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 August 9, 2023, 4D Molecular Therapeutics, Inc. (“4DMT”) announced its financial results for the three months ended June 30, 2023. A copy of 4DMT’s press release, titled “4D Molecular Therapeutics Reports Second 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: |
August 9, 2023 |
By: |
/s/ August J. Moretti |
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August J. Moretti |
Exhibit 99.1
4D Molecular Therapeutics Reports Second Quarter 2023 Financial Results
and Operational Highlights
EMERYVILLE, Calif., Aug. 9, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company) a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases, today reported second quarter 2023 financial results and provided operational highlights.
“We are excited by the significant progress we have made across our large market product candidate portfolio in the second quarter,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “In ophthalmology, we presented positive interim clinical data from the Dose Exploration stage of our Phase 1/2 PRISM clinical trial of 4D-150, which demonstrated excellent tolerability, clinical activity and initial long term durability in high anti-VEGF need patients that we believe support an emerging best-in-class profile. In pulmonology, we presented positive interim clinical data from cohort 1 from the 4D-710 Phase 1/2 AEROW clinical trial for the treatment of cystic fibrosis lung disease, demonstrating widespread and high-level CFTR transgene expression and initial clinical activity in a population who otherwise have no disease-modifying treatment options. Lastly, we continue to execute on business development, including the collaboration with Astellas in July, demonstrating the value of our clinically de-risked customized and evolved vectors for delivery of genetic medicine payloads. Our focus remains on relentlessly executing on our corporate objectives and look forward to sharing multiple key clinical and regulatory milestones over the next 12 months. Our strong cash position and capital-efficient operations continue to provide the foundation for long-term value creation.”
Recent Highlights in Large Market Ophthalmology Portfolio
Recent Highlights in Pulmonary Portfolio
Expected Upcoming Milestones
Financial and Corporate Highlights
Q2 2023 Financial Results
Cash and Cash Equivalents and Marketable Securities: Cash and cash equivalents and marketable securities were $310 million as of June 30, 2023, as compared to $218 million as of December 31, 2022. The net change in cash was primarily a result of cash used in operations that was offset by approximately $129 million of net proceeds from our public offering of common stock completed in May. We also received a $20 million cash upfront payment from our license agreement with Astellas in July. We currently expect cash and cash equivalents, inclusive of net proceeds from the upfront payment from Astellas, to be sufficient to fund operations into the first half of 2026.
R&D Expenses: Research and development expenses were $23.6 million for the quarter ended June 30, 2023 as compared to $20.4 million for the second 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 $8.8 million for the quarter ended June 30, 2023 as compared to $8.2 million for the second quarter of 2022.
Net Loss: Net loss was $29.6 million for the quarter ended June 30, 2023, as compared to $28.1 million for the second quarter of 2022.
About 4DMT
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases. 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 June 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 June 30, |
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Six months ended June 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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$ |
239 |
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$ |
162 |
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$ |
538 |
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$ |
1,382 |
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Operating expenses: |
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Research and development |
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23,584 |
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20,422 |
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46,002 |
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39,819 |
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General and administrative |
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8,791 |
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8,166 |
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16,777 |
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16,381 |
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Total operating expenses |
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32,375 |
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28,588 |
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62,779 |
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56,200 |
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Loss from operations |
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(32,136 |
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(28,426 |
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(62,241 |
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(54,818 |
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Other income, net |
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2,520 |
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340 |
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3,943 |
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394 |
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Net loss |
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$ |
(29,616 |
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$ |
(28,086 |
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$ |
(58,298 |
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$ |
(54,424 |
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Net loss per share, basic and diluted |
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$ |
(0.77 |
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$ |
(0.87 |
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$ |
(1.63 |
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$ |
(1.69 |
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Weighted-average shares outstanding |
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38,335,219 |
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32,324,392 |
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35,661,995 |
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32,263,015 |
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4D Molecular Therapeutics, Inc.
Balance Sheet Data
(Unaudited)
(in thousands)
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June 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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$ |
310,343 |
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$ |
218,462 |
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Working capital |
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304,027 |
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204,780 |
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Total assets |
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352,503 |
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261,846 |
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Total liabilities |
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27,359 |
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30,509 |
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Accumulated deficit |
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(372,788 |
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(314,490 |
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Total stockholders’ equity |
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352,503 |
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231,337 |
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Contacts:
Media:
Katherine Smith
EvokeCanale
Katherine.Smith@evokegroup.com
Investors:
Julian Pei
Head of Investor Relations and Corporate Communications
jpei@4dmt.com
267-644-5097
