EXACT Therapeutics（56F）株式概要臨床段階のバイオ医薬品企業であるEXACT Therapeutics AS社は、標的治療強化のための技術プラットフォーム、Acoustic Cluster Therapy（ACT）を開発している。 詳細56F ファンダメンタル分析スノーフレーク・スコア評価2/6将来の成長0/6過去の実績0/6財務の健全性4/6配当金0/6リスク分析過去5年間で収益は年間9.9%減少しました。 収益が 100 万ドル未満 ( NOK59K )意味のある時価総額がありません ( €4M )German市場と比較して、過去 3 か月間の株価の変動が非常に大きい+1 さらなるリスクすべてのリスクチェックを見る56F Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.NEW496,966 membersJoin community and earn perksGain real feedbackFrom our editorial team, personally. Not silence.Grow your followingReal investors. The kind who actually invest, not scroll past.Unlock free accessFree premium subscription for consistent and quality authors.Learn moreCreate NarrativeBLINROAG496,966 investors already sharing narrativesYour Fair Value€Current Price€0.02112.0k% 割高 内在価値ディスカウントEst. Revenue$PastFuture-87m8m2016201920222025202620282031Revenue NOK 34.0kEarnings NOK 6.2kAdvancedSet Fair ValueView all narrativesEXACT Therapeutics AS 競合他社EpigenomicsSymbol: DB:ECXMarket cap: €763.0k2investSymbol: DB:2INVMarket cap: €45.1mbioXXmedSymbol: XTRA:T5O0Market cap: €329.8kNovogeniaSymbol: MUN:7V0Market cap: €84.6m価格と性能株価の高値、安値、推移の概要EXACT Therapeutics過去の株価現在の株価NOK 0.02152週高値NOK 0.2152週安値NOK 0.02ベータ0.0811ヶ月の変化-16.33%3ヶ月変化-80.29%1年変化-90.24%3年間の変化-97.94%5年間の変化-98.87%IPOからの変化-99.15%最新ニュースBoard Change • May 21No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Vice Chairman Jonathan Allis was the last director to join the board, commencing their role in 2024. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.お知らせ • Feb 13EXACT Therapeutics AS, Annual General Meeting, Jun 12, 2026EXACT Therapeutics AS, Annual General Meeting, Jun 12, 2026.お知らせ • Feb 12+ 1 more updateEXACT Therapeutics AS to Report First Half, 2026 Results on Sep 03, 2026EXACT Therapeutics AS announced that they will report first half, 2026 results on Sep 03, 2026お知らせ • Jun 24EXACT Therapeutics Announces First Patient Dosed in Phase 2 Trial in Patients with Locally Advanced Pancreatic CancerEXACT Therapeutics announced first patient dosed in its ENACT trial. The trial is a multi-centre, open-label Phase 2 clinical trial testing the safety and efficacy of Acoustic Cluster Therapy (ACT®) in combination with standard of care (modified FOLFIRINOX chemotherapy) in first line patients with borderline resectable or unresectable locally advanced pancreatic cancer. Dosing of the first patient in the Phase 2 trial follows the announcement of positive final efficacy and safety data in the Phase 1 trial in patients with liver metastases of colorectal origin. The Phase 2 trial will enroll up to 25 patients in the U.S., U.K. and Europe, and has the ClinicalTrials.gov Identification: NCT06850623.お知らせ • Jun 13Exact Therapeutics AS Approves Election of Following Nomination Committee CompositionEXACT Therapeutics AS at its AGM held on June 13, 2025 approved to elect the following Nomination Committee composition: Svein Kvåle (Chair), Birgitte Gangmark Villmo, Sir William Castell.お知らせ • May 20EXACT Therapeutics Announces Positive Final Results in Phase 1 ACTIVATE Trial in Liver Metastases from Colorectal CancerEXACT Therapeutics AS announced positive final results in Phase 1 ACTIVATE trial in liver metastases from colorectal cancer. These results indicate that EXACT Therapeutics' Acoustic Cluster Therapy (ACT®?) significantly enhances the local effect of chemotherapy; In the patients who had a response to chemotherapy, ACT-treated tumours showed a significantly greater reduction in diameter compared to control tumours (-29% vs. -7%, p. The final results affirm the previously reported positive ACTIVATE outcomes and indicate the significant added efficacy of ACT with chemotherapy compared with chemotherapy alone. Among patients who responded to chemotherapy, tumor shrinkage was significantly greater with ACT and chemotherapy compared to chemotherapy alone in the same individuals (29% vs. 7%, p<0.05).最新情報をもっと見るRecent updatesBoard Change • May 21No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Vice Chairman Jonathan Allis was the last director to join the board, commencing their role in 2024. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.お知らせ • Feb 13EXACT Therapeutics AS, Annual General Meeting, Jun 12, 2026EXACT Therapeutics AS, Annual General Meeting, Jun 12, 2026.お知らせ • Feb 12+ 1 more updateEXACT Therapeutics AS to Report First Half, 2026 Results on Sep 03, 2026EXACT Therapeutics AS announced that they will report first half, 2026 results on Sep 03, 2026お知らせ • Jun 24EXACT Therapeutics Announces First Patient Dosed in Phase 2 Trial in Patients with Locally Advanced Pancreatic CancerEXACT Therapeutics announced first patient dosed in its ENACT trial. The trial is a multi-centre, open-label Phase 2 clinical trial testing the safety and efficacy of Acoustic Cluster Therapy (ACT®) in combination with standard of care (modified FOLFIRINOX chemotherapy) in first line patients with borderline resectable or unresectable locally advanced pancreatic cancer. Dosing of the first patient in the Phase 2 trial follows the announcement of positive final efficacy and safety data in the Phase 1 trial in patients with liver metastases of colorectal origin. The Phase 2 trial will enroll up to 25 patients in the U.S., U.K. and Europe, and has the ClinicalTrials.gov Identification: NCT06850623.お知らせ • Jun 13Exact Therapeutics AS Approves Election of Following Nomination Committee CompositionEXACT Therapeutics AS at its AGM held on June 13, 2025 approved to elect the following Nomination Committee composition: Svein Kvåle (Chair), Birgitte Gangmark Villmo, Sir William Castell.お知らせ • May 20EXACT Therapeutics Announces Positive Final Results in Phase 1 ACTIVATE Trial in Liver Metastases from Colorectal CancerEXACT Therapeutics AS announced positive final results in Phase 1 ACTIVATE trial in liver metastases from colorectal cancer. These results indicate that EXACT Therapeutics' Acoustic Cluster Therapy (ACT®?) significantly enhances the local effect of chemotherapy; In the patients who had a response to chemotherapy, ACT-treated tumours showed a significantly greater reduction in diameter compared to control tumours (-29% vs. -7%, p. The final results affirm the previously reported positive ACTIVATE outcomes and indicate the significant added efficacy of ACT with chemotherapy compared with chemotherapy alone. Among patients who responded to chemotherapy, tumor shrinkage was significantly greater with ACT and chemotherapy compared to chemotherapy alone in the same individuals (29% vs. 7%, p<0.05).お知らせ • Jan 29Cordance Medical and EXACT Therapeutics Announces Early Encouraging Data in Brain Cancer Mice ModelCordance Medical and EXACT Therapeutics announced initial positive results indicating more than a doubling (+127-145%) of the uptake of a radiopharmaceutical in brain tumors of mice inoculated with glioblastoma cancer cells, one of the most aggressive and hard-to-treat brain cancers. The increased uptake resulted from combining Exact Therapeutics' proprietary Acoustic Cluster Therapy (ACT®) with a device designed by Cordance Medical to deliver ultrasound energy non-invasively into the brain. The studies were performed at The Arctic University of Norway and University Hospital North-Norway in Tromsø by Dr. Mathias Kranz. The combination of ACT® and the device can be used in a wide range of brain diseases to potentially access large regions of the brain. The combination can stimulate bioeffects including increasing the uptake of therapeutic agents and temporarily making the blood-brain barrier more permeable in these regions. The combination of ACT® and the device may be utilized for both diagnostic and targeted therapeutic brain applications. Further experiments are ongoing to expand the early data, and the results will be submitted for publication in scientific journals.お知らせ • Jan 28Exact Therapeutics and Cordance Medical Announce Early Encouraging Data in Brain Cancer Mice ModelEXACT Therapeutics and Cordance Medical announced initial positive results indicating more than a doubling (+127-145%) of the uptake of a radiopharmaceutical in brain tumors of mice inoculated with glioblastoma cancer cells, one of the most aggressive and hard-to-treat brain cancers. The increased uptake resulted from combining Exact Therapeutics’ proprietary Acoustic Cluster Therapy (ACT®) with a device designed by Cordance Medical to deliver ultrasound energy non-invasively into the brain. The studies were performed at The Arctic University of Norway and the University Hospital of North-Norway in Tromsø by Dr. Mathias Kranz. The combination of ACT and the device may offer potential applications across a wide range of brain diseases, by enabling therapeutic access to large brain regions. The combined technologies can induce bioeffects, such as temporarily increasing blood-brain barrier permeability in targeted regions and increasing the uptake of therapeutic agents. ACT and the device may be utilized for both diagnostic and targeted therapeutic brain applications. Further experiments are ongoing to expand the early data, and the results will be submitted for publication in scientific journals.お知らせ • Jan 08EXACT Therapeutics AS, Annual General Meeting, Jun 13, 2025EXACT Therapeutics AS, Annual General Meeting, Jun 13, 2025.お知らせ • Jan 07+ 1 more updateEXACT Therapeutics AS to Report Fiscal Year 2025 Results on Apr 09, 2025EXACT Therapeutics AS announced that they will report fiscal year 2025 results on Apr 09, 2025お知らせ • Dec 19+ 1 more updateEXACT Therapeutics AS Announces Board AppointmentsEXACT Therapeutics AS welcomed two new board members, Vice Chair Jonathan Allis and Director Flavien Daloz, following the extraordinary general meeting on 17 December, 2024. In line with the development ambitions and internationalization of the Company over the last years and following the investment by GE Medical Holdings AB it has been the ambition to further internationalize the Board of Directors. The new board members, Jonathan Allis and Flavien Daloz, both bring significant industry experience. Dr. Jonathan Allis is a scientist turned entrepreneur and was the founding CEO of Blue Earth Diagnostics, a spin-out from GE Healthcare established in 2014. Blue Earth Diagnostics developed a prostate cancer diagnostic approved by the FDA in 2016, which became a successful product in the USA. The company was acquired by Bracco Imaging in 2019. Jonathan also served as a Board member and Chair of Polarean Imaging. Prior to these roles, Jonathan was the general manager for PET at GE Healthcare Life Sciences and was responsible for GE Healthcare’s PET agent and PET synthesis platforms business globally. He has previously held positions in R&D, Marketing and Product Development at GE Healthcare, Amersham plc., Siemens Medical Solutions and Oxford Magnet Technology in the UK, USA and Germany. Jonathan has an undergraduate degree in Physics from the University of Cape Town and a doctorate in Biochemistry from the University of Oxford. Mr. Flavien Daloz is the Chief Technology Officer for Ultrasound Probes under the GEHC Advanced Visualization Solutions segment. In his 15+ years of experience, Mr. Daloz has held various leadership positions in the Medical Ultrasound industry, with a proven record in innovation and new product introductions. He was the recipient of GEHC Edison Pioneer Award in 2021 for his influence in medical ultrasound transducer breakthrough. Mr. Daloz holds an engineering degree from ESPCI school in Paris and an MSc in Bioimaging sciences from Imperial College, London. He has completed a Business Leadership Program from Michigan Ross, US.お知らせ • Aug 07EXACT Therapeutics AS Announces Full Focus on Phase 2 Pancreatic Cancer TrialEXACT Therapeutics AS announced that it will now be focusing all clinical efforts on the upcoming Phase 2 ENACT trial in locally advanced pancreatic cancer and is stopping recruitment in the Phase 1 ACTIVATE clinical trial in cancer patients with liver metastases of colorectal origin. Previously, the Phase 1 ACTIVATE trial reported positive interim efficacy and safety data. The enrolled patients will be followed through the planned follow-up. The final results from the ACTIVATE Phase 1 trial (11 patients) will be reported after completion of independent blinded review, expected early 2025. So far, there has been no change to the previously reported excellent safety profile of PS101 in the ACTIVATE trial.New Risk • Apr 15New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings have declined by 17% per year over the past 5 years. Revenue is less than US$1m (kr453k revenue, or US$42k). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Shareholders have been diluted in the past year (6.9% increase in shares outstanding). Market cap is less than US$100m (€16.6m market cap, or US$17.6m).お知らせ • Jan 23+ 2 more updatesEXACT Therapeutics AS to Report Fiscal Year 2023 Results on Apr 18, 2024EXACT Therapeutics AS announced that they will report fiscal year 2023 results on Apr 18, 2024New Risk • Dec 22New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 6.9% This is considered a minor 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 have declined by 17% per year over the past 5 years. Revenue is less than US$1m (kr453k revenue, or US$44k). Minor Risks Share price has been volatile over the past 3 months (7.8% average weekly change). Shareholders have been diluted in the past year (6.9% increase in shares outstanding). Market cap is less than US$100m (€31.4m market cap, or US$34.5m).お知らせ • Dec 02EXACT Therapeutics AS has completed a Follow-on Equity Offering in the amount of NOK 24.999996 million.EXACT Therapeutics AS has completed a Follow-on Equity Offering in the amount of NOK 24.999996 million. Security Name: Ordinarey Shares Security Type: Common Stock Securities Offered: 2,083,333 Price\Range: NOK 12 Transaction Features: Subsequent Direct ListingNew Risk • Sep 29New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr40m 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 (-kr40m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings have declined by 17% per year over the past 5 years. Revenue is less than US$1m (kr453k revenue, or US$42k). Minor Risk Market cap is less than US$100m (€40.9m market cap, or US$43.3m).お知らせ • Sep 28EXACT Therapeutics AS Announces Appointment of Caspar Foghsgaard as SVP Commercial & Business Development Effective 1 November 2023EXACT Therapeutics AS announced that Caspar Foghsgaard is joining the company as Senior Vice President Commercial and Business Development, effective 1 November 2023. Caspar Foghsgaard joins Exact Therapeutics from Nykode Therapeutics where his latest role was as Sr. Director Special Projects and part of the extended leadership team. He joined Nykode in 2018 and have been closely involved in Nykode’s transformation from a small biotech to a leading company at Oslo Stock Exchange. Prior to his role as Sr. Director Special Projects, he was heading Nykode’s business development activities as Director Business Development. Other previous employers include Arcus where he was responsible for business development in the spirits division and part of the divisional management, and Elopak as Program Director Strategy. In addition, he has held various business development and strategy positions including with Novozymes in Denmark, U.S. and U.K.お知らせ • Sep 27EXACT Therapeutics Announces Positive Clinical Results from the Activate Phase I Dose EscalationEXACT THERAPEUTICS AS announced positive safety and anticancer activity results from the dose escalation part of the ACTIVATE trial. The data will be presented at a medical conference in early 2024. Eight patients were enrolled into the dose escalation part of the study. The results suggest that ACT treatment in combination with FOLFOX or FOLFIRI is well tolerated without unexpected acute or delayed side effects of the ACT treatment or worsening of side effects of the chemotherapy. Positive anticancer responses have been seen in all but one of the evaluable patients in this hard-to-treat patient population, showing that the ACT treatment can enhance anticancer response to Standard of Care chemotherapy.お知らせ • Aug 08EXACT Therapeutics Completes the Dose Escalation Part of ACTIVATE StudyEXACT Therapeutics AS announced that the dose escalation part of the ACTIVATE study is completed. This part of the study enrolled 8 patients, with 6 patients eligible for evaluation. The study is conducted at the Institute of Cancer Research (ICR), Royal Marsden Hospital, London with Professor Udai Banerji as the principal investigator. A presentation of the safety and efficacy findings will be released when the full results are available. The study Trial Monitoring Committee reviewed the safety data from the dose escalation and approved initiation of the dose expansion part of the ACTIVate study. The dose expansion is designed to determine the dose level for further development of ACT and expand the safety and efficacy data with 12 to 20 patients with metastatic colorectal cancer. All necessary approvals have already been awarded by the UK MHRA, as reported on July 31, and enrolment will now commence.お知らせ • Aug 01EXACT Therapeutics AS Receives Regulatory Approval to Start the Dose Expansion Part of ACTIVATE StudyEXACT THERAPEUTICS AS announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has awarded all necessary approvals to start the dose expansion part of the ACTIVATE study. This part of the ACTIVATE study is designed to determine the dose level for further development and expand the safety and efficacy data of ACT in patients with metastatic colorectal cancer. 12 to 20 patients are planned to be enrolled into the dose expansion part of the ACTIVATE study.お知らせ • Jun 10EXACT Therapeutics AS Announces Management ChangesEXACT Therapeutics AS at its Annual General Meeting held on June 9, 2023, announced Jean-Michel Cosséry is not seeking re-election as board member. In accordance with the Nomination Committee's proposal, the following Nomination Committee composition was made: Leiv Askvig (Chair); Dag Strømme; Birgitte Gangmark Villmo and Svein Kvåle.お知らせ • Feb 03Exact Therapeutics Receives Regulatory Approval to Reopen the Activate Clinical TrialOn February 2, 2023, EXACT Therapeutics AS announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has approved reopening of the clinical phase I ACTIVATE trial. As communicated in a press release of 8 March 2022, EXACT-Tx received a request from the MHRA for an additional submission and approval of medical device documentation associated to the protocol amendment filed with the ACTIVATE phase I clinical trial. EXACT-Tx responded to the request and has now received MHRA’s approval on both the medical device documentation and the amended protocol. The approvals were made without objections. For EXACT-Tx, this mean that the ACTIVATE phase I trial will be reopened and additional patients will be recruited for the trial. So far, there have been seven patients enrolled in the study with five patients’ data being evaluable for the study endpoints. Several valuable and encouraging insights have been gained from this first cohort of treated patients.お知らせ • Jan 14+ 2 more updatesEXACT Therapeutics AS, Annual General Meeting, Jun 09, 2023EXACT Therapeutics AS, Annual General Meeting, Jun 09, 2023.お知らせ • Dec 22Norwegian Research Council Awards EXACT Therapeutics AS Exact-Tx NOK 16 Million to Support the Research of Immunotherapy Responses in Solid Tumours with Acoustic Cluster TherapyEXACT Therapeutics AS announced that the Norwegian Research Council has awarded EXACT-Tx NOK 16 million to support the research of immunotherapy responses in solid tumours with Acoustic Cluster Therapy (ACT®). The research project is in collaboration with three renowned academic partners; Norwegian University of Science and Technology (NTNU)(Norway), Institute of Cancer Research (ICR)/Royal Marsden Hospital (UK) and Translational Genomics Research Institute (TGen)(USA). ACT® is currently in clinical development for combination with standard of care chemotherapeutic agents. Several preclinical studies have shown that ACT® can provide a remarkable increase in the therapeutic efficacy of this class of cancer drugs. The aim of the awarded research project is preclinical development of ACT® combined with immuno-oncology (IO) agents for treatment of solid cancers. IO-agents, and especially checkpoint inhibitors, represent an emerging and important class of cancer drugs that can provide long-term response in some cancer patients. Unfortunately, only a minority of patients respond to immunotherapy and the efficacy may partly be hampered by insufficient delivery to target tissues. Research into novel drug delivery systems is therefore of great importance. The awarded research project comprises six preclinical work packages investigating ACT® with checkpoint inhibitors for treatment of breast cancer, colon cancer and pancreatic cancer. The primary objective is to demonstrate preclinical proof of concept for treatment of one or more of these diseases. The project end point is performing a clinical trial within the IO segment.Board Change • Nov 16No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 5 non-independent directors. Chair of the Board Anders Wold was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.お知らせ • Sep 17EXACT Therapeutics AS Announces Appointment of Amir Snapir as Chief Medical Officer, Effective 21 September 2022EXACT Therapeutics AS announced the appointment of Dr. Amir Snapir as Chief Medical Officer (CMO), effective 21 September 2022. Dr. Snapir has a PhD from the University of Turku, Finland and an MD from the University of Tel Aviv, Israel. He has extensive experience in global clinical development of novel therapeutics, from early clinical translation to marketing authorisation, combined with extensive international regulatory experience. Dr. Snapir also has years of experience in business collaborations, alliances and product co-developments. Dr. Snapir comes from the position as CMO of PCI Biotech where he was responsible for the clinical development of drug-device combination product candidates. From 2007 to 2020 he held various positions at Orion Pharma, Espoo, Finland, spanning from leader of clinical pharmacogenomics to clinical development leader in Oncology. Dr. Snapir is the author of numerous scientific publications.お知らせ • Sep 01EXACT Therapeutics AS Appoints John Edminson as Chief Financial Officer, Effective 1 October 2022EXACT Therapeutics AS announced the appointment of John Edminson as Chief Financial Officer, effective 1 October 2022. John is a graduate from the Norwegian School of Economics with a Master in Auditing and Accounting and he built his career foundations working in audit at KPMG, which included 1.5 years in Boston, USA. He subsequently gained experience in both finance and operations in a variety of companies, including Telenor, ACNielsen, and Kistefos, before taking on CFO roles in PatientSky and Questback.お知らせ • Jun 09EXACT Therapeutics as Announces Board ChangesEXACT Therapeutics AS announced that Anders Wold, Board Director since December 2021, has been appointed Chair of the Board, with immediate effect. Anders Wold started his career in the field of medical ultrasound in 1984 as he joined the start-up Vingmed which was acquired in 1998 by GE Healthcare. He has nearly forty years of leadership experience in the healthcare and ultrasound industry including President and CEO of GE Healthcare Clinical Care Solutions. The current Executive Chair of the Board, Dr. Masha Strømme will assume the role of Vice-Chair of the Board. Sir William Castell, current Vice-Chair of the Board, will assume the role of Director of the Board alongside Dr. Jean-Michel Cosséry and Ann-Tove Kongsnes. Dr. Aitana Peire did not seek re-election and on behalf of the shareholders, the Board of Directors would like to thank her for her support and excellent contribution.お知らせ • May 20EXACT Therapeutics AS Announces Resignation of Dr. Jean-Claude Provost as Board MemberEXACT Therapeutics AS announced that its Board Member, Dr. Jean-Claude Provost will step down with immediate effect. Dr. Provost has taken on a new role as interim CMO of Lantheus Holdings. As this could represent a conflict of interest with his current Board appointment to EXACT-Tx, the Company and Dr. Provost have agreed that he will resign from the Board of Directors with immediate effect. The Nomination Committee is recommending that he is not replaced at the AGM in June.Board Change • Apr 28No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 7 non-independent directors. Director Anders Wold was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.お知らせ • Mar 29EXACT Therapeutics AS Appoints Per Walday as Chief Executive OfficerEXACT Therapeutics AS announced that its Board of Directors has appointed Dr. Per Walday as Chief Executive Officer (CEO). A successful senior executive in the healthcare industry, Per has experience from research to commercialization of therapeutics and medical devices globally, including drug-device combination within the field of oncology. As CEO of PCI Biotech, Per built an effective organization that progressed the platform technology into a pipeline of assets including in late stage clinical programs through FDA and EMA regulatory paths. Prior to this, Per spent almost two decades with Nycomed Imaging and GE Healthcare based in Norway where, as Global Head Project Management, he was responsible for all development programs of new pharmaceutical products.お知らせ • Mar 10EXACT Therapeutics AS Announces Clinical Trial UpdateEXACT THERAPEUTICS AS provided an update regarding the phase I ACTIVATE study. As reported in Fourth Quarter 2021, EXACT-Tx filed a protocol amendment regarding its ACTIVATE phase I clinical trial with the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA). This week the MHRA issued a response to EXACT-Tx requiring an additional submission and approval of documentation regarding the protocol amendment. The Company expects that meeting this requirement which is specifically focused on the Ultrasound system used in combination with PS101, from the regulator will impact the timing of additional patient recruitment. So far, there have been seven patients enrolled in the study with five patients' data evaluable to date for dose limiting toxicity. A number of valuable and encouraging insights have been gained from this first cohort of treated patients.Executive Departure • Dec 06Director Hans Klouman has left the companyOn the 3rd of December, Hans Klouman's tenure as Director ended. As of September 2021, Hans still personally held 399.75k shares (€815k worth at the time). A total of 2 executives have left over the last 12 months. The current median tenure of the management team is less than a year, which is considered inexperienced in the Simply Wall St Risk Model.Recent Insider Transactions • Jun 12Deputy Chairperson recently bought €21k worth of stockOn the 4th of June, William Castell bought around 10k shares on-market at roughly €2.06 per share. This was the largest purchase by an insider in the last 3 months. This was William's only on-market trade for the last 12 months.お知らせ • May 29EXACT Therapeutics AS Announces Clinical Trial UpdateEXACT Therapeutics AS provided an update regarding the ongoing phase I ACTIVATE study. Enrolment of patients in the study at the Royal Marsden Hospital in London has been adversely impacted through the Covid-19 pandemic period. There have been seven patients enrolled in the study with five patients’ data evaluable to date. A number of valuable and encouraging insights have been gained from this first cohort of treated patients, particularly with respect to application of ultrasound. In addition, as the organisation has expanded with appointment of experienced senior executives, focus has increased on improving quality management and internal governance processes. As a consequence, robust internal governance processes have been developed and implemented. In parallel, a protocol amendment is planned with a consequent impact on patient enrolment, which is anticipated to restart in fourth quarter 2021.株主還元56FDE BiotechsDE 市場7D-22.6%-1.3%-2.3%1Y-90.2%12.7%0.3%株主還元を見る業界別リターン: 56F過去 1 年間で12.7 % の収益を上げたGerman Biotechs業界を下回りました。リターン対市場: 56Fは、過去 1 年間で0.3 % のリターンを上げたGerman市場を下回りました。価格変動Is 56F's price volatile compared to industry and market?56F volatility56F Average Weekly Movement38.5%Biotechs Industry Average Movement8.2%Market Average Movement5.4%10% most volatile stocks in DE Market12.6%10% least volatile stocks in DE Market2.8%安定した株価: 56Fの株価は、 German市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 56Fの 週次ボラティリティ は、過去 1 年間で30%から39%に増加しました。会社概要設立従業員CEO（最高経営責任者ウェブサイト201211Per Waldayexact-tx.com臨床段階のバイオ医薬品企業であるEXACT Therapeutics AS社は、標的治療強化のための技術プラットフォームであるAcoustic Cluster Therapy（ACT）を開発している。ACTは、超音波を介した標的薬剤増強のアプローチであり、がんや脳疾患を含む様々な適応症において、様々な治療薬の臨床的有用性を増幅させる可能性がある。同社のACTプラットフォームは、肝転移を対象とした第I相臨床試験中であり、膵疾患、膠芽腫、免疫療法疾患、中枢神経系疾患、遺伝子治療を対象とした前臨床試験中である。GEヘルスケアと共同研究を行っている。以前はPhoenix Solutions ASとして知られていた。EXACT Therapeutics ASは2012年に設立され、ノルウェーのオスロを拠点としている。もっと見るEXACT Therapeutics AS 基礎のまとめEXACT Therapeutics の収益と売上を時価総額と比較するとどうか。56F 基礎統計学時価総額€3.80m収益（TTM）-€7.85m売上高(TTM)€5.33k713.1xP/Sレシオ-0.5xPER（株価収益率56F は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計56F 損益計算書（TTM）収益NOK 59.00k売上原価NOK 0売上総利益NOK 59.00kその他の費用NOK 87.03m収益-NOK 86.97m直近の収益報告Dec 31, 2025次回決算日Sep 03, 2026一株当たり利益（EPS）-1.37グロス・マージン100.00%純利益率-147,402.80%有利子負債／自己資本比率0%56F の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/07/14 02:19終値2026/07/14 00:00収益2025/12/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレークこのレポートを生成するために使用した分析モデルの詳細は、当社のGitHubページでご覧いただけます。また、レポートの活用方法に関するガイドやYouTubeのチュートリアルも用意しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋EXACT Therapeutics AS 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。0
Board Change • May 21No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Vice Chairman Jonathan Allis was the last director to join the board, commencing their role in 2024. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.
お知らせ • Feb 13EXACT Therapeutics AS, Annual General Meeting, Jun 12, 2026EXACT Therapeutics AS, Annual General Meeting, Jun 12, 2026.
お知らせ • Feb 12+ 1 more updateEXACT Therapeutics AS to Report First Half, 2026 Results on Sep 03, 2026EXACT Therapeutics AS announced that they will report first half, 2026 results on Sep 03, 2026
お知らせ • Jun 24EXACT Therapeutics Announces First Patient Dosed in Phase 2 Trial in Patients with Locally Advanced Pancreatic CancerEXACT Therapeutics announced first patient dosed in its ENACT trial. The trial is a multi-centre, open-label Phase 2 clinical trial testing the safety and efficacy of Acoustic Cluster Therapy (ACT®) in combination with standard of care (modified FOLFIRINOX chemotherapy) in first line patients with borderline resectable or unresectable locally advanced pancreatic cancer. Dosing of the first patient in the Phase 2 trial follows the announcement of positive final efficacy and safety data in the Phase 1 trial in patients with liver metastases of colorectal origin. The Phase 2 trial will enroll up to 25 patients in the U.S., U.K. and Europe, and has the ClinicalTrials.gov Identification: NCT06850623.
お知らせ • Jun 13Exact Therapeutics AS Approves Election of Following Nomination Committee CompositionEXACT Therapeutics AS at its AGM held on June 13, 2025 approved to elect the following Nomination Committee composition: Svein Kvåle (Chair), Birgitte Gangmark Villmo, Sir William Castell.
お知らせ • May 20EXACT Therapeutics Announces Positive Final Results in Phase 1 ACTIVATE Trial in Liver Metastases from Colorectal CancerEXACT Therapeutics AS announced positive final results in Phase 1 ACTIVATE trial in liver metastases from colorectal cancer. These results indicate that EXACT Therapeutics' Acoustic Cluster Therapy (ACT®?) significantly enhances the local effect of chemotherapy; In the patients who had a response to chemotherapy, ACT-treated tumours showed a significantly greater reduction in diameter compared to control tumours (-29% vs. -7%, p. The final results affirm the previously reported positive ACTIVATE outcomes and indicate the significant added efficacy of ACT with chemotherapy compared with chemotherapy alone. Among patients who responded to chemotherapy, tumor shrinkage was significantly greater with ACT and chemotherapy compared to chemotherapy alone in the same individuals (29% vs. 7%, p<0.05).
Board Change • May 21No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Vice Chairman Jonathan Allis was the last director to join the board, commencing their role in 2024. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.
お知らせ • Feb 13EXACT Therapeutics AS, Annual General Meeting, Jun 12, 2026EXACT Therapeutics AS, Annual General Meeting, Jun 12, 2026.
お知らせ • Feb 12+ 1 more updateEXACT Therapeutics AS to Report First Half, 2026 Results on Sep 03, 2026EXACT Therapeutics AS announced that they will report first half, 2026 results on Sep 03, 2026
お知らせ • Jun 24EXACT Therapeutics Announces First Patient Dosed in Phase 2 Trial in Patients with Locally Advanced Pancreatic CancerEXACT Therapeutics announced first patient dosed in its ENACT trial. The trial is a multi-centre, open-label Phase 2 clinical trial testing the safety and efficacy of Acoustic Cluster Therapy (ACT®) in combination with standard of care (modified FOLFIRINOX chemotherapy) in first line patients with borderline resectable or unresectable locally advanced pancreatic cancer. Dosing of the first patient in the Phase 2 trial follows the announcement of positive final efficacy and safety data in the Phase 1 trial in patients with liver metastases of colorectal origin. The Phase 2 trial will enroll up to 25 patients in the U.S., U.K. and Europe, and has the ClinicalTrials.gov Identification: NCT06850623.
お知らせ • Jun 13Exact Therapeutics AS Approves Election of Following Nomination Committee CompositionEXACT Therapeutics AS at its AGM held on June 13, 2025 approved to elect the following Nomination Committee composition: Svein Kvåle (Chair), Birgitte Gangmark Villmo, Sir William Castell.
お知らせ • May 20EXACT Therapeutics Announces Positive Final Results in Phase 1 ACTIVATE Trial in Liver Metastases from Colorectal CancerEXACT Therapeutics AS announced positive final results in Phase 1 ACTIVATE trial in liver metastases from colorectal cancer. These results indicate that EXACT Therapeutics' Acoustic Cluster Therapy (ACT®?) significantly enhances the local effect of chemotherapy; In the patients who had a response to chemotherapy, ACT-treated tumours showed a significantly greater reduction in diameter compared to control tumours (-29% vs. -7%, p. The final results affirm the previously reported positive ACTIVATE outcomes and indicate the significant added efficacy of ACT with chemotherapy compared with chemotherapy alone. Among patients who responded to chemotherapy, tumor shrinkage was significantly greater with ACT and chemotherapy compared to chemotherapy alone in the same individuals (29% vs. 7%, p<0.05).
お知らせ • Jan 29Cordance Medical and EXACT Therapeutics Announces Early Encouraging Data in Brain Cancer Mice ModelCordance Medical and EXACT Therapeutics announced initial positive results indicating more than a doubling (+127-145%) of the uptake of a radiopharmaceutical in brain tumors of mice inoculated with glioblastoma cancer cells, one of the most aggressive and hard-to-treat brain cancers. The increased uptake resulted from combining Exact Therapeutics' proprietary Acoustic Cluster Therapy (ACT®) with a device designed by Cordance Medical to deliver ultrasound energy non-invasively into the brain. The studies were performed at The Arctic University of Norway and University Hospital North-Norway in Tromsø by Dr. Mathias Kranz. The combination of ACT® and the device can be used in a wide range of brain diseases to potentially access large regions of the brain. The combination can stimulate bioeffects including increasing the uptake of therapeutic agents and temporarily making the blood-brain barrier more permeable in these regions. The combination of ACT® and the device may be utilized for both diagnostic and targeted therapeutic brain applications. Further experiments are ongoing to expand the early data, and the results will be submitted for publication in scientific journals.
お知らせ • Jan 28Exact Therapeutics and Cordance Medical Announce Early Encouraging Data in Brain Cancer Mice ModelEXACT Therapeutics and Cordance Medical announced initial positive results indicating more than a doubling (+127-145%) of the uptake of a radiopharmaceutical in brain tumors of mice inoculated with glioblastoma cancer cells, one of the most aggressive and hard-to-treat brain cancers. The increased uptake resulted from combining Exact Therapeutics’ proprietary Acoustic Cluster Therapy (ACT®) with a device designed by Cordance Medical to deliver ultrasound energy non-invasively into the brain. The studies were performed at The Arctic University of Norway and the University Hospital of North-Norway in Tromsø by Dr. Mathias Kranz. The combination of ACT and the device may offer potential applications across a wide range of brain diseases, by enabling therapeutic access to large brain regions. The combined technologies can induce bioeffects, such as temporarily increasing blood-brain barrier permeability in targeted regions and increasing the uptake of therapeutic agents. ACT and the device may be utilized for both diagnostic and targeted therapeutic brain applications. Further experiments are ongoing to expand the early data, and the results will be submitted for publication in scientific journals.
お知らせ • Jan 08EXACT Therapeutics AS, Annual General Meeting, Jun 13, 2025EXACT Therapeutics AS, Annual General Meeting, Jun 13, 2025.
お知らせ • Jan 07+ 1 more updateEXACT Therapeutics AS to Report Fiscal Year 2025 Results on Apr 09, 2025EXACT Therapeutics AS announced that they will report fiscal year 2025 results on Apr 09, 2025
お知らせ • Dec 19+ 1 more updateEXACT Therapeutics AS Announces Board AppointmentsEXACT Therapeutics AS welcomed two new board members, Vice Chair Jonathan Allis and Director Flavien Daloz, following the extraordinary general meeting on 17 December, 2024. In line with the development ambitions and internationalization of the Company over the last years and following the investment by GE Medical Holdings AB it has been the ambition to further internationalize the Board of Directors. The new board members, Jonathan Allis and Flavien Daloz, both bring significant industry experience. Dr. Jonathan Allis is a scientist turned entrepreneur and was the founding CEO of Blue Earth Diagnostics, a spin-out from GE Healthcare established in 2014. Blue Earth Diagnostics developed a prostate cancer diagnostic approved by the FDA in 2016, which became a successful product in the USA. The company was acquired by Bracco Imaging in 2019. Jonathan also served as a Board member and Chair of Polarean Imaging. Prior to these roles, Jonathan was the general manager for PET at GE Healthcare Life Sciences and was responsible for GE Healthcare’s PET agent and PET synthesis platforms business globally. He has previously held positions in R&D, Marketing and Product Development at GE Healthcare, Amersham plc., Siemens Medical Solutions and Oxford Magnet Technology in the UK, USA and Germany. Jonathan has an undergraduate degree in Physics from the University of Cape Town and a doctorate in Biochemistry from the University of Oxford. Mr. Flavien Daloz is the Chief Technology Officer for Ultrasound Probes under the GEHC Advanced Visualization Solutions segment. In his 15+ years of experience, Mr. Daloz has held various leadership positions in the Medical Ultrasound industry, with a proven record in innovation and new product introductions. He was the recipient of GEHC Edison Pioneer Award in 2021 for his influence in medical ultrasound transducer breakthrough. Mr. Daloz holds an engineering degree from ESPCI school in Paris and an MSc in Bioimaging sciences from Imperial College, London. He has completed a Business Leadership Program from Michigan Ross, US.
お知らせ • Aug 07EXACT Therapeutics AS Announces Full Focus on Phase 2 Pancreatic Cancer TrialEXACT Therapeutics AS announced that it will now be focusing all clinical efforts on the upcoming Phase 2 ENACT trial in locally advanced pancreatic cancer and is stopping recruitment in the Phase 1 ACTIVATE clinical trial in cancer patients with liver metastases of colorectal origin. Previously, the Phase 1 ACTIVATE trial reported positive interim efficacy and safety data. The enrolled patients will be followed through the planned follow-up. The final results from the ACTIVATE Phase 1 trial (11 patients) will be reported after completion of independent blinded review, expected early 2025. So far, there has been no change to the previously reported excellent safety profile of PS101 in the ACTIVATE trial.
New Risk • Apr 15New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings have declined by 17% per year over the past 5 years. Revenue is less than US$1m (kr453k revenue, or US$42k). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Shareholders have been diluted in the past year (6.9% increase in shares outstanding). Market cap is less than US$100m (€16.6m market cap, or US$17.6m).
お知らせ • Jan 23+ 2 more updatesEXACT Therapeutics AS to Report Fiscal Year 2023 Results on Apr 18, 2024EXACT Therapeutics AS announced that they will report fiscal year 2023 results on Apr 18, 2024
New Risk • Dec 22New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 6.9% This is considered a minor 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 have declined by 17% per year over the past 5 years. Revenue is less than US$1m (kr453k revenue, or US$44k). Minor Risks Share price has been volatile over the past 3 months (7.8% average weekly change). Shareholders have been diluted in the past year (6.9% increase in shares outstanding). Market cap is less than US$100m (€31.4m market cap, or US$34.5m).
お知らせ • Dec 02EXACT Therapeutics AS has completed a Follow-on Equity Offering in the amount of NOK 24.999996 million.EXACT Therapeutics AS has completed a Follow-on Equity Offering in the amount of NOK 24.999996 million. Security Name: Ordinarey Shares Security Type: Common Stock Securities Offered: 2,083,333 Price\Range: NOK 12 Transaction Features: Subsequent Direct Listing
New Risk • Sep 29New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr40m 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 (-kr40m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings have declined by 17% per year over the past 5 years. Revenue is less than US$1m (kr453k revenue, or US$42k). Minor Risk Market cap is less than US$100m (€40.9m market cap, or US$43.3m).
お知らせ • Sep 28EXACT Therapeutics AS Announces Appointment of Caspar Foghsgaard as SVP Commercial & Business Development Effective 1 November 2023EXACT Therapeutics AS announced that Caspar Foghsgaard is joining the company as Senior Vice President Commercial and Business Development, effective 1 November 2023. Caspar Foghsgaard joins Exact Therapeutics from Nykode Therapeutics where his latest role was as Sr. Director Special Projects and part of the extended leadership team. He joined Nykode in 2018 and have been closely involved in Nykode’s transformation from a small biotech to a leading company at Oslo Stock Exchange. Prior to his role as Sr. Director Special Projects, he was heading Nykode’s business development activities as Director Business Development. Other previous employers include Arcus where he was responsible for business development in the spirits division and part of the divisional management, and Elopak as Program Director Strategy. In addition, he has held various business development and strategy positions including with Novozymes in Denmark, U.S. and U.K.
お知らせ • Sep 27EXACT Therapeutics Announces Positive Clinical Results from the Activate Phase I Dose EscalationEXACT THERAPEUTICS AS announced positive safety and anticancer activity results from the dose escalation part of the ACTIVATE trial. The data will be presented at a medical conference in early 2024. Eight patients were enrolled into the dose escalation part of the study. The results suggest that ACT treatment in combination with FOLFOX or FOLFIRI is well tolerated without unexpected acute or delayed side effects of the ACT treatment or worsening of side effects of the chemotherapy. Positive anticancer responses have been seen in all but one of the evaluable patients in this hard-to-treat patient population, showing that the ACT treatment can enhance anticancer response to Standard of Care chemotherapy.
お知らせ • Aug 08EXACT Therapeutics Completes the Dose Escalation Part of ACTIVATE StudyEXACT Therapeutics AS announced that the dose escalation part of the ACTIVATE study is completed. This part of the study enrolled 8 patients, with 6 patients eligible for evaluation. The study is conducted at the Institute of Cancer Research (ICR), Royal Marsden Hospital, London with Professor Udai Banerji as the principal investigator. A presentation of the safety and efficacy findings will be released when the full results are available. The study Trial Monitoring Committee reviewed the safety data from the dose escalation and approved initiation of the dose expansion part of the ACTIVate study. The dose expansion is designed to determine the dose level for further development of ACT and expand the safety and efficacy data with 12 to 20 patients with metastatic colorectal cancer. All necessary approvals have already been awarded by the UK MHRA, as reported on July 31, and enrolment will now commence.
お知らせ • Aug 01EXACT Therapeutics AS Receives Regulatory Approval to Start the Dose Expansion Part of ACTIVATE StudyEXACT THERAPEUTICS AS announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has awarded all necessary approvals to start the dose expansion part of the ACTIVATE study. This part of the ACTIVATE study is designed to determine the dose level for further development and expand the safety and efficacy data of ACT in patients with metastatic colorectal cancer. 12 to 20 patients are planned to be enrolled into the dose expansion part of the ACTIVATE study.
お知らせ • Jun 10EXACT Therapeutics AS Announces Management ChangesEXACT Therapeutics AS at its Annual General Meeting held on June 9, 2023, announced Jean-Michel Cosséry is not seeking re-election as board member. In accordance with the Nomination Committee's proposal, the following Nomination Committee composition was made: Leiv Askvig (Chair); Dag Strømme; Birgitte Gangmark Villmo and Svein Kvåle.
お知らせ • Feb 03Exact Therapeutics Receives Regulatory Approval to Reopen the Activate Clinical TrialOn February 2, 2023, EXACT Therapeutics AS announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has approved reopening of the clinical phase I ACTIVATE trial. As communicated in a press release of 8 March 2022, EXACT-Tx received a request from the MHRA for an additional submission and approval of medical device documentation associated to the protocol amendment filed with the ACTIVATE phase I clinical trial. EXACT-Tx responded to the request and has now received MHRA’s approval on both the medical device documentation and the amended protocol. The approvals were made without objections. For EXACT-Tx, this mean that the ACTIVATE phase I trial will be reopened and additional patients will be recruited for the trial. So far, there have been seven patients enrolled in the study with five patients’ data being evaluable for the study endpoints. Several valuable and encouraging insights have been gained from this first cohort of treated patients.
お知らせ • Jan 14+ 2 more updatesEXACT Therapeutics AS, Annual General Meeting, Jun 09, 2023EXACT Therapeutics AS, Annual General Meeting, Jun 09, 2023.
お知らせ • Dec 22Norwegian Research Council Awards EXACT Therapeutics AS Exact-Tx NOK 16 Million to Support the Research of Immunotherapy Responses in Solid Tumours with Acoustic Cluster TherapyEXACT Therapeutics AS announced that the Norwegian Research Council has awarded EXACT-Tx NOK 16 million to support the research of immunotherapy responses in solid tumours with Acoustic Cluster Therapy (ACT®). The research project is in collaboration with three renowned academic partners; Norwegian University of Science and Technology (NTNU)(Norway), Institute of Cancer Research (ICR)/Royal Marsden Hospital (UK) and Translational Genomics Research Institute (TGen)(USA). ACT® is currently in clinical development for combination with standard of care chemotherapeutic agents. Several preclinical studies have shown that ACT® can provide a remarkable increase in the therapeutic efficacy of this class of cancer drugs. The aim of the awarded research project is preclinical development of ACT® combined with immuno-oncology (IO) agents for treatment of solid cancers. IO-agents, and especially checkpoint inhibitors, represent an emerging and important class of cancer drugs that can provide long-term response in some cancer patients. Unfortunately, only a minority of patients respond to immunotherapy and the efficacy may partly be hampered by insufficient delivery to target tissues. Research into novel drug delivery systems is therefore of great importance. The awarded research project comprises six preclinical work packages investigating ACT® with checkpoint inhibitors for treatment of breast cancer, colon cancer and pancreatic cancer. The primary objective is to demonstrate preclinical proof of concept for treatment of one or more of these diseases. The project end point is performing a clinical trial within the IO segment.
Board Change • Nov 16No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 5 non-independent directors. Chair of the Board Anders Wold was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.
お知らせ • Sep 17EXACT Therapeutics AS Announces Appointment of Amir Snapir as Chief Medical Officer, Effective 21 September 2022EXACT Therapeutics AS announced the appointment of Dr. Amir Snapir as Chief Medical Officer (CMO), effective 21 September 2022. Dr. Snapir has a PhD from the University of Turku, Finland and an MD from the University of Tel Aviv, Israel. He has extensive experience in global clinical development of novel therapeutics, from early clinical translation to marketing authorisation, combined with extensive international regulatory experience. Dr. Snapir also has years of experience in business collaborations, alliances and product co-developments. Dr. Snapir comes from the position as CMO of PCI Biotech where he was responsible for the clinical development of drug-device combination product candidates. From 2007 to 2020 he held various positions at Orion Pharma, Espoo, Finland, spanning from leader of clinical pharmacogenomics to clinical development leader in Oncology. Dr. Snapir is the author of numerous scientific publications.
お知らせ • Sep 01EXACT Therapeutics AS Appoints John Edminson as Chief Financial Officer, Effective 1 October 2022EXACT Therapeutics AS announced the appointment of John Edminson as Chief Financial Officer, effective 1 October 2022. John is a graduate from the Norwegian School of Economics with a Master in Auditing and Accounting and he built his career foundations working in audit at KPMG, which included 1.5 years in Boston, USA. He subsequently gained experience in both finance and operations in a variety of companies, including Telenor, ACNielsen, and Kistefos, before taking on CFO roles in PatientSky and Questback.
お知らせ • Jun 09EXACT Therapeutics as Announces Board ChangesEXACT Therapeutics AS announced that Anders Wold, Board Director since December 2021, has been appointed Chair of the Board, with immediate effect. Anders Wold started his career in the field of medical ultrasound in 1984 as he joined the start-up Vingmed which was acquired in 1998 by GE Healthcare. He has nearly forty years of leadership experience in the healthcare and ultrasound industry including President and CEO of GE Healthcare Clinical Care Solutions. The current Executive Chair of the Board, Dr. Masha Strømme will assume the role of Vice-Chair of the Board. Sir William Castell, current Vice-Chair of the Board, will assume the role of Director of the Board alongside Dr. Jean-Michel Cosséry and Ann-Tove Kongsnes. Dr. Aitana Peire did not seek re-election and on behalf of the shareholders, the Board of Directors would like to thank her for her support and excellent contribution.
お知らせ • May 20EXACT Therapeutics AS Announces Resignation of Dr. Jean-Claude Provost as Board MemberEXACT Therapeutics AS announced that its Board Member, Dr. Jean-Claude Provost will step down with immediate effect. Dr. Provost has taken on a new role as interim CMO of Lantheus Holdings. As this could represent a conflict of interest with his current Board appointment to EXACT-Tx, the Company and Dr. Provost have agreed that he will resign from the Board of Directors with immediate effect. The Nomination Committee is recommending that he is not replaced at the AGM in June.
Board Change • Apr 28No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 7 non-independent directors. Director Anders Wold was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.
お知らせ • Mar 29EXACT Therapeutics AS Appoints Per Walday as Chief Executive OfficerEXACT Therapeutics AS announced that its Board of Directors has appointed Dr. Per Walday as Chief Executive Officer (CEO). A successful senior executive in the healthcare industry, Per has experience from research to commercialization of therapeutics and medical devices globally, including drug-device combination within the field of oncology. As CEO of PCI Biotech, Per built an effective organization that progressed the platform technology into a pipeline of assets including in late stage clinical programs through FDA and EMA regulatory paths. Prior to this, Per spent almost two decades with Nycomed Imaging and GE Healthcare based in Norway where, as Global Head Project Management, he was responsible for all development programs of new pharmaceutical products.
お知らせ • Mar 10EXACT Therapeutics AS Announces Clinical Trial UpdateEXACT THERAPEUTICS AS provided an update regarding the phase I ACTIVATE study. As reported in Fourth Quarter 2021, EXACT-Tx filed a protocol amendment regarding its ACTIVATE phase I clinical trial with the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA). This week the MHRA issued a response to EXACT-Tx requiring an additional submission and approval of documentation regarding the protocol amendment. The Company expects that meeting this requirement which is specifically focused on the Ultrasound system used in combination with PS101, from the regulator will impact the timing of additional patient recruitment. So far, there have been seven patients enrolled in the study with five patients' data evaluable to date for dose limiting toxicity. A number of valuable and encouraging insights have been gained from this first cohort of treated patients.
Executive Departure • Dec 06Director Hans Klouman has left the companyOn the 3rd of December, Hans Klouman's tenure as Director ended. As of September 2021, Hans still personally held 399.75k shares (€815k worth at the time). A total of 2 executives have left over the last 12 months. The current median tenure of the management team is less than a year, which is considered inexperienced in the Simply Wall St Risk Model.
Recent Insider Transactions • Jun 12Deputy Chairperson recently bought €21k worth of stockOn the 4th of June, William Castell bought around 10k shares on-market at roughly €2.06 per share. This was the largest purchase by an insider in the last 3 months. This was William's only on-market trade for the last 12 months.
お知らせ • May 29EXACT Therapeutics AS Announces Clinical Trial UpdateEXACT Therapeutics AS provided an update regarding the ongoing phase I ACTIVATE study. Enrolment of patients in the study at the Royal Marsden Hospital in London has been adversely impacted through the Covid-19 pandemic period. There have been seven patients enrolled in the study with five patients’ data evaluable to date. A number of valuable and encouraging insights have been gained from this first cohort of treated patients, particularly with respect to application of ultrasound. In addition, as the organisation has expanded with appointment of experienced senior executives, focus has increased on improving quality management and internal governance processes. As a consequence, robust internal governance processes have been developed and implemented. In parallel, a protocol amendment is planned with a consequent impact on patient enrolment, which is anticipated to restart in fourth quarter 2021.
