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 9, 2023, 4D Molecular Therapeutics, Inc. (“4DMT”) announced its financial results for the three months ended September 30, 2023. A copy of 4DMT’s press release, titled “4DMT Reports Third 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 |
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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 9, 2023 |
By: |
/s/ Uneek Mehra |
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Uneek Mehra |
Exhibit 99.1
4DMT Reports Third Quarter 2023 Financial Results and Operational Highlights
EMERYVILLE, Calif., Nov. 9, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company) a genetic medicines company with three novel, highly targeted next generation AAV vectors currently in human clinical studies, today reported third quarter 2023 financial results and provided operational highlights.
“The third quarter of 2023 was another period of tremendous progress across our large market product candidate portfolio,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “In our ophthalmology portfolio, the European Medicines Agency has awarded PRIME designation to intravitreal 4D-150 which validates the promising clinical data to date in wet AMD patients. We also enrolled the first patient in the Population Extension cohort to the PRISM clinical trial to include the broader wet AMD patient population with lower anti-VEGF need. In our pulmonology portfolio, we presented positive interim clinical and lung biopsy biomarker data for 4D-710 in the Phase 1/2 AEROW clinical trial for the treatment of cystic fibrosis lung disease, and we selected a dose to move forward into Phase 2. We remain highly focused in executing our corporate objectives and look forward to sharing multiple key clinical and regulatory milestones over the next few months."
Recent Highlights in Large Market Ophthalmology Portfolio
Recent Highlights in Pulmonary Portfolio
Recent Highlights in Cardiology Portfolio
Expected Upcoming Milestones
Q3 2023 Financial Results
Cash and Cash Equivalents and Marketable Securities: Cash and cash equivalents and marketable securities were approximately $320 million as of September 30, 2023, as compared to $218 million as of December 31, 2022. The net increase in cash was primarily a result of cash inflows from $129 million of net proceeds from our public offering of common stock completed in May, $19 million of net proceeds under our Open Market Sales Agreement, and the $20 million upfront payment in connection with the Astellas License Agreement and was partially offset by cash used in operations. We currently expect cash and cash equivalents to be sufficient to fund operations into the first half of 2026.
R&D Expenses: Research and development expenses were $25.1 million for the quarter ended September 30, 2023 as compared to $18.9 million for the third quarter of 2022. 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 $9.1 million for the quarter ended September 30, 2023 as compared to $8.1 million for the third quarter of 2022.
Net Loss: Net loss was $10.3 million for the quarter ended September 30, 2023, as compared to net loss of $25.7 million for the third quarter of 2022. The decrease in net loss was primarily a result of the $20 million upfront payment in connection with the Astellas License Agreement.
About 4DMT
4DMT is a genetic medicines company with three novel, highly targeted next generation AAV vectors currently in human clinical studies targeting multiple large market diseases in ophthalmology and pulmonology, plus other therapeutic areas. 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. 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 of 4DMT’s product candidates, as well as the plans, announcements and related timing for the clinical development of our clinical and preclinical 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. Our results for the quarter ended September 30, 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)
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Three months ended September 30, |
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Nine months ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Revenue: |
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Collaboration and license revenue |
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$ |
20,204 |
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$ |
500 |
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$ |
20,742 |
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$ |
1,882 |
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Operating expenses: |
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Research and development |
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25,066 |
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18,940 |
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71,068 |
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58,753 |
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General and administrative |
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9,112 |
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8,055 |
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25,889 |
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24,441 |
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Total operating expenses |
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34,178 |
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26,995 |
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96,957 |
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83,194 |
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Loss from operations |
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(13,974 |
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(26,495 |
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(76,215 |
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(81,312 |
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Other income, net |
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3,718 |
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804 |
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7,661 |
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1,197 |
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Net loss |
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$ |
(10,256 |
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$ |
(25,691 |
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$ |
(68,554 |
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$ |
(80,115 |
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Net loss per share, basic and diluted |
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$ |
(0.24 |
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$ |
(0.79 |
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$ |
(1.81 |
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$ |
(2.48 |
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Weighted-average shares outstanding |
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42,256,629 |
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32,385,791 |
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37,884,363 |
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32,305,074 |
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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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2023 |
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2022 |
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Cash, cash equivalents and marketable securities |
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$ |
319,664 |
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$ |
218,462 |
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Working capital |
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310,080 |
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204,780 |
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Total assets |
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361,613 |
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261,846 |
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Total liabilities |
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31,679 |
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30,509 |
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Accumulated deficit |
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(383,044 |
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(314,490 |
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Total stockholders’ equity |
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329,934 |
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231,337 |
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Contacts:
Media:
Katherine Smith
Evoke Canale
Katherine.Smith@evokegroup.com
Investors:
Julian Pei
Head of Investor Relations and Corporate Communications
jpei@4dmt.com
267-644-5097
