Taysha Gene Therapies, Inc. reports company developments as a clinical-stage biotechnology company advancing adeno-associated virus, or AAV, gene therapies for severe monogenic diseases of the central nervous system. Its lead program, TSHA-102, is an intrathecally delivered, self-complementary AAV9 investigational gene transfer therapy in clinical evaluation for Rett syndrome.
Recurring updates cover TSHA-102 clinical and preclinical data, FDA regulatory interactions and designations, manufacturing and comparability topics, financial results, corporate updates, and employee inducement equity grants under Nasdaq listing rules. Company communications also describe the program’s MECP2 construct design, miRARE technology, and clinical trial activity in Rett syndrome.
Taysha Gene Therapies (Nasdaq: TSHA) has announced a public offering of up to $75 million in common stock and pre-funded warrants. This offering allows certain investors the option to purchase pre-funded warrants instead of common stock. Additionally, underwriters Jefferies, Goldman Sachs, and Cantor have a 30-day option to buy up to 15% more shares under the same terms. The offering is dependent on market conditions, and there is no guarantee of its completion or terms. A previously filed and approved shelf registration statement with the SEC covers the securities. The offering will proceed via a prospectus and prospectus supplement filed with the SEC. Copies of these documents are available from Jefferies or Goldman Sachs.
Taysha Gene Therapies announced positive clinical data from their ongoing REVEAL Phase 1/2 trials evaluating TSHA-102 for Rett Syndrome. Notable improvements were seen in both adult and pediatric patients across various clinical domains such as motor skills, communication, autonomic function, and seizures. No serious adverse events were linked to TSHA-102. The initial data showed sustained improvements in adults over 52 weeks and promising early developmental gains in children. The Independent Data Monitoring Committee (IDMC) approved advancing to a higher dose cohort in the pediatric trial, with dosing expected in Q3 2024.
Taysha Gene Therapies (Nasdaq: TSHA), a biotechnology firm advancing AAV-based gene therapies for severe CNS diseases, will present clinical data from its REVEAL Phase 1/2 trials assessing TSHA-102 for Rett syndrome. The company will host a webcast on June 18, 2024, at 8:00 AM Eastern Time, and the data will also be shared at the 2024 IRSF Rett Syndrome Scientific Meeting on June 18-19, 2024. Presentations will feature data from both adolescent/adult and pediatric trials, delivered by Dr. Elsa Rossignol and Dr. Colleen Buhrfiend. The webcast can be accessed via Taysha’s website.
Taysha Gene Therapies announced on June 3, 2024, the grant of stock options to three new employees under its 2023 Inducement Plan, following Nasdaq Listing Rule 5635(c)(4). The total of 360,000 shares was offered at an exercise price of $3.62 per share, matching the closing price on the grant date. The options, with a 10-year term, will vest 25% after one year and the rest monthly over the subsequent 36 months, contingent on continued employment.
Taysha Gene Therapies reported its Q1 2024 financial results and provided a corporate update.
The company completed dosing in the first low-dose cohort of the REVEAL Phase 1/2 trial for adolescents and adults, and dosed the second pediatric patient in the same phase.
The FDA granted RMAT designation for TSHA-102, enabling expedited development.
Initial data from both trials is expected in mid-2024, with updates from higher dose cohorts due in 2H 2024.
For Q1 2024, Taysha reported an increase in R&D expenses to $20.7 million and a decrease in G&A expenses to $7.1 million, resulting in a net loss of $24.1 million.
With $124 million in cash, Taysha's resources are expected to support operations into 2026.
Taysha Gene Therapies, a gene therapy company, will release its first-quarter 2024 financial results on March 31 and host a conference call on May 14. The company focuses on AAV-based gene therapies for CNS diseases.
Taysha Gene Therapies, a clinical-stage gene therapy company, granted options to purchase 528,000 shares of common stock to four new employees under the 2023 Inducement Plan. The options have an exercise price of $2.42 per share, a 10-year term, and will vest over four years. This grant is in accordance with Nasdaq Listing Rule 5635(c)(4).
Taysha Gene Therapies has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA for TSHA-102 in Rett syndrome. This designation allows for increased dialogue with the FDA to support expedited development and review of the therapy. The RMAT designation was granted based on the safety and efficacy data from the first three patients dosed with TSHA-102 in clinical trials.
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