Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a
biopharmaceutical company focused on improving the intracellular
delivery of critical therapeutics through its paradigm-changing
lipid nanocrystal (LNC) delivery platform, today reported financial
results for the first quarter ended March 31, 2021, along with a
corporate update.
First Quarter Highlights and Looking
Ahead
- Patient enrollment in Cohort Two of the EnACT study
(Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial)
has reached approximately 70 percent; DSMB evaluation of full
safety and efficacy data from Cohort Two is anticipated in the
third quarter of 2021.
- The Company has advanced MAT2501 into preclinical toxicology
and efficacy studies, with the goal of completing a Phase 1 single
ascending dose (SAD) pharmacokinetic study in healthy volunteers by
the end of 2021. The Company expects to initiate a Phase 2 program
in cystic fibrosis patients with nontuberculous mycobacterial
infections in 2022 following successful completion of the Phase 1
SAD study.
- Following the announcement of its collaboration with the
National Institutes of Allergy and Infectious Disease (NIAID) in
December 2020 to create and evaluate oral formulations of Gilead’s
antiviral remdesivir, the Company recently prepared and delivered
several formulations to NIAID and expects to receive data from the
first in vitro studies in the near term.
- The Company is pleased to announce that it will hold a virtual
R&D Day on June 17, 2021. The management team plans to provide
an overview of the Company’s LNC platform, including a detailed
discussion on the platform’s clinical programs.
- The process of identifying and securing one or more partners
for LYPDISO is ongoing, with interested parties globally, including
in the United States, European Union and China.
“We are excited by the opportunities ahead for
our LNC platform and associated drug candidates, and have made
meaningful progress since the beginning of 2021,” commented Jerome
D. Jabbour, Chief Executive Officer of Matinas. “Specifically, we
continue to advance MAT2203 in cryptococcal meningitis through
Cohort 2 of the EnACT trial towards its next DSMB review, which is
anticipated in the third quarter of 2021. We believe that Cohort 2
data will further validate the LNC platform and highlight its
ability to facilitate oral bioavailability and carry molecules
safely and effectively across the blood-brain barrier in combating
this deadly invasive fungal infection. We will also take the
opportunity to present these data to the U.S. Food and Drug
Administration in discussions about further accelerating
development of MAT2203. In addition, we have advanced MAT2501 into
preclinical toxicology and efficacy studies, with the goal of
developing the first oral aminoglycoside for the treatment of
nontuberculous mycobacterial infections, as well as gram negative
bacterial infections. Finally, we continue to expand the
application of the LNC platform with our collaborations with
Genentech and with the NIAID in creating an oral formulation of
Gilead’s remdesivir.”
First Quarter 2021 Financial
Results
Cash, cash equivalents and marketable securities
at March 31, 2021, were approximately $60.7 million, compared to
$58.7 million at December 31, 2020.
In July 2020, the Company entered into an
At-The-Market Sales Agreement (Sales Agreement) with BTIG, LLC
(BTIG), pursuant to which the Company may offer and sell, from time
to time, through BTIG, shares of its common stock having an
aggregate offering price of up to $50 million, subject to certain
limitations on the amount of common stock that may be offered and
sold by the Company set forth in the Sales Agreement. During the
first quarter of 2021, BTIG sold approximately 3 million shares of
the Company’s common stock under the Sales Agreement generating net
proceeds to the Company of approximately $5.6 million.
Based on current projections, the Company
believes that cash on hand is sufficient to fund operations into
2024.
For the first quarter of 2021, net loss
attributable to common shareholders was $5.2 million, or a net loss
of $0.03 per share (basic and diluted). These results are identical
to those of the first quarter of 2020.
Research and development expenses for the first
quarter of 2021 were $3.2 million, compared to $4.1 million for the
same period in 2020. The decrease was primarily due to the
completion of the ENHANCE-IT study of LYPDISO in January 2021.
General and administrative expenses for the
first quarter of 2021 were $3.1 million, compared to $2.3 million
in the same period in 2020. The increase was primarily due to
higher compensation expense related to the exercise of stock
options during the first quarter of 2021.
*Vascepa® is a registered trademark of the
Amarin group of companies. Conference Call and
Webcast DetailsThe Company will host a live conference
call and webcast to discuss these results today, Monday, May 10,
2021, at 8:00 a.m. ET.To participate in the call, please dial (877)
407-5976 (Toll-Free) or (412) 902-0031 (Toll) and reference
conference ID 13719092. 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 proprietary lipid nanocrystal (LNC)
delivery platform. Company leadership has a deep history and
knowledge of drug development and is supported by a world-class
team of scientific advisors.
Matinas is developing a portfolio of products
based upon its proprietary LNC drug delivery platform, which can
solve complex challenges relating to the safe and effective
intracellular delivery of both small and larger, more complex
molecules.
MAT2203 is an oral, LNC formulation of the
well-known, but highly toxic, antifungal medicine amphotericin B,
primarily used to treat serious invasive fungal infections. MAT2203
is currently in a Phase 2 open-label, sequential cohort study
(EnACT) in HIV-infected patients with cryptococcal meningitis.
EnACT is currently enrolling patients in its second cohort, with
the next DSMB evaluation of safety and efficacy data anticipated to
occur in the third quarter of 2021.
MAT2501 is an oral, LNC formulation of the
broad-spectrum aminoglycoside antibiotic medicine amikacin,
primarily used to treat chronic and acute bacterial infections. The
Company has been awarded up to $3.75 million from the Cystic
Fibrosis Foundation (CFF) to support development of MAT2501 toward
an indication to treat nontuberculous mycobacterial (NTM) lung
disease, including infections in patients with cystic fibrosis
(CF).
Each of MAT2203 and MAT2501 has received
Qualified Infectious Disease Product (QIDP) and Orphan Drug
designations which, upon approval, could potentially provide up to
twelve years of regulatory marketing exclusivity for each
product.
LYPDISO™, the Company’s product candidate
intended for the treatment of cardiovascular and metabolic
conditions, is a prescription-only omega-3 fatty acid-based
composition, comprised primarily of EPA and DPA, recently announced
data from the ENHANCE-IT study, a head-to-head crossover study
evaluating LYPDISO vs. Vascepa in patients with elevated
triglycerides. Data demonstrating superior levels of
eicosapentaenoic acid (EPA) in the blood with LYPDISO support the
potential superior cardioprotective effect of LYPDISO vs. Vascepa.
The Company has initiated a process to identity and secure a
potential partner to continue development of LYPDISO toward a
cardiovascular outcomes indication.
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 the LNC platform
delivery technology, the Company’s strategic focus and the future
development of its product candidates, including MAT2203, MAT2501
and LYPDISO, 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. |
Condensed
Consolidated Balance Sheets |
|
|
|
|
|
|
|
|
|
March 31, 2021 |
|
December 31, 2020 |
|
|
(Unaudited) |
|
(Audited) |
ASSETS: |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
23,382,743 |
|
|
$ |
12,432,481 |
|
|
Marketable securities |
|
|
37,283,697 |
|
|
|
46,246,573 |
|
|
Restricted cash - security deposits |
|
|
136,000 |
|
|
|
136,000 |
|
|
Prepaid expenses and other current assets |
|
|
2,333,225 |
|
|
|
2,739,791 |
|
|
|
Total current assets |
|
|
63,135,665 |
|
|
|
61,554,845 |
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
Leasehold improvements and equipment - net |
|
|
1,465,303 |
|
|
|
1,523,950 |
|
|
Operating lease right-of-use assets - net |
|
|
3,149,744 |
|
|
|
3,276,639 |
|
|
Finance lease right-of-use assets - net |
|
|
45,992 |
|
|
|
58,007 |
|
|
In-process research and development |
|
|
3,017,377 |
|
|
|
3,017,377 |
|
|
Goodwill |
|
|
1,336,488 |
|
|
|
1,336,488 |
|
|
Restricted cash - security deposits |
|
|
200,000 |
|
|
|
200,000 |
|
|
|
Total non-current assets |
|
|
9,214,904 |
|
|
|
9,412,461 |
|
|
|
|
Total assets |
|
$ |
72,350,569 |
|
|
$ |
70,967,306 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
421,645 |
|
|
$ |
349,941 |
|
|
Accrued expenses |
|
|
1,405,745 |
|
|
|
2,795,329 |
|
|
Operating lease liabilities - current |
|
|
364,566 |
|
|
|
391,498 |
|
|
Financing lease liabilities - current |
|
|
29,396 |
|
|
|
30,853 |
|
|
|
Total current liabilities |
|
|
2,221,352 |
|
|
|
3,567,621 |
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
Deferred tax liability |
|
|
341,265 |
|
|
|
341,265 |
|
|
Operating lease liabilities - net of current portion |
|
|
3,214,714 |
|
|
|
3,304,063 |
|
|
Financing lease liabilities - net of current portion |
|
|
17,134 |
|
|
|
23,660 |
|
|
|
Total non-current liabilities |
|
|
3,573,113 |
|
|
|
3,668,988 |
|
|
|
|
Total liabilities |
|
|
5,794,465 |
|
|
|
7,236,609 |
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
Series B Convertible preferred stock |
|
3,673,176 |
|
|
|
3,797,705 |
|
|
Common stock |
|
20,427 |
|
|
|
20,010 |
|
|
Additional paid-in capital |
|
|
175,189,608 |
|
|
|
167,192,003 |
|
|
Accumulated deficit |
|
|
(112,463,513 |
) |
|
|
(107,507,193 |
) |
|
Accumulated other comprehensive income/(loss) |
|
|
136,406 |
|
|
|
228,172 |
|
|
|
Total stockholders' equity |
|
|
66,556,104 |
|
|
|
63,730,697 |
|
|
|
|
Total liabilities and stockholders' equity |
$ |
72,350,569 |
|
|
$ |
70,967,306 |
|
|
|
|
|
|
|
|
Matinas
BioPharma Holdings, Inc. |
Condensed
Consolidated Statements of Operations and Comprehensive
Loss |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2021 |
|
|
2020 |
|
Revenue: |
|
|
|
|
|
|
|
Contract research revenue |
|
$ |
33,333 |
|
|
$ |
- |
|
Costs and expenses: |
|
|
|
|
|
|
|
Research and
development |
|
|
3,241,432 |
|
|
|
4,086,883 |
|
|
General and
administrative |
|
|
3,145,010 |
|
|
|
2,259,631 |
|
|
|
|
|
|
|
|
|
Total costs
and expenses |
|
|
6,386,442 |
|
|
|
6,346,514 |
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(6,353,109 |
) |
|
|
(6,346,514 |
) |
|
|
|
|
|
|
|
Sale of New Jersey net operating loss |
|
|
1,328,470 |
|
|
|
1,073,289 |
|
Other income, net |
|
|
68,319 |
|
|
|
227,327 |
|
Net loss |
|
$ |
(4,956,320 |
) |
|
$ |
(5,045,898 |
) |
|
|
|
|
|
|
|
Preferred stock series B accumulated dividends |
|
|
(210,900 |
) |
|
|
(170,700 |
) |
|
|
|
|
|
|
|
Net loss attributable to common shareholders |
|
$ |
(5,167,220 |
) |
|
$ |
(5,216,598 |
) |
|
|
|
|
|
|
|
Net loss available for common shareholders per share - basic and
diluted |
|
$ |
(0.03 |
) |
|
$ |
(0.03 |
) |
|
|
|
|
|
|
|
Weighted average common shares outstanding - basic and diluted |
|
|
203,871,820 |
|
|
|
191,671,153 |
|
|
|
|
|
|
|
|
Other comprehensive (loss)/income, net of tax |
|
|
|
|
|
|
|
Unrealized
(loss)/gains on securities available-for-sale |
|
|
(91,766 |
) |
|
|
523,246 |
|
|
Other
comprehensive (loss)/income, net of tax |
|
|
(91,766 |
) |
|
|
523,246 |
|
Comprehensive loss attributable to stockholders |
|
$ |
(5,048,086 |
) |
|
$ |
(4,522,652 |
) |
|
|
|
|
|
|
|
Investor and Media Contacts
Peter
VozzoWestwicke/ICR443-213-0505peter.vozzo@westwicke.com
Source: Matinas BioPharma Holdings, Inc.
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