Tonix Pharmaceuticals — Second Quarter 2026 Earnings Summary

Financial Performance

• Net product revenue for Q2 2026 was $13.5 million, compared to $2.0 million in Q2 2025.
• TONMYA net sales totaled approximately $11.0 million in Q2 2026.
• Revenue from Zembrace SymTouch and Tosymra was $2.5 million in Q2 2026, compared to $2.0 million in Q2 2025.
• Cost of sales was $0.7 million in Q2 2026, down from $3.3 million in Q2 2025, driven by product mix changes and a 2025 write-off related to migraine products.
• Research and development expenses were $19.4 million in Q2 2026, up from $10.8 million in Q2 2025.
• Selling, general, and administrative expenses were $36.0 million in Q2 2026, up from $16.2 million in Q2 2025.
• Net loss available to common stockholders was $40.6 million ($2.44 per share) in Q2 2026, compared to $28.3 million ($3.86 per share) in Q2 2025.
• Net cash used in operating activities was $84.6 million for the six months ended June 30, 2026, compared to $31.4 million for the same period in 2025.
• Cash and cash equivalents were $176.2 million as of June 30, 2026, down from $207.6 million as of December 31, 2025.
• Total liabilities were $31.8 million as of June 30, 2026, compared to $32.0 million as of December 31, 2025.

Guidance and Future Outlook

• The company expects cash resources and net proceeds from equity offerings in Q3 2026 to meet operating and capital expenditure requirements into early Q2 2027.
• The managed Medicare payer coverage agreement is scheduled to go into effect on January 1, 2027, adding approximately 9 million Medicare lives.
• The Phase 2 adaptive field study for TNX-4800 is on track to start in Q1 2027 pending final FDA review and protocol agreement.
• TNX-801 is expected to enter a Phase 1 study in mid-2027 pending FDA clearance of the IND application.
• A Phase 2 study for TNX-1500 in adult kidney transplant patients is expected to initiate in the second half of 2026 pending FDA clearance.
• A Phase 2 study for TNX-2900 in children and adolescents with Prader-Willi syndrome is planned for the second half of 2027.

Business Segments and Product Lines

• TONMYA (cyclobenzaprine HCl sublingual tablets) is the first FDA-approved treatment for fibromyalgia in 15 years.
• TONMYA total prescriptions reached 12,592 in Q2 2026, a 100% increase quarter-over-quarter.
• New patient prescriptions for TONMYA increased 36% quarter-over-quarter, while refills increased 207% quarter-over-quarter.
• The company plans to deploy 50 new sales representatives by September 2026, bringing the total sales force to approximately 150 people.
• Commercial payer agreements with two leading GPOs in May and June 2026 provide access to approximately 52 million lives (29% of total commercial lives).
• Total coverage for TONMYA reached approximately 136 million covered lives (43% of total U.S. lives) as of Q2 2026.
• TNX-102 SL (cyclobenzaprine HCl sublingual tablets) enrolled its first patient in the Phase 2 HORIZON study for major depressive disorder (MDD) in June 2026.
• TNX-1300 (double-mutant cocaine esterase) has Breakthrough Therapy designation for cocaine intoxication; the company plans to meet with the FDA in 2026 regarding the next Phase 2 study design.
• TNX-4800 is a long-acting human monoclonal antibody for Lyme disease prevention, with no FDA-approved vaccines currently available for this indication.
• TNX-1500 (dimeric Fc-modified anti-CD40L) received a proposed International Nonproprietary Name (pINN) of "mosdaprubart" from the WHO in July 2026.
• TNX-2900 (intranasal potentiated oxytocin) has Orphan Drug and Rare Pediatric Disease designations for Prader-Willi syndrome.
• TNX-1700 (TFF2-albumin fusion protein) is in preclinical development for gastric and colorectal cancer.
• TNX-4200 is supported by a Department of Defense contract of up to $34 million over five years.

Market and Competitive Landscape

• TONMYA is positioned as a first-in-class, non-opioid analgesic for daily bedtime administration and long-term use.
• TNX-1300 targets an indication with no products currently on the market.
• TNX-4800 targets the prevention of Lyme disease in the U.S., an area with no FDA-approved vaccines or prophylactics.
• TNX-1500 is described as a potentially first-in-class, best-in-class, third-generation anti-CD40L monoclonal antibody.
• TNX-2900's designations could potentially make the company eligible for a Priority Review Voucher upon approval.

Risks and Challenges

• The company faces risks related to the failure to successfully launch and commercialize TONMYA and other approved products.
• Risks include the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations.
• Uncertainties exist regarding the timing and progress of clinical development programs.
• The company requires additional financing to meet its operating requirements.
• Risks include uncertainties of patent protection, litigation, and government or third-party payor reimbursement.
• The company faces substantial competition in its target markets.

Management Commentary and Tone

• CEO Seth Lederman expressed pleasure with the execution of the TONMYA launch, noting nearly tripled net sales and growth across key metrics.
• Management stated that TONMYA's value is resonating among healthcare providers and patients.
• Dr. Lederman highlighted that coverage is translating into broader patient access following agreements with commercial payers, managed Medicare, and Medicaid.
• Management indicated the company is well-positioned to reach more target prescribers with the newly expanded sales force.
• The tone regarding the pipeline was positive, citing progress on the HORIZON study and alignment with the FDA for the TNX-4800 development path.

Other Key Points

• Subsequent to quarter-end, the company raised $3.7 million in proceeds under its At-the-Market facility.
• As of August 7, 2026, the company had 17,151,024 shares of common stock outstanding.
• The weighted average common shares outstanding for Q2 2026 was 16,635,254, compared to 7,327,257 in Q2 2025.
• Bridge prescriptions facilitated through the digital pharmacy channel represented initial patient fills while coverage determinations were pending and did not immediately generate net product revenue.
• Tonix presented data on TONMYA at the EULAR 2026, ASCP 2026, and ISPOR 2026 annual meetings and published a manuscript in Clinical Pharmacology in Drug Development.
• The U.S. Department of Defense-funded OASIS study for TNX-102 SL in acute stress disorder/acute stress reaction is expected to report topline data in mid-2027.
• Tonix presented Phase 1 data for TNX-4800 at the 4th Annual Ticks and Tickborne Diseases Symposium in April 2026.
• Tonix presented preclinical data for TNX-1700 at the Ninth JCA-AACR Special Joint Conference in June 2026.