Core Insights - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is currently viewed as a promising investment opportunity based on recent observations [1] Company Overview - The company has been under close observation for a significant period, indicating a potential shift in market dynamics that could favor its stock performance [1] Market Context - The investment landscape has been influenced by various historical events, including the dot com bubble, the credit default crisis of 2008, and the recent AI boom, suggesting that the company operates in a volatile yet potentially lucrative environment [1]

Core Insights - TNX-102 SL is a sublingual formulation of cyclobenzaprine aimed at treating fibromyalgia, with an FDA PDUFA goal date of August 15, 2025, potentially becoming the first new non-opioid analgesic for fibromyalgia in over 15 years [1][7] - The drug has shown statistically significant improvement in reducing fibromyalgia pain in two Phase 3 studies, demonstrating durable activity over 14 weeks [2][3] - TNX-102 SL targets sleep disturbances associated with fibromyalgia and has a favorable tolerability profile, acting as a potent antagonist at four post-synaptic receptors [3][6] Company Overview - Tonix Pharmaceuticals is a biotechnology company focused on developing therapies for pain management and CNS disorders, with TNX-102 SL as a priority product candidate for fibromyalgia [7] - The company has submitted a New Drug Application (NDA) for TNX-102 SL based on positive Phase 3 study results and has received Fast Track designation from the FDA [7] - Tonix also has a diverse development portfolio, including treatments for acute stress reactions, organ transplant rejection, and infectious diseases [7] Industry Context - Fibromyalgia affects over 10 million adults in the U.S., primarily women, and is characterized by chronic pain, non-restorative sleep, and cognitive dysfunction [4] - Current treatment options are often unsatisfactory, leading many patients to rely on chronic opioids, which carry risks of addiction and overdose [2][4] - TNX-102 SL's unique formulation aims to provide a new therapeutic option that addresses both pain and sleep disturbances without the risks associated with opioids [2][6]

Group 1 - Tonix Pharmaceuticals is a clinical-stage biotechnology firm focused on developing TNX-102 SL, a compound aimed at improving sleep quality in fibromyalgia patients [1] - The FDA is currently reviewing TNX-102 SL, with a Prescription Drug User Fee Act (PDUFA) date set for August 15, 2025 [1] - The company aims to bridge the gap between scientific advancements and financial strategies in the healthcare sector, assisting clients in uncovering hidden value and assessing risks [1]

Core Insights - Tonix Pharmaceuticals has appointed James "Jim" Hunter to its Board of Directors, effective June 12, 2025, to strengthen its commercial strategy and governance as it prepares for the potential launch of TNX-102 SL for fibromyalgia later this year [1][2][4] Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges, with a development portfolio centered on central nervous system (CNS) disorders [5] - The company is advancing TNX-102 SL, a product candidate for fibromyalgia management, with a New Drug Application (NDA) submitted based on two statistically significant Phase 3 studies, and a PDUFA goal date of August 15, 2025, for marketing authorization [5] Leadership and Experience - Jim Hunter has over 40 years of experience in the biopharmaceutical industry, having held leadership roles at Validus Pharmaceuticals, Relialab, and Novartis, and was instrumental in launching Tonix Medicines and entering the migraine market [1][3] - As Executive Vice President of Commercial Operations at Tonix, Hunter managed all aspects of the company's commercial efforts, including sales, marketing, and market access initiatives [2][4] Product Development and Pipeline - Tonix's immunology development portfolio includes biologics targeting organ transplant rejection, autoimmunity, and cancer, such as TNX-1500, an Fc-modified humanized monoclonal antibody [6] - The infectious disease portfolio features TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million over five years with the U.S. Department of Defense [6] Commercial Strategy - Tonix Medicines, the commercial subsidiary, markets Zembrace SymTouch and Tosymra for the treatment of acute migraines, and is actively involved in pre-launch activities for TNX-102 SL, including launch strategy and market analysis [2][5][6]

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully integrated biotechnology company focused on pain management therapies and vaccines for public health challenges [3] - The company has a development portfolio primarily targeting central nervous system (CNS) disorders [3] Key Product Candidates - TNX-102 SL is a product candidate for fibromyalgia management, with an NDA submitted based on two statistically significant Phase 3 studies, and a PDUFA goal date of August 15, 2025 [3] - TNX-102 SL has received Fast Track designation from the FDA for fibromyalgia management [3] - The company is also developing TNX-102 SL for acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina [3] Immunology and Infectious Disease Portfolio - Tonix's immunology portfolio includes TNX-1500, an Fc-modified humanized monoclonal antibody targeting CD40-ligand for preventing allograft rejection and treating autoimmune diseases [3] - The infectious disease portfolio features TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million over five years with the U.S. Department of Defense [3] Commercial Products - Tonix Medicines, the commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray) for treating acute migraine in adults [3]

Core Insights - Tonix Pharmaceuticals Holding Corp. is set to present a poster at the Annual European Congress of Rheumatology (EULAR) 2025, focusing on its product candidate TNX-102 SL for fibromyalgia treatment [1][3] Company Overview - Tonix is a fully-integrated biotechnology company with a focus on pain management therapies and vaccines for public health challenges [4] - The company is advancing TNX-102 SL, which has a PDUFA goal date of August 15, 2025, for marketing authorization based on two significant Phase 3 studies [4] - TNX-102 SL has received Fast Track designation from the FDA for fibromyalgia management [4] - The company is also developing TNX-102 SL for acute stress reaction and acute stress disorder under a study funded by the U.S. Department of Defense [4] Product Development - Tonix's immunology portfolio includes TNX-1500, a monoclonal antibody targeting CD40-ligand for preventing organ transplant rejection and treating autoimmune diseases [4] - The infectious disease portfolio features TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million from the U.S. DoD [4] Marketed Products - Tonix Medicines, the commercial subsidiary, markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment [4]

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company focused on pain management therapies and vaccines for public health challenges [2] - The company has a development portfolio primarily targeting central nervous system (CNS) disorders [2] Product Development - Tonix's lead product candidate, TNX-102 SL, is aimed at managing fibromyalgia, with an NDA submitted based on two statistically significant Phase 3 studies [2] - The FDA has assigned a PDUFA goal date of August 15, 2025, for a decision on marketing authorization for TNX-102 SL, which has also received Fast Track designation [2] - TNX-102 SL is additionally being developed for acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina [2] Immunology and Infectious Disease Portfolio - The immunology portfolio includes TNX-1500, a monoclonal antibody targeting CD40-ligand for preventing allograft rejection and treating autoimmune diseases [2] - The infectious disease portfolio features TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million over five years with the U.S. Department of Defense [2] Commercial Products - Tonix Medicines, the commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) for treating acute migraine in adults [2][5]

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully integrated biotechnology company focused on developing therapies for pain management and vaccines for public health challenges [8] - The company is advancing TNX-102 SL, a product candidate for managing fibromyalgia, with a New Drug Application (NDA) submitted based on two statistically significant Phase 3 studies [8] - TNX-102 SL has received Fast Track designation from the FDA for the management of fibromyalgia and is also being developed for acute stress reaction and acute stress disorder [8] Clinical Trial Details - The OASIS trial, an investigator-initiated Phase 2 trial, aims to evaluate TNX-102 SL's potential to reduce the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) [2][3] - The trial is sponsored by the University of North Carolina (UNC) and supported by a $3 million grant from the U.S. Department of Defense [2][3] - Approximately 180 motor vehicle collision (MVC) trauma survivors will be enrolled in the trial, which will randomize participants to receive either TNX-102 SL 5.6 mg or a placebo for two weeks [3] Market Need and Background - There is a significant unmet need for treating ASR after traumatic events, with about 60% of men and 50% of women in the U.S. experiencing at least one trauma in their lives [5] - One-third of emergency department visits in the U.S. (40-50 million patients per year) involve evaluations after trauma exposures [5] - Currently, no medication is available to treat the initial reaction to traumatic events and support long-term health, which could prevent the development or worsening of ASD and PTSD [5] Drug Mechanism and Composition - TNX-102 SL is a non-opioid investigational drug designed for chronic use, formulated as a sublingual tablet of cyclobenzaprine hydrochloride for bedtime dosing [6][7] - The formulation aims to improve sleep quality and manage fibromyalgia symptoms by targeting non-restorative sleep [6][7] - Patents for TNX-102 SL's formulation provide market protection until 2034, with successful maintenance of its European Patent [7] Research Initiatives - The OASIS trial builds upon the knowledge and infrastructure from the UNC-led AURORA initiative, a $40 million national research effort to improve understanding and recovery from traumatic events [4] - AURORA is supported by funding from the National Institutes of Health (NIH) and partnerships with leading tech companies [4]

Core Viewpoint - The appointment of Joseph Hand as General Counsel and Executive Vice President of Operations at Tonix Pharmaceuticals is a strategic move as the company prepares for the potential approval of TNX-102 SL for fibromyalgia management next quarter [1][2]. Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on developing therapies for pain management and vaccines for public health challenges, with a particular emphasis on central nervous system (CNS) disorders [3]. - The company is advancing TNX-102 SL, a product candidate for fibromyalgia management, for which a New Drug Application (NDA) has been submitted based on two statistically significant Phase 3 studies [3]. - The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing authorization for TNX-102 SL, which has also received Fast Track designation [3]. Leadership Experience - Joseph Hand brings over 20 years of strategic legal and business leadership experience in the biopharmaceutical industry, including nearly a decade at Celgene Corporation, where he held senior executive positions [1][2]. - At Celgene, Mr. Hand was involved in significant transactions, including the $74 billion acquisition by Bristol Myers Squibb and the $13.4 billion divestiture of Otezla to Amgen [2]. Strategic Importance - The addition of Mr. Hand is seen as crucial for driving company growth and operational excellence at a pivotal time in Tonix's history, particularly as it prepares for the launch of TNX-102 SL [2]. - The company aims to position itself for long-term growth while delivering meaningful therapies to patients [3]. Development Portfolio - Tonix's development portfolio includes biologics targeting organ transplant rejection, autoimmunity, and cancer, such as TNX-1500, an Fc-modified humanized monoclonal antibody [3]. - The company is also developing a vaccine for mpox, TNX-801, and has secured a contract with the U.S. Department of Defense for up to $34 million over five years to develop TNX-4200, a broad-spectrum antiviral agent [3].

[Executive Summary & Operational Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Operational%20Highlights) [First Quarter 2025 Highlights](index=1&type=section&id=First%20Quarter%202025%20Financial%20Results%20and%20Operational%20Highlights) Tonix Pharmaceuticals reported key operational advancements including a PDUFA goal date for TNX-102 SL for fibromyalgia, positive Phase 1 results for TNX-1500, and a strong cash position of **$131.7 million**, sufficient to fund operations into **Q2 2026** - FDA PDUFA goal date of **August 15, 2025**, for TNX-102 SL for the management of fibromyalgia; if approved, it would be the **first new drug** for treating fibromyalgia in over **15** years[1](index=1&type=chunk) - Announced **positive topline results** from Phase 1 study of TNX-1500, a next-generation anti-CD40L mAb candidate for prevention of kidney transplant rejection and treatment of autoimmune disorders[1](index=1&type=chunk) Cash and Cash Equivalents Summary | Metric | As of March 31, 2025 | | :----- | :------------------- | | Cash and cash equivalents | $131.7 million | - Current cash is **sufficient to fund operations into the second quarter of 2026**[1](index=1&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) The CEO highlighted the progress of TNX-102 SL towards its PDUFA date and anticipated Q4 launch, emphasizing its potential as a new non-opioid therapeutic option for fibromyalgia. He also expressed encouragement regarding pipeline achievements, including TNX-1500 and TNX-801 - TNX-102 SL is on track for a new therapeutic option for fibromyalgia, with an FDA PDUFA goal date of **August 15, 2025**, and commercial team building for an anticipated **Q4 launch**[2](index=2&type=chunk) - Encouraged by continued achievements in the pipeline, including **positive Phase 1 results for TNX-1500** and **preclinical results for TNX-801**[2](index=2&type=chunk) [Key Investigational Product Candidates - Recent Highlights](index=1&type=section&id=Key%20Investigational%20Product%20Candidates*%20--%20Recent%20Highlights) [Central Nervous System (CNS) Pipeline](index=1&type=section&id=Central%20Nervous%20System%20(CNS)%20Pipeline) The CNS pipeline focuses on TNX-102 SL for fibromyalgia and acute stress disorders, and TNX-1300 for cocaine intoxication, with significant regulatory milestones and ongoing studies [TNX-102 SL (Fibromyalgia)](index=1&type=section&id=TNX-102%20SL%20(cyclobenzaprine%20HCl%20sublingual%20tablets)%3A%205.6%20mg%2C%20once-daily%20at%20bedtime%20small%20molecule%20for%20the%20management%20of%20fibromyalgia%20(FM)) - FDA will **not require an Advisory Committee meeting** to discuss the NDA for TNX-102 SL for fibromyalgia[4](index=4&type=chunk) - FDA previously granted **Fast Track designation** to TNX-102 SL for fibromyalgia in **2024**[4](index=4&type=chunk) - NDA for TNX-102 SL for fibromyalgia was accepted by FDA in **December 2024** with a PDUFA goal date of **August 15, 2025**[4](index=4&type=chunk) - Presented data and analyses of TNX-102 SL treatment and effects on fibromyalgia at the American Academy of Pain Medicine (AAPM) **2025** Annual Meeting and the **7th** International Congress on Controversies in Fibromyalgia[7](index=7&type=chunk) [TNX-102 SL (Acute Stress Reaction/Disorder & PTSD)](index=2&type=section&id=TNX-102%20SL%20in%20development%20for%20the%20treatment%20of%20acute%20stress%20reaction%20(ASR)%20and%20acute%20stress%20disorder%20(ASD)%2C%20and%20prophylaxis%20against%20development%20of%20posttraumatic%20stress%20disorder%20(PTSD)) - The U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) trial for TNX-102 SL is expected to be initiated in the **second quarter of 2025**[5](index=5&type=chunk) [TNX-1300 (Cocaine Intoxication)](index=2&type=section&id=TNX-1300%20(recombinant%20double%20mutant%20cocaine%20esterase)%3A%20under%20investigation%20for%20biologic%20for%20cocaine%20intoxication) - The National Institutes of Health (NIH)'s National Institute of Drug Abuse (NIDA) **awarded Tonix a Cooperative Agreement grant for approximately $5 million** to support development of TNX-1300[8](index=8&type=chunk) - TNX-1300 has been granted **Breakthrough Therapy designation** by the FDA[8](index=8&type=chunk) - The Phase 2 CATALYST study of TNX-1300 was **discontinued due to slower than projected enrollment**, **not for safety or efficacy reasons**; **new study designs and endpoints are being evaluated**[8](index=8&type=chunk) [Immunology Pipeline](index=2&type=section&id=Immunology%20Pipeline) The immunology pipeline is centered on TNX-1500, a next-generation anti-CD40L mAb, which showed positive Phase 1 results and is being developed for organ transplant rejection and autoimmune disorders [TNX-1500 (Organ Transplant Rejection & Autoimmune Disorders)](index=2&type=section&id=TNX-1500%20(anti-CD40L%20Fc-modified%20humanized%20monoclonal%20antibody)%3A%20third%20generation%20anti-CD40L%20monoclonal%20antibody%20under%20investigation%20for%20prophylaxis%20for%20organ%20transplant%20rejection%20and%20treatment%20of%20autoimmune%20disorders.)) - Announced **positive topline results** from its Phase 1, single ascending dose (SAD) first-in-human trial of TNX-1500 in healthy participants in **February 2025**, **meeting all objectives and supporting progression to a Phase 2 trial**[6](index=6&type=chunk) - TNX-1500 showed a **mean half-life of 34-38 days** for **10 mg/kg** and **30 mg/kg** doses, **supporting monthly dosing** for future efficacy trials[6](index=6&type=chunk) - The first proposed indication for TNX-1500 is prophylaxis of organ rejection in adult patients receiving a kidney transplant, with multiple additional indications possible, including autoimmune diseases[9](index=9&type=chunk) [Infectious Disease Pipeline](index=3&type=section&id=Infectious%20Disease%20Pipeline) The infectious disease pipeline features TNX-801, a potential vaccine for mpox and smallpox, which has shown positive preclinical efficacy and received grant support [TNX-801 (Mpox and Smallpox Vaccine)](index=3&type=section&id=TNX-801%20(recombinant%20horsepox%20virus%2C%20minimally%20replicative%20live%20vaccine)%3A%20potential%20vaccine%20to%20protect%20against%20mpox%20and%20smallpox.)) - Presented **positive preclinical efficacy data** on TNX-801 at the World Vaccine Congress Washington **2025**, demonstrating protection of animals from mpox and rabbitpox, and **good tolerability** even in immunocompromised animals[12](index=12&type=chunk) - **Awarded a grant from the Medical CBRN Defense Consortium (MCDC)** in **March 2025** to support the development of a commercialization plan for TNX-801[12](index=12&type=chunk) [Corporate and Partnerships – Recent Highlights](index=3&type=section&id=Corporate%20and%20Partnerships%20%E2%80%93%20Recent%20Highlights*) [Strategic Collaborations & Grants](index=3&type=section&id=Strategic%20Collaborations%20%26%20Grants) Tonix has engaged in new strategic collaborations, including a research agreement with Makana Therapeutics for TNX-1500 in xenotransplantation, and secured a grant for TNX-801 development - Entered into a collaborative research agreement with Makana Therapeutics to study TNX-1500 in combination with Makana's human-compatible pig organs and cells for xenotransplant[12](index=12&type=chunk) - **Awarded a grant from the Medical CBRN Defense Consortium (MCDC)** to support the development of a commercialization plan for TNX-801[12](index=12&type=chunk) [Digital Health Platform Launch](index=3&type=section&id=Digital%20Health%20Platform%20Launch) Tonix launched TONIX ONE, a new digital platform designed to provide resources and telehealth access to migraine specialists for patients - **Launched TONIX ONE, a fully-integrated digital platform** providing educational resources and connecting migraine patients to independent specialists via telehealth services and e-prescription requests[12](index=12&type=chunk) [Management Appointments](index=3&type=section&id=Management%20Appointments) During **Q1 2025**, Tonix announced the promotion of Siobhan Fogarty to Chief Technical Officer and the appointment of Gary Ainsworth as Vice President, Market Access - **Promoted Siobhan Fogarty to Chief Technical Officer and appointed Gary Ainsworth as Vice President, Market Access** during the first quarter of **2025**[12](index=12&type=chunk) [Financial - Recent Highlight & Results](index=4&type=section&id=Financial%20-%20Recent%20Highlight) [Cash Position & Liquidity](index=4&type=section&id=Cash%20Position%20%26%20Liquidity) Tonix's cash and cash equivalents increased to **$131.7 million** as of **March 31, 2025**, supported by equity offerings. The company projects its current cash resources to fund operations into the **second quarter of 2026** Cash and Cash Equivalents Summary | Metric | March 31, 2025 | December 31, 2024 | Change | | :----- | :------------- | :---------------- | :----- | | Cash and cash equivalents | $131.7 million | $98.8 million | +$32.9 million | - **Net cash used in operations was approximately $16.6 million for Q1 2025, compared to $17.6 million for Q1 2024, representing a decrease of $1.0 million**[14](index=14&type=chunk) - **Sold approximately 2.7 million shares of common stock for net proceeds of $59.8 million during Q1 2025, and an additional 0.6 million shares for $9.9 million subsequent to March 31, 2025**[15](index=15&type=chunk) - **The Company believes its cash resources at March 31, 2025, along with subsequent equity proceeds, will meet operating and capital expenditure requirements into the second quarter of 2026**[16](index=16&type=chunk) [First Quarter 2025 Financial Results](index=4&type=section&id=First%20Quarter%202025%20Financial%20Results) The company experienced a slight decline in net product revenue and a significant reduction in R&D expenses, while SG&A expenses increased. This resulted in an increased net loss for **Q1 2025** compared to **Q1 2024**, alongside a substantial increase in weighted average common shares outstanding [Net Product Revenue & Cost of Sales](index=4&type=section&id=Net%20Product%20Revenue%20%26%20Cost%20of%20Sales) Net Product Revenue and Cost of Sales | Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Net product revenue | $2.4 million | $2.5 million | -$0.1 million (-4.0%) | | Cost of Sales | $0.9 million | $1.7 million | -$0.8 million (-47.1%) | [Operating Expenses](index=4&type=section&id=Operating%20Expenses) Operating Expenses Breakdown | Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Research and development expenses | $7.4 million | $12.9 million | -$5.5 million (-42.6%) | | Selling, general and administrative expenses | $10.1 million | $9.3 million | +$0.8 million (+8.6%) | - **Decrease in R&D expenses predominantly due to decreased clinical, non-clinical, manufacturing, and employee-related expenses**[18](index=18&type=chunk) - **Increase in SG&A expenses primarily due to an increase in sales and marketing expenses, offset by a decrease in employee-related expenses resulting from a workforce reduction in early 2024**[19](index=19&type=chunk) [Net Loss & EPS](index=4&type=section&id=Net%20Loss%20%26%20EPS) Net Loss and Earnings Per Share | Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Net loss available to common stockholders | $(16.8) million | $(14.9) million | -$(1.9) million (+12.8%) | | Net loss per common share, basic and diluted | $(2.84) | $(535.72) | Significant decrease due to share count increase | | Weighted average common shares outstanding | 5,927,231 | 27,886 | +5,899,345 (+21155.7%) | [Company Information](index=4&type=section&id=About%20Tonix%20Pharmaceuticals%20Holding%20Corp.) [About Tonix Pharmaceuticals Holding Corp.](index=4&type=section&id=About%20Tonix%20Pharmaceuticals%20Holding%20Corp.) Tonix is a **fully-integrated biopharmaceutical company** focused on CNS disorders, pain management, and public health vaccines. Its priority is advancing TNX-102 SL for fibromyalgia, with other key programs including TNX-1500 for immunology and TNX-801 for infectious diseases. The company also markets Zembrace® SymTouch® and Tosymra® for acute migraine - **Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges, with a development portfolio focused on central nervous system (CNS) disorders**[21](index=21&type=chunk) - **Priority is to advance TNX-102 SL for fibromyalgia**, with an **NDA submitted** and a PDUFA goal date of **August 15, 2025**[21](index=21&type=chunk) - **Immunology development portfolio includes TNX-1500 for organ transplant rejection and autoimmune diseases**; **infectious disease portfolio includes TNX-801 for mpox and smallpox, and TNX-4200 (broad-spectrum antiviral) with a DoD contract**[21](index=21&type=chunk) - **Commercial subsidiary, Tonix Medicines, markets Zembrace® SymTouch® and Tosymra® for the treatment of acute migraine**[21](index=21&type=chunk) [Legal & Disclosures](index=6&type=section&id=Legal%20%26%20Disclosures) [Trademarks & Website](index=6&type=section&id=Trademarks%20%26%20Website) This section clarifies the trademarks associated with Tonix's products and directs readers to the company's website for additional information - **Zembrace SymTouch, Tosymra and TONIX ONE are trademarks of Tonix Medicines**[22](index=22&type=chunk) - **Further information about Tonix can be found at www.tonixpharma.com**[23](index=23&type=chunk) [Forward Looking Statements](index=6&type=section&id=Forward%20Looking%20Statements) The report contains forward-looking statements based on current expectations, with actual results potentially differing due to various risks. Investors are advised to review risk factors detailed in the company's SEC filings - **Certain statements are forward-looking, based on current expectations, and actual results could differ materially due to various factors**[24](index=24&type=chunk) - **Factors include risks related to FDA clearances/approvals, marketing success, clinical development timing, financing needs, patent protection, reimbursement, and competition**[24](index=24&type=chunk) - **Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC**[24](index=24&type=chunk) [Condensed Consolidated Financial Statements](index=7&type=section&id=Condensed%20Consolidated%20Financial%20Statements) [Condensed Consolidated Statements of Operations](index=7&type=section&id=TONIX%20PHARMACEUTICALS%20HOLDING%20CORP.%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) The condensed consolidated statements of operations for **Q1 2025** show a net product revenue of **$2.4 million**, an operating loss of **$(16.1) million**, and a net loss available to common stockholders of **$(16.8) million**, or **$(2.84)** per share Condensed Consolidated Statements of Operations | Metric (in thousands) | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Product revenue, net | $2,429 | $2,482 | | Cost of sales | $943 | $1,660 | | Research and development | $7,436 | $12,863 | | General and administrative | $10,104 | $9,310 | | Total operating expenses | $18,483 | $23,833 | | Operating loss | $(16,054) | $(21,351) | | Grant income | $923 | — | | Gain on change in fair value of warrant liabilities | — | $7,005 | | Loss on extinguishment of debt | $(2,092) | — | | Other income (expense), net | $394 | $(593) | | Net loss available to common stockholders | $(16,829) | $(14,939) | | Net loss per common share, basic and diluted | $(2.84) | $(535.72) | | Weighted average common shares outstanding, basic and diluted | 5,927,231 | 27,886 | [Condensed Consolidated Balance Sheets](index=8&type=section&id=TONIX%20PHARMACEUTICALS%20HOLDING%20CORP.%20CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of **March 31, 2025**, Tonix reported total assets of **$192.9 million**, an increase from **$162.9 million** at **December 31, 2024**. This increase was primarily driven by a rise in cash and cash equivalents, contributing to an increase in total stockholders' equity Condensed Consolidated Balance Sheets | Metric (in thousands) | March 31, 2025 | December 31, 2024 | | :-------------------- | :------------- | :---------------- | | Cash and cash equivalents | $131,716 | $98,776 | | Total current assets | $149,573 | $119,002 | | Total assets | $192,870 | $162,890 | | Total liabilities | $12,474 | $23,332 | | Stockholders' equity | $180,396 | $139,558 | [Marketed Product Information](index=9&type=section&id=Marketed%20Product%20Information) [Investor & Media Contact](index=9&type=section&id=Investor%20Contact) This section provides contact information for investor relations and media inquiries for Tonix Pharmaceuticals - **Investor Contact: Jessica Morris (Tonix Pharmaceuticals) and Peter Vozzo (ICR Healthcare)**[29](index=29&type=chunk) - **Media Contact: Ray Jordan (Putnam Insights)**[29](index=29&type=chunk) [About Zembrace SymTouch and Tosymra](index=9&type=section&id=About%20Zembrace%20SymTouch%20and%20Tosymra) Zembrace® SymTouch® and Tosymra® are prescription medicines for acute migraine headaches with or without aura in adults, **not for prevention**, and their **safety and effectiveness in children under 18 years of age are not known** - **Zembrace® SymTouch® (sumatriptan succinate) injection and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults**[29](index=29&type=chunk) - **These products are not used to prevent migraines, and their safety and effectiveness in children under 18 years of age are not known**[30](index=30&type=chunk) [Important Safety Information](index=9&type=section&id=Important%20Safety%20Information) Zembrace and Tosymra carry **serious risks**, including heart attack and other cardiovascular problems, and are contraindicated for individuals with certain medical conditions or those taking specific medications. Patients should be aware of potential side effects and seek immediate medical attention for severe symptoms - **Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death**[31](index=31&type=chunk) - **Contraindications include a history of heart problems, peripheral vascular disease, uncontrolled high blood pressure, specific migraine types (hemiplegic or basilar), stroke history, severe liver problems, and concurrent use with certain medications (e.g., other triptans, ergotamines, MAO-A inhibitors)**[34](index=34&type=chunk)[37](index=37&type=chunk) - **Common side effects include injection site pain/redness (Zembrace), tingling/numbness, dizziness, flushing, neck discomfort, weakness, drowsiness, application site reactions (Tosymra), and throat irritation (Tosymra)**[34](index=34&type=chunk) - **Serious side effects can include changes in color or sensation in fingers/toes, sudden or severe stomach pain, leg/hip cramping, increased blood pressure, medication overuse headaches, serotonin syndrome, allergic reactions (hives, swelling), and seizures**[37](index=37&type=chunk) - Patients are encouraged to report adverse effects of prescription drugs to the FDA[36](index=36&type=chunk)