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 11, 2022, 4D Molecular Therapeutics, Inc. (“4DMT”) announced its financial results for the quarter ended June 30, 2022. A copy of 4DMT’s press release, titled “4D Molecular Therapeutics Reports Second Quarter 2022 Financial Results and Provides 4D-310 Program Update” 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 11, 2022 |
By: |
/s/ August J. Moretti |
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August J. Moretti |
Exhibit 99.1
4D Molecular Therapeutics Reports Second Quarter 2022 Financial Results and Provides 4D-310 Program Update
Emeryville, CA – August 11, 2022 – 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, announced second quarter 2022 financial results and provided corporate updates.
"Maintaining our momentum from the first quarter, we have continued to execute on our clinical and corporate milestones, making progress across all of our on-going clinical trials,” said David Kirn, M.D., Co-founder, President and Chief Executive Officer of 4DMT. “In addition, the protocol amendment for the 4D-310 Phase 1/2 clinical trial in Fabry disease will expand access for female patients, enable the assessment of an alternative steroid-sparing immune-suppression regimen, and provide investigators the flexibility to enroll patients concurrently across all cohorts. We have maintained our focus on efficient cash utilization and building value across the pipeline. Our team is committed to relentless execution as we make progress toward key clinical data readouts throughout 2023."
Update on 4D-310 Phase 1/2 Clinical Trial for Fabry Disease
Second Quarter 2022 Financial Results
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities were $261.6 million as of June 30, 2022. We expect cash, cash equivalents and marketable securities to be sufficient to fund operations into the first half of 2025.
Revenue: Total revenue for the quarter ended June 30, 2022, was $0.2 million, as compared to $14.6 million for the quarter ended June 30, 2021.
R&D Expenses: Research and development expenses were $20.4 million for the quarter ended June 30, 2022, as compared to $15.2 million for the quarter ended June 30, 2021. This increase was primarily driven by the progression of our five existing clinical product candidates, including clinical trial expenses for 4D-150 (for wet AMD), 4D-310 (for Fabry disease) and 4D-710 (for cystic fibrosis lung disease).
G&A Expenses: General and administrative expenses were $8.2 million for the quarter ended June 30, 2022, as compared to $7.0 million for the quarter ended June 30, 2021. This increase was primarily due to increased payroll, stock-based compensation, insurance and professional service expenses.
Net Loss: Net loss was $28.1 million for the quarter ended June 30, 2022, as compared to $7.6 million for the quarter ended June 30, 2021.
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-150 for wet AMD, 4D-310 for Fabry disease, 4D-710 for cystic fibrosis, 4D-125 for XLRP, and 4D-110 for choroideremia.
4D-150, 4D-310, 4D-710, 4D-125, and 4D-110 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-150, 4D-310, 4D-710, 4D-125, and 4D-110 for the therapeutic use 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 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; the implications of clinical data for 4D-310’s Phase 1/2 clinical trial; the potential outcomes as a result the amended protocol for the 4D-310 Phase 1/2 clinical trial, including outcomes resulting from the expanded eligible patient populations, concurrent patient enrollment across cohorts, and the assessment for an alternative steroid-sparing immune suppression regimen in a newly added cohort of 4D-310; the ability to continue to enroll 4D Molecular Therapeutics' ongoing clinical trials; expectations on how long our cash and cash equivalents
can fund operations; 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’ 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 June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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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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$ |
162 |
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$ |
14,580 |
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$ |
1,382 |
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$ |
16,580 |
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Total revenue |
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162 |
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14,580 |
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1,382 |
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16,580 |
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Operating expenses: |
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Research and development |
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20,422 |
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15,223 |
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39,819 |
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27,992 |
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General and administrative |
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8,166 |
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6,953 |
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16,381 |
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12,496 |
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Total operating expenses |
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28,588 |
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22,176 |
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56,200 |
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40,488 |
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Loss from operations |
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(28,426 |
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(7,596 |
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(54,818 |
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(23,908 |
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Other income (expense), net: |
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340 |
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7 |
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394 |
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(87 |
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Net loss |
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$ |
(28,086 |
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$ |
(7,589 |
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$ |
(54,424 |
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$ |
(23,995 |
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Net loss per share, basic and diluted |
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$ |
(0.87 |
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$ |
(0.28 |
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$ |
(1.69 |
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$ |
(0.90 |
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Weighted-average shares outstanding used in computing net loss per share, basic and diluted |
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32,324,392 |
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26,739,149 |
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32,263,015 |
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26,715,014 |
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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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2022 |
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2021 |
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Cash, cash equivalents and marketable securities |
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$ |
261,620 |
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$ |
315,429 |
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Working capital |
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232,192 |
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239,942 |
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Total assets |
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302,936 |
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353,487 |
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Total liabilities |
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30,419 |
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34,380 |
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Accumulated deficit |
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(261,420 |
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(206,996 |
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Total stockholders’ equity |
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272,517 |
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319,107 |
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Contacts:
Media:
Katherine Smith
EvokeCanale
Katherine.Smith@evokegroup.com
Investors:
Mike Zanoni
VP, Investor Relations & Corporate Affairs
mzanoni@4dmt.com