Shares of Celcuity Inc. (CELC) are down 34% from their 52-week high of $14.40, recorded in January of this year, to trade around $9.<\/p>\n
This clinical-stage biotechnology company is focused on discovering previously undetectable cancer drivers and develops drugs to treat them. The lead drug candidate is Gedatolisib, which works by targeting the PI3K\/mTOR pathway that has been implicated in breast, prostate, endometrial, ovarian and hematological cancers, among others. <\/p>\n
Celcuity acquired the exclusive rights to Gedatolisib from Pfizer under a global licensing agreement signed in April 2021.<\/p>\n
The company also has a companion diagnostic test by the name CELsignia that helps identify patients with abnormal oncogenic signaling pathways to detect new treatment options for patients. CELsignia uses a patient’s own live tumor cells to measure pathway signaling, the activity that drives cancer.<\/p>\n
The Ongoing\/Planned Trials and Anticipated Milestones <\/b><\/p>\n
— A phase III study evaluating Gedatolisib plus Fulvestrant with and without Palbociclib for the treatment of patients with PIK3CA-mutated or wild-type hormone receptor (HR)-positive\/HER2-negative breast cancer who have previously progressed on first-line therapy with a CDK4\/6 inhibitor and a non-steroidal aromatase inhibitor, dubbed VIKTORIA-1, is underway.<\/p>\n
Initial data and analysis of the PIK3CA wild type patient sub-group is expected to be reported in the second half of 2024 and data for the PIK3CA mutated patient sub-group in the first half of 2025.<\/p>\n
— A phase Ib\/II clinical trial evaluating Gedatolisib plus Nubeqa (Darolutamide), an androgen receptor (AR) inhibitor, in patients previously treated with an AR inhibitor for metastatic castration resistant prostate cancer, dubbed CELC-G-201, is expected to enrol the first patient in the first quarter of 2024.<\/p>\n
— Two clinical trials that used the CELsignia Test to select patents for treatment with an ant-HER2 drug regimen, dubbed FACT-1 and FACT-2, are currently in progress.<\/p>\n
FACT-1 is a phase II trial evaluating the efficacy of neoadjuvant chemotherapy with anti-HER2 antibodies in patients with HER2-negative invasive breast cancer who have abnormal HER2 signaling activity determined by the CELsignia Test.<\/p>\n
FACT- 2 is a phase II trial evaluating the efficacy and safety of neoadjuvant Neratnib followed by weekly Paclitaxel and Carboplatin plus Neratnib in early-stage triple-negative breast cancer patients have abnormal HER2 signaling activity determined by the CELsignia Test.<\/p>\n
Enrollment is underway in the FACT-1 and FACT-2 trials, with interim results expected in the first half of 2024.<\/p>\n
Cash position<\/b><\/p>\n
Celcuity ended June 30, 2023, with cash, cash equivalents and short-term investments of $146.2 million.<\/p>\n
The company’s shares began trading on the NASDAQ Capital Market under the symbol “CELC”, on September 20, 2017, priced at $9.50 each.<\/p>\n
CELC has traded in a range of $7.50 to $14.40 in the last 1 year. The stock closed yesterday’s trading at $9.48, down 0.63%. <\/p>\n