Financial Data and Key Metrics Changes - Research and development expenses decreased to $15.1 million for Q2 2024 from $19.8 million in Q2 2023, primarily due to a milestone fee payable in the prior year [18] - General and administrative expenses increased to $7.3 million in Q2 2024 from $6 million in Q2 2023, attributed to higher noncash stock-based compensation and consulting fees [19] - Net loss for Q2 2024 was $20.9 million or $0.09 per share, compared to a net loss of $24.6 million or $0.38 per share in Q2 2023 [19] - As of June 30, 2024, the company had $172.7 million in cash and cash equivalents, with expectations to support operations into Q4 2026 [19] Business Line Data and Key Metrics Changes - The TSHA-102 program for Rett Syndrome showed promising safety and efficacy data from the low dose cohort in ongoing clinical trials [7][11] - The company initiated the high dose cohort and expanded its pediatric trial into Canada, indicating progress in clinical evaluations [7][10] Market Data and Key Metrics Changes - Rett Syndrome affects an estimated 15,000 to 20,000 patients in the U.S., EU, and UK, with no approved disease-modifying therapies currently available [8] Company Strategy and Development Direction - The company aims to develop a transformative therapeutic option for all patients suffering from Rett Syndrome, focusing on clinical trial execution and data collection [8][21] - The strategy includes advancing to high dose cohorts based on encouraging preliminary data from low dose cohorts, which is expected to inform regulatory discussions [12][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety profile and clinical effects of TSHA-102, emphasizing the potential to address significant unmet medical needs in Rett Syndrome [20][21] - The company plans to report safety and efficacy data from both low and high dose cohorts in the first half of 2025, indicating a commitment to transparency and data-driven decision-making [14][21] Other Important Information - The company completed a public follow-on offering, resulting in net proceeds of $76.8 million, which is expected to extend the cash runway into Q4 2026 [13] Q&A Session Summary Question: How will the high-dose data be measured for dose response? - Management indicated that preclinical data showed improvements at high doses and that consistent effects across clinical domains are expected [22] Question: What is the status of regulatory discussions? - The company has an upcoming Type B meeting with regulatory authorities to align on trial design and data sharing [26] Question: Will the timeline for data impact the timeline for FDA meetings? - Management stated that they aim to complete dosing and natural history analysis before engaging with the FDA, with flexibility in the timeline [42] Question: What are the baseline characteristics of high-dose patients? - Management noted that baseline characteristics are consistent with Rett Syndrome, with common clinical features expected across patients [48] Question: Are there any updates on safety events related to the immunosuppressive regimen? - Management confirmed that there have been no new significant adverse events reported and that discussions regarding the dosing stagger are ongoing [52]

Taysha Gene Therapies, Inc. (TSHA) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.10. This compares to loss of $0.38 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 10%. A quarter ago, it was expected that this company would post a loss of $0.11 per share when it actually produced a loss of $0.10, delivering a surprise of 9.09%. Over the last four quarters, the company ha ...

Financial Performance - Taysha Gene Therapies reported a net loss of $20.9 million, or $0.09 per share, for Q2 2024, compared to a net loss of $24.6 million, or $0.38 per share, in Q2 2023[5]. - Research and development expenses decreased to $15.1 million in Q2 2024 from $19.8 million in Q2 2023, primarily due to a milestone fee in the prior year[4]. - General and administrative expenses increased to $7.3 million in Q2 2024 from $6.0 million in Q2 2023, driven by higher stock-based compensation and consulting fees[5]. - The accumulated deficit widened from $(513,007,000) to $(557,996,000), indicating ongoing investment in growth despite losses[14]. Cash and Assets - Cash and cash equivalents as of June 30, 2024, were $172.7 million, providing a runway into Q4 2026[5]. - Total current assets as of December 31, 2023, amount to $149,868,000, with cash and cash equivalents at $143,940,000[12]. - Total assets increased from $172,731,000 to $200,393,000, indicating a strong growth trajectory[14]. - The company holds $2,000,000 in assets held for sale, indicating potential divestitures or restructuring[12]. - The company has $449,000 in restricted cash, which may be earmarked for specific future obligations[12]. Liabilities and Equity - Total liabilities decreased from $97,794,000 to $91,525,000, reflecting a reduction in current liabilities from $36,756,000 to $34,176,000[13]. - Stockholders' equity increased significantly from $74,937,000 to $108,868,000, driven by an increase in additional paid-in capital from $587,942,000 to $664,457,000[14]. - Deferred revenue decreased from $18,106,000 to $13,583,000, suggesting a potential shift in revenue recognition[13]. - Operating lease liabilities remain stable, with a slight decrease in the current portion from $18,953,000 to $18,134,000[13]. Clinical Trials and Developments - TSHA-102 was generally well tolerated with no serious adverse events reported in both pediatric and adolescent/adult trials[2]. - Dosing of the second patient in the high dose cohort of the adolescent/adult trial is scheduled for Q3 2024[4]. - Safety and efficacy data from cohort two (n=3) and updates from cohort one (n=2) are expected in the first half of 2025[4]. - The pediatric trial has received clearance to expand into Canada, enhancing the study's geographical reach[3]. - Taysha aims to report clinical data from both high and low dose cohorts in the first half of 2025, focusing on further informing regulatory discussions[2]. Capital Raising - The company completed a public follow-on offering with total net proceeds of $76.8 million[3]. - The increase in common stock issued from 186,960,193 to 201,381,450 shares reflects ongoing capital raising efforts[14].

DALLAS, June 26, 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 the pricing of an underwritten public offering of 14,361,113 shares of its common stock at a price to the public of $2.25 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 18,972,221 shares of ...

Taysha Gene Therapies (NASDAQ:TSHA) stock is taking a beating on Wednesday after the gene therapy company announced a proposed public offering for its shares. What we do know is that it also intends to offer pre-funded warrants for certain investors. On top of that, underwriters have a 30-day option to acquire an additional 15% of shares included in the offering. How This Affects TSHA Stock On top of that, the pricing of the offering may upset investors. It's expected to be discounted compared to the compan ...

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 ...

DALLAS, June 25, 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 it has commenced an underwritten public offering of up to $75 million of shares of its common stock and, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its common stock. All ...

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 ...

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 ...

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 ...