Talaris Therapeutics Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
$TALS
Biotechnology: Pharmaceutical Preparations
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): January 8, 2024
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Item 7.01 Regulation FD Disclosure.
On January 8, 2024, Tourmaline Bio, Inc. (the “Company”) made available an updated corporate presentation that may be used in connection with presentations at conferences and investor meetings, which can be found on the Company’s website (the “Corporate Presentation”). The Corporate Presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference in this Item 7.01.
On January 8, 2024, the Company also issued a press release (the “Press Release”). A copy of the Press Release is furnished as Exhibit 99.2 to this Current Report on Form 8-K and incorporated by reference in this Item 7.01.
The information furnished under this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference into any of the Company’s filings with the Securities and Exchange Commission (the “SEC”) under the Exchange Act or the Securities Act of 1933, as amended (the “Securities Act”), whether made before or after the date hereof, regardless of any general incorporation language in such a filing, except as otherwise expressly stated in such filing.
Item 8.01 Other Events.
As noted above under Item 7.01, the Company issued the Press Release on January 8, 2024. Key highlights from the Press Release include:
•The Company is planning to commence a pivotal Phase 3 trial for TOUR006, its lead product candidate, in thyroid eye disease (“TED”) in 2024. This second pivotal trial will replace the previously planned TED basket trial and does not impact the Company’s expected cash runway through 2026. Topline data from the ongoing Phase 2b spiriTED trial are expected in the first half of 2025 and data from the planned Phase 3 trial are expected in 2026.
•Alignment has been reached with the U.S. Food & Drug Administration on the clinical development program for atherosclerotic cardiovascular disease (“ASCVD”), including a Phase 2 trial evaluating the reduction of C-reactive protein (CRP), a validated biomarker for inflammation, with quarterly dosing of TOUR006 in patients with elevated cardiovascular risk. This trial is targeted to commence in the first half of 2024, with topline data expected in the first half of 2025. Pending success, the results from the Phase 2 trial are expected to position the Company to be ready in 2025 to commence a pivotal Phase 3 trial in cardiovascular disease.
Forward-Looking Statements
This Form 8-K contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the timing, initiation and success of ongoing and new clinical trials for TOUR006 in TED and ASCVD; and expectations regarding the sufficiency of the Company’s capital resources and cash runway. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including the uncertainties associated with the Company’s platform technologies, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; risks related to the inability of the Company to obtain sufficient additional capital to continue to advance its product candidates and its clinical programs; uncertainties in obtaining successful clinical results for the Company’s product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed by the Company in light of inherent risks and difficulties involved in successfully bringing product candidates to market; the impacts of general macroeconomic and geopolitical conditions, rising inflation, and uncertain credit and financial markets on the Company’s business, clinical trials, and financial position; and other risks and uncertainties described under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, which is on file with the SEC; and risks described in other filings that the Company makes with the SEC in the future. Any forward-looking statements contained in this Form 8-K speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 99.2 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| TOURMALINE BIO, INC. | ||||||||
| Date: January 8, 2024 | By: | /s/ Ryan Robinson | ||||||
Name: | Ryan Robinson | |||||||
Title: | Interim Chief Financial Officer, Vice President, Finance and Controller | |||||||