UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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 9, 2024, 4D Molecular Therapeutics, Inc. (“4DMT”) announced its financial results for the three months ended March 31, 2024. A copy of 4DMT’s press release, titled “4DMT Reports First Quarter 2024 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 |
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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.
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4D MOLECULAR THERAPEUTICS, INC. |
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Date: |
May 9, 2024 |
By: |
/s/ Uneek Mehra |
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Uneek Mehra |
Exhibit 99.1
4DMT Reports First Quarter 2024 Financial Results and Operational Highlights
EMERYVILLE, Calif., May. 9, 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 first quarter 2024 financial results and provided operational highlights.
“The first quarter of 2024 kicks off another transformative year for 4DMT with exceptional progress across our product pipeline and platform in multiple therapeutic areas, particularly our lead program 4D-150 in large market VEGF-driven retinal diseases,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “With robust clinical activity from 4D-150 demonstrated in our initial interim 24-week results from the Phase 2 PRISM Dose Expansion cohort in the severe disease activity wet AMD patient population, we set the stage for additional important data readouts in 2024, including 24-week results from the Phase 2 PRISM Population Extension cohort in the broader wet AMD patient population expected to be announced at ASRS in July and 24-week results from the Phase 2 SPECTRA Dose Confirmation cohort in DME expected to be announced in the fourth quarter. We believe the emerging profile of 4D-150 shows its potential to be the best-in-class, long-acting genetic medicine for broad market use in VEGF-driven retinal diseases, and we look forward to completing alignment with the FDA and EMA to rapidly advance 4D-150 into its first pivotal trial for global development. Building on the success of intravitreal R100, we are also encouraged by the preclinical results from 4D-175 that we shared today at the 2024 Association for Research in Vision and Ophthalmology (ARVO) Annual Scientific Meeting and are looking forward to bringing the program into the clinic for treatment of geographic atrophy in the second half of the year, demonstrating the power of our modular vectors and product engine. In addition, we continue to advance towards important milestones for 4D-710 for cystic fibrosis, 4D-725 for A1AT deficiency and 4D-310 for Fabry disease cardiomyopathy. Our successful financing puts us in a strong position to execute on all our corporate objectives, with expected cash runway into the first half of 2027.”
Recent Highlights in Large Market Ophthalmology Portfolio
Recent Highlights in Pulmonology Portfolio
Recent Highlights in Cardiology Portfolio
Expected Upcoming Milestones
Q1 2024 Financial Results
Cash and Cash Equivalents and Marketable Securities: Cash and cash equivalents and marketable securities were $589 million as of March 31, 2024, as compared to $299 million as of December 31, 2023. The net increase in cash was primarily a result of cash inflows from approximately $316 million of net proceeds from our public offering of common stock completed in February including partial exercise of
underwriters’ option to purchase additional shares. 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 $27.9 million for the first quarter of 2024, as compared to $22.4 million for the first quarter of 2023. 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 $10.3 million for the first quarter of 2024, as compared to $8.0 million for the first quarter of 2023.
Net Loss:Net loss was $32.4 million for the first quarter of 2024, as compared to net loss of $28.7 million for the first quarter of 2023.
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®, 4D®, 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.comand 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, as well as the plans, announcements and related timing for the clinical development of, 4DMT’s 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 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.
4D Molecular Therapeutics, Inc.
Statements of Operations
(Unaudited)
(in thousands, except share and per share amounts)
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Three months ended March 31, |
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2024 |
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2023 |
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Revenue: |
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Collaboration and license revenue |
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$ |
28 |
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$ |
298 |
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Operating expenses: |
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Research and development |
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27,870 |
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22,412 |
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General and administrative |
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10,294 |
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7,992 |
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Total operating expenses |
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38,164 |
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30,404 |
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Loss from operations |
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(38,136 |
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(30,106 |
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Other income, net |
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5,735 |
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1,424 |
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Net loss |
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$ |
(32,401 |
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$ |
(28,682 |
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Net loss per share, basic and diluted |
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$ |
(0.66 |
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$ |
(0.88 |
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Weighted-average shares outstanding used in computing net loss per share, basic and diluted |
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49,271,984 |
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32,723,530 |
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4D Molecular Therapeutics, Inc.
Balance Sheet Data
(Unaudited)
(in thousands)
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March 31, |
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December 31, |
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2024 |
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2023 |
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Cash, cash equivalents and marketable securities |
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$ |
588,853 |
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$ |
299,186 |
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Working capital |
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519,186 |
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277,637 |
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Total assets |
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629,884 |
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339,891 |
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Total liabilities |
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29,323 |
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32,062 |
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Accumulated deficit |
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(447,728 |
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(415,327 |
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Total stockholders’ equity |
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600,561 |
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307,829 |
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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
