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 (ELONA)

This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.

Start Date02 Dec 2022

Sponsor / Collaborator

Context Therapeutics, Inc.

NCT04738292

/ TerminatedPhase 2IIT

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

A phase II single-arm trial of onapristone in combination with fulvestrant for women and men with ER-positive, PgR-positive or negative and HER2-negative locally advanced or metastatic breast cancer after progression on aromatase and CDK4/6 inhibitors. The study will enroll up to 39 participants.

Start Date05 Oct 2021

Sponsor / Collaborator

University of Wisconsin Madison

[+1]

NCT04872608

/ WithdrawnPhase 1IIT

ctDNA-guided Adaptive Therapy Escalation in ER+ MBC: A Phase 1b Study With Letrozole, Palbociclib and Onapristone ER

The researchers are doing this study to find out whether the study drug onapristone ER, combined with the standard treatment for your cancer (letrozole and palbociclib), is a safe treatment for people who have metastatic or unresectable ER+/PR+/HER2- breast cancer. The researchers will test different doses of the study drug to find the highest dose that causes few or mild side effects.

Start Date09 Sep 2021

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

100 Clinical Results associated with Onapristone

100 Translational Medicine associated with Onapristone

100 Patents (Medical) associated with Onapristone

363

Literatures (Medical) associated with Onapristone

01 Apr 2025·Clinical Breast Cancer

A Phase II Trial of Onapristone and Fulvestrant for Patients With ER+ and HER2- Metastatic Breast Cancer

Article

Author: Parkes, Amanda ; Fowler, Amy M ; Bradshaw, Tyler J ; Perlman, Scott B ; Twaroski, Kyleigh ; Wisinski, Kari ; Zurbriggen, Luke ; Stella, Amy ; Kamaraju, Sailaja ; Jorns, Julie M ; Rajguru, Saurabh ; Giever, Thomas ; Lange, Carol A ; Pipp-Dahm, Michele ; Hegeman, Robert ; Burkard, Mark E ; Siddiqui, Nauman ; Sahmoud, Tarek ; Keigley, Quinton J ; Salem, Kelley ; Cheng, Yee C ; Chaudhary, Lubna N ; Rui, Hallgeir ; Tarima, Sergey

BACKGROUND:

The SMILE study is a multi-institutional phase II clinical trial to determine the efficacy and safety of an antiprogestin, onapristone, in combination with fulvestrant as second-line therapy for patients with ER+, PgR+/-, HER2- metastatic breast cancer. This study was terminated early and herein, we report patient characteristics, and outcomes.

METHODS:

Eligibility criteria included disease progression on ≥2 lines of prior therapy, ECOG performance status ≤ 2, measurable disease per RECIST 1.1 criteria, and optional ¹⁸F-fluorofuranylnorprogesterone (¹⁸F-FFNP) PET/CT imaging.

RESULTS:

Consented subjects received standard-dose fulvestrant plus onapristone 50 mg orally, twice daily, until disease progression, or unacceptable toxicity. The study enrolled 11 women from 2 sites within the Wisconsin Oncology Network from November 2021 through March 2023. Mean age of the subjects was 58.5 years. Other than grade 1 toxicities, the treatment was well tolerated. None of the 11 subjects met RECIST 1.1 definition of response. The median time to progression was 63 days. A total of 4 of 11 patients had stable disease as best response and 2 of them were on treatment for 5.5 and 7.7 months. Two of the 11 subjects underwent functional imaging with ¹⁸F-FFNP PET/CT before and 10 or 14 days after starting treatment. For both subjects, tumor uptake of ¹⁸F-FFNP was stable or increased in all target lesions while ¹⁸F-FFNP uptake in the uterus, a normal PgR-rich internal control organ, was decreased.

CONCLUSION:

The study regimen was well-tolerated with no significant toxicities. Future studies may evaluate antiprogestins with various combinations such as targeted therapies.

01 Jan 2025·INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER

Basket study of oral progesterone antagonist onapristone extended-release in combination with anastrozole in progesterone receptor-positive recurrent adult-type granulosa cell tumor of the ovary

Article

Author: Finch, Lindsey ; Makker, Vicky ; Kyi, Chrisann ; Jang, Dasom ; Chhetri-Long, Rashmi ; Selenica, Pier ; Weigelt, Britta ; Girshman, Jeffrey ; Chiang, Sarah ; Friedman, Claire F ; Aghajanian, Carol ; Green, Hunter ; O'Cearbhaill, Roisin E ; Grisham, Rachel N ; Iasonos, Alexia ; Sonoda, Yukio ; Zhou, Qin ; Andres, Sarah ; Chi, Dennis S ; Cohen, Seth

OBJECTIVE:

We sought to determine the safety and efficacy of the oral progesterone antagonist onapristone in combination with anastrozole in patients with recurrent progesterone receptor-positive adult-type granulosa cell tumor of the ovary.

METHODS:

This was a single-institution phase II study of patients with progesterone receptor-positive adult-type granulosa cell tumor who received at least 1 prior line of chemotherapy. Patients were enrolled from November 2021 to August 2022 and tissue was evaluated for progesterone receptor status via immunohistochemistry. Eligible patients had progesterone receptor expression ≥1% on tissue collected within 3 years of enrollment. Patients received 50 mg of onapristone extended-release twice daily and 1 mg of anastrozole by mouth daily until progression of disease or discontinuation of treatment. Adverse events were graded by Common Terminology Criteria for Adverse Events version 5.0. The primary end point was the overall response rate by Response Evaluation Criteria in Solid Tumors version 1.1. Secondary end points were response duration, clinical benefit rate, progression-free survival, and safety.

RESULTS:

Fourteen patients with adult-type granulosa cell tumor enrolled and completed stage 1 accrual. There were no objective responses seen during the study period. The study was closed when further development of onapristone extended-release was discontinued. All 14 patients were evaluable, with median progression-free survival of 3.6 months (range; 1.7-7.1), a 6-month progression-free survival rate of 28.6% (range; 8.8%-52.4%), a 12-month progression-free survival rate of 10.7% (range; 0.8%-35.4%), and a clinical benefit rate of 42.9% (range; 17.7%-71.7%).

CONCLUSION:

The study did not meet its primary end point. Although the combination of onapristone extended-release and anastrozole was well-tolerated, there were no objective responses in patients with progesterone receptor-positive adult-type granulosa cell tumor.

01 Oct 2024·GYNECOLOGIC ONCOLOGY

Basket study of oral progesterone antagonist onapristone extended release in progesterone receptor-positive recurrent granulosa cell, low-grade serous ovarian cancer, or endometrioid endometrial cancer

Article

Author: Cohen, Seth ; Kyi, Chrisann ; Jang, Dasom ; Finch, Lindsey ; Chhetri-Long, Rashmi ; Makker, Vicky ; Weigelt, Britta ; Girshman, Jeffrey ; Chiang, Sarah ; Green, Hunter ; Grisham, Rachel N ; Aghajanian, Carol ; Sonoda, Yukio ; Iasonos, Alexia ; O'Cearbhaill, Roisin ; Friedman, Claire ; Andres, Sarah ; Chi, Dennis S ; Zhou, Qin

OBJECTIVE:

To determine the safety and efficacy of the oral progesterone antagonist onapristone extended release (onapristone-XR) in patients with recurrent progesterone receptor (PR)-positive adult-type granulosa cell tumor (aGCT), low-grade serous ovarian cancer (LGSOC), or endometrioid endometrial cancer (EEC).

METHODS:

This single-institution phase II study included patients with PR-positive aGCT, LGSOC, or EEC who received ≥1 prior line of chemotherapy. Patients were enrolled from 5/2019-5/2020. PR status was evaluated via immunohistochemistry. Eligible patients had PR expression ≥1% on tissue collected within 3 years of enrollment. Patients received 50 mg of onapristone-XR twice daily until disease progression or treatment discontinuation. Adverse events were graded by Common Terminology Criteria for Adverse Events version 5.0. The primary endpoint was overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors 1.1. Secondary endpoints were response duration, clinical benefit rate (CBR), and safety.

RESULTS:

Five patients with LGSOC and 1 with EEC enrolled, but both cohorts closed early due to slow accrual. Fourteen patients with aGCT enrolled and completed stage 1 accrual. No responses were observed. Four patients with LGSOC were evaluable, with median PFS of 4.4 months (range, 1.8-NE) and CBR of 50% (range, 6.8%-93.2%). All 14 patients with aGCT were evaluable, with median PFS of 2.8 months (range, 1.6-4.9), 6-month PFS rate of 21.4% (range, 5.2%-44.8%), 12-month PFS rate of 14.3% (range, 2.3%-36.6%), and a CBR of 35.7% (range, 12.8%-64.9%).

CONCLUSIONS:

The study did not meet its primary endpoint. While onapristone-XR was well tolerated in all 3 arms, no objective responses were observed.

News (Medical) associated with Onapristone

08 May 2024

·www.biospace.com

Context Therapeutics Reports First Quarter 2024 Operating and Financial Results

Announced FDA clearance of IND application for a Phase 1 clinical trial of CTIM-76 Completed $100 million financing; expected to extend funding into 2028 PHILADELPHIA, May 08, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced its financial results for the first quarter ended March 31, 2024, and reported on recent business highlights. “We believe Context has had a great start to 2024 including achieving significant regulatory goals, demonstrating robust progress, and positioning us for future growth. The Company successfully closed a private placement, generating approximately $100 million in gross proceeds from leading institutional investors, underscoring confidence from new and existing investors in our vision and potential,” said Martin Lehr, CEO of Context. “Additionally, we were excited to recently announce that the U.S. Food and Drug Administration (“FDA”) granted clearance for our Investigational New Drug (“IND”) application for CTIM-76, a promising Claudin 6 (“CLDN6”) x CD3 T cell engaging bispecific antibody, paving the way for the initiation of a Phase 1 dose escalation and expansion clinical trial targeting CLDN6-positive gynecologic and testicular cancers. We anticipate enrolling the first patient in the dose escalation portion of this clinical trial in mid-2024, marking a significant step forward in our mission to address unmet medical needs and advance innovative treatments for patients.” First Quarter 2024 and Recent Corporate Highlights In May 2024, Context announced a private placement that resulted in gross proceeds of approximately $100 million, before deducting placement agent fees and estimated offering expenses. Also in May 2024, Context announced that the FDA cleared its IND for CTIM-76, a CLDN6 x CD3 T cell engaging bispecific antibody, submitted in March 2024. The IND supports the initiation of a Phase 1 dose escalation and expansion clinical trial of CTIM-76 in patients with CLDN6-positive gynecologic and testicular cancers. The Company anticipates the enrollment of the first patient in the dose escalation portion of its clinical trial in mid-2024. In April 2024, the Company participated in the 23rd Annual Needham Virtual Healthcare Conference. First Quarter 2024 Financial Results Cash and cash equivalents were $10.1 million at March 31, 2024, compared to $14.4 million at December 31, 2023. Research and development (“R&D”) expenses were $2.0 million for the first quarter 2024, as compared to $4.5 million for the same period in 2023. The decrease in R&D expenses was primarily driven by lower onapristone extended release (“ONA-XR”) expenses, mostly due to the Company’s decision in March 2023 to discontinue the development of ONA-XR, as well as lower CTIM-76 contract manufacturing costs and personnel-related expenses, partially offset by an increase in preclinical, regulatory, and clinical costs as a result of IND-enabling studies and preparing to initiate the Company’s planned Phase 1 clinical trial. General and administrative expenses were $1.9 million for the first quarter 2024, as compared to $2.1 million for the same period in 2023. The decrease was primarily driven by decreases in insurance and professional fees as well as lower compensation and share-based compensation costs. Other income was $0.2 million for the first quarter 2024, as compared to $0.4 million for the same period in 2023, primarily due to lower interest income earned on cash and cash equivalent balances. Context reported a net loss of $3.7 million for the first quarter of 2024, as compared to $6.3 million for the same period in 2023. 2024 Cash Guidance The Company expects that the net proceeds from the private placement, together with its cash and cash equivalents at March 31, 2024, will be sufficient to fund its operations into 2028. About Context Therapeutics® Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing medicines for solid tumors. Context’s clinical stage product candidate, CTIM-76, is a selective CLDN6 x CD3 bispecific antibody for CLDN6-positive tumors. CLDN6 is a tight junction membrane protein target expressed in multiple solid tumors, including ovarian, endometrial, testicular, and lung, and absent from or expressed at low levels in healthy adult tissues. Context is headquartered in Philadelphia. For more information, please visit or follow the Company on X (formerly 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,” “look forward,” “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) our expectation to enroll the first patient in a Phase 1 clinical trial for CTIM-76 in mid-2024, (ii) our expectation regarding the trial design, treatment indications, and patient size of our Phase 1 CTIM-76 trial, (iii) our expectation that the proceeds from the private placement extends our operations into 2028, (iv) the potential benefits, characteristics, safety and side effect pro CTIM-76, (v) the ability of CTIM-76 to have benefits, characteristics, manufacturability, and a side effect pro is differentiated and/or better than third party product candidates, (vi) the likelihood data will support future development of CTIM-76, and (vii) the likelihood of obtaining regulatory approval for CTIM-76. 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. Context Therapeutics Inc. Condensed Statements of Operations (Unaudited) Three Months Ended March 31, 2024 2023 Operating Expenses Research and development 1,973,209 4,534,676 General and administrative 1,850,292 2,131,872 Loss from operations (3,823,501 ) (6,666,548 ) Other income 155,704 358,230 Net loss $ (3,667,797 ) $ (6,308,318 ) Net loss per common share, basic and diluted ($0.23 ) ($0.40 ) Weighted average shares outstanding, basic and diluted 15,966,053 15,966,053 Context Therapeutics Inc. Condensed Balance Sheets Data (Unaudited) March 31, December 31, 2024 2023 Cash and cash equivalents $ 10,089,207 $ 14,449,827 Other assets 962,445 1,612,908 Total assets $ 11,051,652 $ 16,062,735 Total liabilities $ 2,608,422 $ 4,191,715 Total stockholders' equity 8,443,230 11,871,020 Total liabilities and stockholders' equity $ 11,051,652 $ 16,062,735 Media Contact: Gina Mangiaracina 6 Degrees 917-797-7904 gmangiaracina@6degreespr.com Investor Relations Contact: Jennifer Minai-Azary Context Therapeutics IR@contexttherapeutics.com

Phase 1INDFinancial Statement

21 Mar 2024

·www.biospace.com

Context Therapeutics Reports Full Year 2023 Operating and Financial Results

CTIM-76 IND filing on track for late March 2024 Cash and cash equivalents of $14.4 million as of December 31, 2023 Company expects its cash and cash equivalents will continue to fund operations into late 2024 PHILADELPHIA, March 21, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced its financial results for the year ended December 31, 2023, and reported on recent and upcoming business highlights. “During the fourth quarter of 2023, 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 highlighted the broad therapeutic potential of CTIM-76 when targeting CLDN6-positive tumors. The preclinical data further support CTIM-76’s differentiated product profile, including its potential to address limitations of first-generation CLDN6-targeted clinical-stage therapies,” 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 (“FDA”) by the end of March 2024 for CTIM-76. We then plan to initiate a Phase 1 clinical trial to focus on CLDN6-positive gynecologic and testicular cancers upon receiving IND clearance from the FDA.” Fourth Quarter 2023 and Recent Corporate Highlights In February 2024, Context amended its collaboration and licensing agreement with Integral Molecular, Inc. (“Integral”) to reflect updated financial terms to reduce various payment obligations and narrow the license grant to only cover CTIM-76. In November 2023, Context presented preclinical data at the SITC 38th Annual Meeting that demonstrated CTIM-76 was well tolerated and induced dose-proportional tumor regressions in xenograft 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 pro 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. Upcoming Corporate Presentation The Company will present at the 23rd Annual Needham Virtual Healthcare Conference on Monday, April 8, 2024, at 2:15 p.m. ET. Context will also participate in one-on-one meetings. Fiscal Year 2023 Financial Results Cash and cash equivalents were $14.4 million at December 31, 2023, compared to $35.5 million at December 31, 2022. Acquired in-process research and development expense (“IPR&D”) was $0.5 million for 2022 and reflects the expense recognized related to a development milestone achieved under the collaboration and license agreement with Integral. There was no IPR&D expense recognized in 2023. Research and development (“R&D”) expenses were $17.8 million for 2023, as compared to $7.1 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 $7.3 million for 2023, as compared to $7.8 million for the same period in 2022. The decrease was primarily driven by decreases in insurance expenses and other administrative costs, partially offset by an increase in professional fees. Other income was $1.1 million for 2023, as compared to $0.5 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 $24.0 million for 2023, as compared to $14.8 million for the same period in 2022. 2024 Cash Guidance The Company expects its cash and cash equivalents will be sufficient to fund its operations into late 2024. About Context Therapeutics® Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing medicines for solid tumors. Context is developing CTIM-76, a selective CLDN6 x CD3 bispecific antibody for CLDN6-positive tumors, currently in preclinical development. CLDN6 is a tight junction membrane protein target expressed in multiple solid tumors, including ovarian, endometrial, testicular, and lung, and absent from or expressed at low levels in healthy adult tissues. Context is headquartered in Philadelphia. For more information, please visit or follow the Company on X (formerly 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,” “look forward,” “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) our expectation of filing an IND submission for CTIM-76 in late March 2024, (ii) our expectation to initiate a Phase 1 trial and the indications to be part of such trials, (iii) our expectation to receive IND clearance with the FDA, (iv) having sufficient cash and cash equivalents to fund our current operations into late 2024, (v) the ability of the Company and its employees to participate in and present at conferences, (vi) the potential benefits, characteristics, and side effect pro our product candidate, (vii) the ability of our product candidate to have benefits, characteristics, and a side effect pro is differentiated and/or better than third party product candidates, (viii) the likelihood data will support future development, and (ix) the likelihood of obtaining regulatory approval of our product candidate. 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. Context Therapeutics Inc. Condensed Statements of Operations (Unaudited) Year Ended December 31, 2023 2022 Operating Expenses Acquired in-process research and development $ - $ 500,000 Research and development 17,782,731 7,091,163 General and administrative 7,289,885 7,790,040 Loss from operations (25,072,616 ) (15,381,203 ) Other income (expense), net 1,108,405 545,264 Net loss $ (23,964,211 ) $ (14,835,939 ) Net loss per common share, basic and diluted ($ 1.50 ) ($ 0.93 ) Weighted average shares outstanding, basic and diluted 15,966,053 15,966,053 Context Therapeutics Inc. Condensed Balance Sheets Data (Unaudited) December 31, December 31, 2023 2022 Cash and cash equivalents $ 14,449,827 $ 35,497,445 Other assets 1,612,908 2,468,498 Total assets $ 16,062,735 $ 37,965,943 Total liabilities $ 4,191,715 $ 3,207,577 Total stockholders' equity 11,871,020 34,758,366 Total liabilities and stockholders' equity $ 16,062,735 $ 37,965,943 Media Contact: Gina Mangiaracina 6 Degrees 917-797-7904 gmangiaracina@6degreespr.com Investor Relations Contact: Jennifer Minai-Azary Context Therapeutics IR@contexttherapeutics.com

License out/inFinancial StatementImmunotherapyAACRPhase 1

09 Nov 2023

·www.biospace.com

Context Therapeutics Reports Third Quarter 2023 Operating and Financial Results

CTIM-76 IND filing on track for late Q1 2024 Cash and cash equivalents of $21.7 million as of September 30, 2023 Company expects its cash and cash equivalents will continue to fund operations into late 2024 PHILADELPHIA, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today 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 pro 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. About Context Therapeutics® Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing medicines for solid tumors. Context is developing CTIM-76, a selective CLDN6 x CD3 bispecific antibody for CLDN6-positive tumors, currently in preclinical development. CLDN6 is a tight junction membrane protein target expressed in multiple solid tumors, including ovarian, lung, and testicular, and absent from or expressed at low levels in healthy adult tissues. Context is headquartered in Philadelphia. For more information, please visit 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,” “look forward,” “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) our expectation of filing an IND submission for CTIM-76 late in the first quarter of 2024, (ii) having sufficient cash and cash equivalents to fund our current operations into late 2024, (iii) the potential benefits, characteristics, and side effect pro our product candidate, (iv) the ability of our product candidate to have benefits, characteristics, and a side effect pro is differentiated and/or better than third party product candidates, (v) the likelihood data will support future development, and (vi) the likelihood of obtaining regulatory approval of our product candidate. 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. Context Therapeutics Inc. Condensed Statements of Operations (Unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Operating Expenses Acquired in-process research and development $ - $ - $ - $ 500,000 Research and development 4,485,223 2,077,566 12,480,836 4,946,304 General and administrative 1,695,272 1,970,521 5,658,575 6,052,556 Loss from operations (6,180,495 ) (4,048,087 ) (18,139,411 ) (11,498,860 ) Other income 305,809 193,777 945,086 219,702 Net loss $ (5,874,686 ) $ (3,854,310 ) $ (17,194,325 ) $ (11,279,158 ) Net loss per common share, basic and diluted ($0.37 ) ($0.24 ) ($1.08 ) ($0.71 ) Weighted average shares outstanding, basic and diluted 15,966,053 15,966,053 15,966,053 15,966,053 Context Therapeutics Inc. Condensed Balance Sheets Data (Unaudited) September 30, December 31, 2023 2022 Cash and cash equivalents $ 21,676,999 $ 35,497,445 Other assets 1,311,624 2,468,498 Total assets $ 22,988,623 $ 37,965,943 Total liabilities $ 4,603,768 $ 3,207,577 Total stockholders' equity 18,384,855 34,758,366 Total liabilities and stockholders' equity $ 22,988,623 $ 37,965,943 Media Contact: Gina Cestari 6 Degrees 917-797-7904 gcestari@6degreespr.com Investor Relations Contact: Jennifer Minai-Azary Context Therapeutics IR@contexttherapeutics.com

Financial StatementImmunotherapyAACR

100 Deals associated with Onapristone

External Link

KEGG	Wiki	ATC	Drug Bank
D09571	Onapristone	-	DB12637

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 3	Germany	Bayer Schering Pharma AG	-
Granular Cell Tumor	Phase 2	-	Context Therapeutics LLC	05 May 2022
Endometrial Carcinoma	Phase 2	-	Context Therapeutics LLC	05 May 2022
ER-positive/HER2-negative Breast Cancer	Phase 2	United States	Context Therapeutics, Inc.	05 Oct 2021
Estrogen receptor positive breast cancer	Phase 2	United States	Context Therapeutics, Inc.	05 Oct 2021
HER2-negative breast cancer	Phase 2	United States	Context Therapeutics, Inc.	05 Oct 2021
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 2	United States	Context Therapeutics, Inc.	05 Oct 2021
Neoplasm Metastasis	Phase 2	United States	Context Therapeutics, Inc.	05 Oct 2021
Hormone receptor positive Endometrial Carcinoma	Phase 2	United States	Context Therapeutics, Inc.	28 Jan 2021
Refractory Endometrial Adenocarcinoma	Phase 2	United States	Context Therapeutics, Inc.	28 Jan 2021

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04738292 (SMILE, CTgov)	Phase 2	Neoplasm Metastasis \| ER-positive/HER2-negative Breast Cancer \| Metastatic human epidermal growth factor 2 positive carcinoma of breast ... View more	11	Fulvestrant+Onapristone	xgltpevfil = iotqmaamnt hxqbeicibl (uhtjbgysjf, pyeahaqquw - xwpjhqufuv) View more	-	03 May 2024
NCT04719273 (OATH, ASCO 12023 \| ASCO 22023) Manual	Phase 2	Hormone receptor positive Endometrial Carcinoma HR Positive	14	onapristone 50 mg+anastrozole 1 mg	stdhtcwkdw(szjsvlukwb) = eauosfmxkz hoxmeqkjvp (qzntgcefay ) View more	Positive	26 May 2023
NCT04738292 (SMILE, Corporate Publications) Manual	Phase 2	Metastatic breast cancer	-	Fulvestrant+Onapristone	buepqeovcj(lfjsezyttp) = pofbimkibc rnjfglpkdf (ookriueazx )	Positive	08 Dec 2022
NCT04142892 (ONAWA (SOLTI-1802), SABCS2022)	Early Phase 1	PR-positive breast cancer PgR+ \| Ser294-PgR \| CD24 ... View more	10	ONA XR 50 mg BID	avibfwsrqb(okzjiouziz) = Most common grade 1 or 2 AEs were GGT increased bbrlwzqked (rdfxsringk ) View more	Positive	15 Feb 2022
NCT03909152 (Pubmed \| Drug Saf) Manual	Phase 1/2	PR-positive breast cancer PR Positive	88	Onapristone	pvldxbcylb(ooaloyybou) = alanine aminotransferase elevations with or without bilirubin elevations (four with breast cancer and one with endometrial cancer) jwkygbtjmw (yyljzjclcb ) View more	Positive	01 Oct 2020
NCT02052128 \| NCT02049190 (ASCO2019)	Phase 1/2	Neoplasm Metastasis	88	Onapristone extended release (ONA ER)	aiuaksjagr(lhhcxhmjeh) = uqudkqgnvv uelsexsbzt (gldcsygnev ) View more	-	26 May 2019
NCT02052128 \| NCT02049190 (ASCO2019)	Phase 1/2	Neoplasm Metastasis	88	onapristone extended release (ONA ER) (Metastatic breast cancer (BC))	rnndefjwcr(lrqhgqzzkc) = tsguypldbg okhkviewvm (vshpgndfnl ) View more	-	26 May 2019
NCT02052128 (Pubmed \| J Biol Chem \| PLoS One) Manual	Phase 1	Neoplasms	60	onapristone	atcyqqqczd(opresmpoza) = 50 mg ER BID lhubxajhsi (vhmmlyayuv )	Positive	10 Oct 2018
NCT02049190 (ASCO 12017 \| ASCO 22017) Manual	Phase 1/2	Castration-Resistant Prostatic Cancer AR Negative	36	onapristone (AR normal)	czoaiepuyg(jvaimuhjtv) = oahxvrzsih axmjwgkjqh (ljdhdmnatx ) View more	Positive	05 Jun 2017
NCT02049190 (ASCO 12017 \| ASCO 22017) Manual	Phase 1/2	Castration-Resistant Prostatic Cancer AR Negative	36	onapristone (AR aberrant)	czoaiepuyg(jvaimuhjtv) = oysbpprrvx axmjwgkjqh (ljdhdmnatx ) View more	Positive	05 Jun 2017
SGO2016	Not Applicable	Uterine Neoplasms	-	Onapristone	quqcoasenu(qdyfneezdy) = The combination therapy significantly increased G1/S arrest uqzbkahqbj (mbmnmmbyye ) View more	-	01 Jun 2016
SGO2016	Not Applicable	Uterine Neoplasms	-	Trametinib		-	01 Jun 2016
NCT02052128 (ASCO2015)	Phase 1/2	Neoplasms	90	ER ONA tablets 10-50 mg BID	eqlskpwzbn(amkwwwfkcp) = pjrfkmrjmp waekzbxbma (uhbfeboiba )	-	20 May 2015
NCT02052128 (ASCO2015)	Phase 1/2	Neoplasms	90	100 mg immediate release QD	eqlskpwzbn(amkwwwfkcp) = efcmgqrxzd waekzbxbma (uhbfeboiba )	-	20 May 2015

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