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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.001 par value per share CELC The Nasdaq Stock Market LLC 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, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Co ...

Exhibit 99.1 Celcuity Inc. Reports Second Quarter Financial Results and Provides Corporate Update - Announced plan to initiate Phase 3 VIKTORIA-2 trial evaluating gedatolisib combined with fulvestrant plus a CDK4/6 inhibitor as first-line treatment for patients with HR+, HER2- advanced breast cancer; expect to enroll first patient in Q2 2025 - Expect to reach enrollment target for VIKTORIA-1 PIK3CA WT cohort in Q4 2024 and report topline data for this cohort in late Q4 2024 or Q1 2025 - Raised $129 million ...