Galera Therapeutics reports Q3 loss; FDA requires new avasopasem trial; GRECO trials halted

Galera Therapeutics, Inc.

FDA issued Complete Response Letter for avasopasem NDA; requires an additional Phase 3 trial for resubmission.
GRECO-2 (pancreatic cancer) and GRECO-1 (NSCLC) trials halted following futility analyses.
Workforce reduced by 22 employees (~70%) in August 2023; restructuring charges of $2.3M in Q3.
Q3 2023 net loss of $15.1M ($0.33 per share) vs. $16.0M ($0.60) in Q3 2022; cash $28.4M.
Company exploring strategic alternatives including mergers, asset sales; may be required to cease operations.

Key facts

Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 0.97

Galera Therapeutics, Inc. reported third quarter ended September 30, 2023 results: net income $(15.1) million, EPS $(0.33) per share.

Period: third quarter ended September 30, 2023
Net income: $(15.1) million
EPS: $(0.33) per share
Result: reported results

Exact text from the filing

Galera reported a net loss of $(15.1) million, or $(0.33) per share

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Galera Therapeutics, Inc. filing history →

Source: SEC EDGAR

accession 0001193125-23-276640

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