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.

Earnings data Q4 2020

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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

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MINNEAPOLIS, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the third quarter 2023 before the market opens on Monday, November 13, 2023. Management will host a webcast/teleconference the same day at 8:00 a.m. Eastern Time to discuss the results and provide a corporate update.

Celcuity Inc. Schedules Release of Third Quarter 2023 Financial Results and Webcast/Conference Call

MINNEAPOLIS, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences:

Celcuity To Present at Upcoming Stifel and Jefferies Investor Conferences

MINNEAPOLIS, MN / ACCESSWIRE / October 18, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, announced today that it has entered into a securities purchase agreement to sell securities in a private placement that is expected to result in gross proceeds of approximately $50 million. In the private placement, an institutional investor has agreed to purchase pre-funded warrants to purchase shares of Celcuity's common stock at a price of $8.699 per warrant, each with an exercise price of $0.001 per share (for aggregate consideration equating to $8.70 per share).

Celcuity Inc. Announces $50 Million Private Placement

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MINNEAPOLIS, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will host a Virtual Science Day for analysts and investors from 10:00 a.m. – 12:00 p.m. ET on Thursday, September 21, 2023. During this informative event, Celcuity will provide an in-depth overview of its lead compound, the equipotent pan-PI3K/mTOR inhibitor gedatolisib, discuss the importance of comprehensive, rather than selective, inhibition of the PI3K/mTOR pathway, and review its anticipated clinical development strategy in breast and prostate cancer.

Celcuity to Host Virtual Science Day for Investors

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MINNEAPOLIS, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it has entered into a clinical trial collaboration and supply agreement with Bayer AG for Celcuity's Phase 1b/2 clinical trial of gedatolisib and Nubeqa® (darolutamide) in patients with metastatic castration resistant prostate cancer (mCRPC). As part of the supply agreement, Bayer will provide Nubeqa to Celcuity at no cost.

Celcuity Enters into a Clinical Trial Collaboration and Supply Agreement with Bayer to Provide Nubeqa® (darolutamide) for Planned Phase 1b/2 Clinical Trial

- Received FDA clearance of IND for gedatolisib in combination with darolutamide - Virtual Science Day to be held on September 21, 2023 from 10:00 a.m. – 12:00 p.m.

Celcuity Announces Plan to Conduct Phase 1b/2 Clinical Trial in Metastatic Castration Resistant Prostate Cancer

Celcuity Inc. (NASDAQ:CELC ) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Robert Uhl – ICR Westwicke Brian Sullivan – Chief Executive Officer and Co-Founder Vicky Hahne – Chief Financial Officer Conference Call Participants Maury Raycroft – Jefferies Boris Peaker – Cowen Gil Blum – Needham and Company Operator Good afternoon, ladies and gentlemen, and welcome to the Celcuity Second Quarter 2023 Earnings Conference Call. At this time, all lines are in a listen-only mode.

Celcuity Inc. (CELC) Q2 2023 Earnings Call Transcript

MINNEAPOLIS, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today reported financial results for the second quarter ended June 30, 2023 and provided other recent corporate updates.

Celcuity Inc. Reports Second Quarter 2023 Financial Results and Provides Corporate Updates

MINNEAPOLIS, Aug. 03, 2023 (GLOBE NEWSWIRE) -- 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 second quarter 2023 after the stock market close on Thursday, August 10, 2023. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.

Celcuity Inc. Schedules Release of Second Quarter 2023 Financial Results and Webcast/Conference Call

MINNEAPOLIS, July 31, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced that Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, will participate in one-on-one meetings at the BTIG Virtual Biotechnology Conference being held on August 7-8, 2023.

Celcuity to Participate in the BTIG Virtual Biotechnology Conference 2023

MINNEAPOLIS, MN / ACCESSWIRE / June 20, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, is set to join the Russell 2000® and 3000® Indexes at the conclusion of the 2023 Russell indexes annual reconstitution, effective after the U.S. market opens on June 26, according to the most recent list of additions posted June 16. Annual Russell indexes reconstitution captures the 4,000 largest U.S. stocks as of April 28, ranking them by total market capitalization.

Celcuity Set to Join Russell 2000 and 3000 Indexes

MINNEAPOLIS, MN / ACCESSWIRE / May 24, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced that Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, will participate in the following investor conferences: One-on-one and small group meetings at the 20th Annual Craig-Hallum Institutional Investor Conference in Minneapolis on Wednesday, May 31, 2023; and A fireside chat at the Jefferies Healthcare Conference in New York at 12:15 p.m. ET on Friday, June 9, 2023.

Celcuity to Participate in Upcoming Craig-Hallum and Jefferies Investor Conferences

Celcuity Inc. (NASDAQ:CELC ) Q1 2023 Earnings Conference Call May 15, 2023 4:30 PM ET Company Participants Robert Uhl - ICR Westwicke, IR Brian Sullivan - CEO and Co-Founder Vicky Hahne - CFO Conference Call Participants Maury Raycroft - Jefferies Nicholas Lorusso - Cowen and Company Rohit Bhasin - Needham & Company Alex Nowak - Craig-Hallum Capital Group Operator Greetings and welcome to Celcuity First Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Celcuity Inc. (CELC) Q1 2023 Earnings Call Transcript

Presented updated results for treatment-naïve patients from Phase 1b study of gedatolisib at the ESMO Breast Cancer Annual Congress - median progression free survival (PFS) was 48.6 months Presented nonclinical prostate cancer data at ASCO GU Cancers Symposium demonstrating the superior therapeutic effect of gedatolisib compared to other PI3K, AKT, and mTOR inhibitors regardless of PTEN or P13K mutational status Presented nonclinical gynecological cancer data at AACR demonstrating the superior therapeutic effect of gedatolisib compared to other PI3K, AKT, and mTOR inhibitors regardless of PTEN, P13K, or AKT mutational status Management to host webcast and conference call today, May 15, 2023, at 4:30 p.m. ET MINNEAPOLIS, MN / ACCESSWIRE / May 15, 2023 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today reported financial results for the first quarter ended March 31, 2023 and provided other recent corporate updates.

Celcuity Inc. Reports First Quarter 2023 Financial Results and Provides Corporate Updates

Median progression free survival (PFS) was 48.6 months in treatment-naïve patients with HR+/HER2- advanced breast cancer who were treated with gedatolisib in combination with palbociclib and letrozole Median duration of response (DOR) was 46.9 months MINNEAPOLIS, MN / ACCESSWIRE / May 12, 2023 / 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, a pan-PI3K/mTOR inhibitor, in combination with palbociclib, a CDK4/6 inhibitor, and letrozole, an aromatase inhibitor, were presented at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress in Berlin, Germany. The presentation reported efficacy and safety data in treatment-naïve patients with HR+, HER2- advanced breast cancer enrolled in Escalation Arm A and Expansion Arm A.

Celcuity Presents Updated Results from Phase 1b Study of Gedatolisib in Treatment-Naïve Patients at the 2023 ESMO Breast Cancer Annual Congress

MINNEAPOLIS, MN / ACCESSWIRE / May 8, 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 first quarter 2023 after the stock market close on Monday, May 15, 2023. Management will host a webcast/teleconference the same day at 4:30 p.m.

Celcuity Inc. Schedules Release of First Quarter 2023 Financial Results and Webcast/Conference Call

MINNEAPOLIS, MN / ACCESSWIRE / May 8, 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 updated results for treatment-naïve patients from the Phase 1b study of gedatolisib, a pan-PI3K/mTOR inhibitor, in combination with palbociclib and letrozole in women with HR+/HER2- advanced breast cancer (ABC). A poster will be presented at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress, which is being held May 11-13, 2023 in Berlin, Germany.

Celcuity to Present Updated Results for Treatment-Naïve Patients from Phase 1b Study of Gedatolisib at the 2023 ESMO Breast Cancer Annual Congress

Gedatolisib demonstrated superior anti-proliferative potency and efficacy in endometrial, ovarian and cervical cancer cell lines compared to other PAM inhibitors evaluated regardless of PTEN, P13K, or AKT mutational status MINNEAPOLIS, MN / ACCESSWIRE / April 18, 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 (PAM) inhibitors in endometrial, ovarian, and cervical cancer cell lines. The poster was presented at the 2023 Annual Meeting of the American Association for Cancer Research (AACR), which is being held April 14-19, 2023 in Orlando, Florida.

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

MINNEAPOLIS, MN / ACCESSWIRE / April 12, 2023 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for oncology, today announced its participation in the 22nd Annual Needham Virtual Healthcare Conference. Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, is scheduled to present at 1:30 p.m.

Celcuity to Participate in 22nd Annual Needham Virtual Healthcare Conference

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.

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