Biotech company Celcuity Inc. (CELC) is making significant advances in targeted cancer therapies, with Its lead candidate gedatolisib undergoing a Phase 3 clinical trial for HR+/HER2- advanced breast cancer. Its research focuses on identifying cancer patients who can benefit from already-approved therapies with the help of its unique CELsignia diagnostic platform. In a recent update, the company confirmed steady progress in two major trials, the VIKTORIA-1 and VIKTORIA-2 studies, with the former expecting top-line data for two groups of patients in 2025.
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An additional trial is ongoing for the treatment of metastatic castration-resistant prostate cancer. The company is in the clinical stage and burning significant amounts of cash, as evidenced by the Q3 net loss of $29.8 million, which exceeded expectations. While the stock is down 14% over the past year, Wall Street analysts are bullish on its outlook. It is an interesting biotech opportunity for those who can stomach higher levels of risk.
Celcuity’s Pipeline of Candidates Is Impressive
Celcuity is a clinical-stage biotechnology company that primarily focuses on formulating targeted therapies for numerous types of cancer. One prominent therapeutic candidate the company is currently advancing is gedatolisib, touted as a potential first-in-class pan-PI3K and mTOR inhibitor. The treatment is presently in a Phase 3 clinical trial to examine its effectiveness on patients diagnosed with HR+/HER2-advanced breast cancer.
The company has also reported significant progress in its ongoing oncology trials. The VIKTORIA-1 study, focusing on targeted therapies for advanced breast cancer, is proceeding as planned, with full enrollment in the PIK3CA wild-type cohort and the PIK3CA mutant cohort on track. Preliminary results for both cohorts are slated for release in 2025.
Further, enrollment for the VIKTORIA-2 Phase 3 clinical trial is set to begin in Q2 2025, and pre-trial safety assessments will be conducted in the interim. An additional Phase 1b/2 trial studying the combo use of gedatolisib and darolutamide for the treatment of metastatic castration-resistant prostate cancer is ongoing, with preliminary results expected in Q2 2025. Finally, nonclinical data on the mechanism of action of gedatolisib and its effect on breast cancer cell metabolic functions will be presented at the San Antonio Breast Cancer Symposium in December 2024.
Alongside this, Celcuity’s CELsignia is a distinct companion diagnostic platform capable of analyzing live patient tumor cells. This analysis assists in identifying new patient groups who stand to benefit from existing approved targeted therapies.
Cash Burn Rises
The company recently reported financial results for the third quarter of 2024. The total operating expenses for the quarter were $30.1 million, a marked increase from $18.9 million in the same period in 2023. The rise was primarily driven by a substantial increase in research and development expenses, from $10.1 million to $27.6 million. Most of this increase is attributed to supporting the VIKTORIA-1 Phase 3 trial, the Phase 1b/2 trial, the initiation of the VIKTORIA-2 Phase 3 trial, and increased employee and consulting expenses.
General and administrative expenses also increased, from $1.4 million in Q3 2023 to $2.5 million in Q3 2024. The net loss for the third quarter of 2024 was $29.8 million, or a $0.70 loss per share, compared to a net loss of 18.4 million, or a $0.83 loss per share, in the third quarter of 2023. The loss per share fell below analyst estimates for the quarter.
Cash used in operating activities for the quarter was $20.6 million, compared to $12.7 million for the third quarter of 2023. As of the quarter’s end, Celcuity reported cash, cash equivalents, and short-term investments of $264.1 million. While the cash burn has increased, the company still has sufficient liquidity to operate at these levels for several years.
Analysts Project Strong Potential Upside
The stock has been relatively range-bound for several years but recently shed 17% in the past three months. It trades near the low end of its 52-week price range of $11.51 – $22.19 and shows ongoing negative price momentum as it trades below major moving averages.
Analysts following the company have been bullish on CELC stock. For example, H.C. Wainwright analyst Swayampakula Ramakanth, a four-star analyst according to Tipranks’ ratings, recently reiterated a Buy rating on the shares with a price target of $27.00, noting the company’s promising clinical progress, particularly with the ongoing VIKTORIA-1 study and the expected top-line data in the first half of 2025. Based on previous favorable results, the anticipated positive data readout points to the potential success of gedatolisib in combination therapies.
Celcuity is rated a Strong Buy overall, based on the recommendations of seven analysts. Their average price target for CELC stock is $29.40, representing a potential upside of 134.26% from current levels.
CELC in Review
Celcuity is making impressive strides in its research, with gedatolisib, its top candidate, currently in Phase 3 clinical trials to treat HR+/HER2- advanced breast cancer. Other trials are also ongoing with promising signs of progress, including studies on metastatic castration-resistant prostate cancer. Despite a significant Q3 net loss exceeding expectations, the company boasts sufficient liquidity to see its robust pipeline through the clinical testing process. Given analysts’ optimistic view of the future for the stock, investors with a higher risk tolerance may find this an intriguing opportunity to consider.
