Company Description
Matinas BioPharma Holdings, Inc. (NYSE American: MTNB) is a clinical-stage biopharmaceutical company in the pharmaceutical preparation manufacturing sector. According to the company, Matinas is focused on delivering groundbreaking therapies using its proprietary lipid nanocrystal (LNC) platform delivery technology. This technology is being applied to develop oral formulations and intracellular delivery approaches for challenging therapeutic agents.
The company describes itself as a clinical-stage organization, reflecting that its lead programs are in human trials rather than commercial use. Matinas’ work centers on using its LNC platform to address limitations of existing therapies and to enable oral and intracellular delivery for both small molecules and more complex molecular cargos.
Lead program: MAT2203 oral amphotericin B
Matinas’ lead LNC-based therapy is MAT2203, an oral formulation of the broad-spectrum antifungal drug amphotericin B. Amphotericin B is characterized in company disclosures as a potent fungicidal agent that is currently only available through an intravenous route of administration and is associated with significant safety issues such as renal toxicity and anemia due to very high circulating levels of the drug. Matinas states that its LNC platform provides oral delivery of amphotericin B without the significant nephrotoxicity otherwise associated with intravenous formulations.
According to Matinas, MAT2203 is being developed as a potential oral broad-spectrum treatment for invasive deadly fungal infections. The company reports that combining comparable fungicidal activity with targeted delivery may result in a lower risk of toxicity and potentially create an attractive antifungal option for invasive infections. MAT2203 was successfully evaluated in the completed Phase 2 EnACT study in HIV patients suffering from cryptococcal meningitis, where it met its primary endpoint and achieved robust survival, based on the company’s description of the study results.
Matinas has also reported real-world experience with MAT2203 through a Compassionate/Expanded Use Access Program for patients with serious invasive fungal infections who have limited or no other treatment options. Company updates describe multiple cases, including treatment of invasive aspergillosis and other invasive fungal infections, and note that in patients who experienced serious renal toxicity while receiving intravenous amphotericin B and were subsequently treated with MAT2203, renal toxicity was reversed and renal function returned to baseline, as reported by treating physicians. MAT2203 is described by the company as Phase 3-ready and intended to be further evaluated in a single Phase 3 registration trial (the “ORALTO” trial) as an oral step-down monotherapy following treatment with AmBisome (liposomal amphotericin B) compared with the standard of care in patients with invasive aspergillosis who have limited treatment options.
Lipid nanocrystal (LNC) platform
Beyond MAT2203, Matinas emphasizes the broader potential of its LNC platform technology. Company communications state that preclinical and clinical data have demonstrated that this technology can potentially provide solutions to many challenges of achieving safe and effective intracellular delivery of both small molecules and larger, more complex molecular cargos, including small oligonucleotides such as antisense oligonucleotides (ASOs) and small interfering RNA (siRNA).
Matinas reports that its LNCs can encapsulate and protect small oligonucleotides even when exposed to gastric fluid and can deliver them to a variety of cells with demonstrable biological activity in vitro. In particular, the company has discussed in vitro studies showing avid uptake of LNC formulations of various cytokine-targeted small oligonucleotides in murine macrophages, with notable gene knockdown observed for each targeted cytokine. These characteristics are presented by Matinas as supporting the potential of LNCs as an oral drug delivery platform for applications requiring oral delivery of small oligonucleotides.
In addition, Matinas has described in vivo work with LNC-formulated chemotherapeutic agents, including LNC-docetaxel and an LNC formulation of miriplatin, in various tumor models. The company reports varying degrees of tumor growth inhibition and ongoing efforts to optimize therapeutic index and better understand factors driving LNC uptake, such as surface phosphatidylserine expression on tumor cells. These activities underscore the company’s stated goal of expanding the use of its LNC platform in oncology and inflammation, although these programs remain at preclinical or early development stages based on the company’s disclosures.
Strategic and corporate developments
Matinas trades on the NYSE American under the ticker symbol MTNB. The company has disclosed that it is engaged in a strategic review, including exploring strategic alternatives for MAT2203 and other potential strategic alternatives for the company. Public communications from an outside investor and from Matinas reference possibilities such as monetizing existing assets, including a potential asset sale of MAT2203, and leveraging Matinas’ status as a listed security for potential merger candidates, as well as focusing on the company’s balance sheet. Matinas has also indicated that its board has directed management to reduce operating costs while strategic alternatives are being evaluated.
From a capital structure perspective, Matinas has undertaken financing activities, including issuing Series C Convertible Preferred Stock and accompanying warrants, and has entered into warrant exchange agreements to issue common stock in exchange for certain outstanding warrants. The company’s stockholders have approved measures such as an increase in authorized shares of common stock and a 2025 Equity Incentive Plan, as reflected in its SEC filings. In addition, Matinas has received a NYSE American noncompliance notice related to the timing of its annual meeting of stockholders and has stated its intention to hold the meeting by a specified deadline to regain compliance.
Corporate governance and leadership
Matinas’ public disclosures highlight ongoing evolution in its board of directors and governance structure. The company has appointed multiple independent directors with backgrounds in biotechnology, healthcare, finance, and corporate governance, including individuals with experience in audit committees, compensation committees, and nominating and governance committees. These appointments have included the designation of committee chairs for the Audit Committee, Compensation Committee, and Nominating and Governance Committee. The company has also reported departures and retirements of certain directors and changes in committee leadership over time.
In addition, Matinas has amended the employment agreement of its Chief Executive Officer to adjust retention bonus terms and to modify the definition of “Change in Control” to include a transaction resulting in a material change to the company’s or its successor’s primary business, as described in its SEC filings. These governance and compensation arrangements are framed in company disclosures as aligning leadership incentives with potential strategic transactions and corporate outcomes.
Regulatory and development considerations
As a clinical-stage biopharmaceutical company, Matinas emphasizes in its public statements that its product candidates, including MAT2203, are in development and are not licensed or approved anywhere globally. The company notes that the future development of its product candidates and platform technologies is subject to risks and uncertainties typical of drug development, including clinical testing outcomes, regulatory approvals, capital needs, and competitive and regulatory factors. These considerations are detailed in Matinas’ forward-looking statements and risk factor discussions in its SEC filings and press releases.
For investors and observers, Matinas represents a development-stage biopharmaceutical issuer whose value proposition is closely tied to the progress of MAT2203 as an oral amphotericin B candidate for invasive fungal infections and to the broader potential applications of its lipid nanocrystal platform in infectious disease, oncology, and oligonucleotide delivery, as described in the company’s own communications.