Taysha Gene Therapies announces updates from TSHA-102 clinical program
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Taysha Gene Therapies Inc (TSHA) Q2 2025 Earnings Call Highlights: Regulatory Milestones and ...
Research and Development Expenses: $2.1 million for Q2 2025, compared to $15.1 million for Q2 2024. General and Administrative Expenses: $8.6 million for Q2 2025, compared to $7.3 million for Q2 2024. Net Loss: $26.9 million or $0.9 per share for Q2 2025, compared to $20.9 million or $0.9 per share for Q2 2024. Cash and Cash Equivalents: $312.8 million as of June 30, 2025. Follow-on Financing Proceeds: $230 million from May 2025, including full exercise of underwriters' option. Refinanced Loan: New debt facility of $50 million upfront with Trinity Capital, deferring principal payments by over 2.5 years. Warning! GuruFocus has detected 4 Warning Signs with TSHA. Release Date: August 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Taysha Gene Therapies Inc (NASDAQ:TSHA) has obtained alignment with the FDA and Health Canada to proceed with initiating their REVEAL pivotal trial for TSHA-102, indicating strong regulatory progress. The company reported positive clinical data supporting the therapeutic potential of TSHA-102, with all 10 patients in Part A of the REVEAL trials gaining or regaining developmental milestones. TSHA-102 is designed to target the genetic root cause of Rett syndrome, leveraging a clinically proven AAV9 vector and a minimally invasive lumbar intrathecal injection method. The company completed a public follow-on offering, resulting in total gross proceeds of $230 million, extending their cash runway into 2028. Taysha Gene Therapies Inc (NASDAQ:TSHA) has a defined path to registration for TSHA-102, with a pivotal trial underway and a strengthened balance sheet. Negative Points The company reported a net loss of $26.9 million for the three months ended June 30, 2025, compared to a net loss of $20.9 million for the same period in 2024. General and administrative expenses increased to $8.6 million for the three months ended June 30, 2025, primarily due to higher legal and professional fees. There are no currently approved therapies that treat the underlying genetic root cause of Rett syndrome, highlighting the urgency and challenge of developing effective treatments. The company faces risks and uncertainties that may cause actual results to differ materially from forward-looking statements, as noted in their SEC filings. The pivotal trial design relies on a novel regulatory pathway, which may present challenges in terms of regulatory approval and market acceptance. Q & A Highlights Q: Given there was a 100% response rate for the pivotal trial primary endpoint in Part A of the study, is this the bar for Part B in your view? A: Sean Nolan, CEO: The results from Part A are compelling, but maintaining a 100% response rate is challenging. The statistical plan for Part B uses a null hypothesis of 6.7%, meaning only 1 out of 15 patients might spontaneously gain or regain a milestone. The statistical bar is relatively low, around 33%, and the numbers from Part A are significantly above this threshold. Q: Are there certain time points where all milestones are occurring, or are additional ones seen over time? Have the benefits of the gene therapy plateaued? A: Elsa Rosignol, Director of Integrated Rett Syndrome Clinic: We see increasing improvements over time, not just at one visit. Gains occur at most follow-up visits, and some critical gains in daily functioning are not captured in the developmental milestone assessment but are still significant improvements. Q: How does your gene therapy differentiate from competitors, particularly regarding study design and primary endpoints? A: Sean Nolan, CEO: Our approach is unique, focusing on clinically meaningful and objective gains in activities of daily living. We've worked with regulators to establish a new paradigm in assessing clinical efficacy through milestone gains. This approach is supported by KOLs, advocacy groups, and regulators, emphasizing the therapy's impact on quality of life. Q: Would you expect any pushback on using your interim readout to support BLA filing, given your competitor's feedback on a 6-month endpoint? A: Sean Nolan, CEO: Our interim analysis approach is data-driven, based on robust support from Part A data. We've discussed this with the FDA, focusing on further refinements of the analysis rather than overturning key trial design elements. We feel confident about our position. Q: Can you characterize any changes from Part A CMC material batch to Part B, specifically regarding full to empty capsid ratio? How many patients can you supply with commercial-scale material? A: Sean Nolan, CEO: We've aligned with the FDA that Part A and pivotal material are analytically comparable. We've made the product for the pivotal trial with the commercial process at scale. Our cash runway into 2028 allows us to build commercial inventory as needed, ensuring we're well-positioned on the CMC side. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
