UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On August 15, 2022, Talaris Therapeutics, Inc. announced its financial results for the quarter ended June 30, 2022 and other corporate updates. A copy of the press release in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit relating to Item 2.02 of this Form 8-K shall be deemed to be furnished and not filed:
Exhibit No. |
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Description |
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99.1 |
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Press Release issued by Talaris Therapeutics, Inc. on August 15, 2022. |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Talaris Therapeutics, Inc. |
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Date: |
August 15, 2022 |
By: |
/s/ Scott Requadt |
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Scott Requadt |
Exhibit 99.1
Talaris Therapeutics Announces Second Quarter Financial Results and Corporate Update
All FREEDOM-1 patients who received FCR001 at least three months prior to the data cutoff date of June 15, 2022 had achieved and maintained >50% T-cell chimerism, and all three patients who were dosed at least 12 months post-transplant have discontinued their chronic anti-rejection drugs
Multiple oral and poster presentations at the American Transplant Congress (ATC) 2022 highlighted key research findings and long-term Phase 2 follow up
Strong cash balance with expected runway through 2024
BOSTON, MA, and LOUISVILLE, KY, August 15, 2022 – 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 continue to remain off these drugs. With 17 centers actively recruiting patients, we are building momentum as we look forward to the continued enrollment 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
Pipeline Highlights
[1] Organ transplant population estimates based on UNOS/OPTN data for patients 1 year to 18 months delayed from incident LDKT
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 therapeutic 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.
Media Contact
Lisa Raffensperger
Ten Bridge Communications
lisa@tenbridgecommunications.com
(617) 903-8783
Investor Contact
Chris Brinzey
ICR Westwicke
chris.brinzey@westwicke.com
(339) 970-2843
TALARIS THERAPEUTICS, INC (TALS)
Statements of Operations
(Unaudited, in thousands, except share and per share amounts)
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Three months ended June 30, |
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2022 |
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2021 |
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(in thousands) |
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Operating expenses |
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Research and development |
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$ |
13,187 |
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$ |
7,570 |
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General and administrative |
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$ |
5,228 |
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$ |
3,487 |
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Total operating expenses |
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18,415 |
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11,057 |
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Loss from operations |
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(18,415 |
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(11,057 |
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Interest and other income (expense), net |
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$ |
319 |
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$ |
(295 |
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Net loss attributable to common stockholders |
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$ |
(18,096 |
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$ |
(11,352 |
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Net loss per common share, basic and diluted |
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$ |
(0.44 |
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$ |
(0.41 |
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Weighted average number of common shares outstanding used in |
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$ |
41,088,085 |
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$ |
27,373,165 |
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Balance Sheets Selected Financial Data
(Unaudited, in thousands)
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June 30, |
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December 31, |
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2022 |
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2021 |
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Cash, cash equivalents and marketable securities |
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$ |
207,112 |
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$ |
243,971 |
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Working capital |
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204,706 |
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238,527 |
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Total assets |
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220,916 |
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251,422 |
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Other liabilities |
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2,822 |
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626 |
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Total liabilities |
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10,174 |
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8,613 |
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Total convertible preferred stock and stockholders’ deficit |
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210,742 |
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242,809 |
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