Shares of the Galera Therapeutics, Inc. (GRTX) stock skyrocketed in the current market today on December 14, 2021. GRTX stock price saw an uptrend of 133.69% to reach $3.22 a share as of this writing. The trading volume on the last check was 129,885,465 which is far higher than the average trading volume. Let’s deep dive to understand the reason behind this bull.
What’s Happening?
Galera Therapeutics today announced the corrected results from the Phase 3 ROMAN trial of its product avasopasem. This product is intended to treat RT-induced severe oral mucositis in patients with advanced head and neck cancer. The trial showed statistically significant results and met the primary endpoint of reduced incidence of SOM. The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to Avasopasem for the reduction of SOM caused by RT.
Galera Therapeutics previously reported that the Phase 3 ROMAN trial of avasopasem did not meet the primary endpoint. The company that analyzed that it was an error made by a contract research organization in the statistical program. The p-values for the primary as well as secondary endpoints improved after the correction.
Galera also announced the topline results from its single-arm Phase 2a EUSOM trial of avasopasem. In the trial, the study team is evaluating the patients with RT-induced SOM. Galera conducted the trial in 12 centers in the six countries of Europe. 38 patients participated in the trial out of which 33 patients got the full treatment. Avasopasem showed well tolerance during the treatment and the incidence of SOM was 54.5%.
Financial View of GRTX stock:
In the previous month on November 10, 2021, GRTX announced third quarter 2021 financial results according to which
- Research and development expenses of GRTX stock were $14.8 million in the three months ended September 30, 2021. In the same period of the previous year, these expenses were $12.1 million. Rucosopasem development costs and the cost associated with the SOM program increased the R&D expenses.
- GRTX stock recorded $5.5 million in general and administrative expenses in the recently reported quarter. These expenses were $3.9 million in the same tenure of the previous year.
- GRTX stock suffered a net loss of $(22.6) million in the third quarter of 2021 as compared to $(17.1) million in the same period of the previous year.
- Galera ended the quarter with $88.7 million in cash, cash equivalents, and short-term investments.
Wrap Up:
GRTX stock enjoyed a huge gain following the announcement of corrected results of the Phase 3 ROMAN trial of avasopasem. The company is now planning to discuss the avasopasem data with FDA in the upcoming year.
