Taysha Gene Therapies

Taysha Gene Therapies, Inc.is a patient-centric, clinical-stage gene therapy company, which engages in the development and commercialization of adeno-associated viruses (AAV) based gene therapies for the treatment of monogenic diseases of the central nervous system. It also develops multiple gene therapy platforms which include AAV9 Discovery, Novel Capsid, and AAV Redosing. The company was founded by Steven Gray, Berge Minassian, and R. A. Session II in 2019 and is headquartered in Dallas, TX.

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Earnings data Q1 2024

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Earnings data Q4 2024

Taysha Gene Therapies advances TSHA-102 trials, secures financial stability

Taysha Gene Therapies showcased positive TSHA-102 trial results, faced financial challenges with increased expenses, and highlighted the potential of gene therapy in treating Rett syndrome. The company's focus on safety, sustained improvements, and regulatory advancements positions it for future success.

Taysha Gene Therapies reports positive TSHA-102 data and financial growth

Taysha Gene Therapies showcased promising advancements in the TSHA-102 program for Rett syndrome, supported by positive clinical data and a strengthened financial position.
While challenges exist in regulatory clarity and cost management, the company's strategic focus on data integrity and patient safety bodes well for future growth.
Opportunities for expansion, regulatory milestones, and market positioning through effective resource allocation and research advancements position Taysha for continued success.

Taysha Gene Therapies advances TSHA-102 program with FDA approvals

Taysha Gene Therapies showcased positive progress in their TSHA-102 program for Rett syndrome, securing FDA approvals and demonstrating promising safety profiles in high-dose patients.
While challenges exist in regulatory discussions and optimizing dosing strategies, the company's proactive approach, strategic alliances, and ongoing enrollment position them well for future success.
Excitement for 2025 lies in the company's active enrollment sites, dosing progress, and the potential for improved outcomes in pediatric patients, signaling a positive trajectory for Taysha Gene Therapies.

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Fast Track Designation (FTD) is designed to accelerate the development and expedite the review of therapies with potential to address unmet medical needs for a serious or life-threatening condition

Taysha Gene Therapies Announces Fast Track Designation Granted by U.S. FDA for TSHA-102 in Rett Syndrome

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DALLAS--(BUSINESS WIRE)--GordonMD® Global Investments LP announced today it has participated in a $150 million private placement financing for Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS). Net proceeds will be used primarily to fund clinical development of TSHA-102 in Rett syndrome and to provide support for program a.

GordonMD® Invests in Private Placement for Taysha Gene Therapies

Taysha Gene Therapies has made significant progress with its gene therapy, TSHA-102, for the treatment of Rett Syndrome. Positive results were observed in the first patient treated with TSHA-102, showing improvement in key efficacy measures. The company is also advancing another gene therapy candidate, TSHA-120, for the treatment of Giant Axonal Neuropathy.

Taysha Gene Therapies: Rett Syndrome Data Makes This A Must Watch

Data from first adult patient dosed in REVEAL Phase 1/2 trial showed TSHA-102 was well-tolerated with no treatment-emergent serious adverse events (SAEs) as of six-week assessment and improvement in key efficacy measures, including Clinical Global Impression – Improvement (CGI-I), Clinical Global Impression – Severity (CGI-S) and Rett Syndrome Behavior Questionnaire (RSBQ), four weeks post-treatment

Taysha Gene Therapies Reports Initial Clinical Data from First Adult Rett Syndrome Patient Dosed in REVEAL Phase 1/2 Trial and Provides Corporate Update with Second Quarter 2023 Financial Results

Financing led by RA Capital Management with participation from new and existing investors Expected net proceeds, along with existing cash and cash equivalents, are expected to extend cash runway into the third quarter of 2025 DALLAS, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS), announced today that it has entered into a securities purchase agreement for a private placement financing (the “PIPE”) that is expected to result in gross proceeds of approximately $150 million, before deducting placement agent commissions and offering expenses. The PIPE was led by new investor, RA Capital Management, with participation from a large institutional investor, PBM Capital, RTW Investments, LP, Venrock Healthcare Capital Partners, TCGX, Acuta Capital Partners, Kynam Capital Management, LP, Octagon Capital, Invus, GordonMD® Global Investments LP, and B Group Capital.

Taysha Gene Therapies Announces $150 Million Private Placement Financing

Independent Data Monitoring Committee recommended REVEAL Phase 1/2 trial continuation and proceeding with dosing of second patient based on encouraging initial clinical data from the first adult with Rett syndrome dosed with investigational gene therapy TSHA-102

Taysha Gene Therapies Announces Positive Recommendation from Independent Data Monitoring Committee of REVEAL Phase 1/2 Trial in Rett Syndrome

Company views that results of comprehensive data analysis of TSHA-120 and development of disease progression model (DPM) address U.S. Food and Drug Administration (FDA) feedback regarding the effort-dependent nature of MFM32 as primary endpoint in an unblinded study and heterogeneity of GAN; Taysha plans to review potential regulatory pathway for TSHA-120 at a formal meeting with the FDA expected in Q3 2023

Taysha Gene Therapies Provides Clinical Updates for Investigational Programs TSHA-120 in Giant Axonal Neuropathy (GAN) and TSHA-102 in Rett Syndrome at R&D Day

Virtual R&D Day featuring collaborator Salman Bhai, MD, and Taysha's leadership team at 10:00 AM ET on June 28, 2023

Taysha Gene Therapies to Host Virtual R&D Day on Lead Clinical Investigational Programs TSHA-120 in Giant Axonal Neuropathy (GAN) and TSHA-102 in Rett Syndrome

The Phase 1/2 REVEAL trial is a first-in-human, randomized, dose-escalation and dose-expansion study evaluating the safety and preliminary efficacy of TSHA-102 in adults with Rett syndrome

Taysha Gene Therapies Announces First Patient Dosed with TSHA-102 in the REVEAL Phase 1/2 Trial Under Investigation for the Treatment of Rett Syndrome

New preclinical data after neonatal administration in wild-type mice showed no detectable impact on survival, neurobehavioral functions and overall health, suggesting TSHA-102, engineered with novel miRARE technology, avoided toxic overexpression of MeCP2 within cells already expressing MeCP2

Taysha Gene Therapies Presents Preclinical Data on TSHA-102 for Rett Syndrome Demonstrating Cellular Regulation of MeCP2 Expression in Key Mouse Models at the American Society of Gene and Cell Therapy 26th Annual Meeting

Taysha Gene Therapies, Inc. (NASDAQ:TSHA ) Q1 2023 Earnings Conference Call May 11, 2023 4:30 PM ET Company Participants Hayleigh Collins - Director and Head of Corporate Communications Sean Nolan - CEO Sukumar Nagendran - President and Head of Research and Development Salman Bhai - Assistant Professor of Neurology at UT Kamran Alam - CFO Conference Call Participants Abigail Gray - Baird Gil Blum - Needham & Co. Operator Thank you for standing by. This is the conference operator.

Taysha Gene Therapies, Inc. (TSHA) Q1 2023 Earnings Call Transcript

Screening completed and dosing scheduled for first potential subject in the Phase 1/2 REVEAL trial in Rett syndrome; dosing of first adult patient with TSHA-102 expected in Q2 2023; initial available Phase 1/2 clinical data, primarily on safety, expected in Q2 2023

Taysha Gene Therapies Reports First Quarter 2023 Financial Results and Provides Corporate Update

DALLAS, May 04, 2023 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS), today announced that it will report its financial results for the first quarter ended March 31, 2023, and host a corporate update conference call and webcast on Thursday, May 11, 2023, at 4:30 PM Eastern Time.

Taysha Gene Therapies to Release First Quarter 2023 Financial Results and Host Conference Call and Webcast on May 11

DALLAS, April 27, 2023 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS), today announced that an abstract related to its TSHA-102 program in Rett syndrome was accepted for presentation at the upcoming American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting, taking place in Los Angeles, CA from May 16-20, 2023. The abstract includes new preclinical data from a Taysha-sponsored study for TSHA-102, a self-complementary intrathecally delivered AAV9 gene transfer therapy in clinical evaluation for Rett syndrome, a rare neurodevelopmental disorder caused by mutations in the X-linked MECP2 gene.

Taysha Gene Therapies Announces Presentation on New Preclinical Data for TSHA-102 in Rett Syndrome at Upcoming American Society of Gene and Cell Therapy 26th Annual Meeting

Taysha Gene Therapies, Inc. (NASDAQ:TSHA ) Q4 2022 Earnings Conference Call March 28, 2023 4:30 PM ET Company Participants Hayleigh Collins - Director and Head of Corporate Communications Sean Nolan - Chief Executive Officer Sukumar Nagendran - President and Head of Research and Development Kamran Alam - Chief Financial Officer Conference Call Participants Whitney Ijem - Canaccord Genuity Jack Allen - Robert W. Baird & Co. Silvan Tuerkcan - JMP Securities Yun Zhong - BTIG David Hoang - SMBC Nikko Securities Joon Lee - Truist Securities Operator Greetings, and welcome to the Taysha Gene Therapies Fourth Quarter and Full-Year 2022 Earnings Call.

Taysha Gene Therapies, Inc. (TSHA) Q4 2022 Earnings Call Transcript

Initiated screening of first potential subject in Phase 1/2 REVEAL trial in Rett syndrome; dosing of first adult patient with TSHA-102 expected in H1 2023; submitted protocol amendment to allow for younger patients; initial available Phase 1/2 clinical data, primarily on safety, expected in H1 2023

Taysha Gene Therapies Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

DALLAS, March 15, 2023 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric, clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic rare diseases of the central nervous system (CNS), today announced that it will report its financial results for the fourth quarter and full-year ended December 31, 2022, and host a corporate update conference call and webcast on Tuesday, March 28, 2023, at 4:30 PM Eastern Time.

Taysha Gene Therapies to Release Fourth Quarter and Full-Year 2022 Financial Results and Host Conference Call and Webcast on March 28

Taysha has a good chance of scoring with the GAN indication. Astellas may license this program if that happens.

Taysha: The FDA Just Stuck A Major Blow To Their Plans

Type B end-of-Phase 2 meeting with U.S. Food and Drug Administration (FDA) provided additional clarity for TSHA-120 for the treatment of giant axonal neuropathy (GAN) ultra-rare disease program  - FDA acknowledged MFM32 as an acceptable endpoint with a recommendation to dose additional patients in a double-blind, placebo-controlled design to support Biologics License Application (BLA) submission

Taysha Gene Therapies Provides Update on TSHA-120 Program in Giant Axonal Neuropathy and a 2023 Corporate Outlook

Chair of the Board of Directors, Sean P. Nolan, appointed Chief Executive Officer

Taysha Gene Therapies Announces Executive Leadership Changes

Taysha Gene Therapies, Inc. (TSHA) witnesses a hammer chart pattern, indicating support found by the stock after losing some value lately. This coupled with an upward trend in earnings estimate revisions could mean a trend reversal for the stock in the near term.

Taysha Gene Therapies, Inc. (TSHA) Could Find Support Soon, Here's Why You Should Buy the Stock Now

DALLAS, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric, pivotal-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS) in both rare and large patient populations, today announced that it will participate in the JMP Securities Hematology and Oncology Summit, which is taking place virtually from Tuesday, December 6, 2022, through Wednesday, December 7, 2022. Taysha's President, Founder and Chief Executive Officer, RA Session II, will participate in a fire side chat with Silvan Turkan, Ph.D., Senior Research Analyst at JMP Securities, at 3:40 PM ET on Wednesday, December 7, 2022.

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