4D Molecular Therapeutics Files 8-K

TL;DR

4D Molecular Therapeutics filed an 8-K on Feb 8, 2025, reporting 'Other Events'.

AI Summary

On February 8, 2025, 4D Molecular Therapeutics, Inc. filed an 8-K report. The filing indicates "Other Events" as the primary item of information. The company is incorporated in Delaware and its principal executive offices are located at 5858 Horton Street #455, Emeryville, California.

Why It Matters

This 8-K filing signals a material event or change for 4D Molecular Therapeutics, Inc., requiring disclosure to investors.

Risk Assessment

Risk Level: low — The filing is a standard 8-K for 'Other Events' and does not contain specific financial or operational details that would immediately indicate high risk.

Key Numbers

• 001-39782 — Commission File Number (Identifies the company's SEC filing history.)
• 47-3506994 — IRS Employer Identification No. (Company's tax identification number.)

Key Players & Entities

• 4D Molecular Therapeutics, Inc. (company) — Registrant
• February 08, 2025 (date) — Date of earliest event reported
• Delaware (jurisdiction) — State of Incorporation
• 5858 Horton Street #455 (address) — Principal Executive Offices
• Emeryville, California (location) — City and State of Principal Executive Offices

FAQ

Key Financial Figures

• $0.0001 — nge on which registered Common Stock, $0.0001 par value per share FDMT Nasdaq Glo

Filing Documents

• fdmt-20250208.htm (8-K) — 58KB
• 0000950170-25-016708.txt ( ) — 171KB
• fdmt-20250208.xsd (EX-101.SCH) — 24KB
• fdmt-20250208_htm.xml (XML) — 5KB

01 Other Events

Item 8.01 Other Events On February 8, 2025, 4D Molecular Therapeutics, Inc. (the "Company") reported positive initial interim 52-week data from the Phase 2b Population Extension cohort of the PRISM clinical trial evaluating 4D-150 in a broad wet age-related macular degeneration ("wet AMD") patient population. Additional data were provided on the durability of aflibercept expression for up to two years. Topline 52-Week Efficacy Results for 4D-150 3E10 vg/eye (Planned Phase 3 Dose) from Phase 2b Population Extension Cohort of PRISM (Data Cut-Off January 15, 2025): Phase 2b (n=30): Broad Wet AMD Disease Activity o Supplemental aflibercept injections: 83% reduction, representing 0.97 mean supplemental injections per patient over 52-weeks vs. 6.0 injections projected with on-label aflibercept 2 mg Q8W 70% 0-1 injection 57% injection-free o Improved and maintained best corrected visual acuity ("BCVA") of +2.2 letters o Durable central subfield thickness ("CST") improvement with fewer fluctuations, as measured by optical coherence tomography ("OCT"), of -11 m; -13 m in supplemental injection-free patients Phase 2b (n=15): Recently Diagnosed Subgroup o Supplemental aflibercept injections: 94% reduction, representing 0.33 mean supplemental injections per patient over 52-weeks vs. 6.0 injections projected with on-label aflibercept 2 mg Q8W 87% 0-1 injection 80% injection-free o Improved and maintained BCVA of +3.1 letters o Durable CST improvement with fewer fluctuations, as measured by OCT, of -10 m; -20 m in supplemental injection-free patients 4D-150 Safety Update from PRISM (Data Cut-Off January 15, 2025): 4D-150 continues to be well tolerated during up to three years of follow up in all patients treated with 3E10 vg/eye o 2.8% (2 of 71) had 4D-150–related 1+ intraocular inflammation ("IOI") (SUN/NEI scales); transient 1+ vitreous cells noted at a single timepoint, as previously reported o 99% (70 of 71) completed steroid prophylaxi

Forward-Looking Statements

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, but are not limited to, statements regarding the Company's clinical development plans for its product candidates, including 4D-150, timing for the announcement of results from ongoing clinical trials, anticipated resource allocations and cash runway, the therapeutic potential, and clinical benefits and market potential of 4DMT's product candidates, as well as the regulatory interactions regarding 4D-150. 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

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. 4D MOLECULAR THERAPERUTICS, INC. Date: February 10, 2025 By: /s/ Uneek Mehra Uneek Mehra Chief Financial and Business Officer

View Full Filing

View this 8-K filing on SEC EDGAR