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]

Exhibit 99.1 Celcuity Inc. Reports Third Quarter Financial Results and Provides Corporate Update - The PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial is 100% enrolled; expect to report topline data for this cohort in late Q1 2025 or Q2 2025 - Approximately $264 million in cash, cash equivalents and investments at end of Q3 2024 expected to fund current clinical development program activities through 2026 - Management to host webcast and conference call today, November 14, 2024, at 4:30 p.m. ET MINN ...

The PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial is 100% enrolled; expect to report topline data for this cohort in late Q1 2025 or Q2 2025Approximately $264 million in cash, cash equivalents and investments at end of Q3 2024 expected to fund current clinical development program activities through 2026 Management to host webcast and conference call today, November 14, 2024, at 4:30 p.m. ET MINNEAPOLIS, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology ...

MINNEAPOLIS, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences: A fireside chat at the Stifel 2024 Healthcare Conference at 1:15 p.m. ET on Tuesday, November 19, 2024. A live webcast will be available using this ...

MINNEAPOLIS, Nov. 07, 2024 (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 2024 after the market closes on Thursday, November 14, 2024. 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 InformationTo participate in ...

Celcuity, Inc. (CELC) closed the last trading session at $15.23, gaining 1.1% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $28.57 indicates an 87.6% upside potential. The average comprises seven short-term price targets ranging from a low of $23 to a high of $39, with a standard deviation of $4.96. While the lowest estimate indicates an increase of 51% from the current price lev ...

Celcuity, Inc. (CELC) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices. A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years. Individual invest ...

Celcuity Inc. (NASDAQ:CELC) Q2 2024 Earnings Conference Call August 14, 2024 4:30 AM ET Company Participants Maria Yonkoski - ICR Westwicke, IR Brian Sullivan - Co-Founder and CFO Vicky Hahne - Chief Financial Officer Igor Gorbatchevsky - Chief Medical Officer Conference Call Participants Maury Raycroft - Jefferies Tara Bancroft - TD Cowen Brad Canino - Stifel Operator Good afternoon, ladies and gentlemen, and welcome to the Celcuity Second Quarter 2024 Financial Results Conference Call. At this time all li ...