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Talaris Therapeutics Announces Second Quarter 2021 Financial Results and Provides Business Update On track to provide FREEDOM-1 initial clinical update, initiate FREEDOM-2 and FREEDOM-3 trials, and to disclose additional

Key Takeaway: Talaris Therapeutics Announces Second Quarter 2021 Financial Results and Provides Business Update On track to provide FREEDOM-1 initial clinical update, initiate FREEDOM-2 and FREEDOM-3 trials, and to disclose additional indication for FCR001 before year-end BOSTON, MA, and LOU

Full Press Release Details

Talaris Therapeutics Announces Second Quarter 2021 Financial Results and Provides Business Update
On track to provide FREEDOM-1 initial clinical update, initiate FREEDOM-2 and FREEDOM-3 trials, and to disclose additional indication for FCR001 before year-end
BOSTON, MA, and LOUISVILLE, KY, August 12, 2021 - 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, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders, today reported financial results for the three- and six-month periods ended June 30, 2021, and provided an update on its business.
"As we enter the second half of 2021, we remain on track to provide the first clinical update on our first FREEDOM-1 patients," stated Scott Requadt, Chief Executive Officer of Talaris. "Based on what we observed in our Phase 2 trial, we believe that chimerism, as early as three months post-transplant, has the potential to be highly predictive of establishing durable tolerance to the donated organ without chronic immunosuppression. We are also continuing to advance the rest of our pipeline as we plan for two phase 2 clinical trial initiations in FCR001 in delayed tolerance induction (FREEDOM-2) and in patients with a severe form of scleroderma (FREEDOM-3). We also expect to announce an additional indication for FCR001 before the end of this year."
Corporate Highlights
Program Updates and Milestones
Second Quarter 2021 Financial Results
About Talaris Therapeutics
Talaris Therapeutics, Inc. is a late-clinical stage biopharmaceutical company developing investigational, one-time, allogeneic cell therapies with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders. Talaris maintains corporate offices in Boston, MA, and at its cell processing facility in Louisville, KY.
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 FCR002; expectations regarding the timing and data from the planned clinical update of FREEDOM-1; expectations regarding Talaris' use of capital, expenses and other financial results during 2021 and in the future, and its ability to fund operations into 2025. 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 planned initiation of FREEDOM-2 and FREEDOM-3, the planned initiation and timing of IND-enabling studies of FCR001 and FCR002 in deceased donor transplants and the announcement of an additional indication for FCR001; the Company's expectations regarding its management hires; the risk that the results of Talaris' clinical trials may not be predictive of future results in connection with future clinical trials; 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, 2021, 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.
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TALARIS THERAPEUTICS, INC (TALS)
Statements of Operations
(Unaudited, in thousands, except share and per share amounts)
Three months ended June 30,
2021 2020
(in thousands)
Operating expenses
Research and development $ 7,570 $ 3,402
General and administrative $ 3,487 $ 1,335
Total operating expenses 11,057 4,737
Loss from operations (11,057 ) (4,737 )
Interest and other income (expense), net $ (295 ) $ 74
Net loss attributable to common stockholders $ (11,352 ) $ (4,663 )
Net loss per common share, basic and diluted $ (0.41 ) $ (0.73 )
Weighted average number of common shares outstanding used in computation of net loss per common share, basic and diluted $ 27,373,165 $ 6,397,025
Balance Sheets Selected Financial Data
(Unaudited, in thousands)
As of June 30, 2021 As of December 31, 2020
Cash, cash equivalents and marketable securities $ 266,220 $ 149,488
Working capital 265,809 147,347
Total assets 272,814 152,778
Other liabilities 800 1,369
Total liabilities 5,461 4,774
Total convertible preferred stock and stockholders' deficit 267,353 148,004
Last updated: Aug 12, 2021