Central Nervous System Fungal Infections

BEDMINSTER, N.J., April 03, 2024 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE American: MTNB) (“Matinas BioPharma” or the “Company”), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, today announced it has entered into securities purchase agreements with healthcare-focused institutional investors for the purchase and sale of 33,333,334 shares of common stock, par value $0.0001 per share, and warrants to purchase up to an aggregate of 33,333,334 shares of common stock, at a combined offering price of $0.30 per share and accompanying warrant, pursuant to a registered direct offering. The warrants will have an exercise price of $0.35 per share, will be exercisable commencing six months from the date of issuance and will expire five and one-half years following the date of issuance. The gross proceeds of the offering will be approximately $10 million before deducting fees and other estimated offering expenses. The closing of the offering is expected to take place on or about April 5, 2024, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. A.G.P./Alliance Global Partners is acting as sole placement agent for the offering. This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-272580) previously filed with the U.S. Securities and Exchange Commission (the “SEC”) and was declared effective on June 20, 2023. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. A final prospectus supplement and accompanying base prospectus relating to the offering will be filed by Matinas BioPharma with the SEC. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, New York 10022 or by e-mail at Investmentbanking@allianceg.com. 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. 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. Forward-looking StatementsThis press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the expected closing date of the offering described in this press release. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate, and management's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include, but are not limited to, those set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, as well as other documents filed by the Company from time to time thereafter with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Investor ContactLHA Investor RelationsJody CainJcain@lhai.com310-691-7100

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced an update following the initial analysis of results from the first of two induction studies in the Phase 3 YELLOWSTONE clinical trial program evaluating Zeposia (ozanimod) in adult patients with moderate to severe active Crohn’s disease. The study did not meet its primary endpoint of clinical remission at Week 12. The safety pro Zeposia in this study was consistent with that observed in previously reported trials. The company will complete a full evaluation of the YELLOWSTONE trial data and work with investigators to share the results with the scientific community in the future. “To date, no S1P modulator has shown an effect in a Phase 3 trial in Crohn’s disease, where a high unmet medical need remains for new therapies that offer more patients relief from symptoms and the potential for remission,” said Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb. “While we are disappointed that the primary endpoint was not reached in this first induction trial, we are committed to driving transformative science on behalf of individuals with immune-mediated diseases and would like to thank the investigators and patients who are participating in the YELLOWSTONE clinical trial program.” About the YELLOWSTONE Clinical Trial Program YELLOWSTONE is a Phase 3, multicenter clinical trial program consisting of two 12-week induction studies, a 52-week maintenance study and a 264-week open-label extension study. YELLOWSTONE is designed to evaluate the safety and efficacy of Zeposia (ozanimod) administered orally to patients with Crohn’s disease versus placebo. The induction studies include approximately 600 patients each, with responders moving on to participate in the maintenance study. Nonresponders, those with disease relapse during maintenance, and completers of the maintenance study have the option to enroll in the open-label extension trial. Patients in the trial program are receiving Zeposia 0.92 mg (equivalent to 1 mg). The primary endpoint of the induction studies is the proportion of patients with a Crohn’s Disease Activity Index (CDAI) score of less than 150. The co-primary endpoints of the maintenance study are the proportion of patients with a CDAI score of less than 150 and the proportion of patients with a Simple Endoscopic Score for Crohn’s disease (SES-CD) score decrease from baseline of at least 50%. About Crohn’s disease Crohn's disease is a chronic inflammatory bowel disease (IBD) affecting the digestive tract. IBD results in the swelling or inflammation of the intestines, which may result in permanent damage and impact everyday life during disease flares. It is estimated that approximately 12.6 million people worldwide have IBD. For many patients, Crohn’s disease occurs in the colon or the third segment of the small intestine, the ileum, but may occur in any part of the intestinal tract. Signs and symptoms of Crohn’s disease can range from mild to severe. Most often, symptoms appear gradually but can sometimes develop suddenly or without warning. Patients with Crohn’s disease may experience ongoing disease symptoms, or have episodes of symptom-free remission, which can be followed by relapse or flares. Patients with Crohn's disease are also at an increased risk of developing colorectal cancer. Living with Crohn’s disease may severely affect quality of life both physically and psychologically, particularly during disease flares and relapses. Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients’ Lives Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can take a toll on their physical, emotional and social well-being, making simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, and our passion to help patients, the company continues to pursue pathbreaking science with the goal of delivering meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and pulmonology. We follow the science, aiming to tailor therapies to individual needs, improve outcomes and expand treatment options by working to identify mechanisms with the potential to achieve long-term remission – and perhaps even cures – in the future. By building partnerships with researchers, patients and caregivers to deliver innovative treatments, Bristol Myers Squibb strives to elevate patient care to new standards and deliver what matters most – the promise of living a better life. About Zeposia (ozanimod) Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which Zeposia exerts therapeutic effects in Crohn’s disease is unknown but may involve the reduction of lymphocyte migration into the gut. Zeposia is approved in numerous countries around the world for the treatment of adults with relapsing forms of MS and adults with moderately to severely active ulcerative colitis. U.S. FDA APPROVED INDICATIONS ZEPOSIA® (ozanimod) is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Moderately to severely active ulcerative colitis (UC) in adults. IMPORTANT SAFETY INFORMATION Contraindications: Patients who in the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III/IV heart failure or have a presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker Patients with severe untreated sleep apnea Patients taking a monoamine oxidase (MAO) inhibitor Infections: ZEPOSIA may increase the susceptibility to infections. Life-threatening and rare fatal infections have occurred in patients receiving ZEPOSIA. Obtain a recent (i.e., within 6 months or after discontinuation of prior MS or UC therapy) complete blood count (CBC) including lymphocyte count before initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with an active infection until the infection is resolved. Consider interruption of treatment with ZEPOSIA if a patient develops a serious infection. Continue monitoring for infections up to 3 months after discontinuing ZEPOSIA. Herpes zoster was reported as an adverse reaction in ZEPOSIA-treated patients. Herpes simplex encephalitis and varicella zoster meningitis have been reported with sphingosine 1-phosphate (S1P) receptor modulators. Patients without a healthcare professional-confirmed history of varicella (chickenpox), or without documentation of a full course of vaccination against varicella zoster virus (VZV), should be tested for antibodies to VZV before initiating ZEPOSIA. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with ZEPOSIA. Cases of fatal cryptococcal meningitis (CM) were reported in patients treated with another S1P receptor modulator. If CM is suspected, ZEPOSIA should be suspended until cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated. In the MS and UC clinical studies, patients who received ZEPOSIA were not to receive concomitant treatment with antineoplastic, non-corticosteroid immunosuppressive, or immune-modulating therapies used for treatment of MS and UC. Concomitant use of ZEPOSIA with any of these therapies would be expected to increase the risk of immunosuppression. When switching to ZEPOSIA from immunosuppressive medications, consider the duration of their effects and their mode of action to avoid unintended additive immunosuppressive effects. Use of live attenuated vaccines should be avoided during and for 3 months after treatment with ZEPOSIA. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA. Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability. PML has been reported in patients treated with S1P receptor modulators, including ZEPOSIA, and other MS and UC therapies and has been associated with some risk factors. If PML is suspected, withhold ZEPOSIA and perform an appropriate diagnostic evaluation. If confirmed, treatment with ZEPOSIA should be discontinued. Immune reconstitution inflammatory syndrome (IRIS) has been reported in MS patients treated with S1P receptor modulators who developed PML and subsequently discontinued treatment. IRIS presents as a clinical decline in the patient’s condition that may be rapid, can lead to serious neurological complications or death, and is often associated with characteristic changes on MRI. The time to onset of IRIS in patients with PML was generally within a few months after S1P receptor modulator discontinuation. Monitoring for development of IRIS and appropriate treatment of the associated inflammation should be undertaken. Bradyarrhythmia and Atrioventricular Conduction Delays: Since initiation of ZEPOSIA may result in a transient decrease in heart rate and atrioventricular conduction delays, dose titration is recommended to help reduce cardiac effects. Initiation of ZEPOSIA without dose escalation may result in greater decreases in heart rate. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought for those individuals: with significant QT prolongation with arrhythmias requiring treatment with Class 1a or III anti-arrhythmic drugs with ischemic heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, and uncontrolled hypertension with a history of Mobitz type II second-degree or higher AV block, sick sinus syndrome, or sino-atrial heart block Liver Injury: Elevations of aminotransferases may occur in patients receiving ZEPOSIA. Obtain liver function tests, if not recently available (i.e., within 6 months), before initiation of ZEPOSIA. Patients who develop symptoms suggestive of hepatic dysfunction should have hepatic enzymes checked and ZEPOSIA should be discontinued if significant liver injury is confirmed. Fetal Risk: There are no adequate and well-controlled studies in pregnant women. Based on animal studies, ZEPOSIA may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during treatment and for 3 months after stopping ZEPOSIA. Women who become pregnant while taking ZEPOSIA for MS may enroll in the ZEPOSIA pregnancy registry by calling 1-877-301-9314 or visiting Increased Blood Pressure: Increase in systolic pressure was observed after about 3 months of treatment and persisted throughout treatment. Blood pressure should be monitored during treatment and managed appropriately. Certain foods that may contain very high amounts of tyramine could cause severe hypertension in patients taking ZEPOSIA. Patients should be advised to avoid foods containing a very large amount of tyramine while taking ZEPOSIA. Respiratory Effects: ZEPOSIA may cause a decline in pulmonary function. Spirometric evaluation of respiratory function should be performed during therapy, if clinically indicated. Macular Edema: S1P modulators have been associated with an increased risk of macular edema. Patients with a history of uveitis or diabetes mellitus are at increased risk. Patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to treatment initiation and regular follow-up examinations. An ophthalmic evaluation is recommended in all patients at any time if there is a change in vision. Continued use of ZEPOSIA in patients with macular edema has not been evaluated; potential benefits and risks for the individual patient should be considered if deciding whether ZEPOSIA should be discontinued. Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported in patients receiving a S1P receptor modulator. If a ZEPOSIA-treated patient develops unexpected neurological or psychiatric symptoms or any symptom/sign suggestive of an increase in intracranial pressure, a complete physical and neurological examination should be conducted. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, treatment with ZEPOSIA should be discontinued. Unintended Additive Immunosuppressive Effects From Prior Immunosuppressive or Immune-Modulating Drugs: When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation. Initiating treatment with ZEPOSIA after treatment with alemtuzumab is not recommended. Severe Increase in Multiple Sclerosis (MS) Disability After Stopping ZEPOSIA: In MS, severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping ZEPOSIA treatment so patients should be monitored upon discontinuation. After stopping ZEPOSIA in the setting of PML, monitor for development of immune reconstitution inflammatory syndrome (PML-IRIS). Immune System Effects After Stopping ZEPOSIA: After discontinuing ZEPOSIA, the median time for lymphocyte counts to return to the normal range was 30 days with approximately 90% of patients in the normal range within 3 months. Use of immunosuppressants within this period may lead to an additive effect on the immune system, therefore caution should be applied when initiating other drugs 4 weeks after the last dose of ZEPOSIA. Most Common Adverse Reactions that occurred in the MS clinical trials of ZEPOSIA-treated patients (≥4%): upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension. In the UC clinical trials, the most common adverse reactions that occurred in ≥4% of ZEPOSIA-treated patients and greater than in patients who received placebo were upper respiratory infection, liver test increased, and headache. Use in Specific Populations: Hepatic Impairment: Dosage adjustment in patients with mild or moderate hepatic impairment (Child-Pugh class A or B) is required, and use of ZEPOSIA in patients with severe hepatic impairment (Child-Pugh class C) is not recommended. For additional safety information, please see the full Prescribing Information and Medication Guide. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, the possibility of unfavorable results from further clinical trials involving Zeposia (ozanimod) and whether Zeposia for the additional indication described in this release will be successfully developed and commercialized. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news

Clear registration pathway and FDA agreement on the ORALTO Phase 3 trial for MAT2203 represent critical steps forward and supports partnership discussions Continued success of Compassionate/Expanded Use Access Program demonstrates potential of MAT2203 in treating multiple severe invasive fungal infections, including invasive aspergillosis Successful in vivo LNC platform studies demonstrating (a) the oral delivery of small oligonucleotides with biological activity and (b) the dramatically improved safety of LNC-docetaxel over IV-docetaxel, with similar efficacy, supports the future use of the LNC platform in inflammation and oncology Conference call begins at 4:30 p.m. Eastern time today BEDMINSTER, N.J., March 27, 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 2023 financial results and provides a business update. “A clear regulatory approval pathway for oral MAT2203 is a critical step toward future commercialization in its initial indication of the treatment of invasive aspergillosis in patients with limited treatment options,” said Jerome D. Jabbour, Chief Executive Officer of Matinas. “Reaching agreement with FDA on the design of the ORALTO registration trial and the consistent successful treatment outcomes in our ongoing Compassionate/Expanded Use Access Program have elevated our confidence that, if approved, MAT2203 could represent a new treatment paradigm for addressing the unmet medical need in the treatment of a variety of difficult to treat invasive fungal infections. With these important elements secured, we are actively pursuing partnership opportunities to advance MAT2203 into Phase 3 as quickly as possible. “We have also advanced the application of our LNC platform into exciting areas, including oncology and inflammation. In the oncology space, our in vivo data demonstrate that treatment with oral LNC-docetaxel at dosages substantially higher than those proven effective in targeting melanoma tumors resulted in tumor size reductions comparable to IV-docetaxel and was associated with none of the toxicity (body weight loss) observed with conventional IV-docetaxel. In the field of inflammation, we have demonstrated the successful oral delivery of biologically active – and potentially therapeutic – small oligonucleotides in several inflammatory disease models. “Overall, we are pleased with all of the progress made by our team throughout 2023 and so far in 2024, and our focus remains on executing our strategic plan to make the LNC platform the preferred next-generation orally available intracellular drug delivery technology, facilitating an internal and external pipeline of drug candidates.” Key Program Updates MAT2203 (Oral Amphotericin B) Program Phase 3 ORALTO Registration Trial Matinas reached alignment with the FDA on the design of a single Phase 3 registration trial of oral MAT2203 in patients with invasive aspergillosis who have limited treatment options. This is a serious and life-threatening invasive fungal infection that occurs primarily in severely immunocompromised patients, including those with hematological malignancies and in transplant recipients. In 2022, the World Health Organization released its Fungal Priority Pathogen List that designated the most common invasive aspergillosis, Aspergillus fumigatus, to be in the Critical Priority group, which is designated as the highest perceived public health threat. Aspergillus fumigatus is also included in the FDA qualified designation list of pathogens that pose a serious and life-threatening risk. The Phase 3 randomized, multicenter, open-label, adjudicator-blinded ORALTO trial will evaluate the efficacy and safety of MAT2203 as an oral step-down treatment following two days of treatment with AmBisome® (liposomal IV-amphotericin B) compared with the standard of care in patients with invasive aspergillosis who have limited treatment options. The primary efficacy endpoint in this non-inferiority study is all-cause mortality at study day 42. Key secondary objectives include demonstration of superiority for treatment-related toxicities leading to changes in treatment, long-term survival benefit of MAT2203 using all-cause mortality at study day 84 and the impact of MAT2203 on healthcare resource utilization and quality of life. The Phase 3 ORALTO trial is expected to include approximately 65 investigator sites in the U.S., Europe, South America, the Middle East and Asia Pacific. Enrollment is expected to include approximately 216 adults with recently diagnosed probable or proven invasive aspergillosis who are being treated with AmBisome due to their inability to receive an IV mold-active azole and with limited alternative treatment options. Following up to two days of treatment with AmBisome, eligible participants will be randomized 2:1 to receive either oral MAT2203 or continued AmBisome treatment followed by standard of care. All study participants will receive up to 12 weeks of treatment starting from the first day of treatment with AmBisome. All study participants are expected to be hospitalized during the initial AmBisome treatment period. After step-down to oral MAT2203, study participants may be discharged to continue treatment on an outpatient basis, as clinically appropriate. An independent Data Review Committee, which will be blinded to treatment, will adjudicate primary and secondary endpoints, including clinical, radiological, and mycological responses. Once approximately 75% of participants are enrolled, an independent Data Safety Monitoring Board will review the pooled all-cause mortality rate in a blinded fashion to ensure sample size assumptions are reasonable and the study is adequately powered. Should the pooled event differ substantially from expected levels, a sample size adjustment can be made to the trial. The Company is engaged in active dialogues with potential partners and is seeking to finalize a partnership as soon as possible in order to commence the Phase 3 ORALTO trial. MAT2203 Compassionate/Expanded Use Access Program A total of 19 patients with serious/life-threatening invasive fungal infections have been enrolled in the program to date, with others being evaluated. The infections treated include a variety of micro-organisms (including Aspergillus, Mucorales species, Candidiasis, Fusarium and suspected Coccidioides) at multiple sites of infection including brain, bladder/colon, bone, lung, sinus, and skin. The majority of enrolled patients are post-transplant or are undergoing treatment for underlying malignancies. Patients have been enrolled in the Program at prestigious institutions including the University of Michigan, Johns Hopkins, Nationwide Children’s Hospital, City of Hope, Vanderbilt University Medical Center, the National Institutes of Health, Children’s Hospital of Philadelphia, Memorial Sloan Kettering Cancer Center and the University of California, San Diego School of Medicine. Most patients were receiving AmBisome prior to enrollment but developed treatment-limiting nephrotoxicity, and most also required treatment for azole-resistant organisms or had failed azole therapy and had no other treatment options. All patients who transitioned to MAT2203 after developing renal toxicity following treatment with AmBisome experienced a reversal of renal impairment with a return to baseline renal function and no subsequent renal issues. In addition, most patients to date were able to be discharged from the hospital setting and effectively treated at home, supporting the potential significant pharmacoeconomic impact of MAT2203. Eight patients who completed the desired course of treatment with oral MAT2203 had complete clinical resolution of their infection and patients with ongoing treatment continue to experience significant clinical improvement. LNC Platform Updates Internal Oral LNC Oncology Program Conventional docetaxel, a well-known chemotherapeutic agent used in the management of multiple metastatic and unresectable tumors, is only administered intravenously, and is associated with significant side effects and toxicities. LNC’s crystalline structure encapsulates and protects the body from the docetaxel cargo and selectively delivers drug to tumor cells. This markedly reduces the amount of free drug circulated systemically, avoiding one of the primary drivers of toxicity. LNC-docetaxel is an effective targeting vehicle and an efficient delivery platform for oncology applications due to its unique phospholipid composition that allows for targeting and delivering docetaxel to tumor cells that express phosphatidylserine on their surface. In vivo study data reported in November 2023 demonstrated that oral LNC-docetaxel effectively targeted melanoma tumors and was able to reduce tumor sizes to a degree comparable to that of IV-docetaxel with no apparent toxicity. Additional in vivo study data reported in March 2024 corroborated the lack of toxicity in a more comprehensive safety study with a longer treatment duration and higher doses of oral LNC-docetaxel. Healthy mice administered oral LNC-docetaxel at doses more than 8x greater than IV-docetaxel showed no weight loss, versus an average 20% peak weight loss in mice treated with IV-docetaxel. Mice treated with oral LNC-docetaxel maintained their body weight, which was statistically no different than the weight of control mice treated with oral saline. Internal Oral LNC Small Oligonucleotide Inflammation Program In vivo studies documented the successful oral delivery and biological activity of two different LNC-formulated small oligonucleotides targeting inflammatory cytokines IL-17A and TNFα with reductions in tissue cytokine mRNA in both colitis and psoriasis, along with significant reductions in serum TNFα levels in colitis. The LNC-formulated small oligonucleotides evaluated in these studies interfered with cytokine synthesis rather than simply targeting the cytokine itself, which creates additional opportunities for potential future applications of LNC-delivered therapeutics. Corporate Development The Company received notification from the NYSE American LLC that it has regained compliance with the NYSE American LLC continued listing standards by resolving the continued listing deficiency with respect to the low selling price of its common stock as described in Section 1003(f)(v) of the NYSE American Company Guide. 2023 Financial Results Revenue for 2023 was $1.1 million, which was generated from the Company’s research collaborations with BioNTech SE and Genentech Inc. This compares with revenue for 2022 of $3.2 million, which was generated from the Company’s research collaboration with BioNTech SE. Total costs and expenses for 2023 were $24.9 million compared with $27.8 million for 2022. The decrease was primarily due to lower clinical trial expenses and lower professional and consulting fees. Income from selling unused New Jersey net operating losses (NOLs) and research and development tax credits was $0.5 million and $3.5 million for 2023 and 2022, respectively. The net loss for 2023 was $22.9 million, or $0.11 per share, compared with a net loss for 2022 of $21.0 million, or $0.10 per share. Cash, cash equivalents and marketable securities as of December 31, 2023 were $13.8 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 through the third quarter of 2024. 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 or 201-689-8846. 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 . 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 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 Relations Jody Cain Jcain@lhai.com 310-691-7100 [Financial Tables to Follow] Matinas BioPharma Holdings, Inc. Consolidated Balance Sheets (in thousands, except for share data) December 31, 2023 2022 ASSETS: Current assets: Cash and cash equivalents $ 4,787 $ 6,830 Marketable debt securities 8,969 21,933 Restricted cash – security deposit 50 50 Prepaid expenses and other current assets 1,737 5,719 Total current assets 15,543 34,532 Non-current assets: Leasehold improvements and equipment - net 1,923 2,091 Operating lease right-of-use assets - net 3,064 3,613 Finance lease right-of-use assets - net 21 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 9,561 10,287 Total assets $ 25,104 $ 44,819 LIABILITIES AND STOCKHOLDERS’ EQUITY: Current liabilities: Accounts payable $ 514 $ 618 Accrued expenses and other liabilities 1,447 3,099 Operating lease liabilities - current 656 562 Financing lease liabilities - current 5 7 Total current liabilities 2,622 4,286 Non-current liabilities: Deferred tax liability 341 341 Operating lease liabilities - net of current portion 2,877 3,533 Financing lease liabilities - net of current portion 18 22 Total non-current liabilities 3,236 3,896 Total liabilities 5,858 8,182 Stockholders’ equity: Common stock par value $0.0001 per share, 500,000,000 shares authorized at December 31, 2023 and 2022, respectively; 217,264,526 issued and outstanding as of December 31, 2023 and 2022, respectively 22 22 Additional paid-in capital 195,018 190,070 Accumulated deficit (175,573 ) (152,631 ) Accumulated other comprehensive loss (221 ) (824 ) Total stockholders’ equity 19,246 36,637 Total liabilities and stockholders’ equity $ 25,104 $ 44,819 Matinas BioPharma Holdings, Inc. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) For the Year Ended December 31, 2023 2022 Revenue: Contract Revenue $ 1,096 $ 3,188 Costs and Expenses: Research and development 14,489 16,678 General and administrative 10,373 11,100 Total costs and expenses 24,862 27,778 Loss from operations (23,766 ) (24,590 ) Sale of New Jersey net operating loss & tax credits 484 3,491 Other income, net 340 102 Net loss $ (22,942 ) $ (20,997 ) Net loss per share – basic and diluted $ (0.11 ) $ (0.10 ) Weighted average common shares outstanding: Basic and diluted 217,264,526 216,811,439 Other comprehensive gain/(loss), net of tax Unrealized gain/(loss) on securities available-for-sale 603 (679 ) Other comprehensive gain/(loss), net of tax 603 (679 ) Comprehensive loss $ (22,339 ) $ (21,676 )