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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): August 14, 2024
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 2.02. |
Results of Operations and Financial Condition. |
On August 14, 2024, Matinas BioPharma
Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2024.
The full text of the press release is furnished as Exhibit 99.1 hereto and is incorporated by reference herein.
The information in
Item 2.02 of this Current Report on Form 8-K 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
7.01 |
Regulation FD Disclosure. |
The
Company updated its corporate presentation (the “Corporate Presentation”) which it intends to use at various conferences
and investor meetings. The Corporate Presentation is attached hereto as Exhibit 99.2 and incorporated herein by reference.
The
information in this Item 7.01 and Exhibit 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.
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: August 14, 2024 |
By: |
/s/ Jerome D. Jabbour |
|
Name: |
Jerome D. Jabbour |
|
Title: |
Chief Executive Officer |
Exhibit
99.1
Matinas
BioPharma Reports Second Quarter 2024 Financial Results and Provides a Business Update
Signs
non-binding term sheet granting global rights to develop and commercialize oral MAT2203 for invasive aspergillosis and potentially other
invasive fungal infections
31
patients have enrolled in the MAT2203 Compassionate/Expanded Use Access Program with 6 additional patients under evaluation
Additional
LNC platform work in inflammation and oncology completed; Company evaluating next steps
Conference
call begins at 4:30 p.m. Eastern time today
BEDMINSTER,
N.J. (August 14, 2024) – Matinas BioPharma Holdings, Inc. (NYSE American: MTNB), a clinical-stage biopharmaceutical
company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, reports financial
results for the three and six months ended June 30, 2024 and provides a business update.
“We
continue to engage in constructive partnership dialogues for MAT2203 and are pleased to announce that we have signed a non-binding term
sheet for global licensing rights to this oral formulation of the potent, yet toxic antifungal amphotericin B,” said Jerome
D. Jabbour, Chief Executive Officer of Matinas. “Since June, seven additional patients have gained access to oral MAT2203 in
our Compassionate/Expanded Use Access Program with an additional six patients under evaluation. We are experiencing a dramatic increase
in requests by physicians seeking access for their patients who have limited or no treatment options, which we attribute to the consistently
positive clinical impact of MAT2203 in successfully treating a variety of deadly invasive fungal infections.
“Recent
studies have increased our understanding of the potential for our LNC platform in delivering both small oligonucleotides and small molecule
oncology drugs, including LNC cellular uptake and cargo delivery,” he added. “We continue to expand our knowledge base and
are evaluating the next best steps for this technology as we determine how to maximize return to shareholders. We expect to be in a better
position to provide additional guidance following the consummation of a MAT2203 partnership.”
Key
Program Updates
MAT2203
(Oral Amphotericin B)
|
● |
Matinas
signed a non-binding term sheet with a single partner for global licensing rights to develop, manufacture and commercialize MAT2203
for all future treatment indications, including the intended initial indication of treatment for patients with invasive aspergillosis
with limited or no other treatment options. Preparations are ongoing to enable the initiation of the ORALTO Phase 3 registration
trial of MAT2203 to commence as soon as possible following a successful partnership announcement. |
|
● |
Under
the Compassionate/Expanded Use Access Program, 31 patients with a variety of serious and even life-threatening invasive fungal infections
with limited or no other treatment options have been provided access to oral MAT2203, and 6 additional requests are under evaluation.
Importantly, 7 patients have been or are being treated for invasive aspergillosis, each with positive results. |
|
|
|
|
● |
Of
the 15 patients in the Compassionate/Expanded Use Access Program who have completed treatment with MAT2203 (median treatment of 16
weeks with a range of 2 to 49 weeks), 8 had a complete response and 7 were improved. Response to treatment was assessed by the treating
physician. Nine additional patients are continuing to receive longer-term treatment with positive ongoing effects and 5 have just
recently initiated treatment. To date, only 2 patients have discontinued MAT2203 in this program, both occurring during the first
week of treatment, with one due to an intolerance and the other due to a terminal condition not otherwise related to the underlying
fungal infection. |
LNC
Platform
|
● |
Following
early success in melanoma, recent additional in vivo studies in animal breast, prostate and lung cancer models have demonstrated
varying degrees of tumor growth inhibition with daily oral dosing of LNC-docetaxel. Additionally, daily oral LNC-docetaxel in combination
with intravenous docetaxel demonstrated greater degrees of tumor inhibition, but also resulted in additional weight loss. Additional
studies are evaluating several strategies to potentially improve the therapeutic index of docetaxel. |
|
|
|
|
● |
An
LNC formulation of an additional chemotherapeutic agent, miriplatin, a highly toxic agent only approved outside the U.S. for intra-arterial
use, demonstrated strong cellular uptake and tumor cell-killing capabilities in vitro in testing conducted during the second
quarter. More recent in vivo testing showed the oral LNC formulation of miriplatin as very effective in reducing tumor sizes
with significant weight loss also observed. |
|
|
|
|
● |
A
series of in vitro studies was recently completed investigating potential relationships between the amount of surface phosphatidylserine
(PS) and the extent of LNC uptake into certain tumor cells. Based upon these studies, surface PS expression appears to be one, but
not the only, driving factor for cellular uptake. Additional work is ongoing to better understand and predict the efficacy of LNC-delivered
chemotherapeutics. |
|
|
|
|
● |
Following
early encouraging in vivo data demonstrating the successful oral delivery, biological activity, and potential therapeutic
efficacy of two different LNC-formulated small oligonucleotides targeting inflammatory cytokines IL-17A and TNFα, more recent
follow-up in vivo studies of orally administered LNC-formulated small oligonucleotides have been less consistent in showing
therapeutic efficacy in certain inflammatory conditions. Additional optimization is required prior to identifying a potential product
candidate. |
Second
Quarter Financial Results
The
Company reported no revenue for the second quarters of 2024 and 2023.
Total
costs and expenses for the second quarter of 2024 were $5.8 million, compared with $6.2 million for the second quarter of 2023. The decrease
was primarily due to lower clinical development expenses, personnel costs and administrative expenses.
The
net loss for the second quarter of 2024 was $5.7 million, or $0.02 per share, compared with a net loss for the second quarter of 2023
of $6.1 million, or $0.03 per share.
Six
Month Financial Results
The
Company reported no revenue for the six months ended June 30, 2024, compared with $1.1 million for the six months ended June 30, 2023,
which was generated from research collaborations with BioNTech SE and Genentech Inc.
Total
costs and expenses for the first six months of 2024 were $11.7 million, compared with $12.8 million for the first six months of 2023.
The
net loss for the first six months of 2024 was $11.5 million, or $0.05 per share, compared with a net loss for the first six months of
2023 of $11.6 million, or $0.05 per share.
Cash,
cash equivalents and marketable securities as of June 30, 2024, were $14.3 million, compared with $13.8 million as of December 31, 2023.
In April 2024, the Company raised gross proceeds of $10.0 million through a registered direct offering.
Conference
Call and Webcast
Matinas
will host a conference call and webcast today beginning at 4:30 p.m. Eastern time. To participate in the call, please dial (866) 682-6100
or (862) 298-0702. The live webcast will be accessible on the Investors section of the Company’s website and archived for
90 days.
About
Matinas BioPharma
Matinas
BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery
technology.
Matinas’
lead LNC-based therapy is MAT2203, an oral formulation of the broad-spectrum antifungal drug amphotericin B, which although highly potent,
can be associated with significant toxicity. Matinas’ LNC platform provides oral delivery of amphotericin B without the significant
nephrotoxicity otherwise associated with IV-delivered formulations. Combining comparable fungicidal activity with targeted delivery results
in a lower risk of toxicity and potentially creates the ideal antifungal agent for the treatment of invasive fungal infections. MAT2203
was successfully evaluated in the completed Phase 2 EnACT study in HIV patients suffering from cryptococcal meningitis, meeting its primary
endpoint and achieving robust survival. MAT2203 will be further evaluated in a single Phase 3 registration trial (the “ORALTO”
trial) as an oral step-down monotherapy following treatment with AmBisome® (liposomal amphotericin B) compared with the
standard of care in patients with invasive aspergillosis who have limited treatment options.
In
addition to MAT2203, preclinical and clinical data have demonstrated that this novel technology can potentially provide solutions to
many challenges of achieving safe and effective intracellular delivery of both small molecules and larger, more complex molecular cargos
including small oligonucleotides such as ASOs and siRNA. The combination of its unique mechanism of action and flexibility with routes
of administration (including oral) positions Matinas’ LNC technology to potentially become a preferred next-generation orally available
intracellular drug delivery platform. For more information, please visit www.matinasbiopharma.com.
Forward-looking
Statements
This
release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995,
including those relating to our business activities, our strategy and plans, the potential of our LNC platform technology, and the future
development of our product candidates, including MAT2203, the Company’s ability to identify and pursue development, licensing and
partnership opportunities for its products, including MAT2203, or platform delivery technologies 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, our ability to continue as a going concern, our ability to obtain additional capital to meet our liquidity needs
on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product
candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the
uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our 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 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.
Investor
Contact:
LHA
Investor Relations
Jody
Cain
Jcain@lhai.com
310-691-7100
[Financial
Tables to Follow]
Matinas
BioPharma Holdings, Inc.
Condensed
Consolidated Balance Sheets
(in
thousands, except for share data)
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
(Unaudited) | | |
(Audited) | |
ASSETS: | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 4,216 | | |
$ | 4,787 | |
Marketable debt securities | |
| 10,097 | | |
| 8,969 | |
Restricted cash – security deposit | |
| 50 | | |
| 50 | |
Prepaid expenses and other current assets | |
| 922 | | |
| 1,737 | |
Total current assets | |
| 15,285 | | |
| 15,543 | |
| |
| | | |
| | |
Non-current assets: | |
| | | |
| | |
Leasehold improvements and equipment – net | |
| 1,739 | | |
| 1,923 | |
Operating lease right-of-use assets – net | |
| 2,770 | | |
| 3,064 | |
Finance lease right-of-use assets – net | |
| 18 | | |
| 21 | |
In-process research and development | |
| 3,017 | | |
| 3,017 | |
Goodwill | |
| 1,336 | | |
| 1,336 | |
Restricted cash – security deposit | |
| 200 | | |
| 200 | |
Total non-current assets | |
| 9,080 | | |
| 9,561 | |
Total assets | |
$ | 24,365 | | |
$ | 25,104 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY: | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 238 | | |
$ | 514 | |
Accrued expenses | |
| 1,442 | | |
| 1,447 | |
Operating lease liabilities – current | |
| 707 | | |
| 656 | |
Financing lease liabilities – current | |
| 5 | | |
| 5 | |
Total current liabilities | |
| 2,392 | | |
| 2,622 | |
| |
| | | |
| | |
Non-current liabilities: | |
| | | |
| | |
Deferred tax liability | |
| 341 | | |
| 341 | |
Operating lease liabilities – net of current portion | |
| 2,514 | | |
| 2,877 | |
Financing lease liabilities – net of current portion | |
| 15 | | |
| 18 | |
Total non-current liabilities | |
| 2,870 | | |
| 3,236 | |
Total liabilities | |
| 5,262 | | |
| 5,858 | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Common stock par value $0.0001 per share, 500,000,000 shares authorized at June 30, 2024 and December 31, 2023; 250,816,164 and 217,264,526 issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | |
| 25 | | |
| 22 | |
Additional paid-in capital | |
| 206,245 | | |
| 195,018 | |
Accumulated deficit | |
| (187,116 | ) | |
| (175,573 | ) |
Accumulated other comprehensive loss | |
| (51 | ) | |
| (221 | ) |
Total stockholders’ equity | |
| 19,103 | | |
| 19,246 | |
Total liabilities and stockholders’ equity | |
$ | 24,365 | | |
$ | 25,104 | |
Matinas
BioPharma Holdings, Inc.
Condensed
Consolidated Statements of Operations and Comprehensive Loss
(in
thousands, except for share and per share data)
Unaudited
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenue: | |
| | | |
| | | |
| | | |
| | |
Contract revenue | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | 1,096 | |
Costs and expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 3,371 | | |
| 3,559 | | |
| 6,817 | | |
| 7,530 | |
General and administrative | |
| 2,468 | | |
| 2,600 | | |
| 4,925 | | |
| 5,311 | |
| |
| | | |
| | | |
| | | |
| | |
Total costs and expenses | |
| 5,839 | | |
| 6,159 | | |
| 11,742 | | |
| 12,841 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (5,839 | ) | |
| (6,159 | ) | |
| (11,742 | ) | |
| (11,745 | ) |
Other income, net | |
| 120 | | |
| 99 | | |
| 199 | | |
| 172 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (5,719 | ) | |
$ | (6,060 | ) | |
$ | (11,543 | ) | |
$ | (11,573 | ) |
Net loss per share – basic and diluted | |
$ | (0.02 | ) | |
$ | (0.03 | ) | |
$ | (0.05 | ) | |
$ | (0.05 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
| 249,350,963 | | |
| 217,264,526 | | |
| 233,354,524 | | |
| 217,264,526 | |
Other comprehensive gain, net of tax | |
| | | |
| | | |
| | | |
| | |
Unrealized gain on securities available-for-sale | |
| 83 | | |
| 81 | | |
| 170 | | |
| 310 | |
Other comprehensive gain, net of tax | |
| 83 | | |
| 81 | | |
| 170 | | |
| 310 | |
Comprehensive loss | |
$ | (5,636 | ) | |
$ | (5,979 | ) | |
$ | (11,373 | ) | |
$ | (11,263 | ) |
#
# #
Exhibit
99.2
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Matinas Biopharma (AMEX:MTNB)
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