Celcuity Inc. develops targeted oncology therapies as a clinical-stage biotechnology company, with news centered on gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor for solid tumors. Company updates frequently cover Phase 3 VIKTORIA-1 data in HR+/HER2- advanced breast cancer, including PIK3CA wild-type and mutant cohorts and combination regimens with fulvestrant and palbociclib.
Recurring announcements also address FDA regulatory submissions and review status for gedatolisib, publications and medical-meeting presentations, quarterly financial results, corporate updates, investor conference participation, and board governance changes.
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.
Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company, will participate in the virtual Cowen 42nd Annual Health Care Conference from March 7-9, 2022. Brian Sullivan, the CEO, will join the "Breast Cancer" panel session on March 9 at 2:10 p.m. ET. Investors can access a live webcast of the event via this link or through the company's website, with a replay available post-event.
Celcuity focuses on developing targeted therapies and companion diagnostics to improve cancer treatment.
Celcuity has received FDA Fast Track designation for its drug gedatolisib, aimed at treating HR+/HER2- metastatic breast cancer after CDK4/6 therapy failure. This designation accelerates development and approval opportunities. The company plans to finalize Phase 3 trial design by Q1 2022 and initiate two Phase 2 trials to evaluate gedatolisib in select patients based on CELsignia tests. With an anticipated enrollment of 40%-45% of tested patients qualifying for trials, Celcuity aims to enhance patient screening and maximize participation.
Celcuity Inc. (Nasdaq:CELC) presented updated results from a Phase 1b study at the 2021 San Antonio Breast Cancer Symposium. The study evaluated gedatolisib combined with palbociclib and endocrine therapy for treating women with ER+/HER2- advanced breast cancer. Notably, a 78% objective response rate (ORR) was reported in patients with two or more prior treatments and a 63% ORR overall. Gedatolisib showed good tolerability with minimal discontinuations due to adverse events. The company plans to initiate a Phase 3 trial in the first half of 2022.
Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology firm, has announced the acceptance of a poster presentation at the 2021 San Antonio Breast Cancer Symposium (SABCS) taking place from December 7-10, 2021. The poster titled "Phase 1b expansion study of gedatolisib in combination with palbociclib and endocrine therapy in women with ER+ advanced breast cancer" will be presented by Dr. Rachel M. Layman on December 10, 2021, during Poster Session 5 from 7 - 8:30 a.m. CT. The presentation will also be available on Celcuity's website.