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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 (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.
Taysha Gene Therapies (Nasdaq: TSHA) announced a conference call on October 25, 2022, at 8:00 AM ET to discuss Astellas Pharma’s strategic investment in two gene therapy programs: TSHA-102 for Rett syndrome and TSHA-120 for giant axonal neuropathy (GAN). This investment aims to bolster the development of AAV-based therapies targeting rare and large patient populations suffering from monogenic diseases of the central nervous system (CNS). For details, visit Taysha's webcast.
Taysha Gene Therapies has announced a strategic partnership with Astellas Pharma, securing a $50 million investment for a 15% ownership stake. This collaboration aims to advance Taysha's innovative gene therapies, TSHA-102 for Rett syndrome and TSHA-120 for giant axonal neuropathy (GAN), addressing serious unmet medical needs. Astellas will acquire exclusive licensing options for these therapies and gain rights related to any change of control at Taysha, along with a Board observer seat. This investment is expected to enhance Taysha's R&D and commercialization efforts in gene therapy.
Astellas Pharma and Taysha Gene Therapies announced a strategic investment of $50 million, acquiring a 15% stake in Taysha while gaining exclusive licensing options for two gene therapy candidates, TSHA-102 and TSHA-120. This collaboration aims to develop therapies for Rett syndrome and Giant Axonal Neuropathy (GAN), addressing significant unmet medical needs. Astellas will also receive a Board observer seat and certain rights regarding potential control changes at Taysha, enhancing their gene therapy capabilities in the central nervous system domain.
Taysha Gene Therapies (TSHA) reported progress in treating giant axonal neuropathy (GAN) with TSHA-120, showing improved sensory nerve amplitude potential (SNAP) in patients. Positive feedback from the MHRA supports their regulatory strategy. In Rett syndrome, preclinical data for TSHA-102 indicated near normalization of behavior in neonatal mice, with clinical data expected by year-end 2022. Financially, Q2 2022 net loss was $33.9 million, a reduction from $40.9 million in Q2 2021. As of June 30, 2022, Taysha had $66.2 million in cash, sufficient to fund operations into Q4 2023.
Taysha Gene Therapies (Nasdaq: TSHA) will report its financial results for Q2 2022 on August 11, 2022, at 8:00 AM ET. This pivotal-stage company focuses on developing AAV-based gene therapies for central nervous system diseases. The conference call will provide insights into the company's financial performance and updates on its gene therapy pipeline. Taysha's mission is to eradicate monogenic CNS diseases through rapid translation of treatments from research to clinical applications, leveraging a fully integrated platform to improve patients' lives.
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