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Celcuity Presents Results from Three Studies at the 2018 San Antonio Breast Cancer Symposium Evaluating HER2-Negative Breast Cancer Tumors with Hyperactive and Co-Activated HER Family and c-Met Signaling

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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 that it presented
results from three studies of the CELx MP Signaling Function Test at the
2018 San Antonio Breast Cancer Symposium on December 6, 2018.

The CELx MP test identifies a significant subset of HER2-negative breast
cancer patients with coincidental hyperactive c-Met and HER family
signaling tumors that respond ex vivo to a combination of pan-HER
and c-Met tyrosine kinase inhibitors. These studies characterize the
CELx MP Test's analytical performance and provide a demonstration of the
pathogenicity of coincidental hyperactive HER-family and c-Met signaling
in HER2-negative breast cancer tumors using an animal model.

Posters and primary results included:

  • Abstract # 183, Poster # P3-10-20
    Title: Sub-group of HER2-
    breast cancer patients with hyperactive and co-involved c-Met and ErbB
    pathways identified: Functional signal profiling test identifies
    patient group that may benefit from c-Met and pan-HER combination
    therapy
    • CELx MP Test analysis of primary breast cancer cells from 79
      HER2-negative breast cancer patients revealed that 19 of 79,
      (24.1%; 95% CI=16–35%) had both hyperactive c-MET signaling and at
      least one hyperactive signaling HER family receptor.
    • For hyperactive c-Met signaling, analytical specificity was
      determined to be >99% and analytical sensitivity >84%.
    • A combination of pan-HER and c-Met tyrosine kinase inhibitors
      reduce hyperactive HER family and c-Met functional signaling ex
      vivo
      more effectively than either antagonist alone.
    • Pathway crosstalk analysis using the CELx MP Test supports third
      party reports that c-Met and HER family signaling pathways are
      co-involved.
  • Abstract # 497, Poster: # P2-05-05
    Title: Results from a study
    Evaluation of pan-HER and c-MET inhibitors tested in primary HER2-
    breast cancer cells with hyperactive c-MET and ErbB family signaling
    • The average IC50 values for the individual pan-HER inhibitors
      ranged from 1.23 nM – 137.27 nM.
    • The average IC50 values for the individual c-Met inhibitors ranged
      from 3.10 nM – 28 nM.
    • In drug efficacy studies, an average of at least 80% of the ErbB
      and c-MET signaling activated by NRG1b, EGF, and HGF
      co-stimulation was inhibited by each combination of c-Met and
      pan-HER inhibitors.
  • Abstract # 182, Poster: P3-10-15
    Title: Evaluating contribution
    of hyperactive c-Met and ErbB signaling to tumor progression in mouse
    breast tumor xenografts: A study of c-Met and ErbB targeted therapies
    • HER1 or c-Met inhibitors have limited single agent effectiveness
      when HER and c-Met pathways are co-activated either in vitro
      (real-time live cell CELx MP Test) or in vivo (Xenograft
      mouse model).
    • Combination of a c-Met with a pan-HER inhibitor reduced the mouse
      breast tumor xenograft size most significantly.
    • The real-time live cell CELx MP test results are consistent with
      xenograft HCC1954 tumor model data and suggest that c-Met and HER
      pathways are co-activated and must both be inhibited.

Copies of the abstracts and posters Celcuity presented at the 2018 San
Antonio Breast Cancer Symposium can be found at www.celcuity/publications

About Celcuity
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 and
the abstracts and posters referred to herein contain statements that
constitute "forward-looking statements." In some cases, you can identify
forward-looking statements by terminology such as "may," "should,"
"suggests," "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 and the abstracts and posters
referred to herein include, without limitation, expectations with
respect to the responsiveness of cancer patients with certain cell
signaling to certain inhibitors (or combinations thereof), beliefs
regarding the ability to minimize drug toxicities without impacting
efficacy of treatment and beliefs regarding the merits of conducting
additional clinical trials to evaluate responsiveness of certain cancer
patient subsets to certain inhibitors.
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, 2017 filed with the Securities and Exchange
Commission on March 15, 2018.
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 as required by law.

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