Taysha Loss Widens as Gene-Therapy Spending Nearly Doubles
Cash reached $455.4 million after a $230 million follow-on offering extended the runway into 2028.
Taysha Gene Therapies (TSHA), a clinical-stage gene-therapy developer, reported a wider second-quarter loss as it increased spending on manufacturing and clinical trials for its Rett syndrome treatment.
The quarter marked a shift toward regulatory and commercial preparation for TSHA-102. Taysha completed dosing in two studies, advanced production work needed for a biologics license application, and expanded its commercial-supply agreement with Catalent.
Revenue fell to zero from $2.0 million a year earlier. The net loss widened to $46.6 million, or $0.13 a share, from $26.9 million, or $0.09 a share, while the operating loss increased to $47.3 million from $26.8 million. A newly disclosed $3.4 million gain from a lease termination partly offset the higher expenses.
Research-and-development expense rose 92% to $38.6 million, driven primarily by manufacturing work for the BLA-enabling process-performance-qualification campaign, higher REVEAL and ASPIRE trial costs, and increased compensation. General-and-administrative expense climbed 41% to $12.1 million as Taysha spent more on compensation, consulting, professional fees, and launch readiness.
Taysha overenrolled the pivotal REVEAL study with 17 patients after previously planning for 15, and it completed dosing by June. ASPIRE also exceeded its initial three-patient target, with four patients dosed by the August update. The TSHA-102 safety population grew to 33 patients from 29 at the June cutoff, with no severe treatment-related serious adverse events or dose-limiting toxicities reported.
Longer-term REVEAL results showed that all 12 patients evaluated gained or regained at least one developmental milestone by 12 months. The patients recorded 310 functional gains, or about 26 each, with benefits continuing to deepen through at least one year.
Taysha expects six-month interim topline data from pivotal REVEAL and FDA feedback on the BLA pathway in the first half of 2027. It also expects to complete the PPQ manufacturing campaign in the fourth quarter of 2026. The financing provides a projected cash runway through potential TSHA-102 approval and into the second half of 2028.
Commercial preparations advanced with completed payer research and an expanded Catalent agreement designating the manufacturer as Taysha's primary commercial supplier under a long-term framework for launch and future demand.