Celcuity Reports First Quarter 2019 Financial Results Minneapolis, Minnesota

Celcuity Reports First Quarter 2019 Financial

Minneapolis, Minnesota-May 7, 2019-Celcuity Inc.

(Nasdaq: CELC), a functional cellular analysis company that is discovering new cancer subtypes and commercializing diagnostic tests

designed to significantly improve clinical outcomes of cancer patients treated with targeted therapies, announced financial results

for the first quarter ended March 31, 2019.

Unless otherwise stated, all comparisons are for the first quarter

ended March 31, 2019, compared to the first quarter ended March 31, 2018.

Celcuity reported a net loss of $1.85 million, or $0.18 per

share, for the first quarter of 2019, compared to a net loss of $1.97 million, or $0.19 per share, for the first quarter of 2018.

Non-GAAP adjusted net loss was $1.66 million, or $0.16 per share, for the first quarter of 2019, compared to non-GAAP adjusted

net loss of $1.63 million, or $0.16 per share, for the first quarter of 2018. Non-GAAP adjusted net loss excludes stock-based compensation

expense. Because this item has no impact on the cash position of the Company, management believes

Non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial

measures in accordance with generally accepted accounting principles of the United States (GAAP) to non-GAAP financial measures

in this release, please see the financial tables at the end of this news release.

Net cash used in operating activities for the first quarter

of 2019 was $1.59 million. At March 31, 2019, Celcuity had cash, cash equivalents and investments of $23.4 million, compared to

cash, cash equivalents and investments of $30.0 million at March 31, 2018.

"To accelerate enrollment in the FACT 1 trial, we began

the process of adding new clinical sites in late 2018," said Chairman and Chief Executive Officer, Brian Sullivan. "The

FACT 1 trial is evaluating the safety and efficacy of Genentech's drugs, Herceptin and Perjeta , and chemotherapy,

in early stage breast cancer patients selected with Celcuity's CELx HSF Test. During the first quarter of 2019, we met our

goal of getting 16 new clinical sites to begin the activities required to participate in the FACT 1 trial. These sites are now

at various stages of obtaining Institutional Review Board (IRB) and other related approvals. These approval-related activities

are expected to take between three to nine months, depending on a site's internal processes. The addition of these sites

would more than double the current number of activated sites enrolling patients for this trial. We expect interim results will

be available from this trial in late 2019 and final results approximately nine months later.

"The FACT 2 clinical trial was activated as planned in

early April and will evaluate Puma Biotechnology Inc.'s targeted therapy, Nerlynx , in patients our CELx HSF test selects.

We expect interim results from this trial in late 2019 or early 2020 and final results approximately 12 months later. The trial

with NSABP and Puma Biotechnology, Inc. to evaluate tissue samples from a Phase II study evaluating Puma Biotechnology's

pan-HER inhibitor, Nerlynx, Genentech's HER2 antibody, Herceptin, and Bristol-Myers Squibb's EGFR inhibitor, Erbitux,

in metastatic colorectal cancer patients also continues to progress."

Mr. Sullivan added, "We continued to advance development

of new tests in breast cancer and two additional tissue types. Our goal is to complete development of another cell signaling function

test for breast cancer that diagnoses a new sub-type of breast cancer not currently detected with a molecular test. The tests for

two new tumor types would further increase the opportunities for us to provide companion diagnostics that we believe will enable

pharmaceutical companies to obtain new drug indications for the cancer sub-types our tests diagnose.

"We also continued progress towards finalizing a clinical

collaboration with a pharmaceutical company to study breast cancer patients identified by our CELx MP test with hyperactive and

co-activated HER family and c-Met signaling activity."

Total operating expenses were $1.97 million for the first quarter

of 2019, compared to $2.08 million for the first quarter of 2018.

Research and Development Expenses:

Research and development (R&D) expenses were $1.59 million

for the first quarter of 2019, compared to $1.55 million for the first quarter of 2018. The approximately $0.05 million increase

resulted primarily from legal expenses related to patent costs and operational and business development activities.

General and Administrative Expenses:

General and administrative (G&A) expenses were $0.38 million

for the first quarter of 2019, compared to $0.53 million for the first quarter of 2018. The approximately $0.15 million decrease

primarily resulted from non-cash stock-based compensation.

Management will host a teleconference call at 4:30 PM Eastern

Time today to discuss the results. Anyone interested in participating should dial 1-877-876-9173 referencing confirmation code

"Celcuity." Participants are asked to dial in 5 to 10 minutes prior to the start of the call and inform the operator

you would like to join the "Celcuity Conference Call."

Celcuity Inc. is a cellular analysis

company that is discovering new cancer sub-types and commercializing diagnostic tests designed to significantly improve the clinical

outcomes of cancer patients treated with targeted therapies. Celcuity's proprietary CELx diagnostic platform uses a

patient's living tumor cells to identify the specific abnormal cellular activity driving a patient's cancer and the

targeted therapy that can best treat that patient's disease. Celcuity is headquartered in Minneapolis, MN. Further information

about Celcuity can be found at www.celcuity.com.

Forward-Looking Statements

This press release contains statements

that constitute "forward-looking statements." In some cases, you can identify forward-looking statements by terminology

such as "may," "should," "expects," "plans," "anticipates," "believes,"

"estimates," "predicts," "potential," "intends" or "continue," and

other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or

other comparable terminology. Forward looking statements in this release include, without limitation, expectations with respect

to commercializing diagnostic tests, the use of cash, the discovery of additional cancer sub-types, the development of additional

CELx signaling function tests, the uses and breadth of application of CELx signaling function tests, whether alone or in collaboration

with other tests, collaboration with pharmaceutical companies and the outcomes of such collaboration, the outcome of our FACT 1

clinical trial with NSABP Foundation and Genentech, the outcome of our FACT 2 clinical trial with Puma Biotechnology, Inc.

and the West Cancer Center, the outcome of the clinical trial Puma Biotechnology and the NSABP

Foundation are fielding and of which we are providing services, clinical trial site approval activities

and the timing of such activities, clinical trial patient enrollment and timing of results, anticipated benefits that our

tests may provide to pharmaceutical companies and to the clinical outcomes of cancer patients and

plans to expand research and development and operational processes. Forward-looking statements are subject to numerous conditions,

many of which are beyond the control of Celcuity, which include, but are not limited to, those set forth in the Risk Factors section

in our Annual Report on Form 10-K for the year ended December 31, 2018 filed with the Securities and Exchange Commission on March

1, 2019. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date

hereof. Celcuity undertakes no obligation to update these statements for revisions or changes after the date of this release, except

Brian Sullivan, bsullivan@celcuity.com

Vicky Hahne, vhahne@celcuity.com

Cautionary Statement

Regarding Non-GAAP Financial Measures

This news release contains references to non-GAAP

adjusted net loss and non-GAAP adjusted net loss per share. Management believes these non-GAAP financial measures are useful supplemental

measures for planning, monitoring, and evaluating operational performance as they exclude stock-based compensation expense from

net loss and net loss per share. Management excludes this item because it does not impact the cash position of the Company, which

management believes better enables Celcuity to focus on cash used in operations. However, non-GAAP adjusted net loss and non-GAAP

adjusted net loss per share are not recognized measures under GAAP and do not have a standardized meaning prescribed by GAAP. Therefore,

non-GAAP adjusted net loss and non-GAAP adjusted net loss per share may not be comparable to similar measures presented by other

issuers. Investors are cautioned that non-GAAP adjusted net loss and non-GAAP adjusted net loss per share should not be construed

as alternatives to net loss, net loss per share or other statements of operations data (which are determined in accordance with

GAAP) as an indicator of Celcuity's performance or as a measure of liquidity and cash flows. Management's method of

calculating non-GAAP adjusted net loss and non-GAAP adjusted net loss per share may differ materially from the method used by other

companies and accordingly, may not be comparable to similarly titled measures used by other companies.