4D Molecular Therapeutics, Inc. [FDMT] Filings

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10-Q 1 fdmt-20230630.htm 10-Q 10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2023


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO

Commission File Number 001-39782

4D Molecular Therapeutics, Inc.

(Exact name of registrant as specified in its Charter)


Delaware	47-3506994
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
5858 Horton Street #455 Emeryville, CA	94608
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (510) 505-2680

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, par value $0.0001 per share

FDMT

The Nasdaq Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

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. ☐

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 4, 2023, there were 42,052,980 shares of 4D Molecular Therapeutics, Inc.'s common stock outstanding.

Table of Contents


		Page
PART I.	FINANCIAL INFORMATION	3
Item 1.	Condensed Unaudited Financial Statements	3
	Condensed Balance Sheets as of June 30, 2023 and December 31, 2022	3
	Condensed Statements of Operations for the Three and Six Months Ended June 30, 2023 and 2022	4
	Condensed Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2023 and 2022	5
	Condensed Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2023 and 2022	6
	Condensed Statements of Cash Flows for the Six Months Ended June 30, 2023 and 2022	7
	Notes to Unaudited Condensed Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	26
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	36
Item 4.	Controls and Procedures	37

PART II.	OTHER INFORMATION	38
Item 1.	Legal Proceedings	38
Item 1A.	Risk Factors	38
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	100
Item 3.	Default Upon Senior Securities	100
Item 4.	Mine Safety Disclosures	100
Item 5.	Other Information	100
Item 6.	Exhibits	101
Signatures		102

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

•

the success, cost and timing of our development activities, preclinical studies and clinical trials, including our clinical trials for 4D-150, 4D-710, 4D-310, 4D-125 and 4D-110;

•

the number, size and design of our planned clinical trials, and what regulatory authorities may require to obtain marketing approval;

•

the timing of Investigational New Drug Application (“IND”) enabling studies and results from such studies;

•

the timing and success of lead optimization for our product candidates in lead optimization;

•

the translation of our preclinical results and data into future clinical trials in humans;

•

the timing of any manufacturing runs for materials to be used in patient trials;

•

the timing or likelihood of regulatory filings and approvals;

•

our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of any approved product candidate;

•

our ability to obtain funding for our operations, including funding necessary to develop and commercialize our product candidates;

•

the rate and degree of market acceptance of our product candidates, if approved;

•

the success of competing products or platform technologies that are or may become available;

•

our plans and ability to establish sales, marketing and distribution infrastructure to commercialize any product candidates for which we obtain approval;

•

future agreements with third parties in connection with the commercialization of our product candidates;

•

the size and growth potential of the markets for our product candidates, if approved for commercial use, and our ability to serve those markets;

•

existing regulations and regulatory developments in the United States and foreign countries;

•

the expected potential benefits of strategic collaboration agreements, including our relationships with Astellas Gene Therapies, Inc., uniQure biopharma B.V. and Cystic Fibrosis Foundation, and our ability to attract collaborators with development, regulatory and commercialization expertise;

•

the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;

•

potential claims relating to our intellectual property and third-party intellectual property;

•

our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;

•

the pricing and reimbursement of our product candidates, if approved;

•

the potential effects of public health emergencies, including the COVID-19 pandemic, to our preclinical and clinical programs and our business;

•

our ability to attract and retain key managerial, scientific and medical personnel;

•

the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing;

•

our financial performance; and

•

our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act.

These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and management’s beliefs and assumptions and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this Quarterly Report on Form 10-Q may turn out to be inaccurate. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Potential investors are urged to consider these factors carefully in evaluating the forward-looking statements. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. You should, however, review the factors and risks we describe in the reports we will file from time to time with the SEC after the date of this Quarterly Report on Form 10-Q.

4D Molecular Therapeutics, Inc.

Condensed Balance Sheets (Unaudited)

(In thousands, except share and per share amounts)



	June 30,			December 31,
	2023			2022
Assets
Current assets:
Cash and cash equivalents	$	236,311		$	52,351
Marketable securities		74,032			161,203
Prepaid expenses and other current assets		7,433			6,957
Total current assets		317,776			220,511
Marketable securities, long-term		—			4,908
Property and equipment, net		21,295			22,262
Operating lease right-of-use assets, net		12,352			13,085
Other assets		1,080			1,080
Total assets	$	352,503		$	261,846
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable	$	3,493		$	3,322
Accrued and other current liabilities		6,577			8,870
Deferred revenue		576			884
Operating lease liabilities, current portion		3,103			2,655
Total current liabilities		13,749			15,731
Deferred revenue, net of current portion		847			1,076
Derivative liability		212			212
Operating lease liabilities, long-term portion		12,527			13,469
Other liabilities		24			21
Total liabilities		27,359			30,509
Commitments and contingencies (Note 9)
Stockholders’ equity
Preferred stock, $0.0001 par value, 10,000,000 shares authorized at June 30, 2023 and December 31, 2022; no shares issued and outstanding at June 30, 2023 and December 31, 2022		—			—
Common stock, $0.0001 par value, 300,000,000 shares authorized at June 30, 2023 and December 31, 2022; 42,016,622 and 32,626,627 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively		4			3
Additional paid-in-capital		697,583			547,020
Accumulated other comprehensive gain (loss)		345			(1,196	)
Accumulated deficit		(372,788	)		(314,490	)
Total stockholders’ equity		325,144			231,337
Total liabilities and stockholders’ equity	$	352,503		$	261,846

The accompanying notes are an integral part of these unaudited condensed financial statements.

4D Molecular Therapeutics, Inc.

Condensed Statements of Operations (Unaudited)

(In thousands, except share and per share amounts)


	Three Months Ended June 30,						Six Months Ended June 30,
	2023			2022			2023			2022
Revenue:
Collaboration and license revenue	$	239		$	162		$	538		$	1,382
Operating expenses:
Research and development (includes $0 for each of the three months ended June 30, 2023 and 2022, and $0 and $134 for the six months ended June 30, 2023 and 2022, respectively, attributable to related parties)		23,584			20,422			46,002			39,819
General and administrative		8,791			8,166			16,777			16,381
Total operating expenses		32,375			28,588			62,779			56,200
Loss from operations		(32,136	)		(28,426	)		(62,241	)		(54,818	)
Other income (expense):
Interest income		2,512			340			3,955			440
Other income (expense), net		8			—			(12	)		(46	)
Total other income (expense), net		2,520			340			3,943			394
Net loss	$	(29,616	)	$	(28,086	)	$	(58,298	)	$	(54,424	)
Net loss per share, basic and diluted	$	(0.77	)	$	(0.87	)	$	(1.63	)	$	(1.69	)
Weighted-average shares outstanding used in computing net loss per share, basic and diluted		38,335,219			32,324,392			35,661,995			32,263,015

The accompanying notes are an integral part of these unaudited condensed financial statements.

4D Molecular Therapeutics, Inc.

Condensed Statements of Comprehensive Loss (Unaudited)

(In thousands)


	Three Months Ended June 30,						Six Months Ended June 30,
	2023			2022			2023			2022
Net loss	$	(29,616	)	$	(28,086	)	$	(58,298	)	$	(54,424	)
Other comprehensive loss:
Net unrealized gain (loss) on marketable securities		615			(406	)		1,541			(1,404	)
Total comprehensive loss	$	(29,001	)	$	(28,492	)	$	(56,757	)	$	(55,828	)

The accompanying notes are an integral part of these unaudited condensed financial statements.

4D Molecular Therapeutics, Inc.

Condensed Statements of Stockholders' Equity (Unaudited)

(In thousands, except share amounts)


	Common Stock				Additional Paid-In			Accumulated Other Comprehensive			Accumulated			Total Stockholders’
	Shares		Amount		Capital			Gain (Loss)			Deficit			Equity
Balances at December 31, 2022		32,626,627	$	3	$	547,020		$	(1,196	)	$	(314,490	)	$	231,337
Issuance of common stock upon exercise of stock options		122,207		—		1,135			—			—			1,135
Issuance of common stock for the ATM offering program, net of issuance costs		487,934		—		9,647			—			—			9,647
Stock-based compensation expense		—		—		4,221			—			—			4,221
Vesting of common stock warrants issued for services		—		—		22			—			—			22
Net unrealized gain on marketable securities		—		—		—			926			—			926
Net loss		—		—		—			—			(28,682	)		(28,682	)
Balances at March 31, 2023		33,236,768	$	3	$	562,045		$	(270	)	$	(343,172	)	$	218,606
Issuance of common stock upon exercise of stock options		72,217		—		894			—			—			894
Issuance of common stock upon public offering, net of issuance costs		8,625,000		1		129,207			—			—			129,208
Issuance of common stock - 2020 ESPP		82,637		—		658			—			—			658
ATM offering costs		—		—		(212	)		—			—			(212	)
Stock-based compensation expense		—		—		4,969			—			—			4,969
Vesting of common stock warrants issued for services		—		—		22			—			—			22
Net unrealized gain on marketable securities		—		—		—			615			—			615
Net loss		—		—		—			—			(29,616	)		(29,616	)
Balances at June 30, 2023		42,016,622	$	4	$	697,583		$	345		$	(372,788	)	$	325,144


	Common Stock				Additional Paid-In		Accumulated Other Comprehensive			Accumulated			Total Stockholders’
	Shares		Amount		Capital		Loss			Deficit			Equity
Balances at December 31, 2021		32,224,524	$	3	$	526,523	$	(423	)	$	(206,996	)	$	319,107
Issuance of common stock upon exercise of stock options		39,541		—		330		—			—			330
Stock-based compensation expense		—		—		3,933		—			—			3,933
Vesting of common stock warrants issued for services		—		—		22		—			—			22
Net unrealized loss on marketable securities		—		—		—		(998	)		—			(998	)
Net loss		—		—		—		—			(26,338	)		(26,338	)
Balances at March 31, 2022		32,264,065	$	3	$	530,808		(1,421	)	$	(233,334	)	$	296,056
Issuance of common stock upon exercise of stock options and warrants		51,261		—		138		—			—			138
Stock-based compensation expense		—		—		4,322		—			—			4,322
Issuance of common stock - 2020 ESPP		61,552		—		471		—			—			471
Vesting of common stock warrants issued for services		—		—		22		—			—			22
Net unrealized loss on marketable securities		—		—		—		(406	)		—			(406	)
Net loss		—		—		—		—			(28,086	)		(28,086	)
Balances at June 30, 2022		32,376,878	$	3	$	535,761		(1,827	)	$	(261,420	)	$	272,517

The accompanying notes are an integral part of these unaudited condensed financial statements.

4D Molecular Therapeutics, Inc.

Condensed Statements of Cash Flows (Unaudited)

(In thousands)


	Six Months Ended June 30,
	2023			2022
Cash flows from operating activities
Net loss	$	(58,298	)	$	(54,424	)
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation expense		9,190			8,255
Vesting of common stock warrants in return for services		44			44
Change in fair value of derivative liability		—			8
Depreciation and amortization		2,108			872
Amortization of right-of-use assets

4D Molecular Therapeutics, Inc. [FDMT] Filings
10-Q	[2023-08-09]
10-Q	[2023-05-11]
10-K	[2023-03-15]
10-Q	[2022-11-08]
10-Q	[2022-08-11]
10-Q	[2022-05-12]
10-K	[2022-03-28]
10-Q	[2021-11-10]
S-1	[2021-10-26]
10-Q	[2021-08-12]
10-Q	[2021-05-13]
10-K	[2021-03-25]
S-1	[2020-11-17]
S-1	[2019-09-30]