UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01. | Regulation FD Disclosure. |
On July 30, 2024, Tectonic Therapeutic, Inc. (the “Company”) issued a press release titled “Tectonic Therapeutic Announces U.S. FDA Clearance of IND Application of TX45 for Subjects with Group 2 PH Due to Heart Failure with Preserved Ejection Fraction.” A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The Company has updated its corporate presentation for use in meetings with investors, analysts and others. A copy of the updated corporate presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K. Investors may access the presentation by visiting the “Events & Presentations” section of the Company’s investor website at https://investors.tectonictx.com.
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 (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, regardless of any general incorporation language in such a filing.
| Item 8.01. | Other Events. |
The Company announced today that the U.S. Food and Drug Administration (the “FDA”) has cleared its Investigational New Drug (“IND”) application for TX45, an Fc-relaxin fusion protein being evaluated for the treatment of patients with Group 2 Pulmonary Hypertension (“PH”) due to Heart Failure with Preserved Ejection Fraction (“HFpEF”).
The Company is also updating its guidance in regard to the TX45 program as follows:
| • | Topline trial results of the Phase 1a clinical trial of TX45 in healthy volunteers is expected to be released in September 2024. |
| • | Phase 1b hemodynamic trial evaluating single doses of TX45 in subjects with Group 2 PH due to HFpEF continues to enroll as planned, with topline trial results expected in mid-2025. |
| • | The Company expects to initiate a global, 24-week Phase 2 clinical trial to evaluate TX45 administered subcutaneously in subjects with Group 2 PH due to HFpEF in the third quarter of 2024. |
Forward-Looking Statements
Statements contained in this Current Report on Form 8-K regarding matters that are not historical facts are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as “aims”, “anticipates”, “believes”, “could”, “estimates”, “expects”, “forecasts”, “goal”, “intends”, “may”, “plans”, “possible”, “potential”, “seeks”, “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements regarding: the design, objectives, initiation, timing, progress and results of current and future clinical trials of the Company’s product candidate, TX45, including the ongoing Phase 1a and Phase 1b clinical trials of TX45 and initiation of the Phase 2 clinical trial of TX45. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this filing. Each of these forward-looking statements involves risks and uncertainties that could cause the Company’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including the conflict in Ukraine and the conflict between Israel and Hamas, heightened inflation and uncertain credit and financial markets, on the Company’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; the Company’s ability to realize the benefits of its collaborations and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements are identified in the section titled “Risk Factors” in the final prospectus on Form 424(b)(3) filed by AVROBIO with the Securities and Exchange Commission on May 3, 2024, and in other filings that the Company makes and will make with the Securities and Exchange Commission in the future. The Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press release dated July 30, 2024. | |
| 99.2 | Corporate Presentation dated July 2024. | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL). | |
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 hereunto duly authorized.
| TECTONIC THERAPEUTIC, INC. | ||||||
| Date: July 30, 2024 | By: | /s/ Daniel Lochner | ||||
| Daniel Lochner | ||||||
| Chief Financial Officer | ||||||