TGTX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-05

• In May 2026, we announced positive topline results from the Phase 3 ENHANCE trial, a randomized, double-blind study evaluating a consolidated single infusion regimen for initiation of BRIUMVI® (ublituximab-xiiy) in adults with relapsing forms of multiple sclerosis (RMS). The trial met its primary en…

• In June 2026, we announced positive pharmacokinetic (PK), pharmacodynamic (PD), safety, and tolerability data from the Phase 1 clinical trial evaluating subcutaneous formulation of ublituximab (the active agent in BRIUMVI®). The PK and PD data from the Phase 1 clinical trial support quarterly subcut…

• In June 2026, we announced positive topline data from our Phase 1 clinical trial for BRIUMVI in patients with myasthenia gravis (MG) and the initiation of a Phase 2 clinical trial evaluating BRIUMVI as a maintenance therapy following induction with efgartigimod in adult patients with MG.

• In July 2026, we announced the initiation of a Phase 2 clinical trial evaluating BRIUMVI in adults with treatment-resistant schizophrenia.

• We currently license worldwide development and commercial rights, subject to certain limited geographical restrictions, for all of our products under development. The following table summarizes select ongoing and planned clinical development programs for our lead drug candidates as of July 2026.

Text removed vs the prior filing · source: 10-Q · 2026-05-06

• In April 2026, we announced the Phase 3 trial evaluating subcutaneous BRIUMVI completed enrollment and topline data is expected around year-end 2026 or first quarter 2027.

• In March 2026, we entered into a new five-year, $750 million senior secured credit facility with funds managed by Blue Owl Capital. As part of the transaction, we repaid our outstanding $250 million senior secured credit facility, resulting in a net raise of $500 million in non-dilutive capital. The…

• We currently license worldwide development and commercial rights, subject to certain limited geographical restrictions, for all of our products under development. The following table summarizes the current clinical trial status for our lead drug candidates as of March 2026.

• Ublituximab IV Simplified Dosing Schedule RMS Phase 3 completed enrollment

• BRIUMVI is an anti-CD20 monoclonal antibody that can be administered to adults with RMS in a one-hour infusion every 24 weeks, following the starting dose. BRIUMVI received approval from the FDA primarily based on results from the ULTIMATE I and ULTIMATE II Phase 3 trials. Each trial was an independ…

Text added vs the prior filing · source: 10-Q · 2026-08-05

• We have a history of losses and our ability to maintain profitability in the future remains uncertain. We expect to incur significant expenses for the foreseeable future as we commercialize BRIUMVI and advance our other product candidates through clinical trials, seek regulatory approvals and pursue…

Text removed vs the prior filing · source: 10-Q · 2026-05-06

• We have incurred substantial operating losses since our inception, and we may incur losses in the future.

Text added vs the prior filing · source: 10-Q · 2026-08-05

• We have a history of losses and our ability to maintain profitability in the future remains uncertain. We expect to incur significant expenses for the foreseeable future as we commercialize BRIUMVI and advance our other product candidates through clinical trials, seek regulatory approvals and pursue…

Text removed vs the prior filing · source: 10-Q · 2026-05-06

• We have incurred substantial operating losses since our inception, and we may incur losses in the future.

Text added vs the prior filing · source: 10-Q · 2026-08-05

• We have a history of losses and our ability to maintain profitability in the future remains uncertain. We expect to incur significant expenses for the foreseeable future as we commercialize BRIUMVI and advance our other product candidates through clinical trials, seek regulatory approvals and pursue…

Text removed vs the prior filing · source: 10-Q · 2026-05-06

• We have incurred substantial operating losses since our inception, and we may incur losses in the future.

Text added vs the prior filing · source: 10-Q · 2026-08-05

• We have a history of losses and our ability to maintain profitability in the future remains uncertain. We expect to incur significant expenses for the foreseeable future as we commercialize BRIUMVI and advance our other product candidates through clinical trials, seek regulatory approvals and pursue…

• Biopharmaceutical drug development is a highly speculative undertaking and involves a substantial degree of risk. We commenced operations in January 2012 and currently have one marketed product, BRIUMVI, which received approval from the FDA in December 2022. We have focused our efforts and financial…

• To remain profitable, we must succeed in developing (or in-licensing) and commercializing our products or product candidates, and continue to successfully commercialize BRIUMVI. It is uncertain when and if we will generate or continue to generate any significant revenue from the sale of our product …

• We may seek additional capital to support our business, strategic initiatives or other corporate purposes, and if adequate financing is not available when needed, our business and growth prospects could be adversely affected.

• The development and commercialization of innovative therapies is capital intensive. We expect to continue to invest substantially in the commercialization and lifecycle management of BRIUMVI, including the generation of additional clinical data to support its long-term commercial adoption and potent…

Text removed vs the prior filing · source: 10-Q · 2026-05-06

• We believe there is potential market opportunity for BRIUMVI outside of the U.S., including in the EU. We have entered into a Commercialization Agreement for the sale of BRIUMVI in certain territories outside the U.S., Canada and Mexico, the commercialization rights for which had been previously ret…

• We have incurred substantial operating losses since our inception, and we may incur losses in the future.

• Biopharmaceutical drug development is a highly speculative undertaking and involves a substantial degree of risk. We commenced operations in January 2012. To date, our operations have been limited primarily to organizing and staffing our company, business planning, raising capital, developing our te…

• We have focused our efforts and financial resources on clinical trials, manufacturing of our products and product candidates, establishing a commercial infrastructure and preparing to support a commercial product. To date, we have financed our operations primarily through public offerings of our com…

• To remain profitable, we must succeed in developing (or in-licensing) and commercializing our products or product candidates, and continue to successfully commercialize BRIUMVI. It is uncertain when and if we will generate or continue to generate any significant revenue from the sale of our product …

Text added vs the prior filing · source: 10-Q · 2026-08-05

• We have a history of losses and our ability to maintain profitability in the future remains uncertain. We expect to incur significant expenses for the foreseeable future as we commercialize BRIUMVI and advance our other product candidates through clinical trials, seek regulatory approvals and pursue…

Text removed vs the prior filing · source: 10-Q · 2026-05-06

• We have incurred substantial operating losses since our inception, and we may incur losses in the future.