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Taysha Gene Therapies(TSHA) - 2024 Q1 - Quarterly Results
2024-06-26 10:14
Exhibit 99.2 We are a clinical-stage biotechnology company focused on advancing AAV-based gene therapies for the treatment of severe monogenic diseases of the central nervous system, or CNS. Our lead clinical program TSHA-102 is in development for the treatment of Rett syndrome, a rare neurodevelopmental disorder with no approved disease-modifying therapies that address the genetic root cause of the disease. With a singular focus on developing transformative medicines, we aim to address severe unmet medical ...
Taysha Gene Therapies Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants
Newsfilter· 2024-06-25 22:34
Core Viewpoint - Taysha Gene Therapies, Inc. has initiated an underwritten public offering of up to $75 million in common stock and pre-funded warrants, subject to market conditions [1][2]. Company Overview - Taysha Gene Therapies is a clinical-stage biotechnology company focused on AAV-based gene therapies for severe monogenic diseases of the central nervous system [6]. - The company's lead clinical program, TSHA-102, is in development for Rett syndrome, a rare neurodevelopmental disorder with no approved disease-modifying therapies [6]. - Taysha aims to address severe unmet medical needs and improve the lives of patients and caregivers through transformative medicines [6]. Offering Details - The public offering includes a 30-day option for underwriters to purchase an additional 15% of the shares offered [1]. - Jefferies and Goldman Sachs & Co. LLC are acting as joint book-running managers for the offering, with Cantor also serving as a book-running manager [2].
Taysha Gene Therapies Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants
GlobeNewswire News Room· 2024-06-25 22:34
Jefferies and Goldman Sachs & Co. LLC are acting as joint book-running managers for the offering, and Cantor is also serving as a book-running manager for the proposed offering. About Taysha Gene Therapies time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Taysha disclaims any obligation to update these statements except as may be required by law. DALLAS, June 25, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (NASDAQ:TSHA), a clinicalstage biotechnology ...
Taysha Gene Therapies Announces Positive Clinical Data Across Adult and Pediatric Patients from Low Dose Cohort in Ongoing REVEAL Phase 1/2 Trials Evaluating TSHA-102 in Rett Syndrome
Newsfilter· 2024-06-18 11:30
Durable improvements across consistent clinical domains in both adult and pediatric patients, including motor skills, communication/socialization, autonomic function, seizures, and an encouraging safety profile seen across adult (up to 52 weeks) and pediatric (up to 22 weeks) patients with different genetic mutation severity Initial data from first two pediatric patients showed improvements across multiple efficacy measures and clinical domains, with early evidence of developmental gains (patient one: impro ...
Taysha Gene Therapies to Present Clinical Data from Both REVEAL Phase 1/2 Trials During Company-Hosted Webcast and at 2024 IRSF Rett Syndrome Scientific Meeting
Newsfilter· 2024-06-12 11:00
Company to host webcast on Tuesday, June 18, 2024, at 8:00 AM Eastern Time Date/Time: Tuesday, June 18, 2024, at 8:00 AM Eastern Time Registration: https://lifescievents.com/event/taysha-2/ The live webcast and replay will be available through Taysha's website here. About Taysha Gene Therapies Media Contact: Carolyn Hawley Taysha-Hosted Webcast Details Oral Presentation Title: TSHA-102 gene therapy for Rett syndrome: First-cohort data from the REVEAL Adolescent/Adult and Pediatric studies Date/Time: Wednesd ...
Taysha Gene Therapies Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
Newsfilter· 2024-06-07 12:00
DALLAS, June 07, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinicalstage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today announced that, on June 3, 2024, the Compensation Committee of Taysha's Board of Directors granted three new employees, in the aggregate, options to purchase 360,000 shares of the Company's common stock in connection with their employment. The ...
Taysha Gene Therapies(TSHA) - 2024 Q1 - Earnings Call Transcript
2024-05-15 08:55
Financial Data and Key Metrics Changes - The net loss for the three months ended March 31, 2024, was $24.1 million or $0.10 per share, compared to a net loss of $17.6 million or $0.28 per share for the same period in 2023, indicating an increase in losses [90] - Research and development expenses were $20.7 million for the three months ended March 31, 2024, compared to $12.5 million for the same period in 2023, reflecting increased clinical trial activities [108] - As of March 31, 2024, the company had $124 million in cash and cash equivalents, which is expected to support planned operating expenses and capital requirements into 2026 [110] Business Line Data and Key Metrics Changes - The company is focused on the TSHA-102 program, which is in clinical evaluation for the treatment of Rett Syndrome, with ongoing Phase I/II REVEAL trials for both adolescent/adult and pediatric populations [21][24] - Encouraging longer-term data was reported for the first two adult patients treated in the low-dose cohort, showing sustained improvements across key efficacy measures [26][28] - The second pediatric patient has been dosed in the low-dose cohort, with initial data expected to be reported in mid-2024 [29][86] Market Data and Key Metrics Changes - Rett Syndrome affects an estimated 15,000 to 20,000 patients in the United States, European Union, and the United Kingdom, with no approved disease-modifying therapies currently available [42] - The company received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, which facilitates closer collaboration and expedited development processes [31][70] Company Strategy and Development Direction - The company aims to generate critical longer-term clinical data across a broad range of ages and stages of patients with Rett Syndrome, guiding the next phase of studies [22][51] - The strategy includes expanding clinical trials into pediatric populations and evaluating the high dose of TSHA-102 across different age groups [51][62] - The company is committed to working closely with the FDA and other regulatory agencies to advance the TSHA-102 program [51] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the therapeutic potential of TSHA-102, highlighting the sustained improvements observed in adult patients and the potential for similar outcomes in pediatric patients [41][82] - The management acknowledged the high unmet medical need in Rett Syndrome and the importance of their gene therapy approach in addressing this challenge [42][70] - Future updates are anticipated, including initial clinical data from the pediatric trial and further insights from the completed low-dose cohort of the adolescent and adult trial [71][92] Other Important Information - The company is currently enrolling patients in both the adolescent/adult and pediatric trials, with a focus on diverse genetic backgrounds to evaluate the clinical impact of TSHA-102 [63][69] - The independent data monitoring committee approved the request to proceed to an early dose escalation in the adolescent and adult trial [25] Q&A Session Summary Question: What are the expectations for younger patients in the trial? - Management indicated that while the pediatric population is heterogeneous, they expect to see consistent clinical impacts across multiple domains similar to adult patients, with a focus on gross and fine motor function, socialization, and seizure improvement [95][113] Question: Can you comment on the RMAT designation and the data provided to the FDA? - The RMAT designation was granted based on data from two adult patients and one pediatric patient, indicating significant clinical impact and unmet medical needs [115][119] Question: How is Astellas involved in data sharing? - The company provides quarterly updates to Astellas, and they are involved in regulatory interactions, ensuring transparency regarding data generation and strategic aspects of the program [120] Question: When can we expect initial pediatric data? - Initial pediatric data is expected to be presented at the Rett conference on June 19, with plans for a webcast for investors [125] Question: What are the advantages of intrathecal administration compared to competitors? - Management highlighted that preclinical and clinical data support the effectiveness of TSHA-102 via intrathecal administration, showing significant impacts on various clinical domains [130]
Taysha Gene Therapies(TSHA) - 2024 Q1 - Quarterly Report
2024-05-14 20:12
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-39536 Taysha Gene Therapies, Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 84- ...
Taysha Gene Therapies(TSHA) - 2023 Q4 - Earnings Call Transcript
2024-03-20 01:04
Taysha Gene Therapies, Inc. (NASDAQ:TSHA) Q4 2023 Earnings Conference Call March 19, 2024 4:30 PM ET Company Participants Hayleigh Collins - Director, Head of Corporate Communications and Investor Relations 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 Elizabeth Webster - Goldman Sachs Kristen Kluska - Cantor Fitzgerald Gil Blum - Needham & Company Mehdi Gouda ...
Taysha Gene Therapies(TSHA) - 2023 Q4 - Earnings Call Presentation
2024-03-19 22:21
FORWARD LOOKING STATEMENTS This presentation is intended to be viewed by investors in the U.S. only 2 TSHA-102: Lead Clinical Program in Rett Syndrome • Clinically and commercially proven AAV9 capsid with clinical activity and tolerability across multiple CNS indications • Intrathecal delivery in an outpatient setting targets key CNS regions and minimizes viral load, potentially reducing risk of systemic inflammatory response • Self-complementary technology facilitates more rapid transgene expression Proven ...