Welcome to our dedicated page for Celcuity news (Ticker: CELC), a resource for investors and traders seeking the latest updates and insights on Celcuity stock.
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 Inc. (Nasdaq: CELC) announced a collaboration for a Phase II clinical trial with MD Anderson Cancer Center, Novartis, and Puma Biotechnology. The study will evaluate the efficacy of TABRECTA® and NERLYNX® in metastatic HER2-negative breast cancer using Celcuity’s CELsignia Multi-Pathway Activity Test for patient selection. MD Anderson leads the trial, expecting interim results 12-15 months post-activation. Celcuity believes there's significant interest in new therapies for patients whose cancers have progressed, marking this as their fifth collaboration in cancer research.
Celcuity Inc. (NASDAQ:CELC) announced the closing of its public offering of 1,971,100 shares of common stock on February 26, 2021, raising gross proceeds of $27.6 million. This includes 257,100 shares from the underwriter's full exercise of their option for over-allotments. The shares were sold at $14.00 each, under an effective shelf registration statement filed with the SEC. The managing underwriter for this offering was Craig-Hallum Capital Group. The funds raised will support Celcuity's ongoing development of its 3rd generation diagnostic platform for cancer treatment.
Celcuity Inc. (NASDAQ:CELC) has priced an upsized underwritten public offering of 1,714,000 shares at $14.00 per share, aiming for gross proceeds of approximately $24 million. This offering, set to close on February 26, 2021, includes a 30-day option for the underwriter to purchase an additional 257,100 shares. Proceeds from the offering will be utilized for working capital and general corporate purposes, including R&D and clinical trials. The offering is conducted under an effective shelf registration statement previously filed with the SEC.
Celcuity Inc. (NASDAQ:CELC) announced a public offering of $20 million in common stock, with a potential additional 15% available for purchase by the underwriter within 30 days. The funds will be used for working capital, including research and development and clinical trials. The offering is pending market conditions and is being managed by Craig-Hallum Capital Group. The shares are being offered under an effective shelf registration statement previously filed with the SEC.
Celcuity announced a collaboration with Massachusetts General Hospital, UCLA, and others to conduct a Phase II trial for cancer treatments. Financial results for Q4 and the fiscal year 2020 showed a net loss of $2.55 million in Q4, up from $1.81 million in Q4 2019, with total expenses rising to $9.56 million for the year. The company expects interim results from its FACT-1 and FACT-2 trials in late 2021 or early 2022, while additional clinical trial collaborations are anticipated. Cash and equivalents dropped to $11.6 million from $18.7 million year-over-year.
Celcuity Inc. (Nasdaq: CELC) has announced a collaboration with Sarah Cannon Research Institute and Pfizer to conduct a Phase II clinical trial for metastatic HER2-negative breast cancer. The trial will assess the efficacy of Pfizer's therapies, VIZIMPRO and XALKORI, using Celcuity's CELsignia Multi-Pathway Activity Test to select patients. Enrollment is expected to start in Q2 2021, with interim results projected 12-15 months post-activation. This trial marks Celcuity's fourth collaboration in clinical oncology, indicating significant potential for new treatment options in this population.
Celcuity Inc. (Nasdaq: CELC), a biotechnology firm focused on developing companion diagnostics for cancer, announced that CEO Brian Sullivan will present at the B. Riley Oncology Investor Conference on January 21, 2021, at 1:00 pm ET. Attendees can register for the live webcast and participate in online one-on-one meetings with Mr. Sullivan. Following the event, a replay of the presentation will be available on Celcuity's website. The company’s CELsignia platform aims to improve cancer diagnostics and expand treatment options for patients.
Celcuity Inc. (NASDAQ:CELC) has announced a Phase II clinical trial collaboration with Massachusetts General Hospital and Puma Biotechnology to assess the efficacy and safety of NERLYNX and FASLODEX in HR-positive, HER2-negative metastatic breast cancer patients. The trial will utilize Celcuity's CELsignia HER2 Activity Test to identify eligible patients, with interim results expected in 12 to 15 months. Celcuity will cover patient-related costs, marking their first collaboration focusing on targeted therapies for this patient population. The trial aims to address resistance to anti-estrogen therapies.
Celcuity Inc. (NASDAQ:CELC) reported its third quarter results for 2020, revealing a net loss of $2.47 million or $0.24 per share, a decline from $1.98 million or $0.19 per share in Q3 2019. Operating expenses rose to $2.48 million from $2.09 million year-over-year, driven by increased R&D and G&A costs. The company holds $13.7 million in cash, expected to fund operations through 2021. Upcoming collaborations with pharmaceutical companies on cancer trials are progressing, with interim results from FACT-1 and FACT-2 trials anticipated in late 2021.
Celcuity Inc. (Nasdaq: CELC) has announced the release of its financial results for the third quarter of 2020 on November 9, 2020, after market close. A teleconference will follow at 4:30 p.m. ET to discuss these results. The company specializes in innovative cancer diagnostics through its CELsignia platform, which analyzes living tumor cells to identify new cancer sub-types that traditional diagnostics may miss. This advancement aims to improve patient outcomes and enhance targeted therapy definitions.