Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders, today reported financial results for the three- and six-month periods ended June 30, 2022 and provided an update on its business.
“The interim data from our Phase 3 FREEDOM-1 trial update this quarter highlighted that all patients treated with FCR001 at least three months prior to the data cutoff date had achieved and maintained chimerism at all measured timepoints post-transplant,” stated Scott Requadt, Chief Executive Officer of Talaris. “In addition, all patients 12-months post-transplant, including the first patient now 24 months out, had been successfully weaned off chronic anti-rejection drugs and continued to remain off these drugs. With 17 centers actively recruiting patients, we expect to increase the enrollment rate of our Phase 3 FREEDOM-1 trial.”
Mr. Requadt added: “I also would like to take a moment to acknowledge the extraordinary contributions of Dr. Suzanne Ildstad who will be stepping into the newly created role of Senior Scientific Advisor at the end of the month. On behalf of the Board and the entire Talaris Team, I want to thank Suzanne for her contributions in advancing the field of immune tolerance, for her entrepreneurialism in forming what has become Talaris today, and most notably, for her vision and compassion for patients who want to live a life free of immunosuppression.”
Corporate Highlights
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Second Quarter Financial Results
About Talaris Therapeutics
Talaris Therapeutics, Inc. is a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders. Talaris maintains corporate offices in Boston, MA, its cell processing facility in Louisville, KY, and additional research operations in Houston, TX.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Talaris Therapeutics, Inc.’s (“Talaris,” the “Company,” “we,” or “our”) strategy, business plans and focus; the progress and timing of the preclinical and clinical development of Talaris’ programs, including FCR001 and the rate of enrollment for its clinical trials; expectations regarding the timing and data from the planned clinical update of FREEDOM-1, FREEDOM-2 or FREEDOM-3, including potential safety, tolerability and therapeutics effects; expectations around the anticipated contribution of the members of Talaris’ board of directors and executives to its operations and progress; and expectations regarding Talaris’ growth as a company and use of capital, expenses and other financial results during the second quarter ended on June 30, 2022 and in the future as well as Talaris’ expected cash runway through 2024. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on countries or regions in which the Company has operations or does business, as well as on the timing and anticipated timing and results of its clinical trials, strategy and future operations, including the expected timing and results from FREEDOM-1; the risk that the results of Talaris’ clinical trials, including the early data from the FREEDOM-1 study, may not be predictive of future results in connection with future clinical trials; the Company’s expectations regarding the potential urinary biomarker of immune quiescence, the Company’s ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of Talaris’ planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Talaris’ views only as of today and should not be relied upon as representing our views as of any subsequent date. Talaris explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
TALARIS THERAPEUTICS, INC (TALS) | |||||||||
Statements of Operations | |||||||||
(Unaudited, in thousands, except share and per share amounts) | |||||||||
Three Months Ended June 30, | |||||||||
2022 | 2021 | ||||||||
Operating expenses | |||||||||
Research and development | $ | 13,187 | $ | 7,570 | |||||
General and administrative | 5,228 | 3,487 | |||||||
Total operating expenses | 18,415 | 11,057 | |||||||
Loss from operations | (18,415 | ) | (11,057 | ) | |||||
Interest and other income (expense), net | 319 | (295 | ) | ||||||
Net loss | $ | (18,096 | ) | $ | (11,352 | ) | |||
Net loss per common share, basic and diluted | $ | (0.44 | ) | $ | (0.41 | ) | |||
Weighted average number of common shares outstanding used in computation of net loss per common share, basic and diluted | 41,088,085 | 27,373,165 | |||||||
Balance Sheets Selected Financial Data | |||||||||
(Unaudited, in thousands) | |||||||||
As of June 30, | As of December 31, | ||||||||
2022 | 2021 | ||||||||
Cash, cash equivalents and marketable securities | $ | 207,112 | $ | 243,971 | |||||
Working capital | 204,706 | 238,527 | |||||||
Total assets | 220,916 | 251,422 | |||||||
Other liabilities | 2,843 | 626 | |||||||
Total liabilities | 10,174 | 8,613 | |||||||
Total stockholders' equity | 210,742 | 242,809 | |||||||
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Investor Contact
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(339) 970-2843
Last Trade: | US$2.72 |
Daily Volume: | 0 |
Market Cap: | US$116.440M |
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