Tillkännagivande • 4h
Context Therapeutics Announces Positive Interim Efficacy and Safety Results from Ongoing Phase 1 Clinical Trial for Ctim-76 Context Therapeutics Inc. announced positive interim Phase 1 clinical data for its CLDN6 x CD3 T cell engaging bispecific antibody, CTIM-76, in advanced, late-line platinum-resistant ovarian cancer. The data are as of a May 29, 2026 data cutoff from the ongoing CTIM-76 Phase 1 study. CTIM-76 has been granted FDA Fast Track Designation in platinum-resistant ovarian cancer. 21 patients with platinum-resistant ovarian cancer (n=14), testicular (n=4), and endometrial (n=3) cancer were treated with CTIM-76 at doses ranging from 22.5µg to 560µg every week. At the active doses of 140µg to 280µg, 13 patients were treated in total, 10 of whom were efficacy evaluable, having had at least one post-baseline tumor assessment as of the data cutoff. 560µg exceeded target exposures with weekly dosing and was not pursued further. Patients (n=9) received a median of 7 prior lines of therapy (range 5-16). Prior patient treatments included ADC (89%), checkpoint inhibitor (55%), VEGF (100%), or DNA repair agent (78%). 44% of patients had liver metastases. As of the data cutoff, 7 platinum-resistant ovarian cancer patients were efficacy-evaluable at doses of 140µg to 280µg. Overall response rate: 29% of platinum-resistant ovarian cancer patients (2/7) achieved confirmed partial RECIST v. 1.1 responses. Disease control rate: 57% (4/7). In early cohort patients who achieved confirmed stable disease or partial response, treatment durability was sustained for at least 6 months (n=3). At active dose levels, CTIM-76 produced a favorable safety profile that is consistent with the expected mechanism of action for a T cell engager and supports continued clinical development. Adverse events generally occurred during the first or second dose and were predominantly low grade, with the majority of events reported as Grade 1 or Grade 2 and reversible with standard management. Cytokine Release Syndrome events were infrequent and limited to Grade 1 (11%, n=1/9) at active dose levels in platinum-resistant ovarian cancer patients, which may be supportive of outpatient dosing in future trials. Approximately dose-dependent increases in CTIM-76 exposure with increasing dose level. Preliminary pharmacokinetic supports exploration of every three weeks dosing schedule. CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody. CLDN6 is enriched in a wide range of solid tumors, including ovarian, endometrial, lung, gastric, and testicular. Preclinical research suggests the potential for convenient dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for CTIM-76 therapy. More information about the CTIM-76 clinical trial (NCT06515613) can be found on clinicaltrials.gov. Disease Control Rate: Patients achieving a confirmed response of stable disease, partial response, or complete response. New Risk • May 22
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 12% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings are forecast to decline by an average of 12% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$67m net loss in 3 years). Tillkännagivande • Apr 02
Context Therapeutics Announces Ctim-76 Receives Fda Fast Track Designation for the Treatment of Platinum-Resistant Ovarian Cancer Context Therapeutics Inc. announced that the U.S. Food and Drug Administration has granted Fast Track Designation to CTIM-76, a CLDN6 x CD3 T cell engaging bispecific antibody, for the treatment of platinum-resistant ovarian cancer in patients that have received all standard of care therapies. Context is currently evaluating CTIM-76 in a Phase 1 clinical trial designed to evaluate the safety and efficacy of CTIM-76 in subjects with CLDN6-positive advanced or metastatic ovarian, endometrial and testicular cancers. The dose escalation and dose expansion portions of the trial are expected to evaluate safety, tolerability and pharmacokinetics, as well as anti-tumor activity by overall response rate, duration of response and disease control rate. The FDA’s Fast Track Designation program is designed to expedite the development and review timelines of drugs that demonstrate the potential to treat serious conditions, aiming to deliver therapeutics to patients more quickly in areas of unmet need. CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody. CLDN6 is enriched in a wide range of solid tumors, including ovarian, endometrial, lung, gastric and testicular. Preclinical research suggests the potential for convenient dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for CTIM-76 therapy. More information about the CTIM-76 clinical trial (NCT06515613) can be found on clinicaltrials.gov. Tillkännagivande • Mar 17
Context Therapeutics Inc., Annual General Meeting, Jun 24, 2026 Context Therapeutics Inc., Annual General Meeting, Jun 24, 2026. Tillkännagivande • Sep 03
Nasdaq Grants Context Therapeutics Inc. an Additional 180 Calendar Days to Regain Compliance with Nasdaq Listing Rule 5550(a)(2) On August 28, 2025, Context Therapeutics Inc. (the Company") received written notice (the Extension Letter") from The Nasdaq Stock Market LLC (Nasdaq") informing the Company that Nasdaq granted the Company an additional 180 calendar days, or until February 23, 2026 (the Extension Deadline"), to regain compliance with Nasdaq Listing Rule 5550(a)(2) (the Minimum Bid Price Rule"). The Extension Letter has no immediate effect on the Nasdaq listing or trading of the Company's common stock. As previously disclosed, on February 27, 2025, the Company received written notice from Nasdaq stating that the Company was not in compliance with the Minimum Bid Price Rule because the Company's common stock failed to maintain a minimum closing bid price of $1.00 per share for 30 consecutive business days. The Company intends to actively monitor the closing bid price of its common stock and will evaluate available options to regain compliance with the Minimum Bid Price Rule. These options include effecting a reverse stock split, if necessary. However, there can be no assurance that the Company will regain compliance with the Minimum Bid Price Rule by the Extension Deadline. Tillkännagivande • May 06
Context Therapeutics Inc Announces Executive Changes Effective May 10, 2025 Context Therapeutics Inc. announced Dr. Karen Smith, MD, PhD, MBA, LLM as interim Chief Medical Officer (“CMO”). Dr. Smith replaces Dr. Claudio Dansky Ullmann, who will be leaving the Company effective May 10, 2025. Dr. Smith will continue in a dual capacity as interim CMO and a member of the Company’s Board of Directors (“Board”) while the Company conducts a search for a new, full-time CMO. Dr. Smith has served on Context’s Board since 2024 and is a biopharmaceutical thought leader with over 20 years of experience bringing drugs into the clinic and through commercialization. She was previously Global Head of Research & Development and Chief Medical Officer of Jazz Pharmaceuticals and has also held senior leadership roles at Allergan, AstraZeneca, and Bristol Myers Squibb. Tillkännagivande • Apr 30
Context Therapeutics Presents Preclinical and Translational Data for CT-95, a Mesothelin Targeting T Cell Engager, at 2025 AACR Annual Meeting Context Therapeutics Inc. announced preclinical and translational data regarding the Company’s clinical asset, CT-95, a mesothelin x CD3 TCE was presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25-30, 2025 in Chicago, IL. Findings from preclinical studies evaluating CT-95 in cancer cell lines and tumor models illustrate the potential of CT-95 to treat mesothelin-positive tumors. Notably, CT-95 has shown to: Selectively bind to mesothelin-expressing cells and targets a unique, membrane-proximal region of mesothelin Avoid impact of shed mesothelin sink Be highly active and well tolerated across in vivo models Activate T cells without inducing broad cytokine release Findings from preclinical studies evaluating CT-95 in cancer cell lines and tumor models illustrate the potential of CT-95 to treat mesothelin-positive tumors. Notably, CT-95 has shown to: Selectively bind to mesothelin-expressing cells and targets a unique, membrane-proximal region of mesothelin Avoid impact of shed mesothelin sink Be highly active and well tolerated across in vivo models Activate T cells without inducing broad cytokine release. CT-95 is a mesothelin (“MSLN”) x CD3 bispecific antibody that is intended to redirect T-cell-mediated lysis toward malignant cells expressing MSLN. MSLN is a membrane protein overexpressed in approximately 30% of cancers. One challenge in developing MSLN-targeted therapies has been the presence of MSLN fragments, also referred to as shed MSLN, found in both blood and the tumor microenvironment that can serve as a decoy or sink for MSLN-targeting antibodies. CT-95 is a fully humanized bispecific T cell engager that has a moderate affinity but high avidity for membrane-bound MSLN, that is intended to minimize the impact of the shed MSLN. The clinical trial is being conducted at clinical sites in the US. Tillkännagivande • Apr 09
Context Therapeutics Inc. Doses First Patient in Phase 1 Clinical Trial of CT-95 Context Therapeutics Inc. announced that the first patient has been dosed in the Phase 1 clinical trial of CT-95, a mesothelin ("MSLN") x CD3 T cell engaging ("TCE") bispecific antibody designed to target mesothelin-expressing cancers. The Company anticipates sharing initial data for the CT-95 Phase 1 trial in mid-2026. This milestone marks Context's second active clinical trial, following the dosing of the first patient in the CTIM-76 trial earlier this year. CTIM-76 is a Claudin 6 ("CLDN6") x CD3 TCE bispecific antibody currently being evaluated in CLDN6-positive tumors, including ovarian, endometrial, and testicular cancers. MSLN is a membrane protein overexpressed in an estimated 30% of all cancers with limited expression in normal tissues. CTIM-95 is being developed as a therapy for advanced cancers associated with MSLN expression, including pancreatic, ovarian, mesothelioma, and other solid tumors. The Phase 1 clinical trial of CT -95 (NCT06756035) is an open-label, dose escalation and expansion study to evaluate the safety and efficacy of CT-95 in subjects with MSLN-expressing advanced solid tumors, including ovarian, pancreatic, lung, and mesothelioma cancers. The dose escalation and dose expansion portions of the trial are expected to evaluate safety, tolerability, and pharmacokinetics, as well as anti-tumor activity by overall response rate, duration of response, and disease control rate. The dose escalation portion of the study is expected to enroll up to 30 patients. Tillkännagivande • Apr 07
Context Therapeutics Inc., Annual General Meeting, Jun 12, 2025 Context Therapeutics Inc., Annual General Meeting, Jun 12, 2025. Tillkännagivande • Mar 01
Context Therapeutics Receives Written Notice from the Nasdaq Stock Market Regarding Minimum Bid Price Rule On February 27, 2025, Context Therapeutics Inc. received written notice from The Nasdaq Stock Market LLC stating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2) because the Company’s common stock failed to maintain a minimum closing bid price of $1.00 per share for 30 consecutive business days. The Notification Letter has no immediate effect on the Nasdaq listing or trading of the Company’s common stock. The Notification Letter provides an initial 180 calendar day period, or until August 26, 2025, in which to regain compliance, pursuant to Nasdaq Listing Rule 5810(c)(3)(A). If at any time before that date the bid price of the Company’s common stock closes at $1.00 per share or more for a minimum of 10 consecutive business days, Nasdaq will notify the Company that it has achieved compliance with the Minimum Bid Price Rule. If the Company does not regain compliance by August 26, 2025, the Company may be eligible for an additional 180-day grace period. The Company intends to actively monitor the closing bid price of its common stock and will evaluate available options to regain compliance with the minimum bid requirement. However, there can be no assurance that the Company will regain compliance with the minimum bid requirement during the 180-day compliance period, secure a second period of 180 days to regain compliance, or maintain compliance with the other Nasdaq listing requirements. Tillkännagivande • Jan 15
Context Therapeutics Inc. Announces First Patient Dosed in the Phase 1 Clinical Trial of CTIM-76 Context Therapeutics Inc. announced that the first patient has been dosed in its Phase 1 clinical trial evaluating CTIM-76, a Claudin 6 (“CLDN6”) x CD3 T cell engaging bispecific antibody. The Phase 1 dose escalation and expansion trial is enrolling patients with CLDN6-positive gynecologic and testicular cancers. The Company anticipates sharing initial data for the CTIM-76 Phase 1 trial in the first half of 2026. The Phase 1 clinical trial is an open-label, dose escalation and expansion study to evaluate the safety and efficacy of CTIM-76 in subjects with CLDN6-positive advanced or metastatic ovarian, endometrial, and testicular cancer. The dose escalation and dose expansion portions of the trial are expected to evaluate safety, tolerability, and pharmacokinetics as well as anti-tumor activity by overall response rate, duration of response, and disease control rate. The study is expected to enroll up to 70 patients. About CTIM-76: CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody. CLDN6 is enriched in a wide range of solid tumors, including ovarian, endometrial, lung, gastric, and testicular. Preclinical research suggests the potential for convenient dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for CTIM-76 therapy. Tillkännagivande • Jan 13
Context Therapeutics Inc. Announces Board Changes Context Therapeutics Inc. announced the appointment of Andy Pasternak as Chairman of its Board of Directors, succeeding Richard Berman, who stepped down from the Board effective January 12, 2025. Andy Pasternak is a biopharmaceutical executive and expert with over 25 years of experience, and currently serves as an Advisory Partner at Bain & Company, a leading global consulting firm. Most recently, Mr. Pasternak served as Executive Vice President, Chief Strategy Officer at Horizon Therapeutics, a biotechnology company focused on serious, rare autoimmune diseases; in this role, he was responsible for corporate strategy, M&A /business development, commercial development, and portfolio management, and he played a central role in the $28 billion acquisition of Horizon by Amgen Inc. in 2023. Prior to joining Horizon in 2019, Mr. Pasternak was a senior partner at Bain & Company, where he served as Head of the Healthcare Practice in the Americas. Mr. Pasternak currently serves on the Board of Directors of Endo Inc., a specialty pharmaceutical company. Mr. Pasternak is also an adjunct lecturer at the Kellogg School of Management at Northwestern University and member of the advisory board of the Healthcare at Kellogg Program. Tillkännagivande • Dec 03
Context Therapeutics Inc. has filed a Follow-on Equity Offering in the amount of $75 million. Context Therapeutics Inc. has filed a Follow-on Equity Offering in the amount of $75 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Tillkännagivande • Sep 04
Context Therapeutics Appoints Karen Smith and Luke Walker to Board of Directors Context Therapeutics Inc. announced the appointments of Karen Smith, MD, PhD, MBA, LLM and Luke Walker, MD, to its Board of Directors. Dr. Karen Smith is a biopharmaceutical thought leader with over 20 years of experience bringing drugs into the clinic and through commercialization. She has been a key contributor to the successful development of multiple approved products in several therapeutic areas, including oncology (Herceptin, Vyxeos), rare disease (Defitelio), cardiology (Irbesartan), dermatology (Voluma, Botox), neuroscience (Abilify) and anti-infectives (Teflaro). Previously, she was Global Head of Research & Development and Chief Medical Officer of Jazz Pharmaceuticals. Earlier in her career, Dr. Smith held senior leadership roles at Allergan, AstraZeneca, and Bristol Myers Squibb. Previously, Dr. Smith served on the Board of Directors of Antares Pharma (acquired by Halozyme for $960 million), Acceleron Pharma (acquired by Merck for $11.5 billion), Mariana Oncology (acquired by Novartis for $1 billion upfront), and Sucampo Pharmaceuticals (acquired by Mallinckrodt for $1.2 billion). Dr. Smith currently serves on the Board of Directors of Aurinia Pharmaceuticals, Capstan Therapeutics, Sangamo Therapeutics, and Skye Bioscience. Dr. Luke Walkerhas more than 20 years of clinical development experience as both an executive and board member. Most recently, he was the Chief Medical Officer of Harpoon Therapeutics, an oncology-focused biopharmaceutical company where he was responsible for oversight of all aspects of clinical development programs using Harpoon’s TriTAC T-cell engager platform, which was acquired by Merck in 2024 for $680 million. Previously, Dr. Walker was Vice President of Clinical Development at Seagen, where he was the global development lead for Tukysa (tucatinib) through the program’s successful completion of a pivotal registrational trial and successful regulatory approvals. Earlier, Dr. Walker was Senior Vice President of Clinical Development at Cascadian Therapeutics, which was acquired by Seagen in 2018 for $614 million. Dr. Walker began his career as a practicing medical oncologist and hematologist at Providence Regional Medical Center and with the Everett Clinic. Dr. Walker currently serves on the Board of Directors of Zentalis Pharmaceuticals. Tillkännagivande • Aug 02
Context Therapeutics Inc. Appoints Claudio Dansky Ullmann as Chief Medical Officer Context Therapeutics Inc. announced the appointment of Claudio Dansky Ullmann, M.D. as Chief Medical Officer (CMO). are thrilled to welcome Dr. Dansky Ullmann and Ms. Andreas to team at this exciting time as the Company advances its product candidates, CTIM-76 and CT-95, into Phase 1 clinical trials, said Martin Lehr, CEO of Context. Dr. Dansky Ullmann and Ms. Andreas are industry veterans with deep expertise in oncology and T cell therapies, and a proven track record of advancing programs through clinical development. Dr. Dansky Ullmann brings over 30 years of experience in early and late-stage oncology therapeutics development. Most recently, he was the CMO at Avenge Bio, where Dr. Dansky Ullmann guided the clinical advancement of AVB-001 allogeneic cell therapy for ovarian cancer. Prior to Avenge, Dr. Dansky Ullmann was CMO at MaxCyte where he was responsible for the development of the CARMA chimeric antigen receptor (CAR) therapy program, including MCY-M11, a mesothelin-targeting CAR therapy. Previously, he was the Senior Vice President, Head of Clinical Development at Infinity Pharmaceuticals, where he led the development of Copiktra through FDA approval and eganelisib through first in human studies. Earlier, he was Global Clinical Lead in the Oncology Therapy Area Unit at Takeda Pharmaceuticals. Before, Dr. Dansky Ullmann was a Senior Investigator in the Cancer Therapy Evaluation Program at the National Cancer Institute, where he was involved in the strategic development of novel agents through Phase 1-3 clinical trials. Dr. Dansky Ullmann earned his M.D. at the School of Medicine, Universidad de Buenos Aires and completed his medical oncology training at Guemes Private Hospital, Buenos Aires. New Risk • May 23
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 370% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Earnings are forecast to decline by an average of 19% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (370% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$36m net loss in 3 years). Breakeven Date Change • May 12
Forecast to breakeven in 2025 The 3 analysts covering Context Therapeutics expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 28% to 2024. The company is expected to make a profit of US$2.16m in 2025. Tillkännagivande • Apr 28
Context Therapeutics Inc., Annual General Meeting, Jun 13, 2024 Context Therapeutics Inc., Annual General Meeting, Jun 13, 2024, at 08:30 US Eastern Standard Time. Agenda: To consider and ratify the selection by the Audit Committee of the Board of Directors of CohnReznick LLP as the independent registered public accounting firm of the Company for its fiscal year ending December 31, 2024; to consider and elect Richard Berman, Dr. Philip Kantoff, Martin Lehr, Jennifer Evans Stacey and Linda West to Board of Directors, each to serve until our 2027 Annual Meeting of Stockholders or until such person's successor is duly elected and qualified; and to consider and conduct any other business properly brought before the Annual Meeting. Tillkännagivande • Apr 02
Context Therapeutics Submits IND Application to Evaluate CTIM-76 in Claudin 6-Positive Cancers Context Therapeutics Inc. announced that on March 28, 2024, the Company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration to begin a first-in-human clinical study of CTIM-76. The IND supports the initiation of a Phase 1 dose escalation and expansion clinical trial of CTIM-76 in patients with Claudin 6 (CLDN6)-positive gynecologic and testicular cancers. CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody. CLDN6 is enriched in a wide range of solid tumors, including ovarian, endometrial, lung, gastric, and testicular. Preclinical research suggests the potential for convenient dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for CTIM-76 therapy. Board Change • Apr 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 1 highly experienced director. Independent Chairman of the Board Richard Jay Berman was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. New Risk • Mar 11
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$18m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$18m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings are forecast to decline by an average of 32% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$38m net loss in 3 years). Market cap is less than US$100m (€17.5m market cap, or US$19.2m). New Risk • Sep 11
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$18m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$18m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings are forecast to decline by an average of 24% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$39m net loss in 3 years). Market cap is less than US$100m (€13.4m market cap, or US$14.4m). Tillkännagivande • Jun 21
Context Therapeutics Regains Compliance with Minimum Bid Price Rule On June 15, 2023, Context Therapeutics Inc. (the ‘company’) received a letter (the ‘Compliance Letter’) from Nasdaq notifying the company that, for the last 10 consecutive business days, the closing bid price of the Company's common stock has been at $1.00 per share or greater and that the company has regained compliance with the Minimum Bid Price Rule. Accordingly, Nasdaq considers the matter closed. As previously disclosed by the company on that certain Current Report on Form 8-K filed on January 27, 2023 with the U.S. Securities and Exchange Commission (the ‘SEC’), on January 24, 2023, the Company received written notice (the ‘Notification Letter’) from The Nasdaq Stock Market LLC (‘Nasdaq’) stating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2) (the ‘Minimum Bid Price Rule’) because the Company's common stock failed to maintain a minimum closing bid price of $1.00 per share for 30 consecutive business days. The Notification Letter provided the Company an initial 180 calendar day period, or until July 24, 2023, in which to regain compliance, pursuant to Nasdaq Listing Rule 5810(c)(3) (A). Tillkännagivande • Feb 07
Context Therapeutics Inc. Highlights Clinical Responses from the Phase 2 OATH Clinical Trial Evaluating ONA-XR for the Treatment of Endometrial Cancer Context Therapeutics Inc. announced that two patients have achieved a confirmed partial response (PR) among the first 12 patients (9 evaluable) enrolled in the Phase 2 OATH clinical trial evaluating the potential of Context’s oral progesterone receptor antagonist onapristone extended release (ONA-XR) in combination with anastrozole (ANA) to treat hormone receptor positive (HR+) metastatic endometrial cancer (EC). Metastatic EC is an aggressive cancer of the uterus that is the fourth leading cause of cancer-related mortality in women and results in approximately 13,000 deaths per year in the United States. Current treatments are limited, with platinum plus taxane combination chemotherapy being the standard of care for first line metastatic disease. After first-line therapy, patients are typically treated with additional toxic infusion therapies, including chemotherapy or Lenvima® (lenvatinib) plus Keytruda® (pembrolizumab) combination therapy. Clinician and patient feedback indicates a high unmet need for a novel orally administered therapeutic that provides toxic therapy-like efficacy but with fewer debilitating side effects. Grade 3 or higher adverse events (AE) with standard EC therapies include diarrhea, nausea, vomiting, and hypertension. Preliminary data from the ongoing Phase 2 OATH clinical trial evaluating the combination of ONA-XR with ANA in HR+ EC found that ONA-XR plus ANA demonstrated a 4-month progression free survival (PFS) rate of 77% and an overall response rate (ORR) of 22%. These results suggest that ONA-XR plus ANA exhibits favorable efficacy and tolerability relative to historical data that evaluated physician’s choice of chemotherapy (doxorubicin or paclitaxel) versus Lenvima plus Keytruda combination therapy in a similar treatment setting of metastatic EC. Updated data regarding the Phase 2 OATH trial is expected to be provided in second quarter of 2023. Tillkännagivande • Jan 06
Context Therapeutics Inc. Enrolls the First Patient in the Elona Study In January 2023, Context Therapeutics Inc. enrolled the first patient in the ELONA study, an open-label, Phase 1b/2 breast cancer clinical trial being conducted in partnership with The Menarini Group ("Menarini”). The ELONA study is designed to explore the efficacy of ONA-XR in combination with elacestrant, Menarini’s selective estrogen receptor degrader, in patients with locally advanced or metastatic breast cancer who have received prior treatment with a CDK4/6 inhibitor. In Menarini’s recently completed EMERALD Phase 3 trial, elacestrant demonstrated a 0.9-month PFS improvement versus the standard-of-care fulvestrant (2.8 vs 1.9 months) in a similar treatment population and as a result may become the standard-of-care antiestrogen treatment2. Compared to elacestrant alone, Context believes that the combination of ONA-XR plus elacestrant may more completely inhibit progesterone and estrogen hormone signaling that is required for breast cancer growth and metastasis. Such a combination would potentially improve outcomes in patients without adding significant toxicity. Tillkännagivande • Dec 10
Context Therapeutics® Reports Encouraging Preliminary Phase 2 Data for ONA-XR in Metastatic Breast Cancer Context Therapeutics Inc. announced preliminary Phase 2 data from the ongoing SMILE trial of onapristone extended release (ONA-XR), the company’s novel, first-in-class, potent, orally administered progesterone receptor (PR) antagonist, in metastatic breast cancer. Being conducted in collaboration with the Wisconsin Oncology Network, the Phase 2 SMILE trial is evaluating ONA-XR in combination with fulvestrant in patients with ER+, HER2- advanced or metastatic breast cancer who progressed on prior CDK4/6 inhibitor therapy. Preliminary Phase 2 findings highlight a 4-month progression free survival (PFS) rate of 44%, and favorable safety and tolerability. The data were presented at the 2022 San Antonio Breast Cancer Symposium® (SABCS®). Also at SABCS, an initial look at the trial design of the recently initiated ELONA Phase 1b/2 clinical trial evaluating the combination of ONA-XR with The Menarini Group’s oral selective estrogen degrader, elacestrant, in patients with second- or third-line advanced or metastatic ER+, PR+, HER2- breast cancer was presented. Data from the Phase 1b portion of the trial is expected in Fourth Quarter 2023. The Company also recently announced preliminary Phase 2 findings for ONA-XR in combination with anastrozole in progesterone receptor-positive (PR+) metastatic endometrial cancer, highlighting a 4-month PFS rate of 77% and favorable safety and tolerability. Tillkännagivande • Sep 28
Context Therapeutics Extends Runway into First Quarter 2024 Context Therapeutics Inc. announced to extend its runway into First Quarter 2024. The company plans to defer noncritical R&D activities, reduce future overhead and infrastructure expenditures, and prioritize its onapristone extended release (ONA-XR) ELONA Phase 1b/2 clinical trial and Claudin 6 (CLDN6) program. The ELONA Phase 1b/2 clinical trial is evaluating ONA-XR, an oral progesterone receptor (PR) antagonist, in combination with Menarini’s elacestrant in estrogen receptor positive (ER+), PR+, HER2- metastatic breast cancer (mBCa) patients who have previously been treated with a CDK4/6 inhibitor. An IND amendment filed specifically for this trial was submitted to the U.S. Food and Drug Administration in September 2022. The Company remains on track to initiate the ELONA clinical trial in Fourth Quarter 2022 and to report Phase 1b data in Fourth Quarter 2023. Context retains worldwide rights for ONA-XR, other than the rights it out-licensed for Greater China. Context anticipates the nomination of a CLDN6xCD3 bispecific monoclonal antibody (BsMAb) development candidate from the organization’s research collaboration with Integral Molecular in Fourth Quarter 2022. An IND submission is planned in First Quarter 2024. Context retains worldwide rights to certain CLDN6 antibody patents in the field of bispecific antibodies. In addition, Context will continue to provide access to ONA-XR through the Company’s ongoing Investigator-Sponsored Trials (ISTs) and anticipates sharing preliminary data from its Phase 2 clinical trials in granulosa cell tumors and endometrial cancer in November 2022, and from its Phase 2 clinical trial in breast cancer in December 2022. Tillkännagivande • Apr 05
Context Therapeutics Inc., Annual General Meeting, Jun 02, 2022 Context Therapeutics Inc., Annual General Meeting, Jun 02, 2022, at 08:30 US Eastern Standard Time. Agenda: To ratify the selection by the Audit Committee of the Board of Directors of CohnReznick LLP as the independent registered public accounting firm of the company for its fiscal year ending December 31, 2022; and to conduct any other business properly brought before the Annual Meeting. Board Change • Dec 31
High number of new directors Independent Chairman of the Board Richard Berman was the last director to join the board, commencing their role in 2021. Tillkännagivande • Dec 11
Context Therapeutics Announces Positive Data from ONA-XR in Early Breast Cancer at 2021 San Antonio Breast Cancer Symposium Context Therapeutics Inc. announced that data from the window-of-opportunity clinical trial of onapristone extended release (ONA-XR) in postmenopausal patients with progesterone receptor positive (PR+) early breast cancer demonstrated ONA-XR significantly increased suppression of tumor cell proliferation. The data were presented during the 2021 San Antonio Breast Cancer Symposium (SABCS). The Phase 0 open-label, single-arm, multicenter ONAWA (SOLTI-1802) trial conducted by Spanish cancer research group SOLTI, enrolled 10 patients with ER+/PR+/HER2- negative tumors and levels of the cell proliferation marker "Ki67" above 10% to evaluate ONA-XR by the rate of Complete Cell Cycle Arrest (CCCR) determined by Ki-67 (=2.7%) when administered for three weeks prior to surgery (Abstract #511). Secondary endpoints of the trial included safety and correlating biological activity with immunohistochemistry (IHC) of tumor expression (ER, PR, Ser294-PgR, CD24, CD44, ALDH1, Ki-67), estradiol, and progesterone blood levels, and gene expression profile (NanoString nCounter® Breast 360TM panel). While no patients achieved a CCCR, tumor Ki-67 expression decreased in six patients, remained stable in one patient, and increased in three patients. Mean percentage decrease of Ki67 for tumors with baseline PR expression =90% (N=4) and <90% (N=6) was -25.23% and 2.54%, respectively, indicating a trend towards enhance response for patients with high levels of PR expression at baseline. In addition, a shift towards more endocrine-sensitive disease was detected, implying an increased chance of the tumor responding to anti-estrogen therapy when used in combination with ONA-XR. Six patients reported adverse events (AEs), of which most were grade 1 or 2 including post-procedural pain, dry mouth, and an increase of gamma-glutamyl transferase (GGT). One patient experienced Grade 3 reversible GGT and aspartate aminotransferase (AST). The design of two additional clinical trials evaluating ONA-XR in metastatic breast cancer (MBC) were also presented in trials-in-progress posters during SABCS: The SMILE Study, a Phase 2 trial evaluating ONA-XR in combination with fulvestrant for patients with ER+ and HER2- metastatic breast cancer after progression on endocrine therapy and CDK4/6 inhibitors that is being conducted in collaboration with the Wisconsin Oncology Network (Abstract #311); and Memorial Sloan Kettering Cancer Center’s Phase 1b trial designed to define the safety, tolerability and recommended Phase 2 dose of ONA-XR in combination with letrozole and palbociclib, in addition to investigating the circulating tumor DNA-guided response of this triplet therapy regimen in high-risk patients (Abstract #1538). Tillkännagivande • Dec 03
Context Therapeutics Inc. announced that it expects to receive $31.25 million in funding Context Therapeutics Inc announced that it has entered into definitive securities purchase agreements for a private placement of 5,000,000 common shares at a price of $6.25 per share for gross proceeds of $31,250,000 on December 1, 2021. The company will also issue 5,000,000 warrants in the transaction. Each warrant will entitle the holder to purchase a common share at a price of $6.25 per share for a term of five and half years. The transaction is expected to close on December 6, 2021, subject to customary closing conditions. 
