Proceeds from follow-on offering along with Astellas strategic investment extends cash runway into first quarter of 2024
Type B end-of-Phase 2 meeting with FDA for TSHA-120 in GAN scheduled for
Preliminary clinical safety and efficacy data for TSHA-102 from the first cohort of adult patients with Rett syndrome and initiation of female pediatric study expected in first half of 2023
Conference call and live webcast today at 8:00 AM Eastern Time
“The strategic investment from Astellas and the successfully completed public follow-on offering have strengthened our balance sheet and extended our cash runway into the first quarter of 2024. The partnership with Astellas underscores the therapeutic and market opportunity of our two lead clinical programs in GAN and Rett syndrome. Importantly, this strategic investment further validates our platform and our scientific approach of combining established gene therapy technology with innovative targeted payload design,” said RA Session II, President, Founder and CEO of Taysha. “In 2023, we expect to provide an update on the regulatory pathway for TSHA-120 in GAN in January following our Type B end-of-Phase 2 meeting with the FDA. In addition, we intend to disclose preliminary clinical data for TSHA-102 from the first cohort of adult patients with Rett syndrome and initiate a Phase 1/2 trial for TSHA-102 in female pediatric patients with Rett syndrome in the first half of 2023.”
Recent Corporate Highlights
Strategic investment from Astellas Pharma validates Taysha’s scientific approach and capabilities as well as reinforces therapeutic and market opportunity of two lead programs
Astellas to invest a total of
- An exclusive option to obtain an exclusive license for worldwide development, manufacturing and commercial rights to:
- TSHA-120 in GAN for a period of time after receipt of the formal Type B end-of-Phase 2 meeting minutes
- TSHA-102 in Rett syndrome for a period of time after the company provides Astellas access to certain clinical data from the female pediatric study
- Right of first offer related to any potential change in control of Taysha for a period of time upon receipt of the Rett data package
- One non-voting Board observer seat on the Taysha Board of Directors
Pricing of public offering of common stock
- On
October 26, 2022 , Taysha raised$28.0 million in gross proceeds through an underwritten public offering of 14,000,000 shares of its common stock at a price to the public of$2.00 per share.
Anticipated Upcoming Milestones
- Regulatory update for TSHA-120 in GAN following receipt of formal meeting minutes from the Type B end-of-Phase 2 meeting with FDA expected in
mid-January 2023 - Preliminary clinical safety and efficacy data for TSHA-102 from the entire first cohort of adult patients with Rett syndrome expected in H1 2023
- Initiation of Phase 1/2 trial for TSHA-102 in female pediatric patients with Rett syndrome in H1 2023
Third Quarter 2022 Financial Highlights
Research and Development (R&D) Expenses: Research and development expenses were
General and Administrative (G&A) Expenses: General and administrative expenses were
Net loss: Net loss for the three months ended
Cash and cash equivalents: As of
Conference Call and Webcast Information
Taysha management will hold a conference call and webcast with slides today at 8:00 am ET / 7:00 am CT to review its financial and operating results and to provide a corporate update. The dial-in number for the conference call is 855-327-6837 (
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” “plans,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning the potential of our product candidates, including our preclinical product candidates, to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed, the potential market opportunity for these product candidates, our corporate growth plans, the forecast of our cash runway and the implementation and potential impacts of our strategic pipeline prioritization initiatives. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(Unaudited)
| For the Three Months Ended |
For the Nine Months Ended |
||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | $ | 16,391 | $ | 39,528 | $ | 77,308 | $ | 94,025 | |||||||||
| General and administrative | 8,683 | 11,153 | 30,019 | 29,518 | |||||||||||||
| Total operating expenses | 25,074 | 50,681 | 107,327 | 123,543 | |||||||||||||
| Loss from operations | (25,074 | ) | (50,681 | ) | (107,327 | ) | (123,543 | ) | |||||||||
| Other income (expense): | |||||||||||||||||
| Interest income | 9 | 37 | 50 | 143 | |||||||||||||
| Interest expense | (1,241 | ) | (543 | ) | (3,002 | ) | (737 | ) | |||||||||
| Other expense | (1 | ) | - | (12 | ) | - | |||||||||||
| Total other expense, net | (1,233 | ) | (506 | ) | (2,964 | ) | (594 | ) | |||||||||
| Net loss | $ | (26,307 | ) | $ | (51,187 | ) | $ | (110,291 | ) | $ | (124,137 | ) | |||||
| Net loss per common share, basic and diluted | $ | (0.64 | ) | $ | (1.35 | ) | $ | (2.77 | ) | $ | (3.31 | ) | |||||
| Weighted average common shares outstanding, basic and diluted | 40,937,808 | 38,003,954 | 39,761,764 | 37,495,537 | |||||||||||||
Condensed Consolidated Balance Sheet Data
(in thousands, except share and per share data)
(Unaudited)
2022 |
2021 |
|||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 34,306 | $ | 149,103 | ||||
| Prepaid expenses and other current assets | 8,696 | 10,499 | ||||||
| Total current assets | 43,002 | 159,602 | ||||||
| Restricted cash | 2,637 | 2,637 | ||||||
| Deferred lease asset | 630 | 667 | ||||||
| Property, plant and equipment, net | 63,954 | 50,610 | ||||||
| Other non-current assets | 1,245 | 440 | ||||||
| Total assets | $ | 111,468 | $ | 213,956 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 15,521 | $ | 21,763 | ||||
| Accrued expenses and other current liabilities | 17,888 | 29,983 | ||||||
| Total current liabilities | 33,139 | 51,746 | ||||||
| Build-to-suit lease liability | 25,496 | 25,900 | ||||||
| Term Loan, net | 37,773 | 37,192 | ||||||
| Other non-current liabilities | 3,934 | 3,735 | ||||||
| Total liabilities | 100,342 | 118,573 | ||||||
| Stockholders' equity | ||||||||
| Preferred stock, |
- | - | ||||||
| Common stock, |
1 | - | ||||||
| Additional paid-in capital | 357,065 | 331,032 | ||||||
| Accumulated deficit | (345,940 | ) | (235,649 | ) | ||||
| Total stockholders’ equity | 11,126 | 95,383 | ||||||
| Total liabilities and stockholders' equity | $ | 111,468 | $ | 213,956 | ||||
Company Contact:
Chief Corporate Affairs Officer
klee@tayshagtx.com
Media Contact:
Evoke Canale
carolyn.hawley@evokegroup.com
Source: Taysha Gene Therapies, Inc.