Celcuity Inc. (NASDAQ:CELC) is among the hottest SMID-cap stocks so far in 2025. Following recent clinical progress, Wolfe Research initiated coverage on Celcuity on November 17, with an Outperform rating and a $110 price target, according to TheFly. Likoper/Shutterstock.com The firm highlighted the company’s strong momentum following the recent Phase 3 success for gedatolisib in second-line PIK3CA-WT breast cancer. With that success, it believes that the upcoming PIK3CA-mt readout should be a key catal ...

Core Insights - Celcuity Inc. has submitted a New Drug Application (NDA) for gedatolisib to the FDA for the treatment of hormone receptor positive, HER2-negative advanced breast cancer, under the Real-Time Oncology Review program, aiming for expedited regulatory review [1][2] - The NDA submission is based on positive clinical results from the Phase 3 VIKTORIA-1 trial, showing significant efficacy improvements with gedatolisib compared to standard treatments [2][3] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumors, with gedatolisib as its lead candidate [5][6] - Gedatolisib is a multi-target PI3K/AKT/mTOR inhibitor that comprehensively blocks the PAM pathway, differentiating it from single-target inhibitors [3][5] Clinical Trial Results - The gedatolisib-triplet therapy reduced the risk of disease progression or death by 76% compared to fulvestrant, with a median progression-free survival (PFS) of 9.3 months versus 2.0 months, an improvement of 7.3 months [2] - The gedatolisib-doublet therapy reduced the risk of disease progression or death by 67%, with a median PFS of 7.4 months compared to 2.0 months with fulvestrant, an improvement of 5.4 months [2] Regulatory Context - The FDA's Real-Time Oncology Review program aims to streamline the review process for oncology drugs, ensuring timely access to safe and effective treatments [4]

Financial Data and Key Metrics Changes - The company's net loss for Q3 2025 was $43.8 million, or $0.92 per share, compared to a net loss of $29.8 million, or $0.70 per share for Q3 2024 [19] - Non-GAAP adjusted net loss was $37.2 million, or $0.78 per share for Q3 2025, compared to a non-GAAP adjusted net loss of $27.6 million, or $0.65 per share for Q3 2024 [19] - Research and development expenses increased to $34.9 million for Q3 2025 from $27.6 million in Q3 2024, with a significant portion attributed to increased employee and consulting expenses [19][20] - General and administrative expenses rose to $7.9 million for Q3 2025 from $2.5 million in Q3 2024, primarily due to increased employee and consulting expenses [20] Business Line Data and Key Metrics Changes - The company achieved significant clinical and regulatory milestones, including the release of positive data from the PIK3CA wild-type cohort of the phase III VIKTORIA-1 study [4][5] - The median progression-free survival (PFS) for the gedatolisib triplet was reported at 9.3 months, compared to 2 months for fulvestrant, indicating a 7.3-month improvement [7] - The objective response rate for the gedatolisib triplet was 32%, with a median duration of response of 17.5 months, while the doublet showed an objective response rate of 28% and a median duration of response of 12.0 months [9][10] Market Data and Key Metrics Changes - The total addressable market for gedatolisib in the second-line setting is estimated to be between $5 billion and $6 billion, with potential peak revenues of $2.5 billion to $3 billion [17][18] - The company estimates there are approximately 37,000 patients in the U.S. with HR positive, HER2 negative, advanced breast cancer who have progressed after treatment with a CDK4/6 inhibitor [17] Company Strategy and Development Direction - The company is preparing for a potential launch of gedatolisib, having ramped up efforts following the positive data release [15] - The strategic launch plan includes building the organization and internal systems required to operate as a commercial stage company [15] - The company aims to establish gedatolisib as the new standard of care in the second-line setting for HR positive, HER2 negative, advanced breast cancer [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for gedatolisib to address critical needs in the second-line space, highlighting its unique mechanism of action and favorable safety and efficacy profile [18] - The company expects to complete the NDA submission for gedatolisib by the end of Q4 2025 [26] - Management noted that the positive interim overall survival data could support the drug's approval process [38] Other Important Information - The company completed concurrent offerings resulting in net proceeds of approximately $287 million, which will support commercial launch preparations and other strategic initiatives [21][22] - The company ended the quarter with approximately $455 million in cash, cash equivalents, and short-term investments [20] Q&A Session Summary Question: Plans for additional data at the San Antonio Breast Cancer Symposium - The company plans to present additional subgroup analyses and efficacy data at the conference [24] Question: Impact of second-line data on enrollment in VIKTORIA II - Enrollment is on track, and investigators are excited about the results, which may positively impact visibility and credibility [24] Question: Real-time oncology review submission process - The submission for the wild-type cohort will be separate from the mutant submission, with potential for a real-time oncology review for the mutant data depending on the results [25][27] Question: Duration of therapy and pricing strategy - The company is analyzing the duration of therapy and pricing strategy, with benchmarks around $25,000 for similar therapeutics [28][29] Question: Plans for commercialization outside the U.S. - The company plans to find partners for commercialization outside the U.S. and is preparing for regulatory submissions in Europe and Japan [31] Question: Overall survival trends and regulatory implications - The interim overall survival analysis showed a favorable trend, which could support the drug's approval process [38]

Core Insights - Celcuity Inc. reported significant clinical and regulatory advancements in Q3 2025, particularly regarding the gedatolisib regimens for advanced breast cancer, with plans to submit a New Drug Application (NDA) to the FDA later this year [2][4][6] Business Highlights - The company presented detailed efficacy and safety results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial at the ESMO Congress, indicating potential practice-changing outcomes for patients with HR+, HER2- advanced breast cancer [4][5] - The gedatolisib triplet (gedatolisib, fulvestrant, and palbociclib) demonstrated a 76% reduction in the risk of disease progression or death compared to fulvestrant, with a median progression-free survival (PFS) of 9.3 months [5] - The gedatolisib doublet (gedatolisib and fulvestrant) showed a 67% reduction in the risk of disease progression or death, with a median PFS of 7.4 months [5] - The PIK3CA mutant cohort of the VIKTORIA-1 trial is fully enrolled, with topline data expected in late Q1 or Q2 2026 [4][8] Financial Results - Total operating expenses for Q3 2025 were $42.8 million, up from $30.1 million in Q3 2024 [6] - Research and development (R&D) expenses increased to $34.9 million from $27.6 million year-over-year, primarily due to higher employee and consulting costs [7] - General and administrative (G&A) expenses rose to $7.9 million from $2.5 million, largely due to increased employee and consulting expenses [9] - The net loss for Q3 2025 was $43.8 million, or $0.92 loss per share, compared to a net loss of $29.8 million, or $0.70 loss per share, in Q3 2024 [10] - Cash, cash equivalents, and short-term investments totaled $455.0 million as of September 30, 2025, expected to fund operations through 2027 [11]

Summary of Celcuity Conference Call Company Overview - **Company**: Celcuity - **Focus**: Development of gedatolisib, a drug targeting the PI3K/AKT/mTOR pathway, primarily for breast and prostate cancer treatment [3][4] Key Points and Arguments Drug Development and Clinical Trials - **Gedatolisib**: Identified as a promising drug for the PI3K/AKT/mTOR pathway, previously owned by Pfizer and now being developed by Celcuity [4] - **Current Studies**: Two ongoing studies in breast cancer (second-line and first-line metastatic) and a new study in prostate cancer [5] - **Data Validation**: Preliminary data from early-phase studies in prostate cancer is encouraging, supporting the hypothesis that the PI3K pathway is relevant in hormonally driven cancers [5][8] Regulatory and Commercialization Strategy - **NDA Submission**: Preparing for an NDA submission under an accelerated review process, with groundwork laid for commercialization [6][30] - **Market Research**: Positive feedback from market research indicates potential for significant market share in the second-line setting for gedatolisib [10][11] - **Sales Strategy**: Targeting community settings where 80% of patients are treated, while also prioritizing academic centers [33][34] Competitive Landscape - **Comparison with Roche**: Roche's combination therapy is seen as a strategic move, but Celcuity believes gedatolisib offers better tolerability and efficacy [12][16][18] - **Market Positioning**: Gedatolisib is positioned as a safer option with lower toxicity compared to existing treatments like everolimus, which has a high discontinuation rate [15][17] Clinical Data Insights - **Patient Population**: Focus on a diverse patient population, including those with and without specific mutations, which is expected to enhance the drug's applicability [38][40] - **Duration of Response**: Data suggests a potential duration of response of 19 months in the US, which could positively impact market modeling [21][22] Financial Outlook - **Cash Runway**: Current cash reserves and access to additional funding are expected to sustain operations through 2027, with hopes of generating meaningful revenue by then [46][47] Other Important Insights - **Regulatory Interactions**: Ongoing discussions with Japanese health authorities to align on data package expectations for regulatory submissions [36][37] - **Trial Site Selection**: Leveraging previous trial site experiences to enhance enrollment efficiency in ongoing studies [42][44] This summary encapsulates the critical aspects of Celcuity's conference call, highlighting the company's strategic direction, competitive positioning, and financial health as it advances its drug development efforts.

Core Viewpoint - The ATTC platform developed by Hutchison China MediTech Limited (HCM) aims to overcome the toxicity and resistance issues associated with traditional antibody-drug conjugates (ADCs), with potential for combination therapy with chemotherapy as a first-line standard treatment [1][6]. Summary by Sections ATTC Platform - The ATTC platform is designed to link targeted therapeutic agents with antibodies, producing candidate drugs that can target specific driver mutations, potentially reducing chemotherapy toxicity and enabling combination therapy with standard treatments [1][6]. HMPL-A251 - HMPL-A251 is the first candidate drug from the ATTC platform to enter clinical stages, composed of a PI3K/PIKK inhibitor and a HER2 antibody. It is expected to enter Phase 1 clinical trials in Q4 2025 [1][2][6]. - Preclinical data shows that HMPL-A251 exhibits effective endocytosis in HER2-positive cells and demonstrates HER2 expression-dependent cell growth inhibition, overcoming HER2 heterogeneity through a bystander killing effect [2]. PAM Pathway - The PAM (PI3K-AKT-mTOR) pathway plays a crucial role in cell growth, proliferation, differentiation, and apoptosis, with alterations in this pathway closely linked to various human tumors. Overactivation of PI3K is frequently reported in multiple cancer types [3]. - Existing PAM-targeted therapies have limited clinical benefits due to toxicity associated with PI3K/mTOR inhibition, which restricts the safety window for targeted treatments [3]. Future Pipeline - HCM anticipates two additional ATTC candidates (HMPL-A580 and HMPL-A830) to enter global clinical stages in 2026 [3]. - Clinical data for the first-line treatment of PDAC with surufatinib will be presented at the ESMO Asia conference, and the SAFFRON study of savolitinib combined with osimertinib has completed patient enrollment [1][6]. Investment Recommendation - The new generation ATTC platform from HCM is worth attention, with a smoothly advancing pipeline, maintaining an "outperform" rating [1][6].

MINNEAPOLIS, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the third quarter 2025 after the market closes on Wednesday, November 12, 2025. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Webcast and Conference Call Information To participate i ...

Company Overview - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [3] - The company's lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PI3K/AKT/mTOR ("PAM") pathway comprehensively [3] - Celcuity is headquartered in Minneapolis and provides further information on its website [3] Clinical Trials - The Phase 3 clinical trial VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC, has completed enrollment and reported results for the PIK3CA Wild-Type cohort [3] - Enrollment for the PIK3CA mutant cohort in the VIKTORIA-1 trial has also been completed [3] - The ongoing Phase 3 clinical trial VIKTORIA-2 is evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC [3] - A Phase 1/2 clinical trial, CELC-G-201, is currently evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer [3] Upcoming Events - Brian Sullivan, CEO and Co-founder of Celcuity, is scheduled for a fireside chat at the Stifel 2025 Healthcare Conference on November 11, 2025, at 10:00 a.m. ET [2] - A live webcast of the event will be available on the company's website [2]

Core Insights - Celcuity Inc. is a biotechnology company focused on developing innovative therapies for cancer treatment, particularly its drug gedatolisib targeting hormone-positive breast cancer [1] - The company has received a positive price target of $95 from Needham, indicating a potential increase of approximately 31.69% from its current price of $72.14, driven by strong phase 3 data for gedatolisib [2] - Celcuity's market valuation has surged to $2 billion, with a stock price increase of 40.05%, reflecting strong investor interest and market volatility [3] Financial Position - The company has a robust financial position supported by recent fundraising efforts and loan facilities, ensuring a cash runway extending into 2027, which is crucial for filing a New Drug Application (NDA) for gedatolisib [4] - Celcuity's market capitalization is approximately $3.09 billion, with a trading volume of 5,875,995 shares, positioning it well in the biotech sector [5] Market Performance - The stock price has fluctuated between $71.57 and $83, with a 52-week high of $83 and a low of $7.58, indicating strong investor interest and market volatility [3] - The successful results from the VIKTORIA-1 trial have been a key driver of investor confidence in the company's future prospects [2][6]

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].