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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) 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.
Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage biotechnology company focusing on AAV-based gene therapies for CNS diseases, has announced the granting of stock options to two new employees. The Compensation Committee approved options to purchase 356,000 shares of common stock on August 1, 2024, under the company's 2023 Inducement Plan. These options, granted in accordance with Nasdaq Listing Rule 5635(c)(4), have an exercise price of $2.16 per share, equal to the closing price on the grant date. The options have a 10-year term and will 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 (TSHA) has announced an inducement grant under Nasdaq Listing Rule 5635(c)(4). On July 3, 2024, the Compensation Committee granted four new employees options to purchase a total of 484,000 shares of the company's common stock. The options were issued under the 2023 Inducement Plan to encourage the new hires, with an exercise price of $2.15 per share, matching the closing price on the grant date. These options have a 10-year term and follow a four-year vesting schedule—25% vest on the first anniversary of the vesting start date, with the remaining 75% vesting in equal monthly installments over the next three years, contingent on continuous service.
Taysha Gene Therapies (Nasdaq: TSHA), a clinical-stage biotech company specializing in AAV-based gene therapies for severe CNS diseases, has announced the pricing of its public offering. The offering includes 14,361,113 shares of common stock at $2.25 per share and pre-funded warrants for 18,972,221 shares at $2.249 per warrant. Gross proceeds are expected to be approximately $75 million before underwriting discounts and expenses. An additional 15% of shares may be available to underwriters within 30 days. The offering is set to close around June 27, 2024, pending usual conditions. Jefferies and Goldman Sachs are the lead book-running managers, with Cantor also participating.
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.
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