Full Press Release Details
Talaris Therapeutics Announces First Quarter 2021 Financial Results and Provides Business
MA, and LOUISVILLE, KY, June 14, 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-month period ended March 31,
2021, and provided an update on its business.
Following our successful IPO, we are well financed into 2025 and very focused on program
execution, stated Scott Requadt, Chief Executive Officer of Talaris. With our open-label, registrational Phase 3 trial in living donor kidney transplant, FREEDOM-1, already underway, two additional
open-label Phase 2 trials initiating later this year, and multiple potential indications for FCR001 being evaluated, we anticipate several important milestones ahead of us. We appreciate our investors confidence in Talaris and look forward to
advancing our lead product candidate, FCR001, to potentially benefit patients in multiple areas of high unmet need.
Corporate Highlights
Program Updates and Milestones
First 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 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 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 March 31, 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.
Ten Bridge Communications
Westwicke, an ICR Company
TALARIS THERAPEUTICS, INC (TALS)
Statements of Operations
(Unaudited, in thousands,
except share and per share amounts)
| Three months ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses | ||||||||
| Research and development | $ | 6,468 | $ | 3,535 | ||||
| General and administrative | 2,537 | 1,439 | ||||||
| Total operating expenses | 9,005 | 4,974 | ||||||
| Loss from operations | (9,005 | ) | (4,974 | ) | ||||
| Interest and other income (expense), net | (294 | ) | 126 | |||||
| Net loss attributable to common stockholders | $ | (9,299 | ) | $ | (4,848 | ) | ||
| Net loss per common share, basic and diluted | $ | (1.30 | ) | $ | (0.76 | ) | ||
| Weighted average number of common shares outstanding used in computation of net loss per common share, basic and diluted | 7,160,631 | 6,390,771 |
Balance Sheets Selected Financial Data
(Unaudited, in thousands)
| Three months ended March 31, | Year ended December 31, | |||||||
| 2021 | 2020 | |||||||
| Cash, cash equivalents and marketable securities | $ | 140,101 | $ | 149,488 | ||||
| Working capital | 139,222 | 147,347 | ||||||
| Total assets | 144,900 | 152,778 | ||||||
| Other liabilities | 1,634 | 1,369 | ||||||
| Total liabilities | 5,215 | 4,774 | ||||||
| Total convertible preferred stock and stockholders deficit | 139,685 | 148,004 |
Pro Forma Selected Financial Data
(Unaudited, in thousands except share amounts)
| Pro forma | ||||
| March 31, 2021 | ||||
| Cash, cash equivalents and marketable securities | $ | 279,624 | ||
| Total shares outstanding | 41,310,241 |