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]

Financial Performance - 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[14] - Non-GAAP adjusted net loss for Q3 2025 was $37.2 million, or $0.78 loss per share, compared to a non-GAAP adjusted net loss of $27.6 million, or $0.65 loss per share, in Q3 2024[14] - The net loss for the three months ended September 30, 2025, was $43,804,000, compared to a net loss of $29,792,000 in the same period of 2024, reflecting a 47% increase in losses[23] - Non-GAAP adjusted net loss for the three months ended September 30, 2025, was $37,155,000, compared to $27,605,000 in 2024, indicating a 35% increase[27] - The company reported a net loss per share of $0.92 for the three months ended September 30, 2025, compared to $0.70 in the same period of 2024[27] Operating Expenses - Total operating expenses for Q3 2025 were $42.8 million, up from $30.1 million in Q3 2024, representing a 42% increase[10] - Research and development expenses increased to $34.9 million in Q3 2025 from $27.6 million in Q3 2024, a rise of 27%[11] - General and administrative expenses rose to $7.9 million in Q3 2025, compared to $2.5 million in Q3 2024, marking a 216% increase[12] - Total operating expenses for the nine months ended September 30, 2025, reached $122,991,000, compared to $76,837,000 in 2024, marking an increase of 60%[23] Assets and Liabilities - Total assets increased to $476,004,000 as of September 30, 2025, up from $245,123,000 on December 31, 2024, representing a growth of 94%[21] - Current assets rose to $475,497,000, a significant increase of 94% from $244,571,000 in the previous year[21] - Cash and cash equivalents increased significantly to $74,252,000 as of September 30, 2025, from $22,515,000 at the end of 2024, a growth of 230%[21] - Total liabilities surged to $359,041,000 as of September 30, 2025, compared to $129,504,000 at the end of 2024, representing an increase of 177%[21] Clinical Developments - The gedatolisib-triplet reduced the risk of disease progression or death by 76% compared to fulvestrant, with a median progression-free survival of 9.3 months[7] - The gedatolisib doublet reduced the risk of disease progression or death by 67%, with a median progression-free survival of 7.4 months[7] - The FDA accepted the request for a New Drug Application for gedatolisib under the Real-Time Oncology Review program, with submission targeted for Q4 2025[8] - The PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled, with topline data expected in late Q1 2026 or Q2 2026[6] Share Information - The weighted average common shares outstanding for the three months ended September 30, 2025, were 47,589,731, up from 42,793,047 in the same period of 2024[27]

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 Insights - Celcuity Inc. is set to release its financial results for Q3 2025 on November 12, 2025, after market close, followed by a webcast and teleconference at 4:30 p.m. Eastern Time [1] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumor indications [3] - The lead therapeutic candidate, gedatolisib, is a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PI3K/AKT/mTOR pathway comprehensively [3] - Celcuity's clinical trials include: - VIKTORIA-1: A Phase 3 trial evaluating gedatolisib with fulvestrant in HR+/HER2- ABC, which has completed enrollment and reported results for the PIK3CA Wild-Type cohort [3] - VIKTORIA-2: A Phase 3 trial currently enrolling patients, assessing gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- ABC [3] - CELC-G-201: A Phase 1/2 trial ongoing, evaluating gedatolisib with darolutamide in metastatic castration-resistant prostate cancer patients [3]

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 - The article discusses the offerings of the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2]. Group 1: Service Offerings - Biotech Analysis Central offers a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and live chat features for investors [2]. - The service is available for $49 per month, with a discounted annual plan at $399, representing a 33.50% savings [1]. Group 2: Analyst Background - The author of the article runs the Biotech Analysis Central service and emphasizes the depth of analysis provided to help healthcare investors make informed decisions [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].

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