Matinas Biopharma Holdings, Inc. 10K 2020 V1

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38022 MATINAS BIOPHARMA HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware No. 46-3011414 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 1545 Route 206 South, Suite 302 Bedminster, New Jersey 07921 (Address of principal executive offices) (Zip Code) 908-443-1860 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of Each Class Trading Symbol Name of Each Exchange on Which Registered Common Stock, par value $0.0001 MTNB NYSE American Securities registered pursuant to Section 12(g) of the Act: None. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes [ ] No [X] Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes [ ] No [X] Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ] Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes [X] No [ ] Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.: Large accelerated filer [ ] Accelerated filer [X] Non-accelerated filer [ ] Smaller reporting company [X] Emerging growth company [ ] If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ] Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes [ ] No [X] The aggregate market value of the registrant’s voting and non-voting common stock held by non-affiliates of the registrant computed by reference to the price at which the common stock was last sold on June 28, 2019 was approximately $111.8 million. As of March 3, 2020, there were 196,556,863 shares of the registrant’s common stock, $0.0001 par value, outstanding. DOCUMENTS INCORPORATED BY REFERENCE None. MATINAS BIOPHARMA HOLDINGS, INC. Annual Report on Form 10-K Fiscal Year Ended December 31, 2019 Table of Contents Page PART I ...................................................................................................................................................................... 1 Item 1. Business ....................................................................................................................................... 2 Item 1A. Risk Factors .................................................................................................................................. 32 Item 1B. Unresolved Staff Comments ........................................................................................................ 58 Item 2. Properties ..................................................................................................................................... 58 Item 3. Legal Proceedings ........................................................................................................................ 58 Item 4. Mine Safety Disclosures............................................................................................................... 58 PART II .................................................................................................................................................................... 59 Item 5. Market For Registrant’s Common Equity, Related Stockholder Matters And Issuer Purchases Of Equity Securities ..................................................................................................................... 59 Item 6. Selected Financial Data ................................................................................................................ 59 Item 7. Management’s Discussion And Analysis Of Financial Condition And Results Of Operations ... 60 Item 7A. Quantitative And Qualitative Disclosures About Market Risk .................................................... 65 Item 8. Financial Statements And Supplementary Data ........................................................................... 65 Item 9. Changes In And Disagreements With Accountants On Accounting And Financial Disclosure .. 65 Item 9A. Controls And Procedures ............................................................................................................. 66 Item 9B. Other Information ......................................................................................................................... 67 PART III ................................................................................................................................................................... 68 Item 10. Directors, Executive Officers And Corporate Governance .......................................................... 68 Item 11. Executive Compensation .............................................................................................................. 72 Item 12. Security Ownership Of Certain Beneficial Owners And Management And Related Stockholder Matters ..................................................................................................................... 79 Item 13. Certain Relationships, Related Transactions, And Director Independence .................................. 81 Item 14. Principal Accounting Fees And Services ..................................................................................... 82 PART IV ................................................................................................................................................................... 83 Item 15. Exhibits And Financial Statement Schedules ............................................................................... 83 Item 16. Form 10-K Summary ................................................................................................................... 85 Financial Statements ................................................................................................................................................. F-1 i [This page intentionally left blank] PART I CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This report on Form 10-K contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future. There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to: ● our ability to raise additional capital to fund our operations and to develop our product candidates; ● our anticipated timing for preclinical development, regulatory submissions, commencement and completion of clinical trials and product approvals; ● our history of operating losses in each year since inception and the expectation that we will continue to incur operating losses for the foreseeable future; ● our dependence on product candidates, including MAT9001 and MAT2203, which are still in an early development stage; ● our reliance on our proprietary lipid nano-crystal (LNC) platform delivery technology, which is licensed to us by Rutgers University;

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