0000950170-24-023088.txt : 20240229 0000950170-24-023088.hdr.sgml : 20240229 20240229161246 ACCESSION NUMBER: 0000950170-24-023088 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20240229 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240229 DATE AS OF CHANGE: 20240229 FILER: COMPANY DATA: COMPANY CONFORMED NAME: 4D Molecular Therapeutics, Inc. CENTRAL INDEX KEY: 0001650648 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 473506994 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39782 FILM NUMBER: 24703751 BUSINESS ADDRESS: STREET 1: 5858 HORTON STREET #455 CITY: EMERYVILLE STATE: CA ZIP: 94608 BUSINESS PHONE: 5105052680 MAIL ADDRESS: STREET 1: 5858 HORTON STREET #455 CITY: EMERYVILLE STATE: CA ZIP: 94608 FORMER COMPANY: FORMER CONFORMED NAME: 4D Molecular Therapeutics Inc. DATE OF NAME CHANGE: 20200506 FORMER COMPANY: FORMER CONFORMED NAME: 4D Molecular Therapeutics Inc DATE OF NAME CHANGE: 20150811 8-K 1 fdmt-20240229.htm 8-K 8-K
0001650648false00016506482024-02-292024-02-29

 

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): February 29, 2024

 

 

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 2.02 Results of Operations and Financial Condition.

 

On February 29, 2024, 4D Molecular Therapeutics, Inc. (“4DMT”) announced its financial results for the year ended December 31, 2023. A copy of 4DMT’s press release, titled “4DMT Reports Full Year 2023 Financial Results and Operational Highlights” 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 February 29, 2024, titled “4DMT Reports Full Year 2023 Financial Results and Operational Highlights”

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 thereunto duly authorized.

 

 

 

4D MOLECULAR THERAPEUTICS, INC.

 

 

 

 

Date:

February 29, 2024

By:

/s/ Uneek Mehra

 

 

 

Uneek Mehra
Chief Financial and Business Officer

 

 EX-99.1 2 fdmt-ex99_1.htm EX-99.1 EX-99.1

 

Exhibit 99.1

 

4DMT Reports Full Year 2023 Financial Results and Operational Highlights
 

•
Presented positive interim data from randomized Dose Expansion cohort of the Phase 2 PRISM study evaluating 4D-150 in wet AMD patients with severe disease activity and high treatment burden, enabling advancement into Phase 3 pivotal development, with initiation expected in Q1 2025
•
Positive interim clinical data for 4D-710 in cystic fibrosis and 4D-310 in Fabry disease continue to demonstrate the potential of these product candidates and the efficient delivery, transgene expression and clinical activity of 4DMT’s three clinical-stage vectors
•
Strategic agreements with Astellas Pharma in rare monogenic retinal diseases and Arbor Biotechnologies in CNS gene editing continue to validate the versatility of 4DMT’s Therapeutic Vector Evolution platform
•
Completed upsized public follow-on offering with total gross proceeds of $300 million supplements our cash position of $299 million (as of December 31, 2023) and extends our operational runway into the first half of 2027

 

EMERYVILLE, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today reported full year 2023 financial results and provided operational highlights.

“2023 was a transformative year for 4DMT with incredible progress across our product pipeline and platform in multiple therapeutic areas, especially for our lead program 4D-150 in wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME),” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “Robust enrollment ahead of schedule across multiple cohorts in the PRISM clinical trial of patients with wet AMD and the SPECTRA clinical trial of patients with DME have set the stage for multiple important data readouts in 2024, starting with our recent positive interim data at Angiogenesis, Exudation, and Degeneration 2024 Conference in the hardest-to-treat wet AMD patients. As of the most recent data update, 110 patients have been dosed with 4D-150 with no clinically significant inflammation, which continues to build on the emerging profile of 4D-150 as a potentially best-in-class long-acting genetic medicine with the opportunity for broad market adoption. We look forward to further updates in the broad wet AMD population and DME patients in the second half of 2024, setting the stage for our first Phase 3 clinical trial in wet AMD currently expected to initiate in the first quarter of 2025. We also look forward to providing updates on other key programs beyond 4D-150 in 2024, including 4D-175 for geographic atrophy, 4D-710 for cystic fibrosis and 4D-310 for Fabry disease cardiomyopathy. Our recent financing and resulting cash position allows us to execute on our vision of becoming a fully integrated, next-generation genetic medicines company.”

Recent Highlights in Large Market Ophthalmology Portfolio

•
4D-150 for Wet Age-Related Macular Degeneration:
o
Rapidly advanced intravitreal 4D-150 for wet AMD in the Phase 1/2 PRISM clinical trial
▪
Randomized Dose Expansion cohort (N=51) in patients with severe disease activity and high treatment burden presented at Angiogenesis, Exudation, and Degeneration 2024 Conference (data cutoff January 19, 2024):

 

 

•
Favorable safety profile demonstrated, with no significant or recurrent intraocular inflammation, and no 4D-150–related serious adverse events (SAEs) or study eye SAEs. All patients were off steroids
•
At 24 weeks, 4D-150 resulted in robust reductions in overall treatment burden, % of patients with 0-1 injections, % of patients injection-free, plus improved retinal anatomical control vs. the aflibercept control
▪
Durable responses demonstrated beyond 1 year in Phase 1 3E10 vg/eye dose cohort, with 3 patients injection-free through 80–104 weeks (up to 2 years) of follow-up
▪
Enrollment completed ahead of schedule in Phase 2 PRISM Population Extension cohort (N=32) evaluating 4D-150 in patients with broad disease activity and treatment burden versus the Dose Expansion cohort
o
Received RMAT and PRIME designations, enabling increased collaboration between the FDA and EMA on regulatory planning
o
Announced preliminary pivotal Phase 3 clinical trial design and plans
•
4D-150 for Diabetic Macular Edema:
o
Enrollment and dosing completed ahead of schedule in Dose Confirmation cohort (N=22) of the Phase 2 SPECTRA clinical trial in DME

Recent Highlights in Pulmonary Portfolio

•
4D-710 for Cystic Fibrosis Lung Disease:
o
Presented positive interim data from the Phase 1/2 AEROW clinical trial at the North American Cystic Fibrosis Conference
o
Dose ranging continues (5E14 – 2E15 vg) with lung biopsy CFTR expression significantly above normal controls, demonstrating the feasibility of efficient delivery and CFTR transgene expression at lower doses; first participant dosed in lower dose Cohort 3 (5E14 vg)
o
Received Rare Pediatric Disease Designation in January 2024 and Orphan Drug Designation from FDA in February 2024

Recent Highlights in Cardiology Portfolio

•
4D-310 for Fabry Disease Cardiomyopathy:
o
Interim clinical and biopsy data from Phase 1/2 INGLAXA clinical trials presented in the late-breaking session at WORLDSymposium™ 2024:
▪
4D-310 demonstrated clinically meaningful improvements on multiple cardiac endpoints through 12-24 months in five evaluable patients
▪
Cardiac biopsies from one patient at week 6 and 24 showed robust and durable delivery, transgene expression and clearance of Gb3 substrate in cardiomyocytes
▪
Safety and tolerability profile maintained; previously reported cases of atypical hemolytic uremic syndrome (aHUS) (n=3) have fully resolved
o
Reached agreement with FDA on a proposed plan to address clinical hold. Single non-human primate safety study evaluating intravenous 4D-310 with the rituximab/sirolimus immunosuppressive regimen underway

 

 

Strategic Agreements & Partnerships

•
In July 2023, entered license agreement with Astellas Pharma for their use of R100 vector for genetic targets implicated in rare monogenic ophthalmic diseases and received $20 million upfront with potential future milestones of up to $942.5 million, including potential near-term development milestones of $15 million for the initial target
•
In December 2023, entered strategic partnership with Arbor Biotechnologies to engineer, co-develop and co-commercialize AAV-delivered CRISPR/Cas-based therapeutics for up to six product candidates in the CNS therapeutic area

Expected Upcoming Milestones

•
4D-150 for Wet AMD:
o
Phase 2 PRISM Population Extension cohort (N=32) in patients with broad disease activity and treatment burden:
▪
Initial interim 24-week landmark analysis expected in Q3 2024
o
Phase 3 Planning:
▪
Additional FDA and EMA regulatory interactions under RMAT and PRIME planned in Q2 2024; update expected in Q3 2024
▪
Phase 3 clinical trial initiation expected in Q1 2025
•
4D-150 for DME:
o
Phase 2 SPECTRA clinical trial Dose Confirmation cohort (N=22):
▪
Initial interim 24-week landmark data expected in H2 2024
•
4D-175 for Geographic Atrophy:
o
IND filing expected in Q2 2024
o
Phase 1 initiation expected in H2 2024
•
4D-710 for CF Lung Disease:
o
Update on FDA feedback on development plan for monotherapy and approved CF modulator combination regimens expected in Q1 2024
o
Interim update from Phase 1/2 AEROW clinical trial expected in mid-2024
•
4D-725 for A1AT Deficiency Lung Disease:
o
Program update and initiation of IND-enabling studies expected in 2024
•
4D-310 for Fabry Disease Cardiomyopathy:
o
FDA submission of preclinical NHP safety data in combination with rituximab/sirolimus immunosuppression regimen expected in Q2 2024
•
4D-110 for Choroideremia and 4D-125 for X-Linked Retinitis Pigmentosa:
o
Program updates expected in 2024

 


Full Year 2023 Financial Results

Cash and Cash Equivalents and Marketable Securities: Cash and cash equivalents and marketable securities were $299 million as of December 31, 2023, as compared to $218 million as of December 31, 2022. The net increase in cash was primarily a result of cash inflows from $129 million of net proceeds

 

 

from our public offering of common stock completed in May, $19 million of net proceeds under our Open Market Sales Agreement, and the $20 million upfront payment in connection with the Astellas License Agreement and was partially offset by cash used in operations. In addition, in February 2024 we completed a public offering of common stock and prefunded warrants that resulted in us receiving net proceeds of approximately $281 million. We currently expect cash and cash equivalents to be sufficient to fund operations into the first half of 2027.

R&D Expenses: Research and development expenses were $97.1 million for 2023, as compared to $80.3 million for 2022. This increase was driven by the progression of our existing clinical trials, primarily 4D-150 in wet AMD and DME, along with increased payroll and stock-based compensation expense due to higher headcount.

G&A Expenses: General and administrative expenses were $36.5 million for 2023, as compared to $32.9 million for 2022.

Net Loss: Net loss was $100.8 million for 2023, as compared to net loss of $107.5 million for 2022.

About 4DMT

4DMT is a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases in ophthalmology and pulmonology. 4DMT’s proprietary invention platform, Therapeutic Vector Evolution, combines the power of the Nobel Prize-winning technology, directed evolution, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors for use in our wholly owned and partnered product candidates. Our product design, development, and manufacturing engine helps us efficiently create and advance our diverse product pipeline with the goal of revolutionizing medicine with potential curative therapies for millions of patients. Currently, 4DMT is advancing five clinical-stage and two preclinical product candidates, each tailored to address rare and large market diseases in ophthalmology, pulmonology, and cardiology. In addition, 4DMT is also advancing programs in CNS through a gene editing partnership. 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 FDA 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 4DMT’s product candidates, as well as the plans, announcements and related timing for the clinical development of our clinical and preclinical product candidates, 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 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,

 

 

 

2023

 

 

2022

 

Revenue:

 

 

 

 

 

 

Collaboration and license revenue

 

$

20,723

 

 

$

3,129

 

Total revenue

 

 

20,723

 

 

 

3,129

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

 

97,096

 

 

 

80,253

 

General and administrative

 

 

36,494

 

 

 

32,908

 

Total operating expenses

 

 

133,590

 

 

 

113,161

 

Loss from operations

 

 

(112,867

)

 

 

(110,032

)

Other income, net

 

 

12,030

 

 

 

2,538

 

Net loss

 

$

(100,837

)

 

$

(107,494

)

Net loss per share, basic and diluted

 

$

(2.58

)

 

$

(3.32

)

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

 

 

39,130,067

 

 

 

32,351,221

 

 

 

 

 

 

 

4D Molecular Therapeutics, Inc.

Balance Sheet Data

(in thousands)

 

 

 

As of December 31,

 

 

 

2023

 

 

2022

 

Cash, cash equivalents and marketable securities

 

$

299,186

 

 

$

218,462

 

Working capital

 

 

277,637

 

 

 

204,780

 

Total assets

 

 

339,891

 

 

 

261,846

 

Total liabilities

 

 

32,062

 

 

 

30,509

 

Accumulated deficit

 

 

(415,327

)

 

 

(314,490

)

Total stockholders’ equity

 

 

307,829

 

 

 

231,337

 

 

 

 

 

Contacts:

 

Media:

 

Katherine Smith

Inizio Evoke Comms

Katherine.Smith@inizioevoke.com

 

Investors:

 

Julian Pei

Head of Investor Relations and Corporate Communications

Investor.Relations@4DMT.com

 


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Document And Entity Information
Feb. 29, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Feb. 29, 2024
Entity Registrant Name 4D Molecular Therapeutics Inc.
Entity Central Index Key 0001650648
Entity Emerging Growth Company true
Entity File Number 001-39782
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 47-3506994
Entity Address, Address Line One 5858 HORTON STREET
Entity Address, Address Line Two #455
Entity Address, City or Town EMERYVILLE
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94608
City Area Code 510
Local Phone Number 505-2680
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Ex Transition Period false
Title of 12(b) Security Common Stock, $0.0001 par value per share
Trading Symbol FDMT
Security Exchange Name NASDAQ
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