AI Earnings Predictions for Taysha Gene Therapies Inc. (TSHA)

EX-99.1

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EX-99.1

EX-99.1

Exhibit 99.1

Taysha Gene Therapies Reports Second Quarter 2026 Financial Results and Provides Corporate Update

Completed dosing in the REVEAL pivotal (N=17) and ASPIRE (N=4) trials evaluating TSHA-102 for Rett syndrome; expect to report topline data from 6-month interim analysis and FDA feedback on the BLA submission pathway in 1H 2027

TSHA-102 continues to be generally well tolerated with no severe treatment-related SAEs or DLTs across REVEAL Phase 1/2, pivotal and ASPIRE trials (N=33) as of the August 2026 data cutoff

Longer-term REVEAL Part A data demonstrated broad, multi-domain functional gains that deepened through ≥12 months post-TSHA-102, with consistent responses across ages and disease severity

Advanced TSHA-102 commercial readiness activities, including market access planning initiatives and expansion of strategic partnership with Catalent to support future commercial manufacturing

Completed $230 million follow-on offering, extending cash runway into 2H 2028 and through potential BLA approval of TSHA-102

Conference call and webcast today at 4:30 PM ET

Dallas – August 11, 2026 – Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage

biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

“During the second quarter, we continued to execute against our clinical development strategy for TSHA-102 while advancing key commercial and manufacturing readiness initiatives in support of a potential BLA submission,” said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. “The completion of dosing in our REVEAL pivotal and ASPIRE trials, as well as positive longer-term follow-up data from our REVEAL Phase 1/2 trials continues to strengthen our conviction in TSHA-102 as a potentially transformative therapy for this devastating disease with high unmet need. In addition, the favorable safety profile observed to date across a broad and diverse patient population supports TSHA-102’s potential to safely deliver durable, meaningful functional benefits.”

Mr. Nolan continued, “We are working diligently to advance our commercial readiness activities to support the potential launch of TSHA-102, if approved. Our ongoing market and payer research continues to inform our market access strategy and reinforces TSHA-102’s significant value proposition and reimbursement potential. We have also expanded our partnership with Catalent, establishing a robust commercial supply framework to support the potential launch of TSHA-102 and strong demand we expect following potential FDA approval. Looking ahead, with a strengthened balance sheet, we remain focused on executing our BLA-enabling activities and anticipate reporting topline data from the REVEAL pivotal trial six-month interim analysis and FDA feedback on the BLA submission pathway in the first half of 2027.”

Recent Corporate and TSHA-102 Program Highlights

•

Completed Dosing in the REVEAL Pivotal Trial. Taysha completed dosing in the overenrolled REVEAL pivotal trial, with a total of 17 patients in the developmental plateau population of Rett syndrome dosed with TSHA-102. The REVEAL pivotal trial is a single-arm, open-label trial evaluating a single intrathecal (IT) administration of high dose TSHA-102 (1x1015 total vector genomes (vg)) in females with Rett syndrome between the ages of 6 to <22 years. The primary endpoint will assess response rate, defined as the percentage of patients who gain or regain ≥one of the 28 natural history-defined developmental milestones, with each patient serving as their own control.

•

The study includes a 6-month interim analysis that may serve as the basis for Biologics License Application (BLA) submission. The interim analysis is expected to occur after all 17 patients complete six months of post-treatment follow-up. Subsequently, Taysha plans to discuss data from the 6-month interim analysis and next steps in the BLA submission pathway with the U.S. Food and Drug Administration (FDA) and is on track to report topline data and regulatory feedback in 1H 2027.

•

Completed Dosing in the ASPIRE Trial. Taysha completed dosing in the overenrolled ASPIRE trial, with a total of four patients with Rett syndrome, aged 2 to <4 years, dosed with TSHA-102. The safety-focused trial is evaluating the safety and preliminary efficacy of a single IT administration of high dose TSHA-102 (1x1015 total vg), scaled to account for the lower brain volume in 2 to <4-year-olds. ASPIRE is designed to support a planned BLA submission to enable broad labeling of TSHA-102 for patients aged ≥2 years with Rett syndrome. A minimum of three months of ASPIRE safety data will be included in the planned BLA submission, while efficacy in the 2 to <6-year-old populati

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