On Thursday, Stifel, a brokerage firm, adjusted its stock price target for Celcuity Inc (NASDAQ:CELC), a clinical-stage biotechnology company, to $39 from the previous $40 while reaffirming a Buy rating on the stock. The revision comes amid a slight delay in the phase 3 readout of gedatolisib for the treatment of HR+ metastatic breast cancer (mBC).
The delay, according to the firm, is not expected to impact the stock negatively as it results from an unexpected mix of patient subtypes in the trial, not from a lack of demand. The PIK3CA wild-type cohort of the phase 3 VIKTORIA-1 trial is over 80% enrolled, with full enrollment anticipated by the fourth quarter of 2024.
Despite the delay, the top-line results from the PIK3CA wild-type cohort could still be released in 2024, following the updated guidance for the fourth quarter of 2024 or the first quarter of 2025. The analyst from Stifel noted that this event is likely to be significant for Celcuity, as it could lead to the first approval for gedatolisib in a large patient population.
Furthermore, the successful readout of the 2L PIK3CA wild-type data is seen as a pivotal moment for Celcuity. It is expected to validate and reduce the risk for the subsequent PIK3CA-mutant cohort expected in the first half of 2025 and for the company's recently announced plans in the first-line endocrine-resistant setting.
The firm believes that the value of Celcuity could increase if the upcoming data proves to be successful, given the potential for these subsequent opportunities.
In other recent news, Celcuity Inc. has experienced a series of significant developments. Jefferies, a global investment banking firm, has reduced Celcuity's price target from $98.00 to $68.00 while reaffirming a Buy rating on the stock, following a slowdown in the sector. Despite the decreased growth forecast, Jefferies maintains that a 15% market share in the United States for Celcuity is attainable over time.
The company reported a net loss of $21.6 million in its first quarter financials for 2024, a substantial increase from the $11.9 million net loss in the same period last year. This rise is primarily due to increased research and development expenses related to ongoing clinical trials.
Celcuity also announced the pricing of an underwritten public offering of 3,871,000 shares of its common stock at $15.50 per share, expected to generate gross proceeds of approximately $60.0 million. The proceeds will be used towards working capital, research and development, clinical trials, and business development activities expansion.
InvestingPro Insights
As Celcuity Inc (NASDAQ:CELC) navigates the clinical trial process for its promising gedatolisib treatment, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, Celcuity holds a market capitalization of $573.2 million, reflecting the biotech firm's growth potential and investor interest. Despite not being profitable in the last twelve months and showing a negative P/E ratio of -5.93, Celcuity has demonstrated a high return over the last year with a price total return of 65.45%.
InvestingPro Tips suggest that while Celcuity's gross profit margins are weak, the company's balance sheet is robust, holding more cash than debt. This financial stability, coupled with liquid assets exceeding short-term obligations, could provide the company with the flexibility to navigate the upcoming phases of its clinical trials. It is worth noting, however, that analysts do not anticipate Celcuity will be profitable this year, and the company does not pay a dividend to shareholders, which may influence investment strategies.
For investors seeking a deeper dive into Celcuity's financials and market performance, additional InvestingPro Tips are available, offering comprehensive analysis and insights. With Celcuity's next earnings date slated for August 14, 2024, and the fair value estimated by analysts at $27.5, compared to InvestingPro's fair value of $14.73, keeping an eye on real-time data and expert tips can help investors make informed decisions in a dynamic market.
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