Bornholm Eye Disease

2024 Outcomes Report demonstrates treatment helps clients get well and stay well, regardless of diagnosis or demographics MIAMI, Oct. 30, 2024 /PRNewswire/ -- A new study reveals that over 52% of individuals entering eating disorder treatment began at or above a normal weight, challenging common misconceptions that people must look underweight to require intervention. Although eating disorders are common, many individuals do not receive the help they need. However, data shows that treatment significantly improves recovery outcomes, helping clients stay well for longer. These important insights are part of the largest longitudinal study on eating disorder treatment outcomes, conducted by Monte Nido, one of the nation's leading eating disorder treatment providers. The study reviewed data from 12,000 participants, and results underscore that eating disorders affect people of all shapes and sizes, and that specialized, client-first programs can have lifesaving, long-lasting benefits. Clients Get Well, Stay Well The long-term impact of eating disorder treatment has proven to be an essential component of the healing process. According to the study: 91% of adults and 94% of adolescents restored weight when needed Clients treated by Monte Nido maintained treatment gains 6-months post-discharge: 81% remained significantly improved in ED symptoms 73% remained significantly improved in depression symptoms 71% remained significantly improved in symptoms of anxiety "We believe that recovery is possible for everyone, and our outcomes study demonstrates that treatment can be effective in helping those with eating disorders live the full life they so deserve," Cassie McLean, Chief Executive Officer of Monte Nido. Co-Occurring Diagnoses Are Common The study shows that 85% of all clients had a co-occurring diagnosis of a mood, anxiety or substance use disorder, obsessive compulsive disorder, and/or posttraumatic stress disorder. A co-occurring diagnosis is a significant marker of the complexity of life with an eating disorder. "By addressing both the eating disorder and co-occurring mental health conditions, providers open sustainable pathways for client's healing," McLean emphasized. 45% of adults and 35.4% of adolescents in residential treatment had PTSD These clients demonstrated significantly higher scores on all measures including measures of eating disorder psychopathology, major depression, anxiety disorders and quality of life These clients experience both clinically and statistically significant decreases in their symptoms from admission to discharge Clients who completed cognitive processing therapy (CPT) sessions showed a significant reduction in PCL-5 scores, dropping from an average of 52.6 to 29, which is below the threshold score of 33, meaning clients no longer met criteria for PTSD at the end of treatment. Eating Disorders Don't Discriminate Despite social and cultural expectations about how those with eating disorders appear, they can and do impact anyone, regardless of gender, sexuality, race, ethnicity, age, socio-economic background and size. Nearly 29 million Americans will experience an eating disorder in their lifetime, and very few will get the care they need, largely due to barriers created by discrimination and weight stigma. "This study has shed light on who is living with eating disorders, and that they are far more complex and diverse than our socially conditioned image of those living with an eating disorder," said McLean. "This data will help expand our cultural understanding of individuals that are struggling with a range of eating disorders, and hopefully help remove some of the stigma that so often goes hand-in-hand with a diagnosis." Size & Weight 52% of people entering treatment were at or above "normal" weight at admission according to the NIH body mass index (BMI) calculator Most clients who were diagnosed with other specified feeding or eating disorder (OSFED) have atypical anorexia nervosa Gender & Sexuality 36% of all clients identified as LGBTQIA+ 63% of LGBTQIA+ adults in residential treatment met criteria for PTSD, compared to 45% cisgender heterosexual adults Age 77.6% of adolescents in residential treatment (average age of 15) had a co-occurring diagnosis, such as a mood disorder, anxiety disorder, or PTSD. 38% reported that someone else in their family has struggled with an eating disorder or disordered eating 75% of these adolescents had their families that were either very or extremely involved in treatment as indicated by regular family therapy and consistent communication with the clinical team Data Shines a Light on ARFID and BED Findings also emphasize the commonality of two lesser-known eating disorders, avoidant/restrictive food intake disorder (ARFID) and binge eating disorder (BED) within the client population. This data is important as certain disorders, like BED, are often misunderstood and misdiagnosed due to an overreliance on BMI as a measure of health. This misconception can lead to inadequate treatment, and even unhelpful guidance from providers. Adults, with an average admission age of 32, had binge eating disorder for 20 years before receiving treatment at Monte Nido, and 14 years before seeking any form of treatment. Clients with BED got better on all measures in all levels of care ARFID, which is characterized by "selective behaviors" or disinterest in food, has historically been difficult to diagnose, explaining why it's sometimes considered a "new" eating disorder. This year, Monte Nido developed the first measuring tool of its kind to help inform ARFID treatment, the Food Flexibility Scale™, which illustrates the levels of food flexibility that clients achieve through treatment. By using the novel food flexibility scale that measures progress across various degrees of variety, volume, and exposure to different food settings, the study indicates significant growth over the course of treatment. Of clients treated for ARFID, 92% of clients reached adequate nutritional intake levels by the end of treatment. Flexible Treatment Modalities Increase Accessibility The study also highlights the importance of flexible treatment options in improving accessibility, particularly through expanded virtual programs. These options allow clients to receive care despite geographic, scheduling, or familial barriers. "Access to flexible, innovative treatment options, especially virtual programs, is a game-changer for clients who might otherwise forgo the care they need," said Molly Perlman, MD, MPH, CEDS-C, Chief Medical Officer of Monte Nido. "By removing obstacles, virtual treatment is transforming how and when individuals seek help, making care more adaptable to real-life demands." Regardless of being in-person or online, data shows that less-intensive but highly structured remote treatment facilitates meaningful recovery among clients. 88% of clients discharged from virtual treatment described their experience as good to excellent Clients discharging from virtual programs with Monte Nido rated their experience with program staff- including clinical directors, primary therapists, dieticians, recovery coaches, their psychiatric and medical providers as excellent on average For more information about Monte Nido or to read the complete study, click here. To inquire about treatment at one of the Monte Nido programs, please visit . About the Monte Nido 2024 Outcomes Report The 2024 Outcomes Report is based on analysis of outcomes from Monte Nido programs nationwide, spanning all levels of care and more than 12,000 clients. Clients who consented to participate in the research study completed a series of clinical questionnaires at select intervals: at admission, upon transfer to a new level of care, and upon discharge from a program. In addition, follow-up data was obtained from consenting clients at specified time points after discharge. About Monte Nido Monte Nido is a national mental health provider committed to eradicating eating disorders by offering industry-leading care to adults and adolescents of all genders in a healing environment. Our clinically comprehensive, research-backed treatment in inpatient, residential, and day and virtual treatment programs show exceptional outcomes. Our clients get well and stay well six months after treatment. Founded in 1996, our expert staff of eating disorder professionals deliver compassionate care, breakthrough outcomes, and long-term recovery for our clients. Monte Nido operates 50 programs and in 28 states virtually across our family of programs: Monte Nido, Monte Nido Walden, Monte Nido Rosewood, and Monte Nido Clementine. Contact: Hannah Miller L.C. Williams & Associates 312-565-3900 [email protected] SOURCE Monte Nido WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

On track to submit NDA in second half 2024 for TNX-102 SL for fibromyalgia; completed successful pre-NDA meetings with FDA in second quarter 2024 FDA granted Fast Track designation for TNX-102 SL for fibromyalgia Commercial planning continues for U.S. launch of TNX-102 SL, a potential new first-line, centrally-acting, non-opioid analgesic for the management of fibromyalgia U.S. Department of Defense contract awarded for up to $34 million over 5 years to develop a broad-spectrum antiviral drug World Health Organization (WHO) recently declared spread of mpox in multiple African countries a public health emergency of international concern – Tonix’s TNX-801 is an mpox vaccine in development which protects animals against lethal challenge of monkeypox virus CHATHAM, N.J., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced financial results for the second quarter ended June 30, 2024, and provided an overview of recent operational highlights. “In the second quarter of 2024, we made significant progress advancing our New Drug Application (NDA) and market access strategy for TNX-102 SL (cyclobenzaprine HCl sublingual tablets),” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “We are working diligently on the regulatory submission and are pleased to have been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) and to be in alignment with the agency regarding the content of our proposed NDA package. Fast Track is designed to facilitate the development and expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need. We are hopeful that TNX-102 SL can be the first new drug to treat fibromyalgia in more than 15 years.” Dr. Lederman continued, “Additionally, we continue to advance other key pipeline candidates through a capital efficient strategy, including TNX-4200, our broad-spectrum antiviral program for which we were awarded up to $34 million over five years from the U.S. Department of Defense (DoD) to advance its development.” Recent Highlights – Key Product Candidates* Central Nervous System (CNS) Pipeline TNX-102 SL (cyclobenzaprine HCl sublingual tablets): a centrally-acting, non-opioid, analgesic taken once-daily at bedtime for the management of fibromyalgia. In July 2024, the FDA granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. The designation validates that fibromyalgia is a serious condition and that TNX-102 SL has the potential to address this unmet medical need. The Company continues to guide for submission of the NDA for TNX-102 SL in the second half of 2024 which would allow for a potential FDA approval in 2025.In July 2024, Tonix announced that, based on the new definition of Long COVID by the U.S. National Academies of Sciences, Engineering and Medicine (NASEM), fibromyalgia is a ‘diagnosable condition’ in people suffering from Long COVID. The Company believes that diagnosing fibromyalgia in Long COVID patients will increase the potential market for TNX-102 SL following approval as compared to market estimates from before the COVID-19 pandemic.During the second quarter, Tonix successfully completed two positive pre-NDA meetings with the FDA for TNX-102 SL for the management of fibromyalgia. The first, with minutes announced in June 2024, was a Type B Chemistry, Manufacturing, and Controls (CMC) meeting to seek alignment and agreement with the FDA on key CMC topics to support the planned NDA submission for TNX-102 SL. Based on formal meeting minutes, the Company believes it is aligned with the FDA on proposed drug substance and drug product commercial specifications, shelf life assignment, manufacturing and commercial drug packaging. At the second pre-NDA meeting announced in July 2024, the Company and the FDA aligned on nonclinical, clinical pharmacology and clinical matters and agreed that the proposed data package is sufficient to support the NDA submission.In June 2024, at the American Society of Clinical Psychopharmacology (ASCP) meeting the Company presented new, additional data on TNX-102 SL, highlighting improvement in depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II) as well as improvements in anxiety, memory and energy items on the Fibromyalgia Impact Questionnaire-Revised (FIQR). Depression was frequent among patients enrolled in the Phase 3 RESILIENT study, as ~47% reported experiencing depression within the past six months upon fibromyalgia diagnosis and ~25% of the intent-to-treat (ITT) population had experienced a lifetime major depressive episode (MDE). However, by Week 14 of the trial, the total BDI-II score in the TNX-102 SL group improved over placebo with a nominal p-value of 0.005 and an effect size of 0.27. On the FIQR, exploratory analyses uncorrected for multiplicity demonstrated improvement in the TNX-102 SL group over placebo in depression (p < 0.001), anxiety (p = 0.001), sensitivity (p = 0.020), memory problems (p = 0.001) and energy (p < 0.001). TNX-102 SL was well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablet under the tongue. Together these findings provide further support that TNX-102 SL has broad-spectrum activity against fibromyalgia symptoms and may improve fibromyalgia at the syndromal level.EVERSANA® Life Science Services, LLC, a leading provider of commercialization services to the global life sciences industry, completed the initial phase of an assessment of the U.S market opportunity for TNX-102 SL. Tonix had previously announced that EVERSANA was selected to support the launch strategy and commercial planning of TNX-102 SL. Specifically, EVERSANA is working with Tonix to assess the fibromyalgia landscape and help plan an efficient go-to-market strategy. EVERSANA conducted primary research, analyzed potential market size, surveyed currently marketed treatment options and their market shares and interviewed physicians for feedback regarding the currently prescribed treatments and their interest in TNX-102 SL as a potential new treatment option. This physician feedback demonstrated high levels of dissatisfaction with currently prescribed drugs, a high unmet need for their fibromyalgia patients, and high levels of interest in TNX-102 SL’s favorable activity and tolerability profile. Further analysis showed that addictive opioids are prescribed more frequently than the currently approved drugs following fibromyalgia diagnosis. Physicians also indicated they would intend to use TNX-102 SL in 40% of their fibromyalgia patients.1 TNX-102 SL for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD) In May 2024, Tonix announced a plan for a Phase 2, investigator-initiated OASIS trial, designed to examine the safety and efficacy of TNX-102 SL in treating Acute Stress Disorder (ASD) after motor vehicle collision. The trial is sponsored by the University of North Carolina Institute for Trauma Recovery and supported by a $3 million contract from the DoD, which was awarded in September 2023. TNX-102 SL will be evaluated for the reduction in severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) in civilians after a motor vehicle collision. Previous trials of TNX-102 SL showed that it reduced military PTSD symptoms within two weeks while evidencing similar favorable tolerability as in fibromyalgia patients.Tonix expects to enroll the first patient in the Phase 2 OASIS trial in the third quarter of 2024. TNX-1300 (recombinant double mutant cocaine esterase): biologic for life-threatening cocaine intoxication Tonix expects to initiate a Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in emergency rooms in the third quarter of 2024. In 2022, Tonix was awarded a Cooperative Agreement grant from the National Institutes of Health (NIH)’s National Institute of Drug Abuse (NIDA) to support development of TNX-1300.TNX-1300 has been granted Breakthrough Therapy designation by the FDA. TNX-1900 (intranasal potentiated oxytocin): small peptide in development through investigator-initiated studies for adolescent obesity, binge eating disorder (BED), bone health in autism and social anxiety disorder (SAD). TNX-1900 continues to be studied in four ongoing investigator-initiated Phase 2 studies. There are three studies at Massachusetts General Hospital: the POWER study for the treatment of adolescent obesity, the STROBE study for the treatment of BED, and the BOX study for the treatment of bone health in pediatric autism. In addition, Tonix is conducting an investigator-initiated study of TNX-1900 for the treatment of SAD at the University of Washington. Rare Disease Pipeline TNX-2900 (intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS) In March 2024, Tonix announced that it received Rare Pediatric Disease designation from the FDA for TNX-2900 for the treatment of PWS. Tonix has an investigational new drug (IND) to support clinical development of TNX-2900 to treat PWS in children and adolescents, including a planned Phase 2, dose-finding study involving approximately 36 PWS patients. TNX-2900 for the treatment of PWS was granted Orphan Drug designation by the FDA in 2022. PWS is a rare genetic disorder which causes cognitive and behavioral symptoms including pathological over-eating in childhood, which leads to severe metabolic sequelae in adolescence and adulthood. Immunology Pipeline TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders. The first proposed indication for TNX-1500 is prophylaxis of organ rejection in adult patients receiving a kidney transplant; but multiple additional indications are possible, including autoimmune diseases. Preclinical studies have shown that TNX-1500 maintains the activity of first-generation monoclonal antibodies (mAbs), yet with reduced risk of thrombotic complications.2-4 Modeling studies from animal pharmacokinetic data2 predict a half-life of greater than three weeks for TNX-1500 in humans, which supports a monthly i.v. dosing regimen5,6. This analysis together with TNX-1500’s activity and tolerability in animals, suggests that the protein engineering of TNX-1500’s Fc region has achieved its design goals.In June 2024, at the American Transplant Congress 2024, Tonix announced data demonstrating the combined use of TNX-1500 and anti-CD28 monoclonal antibody, VEL-101 is associated with durable protection and graft survival and function in a nonhuman primate model. Further data demonstrated that TNX-1500 has promise to prevent rejection of 9-, or 10-gene-edited (GE) pig hearts.7,8 All research has been directed by the faculty of the Center for Transplantation Sciences at Massachusetts General Hospital.Tonix completed the clinical stage of its Phase 1 single ascending dose study of TNX-1500 in healthy volunteers. The primary objectives of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous TNX-1500. This first-in-human study is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients. Infectious Disease Pipeline TNX-4200 (orally available CD45 antagonist), TNX-3900 (cathepsin inhibitor), TNX-4000 (glycan-targeted biologic) Tonix is developing potential broad-spectrum antiviral drugs in three programs: CD45-targeted therapeutics (TNX-4200), cathepsin inhibitors (TNX-3900) and viral glycan-targeted engineered biologics (TNX-4000).In July 2024, the Company announced that the DoD’s Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (OTA). The objective of the contract is to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. The $34 million five-year contract will help fund and accelerate the development of Tonix’s broad-spectrum antiviral program, which has the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. The Company’s program will focus on optimization and development of its TNX-4200 program, to develop an orally available CD45 antagonist, with broad-spectrum efficacy against a range of viral families through preclinical evaluation. The program is expected to establish physicochemical properties, pharmacokinetics, and safety attributes to support an IND submission and to fund a first-in-human Phase 1 clinical study. TNX-801 (recombinant horsepox virus, live vaccine): potential vaccine to protect against mpox disease and smallpox. In June 2024, Tonix announced data at an oral keynote presentation at the Vaccine Congress 2024, detailing the company vaccine platform, including TNX-801 (horsepox, live virus) vaccine for preventing mpox (formerly known as monkeypox). TNX-801 is a live replicating attenuated vaccine based on horsepox that is believed to provide immune protection with better tolerability than modern vaccinia viruses. In the data, Tonix highlighted positive preclinical efficacy, demonstrating that TNX-801 protected non-human primates against lethal challenge with intratracheal Clade 1 monkeypox virus.9 After a single dose vaccination, TNX-801 prevented clinical disease and lesions and also decreased shedding in the mouth and lungs of non-human primates. These findings are consistent with mucosal immunity and suggest the ability to block forward transmission. The WHO determined that the upsurge of mpox in a growing number of countries in Africa constitutes a public health emergency of international concern, the second such declaration in the past two years called in response to transmission of the virus.Mpox is epidemic in Central Africa and experts fear the new Clade 1 strain may spread to the U.S.The company’s Good Manufacturing Practice (GMP)-capable advanced manufacturing facility in Dartmouth, MA was purpose-built to manufacture TNX-801 and the GMP suites are ready to be reactivated in case of a national or international emergency. TNX-1800 (modified recombinant horsepox virus, live vaccine): potential vaccine to protect against COVID-19 designed to express the SARS-CoV-2 spike protein In June 2024, the Company announced preclinical data, demonstrating immunity and tolerability, during an oral keynote talk at the Vaccine Congress 2024.10,11 Like TNX-801, TNX-1800 is a live replicating attenuated vaccine based on horsepox that is believed to provide immune protection with better tolerability than modern vaccinia viruses. TNX-1800 was selected by the NIH’s Project NextGen for inclusion in clinical trials as part of a select group of next generation COVID-19 vaccine candidates with the intent to identify promising vaccine platforms. NIH plans to conduct a Phase 1 trial and cover the full cost, while Tonix provides the vaccine candidate. Marketed Products – Recent Highlights As of April 1, 2024, Tonix completed the transition to becoming a fully integrated biopharmaceutical company. Tonix Pharmaceuticals has implemented personnel, systems and contracts required to support a commercial organization and has assumed responsibility for distribution, selling and marketing of Zembrace SymTouch® and Tosymra®, as well as supply chain, regulatory and quality control of the two products.In June 2024, the Company presented data at the 66th Annual Scientific Meeting of the American Headache Society (AHS) comparing real-world data with real-world usage of non-oral migraine products with the most recent AHS consensus statement. This data stressed the need for customizing treatment of migraine headaches to the needs of patients. Thus far, real world data show that conformity with the guidelines and the consensus statement have yet to be achieved but has the potential to be increased. The data show the use of non-oral drugs for treating an acute migraine attack was only 7% in 2012 and has decreased to below 4% in 2023, when the potential need for such drugs is anticipated to be a more substantial percentage of migraineurs based on epidemiological data. TNX-102 SL has not been approved for any indication. 1EVERSANA primary physician research, May 2024; commissioned by Tonix 2Lassiter G., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.022 3Miura S., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.025 4Anand RP., et al. Nature. 2023:622, 393–401. https://doi.org/10.1038/s41586-023-06594-4 5Deng R., et al. Mabs. 2011. https://doi.org/10.4161/mabs.3.1.13799 6Tonix Pharmaceuticals – Data on File 7Revivicor 9-GE pigs: GalKO.β4GalNT2KO.GHRKO.hCD46.hCD55.hTBM.hEPCR.hCD47.hHO-1 8 Revivicor 10-GE pigs: GalKO.β4GalNT2KO.CMAHKO.GHRKO.hCD46.CD55.hTBM.hEPCR.hCD47.hHO-1. 9Noyce RS, et al. Viruses. 2023;15(2):356. doi:10.3390/v15020356. 10Awasthi M., et al. Viruses. 2023;15(10):2131. doi:10.3390/v15102131. 11Awasthi M., et al. Vaccines (Basel). 2023;11(11):1682. doi:10.3390/vaccines11111682. Recent Highlights – Financial As of June 30, 2024, Tonix had $4.2 million of cash and cash equivalents, compared to $24.9 million as of December 31, 2023. Net cash used in operations was approximately $30.5 million for the six months ended June 30, 2024, compared to $56.3 million for the same period in 2023. Subsequent to the quarter ending June 30, 2024, Tonix received net proceeds of approximately $3.5 million in a securities purchase agreement with certain institutional and retail investors, and sold 0.8 million shares of common stock under the ATM Sales Agreement, for net proceeds of approximately $0.4 million. Second Quarter 2024 Financial Results Net product revenue for the second quarter 2024 was approximately $2.2 million. Net product revenue consisted of combined net sales of Zembrace® SymTouch® and Tosymra®, which were acquired from Upsher-Smith Laboratories, LLC on June 30, 2023. Cost of Sales for the second quarter 2024 was approximately $3.4 million, which included a write-down related to Tosymra and Zembrace finished goods inventory of approximately $1.7 million based on an assessment of inventory on hand and projected sales prior to the respective expiration dates. Research and development expenses for the second quarter 2024 were $9.7 million, compared to $22.0 million for the same period in 2023. This decrease is predominantly due to decreased clinical, non-clinical and manufacturing expenses aligned with the Company’s capital efficient strategy. Selling, general and administrative expenses for the second quarter 2024 were $7.5 million, compared to $7.0 million for the same period in 2023. The increase was primarily due to sales and marketing and the transition services expenses associated with the Company’s recently acquired marketed products offset by a decrease in financial reporting expenses. Net loss available to common stockholders was $78.8 million, or $19.28 per share, basic and diluted, for the second quarter 2024, compared to net loss of $28.4 million, or $49.23 per share, basic and diluted, for the same period in 2023. Included in the net loss for the three months ended June 30, 2024, are non-cash asset impairment charges totaling $58.9 million. The basic and diluted weighted average common shares outstanding for the second quarter 2024 was 4,085,132 compared to 576,047 shares for the same period in 2023. The impairment of the Tosymra and Zembrace inventory, intangibles and goodwill was driven by our delayed investment in the sales personnel required to drive growth in the business as we are focusing our cash resources to further our efforts to bring TNX-102 SL through the FDA approval process and to market. However, we believe that the benefits and long-term value proposition of the 2023 acquisition of Tosymra and Zembrace remain, in that we now have the infrastructure to be ready to manufacture and sell TNX-102 SL under an expedited timeline pending FDA approval for which we expect an FDA decision in 2025. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (OTA) to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD, instrumental in progressing this development. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. *Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at www.tonixpharma.com. Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(In Thousands, Except Share and Per Share Amounts)(unaudited) Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 REVENUE: Product revenue, net $2,208 $— $4,690 $— COSTS AND EXPENSES: Cost of revenue $3,367 $— $5,027 $— Research and development 9,698 21,976 22,561 48,487 Selling, general and administrative 7,502 7,026 16,812 14,417 Asset impairment charges 58,957 — 58,957 — 79,524 29,002 103,357 62,904 Operating loss (77,316) (29,002) (98,667) (62,904) (Loss) gain on change in fair value of warrant liabilities (855) — 6,150 — Other (expense) income, net (605) 646 (1,198) 1,543 Net loss available to common stockholders $(78,776) $(28,356) $(93,715) $(61,361) Net loss per common share, basic and diluted $(19.28) $(49.23) $(27.33) $(107.45) Weighted average common shares outstanding, basic and diluted 4,085,132 576,047 3,428,906 571,089 See the accompanying notes to the condensed consolidated financial statements TONIX PHARMACEUTICALS HOLDING CORP.CONDENSED CONSOLIDATED BALANCE SHEETS (In Thousands)(Unaudited) June 30, 2024 December 31, 20231Assets Cash and cash equivalents$4,156 $24,948 Accounts Receivable, net3,339 - Inventory9,457 13,639 Prepaid expenses and other8,335 9,181 Total current assets25,287 47,768 Other non-current assets45,020 106,689 Total assets$70,307 $154,457 Liabilities and stockholders' equity Total liabilities$28,204 $48,932 Stockholders' equity42,103 105,525 Total liabilities and stockholders' equity$70,307 $154,457 1The condensed consolidated balance sheet for the year ended December 31, 2023 has been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. Investor Contact Jessica MorrisTonix Pharmaceuticalsinvestor.relations@tonixpharma.com (862) 904-8182 Peter VozzoICR Westwickepeter.vozzo@westwicke.com (443) 213-0505 Media Contact Lisa DeScenzaLaVoieHealthScienceldescenza@lavoiehealthscience.com(617) 351-0243

Total 2Q 2024 net product revenue of $87.2 million, representing 87% year-over-year growth Auvelity® 2Q 2024 net product sales of $65.0 million, representing 135% year-over-year growth Sunosi® 2Q 2024 net product revenue of $22.1 million representing 16% year-over-year growth NDA for AXS-07 in migraine resubmitted Topline results of ADVANCE-2 Phase 3 trial of AXS-05 in Alzheimer’s disease agitation anticipated 2H 2024 Topline results of ACCORD-2 Phase 3 randomized withdrawal trial of AXS-05 in Alzheimer's disease agitation anticipated 2H 2024; target enrollment reached Topline results of FOCUS Phase 3 trial of solriamfetol in ADHD anticipated 2H 2024 SUSTAIN Phase 3 trial of solriamfetol in shift work disorder initiated NDA submission for AXS-14 in fibromyalgia expected 3Q 2024 NEW YORK, Aug. 05, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced financial results for the second quarter of 2024. “We delivered another robust quarter driven by focused commercial execution and continued pipeline advancement,” said Herriot Tabuteau, MD, CEO of Axsome Therapeutics. “We continue to see strong demand for Auvelity and increased commercial payer coverage by more than 22 million lives as of August 1st. The NDA for AXS-07 in migraine has been resubmitted, and we are tracking to submit the NDA for AXS-14 in fibromyalgia in the third quarter. Trials in four new indications for solriamfetol are now underway, and we remain on track to deliver topline results from the FOCUS Phase 3 trial in ADHD in the second half of this year. For our AXS-05 program in Alzheimer’s disease agitation, the ADVANCE-2 Phase 3 trial continues to progress, and the ACCORD-2 Phase 3 trial has reached target enrollment, positioning us to potentially report topline results for both of these pivotal trials in the second half of the year.” Second Quarter 2024 Financial Highlights Total net product revenue for the second quarter of 2024 was $87.2 million, representing 87% year-over-year growth. Total net product revenue for the comparable period in 2023 was $46.7 million.Auvelity net product sales were $65.0 million for the second quarter of 2024, representing 135% year-over-year growth. Auvelity net product sales for the comparable period in 2023 were $27.6 million.Sunosi net product revenue was $22.1 million for the second quarter of 2024, consisting of $21.5 million in net product sales and $0.6 million in royalty revenue associated with sales in out-licensed territories, representing 16% year-over-year growth. Sunosi net product revenue for the comparable period in 2023 was $19.1 million, consisting of $18.4 million in net product sales and $0.7 million in royalty revenue.Total cost of revenue was $8.1 million for the second quarter of 2024. Total cost of revenue for the comparable period in 2023 was $4.6 million.Research and development (R&D) expenses were $49.9 million for the second quarter of 2024, compared to $20.6 million for the comparable period in 2023. The increase was primarily related to the initiation and continuation of solriamfetol Phase 3 trials in major depressive disorder, ADHD, and binge eating disorder, ongoing trials of AXS-05 and AXS-12, manufacturing costs associated with AXS-07 and AXS-14, post-marketing commitments for Auvelity and Sunosi, and higher personnel costs, including non-cash stock-based compensation, due to organizational growth.Selling, general, and administrative (SG&A) expenses were $103.6 million for the second quarter of 2024, compared to $78.9 million for the comparable period in 2023. The increase was primarily related to commercialization expenses largely driven by field force expansion and higher personnel costs, including non-cash stock-based compensation, due to organizational growth.Net loss for the second quarter of 2024 was $79.3 million or $(1.67) per share, compared to a net loss of $67.2 million or $(1.54) per share for the comparable period in 2023. The net loss in the second quarter of 2024 reflects $26.0 million in non-cash charges.Cash and cash equivalents totaled $315.7 million at June 30, 2024, compared to $386.2 million at December 31, 2023.Shares of common stock outstanding were 47,801,578 at June 30, 2024. Financial Guidance Axsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan. Commercial Highlights Auvelity Approximately 123,000 prescriptions were written for Auvelity in the second quarter of 2024, representing a 29% sequential increase versus the first quarter of 2024.Payer coverage for Auvelity in the commercial channel increased from 48% of lives covered last quarter to 60% of lives covered as of August 1. The proportion of lives covered in the government channel (Medicare and Medicaid) remains at approximately 100%. Payer coverage for Auvelity across all channels is now at approximately 76% of all covered lives. Axsome expects coverage to continue to expand and evolve. Sunosi Approximately 45,000 prescriptions were written for Sunosi in the U.S. in the second quarter of 2024, representing an 8% increase versus the first quarter of 2024.Sunosi maintains broad payer coverage in the commercial channel with 95% of lives covered. Currently 83% of total lives across all channels are covered. Development Pipeline Axsome is advancing an industry-leading neuroscience pipeline encompassing five innovative, late-stage, patent-protected product candidates for 9 serious psychiatric and neurologic conditions, which affect more than 140 million people in the U.S. alone. Recent and anticipated progress for key pipeline programs is summarized below. AXS-05 AXS-05 (dextromethorphan-bupropion) is Axsome’s novel, oral, investigational NMDA receptor antagonist and sigma-1 agonist being developed for the treatment of Alzheimer’s disease (AD) agitation and smoking cessation. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for AD agitation. Alzheimer’s Disease Agitation: Axsome is conducting the ADVANCE-2 study, a Phase 3, placebo-controlled, parallel group trial evaluating the efficacy and safety of AXS-05 in AD agitation. Patients completing ADVANCE-2 may enter a long-term open label safety extension trial. The Company anticipates topline results from the ADVANCE-2 trial in the second half of 2024.Axsome is also conducting the ACCORD-2 study, a Phase 3, double-blind, placebo-controlled, randomized withdrawal trial evaluating the efficacy and safety of AXS-05 in AD agitation. The enrollment target for the ACCORD-2 trial has been met and the Company now anticipates topline results in the second half of 2024. Smoking Cessation: Axsome plans to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in 2024. AXS-07 AXS-07 (MoSEIC™ meloxicam-rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine being developed for the acute treatment of migraine. Migraine: The Company has resubmitted its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. The Company expects the NDA resubmission to be designated as Class 2, which would be subject to a six-month review.Axsome is conducting the EMERGE study, a multicenter, Phase 3, single-group trial evaluating the efficacy and safety of AXS-07 for the acute treatment of migraine headache in adults with a prior inadequate response to an oral CGRP inhibitor. The Company anticipates topline results from the EMERGE trial in the second half of 2024. AXS-12 AXS-12 (reboxetine) is Axsome’s novel, oral, potent, investigational highly selective norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for narcolepsy. Narcolepsy: Axsome is conducting a Phase 3 open label safety extension trial of AXS-12 with topline results anticipated in the fourth quarter of 2024. AXS-12 has previously met the primary endpoints and demonstrated positive and statistically significant results in the completed SYMPHONY Phase 3 and CONCERT Phase 2 trials in patients with narcolepsy. AXS-14 AXS-14 (esreboxetine) is Axsome’s novel, oral, potent, highly selective investigational norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine. Fibromyalgia: Pre-submission activities for the Company’s NDA for AXS-14 for the management of fibromyalgia are substantially complete. The Company expects to submit the NDA in the third quarter of 2024. AXS-14 has previously met the primary endpoints and demonstrated positive and statistically significant results in a Phase 3 and in a Phase 2 trial for the management of fibromyalgia. Solriamfetol Solriamfetol is Axsome’s dopamine and norepinephrine reuptake inhibitor and TAAR1 agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD). Attention Deficit Hyperactivity Disorder: Axsome is conducting the FOCUS study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol for the treatment of ADHD in adults. The Company anticipates topline results in the second half of 2024.Major Depressive Disorder: Axsome is conducting the PARADIGM study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol for the treatment of MDD. The Company anticipates topline results in 2025.Binge Eating Disorder: Axsome is conducting the ENGAGE study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol for the treatment of BED. The Company anticipates topline results in 2025.Shift Work Disorder: Axsome has initiated the SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol for the treatment of SWD in adults. The Company anticipates topline results in 2026. Business Update In June 2024, Axsome announced that it has resolved patent litigation with Unichem Laboratories Ltd. (Unichem) seeking approval to market a generic equivalent of Sunosi in the United States. The Company entered into a settlement agreement with Unichem Laboratories Ltd., which permits Unichem to begin selling its generic version of Sunosi on June 30, 2042, or earlier under certain circumstances. The June 30, 2042 date is also subject to potential extension for pediatric exclusivity. Anticipated Milestones Regulatory: AXS-14 for fibromyalgia, NDA submission (3Q 2024) Clinical Trial Topline Results: Phase 3 ADVANCE-2 trial of AXS-05 in Alzheimer’s disease agitation (2H 2024)Phase 3 ACCORD-2 trial of AXS-05 in Alzheimer’s disease agitation (2H 2024)Phase 3 open-label safety extension trial of AXS-12 in narcolepsy (2H 2024)Phase 3 FOCUS trial of solriamfetol in ADHD in adults (2H 2024)Phase 3 EMERGE trial of AXS-07 in patients with migraine with inadequate response to oral CGRP inhibitors (2H 2024)Phase 3 PARADIGM trial of solriamfetol in major depressive disorder (2025)Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (2025)Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2026) Clinical Trial Initiations and Progress: Pivotal Phase 2/3 trial of AXS-05 in smoking cessation, initiation (2024) Conference Call Information Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss second quarter 2024 financial results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic). The live webcast can be accessed on the Investors page of the Company’s website at axsome.com. A replay of the webcast will be available for approximately 30 days following the live event. About Axsome Therapeutics, Inc. Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website. 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 continued commercial success of the Company’s Sunosi® and Auvelity® 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; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to the Company’s special protocol assessment for the MOMENTUM clinical trial; 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 continued commercialization of Sunosi and Auvelity 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. Axsome Therapeutics, Inc.Selected Consolidated Financial Data Axsome Therapeutics, Inc.Consolidated Balance Sheets(In thousands, except share and per share amounts) June 30,2024 December 31,2023 (Unaudited) Assets Current assets: Cash and cash equivalents $315,657 $386,193 Accounts receivables, net 120,342 94,820 Inventories, net 15,220 15,135 Prepaid and other current assets 11,808 8,115 Total current assets 463,027 504,263 Equipment, net 724 846 Right-of-use asset - operating lease 6,071 6,772 Goodwill 12,042 12,042 Intangible asset, net 50,107 53,286 Non-current inventory and other assets 16,255 11,027 Total assets $548,226 $588,236 Liabilities and stockholders’ equity Current liabilities: Accounts payable $61,340 $40,679 Accrued expenses and other current liabilities 116,771 90,501 Operating lease liability, current portion 1,419 1,267 Contingent consideration, current 7,040 6,407 Total current liabilities 186,570 138,854 Contingent consideration, non-current 69,620 73,300 Loan payable, long-term 179,330 178,070 Operating lease liability, long-term 6,829 7,035 Finance lease liability, long-term 3,025 — Total liabilities 445,374 397,259 Stockholders’ equity: Preferred stock, $0.0001 par value per share (10,000,000 shares authorized, none issued and outstanding) — — Common stock, $0.0001 par value per share (150,000,000 shares authorized, 47,801,578 and 47,351,363 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively) 5 5 Additional paid-in capital 1,086,120 1,026,543 Accumulated deficit (983,273) (835,571)Total stockholders’ equity 102,852 190,977 Total liabilities and stockholders’ equity $548,226 $588,236 Axsome Therapeutics, Inc.Consolidated Statements of Operations (Unaudited)(In thousands, except share and per share amounts) Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Revenues: Product sales, net $86,520 $46,017 $160,616 $74,586 License revenue — — — 65,735 Royalty revenue 646 683 1,549 955 Total revenues 87,166 46,700 162,165 141,276 Operating expenses: Cost of revenue (excluding amortization and depreciation) 8,055 4,599 14,352 12,155 Research and development 49,853 20,581 86,683 38,374 Selling, general and administrative 103,554 78,935 202,524 153,126 Loss in fair value of contingent consideration 2,160 6,053 748 5,891 Intangible asset amortization 1,590 1,589 3,179 3,161 Total operating expenses 165,212 111,757 307,486 212,707 Loss from operations (78,046) (65,057) (145,321) (71,431)Interest expense, net (1,299) (2,730) (2,381) (4,994)Loss before income taxes (79,345) (67,787) (147,702) (76,425)Income tax benefit (expense) — 617 — (1,963)Net loss $(79,345) $(67,170) $(147,702) $(78,388)Net loss per common share, basic and diluted $(1.67) $(1.54) $(3.11) $(1.80)Weighted average common shares outstanding, basic and diluted 47,573,229 43,669,820 47,482,602 43,597,131 Axsome Contacts:Investors:Mark JacobsonChief Operating OfficerAxsome Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY 10007Tel: 212-332-3243Email: mjacobson@axsome.com www.axsome.com Media:Darren OplandDirector, Corporate CommunicationsAxsome Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY 10007Tel: 929-837-1065Email: dopland@axsome.com www.axsome.com