Core Viewpoint - Needham upgraded Celcuity Inc. to a "Buy" rating with a new price target of $95, reflecting confidence in the company's recent clinical trial results for its cancer treatment therapy [1][6]. Group 1: Clinical Trial Results - Celcuity's Phase 3 VIKTORIA-1 clinical trial for gedatolisib demonstrated significant improvement in median progression-free survival for patients with advanced breast cancer [2][6]. - The gedatolisib triplet regimen reduced the risk of disease progression or death by 76% compared to fulvestrant, while the doublet regimen showed a 67% reduction in risk [3][6]. Group 2: Adverse Events and Management Plans - Adverse events were minimal, with hyperglycemia reported in 9.2% of patients on the triplet regimen and 11.5% on the doublet, and treatment discontinuation due to adverse events was low at 2.3% for the triplet and 3.1% for the doublet [4]. - Celcuity's management plans to discuss the trial findings further in a webcast and conference call [4]. Group 3: Stock Performance - Currently, CELC is trading at $72.33, reflecting a 39.20% increase over the past year, with a market capitalization of approximately $3.07 billion [5][6]. - The stock has fluctuated between $71.50 and $83 today, with a 52-week high of $83 and a low of $7.57 [5].

Group 1 - The article does not provide any specific content related to a company or industry [1]

Core Insights - The presentation focuses on the additional results from the Phase III VIKTORIA-1 clinical trial, specifically for the PIK3CA wild-type cohort, which were recently presented at the ESMO Congress in Berlin [1]. Group 1: Company Overview - Celcuity is led by CEO and Co-Founder Brian Sullivan, who is joined by Chief Medical Officer Dr. Igor Gorbatchevsky for the presentation [1]. Group 2: Clinical Trial Details - The VIKTORIA-1 trial is significant as it explores the PAM pathway, which is a crucial oncogenic pathway involving PI3K, AKT, and mTOR [3].

Core Insights - Biotech stocks are experiencing significant gains, with several clinical-stage companies reporting double-digit increases due to new catalysts [1] Group 1: Earnings and Financial Performance - Companies are reporting earnings beats, contributing to the positive momentum in biotech stocks [1] - Promising trial data has been a key driver for the stock price increases among clinical-stage firms [1] Group 2: Partnerships and Collaborations - Billion-dollar partnerships are being formed, further enhancing the market outlook for these biotech companies [1]

Summary of Conference Call for Celcuity's Victoria-1 Phase 3 Clinical Trial Results Company and Industry - **Company**: Celcuity - **Industry**: Oncology, specifically focusing on advanced breast cancer treatments Key Points and Arguments Clinical Trial Overview - The Victoria-1 trial is a global Phase 3 study targeting patients with hormone receptor (HR) positive, HER2 negative advanced breast cancer, including both PIK3CA mutant and wild type patients [9][10] - The trial involved 392 patients randomized into three arms: triplet regimen (gedatolisib, palbociclib, and fulvestrant), doublet regimen (gedatolisib and fulvestrant), and control arm (fulvestrant) [10][11] Efficacy of Gedatolisib - The gedatolisib triplet regimen showed a statistically significant improvement in median progression-free survival (PFS) of 7.3 months over fulvestrant, with a median PFS of 9.3 months and a hazard ratio of 0.24, indicating a 76% reduction in the risk of disease progression or death [13][15] - The doublet regimen also demonstrated a significant improvement of 5.4 months in median PFS over fulvestrant, with a hazard ratio of 0.33, representing a 67% reduction in risk [15] - Subgroup analyses indicated that the clinical benefits of the triplet regimen were consistent across predefined groups, including patients in the U.S. and Canada, where median PFS was 19.3 months for the triplet [16][18] Safety and Tolerability - The gedatolisib regimens were generally well tolerated, with low discontinuation rates due to treatment-related adverse events: 2.3% for the triplet and 3.1% for the doublet [21] - Adverse events were primarily low grade, with no new safety signals observed. Notably, hyperglycemia rates were lower than expected, with 9.2% in the triplet and 11.5% in the doublet [22] Market Opportunity - There is an estimated 37,000 patients who progress to second-line treatment after CDK4/6 inhibitors, with approximately 60% being PIK3CA wild type, representing a significant market opportunity [23] - The potential addressable market for gedatolisib is projected to be around $5 billion, with a smoother reimbursement process for IV-administered drugs compared to oral therapies [24] Future Milestones - Celcuity plans to submit a New Drug Application (NDA) for the Victoria-1 PIK3CA wild type cohort in the current quarter, with additional data presentations expected at major medical conferences later this year [25] - Top-line data for the PIK3CA mutation cohort is anticipated by late Q1 or Q2 2026 [25] Competitive Landscape - The results from the gedatolisib regimens are positioned to potentially establish a new standard of care for patients with advanced breast cancer, especially in comparison to existing therapies like Roche's everolimus [34][35] - The differentiation of gedatolisib is emphasized, particularly for the broader patient population, as it may address the needs of approximately 85% of patients who do not have specific mutations [35] Intellectual Property and Development Strategy - Celcuity holds multiple patents related to gedatolisib, extending exclusivity until at least 2042, which includes patents for the drug formulation and dosing schedule [50][51] - The company is exploring additional clinical development opportunities, including combinations with oral SERDs and indications in earlier lines of therapy [28] Additional Important Content - The PAM pathway is highlighted as a critical target in oncology, with evidence suggesting that comprehensive blockade of this pathway is essential for effective treatment [3][4] - The trial's design and statistical analysis were structured to maximize the potential for demonstrating statistical significance in overall survival with mature follow-up data [55] This summary encapsulates the key findings and strategic insights from Celcuity's conference call regarding the Victoria-1 Phase 3 clinical trial results, emphasizing the potential impact of gedatolisib in the treatment landscape for advanced breast cancer.

Phase 3 VIKTORIA-1 HR+/HER2-/PIK3CA WT Trial Results Gedatolisib is an investigational agent and is not approved by any regulatory agency as a treatment for any indication. October 20, 2025 Forward-Looking Statements This presentation contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to Celcuity's business, operations, and financial condition, and include but are not limited to our current beli ...

Core Insights - Celcuity Inc. has announced that the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled and expects to report topline data in late Q1 or Q2 2026 [2] - The company provided updated analysis from a Phase 1b clinical trial evaluating gedatolisib combined with fulvestrant and palbociclib in patients with HR+/HER2- advanced breast cancer [2][6] Company Updates - The VIKTORIA-1 study is evaluating gedatolisib plus fulvestrant with and without palbociclib against alpelisib and fulvestrant in patients with hormone receptor-positive, HER2-negative, PIK3CA mutant tumors [1] - The Phase 1b trial included patients treated with the same drug regimen as in the VIKTORIA-1 study, with a focus on efficacy data [2][4] Clinical Trial Data - In the Phase 1b trial, patients with PIK3CA mutant tumors had a median progression-free survival (PFS) of 14.6 months and an objective response rate (ORR) of 48% [4][6] - For patients receiving the intermittent dose of gedatolisib, median PFS was 19.7 months and ORR was 64% for those with PIK3CA mutant tumors [4][5] - In contrast, patients with PIK3CA wild-type tumors had a median PFS of 9.0 months and an ORR of 41% [4][5] Future Outlook - The company is optimistic about the results from the PIK3CA mutant patient subgroup and looks forward to reporting Phase 3 data in 2026 [6][7] - Celcuity is also conducting other clinical trials, including VIKTORIA-2, which is currently enrolling patients [7]

Core Insights - Celcuity Inc. announced significant efficacy and safety results from the Phase 3 VIKTORIA-1 clinical trial of gedatolisib for advanced breast cancer, showing a 76% reduction in disease progression risk with the triplet therapy compared to fulvestrant [1][3][6] Efficacy Results - The gedatolisib triplet therapy achieved a median progression-free survival (PFS) of 9.3 months, an improvement of 7.3 months over fulvestrant, with a hazard ratio (HR) of 0.24 [3][6] - The objective response rate (ORR) for the triplet was 31.5%, while the doublet showed an ORR of 28.3% [3][6] - For the gedatolisib doublet, the median PFS was 7.4 months, an improvement of 5.4 months over fulvestrant, with a HR of 0.33 [3][6] Safety Profile - Hyperglycemia occurred in 9.2% of patients on the triplet and 11.5% on the doublet, with treatment discontinuation due to adverse events at 2.3% and 3.1%, respectively [5][7] - The most common grade 3 treatment-related adverse events included neutropenia (52.3% for triplet), stomatitis (19.2% for triplet), and hyperglycemia (2.3% for triplet) [7] Clinical Significance - The results from the VIKTORIA-1 trial represent a potential new standard of care for patients with HR+/HER2- advanced breast cancer who have progressed after CDK4/6 inhibitor treatment [7][9] - Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR pathway to show positive Phase 3 results in this patient population [6][9] Future Developments - Celcuity has initiated a rolling New Drug Application (NDA) submission to the FDA, targeting completion in Q4 2025 [9] - The PIK3CA mutant cohort of the VIKTORIA-1 trial is fully enrolled, with topline data expected in late Q1 or Q2 2026 [9]

Core Insights - Celcuity Inc. announced updated clinical results from a Phase 1 trial evaluating gedatolisib in combination with darolutamide for men with metastatic castration-resistant prostate cancer (mCRPC) [1][5] Group 1: Clinical Trial Details - The Phase 1 study involved 38 patients with mCRPC, randomly assigned to receive either 120 mg or 180 mg of gedatolisib alongside 600 mg of darolutamide twice daily [2] - The median duration of follow-up for the trial was 9.0 months, with 61% of patients having received one line of prior systemic therapy and 39% having received two or more lines [2] Group 2: Efficacy Results - The combined six-month radiographic progression-free survival (rPFS) rate was 67%, with a median rPFS of 9.1 months [3][7] - For the 120 mg gedatolisib group, the six-month rPFS rate was 74% and median rPFS was 9.5 months, while for the 180 mg group, the rates were 61% and 7.4 months, respectively [3] Group 3: Safety Profile - The combination therapy was generally well tolerated, with mostly low-grade treatment-related adverse events (TRAEs) [4] - No dose-limiting toxicities were observed, and the only Grade 3 TRAEs reported were rash (5.3%), stomatitis (2.6%), and pruritus (2.6%) [4] Group 4: Future Plans - The company is enrolling patients in an updated Phase 1/1b trial to determine the recommended Phase 2 dose, with plans to enroll up to six patients in each of three arms [5] - Following the Phase 1 completion, an additional 40 patients will be randomly assigned to four Phase 1b cohorts to establish the recommended Phase 2 dose [5]

Core Insights - The article discusses the valuation disparity of Celcuity (NASDAQ: CELC) as it progresses through a phase 3 clinical trial for its cancer platform [1] Group 1: Company Overview - Celcuity is currently deep into enrollment for a phase 3 trial, indicating significant progress in its developmental cancer platform [1] Group 2: Analyst Background - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies, emphasizing a commitment to educating investors on the science behind these businesses [1]