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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 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.
Taysha Gene Therapies (Nasdaq: TSHA) announced an upcoming oral presentation at the 9th World Rett Syndrome Congress in Queensland, Australia, from October 2-5, 2024. The presentation will cover previously disclosed clinical data on the TSHA-102 program for Rett syndrome, including:
1. Positive clinical data up to 52 weeks from the ongoing REVEAL Phase 1/2 adolescent and adult trial
2. Initial clinical data up to 22 weeks from the REVEAL Phase 1/2 pediatric trial
The company expects to provide additional clinical data in the first half of 2025, including:
- Cohort two (high dose, n=3) results
- Longer-term update on cohort one (low dose, n=2) from both trials
The presentation, titled 'First cohort data from the REVEAL adolescent/adult and pediatric studies of TSHA-102 gene therapy for Rett syndrome,' will be given by Dr. Sukumar Nagendran, President and Head of Research and Development at Taysha Gene Therapies.
Taysha Gene Therapies (Nasdaq: TSHA), a clinical-stage biotech 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 September 3, 2024, the company's Compensation Committee granted a new employee an option to purchase 311,000 shares of common stock. The stock option, issued under Taysha's 2023 Inducement Plan, has an exercise price of $2.06 per share, equal to the closing price on the grant date. The option has a 10-year term and will vest over four years, with 25% vesting on the first anniversary and the remaining 75% vesting monthly over the following 36 months, subject to continued employment.
Taysha Gene Therapies (NASDAQ: TSHA) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
- Presented encouraging data from TSHA-102 trials for Rett syndrome in adult and pediatric patients
- Dosed first patient in high-dose cohort of adolescent/adult trial with no serious adverse events
- Raised $76.8 million in June 2024 offering, extending cash runway into Q4 2026
- Q2 2024 net loss of $20.9 million ($0.09 per share)
- Cash and equivalents of $172.7 million as of June 30, 2024
The company plans to report clinical data from high-dose cohorts and update on low-dose cohorts for both REVEAL trials in 1H 2025.
Taysha Gene Therapies (Nasdaq: TSHA), a clinical-stage biotechnology company focusing on AAV-based gene therapies for severe monogenic CNS diseases, has announced its plans to release second quarter 2024 financial results and host a corporate update conference call on August 12, 2024. The event is scheduled for 8:30 AM Eastern Time.
Investors and interested parties can access the conference call via toll-free and international numbers, or join the webcast through the company's investor relations website. This upcoming financial disclosure and corporate update will provide insights into Taysha's performance and progress in developing gene therapies for CNS disorders.
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