Congenital Bone Marrow Failure Syndromes

By acquiring The Sleep Center of Nevada, Vivos expands its business model to make its OSA treatments available to thousands of patients in the greater Las Vegas metro area Acquisition expected to close later this quarter or in the third quarter LITTLETON, Colo., April 16, 2025 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company”) (NASDAQ: VVOS), a leader in proprietary, non-invasive treatments for obstructive sleep apnea (OSA), today announced a definitive agreement to acquire the operating assets of The Sleep Center of Nevada (“SCN”), the largest operator of medical sleep centers in Nevada. Significant Vivos investor New Seneca Partners, Inc., a leading North American private equity sponsor, assisted in sourcing, structuring and executing this transaction. The acquisition is expected to close in the later this quarter or in the third quarter, subject to financing, audit and other customary conditions. The proposed transaction does not require Vivos shareholder approval. Vivos’ acquisition of the profitable and high patient volume SCN accelerates Vivos’ new marketing and distribution model following its June 2024 strategic alliance with Colorado-based sleep center operator Rebis Health. Vivos’ new model is designed to introduce Vivos’ FDA-cleared oral appliance treatments for OSA more directly to the very large and growing population of patients who suffer from OSA. Many of these patients are looking for lasting solutions for their OSA but are typically forced to choose between unappealing treatment options such as continuous positive airway pressure (CPAP) or surgery or abandoning treatment altogether. The acquisition aligns with Vivos’ mission to make its clinically proven treatments accessible to the millions of individuals who suffer with OSA. By leveraging SCN’s infrastructure and patient base, Vivos expects to enhance case acceptance, diversify services, and strengthen its market position in a fast-growing region. Founded in 2008 by Dr. Prabhu Rachakonda, a board-certified physician in internal medicine, pulmonology, and sleep medicine, SCN is the top sleep center operator in Nevada, serving the sleep testing and treatment referral needs of OSA patients. SCN sees approximately 3,000 new patients per month for testing, consultation, and treatment of conditions like OSA, insomnia and restless leg syndrome and has generated annual net revenues in the high seven figure range in recent years. About 90% of SCN patients test positive for OSA and/or other sleep disorders and yet, 95% of those patients are typically referred out for CPAP, traditional oral devices or surgical options, highlighting a critical need for alternatives like Vivos’ oral appliances. Since 2019, SCN’s physicians and nurse practitioners have tested and treated over 200,000 patients, many of whom have either stopped using CPAP or are looking for OSA treatment alternatives. Under Dr. Rachakonda’s leadership, SCN has grown to seven locations with nearly 50 beds currently available for overnight polysomnogram (PSG) testing and consultation. Vivos has agreed to pay up to $9 million for the SCN operating assets, including $6 million in cash and $1.5 million in Vivos common stock at closing. An additional $1.5 million in Vivos common stock may be earned in the future if SCN achieves an agreed to financial milestone. Vivos intends to secure the funding for the upfront cash payment primarily with a senior debt facility and also potential equity financing. Kirk Huntsman, Chairman and CEO of Vivos stated, “We believe this transaction will be a game-changer for Vivos, with the prospect of meaningfully adding to our revenues in the coming months through SCN’s diagnostic and other services as well as adding thousands of patients as candidates for Vivos OSA treatment. SCN has a dominant market share for OSA detection and treatment in the fast-growing Las Vegas region. We anticipate SCN patients will prefer Vivos treatment options over a lifelong maintenance device such as CPAP. Through our existing strategic alliance with Rebis Health in Colorado, we are seeing two-thirds of OSA patients selecting Vivos treatment over CPAP or surgical options. We will be working closely with Dr. Rachakonda and his team to expand the range of diagnostic and therapeutic services to patients, which we expect will materially impact revenue and gross profits even further. This transaction represents a great example of our initiative to extend Vivos’ technology and treatment options to as many OSA patients as possible by creating strategic collaborations with, or outright acquisitions of, key players in the approximately 2,600 AASM-certified sleep clinics around the country. We look forward to closing this transaction as we also continue to explore further expansions of our marketing and sales model.” Michael Skaff, Managing Director of New Seneca Partners, stated “As an investor in and strategic advisor to Vivos, we are very excited about this transaction and its potential to materially expand and further validate the ongoing strategic shift in Vivos’ business model. Moreover, we believe SCN’s existing revenues will be meaningfully augmented in several important ways, such as the expansion of diagnostic and consultative services and the sale of Vivos OSA treatment to SCN patients, all of which we expect to significantly reduce Vivos’ cash burn and move Vivos towards cash flow positivity. The SCN transaction and similar potential future strategic transactions can provide Vivos with access to the significant potential patient volume which is critical to executing on the new business model. We look forward to continuing our full support of this transaction through the financing, closing and post-closing integration phases.” Dr. Rachakonda commented on what this transaction will mean for SCN’s patients, “Sleep medicine has been waiting for many years for an alternative treatment for OSA that works to resolve the condition over a relatively short treatment time with potentially lasting effects. After looking carefully into Vivos’ appliance treatments, I believe the vast majority of our patients will choose Vivos over CPAP or other alternatives that they struggle with. We look forward to closing this transaction as we are eager to bring Vivos’ effective portfolio of OSA treatments options to our community.” Dr. Tara Rachakonda, also a board certified sleep specialist at SCN and the daughter of Dr. Prabhu Rachakonda, said “As a sleep specialist and parent of a child with sleep apnea, I’m particularly excited to expand our pediatric services with Vivos’ FDA-cleared DNA appliance treatment for children ages 6 to 17. Simply put, this transaction opens significant new growth opportunities for our practice and better care options for our patients.” Additional details will be disclosed in a Current Report on Form 8-K to be filed with the U.S. Securities and Exchange Commission. About Vivos Therapeutics Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as obstructive sleep apnea (OSA) and snoring in adults. Vivos’ devices have been cleared by the U.S. Food and Drug Administration (FDA) for adult patients diagnosed with all severity levels of OSA and moderate-to-severe OSA in children ages 6 to 17. Vivos’ groundbreaking CARE devices are the only FDA 510(k) cleared technology for treating severe OSA in adults and the first to receive clearance for treating moderate to severe OSA in children. Obstructive sleep apnea (OSA) affects over 1 billion people worldwide, yet 90% remain undiagnosed and unaware of their condition. This chronic disorder is not just a sleep issue—it’s closely linked to many serious chronic health conditions. While the medical community has made strides in treating sleep disorders, breathing and sleep health remain areas that are still not fully understood. As a result, solutions are often mechanistic and fail to address the root causes of OSA. Vivos Therapeutics, founded in 2016 and based in Littleton, CO, is changing this. Through innovative technology, education, and partnerships with dentists, functional medicine doctors, and sleep specialists, Vivos is empowering healthcare providers to more thoroughly address the complex needs of patients. The Vivos Method offers a proprietary, clinically effective solution that is nonsurgical, noninvasive, and nonpharmaceutical, providing hope to allow patients to Breathe New Life. For more information, visit www.vivos.com. Cautionary Note Regarding Forward-Looking Statements This press release, including statements of the Company’s management and other parties made herein, contain “forward-looking statements” (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events. Words such as “may”, “would”, “should”, “expects”, “projects,” “potential,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates”, “goal”. “aim” and variations of such words and similar expressions are intended to identify forward-looking statements. In this press release, forward-looking statements include, without limitation, those relating to (i) the timing for closing of the SCN acquisition (which remains subject to key conditions such as financing), (ii) the actual future impact of the SCN acquisition on Vivos’ future revenues and results of operations and (ii) the anticipated benefits and potential expansion of Vivos’ marketing and distribution model as described herein. These statements involve significant known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Readers are cautioned that actual results may differ materially and adversely from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to: (i) the risk that Vivos may be unable to finance the cash portion of the acquisition purchase price on favorable terms, if at all, or otherwise, (ii) the risk that Vivos may be unable to successfully integrate SCN’s business into its own or otherwise implement sales, marketing and other strategies that increase revenues, (iii) the risk that some patients may not achieve the desired results from using Vivos’ products, (iv) risks associated with regulatory scrutiny of and adverse publicity in the sleep apnea diagnosis and treatment sector; (v) the risk that Vivos may be unable to secure additional financing beyond that which is needed to acquire SCN on reasonable terms when needed, if at all, or maintain its Nasdaq listing, (vi) market and other conditions that could impact Vivos’ business or ability to obtain financing, and (vii) other risk factors described in Vivos’ filings with the Securities and Exchange Commission (“SEC”). Vivos’ filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, Vivos expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Vivos’ expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based. Media Inquiries: Karla Jo Helms JOTO PR™ 727-777-4629 jotopr.com

Late-breaking oral presentation of results from the positive pivotal ACCORD-2 Phase 3 trial of AXS-05 in Alzheimer’s disease agitation Presentation featuring network meta-analysis of SYMBRAVO® versus oral CGRPs NEW YORK, April 04, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced multiple presentations spanning its innovative, industry-leading psychiatry and neurology portfolio at the 2025 American Academy of Neurology (AAN) Annual Meeting, being held April 5-9 in San Diego, California. Oral and poster presentations include data from the positive pivotal ACCORD-2 Phase 3 trial of AXS-05 in Alzheimer’s disease (AD) agitation, accepted as a late-breaking abstract, and from the positive pivotal SYMPHONY Phase 3 trial of AXS-12 in narcolepsy. Additional data being presented includes a network meta-analysis comparing the efficacy of SYMBRAVO® (AXS-07) to oral CGRPs in the acute treatment of migraine. Details for the presentations are as follows: Alzheimer’s Disease Agitation Title: Efficacy and Safety of AXS-05 in Alzheimer's Disease Agitation: A Phase 3 Randomized Withdrawal Double-Blind Placebo-Controlled Study Oral Presentation Date and Time: Monday, April 7, 11:27 - 11:33 a.m. PT Poster Presentation Date and Time: Monday, April 7, 12:09 - 12:45 p.m. PT Session Name: Late-breaking Science 1 Poster Number: 3 Abstract: 246 Narcolepsy Title: AXS-12 for the Treatment of Narcolepsy: Topline Results from the Phase 3 SYMPHONY Trial Oral Presentation Date and Time: Tuesday, April 8, 10:45 - 11 a.m. PT Lead Author: Michael J. Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY Session Name: Clinical Trials Plenary Session Program Number: PL5 Title: CRESCENDO: Results from a Survey of Symptom Burden and Quality of Life in Patients with Narcolepsy Type 1 Poster Presentation Date and Time: Tuesday, April 8, 8 - 9 a.m. PT Lead Author: Michael J. Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY Session Name: Sleep 2 Program Number: P8:001 Migraine Title: Comparative Efficacy of AXS-07 vs. Gepants for Acute Treatment of Migraine: A Network Meta-Analysis Poster Presentation Date and Time: Tuesday, April 8, 5 - 6 p.m. PT Lead Author: Stephanie Nahas, MD, Associate Professor of Neurology at the Thomas Jefferson University Hospitals-Jefferson Health Center, Philadelphia, PA Session Name: Headache: Advances in CGRP Inhibitors and Migraine 3 Program Number: P10.006 About SYMBRAVO SYMBRAVO is a novel, oral, single-dose medicine approved for the acute treatment of migraine with or without aura in adults. SYMBRAVO consists of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which enables the rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug (NSAID) and rizatriptan is a 5-HT1B/1D agonist. SYMBRAVO is designed to provide rapid, enhanced, and consistent migraine pain relief, and reduced symptom recurrence. The exact mechanism of action of SYMBRAVO in the treatment of acute migraine is unknown. For more information, visit www.symbravo.com. INDICATION AND IMPORTANT SAFETY INFORMATION What is SYMBRAVO (sim-BRAH-voh)? SYMBRAVO is a combination of meloxicam (an NSAID) and rizatriptan (a triptan). SYMBRAVO is an oral prescription medicine used to treat acute migraine headaches with or without aura in adults. SYMBRAVO is not used to prevent or decrease the number of migraine headaches you have or for treatment of hemiplegic or basilar migraines. SYMBRAVO is not indicated as a treatment for cluster headaches or for use in children. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SYMBRAVO? SYMBRAVO may increase the risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase with increasing doses, and longer use, of NSAIDs. Do not take SYMBRAVO right before or after a heart surgery called a “coronary artery bypass graft” (CABG). Avoid taking SYMBRAVO after a recent heart attack unless your healthcare provider (HCP) tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Stop taking SYMBRAVO and get emergency help right away if you have any of the following symptoms which can be indicative of a heart attack or stroke: discomfort in your chest that lasts for more than a few minutes, or that goes away and comes back breaking out in a cold sweat nausea or vomiting feeling lightheaded severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw weakness in one part or one side of your body pain or discomfort in your arms, back, neck, jaw, or stomach slurred speech shortness of breath with or without chest discomfort People with risk factors for heart disease should not take SYMBRAVO unless a heart exam is done and shows no problem. You have higher risk for heart disease if you: have high blood pressure smoke have high cholesterol are overweight have diabetes or a family history of diabetes SYMBRAVO can increase the risk of potentially life-threatening bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach, and intestines that can occur anytime during use and without warning symptoms. SYMBRAVO may cause serious allergic or skin reactions which can be life-threatening. Stop taking SYMBRAVO and get emergency help right away if you develop: sudden wheezing or problems breathing or swallowing blisters or bleeding of your lips, eye lids, mouth, nose, or genitals rash or reddening of your skin with blisters or peeling swelling of your lips, tongue, throat or body fainting SYMBRAVO already contains an NSAID (meloxicam). Do not use SYMBRAVO with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking to your HCP first, because they may contain an NSAID also. Do not take SYMBRAVO if you: have or had heart problems or right before or after heart bypass surgery have or had a stroke or transient ischemic attack (TIA) take an antidepressant medicine called monoamine oxidase inhibitor (MAOI) or have taken a MAOI within the last 2 weeks have or had blood vessel problems of your legs and arms, stomach (ischemic bowel disease), or kidneys are allergic to meloxicam, rizatriptan, NSAIDs, or any of the ingredients in SYMBRAVO have or had hemiplegic or basilar migraines have uncontrolled high blood pressure have had an asthma attack, hives, or other allergic reaction after taking aspirin or any other NSAIDs take propranolol containing medicines have taken other triptan or ergot-containing medicines within the last 24 hours have moderate to severe kidney problems and are at risk of kidney failure or if you are on dialysis SYMBRAVO may cause serious side effects. These serious side effects include: heartbeats that are too fast or too slow (arrhythmias) liver or kidney problems including organ failure new or worse high blood pressure low red blood cell count (anemia) heart failure life-threatening skin reactions asthma attacks in people who have asthma Medication Overuse Headaches: Some people who use too many SYMBRAVO tablets may have worse headaches. If your headaches get worse, your HCP may decide to stop your treatment with SYMBRAVO. Stop taking SYMBRAVO and get emergency help right away if you have any of the following: Stomach and intestinal problems. Symptoms of gastrointestinal and colonic ischemic events may include sudden or severe stomach pains even after meals; sudden weight loss; severe nausea, vomiting, constipation, diarrhea; and bloody diarrhea. Circulation problems to legs and feet. Symptoms of peripheral vascular ischemia may include cramping and pain in your legs and hips; heaviness or tightness in leg muscles; burning, aching, numbness, tingling, or weakness in your legs, feet, or toes; cold feelings or color changes in one or both legs or feet. Serotonin syndrome. Can happen when taking SYMBRAVO with antidepressant medicines called SSRIs or SNRIs. Stop taking SYMBRAVO and call your doctor right away if you have any of the following symptoms: mental status changes including agitation, hallucinations, or coma fast heartbeat changes in your blood pressure increased body temperature tight muscles trouble walking mental status changes including agitation, hallucinations, or coma fast heartbeat changes in your blood pressure increased body temperature tight muscles trouble walking Stop taking SYMBRAVO and call your healthcare provider right away if you have any of the following symptoms: nausea vomiting blood more tired or weaker than usual blood in your bowel movement or it is black and sticky like tar diarrhea itching, skin rash, or blisters with fever unusual weight gain your skin or eyes look yellow indigestion or stomach pain swelling of the arms, legs, hands, or feet flu-like symptoms tenderness in your right upper side vision problems COMMON SIDE EFFECTS The most common side effects of SYMBRAVO include dizziness and tiredness. These are not all the possible side effects of SYMBRAVO. Tell your doctor if you have any side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088. BEFORE USING Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is important to tell your HCP if you are taking: Propranolol containing medicines such as Inderal® LA or Innopran® XL Aspirin or other anti-coagulants (blood thinners) Medicines to help your mood including SSRIs and SNRIs If you are unsure if you take any of these medicines, ask your HCP. They can tell you if it is safe to take SYMBRAVO with your other medicines. Tell your HCP if you are pregnant or plan to become pregnant. SYMBRAVO is not recommended during pregnancy. Taking NSAIDs, including SYMBRAVO, at about 20 weeks of pregnancy or later may harm your unborn baby. NSAIDs, including SYMBRAVO, should not be taken after about 30 weeks of pregnancy. Tell your HCP if you are breastfeeding or plan to breastfeed. Propranolol containing medicines such as Inderal® LA or Innopran® XL Aspirin or other anti-coagulants (blood thinners) Medicines to help your mood including SSRIs and SNRIs Tell your HCP about all your medical conditions, including if you: have or have had heart problems, high blood pressure, chest pain, or shortness of breath have any risk factors for heart or blood vessel problems have kidney or liver problems have asthma Review the list below with your HCP. SYMBRAVO may not be right for you if: take daily preventative aspirin you are pregnant or plan to become pregnant you are breastfeeding or plan to breastfeed HOW TO TAKE SYMBRAVO is available by prescription only. Take SYMBRAVO exactly as instructed by your HCP. The maximum daily dose of SYMBRAVO is 1 tablet. Talk to your HCP about what to do if your headache does not go away or comes back. Take SYMBRAVO for the shortest time needed. Swallow SYMBRAVO tablets whole. Do not crush, chew, or divide the tablets. SYMBRAVO can be taken with or without food. Do not give SYMBRAVO to other people. If you take too much SYMBRAVO call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away. LEARN MORE For more information about SYMBRAVO, call 866-496-2976 or visit SYMBRAVO.com. This summary provides basic information about SYMBRAVO but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about SYMBRAVO and how to take it. Your HCP is the best person to help you decide if SYMBRAVO is right for you. SYM CON BS 01/2025 Please see full Prescribing Information, including Boxed Warning for risk of serious cardiovascular and gastrointestinal adverse events, and Medication Guide. About AXS-05 AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor under development for the treatment of Alzheimer’s disease (AD) agitation and smoking cessation. AXS-05 utilizes a proprietary formulation and dose of dextromethorphan and bupropion, and Axsome’s metabolic inhibition technology, to modulate the delivery of the components. The dextromethorphan component of AXS-05 is an uncompetitive NMDA receptor antagonist, also known as a glutamate receptor modulator, and a sigma-1 receptor agonist. The bupropion component of AXS-05 serves to increase the bioavailability of dextromethorphan and is a norepinephrine and dopamine reuptake inhibitor. AXS-05 is covered by a robust patent estate extending out to at least 2043. AXS-05 was granted U.S. FDA Breakthrough Therapy designation for the treatment of Alzheimer’s disease agitation in June 2020. About AXS-12 AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator under development for the treatment of narcolepsy. AXS-12 is thought to modulate noradrenergic activity to promote maintain tone during wakefulness, and noradrenergic and cortical dopamine signaling to promote wakefulness and enhance cognition. AXS-12 has been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation for the treatment of narcolepsy. AXS-12 is covered by issued patents providing protection to at least 2039. AXS-12 is an investigational drug product not approved by the FDA. About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit the Company’s website at www.axsome.com. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s Sunosi®, Auvelity®, and Symbravo® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of Sunosi, Auvelity, and Symbravo and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance. Investors: Mark Jacobson Chief Operating Officer (212) 332-3243 mjacobson@axsome.com Media: Darren Opland Director, Corporate Communications (929) 837-1065 dopland@axsome.com Source: Axsome Therapeutics, Inc.

MNV-201 is Minovia’s second generation mitochondrial cell therapy product composed of autologous hematopoietic stem cells enriched with allogeneic mitochondria Rare Pediatric Designation granted MNV-201 is also being studied in a Phase Ib for low-risk Myelodysplastic Syndrome; Preliminary clinical data demonstrate safety and efficacy HAIFA, Israel, April 03, 2025 (GLOBE NEWSWIRE) -- Minovia Therapeutics Ltd, a clinical stage biopharmaceutical company advancing mitochondrial therapies for primary and secondary mitochondrial diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its second Investigational New Drug (IND) application for MNV-201, an autologous hematopoietic stem cell product augmented with allogeneic mitochondria. The IND supports the initiation of a Phase II clinical trial of MNV-201 in pediatric patients with Pearson Syndrome, a primary mitochondrial disease. Based on previous clinical experience from the 1st generation product, MNV-101 (autologous hematopoietic stem cell product augmented with syngeneic maternal mitochondria), Minovia designed this phase II study with change in growth (height SDS) as primary endpoint. According to the natural history study recently published by Dr. Rebecca Ganetzky from CHOP, all patients with Pearson Syndrome suffer from failure to thrive and do not respond to growth hormone. Natural history shows an annual reduction of 0.5 units in height SDS, while MNV-101 treated patients showed stabilization or improvement, with no decline of height SDS at the 6 and 12 month follow up time points in a comparable subset of patients. This change in growth correlated with an improved International Pediatric Mitochondrial Disease Scale (IPMDS), which measures how the patient feels and functions (R2=0.9; p=0.0036). Linear growth was also suggested as an objective and clinically meaningful endpoint for a pivotal trial in Pearson by the FDA in early interactions. “The FDA’s clearance of our IND marks an important achievement for Minovia, allowing us to clinically evaluate our allogeneic mitochondrial cell therapy approach and proceed with the Phase II clinical program for this first-in-class allogeneic mitochondrial therapy for Pearson Syndrome patients,” said Natalie Yivgi Ohana, PhD, CEO of Minovia. “We are pleased to have safely dosed three Pearson patients enrolled in an ongoing study under the Israeli Ministry of Health. We look forward to treating additional patients under this IND, as well as to learning about the potential of MNV-201 to improve growth in this patient population.” “We are pleased that our cumulative interactions with the FDA enabled alignment on requirements for the entire MNV-201 program, including preclinical, CMC, and clinical aspects,” said Noa Sher, PhD, CSO of Minovia. “Early clinical and regulatory experience with MNV-101 shaped the current program and enabled a successful IND submission.” The Phase II clinical trial is an open-label, single dose study to evaluate the safety and efficacy of MNV-201 in pediatric subjects diagnosed with Pearson Syndrome. The trial will also enable assessment of efficacy in improving growth and quality of life. The study is expected to enroll three additional patients up to a total of 6 patients. For more information visit clinicaltirals.gov About MNV-201MNV-201 is an autologous hematopoietic stem cell product enriched with allogeneic mitochondria. MNV-201 aims to restore mitochondrial function in patient hematopoietic stem cells, resulting in improved differentiation and function. Preclinical research suggests the potential for safe dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for MNV-201 therapy. About Pearson SyndromePearson Syndrome is a multisystem progressive pediatric mitochondrial disease caused by single large-scale mitochondrial deletions (SLSMDS) of mitochondrial DNA (mtDNA), with consequent defects in the mitochondrial respiratory chain function. Pearson Syndrome classically presents in the first year of life with bone marrow failure and exocrine pancreatic dysfunction. Patients have macrocytic sideroblastic anemia that is frequently transfusion-dependent and may be accompanied by thrombocytopenia and neutropenia. Pancreatic dysfunction occurs secondary to fibrosis and leads to chronic diarrhea, malabsorption, and failure to thrive. Pearson Syndrome is marked by accumulating organ system involvement and worsening disease: variable other organ involvement can occur, including renal tubulopathy, liver cholestasis and/or fibrosis, adrenal insufficiency, diabetes mellitus, cardiomegaly, and/or cardiac conduction defects. Pearson Syndrome is universally fatal and since there is no effective therapy, the diagnosis of Pearson Syndrome is one of the worst diagnoses that a caregiver must deliver to parents of an affected infant. MNV-201 aims to reduce disease-associated symptoms and the risk of disease progression and death, thereby improving both lifespan and quality of life. About Minovia TherapeuticsMinovia Therapeutics Ltd. is a clinical stage biotechnology company advancing mitochondrial therapies for primary-genetic and age-related mitochondrial diseases. Minovia's clinical stage product candidate, MNV-201, is composed of mobilized peripheral blood, autologous CD34+ cells enriched with allogeneic, cryopreserved placental derived mitochondria, produced by Minovia's proprietary Mitochondrial Augmentation Technology (MAT). The enrichment of hematopoietic stem cells with healthy and functional mitochondria aims to restore stem cells function of patients suffering mitochondrial dysfunction, caused both by mtDNA mutations or deletions in pediatric patients suffering from primary mitochondrial diseases, or in adults with age-related diseases. MNV-201 is currently in clinical studies for pediatric patients with single-large scale mtDNA deletion syndromes (Pearson Syndrome and Kearn Sayre Syndrome) with five patients successfully dosed; and in Low Risk Myelodysplastic Syndrome. For more information, please visit www.minoviatx.com or follow the Company LinkedIn. Contact Information: Natalie Yivgi Ohana, Co-Founder and CEO Phone: +972-74-7039954 Email: info@minoviatx.com