Taysha Gene Therapies (TSHA) Q2 2025 earnings summary

Executive summary

• Achieved FDA and Health Canada alignment on pivotal trial design for TSHA-102 in Rett syndrome, with site activation underway and patient enrollment expected in Q4 2025; Part A of the REVEAL phase I/II trial showed a 100% response rate for the primary endpoint, with all evaluable patients gaining or regaining at least one developmental milestone and no treatment-related serious adverse events or dose-limiting toxicities in 12 patients as of August 2025.

• Raised $230 million in a follow-on offering in May 2025, extending cash runway into 2028; new $50 million term loan drawn in August 2025, replacing previous facility.

• Cash and cash equivalents totaled $312.8 million as of June 30, 2025, expected to fund operations into 2028.

Financial highlights

• R&D expenses were $20.1 million for Q2 2025, up from $15.1 million in Q2 2024, driven by manufacturing, clinical trial activities, and increased headcount.

• G&A expenses rose to $8.6 million from $7.3 million year-over-year, mainly due to higher legal and professional fees.

• Net loss for Q2 2025 was $26.9 million ($0.09/share), compared to $20.9 million ($0.09/share) in Q2 2024.

• Weighted average shares outstanding increased to 297.99 million in Q2 2025 from 232.82 million in Q2 2024.

• Revenue of $2.0 million for Q2 2025, up from $1.1 million in Q2 2024, driven by Rett research and development activities under the Astellas agreement.

Outlook and guidance

• Patient enrollment for the pivotal trial is expected to begin in Q4 2025.

• New supplemental clinical data from Part A of the REVEAL trial will be reported in Q4 2025.

• Current cash resources are expected to fund operations into 2028; additional capital may be needed for future development and commercialization.