Galera reports FY2022 net loss $62.2M; avasopasem NDA priority review, PDUFA Aug 9, 2023

Galera Therapeutics, Inc.

Q4 2022 net loss of $16.2M ($0.58 per share); FY2022 net loss $62.2M ($2.30 per share).
Cash, cash equivalents and short-term investments $31.6M as of Dec 31, 2022; raised $30M in Feb 2023 offering.
NDA for avasopasem (radiotherapy-induced severe oral mucositis) granted FDA priority review; PDUFA date August 9, 2023.
No FDA-approved drug currently exists for SOM in head and neck cancer patients; ~43,500 US patients at high risk annually.
Enrollment ongoing in Phase 2b GRECO-2 (LAPC) and GRECO-1 (NSCLC) trials of rucosopasem; completion expected H2 2023.

Key facts

Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 0.95

Galera Therapeutics, Inc. reported the fourth quarter ended December 31, 2022 results: net income $(16.2) million, or $(0.58) per share, EPS $(0.58) per share.

Period: the fourth quarter ended December 31, 2022
Net income: $(16.2) million, or $(0.58) per share
EPS: $(0.58) per share
Result: reported results

Exact text from the filing

Galera reported a net loss of $(16.2) million, or $(0.58) per share, for the fourth quarter of 2022

View on SEC.gov

Earnings Releases SEC 8-K Item 2.02 confidence 0.95

Galera Therapeutics, Inc. reported the year ended December 31, 2022 results: net income $(62.2) million, or $(2.30) per share, EPS $(2.30) per share.

Period: the year ended December 31, 2022
Net income: $(62.2) million, or $(2.30) per share
EPS: $(2.30) per share
Result: reported results

Exact text from the filing

Galera reported a net loss of $(62.2) million, or $(2.30) per share, for the year ended December 31, 2022

View on SEC.gov

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Galera Therapeutics, Inc. filing history →

Source: SEC EDGAR

accession 0001193125-23-063736

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