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]

Drug Development and Clinical Trials - Gedatolisib is a pan-class I isoform PI3K inhibitor with low nanomolar potency for p110α, p110β, p110γ, and p110δ isoforms, and mTORC1 and mTORC2 complexes, providing comprehensive inhibition of the PAM pathway[93]. - In the Phase 1b clinical trial, the overall response rate (ORR) for treatment-naïve patients with advanced breast cancer was 85%, while the ORR for patients who received prior hormonal therapy ranged from 36% to 77%[99]. - The median progression-free survival (PFS) for treatment-naïve patients receiving gedatolisib combined with palbociclib plus letrozole was 48.6 months[100]. - As of September 30, 2025, 492 patients with solid tumors have received gedatolisib across eight completed clinical trials[97]. - The VIKTORIA-1 Phase 3 trial has completed enrollment of 351 subjects for the PIK3CA wild-type cohort, with primary completion achieved in May 2025[108]. - The Phase 3 trial VIKTORIA-2 is currently enrolling patients, evaluating gedatolisib in combination with a CDK 4/6 inhibitor and fulvestrant for advanced breast cancer[91]. - The median PFS for patients with PIK3CA mutant tumors was 14.6 months, with an ORR of 48%[104]. - Topline data for the PIK3CA mutant cohort of the VIKTORIA-1 trial is expected to be available in late Q1 2026 or Q2 2026[108]. - The gedatolisib triplet demonstrated 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, indicating a 76% reduction in the risk of disease progression or death[109]. - The gedatolisib doublet showed a median PFS of 7.4 months, an improvement of 5.4 months over fulvestrant, with a HR of 0.33, indicating a 67% reduction in the risk of disease progression or death[109]. - The overall response rate (ORR) for the gedatolisib triplet was 31.5%, with a median duration of response (DOR) of 17.5 months, while the ORR for the gedatolisib doublet was 28.3% with a median DOR of 12.0 months[109]. - The CELC-G-201 Phase 1b trial reported a six-month radiographic progression-free survival (rPFS) rate of 67% and a median rPFS of 9.1 months across both treatment arms[118]. Financial Performance and Expenses - The company reported a net loss of approximately $43.8 million for the three months ended September 30, 2025, compared to a net loss of $29.8 million for the same period in 2024[128]. - As of September 30, 2025, the company had an accumulated deficit of approximately $397.9 million and cash and cash equivalents of approximately $455.0 million[128]. - Research and development expenses for Q3 2025 were approximately $34.9 million, an increase of 27% compared to Q3 2024[140]. - General and administrative expenses for Q3 2025 were approximately $7.9 million, reflecting a significant increase of 221% compared to Q3 2024[143]. - Total operating expenses for Q3 2025 reached $42.8 million, a 43% increase from $30.1 million in Q3 2024[137]. - Research and development expenses for the nine months ended September 30, 2025, were approximately $107.4 million, a 52% increase from $70.7 million in the same period of 2024[141]. - Total operating expenses for the nine months ended September 30, 2025, were $123.0 million, a 60% increase compared to $76.8 million in the same period of 2024[139]. - Interest expense for Q3 2025 was $4.6 million, a 37% increase compared to $3.3 million in Q3 2024[146]. Capital and Funding Activities - The company completed an equity offering of 1,836,842 shares at $38.00 per share, raising approximately $69.7 million[123]. - The company raised approximately $481.7 million through equity securities and $194.9 million through the issuance of convertible notes since inception[150]. - The company completed an equity offering in July 2025, generating approximately $91.6 million in net proceeds for working capital and general corporate purposes[152]. - The company received net proceeds of approximately $27.8 million from the disbursement of the $30.0 million Term D Loan[166]. - The company achieved the Term D Milestone, allowing for the draw of an additional $30.0 million of indebtedness under the Term D Loan[171]. - The company is entitled to make interest-only payments for up to 48 months under the A&R Loan Agreement, with interest rates starting at 7.75% plus 2.85%[175]. - The company recognized a Final Fee of $4.5 million as additional debt principal, which will be amortized over the life of the loan[176]. Future Outlook and Risks - The company expects research and development expenses to increase as it continues to develop gedatolisib and conduct multiple clinical trials[179]. - The company believes its current cash and available borrowings will be sufficient to finance operations through 2027[180]. - The company may seek to raise additional capital through equity or convertible debt securities, which could result in dilution to stockholders[181]. - The company is facing known and unknown risks that may cause actual results to differ materially from forward-looking statements[196]. - There are uncertainties and costs associated with the development and commercialization of gedatolisib, which may impact timely regulatory approval[196]. - The company may encounter challenges in maintaining relationships with pharmaceutical partners and suppliers[196]. - Market acceptance by physicians, patients, and payors remains uncertain, affecting potential market opportunities[196]. - The company is subject to risks related to hiring and retaining qualified personnel, which could impact growth management[196]. - Changes in government regulations and tightening credit markets may affect capital access[196]. - The company has no obligation to update forward-looking statements unless required by law[197]. - As a smaller reporting company, the company is not required to provide specific market risk disclosures[198].

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.

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 - 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]