4D Molecular Therapeutics (Nasdaq: FDMT) posts positive 2-year wet AMD data

Rhea-AI Filing Summary

4D Molecular Therapeutics, Inc. reported positive 2-year data from the PRISM Phase 2b clinical trial evaluating its product candidate 4D-150 in a broad wet age-related macular degeneration population, based on a data cutoff of May 18, 2026. The disclosure highlights trial and patient cohort overview information, Phase 2b efficacy results through 2 years, and safety data for the selected Phase 3 dose across the overall PRISM Phase 1/2a and 2b clinical trial population of 71 patients.

The company explains that statements about the therapeutic potential, treatment-burden reduction, durability and success of clinical trials for 4D-150 are forward-looking statements under the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties described in its most recent quarterly report filed on May 7, 2026, and the company disclaims any obligation to update forward-looking statements.

Positive

• The company reported positive 2-year data from its PRISM Phase 2b clinical trial of 4D-150 in a broad wet AMD population, including efficacy and safety data at the planned Phase 3 dose level across the overall PRISM program.

Negative

• None.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Key Figures

Follow-up duration: 2 years Data cutoff date: May 18, 2026 Patients in safety dataset: 71 patients +1 more

4 metrics

Follow-up duration 2 years Efficacy results from the PRISM Phase 2b clinical trial of 4D-150

Data cutoff date May 18, 2026 Data cutoff for 2-year PRISM Phase 2b clinical trial results

Patients in safety dataset 71 patients Safety data for the Phase 3 dose in overall PRISM Phase 1/2a & 2b clinical trial

Announcement date July 18, 2026 Date the company reported positive 2-year PRISM Phase 2b data

Key Terms

wet age-related macular degeneration, PRISM Phase 2b clinical trial, forward-looking statements, treatment-burden reduction, +1 more

5 terms

wet age-related macular degeneration medical

"evaluating 4D-150 in a broad wet age-related macular degeneration (“wet AMD”) population"

A severe eye condition in which abnormal, fragile blood vessels grow beneath the macula — the small central part of the retina responsible for sharp, detailed vision — and leak fluid or blood, causing rapid loss of central sight. Investors care because the condition drives demand for high-cost therapies, medical devices and ongoing care; successful treatments can create sizable markets, affect healthcare spending and influence regulatory and reimbursement decisions, much like fixing a leaking camera lens restores image quality and value.

PRISM Phase 2b clinical trial medical

"2-year data from the PRISM Phase 2b clinical trial evaluating 4D-150"

forward-looking statements regulatory

"contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act"

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

treatment-burden reduction medical

"including, without limitation, implied and expressed statements regarding the therapeutic potential, treatment-burden reduction, durability"

data cutoff technical

"2-Year Data from PRISM Phase 2b Clinical Trial (Data Cutoff May 18, 2026)"

Data cutoff is the final date and time through which information was collected and included in an analysis, report, or disclosure; events or figures occurring after that point are not reflected. It matters to investors because it defines the snapshot on which results and claims are based—like a camera shutter freezing a moment—so knowing the cutoff helps assess whether more recent developments could meaningfully change the picture.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Understanding 8-K Material Events →

Available on EDGAR 07/20/2026 - 08:30 AM Accepted by SEC EDGAR 07/20/2026 - 08:30 AM Learn about SEC filing dates

FAQ

What did 4D Molecular Therapeutics (FDMT) announce on July 18, 2026?

4D Molecular Therapeutics announced positive 2-year data from its PRISM Phase 2b clinical trial of 4D-150 in wet age-related macular degeneration. The update covers efficacy through two years and safety for the selected Phase 3 dose.

What condition is 4D-150 targeting in 4D Molecular Therapeutics (FDMT)’s PRISM trial?

4D-150 is being evaluated in patients with wet age-related macular degeneration (wet AMD). The PRISM Phase 2b trial focuses on a broad wet AMD population, assessing long-term efficacy and potential reduction in treatment burden.

How long is the follow-up for the PRISM Phase 2b trial reported by FDMT?

The company reported 2-year data from the PRISM Phase 2b clinical trial. This two-year follow-up provides longer-term information on efficacy and durability of 4D-150 treatment in patients with wet age-related macular degeneration.

What was the data cutoff date and patient count in FDMT’s PRISM program update?

The data cutoff date was May 18, 2026, with safety data for the Phase 3 dose based on 71 patients in the overall PRISM Phase 1/2a and 2b clinical trial population, supporting a more comprehensive safety assessment.

What forward-looking statements did 4D Molecular Therapeutics (FDMT) include about 4D-150?

The company’s statements about therapeutic potential, treatment-burden reduction, durability and trial success for 4D-150 are forward-looking. It notes these are subject to risks described in its most recent quarterly risk-factor disclosures.

Where does FDMT say investors can find risk factors related to 4D-150 and the PRISM trial?

Risk factors are referenced in the company’s most recent quarterly report filed on May 7, 2026. That report contains a detailed Risk Factors section addressing uncertainties that could affect clinical and business outcomes.

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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 18, 2026

4D Molecular Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware		001-39782		47-3506994
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

5858 Horton Street #455
Emeryville, California		94608
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: (510) 505-2680

(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:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		FDMT		Nasdaq Global Select Market

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. ☐

Item 8.01 Other Events.

On July 18, 2026, 4D Molecular Therapeutics, Inc. (the “Company”) reported positive 2-year data from the PRISM Phase 2b clinical trial evaluating 4D-150 in a broad wet age-related macular degeneration (“wet AMD”) population.

2-Year Data from PRISM Phase 2b Clinical Trial (Data Cutoff May 18, 2026):

Trial and Patient Cohort Overview

• The Phase 2b trial enrolled 45 patients at two dose levels of a single intravitreal dose of 4D-150 (3E10 and 1E10 vg/eye); 3E10 vg/eye was chosen as the dose for the 4FRONT Phase 3 clinical trials

• The Phase 2b overall cohort enrolled patients with broad disease activity (n=30 dosed with 3E10 vg/eye and n=15 dosed with 1E10 vg/eye)

• The Phase 2b cohort subgroup comprised recently diagnosed patients (diagnosed within 6 months, n=15 at 3E10 vg/eye), which is most comparable to the population enrolled in the 4FRONT Phase 3 clinical trials

Phase 2b Efficacy Results Through 2 Years:

• Consistent maintenance of best corrected visual acuity (“BCVA”)

• Consistent control of central subfield thickness (“CST”) as measured by optical coherence tomography

• Consistent, durable and clinically meaningful reduction in treatment burden:

• Overall cohort:

• 78% overall treatment burden reduction (2.7 mean supplemental injections per patient vs. 12.0 injections projected with on-label aflibercept 2 mg Q8W)

• Recently diagnosed subgroup:

• 87% overall treatment burden reduction (1.6 mean supplemental injections per patient vs. 12.0 injections projected with on-label aflibercept 2 mg Q8W)

• Dose response maintained throughout 2 years in favor of the Phase 3 dose

Safety Data for Phase 3 Dose in Overall PRISM Phase 1/2a & 2b Clinical Trial (n=71)

• 4D-150 continues to be well tolerated:

• Intraocular inflammation:

• As previously reported, within approximately the first 6 months (28 weeks) post-4D-150 dosing, 2.8% (2 of 71) of patients had 4D-150-related 1+ (mild) intraocular inflammation (“IOI”) (SUN/NEI scales), which were transient 1+ vitreous cells noted at a single timepoint

• Following the first 28 weeks post-4D-150 dosing, no new cases of inflammation with 2 to more than 4 years of follow-up on all patients as of the data cutoff

• No 4D-150-related hypotony, endophthalmitis, vasculitis, occlusive/non-occlusive retinal vasculitis or choroidal effusions observed to date

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and expressed statements regarding the therapeutic potential, treatment-burden reduction, durability, and success of clinical trials for 4D-150. In some cases, you can identify these statements by forward-looking words such as “may,” “will,” “anticipate,” “intend,” “project,” “continue,” “target” 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 filed on May 7, 2026, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics’ current views and should not be relied upon as representing its views as of any subsequent time. The Company explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

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 THERAPEUTICS, INC.
Date: July 20, 2026				By:		/s/ Kristian Humer
						Kristian Humer Chief Financial Officer

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