On November 10, 2022 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on development of targeted therapies for a number of different cancers, reported financial results for the third quarter ended September 30, 2022 and other recent business developments (Press release, Celcuity, NOV 10, 2022, View Source [SID1234623705]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are encouraged by the significant interest from clinical sites across the world to participate in our Phase 3 VIKTORIA-1 study for gedatolisib," said Brian Sullivan, CEO and Co-Founder of Celcuity. "We completed selection of sites for the study in the third quarter, and we are now focused on activating these selected sites. We are pleased that updated data from our Phase 1b study in advanced breast cancer will be reviewed during a Spotlight Poster Discussion Session at the 2022 San Antonio Breast Cancer Symposium in December 2022. Finally, I am excited that Dr. Polly Murphy has joined our Board of Directors. Her business development and commercial experience will provide a very helpful perspective to our board."
Third Quarter 2022 Business Highlights and Other Recent Developments
●In July, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Celcuity’s lead drug product candidate gedatolisib, an investigational pan-PI3K/mTOR inhibitor, for the treatment of HR+/HER2- locally advanced, inoperable or metastatic breast cancer that has progressed after treatment with a CDK4/6 inhibitor in combination with a nonsteroidal aromatase inhibitor. This designation allows for more intensive guidance from the FDA and a potentially accelerated review time if relevant criteria are met. Gedatolisib previously received Fast Track designation from the FDA in January 2022.
●In August, Celcuity amended its existing debt facility with an affiliate of Innovatus Capital Partners, LLC to provide Celcuity with up to $75 million in term loans, a $50 million increase from the original debt facility. Among other changes, the amended facility provides Celcuity with the ability to draw on a $20 million tranche following the closing of the $100 million private placement announced in May 2022. The closing of the private placement is expected to occur shortly after the first patient in VIKTORIA-1 receives their first dose at a clinical site located in the United States, provided that such dose occurs on or before December 31, 2022.
●In September, Celcuity appointed Polly Murphy, D.V.M., Ph.D., to its Board of Directors. Dr. Murphy has over 20 years of business development and commercial strategy experience at leading global pharmaceutical companies, including 12 years in leadership positions with increasing responsibility at Pfizer.
●In the third quarter, Celcuity completed selection of 200 clinical trial sites for the Phase 3 VIKTORIA-1 clinical trial. The first clinical trial site was also activated. VIKTORIA-1 is evaluating the safety and efficacy of gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- advanced breast cancer whose disease progressed while receiving prior CDK4/6 therapy.
●An abstract with updates to results from Celcuity’s Phase 1b study was accepted for a Spotlight Poster Discussion presentation at the 2022 San Antonio Breast Cancer Symposium. Ongoing enrollment in the FACT-1 and FACT-2 trials for CELsignia selected patients who have early-stage HR+/HER2- breast cancer with interim results expected in mid-2023.
Third Quarter 2022 Financial Results
Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2022, compared to the third quarter ended September 30, 2021.
The following discussion should be read in conjunction with Celcuity’s unaudited condensed consolidated financial statements and related notes on Form 10-Q for the third quarter ended September 30, 2022. Total operating expenses were $10.6 million for the third quarter of 2022, compared to $5.6 million for the third quarter of 2021.
Research and development (R&D) expenses were $9.6 million for the third quarter of 2022, compared to $5.0 million for the third quarter of 2021. Of the approximately $4.7 million increase in R&D expenses in the third quarter of 2022, compared to the third quarter of 2021, $1.2 million was related to employee related expenses, including consulting fees. The remaining $3.5 million increase in R&D expenses is primarily related to activities supporting the initiation of the VIKTORIA-1 pivotal trial and costs for existing clinical trials.
General and administrative (G&A) expenses were $1.0 million for the third quarter of 2022, compared to $0.6 million for the third quarter of 2021. The approximately $0.4 million increase in G&A expenses during the third quarter of 2022, compared to the third quarter of 2021, arose primarily from approximately $0.3 million in non-cash stock-based compensation.
Net loss for the third quarter of 2022 was $10.9 million, or $0.75 loss per share, compared to a net loss of $6.0 million, or $0.41 loss per share, for the third quarter of 2021. For purposes of calculating net loss per share, the reported net loss was increased by an additional $.02 loss per share, related to the approximately $0.3 million deemed dividend resulting from a warrant modification. Non-GAAP adjusted net loss for the third quarter of 2022 was $9.5 million, or $0.63 loss per share, compared to non-GAAP adjusted net loss of $5.1 million, or $0.35 loss per share, for the third quarter of 2021. 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 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 2022 was $9.3 million, compared to $4.0 million for the third quarter of 2021. At September 30, 2022, Celcuity had cash and cash equivalents of $57.5 million.
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 2022 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-888-999-6281 and international callers should dial 1-848-280-6550 and reference Celcuity. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=f9185283fd. A replay of the webcast will be available on the Celcuity website following the live event.