PHILADELPHIA, PA — Context Therapeutics Inc. (Nasdaq: CNTX) recently announced its financial results for the third quarter ended September 30, 2023, and reported on recent and upcoming business highlights.
“During the third quarter of this year, Context continued to advance our lead clinical candidate, CTIM-76, a Claudin 6 (“CLDN6”) x CD3 bispecific antibody, toward a first-in-human clinical study. Preclinical data presented at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting showed the broad therapeutic potential of CTIM-76 when targeting CLDN6-positive tumors and identified a potential first-in-human dose. The preclinical data supported CTIM-76’s differentiated product profile, including its potential to address limitations of first-generation CLDN6-targeted clinical-stage therapies and the requirement of high CLDN6 expression and off-target toxicities,” said Martin Lehr, CEO of Context. “We look forward to filing an Investigational New Drug Application (“IND”) with the U.S. Food and Drug Administration late in the first quarter of 2024 for CTIM-76.”
Third Quarter 2023 and Recent Corporate Highlights
- In November 2023, announced encouraging preclinical data presented at the SITC 38th Annual Meeting that demonstrated CTIM-76 was well tolerated and induced dose-proportional tumor regressions in models of CLDN6-positive cancer. Benchmarking studies were conducted to compare CTIM-76 to clones of other CLDN6 clinical-stage compounds, including TORL-1-23 and AMG-794. In these studies, CTIM-76 was potent across a wide-range of CLDN6 expression profiles, whereas TORL-1-23 potency was limited to CLDN6-high expression. In addition, CTIM-76 demonstrated ten-fold higher potency than that of AMG-794 in in vitro cytotoxicity and cytokine activation assays.
- In August 2023, participated in the H.C. Wainwright Immune Cell Engager Virtual Conference.
Third Quarter 2023 Financial Results
- Cash and cash equivalents were $21.7 million at September 30, 2023, compared to $35.5 million at December 31, 2022.
- Research and development (“R&D”) expenses were $4.5 million for the third quarter 2023, as compared to $2.1 million for the same period in 2022. The increase in R&D expenses was driven by higher CTIM-76 contract manufacturing costs and preclinical costs as a result of ongoing IND-enabling studies and activities. This increase was partially offset by a decrease in onapristone extended release (“ONA-XR”) expenses, primarily due to the Company’s decision in March 2023 to discontinue the development of ONA-XR and focus on the development of CTIM-76.
- General and administrative expenses were $1.7 million for the third quarter 2023, as compared to $2.0 million for the same period in 2022. The decrease was primarily driven by decreases in insurance expense, professional fees, compensation and share-based compensation costs.
- Other income was $0.3 million for the third quarter of 2023, as compared to $0.2 million for the same period in 2022, primarily due to higher interest income earned on cash and cash equivalent balances.
- Context reported a net loss of $5.9 million for the third quarter 2023, as compared to $3.9 million for the same period in 2022.
2023 Cash Guidance
The Company expects its cash and cash equivalents will be sufficient to fund its operations into late 2024.
For more information, please visit www.contexttherapeutics.com.
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