Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP ) was down about 20% on Monday despite securing that much-anticipated FDA approval on Friday for its fibromyalgia therapy. Tonmya, which had initially sent shares soaringI’m a retired Wall Street PM specializing in TMT; since kickstarting my career, I’ve spent over two decades in the market navigating the technology landscape, focusing on risk mitigation through the dot com bubble, credit default of ‘08, and, more recently, with the AI boom. In one word, wha ...

Summary of Tonix Pharmaceuticals Holding (TNXP) Conference Call - August 18, 2025 Company Overview - **Company**: Tonix Pharmaceuticals Holding Corp (TNXP) - **Product**: Tonmya (sublingual cyclobenzaprine HCL tablets) - **Indication**: Treatment of fibromyalgia - **FDA Approval Date**: August 15, 2025 Key Points Industry Context - **Fibromyalgia**: A common chronic pain condition affecting over 10 million adults in the U.S. [12][33] - **Market Need**: Significant unmet medical need with only 2.7 million diagnosed and treated annually, while 75% of patients remain undiagnosed [33][34] - **Current Treatment Landscape**: High dissatisfaction with existing therapies, with first-line treatments failing in 85% of patients [34] Product Highlights - **Tonmya**: First new FDA-approved medication for fibromyalgia in over 15 years, designed for long-term treatment [15][49] - **Mechanism of Action**: Non-opioid analgesic that bypasses first-pass liver metabolism, leading to effective pain relief [18][19] - **Clinical Trials**: Two pivotal phase three trials with nearly 1,000 patients demonstrated significant pain reduction compared to placebo [24][25] - **Trial Results**: - Trial 1: 1.9 reduction in pain for Tonmya vs. 1.5 for placebo (p=0.01) - Trial 3: 1.8 reduction for Tonmya vs. 1.2 for placebo (p<0.001) [25] Financial Position - **Cash Reserves**: Approximately $125 million at the end of Q2 2025, with an additional $50 million raised in Q3 2025 [16] - **Debt Status**: No debt, providing a runway into 2026 for the product launch [16] Launch Strategy - **Commercial Readiness**: Experienced leadership team in place, with 90 sales representatives (10 internal, 80 contract) prepared for launch [55][32] - **Targeting High Prescribers**: Focus on the 5% of healthcare providers responsible for 70% of fibromyalgia prescriptions [40][43] - **Omnichannel Engagement**: Combining in-person promotion with digital outreach to educate both patients and healthcare providers [44][46] Market Dynamics - **Patient Engagement**: Early disease awareness campaign "Move Fibro Forward" attracted 36,000 unique visitors in the first three weeks [38][39] - **Opioid Crisis Context**: Tonmya aims to provide a non-addictive alternative to off-label opioid prescriptions commonly used for fibromyalgia [37][38] Intellectual Property - **Patent Portfolio**: Strong intellectual property with issued patents covering the unique formulation of Tonmya, providing exclusivity until at least 2034 [96] Future Outlook - **Sales Projections**: Conservative estimates for initial sales in 2025, with expectations for growth in 2026 as awareness and access improve [98] - **Research Plans**: Ongoing studies to explore the long-term impact of Tonmya and its role in earlier treatment of fibromyalgia [80] Conclusion - **Significance of Approval**: The approval of Tonmya represents a major advancement for fibromyalgia treatment, addressing a long-standing unmet need in the market [50][49] - **Commitment to Patients**: The company emphasizes its dedication to improving the lives of those suffering from fibromyalgia and plans to maintain open communication with stakeholders [104]

Tonmya Approval and Launch - TonmyaTM is the first FDA-approved medicine for fibromyalgia in over 15 years[1,13] - Tonix is well-positioned to support the commercial launch of TonmyaTM, expected in Q4 2025[13] - Tonix ended Q2 2025 with approximately $125 million in cash and cash equivalents and raised approximately $50 million in Q3 2025 through equity sales[41] - The company anticipates its cash runway will support the launch and other operations into Q3 2026[13,41] Clinical Efficacy and Safety - Clinical trials demonstrated durable reduction in fibromyalgia pain with TonmyaTM[22] - In Trial 1, the TONMYA group showed a change from baseline of -1.9 compared to -1.5 in the placebo group, with a p-value of 0.010[28] - In Trial 3, the TONMYA group showed a change from baseline of -1.8 compared to -1.2 in the placebo group, with a p-value of less than 0.001[29] - A greater percentage of study participants taking Tonmya experienced a clinically meaningful (≥30%) improvement in their pain after three months, compared to placebo[35] - The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer[24,40,94] Market Opportunity and Commercial Strategy - Over 10 million people in the US are living with fibromyalgia[13,50] - Approximately 5% of fibromyalgia-diagnosing HCPs write approximately 70% of fibromyalgia prescriptions[62]

Group 1 - Tonix Pharmaceuticals (NASDAQ: TNXP) shares experienced a decline of nearly 15% during the day but rebounded with an increase of nearly 18% in post-market trading [1] - The Haggerston BioHealth investing group offers insights for both novice and experienced biotech investors, including catalysts to monitor and buy/sell ratings [1] - The group provides comprehensive financial analyses, including product sales forecasts, integrated financial statements, discounted cash flow analysis, and market-by-market analysis for major pharmaceutical companies [1] Group 2 - Edmund Ingham, a biotech consultant with over 5 years of experience, has compiled detailed reports on more than 1,000 companies in the biotech, healthcare, and pharma sectors [1]

Core Insights - Tonmya is the first FDA-approved therapy for fibromyalgia in over 15 years, representing a significant advancement for the treatment of this chronic pain condition affecting over 10 million adults in the U.S. [1][2] - The approval of Tonmya was based on two pivotal Phase 3 clinical trials that demonstrated its efficacy in significantly reducing fibromyalgia pain compared to placebo [2][10] - Tonmya is expected to be commercially available in the fourth quarter of 2025 [1][6] Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company focused on developing treatments for central nervous system disorders, immunology, immuno-oncology, and infectious diseases [12][13] - The company has a proprietary formulation for Tonmya, which is a sublingual tablet designed for rapid absorption and reduced production of long half-life metabolites [9] Industry Context - Fibromyalgia is a chronic pain disorder that affects an estimated 10 million adults in the U.S., with approximately 80% being women. It is characterized by chronic widespread pain, fatigue, and sleep disturbances [8] - The chronic pain associated with fibromyalgia significantly disrupts patients' daily lives and is often inadequately managed due to a lack of effective treatment options [4][8]

[Q2 2025 Financial Results and Operational Highlights](index=1&type=section&id=Tonix%20Pharmaceuticals%20Reports%20Second%20Quarter%202025%20Financial%20Results%20and%20Operational%20Highlights) 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](index=1&type=chunk)[2](index=2&type=chunk) - In June 2025, Tonix was added to the **Russell 3000® and Russell 2000® Indexes**, increasing its visibility to institutional investors[1](index=1&type=chunk)[16](index=16&type=chunk) - 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](index=1&type=chunk)[12](index=12&type=chunk)[13](index=13&type=chunk) - Results from the Phase 3 RESILIENT trial showed a **statistically significant reduction in fibromyalgia pain** with TNX-102 SL[1](index=1&type=chunk)[8](index=8&type=chunk) [Management Commentary](index=1&type=section&id=Management%20Commentary) 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](index=2&type=chunk) - The first patient was dosed in the DoD-funded **OASIS trial** of TNX-102 SL for acute stress reaction[2](index=2&type=chunk)[5](index=5&type=chunk) - New data for the TNX-801 vaccine demonstrated **durable, single-dose protection against mpox** in animal models[2](index=2&type=chunk)[9](index=9&type=chunk) - Positive Phase 1 data for the next-generation anti-CD40L antibody, TNX-1500, supports its advancement into a **Phase 2 kidney-transplant study**[2](index=2&type=chunk)[7](index=7&type=chunk) [Pipeline Development Highlights](index=2&type=section&id=Key%20Investigational%20Product%20Candidates) The development pipeline is advancing with key candidates in CNS, immunology, and vaccines showing positive clinical and preclinical results [Central Nervous System (CNS) Pipeline](index=2&type=section&id=Central%20Nervous%20System%20(CNS)%20Pipeline) 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)](index=2&type=section&id=TNX-102%20SL%20for%20Fibromyalgia%20(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](index=8&type=chunk) - 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](index=8&type=chunk) - The PDUFA goal date for a decision on marketing authorization is **August 15, 2025**[1](index=1&type=chunk)[8](index=8&type=chunk) [TNX-102 SL for Acute Stress Reaction (ASR)](index=2&type=section&id=TNX-102%20SL%20for%20Acute%20Stress%20Reaction%20(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](index=5&type=chunk) - 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](index=5&type=chunk) - 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](index=5&type=chunk) [Immunology Pipeline](index=2&type=section&id=Immunology%20Pipeline) 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)](index=2&type=section&id=TNX-1500%20(anti-CD40L%20Antibody)) 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](index=7&type=chunk) - TNX-1500 met all safety, pharmacokinetic, and pharmacodynamic goals, supporting a planned **Phase 2 study for preventing rejection in kidney transplants**[7](index=7&type=chunk) - The antibody demonstrated a mean half-life of **34–38 days**, which supports a monthly intravenous dosing schedule[7](index=7&type=chunk) [TNX-801 (Mpox/Smallpox Vaccine)](index=3&type=section&id=TNX-801%20(Mpox/Smallpox%20Vaccine)) 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](index=9&type=chunk) - The vaccine was well tolerated, even in immunocompromised models, and meets key attributes of the **WHO's target product profile** for mpox vaccines[9](index=9&type=chunk) [Corporate and Financial Review](index=3&type=section&id=Corporate%20and%20Financial%20Review) The company strengthened its leadership team and investor visibility while reporting a strong cash position and increased operating expenses [Corporate Updates](index=3&type=section&id=Corporate%20Updates) 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](index=16&type=chunk) - Commercial veteran James Hunter joined the **Board of Directors** in June 2025 to strengthen strategy ahead of the potential TNX-102 SL launch[16](index=16&type=chunk) - In June 2025, the company was added to the **Russell 3000® and Russell 2000® Indexes**[16](index=16&type=chunk) [Financial Review](index=3&type=section&id=Financial%20Review) 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](index=6&type=section&id=Financial%20Statements) The condensed consolidated financial statements detail the company's operating results and financial position as of June 30, 2025 [Condensed Consolidated Statements of Operations](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) 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](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) 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](index=4&type=section&id=About%20Tonix%20Pharmaceuticals%20Holding%20Corp.) 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](index=19&type=chunk) - 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](index=19&type=chunk) - The commercial subsidiary, Tonix Medicines, markets **Zembrace SymTouch and Tosymra** for the treatment of acute migraine in adults[19](index=19&type=chunk) - 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](index=22&type=chunk) [Marketed Products Information](index=8&type=section&id=Marketed%20Products%20Information) 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](index=27&type=chunk) - These products are **not intended for the prevention of migraines**[28](index=28&type=chunk) - Serious side effects can include **heart attack and other heart problems**, and the drugs are not for people with certain cardiovascular risk factors[29](index=29&type=chunk)[30](index=30&type=chunk)[31](index=31&type=chunk) - Common side effects include injection site reactions (Zembrace), tingling, dizziness, flushing, and throat irritation (Tosymra)[32](index=32&type=chunk)

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents Tonix Pharmaceuticals' unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows, with detailed notes for the periods ended June 30, 2025 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, reflects increased cash and equity, and decreased liabilities due to term loan repayment Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $125,331 | $98,776 | +$26,555 | | Total current assets | $143,535 | $119,002 | +$24,533 | | Total assets | $187,359 | $162,890 | +$24,469 | | Term loan payable (short & long term) | $0 | $7,487 | -$7,487 | | Total liabilities | $19,358 | $23,332 | -$3,974 | | Total stockholders' equity | $168,001 | $139,558 | +$28,443 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss significantly decreased for the three and six months ended June 30, 2025, primarily due to the absence of a 2024 asset impairment charge Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $1,998 | $2,208 | $4,427 | $4,690 | | Research and development | $10,820 | $9,698 | $18,256 | $22,561 | | Selling, general and administrative | $16,202 | $7,502 | $26,306 | $16,812 | | Asset impairment charges | $0 | $58,957 | $0 | $58,957 | | Operating loss | $(28,296) | $(77,316) | $(44,350) | $(98,667) | | Net loss | $(28,272) | $(78,776) | $(45,101) | $(93,715) | | Net loss per share | $(3.86) | $(1,920.85) | $(6.80) | $(2,720.40) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash increased by **$26.6 million** for the six months ended June 30, 2025, driven by **$60.5 million** in financing activities Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(31,412) | $(27,494) | | Net cash used in investing activities | $(2,545) | $(108) | | Net cash provided by financing activities | $60,526 | $6,813 | | **Net increase (decrease) in cash** | **$26,556** | **$(20,792)** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail business operations, accounting policies, and financial items, including a going concern warning, equity transactions, and subsequent events - The company's priority is advancing TNX-102 SL for fibromyalgia, with a PDUFA goal date of **August 15, 2025**, and Fast Track designation[21](index=21&type=chunk) - Recurring losses and negative cash flows raise substantial doubt about the company's ability to continue as a going concern, though current cash is expected to fund operations into **Q3 2026**[25](index=25&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk) - The company effected a **1-for-100 reverse stock split** on February 5, 2025, and a **1-for-32 reverse stock split** on June 10, 2024, with all share data retrospectively adjusted[32](index=32&type=chunk) - In Q1 2025, the company fully repaid its term loan, incurring a **$2.1 million** loss on extinguishment of debt for the six-month period[116](index=116&type=chunk) - Subsequent to June 30, 2025, the company raised approximately **$49.8 million** in net proceeds from ATM common stock sales[180](index=180&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=37&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, liquidity, and operational developments, highlighting the TNX-102 SL program, decreased net loss, increased SG&A, and ongoing financing efforts [Results of Operations](index=39&type=section&id=Results%20of%20Operations) Operating results show a significant decrease in net loss due to the absence of 2024 impairment charges, alongside increased SG&A and fluctuating R&D expenses Comparison of Operating Results (in thousands) | Metric | Q2 2025 | Q2 2024 | Change | YTD 2025 | YTD 2024 | Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $1,998 | $2,208 | -9.5% | $4,427 | $4,690 | -5.6% | | R&D Expenses | $10,820 | $9,698 | +11.6% | $18,256 | $22,561 | -19.1% | | SG&A Expenses | $16,202 | $7,502 | +116.0% | $26,306 | $16,812 | +56.5% | | Asset Impairment | $0 | $58,957 | N/A | $0 | $58,957 | N/A | | Net Loss | $(28,272) | $(78,776) | -64.1% | $(45,101) | $(93,715) | -51.9% | - The increase in SG&A expenses is primarily due to higher sales and marketing costs (**$5.3 million** in Q2), employee-related expenses, and professional fees for migraine assets and TNX-102 SL launch preparation[197](index=197&type=chunk)[206](index=206&type=chunk) - Significant 2024 asset impairment charges included **$48.8 million** for the decommissioned ADC facility, **$1.0 million** for goodwill, and **$9.2 million** for developed technology intangible assets[198](index=198&type=chunk)[207](index=207&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had **$125.3 million** in cash, with financing activities expected to fund operations into Q3 2026, despite ongoing going concern doubts - The company's cash resources, supplemented by Q3 2025 equity offerings, are expected to fund operations into the **third quarter of 2026**[215](index=215&type=chunk) - Recurring losses and future funding needs raise substantial doubt about the company's ability to continue as a going concern, despite recent financing[216](index=216&type=chunk) Recent Financing Activities (2024-2025) | Program | Total Facility Size | Net Proceeds (YTD 2025) | Status | | :--- | :--- | :--- | :--- | | 2024 ATM Offering | $250.0M | $75.4M | Completed/Fully Utilized | | 2025 ATM Offering | $150.0M | $0 (in Q2) | Active | | 2025 Lincoln Park Agreement | $75.0M | N/A | Active | - During the six months ended June 30, 2025, the company repurchased **400,000 shares** of common stock for approximately **$5.9 million** under its 2024 share repurchase program[245](index=245&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=54&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is noted as not applicable for the company - The company states that this item is not applicable[275](index=275&type=chunk) [Item 4. Controls and Procedures](index=54&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting - Management concluded that as of **June 30, 2025**, the company's disclosure controls and procedures were effective at a reasonable assurance level[277](index=277&type=chunk) - No material changes occurred in the company's internal control over financial reporting during the quarter ended **June 30, 2025**[278](index=278&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=54&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no involvement in any material legal proceedings or claims - As of the filing date, the company is not involved in any material legal proceedings[280](index=280&type=chunk) [Item 1A. Risk Factors](index=54&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors from the 2024 Form 10-K, except for a new risk concerning the 'One Big Beautiful Bill Act' (OBBBA) - A new risk factor relates to the 'One Big Beautiful Bill Act' (OBBBA), enacted on **July 4, 2025**, which could adversely affect the company's business and financial condition, with impact currently being assessed[282](index=282&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=54&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section discloses the issuance of **48,708 shares** to Lincoln Park as a commitment fee and details the repurchase of **150,000 shares** during Q2 2025 - On **June 11, 2025**, the company issued **48,708 shares** of common stock to Lincoln Park as a commitment fee for a purchase agreement[283](index=283&type=chunk) Share Repurchase Activity for Q2 2025 | Month | Total Shares Purchased | Average Price Paid Per Share | Total Cost (in thousands) | | :--- | :--- | :--- | :--- | | April 2025 | 0 | N/A | $0 | | May 2025 | 150,000 | $19.31 | $2,902 | | June 2025 | 0 | N/A | $0 | | **Q2 Total** | **150,000** | **$19.31** | **$2,902** | [Item 5. Other Information](index=55&type=section&id=Item%205.%20Other%20Information) The company discloses the adoption of Rule 10b5-1 trading plans by two executive officers for the sale of common stock, with sales commencing in February 2026 - On **June 20, 2025**, CFO Bradley Saenger adopted a Rule 10b5-1 plan for selling up to **51,584 shares**[287](index=287&type=chunk) - On **June 18, 2025**, COO Jessica Morris adopted a Rule 10b5-1 plan for selling up to **19,520 shares**[288](index=288&type=chunk)

Core Insights - Tonix Pharmaceuticals is anticipating FDA approval for TNX-102SL for fibromyalgia by August 15, 2025, which would mark the first new drug for this condition in over 16 years [1][2] - The company reported a cash position of $125.3 million as of June 30, 2025, which is expected to fund operations into the third quarter of 2026 [1][8][9] - Recent Phase 3 trial results for TNX-102SL demonstrated statistically significant pain reduction in fibromyalgia patients, supporting the ongoing New Drug Application (NDA) review [5][10] Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company focused on developing therapies for pain management and vaccines for public health challenges, with a strong emphasis on central nervous system disorders [15] - The company has a diverse pipeline, including TNX-102SL for fibromyalgia and acute stress reactions, TNX-1500 for organ transplant rejection, and TNX-801 as a vaccine candidate [15][6] Financial Performance - For the second quarter of 2025, Tonix reported net product revenue of approximately $2.0 million, a slight decrease from $2.2 million in the same period of 2024 [10] - Research and development expenses increased to $10.8 million in Q2 2025 from $9.7 million in Q2 2024, primarily due to heightened clinical and manufacturing costs [11] - Selling, general, and administrative expenses rose significantly to $16.2 million in Q2 2025, compared to $7.5 million in Q2 2024, reflecting increased spending on pre-launch activities for TNX-102SL [12] Pipeline Developments - The company is advancing TNX-102SL for acute stress reaction and acute stress disorder, with the first patient dosed in the OASIS trial funded by the U.S. Department of Defense [4][15] - TNX-1500 has shown positive Phase 1 results and is being prepared for a Phase 2 study targeting kidney transplant rejection [6] - TNX-801 has demonstrated durable protection in animal models against mpox and rabbitpox, supporting its potential as a vaccine candidate [6] Market Position - In June 2025, Tonix was added to the Russell 3000® and Russell 2000® Indexes, enhancing its visibility among institutional investors as it approaches key regulatory milestones [1][13]

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges [4] - The company operates a state-of-the-art infectious disease research facility in Frederick, MD, and its development portfolio includes central nervous system disorders, immunology, and infectious diseases [4] Campaign Launch - Tonix Medicines, Inc., a commercial subsidiary of Tonix Pharmaceuticals, launched the "Move Fibro Forward" campaign to raise awareness and support for individuals affected by fibromyalgia [1][2] - The campaign aims to validate the experiences of those suffering from fibromyalgia and encourage them to seek education and resources [2] Fibromyalgia Insights - Fibromyalgia is a chronic pain disorder affecting an estimated 10 million adults in the U.S., with approximately 90% being women [3] - Common symptoms include chronic widespread pain, nonrestorative sleep, fatigue, and cognitive dysfunction, leading to impaired quality of life and frequent disability [3]

Core Insights - Tonix Pharmaceuticals Holding Corp. presented new findings on TNX-801, a recombinant horsepox live virus vaccine, demonstrating its potential for durable immunity against mpox and smallpox with significantly reduced virulence compared to traditional vaccines [1][2][3] Group 1: TNX-801 Vaccine Development - TNX-801 is shown to be up to 100,000-fold less virulent than live smallpox vaccine strains, providing robust immunogenicity and protection for over one year in animal studies [1][2] - Subcutaneous administration of TNX-801 offers equivalent protection to traditional percutaneous methods, potentially reducing risks of administration-site infections and scarring [2][3] - Preclinical studies indicate that a single dose of TNX-801 generates strong antibody responses across various animal models, including immunocompromised subjects, with all vaccinated macaques surviving lethal mpox challenges [2][3] Group 2: Strategic Importance and Future Directions - The vaccine's unique risk-benefit profile may make it a critical tool for public health, particularly in response to mpox outbreaks and potential smallpox threats [2][3] - Tonix Pharmaceuticals aims to advance TNX-801 into clinical evaluation, focusing on subcutaneous delivery to streamline vaccination processes [2][3] - The ongoing classification of mpox as a public health concern by organizations like the WHO and CDC underscores the importance of developing effective vaccines like TNX-801 [3] Group 3: Company Overview - Tonix Pharmaceuticals is a fully integrated biopharmaceutical company with a focus on pain management therapies and vaccines for public health challenges [4] - The company is advancing TNX-102 SL for fibromyalgia management, with a PDUFA goal date of August 15, 2025, for marketing authorization [4] - Tonix's infectious disease portfolio includes TNX-801 and TNX-4200, the latter being a broad-spectrum antiviral agent with a contract worth up to $34 million from the U.S. Department of Defense [4]