GRTX - Galera plunges after citing risks to business continuity

2023-10-31 13:29:52 ET

Nano-cap biotech Galera Therapeutics ( NASDAQ: GRTX ) lost more than half of its value on Tuesday after announcing that the company will be forced to discontinue operations if it fails to find strategic alternatives.

The warnings come after an FDA Type A meeting in September, during which the regulator requested an additional Phase 3 trial to review its lead asset, avasopasem manganese, targeted at radiotherapy-driven severe oral mucositis.

Meanwhile, the company has decided to halt two mid-stage trials for the candidate in pancreatic and non-small cell lung cancer. The decision follows a data analysis from one of those trials, called GRECO-2.

The Phase 2b trial targeted at locally advanced pancreatic cancer indicated 35 deaths out of 177 patients enrolled at a data cutoff on October 9, 2023.

“In light of our current resources and the results of the futility analysis, we have made the difficult decision to discontinue both GRECO trials,” CEO Mel Sorensen remarked.

After a preliminary review of financials, the company reported $28.4M in cash, cash equivalents, and short-term investments as of September 30. Galera ( GRTX ) is working with Stifel, Nicolaus & Company in evaluating strategic alternatives.

More on Galera Therapeutics

• Galera cut to Underperform at BofA after FDA snub for lead asset
• FDA rejects Galera mouth sores treatment; stock -83% after hours
• Seeking Alpha’s Quant Rating on Galera Therapeutics
• Historical earnings data for Galera Therapeutics
• Financial information for Galera Therapeutics

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