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 the pricing of its underwritten public offering, which includes 2,250,000 shares at $25.00 each, aiming for gross proceeds of about $56.25 million. The offering has a 30-day option for underwriters to buy an additional 337,500 shares. Closing is expected on July 1, 2021. Proceeds will support working capital, R&D, and business expansion efforts. The company emphasizes its focus on innovative cancer treatments through its CELsignia platform.
Celcuity Inc. (CELC) announced the launch of an underwritten public offering of its common stock. The offering includes a 30-day option for underwriters to purchase an additional 15% of shares. Proceeds from the offering will be used for working capital and general corporate purposes, including R&D and clinical trials. Jefferies and Cowen are acting as joint bookrunning managers, with additional participation from Canaccord Genuity and Needham & Company. The actual size and terms of the offering remain subject to market conditions.
Celcuity Inc. (NASDAQ:CELC) announced the hiring of two senior executives to strengthen its clinical team: Dr. Igor Gorbatchevsky as VP of Clinical Development and Jill Krause as VP of Clinical Operations. Both leaders bring extensive experience from previous roles in oncology and clinical operations. Celcuity is advancing gedatolisib, a dual inhibitor targeting PI3K/mTOR, with promising Phase 1b trial results. The company plans to initiate a Phase 3 trial for ER+/HER2- metastatic breast cancer, pending FDA feedback, aiming to enhance patient treatment options.
Celcuity (NASDAQ:CELC) announced a global licensing agreement with Pfizer for gedatolisib, aimed at treating ER+/HER2-negative metastatic breast cancer. Preliminary Phase 1b trial results show a 60% objective response rate. The company secured $43 million in financing and entered collaborations for clinical trials with leading research centers, including Novartis and Puma. Total operating expenses were $2.79 million, with a net loss of $2.79 million or $0.25 per share. Cash reserves reached $34.9 million at the end of Q1 2021, expected to grow with new funding.
Celcuity Inc. (NASDAQ:CELC) will release its financial results for the first quarter of 2021 on May 10, 2021, after market close. The management team will host a webcast/conference call at 4:30 p.m. ET to discuss these results. Celcuity focuses on extending cancer patients' lives through its CELsignia companion diagnostic platform, which analyzes live tumor cells to identify suitable targeted therapies. The company aims to align its diagnostics with therapeutic developments to enhance patient outcomes.
Celcuity Inc. (NASDAQ:CELC) presented new findings at the AACR Annual Meeting regarding gedatolisib, a pan-PI3K/mTOR inhibitor, which inhibited hyperactive RAS network signaling significantly more effectively than a PI3K-α inhibitor. Key data revealed that gedatolisib was nine times more effective in inhibiting such signaling. Additionally, it was noted that combining gedatolisib with a BCL inhibitor like navitoclax could enhance anti-tumor effects. The company aims to start a Phase 2/3 clinical trial in 2022 for advanced breast cancer.
Celcuity Inc. (Nasdaq:CELC) announced promising preliminary data from its Phase 1b trial of gedatolisib, a dual PI3K/mTOR inhibitor, in 103 patients with advanced ER+/HER2- breast cancer. As of January 11, 2021, 60% of evaluable patients achieved an objective response, with 75% showing clinical benefit. Gedatolisib was well tolerated, with most side effects being mild. The company plans to initiate a Phase 2/3 trial in H1 2022, subject to FDA feedback. Additionally, Celcuity secured a $25 million debt financing agreement for further development.
Celcuity Inc. (Nasdaq:CELC) has signed a global licensing agreement with Pfizer Inc. for exclusive rights to gedatolisib, a Phase 1b pan-PI3K/mTOR inhibitor aimed at treating ER+/HER2-negative advanced breast cancer. Celcuity paid $10 million, comprising cash and stock, to Pfizer. Pfizer is entitled to potential milestone payments of up to $330 million and tiered royalties on sales. Gedatolisib shows promise in overcoming endocrine resistance in breast cancer patients, and a Phase 2/3 clinical trial is set to initiate in 2022, pending FDA feedback.
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.