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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 initiated screening for its Phase 1/2 REVEAL trial targeting Rett syndrome, with the first adult patient anticipated to be dosed in H1 2023. The company plans to submit a Clinical Trial Application to the UK MHRA and an IND to the U.S. FDA for TSHA-102 in pediatric patients in mid-2023 and H2 2023, respectively. Taysha's research and development expenses decreased significantly to $13.9 million in Q4 2022 from $37.9 million a year prior. Despite a net loss of $55.7 million for Q4 2022, the company holds $87.9 million in cash, expected to cover expenses into Q1 2024.
Taysha Gene Therapies (Nasdaq: TSHA) will disclose its financial results for Q4 and full-year 2022 on March 28, 2023, at 4:30 PM ET.
The conference call will provide updates on the company's progress in developing AAV-based gene therapies for rare CNS diseases. Participants can join via toll-free and international numbers. Taysha aims to eradicate monogenic CNS diseases by leveraging expertise and a robust gene therapy program.
Taysha Gene Therapies (Nasdaq: TSHA) provided an update on its TSHA-120 program for giant axonal neuropathy (GAN) following a Type B end-of-Phase 2 meeting with the FDA. The FDA acknowledged MFM32 as an acceptable endpoint and recommended dosing additional patients to support a Biologics License Application (BLA) submission. The company also announced the anticipated dosing of the first adult patient with Rett syndrome and plans to submit a Clinical Trial Application (CTA) in mid-2023. New management has implemented operational changes to enhance execution and milestones in 2023 are expected to drive key clinical developments.
Taysha Gene Therapies (Nasdaq: TSHA) has announced significant executive leadership changes as of December 16, 2022. Sean P. Nolan, formerly Chair of the Board, is now the Chief Executive Officer, succeeding RA Session II, who remains on the Board. Dr. Sukumar Nagendran has been appointed President and Head of R&D. Both leaders aim to advance clinical programs in Giant Axonal Neuropathy (GAN) and Rett syndrome and strengthen Taysha's partnership with Astellas. The company plans to host an investor call in January to discuss feedback from the FDA regarding GAN.
Taysha Gene Therapies (Nasdaq: TSHA) announced its participation in the JMP Securities Hematology and Oncology Summit from December 6-7, 2022. The company's President and CEO, RA Session II, will engage in a fireside chat on December 7 at 3:40 PM ET with Dr. Silvan Turkan from JMP Securities. A webcast of the discussion will be accessible on Taysha's corporate website, with an archived version available for 90 days. Taysha is committed to developing AAV-based gene therapies for monogenic CNS diseases, aiming to translate innovative treatments from bench to bedside.
Taysha Gene Therapies (TSHA) announced a $50 million strategic investment from Astellas Pharma to support the development of TSHA-120 for giant axonal neuropathy (GAN) and TSHA-102 for Rett syndrome. This investment, alongside a recent public offering that raised $28 million, extends the company's cash runway into Q1 2024. Taysha will provide a regulatory update on TSHA-120 in January 2023 and expects preliminary clinical data for TSHA-102 in H1 2023. For Q3 2022, R&D expenses were $16.4 million, with a net loss of $26.3 million, showing significant cost reductions compared to the previous year.
Taysha Gene Therapies (Nasdaq: TSHA) will announce its third-quarter financial results on November 8, 2022, at 8:00 AM ET, alongside a corporate update conference call. The company focuses on developing AAV-based gene therapies for monogenic diseases of the central nervous system. This pivotal-stage organization aims to translate treatments quickly from bench to bedside, leveraging a partnership with UT Southwestern Gene Therapy Program.
Taysha Gene Therapies (Nasdaq: TSHA) announced the pricing of a public offering of 14,000,000 shares at $2.00 each, potentially raising approximately $28.0 million in gross proceeds before underwriting costs. Additionally, the underwriter has a 30-day option for 2,100,000 extra shares. The offering is expected to close by October 31, 2022, pending standard conditions. Goldman Sachs is the sole book-runner for this transaction. Proceeds will support Taysha's mission to develop AAV-based gene therapies for CNS diseases.
Taysha Gene Therapies (Nasdaq: TSHA) announced plans for a public offering of $30 million in common stock, subject to market conditions. The company will grant underwriters a 30-day option to purchase up to an additional 15% of the shares. Goldman Sachs & Co. LLC is the sole book-runner for the offering. This move aims to bolster Taysha's resources for developing AAV-based gene therapies for CNS diseases. The offering follows a previously filed shelf registration statement with the SEC, effective since October 14, 2021.
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