Taysha Gene Therapies reports Q2 EPS (38c), consensus (31c)

Reports Q2 revenue $2.4M, consensus $1.05M. “We are pleased with the progress we have made this quarter in the clinical evaluation of our two lead investigational programs. For TSHA-102 in Rett syndrome, we believe the initial safety profile and significant clinical improvements seen in the first adult patient with severe disease four weeks post-treatment reinforces the transformative potential of our gene therapy to address the root cause of Rett syndrome. Importantly, these early data indicate that the miRNA-Responsive Auto-Regulatory Element technology is mediating MECP2 expression in the CNS on a cell-by-cell basis, supporting the regulatory control of miRARE. We are highly encouraged by the initial data for TSHA-102 and are focused on continuing to explore its therapeutic potential, with the dosing of the second patient expected in the third quarter. We also received FDA clearance to initiate clinical development of TSHA-102 in pediatric patients in the U.S. and have submitted a CTA to the MHRA for TSHA-102 in pediatric patients with Rett syndrome, which will expand our clinical evaluation to children with earlier stages of disease progression,” said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. “For TSHA-120 in GAN, our new comprehensive data analysis utilizing the Disease Progression Model as submitted to the FDA, and we plan to review the potential regulatory pathway for TSHA-120 with the Agency expected in the third quarter. Our successful completion of a $150 million PIPE from top-tier investors significantly bolsters our balance sheet and we believe highlights the enthusiasm for our TSHA-102 program and the early clinical readout of the first patient treated in the REVEAL trial. By extending our cash runway into the third quarter of 2025, we can focus on execution as we endeavor to deliver on key value-creating milestones.”