Item 8.01. Other Events.

On January 9, 2023, the Company issued a press release announcing the receipt of feedback from a pre-Investigational New Drug supplemental Type C response from the U.S. Food and Drug Administration and providing further detail with respect to anticipated key milestones that the Company expects to achieve in 2023 regarding its PGN-600 program. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.



99.1      Press Release, dated January 9, 2023

104     Cover Page Interactive Data File (embedded within the Inline XBRL document)

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