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Monday, March 30: Phase 1 data on TNX-4800 (long-acting anti-Borrelia OspA human monoclonal antibody) for the seasonal prevention of Lyme disease Wednesday, April 1: Animal and in vitro studies on TNX-801 (horsepox, live virus vaccine) for the prevention of smallpox and mpox Wednesday, April 1: Horsepox as a modular antigen-delivery system for broad and sustained immunity in novel vaccines to protect against other pathogens BERKELEY HEIGHTS, N.J., March 23, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Ho ...

BERKELEY HEIGHTS, N.J., March 18, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced today that Seth Lederman, MD, Chief Executive Officer, will deliver a company presentation at BIO-Europe Spring 2026, being held March 23-25, 2026, in Lisbon, Portugal. Company Presentation Details Date and Time: Tuesday, March 24, 2026, 1:30-1:45 p.m. WETLocation: Presentation Theatre APresenter: Seth Lederm ...

Core Insights - Tonix Pharmaceuticals Holding Corp. announced presentations on its preclinical immuno-oncology portfolio at the AACR Annual Meeting 2026, scheduled for April 17–22, 2026, in San Diego, California [1] Oral Presentation Details - The oral presentation titled "TFF2 deficiency amplifies IL-1β-driven inflammation and promotes aging-associated gastric tumor progression" will take place on April 21, 2026, from 2:30–4:30 p.m. PT [2] - Presenters include Shuang Li, MD, PhD, and Timothy C. Wang, MD, with Tonix co-authors Seth Lederman, MD, and Bruce L. Daugherty, PhD, MBA [2] Poster Presentation Details - The first poster presentation titled "In vitro characterization of fully human antagonistic anti-BTLA monoclonal antibodies" is scheduled for April 21, 2026, from 2:00-5:00 p.m. PT [3] - The second poster presentation titled "Pharmacokinetics of TNX-1700 in non-human primates and human FcRn/serum albumin transgenic mice" will occur on April 22, 2026, from 9:00 a.m.–12:00 p.m. PT [3] - Both presentations will be led by Bruce Daugherty, PhD, MBA [3] About TNX-1700 - TNX-1700 is a fusion protein of TFF2 and albumin, currently in preclinical development for treating gastric and colorectal cancer in combination with PD-1 blockade [4] - The drug is in the pre-Investigational New Drug (IND) stages of development and was in-licensed from Columbia University [4] Company Overview - Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on CNS and immunology treatments for high unmet medical needs [5] - The company’s marketed products include TONMYA for fibromyalgia, Zembrace® Symtouch® for acute migraines, and Tosymra® [5] - Tonix is also investigating TONMYA in Phase 2 clinical trials for major depressive disorder and acute stress disorder, and has a pipeline including TNX-2900 for Prader-Willi syndrome and monoclonal antibodies for Lyme disease prophylaxis and kidney transplant rejection [5]

Core Viewpoint - Tonix Pharmaceuticals Holding Corp. reported significant developments in its product pipeline and financial results for the fourth quarter and full year, leading to a rise in share prices during premarket trading [1]. Financial Performance - The company reported a fourth-quarter loss of $3.98 per share, which was worse than the consensus loss estimate of $3.16. However, sales reached $5.39 million, exceeding the consensus estimate of $2.88 million [2]. - As of December 31, 2025, Tonix Pharmaceuticals had approximately $207.6 million in cash and cash equivalents, which is expected to support operations into the first quarter of 2027 [4]. Product Pipeline and Market Engagement - Since the launch of Tonmya (cyclobenzaprine HCl sublingual tablets) in November 2025, over 1,500 healthcare providers have prescribed the drug, with approximately 2,500 patients initiating treatment and cumulative prescriptions totaling around 4,200 [2][3]. - The U.S. FDA approved Tonmya for fibromyalgia in adults in August 2025, marking it as the first new prescription medicine approved for this indication in over 15 years. The company is focusing on expanding payer engagement and establishing contracts with commercial payers while progressing discussions with Medicare and Medicaid [3]. Technical Analysis - Tonix Pharmaceuticals is currently trading 5.2% below its 20-day simple moving average (SMA) and 18.7% below its 100-day SMA, indicating a bearish trend in the short to medium term. Over the past 12 months, shares have decreased by 1.69% [5]. - The Relative Strength Index (RSI) is at 36.03, indicating neutral territory, while the MACD is at -0.6454, suggesting a potential for upward momentum as it is above the signal line [6]. Market Position - The Benzinga Edge scorecard indicates that Tonix Pharmaceuticals has a weak momentum score of 10.4, suggesting that the stock is underperforming relative to the broader market [7]. - During premarket trading, Tonix Pharmaceuticals shares were up 1.12% at $13.56 [8]. Key resistance is identified at $14.50, while key support is at $12.80 [9].

TONIX PHARMACEUTICALS HOLDING CORP Exhibit 99.01 Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights TONMYA™ (cyclobenzaprine HCl sublingual tablets) launched November 17, 2025, for the treatment of fibromyalgia; through February 27, 2026, more than 1,500 healthcare providers have prescribed TONMYA to patients, approximately 2,500 patients have initiated treatment with TONMYA, and cumulative prescriptions totaled approximately 4,200 Expect to initiate ...

Core Insights - Tonix Pharmaceuticals achieved FDA approval and launched TONMYA, the first new medicine for fibromyalgia in over 15 years, with over 1,500 healthcare providers prescribing it to approximately 2,500 patients by February 27, 2026 [2][4] - The company reported a net product revenue of approximately $13.1 million for the full year 2025, an increase from $10.1 million in 2024, with TONMYA contributing approximately $1.4 million from its launch until year-end [17][19] - Tonix has a robust clinical pipeline, including TNX-4800 for Lyme disease prevention and TNX-102 SL for major depressive disorder, with plans for further development and FDA discussions in 2026 [2][6][9] Commercial Updates - TONMYA was launched on November 17, 2025, and has shown favorable early prescription trends, with cumulative prescriptions totaling approximately 4,200 by February 27, 2026 [4][3] - The company has deployed a salesforce of approximately 90 members to support the commercialization of TONMYA and enhance awareness among healthcare providers and patients [2][4] Financial Highlights - As of December 31, 2025, Tonix had approximately $207.6 million in cash and cash equivalents, a significant increase from $98.8 million in 2024 [13][30] - The company completed a $20.0 million registered direct offering with Point72 in December 2025 to fund commercialization and pipeline development [14] - Research and development expenses for 2025 were approximately $44.5 million, reflecting increased investment in pipeline projects [18] Product Pipeline - TNX-4800, a long-acting monoclonal antibody for Lyme disease prevention, is set for FDA discussions regarding Phase 2/3 development in 2026 [6][9] - TNX-102 SL has received IND clearance for a Phase 2 study in major depressive disorder, with enrollment expected to begin in mid-2026 [9][12] - TNX-2900, targeting Prader-Willi syndrome, is planned for a Phase 2 trial initiation in Q1 2027 [11] Operational Highlights - The company has established partnerships for distribution and patient access programs to facilitate the commercialization of TONMYA [8] - Tonix is focusing on expanding payer engagement and establishing contracts with commercial payers while progressing discussions with Medicare and Medicaid [8]

Drug Approvals and Launches - TONMYA received FDA approval for the treatment of fibromyalgia in adults on August 15, 2025, and was launched on November 17, 2025[16]. - Tonix received FDA approval for TONMYA (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia, marking the first new treatment in over 15 years[70]. - The company launched TONMYA in the U.S. on November 17, 2025, which addresses core symptoms of fibromyalgia including pain, disturbed sleep, and fatigue[70]. Clinical Development Pipeline - The company has a diversified pipeline with multiple programs in clinical and preclinical development, including TNX-102 SL for major depressive disorder, which is expected to enter Phase 2 in mid-2026[19]. - TNX-1500, aimed at preventing kidney transplant rejection, is Phase 2-ready with a study expected to start in mid-2026[20]. - The company plans to initiate a Phase 2 study for TNX-2900, targeting Prader-Willi syndrome, in Q1 2027[21]. - TNX-1300, for cocaine intoxication, is currently in Phase 2 and has received Breakthrough Therapy designation from the FDA[20]. - TNX-1900 is being developed for binge eating disorder, adolescent obesity, and other CNS disorders through investigator-initiated studies at Massachusetts General Hospital[36]. - TNX-4800, a long-acting monoclonal antibody for Lyme disease, showed 95% effectiveness in preventing infection after 6 days of exposure to infected ticks; plans for Phase 2 studies are set for 2026 and 2028[39][40]. - TNX-2900, for Prader-Willi syndrome, received Orphan-Drug Designation and IND clearance in late 2023, with a Phase 2 study planned to begin in Q1 2027[48][49]. - TNX-102 SL is expected to enter Phase 2 for MDD in mid-2026, with a pivotal study enrolling approximately 360 patients across 30 U.S. sites[86]. - The OASIS trial, funded by a $3 million DoD grant, aims to investigate TNX-102 SL's efficacy in reducing adverse effects of acute trauma[88]. Market Strategy and Commercialization - The company aims to commercialize TONMYA for fibromyalgia, launched in November 2025, with approximately 90 U.S. sales representatives promoting it to healthcare providers[52]. - The company has established commercial operations and is focused on expanding TONMYA's market presence through lifecycle management strategies[27]. - The commercialization strategy for TONMYA includes a targeted sales approach with approximately 90 field sales representatives as of December 31, 2025[138]. - Tonix has implemented a market access strategy to support patient access to TONMYA across key payer segments, including commercial plans and government programs[141]. Intellectual Property and Patent Strategy - Tonix is pursuing a broad intellectual property strategy to protect its product candidates, including patents for TONMYA's composition and methods of use[55]. - The patent portfolio includes 45 issued U.S. patents and 46 issued non-U.S. patents as of March 5, 2026, with additional applications in progress[160]. - The company is actively pursuing 22 U.S. non-provisional patent applications and 238 non-U.S./non-PCT patent applications to strengthen its intellectual property position[160]. - TNX-102 SL has received U.S. market exclusivity for PTSD treatment until 2030, based on U.S. Patent No. 9,918,948[172]. - TNX-102 SL has European market exclusivity for depression treatment until March 2032, as per European patent 2,683,245[180]. Competitive Landscape - The U.S. fibromyalgia market has seen the introduction of TONMYA, the first new treatment in over 15 years, approved in August 2025, targeting non-restorative sleep[145]. - As of 2026, the U.S. fibromyalgia therapeutic landscape includes four FDA-approved treatments, with the first three being pregabalin, duloxetine, and milnacipran, which have been the standard of care since 2007-2009[145]. - Axsome Therapeutics initiated a Phase 3 trial of AXS-14 for fibromyalgia management in January 2026, indicating ongoing competition in the sector[146]. - The competitive landscape for migraine treatments has expanded with the FDA approval of Axsome Therapeutics' Symbravo and Satsuma Pharmaceuticals' Atzumi in 2025, highlighting increased innovation[148]. Research and Development Facilities - The company operates a 48,000 square foot RDC in Frederick, Maryland, and a 45,000 square foot ADC in Dartmouth, Massachusetts, for research and manufacturing of vaccines and biologics[50]. - The Advanced Development Center in Dartmouth, MA, is equipped for GMP production of live-virus vaccines and biologics, ready for reactivation by 2027 or in case of emergencies[132]. Specific Drug Developments - TNX-1300 is a recombinant protein enzyme that catalyzes the breakdown of cocaine, offering a targeted approach to cocaine intoxication management[102]. - TNX-801 is a potential smallpox and mpox vaccine with improved tolerability and efficacy compared to existing vaccines, requiring only a single dose for durable protection[121][122]. - TNX-4900, a selective S1R antagonist, has shown significant analgesic activity in preclinical models, with a Ki of 7.5 nM and oral bioavailability of approximately 28%[129]. - TNX-1700 has shown efficacy in preclinical studies for gastric and colorectal cancers, demonstrating tumor reduction and increased survival rates[116].

Tonix Pharmaceuticals Conference Call Summary Company Overview - **Company**: Tonix Pharmaceuticals (NasdaqCM: TNXP) - **Focus**: Development and commercialization of pharmaceutical products, particularly for fibromyalgia and Lyme disease Key Points on Fibromyalgia Treatment - **Product Launch**: Tonmya, a sublingual cyclobenzaprine, launched on November 17, 2025, is the first new treatment for fibromyalgia in over 15 years [4][5] - **Commercial Transition**: The company has transitioned to a commercial stage over the past two and a half years, acquiring two migraine products to establish its commercial infrastructure [4][5][6] - **Sales Force**: Approximately 90 representatives are actively promoting Tonmya, utilizing omnichannel strategies to connect with healthcare providers [5][6] - **Physician Feedback**: Early anecdotal feedback from physicians indicates positive patient results, with no significant negative surprises reported [9][10] - **Prescriber Demographics**: Prescribers include 30% rheumatologists, 30% primary care physicians, and others from pain management and neurology specialties [10][11] - **Market Positioning**: Tonmya is being positioned as a first-line monotherapy for fibromyalgia, with a focus on patients who may cycle through various treatments due to limited benefits of existing drugs [13][14] Access and Reimbursement - **Payer Coverage**: The company is actively engaging with payers to secure coverage, emphasizing the importance of maintaining reasonable rebates to ensure profitability [20][21] - **Market Dynamics**: The three major payers control over 90% of the market, and the company is hopeful that the value proposition of a non-opioid analgesic will be recognized [22] Key Metrics for Launch Success - **Metrics Monitored**: Total prescriptions, new prescriptions, and the number of unique prescribers are key metrics being tracked to assess the launch's success [23][24] - **Growth Pattern**: The company describes its growth as linear rather than exponential at this stage, with ongoing efforts to increase prescription rates [24][25] Lyme Disease Program - **Product Overview**: The Lyme disease program involves a long-acting monoclonal antibody designed to prevent Lyme disease, with an expected duration of protection from spring to fall [27][28] - **Target**: The antibody targets the OspA protein on Borrelia, the bacteria causing Lyme disease, and is distinct from vaccines as it provides passive immunity [30][31] - **Market Demand**: An estimated 70 million Americans live in Lyme endemic areas, with 500,000 cases reported annually, indicating a significant potential demand for preventative therapy [33] Investor Insights - **Underestimated Aspects**: Investors may not fully appreciate the significance of the launch of Tonmya and the potential of the Lyme disease program, as well as the company's financial position with $208 million in cash and a one-year runway for launch efforts [34][35] Conclusion - **Future Outlook**: The company is optimistic about its growth trajectory and the potential impact of its products on underserved patient populations, particularly in fibromyalgia and Lyme disease [34][35]

Company launched TONMYA, approved by the FDA as a treatment for fibromyalgia, in November 2025 In post hoc analysis of the pivotal RESILIENT study, TONMYA produced rapid pain relief as early as Day 2 of treatment, with durable pain reduction and significant improvements in all key secondary endpoints as compared to placebo In pooled post hoc analysis of the pivotal RELIEF and RELISIENT studies, TONMYA showed favorable benefit-risk profile using number needed to treat, number needed to harm, and likelihood t ...