Tonix Pharmaceuticals (TNXP) - 2025 Q2 - Quarterly Results

Q2 2025 Financial Results and Operational Highlights The company highlights a PDUFA goal date for TNX-102 SL, its inclusion in Russell indexes, a strong cash position, and positive Phase 3 trial data - The FDA has set a PDUFA goal date of August 15, 2025, for TNX-102 SL for fibromyalgia, which could be the first new drug for the condition in over 16 years[1][2] - In June 2025, Tonix was added to the Russell 3000® and Russell 2000® Indexes, increasing its visibility to institutional investors[1][16] - The company's cash and cash equivalents were $125.3 million as of June 30, 2025, with the current cash runway expected to fund operations into the third quarter of 2026[1][12][13] - Results from the Phase 3 RESILIENT trial showed a statistically significant reduction in fibromyalgia pain with TNX-102 SL[1][8] Management Commentary Management expresses optimism for the TNX-102 SL launch and highlights positive momentum across its CNS, immunology, and vaccine pipelines - The company anticipates making TNX-102 SL available to fibromyalgia patients in the fourth quarter of 2025, pending FDA approval[2] - The first patient was dosed in the DoD-funded OASIS trial of TNX-102 SL for acute stress reaction[2][5] - New data for the TNX-801 vaccine demonstrated durable, single-dose protection against mpox in animal models[2][9] - Positive Phase 1 data for the next-generation anti-CD40L antibody, TNX-1500, supports its advancement into a Phase 2 kidney-transplant study[2][7] Pipeline Development Highlights The development pipeline is advancing with key candidates in CNS, immunology, and vaccines showing positive clinical and preclinical results Central Nervous System (CNS) Pipeline The CNS pipeline is led by TNX-102 SL, which has published positive Phase 3 data for fibromyalgia and initiated a Phase 2 trial for acute stress reaction TNX-102 SL for Fibromyalgia (FM) The New Drug Application for TNX-102 SL is supported by positive Phase 3 results, with a PDUFA goal date set for August 2025 - Full results from the confirmatory Phase 3 RESILIENT trial were published in Pain Medicine, supporting the ongoing New Drug Application (NDA) review[8] - The trial demonstrated that once-nightly TNX-102 SL (5.6mg) achieved a statistically significant reduction in fibromyalgia pain compared to placebo and was generally well tolerated[8] - The PDUFA goal date for a decision on marketing authorization is August 15, 2025[1][8] TNX-102 SL for Acute Stress Reaction (ASR) A DoD-funded Phase 2 trial for TNX-102 SL in acute stress reaction has commenced, with results expected in the second half of 2026 - In May 2025, the first patient was dosed in the Phase 2 investigator-initiated OASIS trial[5] - The study is evaluating a two-week course of TNX-102 SL to reduce the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD)[5] - The trial is supported by a $3 million U.S. Department of Defense grant, with topline results anticipated in the second half of 2026[5] Immunology Pipeline The immunology pipeline features positive data for TNX-1500, an antibody for transplant rejection, and TNX-801, a vaccine for mpox TNX-1500 (anti-CD40L Antibody) Positive Phase 1 data for the TNX-1500 antibody supports its advancement into a Phase 2 study for preventing kidney transplant rejection - In May 2025, Tonix reported positive topline data from a Phase 1 single-ascending-dose study in healthy volunteers[7] - TNX-1500 met all safety, pharmacokinetic, and pharmacodynamic goals, supporting a planned Phase 2 study for preventing rejection in kidney transplants[7] - The antibody demonstrated a mean half-life of 34–38 days, which supports a monthly intravenous dosing schedule[7] TNX-801 (Mpox/Smallpox Vaccine) New preclinical data demonstrates that a single dose of the TNX-801 vaccine provides durable protection against mpox - New preclinical data presented in April 2025 showed a single dose of TNX-801 protected animals from mpox and rabbitpox for at least six months[9] - The vaccine was well tolerated, even in immunocompromised models, and meets key attributes of the WHO's target product profile for mpox vaccines[9] Corporate and Financial Review The company strengthened its leadership team and investor visibility while reporting a strong cash position and increased operating expenses Corporate Updates Tonix strengthened its leadership and governance with key appointments and gained investor visibility through inclusion in Russell indexes - Joseph Hand, Esq. was appointed as General Counsel and Executive Vice President of Operations in May 2025[16] - Commercial veteran James Hunter joined the Board of Directors in June 2025 to strengthen strategy ahead of the potential TNX-102 SL launch[16] - In June 2025, the company was added to the Russell 3000® and Russell 2000® Indexes[16] Financial Review The company reported $125.3 million in cash with a runway into Q3 2026, alongside increased R&D and SG&A expenses for the quarter Cash Position and Runway | Metric | Amount | As of / Period | | :--- | :--- | :--- | | Cash and cash equivalents | $125.3 million | June 30, 2025 | | Cash and cash equivalents | $98.8 million | December 31, 2024 | | Net cash used in operations | $31.4 million | Six months ended June 30, 2025 | | Projected Cash Runway | Into Q3 2026 | - | Q2 2025 vs Q2 2024 Financials (in millions, except per share data) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Net Product Revenue | $2.0 | $2.2 | ($0.2) | | R&D Expenses | $10.8 | $9.7 | +$1.1 | | SG&A Expenses | $16.2 | $7.5 | +$8.7 | | Net Loss | $28.3 | $78.8 | ($50.5) | | Net Loss Per Share | $3.86 | $1,920.85 | ($1,916.99) | | Weighted Avg. Shares | 7,327,257 | 41,011 | +7,286,246 | Financial Statements The condensed consolidated financial statements detail the company's operating results and financial position as of June 30, 2025 Condensed Consolidated Statements of Operations The statement of operations shows a narrowed net loss for the three and six-month periods, primarily due to the absence of a prior-year impairment charge Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Product revenues, net | $1,998 | $2,208 | $4,427 | $4,690 | | Cost of sales | $3,272 | $3,367 | $4,215 | $5,027 | | Research and development | $10,820 | $9,698 | $18,256 | $22,561 | | General and administrative | $16,202 | $7,502 | $26,306 | $16,812 | | Asset impairment charges | $— | $58,957 | $— | $58,957 | | Total operating expenses | $30,294 | $79,524 | $48,777 | $103,357 | | Operating Loss | ($28,296) | ($77,316) | ($44,350) | ($98,667) | | Net loss available to common stockholders | ($28,272) | ($78,776) | ($45,101) | ($93,715) | | Net loss per common share, basic and diluted | ($3.86) | ($1,920.84) | ($6.80) | ($2,720.43) | | Weighted average common shares outstanding | 7,327,257 | 41,011 | 6,631,111 | 34,449 | Condensed Consolidated Balance Sheets The balance sheet reflects a stronger financial position with increased cash and total assets, and a decrease in total liabilities Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $125,331 | $98,776 | | Total current assets | $143,535 | $119,002 | | Total assets | $187,359 | $162,890 | | Liabilities and stockholders' equity | | | | Total liabilities | $19,358 | $23,332 | | Stockholders' equity | $168,001 | $139,558 | | Total liabilities and stockholders' equity | $187,359 | $162,890 | About Tonix Pharmaceuticals and Forward-Looking Statements Tonix is a biotechnology company focused on CNS disorders, immunology, and infectious diseases, and its press release contains standard forward-looking statement disclaimers - The company's priority is advancing TNX-102 SL for fibromyalgia, which has a PDUFA goal date of August 15, 2025[19] - The development portfolio includes CNS disorders, immunology candidates like TNX-1500 for organ transplant rejection, and infectious disease vaccines like TNX-801 for mpox[19] - The commercial subsidiary, Tonix Medicines, markets Zembrace SymTouch and Tosymra for the treatment of acute migraine in adults[19] - Forward-looking statements are subject to significant risks, including failure to obtain FDA approvals, need for additional financing, patent protection uncertainties, and substantial competition[22] Marketed Products Information This section details the approved use, contraindications, and critical safety information for the company's marketed migraine treatments - Zembrace® SymTouch® and Tosymra® are prescription medicines for the acute treatment of migraine with or without aura in adults[27] - These products are not intended for the prevention of migraines[28] - Serious side effects can include heart attack and other heart problems, and the drugs are not for people with certain cardiovascular risk factors[29][30][31] - Common side effects include injection site reactions (Zembrace), tingling, dizziness, flushing, and throat irritation (Tosymra)[32]