On November 13, 2023 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the third quarter ended September 30, 2023 and provided other recent corporate updates (Press release, Celcuity, NOV 13, 2023, View Source [SID1234637530]).

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"Despite the important role the PI3K/mTOR pathway plays in tumor types such as breast and prostate cancer, the available therapies that target this pathway have only reported limited improvements in outcomes for patients. Development of an optimized PI3K/mTOR inhibitor, like gedatolisib, thus represents, we believe, one of the most important opportunities to improve the standard of care in these cancers. With our Phase 3 program in HR+/HER2- advanced breast cancer, and our newly initiated Phase 1b/2 program in metastatic castration resistance prostate cancer, we are hoping to eventually impact over 200,000 patients globally," said Brian Sullivan, CEO and Co-Founder of Celcuity. "The equity financing we recently closed further supports these programs and extends our cash runway into mid-2026."

Third Quarter 2023 Business Highlights and Other Recent Developments

● The VIKTORIA-1 Phase 3 trial remains on track to provide initial data and analysis of the PIK3CA wild type patient sub-group in the second half of 2024 and data for the PIK3CA mutated patient sub-group in the first half of 2025.

○ The Phase 3 VIKTORIA-1 clinical trial is now recruiting patients at nearly 220 sites in 23 countries in North and South America, Europe, and Asia.

○ VIKTORIA-1 is evaluating gedatolisib in combination with fulvestrant, an endocrine therapy, with and without palbociclib, a CDK4/6 inhibitor, in adults with HR+, HER2- advanced breast cancer.

● The CELC-G-201 Phase 1b/2 clinical trial evaluating gedatolisib in combination with Nubeqa (darolutamide) for the treatment of metastatic castration resistant prostate cancer (mCRPC) is on track to activate trial sites in the first quarter of 2024 and to report initial data in the first half of 2025.

○ The U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) submission that enables Celcuity to proceed with a trial to evaluate gedatolisib in combination with darolutamide in August 2023.

○ We entered into a clinical trial collaboration and supply agreement with Bayer AG in August 2023 to provide Nubeqa (darolutamide) at no cost.

○ The Phase 1b/2 trial will enroll up to 54 patients with mCRPC whose disease progressed after treatment with an androgen receptor inhibitor.

● Celcuity closed a private placement of equity that resulted in net proceeds of approximately $50 million in October 2023.

Third Quarter 2023 Financial Results

Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2023, compared to the third quarter ended September 30, 2022.

Total operating expenses were $18.9 million for the third quarter of 2023, compared to $10.6 million for the third quarter of 2022. Research and development (R&D) expenses were $17.5 million for the third quarter of 2023, compared to $9.6 million for the third quarter of 2022. Of the approximately $7.9 million increase in R&D expenses, $7.5 million was due to an increase in expenses related to the VIKTORIA-1 Phase 3 clinical trial, and $0.4 million was related to increased employee-related expenses.

General and administrative expenses were $1.4 million for the third quarter of 2023, compared to $1.0 million for the third quarter of 2022. Employee-related expenses accounted for $0.3 million of the increase. The remaining $0.1 million increase resulted from professional fees and other expenses associated with being a public company.

Net loss for the third quarter of 2023 was $18.4 million, or $0.83 loss per share, compared to a net loss of $10.9 million, or $0.75 loss per share, for the third quarter of 2022. Non-GAAP adjusted net loss for the third quarter of 2023 was $17.3 million, or $0.78 loss per share, compared to non-GAAP adjusted net loss for the third quarter of 2022 of $9.5 million, or $0.63 loss per share. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States (GAAP) to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the third quarter of 2023 was $12.7 million, compared to $9.3 million for the third quarter of 2022. At September 30, 2023, Celcuity reported cash, cash equivalents and short-term investments of $133.9 million.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 8:00 a.m. ET today to discuss the third quarter financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-877-407-0784 or1-201-689-8560. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=7d2827005c. A replay of the webcast will be available on the Celcuity website following the live event.