Matinas BioPharma Holdings, Inc. (MTNB) is a clinical-stage biopharmaceutical company with a focus on identifying and developing novel pharmaceutical products using its proprietary lipid nanocrystal (LNC) platform delivery technology. Matinas BioPharma has experienced net losses and negative cash flows from operations since its inception, with an accumulated deficit of $181,397 as of March 31, 2024. For the full year 2023, Matinas BioPharma reported an annual net loss of $22,942,000, annual revenue of $1,096,000, annual operating cash flow of -$15,278,000, and annual free cash flow of -$15,496,000.

Financials

In the first quarter of 2024, Matinas BioPharma reported a net loss of $5,824,000, with no revenue generated during the period. This compares to a net loss of $5,513,000 and revenue of $1,096,000 in the first quarter of 2023. The decrease in revenue was due to the completion of Matinas BioPharma's research collaborations with BioNTech SE and Genentech Inc. in 2023.

Research and development expenses for the first quarter of 2024 were $3,446,000, down from $3,970,000 in the same period of 2023. The decrease was primarily attributable to lower clinical trial consulting costs and reduced headcount. General and administrative expenses also decreased to $2,456,000 in the first quarter of 2024, compared to $2,712,000 in the prior-year period, due to lower stock-based compensation expense and decreased insurance premiums.

Liquidity

As of March 31, 2024, Matinas BioPharma had cash, cash equivalents, and marketable debt securities totaling $8,110,000. Subsequent to the end of the quarter, Matinas BioPharma completed a registered direct offering, raising gross proceeds of approximately $10,000,000. Based on Matinas BioPharma's current projections, the combined cash resources are expected to fund planned operations into the second quarter of 2025.

Business Overview

Matinas BioPharma's key focus is on advancing its lead LNC product candidate, MAT2203, an oral formulation of the antifungal agent amphotericin B, through clinical development. Matinas BioPharma is currently in discussions to secure one or more development and commercialization partners to advance MAT2203 into the Phase III ORALTO trial, which is designed to evaluate the drug's potential as a safe and effective long-term treatment option for a variety of invasive and often deadly fungal infections.

Matinas BioPharma's confidence in the success of oral MAT2203 in the ORALTO trial, as well as its positive outlook in other invasive fungal infections, continues to build as it sees mounting evidence of favorable outcomes in extremely ill patients from its compassionate expanded use access program. To date, Matinas BioPharma has enrolled 22 patients in this program, with additional patients under evaluation. The data from this program have been recently published in a manuscript in Antimicrobial Agents and Chemotherapy, demonstrating prolonged and enhanced survival, reduced fungal burden, and improvement in lung infection with MAT2203 compared to placebo in treating pulmonary mucormycosis fungal infections in immunosuppressed mice.

Recent Developments

While Matinas BioPharma's primary focus remains on securing a partner for MAT2203, it has also shifted its attention towards expanding the applications of its LNC platform technology into other therapeutic areas, such as oncology and inflammation. Matinas BioPharma has generated highly encouraging results from in vivo studies with its LNC formulation of the chemotherapeutic agent docetaxel, which has shown the ability to deliver the drug directly to tumor cells and achieve longer treatment duration than the intravenous formulation, all with no indications of toxicity. Additionally, Matinas BioPharma has successfully formulated miriplatin, an insoluble platinum chemotherapeutic approved in Japan for hepatocellular carcinoma, using its LNC platform and has demonstrated strong cellular uptake and tumor cell killing capabilities in in vitro testing.

In the area of small oligonucleotides, Matinas BioPharma has successfully delivered biologically active small oligonucleotides in several inflammatory disease models, and it is continuing to explore the delivery of cytokine-inhibiting small oligonucleotides for inflammation, with additional data expected in the third quarter of 2024.

Matinas BioPharma's highly promising data from ex vivo, in vitro, and in vivo studies showcasing its LNC platform for the uptake and targeted delivery of small oligonucleotides have generated significant interest, with Matinas BioPharma's Chief Medical Officer and Chief Technology Officer presenting the findings at various industry conferences.

Outlook

As Matinas BioPharma works to capitalize on the unique capabilities of its LNC drug delivery platform, which has been clinically validated by MAT2203 in infectious disease, Matinas BioPharma sees a bright future in continuing to expand the applications of the LNC platform into areas of significant unmet medical need, such as oncology and inflammation. The early data in these areas are part of Matinas BioPharma's strategy to establish the LNC platform as a preferred next-generation, orally available, and targeted intracellular drug delivery technology.

Conclusion

In summary, Matinas BioPharma is at a pivotal point in its development, with its key focus on securing a partner or partners to advance MAT2203 into the Phase III ORALTO trial and toward commercialization. Matinas BioPharma's confidence in the potential of MAT2203 to address the significant challenges and unmet medical need in the treatment of invasive fungal infections continues to grow, supported by the positive feedback from key opinion leaders and the clinical experience and data from its compassionate expanded use access program.

At the same time, Matinas BioPharma's efforts to expand the applications of its LNC platform technology into oncology and inflammation have yielded highly promising initial results, further reinforcing the substantial potential of the LNC platform for the intracellular delivery of complex therapeutics in multiple therapeutic areas. As Matinas BioPharma works to create a portfolio of internal and external drug candidates leveraging its unique delivery technology, investors can look forward to Matinas BioPharma providing additional updates on its progress in the coming quarters.