[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]

Core Insights - Tonix Pharmaceuticals announced that its vaccine candidate TNX-801 provides durable protection against monkeypox after a single dose [1][3] - The vaccine is well tolerated in immunocompromised animals, showing no evidence of spreading to blood or tissues even at high doses [2][3] - TNX-801 is designed to generate both humoral and cellular immunity and serves as a platform for delivering multiple protective antigens against various viral pathogens [3][4] Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on developing therapies for pain management and vaccines for public health challenges [6] - The company has a diverse development portfolio, including TNX-102 SL for fibromyalgia, which has a PDUFA goal date of August 15, 2025 [6] - Tonix's infectious disease portfolio includes TNX-801 for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million with the U.S. Department of Defense [6]

Core Insights - The combination treatment of mTNX-1700 with anti-PD1 antibody has shown increased survival and decreased metastases in animal models of gastric cancer compared to anti-PD1 treatment alone [1][3] - mTNX-1700 activates cancer-killing CD8+ T cells and limits neutrophil-mediated immune evasion, indicating its potential in overcoming resistance to anti-PD-1 immunotherapy [1][2] Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, focusing on immunology and oncology [1][7] - The company is developing TNX-1700, a fusion protein for the treatment of gastric and colorectal cancers, under a license from Columbia University [4][5] Research Findings - The study published in Cancer Cell demonstrates that mTNX-1700 in combination with anti-PD-1 therapy shrank primary tumors, reduced liver and lung metastases, and increased survival in mouse models [2][3] - The research highlights the role of Trefoil Factor 2 (TFF2) in reducing immunosuppressive neutrophils and enhancing anti-tumoral CD8+ T cell responses [3][4] Future Development - Tonix Pharmaceuticals aims to further develop TNX-1700 to address the challenges of anti-PD-1 resistant cancers, with ongoing studies to identify potential clinical biomarkers [2][3] - The collaboration with Columbia University is expected to enhance understanding of TFF2's role in the tumor microenvironment and its impact on immunotherapy resistance [3][4]

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 [5] - The company is advancing TNX-102 SL, a product candidate for the management of fibromyalgia, with a PDUFA goal date of August 15, 2025, for marketing authorization [5] - Tonix's development portfolio includes biologics for organ transplant rejection, autoimmunity, and cancer, as well as vaccines for infectious diseases [5] Market Position - Tonix Pharmaceuticals will be added to the Russell 3000® Index and automatically included in the small-cap Russell 2000® Index as part of the 2025 Russell indexes reconstitution [1][3] - The Russell indexes are widely used by investment managers and institutional investors, with approximately $10.6 trillion in assets benchmarked against them as of June 2024 [3] Strategic Goals - The inclusion in the Russell Indexes is expected to enhance the company's visibility and awareness as it progresses towards potential FDA approval for TNX-102 SL [3] - The company is also developing TNX-4200, a broad-spectrum antiviral agent, under a contract with the U.S. Department of Defense for up to $34 million over five years [5]

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]