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 - The core point of the article is that Tonix Pharmaceuticals (TNXP.US) experienced a pre-market increase of over 10% following the FDA's approval of its drug for treating chronic pain-related symptoms [1] Group 2 - The FDA approval is a significant milestone for Tonix, potentially enhancing its market position in the biopharmaceutical industry [1]

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]

Core Insights - The RESILIENT trial data demonstrates that TNX-102 SL significantly reduces fibromyalgia pain compared to placebo, confirming previous findings from the RELIEF trial [1][2] - If approved, TNX-102 SL will be the first new drug for fibromyalgia in over 15 years, with a PDUFA target date set for August 15, 2025 [1][2] Company Overview - Tonix Pharmaceuticals Holding Corp. is a clinical-stage biopharmaceutical company focused on developing therapies for pain management and central nervous system disorders [8] - The company has submitted a New Drug Application (NDA) for TNX-102 SL based on two statistically significant Phase 3 studies [2][8] Study Details - The RESILIENT study was a randomized, double-blind, placebo-controlled trial involving 457 adults with fibromyalgia across 33 sites in the U.S. [2][7] - Participants received TNX-102 SL in two dosage phases: 2.8 mg for two weeks followed by 5.6 mg for twelve weeks, with a primary endpoint of pain reduction assessed over fourteen weeks [2][7] Efficacy Results - TNX-102 SL achieved a least-squares mean reduction of 1.8 points on the eleven-point daily pain numeric rating scale, compared to a 1.2-point reduction for placebo, indicating high statistical significance [2][7] - Statistically significant improvements were also noted across all six prespecified key secondary endpoints, including various patient-reported outcomes [2][3] Safety Profile - TNX-102 SL was generally well tolerated, with the most common adverse events being mild and transient, such as oral tingling/numbness and a bitter aftertaste [3] - No serious drug-related adverse events or deaths were reported, highlighting a favorable risk-benefit profile [3] Fibromyalgia Context - Fibromyalgia affects an estimated 6-12 million adults in the U.S., predominantly women, and is characterized by chronic pain, fatigue, and sleep disturbances [4] - Current treatment options are often met with dissatisfaction from both physicians and patients, indicating a significant unmet need in the market [4] Product Information - TNX-102 SL is a patented sublingual formulation of cyclobenzaprine hydrochloride designed for rapid absorption and reduced side effects [5][6] - The drug is also being explored for other indications, including acute stress reaction, Long COVID, and alcohol use disorder [5][8]