Taysha Gene Therapies (NASDAQ:TSHA) Issues Earnings Results

Key Points

• Management said a Breakthrough Therapy Type B meeting with the FDA reaffirmed the BLA pathway and endpoints, including the option to pursue approval based on a 6‑month interim analysis, with a BLA‑enabling PPQ campaign expected to complete by Q4 2026.
• Dosing in the REVEAL pivotal and ASPIRE trials is on track to finish in Q2 2026, and Part A showed strong efficacy—high‑dose response rates of 83% at 6 months and 100% at 9 months—with no treatment‑related serious adverse events reported as of the May cutoff.
• Financially, Taysha missed EPS expectations (reported ($0.12) vs. consensus ($0.10)), saw Q1 net loss widen to $42.4 million, but holds $276.6 million in cash, which management says should fund operations into 2028.

Taysha Gene Therapies (NASDAQ:TSHA - Get Free Report) released its earnings results on Wednesday. The company reported ($0.12) earnings per share for the quarter, missing analysts' consensus estimates of ($0.10) by ($0.02), FiscalAI reports.

Here are the key takeaways from Taysha Gene Therapies' conference call:

• Management said a Breakthrough Therapy Type B meeting with the FDA reaffirmed the BLA pathway and endpoints — including the option to pursue approval based on a 6‑month interim analysis — and a BLA‑enabling PPQ campaign started in April and is expected to complete by Q4 2026, with the FDA agreeing clinical and commercial material are comparable to allow data pooling.
• Dosing in the REVEAL pivotal and ASPIRE trials is on track to finish in Q2 2026, and Part A reported strong efficacy (high‑dose response rates of 83% at 6 months and 100% at 9 months) with no treatment‑related serious adverse events or dose‑limiting toxicities as of the May cutoff.
• Preclinical data (to be presented at ASGCT) showed self‑complementary AAV9 produces ~30‑fold higher neuronal transduction versus single‑stranded AAV9, miniMECP2 is functionally comparable to full‑length MECP2, and NHP studies support lumbar intrathecal delivery as a minimally invasive, scalable CNS route.
• Taysha said it has assembled senior commercial leadership and is developing launch, payer, and health‑systems strategies, with additional commercial plans to be shared in the second half of 2026.
• Operating spend rose sharply (R&D and G&A), widening the Q1 net loss to $42.4 million from $21.5 million a year earlier, although the company reported $276.6 million in cash, which it expects will fund operations into 2028.

Taysha Gene Therapies Stock Performance

Shares of TSHA stock traded down $0.03 during trading on Wednesday, reaching $6.91. 3,005,222 shares of the company's stock traded hands, compared to its average volume of 2,748,847. The company has a market capitalization of $1.99 billion, a P/E ratio of -20.40 and a beta of 1.25. The company has a current ratio of 12.23, a quick ratio of 12.23 and a debt-to-equity ratio of 0.20. The firm's 50-day moving average is $4.99 and its 200 day moving average is $4.90. Taysha Gene Therapies has a 1 year low of $1.85 and a 1 year high of $7.30.

Insider Activity at Taysha Gene Therapies

In related news, insider Sukumar Nagendran sold 200,000 shares of the company's stock in a transaction that occurred on Friday, April 10th. The shares were sold at an average price of $4.46, for a total transaction of $892,000.00. Following the sale, the insider directly owned 1,136,410 shares in the company, valued at approximately $5,068,388.60. This represents a 14.97% decrease in their position. The sale was disclosed in a filing with the SEC, which can be accessed through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders own 3.78% of the company's stock.

Institutional Trading of Taysha Gene Therapies

A number of institutional investors have recently modified their holdings of TSHA. Marex Group plc purchased a new stake in shares of Taysha Gene Therapies during the 2nd quarter valued at approximately $29,000. E Fund Management Co. Ltd. purchased a new stake in shares of Taysha Gene Therapies during the 2nd quarter valued at approximately $31,000. Tower Research Capital LLC TRC lifted its stake in shares of Taysha Gene Therapies by 156.5% during the 2nd quarter. Tower Research Capital LLC TRC now owns 17,606 shares of the company's stock valued at $41,000 after buying an additional 10,742 shares in the last quarter. BNP Paribas Financial Markets increased its holdings in Taysha Gene Therapies by 51.9% during the 2nd quarter. BNP Paribas Financial Markets now owns 18,591 shares of the company's stock worth $43,000 after acquiring an additional 6,350 shares during the period. Finally, Caitong International Asset Management Co. Ltd increased its holdings in Taysha Gene Therapies by 143.8% during the 4th quarter. Caitong International Asset Management Co. Ltd now owns 7,811 shares of the company's stock worth $43,000 after acquiring an additional 4,607 shares during the period. 77.70% of the stock is currently owned by hedge funds and other institutional investors.

Analyst Upgrades and Downgrades

TSHA has been the topic of a number of research analyst reports. Weiss Ratings reiterated a "sell (d-)" rating on shares of Taysha Gene Therapies in a research note on Friday, March 27th. Needham & Company LLC boosted their target price on shares of Taysha Gene Therapies from $10.00 to $12.00 and gave the company a "buy" rating in a research note on Thursday, March 19th. Truist Financial upgraded shares of Taysha Gene Therapies to a "strong-buy" rating in a research note on Wednesday, March 25th. Raymond James Financial reiterated a "strong-buy" rating and issued a $13.00 target price on shares of Taysha Gene Therapies in a research note on Tuesday, January 6th. Finally, Chardan Capital reiterated a "buy" rating and issued a $12.00 target price on shares of Taysha Gene Therapies in a research note on Thursday, March 19th. Two analysts have rated the stock with a Strong Buy rating, ten have issued a Buy rating and one has assigned a Sell rating to the stock. According to data from MarketBeat.com, the stock presently has a consensus rating of "Buy" and an average target price of $11.64.

Taysha Gene Therapies Company Profile

Taysha Gene Therapies, Inc NASDAQ: TSHA is a clinical-stage biotechnology company focused on developing gene therapies for rare monogenic diseases of the central nervous system. Using a proprietary adeno-associated viral (AAV) vector platform, the company engineers novel capsids and regulatory elements to optimize delivery and expression of therapeutic genes. Its pipeline features lead programs such as TSHA-102 for GM2 gangliosidoses (Tay–Sachs and Sandhoff diseases), TSHA-101 for GM1 gangliosidosis and TSHA-103 for aromatic l-amino acid decarboxylase (AADC) deficiency, alongside earlier-stage candidates targeting other life-threatening pediatric CNS disorders.

Founded in 2019 and headquartered in Dallas, Texas, Taysha Gene Therapies completed its initial public offering in May 2021.

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