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 six months
ended June 30, 2023 and provides a business update.
“Feedback we recently received from the U.S.
Food and Drug Administration (FDA) underscores the challenges in
developing novel antifungal therapies, with a high bar for
efficacy, rigorously defined comparator groups and significant
patient numbers for a first-line indication. Nevertheless, we are
pleased that during our meeting earlier this year, the FDA
recognized the need for a therapy like MAT2203, which is designed
for patients with limited or no treatment options who require
longer-term treatment,” said Jerome D. Jabbour, Chief Executive
Officer of Matinas. “Compassionate use cases both ongoing and
completed represent powerful examples of the life-saving potential
of MAT2203, and we remain committed to positioning this important
drug for approval as quickly and efficiently as possible.
“We continue to refine the clinical development
pathway to support registration of MAT2203, including the Limited
Population Pathway for Antifungals (LPAD) Pathway, which we believe
could require fewer patients. We plan to engage with the Biomedical
Research and Development Authority (BARDA) as soon as possible to
discuss next steps to fund MAT2203 through registration based on
this feedback,” he added.
Key Program Updates
MAT2203 (Oral Amphotericin B)
Program
FDA Feedback
- For a first-line treatment
indication for invasive aspergillosis, the FDA recommended a 10%
non-inferiority margin for an all-cause mortality endpoint, which
would require approximately 700 patients in a 1:1 randomization
against standard of care.
- The Company believes that MAT2203
could be an attractive option for those patients who are intolerant
of azole therapy or have azole-resistant infections, which
represents an important unmet medical need. The FDA provided
alternative study designs for consideration, which include these
highest need patients and which we believe could ultimately
position MAT2203 for registration under the LPAD Pathway. This
approach could require significantly fewer patients than required
for first-line, unrestricted use.
Compassionate Use Program
- Eight patients have been enrolled
in the Company’s Compassionate/Expanded Use Access Program, with an
additional case pending. In these eight enrolled patients, MAT2203
has successfully treated numerous types of invasive fungal
infections at various locations in the body. In
addition to the compelling case presented earlier in 2023 at the
European Congress of Clinical Microbiology and Infectious Disease
(ECCMID), the following update was made available to the Company by
the investigating physician: Nationwide Children’s
Hospital
- MAT2203 was used to treat a
critically ill 15-year-old female patient with acute myeloid
leukemia and diabetes who suffered from invasive fungal infections
in sinus, lung, and brain due to multiple, extremely resistant
mucor species, as well as aspergillus species. The patient was
initially treated with IV liposomal amphotericin B but developed
treatment-limiting electrolyte abnormalities and renal toxicity as
well as significant feeding intolerance that required
hospitalization for intravenous hydration and electrolyte
supplementation. Upon enrolling in the Expanded Access Program,
IV-amphotericin B was discontinued, and the patient began treatment
with MAT2203 and was discharged from the hospital to continue the
remainder of her treatment at home.
- The patient began to show clinical
improvement following only three weeks of therapy on MAT2203, renal
function returned to normal and repeated sinus/brain MRI showed no
evidence of active mucormycosis infection. Similarly, repeated
chest CT showed a reduction in pulmonary nodules with no new
lesions. The patient continued MAT2203 therapy for a total of 17
weeks with no evidence of nephrotoxicity.
- ”Our decision to switch this
patient to MAT2203 proved to be a turning point in our patient’s
journey,” commented Eunkyung Song, MD, Infectious Disease/Host
defense program, Nationwide Children’s Hospital. “Rapidly, her
gastrointestinal intolerance and renal dysfunction resolved,
enabling her to continue MAT2203 therapy for an additional three
months. Throughout this period, the patient displayed excellent
tolerance to MAT2203, and subsequent imaging revealed radiologic
improvement in the invasive fungal infections. We are delighted
with the remarkable outcome achieved with MAT2203, which addressed
this patient’s very challenging condition effectively.”
LNC Platform Updates
Internal Small Oligonucleotide Program
- In vitro studies of LNC
formulations of small oligonucleotides (including an RNAi therapy)
conducted during the second and third quarters of 2023 demonstrated
efficient intracellular delivery with measurable knockdown of
certain inflammatory markers. Based on these results, Matinas is
working with its partners to generate in vivo data evaluating
biological activity with LNC oral formulations and expects initial
data later in 2023. Successful demonstration of in vivo efficacy
would represent a first for the oral delivery of small
oligonucleotides.
National Resilience
- Matinas’
collaboration with National Resilience continues to focus on in
vitro and in vivo delivery of mRNA and expects initial data later
in 2023.
Second Quarter Financial
Results
The Company reported no revenue for the second
quarter of 2023 compared with $1.1 million of revenue for the
second quarter of 2022, which was generated from the Company’s
research collaborations with BioNTech SE.
Total costs and expenses for the second quarter
of 2023 were $6.2 million compared with $7.0 million for the second
quarter of 2022. The decrease was primarily attributable to lower
manufacturing costs of clinical trial materials and a decrease in
clinical trial consulting fees, partially offset by higher
headcount.
The net loss for the second quarter of 2023 was
$6.1 million, or $0.03 per share, compared with a net loss for the
second quarter of 2022 of $5.9 million, or $0.03 per share.
Six Month Financial Results
Revenue for the first six months of 2023 and
2022 was $1.1 million. Total costs and expenses for the first half
of 2023 was $12.8 million versus $14.7 million for the first half
of 2022.
The net loss for the first six months of 2023
was $11.6 million, or $0.05 per share, compared with a net loss for
the first six months of 2022 of $11.9 million, or $0.06 per
share.
Cash, cash equivalents and marketable securities
as of June 30, 2023 were $22.5 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 proceeds 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 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.
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
successfully completed the Phase 2 EnACT program in cryptococcal
meningitis, meeting its primary endpoint and achieving robust
survival. MAT2203 is being positioned for a single pivotal Phase 3
study in the treatment of aspergillosis and other invasive fungal
infections, including mucormycosis, c. auris and other candidiasis,
and certain endemic mycoses in patients with limited treatment
options who are unable to be treated with azoles or echinocandins
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 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 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 and PS-NP delivery technologies, 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)
|
|
June 30, 2023 |
|
|
December 31, 2022 |
|
|
|
(Unaudited) |
|
|
(Audited) |
|
ASSETS: |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
9,743 |
|
|
$ |
6,830 |
|
Marketable debt securities |
|
|
12,770 |
|
|
|
21,933 |
|
Restricted cash – security deposit |
|
|
50 |
|
|
|
50 |
|
Prepaid expenses and other current assets |
|
|
1,437 |
|
|
|
5,719 |
|
Total current assets |
|
|
24,000 |
|
|
|
34,532 |
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
Leasehold improvements and equipment – net |
|
|
2,103 |
|
|
|
2,091 |
|
Operating lease right-of-use assets – net |
|
|
3,345 |
|
|
|
3,613 |
|
Finance lease right-of-use assets – net |
|
|
24 |
|
|
|
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 |
|
|
10,025 |
|
|
|
10,287 |
|
Total assets |
|
$ |
34,025 |
|
|
$ |
44,819 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
604 |
|
|
$ |
618 |
|
Accrued expenses |
|
|
1,372 |
|
|
|
3,099 |
|
Operating lease liabilities – current |
|
|
608 |
|
|
|
562 |
|
Financing lease liabilities – current |
|
|
5 |
|
|
|
7 |
|
Total current liabilities |
|
|
2,589 |
|
|
|
4,286 |
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Deferred tax liability |
|
|
341 |
|
|
|
341 |
|
Operating lease liabilities – net of current portion |
|
|
3,221 |
|
|
|
3,533 |
|
Financing lease liabilities – net of current portion |
|
|
20 |
|
|
|
22 |
|
Total non-current liabilities |
|
|
3,582 |
|
|
|
3,896 |
|
Total liabilities |
|
|
6,171 |
|
|
|
8,182 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock par value $0.0001 per share, 500,000,000 shares
authorized at June 30, 2023 and December 31, 2022; 217,264,526
issued and outstanding as of June 30, 2023 and December 31,
2022 |
|
|
22 |
|
|
|
22 |
|
Additional paid-in capital |
|
|
192,550 |
|
|
|
190,070 |
|
Accumulated deficit |
|
|
(164,204 |
) |
|
|
(152,631 |
) |
Accumulated other comprehensive loss |
|
|
(514 |
) |
|
|
(824 |
) |
Total stockholders’ equity |
|
|
27,854 |
|
|
|
36,637 |
|
Total liabilities and stockholders’ equity |
|
$ |
34,025 |
|
|
$ |
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 EndedJune 30, |
|
|
Six Months EndedJune 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract Revenue |
|
$ |
- |
|
|
$ |
1,063 |
|
|
$ |
1,096 |
|
|
$ |
1,063 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,559 |
|
|
|
4,127 |
|
|
|
7,530 |
|
|
|
9,105 |
|
General and administrative |
|
|
2,600 |
|
|
|
2,861 |
|
|
|
5,311 |
|
|
|
5,606 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
|
|
6,159 |
|
|
|
6,988 |
|
|
|
12,841 |
|
|
|
14,711 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(6,159 |
) |
|
|
(5,925 |
) |
|
|
(11,745 |
) |
|
|
(13,648 |
) |
Sale of New Jersey net
operating losses & tax credits |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,734 |
|
Other income, net |
|
|
99 |
|
|
|
2 |
|
|
|
172 |
|
|
|
13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(6,060 |
) |
|
$ |
(5,923 |
) |
|
$ |
(11,573 |
) |
|
$ |
(11,901 |
) |
Net loss per share – basic and
diluted |
|
$ |
(0.03 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.06 |
) |
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
217,264,526 |
|
|
|
216,864,526 |
|
|
|
217,264,526 |
|
|
|
216,755,261 |
|
Other comprehensive
gain/(loss), net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain/(loss) on securities available-for-sale |
|
|
81 |
|
|
|
(125 |
) |
|
|
310 |
|
|
|
(609 |
) |
Other comprehensive gain/(loss), net of tax |
|
|
81 |
|
|
|
(125 |
) |
|
|
310 |
|
|
|
(609 |
) |
Comprehensive loss |
|
$ |
(5,979 |
) |
|
$ |
(6,048 |
) |
|
$ |
(11,263 |
) |
|
$ |
(12,510 |
) |
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