Celcuity Inc. (CELC) Q4 2024 Earnings Conference Call March 31, 2025 04:30 PM ET Company Participants Vicki Hahn - Chief Financial OfficerBrian Sullivan - Chief Executive Officer and Co-FounderModerator - Conference Call ModeratorOperator - Call Operator/FacilitatorAparva Chaluri - Investor Relations, ICR Healthcare Conference Call Participants Frances Doval (on behalf of Tara Bancroft) - Analyst, Teddy CohenHeather - AnalystChase Knickerbocker - Analyst, Craig Hallam Capital GroupUnknown - Analyst, Craig H ...

Financial Performance - Net loss for Q4 2024 was $36.7 million, or $0.85 loss per share, compared to a net loss of $18.8 million, or $0.65 loss per share, for Q4 2023[13] - The net loss for the three months ended December 31, 2024, was $36,653,041, compared to a net loss of $18,848,472 for the same period in 2023, representing a 94.5% increase[22] - The total net loss for the twelve months ended December 31, 2024, was $111,779,105, compared to $63,779,116 for the same period in 2023, a 75.2% increase[22] - The non-GAAP adjusted net loss for the three months ended December 31, 2024, was $32,271,697, compared to $17,631,428 for the same period in 2023, indicating an increase of 83.1%[26] - The non-GAAP adjusted net loss per share for the three months ended December 31, 2024, was $0.75, compared to $0.61 for the same period in 2023, indicating a 22.9% increase[26] Operating Expenses - Total operating expenses for Q4 2024 were $36.4 million, up from $19.7 million in Q4 2023, representing an increase of 84.5%[7] - General and administrative (G&A) expenses for Q4 2024 were $3.0 million, up from $1.6 million in Q4 2023, an increase of 87.5%[11] - For the three months ended December 31, 2024, the total operating expenses were $36,430,131, a 84.8% increase from $19,729,273 in the same period of 2023[22] Research and Development - Research and development (R&D) expenses for Q4 2024 were $33.5 million, compared to $18.1 million in the prior-year period, reflecting an increase of 85.0%[8] - R&D expenses for the full year 2024 totaled $104.2 million, compared to $60.6 million in 2023, marking an increase of 72.0%[9] - Research and development expenses for the three months ended December 31, 2024, were $33,471,213, up from $18,081,194 in the same period of 2023, marking an increase of 85.1%[22] Cash and Investments - Cash, cash equivalents, and short-term investments were approximately $235.1 million at the end of Q4 2024, expected to fund clinical development activities through 2026[5] Trials and Clinical Development - The VIKTORIA-1 Phase 3 trial is fully enrolled for the PIK3CA wild-type cohort, with topline data expected in Q2 2025[6] - The Phase 1b/2 trial for metastatic castration resistant prostate cancer is on track to report preliminary data in late Q2 2025[10] - The VIKTORIA-2 Phase 3 trial is expected to enroll its first patient in Q2 2025, with approximately 200 sites planned across multiple regions[6] Liabilities and Shares - Total liabilities increased to $129.5 million as of December 31, 2024, compared to $51.5 million at the end of 2023[20] - The weighted average common shares outstanding, basic and diluted, increased to 42,873,934 for the three months ended December 31, 2024, from 28,900,075 in the same period of 2023, a rise of 48.4%[26] Interest Income and Expense - Interest expense for the three months ended December 31, 2024, was $3,275,161, compared to $1,397,247 in the same period of 2023, reflecting a 134.0% increase[22] - Interest income for the three months ended December 31, 2024, was $3,052,251, up from $2,278,048 in the same period of 2023, representing an increase of 33.9%[22]

MINNEAPOLIS, March 31, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the fourth quarter ended December 31, 2024 and other recent business developments. "We expect 2025 to be a transformational year for Celcuity as we anticipate reporting several clinical data readouts, including primary analysis for the PIK3CA wild-type cohort of the VIKTORIA-1 trial. We expect to sh ...

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 mTOR inhibitor, which has differentiated pharmacokinetic properties compared to other therapies targeting PI3K or mTOR [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 1b/2 clinical trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3] - A second Phase 3 clinical trial, VIKTORIA-2, is expected to begin enrolling patients in Q2 2025, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [3] Financial Results Announcement - Celcuity will release its financial results for Q4 and full year 2024 after market close on March 31, 2025, followed by a webcast/teleconference at 4:30 p.m. Eastern Time [1]

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 mTOR inhibitor, which has differentiated pharmacokinetic properties compared to other therapies targeting PI3K or mTOR [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 1b/2 clinical trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3] - A second Phase 3 clinical trial, VIKTORIA-2, is expected to begin enrolling patients in Q2 2025, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [3] Financial Results Announcement - Celcuity will release its financial results for Q4 and full year 2024 after market close on March 31, 2025, followed by a webcast/teleconference at 4:30 p.m. Eastern Time [1]

Company Overview - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [1] - The company's lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTOR inhibitor, which has a differentiated mechanism of action compared to other therapies targeting PI3K or mTOR [1] 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 [1] - A Phase 1b/2 clinical trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [1] - A second Phase 3 clinical trial, VIKTORIA-2, is expected to begin enrolling patients in Q2 2025, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [1] Investor Engagement - Brian Sullivan, CEO and Co-founder of Celcuity, will present at investor conferences, including the TD Cowen 45th Annual Health Care Conference on March 4, 2025, and the Leerink Global Healthcare Conference 2025 on March 12, 2025 [2]

Group 1 - Celcuity is focused on developing gedatolisib, a pan-PI3K/mTOR inhibitor aimed at treating advanced breast cancer [1] - The company is currently undervalued, with its market valuation reflecting skepticism rather than its potential [1] - Gedatolisib has been designated as a Breakthrough Therapy, indicating its significance in the treatment landscape [1] Group 2 - The company operates in a high-growth sector, particularly in the field of innovative cancer therapies [1] - There is a strong belief in the potential of disruptive technologies to generate substantial returns in the investment landscape [1]

Core Insights - Celcuity Inc. announced promising overall survival data from a Phase 1b trial of gedatolisib in combination with palbociclib for patients with HR+, HER2- advanced breast cancer [1][2][3] Group 1: Clinical Trial Results - Median overall survival (OS) for treatment-naïve patients was reported at 77.3 months with a 95% confidence interval (CI) of 50.3 to 89.0 [2] - For patients previously treated with a CDK4/6 inhibitor, the median OS was 33.9 months with a 95% CI of 17.8 to 52.3 [2] - The results are favorable compared to existing first- or second-line standard-of-care regimens for the same patient population [3] Group 2: Mechanism and Development Strategy - Gedatolisib is a pan-PI3K/mTORC1/2 inhibitor that targets all Class I PI3K isoforms, potentially reducing drug resistance compared to isoform-specific inhibitors [4] - The clinical development strategy involves blocking multiple signaling pathways (ER, CDK4/6, and PAM) to enhance treatment efficacy [3] - Two Phase 3 clinical trials, VIKTORIA-1 and VIKTORIA-2, are planned to further evaluate this treatment strategy in HR+, HER2- advanced breast cancer [3][5] Group 3: Company Overview - Celcuity is a clinical-stage biotechnology company focused on targeted therapies for solid tumors, with gedatolisib as its lead candidate [5] - The company is currently enrolling patients for the VIKTORIA-1 trial and plans to begin the VIKTORIA-2 trial in Q2 2025 [5]

Financial Data and Key Metrics Changes - The net loss for Q3 2024 was $29.8 million or $0.70 per share, compared to a net loss of $18.4 million or $0.83 per share for Q3 2023 [32] - The non-GAAP adjusted net loss was $27.6 million or $0.65 per share for Q3 2024, compared to a non-GAAP adjusted net loss of $17.3 million or $0.78 per share for Q3 2023 [33] - Cash, cash equivalents, and short-term investments at the end of Q3 2024 were approximately $264.1 million, up from $180.6 million at December 31, 2023 [36] Business Line Data and Key Metrics Changes - Research and development expenses increased to $27.6 million in Q3 2024 from $17.5 million in Q3 2023, primarily due to activities supporting the VIKTORIA-1 and VIKTORIA-2 trials [34] - General and administrative expenses rose to $2.5 million in Q3 2024 from $1.4 million in Q3 2023, driven by employee and consulting-related expenses [35] Market Data and Key Metrics Changes - The company is on track to enroll the first patient in the VIKTORIA-2 Phase III trial in Q2 2025, with site qualification activities ongoing across multiple regions [24][25] Company Strategy and Development Direction - The company aims to establish a triplet regimen that includes gedatolisib to optimize antitumor control in HR-positive, HER2-negative advanced breast cancer [19][21] - Feedback from oncologists indicates a preference for delaying chemotherapy until the benefits of endocrine therapies are exhausted, which may favor gedatolisib's positioning [16][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for gedatolisib, particularly regarding its IV administration route and its expected peak revenue potential exceeding $2 billion [23] - The company is focused on the evolving treatment landscape and believes that simultaneous blockade of key signaling pathways is essential for improving patient outcomes [19] Other Important Information - The company plans to present clinical and non-clinical data at the San Antonio Breast Cancer Symposium in December, highlighting the progress made in clinical development [30] Q&A Session Summary Question: Insights on event rate and enrollment - Management noted that the higher proportion of mutated patients affected the enrollment rate for the wild-type population, but overall enrollment is ahead of expectations [40] Question: Impact of Roche's approval on gedatolisib - Management believes that the approval of inavolisib will not significantly reduce the patient population for gedatolisib, as their target population is different [43] Question: Expectations for mPFS numbers - Management indicated a desire to see two years of median progression-free survival (mPFS) and noted that a three-month delta relative to control would be meaningful [56][59] Question: Enrollment expectations for VIKTORIA-2 - Management is optimistic about enrollment rates for VIKTORIA-2, expecting them to be at least as good as VIKTORIA-1 due to the experience gained [65]

Clinical Trials and Drug Development - Celcuity's lead therapeutic candidate, gedatolisib, is a pan-PI3K/mTOR inhibitor currently in clinical trials for multiple solid tumor indications, including HR+, HER2- advanced breast cancer and metastatic castration resistant prostate cancer (mCRPC) [62] - As of September 30, 2024, 492 patients with solid tumors have received gedatolisib across eight completed clinical trials, with 129 treated as a single agent and 363 in combination with other anti-cancer agents [67] - In the Phase 1b clinical trial for HR+/HER2- metastatic breast cancer, the median progression-free survival (mPFS) was 48.6 months, and the overall response rate (ORR) was 79% for treatment-naïve patients [69] - The VIKTORIA-1 clinical trial is fully enrolled for the PIK3CA wild-type cohort, with topline data expected in late Q1 2025 or Q2 2025, and for the PIK3CA mutant cohort in the second half of 2025 [72] - The Phase 1b/2 study evaluating gedatolisib combined with darolutamide for mCRPC is ongoing, with preliminary data expected in Q2 2025 [82] - The VIKTORIA-2 Phase 3 clinical trial is set to enroll its first patient in Q2 2025, evaluating gedatolisib combined with fulvestrant and a CDK4/6 inhibitor [77] - The company plans to initiate a Phase 3 clinical trial, VIKTORIA-2, to evaluate gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant for advanced breast cancer [87] - The company is currently conducting a Phase 3 clinical trial (VIKTORIA-1) and a Phase 1b/2 study for gedatolisib, with plans for a Phase 3 trial (VIKTORIA-2) in the future [130] Financial Performance - For the three months ended September 30, 2024, the company reported a net loss of approximately $29.8 million, compared to a net loss of $18.4 million for the same period in 2023, representing a 62% increase in net loss [85] - Research and development expenses for the three months ended September 30, 2024, were approximately $27.6 million, an increase of 58% compared to $17.5 million in the same period in 2023 [96] - The company has an accumulated deficit of approximately $235.2 million as of September 30, 2024 [85] - General and administrative expenses for the three months ended September 30, 2024, were approximately $2.5 million, reflecting a 75% increase from $1.4 million in the same period in 2023 [99] - Interest expense for the three months ended September 30, 2024, was $3.3 million, an increase of 144% compared to $1.4 million in the same period in 2023 [101] - Interest income for the three months ended September 30, 2024, was $3.6 million, representing a 94% increase compared to $1.9 million in the same period in 2023 [103] - Research and development expenses for the nine months ended September 30, 2024, were approximately $70.7 million, an increase of 66% compared to $42.5 million in the same period in 2023 [97] - Net cash used in operating activities was approximately $55.7 million for the nine months ended September 30, 2024, primarily due to a net loss of approximately $75.1 million [121] - Net cash used in investing activities was approximately $100.6 million for the nine months ended September 30, 2024, mainly for net purchases of short-term investments [123] - Net cash provided by financing activities was approximately $138.2 million for the nine months ended September 30, 2024, primarily from incremental debt financing and an equity offering [125] Capital and Funding - The Company raised approximately $50.0 million through a private placement of pre-funded warrants on October 20, 2023 [106] - The Company sold 1,034,500 shares of common stock at $14.50 per share on December 1, 2023, generating gross proceeds of $15.0 million [107] - The Company raised approximately $60.0 million from an equity offering of 3,871,000 shares at $15.50 per share on May 30, 2024, resulting in net proceeds of approximately $56.3 million [108] - The Company entered into a loan agreement for up to $180 million, with $100 million funded on May 30, 2024, including $61.7 million of new borrowings [110] - The Company recognized a Final Fee of $4.5 million as additional debt principal under the loan agreement, to be amortized over the life of the loan [113] - The Company anticipates that its current cash and available borrowings will be sufficient to finance operations through 2026 [117] - The Company may seek additional capital to finance future expenditures and operations, which could result in dilution to existing shareholders [118] Strategic Plans and Future Outlook - If gedatolisib receives FDA approval for both PIK3CA wild-type and mutant populations, the peak revenue potential for the second-line indication could exceed $2 billion [72] - Gedatolisib has shown a favorable safety profile, with only 7% of patients experiencing Grade 3 or 4 hyperglycemia in clinical trials, compared to 39% for an FDA-approved oral p110-α specific inhibitor [66] - The company has exclusive global development and commercialization rights to gedatolisib under a license agreement with Pfizer, Inc. [63] - The company expects to incur increased research and development expenses as it continues to develop gedatolisib and manage clinical trials [116] - The company anticipates revenue growth and is exploring business development activities, including collaborations with pharmaceutical companies [130] - The company has sufficient cash on hand to fund research and development expenses, capital expenditures, and general corporate expenses [130] Compliance and Legal Matters - There were no changes in internal control over financial reporting during the three months ended September 30, 2024 [136] - The company is not currently involved in any legal proceedings that could materially affect its business or financial condition [137]