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 fourth quarter and full year ended December 31,
2020, along with a corporate update.
“2020 was a year of significant progress and
timely execution for Matinas, despite the ongoing global pandemic.
The completion of the head-to-head ENHANCE-IT trial of LYPDISO vs.
Vascepa® and the results which support the potential for LYPDISO to
demonstrate a superior cardioprotective effect to Vascepa®, have
positioned us to identify and potentially secure a global partner
for the continued development of this promising, next-generation
drug,” commented Jerome D. Jabbour, Chief Executive Officer of
Matinas. “This process provides us the opportunity, as we move
forward, to re-focus our internal expertise and financial resources
on our LNC platform delivery technology. We believe that the unique
capability of our LNC formulations to mimic enveloped viruses and
efficiently deliver small and large molecules intracellularly
without causing adverse immune responses or damage to cellular
membranes, differentiates our technology from any other available
intracellular delivery technology being applied
today.”
Mr. Jabbour continued, “There are three key
areas which highlight tangible progress with the LNC platform.
First, DSMB review and cohort progression in the EnACT study of
MAT2203 in cryptococcal meningitis is anticipated in the third
quarter of 2021 and provides a near-term opportunity to further
validate the LNC platform and highlight its ability to facilitate
oral bioavailability and then carry molecules effectively across
the blood-brain barrier in combating deadly invasive fungal
infections. Second, with the support of the Cystic Fibrosis
Foundation, we are rapidly advancing our second LNC platform drug,
MAT2501 (oral amikacin), into preclinical toxicology and efficacy
studies with the ultimate 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 make important progress in expanding the utilization
of the LNC platform through our collaborations with Genentech and
with NIAID in creating an oral formulation of Gilead’s remdesivir.
We are also evaluating additional opportunities to expand
application of our LNC platform in other innovative areas, such as
mRNA and gene therapy. 2021 will be an exciting and potentially
transformational year for our Company, and we look forward to
continuing to execute on our corporate strategy and keeping
investors informed as to our progress.”
MAT2203 Program Update (orally
bioavailable amphotericin B, with targeted delivery, under
development for the treatment and prevention of invasive fungal
infections, including cryptococcal meningitis)
- Data from
the Phase 1 portion of the EnACT study were published in the
Antimicrobial Agents and Chemotherapy, (ACC), a journal of the
American Society of Microbiology, in a manuscript entitled “Safety
and tolerability of a novel oral formulation of amphotericin B:
Phase I EnACT trial”. In the published manuscript, trial
investigators concluded that MAT2203 was well-tolerated when
administered in 4-6 divided daily doses without the toxicities
commonly seen with IV amphotericin B, with nearly 100% of patients
expressing a preference for oral MAT2203 relative to amphotericin B
delivered intravenously.
- In
October 2020, the Company announced that the independent DSMB of
the EnACT study completed a pre-specified review of the first
cohort and unanimously recommended progression to the second
cohort.
- We have
recently reached 50 percent of patient enrollment (28/56) in Cohort
Two of the EnACT study (Encochleated Oral Amphotericin for
Cryptococcal Meningitis Trial); DSMB evaluation of full safety and
efficacy data from Cohort Two is anticipated in the third quarter
of 2021.
- As
previously reported, the U.S. Food and Drug Administration (FDA)
has designated MAT2203 as a Qualified Infectious Disease Product
(QIDP) with Fast Track status for four indications, specifically,
the prevention of invasive fungal infections due to
immunosuppressive therapy, and the treatment of invasive
candidiasis, invasive aspergillus and cryptococcal
meningitis. In addition, the FDA has granted orphan drug
designation to MAT2203 for the treatment of
cryptococcosis. If MAT2203 is ultimately approved by
the FDA, the seven-year period of marketing exclusivity from orphan
designation combined with the additional five years of marketing
exclusivity provided by the QIDP designation, provides for a
potential total of 12 years of marketing exclusivity.
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 140
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.
In total, the trial includes four cohorts of patients, with each
cohort increasing the treatment duration of MAT2203 vs. IV
amphotericin B. The primary efficacy endpoint includes 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.
MAT2501 Program Update (orally
bioavailable amikacin, with targeted delivery, under development
for the treatment of nontuberculous mycobacterial (NTM) lung
disease, including infections in patients with cystic fibrosis
(CF))
- In
November 2020, the Company received a commitment for $3.75 million
of funding from the Cystic Fibrosis Foundation (CFF) to support
preclinical development of MAT2501 toward an indication to treat
NTM lung disease, including infections in patients with CF.
- The
Company is progressing development of MAT2501 through preclinical
toxicology and efficacy studies in 2021, with the goal of
completing a Phase 1 single ascending dose pharmacokinetic study in
healthy volunteers by the end of 2021.
- MAT2501
has been designated as a QIDP and as an Orphan Drug for the
treatment of NTM by the FDA. If MAT2501 is ultimately approved by
the FDA, the seven-year period of marketing exclusivity from orphan
designation combined with the additional five years of marketing
exclusivity provided by the QIDP designation, provides for a
potential total of 12 years of marketing exclusivity.
LNC Platform Update
- The
Company’s feasibility agreement with Genentech, which involves the
formulation of up to three different Genentech compounds, was
extended for an additional two years in November of 2020.
- In
December 2020, the Company announced a collaboration with the NIAID
to evaluate oral formulations of Gilead’s antiviral remdesivir
utilizing Matinas’ LNC platform delivery technology. The Company
recently prepared and delivered several formulations to NIAID,
which will commence planned preclinical studies promptly.
LYPDISO™ Program Update (next
generation, prescription-only omega-3 fatty acid-based composition
under development for treatment of cardiovascular and metabolic
conditions, including hypertriglyceridemia)
- In
February 2021, the Company announced topline results from
ENHANCE-IT (Pharmacodynamic Effects of a Free-fatty Acid
Formulation of Omega-3 Pentaenoic Acids to ENHANCE Efficacy in
Adults with Hypertriglyceridemia), a second head-to-head
comparative study of LYPDISO vs. Vascepa®. The study assessed
LYPDISO’s effectiveness in reducing triglyceride levels and other
important lipid markers, as well as characterizing bioavailability
and blood levels of eicosapentaenoic acid (EPA) and other omega-3
fatty acids. While the primary endpoint of percent change in
triglycerides (TGs) from baseline to end-of-treatment did not meet
statistical significance in the pre-specified pharmacodynamic
population, analysis of the per protocol population demonstrated
statistically significant improvement and superiority of LYPDISO
over Vascepa® in reducing TGs, total cholesterol and
very-low-density lipoprotein cholesterol. A key
secondary endpoint in ENHANCE-IT was the measurement of EPA levels
in the blood, as that has become a key surrogate marker in
determining cardiovascular risk reduction. In ENHANCE-IT, plasma
EPA concentrations were significantly higher with LYPDISO vs.
Vascepa® (46% relative percent increase in the change from baseline
EPA level vs. Vascepa®), which the Company believes indicates the
potential for superior cardioprotection with LYPDISO vs.
Vascepa®.
- The
Company believes that the results from ENHANCE-IT suggest potential
for LYPDISO as a best-in-class prescription-only omega-3 drug for
cardiovascular risk reduction and is pursuing a partnership to
continue further development of LYPDISO toward a cardiovascular
outcomes indication. Accordingly, the Company no longer plans to
pursue an indication for the treatment of severe
hypertriglyceridemia.
Fourth Quarter and Full Year 2020
Financial Results
Cash, cash equivalents and marketable securities
at December 31, 2020 were approximately $58.7 million, compared to
$27.8 million at December 31, 2019.
In January 2020, the Company sold an aggregate
of 32.3 million shares of its common stock at a price of $1.55 per
share for net proceeds of approximately $46.7 million, after
deducting underwriting discounts and commissions and other offering
expenses.
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. As of
December 31, 2020, the Company did not sell any shares of its
common stock under the Sales Agreement. During January 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, including net proceeds from issuances
under the Sales Agreement in January 2021, is sufficient to fund
operations into 2024.
For the fourth quarter of 2020, net loss
attributable to common shareholders was $6.6 million, or a net loss
of $0.03 per share (basic and diluted), compared to a net loss
attributable to common shareholders of $5.8 million, or a net loss
of $0.04 per share (basic and diluted) for the same period in 2019.
For the full year of 2020, net loss attributable to common
shareholders was $23.2 million, or a net loss per share of $0.12
(basic and diluted), compared to a net loss attributable to common
shareholders of $18.3 million, or a net loss per share of $0.13
(basic and diluted) for the full year of 2019. The increase for
both periods was due primarily to an increase in operating
expenses, as more fully described below.
Research and development (R&D) expenses for
the fourth quarter of 2020 were $3.5 million, compared to $3.4
million for the same period in 2019. For the full year of 2020,
R&D expenses were $14.4 million, compared to $11.2 million for
the full year of 2019. The increase for full year 2020 was due
primarily to higher preclinical and clinical development expenses
and employee compensation related to the development of LYPDISO,
MAT2203 and MAT2501.
General and administrative (G&A) expenses
for the fourth quarter of 2020 were $3.0 million, compared to $2.3
million in the same period in 2019. For the full year of 2020,
G&A expenses were $10.0 million, compared to $7.8 million for
the full year of 2019. The increase was due primarily to employee
related expenses and professional fees.
*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 on Monday, March 29,
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 13716272. 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. 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).
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.Consolidated Balance Sheets
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
ASSETS: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
12,432,481 |
|
|
$ |
22,170,438 |
|
Marketable securities |
|
|
46,246,573 |
|
|
|
5,604,634 |
|
Restricted cash |
|
|
136,000 |
|
|
|
250,000 |
|
Prepaid expenses and other current assets |
|
|
2,739,791 |
|
|
|
1,897,784 |
|
Total current assets |
|
|
61,554,845 |
|
|
|
29,922,856 |
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
Leasehold improvements and equipment - net |
|
|
1,523,950 |
|
|
|
1,749,259 |
|
Operating lease right-of-use assets - net |
|
|
3,276,639 |
|
|
|
3,761,207 |
|
Finance lease right-of-use assets - net |
|
|
58,007 |
|
|
|
116,968 |
|
In-process research and development |
|
|
3,017,377 |
|
|
|
3,017,377 |
|
Goodwill |
|
|
1,336,488 |
|
|
|
1,336,488 |
|
Restricted cash - security deposits |
|
|
200,000 |
|
|
|
336,000 |
|
Total non-current assets |
|
|
9,412,461 |
|
|
|
10,317,299 |
|
Total assets |
|
$ |
70,967,306 |
|
|
$ |
40,240,155 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
349,941 |
|
|
$ |
679,310 |
|
Accrued expenses and other liabilities |
|
|
2,795,329 |
|
|
|
1,939,510 |
|
Operating lease liabilities - current |
|
|
391,498 |
|
|
|
423,741 |
|
Financing lease liabilities - current |
|
|
30,853 |
|
|
|
54,673 |
|
Total current liabilities |
|
|
3,567,621 |
|
|
|
3,097,234 |
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Deferred tax liability |
|
|
341,265 |
|
|
|
341,265 |
|
Operating lease liabilities - net of current portion |
|
|
3,304,063 |
|
|
|
3,695,561 |
|
Financing lease liabilities - net of current portion |
|
|
23,660 |
|
|
|
54,513 |
|
Total non-current liabilities |
|
|
3,668,988 |
|
|
|
4,091,339 |
|
Total liabilities |
|
|
7,236,609 |
|
|
|
7,188,573 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Series B Convertible preferred stock, stated value $1,000 per
share, 8,000 shares authorized as of December 31, 2020 and 2019,
respectively; 4,361 and 4,577 shares issued and outstanding as of
December 31, 2020 and 2019, respectively; (liquidation preference -
$4,361,000 at December 31, 2020) |
|
|
3,797,705 |
|
|
|
3,985,805 |
|
Common stock par value $0.0001 per share, 500,000,000 shares
authorized at December 31, 2020 and 2019, respectively; 200,113,431
and 163,156,984 issued and outstanding as of December 31, 2020 and
2019, respectively |
|
|
20,010 |
|
|
|
16,315 |
|
Additional paid-in capital |
|
|
167,192,003 |
|
|
|
113,427,897 |
|
Accumulated deficit |
|
|
(107,507,193 |
) |
|
|
(84,377,555 |
) |
Accumulated other comprehensive income/(loss) |
|
|
228,172 |
|
|
|
(880 |
) |
Total stockholders’ equity |
|
|
63,730,697 |
|
|
|
33,051,582 |
|
Total liabilities and stockholders’ equity |
|
$ |
70,967,306 |
|
|
$ |
40,240,155 |
|
|
Matinas
BioPharma Holdings, Inc. |
Consolidated
Statements of Operations and Comprehensive Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
For the Year Ended December 31, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Contract research revenue |
$ |
62,500 |
|
|
$ |
- |
|
|
$ |
158,333 |
|
|
$ |
89,812 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
3,525,573 |
|
|
|
3,419,706 |
|
|
|
14,358,918 |
|
|
|
11,234,548 |
|
|
General and administrative |
|
3,025,812 |
|
|
|
2,316,277 |
|
|
|
10,005,967 |
|
|
|
7,776,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
|
6,551,385 |
|
|
|
5,735,983 |
|
|
|
24,364,885 |
|
|
|
19,010,848 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(6,488,885 |
) |
|
|
(5,735,983 |
) |
|
|
(24,206,552 |
) |
|
|
(18,921,036 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of New Jersey net operating loss |
|
- |
|
|
|
- |
|
|
|
1,073,289 |
|
|
|
1,007,082 |
|
Other income, net |
|
148,005 |
|
|
|
163,152 |
|
|
|
686,425 |
|
|
|
541,303 |
|
Net loss |
$ |
(6,340,880 |
) |
|
$ |
(5,572,831 |
) |
|
$ |
(22,446,838 |
) |
|
$ |
(17,372,651 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock series A accumulated dividends |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(338,613 |
) |
Preferred stock series B accumulated dividends |
|
(218,050 |
) |
|
|
(236,047 |
) |
|
|
(793,442 |
) |
|
|
(585,547 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common shareholders |
$ |
(6,558,930 |
) |
|
$ |
(5,808,878 |
) |
|
$ |
(23,240,280 |
) |
|
$ |
(18,296,811 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available for common shareholders per share - basic and
diluted |
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.13 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding - basic and diluted |
|
199,347,750 |
|
|
|
162,791,879 |
|
|
|
196,894,628 |
|
|
|
145,195,196 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive (loss)/income, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized (loss)/gain on securities available-for-sale |
|
(129,596 |
) |
|
|
(880 |
) |
|
|
237,537 |
|
|
|
(880 |
) |
|
Reclassification of realized gain on securities available-for-sale
to net loss |
|
(5,777 |
) |
|
|
- |
|
|
|
(8,485 |
) |
|
|
- |
|
|
Other comprehensive (loss)/income, net of tax |
|
(135,373 |
) |
|
|
(880 |
) |
|
|
229,052 |
|
|
|
(880 |
) |
Comprehensive loss attributable to stockholders |
$ |
(6,476,253 |
) |
|
$ |
(5,573,711 |
) |
|
$ |
(22,217,786 |
) |
|
$ |
(17,373,531 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying
notes are an integral part of these condensed consolidated
financial statements |
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor and Media Contacts
Peter
VozzoWestwicke/ICR443-213-0505peter.vozzo@westwicke.com
Source: Matinas BioPharma Holdings, Inc.
Matinas Biopharma (AMEX:MTNB)
Historical Stock Chart
From Apr 2024 to May 2024
Matinas Biopharma (AMEX:MTNB)
Historical Stock Chart
From May 2023 to May 2024