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4D Molecular Therapeutics (NASDAQ: FDMT) posts 2025 results, inks Otsuka deal, extends cash runway

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(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

4D Molecular Therapeutics reported full year 2025 results and highlighted major partnering and financing activities that support its late-stage gene therapy pipeline. Collaboration and license revenue rose to $85.2 million, mainly from an upfront payment under the Otsuka partnership, while net loss narrowed to $140.1 million from $160.9 million in 2024. Research and development expenses increased to $195.7 million, reflecting advancement of the 4D-150 Phase 3 wet AMD program and other trials. Cash, cash equivalents and marketable securities were $514.0 million as of December 31, 2025, which the company expects will fund its operating plan into the second half of 2028. The company also completed an additional $118 million in equity financings and reported positive interim data and upcoming milestones for 4D-150 in retinal diseases and 4D-710 for cystic fibrosis lung disease.

Positive

  • Strategic Otsuka partnership: 4DMT received an $85 million upfront payment, expects at least $50 million of cost sharing over three years, and is eligible for up to $336 million in milestones plus tiered double-digit royalties, while retaining ex-Asia-Pacific rights to 4D-150.
  • Extended cash runway: Cash, cash equivalents and marketable securities of $514.0 million as of December 31, 2025, combined with expected collaboration payments, are projected to fund operations into the second half of 2028, supporting multiple late-stage trials.
  • Advancing late-stage pipeline: 4FRONT-1 Phase 3 wet AMD trial enrollment was completed ahead of projections with over 500 patients expected to be randomized, and multiple 4D-150 and 4D-710 data readouts are scheduled across 2026–2027.

Negative

  • None.

Insights

Otsuka partnership, strong cash runway and advancing Phase 3 programs are the key 2025 takeaways.

4D Molecular Therapeutics combined business development and capital raising to support its late-stage ophthalmology and cystic fibrosis programs. Collaboration and license revenue jumped to $85.2M, driven by the Otsuka upfront for 4D-150 in the Asia-Pacific region, while the company retained full rights elsewhere.

Operating investment was significant, with research and development expenses of $195.7M and general and administrative expenses of $49.1M, leading to a narrowed net loss of $140.1M. The equity financings plus the Otsuka deal lifted cash, cash equivalents and marketable securities to $514.0M as of December 31, 2025.

The company estimates this cash, together with expected collaboration payments, will fund operations into the second half of 2028. Upcoming catalysts include Phase 3 4FRONT-1 topline wet AMD data in H1 2027, 4FRONT-2 data in H2 2027, and multiple Phase 2 readouts for 4D-150 and 4D-710 during 2026, which will further clarify the platform’s clinical and commercial potential.

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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): March 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

 

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.

On March 18, 2026, 4D Molecular Therapeutics, Inc. (“4DMT”) announced its financial results for the year ended December 31, 2025. A copy of 4DMT’s press release, titled “4DMT Reports Full Year 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number

Description

99.1

Press Release, dated March 18, 2026, titled “4DMT Reports Full Year 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones”

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 


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:

March 18, 2026

By:

/s/ Kristian Humer

 

 

 

Kristian Humer
Chief Financial Officer

 


 

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
4D-150 continues to be well tolerated with no new safety or intraocular inflammation findings with up to 3.5 years of follow-up
2-year Phase 2b 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 mid-2026
4D-150 for Diabetic Macular Edema:
o
2-year SPECTRA Phase 1/2 clinical trial data expected in H2 2026
o
Phase 3 trial design expected mid-2026
o
Global Phase 3 trial initiation expected in Q3 2026

Recent Highlights and Expected Milestones in 4D-710 Program for CF Lung Disease

Announced positive long-term interim results from the AEROW Phase 1/2 clinical trial (data cut-off: December 1, 2025)
o
Clinically meaningful lung function activity, measured by ppFEV1 and LCI2.5, with follow-up through 1 year at dose selected for Phase 2
o
Durable CFTR transgene expression within target therapeutic range with follow-up through at least 1 year
Phase 2 ongoing, fully funded by the Cystic Fibrosis Foundation, with program update expected in H2 2026

Full Year 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $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 $85 million for the year ended December 31, 2025, as compared to $0 million for the year ended December 31, 2024. This increase was primarily due to the $85 million upfront cash payment related to the Otsuka collaboration agreement.

R&D Expenses: Research and development expenses were $196 million for 2025, as compared to $141 million for 2024. 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 $49 million for 2025, as compared to $47 million for 2024.

Net Loss: Net loss was $140 million for 2025, as compared to net loss of $161 million for 2024.

 


 

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™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT.  

All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company’s product candidates for the therapeutic uses for which they are being studied. 

Learn more at www.4DMT.com and follow us on LinkedIn.

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential and clinical benefits of, as well as the plans, announcements and related timing for the clinical development of our product candidates, the potential benefits of the strategic partnership with Otsuka, the amount of any potential cost sharing or milestone payments pursuant to the Company’s agreement with Otsuka, the Company’s use of proceeds, the potential benefits of the investment from and collaboration with the CF Foundation, the potential additional second tranche funding from the CF Foundation and statements regarding our financial performance, results of operations and anticipated cash runway. The words "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled "Risk Factors" in 4D Molecular Therapeutics’ most recent Annual Report on Form 10-K filed on or about the date hereof, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics 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. 

 


 

4D Molecular Therapeutics, Inc.

Statements of Operations

(in thousands, except share and per share amounts)

 

 

 

 

Year Ended December 31,

 

 

 

2025

 

 

2024

 

Revenue:

 

 

 

 

 

 

Collaboration and license revenue

 

$

85,209

 

 

$

37

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

 

195,696

 

 

 

141,299

 

General and administrative

 

 

49,060

 

 

 

46,579

 

Total operating expenses

 

 

244,756

 

 

 

187,878

 

Loss from operations

 

 

(159,547

)

 

 

(187,841

)

Other income, net

 

 

19,438

 

 

 

26,973

 

Net loss

 

$

(140,109

)

 

$

(160,868

)

Net loss per share, basic and diluted

 

$

(2.42

)

 

$

(2.98

)

Weighted-average shares outstanding used in computing net loss per share, basic and diluted

 

 

57,930,180

 

 

 

53,943,741

 

 

 


 

4D Molecular Therapeutics, Inc.

Balance Sheet Data

(in thousands)

 

 

 

As of December 31,

 

 

 

2025

 

 

2024

 

Cash, cash equivalents and marketable securities

 

$

514,034

 

 

$

505,460

 

Total assets

 

 

566,711

 

 

 

560,384

 

Total liabilities

 

 

61,047

 

 

 

49,778

 

Accumulated deficit

 

 

(716,304

)

 

 

(576,195

)

Total stockholders’ equity

 

 

505,664

 

 

 

510,606

 

 

 

 

 

Contacts:

 

Media:

 

Jenn Gordon

dna Communications

Media@4DMT.com

 

Investors:

 

Julian Pei

Head of Investor Relations and Strategic Finance

Investor.Relations@4DMT.com

 

 

img216297824_0.jpg

 


FAQ

How did 4D Molecular Therapeutics (FDMT) perform financially in 2025?

4D Molecular Therapeutics reported collaboration and license revenue of $85.2 million and a net loss of $140.1 million for 2025. Higher R&D spending on late-stage programs drove expenses, but the net loss improved from $160.9 million in 2024.

What is 4D Molecular Therapeutics’ cash position and runway after 2025?

The company ended 2025 with $514.0 million in cash, cash equivalents and marketable securities. It expects this, plus anticipated collaboration payments, will fund operating expenses and capital needs at least into the second half of 2028, supporting multiple ongoing clinical trials.

What are the key terms of 4D Molecular Therapeutics’ Otsuka partnership?

For 4D-150 in the Asia-Pacific region, 4DMT received an $85 million upfront payment and expects at least $50 million in cost sharing over three years. It is eligible for up to $336 million in milestones and tiered double-digit royalties, retaining rights elsewhere.

What progress did 4D Molecular Therapeutics make with 4D-150 in 2025?

4DMT completed enrollment in the 4FRONT-1 Phase 3 wet AMD trial within about 11 months and increased target enrollment to 480 patients per Phase 3 trial. Topline 4FRONT-1 data are expected in H1 2027 and 4FRONT-2 data in H2 2027.

What upcoming clinical milestones does 4D Molecular Therapeutics expect for 4D-150?

The company expects PRISM Phase 2b 2-year wet AMD data in mid-2026, SPECTRA DME 2-year data in H2 2026, Phase 3 DME trial design in mid-2026, and global Phase 3 DME trial initiation in Q3 2026, with Phase 3 wet AMD readouts in 2027.

What are the latest results from 4D Molecular Therapeutics’ 4D-710 cystic fibrosis program?

4DMT reported positive long-term interim data from the AEROW Phase 1/2 trial, showing clinically meaningful lung function activity and durable CFTR expression through at least one year. The Phase 2 study is ongoing and fully funded by the Cystic Fibrosis Foundation, with a program update expected in H2 2026.

Filing Exhibits & Attachments

2 documents
4D Molecular Therapeutics Inc.

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Biotechnology
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