Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a
clinical-stage biopharmaceutical company focused on improving
the intracellular delivery of critical therapeutics through its
paradigm-changing lipid nanocrystal (LNC) platform delivery
technology, today reported financial results for the third quarter
ended September 30, 2021, along with a corporate update.
“We continue to achieve significant pipeline
progress, having advanced to the second half of the EnACT study
with MAT2203 following positive and impressive data from the first
two cohorts of patients, and, recently, initiating our Phase 1
study with MAT2501, our second clinical stage LNC asset,” commented
Jerome D. Jabbour, Chief Executive Officer of Matinas.
“Importantly, we have also commenced an in vivo efficacy study of
LNC remdesivir with our partners at the National Institutes of
Health and Gilead and look forward to potentially sharing data
later this year as an additional proof of concept of the effective
oral delivery of an antiviral prodrug. Finally, we continue to
evaluate opportunities to capitalize on what we believe is the
enormous potential of our LNC platform delivery and its unique
ability to solve the oral administration and intracellular delivery
challenges presented by vaccines and complex nucleic acid polymers,
such as mRNA.”
Third Quarter Highlights and Recent
Events
- Positive
efficacy and safety data announced from the first two cohorts of
patients in the ongoing EnACT study (Encochleated Oral Amphotericin
for Cryptococcal Meningitis Trial) of MAT2203 (oral amphotericin B)
for the treatment of cryptococcal meningitis, exceeding the
prespecified primary endpoint. Key topline results from Cohort 2 of
EnACT include eradication of the fungal infection, survival, and
safety, including longer-term use of MAT2203 beyond the 2-week
induction period. The EnACT independent Data and Safety Monitoring
Board (DSMB) unanimously recommended progression to the second half
of the study. Cohort 3 of EnACT (the safety lead-in for Cohort 4,
which will be an all-oral MAT2203 treatment regimen) has enrolled
13 out of 14 patients and the DSMB evaluation and cohort
progression assessment is expected by the end of 2021.
- The
Company plans to meet with the U.S. Food and Drug Administration in
December of 2021 to review the data to date and discuss the
potential for approval of MAT2203 as step-down therapy from IV
amphotericin B under one or more accelerated regulatory pathways
for important anti-infective medicines that address significant
unmet medical needs in small or vulnerable patient
populations.
- In August
2021, the U.S. Patent and Trademark Office (USPTO) issued a patent
protecting the use of MAT2203 to treat or prevent cryptococcus
infections. The allowed patent application, entitled, “Encochleated
Antifungal Compounds for Central Nervous System Delivery and
Treatment of Cryptococcus Infections,” includes claims directed to
using an orally administered amphotericin B LNC composition in
combination with a second antifungal compound, such as
5-Flucytosine or an azole antifungal, to treat or prevent
a Cryptococcus infection of the central nervous system.
The base patent term extends to 2037, excluding any patent term
adjustments or patent term extensions that may provide additional
protection.
- In
October 2021, the Company announced it has dosed the first patient
in a Phase 1 single ascending dose (SAD) pharmacokinetic study of
MAT2501 in healthy volunteers. The Company expects to complete
enrollment of the Phase 1 SAD study in the first quarter of 2022,
with data anticipated during the second quarter of 2022. Pending
successful completion of the Phase 1 SAD study, the Company expects
to start a Phase 2 program in patients with nontuberculous
mycobacterial (NTM) infections by the first quarter of 2023,
following required longer-term preclinical toxicology studies to be
conducted during 2022. Initiation of the Phase 1 SAD study follows
positive feedback received from the FDA on the Company’s ongoing
preclinical toxicology and efficacy studies of MAT2501 conducted in
collaboration with the Cystic Fibrosis Foundation (CFF).
-
Accomplished biotechnology executive, Kathryn Penkus Corzo, has
received shareholder approval to join the Company’s Board of
Directors, effective November 1, 2021. Ms. Corzo brings to Matinas
over 25 years of successful biopharma experience, including an
extensive record of drug development accomplishments at Takeda,
Sanofi Genzyme, and Eli Lilly.
- The in
vivo efficacy study of LNC remdesivir being conducted in
collaboration with the National Institute of Allergy and Infectious
Diseases (NIAID), with cooperation from Gilead Sciences, Inc., has
commenced at the University of North Carolina, with data expected
in the fourth quarter of 2021.
Third Quarter 2021 Financial
Results
Cash, cash equivalents and marketable securities
at September 30, 2021, were approximately $53.8 million, compared
to $58.7 million at December 31, 2020. Based on current
projections, the Company believes that cash on hand is sufficient
to fund planned operations into 2024.
For the third quarter of 2021, net loss
attributable to common shareholders was $6.8 million, or a net loss
of $0.03 per share (basic and diluted), compared to a net loss
attributable to common shareholders of $5.7 million, or a net loss
of $0.03 per share (basic and diluted), for the same period in
2020. The increase was due primarily to an increase in research and
development expenses.Conference Call and Webcast
DetailsThe Company will host a live conference call and
webcast to discuss these results today, Monday, November 8, 2021,
at 8:30 a.m. ET.To participate in the call, please dial (877)
407-5976 (Toll-Free) or (412) 902-0031 (Toll) and reference
conference ID 13723555. The live webcast will be accessible on the
Investors section of Matinas’ website, www.matinasbiopharma.com,
and archived for 90 days
About Matinas BioPharma
Matinas BioPharma is a biopharmaceutical company
focused on improving the intracellular delivery of critical
therapeutics through its paradigm-changing lipid nanocrystal (LNC)
delivery platform. The Company is developing its own internal
portfolio of products as well as partnering with leading
pharmaceutical companies to develop new formulations that take full
advantage of the unique characteristics of the LNC platform.
Preclinical and clinical data have demonstrated
that this novel technology can provide solutions to many of the
complex challenges in achieving safe and effective intracellular
delivery, for both small molecules and larger, more complex
molecules, such as mRNA, DNA plasmids, antisense oligonucleotides
and vaccines. The combination of a unique mechanism of action and
flexibility in both the formulation and route of administration
(including oral), position Matinas’ LNC technology to potentially
become the preferred next-generation intracellular drug delivery
vehicle and an important improvement over both lipid nanoparticles
and viral vectors.
MAT2203 is an oral, LNC formulation of the
highly effective, but also highly toxic, antifungal medicine
amphotericin B, primarily used as a first-line treatment for
invasive fungal infections. MAT2203 is currently in a Phase 2
open-label, sequential cohort study (EnACT) in HIV-infected
patients with cryptococcal meningitis. Enrollment in Cohort 3 of
EnACT has commenced following unanimous approval from the Data and
Safety Monitoring Board (DSMB), with enrollment completion and DSMB
evaluation of Cohort 3 data expected in the fourth quarter of
2021.
MAT2501 is an oral, LNC formulation of the
broad-spectrum aminoglycoside antibiotic amikacin, primarily used
to treat chronic and acute bacterial infections. With the support
of the Cystic Fibrosis Foundation, MAT2501 is currently undergoing
important preclinical studies and commenced a Phase 1 human
clinical trial in the fourth quarter of 2021. MAT2501 would be the
first and only oral aminoglycoside, and is being positioned with an
initial indication for the treatment of nontuberculous
mycobacterial (NTM) lung disease, including infections in patients
with cystic fibrosis.
LYPDISO™, is a prescription-only omega-3 fatty
acid-based composition, comprised primarily of EPA and DPA,
intended for the treatment of cardiovascular and metabolic
conditions. This next-generation omega-3 therapy has been shown in
two head-to-head studies to provide effective triglyceride-lowering
and significantly higher EPA blood levels than Vascepa®. The
Company has initiated a process to identity and potentially secure
a partner to continue development of LYPDISO.
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 delivery technology, and the future development of its
product candidates, including MAT2203, MAT2501, 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. 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 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.
Matinas
BioPharma Holdings Inc. |
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Condensed
Consolidated Balance Sheets |
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September 30, 2021 |
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December 31, 2020 |
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(Unaudited) |
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(Audited) |
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ASSETS: |
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Current assets: |
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Cash and cash equivalents |
|
$ |
24,922,760 |
|
|
$ |
12,432,481 |
|
|
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Marketable securities |
|
|
28,907,045 |
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|
46,246,573 |
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|
|
Restricted cash - security deposits |
|
|
50,000 |
|
|
|
136,000 |
|
|
|
Prepaid expenses and other current assets |
|
|
2,601,126 |
|
|
|
2,739,791 |
|
|
|
|
Total current assets |
|
|
56,480,931 |
|
|
|
61,554,845 |
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Non-current assets: |
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Leasehold improvements and equipment - net |
|
|
1,568,717 |
|
|
|
1,523,950 |
|
|
|
Operating lease right-of-use assets - net |
|
|
4,352,588 |
|
|
|
3,276,639 |
|
|
|
Finance lease right-of-use assets - net |
|
|
28,707 |
|
|
|
58,007 |
|
|
|
In-process research and development |
|
|
3,017,377 |
|
|
|
3,017,377 |
|
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|
Goodwill |
|
|
|
1,336,488 |
|
|
|
1,336,488 |
|
|
|
Restricted cash - security deposits |
|
|
200,000 |
|
|
|
200,000 |
|
|
|
|
Total non-current assets |
|
|
10,503,877 |
|
|
|
9,412,461 |
|
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|
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|
Total assets |
|
$ |
66,984,808 |
|
|
$ |
70,967,306 |
|
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LIABILITIES AND STOCKHOLDERS' EQUITY: |
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Current liabilities: |
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Accounts payable |
|
$ |
661,998 |
|
|
$ |
349,941 |
|
|
|
Accrued expenses |
|
|
2,893,903 |
|
|
|
2,795,329 |
|
|
|
Operating lease liabilities - current |
|
|
518,786 |
|
|
|
391,498 |
|
|
|
Financing lease liabilities - current |
|
|
24,309 |
|
|
|
30,853 |
|
|
|
|
Total current liabilities |
|
|
4,098,996 |
|
|
|
3,567,621 |
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|
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Non-current liabilities: |
|
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|
|
|
|
|
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|
Deferred tax liability |
|
|
341,265 |
|
|
|
341,265 |
|
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Operating lease liabilities - net of current portion |
|
|
4,284,552 |
|
|
|
3,304,063 |
|
|
|
Financing lease liabilities - net of current portion |
|
|
5,745 |
|
|
|
23,660 |
|
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|
Total non-current liabilities |
|
|
4,631,562 |
|
|
|
3,668,988 |
|
|
|
|
|
Total liabilities |
|
|
8,730,558 |
|
|
|
7,236,609 |
|
|
|
|
|
|
|
|
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|
Stockholders' equity: |
|
|
|
|
|
|
|
|
|
Series B Convertible preferred stock |
|
- |
|
|
|
3,797,705 |
|
|
|
Common stock |
|
21,625 |
|
|
|
20,010 |
|
|
|
Additional paid-in capital |
|
|
183,168,987 |
|
|
|
167,192,003 |
|
|
|
Accumulated deficit |
|
|
(124,934,768 |
) |
|
|
(107,507,193 |
) |
|
|
Accumulated other comprehensive (loss)/income |
|
|
(1,594 |
) |
|
|
228,172 |
|
|
|
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Total stockholders' equity |
|
|
58,254,250 |
|
|
|
63,730,697 |
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
66,984,808 |
|
|
$ |
70,967,306 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Matinas
BioPharma Holdings, Inc. |
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss |
|
(Unaudited) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2021 |
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2020 |
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|
2021 |
|
|
2020 |
|
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Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
- |
|
|
$ |
95,833 |
|
|
$ |
33,333 |
|
|
$ |
95,833 |
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
4,621,255 |
|
|
|
3,336,225 |
|
|
|
10,343,451 |
|
|
|
10,833,345 |
|
|
|
General and
administrative |
|
2,256,689 |
|
|
|
2,364,214 |
|
|
|
7,710,625 |
|
|
|
6,980,155 |
|
|
|
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|
|
|
|
|
|
|
|
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|
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|
Total costs
and expenses |
|
6,877,944 |
|
|
|
5,700,439 |
|
|
|
18,054,076 |
|
|
|
17,813,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(6,877,944 |
) |
|
|
(5,604,606 |
) |
|
|
(18,020,743 |
) |
|
|
(17,717,667 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of New
Jersey net operating loss & tax credits |
|
- |
|
|
|
- |
|
|
|
1,328,470 |
|
|
|
1,073,289 |
|
|
|
Other
income, net |
|
41,394 |
|
|
|
155,093 |
|
|
|
108,298 |
|
|
|
538,420 |
|
|
Net loss |
$ |
(6,836,550 |
) |
|
$ |
(5,449,513 |
) |
|
$ |
(16,583,975 |
) |
|
$ |
(16,105,958 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock series B accumulated dividends |
|
- |
|
|
|
(227,600 |
) |
|
|
(395,799 |
) |
|
|
(575,392 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common shareholders |
$ |
(6,836,550 |
) |
|
|
(5,677,113 |
) |
|
$ |
(16,979,774 |
) |
|
$ |
(16,681,350 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available for common shareholders per share - basic and
diluted |
$ |
(0.03 |
) |
|
|
(0.03 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.09 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding - basic and diluted |
|
215,179,949 |
|
|
|
198,909,016 |
|
|
|
208,130,431 |
|
|
|
196,070,952 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive (loss)/income, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized
(loss)/gains on securities available-for-sale |
|
(52,837 |
) |
|
|
(114,159 |
) |
|
|
(229,766 |
) |
|
|
367,144 |
|
|
|
Reclassification to net loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2,719 |
) |
|
|
Other
comprehensive (loss)/income, net of tax |
|
(52,837 |
) |
|
|
(114,159 |
) |
|
|
(229,766 |
) |
|
|
364,425 |
|
|
Comprehensive loss attributable to stockholders |
$ |
(6,889,387 |
) |
|
$ |
(5,563,672 |
) |
|
$ |
(16,813,741 |
) |
|
$ |
(15,741,533 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor and Media Contacts
Peter VozzoICR
Westwicke443-213-0505peter.vozzo@westwicke.com
Source: Matinas BioPharma Holdings, Inc.
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