FDMT 8-K
4D Molecular Therapeutics, Inc. (FDMT)
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): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
(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:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
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 May 8, 2025, 4D Molecular Therapeutics, Inc. (“4DMT”) announced its financial results for the three months ended March 31, 2025. A copy of 4DMT’s press release, titled “4DMT Reports First Quarter 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 |
|
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: |
May 8, 2025 |
By: |
/s/ Uneek Mehra |
|
|
|
Uneek Mehra |
Exhibit 99.1
4DMT Reports First Quarter 2025 Financial Results, Operational Highlights
and Expected Upcoming Milestones
EMERYVILLE, Calif., May 8, 2025 (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 2025 financial results, provided operational highlights and outlined expected upcoming milestones.
“The first quarter of 2025 marked a pivotal moment for 4DMT as we focused our pipeline on our highest value programs, 4D-150 and 4D-710, reported compelling 4D-150 Phase 2 results in wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), and initiated our first 4D-150 Phase 3 clinical trial 4FRONT-1 in wet AMD,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “With strong Phase 1/2 data, optimized Phase 3 trial design, and a world-class leadership team, we are well positioned to execute on our mission to dramatically improve lives and outcomes for patients living with retinal vascular diseases with 4D-150, a backbone therapy designed to provide long-lasting relief from frequent and burdensome injections. Our strong balance sheet provides us an expected operational runway into 2028, enabling us to deliver topline results from both wet AMD Phase 3 clinical trials in H2 2027 without raising additional capital. We look forward to sharing data and programmatic updates in H2 2025 for both our 4D-150 program in wet AMD and DME and our 4D-710 program in cystic fibrosis lung disease.”
Recent Corporate Highlights
Recent Highlights and Expected Milestones in Large Market Ophthalmology Portfolio
Recent Highlights and Expected Milestones in Pulmonology Program
Q1 2025 Financial Results
Cash position: Cash, cash equivalents, and marketable securities were $458 million as of March 31, 2025, as compared to $505 million as of December 31, 2024. The net decrease in cash was primarily a result of cash used in operations. We currently expect cash, cash equivalents, and marketable securities to be sufficient to fund planned operations into 2028.
R&D Expenses: Research and development expenses were $40.7 million for the first quarter of 2025, as compared to $27.9 million for the first quarter of 2024. This increase was primarily driven by the initiation of our first Phase 3 clinical trial of 4D-150 in wet AMD, including increased personnel and professional services to support Phase 3 development.
G&A Expenses: General and administrative expenses were $12.9 million for the first quarter of 2025, as compared to $10.3 million for the first quarter of 2024. This increase was primarily driven by professional services.
Net Loss: Net loss was $48.0 million for the first quarter of 2025, as compared to net loss of $32.4 million for the first quarter of 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. Our 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 (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. Our 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. Our 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 our 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 our 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 and interactions with FDA 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 Quarterly Report on Form 10-Q to be 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
(Unaudited)
(in thousands, except share and per share amounts)
|
|
Three months ended March 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Revenue: |
|
|
|
|
|
|
||
Collaboration and license revenue |
|
$ |
14 |
|
|
$ |
28 |
|
Operating expenses: |
|
|
|
|
|
|
||
Research and development |
|
|
40,699 |
|
|
|
27,870 |
|
General and administrative |
|
|
12,936 |
|
|
|
10,294 |
|
Total operating expenses |
|
|
53,635 |
|
|
|
38,164 |
|
Loss from operations |
|
|
(53,621 |
) |
|
|
(38,136 |
) |
Other income, net |
|
|
5,649 |
|
|
|
5,735 |
|
Net loss |
|
$ |
(47,972 |
) |
|
$ |
(32,401 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.86 |
) |
|
$ |
(0.66 |
) |
Weighted-average shares outstanding used in computing net loss per share, basic and diluted |
|
|
55,744,047 |
|
|
|
49,271,984 |
|
4D Molecular Therapeutics, Inc.
Balance Sheet Data
(Unaudited)
(in thousands)
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2025 |
|
|
2024 |
|
||
Cash, cash equivalents and marketable securities |
|
$ |
458,441 |
|
|
$ |
505,460 |
|
Total assets |
|
|
515,729 |
|
|
|
560,384 |
|
Total liabilities |
|
|
46,006 |
|
|
|
49,778 |
|
Accumulated deficit |
|
|
(624,167 |
) |
|
|
(576,195 |
) |
Total stockholders’ equity |
|
|
469,723 |
|
|
|
510,606 |
|
Contacts:
Media:
Jenn Gordon
dna Communications
Investors:
Julian Pei
Head of Investor Relations and Corporate Finance
