Tonix Pharmaceuticals (TNXP) - 2025 Q1 - Quarterly Results

Executive Summary & Operational Highlights First Quarter 2025 Highlights 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] - 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] 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] CEO Commentary 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] - Encouraged by continued achievements in the pipeline, including positive Phase 1 results for TNX-1500 and preclinical results for TNX-801[2] Key Investigational Product Candidates - Recent Highlights Central Nervous System (CNS) Pipeline 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) - FDA will not require an Advisory Committee meeting to discuss the NDA for TNX-102 SL for fibromyalgia[4] - FDA previously granted Fast Track designation to TNX-102 SL for fibromyalgia in 2024[4] - NDA for TNX-102 SL for fibromyalgia was accepted by FDA in December 2024 with a PDUFA goal date of August 15, 2025[4] - 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] TNX-102 SL (Acute Stress Reaction/Disorder & 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] TNX-1300 (Cocaine Intoxication) - 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] - TNX-1300 has been granted Breakthrough Therapy designation by the FDA[8] - 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] Immunology Pipeline 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)) - 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] - 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] - 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] Infectious Disease Pipeline 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)) - 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] - 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] Corporate and Partnerships – Recent Highlights Strategic Collaborations & Grants 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] - Awarded a grant from the Medical CBRN Defense Consortium (MCDC) to support the development of a commercialization plan for TNX-801[12] Digital Health Platform Launch 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] Management Appointments 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] Financial - Recent Highlight & Results Cash Position & Liquidity 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] - 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] - 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] First Quarter 2025 Financial Results 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 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 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] - 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] Net Loss & EPS 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 About Tonix Pharmaceuticals Holding Corp. 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] - Priority is to advance TNX-102 SL for fibromyalgia, with an NDA submitted and a PDUFA goal date of August 15, 2025[21] - 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] - Commercial subsidiary, Tonix Medicines, markets Zembrace® SymTouch® and Tosymra® for the treatment of acute migraine[21] Legal & Disclosures Trademarks & Website 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] - **Further information about Tonix can be found at www.tonixpharma.com**[23](index=23&type=chunk) Forward Looking Statements 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] - Factors include risks related to FDA clearances/approvals, marketing success, clinical development timing, financing needs, patent protection, reimbursement, and competition[24] - 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] Condensed Consolidated Financial Statements Condensed Consolidated Statements of Operations 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 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 Investor & Media Contact 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] - Media Contact: Ray Jordan (Putnam Insights)[29] About Zembrace SymTouch and Tosymra 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] - These products are not used to prevent migraines, and their safety and effectiveness in children under 18 years of age are not known[30] Important Safety Information 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] - 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][37] - 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] - 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] - Patients are encouraged to report adverse effects of prescription drugs to the FDA[36]