8-K

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): May 10, 2023

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 May 10, 2023, 4D Molecular Therapeutics, Inc. (“4DMT”) announced its financial results for the three months ended March 31, 2023. A copy of 4DMT’s press release, titled “4D Molecular Therapeutics Reports First Quarter 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 May 10, 2023 titled “4D Molecular Therapeutics Reports First Quarter 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:	May 10, 2023	By:	/s/ August J. Moretti
			August J. Moretti Chief Financial Officer

EX-99

Exhibit 99.1

4D Molecular Therapeutics Reports First Quarter 2023 Financial Results

and Operational Highlights

•Presented positive interim data from intravitreal 4D-150 Phase 1/2 PRISM clinical trial for wet age-related macular degeneration (wet AMD) at the 2023 ARVO Annual Meeting

•On track for completion of enrollment of the Phase 2 Dose Expansion Stage of the PRISM clinical trial in Q3 2023

•Acquired all worldwide rights to short-form human complement factor H (sCFH) from Aevitas Therapeutics, Inc. and announced sCFH as payload for 4D-175 lead product candidate for geographic atrophy (GA)

•Multiple additional clinical data updates on clinical-stage product candidates expected later in 2023, including on 4D-710 for cystic fibrosis lung disease in Q2 2023

•Closed upsized public offering of common stock including full exercise of underwriters’ option to purchase additional shares with total net proceeds of approximately $129 million

•Cash, cash equivalents and marketable securities inclusive of net proceeds from the public offering expected to be sufficient to fund operations into the first half of 2026

EMERYVILLE, Calif., May 10, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company) a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases, today reported first quarter 2023 financial results and provided operational highlights.

“We are pleased with the progress of our large market ophthalmology portfolio this year. In April at ARVO, we released positive interim clinical data on all three dose cohorts in the Dose Exploration stage of our Phase 1/2 PRISM clinical trial of 4D-150 for the treatment of wet AMD. We observed excellent tolerability and clinical activity in these high anti-VEGF need patients that we believe support a differentiated profile. We are excited to see faster than expected enrollment of the Phase 2 Dose Expansion stage of the PRISM trial and believe this highlights the belief by investigators that 4D-150 has potential to be a transformative treatment for patients with wet AMD. We also announced the acquisition of the rights and know-how for sCFH from Aevitas for use in our preclinical product candidate 4D-175 for treatment of GA,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “We believe we have the opportunity to build a franchise in large market ophthalmology with 4D-150 for the treatment of wet AMD and diabetic macular edema (DME) and 4D-175 in for GA, each using our retinotropic vector R100. Our capital-efficient operations and strong cash position are expected to support operations into the first half of 2026.”

Recent Highlights in Large Market Ophthalmology Portfolio

•Significant progress advancing the 4D-150 program for the intravitreal treatment of patients with wet AMD and with DME

oPresented positive interim data from the three dose cohorts studied (3E10, 1E10, and 6E9 vg/eye; n=5 each) in the Dose Exploration stage of the Phase 1/2 PRISM clinical trial for wet AMD in April at the ARVO 2023 Conference

▪All three doses were well-tolerated and demonstrated clinical activity

▪Dose response observed in favor of 3E10 vg/eye vs lower doses of 1E10 and 6E9 vg/eye

▪In the 3E10 vg/eye cohort, 4 of 4 (100%) of Phase 2 BCVA-eligible patients remained injection-free at 36 weeks with a mean reduction in central subfield thickness (CST) of 72µm

oEnrollment in Phase 2 Dose Expansion (n=50) stage of the PRISM is more than 50% completed

•Acquired the rights and know-how for sCFH from Aevitas Therapeutics, Inc. and announced sCFH as payload for 4D-175 product candidate for GA

Expected Upcoming Milestones

•4D-150 for Wet AMD and DME:

oEnrollment of the Phase 2 randomized Dose Expansion stage of the PRISM clinical trial expected to complete in Q3 2023

oInitial interim 4D-150 for wet AMD Phase 2 data expected in H1 2024

oEnrollment of the Phase 2 SPECTRA clinical trial for DME expected to begin in Q3 2023

oInitial interim 4D-150 for DME Phase 2 data expected in H1 2024

•4D-175 for GA:

oProgram update expected in Q4 2023

•4D-710 for Cystic Fibrosis Lung Disease:

oInterim data from the Dose Exploration stage of the Phase 1/2 AEROW clinical trial expected to be presented at a scientific conference in Q2 2023

oUpdate on development plan for modulator combination expected in 2H 2023

•4D-310 for Fabry Disease Cardiomyopathy:

oProgram update expected in 2H 2023

First Quarter 2023 Financial Results

Cash and Cash Equivalents and Marketable Securities: Cash and cash equivalents and marketable securities were $202 million as of March 31, 2023, as compared to $218 million as of December 31, 2022. The decrease in cash was primarily a result of cash used in operations, which was partially offset by $9.6M of net proceeds from the sale of shares pursuant to our Open Market Sales Agreement. In addition, in May 2023 we completed a public offering of common stock that resulted in us receiving net proceeds of approximately $129 million. We currently expect cash and cash equivalents, inclusive of net proceeds from the May 2023 offering, to be sufficient to fund operations into the first half of half of 2026.

R&D Expenses: Research and development expenses were $22.4 million for the quarter ended March 31, 2023 as compared to $19.4 million for the first quarter of 2022. This increase was primarily driven by the progression of our existing clinical trials, primarily 4D-150, along with increased payroll and stock-based compensation expense.

G&A Expenses: General and administrative expenses were $8.0 million for the quarter ended March 31, 2023 as compared to $8.2 million for the first quarter of 2022 .

Net Loss: Net loss was $28.7 million for the quarter ended March 31, 2023, as compared to $26.3 million for the first quarter of 2022.

About 4DMT

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases. 4DMT seeks to unlock the full potential of genetic medicines using its proprietary invention platform, Therapeutic Vector Evolution, which 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 product candidates. All of our vectors are proprietary to 4DMT and were invented at 4DMT, including the vectors utilized in our clinical-stage and preclinical pipeline product candidates: R100, A101, and C102. The Company is initially focused on five clinical-stage product candidates in three therapeutic areas for both rare and large market diseases: ophthalmology, pulmonology, and cardiology (Fabry disease cardiomyopathy). The 4DMT customized and evolved vectors were invented with the goal of being delivered at relatively low doses through clinically routine, well-tolerated, and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. 4DMT is currently advancing five product candidates in clinical development: 4D-150 for wet AMD and DME, 4D-710 for cystic fibrosis lung disease, 4D-310 for Fabry disease cardiomyopathy, 4D-125 for XLRP, and 4D-110 for choroideremia. The 4D preclinical product candidates in development are: 4D-175 for geographic atrophy and 4D-725 for AATLD.

4D-150, 4D-710, 4D-310, 4D-125, and 4D-110 are our product candidates in clinical development and have not yet been approved for marketing by the US FDA or any other regulatory authority. No representation is made as to the safety or effectiveness of 4D-150, 4D-710, 4D-310, 4D-125, or 4D-110 for the therapeutic uses for which they are being studied.

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

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, as well as the plans and related timing for the clinical development of 4D-150, 4D-710, 4D-310, 4D-125, 4D-110, and 4D-175; and the expectation that the company's current cash position will be sufficient to fund operations into the first half of 2026. 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. Our results for the quarter ended March 31, 2023 are also not necessarily indicative of our operating results for any future periods.

4D Molecular Therapeutics, Inc.

Statements of Operations

(Unaudited)

(in thousands, except share and per share amounts)

	Three months ended March 31,
	2023			2022
Revenue:
Collaboration and license revenue	$	298		$	1,219
Operating expenses:
Research and development		22,412			19,381
General and administrative		7,992			8,230
Total operating expenses		30,404			27,611
Loss from operations		(30,106	)		(26,392	)
Other income, net		1,424			54
Net loss	$	(28,682	)	$	(26,338	)
Net loss per share, basic and diluted	$	(0.88	)	$	(0.82	)
Weighted-average shares outstanding used in computing net loss per share, basic and diluted		32,723,530			32,232,378

4D Molecular Therapeutics, Inc.

Balance Sheet Data

(Unaudited)

(in thousands)

	March 31,			December 31,
	2023			2022
Cash, cash equivalents and marketable securities	$	201,859		$	218,462
Working capital		195,762			204,780
Total assets		244,021			261,846
Total liabilities		25,415			30,509
Accumulated deficit		(343,172	)		(314,490	)
Total stockholders’ equity		218,606			231,337

Contacts:

Media:

Katherine Smith

EvokeCanale

Katherine.Smith@evokegroup.com

Investors:

Julian Pei

Head of Investor Relations and Corporate Communications

jpei@4dmt.com

267-644-5097

XML

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Cover [Abstract]
Document Type	8-K
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Document Period End Date	May 10, 2023
Entity Registrant Name	4D Molecular Therapeutics Inc.
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Entity Address, Address Line Two	#455
Entity Address, City or Town	EMERYVILLE
Entity Address, State or Province	CA
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Title of 12(b) Security	Common Stock, $0.0001 par value per share
Trading Symbol	FDMT
Security Exchange Name	NASDAQ