Post Acute COVID 19 Syndrome

CHATHAM, N.J., March 28, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced it has entered into a securities purchase agreement with existing healthcare focused institutional investors of the Company for the purchase and sale of 14,666,666 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 14,666,666 shares of common stock in a registered direct offering at a combined offering price of $0.30 per share and accompanying warrant. The warrants have an exercise price of $0.33 per share, will be exercisable commencing six months from the date of issuance and will expire five and one-half years following the date of issuance. The closing of the offering is expected to take place on or about April 1, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds of the offering will be approximately $4.4 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, as well as for the satisfaction of a portion of the Company’s debt. A.G.P./Alliance Global Partners is acting as sole placement agent for the offering. In connection with this offering, the Company has also agreed that certain existing warrants issued in August 2023 to purchase up to an aggregate of 6,950,000 shares at an exercise price of $1.00 per share and a termination date of August 2028, will be amended, so that the amended warrants will have a reduced exercise price of $0.33 per share and a termination date of April 2029. The company has further agreed that certain existing warrants issued in October 2023 to purchase up to an aggregate of approximately 17,800,000 shares with an exercise price of $0.50 per share and termination dates ranging from October 2024 to October 2028, will be amended, so that the amended warrants will have a reduced exercise price of $0.33 per share and a termination date of April 2025 and April 2029, respectively. The company has further agreed that certain existing Series C and Series D warrants issued in December 2023 to purchase up to an aggregate of 69,647,856 shares with respective exercise prices ranging from $0.55 to $0.85 per share and termination dates ranging from December 2025 to December 2028, will be amended, so that the amended warrants will have a reduced exercise price of $0.33 per share and a termination date equal to the earlier of April 2026 and 10 trading days following notice by the Company to the warrant holder of the Company’s public announcement of the U.S. Food and Drug Administration’s acknowledgement and acceptance of the Company’s new drug application relating to TNX-102 SL in patients with Fibromyalgia for the Series C warrants and April 2029 for the Series D warrants. All of the amendments to the August 2023, October 2023 and December 2023 warrants are subject to shareholder approval, if shareholder approval is not received on or before the six-month anniversary of the closing of this offering, such existing warrants will have an exercise price equal to the Nasdaq minimum price on the six-month anniversary of the closing of this offering. The other terms of such warrants will remain unchanged. This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). A prospectus supplement describing the terms of the proposed Offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at prospectus@allianceg.com. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Tonix Pharmaceuticals Holding Corp.* Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with 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 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. Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia. 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 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statement that are predictive in nature. 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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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. Investor ContactJessica MorrisTonix Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182 Peter VozzoICR Westwickepeter.vozzo@westwicke.com(443) 213-0505 Media ContactBen ShannonICR Westwickeben.shannon@westwicke.com(919) 360-3039

WARREN, N.J., March 28, 2024 (GLOBE NEWSWIRE) -- Tevogen Bio Holdings ('Tevogen Bio') (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech pioneer developing off-the-shelf, genetically unmodified T cell therapeutics in virology, oncology, and neurology, has entered into a securities purchase agreement with an existing investor pursuant to which the investor agreed to purchase shares of newly designated Series A-1 Preferred Stock of the Company in lieu of Series A Preferred Stock that the investor earlier agreed to purchase, for an aggregate purchase price of $6.0 million. “Tevogen Bio’s precision T cell platform, ExacTcell, and its AI initiative have the potential to develop much-needed new class of off-the-shelf cell therapies to address the unmet need for large patient populations in Long COVID, oncology, virology, and neurology. The company’s highly cost-efficient business model and rapid progress since inception in 2020 are unprecedented and reinforce our confidence in the leadership's deep understanding of the biopharma market,” commented the prominent physician and investor Dr. Manmohan Patel, MD. “Our continued support and decision to increase the conversion price by sixty percent of the current equity investment is a reflection of our confidence in Tevogen’s highly promising commercial success,” added Dr. Patel. “We’re fortunate to have a long-term investment partner who shares the business acumen that sustainability and commercial success in the forthcoming era of medicine will rely on ensuring patient accessibility through advanced science, and innovative business models,” remarked the founder and CEO Dr. Ryan Saadi, MD, MPH, Tevogen Bio. The shares of Series A-1 Preferred Stock will be issued in the first quarter and will be convertible at a conversion price of $10.00, as opposed to the $4.00 conversion price of the Series A Preferred Stock, into a total of 600,000 shares of the Company’s common stock at the election of the holder. The Series A-1 Preferred Stock is subject to a call right providing the Company the right to call the stock if the volume weighted average price of the common stock for the 20 days prior to delivery of the call notice is greater than $5.00 per share and there is an effective resale registration statement on file covering the underlying common stock. The Series A-1 Preferred Stock is non-voting, has no mandatory redemption, carries an annual 5% cumulative dividend, increasing by 2% each year, with a cap of 12% per year. About Tevogen Bio Tevogen Bio is a clinical-stage specialty immunotherapy company harnessing one of nature’s most powerful immunological weapons, CD8+ cytotoxic T lymphocytes, to develop off-the-shelf, genetically unmodified precision T cell therapies for the treatment of infectious diseases, cancers, and neurological disorders, aiming to address the significant unmet needs of large patient populations. Tevogen Leadership believes that sustainability and commercial success in the current era of healthcare rely on ensuring patient accessibility through advanced science and innovative business models. Tevogen has reported positive safety data from its proof-of-concept clinical trial, and its key intellectual property assets are wholly owned by the company, not subject to any third-party licensing agreements. These assets include three granted patents and twelve pending patents, two of which are related to artificial intelligence. Tevogen Bio is driven by a team of highly experienced industry leaders and distinguished scientists with drug development and global product launch experience. Tevogen Bio’s leadership believes that accessible personalized therapeutics are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation. Forward Looking Statements This press release contains certain forward-looking statements, including without limitation statements relating to: expectations regarding the healthcare and biopharmaceutical industries; Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases, cancer and neurological disorders, including TVGN 489 for the treatment of COVID-19 and Long COVID; Tevogen’s ability to develop additional product candidates, including through use of Tevogen’s ExacTcell platform; the anticipated benefits of ExacTcell; expectations regarding Tevogen’s future clinical trials; Tevogen’s manufacturing plans; and Tevogen’s ability to generate revenue in the future. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “possible,” “potential,” “goal,” “opportunity,” “project,” “believe,” “future,” and similar words and expressions or their opposites. These statements are based on management’s expectations, assumptions, estimates, projections and beliefs as of the date of this presentation and are subject to a number of factors that involve known and unknown risks, delays, uncertainties and other factors not under the company’s control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements. These factors include, but are not limited to: (i) the effect of the recent business combination with Semper Paratus Acquisition Corporation (the “Business Combination”) on Tevogen’s business relationships, operating results, and business generally; (ii) the outcome of any legal proceedings that may be instituted against Tevogen related to the Business Combination; (iii) changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; (iv) changes in domestic and global general economic conditions; (v) the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; (vi) the risk that Tevogen may not be able to develop and maintain effective internal controls; (vii) costs related to the Business Combination and the failure to realize anticipated benefits of the Business Combination; (viii) the failure to achieve Tevogen’s commercialization and development plans, and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen to grow and manage growth economically and hire and retain key employees; (ix) the risk that Tevogen may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; (x) the ability to develop, license or acquire new therapeutics; (xi) that Tevogen will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (xii) the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; (xiii) uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; (xiv) risks related to regulatory review, and approval and commercial development; (xv) risks associated with intellectual property protection; (xvi) Tevogen’s limited operating history; and (xvii) those factors discussed in Tevogen’s filings with the SEC and that that are contained in the Proxy Statement/Prospectus relating to the Business Combination. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Tevogen undertakes no obligation to update any forward-looking statements, except as required by applicable law. Contacts Tevogen Bio CommunicationsT: 1 877 TEVOGEN, Ext 701 Communications@Tevogen.com

A new bioluminescence imaging technique has created highly detailed, and visually striking, images of the movement of oxygen in the brains of mice. The method, which can be easily replicated by other labs, will enable researchers to more precisely study forms of hypoxia in the brain, such as the denial of oxygen to the brain that occurs during a stroke or heart attack. The new research tool is already providing insight into why a sedentary lifestyle may increase risk for diseases like Alzheimer's. The human brain consumes vast amounts of energy, which is almost exclusively generated from a form of metabolism that requires oxygen. While the efficient and timely delivery of oxygen is known to be critical to healthy brain function, the precise mechanics of this process have largely remained hidden from scientists. A new bioluminescence imaging technique, described today in the journal Science, has created highly detailed, and visually striking, images of the movement of oxygen in the brains of mice. The method, which can be easily replicated by other labs, will enable researchers to more precisely study forms of hypoxia in the brain, such as the denial of oxygen to the brain that occurs during a stroke or heart attack. The new research tool is already providing insight into why a sedentary lifestyle may increase risk for diseases like Alzheimer's. "This research demonstrates that we can monitor changes in oxygen concentration continuously and in a wide area of the brain," said Maiken Nedergaard, co-director of the Center for Translational Neuromedicine (CTN), which is based at both the University of Rochester and the University of Copenhagen. "This provides us a with a more detailed picture of what is occurring in the brain in real time, allowing us to identify previously undetected areas of temporary hypoxia, which reflect changes in blood flow that can trigger neurological deficits." Fireflies and serendipitous science The new method employs luminescent proteins, chemical cousins of the bioluminescent proteins found in fireflies. These proteins, which have been used in cancer research, employs a virus that delivers instructions to cells to produce a luminescent protein in the form of an enzyme. When the enzyme encounters a second chemical compound, a substrate called furimazine, the chemical reaction generates light. Like many important scientific discoveries, employing this process to image oxygen in the brain was stumbled upon by accident. Felix Beinlich, PhD, an assistant professor in the CTN at the University of Copenhagen, had originally intended to use the luminescent protein to measure calcium activity in the brain. It became apparent that there was an error in the production of the proteins, causing a months-long delay in the research. While Beinlich waited for a new batch from the manufacturer, he decided move forward with the experiments to test and optimize the monitoring systems. The virus was used to deliver enzyme-producing instructions to astrocytes, ubiquitous support cells in the brain that maintain the health and signaling functions of neurons, and the substrate was injected into the brain via a craniotomy. The recordings revealed activity, identified by a fluctuating intensity of bioluminescence, something that the researchers suspected, and would later confirm, reflected the presence and concentration of oxygen. "The chemical reaction in this instance was oxygen dependent, so when there is the enzyme, the substrate, and oxygen, the system starts to glow," said Beinlich. While existing oxygen monitoring techniques provide information about a very small area of the brain, the researchers were able to observe, in real time, a large section of the cortex of the mice. The intensity of the bioluminescence corresponded with the concentration of oxygen, which the researchers demonstrated by changing the amount of oxygen in the air the animals were breathing. Changes in light intensity also corresponded with sensory processing. For example, when the mice's whiskers were stimulated with a puff of air, the researchers could see the corresponding region of the brain light up. "Hypoxic pockets" could point to Alzheimer's risk The brain cannot survive long without oxygen, a concept demonstrated by the neurological damage that quickly follows a stroke or heart attack. But what happens when very small parts of the brain are denied oxygen for brief periods? This question was not even being asked by researchers until the team in the Nedergaard lab began to look closely at the new recordings. While monitoring the mice, the researchers observed that specific tiny areas of the brain would go dark, sometimes for minutes, meaning that the oxygen supply was being cut off. Oxygen is circulated throughout the brain via a vast network of arteries and smaller capillaries-or microvessels-which permeate brain tissue. Through a series of experiments, the researchers were able to determine that oxygen was being denied due to capillary stalling, which occurs when white blood cells temporarily block microvessels and prevent the passage of oxygen carrying red blood cells. These areas, which the researchers named "hypoxic pockets," were more prevalent in the brains of mice during a resting state, compared to when the animals were active. Capillary stalling is believed to increase with age and has been observed in models of Alzheimer's disease. "The door is now open to study a range of diseases associated with hypoxia in the brain, including Alzheimer's, vascular dementia, and long COVID, and how a sedentary lifestyle, aging, hypertension, and other factors contribute to these diseases," said Nedergaard. "It also provides a tool to test different drugs and types of exercise that improve vascular health and slow down the road to dementia." Additional authors include Hajime Hirase with the University of Rochester, Antonios Asiminas, Verena Untiet, Zuzanna Bojarowska, Virginia Plá, and Björn Sigurdsson with the University of Copenhagen, and Vincenzo Timmel, Lukas Gehrig, and Michael H. Graber with the University of Applied Sciences and Arts Northwestern Switzerland. The study was supported with funding from the National Institute of Neurological Disorders and Stroke, the Dr. Miriam and Sheldon G. Adelson Medical Research Foundation, the Novo Nordisk Foundation, the Lundbeck Foundation, Independent Research Fund Denmark, and the US Army Research Office.