FDMT

EX-99.1

2 fdmt-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

4DMT Reports First Quarter 2026 Financial Results, Operational Highlights

and Expected Upcoming Milestones

• 4D-150 4FRONT-1 wet AMD Phase 3 randomization complete (N=523); topline data expected in H1 2027

• 4FRONT - 2 enrollment completion expected in H2 2026; topline data expected in H2 2027

• 4D-150 PRISM wet AMD Phase 2b 2-year data expected at a scientific conference in Q3 2026, and SPECTRA DME trial 2-year data expected in H2 2026

• $458 million in cash, cash equivalents and marketable securities expected to fund current operating plan into second half of 2028

EMERYVILLE, Calif., May 7, 2026 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported Q1 2026 financial results, provided operational highlights and outlined expected upcoming milestones.

“We started 2026 with strong execution, completing enrollment in 4FRONT-1 ahead of schedule reflecting strong investigator and patient enthusiasm for 4D-150,” said David Kirn, M.D., Co-founder, President and Chief Executive Officer of 4DMT. “For the remainder of the year, we look forward to completing 4FRONT-2 enrollment, initiating our global Phase 3 clinical trial in DME, and sharing 2-year data from PRISM and SPECTRA.”

Recent Highlights and Expected Milestones

• 4D-150 for Wet Age-related Macular Degeneration:

o 4FRONT Global Phase 3 Program:

▪ 4FRONT-1, North American Clinical Trial:

• Enrollment completed in February 2026 and randomization completed (N=523) in March 2026; topline data expected in H1 2027

▪ 4FRONT-2, Global Clinical Trial:

• Enrollment completion expected in H2 2026; topline data expected in H2 2027

o PRISM Phase 1/2 Clinical Trial:

▪ Phase 2b 2-year data in a broad patient population, including the recently diagnosed subgroup population most comparable to the 4FRONT Phase 3 population, expected to be presented at a scientific conference in Q3 2026

• 4D-150 for Diabetic Macular Edema:

o SPECTRA clinical trial 2-year data expected in H2 2026

o Global Phase 3 trial design expected in mid-2026 and initiation expected in Q3 2026

• 4D-175 for Geographic Atrophy:

o Company maintains an active IND and continues to evaluate strategic funding

alternatives to advance the program into the clinic

• 4D-710 for Cystic Fibrosis:

o AEROW Phase 1/2 clinical trial and program update expected in H2 2026

Q1 2026 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $458 million as of March 31, 2026, as compared to $514 million as of December 31, 2025. Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities, and expected payments under our collaboration agreement with Otsuka, will be sufficient to fund our operating expenses and capital expenditure requirements at least into the second half of 2028.

Collaboration and License Revenue: Collaboration and license revenue was $3.0 million for the first quarter of 2026, as compared to an insignificant amount for the first quarter of 2025. The increase in revenue was primarily due to the clinical trial cost sharing and reimbursement amounts from Otsuka.

R&D Expenses: Research and development expenses were $65.0 million for the first quarter of 2026, as compared to $40.7 million for the first quarter of 2025. This increase was primarily driven by execution of 4D-150 Phase 3 clinical trials in wet AMD.

G&A Expenses: General and administrative expenses were $11.7 million for the first quarter of 2026, as compared to $12.9 million for the first quarter of 2025.

Net Loss: Net loss was $68.8 million for the first quarter of 2026, as compared to net loss of $48.0 million for the first quarter of 2025.

About 4DMT

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF biologics (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4D

EX-99.1

2 fdmt-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

4DMT Reports Full Year 2025 Financial Results, Operational Highlights

and Expected Upcoming Milestones

• Completed enrollment in 4D-150 4FRONT-1 wet AMD Phase 3 trial within approximately 11 months, ahead of initial projections and reflecting strong interest from investigators and patients; topline data expected in H1 2027

• PRISM wet AMD Phase 2b 2-year data expected in mid-2026 and SPECTRA DME trial 2-year data in H2 2026

• 4D-150 DME global Phase 3 trial initiation expected in Q3 2026

• $514 million in cash, cash equivalents and marketable securities expected to fund current operating plan into second half of 2028

EMERYVILLE, Calif., March 18, 2026 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported full year 2025 financial results, provided operational highlights and outlined expected upcoming milestones.

“2025 was a transformative year for 4DMT highlighted by meaningful progress advancing 4D-150 with rapid Phase 3 trial enrollment, presenting strong 4D-150 Phase 1/2 durability data, entering a strategic partnership with Otsuka and strengthening our financial position,” said David Kirn, M.D., Co-founder, President and Chief Executive Officer of 4DMT. “These achievements position us well for execution in 2026 and beyond as we continue toward our goal of redefining the treatment paradigm for retinal vascular disease with 4D-150, with our first pivotal data readout for wet AMD expected in the first half of 2027.”

Recent Corporate Highlights

• Expanded Leadership to Support Late-Stage Execution and Commercial Readiness

o Glenn P. Sblendorio joined the 4DMT Board of Directors and will serve on the Compensation and Science & Technology committees

o Kristian Humer joined as Chief Financial Officer

o Julie Clark, M.D., was promoted to Chief Medical Officer

o Katy Barglow, Ph.D., was promoted to Chief Technical Officer

o Kim Maplestone was promoted to Chief Clinical Operations Officer

o Chris Simms’ role expanded to Chief Commercial & Business Officer

• Entered Strategic Partnership with Otsuka Pharmaceutical Co., Ltd. for 4D-150 in Asia-Pacific Region

o 4DMT received $85 million upfront cash payment in the fourth quarter of 2025 and expects to receive at least $50 million of cost sharing from Otsuka over the next three years for development activities supporting global registration

o The Company is eligible for up to $336 million in potential regulatory and commercial milestones and tiered double-digit royalties

o 4DMT retains full development and commercialization rights for 4D-150 outside the Asia-Pacific region, including in the U.S., Europe and Latin America

• Strengthened Balance Sheet Position with $118 Million Financing, Extending Cash Runway into H2 2028

o In October 2025, secured an equity investment from the Cystic Fibrosis (CF) Foundation of up to $11 million in two tranches, with the first tranche of $7.5 million received upfront, to accelerate the development of 4D-710 for the treatment of CF lung disease

o In October 2025, raised gross proceeds of $10 million from sale of common stock through at-the-market offering facility

o In November 2025, completed an equity offering with gross proceeds of $100 million before underwriting discounts, commissions and offering expenses, resulting in net proceeds of approximately $93 million

Recent Highlights and Expected Milestones for 4D-150

• 4D-150 for Wet Age-related Macular Degeneration:

o 4FRONT Global Phase 3 Program:

▪ To further the potential for global regulatory success, target enrollment for both the 4FRONT-1 and the 4FRONT-2 Phase 3 clinical trials was increased from 400 to 480 patients per trial

• Provides approximately 90% power with a noninferiority margin of 4 letters as aligned with the Japan Pharmaceuticals and Medical Devices Agency and European Medicines Agency

▪ 4FRONT-1, North American Clinical Trial:

• Enrollment completed in February 2026 with over 500 patients expected to be randomized; topline data expected in H1 2027

▪ 4FRONT-2, Global Clinical Trial:

• Ex-U.S. site activation and patient screening accelerating across Europe and Asia-Pacific; enrollment remains on track to be completed in H2 2026, with topline data expected in H2 2027

o PRISM Phase 1/2 Clinical Trial:

▪ Announced positive long-term interim results (data cutoff: August 22, 2025)

• 4D-150 demonstrated consistent and durable benefit across all three patient cohorts as evidenced by maintenance of visual acuity, control of retinal anatomy and reduction of treatment burden at all time points with 1.5-2 years of follow-up

• Consistent dose response in favor of Phase 3 dose (3E10 vg/eye) continues to be demonstrated across all wet AMD cohorts studied

8-K

false000165064800016506482025-12-312025-12-31

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): December 31, 2025

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

N/A

(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 2.02 Results of Operations and Financial Condition. As of December 31, 2025, 4D Molecular Therapeutics, Inc. (the “Company”) estimates that it had approximately $514 million in cash, cash equivalents and marketable securities. This estimate of its cash, cash equivalents and marketable securities balance is preliminary and subject to completion of its financial closing procedures, including the completion of management’s reviews. Accordingly, the unaudited preliminary cash, cash equivalents and marketable securities balance set forth above reflects its preliminary estimate with respect to such information, based on information currently available to management, and may vary from its actual financial position as of December 31, 2025. Further, this preliminary estimate is not a comprehensive statement or estimate of its financial results or financial condition as of December 31, 2025. Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. (b) Departure of President and Chief Operating Officer On December 31, 2025, in connection with his transition to a new part-time employment position, Fariborz Kamal, Ph.D., resigned as President and Chief Operating Officer of the Company effective immediately to pursue other opportunities. Dr. Kamal has agreed to transition to a part-time employment position as Chief Technical Advisor to the Company to, among other things, assist in the transition of his responsibilities. Dr. Kamal’s departure is not the result of any disagreement regarding the Company’s operations, corporate outlook, policies, practices, or any other matter. (c) Appointment of President Effective January 1, 2026, following the resignation of Dr. Kamal as President, the Board of Directors of the Company (the “Board”) appointed David Kirn, M.D., the Company’s current Chief Executive Officer, as the President and Chief Executive Officer of the Company. There is no arrangement or understanding between Dr. Kirn and any other person, pursuant to which he was appointed as President of the Company. The information required by Items 401(b), (d) and (e) and 404(a) of Regulation S-K relating to Dr. Kirn is incorporated herein by reference to the Company’s Definitive Proxy Statement on Schedule 14A for the Company’s 2025 Annual Meeting of Stockholders, as filed with the Securities and Exchange Commission on April 29, 2025, under the captions Executive Officers, Proposal No. 1 Election of Directors—Director Continuing in Office Until the 2027 Annual Meeting of Stockholders, Corporate Governance—Independence of the Board of Directors and Certain Relationships and Related Party Transactions. (d) Appointment of New Director Effective as of January 5, 2026, the Board appointed Glenn Sblendorio to the Board as a Class I director, to serve for a term expiring at the Company’s 2027 annual meeting