Celcuity Inc. has recently released its 10-Q report, providing a detailed update on its financial status and operational progress. The clinical-stage biotechnology company is primarily focused on developing targeted therapies for the treatment of various solid tumors in the United States. Its lead drug candidate, Gedatolisib, selectively targets various Class I isoforms of phosphatidylinositol-3-kinase (PI3K) and the two mechanistic targets of rapamycin (mTOR) sub-complexes, mTORC1 and mTORC2, to treat patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) or HR+/HER2-, advanced or metastatic breast cancer (ABC), and patients with metastatic castration-resistant prostate cancer (mCRPC). The company also engages in developing the CELsignia diagnostic platform and has a license agreement with Pfizer Inc. for the development and commercialization rights to Gedatolisib. Celcuity Inc. was founded in 2011 and is based in Minneapolis, Minnesota.
In the 10-Q report, Celcuity provided an in-depth discussion and analysis of its financial condition and results of operations. The report highlighted the progress of its lead therapeutic candidate, Gedatolisib, including ongoing clinical trials such as VIKTORIA-1, which is evaluating Gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2* advanced breast cancer. The company also discussed the initiation of a Phase 1b/2 clinical trial, CELC-G-201, evaluating Gedatolisib in combination with darolutamide in patients with mCRPC, as well as the site activation activities for the VIKTORIA-2 Phase 3 clinical trial, which is expected to dose the first patient in the second quarter of 2025.
Additionally, the report provided detailed insights into the clinical trial results, including high objective overall response rates and median progression-free survival observed in patients receiving Gedatolisib in combination with other anti-cancer agents. Furthermore, the report outlined the company's future plans, including the ongoing enrollment in the VIKTORIA-1 trial and the expected availability of topline data in the third quarter of 2025, as well as the anticipated topline data for the PIK3CA MT cohort in the fourth quarter of 2025.
The report also highlighted the potential commercialization of Gedatolisib, with an estimated peak revenue potential exceeding $2 billion if it receives FDA approval for both the PIK3CA WT and MT populations. As a result of these announcements, the company's shares have moved -2.3% on the market, and are now trading at a price of $10.61. For the full picture, make sure to review Celcuity's 10-Q report.
