Dallas biotech firm Taysha Gene Therapies reports loss as it ramps up research and development – The Dallas Morning News

Dallas biotech firm Taysha Gene Therapies reported a $40.9 million quarterly loss this week as it expands its research and development efforts and its manufacturing footprint.

The company, founded through a partnership with researchers at the University of Texas Southwestern Medical Center, also announced an agreement to borrow up to $100 million from Silicon Valley Bank. The loan adds to the companys $197.4 million in cash on hand to support its growth as it plans to submit one of its drugs for regulatory approval for the first time later this year.

Taysha is one of several biotech companies looking to stake its claim on the gene therapy frontier as the landscape begins to grow crowded with both startups like Taysha and pharma giants like Swiss firms Roche and Novartis. Many gene therapies, including most of Tayshas, seek to treat genetic disorders by giving patients genetically modified, benign viruses that carry healthy copies of the gene needed.

Founded in April 2020, Taysha became publicly traded less than five months later. Its developing its treatments under a license agreement with the gene therapy program at UT Southwestern led by Steven Gray and Dr. Berge Minassian, who both serve as Taysha advisers.

Taysha began with a pipeline of 15 gene therapy programs, which has since expanded to 26 programs.

It develops therapies to treat disorders of the central nervous system, many of which affect children. While many of its programs treat conditions that are only present in a small number of patients, the company is also working on treatments for larger patient populations.

The financial results come amid a period of rapid growth for Taysha, which raised $181 million in its September 2020 IPO. The company has dramatically increased its research and development expenses as it aims to begin as many as three clinical trials before the end of the year.

Tayshas R&D expenses for the first half of this year totaled almost $54.5 million, compared with $8.6 million in the same period last year.

Not only did we make the transition from private to public company last year, but also a preclinical to clinical company, Taysha founder, president and CEO RA Session II told The News in an interview last month. On the heels of that, weve now made the transition from a clinical-stage company to a pivotal-stage company embarking on regulatory discussions around approval pathways for our lead program. So its a really exciting time.

Taysha plans to initiate phase one and two clinical trials in the U.S. for its gene therapy for GM2 gangliosidosis, also known as Tay-Sachs disease, before the end of the year. The program also is currently in a clinical trial at Queens University in Canada. The Canadian clinical trial will release safety and biomarker data in the second half of this year.

The Silicon Valley Bank loan is expected to add an extra infusion of cash as Taysha pursues regulatory approval for TSHA-120, its program for giant axonal neuropathy, a disorder that causes parts of neurons to deteriorate and causes issues with motion and sensation in young children. Taysha has drawn $30 million of the loan.

The terms of this deal are quite attractive, Session said in the companys earnings call on Monday. Its all about being able to move things [that are] best-in-class forward and not necessarily have to slow anything down or make any particular trade-offs as we get into the next year. Because we cant predict whats going to happen in the equity capital markets, we thought this was just a wonderful opportunity to be able to add some additional dry powder to the tank.

The company also made significant personnel moves this quarter with the hiring of Mary Newman as chief development officer and Claire Aldridge as chief of staff and senior vice president of business operations.

Newman was previously senior vice president of regulatory affairs at Astellas Gene Therapies and has over 30 years of biotech experience. Aldridge has long been a fixture of the Dallas biotech world and is the former associate vice president of commercialization and business development at UT Southwestern. She has also previously worked with Dallas philanthropist and biotech investor Lyda Hill as vice president of venture development at Remeditex Ventures, Hills biotech venture capital firm.

In May, Taysha moved into its new headquarters in the Pegasus Park development near Dallas medical district, a 23-acre campus that seeks to bring the business and science sides of the biotech industry together in one place.

The company also plans to complete its 187,000-square-foot manufacturing facility in Durham, N.C., by the end of 2023 to round out the companys manufacturing process and allow it to continue to scale rapidly. The company is investing $75 million in the facility, which will eventually employ over 200 workers.

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Dallas biotech firm Taysha Gene Therapies reports loss as it ramps up research and development - The Dallas Morning News