4D MOLECULAR THERAPEUTICS, INC. Item 1.02 Termination of a Material Definitive Agreement.
On
Under the Roche Agreement, 4DMT granted Roche a license to make, use, import,
export and sell products and constructs using 4DMT's proprietary AAV vectors to
treat ophthalmological diseases and disorders, excluding treatment and
prevention of cancer and central nervous system conditions (but not retinal
nerves) and delivery of DNA-directed RNA interference. Pursuant to the terms of
the Roche Agreement, 4DMT and Roche designated 4D-110, for the treatment of
choroideremia, as the first collaboration program. Roche requested that 4DMT
conclude the Roche-funded 4D-110 trial in advanced choroideremia patients as a
result of Roche's assessment of a change in the risk-benefit profile.
Subsequently, Roche informed 4DMT in writing on
The foregoing description of the Roche Agreement does not purport to be complete
and is qualified in its entirety by the full text of the agreement. The Roche
Agreement was filed as Exhibit 10.5 to the Company's Registration Statement on
Form S-1, filed with the
Item 8.01 Other Events.
On
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements for purposes
of the safe harbor provisions of the Private Securities Litigation Reform Act of
1995. Forward-looking statements include statements regarding our intentions or
current expectations concerning, among other things, the, rights and obligations
following termination of the Roche Agreement. In some cases you can identify
these statements by forward-looking words such as "may," "will," "continue,"
"anticipate," "intend," "could," "project," "expect" or the negative or plural
of these words or similar expressions. Forward-looking statements are not
guarantees of future performance and are subject to risks and uncertainties that
could cause actual results and events to differ materially from those
anticipated, including, but not limited to: the impact of COVID-19 on countries
or regions in which 4DMT has operations or does business, as well as on the
timing and anticipated results of 4DMT's clinical trials, strategy and future
operations; the delay of any current or planned clinical trials for the
development of 4DMT's drug candidates, the risk that the results of its clinical
trials, including any initial data therefrom, may not be predictive of future
clinical trial results, including those from current and future clinical trials;
4DMT's ability to successfully demonstrate the safety and efficacy of its drug
candidates; the timing and outcome of 4DMT's planned interactions with
regulatory authorities; and obtaining, maintaining and protecting its
intellectual property. 4DMT discusses many of these risks in greater detail
under the heading "Risk Factors" contained in its quarterly report on Form 10-Q
for the quarter ended
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Item 9.01 Financial Statements and Exhibits.
Exhibit Number Description 99.1 Press Release, datedJune 24, 2021 , titled "4D Molecular Therapeutics Announces Rare Disease Ophthalmology Product Candidate Portfolio Update, Including Initial Clinical Safety and Tolerability Data for 4D-110 for Choroideremia and 4D-125 for XLRP, and Termination of Roche Collaboration and License Agreement" 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) 2
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