Tonix Pharmaceut 8-K Filings

Tonix Pharmaceuticals reported strong second quarter 2026 growth in commercial performance driven by TONMYA, its fibromyalgia treatment launched in November 2025. Net product revenue was $13.5 million for the quarter, up from $2.0 million a year earlier, including $11.0 million from TONMYA and $2.5 million from migraine products. TONMYA net sales increased approximately 197% quarter-over-quarter and total prescriptions reached 12,592, doubling versus the prior quarter, with refills up 207%.

Payer coverage expanded meaningfully, with TONMYA now reaching about 136 million covered lives (43% of U.S. covered lives) across commercial, managed Medicare, and Medicaid, expected to rise to roughly 145 million on January 1, 2027. Tonix is growing its TONMYA sales force to about 150 representatives by September 2026. The company continues to invest heavily in its pipeline, including Phase 2 programs for TNX-102 SL in major depressive disorder and adaptive Phase 2 planning for TNX-4800 in Lyme disease prevention. These initiatives contributed to a net loss of $40.6 million for the quarter and net cash used in operating activities of $84.6 million for the first half of 2026, funded by $176.2 million in cash and cash equivalents as of June 30, 2026 and additional ATM proceeds.

Tonix Pharmaceuticals Holding Corp. reported receiving official minutes from a Type C meeting with the U.S. FDA outlining alignment on an adaptive Phase 2 field study of TNX-4800, a long-acting monoclonal antibody to prevent Lyme disease in U.S. adults.

The planned randomized, placebo-controlled study would enroll approximately 3,300 adults in Lyme-endemic areas over two seasons, randomizing participants 1:1 to TNX-4800 450 mg subcutaneously or placebo in a two-dose regimen three months apart. The primary efficacy endpoint is Lyme disease prevention at six months after the first dose, with a key secondary endpoint at three months, and a primary safety objective of assessing safety and tolerability over 52 weeks.

Tonix plans to start the Phase 2 study in the first quarter of 2027 and expects most enrollment in 2028, with possible extension to 2029 if the attack rate is lower than expected. TNX-4800 is Fc-modified for extended half-life, is supported by non-human primate data showing high preventive efficacy, and is covered by a U.S. patent expiring in 2036, alongside potential 12-year biologic exclusivity.

Tonix Pharmaceuticals Holding Corp. reports an upcoming leadership change. On July 20, 2026, Dr. Gregory M. Sullivan informed the company that he will retire from his role as Chief Medical Officer, effective August 20, 2026. This reflects a planned transition in a key executive position.

Tonix Pharmaceuticals Holding Corp. entered into an agreement with a pharmacy benefit manager to provide TONMYA coverage for Medicare Part D beneficiaries, effective January 1, 2027. The agreement adds coverage for approximately 9 million Medicare lives, or 16% of about 55 million Medicare beneficiaries in the U.S.

Combined with two previously announced commercial coverage agreements and Medicaid availability in most states representing approximately 73 million lives, pharmacy coverage for TONMYA is expected to reach about 145 million covered lives on January 1, 2027, or 46% of 314 million covered lives. Tonix plans to expand its sales force by 50 representatives by mid–third quarter 2026, bringing the total to around 150 to support the product’s launch.

TONMYA, a 2.8 mg cyclobenzaprine HCl sublingual tablet, was approved by the FDA on August 15, 2025 for treatment of fibromyalgia in adults, with U.S. patent protection expected to provide market exclusivity until 2034. The disclosure also reiterates extensive safety, contraindication, and use-in-specific-populations information for TONMYA.

Tonix Pharmaceuticals Holding Corp. announced that the first patient has been enrolled in HORIZON, a potentially pivotal Phase 2 trial of TNX-102 SL 5.6 mg as a first-line monotherapy for adults with major depressive disorder. The 6-week, randomized, double-blind, placebo-controlled study plans to enroll approximately 360 patients at about 30 U.S. sites, with a primary endpoint of change from baseline in the MADRS depression score at Week 6 and secondary measures including global impression, anxiety, and sleep quality. TNX-102 SL, a sublingual cyclobenzaprine tablet, is already FDA-approved as TONMYA for fibromyalgia in adults, and Tonix holds multiple U.S. patents expected to provide market exclusivity for TNX-102 SL until 2034, with method-of-use applications that could extend to 2044.

Tonix Pharmaceuticals entered an agreement with a second leading group purchasing organization effective June 1, 2026, expanding commercial payer coverage for TONMYA, its FDA-approved fibromyalgia treatment for adults. The new contract adds access for approximately 17 million U.S. commercially insured individuals with standard utilization management criteria.

Combined with a prior GPO deal, TONMYA now has commercial coverage for about 52 million U.S. lives, representing roughly 29% of an estimated 177 million commercial lives. TONMYA is also available under Medicaid in most states, covering approximately 75 million beneficiaries, and Tonix continues discussions with Medicare while supporting patients through its TONMYA Together savings program.

Tonix Pharmaceuticals Holding Corp. reported that Phase 1 clinical data for its investigational monoclonal antibody TNX-1500 were published in the Journal of Clinical Immunology. In a first-in-human study of 26 healthy adults, single intravenous doses of 3, 10, or 30 mg/kg were generally well tolerated, with no serious adverse events and only mild, transient aphthous ulcers deemed possibly related to TNX-1500.

TNX-1500 significantly suppressed T cell-dependent antibody responses to the KLH antigen, blocking primary responses at all doses and secondary responses at 10 and 30 mg/kg, with about a 70% reduction at 3 mg/kg versus placebo. Pharmacokinetic data showed dose-proportional exposure and terminal half-lives around 34–38 days, supporting monthly dosing. Tonix highlighted that a Phase 2 investigator-initiated study in kidney transplant recipients at Massachusetts General Hospital is expected to begin in the second half of 2026, pending FDA clearance of the IND.

Tonix Pharmaceuticals reported Phase 1 results for TNX-4800, an investigational long-acting monoclonal antibody designed to prevent Lyme disease. In 44 healthy volunteers, single subcutaneous doses showed a favorable safety profile, mostly mild injection-site reactions, and dose‑proportional pharmacokinetics with a mean half‑life of about 62–69 days. Serum levels were detectable within two days and remained quantifiable for up to 12 months in most participants, with exposure at the highest 10 mg/kg dose under 17% of peak levels seen in rat toxicology. Nonclinical primate data support protective serum thresholds, and modeling underpins a two‑dose regimen. Tonix plans an adaptive Phase 2 field study in 2027, pending FDA agreement, while highlighting approximately $185.5 million in cash and no debt as of March 31, 2026.

Tonix Pharmaceuticals reported first quarter 2026 results showing early commercial traction for TONMYA alongside higher spending and losses. Net product revenue rose to approximately $6.9 million, up from $2.4 million a year earlier, driven by TONMYA, Zembrace SymTouch and Tosymra.

Net revenue from TONMYA was about $3.7 million in the quarter, with roughly 2,145 prescribers, 3,588 patients starting treatment and ~5,400 prescriptions filled in the first full quarter since launch. Research and development expenses increased to about $18.2 million and selling, general and administrative expenses to $28.6 million as the company invested in its pipeline and commercial infrastructure.

Tonix posted a net loss available to common stockholders of approximately $40.2 million, or $2.93 per share, compared with a loss of about $16.8 million, or $2.84 per share, in the prior-year quarter. Cash and cash equivalents were roughly $185.5 million as of March 31, 2026, and management believes existing cash plus second-quarter equity proceeds will fund operations into early second quarter 2027.

Tonix Pharmaceuticals Holding Corp. reported results of its annual shareholder meeting. Shareholders approved the 2026 Stock Incentive Plan, allowing equity-based awards to employees, directors and key consultants. They also authorized the Board, within two years of May 7, 2026, to implement one or more reverse stock splits at ratios between 1-for-2 and 1-for-250 of the then-outstanding common shares, with exact terms to be set later. Nine directors were elected and PricewaterhouseCoopers LLP was ratified as independent registered public accounting firm for the fiscal year ending December 31, 2026.

Tonix Pharmaceuticals Holding Corp. entered into an agreement with a leading group purchasing organization, effective May 1, 2026, that provides commercial insurance coverage for TONMYA to approximately 35 million U.S. lives, about 20% of roughly 177 million commercially insured individuals.

TONMYA, a first-in-class non-opioid analgesic and the first new FDA-approved treatment for fibromyalgia in adults in more than 15 years, is also covered under Medicaid in 38 states for approximately 55 million beneficiaries, representing 73% of roughly 75 million Medicaid lives.

Tonix Pharmaceuticals released preliminary figures for the quarter ended March 31, 2026. Net revenue from Zembrace® SymTouch® and Tosymra® was about $3.2 million, up from $2.4 million for the same quarter in 2025, reflecting higher migraine-product sales.

Net revenue from TONMYA® was about $3.7 million in the quarter, following its November 2025 launch and $1.4 million of revenue through December 31, 2025. The company believes its March 31, 2026 cash resources plus $17.4 million of second-quarter 2026 equity-offering proceeds will fund planned operations and capital needs into the second quarter of 2027.

The company emphasized these results are unaudited, preliminary estimates prepared by management and subject to change as closing procedures are completed. Its independent auditor has not reviewed this data. Tonix currently expects to file its full Quarterly Report on Form 10-Q on or about May 11, 2026.

Tonix Pharmaceuticals reported new data and development plans for TNX-4800, a long-acting monoclonal antibody designed to prevent Lyme disease by targeting the OspA protein on Borrelia burgdorferi. The company presented Phase 1 results and program updates at the 4th Annual Ticks and Tickborne Diseases Symposium.

Phase 1, a randomized, double-blind, dose-escalation study in 44 healthy adults, found TNX-4800 to be generally safe and well tolerated, with no significant clinical or laboratory safety signals and mostly mild or moderate adverse events. Tonix plans a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study starting in the first half of 2027, pending FDA agreement, testing a fixed two-dose subcutaneous regimen given in Spring and two months later, aiming to prevent Lyme disease for six months after the initial dose.

Tonix Pharmaceuticals Holding Corp. filed a report describing new preclinical data on its immuno-oncology candidates TNX-1700 and TNX-4700 presented at the 2026 AACR Annual Meeting. Collaborators showed that a murine version of TNX-1700 reversed aging-associated gastric inflammation and attenuated tumor progression in aged mice.

A second study found TNX-1700 had dose-independent, linear pharmacokinetics in non-human primates and human FcRn/serum albumin transgenic mice, with all animals surviving without major weight loss. A third poster reported that TNX-4700, an anti-BTLA antibody, demonstrated potent, high-affinity binding and functional antagonism in vitro.

Tonix Pharmaceuticals Holding Corp. reported Phase 1 results and next-step plans for TNX-4800, a long-acting monoclonal antibody being developed to prevent Lyme disease. The single-dose subcutaneous treatment is designed to offer about four months of protection for people in Lyme-endemic U.S. regions.

The Phase 1 trial enrolled 44 healthy adults, with 41 completing, and showed TNX-4800 was generally safe and well tolerated across doses from 0.5 to 10 mg/kg, with most side effects mild or moderate. Pharmacokinetic data showed rapid absorption, long half-life of roughly two to three months, and serum levels remaining measurable for up to 12 months.

Based on these data, Tonix plans a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study using a fixed 350 mg dose. The primary goal is to test whether TNX-4800 prevents the first occurrence of confirmed Lyme disease over the four months after dosing, with a key secondary endpoint at six months. The company expects GMP clinical material in early 2027 and aims to start Phase 2 in the first half of 2027, pending FDA clearance, with a potential controlled human infection model study in 2028.

Tonix Pharmaceuticals Holding Corp. is advancing its migraine pipeline with the first participant dosed in a Phase 1 investigator-initiated study of TNX-1900, an intranasal potentiated oxytocin candidate. The trial uses a trigeminal neurovascular reactivity model, measuring forehead blood flow responses to capsaicin and electrical stimulation in healthy female volunteers.

The study is led and sponsored by Professor Antoinette Maassen van den Brink at Erasmus University Medical Center under a collaborative research agreement. TNX-1900 targets oxytocin receptors in the trigeminal system to block CGRP release, offering a mechanism distinct from triptans and CGRP inhibitors and aiming at non-opioid treatment options for migraine and other craniofacial pain conditions.

Tonix Pharmaceuticals Holding Corp. changed its independent auditor, dismissing EisnerAmper LLP and appointing PricewaterhouseCoopers LLP for the 2026 audit, with Audit Committee approval. The company states the dismissal was not related to disagreements over accounting, disclosure, or audit scope.

EisnerAmper’s reports for 2024 and 2025 were clean except for an explanatory paragraph highlighting continuing losses and negative operating cash flows that raised substantial doubt about Tonix’s ability to continue as a going concern. Previously disclosed material weaknesses in internal control over financial reporting were remediated by year-end 2024 and did not require financial statement restatements.

Tonix Pharmaceuticals reported fourth quarter and full year 2025 results, highlighted by the November 17 U.S. launch of TONMYA for fibromyalgia. Net product revenue for 2025 was about $13.1M, up from $10.1M in 2024, including roughly $1.4M from TONMYA.

Cash and cash equivalents were approximately $207.6M as of December 31, 2025, compared with $98.8M a year earlier, helped by a $20.0M registered direct offering and ATM usage. The company posted a 2025 net loss available to common stockholders of about $124.0M, versus $130.0M in 2024.

Fourth quarter 2025 net product revenue was roughly $5.4M, up from $2.6M in the prior-year quarter, while the net loss available to common stockholders was $46.9M. Management cites ongoing investment in TONMYA commercialization and a broad CNS, infectious disease, immunology, and rare disease pipeline, and believes existing cash will fund operations into the first quarter of 2027.

Tonix Pharmaceuticals Holding Corp. reported new post hoc Phase 3 data for TONMYA (cyclobenzaprine HCl sublingual tablets), its FDA‑approved fibromyalgia treatment, presented at the 8th International Congress on Controversies in Fibromyalgia.

In the 14‑week RESILIENT study of 457 adults, TONMYA produced rapid pain relief versus placebo as early as Day 2, with statistically significant pain reductions each week through Week 14 and a least‑squares mean treatment difference of -0.65 on numeric rating scale pain scores. All key secondary endpoints favored TONMYA, and discontinuations due to adverse events were 6.1% versus 3.5% with placebo, mainly mild, transient oral cavity reactions.

A pooled analysis of 959 participants from the RELIEF and RESILIENT trials showed a number needed to treat of 7 for ≥30% pain reduction and a number needed to harm of 26 for discontinuation due to adverse events, yielding a likelihood to be helped or harmed of 3.7. The company highlights TONMYA as the first new prescription medicine for fibromyalgia in more than 15 years and provides extensive prescribing, safety, and use‑in‑population information.

Tonix Pharmaceuticals Holding Corp. announced that Nasdaq approved transferring its common stock listing from the Nasdaq Capital Market to the Nasdaq Global Select Market, with trading on the new tier expected to begin at the open of market on March 3, 2026 under the ticker “TNXP.”

The Nasdaq Global Select Market is the highest of Nasdaq’s three tiers, designed for companies that meet higher financial, liquidity and corporate governance requirements. Tonix notes that the uplisting reflects its compliance with these standards and may enhance visibility with institutional investors, improve trading liquidity and broaden market recognition.

Tonix Pharmaceuticals Holding Corp. released preliminary, unaudited operating results for the quarter and year ended December 31, 2025, along with early views on its financial condition as of January 30, 2026.

The company states that based on current estimates, its cash resources at December 31, 2025 are expected to fund planned operating and capital spending into the first quarter of 2027. Management emphasizes that the figures are preliminary, may change as year-end closing and audit work proceed, and should not be treated as final results. Tonix expects to file its full audited financial statements in its Form 10-K for 2025 on or about March 16, 2026.

Tonix Pharmaceuticals Holding Corp. licensed exclusive worldwide rights to TNX-4900, a small-molecule candidate for chronic neuropathic pain, from Rutgers University. TNX-4900 is a highly selective Sigma-1 receptor antagonist with nanomolar affinity (Ki = 7.5 nM) and more than hundred-fold selectivity over Sigma-2, intended as a non-opioid approach to treating neuropathic pain.

In preclinical models of diabetic and chemotherapy-induced neuropathic pain, TNX-4900 produced significant and durable reductions in pain behaviors after both acute and chronic dosing, without evidence of tolerance or motor impairment. The compound shows high blood-brain barrier penetration and oral bioavailability of approximately 28%. Tonix plans additional pharmacokinetic, formulation and safety studies to potentially support an Investigational New Drug application with the U.S. Food and Drug Administration.

Tonix Pharmaceuticals Holding Corp. reported that the U.S. FDA has cleared its Investigational New Drug application for TNX-102 SL 5.6 mg, enabling clinical development for treating major depressive disorder (MDD) in adults. The company plans a potentially pivotal Phase 2 HORIZON study, a 6-week, randomized, double-blind, placebo-controlled trial of TNX-102 SL as first-line monotherapy in about 360 adults across approximately 30 U.S. sites. The primary goal is to measure change in Montgomery-Asberg Depression Rating Scale-II scores at Week 6, with additional measures of overall clinical impression, anxiety, and sleep disturbance, and enrollment is planned to begin in mid-year 2026.

Tonix Pharmaceuticals Holding Corp. reported that on November 21, 2025 it amended its Sales Agreement with A.G.P./Alliance Global Partners. The amendment increases the maximum aggregate offering price of the company’s common shares that may be issued under the agreement from $150,000,000 to $400,000,000, giving Tonix a larger authorized capacity to sell stock through this program as needed over time. The company also filed a legal opinion on the validity of the shares issuable under the Sales Agreement as an exhibit.

Tonix Pharmaceuticals Holding Corp. reported that its Board of Directors approved an increase to its share repurchase program, authorizing the Company to buy back up to an additional $25.0 million of its outstanding common stock. This brings the total amount authorized for repurchases under the program to $35 million.

The decision signals that the Company is willing to allocate a meaningful amount of capital to repurchasing its own shares, which can reduce the number of shares in the market over time and may support shareholder value, depending on execution and future business needs.

Tonix Pharmaceuticals Holding Corp. (TNXP) reported that its product TONMYA, a cyclobenzaprine HCl sublingual tablet, is now commercially available at pharmacies in the United States by prescription. This marks the move of TONMYA from development into the commercial marketplace, allowing eligible patients to obtain the drug through standard retail pharmacy channels.

The company released this information via a press release furnished as an exhibit, and emphasized that the disclosure includes forward-looking statements about its broader product development plans, regulatory timelines and market opportunities, which remain subject to various risks and uncertainties.

Tonix Pharmaceuticals Holding Corp. filed a current report to disclose that it announced its operating results for the quarter ended September 30, 2025.

The company explains that these quarterly results are described in a press release dated November 10, 2025, which is attached as Exhibit 99.01 and incorporated by reference. The report is signed on behalf of the company by Chief Financial Officer Bradley Saenger.

Tonix Pharmaceuticals (TNXP) filed an 8-K with preliminary updates. The company believes its cash at September 30, 2025, plus $29.3 million of net proceeds from equity offerings in the fourth quarter of 2025, will cover planned operating and capital needs into the first quarter of 2027.

Management emphasized these are unaudited, preliminary estimates subject to completion of closing procedures and potential adjustments. The independent auditor has not audited, reviewed, or compiled this information. Tonix currently expects to file its Form 10-Q for the quarter ended September 30, 2025, on or about November 10, 2025.

The company also expects to commence the U.S. commercial launch of Tonmya for the treatment of fibromyalgia in adults by the end of November 2025.

Tonix Pharmaceuticals (TNXP) announced the first patient was dosed in the investigator-initiated FOCUS study at Massachusetts General Hospital in adults with arginine-vasopressin deficiency (AVP-D).

The randomized, double-blind, placebo-controlled crossover pilot will evaluate single-dose intranasal potentiated oxytocin at two doses: 6 IU (TNX-2900) and 24 IU (TNX-1900). The study will assess markers of anxiety, depression, and socioemotional functioning, with an exploratory two-week replacement period to observe mental health outcomes.

Tonix Pharmaceuticals Holding Corp. filed an 8-K to share an updated investor presentation and outline upcoming clinical plans. The company intends to start a Phase 2 trial in 2026 of its TNX-102 SL product candidate, already approved for fibromyalgia, for treating major depressive disorder. Tonix also plans an adaptive Phase 2/3 study in 2027 of TNX-4800 for the seasonal prevention of Lyme disease. The presentation is furnished as Exhibit 99.01 and is not deemed filed for liability purposes under U.S. securities laws.

Tonix Pharmaceuticals Holding Corp. appointed Ganesh Kamath as Head of Market Access, effective September 29, 2025. This role typically focuses on how medicines are reimbursed and accessed by patients through insurers and health systems.

The company also set the wholesale acquisition cost for Tonmya, its treatment for fibromyalgia in adults, at $1,860 per month for a 60‑count supply. For geriatric adults and adults with mild hepatic impairment, the wholesale acquisition cost is $930 per month for a 30‑count supply. These list prices form the starting point for insurer and pharmacy discount negotiations.

Tonix Pharmaceuticals Holding Corp. reported a material event on September 29, 2025 by filing an Form 8-K under Item 8.01 to disclose a press release titled "TNX-2900 Product Presentation Cover Page". The filing indicates the press release and an interactive data file (Inline XBRL) are included as part of the submission. The document is signed by Bradley Saenger, Chief Financial Officer, and the filing notes written communications under Rule 425 and pre-commencement communications under Rule 14d-2(b).

Tonix Pharmaceuticals Holding Corp. reported that it completed a Type B Pre‑Investigational New Drug (Pre‑IND) meeting with the U.S. Food and Drug Administration for its TNX‑102 SL sublingual tablet, being developed for the treatment of major depressive disorder (MDD).

Based on feedback from the FDA, the company plans to pursue a supplemental new drug application to expand the therapeutic indication of TNX‑102 SL to include MDD, using exploratory findings that link improved sleep quality with better depressive symptoms. The FDA considered Tonix’s proposed long‑term safety data collection plan generally reasonable, which may streamline development. An Investigational New Drug filing for TNX‑102 SL in MDD is planned for the fourth quarter of 2025, with Phase 2 clinical trials expected to begin shortly thereafter.

Tonix Pharmaceuticals Holding Corp. filed a report describing that it has in-licensed worldwide rights to TNX-4800, a long-acting fully human monoclonal antibody targeting the outer surface protein A (OspA) of Borrelia burgdorferi, the bacterium that causes Lyme disease in humans. TNX-4800 is engineered for an extended half-life and is designed as a single subcutaneous springtime dose to maintain protective antibody levels through the U.S. tick season, providing pre-exposure prophylaxis without relying on the recipient’s immune system to make antibodies.

The company notes that TNX-4800 has been shown to block transmission of major Borrelia genospecies from ticks to animals and may avoid the multidose schedules used for OspA vaccines in development and previously approved vaccines that were withdrawn over autoimmunity concerns. Tonix intends to advance TNX-4800 through additional clinical trials with the goal of submitting a Biologics License Application to the U.S. Food and Drug Administration.

Tonix Pharmaceuticals Holding Corp. announced that the U.S. Food and Drug Administration has approved Tonmya™ (cyclobenzaprine HCl sublingual tablets), which was investigated as TNX-102 SL, for the treatment of fibromyalgia in adults. To discuss this approval, the company is holding a webcast and conference call on August 18, 2025, at 8:30 a.m., during which management will review a presentation furnished as Exhibit 99.01. The filing also includes customary cautionary language about forward-looking statements related to product launch, commercialization, clinical and regulatory timelines, market opportunity, competitive position, and potential growth.

Tonix Pharmaceuticals describes safety, contraindications, and dosing guidance for TONMYA (cyclobenzaprine), emphasizing serious risks and population-specific recommendations. The filing lists absolute contraindications including prior hypersensitivity and recent or concurrent MAO inhibitor use due to reports of hyperpyretic crisis, seizures, and death when combined with similar drugs. It warns of serotonin syndrome with multiple serotonergic agents and advises immediate discontinuation if symptoms occur. The company notes potential embryofetal toxicity from animal data and recommends avoiding use two weeks before conception through the first trimester and performing a pregnancy test before starting therapy. Lowered dosing is recommended for mild hepatic impairment (2.8 mg once daily), and use is not recommended in moderate or severe hepatic impairment. Other cautions address CNS depression, anticholinergic effects, oral mucosal reactions, limited data in elderly and pediatric populations, and lactation considerations.

Tonix Pharmaceuticals Holding Corp. reported that it announced operating results for the quarter ended June 30, 2025. The company states a press release discussing those results is filed as Exhibit 99.01 and is incorporated by reference into this report. The filing confirms Tonix's common stock trades under the symbol TNXP on The NASDAQ Capital Market.

The filing is a notice of the release of operating results rather than detailed financial statements within the form itself; the cover page interactive XBRL file is referenced as Exhibit 104, and the report is signed by the company’s Chief Financial Officer, Bradley Saenger.

Tonix Pharmaceuticals (TNXP) files Form 8-K with preliminary Q2 2025 figures.

• Cash & equivalents at 6/30/25: $125.3 million; shares outstanding 7/25/25: 8.75 million.
• Operating cash burn rose to $16.3 million from $9.9 million YoY.
• Capital expenditures were $1.1 million (prior-year: $0).
• Net operating loss narrowed sharply to $26.3 million versus $78.8 million in Q2 2024.
• Product revenue slipped to $2.0 million from $2.2 million.

Management says existing cash plus the $50.6 million equity raised in Q3 2025 should fund operations into Q3 2026, extending the runway by roughly 12 months.

All numbers are unaudited and subject to revision; EisnerAmper has performed no procedures. The full 10-Q is expected on or about 11 Aug 2025.

On 16 Jul 2025 Tonix Pharmaceuticals (NASDAQ: TNXP) filed a Form 8-K covering Item 7.01 (Reg FD) and Item 8.01 (Other Events). Management released an updated investor presentation (Exhibit 99.01) and revealed plans to deploy a 70-90 person U.S. sales force to commercialize its lead candidate TNX-102 SL for fibromyalgia if the FDA approves the pending New Drug Application. The materials are furnished, not filed, so they are excluded from Exchange Act liability and are not incorporated by reference into other SEC filings.

The filing contains no financial results, guidance or transactions. While the disclosure signals commercial readiness and confidence in the asset’s prospects, timing, cost, and regulatory outcome remain unspecified, leaving the near-term investment thesis largely unchanged.

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) filed an 8-K to disclose new pre-clinical data for its TNX-801 recombinant horsepox vaccine candidate. The company presented the findings at Vaccine Congress 2025 and furnished both a press release (Ex. 99.01) and slide deck (Ex. 99.02) under Items 7.01 and 8.01. Key highlights:

• Durable, single-dose immunity: A single injection produced strong binding and neutralising antibody responses across multiple animal models, including immunocompromised subjects.
• Highly attenuated safety profile: In primary human dermal cells the virus replicates 27- to 119-fold less than licensed vaccinia strains; in IFN-receptor knockout mice it is up to 100,000-fold less virulent.
• Protection data: All vaccinated macaques survived lethal Clade I mpox challenge without lesions; rabbits remained protected for 14 months.
• Administration advantage: Subcutaneous delivery showed equivalent protection to the standard percutaneous route and may reduce bacterial super-infection, scarring, and inadvertent virus spread.
• Strategic positioning: Management believes TNX-801 could become a critical counter-measure against mpox outbreaks and bioterror-related smallpox re-introduction.

The disclosure contains only forward-looking statements, no financial metrics, and the information is furnished, not filed, limiting legal liability. While the data strengthen the scientific rationale, the asset remains at a pre-clinical stage and faces regulatory, funding, and competitive uncertainties.

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) filed an 8-K to disclose new pre-clinical data on its oncology candidate TNX-1700. A peer-reviewed paper published in Cancer Cell shows the murine analogue, mTNX-1700—a fusion of murine TFF2 and serum albumin—extended survival and reduced metastases in gastric-cancer animal models. The Company believes the findings support further development of the human version, which is being explored for gastric and colorectal cancers and as a means to overcome resistance to anti-PD-1 immunotherapy. The publication is the product of a collaboration with Columbia University’s Vagelos College of Physicians and Surgeons.

The disclosure is delivered under Item 7.01 (Regulation FD) and Item 8.01 (Other Events); no financial metrics, guidance, or contractual commitments were included. Management emphasizes that the information is furnished, not filed, thereby limiting potential liability. Forward-looking-statement language highlights typical development risks and underscores that results are limited to animal studies.