MINNEAPOLIS - Celcuity Inc. (NASDAQ: NASDAQ:CELC), a clinical-stage biotechnology company, announced plans to initiate a Phase 3 clinical trial for gedatolisib, in combination with a CDK4/6 inhibitor and fulvestrant, as a first-line treatment for HR+/HER2- advanced breast cancer patients who are resistant to endocrine therapy.
This announcement was made today, alongside news of the company securing an additional term loan of approximately $62 million through an amendment to its existing debt facility agreement.
The upcoming VIKTORIA-2 trial will be an open-label, randomized study designed to assess the efficacy and safety of the gedatolisib combination versus fulvestrant with a CDK4/6 inhibitor alone. The trial will include a safety run-in for the gedatolisib and ribociclib combination, which has not been clinically tested before.
Investigators in the trial will have the option to choose between ribociclib or palbociclib as the CDK4/6 inhibitor for their patients. Approximately 638 subjects who meet the eligibility criteria will be enrolled, with the primary endpoint being progression-free survival as assessed by blinded independent central review.
The study is expected to enroll its first patient in the second quarter of 2025 and will take place across up to 200 clinical sites in North America, Europe, Latin America, and Asia. The trial design has been reviewed with the U.S. Food and Drug Administration (FDA) during a Type C meeting.
In conjunction with the clinical trial announcement, Celcuity revealed an amended debt financing agreement with Innovatus Capital Partners, LLC, and the addition of Oxford Finance LLC as a new lender. The amended agreement provides Celcuity with up to $180 million in term loans, a significant increase from the previous agreement.
The company received $61.7 million at the closing of the amendment and now has $100 million of total debt outstanding. Additional tranches of the loan are contingent upon achieving certain clinical and regulatory milestones.
Celcuity is a biotechnology company focused on the development of targeted therapies for solid tumor cancers. Its lead therapeutic candidate, gedatolisib, is a pan-PI3K and mTOR inhibitor with a differentiated mechanism of action. The company's CELsignia diagnostic platform identifies cancer patient subgroups likely to benefit from existing targeted therapies.
This information is based on a press release statement from Celcuity Inc. and does not constitute an endorsement of the company or its products.
InvestingPro Insights
As Celcuity Inc. (NASDAQ: CELC) forges ahead with its ambitious Phase 3 clinical trial, the company's financial health and stock performance metrics offer a mixed picture for investors. According to recent data from InvestingPro, Celcuity holds a market capitalization of $463.45 million, which reflects investor valuation of the company in the current market.
Despite the challenging clinical development pathway, Celcuity's balance sheet suggests a position of relative strength, with the company holding more cash than debt. This is a critical factor as the firm navigates the costly process of clinical trials and seeks to bring new therapies to market.
InvestingPro Tips highlight that Celcuity's stock is currently in oversold territory based on the Relative Strength Index (RSI), which could indicate a potential rebound opportunity for investors closely monitoring technical analysis indicators.
Moreover, the company's liquid assets surpass its short-term obligations, providing a cushion for near-term financial commitments. Still, analysts remain cautious, not expecting Celcuity to turn profitable this year, and the company's gross profit margins are considered weak. Celcuity does not pay a dividend, which may influence the investment decisions of income-focused shareholders.
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