4D Molecular Therapeutics Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Other Events, Financial Statements and Exhibits
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FORM
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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.
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):
4D-150 DME Phase 3 Regulatory Update & Next Steps
As a result of the interim data from Part 1 of the SPECTRA clinical trial, the Company has selected 3E10 vg/eye as the Phase 3 dose for 4D-150 in DME. Based on data generated to date for 4D-150 in both the SPECTRA and PRISM clinical trials, FDA is aligned that a single Phase 3 clinical trial, combined with data from the two planned Phase 3 clinical trials in the 4FRONT wet AMD program, would be acceptable as the basis of a BLA submission for 4D-150 in DME. Per FDA feedback, the Company may proceed to Phase 3 (with SPECTRA Part 2 no longer needed) and is aligned with key design elements of a Phase 3 clinical trial with approximately 300-400 patients total with a primary endpoint of BCVA noninferiority vs. on-label aflibercept 2mg (5 loading doses and Q8W), and revised supplemental injection criteria (less stringent compared to Part 1 SPECTRA, in line with prior successful Phase 3 DME clinical trials).
The Company plans to present the next steps for DME development in a corporate webcast on February 10, 2025.
On January 10, 2025, the Company posted an investor presentation on its website containing topline interim data from Part 1 of the SPECTRA clinical trial. The investor presentation is furnished as Exhibit 99.1 of this Current Report on Form 8-K and is incorporated herein by reference. The presentation furnished as Exhibit 99.1 hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
PIPELINE FOCUS AND CASH RUNWAY
On January 10, 2025, the Company announced a strategically focused pipeline, updated Phase 3 4FRONT program plans, initial 4FRONT guidance and resulting updated cash runway guidance.
Strategically Focused Pipeline
Core Programs: Updates & Upcoming Milestones
Large Market Ophthalmology Focus
4D-150 is a potential backbone therapy that is designed to provide multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) targeted to the retina with a single, well tolerated, intravitreal injection. 4D-150 is being developed for wet AMD and DME, each of which affects millions of patients globally, with the goal of preserving vision and relieving patients from burdensome repeated bolus injections, which can total up to 12 per year. The Company will focus the majority of its research and development resources and operations on global development and pre-commercial planning for 4D-150 in wet AMD.
Pulmonology Program
The Company’s proprietary A101 vector is the first known AAV vector to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with CF following aerosol delivery. Given A101-enabled product candidate 4D-710’s proof of delivery, safety data and initial clinical activity signals, and ongoing support from the Cystic Fibrosis Foundation and collaboration with Therapeutics Development Network, the Company intends to complete Phase 1 enrollment in H1 2025, approach the FDA with a pivotal trial proposal mid-2025, and evaluate additional funding options to further advance 4D-710 into late-stage development.
Programs with Reduced Capital Allocation
While the Company believes the therapeutics below hold significant potential, at this time no further significant investment is expected on these programs, pending additional financing or partnerships.
Following a comprehensive review of its portfolio, the Company has decided to terminate the development of the early-stage rare disease clinical programs evaluating 4D-110 for Choroideremia and 4D-125 for X-Linked Retinitis Pigmentosa.
Given the promising portfolio of product candidates and vectors owned and developed by the Company, the Company will not be investing additional capital into new preclinical product candidates at this time.
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.
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
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.
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4D MOLECULAR THERAPERUTICS, INC. |
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Date: |
January 10, 2025 |
By: |
/s/ Uneek Mehra |
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Uneek Mehra |