Will Celcuity's VIKTORIA-1 Hit The Target?

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.

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.

Celcuity acquired the exclusive rights to Gedatolisib from Pfizer under a global licensing agreement signed in April 2021.

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.

The Ongoing/Planned Trials and Anticipated Milestones

— 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.

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.

— 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.

— 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.

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.

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.

Enrollment is underway in the FACT-1 and FACT-2 trials, with interim results expected in the first half of 2024.

Cash position

Celcuity ended June 30, 2023, with cash, cash equivalents and short-term investments of $146.2 million.

The company’s shares began trading on the NASDAQ Capital Market under the symbol “CELC”, on September 20, 2017, priced at $9.50 each.

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%.

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