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 and nine months
ended September 30, 2023 and provides a business update.
“We are very excited by the consistent, positive
clinical data generated with MAT2203 in our Compassionate/Expanded
Use Access Program. The patients treated under this program suffer
from invasive fungal infections with few treatment options. We plan
to treat a similar patient population in our Phase 3 study – those
with invasive aspergillosis and limited treatment options,” said
Jerome D. Jabbour, Chief Executive Officer of Matinas. “Our recent
meeting with FDA supports our Phase 3 strategy, including the
potential for LPAD registration. We’re highly encouraged by FDA’s
openness to a superiority composite primary endpoint, which could
be significant in positioning MAT2203 for commercial success. We
look forward to finalizing the Phase 3 study design as soon as
possible and advancing our ongoing partnership discussions for this
important product.”
Key Program Updates
MAT2203 (Oral Amphotericin B)
Program
FDA Meeting Feedback
- A meeting was held with the U.S.
Food and Drug Administration (FDA) in mid-October with both the
Director and Deputy Director of the Office of Infectious Diseases
in attendance. The FDA agreed with the Phase 3 study design for the
treatment of invasive aspergillosis in patients with limited
treatment options and confirmed that MAT2203 may be a candidate for
the Limited Population Pathway for Antifungal and Antibacterial
Drugs (LPAD).
- During discussions regarding the
statistical assumptions for a noninferiority Phase 3 trial design,
FDA expressed openness to a proposed alternative superiority
composite endpoint, which we believe would best position MAT2203
for commercial success and differentiation upon approval. The
revised superiority composite endpoint is being finalized and will
be submitted to FDA for alignment in the next few weeks.
- The Company believes that a
superiority study incorporating a composite endpoint would not
change the projected study size (<200 patients) or enrollment
timeline (22-24 mos.). The FDA has communicated its commitment to
work with the Company on an off-cycle basis to finalize the Phase 3
protocol as soon as possible.
General MAT2203 Updates
- A total of 12 patients have been
enrolled in the Company’s Compassionate/Expanded Use Access
Program. In October, the Company announced that a 61-year-old male
with a challenging medical history achieved complete clinical
resolution of a Candida krusei infection following only two weeks
of treatment with MAT2203. Treatment with IV-amphotericin B was
discontinued due to renal toxicity and the patient was transitioned
to MAT2203, which was well-tolerated with no adverse effects.
Treatment with MAT2203 led to complete resolution of his symptoms
and improvement of his kidney function to baseline.
- Earlier this month, an additional
patient was enrolled in this Program at Vanderbilt University
Medical Center. This patient is suffering from a CNS-based fusarium
infection and required transition from IV-amphotericin due to
significant electrolyte abnormalities. The patient may also be able
to be discharged from the hospital in order to receive treatment at
home.
- University of Minnesota Medical
School researchers published results from the Phase 2 EnACT trial
evaluating MAT2203 for the treatment of cryptococcal meningitis as
a Major Article and Editor’s Choice in Clinical Infectious
Diseases, an official publication of the Infectious Diseases
Society of America (IDSA).
- The published results of the EnACT
Phase 2 trial, the ongoing positive clinical outcomes in the
Compassionate/Expanded Use Access Program, and the recent
additional clarity and support from the FDA for the MAT2203 Phase 3
program have all resulted in significant new interest from
potential partners for licensing, acquiring or otherwise
collaborating on MAT2203.
- During a meeting held in the third
quarter, the Biomedical Advanced Research and Development Authority
(BARDA) invited the Company to submit a White Paper for Phase 3
funding consideration. The Company intends to submit the White
Paper following finalization of the Phase 3 study design.
LNC Platform Updates
Oral LNC-Docetaxel
- The Company announced positive
results from an in vivo animal study of an oral LNC formulation of
docetaxel, a well-known chemotherapeutic agent used in the
management of multiple metastatic and unresectable tumors.
Anti-tumor effects of daily oral LNC-docetaxel were comparable to
IV-docetaxel with statistically significant reductions in tumor
volume compared with untreated controls at Day 14 (high dose oral
LNC -63%; low dose oral LNC -57%; IV docetaxel -68%), and similar
reductions in tumor weight at Day 14. No systemic toxicities were
noted. Body weight was stable over treatment duration and
hematologic parameters were similar to untreated controls.
- Potential next steps include
evaluating the efficacy of the current LNC-docetaxel formulation in
other tumor models and evaluating longer-term treatment regimens to
confirm lack of toxicity. Additionally, the Company plans to
evaluate the potential anti-tumor activity of LNC formulations of
small oligonucleotides.
Internal Oral LNC Small Oligonucleotide
Program
- The Company is investigating a
variety of LNC formulations of two small oligonucleotides designed
to target inflammatory cytokines IL-17A and TNFa, and has conducted
a series of in vitro and in vivo studies to evaluate the biological
activity associated with oral delivery as well as the corresponding
associated clinical benefit of IL-17A knockdown in an imiquimod
(IMQ) induced murine psoriasis disease model.
- These preliminary studies have
documented biological activity in the form of cytokine knockdown
and have also provided some evidence of associated tangible
clinical benefit with improvements in skin lesion appearance
(redness, scaling) in this qualitative psoriasis model. These data
remain under evaluation and the analyses are focused on (a)
clarifying the strength and time course of cytokine inhibition, and
(b) evaluating cytokine mRNA levels and specific tissue responses
in these models to better understand and interpret these data.
- Additional in vivo studies of
LNC-formulated small oligonucleotides in other disease models are
ongoing with additional data expected in the fourth quarter of this
year.
Third Quarter Financial
Results
The Company reported no revenue for the third
quarter of 2023 compared with $1.1 million of revenue for the third
quarter of 2022, which was generated from the Company’s research
collaborations with BioNTech SE.
Total costs and expenses for the third quarter
of 2023 were $6.1 million compared with $6.5 million for the third
quarter of 2022. The decrease was primarily attributable to
decreases in costs for the manufacturing of clinical trial
materials, and lower clinical trial consulting and headcount
costs.
The net loss for the third quarter of 2023 was
$6.1 million, or $0.03 per share, compared with a net loss for the
third quarter of 2022 of $5.5 million, or $0.03 per share.
Nine Month Financial
Results
Revenue for the first nine months of 2023 was
$1.1 million compared with $2.1 million for the first nine months
of 2022. Total costs and expenses for the first nine months of 2023
were $19.0 million compared with $21.2 million for the first nine
months of 2022.
The net loss for the first nine months of 2023
was $17.6 million, or $0.08 per share, compared with a net loss for
the first nine months of 2022 of $17.4 million, or $0.08 per
share.
Cash, cash equivalents and marketable securities
as of September 30, 2023, were $18.2 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 third quarter of 2024.
The Company is seeking to extend its cash runway
by securing non-dilutive funding from potential third-party
development partners and government grant programs through agencies
such as BARDA, as well as from potential public or private equity
offerings.
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 800-267-6316 or 203-518-9783. 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. MAT2203 also allows for
safe, longer-term use outside of a hospital setting, which could
have substantial favorable pharmacoeconomic impact. MAT2203 was
successfully evaluated in the completed Phase 2 EnACT study in
cryptococcal meningitis, meeting its primary endpoint and achieving
robust survival. MAT2203 will be further evaluated as an oral
step-down monotherapy treatment following IV amphotericin B in a
single pivotal Phase 3 study in the treatment of aspergillosis in
persons with limited treatment options who are unable to be treated
with azoles for reasons related to drug-drug interactions,
resistance or for whom these antifungal agents are unable to be
used for other clinical reasons.
In addition to MAT2203, preclinical and clinical
data have demonstrated that this novel technology can potentially
provide solutions to many of the challenges standing in the way of
achieving safe and effective intracellular delivery of both small
molecules and larger, more complex molecular cargos such as RNAi,
antisense oligonucleotides, and vaccines. 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 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 technology, and the future development of its
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 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) |
|
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
|
|
(Unaudited) |
|
|
(Audited) |
|
ASSETS: |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
6,407 |
|
|
$ |
6,830 |
|
Marketable debt securities |
|
|
11,809 |
|
|
|
21,933 |
|
Restricted cash – security deposit |
|
|
50 |
|
|
|
50 |
|
Prepaid expenses and other current assets |
|
|
1,723 |
|
|
|
5,719 |
|
Total current assets |
|
|
19,989 |
|
|
|
34,532 |
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
Leasehold improvements and equipment – net |
|
|
2,021 |
|
|
|
2,091 |
|
Operating lease right-of-use assets – net |
|
|
3,206 |
|
|
|
3,613 |
|
Finance lease right-of-use assets – net |
|
|
22 |
|
|
|
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 |
|
|
9,802 |
|
|
|
10,287 |
|
Total assets |
|
$ |
29,791 |
|
|
$ |
44,819 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
835 |
|
|
$ |
618 |
|
Accrued expenses |
|
|
1,757 |
|
|
|
3,099 |
|
Operating lease liabilities – current |
|
|
632 |
|
|
|
562 |
|
Financing lease liabilities – current |
|
|
5 |
|
|
|
7 |
|
Total current liabilities |
|
|
3,229 |
|
|
|
4,286 |
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Deferred tax liability |
|
|
341 |
|
|
|
341 |
|
Operating lease liabilities – net of current portion |
|
|
3,052 |
|
|
|
3,533 |
|
Financing lease liabilities – net of current portion |
|
|
19 |
|
|
|
22 |
|
Total non-current liabilities |
|
|
3,412 |
|
|
|
3,896 |
|
Total liabilities |
|
|
6,641 |
|
|
|
8,182 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock par value $0.0001 per share, 500,000,000 shares
authorized at September 30, 2023 and December 31, 2022; 217,264,526
issued and outstanding as of September 30, 2023 and December 31,
2022 |
|
|
22 |
|
|
|
22 |
|
Additional paid-in capital |
|
|
193,746 |
|
|
|
190,070 |
|
Accumulated deficit |
|
|
(170,259 |
) |
|
|
(152,631 |
) |
Accumulated other comprehensive loss |
|
|
(359 |
) |
|
|
(824 |
) |
Total stockholders’ equity |
|
|
23,150 |
|
|
|
36,637 |
|
Total liabilities and stockholders’ equity |
|
$ |
29,791 |
|
|
$ |
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 September
30, |
|
|
Nine Months Ended September
30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract Revenue |
|
$ |
— |
|
|
$ |
1,063 |
|
|
$ |
1,096 |
|
|
$ |
2,125 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,295 |
|
|
|
3,707 |
|
|
|
10,824 |
|
|
|
12,811 |
|
General and administrative |
|
|
2,839 |
|
|
|
2,818 |
|
|
|
8,151 |
|
|
|
8,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
|
|
6,134 |
|
|
|
6,525 |
|
|
|
18,975 |
|
|
|
21,235 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(6,134 |
) |
|
|
(5,462 |
) |
|
|
(17,879 |
) |
|
|
(19,110 |
) |
Sale of New Jersey net
operating losses & tax credits |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,734 |
|
Other income, net |
|
|
79 |
|
|
|
— |
|
|
|
251 |
|
|
|
13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(6,055 |
) |
|
$ |
(5,462 |
) |
|
$ |
(17,628 |
) |
|
$ |
(17,363 |
) |
Net loss per share – basic and
diluted |
|
$ |
(0.03 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
217,264,526 |
|
|
|
216,864,526 |
|
|
|
217,264,526 |
|
|
|
216,792,083 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
gain/(loss), net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain/(loss) on securities available-for-sale |
|
|
155 |
|
|
|
(181 |
) |
|
|
465 |
|
|
|
(790 |
) |
Other comprehensive gain/(loss), net of tax |
|
|
155 |
|
|
|
(181 |
) |
|
|
465 |
|
|
|
(790 |
) |
Comprehensive loss |
|
$ |
(5,900 |
) |
|
$ |
(5,643 |
) |
|
$ |
(17,163 |
) |
|
$ |
(18,153 |
) |
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