4D Molecular Therapeutics Files 8-K

Ticker: FDMT · Form: 8-K · Filed: Jan 10, 2025 · CIK: 1650648

4d Molecular Therapeutics, INC. 8-K Filing Summary
FieldDetail
Company4d Molecular Therapeutics, INC. (FDMT)
Form Type8-K
Filed DateJan 10, 2025
Risk Levellow
Pages7
Reading Time9 min
Key Dollar Amounts$0.0001, $506 million
Sentimentneutral

Sentiment: neutral

Topics: sec-filing, 8-k, biotech

TL;DR

4D Molecular Therapeutics filed an 8-K on Jan 10, 2025. Standard disclosure, no major news in this snippet.

AI Summary

On January 10, 2025, 4D Molecular Therapeutics, Inc. filed an 8-K report. The filing indicates the company is involved in the biological products sector, specifically focusing on biological products without diagnostic substances. No specific financial figures or operational updates were detailed in the provided excerpt.

Why It Matters

This filing signals a routine update or disclosure from 4D Molecular Therapeutics, Inc. to the SEC, which may contain important information for investors regarding the company's status.

Risk Assessment

Risk Level: low — The provided excerpt is a standard SEC filing notification and does not contain specific financial or operational details that would indicate immediate risk.

Key Players & Entities

FAQ

What is the primary business of 4D Molecular Therapeutics, Inc.?

4D Molecular Therapeutics, Inc. is primarily involved in Biological Products (No Diagnostic Substances), as indicated by its SIC code [2836].

When was this 8-K report filed?

This 8-K report was filed on January 10, 2025.

What is the principal executive office address for 4D Molecular Therapeutics, Inc.?

The principal executive office address is 5858 HORTON STREET #455, EMERYVILLE, California, 94608.

In which state is 4D Molecular Therapeutics, Inc. incorporated?

4D Molecular Therapeutics, Inc. is incorporated in Delaware.

What is the Commission File Number for 4D Molecular Therapeutics, Inc.?

The Commission File Number for 4D Molecular Therapeutics, Inc. is 001-39782.

Filing Stats: 2,209 words · 9 min read · ~7 pages · Grade level 16.7 · Accepted 2025-01-10 08:36:20

Key Financial Figures

Filing Documents

02 Results of Operations and Financial Condition

Item 2.02 Results of Operations and Financial Condition. On January 10, 2025, 4D Molecular Therapeutics, Inc. (the "Company") announced a strategically focused pipeline and resulting updated cash runway guidance. As a result of its strategically focused pipeline, resource reallocation, and discontinued future investment plans on non-core product candidates, each of which is described in further detail in Item 8.01 of this Current Report on Form 8-K, the Company has extended its expected cash runway. Under the updated operating plan, based on unaudited cash, cash equivalents and marketable securities of $506 million as of December 31, 2024, the Company now expects its current cash to fund operations into 2028. Cash runway includes full execution and topline 52-week data from 4FRONT-1 and 4FRONT-2 Phase 3 clinical trials in wet age-related macular degeneration ("wet AMD"), and ongoing early-stage development for diabetic macular edema ("DME") and cystic fibrosis ("CF"). Additionally, the Company will explore value-creating partnership opportunities and other strategic financing options.

01 Other Events

Item 8.01 Other Events INTERIM DATA FROM 4D-150 SPECTRA PART 1 CLINICAL TRIAL On January 10, 2025, the Company reported positive topline interim data from Part 1 of the SPECTRA clinical trial evaluating 4D-150 in DME and alignment with the U.S. Food and Drug Administration ("FDA") on registrational pathway for 4D-150 in DME. Clinical Trial Design & Interim Data from 4D-150 SPECTRA Part 1 Clinical Trial (Data Cutoff of December 13, 2024): The objective of the 4D-150 SPECTRA Part 1 clinical trial was to evaluate safety and tolerability and identify dose level for further evaluation. The Part 1 clinical trial utilized stringent supplemental aflibercept criteria and enrolled patients with high central subfield thickness ("CST") to maximize patient safety and assess initial clinical activity. The study population included 22 patients enrolled across 3 dose levels: 3E10 vg/eye (n=9), 1E10 vg/eye (n=12), and 5E9 vg/eye (n=1). One patient in 1E10 vg/eye arm terminated the study due to death unrelated to 4D-150, prior to completion of a post-baseline assessment. Safety data (n=21) demonstrated that 4D-150 was well tolerated with no intraocular inflammation at any timepoint. All patients completed the 16-week topical corticosteroid taper on schedule and remained completely off steroids. No hypotony, endophthalmitis, vasculitis, choroidal effusions or retinal artery occlusions Efficacy Results Through 32 Weeks: 3E10 vg/eye arm: Sustained gain of best corrected visual acuity (BCVA) of +8.4 letters Sustained reduction of CST, as measured by optical coherence tomography (OCT), of -194 m Supplemental injections: Post-aflibercept loading doses (3), 3E10 vg/eye achieved substantially fewer supplemental injections compared to 1E10 vg/eye and projected on-label aflibercept 2mg Q8W: Mean injections per patient: 3E10 vg/eye: 0.6, 1E10 vg/eye: 1.4, projected on-label aflibercept 2mg Q8W: 4.0 3E10 vg/eye demonstrated a reduction of 61% vs. 1E10 vg/eye 3E10

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 and 4D-710, 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.

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit Number Description 99.1 Investor Presentation of 4D Molecular Therapeutics, Inc., dated January 10, 2025 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

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: January 10, 2025 By: /s/ Uneek Mehra Uneek Mehra Chief Financial and Business Officer

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