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Context Therapeutics Inc. - CNTX STOCK NEWS

Welcome to our dedicated page for Context Therapeutics news (Ticker: CNTX), a resource for investors and traders seeking the latest updates and insights on Context Therapeutics stock.

Context Therapeutics Inc. (Nasdaq: CNTX) is a Philadelphia-based biopharmaceutical company dedicated to advancing innovative medicines for solid tumors. The company's core mission is to develop novel therapies for hormone-responsive cancers, with a particular focus on female cancers such as breast, ovarian, and endometrial cancer.

Context Therapeutics’ leading clinical candidate is CTIM-76, a Claudin 6 (CLDN6) x CD3 bispecific antibody designed to target and engage T-cells in attacking CLDN6-positive tumors. Preclinical studies have shown promising results, with CTIM-76 demonstrating a capability to induce complete tumor regressions across multiple dose levels. The company plans to enroll the first patient in a Phase 1 clinical trial in mid-2024.

In addition to CTIM-76, Context Therapeutics is working on other promising programs, including Apristor (onapristone XR), an investigational drug targeting progesterone receptor-positive (PR+) breast cancer. Up to 70% of breast cancers express progesterone receptors, making Apristor a potential treatment option for a significant number of patients.

In recent news, Context Therapeutics announced encouraging financial results for the first quarter of 2024, including gross proceeds of approximately $100 million from a private placement. These funds are expected to support the company's operations and research endeavors well into 2028. The U.S. Food and Drug Administration (FDA) has also recently cleared Context's Investigational New Drug (IND) application for CTIM-76, a crucial step toward initiating clinical trials.

Context Therapeutics has a strong pipeline and strategic partnerships, including collaborations with Integral Molecular, which supports the development of therapies targeting difficult protein targets. The company’s robust financial guidance and innovative approach position it for significant growth in the biopharmaceutical sector.

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Context Therapeutics Inc. (Nasdaq: CNTX) announced that CEO Martin Lehr will participate in two virtual investor conferences in April 2023. The details are: Diamond Equity Emerging Growth Invitational Investor Conference presentation on April 5 at 9:40 a.m. ET, and 22nd Annual Needham Virtual Healthcare Conference on April 19 at 8:45 a.m. ET, where one-on-one meetings will also occur. Context is focused on developing CTIM-76, a bispecific antibody targeting CLDN6-positive tumors, currently in preclinical development. For further information, visit contexttherapeutics.com.

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Context Therapeutics Inc. (Nasdaq: CNTX) announced a strategic shift prioritizing the development of CTIM-76, a Claudin 6 (CLDN6) bispecific antibody to treat solid tumors, while discontinuing the ONA-XR program. The company reported a net loss of $14.8 million for 2022, an increase from $10.5 million in 2021. Cash and equivalents at year-end were approximately $35.5 million, expected to fund operations into late 2024. The IND application for CTIM-76 is anticipated in Q1 2024. Preclinical data will be presented at the AACR Annual Meeting 2023. The decision to cease ONA-XR development was influenced by challenging market conditions and study findings.

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Context Therapeutics (Nasdaq: CNTX), a clinical-stage biopharmaceutical company, announced that its preclinical candidate CTIM-76, a Claudin 6 x CD3 bispecific antibody, has been selected for a poster presentation at the AACR Annual Meeting 2023 on April 17, 2023. The focus of the presentation is on the development of CTIM-76 for treating ovarian cancer. Context will also host a webinar featuring updates on this program and results from the presentation. CTIM-76 targets tumors with Claudin 6 expression, showing promise for significant patient populations.

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Context Therapeutics Inc. (Nasdaq: CNTX) announced promising initial data from the Phase 2 OATH clinical trial for ONA-XR, indicating confirmed tumor shrinkage in two of the first 12 patients. The trial, which examines the efficacy of ONA-XR combined with anastrozole for treating hormone receptor positive metastatic endometrial cancer, shows a 4-month progression-free survival rate of 77% and an overall response rate of 22%. The treatment exhibited favorable safety profiles compared to traditional chemotherapy, with no significant grade 3 or higher adverse events reported. Updated results are expected in Q2 2023.

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Context Therapeutics Inc. (Nasdaq: CNTX) announced the FDA approval of ORSERDU (elacestrant) for treating advanced breast cancer in postmenopausal women and adult men with estrogen receptor-positive, HER2-negative cancers that have progressed after at least one course of endocrine therapy. ORSERDU demonstrated improved efficacy over standard treatment (fulvestrant), with a 45% reduction in risk of progression or death in patients with ESR1 mutations. The ongoing ELONA trial aims to evaluate ORSERDU in combination with Context’s ONA-XR. Context focuses on innovative treatments for solid tumors, particularly female cancers.

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Context Therapeutics (Nasdaq: CNTX) has partnered with Lonza to support the development and manufacturing of CTIM-76, a CLDN6 x CD3 bispecific antibody targeting solid tumors. The collaboration will leverage Lonza’s expertise in complex protein development, providing services such as manufacturability assessment and process development. CTIM-76 is in preclinical stages and aims to selectively target CLDN6-positive tumors, including ovarian and endometrial cancers. This strategic partnership is anticipated to enhance the clinical development of CTIM-76.

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Context Therapeutics (Nasdaq: CNTX) has nominated CTIM-76 as its clinical candidate for Claudin 6 bispecific antibody therapy. Preliminary data from ongoing Phase 2 clinical trials of its ONA-XR therapy show promising results in treating metastatic endometrial and breast cancers. The company reported a 77% progression-free survival rate at four months for ONA-XR combined with anastrozole in endometrial cancer. ONA-XR is also being tested with fulvestrant for breast cancer. Additionally, the ELONA trial has begun enrolling patients. Cash on hand totals $39.4 million.

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Context Therapeutics (Nasdaq: CNTX) presented preliminary data at the San Antonio Breast Cancer Symposium showing a 44% four-month progression-free survival (PFS) rate in its ongoing Phase 2 SMILE trial for metastatic breast cancer. The trial evaluates onapristone extended release (ONA-XR) in combination with fulvestrant for patients who previously failed CDK4/6 inhibitor therapy. Additionally, a 77% PFS rate was reported in a similar ongoing Phase 2 trial for endometrial cancer. The company aims to address unmet needs in both breast and endometrial cancers with ONA-XR.

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Context Therapeutics (CNTX) has selected CTIM-76 as its lead candidate targeting Claudin 6-positive cancers. This bispecific antibody is anticipated to advance rapidly with an IND submission to the FDA expected in Q1 2024. CTIM-76 shows high selectivity for CLDN6, which is prevalent in cancers such as ovarian and endometrial, while avoiding activation of normal cells. The company highlights the potential for scalable manufacturing and low immunogenicity risk. A webinar discussing CTIM-76 will be held on December 1, 2022, featuring insights from Context's team.

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Context Therapeutics (CNTX) provided a positive update on ONA-XR's clinical trials for treating PR+ recurrent endometrial cancer, reporting a preliminary 4-month PFS rate of 77.7%. The company has cash reserves of $39 million, expected to fund operations into Q1 2024. They initiated the Phase 1b trial for ONA-XR combined with elacestrant and continue to assess ONA-XR across ongoing trials. However, R&D expenses increased significantly to $2.1 million for Q3 2022, and the net loss widened to $3.9 million compared to the previous year.

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FAQ

What is the current stock price of Context Therapeutics (CNTX)?

The current stock price of Context Therapeutics (CNTX) is $1.02 as of December 20, 2024.

What is the market cap of Context Therapeutics (CNTX)?

The market cap of Context Therapeutics (CNTX) is approximately 79.9M.

What does Context Therapeutics Inc. do?

Context Therapeutics is a biopharmaceutical company focused on developing innovative therapies for hormone-responsive cancers, particularly targeting solid tumors.

What is CTIM-76?

CTIM-76 is a Claudin 6 (CLDN6) x CD3 bispecific antibody designed to engage T-cells in targeting CLDN6-positive tumors. It is Context Therapeutics' leading clinical candidate.

What types of cancer is Context Therapeutics targeting with their therapies?

Context Therapeutics is targeting hormone-dependent cancers, including breast, ovarian, and endometrial cancers.

What recent milestones has Context Therapeutics achieved?

Recently, Context Therapeutics raised $100 million through a private placement and received FDA clearance for its IND application for CTIM-76, paving the way for a Phase 1 clinical trial.

When does Context Therapeutics plan to start the Phase 1 trial for CTIM-76?

The company plans to enroll the first patient in the Phase 1 clinical trial for CTIM-76 in mid-2024.

What are the financial prospects for Context Therapeutics?

The company expects that its current cash and cash equivalents, along with recent funding, will sustain its operations into 2028.

Who are some of Context Therapeutics' strategic partners?

Context Therapeutics collaborates with Integral Molecular, a leader in developing technologies for therapeutic discovery against difficult protein targets.

What regulatory approvals has Context Therapeutics received recently?

The FDA has cleared Context Therapeutics' IND application for CTIM-76, supporting the initiation of a Phase 1 clinical trial.

Where is Context Therapeutics headquartered?

Context Therapeutics is headquartered in Philadelphia, Pennsylvania.

What is Apristor?

Apristor (onapristone XR) is an investigational drug developed by Context Therapeutics for treating progesterone receptor-positive (PR+) breast cancer.

Context Therapeutics Inc.

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Biotechnology
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