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D Molecular Therapeutics Reports Financial Results for the Year Ended

Key Takeaway: 4D Molecular Therapeutics Reports Financial Results for the Year Ended December 31, 2020 and Provides Operational Highlights - First patient dosed in the 4D-310 Phase 1/2 clinical trial in Fabry disease - Intravitreal product candidates, 4D-125 for the treatment of XLRP and 4D

Full Press Release Details

4D Molecular Therapeutics Reports Financial Results for the Year Ended December 31, 2020
and Provides Operational Highlights
- First patient dosed in the 4D-310 Phase 1/2 clinical trial in Fabry disease
- Intravitreal product candidates, 4D-125 for the treatment of XLRP and 4D-110 for the treatment
of choroideremia, completed dose escalation portion of Phase 1/2 clinical
trials (n=12 patients)
- Intravitreal product candidate 4D-150 for the treatment of wet AMD
initiate clinical trial in the second half of 2021
- Cash and cash equivalents of approximately $277M as of Dec 31, 2020
Emeryville, CA March 25, 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 year ended December 31, 2020 and provided operational highlights.
2020 was a transformational year for 4D Molecular Therapeutics, said David Kirn, M.D., Co-founder and
Chief Executive Officer of 4DMT. We transitioned into a clinical-stage company, with three product candidates currently in clinical development: 4D-125 for
X-linked retinitis pigmentosa, 4D-110 for choroideremia, and 4D-310 for Fabry disease. In addition, we strengthened our
leadership team and corporate governance, with the addition of key clinical development executives and four experienced board members, including our Executive Chairman John Milligan, Ph.D. With the proceeds from our IPO, we raised the capital
necessary to expand our vision for developing transformative next-generation gene therapies in multiple therapeutic areas for both rare and large market diseases.
Recent Operational Highlights
Expected Upcoming Milestones
Financial Results for the Year Ended December 31, 2020
Cash and Cash Equivalents: Cash and cash equivalents was $276.7 million as of December 31, 2020, as compared to $49.7 million as of
December 31, 2019. The increase in cash and cash equivalents was primarily a result of the proceeds received from the December 2020 initial public offering and the issuance of our Series C redeemable convertible preferred stock in the second
quarter of 2020, which was partially offset by cash used in operations. We expect cash and cash equivalents to be sufficient to fund operations into mid-2023.
Revenue: Total revenue was $13.6 million for the year ended December 31, 2020, as compared to $7.0 million for the year ended
December 31, 2019. The increase was primarily driven by the recognition of revenue under the Roche collaboration agreement entered into in 2017.
R&D Expenses: Research and development expenses were $53.0 million for the year ended December 31, 2020, as compared to
$38.7 million for the year ended December 31, 2019. This increase was primarily due to higher external costs incurred to advance our clinical and preclinical programs and higher payroll and stock-based compensation expenses.
G&A Expenses: General and administrative expenses were $17.2 million for the year ended
December 31, 2020, as compared to $13.9 million for the year ended December 31, 2019. This increase was primarily due to higher payroll and stock-based compensation expenses and higher professional service expenses.
Net Loss: Net loss was $56.7 million for the year ended December 31, 2020, as compared to $49.3 million for the year ended
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 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 conducting three clinical trials: 4D-125 is in a Phase 1/2 clinical trial for XLRP
patients, 4D-110 is in a Phase 1 clinical trial for choroideremia patients and 4D-310 is in a Phase 1/2 clinical trial for Fabry disease patients.
4D Molecular Therapeutics , 4DMT ,
Therapeutic Vector Evolution , and the 4DMT logo are trademarks of 4DMT.
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-125 s Phase 1/2 clinical trial and 4D-310 s Phase 1/2 clinical trial; the
estimated timing of initiating the clinical trials for 4D-150 and 4D-710; 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 Annual Report on Form 10-K to be filed on 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-310, 4D-125 and 4D-110 are our
product candidates 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.
4D Molecular Therapeutics, Inc.
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
Year Ended December 31,
2020 2019
(in thousands, except share and per share data)
Statements of Operations and Comprehensive Loss Data:
Revenue:
Collaboration and license revenue $ 13,363 $ 6,960
Collaboration and license revenue, related parties 249 26
Total revenue 13,612 6,986
Operating expenses:
Research and development 53,038 38,718
Acquired in-process research and development 5,137
General and administrative 17,238 13,895
Total operating expenses 70,276 57,750
Loss from operations (56,664 ) (50,764 )
Other income (expense) (29 ) 1,458
Net loss and comprehensive loss $ (56,693 ) $ (49,306 )
Net loss per share attributable to common stockholders, basic and diluted $ (8.82 ) $ (9.59 )
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted 6,430,555 5,142,560
4D Molecular Therapeutics, Inc.
Condensed Balance Sheet Data
As of December 31,
2020 2019
(in thousands)
Balance Sheet Data:
Cash and cash equivalents $ 276,726 $ 49,652
Working capital 265,912 39,553
Total assets 288,331 58,234
Accumulated deficit (135,679 ) (79,025 )
Total stockholders equity (deficit) 256,387 (72,970 )
Last updated: Mar 25, 2021