Celcuity Reports Second Quarter 2019 Financial Results Minneapolis, Minnesota

Celcuity Reports Second Quarter 2019

Minneapolis, Minnesota-August 8,

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 second quarter ended June 30, 2019.

Unless otherwise stated, all comparisons

are for the second quarter ended June 30, 2019, compared to the second quarter ended June 30, 2018.

Celcuity reported a net loss of $1.72 million,

or $0.17 per share, for the second quarter of 2019, compared to a net loss of $1.82 million, or $0.18 per share, for the second

quarter of 2018. Net loss for the first six months of 2019 was $3.57 million, or $0.35 per share, compared to $3.78 million, or

$0.37 per share, for the first six months of 2018. Non-GAAP adjusted net loss was $1.53 million, or $0.15 per share, for the second

quarter of 2019, compared to non-GAAP adjusted net loss of $1.54 million, or $0.15 per share, for the second quarter of 2018. Non-GAAP

adjusted net loss for the first six months of 2019 was $3.19 million, or $0.31 per share, compared to non-GAAP adjusted net loss

of $3.17 million, or $0.31 per share, for the first six months 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 second quarter of 2019 was $1.23 million. At June 30, 2019, Celcuity had cash, cash equivalents and investments of $22.1 million,

compared to cash, cash equivalents and investments of $24.9 million at December 31, 2018.

"We are pleased to report that our

efforts to add new clinical sites to participate in the FACT 1 trial are on track. During the quarter, six new clinical sites obtained

Institutional Review Board (IRB) approval and activated the trial. We now have 20 sites who are enrollment ready and another nine

sites that are at various stages of obtaining IRB and other related approvals. We are hopeful that most, if not all, of the nine

sites that are in the midst of approval-related activities will be enrollment ready by year-end," 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.

"The addition of these six new and

nine pending sites would double the number of activated sites enrolling patients for this trial compared to the end of 2018. Since

most of the new sites only began participating in the past month, they have not yet had an impact on the patient enrollment rate

for the trial. As a result, we now expect interim results will be available from this trial in early to mid-2020 and final results

approximately nine months later.

"The FACT 2 clinical trial is underway.

Although the clinical site was enrollment ready in early April, the study drug, Puma Biotechnology Inc.'s targeted therapy,

Nerlynx , was not made available until late June. As a result, this pushed out the start of enrollment activities. We now expect

interim results from this trial in early to mid-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 are nearing

completion of the development of our next cell signaling function test for breast cancer. We expect to report pre-clinical study

results describing the test by the end of the year. This new test will diagnose a new sub-type of breast cancer not currently detected

with a molecular test. Once development is completed, we would initiate discussions with pharmaceutical companies about collaborating

on a clinical trial. We expect to incorporate this new pathway test into our CELx Multi-Pathway (MP) Signaling Function Test when

available. Development of tests for two new tumor types also progressed during the quarter. With these new tests, we will 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 to 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 $1.84 million

for the second quarter of 2019, compared to $1.93 million for the second quarter of 2018. Operating expenses for the first six

months of 2019 were $3.82 million, compared to $4.0 million for the first six months of 2018.

Research and Development Expenses:

Research and development (R&D) expenses

were $1.47 million for the second quarter of 2019, compared to $1.55 million for the second quarter of 2018. R&D expenses for

the first six months of 2019 were $3.06 million, compared to $3.09 million for the first six months of 2018. The approximately

$0.03 million decrease during the first half of fiscal year 2019, compared to the first half of fiscal year 2018, resulted primarily

from a $0.1 million decrease in non-cash stock-based compensation, offset by a $0.07 million increase in operational and business

development activities.

General and Administrative Expenses:

General and administrative (G&A) expenses

were $0.37 million for the second quarter of 2019, compared to $0.38 million for the second quarter of 2018. G&A expenses for

the first six months of 2019 were $0.76 million, compared to $0.92 million for the first six months of 2018. The approximately

$0.16 million decrease during first half of 2019, compared to the first half of 2018, primarily resulted from a decrease in 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 1-877-876-9174 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."

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

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

Condensed Statements of Operations