Celcuity

Celcuity, Inc. is cellular analysis company. The company discovers new cancer sub-types and commercializing diagnostic tests designed to improve the clinical outcomes of cancer patients treated with targeted therapies. Its proprietary CELx diagnostic platform is the commercially ready technology that uses a patient's living tumor cells to identify the specific abnormal cellular process driving a patient's cancer and the targeted therapy that treats it. The company was founded by Brian F. Sullivan and Lance G. Laing in January 2012 and is headquartered in Minneapolis, MN.

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Celcuity reports strong Q4 performance with Phase 3 trial success

Celcuity's Q4 2022 earnings call showcased positive performance, with the initiation of a significant Phase 3 clinical trial and promising efficacy data.
While facing challenges such as increased expenses and potential trial delays, the company's strengths in innovation and financial stability position it well for future growth.
By leveraging opportunities in expanding studies, engaging with payers, and optimizing development strategies, Celcuity can navigate challenges and drive continued success in the oncology market.

Celcuity reports Q1 loss, showcases breast cancer trial progress

Celcuity's Q1 2023 performance reflects a focus on advancing innovative treatments for breast cancer, supported by positive clinical data and a robust pipeline.
While facing financial challenges with increased operating expenses and a net loss, the company maintains a strong cash position for ongoing operations and future growth.
Opportunities lie in leveraging clinical advancements to drive regulatory progress, expand the product portfolio, and capitalize on strategic growth initiatives.

Celcuity reports Q2 loss, progresses on breast cancer trial

Celcuity's Q2 2023 performance reflects ongoing investments in the gedatolisib trial and financial stability.
While facing challenges in trial execution and financial losses, the company's strengths lie in promising trial results and strong cash reserves.
Opportunities for Celcuity include breakthroughs in breast cancer treatment, strategic partnerships, and market expansion.
Overall, Celcuity's progress in the Phase III trial signals potential for growth and innovation in the oncology space.

Celcuity reports Q3 loss, progresses in cancer trials and funding

Celcuity's financials show a net loss but strong cash reserves, while progress in trials indicates a focus on cancer treatment development.
Challenges lie in financial performance and trial outcomes, but opportunities exist in upcoming data releases and new trial initiatives.

Celcuity progresses on gedatolisib development with strong financial backing

Celcuity's earnings call highlighted advancements in gedatolisib development and the addition of a new Chief Commercial Officer, bolstering its leadership team.
While facing challenges in upcoming data releases and addressing analyst inquiries, the company remains well-positioned with strong financial backing.

Celcuity reports progress in breast cancer trial despite financial challenges

Celcuity's Q1 2024 performance showcased progress in key trials and promising treatment efficacy.
While facing financial challenges with increased R&D expenses, the company maintains a strong cash position.
Opportunities lie in leveraging positive trial outcomes and exploring strategic partnerships for future growth.

Celcuity reports Q2 loss, advances cancer therapies amid financial growth

Celcuity's Q2 2024 performance reflects a mix of financial strength and operational progress in advancing cancer therapies
While facing challenges in study timelines and competitive landscape, the company's strategic initiatives position it well for future growth
Opportunities lie in novel treatment combinations, strong financial footing, and market interest in Celcuity's clinical advancements

Celcuity reports Q3 loss, advances gedatolisib in oncology landscape

Celcuity's Q3 performance reflects increased expenses but a strong financial position, with promising developments in gedatolisib's clinical progress.
While facing challenges in expenses and market competition, the company has opportunities to leverage positive feedback and upcoming data releases.
Overall, Celcuity's strategic focus on gedatolisib's potential in oncology presents a pathway for growth and market differentiation.

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Celcuity Inc. (NASDAQ:CELC ) Q4 2022 Earnings Conference Call March 23, 2023 4:30 PM ET Company Participants Robert Uhl - ICR Westwicke, IR Brian Sullivan - CEO and Co-Founder Vicky Hahne - CFO Igor Gorbatchevsky - Chief Medical Officer Conference Call Participants Maury Raycroft - Jefferies Alex Nowak - Craig-Hallum Operator Greetings. And welcome to Celcuity's Full Year 2022 Financial Results Conference Call.

Celcuity Inc. (CELC) Q4 2022 Earnings Call Transcript

Dosing of first patient in VIKTORIA-1 in the fourth quarter triggered closing of $100 million PIPE financing and drawdown of $20 million term loan tranche, which extends cash runway through 2025 Updated clinical data from the Phase 1b advanced breast cancer trial with gedatolisib was presented at SABCS in December - median PFS was 42.3 months in treatment naïve advanced breast cancer patients Preclinical data reporting therapeutic effects of gedatolisib and other PI3K/AKT/mTOR inhibitors in prostate cancer cell lines was presented at ASCO-GU in February An abstract was published in advance of the AACR Annual Meeting 2023 reporting therapeutic effects of gedatolisib and other PI3K/AKT/mTOR inhibitors in gynecological cell lines Management to host webcast and conference call today, March 23, 2023, at 4:30 p.m. ET MINNEAPOLIS, MN / ACCESSWIRE / March 23, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced financial results for the fourth quarter and full year ended December 31, 2022 and other recent business developments.

Celcuity Inc. Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

MINNEAPOLIS, MN / ACCESSWIRE / March 16, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced that it will release its financial results for the fourth quarter and full year 2022 after the stock market close on Thursday, March 23, 2023. Management will host a webcast/teleconference the same day at 4:30 p.m.

Celcuity Inc. Schedules Release of Fourth Quarter and Full Year 2022 Financial Results and Webcast/Conference Call

MINNEAPOLIS, MN / ACCESSWIRE / March 15, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced publication of an abstract reporting data from preclinical studies evaluating gedatolisib and other PI3K/AKT/mTOR inhibitors in endometrial, ovarian, and cervical cancer cell lines. A poster will be presented at the 2023 Annual Meeting of the American Association for Cancer Research (AACR), which will be held April 14-19, 2023 in Orlando, Florida.

Celcuity to Present Preclinical Data on Therapeutic Effects of Gedatolisib in Gynecological Cancer Models at AACR Annual Meeting 2023

MINNEAPOLIS, MN / ACCESSWIRE / March 1, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced its participation in Cowen's 43rd Annual Health Care Conference to be held in Boston on March 6-8, 2023. Brian Sullivan, Chief Executive Officer and co-founder of Celcuity, is scheduled to present at 11:10 a.m.

Celcuity to Participate in Cowen's 43rd Annual Health Care Conference

Gedatolisib demonstrated superior potency and efficacy in prostate cancer cell lines compared to other PI3K/AKT/mTOR inhibitors evaluated regardless of PI3K or PTEN status MINNEAPOLIS, MN / ACCESSWIRE / February 16, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today presented data from preclinical studies evaluating gedatolisib and other PI3K/AKT/mTOR inhibitors in prostate cancer cell lines. The poster was presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), which is being held February 16-18, 2023.

Celcuity Presents Preclinical Data on Therapeutic Effects of Gedatolisib in Prostate Cancer at ASCO GU Cancers Symposium

NEW YORK , Dec. 20, 2022 /PRNewswire/ -- Purcell & Lefkowitz LLP, a class action law firm dedicated to representing shareholders nationwide, is investigating a potential breach of fiduciary duty claim involving the board of directors of Celcuity Inc. (NASDAQ: CELC). If you are a shareholder of Celcuity Inc. and are interested in obtaining additional information regarding this investigation, free of charge, please visit us at: https://pjlfirm.com/celcuity-inc/  You may also contact Robert H.

SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Is Investigating Celcuity Inc. for Potential Breaches of Fiduciary Duty By Its Board of Directors

MINNEAPOLIS, MN / ACCESSWIRE / December 12, 2022 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company, today announced the closing of its private placement, resulting in gross proceeds of approximately $100 million, before deducting placement agent fees and other expenses. The closing follows dosage of the first patient in Celcuity's Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib, Celcuity's lead therapeutic candidate.

Celcuity Closes $100 Million Private Placement

High response rates and encouraging median progression free survival rates were observed in patients regardless of PIK3CA mutation status Median progression free survival (PFS) of 42.3 months was reported for patients who were treatment naïve in the advanced setting MINNEAPOLIS, MN / ACCESSWIRE / December 9, 2022 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced that updated results from a Phase 1b trial evaluating gedatolisib were presented during a Spotlight Poster Discussion at the 2022 San Antonio Breast Cancer Symposium (SABCS). The presentation reported updated efficacy and safety data and sub-group analysis by PIK3CA mutation status in the four expansion arms of the Phase 1b study.

Celcuity Presents Updated Results of Phase 1b Study of Gedatolisib in Patients with Advanced Breast Cancer at the 2022 San Antonio Breast Cancer Symposium

First patient dosing enables closing of $100 million PIPE financing and drawdown of $20 million term loan tranche MINNEAPOLIS, MN / ACCESSWIRE / December 7, 2022 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company developing targeted therapies for oncology, today announced that the first patient has been dosed in its Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib plus fulvestrant with and without palbociclib for the treatment of patients with HR+/HER2- advanced breast cancer. Gedatolisib, the company's lead therapeutic candidate, is a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms and mTOR.

Celcuity Announces First Patient Dosed in Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib for the Treatment of HR+/HER2- Advanced Breast Cancer

MINNEAPOLIS, MN / ACCESSWIRE / November 22, 2022 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for cancer treatment, today announced that an abstract accepted for a Spotlight Poster presentation at the 2022 San Antonio Breast Cancer Symposium (SABCS) is now available on the SABCS website. The 2022 San Antonio Breast Cancer Symposium (SABCS) is being held virtually and in-person from December 6-10, 2022.

Celcuity to Present Additional Data for Gedatolisib at the 2022 San Antonio Breast Cancer Symposium

Celcuity Inc. (NASDAQ:CELC ) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Robert Uhl - ICR Westwicke Brian Sullivan - CEO and Co-Founder Vicky Hahne - CFO Igor Gorbatchevsky - Chief Medical Officer Conference Call Participants Maury Raycroft - Jefferies Boris Peaker - Cowen Connor Stevenson - Craig-Hallum Operator Good day and welcome to the Celcuity Third Quarter 2022 Financial Results Conference Call. [Operator Instructions] I will now turn the conference over to your host, Robert Uhl with ICR Westwicke.

Celcuity Inc. (CELC) Q3 2022 Earnings Call Transcript

MINNEAPOLIS, MN / ACCESSWIRE / November 10, 2022 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for a number of different cancers, today announced that Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, will participate in one-on-one and small group meetings at the 13th Annual Craig-Hallum Alpha Select Conference in New York on Thursday, November 17, 2022. About Celcuity Celcuity is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications.

Celcuity to Participate in the 13th Annual Craig-Hallum Alpha Select Conference

Completed selection of 200 clinical trial sites for the Phase 3 VIKTORIA-1 breast cancer study; activated first clinical trial site in the third quarter; expect dosing of first patient by year-end Updated Phase 1b data will be reviewed during a Spotlight Poster Discussion Session at the 2022 San Antonio Breast Cancer Symposium in December 2022 Expanded Board of Directors with appointment of Polly Murphy, D.V.M., Ph.D., a seasoned pharmaceutical executive with significant business development and commercialization experience Management to host webcast and conference call today, November 10, 2022, at 4:30 p.m.

Celcuity Inc. Reports Third Quarter 2022 Financial Results and Provides Corporate Update

MINNEAPOLIS, MN/ ACCESSWIRE / November 3, 2022 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for a number of different cancers, today announced that it will release its financial results for the third quarter 2022 after the stock market close on Thursday, November 10, 2022. Management will host a webcast/teleconference the same day at 4:30 p.m.

Celcuity Inc. Schedules Release of Third Quarter 2022 Financial Results and Webcast/Conference Call

Celcuity Inc. (NASDAQ:CELC ) Q2 2022 Earnings Conference Call August 11, 2022 4:30 PM ET Company Participants Robert Uhl - Westwicke Partners, LLC Brian Sullivan - Co-Founder, Chairman & Chief Executive Officer Vicky Hahne - Chief Financial Officer Igor Gorbatchevsky - Chief Medical Officer Conference Call Participants Maurice Raycroft - Jefferies Boris Peaker - Cowen & Co. Operator Good afternoon, and welcome to Celcuity Second Quarter 2022 Financial Results Conference Call. [Operator Instructions] As a reminder this conference is being recorded.

Celcuity Inc. (CELC) CEO Brian Sullivan on Q2 2022 Results - Earnings Call Transcript

Granted Breakthrough Therapy designation by the FDA for gedatolisib in HR+/HER2- advanced breast cancer Entered into agreements for the private placement sale of $100 million of equity and to increase available debt facility from $25 million to $75 million The Phase 3 VICTORIA-1 clinical trial remains on track to dose the first patient in the next few months Management to host webcast and conference call today, August 11, 2022, at 4:30 p.m. ET MINNEAPOLIS, MN / ACCESSWIRE / August 11, 2022 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for a number of different cancers, today announced financial results for the second quarter ended June 30, 2022 and other recent business developments.

Celcuity Inc. Reports Second Quarter 2022 Financial Results and Provides Corporate Update

MINNEAPOLIS, MN / ACCESSWIRE / August 4, 2022 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for hormonally driven cancers, today announced that it will release its financial results for the second quarter 2022 after the stock market close on Thursday, August 11, 2022. Management will host a webcast/teleconference the same day at 4:30 p.m.

Celcuity Inc. Schedules Release of Second Quarter 2022 Financial Results and Webcast/Conference Call

MINNEAPOLIS, MN / ACCESSWIRE / August 3, 2022 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for hormonally driven cancers, today announced its participation in the Canaccord Genuity 42nd Annual Growth Conference to be held in Boston on August 8-11, 2022. Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, is scheduled to present at 11:30 a.m.

Celcuity to Participate in the Canaccord Genuity 42nd Annual Growth Conference

MINNEAPOLIS, MN / ACCESSWIRE / July 18, 2022 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for hormonally driven cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted gedatolisib Breakthrough Therapy designation for the treatment of patients with HR+/HER2- metastatic breast cancer whose disease progressed during treatment with a CDK4/6 therapy and a non-steroidal aromatase inhibitor. Gedatolisib is a potential first-in-class pan-PI3K/mTOR inhibitor.

Celcuity Announces FDA Breakthrough Therapy Designation for Gedatolisib for Treatment of HR+/HER2- Metastatic Breast Cancer

The mean of analysts' price targets for Celcuity, Inc. (CELC) points to a 359.4% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Wall Street Analysts Think Celcuity, Inc. (CELC) Could Surge 359%: Read This Before Placing a Bet

The average of price targets set by Wall Street analysts indicates a potential upside of 461.9% in Celcuity, Inc. (CELC). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

Can Celcuity, Inc. (CELC) Climb 462% to Reach the Level Wall Street Analysts Expect?

Celcuity Inc. (NASDAQ:CELC ) Q1 2022 Earnings Conference Call May 16, 2022 4:30 PM ET Company Participants Robert Uhl - Westwicke Partners, LLC Brian Sullivan - Co-Founder, Chairman & Chief Executive Officer Vicky Hahne - Chief Financial Officer Conference Call Participants Maurice Raycroft - Jefferies Gil Blum - Needham & Company Operator Good afternoon, and welcome to the Celcuity First Quarter 2022 Financial Results and Corporate Update Conference Call. [Operator Instructions] Please note this event is being recorded.

Celcuity Inc. (CELC) CEO Brian Sullivan on Q1 2022 Results - Earnings Call Transcript

Entered into $100 Million Private Placement Agreement Finalized pivotal Phase 3 trial design for gedatolisib Received FDA Fast Track designation for gedatolisib in HR+/HER2- advanced breast cancer Management to host webcast and conference call today, May 16, 2022, at 4:30 p.m. ET MINNEAPOLIS, MN / ACCESSWIRE / May 16, 2022 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, today announced financial results for the first quarter ended March 31, 2022 and other recent business progress.

Celcuity Inc. Reports First Quarter 2022 Financial Results and Business Updates

Proceeds to Advance Clinical Development of Gedatolisib Including Forthcoming Phase 3 Clinical Study (VIKTORIA-1) MINNEAPOLIS, MN / ACCESSWIRE / May 16, 2022 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, today announced that it has entered into a definitive securities purchase agreement with certain institutional and other accredited investors in a private placement for the purchase of common stock, preferred stock that may be convertible into common stock and warrants initially exercisable for preferred stock that is expected to result in aggregate proceeds to the Company of $100 million, before deducting placement agent fees and other offering expenses. The Company expects to use the net proceeds to advance clinical development of gedatolisib, including its planned Phase 3 clinical study (VIKTORIA-1), and for general corporate purposes.

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