Context Therapeutics (NASDAQ:CNTX) Inc, a clinical-stage biopharma company focused on advancing medicines for cancers in women, posted results for the third quarter that revealed ample cash on hand, giving the company scope to advance its pipeline programs.
As of September 30, 2022, the Philadelphia-based women’s oncology company developing treatments for breast and gynecological cancers, had cash, equivalents, and restricted cash which totaled $39 million. Context said this is “expected to provide a runway into Q1 2024”.
The clinical-stage biopharma company reported a net loss of $3.9 million for the third quarter of 2022, compared to $1.4 million for 3Q 2021.
During the quarter, Context’s R&D expenses totaled $2.1 million and were driven primarily by Onapristone extended-release (ONA-XR) contract manufacturing and clinical costs and an increase in salaries due to a higher employee headcount. Meanwhile, general and admin expenses totaled $2.0 million for the quarter.
Context’s pipeline includes small molecule and bispecific antibody drug candidates that target cancer signaling pathways. ONA-XR is a novel, potent and selective progesterone receptor antagonist, which is currently in three Phase 2 trials and one Phase 1/2 trial in hormone-driven breast, ovarian, and endometrial cancers.
“We are pleased with the continued strengthening of ONA-XR’s clinical profile. The preliminary Phase 2 findings for ONA-XR in combination with anastrozole in progesterone receptor-positive (PR+) recurrent endometrial cancer highlight a 4-month progression-free survival (PFS) rate of 77.7%, and favorable safety and tolerability, representing a meaningful improvement over the single activity of either agent alone,” said Context Therapeutics (NASDAQ:CNTX) CEO Martin Lehr.
“Additionally, we are pleased to announce that we initiated the Phase 1b portion of our Phase 1b/2 ELONA breast cancer clinical trial to evaluate ONA-XR in combination with elacestrant. These achievements underscore our commitment to creating new standards of care in the women’s oncology field,” he added.
Context is advancing its ongoing Phase 2 trial in collaboration with Jefferson Health investigating ONA-XR 50 mg BID in combination with anastrozole 1mg QD in women with PR+ endometrial adenocarcinoma, who have failed front-line therapy with a platinum/taxane-based chemotherapy regimen. As of September 30, 2022, the trial had enrolled 12 of 25 planned patients.
“Looking ahead, we plan to complete enrollment of the Phase 2 PR+ recurrent endometrial cancer trial and evaluate a potential registrational path. We will also continue to assess ONA-XR across multiple ongoing clinical trials, including an initial Phase 2 data readout in second- or third-line advanced or metastatic ER+, PR+, HER2- breast cancer in December 2022,” Lehr added.
Claudin 6 update
The company said its Claudin 6 bispecific antibody program remains on track with a development candidate nomination expected in December 2022. Context anticipates an Investigational New Drug Application (IND) submission for the program in 1Q 2024.
“Separately, we anticipate nominating a development candidate for our Claudin 6 bispecific antibody program in December. Our expected cash runway into Q1 2024 gives us the financial flexibility to execute on the advancement of our pipeline targeting female cancers,” concluded Lehr.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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