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Taysha Gene Therapies, Inc. (Nasdaq: TSHA) is a pioneering clinical-stage biotechnology company headquartered in Dallas, Texas. Founded in 2019, Taysha is dedicated to developing and commercializing transformative gene therapies using adeno-associated viruses (AAV) to treat severe monogenic diseases of the central nervous system (CNS).
Taysha focuses on eradicating monogenic CNS diseases, addressing severe unmet medical needs, and dramatically improving the lives of patients and their caregivers. With a robust pipeline, including leading clinical program TSHA-102, the company aims to develop curative medicines. TSHA-102, currently in clinical evaluation for Rett syndrome, employs miRNA-Responsive Auto-Regulatory Element (miRARE) technology to deliver a functional MECP2 gene, aiming to mediate MECP2 levels in the CNS without the risk of overexpression.
Rett syndrome is a rare neurodevelopmental disorder caused by mutations in the MECP2 gene, leading to severe intellectual disabilities and various neurological impairments. TSHA-102 has received multiple designations, including Fast Track, Orphan Drug, and Rare Pediatric Disease from the FDA, and Orphan Drug designation from the European Commission, underscoring its potential to address significant medical needs.
Taysha has also made strategic advances with its partnerships, particularly with the University of Texas Southwestern Medical Center. This collaboration focuses on developing and commercializing AAV-based gene therapies, leveraging Taysha's integrated platform and the university's Gene Therapy Program.
Recently, Taysha achieved numerous milestones, including significant updates to the TSHA-102 program. The Independent Data Monitoring Committee (IDMC) approved dose escalation in the REVEAL Phase 1/2 trials, indicating promising initial safety and efficacy data. Taysha also expanded these trials into the United States, enhancing their ability to evaluate TSHA-102 across broader patient demographics.
Furthermore, Taysha terminated an existing loan agreement and entered a new one to facilitate the transfer of intellectual property (IP) for several programs to third parties. This strategic move extended their cash runway into 2026, demonstrating financial prudence and long-term planning.
The company is actively progressing clinical trials for TSHA-102, including both adolescent/adult and pediatric cohorts, which are crucial for regulatory and clinical development. Taysha's focus on innovative gene therapy solutions, combined with a patient-centric approach, positions it as a significant player in the biotech landscape.
For continuous updates and detailed information, visit the company’s website at www.tayshagtx.com.
Taysha Gene Therapies (NASDAQ: TSHA) has reported its full-year 2024 financial results and provided updates on its TSHA-102 gene therapy program for Rett syndrome. The company has completed dosing of 10 patients in Part A of both REVEAL trials, with 6 patients receiving high dose (1x1015 total vg) and 4 receiving low dose (5.7x1014 total vg).
Key highlights include no treatment-related serious adverse events or dose-limiting toxicities across all treated patients. The company expects to provide updates on the pivotal trial design and clinical data from both REVEAL trials in H1 2025.
Financial results show R&D expenses increased to $66.0 million in 2024 from $56.8 million in 2023, while G&A expenses decreased slightly to $29.0 million. Net loss for 2024 was $89.3 million ($0.36 per share). The company reported cash and cash equivalents of $139.0 million, expected to support operations into Q4 2026.
Taysha Gene Therapies (TSHA), a clinical-stage biotechnology company specializing in AAV-based gene therapies for CNS disorders, has announced it will release its full-year 2024 financial results and host a corporate update conference call on February 26, 2025. The event will take place at 8:30 AM Eastern Time.
The company has provided both domestic and international dial-in numbers for interested parties to participate in the conference call, which will also be accessible via webcast through the company's investor relations website.
Taysha Gene Therapies (TSHA) has announced the granting of stock options to three new employees as inducement awards. The Compensation Committee approved options to purchase a total of 491,000 shares of common stock under the company's 2023 Inducement Plan, in accordance with Nasdaq Listing Rule 5635(c)(4).
The stock options were granted at an exercise price of $1.53, matching the closing price on the grant date. These options have a 10-year term and will vest over four years, with 25% vesting after the first year and the remaining 75% vesting in equal monthly installments over the following 36 months. Vesting is contingent upon continued employment with Taysha.
Taysha Gene Therapies (Nasdaq: TSHA) announced that its Compensation Committee has granted a stock option to one new employee on January 2, 2025. The grant includes options to purchase 311,000 shares of common stock at an exercise price of $1.85 per share, matching the closing price on the grant date. The stock option was issued under the company's 2023 Inducement Plan, complying with Nasdaq Listing Rule 5635(c)(4). The option has a 10-year term and follows a four-year vesting schedule: 25% vests after the first year, with the remaining 75% vesting monthly over the following 36 months, contingent on continued employment.
Taysha Gene Therapies (Nasdaq: TSHA) has announced that its Compensation Committee granted a stock option to one new employee on December 2, 2024. The inducement grant, issued under the company's 2023 Inducement Plan and in accordance with Nasdaq Listing Rule 5635(c)(4), consists of an option to purchase 152,000 shares of common stock at an exercise price of $3.08 per share. The option has a 10-year term and will vest over four years, with 25% vesting after the first year and the remaining 75% vesting monthly over the following 36 months, subject to continued employment.
Taysha Gene Therapies (TSHA) reported Q3 2024 financial results and provided updates on its TSHA-102 program. The high dose treatment was well-tolerated with no serious adverse events across both adult and pediatric trials. The FDA approved the use of pivotal product in REVEAL trials and endorsed the commercial manufacturing process. Research and development expenses increased to $14.9 million from $11.8 million year-over-year, while net loss decreased to $25.5 million from $117.1 million. The company has $157.7 million in cash, expected to support operations into Q4 2026. Clinical data from both REVEAL trials' cohorts is expected in H1 2025.
Taysha Gene Therapies (TSHA), a clinical-stage biotechnology company focused on AAV-based gene therapies for CNS diseases, has scheduled its third quarter 2024 financial results release and corporate update conference call for November 13, 2024, at 4:30 PM Eastern Time. The company will discuss its financial performance for the quarter ended September 30, 2024. Investors can access the conference via toll-free and international dial-in numbers or through a webcast on the company's investor relations website.
Taysha Gene Therapies announced that its Compensation Committee granted stock options to three new employees on November 1, 2024. The options allow the purchase of 157,000 shares of common stock at $1.53 per share, matching the closing price on the grant date. These options were granted under the company's 2023 Inducement Plan, following Nasdaq Listing Rule 5635(c)(4). The options have a 10-year term and vest over four years, with 25% vesting after one year and the remaining 75% vesting monthly over the following 36 months, subject to continued employment.
Taysha Gene Therapies will present biodistribution data from an analysis of 28 non-human primates (NHPs) at the 31st Annual ESGCT Congress in Rome. The analysis, spanning five studies, evaluated AAV9 gene therapy vector delivery using intrathecal (IT) and intra-cisterna magna (ICM) administration.
Key findings include:
- Lumbar IT administration led to widespread and consistent biodistribution across brain and spinal cord regions
- IT and ICM administration achieved comparable biodistribution in NHPs
- Results support IT administration as an effective, safe, and minimally invasive approach for delivering AAV-based gene therapies for CNS diseases in children and adults
The data reinforces Taysha's clinical development strategy, particularly for their TSHA-102 program targeting Rett syndrome. The poster presentation, titled 'Broad CNS Biodistribution of AAV9-based Gene Therapies Delivered by Intrathecal Lumbar Puncture in Non-Human Primates,' will be presented on October 23, 2024.
Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage biotechnology company focusing on AAV-based gene therapies for severe monogenic CNS diseases, has announced an inducement grant under Nasdaq Listing Rule 5635(c)(4). On October 1, 2024, the Compensation Committee of Taysha's Board of Directors granted a new employee an option to purchase 501,600 shares of the company's common stock.
The stock option, granted under the Taysha Gene Therapies, Inc. 2023 Inducement Plan, has an exercise price of $2.02 per share, equal to the closing price on the grant date. It has a 10-year term and will vest over four years, with 25% vesting on the first anniversary and the remaining 75% vesting in equal monthly installments over the following 36 months, subject to continued service.
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