The Company is now subject to the procedures and requirements of Section 1009 of the Company Guide. The Company has until May 2, 2026 to submit a plan (the “Plan”) of actions it has taken or will take to regain compliance with the continued listing standards and may be eligible up to 18 months from receipt of the Notice (“Cure Period”) to regain compliance. The Company intends to submit the Plan to regain compliance with NYSE American listing standards. However, there can be no assurance that the Company will be able to achieve compliance with such standards within the Cure Period. If the NYSE American accepts the Plan, the Company will be able to continue its listing during the Cure Period and will be subject to periodic reviews including quarterly monitoring for compliance with the Plan until it has regained compliance. If the Plan is not accepted by the NYSE American, the Notice states that delisting proceedings will commence. The Company may appeal a staff delisting determination in accordance with Section 1010 and Part 12 of the Company Guide.

The Notice has no immediate impact on the listing of the Company’s shares of common stock, which will continue to be listed and traded on the NYSE American, subject to the Company’s compliance with the other listing requirements of the NYSE American. The Notice does not affect the Company’s ongoing business operations or its reporting requirements with the Securities and Exchange Commission.

Also, as disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, the independent registered public accounting firm’s report includes an explanatory paragraph regarding substantial doubt about the Company’s ability to continue as a going concern. Release of this information is required by Section 610(b) of the NYSE American Company Guide. It does not represent any change or amendment to any of the Company’s filings for the fiscal year ended December 31, 2025.

About Matinas BioPharma

Matinas BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology.

About MAT2203

Matinas BioPharma’s MAT2203 is 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 several 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 results in a lower risk of toxicity and potentially creates the ideal antifungal agent for the treatment of invasive fungal infections. MAT2203 was successfully evaluated in the completed Phase 2 EnACT study in HIV patients suffering from cryptococcal meningitis, meeting its primary endpoint and achieving robust survival. MAT2203 was planned to be further evaluated in a single Phase 3 registration 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.

For more information, please visit www.matinasbiopharma.com.

Forward-Looking Statements

This release contains “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, contained in this release are forward-looking statements. Forward-looking statements contained in this release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including with respect to the Company’s plans related to regaining compliance with the NYSE American’s continued listing standards. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see the risk disclosures in the Annual Report on Form 10-K of the Company for the year ended December 31, 2025 and in other filings made with the Securities and Exchange Commission by the Company. All such forward-looking statements speak only as of the date they are made, and the Company undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise.

Investor Contact
Jerome D. Jabbour
Chief Executive Officer
(908) 484-8805
operations@matinasbiopharma.com

“We are thrilled to announce the addition of Keith and Edward to our Board,” stated Jerome D. Jabbour, Chief Executive Officer of Matinas. “Their deep industry experience, leadership expertise, and capital markets acumen will be of great value as we move the company forward into a new era continuing our work to create long-term value for shareholders. We would also like to take this opportunity to thank the departing Directors Matthew Wikler and Natasha Giordano for their dedicated service, guidance, and insight during their tenure.”

Mr. Murphy will become Chair of the Nominating and Governance Committee, replacing Ms. Giordano, and become a member of the Compensation Committee and Mr. Neugeboren will become Chair of the Compensation Committee, replacing Dr. Wikler, and become a member of the Audit Committee.

Keith Murphy is currently a Director and Executive Chairman of Organovo Holdings, Inc. (Nasdaq: ONVO) and CEO and Chairman of Viscient Bio, Inc. Prior to co-founding Viscient Bio in 2017, Mr. Murphy founded Organovo in 2007 and led all company operations until 2017. He co-invented the NovoGen MMX bioprinter platform and grew Organovo through early investments and pharma corporate partnerships. Prior to Organovo, Mr. Murphy spent ten years at Amgen in roles of increasing responsibility, including four years as the Global Operations Leader of denosumab, now marketed as Prolia & Xgeva ($6B+ annual sales). Prior to Amgen, he played a key role at Alkermes in the successful development of once-monthly human growth hormone (hGH) in partnership with Genentech. 

Mr. Murphy holds a B.S. in Chemical Engineering from the Massachusetts Institute of Technology (MIT) and is an alumnus of the UCLA Anderson School of Management. Mr. Murphy serves as co-chair of the Board of No Patient Left Behind, and on the Board of Directors of California Life Sciences, the state’s life science industry public policy, advocacy and business leadership organization.

Edward Neugeboren has over thirty-three years of diversified healthcare experience in pharmaceutical operations, business development, corporate management, corporate governance, investment banking, asset management and institutional equity research. Mr. Neugeboren currently serves on the Board of Directors of Grace Therapeutics, Inc. (Nasdaq: GRCE), a late-stage biopharmaceutical company addressing rare and orphan diseases where he is a member of the Audit, Compensation and Nominating & Governance Committees. Since January of 2016, Mr. Neugeboren has served as the Chief Strategy Officer of Cronus Pharma, LLC, a fully integrated R&D, manufacturing and sales & marketing animal health pharmaceutical company. Mr. Neugeboren leads Cronus Pharma’s commercial operations, sales and marketing, strategic planning, business development and M&A, and is also responsible for developing and executing overall corporate strategy as well as corporate and portfolio acquisitions and licensing. Previously, Mr. Neugeboren was the Chief Strategy Officer for the parent pharmaceutical group comprised of Rising Pharma Holdings, Inc., a generic pharmaceutical company, and Casper Pharma, LLC, a specialty pharmaceutical company. Additionally, Mr. Neugeboren is Founder and Managing Partner of QuadView Healthcare Advisors, a healthcare investment banking and business development firm. Mr. Neugeboren was previously a Managing Director of Third Ridge Capital Management, LLC, a U.S. equity hedge fund.

Mr. Neugeboren was also Chief Administrative Officer and Director of Equity Research Operations at Lehman Brothers where he was a senior member of the management team responsible for operations for a 200-person department with direct management of technology, finance, editorial and production, human resources, and compliance. He was Deputy Director of Equity Research at UBS, formerly Warburg Dillon Read and Director of Equity Research Operations responsible for operations for a 150-person department. Additionally, he participated on the Investment Policy & Equity Commitment Committees.

Mr. Neugeboren began his career in 1992 as an equity research analyst covering the Specialty Pharmaceuticals industry, including Generic Drugs and Drug Delivery at Dillon, Read & Co., Kidder, Peabody & Co., and Furman, Selz, Inc. He was a member of the top-ranked Greenwich Associates Mid-Cap Pharmaceuticals Team. He also served as an Advisor to Healthcare Capital Corp., Inc., and its merger with AlphaTau, Inc., a radiopharmaceutical company, Director of Elite Pharmaceuticals Inc., a public specialty pharmaceutical company and KineMed, Inc., a private biopharmaceutical company. Mr. Neugeboren graduated with a BA in Economics from Union College.

About Matinas BioPharma
Matinas BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology.

About MAT2203
Matinas BioPharma’s MAT2203 is 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 several 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 results in a lower risk of toxicity and potentially creates the ideal antifungal agent for the treatment of invasive fungal infections. MAT2203 was successfully evaluated in the completed Phase 2 EnACT study in HIV patients suffering from cryptococcal meningitis, meeting its primary endpoint and achieving robust survival. MAT2203 was planned to be further evaluated in a single Phase 3 registration 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.

For more information, please visit www.matinasbiopharma.com.

Forward-looking Statements

This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the appointment of Mr. Murphy and Mr. Neugeboren, 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, the partnering of MAT2203, and the evaluation of other alternatives for the Company, including a winddown or dissolution of the Company; 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
Jerome D. Jabbour
Chief Executive Officer
(908) 484-8805
operations@matinasbiopharma.com

The Investors purchased 1,650 shares of Preferred Stock and accompanying warrants to purchase up to 5,631,404 shares of common stock for gross proceeds to the Company of $1.65 million at an initial closing on February 13, 2025. Subject to the satisfaction of certain closing conditions, on the date on which the Company’s stockholders approve the issuance of all of the shares of Common Stock upon conversion of the Preferred Stock and warrants, as required by the applicable rules and regulations of the NYSE American LLC (the “Shareholder Approval”), the Investors will pay an additional $1.65 million in exchange for an additional 1,650 shares of Preferred Stock and accompanying warrants to purchase up to 5,631,404 shares of common stock at a second closing.

The shares of Preferred Stock will be convertible into common stock at a conversion price of $0.586, and each share of Preferred Stock is initially convertible into 1,706 shares of common stock. The warrants will have an exercise price of $0.6446 per share, will be exercisable, subject to certain exceptions, beginning on the effective date of the Shareholder Approval and will expire five years from the effective date of the Shareholder Approval.

The funds will be used for general corporate purposes, with a focus on reducing operating expenses and exploring strategic alternatives for MAT2203, the Company’s Phase 3-ready antifungal drug candidate for the treatment of invasive fungal infections, as well as other strategic alternatives for the Company.

In connection with the Agreement, Dr. Robin L. Smith, MD, MBA has been appointed to the Board of Directors. Dr. Smith is a global business leader, medical doctor, author and entrepreneur who has held various C-Suite and board positions in the biopharmaceutical industry. She currently serves on the boards of directors of Spiritus Therapeutics, which she co-founded, the International Board of Sanford Health, and is the Chairman, President and founder of the Cura Foundation, a nonsectarian public charity dedicated to improving human health and well-being and increasing quality of life globally.

Dr. Smith has also had extensive experience serving on multiple private and public companies boards of directors and board committees, including audit, nominating, governance, compensation and science and technology committees in healthcare services, biotechnology, AI, technology and consumer products. Dr. Smith also founded numerous companies in regenerative medicine and is a managing partner of BRM Holdings family office. From 2006 until 2015, Dr. Smith was chairman and chief executive officer of Neostem, Inc., where she pioneered the company’s innovative business model, combining proprietary cell therapy development with successful contract development and manufacturing organization.

Dr. Smith has been recognized for her extensive leadership in the biopharmaceutical industry, winning an array of industry awards and business recognitions. She received the Regenerative Medicine Foundation (RMF) 2019 Stem Cell and Regenerative Medicine Action Award for International Diplomacy, the 2018 HEALinc Future Health Humanitarian Award, the Business Intelligence Group’s Woman of the Year Award in 2018 and the 2018 Gold Stevie® Award for Woman of the Year (Government or Non-Profit). In April 2016, Pope Francis awarded Dr. Smith Dame Commander with Star Pontifical Equestrian Order of Saint Sylvester Pope and Martyr and was awarded the Lifetime Achievement in Healthcare and Science by The National Museum of Catholic Art and Library. 

She received her B.A. degree from Yale University and her M.D. degree from the Yale School of Medicine. Dr. Smith holds an M.B.A. degree from the Wharton School of Business and completed the Stanford University Directors Program and received an honorary Doctor of Science degree from Thomas Jefferson Medical College.

The Company also announced that Herbert J. Conrad, founding Chairman of Matinas, has resigned from the Board and will retire. The Company wishes to express its sincere gratitude to Mr. Conrad for his long and dedicated service and support of the Company.

“We are very excited to have Robin join our Board,” commented Jerome D. Jabbour, Chief Executive Officer of Matinas. “She brings deep medical and business knowledge and experience at a critical time for our Company. I believe Dr. Smith will be an invaluable addition to our Board and can be a great contributor as we move forward. I would also like to personally thank Herb Conrad for his unwavering commitment and contributions to Matinas since we began our journey together in 2012. Herb was the first investor in the Company and provided incredible leadership throughout his years on the Board. We wish Herb all the best in his retirement.”

The Board has directed management to continue to reduce operating costs while strategic alternatives are being explored. There can be no assurance that the exploration of strategic alternatives will result in any agreement or transaction, or as to the timing of any such agreement or transaction. Further, there can be no assurance that the Company will receive Stockholder Approval or that the second closing will occur. 

About Matinas BioPharma

Matinas BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology.

About MAT2203
Matinas BioPharma’s MAT2203 is 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 several 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 results in a lower risk of toxicity and potentially creates the ideal antifungal agent for the treatment of invasive fungal infections. MAT2203 was successfully evaluated in the completed Phase 2 EnACT study in HIV patients suffering from cryptococcal meningitis, meeting its primary endpoint and achieving robust survival. MAT2203 was planned to be further evaluated in a single Phase 3 registration 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.

For more information, please visit www.matinasbiopharma.com.

Forward-looking Statements

This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to compliance with NYSE American listing requirements, 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, the satisfaction of closing conditions related to the second closing of the offering; the intended use of proceeds from the offering; the receipt of the Shareholder Approval; the sale of MAT 2203, and the evaluation of other alternatives for the Company, including a winddown or dissolution of the Company; 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
Jerome D. Jabbour
Chief Executive Officer
(908) 484-8805
operations@matinasbiopharma.com

Ms. D’An is an experienced board director and financial leader with extensive corporate governance, financial oversight, and accounting experience with a range of both public and private companies, where she has served as Chair of Audit Committees and as a member of various other board committees. Ms. D’An is also a former partner of Ernst & Young, where she spent 18 years serving clients in retail, consumer products, technology, and other sectors. She will serve as Chair of the Matinas Audit Committee and will also serve as a member of the Matinas Nominating & Governance Committee.

“We are delighted to welcome Evelyn to the Matinas Board,” commented Jerome D. Jabbour, Chief Executive Officer of Matinas. “Evelyn’s background as an experienced Audit Committee chair and business leader fills a need, and her commercial and strategic expertise complements the experience of our other Board members. We are honored that she has chosen to join us at this important time for the Company.”

About Matinas BioPharma

Matinas BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology.

For more information, please visit www.matinasbiopharma.com.

Forward-looking Statements

This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the appointment of Ms. D’An, 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, the sale of MAT 2203, and the evaluation of other alternatives for the Company, including a winddown or dissolution of the Company; 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
Jerome D. Jabbour
Chief Executive Officer
(908) 484-8805
operations@matinasbiopharma.com

The Company intends to hold its annual meeting no later than December 31, 2025 in order to regain compliance under the NYSE American Company Guide.

About Matinas BioPharma

Matinas BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology.

For more information, please visit www.matinasbiopharma.com.

Forward-looking Statements

This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to compliance with NYSE American listing requirements, 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, the sale of MAT 2203, and the evaluation of other alternatives for the Company, including a winddown or dissolution of the Company; 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
Jerome D. Jabbour
Chief Executive Officer
(908) 484-8805
operations@matinasbiopharma.com

The departing senior executives include Chief Medical Officer Dr. James Ferguson, Chief Business Officer Thomas Hoover and Chief Technology Officer Dr. Hui Liu.

The Board intends to retain an advisor to assist the Company with the potential asset sale of MAT2203, its lead Phase 3-ready antifungal drug candidate for the treatment of invasive fungal infections, and will evaluate other alternatives, including but not limited to winddown and dissolution of the Company. There can be no assurance that the Company will be able to sell MAT2203 on favorable terms, or at all.

About MAT2203
Matinas BioPharma’s MAT2203 is 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 several 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 results in a lower risk of toxicity and potentially creates the ideal antifungal agent for the treatment of invasive fungal infections. MAT2203 was successfully evaluated in the completed Phase 2 EnACT study in HIV patients suffering from cryptococcal meningitis, meeting its primary endpoint and achieving robust survival. MAT2203 was planned to be further evaluated in a single Phase 3 registration 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.

About Matinas BioPharma
Matinas BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology.

For more information, please visit www.matinasbiopharma.com.

Forward-looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the sale of MAT2203 and the winddown and dissolution of the Company, 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

Alliance Advisors IR
Jody Cain
Jcain@allianceadvisors.com
310-691-7100

31 patients have enrolled in the MAT2203 Compassionate/Expanded Use Access Program with 6 additional patients under evaluation

Additional LNC platform work in inflammation and oncology completed; Company evaluating next steps

Conference call begins at 4:30 p.m. Eastern time today

BEDMINSTER, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (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, 2024 and provides a business update.

“We continue to engage in constructive partnership dialogues for MAT2203 and are pleased to announce that we have signed a non-binding term sheet for global licensing rights to this oral formulation of the potent, yet toxic antifungal amphotericin B,” said Jerome D. Jabbour, Chief Executive Officer of Matinas. “Since June, seven additional patients have gained access to oral MAT2203 in our Compassionate/Expanded Use Access Program with an additional six patients under evaluation. We are experiencing a dramatic increase in requests by physicians seeking access for their patients who have limited or no treatment options, which we attribute to the consistently positive clinical impact of MAT2203 in successfully treating a variety of deadly invasive fungal infections.

“Recent studies have increased our understanding of the potential for our LNC platform in delivering both small oligonucleotides and small molecule oncology drugs, including LNC cellular uptake and cargo delivery,” he added. “We continue to expand our knowledge base and are evaluating the next best steps for this technology as we determine how to maximize return to shareholders. We expect to be in a better position to provide additional guidance following the consummation of a MAT2203 partnership.”

Key Program Updates

MAT2203 (Oral Amphotericin B)

• Matinas signed a non-binding term sheet with a single partner for global licensing rights to develop, manufacture and commercialize MAT2203 for all future treatment indications, including the intended initial indication of treatment for patients with invasive aspergillosis with limited or no other treatment options. Preparations are ongoing to enable the initiation of the ORALTO Phase 3 registration trial of MAT2203 to commence as soon as possible following a successful partnership announcement.

• Under the Compassionate/Expanded Use Access Program, 31 patients with a variety of serious and even life-threatening invasive fungal infections with limited or no other treatment options have been provided access to oral MAT2203, and 6 additional requests are under evaluation. Importantly, 7 patients have been or are being treated for invasive aspergillosis, each with positive results.

• Of the 15 patients in the Compassionate/Expanded Use Access Program who have completed treatment with MAT2203 (median treatment of 16 weeks with a range of 2 to 49 weeks), 8 had a complete response and 7 were improved. Response to treatment was assessed by the treating physician. Nine additional patients are continuing to receive longer-term treatment with positive ongoing effects and 5 have just recently initiated treatment. To date, only 2 patients have discontinued MAT2203 in this program, both occurring during the first week of treatment, with one due to an intolerance and the other due to a terminal condition not otherwise related to the underlying fungal infection.
  

LNC Platform

• Following early success in melanoma, recent additional in vivo studies in animal breast, prostate and lung cancer models have demonstrated varying degrees of tumor growth inhibition with daily oral dosing of LNC-docetaxel. Additionally, daily oral LNC-docetaxel in combination with intravenous docetaxel demonstrated greater degrees of tumor inhibition, but also resulted in additional weight loss. Additional studies are evaluating several strategies to potentially improve the therapeutic index of docetaxel.

• An LNC formulation of an additional chemotherapeutic agent, miriplatin, a highly toxic agent only approved outside the U.S. for intra-arterial use, demonstrated strong cellular uptake and tumor cell-killing capabilities in vitro in testing conducted during the second quarter. More recent in vivo testing showed the oral LNC formulation of miriplatin as very effective in reducing tumor sizes with significant weight loss also observed.

• A series of in vitro studies was recently completed investigating potential relationships between the amount of surface phosphatidylserine (PS) and the extent of LNC uptake into certain tumor cells. Based upon these studies, surface PS expression appears to be one, but not the only, driving factor for cellular uptake. Additional work is ongoing to better understand and predict the efficacy of LNC-delivered chemotherapeutics.

• Following early encouraging in vivo data demonstrating the successful oral delivery, biological activity, and potential therapeutic efficacy of two different LNC-formulated small oligonucleotides targeting inflammatory cytokines IL-17A and TNFα, more recent follow-up in vivo studies of orally administered LNC-formulated small oligonucleotides have been less consistent in showing therapeutic efficacy in certain inflammatory conditions. Additional optimization is required prior to identifying a potential product candidate.
  

Second Quarter Financial Results

The Company reported no revenue for the second quarters of 2024 and 2023.

Total costs and expenses for the second quarter of 2024 were $5.8 million, compared with $6.2 million for the second quarter of 2023. The decrease was primarily due to lower clinical development expenses, personnel costs and administrative expenses.

The net loss for the second quarter of 2024 was $5.7 million, or $0.02 per share, compared with a net loss for the second quarter of 2023 of $6.1 million, or $0.03 per share.

Six Month Financial Results

The Company reported no revenue for the six months ended June 30, 2024, compared with $1.1 million for the six months ended June 30, 2023, which was generated from research collaborations with BioNTech SE and Genentech Inc.

Total costs and expenses for the first six months of 2024 were $11.7 million, compared with $12.8 million for the first six months of 2023.

The net loss for the first six months of 2024 was $11.5 million, or $0.05 per share, compared with a net loss for the first six months of 2023 of $11.6 million, or $0.05 per share.

Cash, cash equivalents and marketable securities as of June 30, 2024, were $14.3 million, compared with $13.8 million as of December 31, 2023. In April 2024, the Company raised gross proceeds of $10.0 million through a registered direct offering.

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 (866) 682-6100 or (862) 298-0702. 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. Combining comparable fungicidal activity with targeted delivery results in a lower risk of toxicity and potentially creates the ideal antifungal agent for the treatment of invasive fungal infections. MAT2203 was successfully evaluated in the completed Phase 2 EnACT study in HIV patients suffering from cryptococcal meningitis, meeting its primary endpoint and achieving robust survival. MAT2203 will 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.

In addition to MAT2203, preclinical and clinical data have demonstrated that this novel 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 ASOs and siRNA. 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 Statements
This 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, the potential of our LNC platform technology, and the future development of our 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 Relations
Jody Cain
Jcain@lhai.com
310-691-7100

[Financial Tables to Follow]

To participate in the call, please dial (866) 682-6100 (Toll-Free) or (862) 298-0702 (Toll). The webcast will be available on the IR Calendar page of the Matinas website and will be archived for six months.

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. Combining comparable fungicidal activity with targeted delivery results in a lower risk of toxicity and potentially creates the ideal antifungal agent for the treatment of invasive fungal infections. MAT2203 was successfully evaluated in the completed Phase 2 EnACT study in HIV patients suffering from cryptococcal meningitis, meeting its primary endpoint and achieving robust survival. MAT2203 will 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.

In addition to MAT2203, preclinical and clinical data have demonstrated that this novel 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 ASOs and siRNA. 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 Statements
This 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, the future development of our product candidates, including MAT2203, the Company’s ability to identify and pursue development, licensing and partnership opportunities for our products, including MAT2203, 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 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 Relations
Jody Cain
Jcain@lhai.com
310-691-7100

“Our team faced the challenge of an extremely aggressive fungal soft tissue infection in a young patient at high risk for amputation. Treatment with AmBisome^® was initially helpful but, as frequently seen with intravenous amphotericin, was complicated by increasingly severe adverse effects, including significant renal toxicity that required ICU care. Switching to oral MAT2203 allowed us to effectively treat his infection and allow his kidney function to return to baseline,” said Dr. Yadav. “We were very pleased to see the patient improve on this medication, leave the ICU, and eventually be discharged to rehab and later to home, where he can now bear weight on his leg and walk with assistance.”

A total of 24 patients are currently receiving or have completed treatment with MAT2203 under the Compassionate/Expanded Use Access Program, and four additional cases are awaiting submission and/or FDA approval. In each instance, the patient was not responding to azole therapy, was unable to receive azole therapy due to drug/drug interactions or was unable to tolerate IV-amphotericin B for an appropriate treatment duration due to toxicity. In all patients who experienced serious renal toxicity while receiving IV-amphotericin B who were subsequently treated with MAT2203, renal toxicity was reversed, and renal function returned to baseline.

“We remain very excited by the consistently positive clinical impact of broad-spectrum, oral MAT2203,” said Theresa Matkovits, PhD, Chief Development Officer at Matinas. “Our Compassionate/Expanded Use Access Program continues to attract the attention of infectious disease doctors across the country who are treating patients with a wide variety of invasive fungal infections. Our ORALTO Phase 3 registration trial will provide the opportunity to further validate these results and position MAT2203 for a New Drug Application (NDA) filing with an initial indication for the early step-down therapy for invasive aspergillosis in patients with limited treatment options. We continue to work diligently toward securing the ideal global development and commercialization partnership to advance MAT2203 into Phase 3 later this year.”

MAT2203 is not yet licensed or approved anywhere globally.

About MAT2203
Matinas 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 several 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 results in a lower risk of toxicity and potentially creates the ideal antifungal agent for the treatment of invasive fungal infections. MAT2203 was successfully evaluated in the completed Phase 2 EnACT study in HIV patients suffering from cryptococcal meningitis, meeting its primary endpoint and achieving robust survival. MAT2203 will 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.

About Matinas BioPharma
Matinas BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology.

In addition to MAT2203, preclinical and clinical data have demonstrated that this novel 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 ASOs and siRNA. 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 Statements
This 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, 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 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 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 Relations
Jody Cain
Jcain@lhai.com
310-691-7100

BEDMINSTER, N.J., June 13, 2024 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, announces that MAT2203, its oral formulation of the potent antifungal amphotericin B, will be featured in a fireside chat with David S. Perlin, PhD, a recognized expert in antifungals. The event is being sponsored by Alliance Global Partners (A.G.P.) and hosted by Scott Henry, A.G.P. Managing Director and Senior Research Analyst.

Topics of discussion will include an overview of the antifungal market and current treatment options, the clinical potential of MAT2203 as an oral formulation of amphotericin B, the market potential of MAT2203 and the design and key factors in the MAT2203 ORALTO pivotal trial in patients with invasive aspergillosis who have limited treatment options.

Participants will have the opportunity to ask questions through the event platform.

Dr. David Perlin is the inaugural Chief Scientific Officer and Executive Vice President for the Hackensack Meridian Center for Discovery and Innovation, which seeks to rapidly translate innovations in science to improve outcomes for patients with cancer, infectious diseases, autoimmune and other acute and chronic disorders. He is an expert in drug discovery and drug-resistance mechanisms, and has helped develop novel therapeutics and diagnostics against high-threat bacteria, viruses and fungi. He has published more than 320 papers and book chapters, and has co-authored two books. The National Institutes of Health (NIH) has continuously funded his research for more than 30 years.

Dr. Perlin has served on advisory boards for the NIH, Bill & Melinda Gates Foundation, Global Action Fund for Fungal Infections, Aaron Diamond AIDS Research Center and numerous pharma, biotech and diagnostic companies. He is a Fellow of the American Academy of Microbiology (2018) and the New York Academy of Sciences (2006). In 2022, he was named a top 25 Notable Health Care Leader by Crain’s New York Business and in 2023 was awarded the Dr. Sol J. Barer Award for Vision, Innovation and Leadership.

About MAT2203
Matinas 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 several 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 results in a lower risk of toxicity and potentially creates the ideal antifungal agent for the treatment of invasive fungal infections. MAT2203 was successfully evaluated in the completed Phase 2 EnACT study in HIV patients suffering from cryptococcal meningitis, meeting its primary endpoint and achieving robust survival. MAT2203 will 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.

About Matinas BioPharma
Matinas BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology.

In addition to MAT2203, preclinical and clinical data have demonstrated that this novel 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 ASOs and siRNA. 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 Statements
This 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, the future development of our product candidates, including MAT2203, the Company’s ability to identify and pursue development, licensing and partnership opportunities for our products, including MAT2203, 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 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 Relations
Jody Cain
Jcain@lhai.com
310-691-7100