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Celcuity(CELC) - 2020 Q3 - Quarterly Report
2020-11-09 21:46
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Large accelerated filer ☐ Accelerated filer ☒ Non-accelerated filer ☐ Smaller reporting company ☒ Emerging growth company ☒ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commiss ...
Celcuity(CELC) - 2020 Q2 - Earnings Call Transcript
2020-08-10 22:23
Financial Data and Key Metrics Changes - The second quarter net loss was $2.2 million or $0.21 per share, compared to a net loss of $1.72 million or $0.17 per share for the same quarter in 2019 [20] - The non-GAAP adjusted net loss for the second quarter was $1.78 million or $0.17 per share, compared to a non-GAAP adjusted net loss of $1.53 million or $0.15 per share in the second quarter of 2019 [21] - Cash and cash equivalents at the end of the quarter were approximately $15.4 million [24] Business Line Data and Key Metrics Changes - Research and development expenses increased by approximately $0.55 million during the first six months of 2020 compared to the same period in 2019, primarily due to an increase in compensation expenses [22] - General and administrative expenses saw an increase of approximately $0.16 million in the second quarter of 2020 compared to the second quarter of 2019, attributed to non-cash stock-based compensation [23] Market Data and Key Metrics Changes - The company is focused on developing CELsignia tests for various cancers, with a particular emphasis on ovarian cancer and breast cancer [10][18] - The company expects to finalize one to two collaborations with pharmaceutical companies by the end of 2020, with additional collaborations anticipated in the first half of 2021 [14] Company Strategy and Development Direction - The strategy is to assist pharmaceutical companies in obtaining new indications for their targeted therapies through the CELsignia tests [9] - The company aims to address the unmet need for new diagnostic approaches for ovarian cancer patients who lack actionable molecular mutations [13] Management's Comments on Operating Environment and Future Outlook - Management remains confident in finalizing collaborations despite challenges posed by COVID-19 [14] - The company expects to present data for another CELsignia test for breast cancer patients by the end of 2020 and anticipates interim results from FACT-1 and FACT-2 trials in the second half of 2021 [25] Other Important Information - The FACT-1 and FACT-2 trials are evaluating anti-HER2 therapies in early-stage HER2-negative breast cancer patients, with the goal of demonstrating improved treatment responses [17][18] Q&A Session Summary Question: How many new clinical trial collaborations are expected later this year and will they focus on ovarian cancer? - The company expects one to two collaborations to be announced this year, primarily focused on breast cancer, with discussions for ovarian cancer collaborations just beginning [27] Question: Will there be any upfront payment from partners for collaborations? - The company will not characterize the collaborations until they are finalized, at which point details will be provided [28] Question: Are patients still being enrolled in FACT-1 and FACT-2 trials amid the pandemic? - After the end of the quarter, some sites resumed patient enrollment, although there were delays during the second quarter due to COVID-19 [31] Question: When will validation results for the CELsignia RAS assay test be released? - The company expects to provide additional data towards the end of the year [32] Question: How has the reduction in cancer diagnoses impacted enrollment in FACT-1 and FACT-2? - Management noted that while there has been a decline in cancer diagnoses, it is difficult to predict the exact impact on enrollment due to the uncertainties surrounding COVID-19 [36]
Celcuity(CELC) - 2020 Q2 - Quarterly Report
2020-08-10 21:23
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________________ Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.001 par value per shareCELC The Nasdaq Stock Market LLC FORM 10-Q _____________________________________________________ (Mark One) ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐TRANSITION REPORT PU ...
Celcuity(CELC) - 2020 Q1 - Earnings Call Transcript
2020-05-08 03:30
Celcuity Inc. (NASDAQ:CELC) Q1 2020 Earnings Conference Call May 7, 2020 4:30 PM ET Company Participants Vicky Hahne - Chief Financial Officer Brian Sullivan - Chief Executive Officer Conference Call Participants Edward Marks - H.C. Wainwright Per Ostlund - Craig-Hallum Operator Good day, everyone, and welcome to the Celcuity Release of First Quarter 2020 Financial Results. At this time, all participants are in a listen-only mode. Later, you'll have the opportunity to ask questions during the question-and-a ...
Celcuity(CELC) - 2020 Q1 - Quarterly Report
2020-05-07 21:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________________ FORM 10-Q _____________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-38207 _________________ ...
Celcuity(CELC) - 2019 Q4 - Annual Report
2020-03-13 16:58
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________________ to ___________________ Commission File Number: 001-38207 Celcuity Inc. (Exact name of registrant as specified in its charter) Delaware 82-2 ...
Celcuity(CELC) - 2019 Q4 - Earnings Call Transcript
2020-03-13 02:35
Celcuity Inc. (NASDAQ:CELC) Q4 2019 Earnings Conference Call March 12, 2020 4:30 PM ET Company Participants Brian Sullivan - Chief Executive Officer Vicky Hahne - Chief Financial Officer Conference Call Participants Boobalan - HC Wainwright Per Ostlund - Craig-Hallum Operator Good day everyone and welcome to today’s call to discuss the Celcuity Release of Fourth Quarter and Fiscal Year 2019 Financial Results. All participants are in a listen-only mode. Later, you’ll have a chance to ask questions during the ...
Celcuity(CELC) - 2019 Q3 - Earnings Call Transcript
2019-11-10 12:01
Celcuity Inc. (NASDAQ:CELC) Q3 2019 Earnings Conference Call November 7, 2019 4:30 PM ET Company Participants Brian Sullivan - Chief Executive Officer & Co-Founder Vicky Hahne - Chief Financial Officer Conference Call Participants Edward Marks - HC Wainwright Per Ostlund - Craig-Hallum Capital Operator Good day and welcome to the Celcuity Release of Third Quarter 2019 Financial Results Conference. At this time, all participants are in a listen-only mode. Later, you have the opportunity to ask question durin ...
Celcuity(CELC) - 2019 Q3 - Quarterly Report
2019-11-07 21:46
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________________ FORM 10-Q _____________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-38207 _____________ ...
Celcuity(CELC) - 2019 Q2 - Earnings Call Transcript
2019-08-10 06:36
Celcuity Inc (NASDAQ:CELC) Q2 2019 Earnings Conference Call August 8, 2019 4:00 PM ET Company Participants Brian Sullivan – Chief Executive Officer Vicky Hahne – Chief Financial Officer Conference Call Participants Per Ostlund – Craig Hallum Capital Yi Chen – H.C. Wainwright Operator Thank you for joining the Celcuity Releases Second Quarter 2019 Financial Results. [Operator Instructions] Please note, this call may be recorded [Operator Instructions] It is now my pleasure to turn today's conference over to ...