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 March 31, 2024 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 Em ...

Exhibit 99.1 Celcuity Inc. Reports First Quarter Financial Results and Provides Corporate Update - The Phase 3 VIKTORIA-1 trial remains on track to report topline data from PIK3CA wild type patient sub-group in the second half of 2024 - First patient dosed in a Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer - $177.7 million in cash, cash equivalents and short-term investments expected to provide runway into t ...

MINNEAPOLIS, May 08, 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 first quarter 2024 after the market closes on Wednesday, May 15, 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 Information To participate in the ...

MINNEAPOLIS, May 08, 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 first quarter 2024 after the market closes on Wednesday, May 15, 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 Information To participate in the ...

MINNEAPOLIS, April 04, 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 23rd Annual Needham Virtual Healthcare Conference at 2:15 p.m. ET on Thursday, April 11, 2024. A live webcast will be avail ...

公司活动 - Celcuity Inc.是一家临床阶段的生物技术公司，专注于开发针对多种实体肿瘤适应症的靶向疗法[3] - 公司的首席执行官Brian Sullivan将在投资者会议上进行演讲，并提供一对一投资者会议[1] 治疗候选药物 - Celcuity的主要治疗候选药物是gedatolisib，一种强效的全PI3K和mTOR抑制剂，其作用机制和药代动力学特性与目前已批准和正在研究的单独或联合靶向PI3K或mTOR的其他疗法有很大区别[3] 伴侣诊断平台 - 公司的CELsignia伴侣诊断平台能够分析活体患者肿瘤细胞，以识别新的癌症患者群体，这些患者可能从已批准的靶向疗法中受益[3]

Celcuity Inc. (NASDAQ:CELC) Q4 2023 Earnings Conference Call March 27, 2024 4:30 PM ET Company Participants Maria Yonkoski - ICR Westwicke Brian Sullivan - Chief Executive Officer and Co-Founder Vicky Hahne - Chief Financial Officer Igor Gorbatchevsky - Chief Medical Officer Conference Call Participants Tara Bancroft - TD Cowen Maury Raycroft - Jefferies Gil Blum - Needham & Company Bradley Canino - Stifel Nicolaus Swayampakula Ramakanth - H.C. Wainwright Alex Nowak - Craig-Hallum Capital Operator Good afte ...

Celcuity业务概况 - Celcuity是一家专注于肿瘤治疗的临床阶段生物技术公司[168] Gedatolisib药物特点 - Gedatolisib是一种靶向治疗药物，通过抑制所有Class I PI3K异构体和mTOR复合物来阻止肿瘤细胞生存[169] - Gedatolisib相比口服PI3K和mTOR药物更容易被患者耐受，减少了毒性[170] - Gedatolisib与palbociclib和内分泌治疗结合治疗HR+/HER2-晚期乳腺癌患者取得了良好的临床效果[173] Celcuity临床试验和诊断平台 - Celcuity正在进行VIKTORIA-1 Phase 3临床试验，评估gedatolisib在HR+/HER2-晚期乳腺癌患者中的疗效和安全性[174] - Celcuity的CELsignia诊断平台可以通过活体肿瘤细胞识别患者的癌症驱动因子，为靶向治疗提供指导[174] Celcuity的合作与发展 - Celcuity正在支持其他制药公司开发新的靶向治疗药物适应症，这些药物需要依赖CELsignia CDx选择患者[176] 财务状况 - 公司自成立以来从未盈利，截至2023年12月31日，累计亏损达1.601亿美元[178] - 2023年研发支出为6059.4万美元，较2022年同期增加2530.4万美元，增幅达72%[186] - 2023年总管理费用为560万美元，较2022年同期增加了150万美元，增幅为37%[187] - 2022年度经营活动中，净现金流出约为3600万美元，主要由约4040万美元的净亏损和约560万美元的非现金费用项组成[194] - 2023年度投资活动中，净现金流出约为500万美元，主要由约490万美元的购买政府证券和约100万美元的购买固定资产组成[196] - 2023年度融资活动中，净现金流入约为6490万美元，主要来自预先融资权证发行和ATM发行的净收益，总计6440万美元[197]

Exhibit 99.1 Celcuity Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update - Dosed the first patient in a Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide for the treatment of metastatic castration resistant prostate cancer - Presented nonclinical data demonstrating the superior therapeutic effects of gedatolisib compared to other PI3K/AKT/mTOR inhibitors at the 2023 SABCS - Raised $65 million from the sale of equity; expect cash, cash equiva ...

财报预测 - 分析师最新预测显示，CELC本季度每股亏损51美分，高于市场预期的每股亏损70美分[3] - 公司的Zacks Earnings ESP为+26.80%，显示出积极的盈利预期[3] 投资建议 - 公司的Zacks排名为3，加上正面的ESP，投资者可能会考虑在财报发布前购买该股[5]