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 ...

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]

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 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 ...

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 _________________ ...

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 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 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 ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=ITEM%201.%20Financial%20Statements) This section presents Celcuity Inc.'s unaudited condensed financial statements as of September 30, 2019, and for the three and nine-month periods then ended, including balance sheets, statements of operations, changes in stockholders' equity, and cash flows, along with accompanying notes, reporting net losses of approximately $2.0 million for Q3 and $5.6 million for the first nine months of 2019, reflecting its development-stage status with no revenue [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of September 30, 2019, Celcuity's total assets decreased to $21.7 million from $26.0 million at year-end 2018, primarily due to reduced investments, while total liabilities increased to $1.0 million from $0.7 million, mainly from operating lease liabilities, with total stockholders' equity at $20.7 million | Balance Sheet Items | Sep 30, 2019 (unaudited) ($) | Dec 31, 2018 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $16,269,595 | $15,944,609 | | Investments | $4,178,825 | $8,952,907 | | Total current assets | $20,608,885 | $25,218,208 | | Total Assets | $21,741,914 | $26,031,821 | | **Liabilities & Equity** | | | | Total current liabilities | $912,092 | $662,332 | | Total Liabilities | $1,029,485 | $682,210 | | Total Stockholders' Equity | $20,712,429 | $25,349,611 | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) For the three months ended September 30, 2019, the company reported a net loss of $1.98 million, or ($0.19) per share, compared to a net loss of $1.87 million, or ($0.18) per share, for the same period in 2018, with the nine-month net loss at $5.55 million, slightly lower than the $5.66 million loss in the prior year period, having generated no revenue to date | Metric | Three Months Ended Sep 30, 2019 ($) | Three Months Ended Sep 30, 2018 ($) | | :--- | :--- | :--- | | Research and development | $1,711,597 | $1,599,045 | | General and administrative | $379,718 | $376,796 | | Loss from operations | ($2,091,315) | ($1,975,841) | | Net loss | ($1,984,254) | ($1,871,107) | | Net loss per share | ($0.19) | ($0.18) | | Metric | Nine Months Ended Sep 30, 2019 ($) | Nine Months Ended Sep 30, 2018 ($) | | :--- | :--- | :--- | | Research and development | $4,772,286 | $4,691,250 | | General and administrative | $1,135,251 | $1,290,082 | | Loss from operations | ($5,907,537) | ($5,981,332) | | Net loss | ($5,550,339) | ($5,655,514) | | Net loss per share | ($0.54) | ($0.56) | [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2019, net cash used in operating activities was $4.3 million, net cash provided by investing activities was $4.4 million primarily from investment sales, and net cash provided by financing activities was $0.23 million from stock option exercises, resulting in a $0.3 million increase in cash and cash equivalents to $16.3 million | Cash Flow Activity (Nine Months Ended Sep 30) | 2019 ($) | 2018 ($) | | :--- | :--- | :--- | | Net cash used for operating activities | ($4,294,953) | ($4,557,051) | | Net cash provided by investing activities | $4,392,510 | $5,428,574 | | Net cash provided by financing activities | $227,429 | $247,462 | | **Net change in cash** | **$324,986** | **$1,118,985** | | **Cash at end of period** | **$16,269,595** | **$3,808,774** | [Notes to Unaudited Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) The notes detail the company's business as a cellular analysis firm focused on cancer diagnostics, which has not yet generated revenue, discussing significant policies including the adoption of the new lease accounting standard (ASC 842) in 2019, outlining commitments for clinical research studies with potential future payments of approximately $2.7 million and $0.15 million, and providing extensive details on stock-based compensation expenses and assumptions - The company is a cellular analysis company focused on discovering new cancer sub-types and has not generated any revenues to date[24](index=24&type=chunk) - Effective January 1, 2019, the company adopted the new lease accounting standard (ASC 842), resulting in the recognition of operating lease right-of-use assets of **$356,539** and lease liabilities of **$404,931** on the balance sheet[31](index=31&type=chunk) - The company has commitments for two clinical research studies, with maximum estimated additional payments of approximately **$2.69 million** for one and future milestone payments of approximately **$150,000** for the other[46](index=46&type=chunk)[47](index=47&type=chunk) Stock-Based Compensation Expense | Stock-Based Compensation Expense | Three Months Ended Sep 30, 2019 ($) | Nine Months Ended Sep 30, 2019 ($) | | :--- | :--- | :--- | | Research and development | $163,342 | $364,902 | | General and administrative | $139,901 | $315,232 | | **Total** | **$303,243** | **$680,134** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on its proprietary CELx diagnostic platform for cancer treatment and its strategy of collaborating with pharmaceutical companies, noting that the company has not generated any revenue and has incurred losses since inception, with a net loss of $5.6 million for the first nine months of 2019, detailing results of operations, comparing 2019 and 2018 periods, and analyzing liquidity, stating that the current cash position of $20.4 million is sufficient to finance operations for at least the next 24 months - The company's business is centered on its proprietary CELx diagnostic platform, which uses a patient's living tumor cells to identify cancer drivers and guide targeted therapy[59](index=59&type=chunk) - Celcuity has active collaborations and clinical trials with Genentech, NSABP, Puma Biotechnology, and West Cancer Center to evaluate its CELx HSF Test in breast cancer patients[64](index=64&type=chunk) - As of September 30, 2019, the company had cash, cash equivalents, and investments of approximately **$20.4 million** and believes this is sufficient to fund operations for at least the next **24 months**[67](index=67&type=chunk)[90](index=90&type=chunk)[92](index=92&type=chunk) [Results of Operations](index=16&type=section&id=Results%20of%20Operations) For Q3 2019, R&D expenses increased 7% year-over-year to $1.71 million due to higher clinical study and patent costs, while G&A expenses were flat at $0.38 million; for the nine-month period, R&D expenses rose 2% to $4.77 million, and G&A expenses decreased 12% to $1.14 million, primarily due to lower non-cash stock-based compensation and professional fees, with both R&D and G&A expenses anticipated to increase in the future to support test development and public company costs Expense Category (Q3) | Expense Category (Q3) | 2019 ($) | 2018 ($) | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $1,711,597 | $1,599,045 | 7% | | General and administrative | $379,718 | $376,796 | 1% | Expense Category (Nine Months) | Expense Category (Nine Months) | 2019 ($) | 2018 ($) | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $4,772,286 | $4,691,250 | 2% | | General and administrative | $1,135,251 | $1,290,082 | (12)% | - The increase in R&D expenses was primarily driven by higher costs for clinical validation, laboratory studies, and patent-related legal expenses[81](index=81&type=chunk)[82](index=82&type=chunk) [Liquidity and Capital Resources](index=19&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2019, the company had approximately $20.4 million in cash, cash equivalents, and investments, with its primary source of funds being capital raising activities, including a 2017 IPO that generated $23.3 million in net proceeds, and management believes current cash is sufficient to fund operations for at least the next 24 months, with net cash used in operations for the first nine months of 2019 being $4.3 million - The company's primary source of funds since inception has been capital raising activities, including private placements and its 2017 IPO[90](index=90&type=chunk) - Management believes current cash on hand is sufficient to finance operations for at least the next **24 months** based on the current business plan[92](index=92&type=chunk) Cash Flow Summary (Nine Months Ended Sep 30) | Cash Flow Summary (Nine Months Ended Sep 30) | 2019 ($) | 2018 ($) | | :--- | :--- | :--- | | Net cash used in Operating activities | ($4,294,953) | ($4,557,051) | | Net cash provided by Investing activities | $4,392,510 | $5,428,574 | | Net cash provided by Financing activities | $227,429 | $247,462 | [Quantitative and Qualitative Disclosures About Market Risk](index=21&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Celcuity is not required to provide disclosure for this item - The company is exempt from this disclosure requirement due to its status as a smaller reporting company[108](index=108&type=chunk) [Controls and Procedures](index=22&type=section&id=ITEM%204.%20Controls%20and%20Procedures) The company's CEO and CFO concluded that as of September 30, 2019, disclosure controls and procedures were not effective, based on a previously disclosed material weakness in internal control over financial reporting related to limited segregation of duties, and the company is implementing an Enhancement Plan to remediate this weakness - Disclosure controls and procedures were concluded to be **not effective** as of the end of the period[110](index=110&type=chunk) - The ineffectiveness is due to a material weakness related to limited segregation of duties, as previously reported in the 2018 Form 10-K[110](index=110&type=chunk)[112](index=112&type=chunk) - Management has developed and begun implementing an "Enhancement Plan" to address the material weakness, which includes establishing better segregation of duty controls and hiring an outside resource to test key controls[113](index=113&type=chunk) [PART II. OTHER INFORMATION](index=23&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=23&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that are reasonably expected to have a material adverse effect on its business, financial condition, or results of operations - The company reports no material legal proceedings[117](index=117&type=chunk) [Risk Factors](index=23&type=section&id=ITEM%201A.%20Risk%20Factors) As a smaller reporting company, Celcuity is not required to provide this disclosure and refers readers to the Risk Factors section in its Annual Report on Form 10-K for the year ended December 31, 2018 - The company is exempt from this disclosure requirement due to its status as a smaller reporting company and refers to its 2018 Form 10-K for risk factors[118](index=118&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=23&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section discusses the use of proceeds from the company's Initial Public Offering (IPO) on September 22, 2017, which generated net proceeds of approximately $23.3 million, noting no material change in the planned use of these proceeds and no material portion used through September 30, 2019, with no recent unregistered sales of equity securities reported - The company's 2017 IPO generated net proceeds of approximately **$23.3 million** after underwriting discounts and offering expenses[120](index=120&type=chunk) - There has been no material change in the planned use of IPO proceeds, and no material portion had been used as of September 30, 2019[121](index=121&type=chunk) [Defaults Upon Senior Securities](index=23&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[122](index=122&type=chunk) [Mine Safety Disclosures](index=23&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[116](index=116&type=chunk) [Other Information](index=23&type=section&id=ITEM%205.%20Other%20Information) The company reports no other information for this item - None[116](index=116&type=chunk) [Exhibits](index=24&type=section&id=ITEM%206.%20Exhibits) This section provides an index of the exhibits filed with the Form 10-Q, including the Certificate of Incorporation, Bylaws, CEO and CFO certifications required by the Sarbanes-Oxley Act, and financial statements formatted in XBRL - The report includes a list of filed exhibits, such as Sarbanes-Oxley certifications (**31.1, 31.2, 32.1, 32.2**) and XBRL financial data (**101**)[125](index=125&type=chunk)

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 ...