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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Earnings data Q3 2023

Earnings data Q4 2023

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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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Celcuity's (CELC) CEO Brian Sullivan on Q4 2021 Results - Earnings Call Transcript

Finalized pivotal Phase 3 trial design following formal meetings with FDA Received FDA Fast Track designation for gedatolisib in HR+/HER2- metastatic breast cancer Presented updated Phase 1b data during a Spotlight Poster-Discussion Session at the 2021 San Antonio Breast Cancer Symposium in December 2021 Entered into a clinical collaboration and supply agreement with Pfizer for planned Phase 3 clinical trial evaluating gedatolisib in combination with Ibrance® and Faslodex® in advanced breast cancer (ABC) Management to host webcast and conference call today, March 23, 2022, at 4:30 p.m. ET MINNEAPOLIS, MN / ACCESSWIRE / March 23, 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 fourth quarter and full year ended December 31, 2021, the design for its pivotal Phase 3 trial for gedatolisib, an investigational pan-PI3K/mTOR inhibitor, and other recent business progress.

Celcuity Inc. Reports Fourth Quarter and Full Year 2021 Financial Results, Pivotal Phase 3 Trial Design for Gedatolisib in the Treatment of Advanced Breast Cancer, and Business Updates

MINNEAPOLIS, MN / ACCESSWIRE / March 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 will release its financial results for the fourth quarter and full year 2021 after the stock market close on Wednesday, March 23, 2022. Management will host a webcast/teleconference the same day at 4:30 p.m.

Celcuity Inc. Schedules Release of Fourth Quarter and Full Year 2021 Financial Results and Webcast/Conference Call

MINNEAPOLIS, MN / ACCESSWIRE / March 2, 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 its participation in the virtual Cowen 42nd Annual Health Care Conference to be held March 7-9, 2022. Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, is scheduled to participate in the "Breast Cancer" corporate panel session at 2:10 p.m.

Celcuity to Participate in the Cowen 42nd Annual Health Care Conference

FDA's Fast Track Designation for the pan-PI3K/mTOR inhibitor highlights potential to address the urgent need for new treatment options for breast cancer patients On track to finalize Phase 3 clinical trial design for gedatolisib with FDA feedback in first quarter Planning to initiate two studies in breast cancer to evaluate gedatolisib in patients selected with a CELsignia test MINNEAPOLIS, MN / ACCESSWIRE / January 18, 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 the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's lead drug candidate, gedatolisib, for the treatment of patients with HR+/HER2- metastatic breast cancer after progression on CDK4/6 therapy. "There is an urgent need for better treatment options for HR+/HER2- metastatic breast cancer patients whose disease progressed after treatment with a CDK4/6 inhibitor and endocrine therapy," said Brian Sullivan, CEO and co-founder of Celcuity.

Celcuity Receives FDA Fast Track Designation for Gedatolisib in HR+ / HER2- Metastatic Breast Cancer and Provides Corporate Update

78% ORR in 3rd line patients and 63% ORR overall in patients treated with three weeks on/one week off gedatolisib dosing schedule (Arm D) MINNEAPOLIS, MN / ACCESSWIRE / December 10, 2021 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, today presented a poster at the 2021 San Antonio Breast Cancer Symposium (SABCS) with updated results from a four-arm Phase 1b expansion study. This study evaluated gedatolisib, a first-in-class pan-PI3K/mTOR inhibitor, in combination with palbociclib, a CDK4/6 inhibitor and endocrine therapy (either letrozole or fulvestrant) in women with ER+/HER2- advanced breast cancer (ABC).

Celcuity Presents Updated Results of Phase 1b Study of Gedatolisib in Combination with Palbociclib and Endocrine Therapy for ER+ Advanced Breast Cancer (ABC) at the 2021 San Antonio Breast Cancer Symposium

MINNEAPOLIS, MN / ACCESSWIRE / December 2, 2021 / 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 an abstract has been accepted for poster presentation at the 2021 San Antonio Breast Cancer Symposium (SABCS), which is being held virtually and in-person from December 7-10, 2021. Poster presentation details are provided below.

Celcuity to Present at the 2021 San Antonio Breast Cancer Symposium

MINNEAPOLIS, MN / ACCESSWIRE / November 29, 2021 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, today announced the addition of two senior executives to its corporate management team. Michael Snitkovsky joined Celcuity as VP of Program Management and David Bridge joined as VP of Quality Assurance and Process Development.

Celcuity Appoints Michael Snitkovsky as VP of Program Management and David Bridge as VP of Quality Assurance and Process Development

MINNEAPOLIS, MN / ACCESSWIRE / November 15, 2021 / 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 clinical trial collaboration and supply agreement with Pfizer to provide Ibrance® (palbociclib) for use in Celcuity's Phase 3 clinical trial at no cost to Celcuity. As previously disclosed, Celcuity expects to initiate a Phase 3 clinical trial in the first half of 2022 to evaluate gedatolisib, the company's pan-PI3K/mTOR inhibitor, in combination with palbociclib, a CDK4/6 inhibitor, and Faslodex® (fulvestrant), a selective endocrine receptor degrader, in patients with ER+/HER2- advanced breast cancer.

Celcuity Announces Clinical Trial Collaboration and Supply Agreement with Pfizer to Provide Ibrance(R) (palbociclib) for Planned Phase 3 Clinical Trial

MINNEAPOLIS, MN / ACCESSWIRE / November 9, 2021 / 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 Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, will participate in virtual meetings with investors at the following conferences: 12th Annual Craig-Hallum Alpha Select Conference on November 16, 2021; and Jefferies London Healthcare Conference on November 18 - 19, 2021. About Celcuity Celcuity is a clinical-stage biotechnology company seeking to extend the lives of cancer patients by pursuing an integrated therapeutic and companion diagnostic strategy.

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

Celcuity Inc. (CELC) CEO Brian Sullivan on Q3 2021 Results - Earnings Call Transcript

On track to obtain FDA feedback and initiate a Phase 3 study for gedatolisib during the first half of 2022 Will present updated Phase 1b data during a Spotlight Poster Discussion Session at the 2021 San Antonio Breast Cancer Symposium in December 2021 Entered into clinical trial collaboration with University of Rochester Wilmot Cancer Center and Puma Biotechnology to evaluate new therapeutic option for metastatic breast cancer patients with brain metastases Management to host webcast and conference call today, November 8, 2021, at 4:30 p.m. ET / 1:30 p.m.

Celcuity Inc. Reports Third Quarter 2021 Financial Results and Provides Corporate Update

MINNEAPOLIS, MN / ACCESSWIRE / October 29, 2021 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, today announced that it will release its financial results for the third quarter 2021 after the stock market close on Monday, November 8, 2021. Management will host a webcast/teleconference the same day at 4:30 p.m.

Celcuity Inc. Schedules Release of Third Quarter 2021 Financial Results and Webcast/Conference Call

MINNEAPOLIS--(BUSINESS WIRE)---- $CELC #Celcuity--Celcuity announces clinical trial collaboration with U of Rochester and Puma for Phase 2 breast cancer study. Patient selection guided by CELsignia.

Celcuity Announces Clinical Trial Collaboration with University of Rochester Wilmot Cancer Center and Puma to Study Patients with Breast Cancer Brain Metastases

The shares of Celcuity Inc (NASDAQ: CELC) have received a price target of $50. These are the details.

CELC Stock: $50 Price Target From Canaccord

Raised approximately $56.3 million of gross proceeds from a follow-on public offering of common stock in early July to provide funding for clinical development activities  After follow-on offering, Celcuity had approximately $94.4 million of cash on hand  Expanded clinical development and clinical operations capabilities with appointment of two new senior executives and the addition of other key team members  In a Phase 1 study evaluating gedatolisib combined with paclitaxel and carboplatin, 65% of patients (11/17) had an objective response, including three complete responses  Management to host webcast and conference call today, August 9, 2021, at 4:30 p.m. ET / 1:30 p.m.

Celcuity Inc. Reports Second Quarter 2021 Financial Results and Provides Corporate Update

MINNEAPOLIS, MN / ACCESSWIRE / August 5, 2021 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, today announced its participation in the Canaccord Genuity 41st Annual Growth Conference to be held August 10-12, 2021. Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, is scheduled to present in a virtual fireside chat at 8:30 a.m.

Celcuity to Participate in the Canaccord Genuity 41st Annual Growth Conference

MINNEAPOLIS, MN / ACCESSWIRE / August 2, 2021 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic (CDx) and therapeutic strategy for treating patients with cancer, today announced that it will release its financial results for the second quarter 2021 after the stock market close on Monday, August 9, 2021. Management will host a teleconference the same day at 4:30 p.m.

Celcuity Inc. Schedules Release of Second Quarter 2021 Financial Results and Webcast

MINNEAPOLIS, MN / ACCESSWIRE / July 8, 2021 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, today announced its participation in the William Blair Biotech Focus Conference to be held July 14-15, 2021. Brian Sullivan, Chairman, Chief Executive Officer, and Co-Founder of Celcuity, is scheduled to present in a fireside chat at 2 p.m.

Celcuity to Participate in the William Blair Biotech Focus Conference

The clinical-stage biotech announced the pricing of a secondary stock offering.

Why Celcuity Stock Is Crashing Today

MINNEAPOLIS, MN / ACCESSWIRE / June 28, 2021 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, today announced the pricing of its underwritten public offering of 2,250,000 shares of its common stock at a price to the public of $25.00 per share. As part of the offering, Celcuity has granted the underwriters a 30-day option to purchase up to an additional 337,500 shares of common stock at the public offering price, less underwriting discounts and commissions.

Celcuity Announces Pricing of Follow-on Offering

MINNEAPOLIS, MN / ACCESSWIRE / June 28, 2021 / Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, today announced that it has commenced an underwritten public offering of shares of its common stock. As part of the offering, Celcuity expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering.

Celcuity Announces Launch of Follow-on Offering

MINNEAPOLIS, MN / ACCESSWIRE / June 9, 2021 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, today announced the addition of two new senior executives to its clinical drug development and operations team. Igor Gorbatchevsky, MD, joined Celcuity as VP of Clinical Development and Jill Krause joined as VP of Clinical Operations.

Celcuity Announces Appointment of Dr. Igor Gorbatchevsky as VP of Clinical Development and Jill Krause as VP of Clinical Operations

Entered into worldwide licensing agreement with Pfizer to develop and commercialize gedatolisib, a first-in-class PI3K/mTOR inhibitor, in clinical development for breast cancer Announced encouraging preliminary data from a Phase 1b trial of gedatolisib plus Ibrance® and endocrine therapy for patients with ER+/HER2- metastatic breast cancer, in which gedatolisib showed a potentially differentiated safety and tolerability profile Secured additional financing to strengthen cash position and provide funding for expanded clinical development activities Entered into clinical trial collaboration agreements with leading cancer research centers, Novartis, Pfizer, and Puma to evaluate the efficacy of targeted therapies in patients selected with Celcuity's CELsignia Multi-Pathway Activity Test Management to host webcast and conference call today, May 10, at 4:30 p.m. ET / 1:30 p.m.

Celcuity Inc. Reports First Quarter 2021 Financial Results and Provides Corporate Update

MINNEAPOLIS, MN / ACCESSWIRE / April 26, 2021 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic (CDx) and therapeutic strategy for treating patients with cancer, today announced that it will release its financial results for the first quarter 2021 after the stock market close on Monday, May 10, 2021. Management will host a webcast/conference call the same day at 4:30 p.m.

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