SECURITIES AND EXCHANGE COMMISSION
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|Item 7.01||Regulation FD Disclosure.|
Matinas BioPharma Holdings, Inc. (the “Company”) issued a press release announcing that the independent Data and Safety Monitoring Board (“DSMB”) of the EnACT study (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) has completed a pre-specified review of the first cohort and unanimously recommended progression to the second cohort of patients. A copy of the press release is furnished as Exhibit 99.01 hereto and incorporated herein by reference.
The information in this Item 7.01 and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
|Item 8.01.||Other Events.|
On October 19, 2020, the Company announced that the independent DSMB of the EnACT study (Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial) has completed a pre-specified review of the first cohort and unanimously recommended progression to the second cohort of patients. Enrollment in this next randomized EnACT cohort, with 40 active-treatment patients, is expected to begin shortly, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021.
EnACT is a Phase 2 prospective, randomized, open-label, sequential cohort study, financially supported by the National Institutes of Health (NIH), evaluating the safety, tolerability and efficacy of MAT2203 in approximately 100 HIV-infected patients with cryptococcal meningitis. MAT2203 utilizes the Company’s LNC platform delivery technology to orally deliver the traditionally IV-only fungicidal drug, amphotericin B.
The induction period for all patients in each cohort of EnACT is 14 days, followed by an additional 4 weeks of treatment with MAT2203 for all patients during a maintenance period. In total, the trial includes four cohorts of patients, with each cohort increasing the treatment duration of MAT2203 vs. IV amphotericin B. The first cohort received IV amphotericin B for the first five days of the induction period, followed by nine days of oral administration of MAT2203. The second cohort of 40 actively treated patients will receive IV amphotericin B for the first two days of the induction period, followed by twelve days of oral administration of MAT2203. The primary efficacy endpoint will be measured at Day 14, the last day of the induction period, and will include a measure of reduction in fungal count in the cerebral spinal fluid. A control arm, which includes standard of care IV amphotericin B, is included with each cohort. An independent DSMB oversees the safety of the study and reviews all data from each cohort for safety and efficacy and makes a recommendation to proceed to the next cohort of patients.
Forward- Looking Statements
This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company’s ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expects,” “anticipates,” “intends,” “plans,” “could,” “believes,” “estimates” and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, the Company’s ability to obtain additional capital to meet its liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of its product candidates; the ability to successfully complete research and further development and commercialization of its product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; the ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; and the other factors listed under “Risk Factors” in the Company’s filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date hereof. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. The Company’s product candidates are all in a development stage and are not available for sale or use.
|Item 9.01||Financial Statements and Exhibits.|
|99.1||Press Release, dated October 19, 2020.|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|MATINAS BIOPHARMA HOLDINGS, INC.|
|Dated: October 19, 2020||By:||/s/ Jerome D. Jabbour|
|Name:||Jerome D. Jabbour|
|Title:||Chief Executive Officer|