On November 14, 2023, Taysha Gene Therapies Inc (TSHA, Financial) released its 8-K filing, detailing its financial results for the third quarter ended September 30, 2023, and providing updates on its corporate and clinical developments. The company, which specializes in AAV-based gene therapies for central nervous system (CNS) diseases, highlighted the progress of its REVEAL Phase 1/2 trial and its strengthened financial position.
Clinical and Corporate Updates
Taysha Gene Therapies Inc (TSHA, Financial) reported positive data from its REVEAL Phase 1/2 trial for TSHA-102, a gene therapy candidate for Rett syndrome. The treatment was well-tolerated in the first two adult patients, with no treatment-emergent serious adverse events (SAEs) and improvements across key efficacy measures. The Independent Data Monitoring Committee (IDMC) has cleared the dosing of the third adult patient, with completion of the low dose cohort expected in late 2023 or early 2024. The first pediatric patient in the U.S. is anticipated to be dosed in the first quarter of 2024.
“We are highly encouraged by the positive 12-week data from the first adult patient and initial four-week data from the second adult patient in the low dose TSHA-102 cohort,” said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha.
Dr. Elsa Rossignol, Principal Investigator of the REVEAL trial, added, “Following treatment, both patients experienced improvement in key clinical domains impacting activities of daily living... I’m encouraged by the early positive signals and consistent improvement seen in both patients following treatment.”
Financial Highlights
Research and Development (R&D) expenses for Q3 2023 were $11.8 million, a decrease from the $16.8 million reported in Q3 2022. This reduction was primarily due to lower compensation expenses, fewer manufacturing batches, and reduced raw material purchases, partially offset by increased clinical trial activities.
General and Administrative (G&A) expenses were slightly down to $8.6 million in Q3 2023 from $8.7 million in the same period last year. The decrease was attributed to lower compensation expenses and consulting fees, partially offset by issuance costs related to the private placement financing completed in August 2023.
The net loss for the quarter was significantly higher at $117.1 million, or $0.93 per share, compared to a net loss of $26.5 million, or $0.65 per share, in Q3 2022. This increase was largely due to a non-cash expense of $100.5 million recorded from a change in the fair value of warrant liability.
As of September 30, 2023, Taysha had cash and cash equivalents of $164.3 million. The company's financial position is robust, with an expected cash runway extending into 2026, bolstered by a loan and security agreement with Trinity Capital that includes no financial covenants or warrants.
Looking Forward
Taysha Gene Therapies Inc (TSHA, Financial) continues to advance its clinical programs and maintain a strong financial standing. The company's focus on developing gene therapies for CNS diseases has shown promising early results, and its strategic financial management has provided a stable foundation for ongoing and future clinical trials. Investors and stakeholders can expect further updates on the REVEAL trial and other milestones as the company progresses.
For more detailed information, investors and interested parties can access the full earnings report and listen to the webcast on Taysha's website or review the financial statements provided in the 8-K filing.
Explore the complete 8-K earnings release (here) from Taysha Gene Therapies Inc for further details.
