Tonix Pharmaceuticals — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net product revenue for the quarter was $17.2 million, up from $3.3 million in the same period in 2025.
• Net revenue from TONMYA sales was approximately $15.0 million.
• Net revenue from Zembrace SymTouch and Tosymra was $2.2 million, down from $3.3 million in the prior year period.
• Cost of sales was $1.3 million, compared to $1.4 million in the prior year period, driven by a change in product mix.
• Research and development expenses were $25.8 million, an increase from $9.3 million in the prior year period.
• Selling, general, and administrative expenses were $45.6 million, an increase from $25.7 million in the prior year period.
• Net loss available to common stockholders was $53.3 million ($2.89 per share), compared to a net loss of $32.0 million ($3.59 per share) in the prior year period.
• Cash and cash equivalents were $163 million as of September 30, 2026, down from $207.6 million as of December 31, 2025.
• Net cash used in operating activities was $125.6 million for the nine months ended September 30, 2026, compared to $60.2 million for the same period in 2025.
• Accounts receivable increased to $14.6 million from $6.3 million at the end of 2025.
• Inventory decreased to $4.5 million from $6.0 million at the end of 2025.

Guidance and Future Outlook:

• The Company believes its cash resources, combined with approximately $1.5 million raised from equity offerings subsequent to September 30, 2026, will meet operating and capital expenditure requirements into the early third quarter of 2027.
• The adaptive Phase 2 TRAIL field study for TNX-4800 is expected to begin in the first quarter of 2027 pending final FDA agreement on the study protocol.
• Investigational product for the TNX-4800 Phase 2 study is expected to be delivered to clinical sites in the first quarter of 2027.
• A Phase 2 investigator-initiated study for TNX-1500 is expected to initiate in the first quarter of 2027.

Business Segments and Product Lines:

• TONMYA (cyclobenzaprine HCl sublingual tablets):
  • Total prescriptions increased 28% quarter-over-quarter to 16,375.
  • New prescriptions increased 17% quarter-over-quarter.
  • Refills increased 56% quarter-over-quarter.
  • Coverage totals approximately 166 million covered lives (~53% of U.S. covered lives).
  • Payer access expanded with two commercial GPO agreements, two managed Medicare agreements, and Medicaid access in almost every state.
  • Major managed Medicare agreements added approximately 9 million lives in July 2026 and 21 million lives in September 2026.
  • The sales force expanded to approximately 150 representatives on September 1, 2026.
• Zembrace SymTouch and Tosymra:
  • Net revenue for these products decreased to $2.2 million from $3.3 million in the prior year period.
• Pipeline Updates:
  • TNX-102 SL (MDD): Enrollment is ongoing for the HORIZON Phase 2 study.
  • TNX-4800 (Lyme Disease): Received positive official minutes from a Type C FDA meeting; FDA is reviewing the final study protocol.
  • TNX-1500 (Immunology): Phase 2 open-label study at Massachusetts General Hospital is expected to enroll five adult kidney transplant recipients.

Market and Competitive Landscape:

• The Company faces a Paragraph IV patent certification challenge from Dr. Reddy's Laboratories Ltd. regarding a generic version of TONMYA, filed with the FDA on October 2, 2026.
• Tonix intends to vigorously enforce its intellectual property rights but cannot predict the outcome of the litigation.

Risks and Challenges:

• Uncertainties regarding patent protection and the outcome of litigation with Dr. Reddy's Laboratories.
• Risks related to the failure to successfully launch and commercialize TONMYA and other approved products.
• Risks associated with obtaining FDA clearances or approvals and noncompliance with FDA regulations.
• Dependence on third parties for research and development efforts.
• Limited research and development efforts and the need for additional financing.
• Risks related to government or third-party payer reimbursement.

Management Commentary and Tone:

• CEO Seth Lederman, M.D., described the quarter as "strong" for TONMYA, citing a 37% increase in net sales over the second quarter.
• Management highlighted that total prescriptions, new prescriptions, and refills all increased.
• Dr. Lederman noted that expanded payer access contributed to third-quarter sales growth.
• Management expressed confidence in the sales force expansion, noting promising growth in key performance indicators since adding 50 representatives.
• Thomas Englese was promoted to Chief Commercial Officer on September 8, 2026.

Other Key Points:

• The Company had 19,431,516 shares of common stock outstanding as of November 6, 2026.
• The weighted average common shares outstanding for the third quarter of 2026 was 18,440,773, compared to 8,922,792 in the same period in 2025.
• Contract income for the quarter was $666,000.
• Interest income, net, was $1.36 million for the quarter.
• The Company is a fully integrated, commercial-stage biopharmaceutical company focused on CNS disorders, infectious diseases, and immunology conditions.