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4D MOLECULAR THERAPEUTICS, INC.

(FDMT)
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4D MOLECULAR THERAPEUTICS INC. : Termination of a Material Definitive Agreement, Other Events, Financial Statements and Exhibits (form 8-K)

06/25/2021 | 04:03pm EDT

Item 1.02 Termination of a Material Definitive Agreement.

On June 24, 2021, 4D Molecular Therapeutics, Inc. ("4DMT" or the "Company") announced it had received a written notice of termination from F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. ("Roche") of the Company's Collaboration and License Agreement with Roche, dated as of November 16, 2017 (the "Roche Agreement").

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 June 18, 2021 that it exercised its right pursuant to Section 22.2.2 of the Roche Agreement to terminate the Roche Agreement for any reason without cause with 90 days prior notice. The termination will be effective on September 16, 2021 (the "Effective Date"). On the Effective Date, 4DMT will regain full rights to 4D-110.

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 Securities and Exchange Commission on November 17, 2020.



Item 8.01 Other Events.


On June 24, 2021, 4DMT issued a press release 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", announcing the termination of the Roche Agreement and other matters (the "Press Release"). The Press Release, attached as Exhibit 99.1 hereto, is incorporated herein by reference.

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 March 31, 2021, which is on file with the Securities and Exchange Commission. 4DMT expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.



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Item 9.01 Financial Statements and Exhibits.




Exhibit
Number                                  Description
99.1        Press Release, dated June 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)






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