Current Report Filing (8-k)
January 30 2023 - 4:01PM
Edgar (US Regulatory)
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2023-01-30
2023-01-30
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
The
Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): January 30, 2023
MATINAS
BIOPHARMA HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
|
001-38022 |
|
46-3011414 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
ID Number) |
1545
Route 206 South, Suite 302
Bedminster,
New Jersey |
|
07921 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (908) 484-8805
Not
Applicable
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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 |
|
MTNB
|
|
NYSE
American |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405)
or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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. ☐
Item
7.01 |
Regulation
FD Disclosure. |
Matinas
BioPharma Holdings, Inc. (the “Company”) issued a press release providing a business update on each of its ongoing programs
and discussing its strategic outlook for 2023. A copy of the press release is furnished as Exhibit 99. 1 hereto and incorporated herein
by reference.
The
Company also prepared an update presentation (the “Update Presentation”), which it intends to use for today’s scheduled
conference call and for future investor meetings. The Update Presentation is attached hereto as Exhibit 99.2 and incorporated herein
by reference.
The
information in this Item 7.01, including Exhibits 99.1 and 99.2 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,
or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
On
January 30, 2023, the Company announced, among other things, that:
LNC
Platform Internal Data Generated
|
● |
Developed
multiple flow cytometry and florescence cell-based assays with compelling validations of intracellular uptake and gene expression
with our LNC formulations. |
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● |
Successful
delivery of multiple larger nucleic acids coded with reporter genes across multiple cell lines (HeLa, HEK293, A375, etc.). |
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● |
Multiple
oligonucleotide formulations that have demonstrated strong gene expression potency at nanogram per well dosage level, comparable
to industry standard Lipofectamine. |
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|
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● |
Internal
mRNA formulations that have shown excellent stability and remain biologically active over 10 weeks at 4o C storage conditions. |
|
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● |
Multiple
formulations have shown little to no cytotoxicity during in vitro cell viability evaluations supporting an anticipated favorable
safety profile compared with other drug delivery technologies. |
LNC
Internal Pipeline Development
|
● |
Based
on historical data with the LNC platform, along with recent learnings from internal work and its collaborations, the Company believes
the greatest chance of success in developing our own pipeline of nucleic acid drug candidates is with smaller oligonucleotides like
antisense oligonucleotides (ASOs) and small interfering or silencing RNA (siRNAs). The properties of these molecules are particularly
suited for our LNC platform, and the Company believes that its technology can facilitate oral delivery and extrahepatic targeting
– currently two of the greatest challenges in this developing area. |
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|
|
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● |
The
Company has commenced a research program focused on ASOs/siRNAs that it expects will generate in vitro delivery data early
in the second quarter of this year, followed by multiple in vivo biodistribution and animal efficacy studies in the second
half of 2023. If successful, the Company anticipates being in position to identify our next internal product candidate in late 2023.
The Company believes success in these studies could position it to develop an entire pipeline of ASO and siRNA therapies. |
MAT2203
(oral amphotericin B) Program
|
● |
In
November 2022, the Biomedical Advanced Research and Development Authority (BARDA) announced an initiative seeking private sector
partners developing late-stage, broad-spectrum antifungal drugs to treat high priority fungal infections, including aspergillus,
mucormycosis, and certain forms of candidiasis. BARDA has solicited proposals from industry, and the Company believes MAT2203 is
a strong candidate for funding based upon its oral, well-tolerated and broad-spectrum profile, along with its recent clinical success
in Phase 2 with cryptococcal meningitis. The Company is scheduled to meet with BARDA during the first quarter of 2023 and has included
all associated costs for full development for MAT2203 in its proposal. The Company believes pausing the start of its Phase 3 clinical
trial in cryptococcal meningitis pending the outcome of BARDA’s evaluation of MAT2203 is the best possible course for this
life-saving drug. In 2021, BARDA funding for vaccines stood at $36.9 billion, therapeutics at $14.1 billion, and diagnostics at $51
million. |
|
|
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● |
The
Company is preparing to submit a formal Meeting Request to the U.S. Food and Drug Administration (FDA) to discuss plans for a second
Phase 3 study to assess the efficacy, safety, and tolerability of MAT2203 in patients with serious, life-threatening invasive fungal
infections with limited treatment options. The protocol synopsis currently includes the treatment of four invasive fungal infections:
invasive aspergillosis, invasive candidiasis, chronic coccidioidomycosis (Valley Fever), and invasive Mucormycosis. The Company’s
strategy is to leverage the success and data from EnACT to limit the required size of this study. The Company currently plans to
enroll approximately 100 patients in a single arm design with no head-to-head active comparator, which it believes should be acceptable
given historical precedent and the challenges associated with the target patient population to be evaluated. The Company anticipates
meeting with FDA in the second quarter of 2023 to discuss its proposed design and strategy for approval. The Company believes that
FDA guidance on this Phase 3 study is critical to its BARDA proposal as well as to prospective domestic and global partners currently
evaluating MAT2203, based on feedback received to date. |
|
|
|
|
● |
The
success of MAT2203 in the EnACT Phase 2 clinical trial in cryptococcal meningitis has attracted the attention of clinicians and patients
without viable options for the treatment of a variety of fungal infections for which amphotericin B may be suitable, except for significant
concerns relating to the toxicity of the currently available intravenous formulations of amphotericin B. Currently, there are four
(4) patients who have been approved by FDA to receive MAT2203 on an emergency use basis since August of 2022, including one patient
suffering from both mucor and aspergillosis. Overall, these patients have responded well to treatment with notable clinical
improvements. The Company will continue to evaluate opportunities to provide MAT2203 on an emergency basis for patients as it believes
these are opportunities to showcase the safety and efficacy of MAT2203 outside clinical trial settings which represent important
additional patient data for both FDA and prospective partners to review. |
Financial
Outlook
|
● |
The
Company’s preliminary estimate of cash, cash equivalents and marketable securities at December 31, 2022, is approximately $28.8
million, subject to completion of the audit of the Company’s consolidated financial statements for the year ended December
31, 2023, compared to $49.6 million at December 31, 2021. This amount may differ from the amount that will be reflected in the Company’s
audited 2022 financial statements. Additional information and disclosures are required for a more complete understanding of the Company’s
financial position and results of operations as of December 31, 2022. Based on current projections, the Company believes that cash
on hand is sufficient to fund planned operations into the second quarter of 2024. |
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 business activities, the Company’s strategy and plans, collaborations with National Resilience and BioNTech
SE, the potential of its LNC platform delivery technology, and the future development of its product candidates, the Company’s
ability to identify and pursue development, licensing 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. Forward-looking statements include words such as “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; its 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 Company’s
ability to protect its 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 our 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 of this release. 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. Matinas BioPharma’s product candidates are all in a
development stage and are not available for sale or use.
Item
9.01 |
Financial
Statements and Exhibits. |
SIGNATURES
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:
January 30, 2023 |
By:
|
/s/
Jerome D. Jabbour |
|
Name: |
Jerome
D. Jabbour |
|
Title: |
Chief
Executive Officer |
Matinas Biopharma (AMEX:MTNB)
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