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Compassionate Use Patient Treated with Matinas BioPharma's MAT2203 and Showing Complete Clinical Resolution of Rare R. mucilaginosa Fungal Infection Featured in Oral Presentation at ECCMID BEDMINSTER, N.J. (

Key Takeaway: Matinas BioPharma (MTNB) has announced the successful treatment of a patient with a rare Rhodotorula mucilaginosa fungal infection using MAT2203, an oral formulation of amphotericin B. The results were presented at ECCMID and indicate complete clinical resolution and no significant renal adverse effects. The company is preparing for a Phase 3 program with the FDA, aiming to evaluate MAT2203's potential to treat invasive fungal infections more broadly. However, it is important to note that MAT2203 is still in the development stage and not yet approved for use.

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POSITIVE FACTORS

  • Complete clinical resolution of R. mucilaginosa fungal infection in a compassionate use patient.
  • MAT2203 showed robust clinical response with no renal adverse effects.
  • The treatment was well-tolerated and allowed for six months of continuous outpatient care.
  • Promising potential for MAT2203 to overcome limitations of existing amphotericin B treatments.

CONCERNS & RISKS

  • The outcomes are based on limited data from a single compassionate use case.
  • MAT2203 is not yet licensed or approved anywhere globally.

Full Press Release Details

Use Patient Treated with Matinas BioPharma's MAT2203 and Showing Complete Clinical Resolution of Rare R. mucilaginosa Fungal
Infection Featured in Oral Presentation at ECCMID
N.J. (April 18, 2023) - Matinas BioPharma (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused
on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, announces that Marisa H. Miceli,
MD, Professor of Medicine, Specializing in Fungal Infections and Transplant Diseases, Division of Infectious Diseases, Internal Medicine,
at the University of Michigan and her team delivered an oral presentation earlier today at the 33rd European Congress of
Clinical Microbiology & Infectious Diseases (ECCMID) in Copenhagen discussing MAT2203's clinical impact in treating a compassionate
use patient suffering from Rhodotorula mucilaginosa (R. mucilaginosa), a rare and opportunistic invasive fungal infection.
are extremely pleased with the positive clinical impact that MAT2203, oral amphotericin B, had on an extremely ill patient with very
limited treatment options," said Dr. Miceli. "R. mucilaginosa infection is rare and challenging to treat, due to innate
antifungal resistance requiring long-term amphotericin B treatment, which historically leads to significant nephrotoxicity. In our patient,
IV-amphotericin B had to be discontinued due to electrolyte abnormalities and associated toxicities. Following transition, MAT2203 was
well-tolerated, and led to a robust clinical response with no renal adverse effects, allowing for six continuous months of treatment
with regular outpatient monitoring. Based on our experience, MAT2203 appears to represent a safe and well-tolerated oral treatment option
that can be safely administered in the outpatient setting to patients who require long-term antifungal treatment with amphotericin B."
elements of Dr. Miceli's team presentation included:
outcomes observed in this compassionate use case are highly encouraging, although we recognize the data are limited," said Theresa
Matkovits, PhD, Chief Development Officer at Matinas. "This is one of several cases with successful outcomes using MAT2203 as part
of our ongoing Expanded Access Program. We are in the final stages of planning a Phase 3 program for MAT2203 with the U.S. Food &
Drug Administration. Our goal is to add to the growing body of evidence to fully evaluate the significant potential of MAT2203 in the
treatment of invasive fungal infections and, if appropriate, support broader use of this investigational drug."
is not yet licensed or approved anywhere globally.
BioPharma is developing MAT2203 as a potential oral broad-spectrum treatment for invasive deadly fungal infections. Although amphotericin
B is a fungicidal agent, it is currently only available through an intravenous route of administration, which is known to be associated
with a number of significant safety issues such as renal toxicity and anemia due to very high circulating levels of amphotericin B. MAT2203
has the potential to overcome the significant limitations of the currently available amphotericin B products due to its targeted oral
delivery, combining comparable fungicidal activity with targeted delivery resulting in a lower risk of toxicity and potentially creating
the ideal antifungal agent for the treatment of invasive fungal infections.
European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) has become one of the most comprehensive and influential
congresses in the field of infectious diseases and an exciting networking opportunity, bringing together more than 14,000 colleagues
from all over the world. The scientific program is built by the ECCMID Programme Committee, an independent group of experts representing
all disciplines related to clinical microbiology, infectious diseases, infection control and prevention, and public health.
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.
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 mRNA, DNA plasmids, 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 the preferred next-generation intracellular drug delivery vehicle
with distinct advantages over both lipid nanoparticles and viral vectors. For more information, please visit www.matinasbiopharma.com.
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 collaborations with National Resilience, Inc. and BioNTech
SE, the potential of our LNC platform delivery technology, 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 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

Frequently Asked Questions

What is MAT2203 used to treat?

MAT2203 is used to treat Rhodotorula mucilaginosa, a rare fungal infection.

Who presented the findings on MAT2203 at ECCMID?

Dr. Marisa H. Miceli and her team presented the findings at ECCMID.

How does MAT2203 compare to IV-amphotericin B?

MAT2203 is well-tolerated and has no renal adverse effects, unlike IV-amphotericin B.

What platform does Matinas BioPharma use?

Matinas BioPharma uses a lipid nanocrystal (LNC) platform for drug delivery.

Is MAT2203 approved for use?

No, MAT2203 is not yet licensed or approved anywhere globally.

Last updated: Apr 18, 2023