Matinas BioPharma (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 months ended
March 31, 2023 and provides a business update.
“Feedback from our U.S. Food and Drug
Administration (FDA) Type B meeting held in April was encouraging,
with the Agency recognizing the significant clinical potential and
medical need for an oral, well-tolerated, broad-spectrum
amphotericin B product to combat the growing threat of invasive
fungal infections,” said Jerome D. Jabbour, Chief Executive Officer
of Matinas. “The final meeting minutes reflect the FDA’s interest
in continuing to work collaboratively with Matinas to benefit
patients in need and provided us with valuable direction on
designing a Phase 3 IFI trial. We are diligently working to
finalize a protocol and accompanying statistical package that we
believe will support the broadest possible label for MAT2203 for
the treatment of IFIs under a streamlined 505(b)(2) regulatory
pathway.”
“We are pleased with the continued interest from
potential partners and funding sources to advance the development
of MAT2203. We plan to accelerate our ongoing business development
discussions and submit our funding proposals to the Biomedical
Advanced Research and Development Authority (BARDA) and through the
Advanced Research Project Agency for Health (ARPA-H), a new
research funding agency within the National Institutes of Health
(NIH) that supports high-impact research to drive biomedical
breakthroughs, during the second quarter,” he added.
“Our initial in vivo study of oral mRNA
delivery, which was based upon encouraging early in vitro results,
and conducted with our collaborator BioNTech, did not demonstrate
preclinical activity. While disappointing, we recognize that this
was an ambitious goal for a first in vivo study of a new, unique
mRNA formulation, where, to date, no delivery technology has been
successful in achieving oral delivery of mRNA. We are pleased these
formulations showed activity when administered systemically in
other internal studies, in addition to demonstrating prolonged
stability out to 17 weeks at 4° Celsius. We continue to believe
that our technology has potential to provide differentiated
delivery of nucleic acids and are in the process of generating
additional data in this area both through our collaboration with
National Resilience which has expanded to include mRNA following
the expiration of exclusivity with BioNTech, and with our internal
discovery programs in the siRNA space,” Mr. Jabbour concluded.
Key Program Updates and Anticipated
Upcoming 2023 Milestones
MAT2203 (Oral Amphotericin B)
Program
MAT2203 Phase 3 Trial Design
- The Company plans to submit a
revised Phase 3 trial design in the second quarter of 2023 to
assess the safety, efficacy, and tolerability of oral MAT2203 in
patients with life-threatening IFIs, including patients with
limited treatment options. The FDA has indicated support for a
trial in aspergillosis that is designed as a non-inferiority
comparison to standard-of-care IV azole antifungal treatments. The
main cohort in this trial is expected to include both first- and
second-line patients, and its design will likely include an early
step-down to oral treatment with MAT2203 administered as
monotherapy. The trial will also likely include an open-label
cohort of patients with a broad range of proven or probable IFIs
who otherwise have limited treatment options and are not able to
step down to an oral azole. The open-label cohort is expected to
support label expansion beyond aspergillosis under a 505(b)(2)
regulatory pathway and will include patients with invasive
mucormycosis, other rare mold infections, invasive candidiasis,
candida cystitis, and endemic mycoses including coccidioidomycosis,
histoplasmosis and blastomycosis.
- Based on FDA’s most recent
feedback, the Company is re-evaluating the specifics of the
previously contemplated Phase 3 trial in cryptococcal meningitis
(CM). The Company believes that a smaller, more focused trial in
CM, funded by the NIH could satisfy the FDA’s requirement for an
additional indication for the treatment of CM.
Compassionate Use Program
- A MAT2203 compassionate use case
study was presented at the European Congress of Clinical
Microbiology & Infectious Diseases (ECCMID) highlighting the
use of MAT2203 in a patient with a rare and challenging R.
mucilaginosa infection of the bone (osteomyelitis), which placed
her at risk for amputation and historically has usually required
long-term amphotericin B treatment. The patient was transitioned to
MAT2203 under the Company’s Compassionate Use Program after
suffering significant electrolyte abnormalities and associated
renal toxicity related to treatment with IV amphotericin B.
Following the transition to oral MAT2203, the patient’s renal
function returned to normal, and she was able to use MAT2203 safely
for six months, leading to a robust clinical response, avoidance of
amputation, and a return to full mobility.
- To date seven patients with various
IFIs have been treated with MAT2203 under the Company’s
Compassionate Use Program. Inbound requests have been received from
physicians at the NIH, University of Michigan, Nationwide
Children’s Hospital and Johns Hopkins University on behalf of
patients with no treatment alternatives. Clinical data in these
limited cases have demonstrated that orally administered MAT2203
targets infected tissues, is safe and effectively eradicates IFIs
in the most challenging cases. MAT2203 has successfully treated
serious infections throughout the body, including bone, CNS, lung,
sinus, bladder, and skin, highlighting the tissue-targeted nature
of the Company’s LNC platform delivery technology.
Government Grants for MAT2203 Development
- Matinas is pursuing non-dilutive
funding for the development of MAT2203 in multiple IFIs from BARDA
and ARPA-H. The Company believes MAT2203 is well positioned to
receive funding due to its oral, well-tolerated and broad-spectrum
profile, positive feedback from the FDA Type B meeting, clinical
success in the Phase 2 EnACT trial in cryptococcal meningitis and
results from the Compassionate Use Program. A potential BARDA
and/or ARPA-H award could be sufficient to fund development of
MAT2203 through to market approval for the targeted IFI
indications, as well as support supply chain and commercial
readiness.
Platform Collaborations
BioNTech
- In May 2023,
results of an initial in vivo study of an oral mRNA delivery
formulation, conducted in collaboration with BioNTech, did not
demonstrate oral preclinical activity.
- This single
study, conducted in healthy mice, involved oral administration of a
unique, proprietary, non-LNC formulation of BioNTech-supplied
reporter mRNA (firefly luciferase).
- This
proprietary, phosphatidylserine-containing nano-formulation,
distinct from traditional LNCs, was developed by Matinas to handle
the physical complexity and biological fragility of mRNA and other
large oligonucleotides.
- This formulation
had successfully delivered mRNA in vitro in multiple cell lines and
because of the timelines required under the BioNTech collaboration
was brought forward for oral in vivo evaluation.
- Additional
internal Matinas in vivo studies of similar non-LNC mRNA
formulations showed activity when administered systemically
(intramuscularly and intraperitoneally). In addition, these
formulations have demonstrated a high degree of stability out to at
least 17 weeks at 4° Celsius which compares favorably to lipid
nanoparticles (LNPs).
- Matinas has
filed numerous provisional patent applications based upon these
novel, unique, phosphatidylserine-based formulations.
- The research collaboration between
Matinas and BioNTech has been concluded.
National Resilience
- Following
expiration of the exclusive agreement with BioNTech in April 2023,
Matinas’ collaborative research program with National Resilience
was expanded to focus on in vitro and in vivo delivery of
mRNA.
- Specifically, National Resilience and Matinas will collectively
focus on reporter and therapeutic oligonucleotide delivery; both in
vitro and in vivo, against reference LNPs. Initial data is expected
in the third quarter of 2023.
LNC Internal Pipeline
Development
Internal siRNA Program
- Matinas is working toward the
generation of in vitro data from an internal program for the
delivery of silencing RNA (siRNA) therapies utilizing its LNC
platform technology. Initial formulation data are expected in the
third quarter of 2023. This program will continue with multiple in
vivo biodistribution and animal efficacy studies planned for the
second half of 2023.
First Quarter Financial
Results
Revenue for the first quarter of 2023 was $1.1
million, which was generated from research collaborations with
BioNTech and Genentech. There was no revenue reported for the first
quarter of 2022.
Total costs and expenses for the first quarter
of 2023 were $6.7 million compared with $7.7 million for the first
quarter of 2022. The decrease was primarily attributable to lower
manufacturing costs of clinical trial materials, partially offset
by higher headcount.
The net loss for the first quarter of 2023 was
$5.5 million, or $0.03 per share, compared with a net loss for the
first quarter of 2022 of $6.0 million, or $0.03 per share.
Cash, cash equivalents and marketable securities
as of March 31, 2023 were $24.9 million compared with $28.8 million
as of December 31, 2022. Based on current projections, the Company
believes its cash position is sufficient to fund planned operations
into the second half of 2024.
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 877-484-6065 (Toll-Free) or 201-689-8846 (Toll).
The live webcast will be accessible on the Investors section of the
company’s website and archived for 90 days.
About Matinas BioPharmaMatinas
BioPharma is a biopharmaceutical company focused on delivering
groundbreaking therapies using its lipid nanocrystal (LNC) platform
delivery technology to maximize global clinical impact and patient
access. The Company is developing its own internal portfolio of
products as well as partnering with leading pharmaceutical
companies to develop novel formulations that capitalize on the
unique characteristics of the LNC platform.
Preclinical and clinical data have demonstrated
that this novel technology can provide solutions to many of the
challenges in achieving safe and effective intracellular delivery
for both small molecules and larger, more complex molecules such as
siRNA, antisense oligonucleotides, and vaccines. The combination of
a unique mechanism of action and flexibility with formulation and
route of administration (including oral) positions Matinas’ LNC
technology potentially to become a preferred next-generation
intracellular drug delivery platform.
In addition, Matinas has recently developed a
non-LNC phosphatidylserine-based nanoparticle delivery technology
that takes advantage of the same unique biological properties of
phosphatidylserine that play a key role in more traditional LNCs,
but with its own unique structural characteristics that allow the
in vitro and in vivo delivery of larger oligonucleotides like mRNA,
with several distinct potential advantages over lipid nanoparticle
alternatives. For more information, please visit
www.matinasbiopharma.com.
Forward-looking StatementsThis
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,
our collaboration with National Resilience, Inc., the potential of
our LNC platform and PS-NP delivery technologies, 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 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 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 RelationsJody Cain
Jcain@lhai.com310-691-7100
[Financial Tables to Follow]Matinas
BioPharma Holdings, Inc.Condensed Consolidated
Balance Sheets(in thousands, except for share data)
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
|
|
(Unaudited) |
|
|
(Audited) |
|
ASSETS: |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
5,739 |
|
|
$ |
6,830 |
|
Marketable debt securities |
|
|
19,118 |
|
|
|
21,933 |
|
Restricted cash – security deposit |
|
|
50 |
|
|
|
50 |
|
Prepaid expenses and other current assets |
|
|
3,299 |
|
|
|
5,719 |
|
Total current assets |
|
|
28,206 |
|
|
|
34,532 |
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
Leasehold improvements and equipment – net |
|
|
1,998 |
|
|
|
2,091 |
|
Operating lease right-of-use assets – net |
|
|
3,480 |
|
|
|
3,613 |
|
Finance lease right-of-use assets – net |
|
|
25 |
|
|
|
30 |
|
In-process research and development |
|
|
3,017 |
|
|
|
3,017 |
|
Goodwill |
|
|
1,336 |
|
|
|
1,336 |
|
Restricted cash – security deposit |
|
|
200 |
|
|
|
200 |
|
Total non-current assets |
|
|
10,056 |
|
|
|
10,287 |
|
Total assets |
|
$ |
38,262 |
|
|
$ |
44,819 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
516 |
|
|
$ |
618 |
|
Accrued expenses |
|
|
791 |
|
|
|
3,099 |
|
Operating lease liabilities – current |
|
|
585 |
|
|
|
562 |
|
Financing lease liabilities – current |
|
|
4 |
|
|
|
7 |
|
Total current liabilities |
|
|
1,896 |
|
|
|
4,286 |
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Deferred tax liability |
|
|
341 |
|
|
|
341 |
|
Operating lease liabilities – net of current portion |
|
|
3,379 |
|
|
|
3,533 |
|
Financing lease liabilities – net of current portion |
|
|
21 |
|
|
|
22 |
|
Total non-current liabilities |
|
|
3,741 |
|
|
|
3,896 |
|
Total liabilities |
|
|
5,637 |
|
|
|
8,182 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock par value $0.0001 per share, 500,000,000 shares
authorized at March 31, 2023 and December 31, 2022; 217,264,526
issued and outstanding as of March 31, 2023 and December 31,
2022 |
|
|
22 |
|
|
|
22 |
|
Additional paid-in capital |
|
|
191,342 |
|
|
|
190,070 |
|
Accumulated deficit |
|
|
(158,144 |
) |
|
|
(152,631 |
) |
Accumulated other comprehensive loss |
|
|
(595 |
) |
|
|
(824 |
) |
Total stockholders’ equity |
|
|
32,625 |
|
|
|
36,637 |
|
Total liabilities and stockholders’ equity |
|
$ |
38,262 |
|
|
$ |
44,819 |
|
|
|
|
|
|
|
|
|
|
Matinas BioPharma Holdings,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive Loss (in thousands,
except share and per share data)Unaudited
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
|
Contract Revenue |
|
$ |
1,096 |
|
|
$ |
- |
|
Costs and Expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
3,970 |
|
|
|
4,978 |
|
General and administrative |
|
|
2,712 |
|
|
|
2,744 |
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
|
|
6,682 |
|
|
|
7,722 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(5,586 |
) |
|
|
(7,722 |
) |
Sale of New Jersey net
operating loss & tax credits |
|
|
- |
|
|
|
1,734 |
|
Other income, net |
|
|
73 |
|
|
|
10 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,513 |
) |
|
$ |
(5,978 |
) |
Net loss per share – basic and
diluted |
|
$ |
(0.03 |
) |
|
$ |
(0.03 |
) |
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
217,264,526 |
|
|
|
216,644,783 |
|
Other comprehensive
gain/(loss), net of tax |
|
|
|
|
|
|
|
|
Unrealized gain/(loss) on securities available-for-sale |
|
|
229 |
|
|
|
(484 |
) |
Other comprehensive gain/(loss), net of tax |
|
|
229 |
|
|
|
(484 |
) |
Comprehensive loss |
|
$ |
(5,284 |
) |
|
$ |
(6,462 |
) |
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