Celcuity Inc Stock Price, News & Analysis

Celcuity Inc. (Nasdaq:CELC) has announced the recruitment of two senior executives, Michael Snitkovsky as VP of Program Management and David Bridge as VP of Quality Assurance and Process Development. Michael brings over 15 years of drug development experience, while David has a solid background in quality assurance compliance. Their expertise is expected to strengthen Celcuity's leadership and enhance its clinical development initiatives, particularly aimed at improving cancer patient outcomes through innovative therapies and companion diagnostics.

Celcuity Inc. (NASDAQ:CELC) has entered into a clinical trial collaboration and supply agreement with Pfizer to provide Ibrance® (palbociclib) at no cost for its upcoming Phase 3 clinical trial aimed at treating ER+/HER2- advanced breast cancer. The trial will evaluate the efficacy of gedatolisib combined with palbociclib and Faslodex® (fulvestrant). Anticipated initiation is in the first half of 2022. Positive outcomes from a Phase 1b trial indicate potential for addressing unmet needs in treatment options for patients who have progressed on their first-line therapy.

Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company focused on cancer treatment, will have its CEO Brian Sullivan participate in virtual investor meetings at two upcoming conferences. The 12th Annual Craig-Hallum Alpha Select Conference is scheduled for November 16, 2021, followed by the Jefferies London Healthcare Conference on November 18-19, 2021. Celcuity utilizes a unique CELsignia companion diagnostic platform to identify patients who could benefit from targeted therapies by analyzing live tumor cells.

Celcuity Inc. (NASDAQ: CELC) reported financial results for Q3 2021, showing a net loss of $6.0 million or $0.41 per share, up from a loss of $2.5 million or $0.24 per share year-over-year. Operating expenses rose to $5.6 million, primarily driven by R&D costs of $5.0 million associated with the gedatolisib program. The company plans to initiate a Phase 3 trial for gedatolisib in early 2022 and update Phase 1b data at the San Antonio Breast Cancer Symposium in December. Cash reserves increased to $90.4 million compared to $11.6 million at year-end 2020.

Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company, announced it will release its third quarter 2021 financial results on November 8, 2021, after the market closes. A webcast and teleconference will follow at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. The company focuses on extending cancer patients' lives through an integrated companion diagnostic and therapeutic strategy, utilizing its CELsignia platform to identify patients likely to benefit from targeted therapies.

Celcuity announced a Phase 2 clinical trial collaboration with the University of Rochester Wilmot Cancer Center and Puma Biotechnology to evaluate NERLYNX (neratinib) combined with XELODA (capecitabine) in patients with metastatic HER2-negative breast cancer with brain metastases. The trial, utilizing Celcuity's CELsignia HER2 Activity Test to select patients, aims to find effective treatment options for this underserved group. Interim results are expected within 12-15 months post-enrollment.

Celcuity raised approximately $56.3 million through a follow-on public offering, enhancing its balance sheet to support clinical developments for gedatolisib, a potential first-in-class PI3K/mTOR inhibitor. Following the offering, Celcuity reported $94.4 million in cash on hand. Recent clinical trials showed a promising 65% objective response rate in a Phase 1 study combining gedatolisib with paclitaxel and carboplatin. The company plans to initiate a Phase 2/3 trial for ER+/HER2- metastatic breast cancer in early 2022.

Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology firm, will participate in the Canaccord Genuity 41st Annual Growth Conference from August 10-12, 2021. CEO Brian Sullivan will engage in a virtual fireside chat on August 12, 2021, at 8:30 a.m. ET. Interested parties can access the live webcast here or via the company’s Investors page. Celcuity focuses on enhancing cancer patient outcomes through its CELsignia diagnostic platform and related therapeutic strategies.

Celcuity Inc. (Nasdaq:CELC) will release its Q2 2021 financial results on August 9, 2021, after market close. A teleconference is scheduled for 4:30 p.m. Eastern Time on the same day to discuss the results. Celcuity focuses on cancer treatment through an integrated companion diagnostic and therapeutic strategy. Its CELsignia platform analyzes live tumor cells to identify cancer patients who may benefit from targeted therapies. For participation, dial 844-369-8770 (domestic) or 862-298-0840 (international).