On November 13, 2023, Celcuity Inc (CELC, Financial) released its 8-K filing, detailing the financial outcomes for the third quarter ended September 30, 2023, and providing updates on its corporate activities. The company, which specializes in developing targeted therapies for oncology, highlighted several strategic achievements, including FDA clearance for a new clinical trial and a collaboration with Bayer AG.
Strategic and Clinical Developments
Celcuity Inc (CELC, Financial) reported significant progress in its clinical programs. The Phase 3 VIKTORIA-1 clinical trial for gedatolisib, the company's lead therapeutic candidate, is actively recruiting patients across 23 countries. Additionally, the FDA has cleared an IND submission for a trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). A clinical trial collaboration with Bayer AG will supply darolutamide for this upcoming trial. These developments are expected to impact over 200,000 patients globally, according to CEO Brian Sullivan.
Financial Performance Overview
The third quarter of 2023 saw a significant increase in operating expenses, totaling $18.9 million compared to $10.6 million in the same period of 2022. This increase was primarily due to the costs associated with the VIKTORIA-1 Phase 3 clinical trial. Research and development expenses accounted for $17.5 million of the total operating expenses, marking a substantial increase from the $9.6 million reported in the third quarter of 2022. General and administrative expenses also rose to $1.4 million, up from $1.0 million in the previous year, with employee-related expenses contributing to the increase.
The net loss for the quarter was $18.4 million, or $0.83 loss per share, widening from a net loss of $10.9 million, or $0.75 loss per share, in the third quarter of 2022. The non-GAAP adjusted net loss, which excludes stock-based compensation expense and non-cash interest, was $17.3 million, or $0.78 loss per share, compared to the non-GAAP adjusted net loss of $9.5 million, or $0.63 loss per share, for the same period last year.
Liquidity and Capital Resources
Celcuity Inc (CELC, Financial) ended the quarter with a strong cash position, reporting $133.9 million in cash, cash equivalents, and short-term investments. This figure reflects the company's successful $50 million private placement sale of equity, which has extended its cash runway into mid-2026. Net cash used in operating activities for the quarter was $12.7 million, an increase from $9.3 million in the third quarter of 2022.
Balance Sheet and Income Statement Highlights
The balance sheet shows that total current assets decreased to $141.7 million from $175.2 million at the end of 2022. The total liabilities and stockholders' equity amounted to $142.4 million, with liabilities comprising $49.5 million of this total. The condensed statements of operations reveal that the increase in operating expenses, particularly in research and development, has been the primary driver of the net loss for the quarter.
Looking Ahead
Celcuity Inc (CELC, Financial) remains focused on advancing its clinical programs and leveraging its CELsignia diagnostic platform to identify patient populations likely to benefit from targeted therapies. With a solid cash position and strategic collaborations in place, the company is poised to continue its research and development efforts into the coming years.
Investors and interested parties can access a replay of the webcast discussing these financial results and corporate updates on the Celcuity website.
For a detailed reconciliation of GAAP to non-GAAP financial measures, readers are encouraged to review the financial tables included in the press release.
Explore the complete 8-K earnings release (here) from Celcuity Inc for further details.
