TNXP — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-10

• We market TONMYA® (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults in the U.S., as well as Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) for the treatment of acute migraine in adults in the U.S. Tonix received approval from the…

• We are advancing a diversified development pipeline generated through internal discovery, in-licensing, acquisitions, and collaborations with academic and non-profit institutions. The Company’s pipeline addresses conditions that span CNS, infectious disease, immunology, and rare disease, with multip…

• TNX-102 SL is being developed to treat ASD/ASR under an Investigator-Initiated investigational new drug application (“IND”) at the University of North Carolina in the ongoing OASIS study funded by a grant they received from the U.S. Department of Defense (“DoD”). Topline data from the OASIS study is…

• Our clinical stage infectious disease portfolio includes monoclonal antibody TNX-4800 (anti Borrelia OspA human monoclonal antibody) for the prevention of Lyme disease in the U.S. which has no FDA-approved vaccines or prophylactics. We received positive, final minutes from the FDA following a Type C…

• Our pre-clinical, pre-IND infectious disease portfolio includes TNX-801 (horsepox, live virus vaccine), a potential vaccine for mpox and smallpox, which is expected to enter a Phase 1 study in 2027 pending FDA clearance of an IND. We own a facility in Dartmouth, MA that was purpose-built to manufact…

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• In August 2025, we received approval from the FDA for TONMYA® (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia. TONMYA, our first internally developed product to become FDA approved, was commercially launched by us in the United States on November 17, 2025. TONMYA is the fi…

• Our clinical stage infectious disease portfolio includes monoclonal antibody TNX-4800 (anti-Borrelia OspA human monoclonal antibody) for the prevention of Lyme disease in the U.S., for which initiation of an adaptive Phase 2 field study is planned for the first half of 2027, pending FDA agreement. T…

• Revenues. Revenue recognized for the three months ended March 31, 2026 and 2025, was $6.9 million and $2.4 million, respectively.

• Cost of Sales. Cost of sales recognized for the three months ended March 31, 2026 and 2025, was $1.6 million and $0.9 million, respectively. The increase is predominantly due to the launch of Tonmya in November 2025.

• Net Loss. As a result of the forgoing, the net loss for the three months ended March 31, 2026, was $40.2 million, compared to a net loss of $16.8 million for the three months ended March 31, 2025, an increase of $23.4 million or 139%. The increase in loss is predominately due to increased spending o…

Text added vs the prior filing · source: 10-Q · 2026-08-10

• There were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• During the first quarter of 2026, the Company completed the implementation of a new ERP system. Our new ERP system is intended to provide us with enhanced transactional processing, security and management tools, and is an important component of our system of disclosure controls and procedures. We mo…

Text added vs the prior filing · source: 10-Q · 2026-08-10

• There were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• During the first quarter of 2026, the Company completed the implementation of a new ERP system. Our new ERP system is intended to provide us with enhanced transactional processing, security and management tools, and is an important component of our system of disclosure controls and procedures. We mo…

Text added vs the prior filing · source: 10-Q · 2026-08-10

• No directors or officers adopted, modified or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) during the quarter ended June 30, 2026.

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• Rule 10b5-1 Trading Arrangements and Non-Rule 10b5-1 Trading Arrangements

• During the fiscal quarter ended March 31, 2026, none of our officers or directors, as those terms are defined in Rule 16a-1(f), adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Item 408 of Regulation S-K.