Galera: FDA demands new Phase 3 for avasopasem; GRECO-2 futility halts both rucosopasem trials

Galera Therapeutics, Inc.

FDA reiterated need for an additional Phase 3 trial of avasopasem for radiotherapy-induced SOM.
GRECO-2 futility analysis (35 deaths, 177 enrolled) led to discontinuation of both GRECO-1 and GRECO-2 trials.
Preliminary cash, cash equivalents & short-term investments: $28.4M as of Sep 30, 2023.
Engaged Stifel to review strategic alternatives (merger, sale, licensing); may cease operations if none found.
Company assessing strategic options to maximize shareholder value; going concern risk noted.

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