Announcement of New Clinical Trial Collaboration with Menarini Group to Evaluate More Powerful ONA-XR in Metastatic Breast Cancer
Results of the monotherapy portion of the ONA-XR Phase 2 clinical trial in granulosa cell tumors of the ovary presented at the 2022 ASCO Annual Meeting
Preliminary results of several clinical trials planned for the fourth quarter of 2022
On track for the selection of candidates for the development of the bispecific CLDN6xCD3 in the fourth quarter of 2022
PHILADELPHIA, Aug. 11, 2022 (GLOBE NEWSWIRE) — Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a women’s oncology company developing novel treatments for breast and gynecological cancers, has today announced its financial results for the second quarter ended June 30, 2022, and highlighted the company’s recent achievements.
“During the second quarter, Context continued to advance its two pipeline programs, onapristone extended release (“ONA-XR”) and the bispecific antibody Claudin 6xCD3 (“CLDN6xCD3”). We are encouraged by the data from the initial phase of our ongoing Phase 2 clinical trial of ONA-XR in granulosa cell tumors (“GCT”) of the ovary presented at the 2022 Annual Meeting of the American Society of Clinical Oncology (“ASCO”) and recruitment continues for the second part of the trial evaluating the combination of ONA-XR with an oral anti-estrogen,” said Martin Lehr, CEO of Context Therapeutics. .
Lehr continued, “Context recently announced its clinical trial collaboration and supply agreement with the Menarini Group (“Menarini”) for a Phase 1b/2 ELONA trial evaluating ONA-XR in combination with the selective receptor degrader to estrogens (“SERD”) Menarini, elacestrant, in patients with metastatic breast cancer (“mBCa”) ER+, PR+, HER2- who have previously been treated with a CDK4/6 inhibitor. The ELONA trial is expected to start in the fourth quarter of this year. Additionally, Context’s CLDN6xCD3 bispecific antibody program continues to progress as the program completes its first stage of development under Context’s collaboration and licensing agreement with Integral Molecular. Looking ahead, we expect to release initial data from three of our ongoing ONA-XR Phase 2 clinical studies in the fourth quarter of this year and remain on track to announce the selection of our CLDN6xCD3 candidate by end of the year, bringing us one step closer to realizing the potential of our pipeline to transform the way women’s cancers are treated.
Second quarter 2022 and recent company highlights
- In June 2022, results from the monotherapy portion of an ongoing Phase 2 trial of ONA-XR in ovarian GCT were presented at the 2022 ASCO Annual Meeting. The results showed that ONA-XR was well tolerated and had a 12-month progression-free survival rate of 20.1% and a clinical benefit rate of 35.7% in patients with GCT. The summary can be viewed here. Recruitment continues for the second stage of the clinical trial which will evaluate the combination of ONA-XR with an oral anti-estrogen. Additional details about the clinical trial can be found at http://www.clinicaltrials.gov using the identifier NCT03909152.
- Recruitment continues in Phase 2 clinical trials of ONA-XR – second or third line (2L/3L) ER+, PR+, HER2-mBCa, PR+ recurrent ovarian granulosa cell tumor and PR+ cancer of recurrent endometrium – and Context expects to report preliminary data from all three trials in the fourth quarter of this year.
- Recruitment continues in the Phase 1b/2 clinical trial of ONA-XR in first-line (1L) ER+, PR+, HER2- mBCa and, primarily due to slower-than-expected patient recruitment, Context currently expects to report preliminary Phase 1b trial data in mid-2023.
- In August 2022, announced that Context had entered into a clinical trial collaboration and supply agreement with Menarini for its oral SERD, elacestrant. This agreement will support the upcoming ELONA trial, a Phase 1b/2 proof-of-concept clinical trial that will evaluate ONA-XR in combination with elacestrant in ER+, PR+, HER2-mBCa patients who have previously been treated with a CDK4/ 6 inhibitor. Context plans to launch the ELONA trial in the fourth quarter of this year.
Second quarter financial results
- Cash, cash equivalents and restricted cash were $42.9 million as of June 30, 2022, compared to $49.7 million as of December 31, 2021.
- Acquired in-process research and development (IPR&D) expenses were $0.5 million for the second quarter of 2022, compared to $3.1 million for the same period in 2021. Second quarter 2022 expenses were due at a stage of development reached within the framework of the collaboration and license agreement. with Integral Molecular, while the charge for the second quarter of 2021 reflects the fair value of the initial consideration paid/issued under this same agreement.
- Research and development (R&D) expenses were $1.5 million for the second quarter of 2022, compared to $1.3 million for the same period in 2021. The increase in R&D expenses was mainly due to increased manufacturing and clinical costs under the ONA-XR contract and increased wages. and related benefits due to higher employee headcount offset by lower CLDN6 preclinical costs.
- General and administrative (G&A) expenses were $2.0 million for the second quarter of 2022, compared to $0.6 million for the same period in 2021. as higher insurance and professional expenses to support ongoing business operations and compliance obligations associated with being a publicly traded company.
- Context posted a net loss of $4.0 million for the second quarter of 2022, compared to $5.0 million for the same period in 2021.
Financial orientation 2022
Context expects its cash and cash equivalents to be sufficient to fund its operations through the fourth quarter of 2023.
About Context Therapeutics®
Context Therapeutics Inc. (Nasdaq: CNTX) is a clinical-stage biopharmaceutical company committed to advancing medicines for women’s cancers. The Company’s pipeline includes small molecule and bispecific antibody drug candidates that target cancer signaling pathways. Onapristone Extended-Release (ONA-XR), a new, potent and selective first-in-class progesterone receptor antagonist, is currently in three Phase 2 trials and one Phase 1/2 trial in the hormone-induced breast, ovarian and endometrial cancers. Context and The Menarini Group have also entered into a clinical trial collaboration and supply agreement for a Phase 1b/2 proof-of-concept clinical trial evaluating ONA-XR in combination with oral Selective Estrogen Receptor Degrader (SERD) by Menarini, elacestrant. Context is also developing a Claudin 6 (CLDN6) x CD3 selective bispecific antibody for CLDN6 positive tumors, currently in preclinical development. Context is headquartered in Philadelphia. For more information, visit www.contexttherapeutics.com or follow the company on Twitter and LinkedIn.
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 expectation to report preliminary data from our currently ongoing clinical trials in the fourth quarter of 2022 and mid-2023, (ii) the expectation of select a development candidate for our CLDN6xCD3 program before the end of 2022, (iii) the expectation to initiate the combination study of ONA-XR and elacestrant in the fourth quarter of 2022, (iv) have sufficient liquidity to fund our operations through the fourth quarter of 2023, (v) the results of our clinical trials, (vi) the potential benefits of the product candidates, (vii) the probability data will support future development, and (viii) the likelihood of obtaining regulatory approval for our 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 reached. 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.
|Therapeutic Context Inc.|
|Condensed Income Statements|
|Quarter ended June 30||Semester ended June 30|
|Operating Expenses :|
|Research and development in progress acquired||$||500,000||$||3,087,832||$||500,000||$||3,087,832|
|Research and development||1,517,243||1,333,101||2,868,738||1,771,840|
|general and administrative||1,990,568||604 602||4,082,035||1,006,181|
|Other income (expenses), net||21,300||(4,629||)||25,925||(56,360||)|
|Net loss per common share, basic and diluted||$||(0.25||)||$||(14.18||)||$||(0.47||)||$||(16.82||)|
|Weighted average number of shares outstanding, basic and diluted||15,966,053||354,829||15,966,053||352,048|
|Therapeutic Context Inc.|
|Summarized balance sheet data|
|June 30th,||The 31st of December,|
|Cash, cash equivalents and restricted cash||$||42 921 214||$||49,685,586|
|Full shareholder equity||41,649,299||48,272,335|
|Total Liabilities and Equity||$||44,696,793||$||51,305,750|
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