On November 8, 2021 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, reported financial results for the third quarter ended September 30, 2021 and summarized recent business progress (Press release, Celcuity, NOV 8, 2021, View Source [SID1234595207]).

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"We made great progress advancing our gedatolisib program this past quarter. We initiated preparation for a Phase 3 clinical trial evaluating gedatolisib in combination with Ibrance and Faslodex in patients with ER+/HER2- advanced or metastatic breast cancer that we expect to activate in the first half of 2022," said Brian Sullivan, CEO and co-founder of Celcuity. "Site identification and feasibility activities are underway. We are excited to have the opportunity to present updated results from our Phase 1b clinical trial in patients with ER+/HER2- advanced breast cancer at the San Antonio Breast Cancer Symposium in December. Finally, we are pleased to have entered into another clinical trial collaboration to evaluate CELsignia selected patients with advanced breast cancer. The collaboration with University of Rochester Wilmot Cancer Center and Puma represents an important opportunity to identify a potential new treatment for patients with breast cancer that has metastasized to the brain."

Third Quarter 2021 Business Highlights and Other Recent Developments

Completed transfer of regulatory, clinical trial, and safety reporting responsibilities for gedatolisib from Pfizer to Celcuity ahead of schedule.

Updated data from Celcuity’s ongoing Phase 1b clinical trial for patients with ER+/HER2- advanced breast cancer will be presented at the San Antonio Breast Cancer Symposium during a Spotlight Poster Discussion Session on December 10, 2021. Rachel M. Layman, MD, an oncologist at the University of Texas MD Anderson Cancer Center who was a principal investigator for the clinical trial, will be the presenting author.

Celcuity entered into a clinical trial collaboration agreement with the University of Rochester Wilmot Cancer Center and Puma Biotechnology in October 2021. This single arm Phase 2 trial will evaluate the efficacy and safety of Puma’s pan-HER inhibitor, NERLYNX (neratinib), and capecitabine, a chemotherapy, in patients selected with Celcuity’s CELsignia HER2 Activity Test who have metastatic HER2-negative breast cancer that has progressed on prior treatments. Based on estimates of patient enrollment rates, Celcuity expects to obtain interim results 12 to 15 months after initiation of the trial followed by the final results 12 to 15 months later. Enrollment is planned to begin by mid-2022.

Enrollment in the FACT-1 and FACT-2 trials that are evaluating CELsignia selected patients who have early-stage ER+/HER2- breast cancer was negatively impacted by COVID-19 related delays during the third quarter. Hospitalizations of patients with COVID-19 increased dramatically during this period which led hospitals to reduce clinical trial related activities. Interim results are now expected to be available in the second half of 2022.

Third Quarter 2021 Financial Results

Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2021, compared to the third quarter ended September 30, 2020. The following discussion should be read in conjunction with our unaudited condensed consolidated financial statements and related notes on Form 10-Q for the third quarter ended September 30, 2021.

Total operating expenses were $5.6 million for the third quarter of 2021, compared to $2.5 million for the third quarter of 2020.

Research and development (R&D) expenses were $5.0 million for the third quarter of 2021, compared to $2.0 million for the third quarter of 2020. The increase in R&D expenses during the third quarter of 2021 compared to the prior year primarily resulted from costs associated with the development of gedatolisib. Employee related expenses, including consulting fees, accounted for $1.1 million of the increase. The remaining increase of $1.9 million in expenses is related to clinical trials, patent legal fees, and costs associated with the transfer of the gedatolisib-related activities from Pfizer to Celcuity.

General and administrative (G&A) expenses were $0.6 million for the third quarter of 2021, compared to $0.5 million for the third quarter of 2020. The increase in the third quarter of 2021 arose primarily from non-cash stock-based compensation.

Net loss for the third quarter of 2021 was $6.0 million, or $0.41 loss per share, compared to a net loss of $2.5 million for the third quarter of 2020, or $0.24 loss per share. The Non-GAAP adjusted net loss for the third quarter of 2021 was $5.1 million compared to a non-GAAP adjusted net loss of $2.0 million for the third quarter of 2020. Non-GAAP adjusted net loss excludes stock-based compensation expense, issuance of common stock and non-cash interest. 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 (GAAP) in the United States 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 2021 was $4.0 million, compared to $1.6 million for the third quarter of 2020.

At September 30, 2021, Celcuity had cash and cash equivalents of $90.4 million, compared to cash and cash equivalents of $11.6 million at December 31, 2020.

Anticipated Milestones

Celcuity expects to achieve the following potential milestones over the next twelve months:

Obtain formal feedback from the FDA on the design of its proposed Phase 3 clinical trial by early 2022.

Initiate a Phase 3 clinical trial to evaluate gedatolisib in combination with Ibrance and Faslodex in patients with ER+/HER2- advanced breast cancer in the first half of 2022, subject to the FDA feedback.

Provide an update on lifecycle development priorities for gedatolisib in the first half of 2022.

Obtain interim results from the FACT-1 and FACT-2 trials in the second half of 2022.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the third quarter financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial (877) 407-0784 and international callers should dial (201) 689-8560. A live webcast presentation can also be accessed using this weblink: https://78449.themediaframe.com/dataconf/productusers/vvdb/mediaframe/46959/indexl.html. A replay of the webcast will be available on the Celcuity website following the live event.