SEC Form 8-K filed by 4D Molecular Therapeutics Inc.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 17, 2024

4D MOLECULAR THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

5858 Horton Street #455

Emeryville, CA 94608

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (510) 505-2680

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

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. ☐

On July 17, 2024, 4D Molecular Therapeutics, Inc. (the “Company”) announced initial interim 24-week landmark data from the Population Extension cohort of its Phase 2 clinical trial (“PRISM”), which evaluated intravitreal 4D-150 in a broad wet age-related macular degeneration (“wet AMD”) patient population and provided other updates with respect to 4D-150. The interim data were presented on July 17, 2024 at the American Society of Retina Specialists Annual Scientific Meeting held in Stockholm, Sweden.

Phase 2 PRISM Interim Results for Intravitreal 4D-150 in a Broad Wet AMD and Other 4D-150 Updates

The Population Extension cohort of the Company’s Phase 2 clinical trial for wet AMD (“PRISM”) is a clinical trial evaluating 4D-150 in patients with broad disease activity and no minimum or maximum central subfield thickness (“CST”), and with patients who had received between one and six anti-VEGF injections in the prior 12 months. The Population Extension enrolled 45 patients at two dose level arms: 30 patients at 3E10 vg/eye (the planned Phase 3 dose) and 15 at 1E10 vg/eye (low dose control). The dose arms enrolled in the cohort were generally well-balanced with mean CST at 329 mm and mean number of actual injections in the prior 12 months was 4.4.

In the Population Expansion cohort, as of the most recent data cutoff date (June 24, 2024), interim results from the trial include the following:

As of the most recent data cutoff date (June 24, 2024), long-term follow-up results from the Phase 1 clinical trial for 4D-150 include the following:

As of the most recent data cutoff date (June 24, 2024), overall safety results across wet AMD and diabetic macular edema (“DME”) patients treated with 4D-150 include the following:

The Company continues to work with the U.S. Food and Drug Administration and European Medicines Agency, under the RMAT and PRIME designations, to finalize its planned Phase 3 clinical trial design, which the Company expects to announce in September 2024. The Company anticipates the Phase 3 clinical trial will be initiated in the first quarter of 2025.

The Company also expects to release 52-week landmark analysis for both its Dose Expansion cohort (patients with severe disease activity and high treatment burden) and its Population Extension cohort (patients with broad disease activity) in February 2025.

For DME, the Company expects to release an initial 24-week landmark analysis from its SPECRTRA trial’s Dose Confirmation cohort in the fourth quarter of 2024.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the

Company’s clinical development plans for 4D-150 and timing for the announcement of results from ongoing clinical trials. In some cases you can identify these statements by forward-looking words such as “may,” “will,” “continue,” “anticipate,” “intend,” “could,” “project,” “expect” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including risks and uncertainties that are described in greater detail in the section entitled “Risk Factors” in the Company’s most recent Quarterly Report on Form 10-Q as well as any subsequent filings with the Securities and Exchange Commission. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

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.