UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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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 10, 2021, 4D Molecular Therapeutics, Inc. (“4DMT”) announced its unaudited financial results for the quarter ended September 30, 2021. A copy of 4DMT’s press release, titled “4D Molecular Therapeutics Reports Financial Results for the Third Quarter of 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: |
November 10, 2021 |
By: |
/s/ August J. Moretti |
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August J. Moretti |
Exhibit 99.1
4D Molecular Therapeutics Reports Financial Results for the Third Quarter of 2021 and Provides Operational Highlights
Emeryville, CA – November 10, 2021 – 4D Molecular Therapeutics (Nasdaq: FDMT), a clinical-stage gene therapy company harnessing the power of directed evolution for targeted gene therapies, announced financial results for the third quarter of 2021, and provided operational highlights.
“4DMT continues to advance our diverse pipeline of product candidates that utilize our targeted and evolved vectors invented through Therapeutic Vector Evolution. Over this past quarter we released promising initial clinical data on three programs, including on 4D-310 for Fabry disease,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “We also opened INDs for both our wet AMD product candidate 4D-150 and for our cystic fibrosis product candidate 4D-710. Finally, we significantly strengthened our balance sheet through a follow-on offering of common stock raising net proceeds to 4DMT of approximately $111 million. Looking ahead to 2022, the company expects to have five product candidates in clinical development in three different therapeutic areas, including for both rare and large market diseases. By harnessing the power of directed evolution to develop targeted gene therapies, 4DMT is continuing our mission to unlock the full potential of gene therapy for countless patients.”
Recent Operational Highlights
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Expected Upcoming Milestones
Financial Results for the Third Quarter Ended September 30, 2021
Cash and Cash Equivalents and Marketable Securities: Cash and cash equivalents and marketable securities were $227 million as of September 30, 2021. In addition, the October 2021 public offering of common stock resulted in net proceeds of approximately $111 million. 4DMT has granted the underwriters a 30-day option to purchase up to an additional 712,500 shares of common stock at the public offering price, less underwriting discounts and commissions. We currently expect cash and cash equivalents, inclusive of net proceeds from the offering, to be sufficient to fund operations into the second half of 2024.
Revenue: Total revenue was $1.4 million for the quarter ended September 30, 2021, as compared to $7.4 million for the quarter ended September 30, 2020. This decrease was primarily driven by decreased revenue recognized under the Roche collaboration agreement, which was terminated in September 2021.
R&D Expenses: Research and development expenses were $15.8 million for the quarter ended September 30, 2021, as compared to $11.6 million for the quarter ended September 30, 2020. This increase was primarily driven by increased payroll and stock-based compensation expense.
G&A Expenses: General and administrative expenses were $8.2 million for the quarter ended September 30, 2021, as compared to $3.7 million for the quarter ended September 30, 2020. This increase was primarily due to increased payroll and stock-based compensation expense, business insurance expense and professional service expenses.
Net Loss: Net loss was $22.2 million for the quarter ended September 30, 2021, as compared to $7.8 million for the quarter ended September 30, 2020.
About 4DMT
4DMT is a clinical-stage company harnessing the power of directed evolution for targeted gene therapies. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused in three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and
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evolved vectors are invented with the goal of being delivered 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-310 for Fabry disease, 4D-150 for wet AMD, 4D-125 for XLRP, 4D-710 for cystic fibrosis and 4D-110 for choroideremia. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT.
4D-310, 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-310, 4D-125 or 4D-110 for the therapeutic use for which they are being studied.
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Cautionary Note Regarding 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 estimated timing of clinical data being available for 4D-310’s Phase 1/2 clinical trial; the estimated timing of initiating the clinical trials for 4D-150 and 4D-710; expectations for continued enrollment in the clinical trials for 4D-110 and 4D-125; expectations on how long our cash and cash equivalents can fund operations; expectations regarding current and future interactions with the U.S. Food and Drug Administration (FDA); 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.
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4D Molecular Therapeutics, Inc.
Condensed 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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2021 |
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2020 |
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2021 |
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2020 |
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Revenue: |
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Collaboration and license revenue |
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$ |
1,366 |
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$ |
7,421 |
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$ |
17,946 |
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$ |
14,340 |
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Collaboration and license revenue, related parties |
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— |
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— |
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— |
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249 |
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Total revenue |
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1,366 |
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7,421 |
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17,946 |
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14,589 |
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Operating expenses: |
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Research and development |
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15,840 |
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11,555 |
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43,832 |
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40,433 |
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General and administrative |
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8,187 |
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3,682 |
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20,683 |
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10,398 |
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Total operating expenses |
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24,027 |
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15,237 |
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64,515 |
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50,831 |
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Loss from operations |
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(22,661 |
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(7,816 |
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(46,569 |
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(36,242 |
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Other income (expense): |
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422 |
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(17 |
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335 |
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96 |
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Net loss |
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$ |
(22,239 |
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$ |
(7,833 |
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$ |
(46,234 |
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$ |
(36,146 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.82 |
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$ |
(1.51 |
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$ |
(1.72 |
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$ |
(6.97 |
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Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted |
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27,022,380 |
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5,197,982 |
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26,818,595 |
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5,188,628 |
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4D Molecular Therapeutics, Inc.
Condensed Balance Sheet Data
(Unaudited)
(in thousands)
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September 30, |
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December 31, |
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2021 |
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2020 |
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Cash and cash equivalents |
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$ |
90,989 |
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$ |
276,726 |
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Marketable securities |
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136,180 |
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— |
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Working capital |
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154,360 |
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265,912 |
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Total assets |
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240,618 |
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288,331 |
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Accumulated deficit |
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(181,913 |
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(135,679 |
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Total stockholders’ equity |
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224,134 |
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256,387 |
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Contacts:
Media:
Carolyne Zimmermann
Chief Business Officer
czimmermann@4dmt.com
Investors:
Mike Zanoni
VP, Investor Relations
mzanoni@4dmt.com
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