Context Therapeutics and Menarini Group Announce

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Preclinical Data Support Potential of ONA-XR Plus Estrogen Receptor Degraders in Endocrine-Resistant Disease Models

Context to launch the phase 1b/2 clinical trial in the fourth quarter of 2022

PHILADELPHIA and FLORENCE, Italy, Aug. 02, 2022 (GLOBE NEWSWIRE) — Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a women’s oncology company developing small molecule and immunotherapy for breast and gynecological cancers, and The Menarini Group (“Menarini”) today announced an agreement to collaborate and supply clinical trials for Menarini’s oral Selective Estrogen Receptor Degrader (SERD), the elacestrant.

This agreement will support the upcoming ELONA Phase 1b/2 proof-of-concept clinical trial evaluating onapristone extended-release (ONA-XR), an oral progesterone receptor (PR) antagonist, in combination with elacestrant in estrogen receptor positive (ER+), PR+ Patients with HER2 metastatic breast cancer (mBC) who have been previously treated with a CDK4/6 inhibitor. Context will sponsor the clinical trial and Menarini will provide the elacestrant free of charge.

According to the American Cancer Society, breast cancer is the second most common cancer in women, occurring in 1 in 8 women (13%) during a woman’s lifetime, with an estimated 280,000 new cases of cancer invasive breast cancer and 51,400 cases of non-invasive cancer. invasive breast cancer expected in 2022. Elacestrant is the first oral SERD to demonstrate a statistically significant and clinically significant improvement in progression-free survival (PFS) compared to standard-of-care (SOC) hormone therapy in a Phase 3 trial in patients with ER+, HER2-mBC, with a 30% reduction in the risk of progression or death in all patients. The data also showed that 22% of patients were alive and progression-free 12 months after starting treatment with elacestrant compared to 9% with SOC in the overall population. Therefore, elacestrant could become the new core endocrine therapy for ER+, HER2-mBC.

Preliminary data from preclinical studies suggest that dual ER and PR blockade may be associated with better tumor control. The ELONA clinical trial will test this important hypothesis.

“We are grateful to Menarini for his collaboration as we explore the therapeutic potential of adding ONA-XR, our oral PR antagonist, to elacestrant,” said Tarek Sahmoud, MBBCh, Ph.D. , Context’s Chief Medical Officer. “We hope this combination will further improve clinical outcomes in patients with ER+, PR+, HER2-mBC.”
“ONA-XR’s ability to restore hormone sensitivity and its tolerability profile positions it well for combination with elacestrant,” said Nassir Habboubi, MD, Global Head of R&D at Menarini.

Context expects to initiate the Phase 1b/2 clinical trial in Q4 2022. The two companies will form a joint committee to review the results.

About the Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with sales of over $4 billion and more than 17,000 employees. Menarini focuses on therapeutic areas with high unmet need with products for oncology, cardiology, pulmonology, gastroenterology, infectious diseases, diabetes, inflammation and analgesia. With 18 production sites and 9 Research and Development centers, Menarini products are available in 140 countries around the world. For more information, please visit www.menarini.com.

About ONA-XR
ONA-XR (onapristone extended release) is a potent and specific progesterone receptor (PR) antagonist administered orally. Currently, there are no approved therapies that selectively target PR+ cancers. Preclinical and preliminary clinical data suggest that ONA-XR has anticancer activity by inhibiting the binding of progesterone receptors 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 women’s oncology company developing small molecule and immunotherapy treatments to transform breast and gynecological cancer care. The Company’s strong clinical program for lead candidate extended-release onapristone (ONA-XR) includes three Phase 2 clinical trials and one Phase 1b/2 clinical trial in breast, ovarian and cervical cancer. hormone-dependent endometrium. ONA-XR is a first-in-class new small molecule being developed as a potent and specific antagonist of the progesterone receptor, a key uncontrolled mechanism in female hormone-induced cancers. Context is headquartered in Philadelphia, Pennsylvania. For more information, visit www.contexttherapeutics.com.

Forward-looking statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor under the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical facts, included in this press release regarding strategy, future operations, outlook, plans and management objectives, including words such as “may”, “will”, “expect”, “anticipate”, “plan “, “intend” and similar expressions (as well as other words or expressions referring to future events, conditions or circumstances) are forward-looking statements. These include, but are not limited to, statements regarding (i) the timing of initiation, enrollment and obtaining initial data for our clinical trials, (ii) the results of our clinical trials, (iii ) the potential benefits of the product candidates, (iv) the likelihood data will support future development, and (v) the likelihood of obtaining regulatory approval of the product candidates. The forward-looking statements contained 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 therefore we cannot assure you that our plans, intentions , expectations or strategies will be met or achieved. Other factors that could cause actual results to differ from those expressed or implied by the forward-looking statements in this press release are discussed in our filings with the United States Securities and Exchange Commission, including the section entitled “Risk Factors” contained therein. Except as 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.

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