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Context Therapeutics® Announces Clinical Updates on ONA-XR to be Presented at 2022 San Antonio Breast Cancer Symposium

Context Therapeutics Inc.
Context Therapeutics Inc.

Company reports initial ONA-XR data from the ongoing Phase 2 SMILE trial for metastatic breast cancer will be presented

PHILADELPHIA, Nov. 21, 2022 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a women’s oncology company developing novel treatments for breast and gynecologic cancers, today announced clinical data on onapristone extended release (ONA-XR) will be presented at the 2022 San Antonio Breast Cancer Symposium® (SABCS®) taking place in San Antonio, Texas, from December 6-10, 2022.

“We are pleased that ONA-XR will be featured at SABCS. Initial clinical data from the SMILE trial will be presented, which is being conducted in collaboration with the Wisconsin Oncology Network, as well as a presentation providing an early look at the ELONA trial design that we recently initiated as part of our collaboration agreement with The Menarini Group. We’re excited to reconnect with the oncology community at SABCS, to further highlight the potential of ONA-XR to help improve the lives of people living with breast cancer, and to work toward creating new standards of care in the women’s oncology field that will make a meaningful impact,” said Martin Lehr, CEO of Context Therapeutics.

Details on the presentations are as follows:

Poster Title: The SMILE Study: A phase II trial of onapristone in combination with fulvestrant for patients with ER-positive and HER2-negative metastatic breast cancer after progression on endocrine therapy and CDK 4/6 inhibitors
Poster ID: OT2-01-02
Abstract: 1300819
Session: Ongoing Trials Poster Session 2
Date: Wednesday December 7, 2022
Time: 5:00 PM - 6:15 PM CT
Presenters: Sailaja Kamaraju, M.D., Medical College of Wisconsin, Milwaukee, Wis., and Kari Wisinski, M.D., University of Wisconsin - Madison

Poster Title: ELONA: An open-label, phase 1b-2 study of elacestrant, in combination with onapristone in patients with estrogen receptor-positive, progesterone receptor-positive, HER2-negative advanced or metastatic breast cancer
Poster ID: OT2-01-04
Abstract: 1307318
Session: Ongoing Trials Poster Session 2
Date: Wednesday December 7, 2022
Time: 5:00 PM - 6:15 PM CT
Presenter: Erika Hamilton, M.D., Sarah Cannon Research Institute

Details on the presentations listed above are also available on the 2022 SABCS website: https://www.sabcs.org/2022-Symposium-Overview

About ONA-XR
ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor (PR) that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that ONA-XR has anticancer activity by inhibiting progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. ONA-XR is currently being evaluated in three Phase 2 clinical trials and one Phase 1b/2 clinical trial in PR+ breast, ovarian and endometrial cancers. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.

About Context Therapeutics®
Context Therapeutics Inc. (Nasdaq: CNTX) is a clinical-stage biopharmaceutical company committed to advancing medicines for female cancers. The Company’s pipeline includes small molecule and bispecific antibody drug candidates that target cancer signaling pathways. Onapristone extended release (ONA-XR), a novel, first-in-class potent and selective progesterone receptor antagonist, is currently in three Phase 2 clinical trials and one Phase 1/2 clinical trial in hormone-driven breast, ovarian, and endometrial cancers. Context is also developing a selective Claudin 6 (CLDN6) x CD3 bispecific antibody for CLDN6 positive tumors, currently in preclinical development. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on Twitter and LinkedIn.

Forward-looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as "may," "will," "expect," "anticipate," "plan," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the expectation that initial clinical data for the SMILE trial and information regarding the ELONA trial design will be presented at SABCS in December 2022, (ii) the results of our clinical trials, (iii) the potential benefits of our product candidates, (iv) the likelihood data will support future development, and (v) the likelihood of obtaining regulatory approval of our product candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Media Contact:
Gina Cestari
6 Degrees
917-797-7904
gcestari@6degreespr.com

Investor Relations Contact:
Laine Yonker
Edison Group
lyonker@edisongroup.com