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

MINNEAPOLIS

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.

Celcuity Inc.
Brian Sullivan, [email protected]
Vicky Hahne, [email protected]
763-392-0123

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