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EXACT Therapeutics: Exercise of Warrants by GE Medical Holding AB
Globenewswire· 2026-02-05 09:53
Core Viewpoint - GE Medical Holding AB has exercised all its warrants in EXACT Therapeutics, resulting in gross proceeds of NOK 33 million, following a positive safety read-out from the phase 2 ENACT trial in locally advanced pancreatic cancer [1][2]. Group 1: Company Developments - EXACT Therapeutics announced that GE Medical Holding AB will exercise all of its 26,973,169 warrants, leading to gross proceeds of NOK 33 million for the company [2]. - The exercise of warrants is linked to the positive safety read-out from the ENACT phase 2 trial, which has encouraged further investment [2][5]. - The remaining warrant holders have until 26 February 2026 to exercise their warrants, with updates on the exercise expected to follow [2]. Group 2: Clinical Trial Insights - The ENACT phase 2 trial has shown early encouraging results, including significant tumor shrinkage and a decrease in the tumor biomarker CA 19-9 by over 85% [5]. - The Trial Monitoring Committee has issued a positive conclusion for the pre-planned safety read-out, allowing the trial to proceed as planned [5]. Group 3: Company Background - EXACT Therapeutics is a clinical-stage precision medicine company that utilizes ultrasound to activate its proprietary drug PS101, enhancing the clinical benefits of oncology therapies [4]. - PS101 has a unique mode of action and can be combined with various therapeutic agents across multiple indications, including brain diseases [4].
EXACT Therapeutics announces positive final results in Phase 1 ACTIVATE trial in liver metastases from colorectal cancer
Globenewswire· 2025-05-20 06:30
Core Insights - EXACT Therapeutics announced positive final data from its Phase 1 ACTIVATE trial, demonstrating the efficacy of its Acoustic Cluster Therapy (ACT) combined with chemotherapy for patients with liver metastases of colorectal origin [1][3][8] - The results support the initiation of the ENACT Phase 2 study in pancreatic cancer, addressing a significant unmet medical need [1][8] Group 1: Trial Results - The ACTIVATE trial showed that tumor shrinkage was significantly greater with ACT and chemotherapy compared to chemotherapy alone, with a reduction of -29% versus -7% among responding patients (p<0.05) [3][8] - A clear dose-response relationship was observed with the proprietary agent PS101, where 3 out of 4 patients receiving 40 µl/kg PS101 showed tumor shrinkage of more than 30% in diameter [4][8] - The trial enrolled 11 patients, with 9 being evaluable, and was conducted at sites in the United Kingdom [9] Group 2: Safety and Efficacy - PS101 was found to be safe and well-tolerated when administered with chemotherapy, mirroring the excellent safety profile seen in interim results [4][8] - The trial's design allowed each patient to serve as their own control, enhancing the reliability of the anti-tumor activity assessment [7] Group 3: Future Plans - The company plans to present detailed data from the ACTIVATE trial at a future scientific publication and medical conference [5] - The CEO expressed excitement about the upcoming ENACT trial, which will focus on locally advanced pancreatic cancer [2][8] Group 4: Technology Overview - Acoustic Cluster Therapy (ACT) involves the intravenous administration of PS101, which is insonated over target tissue using ultrasound to enhance drug delivery [10][11] - The technology utilizes microclusters of perfluorobutane microbubbles and perfluoromethylcyclopentane microdroplets to improve the efficacy of concurrent chemotherapy [10][11]