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Tonix Pharmaceuticals Holding (TNXP) guidance and outlook

Tonix Pharmaceuticals Holding's 10-Q filed Nov 9, 2026 makes 13 forward-looking statements.

Guidance and outlook

Forward-looking statements, 10-Q filed Nov 9, 2026

• Our clinical-stage infectious disease portfolio includes TNX-4800, a human monoclonal antibody targeting Borrelia OspA, for the prevention of Lyme disease in the U.S., where no vaccines or prophylactics for Lyme disease are approved by the FDA.
• Our clinical-stage immunology development portfolio includes TNX-1500 (provisional international nonproprietary name: mosdaprubart), which is a Phase 2-ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of kidney transplant rejection and for the treatment of autoimmune diseases.
• We met with the FDA in the fourth quarter of 2026 to discuss the clinical design of the next Phase 2 study but do not plan to initiate a study in the near term in order to prioritize our cash and resource allocation toward TONMYA and TNX-4800.
• We are developing a pre-IND infectious disease program designated TNX-4200, which is a small molecule broad-spectrum antiviral agent targeting CD45 to improve the medical readiness of military personnel in biological threat environments.
• We anticipate that our results of operations will fluctuate for the foreseeable future due to several factors, such as the sales of our commercial products, progress of our research and development efforts and the timing and outcome of regulatory submissions.
• We continue to face significant challenges and uncertainties and, as a result, our available capital resources may be consumed more rapidly than currently expected due to changes we may make in our research and development spending plans.
• We expect to continue to incur operating losses and substantial research and development expenses as we advance our prioritized clinical programs.
• We will need to obtain additional capital in order to fund future commercialization, research and development activities.
• The timing and amount of any shares repurchased will be determined based on our evaluation of market conditions and other factors and the share repurchase program may be discontinued or suspended at any time.
• Repurchases will be made in accordance with the rules and regulations promulgated by the Securities and Exchange Commission and certain other legal requirements to which the Company may be subject.
• We also issue premium options to executive officers which have an exercise price greater than the grant date fair value and have issued performance-based options which vest when target parameters are met or probable of being met, subject in each case to a one-year minimum service period prior to vesting.
• Subject to limitations, each participant will be permitted to purchase a number of shares determined by dividing the employee’s accumulated payroll deductions for the offering period by the applicable purchase price, which is equal to 85 percent of the fair market value of our common stock at the beginning or end of each offering period, whichever is less.

Tonix Pharmaceuticals Holding's latest quarter

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What does Tonix Pharmaceuticals Holding expect?

Our clinical-stage infectious disease portfolio includes TNX-4800, a human monoclonal antibody targeting Borrelia OspA, for the prevention of Lyme disease in the U.S., where no vaccines or prophylactics for Lyme disease are approved by the FDA. Our clinical-stage immunology development portfolio includes TNX-1500 (provisional international nonproprietary name: mosdaprubart), which is a Phase 2-ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of kidney transplant rejection and for the treatment of autoimmune diseases. We m

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Updated Nov 9, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.