate Governance Committee met three times during 2020. 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.
Delinquent
Section 16(a) Reports
Section
16(a) of the Securities Exchange Act of 1934, as amended, requires our directors and executive officers, and persons who are beneficial
owners of more than 10% of a registered class of our equity securities, to file reports of ownership and changes in ownership
with the Securities and Exchange Commission (the “SEC”). These persons are required by SEC regulations to furnish
us with copies of all Section 16(a) forms they file. To our knowledge, based solely on a review of the copies of such reports
furnished to us and written representations that no other reports were required during the fiscal year ended December 31, 2020,
all reports required to be filed under Section 16(a) were filed on a timely basis.
Item
11.
Executive
Compensation
Summary
Compensation Table – 2020
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, 2020 for services
rendered in all capacities to us for the years ended December 31, 2020 and December 31, 2019. These individuals are our named
executive officers for 2020.
Name
and Principal Position
Year
Salary
($)
Bonus
($)
Option
Awards
($)
(1)
All Other Compensation ($)
Total ($)
Jerome D. Jabbour
2020
500,000
250,000
2,180,085
-
2,930,085
Chief Executive Officer
2019
444,792
200,000
680,384
-
1,325,176
James J. Ferguson
2020
410,000
150,000
1,090,043
1,650,043
Chief Medical Officer
2019
319,444
50,000
319,926
62,945 (2)
752,315
Theresa Matkovits
2020
367,500
122,500
763,030
-
1,253,030
Chief Development Officer
2019
350,000
30,625
317,513
-
698,138
(1) Amounts
reflect the grant date fair value of option awards granted in 2020 and 2019 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.
(2) Mr.
Ferguson was reimbursed for relocation costs.
87
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.
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 $350,000 per year. In addition,
Ms. Matkovits is eligible to receive an annual bonus, which is targeted at 35% of her base salary but which may be adjusted by
our Compensation Committee based on her individual performance and our performance as a whole. Ms. Matkovits is also eligible
to receive option grants at the discretion of our Compensation Committee. If we terminate Ms. Matkovits’ employment without
cause or Ms. Matkovits resigns with good reason, we are required to pay her severance of up to twelve months of his base salary
plus benefits. In addition, the vesting of 50% of her outstanding options will be accelerated in full upon such termination. Ms.
Matkovits is also subject to a customary non-disclosure agreement, pursuant to which Ms. Matkovits has agreed to be subject to
a non-compete during the term of her employment and for a period of eighteen months following termination of his employment.
88
Outstanding
Equity Awards at Fiscal Year-End Table – 2020
The
following table summarizes, for each of the named executive officers, the number of shares of common stock underlying outstanding
stock options held as of December 31, 2020.
Option Awards
Name
Number
of
securities
underlying
unexercised
options
(#)
exercisable
Number
of
securities
underlying
unexercised
options
(#)
unexercisable
Option
exercise
price
($)
Option
expiration
date
Jerome D. Jabbour
-
500,000
$ 0.82
Jun 16, 2030
-
1,000,000
$ 2.27
Dec 31, 2029
343,750
406,250
$ 1.08
Feb 10, 2029
687,500
312,500
$ 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
-
250,000
$ 0.82
Jun 16, 2030
-
500,000
$ 2.27
Dec 31, 2029
160,417
189,583
$ 1.09
Feb 24, 2029
Theresa Matkovits
-
175,000
$ 0.82
Jun 16, 2030
-
350,000
$ 2.27
Dec 31, 2029
160,417
189,583
$ 1.08
Feb 10, 2029
189,584
160,416
$ 0.79
Oct 14, 2028
2013
Equity Compensation Plan
General
On
August 2, 2013, our Board of Directors adopted the 2013 Equity Compensation Plan pursuant to the terms described herein. The 2013
Equity Compensation Plan was approved by the stockholders on August 7, 2013. Effective May 8, 2014, upon the approval of our Board
of Directors and our stockholders, we amended and restated our 2013 Equity Compensation Plan, primarily to include “evergreen”
provisions, which state provide that 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.
89
Our
Board of Directors believes that the 2013 Plan will advance our interests by enhancing our ability to (a) attract and retain employees,
consultants, directors and advisors who are in a position to make significant contributions to our success; (b) reward our employees,
consultants, directors and advisors for these contributions; and (c) encourage employees, consultants, directors and advisors
to take into account our long-term interests through ownership of our shares.
Description
of the 2013 Equity Compensation Plan
The
following description of the principal terms of the 2013 Plan is a summary and is qualified in its entirety by the full text of
the 2013 Plan, which is attached as Exhibit 10.1 hereto.
Administration .
The 2013 Plan will be administered by the Compensation Committee of our Board of Directors, provided that the entire Board
of Directors may act in lieu of the Compensation Committee on any matter, subject to certain requirements set forth in the 2013
Plan. The Compensation Committee may grant options to purchase shares of our common stock, stock appreciation rights, stock units,
restricted shares of our common stock, performance shares, performance units, incentive bonus awards, other cash-based awards
and other stock-based awards. The Compensation Committee also has broad authority to determine the terms and conditions of each
option or other kind of award, and adopt, amend and rescind rules and regulations for the administration of the 2013 Plan. Subject
to applicable law, the Compensation Committee may authorize one or more reporting persons (as defined in the 2013 Plan) or other
officers to make awards (other than awards to reporting persons, or other officers whom the Compensation Committee has specifically
authorized to make awards). No awards may be granted under the 2013 Plan on or after the ten year anniversary of the adoption
of the 2013 Plan by our Board of Directors, but awards granted prior to such tenth anniversary may extend beyond that date.
Eligibility .
Awards may be granted under the 2013 Plan to any person who is an employee, officer, director, consultant, advisor or other
individual service provider of the Company or any subsidiary, or any person who is determined by the Compensation Committee to
be a prospective employee, officer, director, consultant, advisor or other individual service provider of the Company or any subsidiary.
Shares
Subject to the 2013 Plan . As of March 14, 2021 the aggregate number of shares of common stock available for issuance in
connection with awards granted under the 2013 Plan is 36,952,460 shares, subject to customary adjustments for stock splits, stock
dividends or similar transactions (the “Initial Limit”). Incentive Stock Options may be granted under the 2013 Plan
with respect to all of those shares. The number of shares of common stock available for issuance under the 2013 Plan will automatically
increase on January 1st of each year for a period of ten years, commencing on January 1, 2015, in an amount equal to four percent
(4%) of the total number of shares of common stock outstanding on December 31st of the preceding calendar year (the “Annual
Increase”). Notwithstanding the foregoing, the Board of Directors may act prior to the first day of any calendar year, to
provide that there shall be no increase in the share reserve for such calendar year or that the Annual Increase in the share reserve
for such calendar year shall be a lesser number of shares of common stock than would otherwise occur pursuant to the preceding
sentence. The number of shares of common stock which may be issued in respect of Incentive Stock Options is equal to the Current
Limit, and will be increased on each January 1, by the Annual Increase for such calendar year.
To
the extent that any award under the 2013 Plan payable in shares of common stock is forfeited, cancelled, returned to the Company
for failure to satisfy vesting requirements or upon the occurrence of other forfeiture events, or otherwise terminates without
payment being made thereunder, the shares of common stock covered thereby will be available for future grants under the 2013 Plan.
Shares of common stock that otherwise would have been issued upon the exercise of a stock option or in payment with respect to
any other form of award, that are surrendered in payment or partial payment of taxes required to be withheld with respect to the
exercise of such stock option or the making of such payment, will also be available for future grants under the 2013 Plan.
Terms
and Conditions of Options . Options granted under the 2013 Plan may be either “incentive stock options” that
are intended to meet the requirements of Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”)
or “nonqualified stock options” that do not meet the requirements of Section 422 of the Code. The Compensation Committee
will determine the exercise price of options granted under the 2013 Plan. The exercise price of stock options may not be less
than the fair market value, on the date of grant, per share of our common stock issuable upon exercise of the option (or 110%
of fair market value in the case of incentive options granted to a ten-percent stockholder).
90
If
on the date of grant the common stock is listed on a stock exchange or national market system, the fair market value shall generally
be the closing sale price as of such date, or if there were no trades recorded on such date, then the most recent date preceding
such date on which trades were recorded. If on the date of grant the common stock is traded in an over-the-counter market, the
fair market will generally be the average of the closing bid and asked prices for the shares of common stock as of such date,
or, if there are no closing bid and asked prices for the shares of common stock on such date, then the average of the bid and
asked prices for the shares of common stock on the most recent date preceding such date on which such closing bid and asked prices
are available. If the common stock is not listed on a national securities exchange or national market system or traded in an over-the-counter
market, the fair market value shall be determined by the Compensation Committee in a manner consistent with Section 409A of the
Internal Revenue Code of 1986, as amended. Notwithstanding the foregoing, if on the date of grant the common stock is listed on
a stock exchange or is quoted on a national market system, or is traded in an over-the-counter market, then solely for purposes
of determining the exercise price of any grant of a stock option or the base price of any grant of a stock appreciation right,
the Compensation Committee may, in its discretion, base fair market value on the last sale before or the first sale after the
grant, the closing price on the trading day before or the trading day of the grant, the arithmetic mean of the high and low prices
on the trading day before or the trading day of the grant, or any other reasonable method using actual transactions of the common
stock as reported by the exchange or market on which the common stock is traded. In addition, the determination of fair market
value also may be made using any other method permitted under Treasury Regulation section 1.409A-1(b)(5)(iv).
No
option may be exercisable for more than ten years from the date of grant (five years in the case of an incentive stock option
granted to a ten-percent stockholder). Options granted under the 2013 Plan will be exercisable at such time or times as the Compensation
Committee prescribes at the time of grant. No employee may receive incentive stock options that first become exercisable in any
calendar year in an amount exceeding $100,000. The Compensation Committee may, in its discretion, permit a holder of a nonqualified
stock option to exercise the option before it has otherwise become exercisable, in which case the shares of our common stock issued
to the recipient will continue to be subject to the vesting requirements that applied to the option before exercise.
Generally,
the option price may be paid in cash or by bank check, or such other means as the Compensation Committee may accept. As set forth
in an award agreement or otherwise determined by the Compensation Committee, in its sole discretion, at or after grant, payment
in full or part of the exercise price of an option may be made (a) in the form of shares of common stock that have been held by
the participant for such period as the Compensation Committee may deem appropriate for accounting purposes or otherwise, valued
at the fair market value of such shares on the date of exercise; (ii) by surrendering to the Company shares of common stock otherwise
receivable on exercise of the option; (iii) by a cashless exercise program implemented by the Compensation Committee in connection
with the 2013 Plan; and/or (iv) by such other method as may be approved by the Compensation Committee and set forth in an award
agreement.
No
option may be transferred other than by will or by the laws of descent and distribution, and during a recipient’s lifetime
an option may be exercised only by the recipient or the recipient’s guardian or legal representative. However, the Compensation
Committee may permit the transfer of a nonqualified stock option, share-settled stock appreciation right, restricted stock award,
performance share or share-settled other stock-based award either (a) by instrument to the participant’s immediate family
(as defined in the 2013 Plan), (b) by instrument to an inter vivos or testamentary trust (or other entity) in which the award
is to be passed to the participant’s designated beneficiaries, or (c) by gift to charitable institutions. The Compensation
Committee will determine the extent to which a holder of a stock option may exercise the option following termination of service.
Stock
Appreciation Rights . The Compensation Committee may grant stock appreciation rights independent of or in connection with
an option. The Compensation Committee will determine the terms applicable to stock appreciation rights. The base price of a stock
appreciation right will be determined by the Compensation Committee, but will not be less than 100% of the fair market value of
a share of our common stock with respect to the date of grant of such stock appreciation right. The maximum term of any SAR granted
under the 2013 Plan is ten years from the date of grant. Generally, each SAR stock appreciation right will entitle a participant
upon exercise to an amount equal to:
●
the
excess of the fair market value of a share of common stock on the date of exercise of the stock appreciation right over the
base price of such stock appreciation right, multiplied by
●
the
number of shares as to which such stock appreciation right is exercised.
91
Payment
may be made in shares of our common stock, in cash, or partly in common stock and partly in cash, all as determined by the Compensation
Committee.
Restricted
Stock and Stock Units . The Compensation Committee may award restricted common stock and/or stock units under the
2013 Plan. Restricted stock awards consist of shares of stock that are transferred to a participant subject to restrictions that
may result in forfeiture if specified conditions are not satisfied. Stock units confer the right to receive shares of our common
stock, cash, or a combination of shares and cash, at a future date upon or following the attainment of certain conditions specified
by the Compensation Committee. The Compensation Committee will determine the restrictions and conditions applicable to each award
of restricted stock or stock units, which may include performance-based conditions. Dividends with respect to restricted stock
may be paid to the holder of the shares as and when dividends are paid to stockholders or at the times of vesting or other payment
of the restricted stock award. Stock unit awards may be granted with dividend equivalent rights, which may be accumulated and
may be deemed reinvested in additional stock units, as determined by the Compensation Committee in its discretion. If any dividend
equivalents are paid while a stock unit award is subject to restrictions, the dividend equivalents shall be subject to the same
restrictions on transferability as the underlying stock units, unless otherwise set forth in an award agreement. Unless the Compensation
Committee determines otherwise, holders of restricted stock will have the right to vote the shares.
Performance
Shares and Performance Units . The Compensation Committee may award performance shares and/or performance units
under the 2013 Plan. Performance shares and performance units are awards which are earned during a specified performance period
subject to the attainment of performance criteria, as established by the Compensation Committee. The Compensation Committee will
determine the restrictions and conditions applicable to each award of performance shares and performance units.
Incentive
Bonus Awards . The Compensation Committee may award Incentive Bonus Awards under the 2013 Plan. Incentive Bonus Awards
may be based upon the attainment of specified levels of Company or subsidiary performance as measured by pre-established, objective
performance criteria determined at the discretion of the Compensation Committee. Incentive Bonus Awards will be paid in cash or
common stock, as set forth in an award agreement
Other
Stock-Based and Cash-Based Awards . The Compensation Committee may award other types of equity-based or cash-based
awards under the 2013 Plan, including the grant or offer for sale of unrestricted shares of our common stock and payment in cash
or otherwise of amounts based on the value of shares of common stock.
Effect
of Certain Corporate Transactions . The Compensation Committee may, at the time of the grant of an award, provide for the
effect of a change in control (as defined in the 2013 Plan) on any award, including (i) accelerating or extending the time periods
for exercising, vesting in, or realizing gain from any award, (ii) eliminating or modifying the performance or other conditions
of an award, (iii) providing for the cash settlement of an award for an equivalent cash value, as determined by the Compensation
Committee, or (iv) such other modification or adjustment to an award as the Compensation Committee deems appropriate to maintain
and protect the rights and interests of participants upon or following a change in control. The Compensation Committee may, in
its discretion and without the need for the consent of any recipient of an award, also take one or more of the following actions
contingent upon the occurrence of a change in control: (a) cause any or all outstanding options and stock appreciation rights
to become immediately exercisable, in whole or in part; (b) cause any other awards to become non-forfeitable, in whole or in part;
(c) cancel any option or stock appreciation right in exchange for a substitute option; (d) cancel any award of restricted stock,
stock units, performance shares or performance units in exchange for a similar award of the capital stock of any successor corporation;
(e) redeem any restricted stock, stock unit, performance share or performance unit for cash and/or other substitute consideration
with a value equal to the fair market value of an unrestricted share of our common stock on the date of the change in control;
(f) cancel any option or stock appreciation right in exchange for cash and/or other substitute consideration based on the value
of our common stock on the date of the change in control , and cancel any option or stock appreciation right without any
payment if its exercise price exceeds the value of our common stock on the date of the change in control; (g) cancel any stock
unit or performance unit held by a participant affected by the change in control in exchange for cash and/or other substitute
consideration with a value equal to the fair market value per share of common stock on the date of the change in control, or (h)
make such other modifications, adjustments or amendments to outstanding awards as the Compensation Committee deems necessary or
appropriate.
92
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
In
October 2013, we adopted a compensation policy pursuant to which our non-employee directors receive annualized compensation of
$20,000 per year, with an additional $10,000 per year for the Chairman of the Board and the Chair of the Audit Committee, as well
as an additional $5,000 per year for the Chairs of the Compensation and Nomination & Governance Committees. In addition, our
independent board members will receive an option grant of 150,000 options, with the exception of the Chairman of the Board, who
will be granted 200,000 options. In August 2014, we revised our compensation policy to provide that directors will receive restricted
stock in lieu of cash fees.
In
January 2018, we adopted an amended compensation policy for our non-employee directors. The amended 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, other than the chairman of the board 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 chair of our audit committee is entitled
to receive an annual fee from us of $15,000 and other members of our audit committee are entitled to receive $7,500; (iv) the
chair of our compensation committee is entitled to receive an annual fee from us of $10,000 and other members of our compensation
committee are entitled to receive $6,000; and (v) the chair of our nominating and corporate governance committee is entitled to
receive an annual fee from us of $7,500 and other members are entitled to receive $4,000. In addition, In September 2018, our
Board approved an additional annual fee of $20,000 for our vice chair.
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 $80,000 as determined by the Black Scholes method on the date of grant under our existing equity
incentive plan, or any other equity incentive plan we may adopt in the future, which shall vest in twelve equal monthly installments.
All
fees under the director compensation policy are paid on a quarterly basis in arrears and no per meeting fees are paid. All fees
may be paid in unrestricted shares of common stock at the election of the director. We also reimburse non-employee directors for
reasonable expenses incurred in connection with attending board of director and committee meetings.
93
Director
Compensation Table – 2020
The
following table summarizes the annual compensation for our non-employee directors during 2020.
Name
Cash Compensation
($)
Stock
Awards
($)
(1)
Option
Awards
($) (1)
Total
($)
Herbert Conrad
90,000
-
80,000
170,000
Eric Ende
71,500
-
80,000
151,500
Natasha Giordano
17,344
-
160,000
177,344
Patrick G. LePore
80,000
-
80,000
160,000
James S. Scibetta
75,000
-
80,000
155,000
Adam Stern
41,984
-
-
41,984
Matthew Wikler
-
63,500
80,000
143,500
(1)
Amounts
reflect the grant date fair value of stock awards and option awards granted in 2020 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, and was for the last fiscal year, composed of the following four
non-employee directors: Eric Ende, Chair, Patrick G. LePore, James Scibetta and Matthew Wikler. No member of the Compensation
Committee is or was formerly an officer or an employee of the Company during the last fiscal year. In addition, no executive officer
of the Company serves on the compensation committee or board of directors of a company for which any of the Company’s directors
serve as an executive officer. 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 March 14, 2021 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 204,276,412 shares outstanding as of March 14, 2021. In computing the number of shares
beneficially owned by a person and the percentage ownership of that person, shares of common stock that are subject to options
or warrants held by that person and exercisable as of, or within 60 days of, March 14, 2021 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.
94
Name
of Beneficial Owner
Number
of Shares
Beneficially Owned
Percentage
of Shares
Beneficially Owned
5%
Stockholders
Boxer
Capital, LLC (1)
11,478,634
5.6
%
Directors
and Executive Officers
Jerome
D. Jabbour (2)
3,159,567
1.5
%
Herbert
Conrad (3)
5,753,293
2.8
%
Eric
Ende (4)
974,686
*
%
Natasha
Giordano (5)
63,982
*
%
Patrick
LePore (6)
844,666
*
%
James
Scibetta (7)
1,543,052
*
%
Matthew
Wikler (8)
916,697
*
%
James
J. Ferguson (9)
439,601
*
%
Keith
A. Kucinski (10)
570,034
*
%
Hui
Liu (11)
-
*
%
Raphael
Mannino (12)
2,231,444
1.1
%
Theresa
Matkovits (13)
590,637
*
%
Directors
and Executive Officers as a group (12 persons) (14)
17,087,659
8.0
%
*
Less than 1%
(1)
Based solely on information contained in a Schedule 13G/A filed on February 16, 2021. Shared voting and dispositive power of the
shares is held by Boxer Capital, LLC, Boxer Asset Management Inc. and Joe Lewis. The address for each reporting person is 11682
El Camino Real, Suite 320, San Diego, CA 92130.
(2)
Includes (i) 15 convertible preferred shares if converted to 30,000 common shares, and (ii) 2,705,243shares of common stock issuable
upon exercise of options that are exercisable within sixty days of March 14, 2021. Does not include 2,657,257 shares of common
stock underlying options that are not exercisable within sixty days of March 14, 2021.
(3)
Includes (i) 100 convertible preferred shares if converted to 200,000 common shares, and (ii) 1,098,727 shares of common stock
issuable upon exercise of options that are exercisable within sixty days of March 14, 2021. Does not include 51,085 shares of
common stock underlying options that are not exercisable within sixty days of March 14, 2021.
(4)
Includes (i) 12 convertible preferred shares if converted to 24,000 common shares, and (ii) 835,394 shares of common stock issuable
upon exercise of options that are exercisable within sixty days of March 14, 2021. Does not include 51,085 shares of common stock
underlying options that are not exercisable within sixty days of March 14, 2021.
(5)
Includes 63,982 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 14, 2021.
Does not include 223,935 shares of common stock underlying options that are not exercisable within sixty days of March 14, 2021.
(6)
Includes 444,666 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 14,
2021. Does not include 63,584 shares of common stock underlying options that are not exercisable within sixty days of March 14,
2021.
(7)
Includes (i) 12 convertible preferred shares if converted to 24,000 common shares, and (ii) 897,894 shares of common stock issuable
upon exercise of options that are exercisable within sixty days of March 14, 2021. Does not include 51,085 shares of common stock
underlying options that are not exercisable within sixty days of March 14, 2021.
(8)
Includes (i) 6 convertible preferred shares if converted to 12,000 common shares, and (ii) 660,394 shares of common stock issuable
upon exercise of options that are exercisable within sixty days of March 14, 2021. Does not include 76,085 shares of common stock
underlying options that are not exercisable within sixty days of March 14, 2021.
95
(9)
Includes 439,601 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 14,
2021. Does not include 985,399 shares of common stock underlying options that are not exercisable within sixty days of March 14,
2021.
(10)
Includes 475,534 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 14,
2021. Does not include 899,466 shares of common stock underlying options that are not exercisable within sixty days of March 14,
2021.
(11)
Does not include 600,000 shares of common stock underlying options that are not exercisable within sixty days of March 14, 2021.
(12)
Includes (i) 10 convertible preferred shares if converted to 20,000 common shares, and (ii) 781,879 shares of common stock issuable
upon exercise of options that are exercisable within sixty days of March 14, 2021. Does not include 353,121 shares of common stock
underlying options that are not exercisable within sixty days of March 14, 2021.
(13)
Includes 590,637 shares of common stock issuable upon exercise of options that are exercisable within sixty days of March 14,
2021. Does not include 884,363 shares of common stock underlying options that are not exercisable within sixty days of March 14,
2021.
(14)
See notes (2) through (13).
Securities
Authorized for Issuance under Equity Compensation Plans
The
following table summarizes information about our equity compensation plans as of December 31, 2020.
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)
22,550,715
$ 1.26
3,020,284
Equity compensation plans not approved by stockholders
—
—
—
Total
22,550,715
$ 1.26
3,020,284
(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 8,004,537 shares were automatically
made available for issuance on the first trading day of 2021, which represents 4% of the number of shares outstanding on December
31, 2020; 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, 2020, 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.
96
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, Patrick LePore, James Scibetta, Matthew Wikler and Ms. Natasha Giordano are “independent directors”
as such term is defined in the rules of The NYSE American’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, 2020 and 2019, by EisnerAmper
LLP, the Company’s independent registered public accounting firm.
Years Ended December 31,
2020
2019
(in thousands)
Audit Fees
$ 297
$ 370
Tax Fees
-
-
Total Fees
$ 297
$ 370
97
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.
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). †
98
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). †
10.5
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). †
10.6
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).
10.7
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). +
10.9
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).
10.10
Therapeutic Development Award Agreement, dated November 19, 2020, between Matinas BioPharma Holdings, Inc. and the Cystic Fibrosis Foundation.*
10.11
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).
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, 2020, formatted
in XBRL (eXtensible Business Reporting Language), is filed electronically herewith: (i) Consolidated Balance Sheets as of
December 31, 2020 and 2019; (ii) Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December
31, 2020 and 2019; (iii) Consolidated Statement of Changes in Stockholders’ Equity (Deficit) for the Years Ended December
31, 2020 and 2019; (iv) Consolidated Statements of Cash Flows for the Years Ended December 31, 2020 and 2019; and (v) Notes
to Consolidated Financial Statements.*
+
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.
99
SIGNATURES
Pursuant
to the requirements of the Securities Act, the registrant has duly caused this registration statement to be signed on its behalf
by the undersigned, thereunto duly authorized, in the city of Bedminster, State of New Jersey on March 29, 2021.
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
29, 2021
Jerome
D. Jabbour
(Principal
Executive Officer)
/s/
Keith A. Kucinski
Chief
Financial Officer
March
29, 2021
Keith
A. Kucinski
(Principal
Financial and Accounting Officer)
/s/
Herbert Conrad
Chairman
of the Board
March
29, 2021
Herbert
Conrad
/s/
Patrick G. LePore
Vice
Chairman of the Board
March
29, 2021
Patrick
G. Lepore
/s/
Eric Ende
Director
March
29, 2021
Eric
Ende
/s/
Matthew A. Wikler
Director
March
29, 2010
Matthew
A. Wikler
/s/
James S. Scibetta
Director
March
29, 2021
James
S. Scibetta
/s/
Natasha Giordano
Director
March
29, 2021
Natacha
Giordano
100
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, 2020 and 2019, and the related consolidated statements of operations and comprehensive loss, stockholders’ equity, and
cash flows for each of the years in the two-year period ended December 31, 2020, and the related notes (collectively referred
to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects,
the consolidated financial position of the Company as of December 31, 2020 and 2019, and the consolidated results of their operations
and their cash flows for each of the years in the two-year period ended December 31, 2020, 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 Matters
The
critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements
that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that
are material to the consolidated financial statements and (ii) involved especially challenging, subjective, or complex judgments.
The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken
as a whole, and we are not, by communicating the critical audit 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, 2020, the Company incurred significant
research and development (“R&D”) expenses, which amounted to approximately $14.4 million. At December 31, 2020,
the Company had accrued $1.4 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). The R&D activities with these CROs
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. 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 the corresponding service fees are based on the respective contractual
terms, (iii) we sent confirmations to CROs, 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, 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
29, 2021
F- 1
Matinas
BioPharma Holdings, Inc.
Consolidated
Balance Sheets
2020
2019
December 31,
2020
2019
ASSETS:
Current assets:
Cash and cash equivalents
$ 12,432,481
$ 22,170,438
Marketable securities
46,246,573
5,604,634
Restricted cash
136,000
250,000
Prepaid expenses and other current assets
2,739,791
1,897,784
Total current assets
61,554,845
29,922,856
Non-current assets:
Leasehold improvements and equipment - net
1,523,950
1,749,259
Operating lease right-of-use assets - net
3,276,639
3,761,207
Finance lease right-of-use assets - net
58,007
116,968
In-process research and development
3,017,377
3,017,377
Goodwill
1,336,488
1,336,488
Restricted cash - security deposits
200,000
336,000
Total non-current assets
9,412,461
10,317,299
Total assets
$ 70,967,306
$ 40,240,155
LIABILITIES AND STOCKHOLDERS’ EQUITY:
Current liabilities:
Accounts payable
$ 349,941
$ 679,310
Accrued expenses and other liabilities
2,795,329
1,939,510
Operating lease liabilities - current
391,498
423,741
Financing lease liabilities - current
30,853
54,673
Total current liabilities
3,567,621
3,097,234
Non-current liabilities:
Deferred tax liability
341,265
341,265
Operating lease liabilities - net of current portion
3,304,063
3,695,561
Financing lease liabilities - net of current portion
23,660
54,513
Total non-current liabilities
3,668,988
4,091,339
Total liabilities
7,236,609
7,188,573
Stockholders’ equity:
Series B Convertible preferred stock, stated value $ 1,000 per share, 8,000
shares authorized as of December 31, 2020 and 2019, respectively; 4,361 and 4,577 shares issued and outstanding as of December
31, 2020 and 2019, respectively; (liquidation preference - $ 4,361,000 at December 31, 2020)
3,797,705
3,985,805
Common stock par value $ 0.0001 per share, 500,000,000 shares authorized at
December 31, 2020 and 2019, respectively; 200,113,431 and 163,156,984 issued and outstanding as of December 31, 2020 and 2019,
respectively
20,010
16,315
Additional paid-in capital
167,192,003
113,427,897
Accumulated deficit
( 107,507,193 )
( 84,377,555 )
Accumulated other comprehensive income/(loss)
228,172
( 880 )
Total stockholders’ equity
63,730,697
33,051,582
Total liabilities and stockholders’ equity
$ 70,967,306
$ 40,240,155
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
2020
2019
For the Year Ended December
31,
2020
2019
Revenue:
Contract research revenue
$ 158,333
$ 89,812
Costs and Expenses:
Research and development
14,358,918
11,234,548
General and administrative
10,005,967
7,776,300
Total costs and expenses
24,364,885
19,010,848
Loss from operations
( 24,206,552 )
( 18,921,036 )
Sale of New Jersey net operating loss
1,073,289
1,007,082
Other income, net
686,425
541,303
Net loss
$ ( 22,446,838 )
$ ( 17,372,651 )
Preferred stock series A accumulated dividends
-
( 338,613 )
Preferred stock series B accumulated dividends
( 793,442 )
( 585,547 )
Net loss attributable to common shareholders
$ ( 23,240,280 )
$ ( 18,296,811 )
Net loss attributable to common shareholders per share
- basic and diluted
$ ( 0.12 )
$ ( 0.13 )
Weighted average common shares outstanding:
Basic and diluted
196,894,628
145,195,196
Other comprehensive income/(loss), net of tax
Net unrealized gain/(loss) on securities available-for-sale
237,537
( 880 )
Reclassification of realized gain on securities
available-for-sale to net loss
( 8,485 )
-
Other comprehensive income/(loss), net of tax
229,052
( 880 )
Comprehensive loss attributable to shareholders
$ ( 22,217,786 )
$ ( 17,373,531 )
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
Shares
Amount
Capital
Deficit
Income/(Loss)
Equity
Redeemable
Convertible Preferred Stock A
Redeemable
Convertible
Preferred Stock B
Common
Stock
Additional
Paid - in
Accumulated
Accumulated
Other Comprehensive
Total
Stockholders’
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
Income/(Loss)
Equity
Balance,
December 31, 2018
1,467,858
$
5,583,686
4,819
$
4,196,547
113,287,670
$
11,329
$
72,294,921
$
( 65,944,759
)
$
-
$
16,141,724
Stock-based
compensation
-
-
-
-
-
-
2,625,197
-
-
2,625,197
Issuance
of common stock as compensation for services
-
-
-
-
441,005
44
360,462
-
-
360,506
Issuance
of common stock in exchange for preferred shares A
( 1,467,858
)
( 5,583,686
)
-
-
14,678,580
1,468
5,582,218
-
-
-
Issuance
of common stock in exchange for preferred shares B
-
-
( 242
)
( 210,742
)
484,000
48
210,694
-
-
-
Issuance
of common stock in public offering, net of stock issuance costs ($ 2,315,878 )
-
-
-
-
29,471,986
2,947
30,100,359
-
-
30,103,306
Issuance
of common stock in exchange for Options
-
-
-
-
72,500
7
30,168
-
-
30,175
Issuance
of common stock in exchange for Warrants
-
-
-
-
252,383
25
( 10,105
)
-
-
( 10,080
)
Stock
dividends
-
-
-
-
4,468,860
447
2,233,983
( 1,060,145
)
-
1,174,285
Other
comprehensive loss
-
-
-
-
-
-
-
( 880 )
( 880
)
Net
loss
-
-
-
-
-
-
-
( 17,372,651
)
-
( 17,372,651
)
Balance,
December 31, 2019
-
$
-
4,577
$
3,985,805
163,156,984
$
16,315
$
113,427,897
$
( 84,377,555
)
$
( 880
)
$
33,051,582
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 ($ 3,298,790 )
-
-
-
-
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
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
The
accompanying notes are an integral part of these consolidated financial statements.
F- 4
Matinas
BioPharma Holdings, Inc.
Consolidated
Statements of Cash Flows
2020
2019
For
the Year Ended December 31,
2020
2019
Cash flows from operating activities:
Net loss
$ ( 22,446,838 )
$ ( 17,372,651 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
231,058
205,964
Stock-based compensation expense
4,564,787
2,985,278
Loss on disposal of equipment
-
6,417
Amortization of operating lease right-of-use assets
484,568
452,054
Amortization of finance lease right-of-use assets
58,961
122,798
Amortization of bond discount
239,831
140
Realized gain on sale of marketable securities
8,485
-
Changes in operating assets and liabilities:
Operating lease liabilities
( 423,741 )
( 359,570 )
Prepaid expenses and other current assets
( 611,397 )
( 1,358,713 )
Accounts payable
( 329,369 )
383,657
Accrued expenses and other liabilities
855,819
842,560
Net cash used in operating activities
( 17,367,836 )
( 14,092,066 )
Cash flows from investing activities:
Purchases of marketable securities
( 72,106,359 )
( 5,605,654 )
Proceeds from sales of marketable securities
31,445,156
-
Purchases of leasehold improvements and equipment
( 5,749 )
( 405,604 )
Net cash used in investing activities
( 40,666,952 )
( 6,011,258 )
Cash flows from financing activities:
Net proceeds from public offering of common stock
46,704,210
30,103,306
Proceeds from exercise of warrants
797,581
-
Proceeds from exercise of options
599,713
30,175
Payments of capital lease liability - principal
( 54,673 )
( 81,715 )
Payments of note payable
-
( 199,842 )
Net cash provided by financing activities
48,046,831
29,851,924
Net (decrease)/increase in cash, cash equivalents and restricted cash
( 9,987,957 )
9,748,600
Cash, cash equivalents and restricted cash at beginning
of period
22,756,438
13,007,838
Cash, cash equivalents and restricted cash at end
of period
$ 12,768,481
$ 22,756,438
Supplemental non-cash financing and investing activities:
Unrealized gain (loss) on marketable securities
$ 229,052
$ ( 880 )
Cashless exercise of warrants
$ -
$ 10,080
Stock dividends issued
$ 682,800
$ 2,234,429
Non-Cash prepaid from exercise of options
$ 220,614
$ -
Preferred stock conversion into common stock - series B
$ 188,100
$ 210,742
Unearned restricted stock grants
$ 68,521
$ 58,525
Stock dividends accrual
$ -
$ 1,174,285
Right-of-use assets obtained in exchange for liabilities
$ -
$ 4,453,028
Preferred stock conversion into common stock - series A
$ -
$ 5,583,686
The
accompanying notes are an integral part of these consolidated financial statements.
F- 5
Note 1 – Description of Business
Matinas
BioPharma Holdings Inc. (“Holdings”) is a Delaware corporation formed in 2013. Holdings is the parent company of Matinas
BioPharma, Inc. (“BioPharma”), and Matinas BioPharma Nanotechnologies, Inc. (“Nanotechnologies,” formerly
known as Aquarius Biotechnologies, Inc.), its operating subsidiaries (“Nanotechnologies”, and together with “Holdings”
and “BioPharma”, “the Company” or “we” or “our” or “us”). 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,
2020, the Company had an accumulated deficit of approximately $ 107.5 million. The Company’s net loss for the years ended
December 31, 2020 and 2019 were approximately $ 22.4 million and $ 17.4 million, respectively.
The
Company has been engaged in developing LYPDISO (formerly MAT-9001), its lead product candidate, as well as its lipid nanocrystal
(“LNC”) platform delivery technology and a pipeline of associated product candidates 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, on March 19, 2019, the Company completed an underwritten public offering of common stock, generating
gross cash proceeds of $ 30.0 million and net proceeds of approximately $ 27.8 million. On March 28, 2019, additional shares were
sold pursuant to an over-allotment option granted to the underwriters of the public offering, resulting in additional net proceeds
to the Company of approximately $ 2.3 million. In addition, on January 14, 2020, the Company completed an underwritten public offering
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, 2020, the Company had cash and cash equivalents of approximately $ 12.4 million, marketable securities of approximately
$ 46.2 million and restricted cash of approximately $ 0.3 million. 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. The Company believes the cash and cash equivalents and marketable securities on hand are
sufficient to fund planned operations into 2024.
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, 2020 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 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, contingent consideration and research and development expenses.
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 and corporate debt securities. Marketable securities
are carried at fair value, with unrealized gains and losses reported as accumulated other comprehensive income/(loss), 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. Our 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 we have 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 we
determine this is the case, we 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, we conducted our business in a
single operating segment and reporting unit. For the years ended December 31, 2020 and 2019, 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, 2020 and 2019. 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, 2020 and 2019.
Leases
In
February 2016, the Financial Accounting Standards Board (the “FASB”) established Accounting Standards Codification
(“ASC”) Topic 842, “Leases”, by issuing Accounting Standards Update (“ASU”) No. 2016-02, which
requires lessees to now recognize operating leases on the balance sheet and disclose key information about leasing arrangements.
ASC Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU
No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements . The new standard
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
The
Company adopted the new standard on January 1, 2019 using the modified retrospective transition method, which applies the provisions
of the standard at the effective date without adjusting the comparative periods presented. The Company adopted the following practical
expedients and accounting policies elections related to this standard:
●
Short-term
lease accounting policy election allowing lessees to not recognize ROU assets and liabilities for leases with a term of 12
months or less;
●
The
option to not separate lease and non-lease components in the Company’s lease contracts; and
●
The
package of practical expedients applied to all of its leases, including (i) not reassessing whether any expired or existing
contracts are or contain leases, (ii) not reassessing the lease classification for any expired or existing leases, and (iii)
not reassessing the capitalization of initial direct costs for any existing leases.
Adoption
of this standard resulted in the recognition of operating lease right-of-use assets and corresponding lease liabilities of approximately
$ 4.2 million and approximately $ 4.5 million, respectively, on the consolidated balance sheet as of January 1, 2019. In addition,
the Company reclassified $ 0.2 million from leasehold improvements & equipment to finance lease right-of-use assets in connection
with the adoption of ASC Topic 842. The Company’s accounting for finance leases remained substantially unchanged. Disclosures
related to the amount, timing and uncertainty of cash flows arising from leases are included in Note 8, Leases.
Preferred
stock dividends
Prior
to automatic conversion on July 29, 2019, shares of Series A Preferred Stock earned dividends at a rate of 8.0 % once per year
on the first, second and third anniversary of July 29, 2016, which was paid to the holders of such Series A Preferred Stock in
the form of shares of the Company’s common stock when converted. In addition, and subject to provisions detailed more fully
in Note 12, Stockholders’ Equity, shares of Series B Preferred Stock earn dividends at rates of 10 %, 15 % and 20 % once per
year on the first, second and third anniversary, respectively, of June 19, 2018. Dividends are payable to holders of the Series
B Preferred Stock in the form of shares of the Company’s common stock. Preferred stock dividends do not require declaration
by the Board of Directors and are accrued annually as of the date the dividend is earned in an amount equal to the applicable
rate of the stated value.
Beneficial
conversion feature of convertible preferred stock
The
Company accounts for the beneficial conversion feature on its convertible preferred stock in accordance with ASC 470-20, Debt
with Conversion and Other Options . The Beneficial Conversion Feature (“BCF”) of convertible preferred stock is
normally characterized as the convertible portion or feature that provides a rate of conversion that is below market value or
in-the-money when issued. The Company records a BCF related to the issuance of convertible preferred stock when issued. BCFs that
are contingent upon the occurrence of a future event are recorded when the contingency is resolved.
To
determine the effective conversion price, the Company first allocates the proceeds received to the convertible preferred stock
and then uses those allocated proceeds to determine the effective conversion price. If the convertible instrument is issued in
a basket transaction (i.e., issued along with other freestanding financial instruments), the proceeds should first be allocated
to the various instruments in the basket. Any amounts paid to the investor when the transaction is consummated (e.g., origination
fees, due diligence costs) represent a reduction in the proceeds received by the issuer. The intrinsic value of the conversion
option is measured using the effective conversion price for the convertible preferred stock on the proceeds allocated to that
instrument. The effective conversion price represents proceeds allocable to the convertible preferred stock divided by the number
of shares into which it is convertible. The effective conversion price is then compared to the per share fair value of the underlying
shares on the commitment date.
The
BCF is recognized by allocating the intrinsic value of the conversion option to additional paid-in capital, resulting in a discount
on the convertible preferred stock. This discount is accreted from the date on which the BCF is first recognized through the earliest
conversion date for instruments that do not have a stated redemption date. The intrinsic value of the BCF is recognized as a deemed
dividend on convertible preferred stock over the period specified in the guidance.
F- 9
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 2020 and 2019
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, 2020.
Since
the Company incurred net operating losses in every tax year since inception, the 2014 through 2019 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.
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.
F- 10
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, 2020 and 2019, 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, 2020 and 2019 are as follows (in thousands):
Schedule of Antidilutive Securities
As of December 31,
2020
2019
Stock options
22,551
17,529
Preferred Stock and accrued dividend upon conversion
8,722
9,154
Warrants
1,328
5,397
Total
32,601
32,080
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 intitled 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 and 2019, 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.
As certain contract performance obligations in this contract were completed, it was the Company’s only contract with revenue
from a customer for 2019 and disaggregation of revenue is not required. The Company had approximately $ 125.0 thousand and $ 89.8
thousand of CFF research grant revenue for the years ended December 31, 2020 and 2019, respectively.
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 .0 thousand for three molecules, or approximately $ 33.3
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, 2020, the Company completed the first of three molecules and the Company recognized approximately $ 33.3
thousand of revenue for the year ended
December 31, 2020. The Company is scheduled to complete the remaining two molecules during 2021.
F- 11
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 our 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- 12
Research
and Development Arrangement: Under the terms of our research and development agreement with the Cystic Fibrosis Foundation
Therapeutics, Inc. (“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, 2020, the Company recognized approximately $ 73.4 thousand 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 our 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- 13
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
June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”)
2016-13, “Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments”.
The standard represents a significant change to the impairment model for most financial assets that are measured at amortized
costs and certain other instruments from an incurred loss model to an expected loss model which will be based on an estimate of
current expected credit loss (“CECL”) and provides targeted improvements on evaluating impairment and recording credit
losses on available-for-sale debt securities through an allowance account. The guidance is effective for public entities in fiscal
years beginning after December 15, 2019, including interim periods within those fiscal years. The adoption did not have a material
impact on our consolidated financial statements.
In
November 2019, the FASB Issued ASU 2019-11, “Codification Improvements to Topic 326, Financial Instruments – Credit
Losses”. The amendments in this standard represent changes to clarify, correct errors in, or improve the Codification. The
amendments make the Codification easier to understand and easier to apply by eliminating inconsistencies and providing clarifications.
This standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019.
The adoption did not have a material impact on our consolidated financial statements.
In
August 2018, the FASB issued ASU 2018-13, “Changes to Disclosure Requirements for Fair Value Measurements”, which
will improve the effectiveness of disclosure requirements for recurring and nonrecurring fair value measurements. The standard
removes, modifies, and adds certain disclosure requirements, and is effective for fiscal years, and interim periods within those
fiscal years, beginning after December 15, 2019. The adoption did not have a material impact on our consolidated financial statements.
In
November 2018, the FASB issued ASU 2018-18, “Collaboration Arrangements (Topic 808): Clarifying the Interaction between
Topic 808 and Topic 606”, to clarify when ASC 606 should be used for collaborative arrangements when the counterparty is
a customer. The Guidance precludes an entity from presenting consideration from a transaction in a collaborative arrangement as
revenue from the contracts with the customers if the counterparty is not a customer for that transaction. The guidance is effective
for public entities in fiscal years beginning after December 15, 2019, and interim period therein. The adoption did not
have a material impact on our consolidated financial statements in 2020, see Note 9 – Collaboration Agreements, License
and other Research and Development Agreements.
Recent
accounting pronouncements not yet adopted
In
December 2019, the FASB Issued ASU 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 is currently evaluating the impact this standard
will have on its consolidated financial statements.
F- 14
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, 2020, December 31, 2019 and December
31, 2018 (in thousands):
Schedule of Cash, Cash Equivalents and Restricted Cash
December 31,
2020
December 31,
2019
December 31,
2018
Cash and cash equivalents
$ 12,432
$ 22,170
$ 12,447
Restricted cash included in current/long term assets
336
586
561
Cash, cash equivalents and restricted cash in the statements of cash flows
$ 12,768
$ 22,756
$ 13,008
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 income (loss) 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, 2020 and 2019, the Company recorded unrealized gains/(losses) of approximately $ 237.5 thousand
and $ 0.9 thousand, respectively, and reclassed approximately $ 8.5 thousand to net loss from operations from the sale of certain
securities during 2020. As of December 31, 2020 and 2019, the Company had net accumulated unrealized gains of approximately $ 228.2
thousand and net accumulated unrealized losses of approximately $ 0.9 thousand, respectively.
The
following tables summarizes the Company’s marketable securities for the year ended December 31, 2020 consisted of the following
(in thousands):
Summary of Cash, Cash Equivalents and Marketable Securities
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
F- 15
Maturities
of debt securities classified as available-for-sale were as follows at December 31, 2020 (in thousands):
Schedule of Maturities of Debt Securities Available-for-sale
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
following tables summarizes the Company’s cash, cash equivalents and marketable securities for the year ended December 31,
2019 consisted of the following (in thousands):
Summary of Cash, Cash Equivalents and Marketable Securities
Amortized Cost
Unrealized Gain
Unrealized (Loss)
Fair Value
Cash and cash equivalents
$ 22,169
$ 1
$ —
$ 22,170
U.S. Treasury Bonds
$ 4,003
$ —
$ ( 1 )
$ 4,002
Corporate Debt Securities
1,604
—
( 1 )
1,603
Total marketable securities
$ 5,607
$ —
$ ( 2 )
$ 5,605
Total cash, cash equivalents and marketable securities
$ 27,776
$ 1
$ ( 2 )
$ 27,775
Maturities
of debt securities classified as available-for-sale were as follows at December 31, 2019 (in thousands):
Schedule of Maturities of Debt Securities Available-for-sale
Fair Value
Net
Carrying Amount
Due within one year
$ 5,002
$ 5,019
Due after one year through five years
603
607
$ 5,605
$ 5,626
The
Company determined that the unrealized gains and (losses) are deemed to be temporary as of December 31, 2020. Unrealized gains
and (losses) 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, 2020.
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.
F- 16
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, 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
$ —
Fair Value Hierarchy
December 31, 2019
Total
(Level 1)
(Level 2)
(Level 3)
Assets
Cash and cash equivalents
$ 22,170
$ 22,170
$ —
$ —
Marketable Securities:
U.S. Treasury Bonds
4,002
4,002
—
—
Corporate Debt Securities
1,603
—
1,603
—
Total
$ 27,775
$ 26,172
$ 1,603
$ —
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.
Note
6 – Leasehold Improvements and Equipment
Leasehold
improvements and equipment, summarized by major category, consist of the following for the years ended December 31, 2020 and 2019
(in thousands):
Schedule of Leasehold Improvements and Equipment
December 30,
2020
December 31,
2019
Lab equipment
$ 1,443
$ 1,437
Leasehold improvements
878
878
Total
2,321
2,315
Less: accumulated depreciation and amortization
797
566
Leasehold improvements and equipment, net
$ 1,524
$ 1,749
Depreciation
and amortization expense for the years ended December 31, 2020 and 2019 was approximately $ 231.1 thousand and $ 206 .0 thousand,
respectively. Due to the adoption of the new lease accounting pronouncement in January 2019 and the reclass of certain right-of-use
assets upon adoption, the Company reclassed $ 559 thousand and $ 72 thousand of assets and related accumulated depreciation, respectively.
In addition, in July 2019, the Company recorded an asset write-off of approximately $ 14 thousand, including $ 7 thousand of related
accumulated depreciation.
F- 17
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, 2020 and 2019
(in thousands):
Schedule of Accrued Expenses
2020
2019
As of December 31,
2020
2019
Payroll and incentives
$ 1,094
$ 978
General and administrative expenses
280
441
Research and development expenses
778
421
Deferred revenue and other deferred liabilities *
643
100
Total
$ 2,795
$ 1,940
*
At
December 31, 2020, approximately $ 576.6 thousand is the remaining balance of the CFF Agreement’s deferred liability
and approximately $ 66.6 thousand is deferred revenue related to the Genentech feasibility study agreement. The $ 100.0 thousand
of deferred revenue at December 31, 2019 is the upfront payment for 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, which
is May 2021. The Company was obligated to provide an initial security deposit of $ 300,000 to obtain the office lease space. As
of December 31, 2020, the total deposit had been returned to the Company.
On
September 23, 2020, the Company entered into an amendment to the Bedminster lease. Pursuant to the amendment, the Company will
lease an additional 3,034 rentable square feet (“Expansion Premises”). The amendment becomes effective upon the date
on which the landlord delivers to the Company the Expansion Premises, which is expected to occur in the second quarter of 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.
The total lease commitment over the seven-year extension period is approximately $ 1.8 million.
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 to $ 286,000 . It can be further reduced by $ 86,000 on the next
anniversary of the rent commencement date, after which it will remain at $ 200,000 for the balance of the lease term.
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.
F- 18
The
Company incurred lease expense for its operating leases of approximately $ 813.7 thousand for the years ended December 31, 2020
and 2019. The Company incurred amortization expense on its operating lease right-of-use assets of approximately $ 484.6 thousand
and $ 452.1 thousand for the years ended December 31, 2020 and 2019, respectively.
Finance
Leases
The
Company incurred interest expense on its finance leases of approximately $ 6.7 thousand and $ 11.7 thousand for the years ended
December 31, 2020 and 2019, respectively. The Company incurred amortization expense on its finance lease right-of-use assets of
approximately $ 59.0 thousand and $ 122.8 thousand for the years ended December 31, 2020 and 2019, respectively.
The
following table presents information about the amount and timing of liabilities arising from the Company’s operating leases,
excluding the Expansion Premises of the amended Bedminster lease which the Company has not taken control of as of December 31,
2020, and finance leases as of December 31, 2020 (in thousands):
Schedule of Maturity of Operating and Finance Leases Liabilities
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 %
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, 2019 (in thousands):
Maturity of Lease Liabilities
Operating Lease Liabilities
Finance Lease Liabilities
2020
$ 753
$ 60
2021
685
34
2022
645
19
2023
677
2
2024
710
-
Thereafter
2,203
-
Total undiscounted operating lease payments
$ 5,673
$ 115
Less: Imputed interest
1,554
6
Present value of operating lease liabilities
$ 4,119
$ 109
Weighted average remaining lease term in years
7.5
2.2
Weighted average discount rate
8.4 %
7.8 %
F- 19
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 Cystic Fibrosis Foundation (“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 lipid nanocrystal oral formulation of the broad-spectrum aminoglycoside
amikacin, for the treatment of pulmonary non-tubercular mycobacteria infections and other pulmonary diseases (the “Field”).
The
first payment under the Agreement, in the amount of $ 650.0
thousand, became due upon execution of
the Agreement. The Company invoiced the CFF in November 2020 and payment was subsequently received in February 2021. At December
31, 2020, the related receivable of $ 650.0
thousand is included in prepaid expenses
and other current assets and the related deferred liability balance of $ 576.6
thousand
is included in accrued expense and other current liabilities. The remainder of the Award will be paid to the Company incrementally
in installments 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 year ended December 31, 2020, the Company recognized $ 73.4 thousand,
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.
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 $33.3 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, 2020, the Company completed the first of three molecules
and the Company recognized approximately $ 33.3 thousand of Genentech revenue for the year ended December 31, 2020. The Company
did not complete any contract performance obligations during 2019.
F- 20
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 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 initially $ 10,000 , increasing to the current fee amount 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 .
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.
Acquisition
of Aquarius Biotechnologies, Inc. (now known as Matinas BioPharma Nanotechnologies, Inc.)
Pursuant
to the terms of the merger agreement with Aquarius Biotechnologies, Inc., the Company may be required to issue up to an additional
3,000,000 shares of our common stock upon the achievement of certain milestones. The milestone consideration consists of (i) 1,500,000
shares issuable upon the dosing of the first patient in a phase III trial sponsored by us for a product utilizing Aquarius’
proprietary LNC platform delivery technology and (ii) 1,500,000 shares issuable upon FDA approval of the first NDA submitted by
us for a product utilizing Aquarius’ proprietary LNC platform delivery technology. The Company concluded that the contingent
share issuance represented equity settled contingent consideration and have recorded the amounts to equity since inception. None
of these milestones have been reached, and accordingly, as of December 31, 2020 no additional shares have been issued.
F- 21
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, 2020 and 2019,
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
2020
2019
Year
Ended December 31,
2020
2019
Current expense (benefit):
Federal
$ -
$ -
State
-
-
Foreign
-
-
Total current expense (benefit):
$ -
$ -
Deferred expense (benefit):
Federal
$ -
$ -
State
-
-
Foreign
-
-
Total deferred expense (benefit):
$ -
$ -
Total income tax expense (benefit):
$ -
$ -
Deferred
income taxes reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for financial
reporting purposes and the amounts used for income tax purposes. A reconciliation of the statutory U.S. federal rate to the Company’s
effective tax rate is as follows:
Schedule of Effective Income Tax Rate Reconciliation
Year Ended December 31,
2020
2019
Income at US Statutory Rate
21.00 %
21.00 %
State Taxes, net of Federal benefit
2.95 %
3.82 %
Permanent Differences
- 1.28 %
- 0.88 %
Tax Credits
0.75 %
1.06 %
Valuation Allowance
- 24.53 %
- 29.92 %
Discrete items
1.11 %
4.92 %
0.00 %
0.00 %
F- 22
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 2020 and 2019 consist of the following (in thousands):
Schedule of Deferred Tax Assets and Liabilities
2020
2019
Year Ended December 31,
2020
2019
Share-based Compensation
$ 3,220
$ 2,611
Depreciation and Amortization
( 119 )
( 219 )
Accrued Liability
307
275
Net Operating Loss Carry-forwards
19,927
15,587
R&D Credit Carryforwards
2,264
1,881
Other
( 10 )
( 27 )
IPR&D
( 848 )
( 848 )
ROU Asset
( 921 )
( 1,057 )
ROU Liability
1,045
1,158
Total Deferred tax assets
$ 24,865
$ 19,361
Valuation allowance
( 25,206 )
( 19,702 )
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 allowance
was approximately $ 25.2 million and approximately $ 19.7 million as of December 31, 2020 and 2019, respectively, representing an
increase of approximately $ 5.5 million.
As
of December 31, 2020, 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 $ 45.0 million which have an indefinite carryforward period. The Company also
had federal and state research and development tax credit carryforwards of approximately $ 2.3 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.
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
F- 23
Sale
of net operating losses (NOLs)
The
Company recognized approximately $ 1.1 million and $ 1.0 million for the years ended December 31, 2020 and 2019, 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 net operating loss (NOL) deductions to 80% of net taxable income for losses arising in taxable
years beginning after December 31, 2017. This NOL limitation has currently been 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. As of December 31, 2020, the Company did not sell any shares
of its common stock under the ATM Sales Agreement. During January 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.
Common
Stock
On
January 14, 2020, the Company closed on an underwritten public offering of 32.3 million 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.
On
March 19, 2019, the Company closed an underwritten public offering of its common stock. This offering was made pursuant to an
underwriting agreement between the Company and BTIG, LLC. The offering resulted in the sale of 27,272,727 shares to the public
at a price of $ 1.10 per share. The Company generated gross proceeds of $ 30.0 million. Net proceeds after deducting underwriting
discounts and commissions and other estimated offering expenses are approximately $ 27.8 million. In addition, the Company granted
the underwriters a 30-day option (the “option”) to purchase up to an additional 4,090,909 shares of common stock subject
to the same terms and conditions. On March 28, 2019, an additional 2,199,259 shares were sold pursuant to the option at a price
of $ 1.10 per share, resulting in net proceeds to the Company of approximately $ 2.3 million.
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.
F- 24
Series
B Preferred Stock
On
June 19, 2018, the Company entered into a placement agency agreement with ThinkEquity, a Division of Fordham Financial Management,
Inc., as placement agent, relating to the offering, issuance and sale of up to 8,000 shares of the Company’s Series B Convertible
Preferred Stock, par value $ 0.0001 per share with a stated value of $ 1,000 per share which are convertible into an aggregate of
up to 16,000,000 shares of the Company’s common stock at an initial conversion price of $ 0.50 per share. The offering also
included up to an additional 7,200,000 shares of common stock issuable upon payment of dividends under the Series B Preferred
Stock. The offering closed on June 21, 2018 raising a gross amount of $ 8 million with net proceeds of $ 7.1 million after deducting
issuance costs. The placement agent received 7 % commission on the gross proceeds, 1 % of the gross proceeds to cover non-accountable
expenses and 240,000 warrants fair valued at approximately $ 89,000 treated as a reduction to gross proceeds, that are exercisable
over a 5 -year period at an exercise price of $ 0.75 per share.
As
of December 31, 2020 and 2019, there were 4,361 shares 4,577 shares, respectively, of Series B Preferred Stock outstanding.
Conversion:
Optional
Conversion . Subject to the Beneficial Ownership Limitation (defined below), each share of Series B Preferred Stock will be
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 current conversion price and number of shares outstanding, the Series B Preferred Stock is convertible
into 8,722,000 shares of common stock. Dividends will not accrue and will not be paid following optional conversion. During the
years ended December 31, 2020 and 2019, 216 shares and 242 shares, respectively, of Series B preferred stock were converted into
shares of common stock.
Automatic
Conversion . Subject to the Beneficial Ownership Limitation described below, each share of Series B Preferred Stock shall automatically
convert into 2,000 shares of the Company’s common stock at an initial conversion price of $0.50 per share upon the earlier
of (i) the first FDA approval of one of our product candidates, (ii) the 36-month anniversary of the of the filing of the Certificate
of Designation for the Series B Preferred Stock with the Secretary of State of Delaware (the “COD Effective Date”
which is June 19, 2018) or (iii) the consent to conversion by holders of at least 50.1 % of the outstanding shares of Series B
Preferred Stock. In the event the Series B Preferred Stock automatically converts into common stock prior to the 36 month anniversary
of the COD Effective Date, the holder on the date of such conversion shall also be entitled to receive those dividends which would
have been payable after the conversion date, as if the shares of Series B Preferred Stock had remained unconverted and outstanding
through the 36 month anniversary of the COD Effective Date. Such dividend amount shall be payable as set forth above in shares
of common stock upon such automatic conversion.
Beneficial
Conversion Feature. The Optional and Automatic conversion features do not contain a BCF as the effective conversion price
for the Series B Preferred Stock at issuance was equal to the fair value of the common stock into which the preferred shares are
convertible into.
Beneficial
Ownership Limitation . The Company may not affect any optional or automatic conversion of the Series B Preferred Stock, or
issue shares of common stock as dividends and a holder does not have the right to convert any portion of the Series B Preferred
Stock to the extent that, after giving effect to such conversion such holder would beneficially own in excess of the Beneficial
Ownership Limitation, or such holder, together with such holder’s affiliates, and any persons acting as a group together
with such holder or affiliates, would beneficially own in excess of the Beneficial Ownership Limitation. The “Beneficial
Ownership Limitation” is 4.99% of the number of shares of the Company’s common stock outstanding immediately after
giving effect to the issuance of shares of common stock issuable upon conversion of Series B Preferred Stock held by the applicable
holder. A holder may, prior to issuance of the Series B Preferred Stock or, with 61 days prior notice to us, elect to increase
or decrease the Beneficial Ownership Limitation; provided, however, that in no event may the Beneficial Ownership Limitation exceed
9.99%.
Liquidity
Value and Dividends:
Dividends .
Subject to the Beneficial Ownership Limitation described above, holders of the Series B Preferred Stock are entitled to receive
dividends payable 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 the 12 month anniversary of the COD Effective
Date, (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 the 24-month anniversary of the COD Effective Date 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 the 36-month anniversary
of the COD Effective Date. In the event a purchaser in this offering no longer holds Series B Preferred Stock as of the 12-month
anniversary, the 24-month anniversary or the 36-month anniversary, such purchaser will not be entitled to receive any dividends
on such anniversary date. Based on an accounting of the holders of record of Series B Preferred Stock on June 19, 2019 and 2020,
the Company paid the 12-month anniversary dividend payments of 10 % and 15 %, respectively, totaling 946,000 shares and 1,365,600
shares, respectively, of common stock.
F- 25
In
the event a fundamental transaction is consummated prior to the automatic conversion of the Series B Preferred Stock, the dividends
will be accelerated and paid to the extent not previously paid. In addition, holders of Series B Preferred Stock will be entitled
to receive dividends equal, on an as-if-converted to shares of common stock basis, and in the same form as dividends actually
paid on shares of the common stock when, as, and if such dividends are paid on shares of the common stock. Notwithstanding the
foregoing, to the extent that a holder’s right to participate in any dividend in shares of common stock to which such holder
is entitled would result in such holder exceeding the Beneficial Ownership Limitation, then such holder shall not be entitled
to participate in any such dividend to such extent and the portion of such shares that would cause such holder to exceed the Beneficial
Ownership Limitation shall be held in abeyance for the benefit of such holder until such time, if ever, as such holder’s
beneficial ownership thereof would not result in such holder exceeding the Beneficial Ownership Limitation.
Pursuant
to its Certificate of Designation, the liquidation value of a share of Series B Preferred Stock is equal to the stated value of
$ 1,000 per share (as adjusted for stock splits, stock dividends, combinations or other recapitalizations of the Series A Preferred
Stock) plus any earned but unpaid dividends.
Warrants
The
Company has issued two types of warrants: (i) investor warrants and (ii) placement agent warrants. All warrants 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 investor 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.
For
the 20 million investor warrants issued in 2015, the Company may call the warrants at any time the common stock trades above $3.00
for twenty (20) consecutive days following the effectiveness of the registration statement covering the resale of the shares of
common stock underlying the warrants, provided that the warrants can only be called if such registration statement is current
and remains effective at the time of the call and provided further that the Company can only call the investor warrants for redemption,
if it also calls all other warrants for redemption on the terms described above. The Company did not call any warrants during
the periods ended December 31, 2019 and 2020.
The
placement agent warrants do not have a redemption feature. They may be exercised on a cashless basis at the holder’s option.
The
investor warrants and placement agent warrants are classified as equity instruments.
F- 26
As
of December 31, 2020, the Company had outstanding warrants to purchase an aggregate of 1,327,810 shares of common stock at exercise
prices ranging from $ 0.50 to $ 0.75 per share. A summary of warrants outstanding as of December 31, 2020 and 2019 is presented
below, all of which are fully vested (in thousands):
Summary of Shareholders Equity Warrants Outstanding
Shares
Outstanding at December 31, 2018
5,799
Issued
-
Exercised
( 402 )
Tendered
-
Expired
-
Outstanding at December 31, 2019
5,397 *
Outstanding at January 01, 2020
5,397 *
Issued
-
Exercised
( 2,576 )**
Tendered
-
Expired
( 1,493 )
Outstanding at December 31, 2020
1,328 ***
*
Weighted
average exercise price for outstanding warrants is $ 0.62 .
**
Converted
into approximately 1,737 thousand shares of common stock.
***
Weighted
average exercise price for outstanding warrants is $ 0.55 .
Note
13 – Accumulated Other Comprehensive Income/(Loss)
The
following table summarizes the changes in accumulated other comprehensive income/(loss) by components during the years ended December
31, 2020 and 2019 (in thousands):
Schedule of Components of Accumulated Other Comprehensive Income/(Loss)
Net Unrealized (Losses)/Gains
on Available-for-Sale Securities
Accumulated Other Comprehensive
(Loss)/Gain
Balance, December 31, 2018
$ —
$ —
Net unrealized loss on securities available-for-sale
( 1 )
( 1 )
Reclassifications to net loss
—
—
Net current period other comprehensive loss
( 1 )
( 1 )
Balance, December 31, 2019
$ ( 1 )
$ ( 1 )
Balance, January 01, 2020
$ ( 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 income
229
229
Balance, December 31, 2020
$ 228
$ 228
All
components of accumulated other comprehensive income/(loss) are net of tax.
Note
14 – Stock-based Compensation
The
Company’s Amended and Restated 2013 Equity Compensation Plan (the “Plan”) provides for the granting of incentive
stock options, nonqualified stock options, restricted stock units, performance units, and stock purchase rights. 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, 2020, the Company had 28,947,923
shares of common stock authorized for issuance under the Plan.
With
the approval of the Board of Directors and a majority of shareholders, effective May 8, 2014, the Plan was amended and restated.
The amendment provides for an automatic increase in the number of shares of common stock available for issuance under the Plan
each January (with Board approval), commencing January 1, 2015 in an amount up to four percent ( 4 % ) of the total number of shares
of common stock outstanding on the preceding December 31st.
The
Company recognized stock-based compensation expense (options and restricted share grants) in its consolidated statements of operations
as follows (in thousands):
Schedule of Recognized Stock-Based Compensation
Year Ended December 31,
2020
2019
Research and Development
$ 1,897
$ 973
General and Administrative
2,668
2,012
Total
$ 4,565
$ 2,985
F- 27
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)
28,948 *
25,928 **
3,020
*
Increased
by 6,526 thousand on January 1, 2020, representing 4 % of the total number of shares of common stock outstanding on December
31, 2019.
**
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, 2019
to December 31, 2020 (options in thousands):
Schedule of Stock Option Activity
Number of Options
Weighted Average Exercise Price
Weighted Average Contractual Term in Years
Outstanding at January 1, 2019
13,457
$ 1.13
6.2
Granted
4,539
$ 1.05
Exercised
( 73 )
0.42
Forfeited
( 334 )
$ 1.00
Cancelled
-
-
Expired
( 60 )
$ 2.19
Outstanding at December 31, 2019
17,529
$ 1.11
6.2
Outstanding at January 01, 2020
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
*
Resulted
in the issuance of approximately 782 thousand shares of common stock due to certain cashless exercises.
The
following table summarizes outstanding options at December 31, 2020, by their exercise price (options in thousands):
Schedule of Outstanding Options Exercise Price
Range of Exercise Prices
Number Outstanding
Weighted Average Exercise Price Per Share
$ 0.41 - $ 0.69
2,682
$ 0.48
$ 0.74 - $ 1.12
12,326
$ 0.92
$ 1.24 - $ 1.61
2,788
$ 1.33
$ 2.27 - $ 3.32
4,755
$ 2.55
22,551
$ 1.26
F- 28
As
of December 31, 2020, the number of vested shares underlying outstanding options was 13,413,955 at a weighted average exercise
price of $ 1.15 . The aggregate intrinsic value of in-the-money options outstanding as of December 31, 2020 was $ 8.0 million. The
aggregate intrinsic value is calculated as the difference between the Company’s closing stock price of $ 1.36 on December
31, 2020, and the exercise price of options, multiplied by the number of options. As of December 31, 2020, there was approximately
$ 8.8 million of total unrecognized share-based compensation. Such costs are expected to be recognized over a weighted average
period of approximately 2.6 years.
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, 2020 and 2019, the Company granted restricted stock awards for 379,385 and 441,005 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
$ 291.9 thousand and $ 360.1 thousand in the consolidated statement of operations for the years ended December 31, 2020 and 2019,
respectively. As of December 31, 2020, there was $ 68.5 thousand of total unrecognized compensation costs related to 100,000 non-vested
restricted stock grants which are expected to be recognized over a weighted-average period of 0.8 years.
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 Share Based Payment Assumptions
For
the Year Ended December 31,
2020
2019
Volatility
100.5 %
- 107.4
%
106.1 %
- 111.3
%
Risk-free
interest rate
0.34 %
- 1.74
%
1.59 %
- 2.65
%
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
During
January 2021, the Company sold 3,023,147 shares of its common stock under its ATM Sales Agreement with BTIG, LLC, generating gross
proceeds of approximately $ 5.8 million and net proceeds of approximately $ 5.6 million.
F- 29