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Highlights
- Galera Therapeutics, Inc.’s stock jumped more than 150% in Tuesday's pre-market session.
- The company provided an update about its therapeutic avasopasem.
- The stock has declined 86.51% year-to-date.
The Galera Therapeutics, Inc. (NASDAQ:GRTX) stock jumped 152.90% in pre-market trading Tuesday. The stock was priced at US$3.49 at 8:00 am ET.
Today, the biopharmaceutical company announced the corrected results of the Phase 3 ROMAN trial of its therapeutic avasopasem. As per the announcement, the trial data shows to have achieved a statistical significance on the primary endpoint in RT-induced severe oral mucositis (SOM) treatment.
The U.S. Food and Drug Administration (FDA) has granted the company’s avasopasem Breakthrough Therapy Designation (BTD). This therapy is focused on reducing severe oral mucositis induced by radiotherapy.
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Previously, Galera announced that the Phase 3 ROMAN trial did not achieve the statistical significance on the primary endpoint for avasopasem treatment in SOM. It happened due to an error in the statistical program, and that’s why now the corrected data from the trial has been shared. After this correction, the trial results for primary and secondary endpoints improved.
The company also said that after analyzing the full data set, it plans to meet the FDA in 2022. It will discuss the possibility of a New Drug Application (NDA) submission with the FDA, based on this single Phase 3 trial and other randomized Phase 2b trials.
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Galera Therapeutics is a clinical-stage biopharmaceutical company based in Malvern, Pennsylvania. The healthcare company is focused on developing proprietary therapeutics to transform radiotherapy for cancer.
The company had its IPO in November 2019 and currently has a market capitalization of US$70 million. Its beta is 1.11. The stock traded in the range of US$12.99 to US$1.19 in the last 52 weeks and closed at US$1.38 with a 1.47% gain on December 13, 2021.
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Financials:
Its products are not approved at this stage, and thus, there is no revenue from product sales. Galera has funded the operations till now from equity issuance and sale as well as from a Royalty Agreement with Blackstone Life Sciences.
The company incurred a net loss of US$22.63 million or US$0.86 per share diluted for the September quarter of 2021, compared to a net loss of US$17.08 million or US$0.69 per share diluted in the corresponding period of 2020.
Galera has reported having US$88.7 million in cash and cash equivalent and short-term investments as of September 30, 2021, while the same was US$72.78 million as of December 31, 2020. The company’s accumulated deficit was US$299.3 million at the end of September 30, 2021.
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Bottom line:
The Nasdaq Biotechnology Index fell 2.24% YTD while the GRTX stock fell 86.51% in the same period. Some healthcare sector entrants are smaller companies with nothing to claim as consistent revenue until their product/s are approved. So, the investors must analyze the healthcare companies based on their products in the pipeline and the external factors.
