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 28, 2022, 4D Molecular Therapeutics, Inc. (“4DMT”) announced its audited financial results for the year ended December 31, 2021. A copy of 4DMT’s press release, titled “4D Molecular Therapeutics Reports Financial Results for the Year Ended December 31, 2021 and Provides 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 28, 2022 |
By: |
/s/ August J. Moretti |
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August J. Moretti |
Exhibit 99.1
4D Molecular Therapeutics Reports Full Year 2021 Financial Results and Operational Highlights
— Provided clinical data updates on three programs, including first clinical data on 4D-310 for Fabry disease and 4D-125 and 4D-110 for inherited retinal dystrophies, each demonstrating preliminary evidence of clinical activity
— Advanced two additional programs into clinical development: R100 vector-based 4D-150 for wet AMD, and A101 vector-based 4D-710 for cystic fibrosis
— Initiated expansion of our GMP manufacturing facilities for potential commercial-scale clinical manufacturing capabilities
— $315 million in cash, cash equivalents and investments at end of 2021 expected to fund operations into the second half of 2024
Emeryville, CA – March 28, 2022 – 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, announced full year 2021 financial results and provided operational highlights.
“In our first full year as a publicly traded company, 4DMT continued to advance our diverse pipeline of five clinical-stage product candidates in three distinct therapeutic areas for both rare and large market diseases, all of which utilize targeted and evolved vectors from our Therapeutic Vector Evolution platform. With the release of promising initial clinical data on three programs and the IND clearances of two additional programs, we delivered on our goals and guidance for 2021," said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. "We also continued to build a strong clinical and scientific team that is focused not only on our clinical programs but also on continuing to advance our Therapeutic Vector Evolution platform and preclinical product pipeline. We've entered 2022 with a strong cash runway into the second half of 2024. By harnessing the power of our Therapeutic Vector Evolution and GMP manufacturing platforms, 4DMT has built a robust product development engine to continue our mission to unlock the full potential of genetic medicines for countless patients."
2021 Operational Highlights
2022 Expected Milestones and Objectives
Full Year 2021 Financial Results
Cash and Cash Equivalents and Marketable Securities: Cash and cash equivalents and marketable securities were $315.4 million as of December 31, 2021 as compared to $276.7 million as of December 31, 2020. The increase in cash was primarily a result of the receipt of net proceeds of approximately $111 million from our October 2021 public offering, which was partially offset by cash used in operations. We expect cash and cash equivalents and marketable securities to be sufficient to fund operations into the second half of 2024.
Revenue: Total revenue was $18.0 million for 2021, as compared to $13.6 million for 2020. This increase 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 $61.4 million for 2021, as compared to $53.0 million for 2020. This increase was primarily driven by the progression of our existing clinical trials for 4D-310, 4D-125 and 4D-110, in addition to startup costs for our clinical trials of 4D-150 and 4D-710 along with increased payroll and stock-based compensation expense.
G&A Expenses: General and administrative expenses were $28.0 million for 2021, as compared to $17.2 million for 2020. This increase was primarily due to increased payroll, stock-based compensation, insurance, and professional service expenses.
Net Loss: Net loss was $71.3 million for 2021, as compared to $56.7 million for 2020.
About 4DMT
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. 4DMT seeks to unlock the full potential of genetic medicines using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent targeted and evolved vectors for use in our products. The company is initially focused on five clinical-stage products in three therapeutic areas for both rare and large market diseases: ophthalmology, cardiology (including Fabry disease) and pulmonology. The 4DMT targeted and evolved vectors are 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. The five 4DMT product candidates in clinical development are: 4D-310 for Fabry disease, 4D-150 for wet AMD, 4D-125 for XLRP, 4D-110 for choroideremia and 4D-710 for cystic fibrosis.
4D-310, 4D-150, 4D-125, 4D-110 and 4D-710 are in clinical trials 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-310, 4D-150, 4D-125, 4D-110 or 4D-710 for the therapeutic use for which they are being studied. 4D Molecular TherapeuticsTM,, 4DMTTM, Therapeutic Vector EvolutionTM, 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 plans and timelines for the clinical development of 4D-310, 4D-125, 4D-110, 4D-150 and 4D-710, including the therapeutic potential and clinical benefits thereof; expectations on how long 4D Molecular Therapeutics' cash, cash equivalents and investments can fund its operations; whether the expansion of 4D Molecular Therapeutics' manufacturing facilities will support commercial-scale production and expand our analytical development capabilities; the timing of the first patient dosing in 4D Molecular Therapeutics' planned 4D-710 Phase 1/2 clinical trial; the ability to continue to enroll 4D Molecular Therapeutics' ongoing clinical trials; and 4D Molecular Therapeutics' strategy, business plans and focus. 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, without limitation, risks associated with: the impact of COVID-19 on countries or regions in which we have operations or do business, as well as on the timing and anticipated results of our clinical trials, strategy and future operations; the delay of any current or planned clinical trials for the development of 4D Molecular Therapeutics' drug candidates, the risk that the results of our clinical trials may not be predictive of future results in connection with future clinical trials; 4D Molecular Therapeutics' ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of our planned interactions with regulatory authorities; and obtaining, maintaining and protecting our intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in 4D Molecular Therapeutics’ Annual Report on Form 10-K 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
(in thousands, except share and per share amounts)
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Year Ended |
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2021 |
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2020 |
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Statements of Operations Data: |
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Revenue: |
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Collaboration and license revenue |
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$ |
18,038 |
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$ |
13,363 |
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Collaboration and license revenue, related parties |
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— |
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249 |
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Total revenue |
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18,038 |
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13,612 |
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Operating expenses: |
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Research and development |
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61,360 |
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53,038 |
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General and administrative |
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28,011 |
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17,238 |
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Total operating expenses |
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89,371 |
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70,276 |
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Loss from operations |
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(71,333 |
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(56,664 |
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Other income (expense) |
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16 |
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(29 |
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Net loss |
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$ |
(71,317 |
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$ |
(56,693 |
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Net loss per share, basic and diluted |
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$ |
(2.57 |
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$ |
(8.82 |
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Weighted-average shares outstanding used in computing net loss per |
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27,730,420 |
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6,430,555 |
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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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2021 |
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2020 |
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Balance Sheet Data: |
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Cash and cash equivalents and marketable securities |
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$ |
315,429 |
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$ |
276,726 |
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Working capital |
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239,942 |
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265,912 |
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Total assets |
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353,487 |
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288,331 |
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Total liabilities |
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34,380 |
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31,944 |
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Accumulated deficit |
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(206,996 |
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(135,679 |
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Total stockholders’ equity |
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319,107 |
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256,387 |
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Contacts:
Media:
Ingrid Mezo
Canale Communications
ingrid.mezo@canalecomm.com
Investors:
Mike Zanoni
VP, Investor Relations
mzanoni@4dmt.com