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 March 15, 2023, 4D Molecular Therapeutics, Inc. (“4DMT”) announced its financial results for the year ended December 31, 2022. A copy of 4DMT’s press release, titled “4D Molecular Therapeutics Reports Full Year 2022 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: |
March 15, 2023 |
By: |
/s/ August J. Moretti |
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August J. Moretti |
Exhibit 99.1
4D Molecular Therapeutics Reports Full Year 2022 Financial Results
and Operational Highlights
EMERYVILLE, Calif., March 15, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, ‘4DMT’), a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases, today announced full year 2022 financial results and provided operational highlights.
“We are proud to have validated 4DMT’s Therapeutic Vector Evolution platform over the past year, with clinical efficacy proof-of-concept signals with all three of our lead proprietary vectors invented at 4DMT,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “We believe we’re primed to continue leveraging our robust product design and development engine to grow and diversify our product pipeline with seven total product candidates in development. Our five clinical-stage product candidates address unmet medical needs in seven patient populations, including several large and high incidence rate disease markets. Our capital-efficient operations and strong cash position are expected to support operations into the first half of 2025.”
Recent Highlights
Ophthalmology Therapeutic Area
Pulmonology Therapeutic Area
Cardiology Therapeutic Area
Manufacturing Capabilities
Completed build of commercial-scale GMP manufacturing facility to provide clinical trial material for 4DMT product candidates. These added capabilities are expected to reduce product development timelines, costs, and risk, and improve quality and internal control.
2023 Expected Milestones
Full Year 2022 Financial Results
Cash and Cash Equivalents and Marketable Securities: Cash and cash equivalents and marketable securities were $218.5 million as of December 31, 2022, as compared to $315.4 million as of December 31, 2021. The decrease in cash was primarily a result of cash used in operations. We expect cash and cash equivalents and marketable securities to be sufficient to fund operations into the first half of 2025.
Revenue: Total revenue was $3.1 million for 2022, as compared to $18.0 million for 2021. The decrease was primarily driven by the completion of revenue recognized under the Roche collaboration agreement, which was terminated in September 2021.
R&D Expenses: Research and development expenses were $80.3 million for 2022, as compared to $61.4 million for 2021. This increase was primarily driven by the progression of our existing clinical trials for 4D-150, 4D-710, 4D-310, 4D-125, and 4D-110, along with increased payroll and stock-based compensation expense.
G&A Expenses: General and administrative expenses were $32.9 million for 2022, as compared to $28.0 million for 2021. This increase was primarily due to increased payroll, stock-based compensation, and professional service expenses.
Net Loss: Net loss was $107.5 million for 2022, as compared to $71.3 million for 2021.
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 (Fabry disease cardiomyopathy). 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, as well as the plans and related timing for the clinical development of 4D-150, 4D-710, 4D-310, 4D-125, and 4D-110. 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 Annual Report on Form 10-K, 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
(in thousands, except share and per share amounts)
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Year Ended December 31, |
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2022 |
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2021 |
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Revenue: |
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Collaboration and license revenue |
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$ |
3,129 |
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$ |
18,038 |
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Total revenue |
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3,129 |
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18,038 |
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Operating expenses: |
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Research and development |
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80,253 |
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61,360 |
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General and administrative |
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32,908 |
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28,011 |
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Total operating expenses |
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113,161 |
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89,371 |
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Loss from operations |
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(110,032 |
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(71,333 |
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Other income, net |
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2,538 |
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16 |
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Net loss |
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$ |
(107,494 |
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$ |
(71,317 |
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Net loss per share, basic and diluted |
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$ |
(3.32 |
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$ |
(2.57 |
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Weighted-average shares outstanding used in computing net loss per share, basic and diluted |
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32,351,221 |
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27,730,420 |
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4D Molecular Therapeutics, Inc.
Balance Sheet Data
(in thousands)
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As of December 31, |
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2022 |
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2021 |
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Cash, cash equivalents and marketable securities |
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$ |
218,642 |
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$ |
315,429 |
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Working capital |
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204,780 |
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239,942 |
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Total assets |
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261,846 |
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353,487 |
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Total liabilities |
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30,509 |
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34,380 |
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Accumulated deficit |
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(314,490 |
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(206,996 |
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Total stockholders’ equity |
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231,337 |
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319,107 |
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Contacts:
Media:
Katherine Smith
EvokeCanale
Katherine.Smith@evokegroup.com
Investors:
August J. Moretti
CFO
amoretti@4dmt.com
Julian Pei
Head of Investor Relations and Finance
jpei@4dmt.com
267-644-5097
