Celcuity Inc. has recently released its 10-Q report, detailing the company's financial performance and key developments. The clinical-stage biotechnology company is focused on developing targeted therapies for various solid tumor indications. Celcuity's lead therapeutic candidate, gedatolisib, is a pan-PI3K/mTOR inhibitor and has shown promise in treating HR+, HER2* advanced breast cancer and metastatic castration-resistant prostate cancer. The company's CELsignia companion diagnostic platform analyzes live patient tumor cells to identify new groups of cancer patients likely to benefit from approved targeted therapies.
In the 10-Q report, Celcuity reported a net loss of approximately $23.7 million for the three months ended June 30, 2024, compared to a net loss of $14.6 million for the same period in 2023. For the six months ended June 30, 2024, the company reported a net loss of approximately $45.3 million, compared to $26.5 million for the same period in 2023. As of June 30, 2024, Celcuity had cash and cash equivalents and short-term investments of approximately $283.1 million.
The company highlighted its recent developments, including plans to initiate a Phase 3 VIKTORIA-2 trial evaluating gedatolisib combined with fulvestrant plus a CDK 4/6 inhibitor as first-line treatment for patients with HR+, HER2* advanced breast cancer. Celcuity also expects to reach its enrollment target for the VIKTORIA-1 PIK3CA WT cohort in Q4 2024 and report topline data for this cohort in late Q4 2024 or Q1 2025. Additionally, the company raised $129.0 million in gross proceeds from equity and debt financings during the quarter, providing sufficient cash to finance operations and pay obligations through 2026. Following these announcements, the company's shares moved -2.9%, and are now trading at a price of $16.33. For more information, read the company's full 10-Q submission here.
