Taysha Gene Therapies (TSHA) Company Report

Taysha Gene Therapies (TSHA) reported a net loss of $32.7 million or $0.09 per share for the third quarter ended September 30, 2025.
As of September 30, 2025, TSHA had $297.3 million in cash and cash equivalents, which is expected to support planned operating expenses and capital requirements into 2028.
The company received FDA Breakthrough Therapy Designation for TATIA-102 in September 2025 and finalized alignment with the FDA on the REVEAL pivotal trial protocol and statistical analysis plan for BLA submission.
TSHA is enrolling 15 patients in the REVEAL pivotal trial for Rett syndrome, with the first patient scheduled to be dosed this quarter (Q4 2025).
TSHA regained full global rights to its TATIA-102 Rett Syndrome program in October 2025 and appointed David McNinch as Chief Commercial Officer in September 2025.

Nov 4, 2025, 1:30 PM

Transcript

Taysha Gene Therapies Secures FDA Breakthrough Designation for TSHA-102 and Reports Q3 2025 Financials

TSHA

Earnings

Guidance Update

New Projects/Investments

Taysha Gene Therapies secured FDA Breakthrough Therapy Designation for TSHA-102 for Rett Syndrome in September 2025 and achieved FDA alignment on the REVEAL pivotal trial protocol, including a six-month interim analysis that could accelerate BLA submission.
The REVEAL Part A trials demonstrated a 100% response rate across 10 patients, with the first patient in the REVEAL pivotal trial scheduled for dosing in Q3 2025.
The company regained full global rights to its TSHA-102 program in October 2025, enhancing strategic flexibility.
As of September 30, 2025, Taysha held $297.3 million in cash and cash equivalents, providing a cash runway into 2028. The net loss for Q3 2025 was $32.7 million, or $0.09 per share.

Nov 4, 2025, 1:30 PM

Transcript

Taysha Gene Therapies Reports Q3 2025 Financial Results and Key Program Updates

TSHA

Earnings

Guidance Update

New Projects/Investments

Taysha Gene Therapies' TSHA-102 program for Rett syndrome received Breakthrough Therapy designation from the FDA. The company also finalized FDA alignment on the REVEAL pivotal trial protocol, with the first patient dosing scheduled for Q4 2025.
For the third quarter ended September 30, 2025, the company reported a net loss of $32.7 million, or $0.09 per share, compared to a net loss of $25.5 million, or $0.10 per share, for the same period in 2024.
As of September 30, 2025, Taysha had $297.3 million in cash and cash equivalents, which is expected to support planned operating expenses and capital requirements into 2028.
The company amended its Sales Agreement, increasing the aggregate offering amount for common stock to $212 million as of November 4, 2025, following the termination of the agreement with Leerink Partners LLC.

Nov 4, 2025, 12:12 PM

8-K

Taysha Gene Therapies Regains Full Rights to TSHA-102 Program

TSHA

New Projects/Investments

Taysha Gene Therapies, Inc. has regained full rights to its lead TSHA-102 program for the treatment of Rett syndrome, following the expiration of the 2022 Option Agreement with Astellas.
The TSHA-102 program has demonstrated compelling Part A REVEAL Phase 1/2 safety and efficacy data (May 2025 data cutoff), including a 100% response rate for the pivotal trial primary endpoint.
TSHA-102 has received FDA Breakthrough Therapy designation, and Taysha has finalized the REVEAL pivotal trial protocol and statistical analysis plan with the FDA.
Dosing of the first patient in the REVEAL pivotal trial is scheduled for the current quarter (Q3 2025), evaluating TSHA-102 in 15 females with Rett syndrome.

Oct 16, 2025, 8:10 PM

8-K

Taysha Gene Therapies Presents Positive Supplemental Data for TSHA-102 in Rett Syndrome

TSHA

New Projects/Investments

Taysha Gene Therapies (TSHA) announced new supplemental data analysis from Part A of the REVEAL Phase 1/2 trials for TSHA-102 in Rett Syndrome on October 9, 2025.
The analysis revealed a 100% response rate across all 10 patients in Part A for the pivotal trial primary endpoint, which involved gaining or regaining at least one natural history defined developmental milestone.
A new supplemental analysis showed that 100% of patients also demonstrated multiple skill gains/improvements outside of the natural history defined developmental milestones.
In total, 22 developmental milestones and 165 additional skills/improvements were achieved across the 10 patients treated with TSHA-102.
TSHA-102 is a one-time intrathecally delivered AAV9 investigational gene transfer therapy for Rett syndrome and has received several FDA designations, including Breakthrough Therapy.

Oct 9, 2025, 12:24 PM

8-K

Taysha Gene Therapies Receives FDA Breakthrough Therapy Designation for Rett Syndrome Candidate

TSHA

New Projects/Investments

Guidance Update

Taysha Gene Therapies' stock surged, reaching as high as $4.89 during trading, with volume exceeding 101 million shares, following the U.S. FDA's granting of Breakthrough Therapy designation to its lead candidate, TSHA-102, for Rett syndrome.
The FDA's designation, coupled with alignment on the pivotal REVEAL trial protocol, positions Taysha to potentially expedite its Biologics License Application submission for TSHA-102, with patient enrollment in the trial expected to begin by late 2025.
Analysts, including Needham's Gil Blum, have responded positively by raising the price target for Taysha shares from $8 to $10 while maintaining Buy ratings.
Despite a strong liquidity position, highlighted by a current ratio of 12.48, Taysha faces financial challenges including revenue stagnation and negative operating and net margins.

Oct 2, 2025, 5:00 PM

Morningstar

Taysha Gene Therapies Announces FDA Breakthrough Therapy Designation for TSHA-102 and Regulatory Alignment

TSHA

New Projects/Investments

Guidance Update

Taysha Gene Therapies, Inc. announced on October 2, 2025, that the FDA granted Breakthrough Therapy designation to TSHA-102 for the treatment of Rett syndrome. This designation was based on the FDA's review of clinical evidence from Part A of the REVEAL Phase 1/2 trials, which demonstrated a 100% response rate for the primary endpoint of gaining or regaining developmental milestones (May 2025 data cutoff).
The company has finalized alignment with the FDA on the REVEAL pivotal trial protocol and statistical analysis plan (SAP) for TSHA-102, following the resolution of clinical and statistical queries.
Patient enrollment for the REVEAL pivotal trial is on track to begin in Q4 2025, with key design elements including a 6-month interim analysis that could potentially expedite the Biologics License Application (BLA) submission.

Oct 2, 2025, 12:10 PM

8-K

Earnings Transcripts

Quarterly earnings call transcripts for Taysha Gene Therapies.

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