Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully integrated biotechnology company focused on developing therapies for pain management and vaccines for public health challenges [8] - The company is advancing TNX-102 SL, a product candidate for managing fibromyalgia, with a New Drug Application (NDA) submitted based on two statistically significant Phase 3 studies [8] - TNX-102 SL has received Fast Track designation from the FDA for the management of fibromyalgia and is also being developed for acute stress reaction and acute stress disorder [8] Clinical Trial Details - The OASIS trial, an investigator-initiated Phase 2 trial, aims to evaluate TNX-102 SL's potential to reduce the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) [2][3] - The trial is sponsored by the University of North Carolina (UNC) and supported by a $3 million grant from the U.S. Department of Defense [2][3] - Approximately 180 motor vehicle collision (MVC) trauma survivors will be enrolled in the trial, which will randomize participants to receive either TNX-102 SL 5.6 mg or a placebo for two weeks [3] Market Need and Background - There is a significant unmet need for treating ASR after traumatic events, with about 60% of men and 50% of women in the U.S. experiencing at least one trauma in their lives [5] - One-third of emergency department visits in the U.S. (40-50 million patients per year) involve evaluations after trauma exposures [5] - Currently, no medication is available to treat the initial reaction to traumatic events and support long-term health, which could prevent the development or worsening of ASD and PTSD [5] Drug Mechanism and Composition - TNX-102 SL is a non-opioid investigational drug designed for chronic use, formulated as a sublingual tablet of cyclobenzaprine hydrochloride for bedtime dosing [6][7] - The formulation aims to improve sleep quality and manage fibromyalgia symptoms by targeting non-restorative sleep [6][7] - Patents for TNX-102 SL's formulation provide market protection until 2034, with successful maintenance of its European Patent [7] Research Initiatives - The OASIS trial builds upon the knowledge and infrastructure from the UNC-led AURORA initiative, a $40 million national research effort to improve understanding and recovery from traumatic events [4] - AURORA is supported by funding from the National Institutes of Health (NIH) and partnerships with leading tech companies [4]

Mr. Hand brings more than 20 years of strategic legal and business leadership experience across multiple functions in the biopharmaceutical industry, including nearly a decade in senior executive positions at Celgene Served on Celgene's Executive Committee and played a key leadership role in the BMS transaction, the integration of Celgene into BMS, and the divestiture of Otezla to Amgen Appointment marks a key addition as Tonix readies for the potential approval of TNX-102 SL for the management of fibromyal ...

[Executive Summary & Operational Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Operational%20Highlights) [First Quarter 2025 Highlights](index=1&type=section&id=First%20Quarter%202025%20Financial%20Results%20and%20Operational%20Highlights) Tonix Pharmaceuticals reported key operational advancements including a PDUFA goal date for TNX-102 SL for fibromyalgia, positive Phase 1 results for TNX-1500, and a strong cash position of **$131.7 million**, sufficient to fund operations into **Q2 2026** - FDA PDUFA goal date of **August 15, 2025**, for TNX-102 SL for the management of fibromyalgia; if approved, it would be the **first new drug** for treating fibromyalgia in over **15** years[1](index=1&type=chunk) - Announced **positive topline results** from Phase 1 study of TNX-1500, a next-generation anti-CD40L mAb candidate for prevention of kidney transplant rejection and treatment of autoimmune disorders[1](index=1&type=chunk) Cash and Cash Equivalents Summary | Metric | As of March 31, 2025 | | :----- | :------------------- | | Cash and cash equivalents | $131.7 million | - Current cash is **sufficient to fund operations into the second quarter of 2026**[1](index=1&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) The CEO highlighted the progress of TNX-102 SL towards its PDUFA date and anticipated Q4 launch, emphasizing its potential as a new non-opioid therapeutic option for fibromyalgia. He also expressed encouragement regarding pipeline achievements, including TNX-1500 and TNX-801 - TNX-102 SL is on track for a new therapeutic option for fibromyalgia, with an FDA PDUFA goal date of **August 15, 2025**, and commercial team building for an anticipated **Q4 launch**[2](index=2&type=chunk) - Encouraged by continued achievements in the pipeline, including **positive Phase 1 results for TNX-1500** and **preclinical results for TNX-801**[2](index=2&type=chunk) [Key Investigational Product Candidates - Recent Highlights](index=1&type=section&id=Key%20Investigational%20Product%20Candidates*%20--%20Recent%20Highlights) [Central Nervous System (CNS) Pipeline](index=1&type=section&id=Central%20Nervous%20System%20(CNS)%20Pipeline) The CNS pipeline focuses on TNX-102 SL for fibromyalgia and acute stress disorders, and TNX-1300 for cocaine intoxication, with significant regulatory milestones and ongoing studies [TNX-102 SL (Fibromyalgia)](index=1&type=section&id=TNX-102%20SL%20(cyclobenzaprine%20HCl%20sublingual%20tablets)%3A%205.6%20mg%2C%20once-daily%20at%20bedtime%20small%20molecule%20for%20the%20management%20of%20fibromyalgia%20(FM)) - FDA will **not require an Advisory Committee meeting** to discuss the NDA for TNX-102 SL for fibromyalgia[4](index=4&type=chunk) - FDA previously granted **Fast Track designation** to TNX-102 SL for fibromyalgia in **2024**[4](index=4&type=chunk) - NDA for TNX-102 SL for fibromyalgia was accepted by FDA in **December 2024** with a PDUFA goal date of **August 15, 2025**[4](index=4&type=chunk) - Presented data and analyses of TNX-102 SL treatment and effects on fibromyalgia at the American Academy of Pain Medicine (AAPM) **2025** Annual Meeting and the **7th** International Congress on Controversies in Fibromyalgia[7](index=7&type=chunk) [TNX-102 SL (Acute Stress Reaction/Disorder & PTSD)](index=2&type=section&id=TNX-102%20SL%20in%20development%20for%20the%20treatment%20of%20acute%20stress%20reaction%20(ASR)%20and%20acute%20stress%20disorder%20(ASD)%2C%20and%20prophylaxis%20against%20development%20of%20posttraumatic%20stress%20disorder%20(PTSD)) - The U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) trial for TNX-102 SL is expected to be initiated in the **second quarter of 2025**[5](index=5&type=chunk) [TNX-1300 (Cocaine Intoxication)](index=2&type=section&id=TNX-1300%20(recombinant%20double%20mutant%20cocaine%20esterase)%3A%20under%20investigation%20for%20biologic%20for%20cocaine%20intoxication) - The National Institutes of Health (NIH)'s National Institute of Drug Abuse (NIDA) **awarded Tonix a Cooperative Agreement grant for approximately $5 million** to support development of TNX-1300[8](index=8&type=chunk) - TNX-1300 has been granted **Breakthrough Therapy designation** by the FDA[8](index=8&type=chunk) - The Phase 2 CATALYST study of TNX-1300 was **discontinued due to slower than projected enrollment**, **not for safety or efficacy reasons**; **new study designs and endpoints are being evaluated**[8](index=8&type=chunk) [Immunology Pipeline](index=2&type=section&id=Immunology%20Pipeline) The immunology pipeline is centered on TNX-1500, a next-generation anti-CD40L mAb, which showed positive Phase 1 results and is being developed for organ transplant rejection and autoimmune disorders [TNX-1500 (Organ Transplant Rejection & Autoimmune Disorders)](index=2&type=section&id=TNX-1500%20(anti-CD40L%20Fc-modified%20humanized%20monoclonal%20antibody)%3A%20third%20generation%20anti-CD40L%20monoclonal%20antibody%20under%20investigation%20for%20prophylaxis%20for%20organ%20transplant%20rejection%20and%20treatment%20of%20autoimmune%20disorders.)) - Announced **positive topline results** from its Phase 1, single ascending dose (SAD) first-in-human trial of TNX-1500 in healthy participants in **February 2025**, **meeting all objectives and supporting progression to a Phase 2 trial**[6](index=6&type=chunk) - TNX-1500 showed a **mean half-life of 34-38 days** for **10 mg/kg** and **30 mg/kg** doses, **supporting monthly dosing** for future efficacy trials[6](index=6&type=chunk) - The first proposed indication for TNX-1500 is prophylaxis of organ rejection in adult patients receiving a kidney transplant, with multiple additional indications possible, including autoimmune diseases[9](index=9&type=chunk) [Infectious Disease Pipeline](index=3&type=section&id=Infectious%20Disease%20Pipeline) The infectious disease pipeline features TNX-801, a potential vaccine for mpox and smallpox, which has shown positive preclinical efficacy and received grant support [TNX-801 (Mpox and Smallpox Vaccine)](index=3&type=section&id=TNX-801%20(recombinant%20horsepox%20virus%2C%20minimally%20replicative%20live%20vaccine)%3A%20potential%20vaccine%20to%20protect%20against%20mpox%20and%20smallpox.)) - Presented **positive preclinical efficacy data** on TNX-801 at the World Vaccine Congress Washington **2025**, demonstrating protection of animals from mpox and rabbitpox, and **good tolerability** even in immunocompromised animals[12](index=12&type=chunk) - **Awarded a grant from the Medical CBRN Defense Consortium (MCDC)** in **March 2025** to support the development of a commercialization plan for TNX-801[12](index=12&type=chunk) [Corporate and Partnerships – Recent Highlights](index=3&type=section&id=Corporate%20and%20Partnerships%20%E2%80%93%20Recent%20Highlights*) [Strategic Collaborations & Grants](index=3&type=section&id=Strategic%20Collaborations%20%26%20Grants) Tonix has engaged in new strategic collaborations, including a research agreement with Makana Therapeutics for TNX-1500 in xenotransplantation, and secured a grant for TNX-801 development - Entered into a collaborative research agreement with Makana Therapeutics to study TNX-1500 in combination with Makana's human-compatible pig organs and cells for xenotransplant[12](index=12&type=chunk) - **Awarded a grant from the Medical CBRN Defense Consortium (MCDC)** to support the development of a commercialization plan for TNX-801[12](index=12&type=chunk) [Digital Health Platform Launch](index=3&type=section&id=Digital%20Health%20Platform%20Launch) Tonix launched TONIX ONE, a new digital platform designed to provide resources and telehealth access to migraine specialists for patients - **Launched TONIX ONE, a fully-integrated digital platform** providing educational resources and connecting migraine patients to independent specialists via telehealth services and e-prescription requests[12](index=12&type=chunk) [Management Appointments](index=3&type=section&id=Management%20Appointments) During **Q1 2025**, Tonix announced the promotion of Siobhan Fogarty to Chief Technical Officer and the appointment of Gary Ainsworth as Vice President, Market Access - **Promoted Siobhan Fogarty to Chief Technical Officer and appointed Gary Ainsworth as Vice President, Market Access** during the first quarter of **2025**[12](index=12&type=chunk) [Financial - Recent Highlight & Results](index=4&type=section&id=Financial%20-%20Recent%20Highlight) [Cash Position & Liquidity](index=4&type=section&id=Cash%20Position%20%26%20Liquidity) Tonix's cash and cash equivalents increased to **$131.7 million** as of **March 31, 2025**, supported by equity offerings. The company projects its current cash resources to fund operations into the **second quarter of 2026** Cash and Cash Equivalents Summary | Metric | March 31, 2025 | December 31, 2024 | Change | | :----- | :------------- | :---------------- | :----- | | Cash and cash equivalents | $131.7 million | $98.8 million | +$32.9 million | - **Net cash used in operations was approximately $16.6 million for Q1 2025, compared to $17.6 million for Q1 2024, representing a decrease of $1.0 million**[14](index=14&type=chunk) - **Sold approximately 2.7 million shares of common stock for net proceeds of $59.8 million during Q1 2025, and an additional 0.6 million shares for $9.9 million subsequent to March 31, 2025**[15](index=15&type=chunk) - **The Company believes its cash resources at March 31, 2025, along with subsequent equity proceeds, will meet operating and capital expenditure requirements into the second quarter of 2026**[16](index=16&type=chunk) [First Quarter 2025 Financial Results](index=4&type=section&id=First%20Quarter%202025%20Financial%20Results) The company experienced a slight decline in net product revenue and a significant reduction in R&D expenses, while SG&A expenses increased. This resulted in an increased net loss for **Q1 2025** compared to **Q1 2024**, alongside a substantial increase in weighted average common shares outstanding [Net Product Revenue & Cost of Sales](index=4&type=section&id=Net%20Product%20Revenue%20%26%20Cost%20of%20Sales) Net Product Revenue and Cost of Sales | Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Net product revenue | $2.4 million | $2.5 million | -$0.1 million (-4.0%) | | Cost of Sales | $0.9 million | $1.7 million | -$0.8 million (-47.1%) | [Operating Expenses](index=4&type=section&id=Operating%20Expenses) Operating Expenses Breakdown | Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Research and development expenses | $7.4 million | $12.9 million | -$5.5 million (-42.6%) | | Selling, general and administrative expenses | $10.1 million | $9.3 million | +$0.8 million (+8.6%) | - **Decrease in R&D expenses predominantly due to decreased clinical, non-clinical, manufacturing, and employee-related expenses**[18](index=18&type=chunk) - **Increase in SG&A expenses primarily due to an increase in sales and marketing expenses, offset by a decrease in employee-related expenses resulting from a workforce reduction in early 2024**[19](index=19&type=chunk) [Net Loss & EPS](index=4&type=section&id=Net%20Loss%20%26%20EPS) Net Loss and Earnings Per Share | Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Net loss available to common stockholders | $(16.8) million | $(14.9) million | -$(1.9) million (+12.8%) | | Net loss per common share, basic and diluted | $(2.84) | $(535.72) | Significant decrease due to share count increase | | Weighted average common shares outstanding | 5,927,231 | 27,886 | +5,899,345 (+21155.7%) | [Company Information](index=4&type=section&id=About%20Tonix%20Pharmaceuticals%20Holding%20Corp.) [About Tonix Pharmaceuticals Holding Corp.](index=4&type=section&id=About%20Tonix%20Pharmaceuticals%20Holding%20Corp.) Tonix is a **fully-integrated biopharmaceutical company** focused on CNS disorders, pain management, and public health vaccines. Its priority is advancing TNX-102 SL for fibromyalgia, with other key programs including TNX-1500 for immunology and TNX-801 for infectious diseases. The company also markets Zembrace® SymTouch® and Tosymra® for acute migraine - **Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges, with a development portfolio focused on central nervous system (CNS) disorders**[21](index=21&type=chunk) - **Priority is to advance TNX-102 SL for fibromyalgia**, with an **NDA submitted** and a PDUFA goal date of **August 15, 2025**[21](index=21&type=chunk) - **Immunology development portfolio includes TNX-1500 for organ transplant rejection and autoimmune diseases**; **infectious disease portfolio includes TNX-801 for mpox and smallpox, and TNX-4200 (broad-spectrum antiviral) with a DoD contract**[21](index=21&type=chunk) - **Commercial subsidiary, Tonix Medicines, markets Zembrace® SymTouch® and Tosymra® for the treatment of acute migraine**[21](index=21&type=chunk) [Legal & Disclosures](index=6&type=section&id=Legal%20%26%20Disclosures) [Trademarks & Website](index=6&type=section&id=Trademarks%20%26%20Website) This section clarifies the trademarks associated with Tonix's products and directs readers to the company's website for additional information - **Zembrace SymTouch, Tosymra and TONIX ONE are trademarks of Tonix Medicines**[22](index=22&type=chunk) - **Further information about Tonix can be found at www.tonixpharma.com**[23](index=23&type=chunk) [Forward Looking Statements](index=6&type=section&id=Forward%20Looking%20Statements) The report contains forward-looking statements based on current expectations, with actual results potentially differing due to various risks. Investors are advised to review risk factors detailed in the company's SEC filings - **Certain statements are forward-looking, based on current expectations, and actual results could differ materially due to various factors**[24](index=24&type=chunk) - **Factors include risks related to FDA clearances/approvals, marketing success, clinical development timing, financing needs, patent protection, reimbursement, and competition**[24](index=24&type=chunk) - **Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC**[24](index=24&type=chunk) [Condensed Consolidated Financial Statements](index=7&type=section&id=Condensed%20Consolidated%20Financial%20Statements) [Condensed Consolidated Statements of Operations](index=7&type=section&id=TONIX%20PHARMACEUTICALS%20HOLDING%20CORP.%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) The condensed consolidated statements of operations for **Q1 2025** show a net product revenue of **$2.4 million**, an operating loss of **$(16.1) million**, and a net loss available to common stockholders of **$(16.8) million**, or **$(2.84)** per share Condensed Consolidated Statements of Operations | Metric (in thousands) | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Product revenue, net | $2,429 | $2,482 | | Cost of sales | $943 | $1,660 | | Research and development | $7,436 | $12,863 | | General and administrative | $10,104 | $9,310 | | Total operating expenses | $18,483 | $23,833 | | Operating loss | $(16,054) | $(21,351) | | Grant income | $923 | — | | Gain on change in fair value of warrant liabilities | — | $7,005 | | Loss on extinguishment of debt | $(2,092) | — | | Other income (expense), net | $394 | $(593) | | Net loss available to common stockholders | $(16,829) | $(14,939) | | Net loss per common share, basic and diluted | $(2.84) | $(535.72) | | Weighted average common shares outstanding, basic and diluted | 5,927,231 | 27,886 | [Condensed Consolidated Balance Sheets](index=8&type=section&id=TONIX%20PHARMACEUTICALS%20HOLDING%20CORP.%20CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of **March 31, 2025**, Tonix reported total assets of **$192.9 million**, an increase from **$162.9 million** at **December 31, 2024**. This increase was primarily driven by a rise in cash and cash equivalents, contributing to an increase in total stockholders' equity Condensed Consolidated Balance Sheets | Metric (in thousands) | March 31, 2025 | December 31, 2024 | | :-------------------- | :------------- | :---------------- | | Cash and cash equivalents | $131,716 | $98,776 | | Total current assets | $149,573 | $119,002 | | Total assets | $192,870 | $162,890 | | Total liabilities | $12,474 | $23,332 | | Stockholders' equity | $180,396 | $139,558 | [Marketed Product Information](index=9&type=section&id=Marketed%20Product%20Information) [Investor & Media Contact](index=9&type=section&id=Investor%20Contact) This section provides contact information for investor relations and media inquiries for Tonix Pharmaceuticals - **Investor Contact: Jessica Morris (Tonix Pharmaceuticals) and Peter Vozzo (ICR Healthcare)**[29](index=29&type=chunk) - **Media Contact: Ray Jordan (Putnam Insights)**[29](index=29&type=chunk) [About Zembrace SymTouch and Tosymra](index=9&type=section&id=About%20Zembrace%20SymTouch%20and%20Tosymra) Zembrace® SymTouch® and Tosymra® are prescription medicines for acute migraine headaches with or without aura in adults, **not for prevention**, and their **safety and effectiveness in children under 18 years of age are not known** - **Zembrace® SymTouch® (sumatriptan succinate) injection and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults**[29](index=29&type=chunk) - **These products are not used to prevent migraines, and their safety and effectiveness in children under 18 years of age are not known**[30](index=30&type=chunk) [Important Safety Information](index=9&type=section&id=Important%20Safety%20Information) Zembrace and Tosymra carry **serious risks**, including heart attack and other cardiovascular problems, and are contraindicated for individuals with certain medical conditions or those taking specific medications. Patients should be aware of potential side effects and seek immediate medical attention for severe symptoms - **Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death**[31](index=31&type=chunk) - **Contraindications include a history of heart problems, peripheral vascular disease, uncontrolled high blood pressure, specific migraine types (hemiplegic or basilar), stroke history, severe liver problems, and concurrent use with certain medications (e.g., other triptans, ergotamines, MAO-A inhibitors)**[34](index=34&type=chunk)[37](index=37&type=chunk) - **Common side effects include injection site pain/redness (Zembrace), tingling/numbness, dizziness, flushing, neck discomfort, weakness, drowsiness, application site reactions (Tosymra), and throat irritation (Tosymra)**[34](index=34&type=chunk) - **Serious side effects can include changes in color or sensation in fingers/toes, sudden or severe stomach pain, leg/hip cramping, increased blood pressure, medication overuse headaches, serotonin syndrome, allergic reactions (hives, swelling), and seizures**[37](index=37&type=chunk) - Patients are encouraged to report adverse effects of prescription drugs to the FDA[36](index=36&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission file number: 001-36019 TONIX PHARMACEUTICALS HOLDING CORP. (Exact name of registrant as specified in its charter) Securities ...

Core Insights - Tonix Pharmaceuticals is on track to potentially launch TNX-102 SL, a new non-opioid analgesic for fibromyalgia, with a PDUFA goal date set for August 15, 2025, marking the first new drug for this condition in over 15 years [1][2][4] - The company reported positive topline results from a Phase 1 study of TNX-1500, an anti-CD40L monoclonal antibody aimed at preventing kidney transplant rejection and treating autoimmune disorders [1][8] - As of March 31, 2025, Tonix had cash and cash equivalents of $131.7 million, sufficient to fund operations into the second quarter of 2026 [1][12][14] Product Development Highlights - TNX-102 SL is designed to improve sleep disturbances associated with fibromyalgia, with FDA Fast Track designation granted in 2024 [4][20] - The NDA for TNX-102 SL was accepted by the FDA based on two Phase 3 studies demonstrating significant pain reduction in fibromyalgia patients [4][20] - TNX-1500 has shown a favorable safety profile and pharmacokinetics, supporting its progression to a Phase 2 trial for kidney transplant recipients [8][6] Financial Overview - For Q1 2025, net product revenue was approximately $2.4 million, slightly down from $2.5 million in Q1 2024 [16] - Research and development expenses decreased to $7.4 million in Q1 2025 from $12.9 million in Q1 2024, primarily due to reduced clinical and manufacturing costs [17] - The net loss for Q1 2025 was $16.8 million, or $2.84 per share, compared to a net loss of $14.9 million, or $535.72 per share, in the same period of 2024 [19][24] Pipeline and Partnerships - TNX-801, a live-virus vaccine, is in development for mpox and smallpox, with positive preclinical efficacy data presented at the World Vaccine Congress [15][9] - The company has entered a collaborative research agreement with Makana Therapeutics to study TNX-1500 in combination with xenotransplantation [15] - Tonix is also developing TNX-1300 for cocaine intoxication, which has received Breakthrough Therapy designation from the FDA [7][6]

Core Insights - Tonix Pharmaceuticals is advancing TNX-1700, a combination therapy involving TFF2 and anti-PD1 antibody, showing potential in enhancing anti-tumor immune responses in gastric and colorectal cancers [1][2] - The company presented promising preclinical data at the AACR 2025 Annual Meeting, indicating that TFF2-mediated CXCR4 partial agonism is more effective than antagonism in reducing gastric cancer in animal models [1][2] Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company with a focus on developing therapies for pain management, immunology, and infectious diseases [7] - The company is also working on TNX-102 SL for fibromyalgia, which has received Fast Track designation from the FDA, with a PDUFA goal date of August 15, 2025 [7] Research and Development - TNX-1700 is being developed under a license from Columbia University, with Dr. Timothy Wang as the inventor, who has demonstrated the protective role of TFF2 against cancer development [3] - The research indicates that TFF2 can suppress immunosuppressive neutrophils (PMN-MDSCs) and enhance the activation of CD8+ T cells, which are crucial for anti-tumor immunity [2][3] Clinical Implications - The combination of TFF2 and anti-PD1 therapy has shown promise in reducing immunosuppression in the tumor microenvironment, potentially leading to improved treatment outcomes for patients with gastric cancer [2] - The correlation between TFF2 levels and PMN-MDSCs in gastric cancer patients suggests a potential biomarker for treatment efficacy [2]

Core Viewpoint - TNX-801 is a promising single-dose live virus vaccine in development to protect against mpox and smallpox, demonstrating positive preclinical efficacy and tolerability, particularly in immunocompromised animals [1][2][3]. Group 1: Vaccine Efficacy and Safety - TNX-801 has shown the ability to protect immunocompromised animals from lethal challenges with both clade IIa monkeypox virus and rabbitpox, with a demonstrated six-month durability of protection [1][2]. - The vaccine is well tolerated, with no spreading to blood or tissues observed even at high doses in immunocompromised animals [1][2]. - After a single dose, TNX-801 prevented clinical disease and lesion formation in non-human primates, indicating effective mucosal immunity and potential to block forward transmission [3][4]. Group 2: Market Need and Regulatory Context - The ongoing clade IIb and clade Ib mpox epidemics, declared by the WHO as Public Health Emergencies of International Concern, underscore the urgent need for additional vaccine options, particularly single-dose vaccines [2][4]. - TNX-801 aligns with the WHO's preferred target product profile, which emphasizes single-dose administration, durable protection, and stability at ambient temperature [2][4]. Group 3: Company Overview and Development Plans - Tonix Pharmaceuticals is a fully integrated biopharmaceutical company focused on developing therapies for public health challenges, including TNX-801 for mpox and smallpox [5]. - The company has received feedback from the FDA regarding the development of TNX-801 and is collaborating with the Kenya Medical Research Institute to plan a Phase I clinical study [3][4]. - Tonix's broader portfolio includes other candidates for CNS disorders and infectious diseases, highlighting its commitment to addressing significant health challenges [5].

Core Insights - Tonix Pharmaceuticals will present at the World Vaccine Congress Washington 2025, focusing on a novel mpox vaccine and leading a panel discussion on vaccine development and biosecurity policy [1][2][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, and has received Fast Track designation from the FDA [4] - Tonix's CNS portfolio includes TNX-1300 for cocaine intoxication, which has FDA Breakthrough Therapy designation, and TNX-1500 for organ transplant rejection and autoimmune diseases [4] - The infectious disease portfolio includes TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million with the U.S. DoD [4] Upcoming Events - The oral presentation will be led by Dr. Farooq Nasar on April 23, 2025, at 10:10 a.m., discussing a single-dose mpox vaccine [2] - A panel discussion moderated by Dr. Zeil Rosenberg will take place on the same day at 3:25 p.m., addressing mpox and smallpox threats [3]

Agreement includes the use of Tonix's TNX-1500, as part of an immunomodulatory regimen to reduce rejection of Makana's genetically engineered pig organs in xenotransplantation Establishes framework for Makana's kidney, heart and islet cell programs to utilize TNX-1500 for preclinical studies in support of regulatory filings for potential use in human recipients CHATHAM, N.J. and MIAMI, April 09, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), ("Tonix") a fully-integrated biophar ...

Core Viewpoint - The collaboration between Tonix Pharmaceuticals and Makana Therapeutics aims to utilize Tonix's TNX-1500 monoclonal antibody in conjunction with Makana's genetically engineered pig organs to enhance organ compatibility and reduce rejection in xenotransplantation [1][2]. Group 1: Collaboration Details - Tonix and Makana have established a research agreement to study TNX-1500 in combination with Makana's human-compatible organs for organ failure treatment [1]. - The collaboration will support preclinical studies for kidney, heart, and islet cell transplant programs, aiming for regulatory filings for potential human use [1][2]. - The goal is to submit an investigational new drug application (IND) to the FDA for compassionate use in patients undergoing xenotransplantation [1]. Group 2: Product and Technology Insights - TNX-1500 is an investigational humanized monoclonal antibody targeting CD40L, which plays a crucial role in immune system activation and transplant immunomodulation [2][8]. - Makana's genetically engineered pigs, particularly the SLA DR knockout pig, have shown improved compatibility and potential for producing viable organs for transplantation [2][3][4]. - The collaboration aims to leverage the best-in-class pharmacokinetics and pharmacodynamics of TNX-1500, which has demonstrated effectiveness in preventing rejection in animal studies [2][7]. Group 3: Industry Context - The field of xenotransplantation faces challenges in organ compatibility and rejection, making this collaboration significant for advancing clinical applications [2][5]. - Makana's focus on antigen discovery and deletion, rather than relying on transgenic modifications, positions it favorably for future commercialization of xenotransplantation products [6][5]. - The partnership is expected to streamline the development of safer and more effective transplantation solutions, addressing the critical shortage of available human organs [2][4].