Item 7.01 Regulation FD Disclosure
On July 28, 2022, Moleculin Biotech, Inc. (the “Company”), issued a press
release announcing it has completed the safety review of the fourth cohort in a
dose escalation clinical trial evaluating Annamycin for the treatment of soft
tissue sarcoma (STS) lung metastases, thus concluding the Phase 1b portion of
its U.S. Phase 1b/2 clinical trial. Preliminary results from the study continue
to document clinical activity for Annamycin in the treatment of STS. The safety
review committee (SRC) has deemed the dose of 390 mg/m2 to be safe after
conclusion of the fourth cohort. Notwithstanding that there was safety at this
dose level, tolerability issues present at the 390 mg/m2 dose level caused
delays in follow-on cycles and the reduction of subsequent doses, suggesting
that a Recommended Phase 2 Dose (RP2D) below 390 mg/m2 was warranted.
A copy of the press release is attached to this report as Exhibit 99.1 and is
incorporated by reference herein.
The information contained in Item 7.01 of this Current Report on Form 8-K,
including Exhibit 99.1, is being furnished and shall not be “filed” for the
purpose of the Securities Exchange Act of 1934, as amended (“Exchange Act”), nor
shall it be incorporated by reference in any filing under the Exchange Act or
the Securities Act of 1933, as amended (“Securities Act”), unless specifically
identified therein as being incorporated by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. Exhibit No. Description 99.1 Press Release dated July 28, 2022
104 Cover page Interactive Data File (formatted as Inline XBRL document)
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