Taysha Gene Therapies (TSHA) investor relations material

Executive summary

• Completed dosing in REVEAL pivotal (N=17) and ASPIRE (N=4) trials for TSHA-102 in Rett syndrome, with topline data and FDA feedback expected in 1H 2027 and a planned BLA submission in 2027.

• All 12 patients in REVEAL Part A gained or regained at least one developmental milestone, with robust, durable functional gains and favorable safety profile; long-term data showed 100% response rate at 12 months.

• Expanded commercial manufacturing partnership with Catalent, securing GMP manufacturing and commercial supply at an FDA-licensed facility.

• Strengthened leadership team and legal/compliance functions, and completed $230M follow-on financing, extending cash runway into 2H 2028.

• Received multiple regulatory designations for TSHA-102, including Breakthrough Therapy and RMAT.

Financial highlights

• Research and development expenses rose to $38.6M for Q2 2026 from $20.1M in Q2 2025, driven by BLA-enabling manufacturing and higher clinical costs.

• General and administrative expenses increased to $12.1M from $8.6M year-over-year, mainly due to higher compensation and commercial readiness.

• Net loss was $46.6M ($0.13/share) for Q2 2026, compared to $26.9M ($0.09/share) in Q2 2025.

• Cash and equivalents totaled $455.4M as of June 30, 2026, reflecting the recent financing.

• Net proceeds of $215.6M were raised in a June 2026 public offering.

Outlook and guidance

• Current cash expected to fund operations into the second half of 2028.

• BLA-enabling PPQ campaign on track for completion in Q4 2026.

• Topline data from REVEAL pivotal trial six-month interim analysis and FDA feedback anticipated in 1H 2027; BLA submission planned for 2027.

• Additional capital may be required for further R&D, manufacturing, and commercialization activities.