Aankondiging • 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. Aankondiging • Mar 17
Context Therapeutics Inc., Annual General Meeting, Jun 24, 2026 Context Therapeutics Inc., Annual General Meeting, Jun 24, 2026. Price Target Changed • Dec 22
Price target increased by 7.8% to US$5.57 Up from US$5.17, the current price target is an average from 7 analysts. New target price is 364% above last closing price of US$1.20. Stock is up 22% over the past year. The company is forecast to post a net loss per share of US$0.35 next year compared to a net loss per share of US$0.46 last year. New Risk • Dec 16
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$95.6m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 13% 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$56m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (23% increase in shares outstanding). Market cap is less than US$100m (US$95.6m market cap). New Risk • Nov 19
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 42% 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 Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (42% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$56m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). New Risk • Oct 10
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 7.4% 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$50m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). Aankondiging • 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. New Risk • Jun 26
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 8.7% 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 Earnings are forecast to decline by an average of 8.7% 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$45m net loss in 3 years). Share price has been volatile over the past 3 months (16% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (US$58.7m market cap). Recent Insider Transactions • Jun 11
Co-Founder recently bought US$70k worth of stock On the 9th of June, Martin Lehr bought around 100k shares on-market at roughly US$0.70 per share. This transaction amounted to 10% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Martin's only on-market trade for the last 12 months. Aankondiging • 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. Aankondiging • 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. Price Target Changed • Apr 29
Price target decreased by 19% to US$5.75 Down from US$7.08, the current price target is an average from 4 analysts. New target price is 553% above last closing price of US$0.88. Stock is down 35% over the past year. The company is forecast to post a net loss per share of US$0.28 next year compared to a net loss per share of US$0.46 last year. New Risk • Apr 23
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings are forecast to decline by an average of 5.5% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (462% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$52m net loss in 3 years). Market cap is less than US$100m (US$74.8m market cap). Aankondiging • 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. Aankondiging • Apr 07
Context Therapeutics Inc., Annual General Meeting, Jun 12, 2025 Context Therapeutics Inc., Annual General Meeting, Jun 12, 2025. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Price Target Changed • Jan 08
Price target decreased by 7.1% to US$7.08 Down from US$7.63, the current price target is an average from 6 analysts. New target price is 485% above last closing price of US$1.21. The company is forecast to post a net loss per share of US$0.58 next year compared to a net loss per share of US$1.50 last year. New Risk • Dec 18
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$96.7m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 13% 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 Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$41m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$96.7m market cap). Aankondiging • 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 Aankondiging • 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. Price Target Changed • Aug 19
Price target increased by 17% to US$7.63 Up from US$6.50, the current price target is an average from 4 analysts. New target price is 201% above last closing price of US$2.53. Stock is up 148% over the past year. The company is forecast to post a net loss per share of US$0.29 next year compared to a net loss per share of US$1.50 last year. Aankondiging • 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 22
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 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 Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$36m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). 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 22% to 2024. The company is expected to make a profit of US$2.16m in 2025. Price Target Changed • May 10
Price target increased by 9.9% to US$3.70 Up from US$3.37, the current price target is an average from 3 analysts. New target price is 98% above last closing price of US$1.87. Stock is up 236% over the past year. The company is forecast to post a net loss per share of US$1.36 next year compared to a net loss per share of US$1.50 last year. Aankondiging • 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. Aankondiging • 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). 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). Share price has been volatile over the past 3 months (12% average weekly change). Market cap is less than US$100m (US$19.2m market cap). New Risk • Sep 12
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). 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). Share price has been volatile over the past 3 months (14% average weekly change). Market cap is less than US$100m (US$14.4m market cap). Price Target Changed • Aug 13
Price target decreased by 13% to US$2.10 Down from US$2.42, the current price target is provided by 1 analyst. New target price is 83% above last closing price of US$1.15. Stock is down 41% over the past year. The company is forecast to post a net loss per share of US$1.30 next year compared to a net loss per share of US$0.93 last year. Aankondiging • 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). Price Target Changed • Mar 26
Price target decreased by 55% to US$2.24 Down from US$4.94, the current price target is provided by 1 analyst. New target price is 261% above last closing price of US$0.62. Stock is down 72% over the past year. The company is forecast to post a net loss per share of US$0.65 next year compared to a net loss per share of US$0.93 last year. Aankondiging • 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. Aankondiging • 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. Board Change • Jan 01
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.