Financial Data and Key Metrics Changes - The company reported a net loss of $45.3 million or $1.04 per share for Q2 2025, compared to a net loss of $23.7 million or $0.62 per share for Q2 2024, indicating a significant increase in losses [26] - Non-GAAP adjusted net loss was $40.5 million or $0.93 per share for Q2 2025, compared to a non-GAAP adjusted net loss of $22.2 million or $0.58 per share for Q2 2024 [26] - Research and development expenses increased to $40.2 million for Q2 2025 from $22.5 million in Q2 2024, driven by increased employee and consulting expenses and costs related to ongoing clinical trials [26][27] - General and administrative expenses rose to $3.8 million for Q2 2025 from $1.8 million in Q2 2024, primarily due to increased employee and consulting expenses [27] - The company ended the quarter with approximately $168.4 million in cash, cash equivalents, and short-term investments, which is expected to increase to approximately $455 million after accounting for recent financing activities [28] Business Line Data and Key Metrics Changes - The company achieved significant milestones in its clinical trials, including positive top-line data from the VICTORIA-one trial for patients with HR positive HER2 negative advanced breast cancer, demonstrating unprecedented improvements in progression-free survival (PFS) [6][10] - The median PFS for the gadatholitinib triplet was reported at 9.3 months compared to 2 months for fulvestrant, with a hazard ratio of 0.24, indicating a 4.2 times higher likelihood of survival without disease progression [10][11] - The company also dosed the first patient in the VICTORIA-two trial, which evaluates gadatholitinib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment [8][18] Market Data and Key Metrics Changes - The addressable market potential for a standard of care second-line therapy for the targeted patient population is estimated at approximately $5 billion [18] - There are approximately 34,000 patients moving to second-line treatment after progressing on a CDK4/6 inhibitor, with around 60% being PIK3CA wild type, indicating a large opportunity for the company's therapies [14] Company Strategy and Development Direction - The company aims to establish gadatholitinib as a new standard of care therapy for patients with HR positive HER2 negative advanced breast cancer, focusing on both PIK3CA wild type and mutated populations [6][10] - The company plans to submit a new drug application to the FDA in 2025 based on data from the PIK3CA wild type cohort [13] - The company is preparing for a potential launch of gadatholitinib, having built a commercial team and infrastructure to support the launch [48][52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the market landscape for gadatholitinib, highlighting the significant unmet need for more efficacious therapies in the second-line treatment space [14][15] - The company believes that the favorable safety profile and efficacy of gadatholitinib will position it well against currently available therapies [12][15] - Management is confident in the robustness of the data and the preparations for the NDA submission, indicating a strong belief in the potential approval and market entry [70] Other Important Information - The company raised approximately $287 million through public offerings of convertible notes, common stock, and pre-funded warrants, providing necessary funding for its operations and clinical trials [10][24] - A new patent was issued extending the exclusivity of gadatholitinib into 2042, allowing the company to optimize its development strategy [23][24] Q&A Session Summary Question: What to expect from the upcoming full data presentation for the PIK3CA wild type portion of the Phase III study? - The company will focus on primary analyses and endpoints, with additional subgroup analyses expected at subsequent meetings [30][31] Question: What benchmarks for success are considered for the PIK3CA mutant population? - A statistically significant result would be clinically meaningful if it shows an improvement of less than three months compared to historical data [32] Question: Can more safety data be provided ahead of the full presentation? - Detailed safety data will be provided at the upcoming conference, with a general summary available at this stage [37] Question: Will PFS analysis based on investigator assessment be presented later this year? - The selection of BICR for the study was to eliminate investigator bias, and the investigator data will be used for exploratory analysis [40][42] Question: How is the company preparing for launch readiness? - The company has been building its team and infrastructure since last year, focusing on key positions to support the launch [48][52] Question: What are the practical ramifications for physicians with both doublet and triplet options? - Having both regimens allows physicians to optimize treatment based on patient needs, providing flexibility in managing disease progression [55][56] Question: Is there a consideration for a commercial partnering strategy for the launch? - The company plans to launch itself, believing it has the necessary infrastructure and capital to do so effectively [58][59] Question: What are the competitive landscape thoughts regarding the mutant population? - The company believes that positive data will position it well against competitors, particularly in the context of PIK3CA mutations [65][66]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-38207 CELCUITY INC. (Exact name of registrant as specified in its charter) Delaware No. 82-2863566 (State of incorporation) (IRS Emp ...

Exhibit 99.1 Celcuity Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate Update MINNEAPOLIS, August 14, 2025 — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the second quarter ended June 30, 2025 and other recent business developments. "We have had an eventful past few months at Celcuity. Last month, we announced positive topline data from the PIK3CA wild-type cohort o ...

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 PAM pathway comprehensively [3] - Celcuity is headquartered in Minneapolis and provides further information on its website [3] Clinical Trials - A Phase 3 clinical trial, VIKTORIA-1, is currently enrolling patients to evaluate gedatolisib in combination with fulvestrant with or without palbociclib for HR+/HER2- advanced breast cancer [3] - A Phase 1/2 clinical trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3] - Another Phase 3 clinical trial, VIKTORIA-2, is enrolling patients to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [3] Upcoming Financial Results - Celcuity will release its financial results for the second quarter of 2025 after the market closes on August 14, 2025 [1] - Management will host a webcast/teleconference on the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update [1]

Group 1 - Celcuity (NASDAQ: CELC) recently announced positive results from its phase 3 VIKTORIA-1 trial, which tested its drug gedatolisib in combination with other therapies for treating patients with PIK3CA wildtype HR+/HER2- advanced breast cancer [2] - The trial involved a triplet therapy approach, indicating a potential advancement in treatment options for this specific type of breast cancer [2] Group 2 - The Biotech Analysis Central service offers in-depth analysis of various pharmaceutical companies, including a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2] - The service is available for $49 per month, with a discounted yearly plan at $399, providing a 33.50% savings for subscribers [1]

Core Viewpoint - Celcuity Inc. has announced the pricing of its public offerings, including $175 million in convertible senior notes and approximately 1.84 million shares of common stock at $38.00 per share, aiming to raise a total of approximately $248.7 million for various corporate purposes [1][6]. Offering Details - The company is offering $175 million in 2.750% convertible senior notes due 2031, with an option for underwriters to purchase an additional $26.25 million to cover over-allotments [1][2]. - The common stock offering includes 1,836,842 shares priced at $38.00 each, with pre-funded warrants available at $37.999 per warrant [1][2]. Financial Terms - The convertible notes will accrue interest at 2.750% per year, payable semiannually, and will mature on August 1, 2031 [3]. - The initial conversion rate for the convertible notes is set at 19.4932 shares of common stock per $1,000 principal amount, equating to a conversion price of approximately $51.30 per share, representing a 35% premium over the common stock offering price [4]. Closing Timeline - The expected closing date for the convertible notes offering is August 1, 2025, while the common stock offering is anticipated to close on July 31, 2025, subject to customary closing conditions [5]. Use of Proceeds - The net proceeds from both offerings are estimated to be approximately $248.7 million, which will be used for working capital, clinical trial expenditures, and other general corporate purposes [6]. Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, with its lead candidate, gedatolisib, currently undergoing multiple clinical trials for various cancer indications [11].

Core Viewpoint - Celcuity Inc. is conducting public offerings of $150 million in convertible senior notes and $75 million in common stock to support its oncology-focused development efforts [1][4]. Group 1: Offerings Details - The company plans to offer $150 million in convertible senior notes due in 2031 and $75 million in common stock, with options for underwriters to purchase additional amounts [1][2]. - The convertible notes will be unsecured, with interest payable semi-annually, maturing on August 1, 2031, unless converted or redeemed earlier [3]. - The net proceeds from both offerings will be used for capped call transactions, working capital, and general corporate purposes, including clinical trials and business development [4]. Group 2: Capped Call Transactions - The company expects to enter capped call transactions to mitigate potential dilution from the convertible notes, which will cover shares of common stock underlying the notes [6]. - These transactions are designed to offset cash payments exceeding the principal amount of converted notes, subject to a cap [6]. - The option counterparties may engage in derivative transactions that could influence the market price of the common stock and convertible notes [7][8]. Group 3: Management and Underwriters - Jefferies, TD Cowen, and Leerink Partners are the joint book-running managers for the offerings, with LifeSci Capital acting as lead manager for the convertible notes [9]. - The company has filed a registration statement with the SEC regarding these offerings, providing necessary documentation for potential investors [10]. Group 4: Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for solid tumors, with its lead candidate being gedatolisib, a pan-PI3K and mTORC1/2 inhibitor [12]. - Ongoing clinical trials include VIKTORIA-1 for advanced breast cancer and CELC-G-201 for metastatic castration-resistant prostate cancer [12].

Summary of Celcuity (CELC) Investor Call - July 28, 2025 Company Overview - **Company**: Celcuity (CELC) - **Focus**: Development of geditalisib for HR positive, HER2 negative advanced breast cancer Key Industry Insights - **Clinical Trial**: Phase III VICTORIA-one trial results presented - **Target Population**: Patients with HR positive, HER2 negative advanced breast cancer, specifically those with PIK3CA wild type tumors Core Findings and Results - **Progression-Free Survival (PFS)**: - **Triplet Regimen (geditalisib + fulvestrant + palbociclib)**: Median PFS of 9.3 months vs. 2 months for fulvestrant alone, with a hazard ratio of 0.24, indicating a 4.2 times higher likelihood of survival without disease progression [10][25] - **Doublet Regimen (geditalisib + fulvestrant)**: Median PFS of 7.4 months vs. 2 months for fulvestrant alone, with a hazard ratio of 0.33, indicating a 3 times higher likelihood of survival without disease progression [11][26] - **Significance**: These results are unprecedented in the treatment of this patient population, establishing new milestones in drug development [11][12] Mechanism of Action - **PAM Pathway**: Geditalisib targets the PAM pathway, which is crucial in cancer progression. The drug provides comprehensive blockade of the pathway, reducing the potential for adaptive resistance [8][19] - **Efficacy Across Mutation Status**: Preliminary data shows objective response rates over 50% in patients with or without PIK3CA mutations [20] Safety and Tolerability - **Adverse Events**: Both triplet and doublet regimens were well tolerated, with lower discontinuation rates due to treatment-related adverse events compared to previous studies [28][44] - **Overall Survival Trends**: Positive trends observed, although data is still immature due to crossover from the control arm [29][60] Market Opportunity - **Patient Population**: Estimated 34,000 patients transitioning to second-line treatment after CDK4/6 inhibitors, with approximately 60% being PIK3CA wild type [46] - **Market Size**: Projected market opportunity of $5 billion for geditalisib [46] - **Reimbursement Dynamics**: IV administered drugs like geditalisib typically face smoother reimbursement processes compared to oral drugs [46] Future Plans - **NDA Submission**: Anticipated submission for geditalisib in Q4 2025 [52] - **Upcoming Data Presentations**: Full results from the VICTORIA-one trial to be presented at major medical conferences [30][52] - **Continued Research**: Ongoing studies to explore the efficacy of geditalisib in combination with other therapies, including oral SERDs [74] Conclusion - **Strategic Positioning**: Celcuity is well-positioned to address significant unmet needs in the treatment of HR positive, HER2 negative advanced breast cancer, with geditalisib showing promising clinical results and a strong market opportunity ahead [48][49]

Core Insights - Celcuity Inc. is set to disclose topline results from the Phase 3 VIKTORIA-1 trial on July 28, 2025 [1][2] - The company focuses on developing targeted therapies for oncology, particularly for solid tumors [3] Company Overview - Celcuity is a clinical-stage biotechnology company headquartered in Minneapolis [3] - The lead therapeutic candidate is gedatolisib, a pan-PI3K and mTORC1/2 inhibitor, which targets the PAM pathway [3] - Ongoing clinical trials include VIKTORIA-1 for HR+/HER2- advanced breast cancer and CELC-G-201 for metastatic castration-resistant prostate cancer [3]

Core Insights - Celcuity Inc. has initiated the Phase 3 clinical trial VIKTORIA-2 to evaluate gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant for HR+/HER2- advanced breast cancer patients who are resistant to endocrine therapy [1][2][3] Group 1: Clinical Trial Details - The VIKTORIA-2 trial is an open-label, randomized study comparing the efficacy and safety of gedatolisib combined with fulvestrant and a CDK4/6 inhibitor against the standard treatment of fulvestrant and a CDK4/6 inhibitor [3][4] - Approximately 638 subjects will be enrolled, with random assignment to either the experimental group (gedatolisib, fulvestrant, and a CDK4/6 inhibitor) or the control group (fulvestrant and a CDK4/6 inhibitor) [4] - The trial will assess primary endpoints of progression-free survival (PFS) based on RECIST 1.1 criteria, evaluated separately for PI3KCA wild type and mutant subjects [4] Group 2: Efficacy and Safety - Previous Phase 1b trial results indicated that patients receiving gedatolisib with palbociclib and letrozole had a median progression-free survival of 48.6 months and median overall survival of 77.3 months, with an objective response rate of 79% [2] - The trial aims to provide robust data to support the potential of gedatolisib as a first-line treatment option for patients with endocrine-resistant advanced breast cancer [2][3] Group 3: Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumor indications, with gedatolisib as its lead candidate [5][6] - The company is headquartered in Minneapolis and is also conducting other clinical trials, including VIKTORIA-1 and CELC-G-201, targeting different cancer types [5][6]