Celcuity Inc Stock Price, News & Analysis

Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company, announced its participation in the Canaccord Genuity 42nd Annual Growth Conference in Boston from August 8-11, 2022. CEO Brian Sullivan will present on August 10 at 11:30 a.m. ET. A live webcast will be accessible via this link and from the company's Investors section. Celcuity focuses on developing targeted therapies for hormonally driven cancers, including its lead candidate gedatolisib, expected to enter Phase 3 trials for advanced breast cancer in 2022.

Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company, has received FDA Breakthrough Therapy designation for gedatolisib, a potential treatment for HR+/HER2- metastatic breast cancer in patients whose condition has worsened after receiving CDK4/6 therapy and an aromatase inhibitor. This designation enables expedited development and review, emphasizing gedatolisib's potential to improve significant clinical outcomes. Gedatolisib acts as a pan-PI3K/mTOR inhibitor and is set to enter Phase 3 clinical trials in 2022.

MINNEAPOLIS, MN / ACCESSWIRE / May 26, 2022 / Celcuity (NASDAQ:CELC) announced that CEO Brian Sullivan will participate in two investor conferences: the 19th Annual Craig-Hallum Institutional Investor Conference on June 1, 2022 (virtual), and a fireside chat at the Jefferies Healthcare Conference in New York on June 9, 2022, at 2:30 p.m. ET. A live webcast will be available for the Jefferies event. Celcuity focuses on advancing cancer treatment through its lead candidate, gedatolisib, and its CELsignia companion diagnostic platform, aiming for a Phase 3 study in HR+/HER2- advanced breast cancer.

Celcuity (NASDAQ:CELC) announced a $100 million private placement agreement aimed at supporting the clinical development of gedatolisib for HR+/HER2- advanced breast cancer. The company reported a net loss of $7.9 million or $0.53 per share for Q1 2022, compared to a loss of $2.8 million or $0.25 per share in Q1 2021. Operating expenses grew to $7.5 million, significantly driven by R&D costs for gedatolisib. The FDA granted Fast Track designation for gedatolisib, positioned to address unmet needs in targeted therapies.

Celcuity Inc. (Nasdaq:CELC) announced a $100 million private placement to advance gedatolisib clinical development, specifically the Phase 3 study VIKTORIA-1. Lead investor Venrock Healthcare Capital Partners participated alongside others, with shares priced at $5.75. The placement will support clinical activities and general corporate needs. The closing hinges on the first patient enrollment in VIKTORIA-1, anticipated by year-end 2022. Results are expected in late 2024. The company also plans to register resale securities with the SEC.

Celcuity Inc. (NASDAQ:CELC) will announce its Q1 2022 financial results on May 16, 2022, post-market close. A webcast and conference call are scheduled for the same day at 4:30 p.m. ET to discuss results and corporate updates. The company is focused on an integrated therapeutic and companion diagnostic strategy for cancer treatment. Its lead drug, gedatolisib, is a dual inhibitor targeting PI3K and mTOR, with a Phase 3 study expected to begin in 2022 for HR+/HER2- advanced breast cancer. More details can be found on its website.

Celcuity Inc. (NASDAQ:CELC) has announced participation in two upcoming virtual investor conferences. Chairman and CEO Brian Sullivan will present at the 21st Annual Needham Healthcare Conference on April 12, 2022, at 3:45 p.m. ET, with a live webcast available here. He will also present at the Canaccord Genuity Horizons in Oncology Conference on April 14, 2022, at 11 a.m. ET, with a live webcast here. Webcasts will be accessible from their website shortly after the events.

Celcuity announced its finalized pivotal Phase 3 trial design for gedatolisib, which received FDA Fast Track designation for HR+/HER2- metastatic breast cancer. The trial, named VIKTORIA-1, will evaluate gedatolisib combined with fulvestrant, with or without palbociclib. Management reported a net loss of $6.8 million for Q4 2021, with total operating expenses reaching $6.3 million. Cash and cash equivalents as of December 31, 2021, totaled $84.3 million, a significant increase from $11.6 million in the prior year. A webcast to discuss these results was held on March 23, 2022.

Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company, announced it will release its financial results for Q4 and full year 2021 on March 23, 2022, after market close. A webcast will follow at 4:30 p.m. ET for discussion of results and corporate updates. Celcuity's mission focuses on extending cancer patients' lives through an integrated therapeutic and diagnostic approach. The CELsignia diagnostic platform uniquely identifies suitable patient groups for existing targeted therapies.