Galera Therapeutics, Inc. (GRTX), a clinical-stage biopharmaceutical company, has surged 29.05% in the premarket trading session and is trading at $3.11 at the time of the writing. On Wednesday, GRTX closed the day at $2.41 after soaring 27.51% during the mid-day session. The solid performance is attributable to the expected earnings update by the company in the next few days. For now, let’s discuss some recent developments related to GRTX.
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Results for phase 3 trial
On 19th October, GRTX stock plummeted 69% after the company announced results for the phase 3 ROMAN trial of Avasopasem. The trial was intended for radiotherapy-induced Severe Oral Mucositis. The trial did not meet its primary endpoint of reduction in the incidence of SOM, according to the company. The company continued to analyze the results. There occurred a 16% reduction in the incidence of SOM in the avasopasem treatment vs the placebo group. The study also found out that the Avasopasem was generally well-tolerated with similar rates of adverse events in active and placebo arms.
New appointments in GRTX
On 12th October, GRTX announced to appoint Mark J. Bachleda, Pharm.D. M.B.A as its chief commercial officer (CCO) and Jennifer Evans Stacey, Esq. as chief legal compliance officer (CLCO). Both of the executives had more than 25 years of experience in the biopharmaceutical industry before joining Galera. Before joining the company, Mark was Vice President & U.S. Business Unit Head for Bristol Myers Squibb’s (BMS) CAR T cell therapy franchise. Jennifer served as Vice President, General Counsel, Secretary, and Government Relations at The Wistar Institute before joining Galera.
Q2 2021 financial highlights
On 10th August, GRTX reported the financial results for the second quarter of the fiscal year 2021 which ended on 30th June. The company bore R&D expenses of $16 million during the quarter against $13.8 million for the same period of 2020. The general and administrative expenses during the period were $5.1 million against $3.9 million for the same period of 2020. The net loss for the quarter was $22.4 million (or $0.88 per share) against $18.7 million (or $0.75 per share) for the same period of 2020. The company had cash and cash equivalents of $66.5 million on 30th June.
Comments from CEO
While commenting on the results, Mel Sorensen, M.D., President and CEO of GRTX said that the company had a highly productive quarter in the clinic. He said that the company looks forward to reporting clinical trial results later in the year. Also, the company is continually strengthening its cash position.
What’s next for GRTX?
During the last three months, GRTX has declined more than 70% primarily due to the insignificance of results for phase 3 ROMAN trial of Avasopasem. However, the company hopes to bounce back strongly in near future.