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 November 13, 2024, 4D Molecular Therapeutics, Inc. (“4DMT”) announced its financial results for the three months ended September 30, 2024. A copy of 4DMT’s press release, titled “4DMT Reports Third Quarter 2024 Financial Results, Operational Highlights and Expected Upcoming Milestones” 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: |
November 13, 2024 |
By: |
/s/ Uneek Mehra |
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Uneek Mehra |
Exhibit 99.1
4DMT Reports Third Quarter 2024 Financial Results, Operational Highlights
and Expected Upcoming Milestones
EMERYVILLE, Calif., November 13, 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 third quarter 2024 financial results, provided operational highlights and outlined expected upcoming milestones.
“Throughout 2024, 4DMT has generated compelling Phase 1/2 data and executed on Phase 3 preparations for 4D-150 in wet AMD in support of our mission to bring transformative genetic medicines to patients globally. We have built an experienced clinical and commercial team to execute this mission, including with the upcoming initiation of the 4FRONT Phase 3 program expected in Q1 2025,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “In September, we hosted our 4D-150 Wet AMD Development Day, where we presented positive interim data demonstrating the impressive tolerability and clinical activity of 4D-150 and showcased its potential across multiple populations, from the most severe to recently diagnosed patients. The strong data and enthusiastic feedback from our advisors, clinical trial investigators, the retina physician community and the FDA support pivotal development of 4D-150 in the treatment naïve wet AMD population. We believe that these clinical data and this trial design will enable rapid enrollment and achieve positive topline data in the 4FRONT Phase 3 studies.”
Recent Corporate Highlights
Recent Highlights in Large Market Ophthalmology Portfolio
Recent Highlights in Other Pipeline Programs
Expected Upcoming Milestones in Large Market Ophthalmology Portfolio
Expected Upcoming Milestones in Other Pipeline Programs
Q3 2024 Financial Results
Cash position: Cash, cash equivalents and marketable securities were $551 million as of September 30, 2024. We currently expect cash, cash equivalents and marketable securities to be sufficient to fund planned operations at least into the first half of 2027.
R&D Expenses: Research and development expenses were $38.5 million for the third quarter of 2024, as compared to $25.1 million for the third quarter of 2023. This increase was driven by the progression of our existing clinical trials, primarily Phase 2 4D-150 trials 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 $12.7 million for the third quarter of 2024, as compared to $9.1 million for the third quarter of 2023.
Net Loss: Net loss was $43.8 million for the third quarter of 2024, as compared to net loss of $10.3 million for the third 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 six clinical-stage and one preclinical product candidate, 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 U.S. Food and Drug Administration (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, 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 September 30, |
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Nine months ended September 30, |
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2024 |
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2023 |
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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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$ |
3 |
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$ |
20,204 |
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$ |
36 |
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$ |
20,742 |
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Operating expenses: |
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Research and development |
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38,484 |
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25,066 |
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98,212 |
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71,068 |
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General and administrative |
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12,651 |
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9,112 |
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33,548 |
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25,889 |
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Total operating expenses |
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51,135 |
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34,178 |
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131,760 |
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96,957 |
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Loss from operations |
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(51,132 |
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(13,974 |
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(131,724 |
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(76,215 |
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Other income, net |
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7,289 |
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3,718 |
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20,527 |
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7,661 |
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Net loss |
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$ |
(43,843 |
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$ |
(10,256 |
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$ |
(111,197 |
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$ |
(68,554 |
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Net loss per share, basic and diluted |
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$ |
(0.79 |
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$ |
(0.24 |
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$ |
(2.08 |
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$ |
(1.81 |
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Weighted-average shares outstanding used in computing net loss per share, basic and diluted |
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55,554,476 |
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42,256,629 |
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53,377,712 |
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37,884,363 |
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4D Molecular Therapeutics, Inc.
Balance Sheet Data
(Unaudited)
(in thousands)
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September 30, |
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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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$ |
550,671 |
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$ |
299,186 |
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Total assets |
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604,028 |
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339,891 |
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Total liabilities |
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51,080 |
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32,062 |
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Accumulated deficit |
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(526,524 |
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(415,327 |
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Total stockholders’ equity |
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552,948 |
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307,829 |
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Contacts:
Media:
Katherine Smith
Inizio Evoke Comms
Media@4DMT.com
Investors:
Julian Pei
Head of Investor Relations and Corporate Finance
Investor.Relations@4DMT.com
