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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

OR

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.

 

Large accelerated filer

Accelerated filer

 

 

 

 

Non-accelerated filer

Smaller reporting company

 

 

 

 

 

 

 

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.

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

 

 

 

1


 

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;

1


 

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.

2


 

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.

3


 

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.

 

4


 

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.

5


 

 

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.

6


 

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