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Karolinska Development’s portfolio company Umecrine Cognition raises MSEK 24.6 for the ongoing clinical development of golexanolone
Globenewswire· 2025-07-14 15:01
Core Viewpoint - Umecrine Cognition has successfully raised SEK 24.6 million through a convertible loan to support its ongoing clinical Phase 1b/2a study of golexanolone in primary biliary cholangitis, with participation from existing shareholders including Karolinska Development [1][3]. Group 1: Clinical Study Details - Umecrine Cognition is conducting the second part of its clinical Phase 1b/2a study, aiming to recruit 84 patients across over 30 sites in eight countries [2]. - The first part of the study concluded with interim results indicating that golexanolone was well-tolerated, safe, and resulted in only mild adverse events, achieving clinically relevant drug exposure levels and positive outcomes in anxiety and depression scoring [2]. Group 2: Funding and Ownership - The convertible loan, which includes attached share options, is directed to a consortium of investors, including Karolinska Development, AB Ility, and Ribbskottet AB, and will finance the clinical trial and operational expenses [3]. - Karolinska Development currently holds a 73% ownership stake in Umecrine Cognition, which will decrease to 62% upon conversion of the loan and full exercise of the share options [4]. Group 3: Company Background - Karolinska Development is a Nordic life sciences investment company focused on identifying and developing breakthrough medical innovations in the region [5][6]. - The company has a portfolio of eleven companies targeting innovative treatments for serious diseases and is supported by a team of experienced investment professionals [7].
Karolinska Development’s portfolio company Umecrine Cognition resumes patient inclusion in its Phase 1b/2a clinical study
Globenewswire· 2025-05-26 06:50
Company Overview - Karolinska Development AB is a Nordic life sciences investment company focused on identifying breakthrough medical innovations in the Nordic region [3][4] - The company has a portfolio of eleven companies targeting innovative treatments for life-threatening or serious debilitating diseases [5] - Karolinska Development holds a 73% ownership stake in Umecrine Cognition, which is developing a new class of drugs for cognitive symptoms caused by liver disease [2] Clinical Trial Update - Umecrine Cognition has resumed patient inclusion in the clinical phase 1b/2a trial for the drug candidate golexanolone in patients with primary biliary cholangitis (PBC) [1] - The trial had been previously halted in March due to technical issues in capsule production, but this did not affect patient safety [1] Drug Development Focus - Golexanolone is being evaluated in a randomized, double-blind, placebo-controlled study aimed at patients with PBC who experience significant fatigue and cognitive symptoms [2]
Karolinska Development’s portfolio company Umecrine Cognition presents data validating novel clinical scale in PBC at EASL 2025
Globenewswire· 2025-05-07 06:50
Core Insights - Umecrine Cognition, a portfolio company of Karolinska Development, is presenting new clinical scale data for Primary Biliary Cholangitis (PBC) at the EASL Congress 2025 in Amsterdam [1][2]. Company Overview - Karolinska Development AB holds a 73% ownership stake in Umecrine Cognition [5]. - The company focuses on identifying and investing in breakthrough medical innovations in the Nordic region, aiming to develop these into commercial products [6][8]. Drug Development - Umecrine Cognition is developing golexanolone, a drug candidate currently in a Phase 2a clinical study for PBC [2]. - The newly developed CGI-S-PBC™ scale is designed to evaluate symptom severity in PBC patients, which cannot be measured by conventional laboratory tests [3]. Clinical Research - The CGI-S-PBC™ scale expands on the PBC-40 patient-reported outcome measure and has been validated in two separate studies [3]. - Abstracts summarizing the validation and implementation of CGI-S-PBC™ will be presented at the EASL Congress, focusing on its role as a clinical trials outcome tool [4].
Karolinska Development’s portfolio company Umecrine Cognition receives grant from The Michael J. Fox Foundation
Globenewswire· 2025-05-05 06:50
Company Overview - Karolinska Development AB holds a 73% ownership stake in Umecrine Cognition, which is focused on developing a new class of drugs to alleviate cognitive symptoms associated with Parkinson's disease [6][2]. - The company is a Nordic life sciences investment firm that identifies and invests in breakthrough medical innovations, aiming to create and grow companies that advance these innovations into commercial products [7][8]. Research Grant Announcement - Umecrine Cognition has been awarded a research grant of USD 420,000 from The Michael J. Fox Foundation to finance preclinical studies evaluating the treatment effect of golexanolone in Parkinson's disease [1][5]. - The grant will support further studies to confirm golexanolone's effects on sleep dysfunction and cognitive impairments related to Parkinson's disease, as well as its impact on disease progression [2][5]. Parkinson's Disease Context - Parkinson's disease is characterized by progressive neurodegeneration, primarily affecting motor functions, but non-motor symptoms like sleep disorders and cognitive impairments often appear earlier and have been historically overlooked [4]. - Current treatments primarily target motor dysfunction, with no approved therapies available for non-motor symptoms, highlighting a significant medical need in this area [4][5].
Interim Report - January-March 2025
Globenewswire· 2025-04-30 06:00
Core Insights - Karolinska Development AB reported high developmental intensity levels in its portfolio companies during Q1 2025, with many making significant progress [1] Significant Events During Q1 - AnaCardio secured SEK 205 million in a Series A extension financing round and reported positive results from a phase 1b/2a study of AC01 for heart failure [4] - Dilafor completed regulatory meetings with the FDA and European Health Agencies for tafoxiparin, aligning on pivotal Phase 3 study designs [4] - Promimic published positive results on bacterial growth reduction on its HAnano Surface implant [4] - AnaCardio initiated dosing for the phase 2a part of the GOAL-HF1 clinical study, with results expected by year-end [4] - PharmNovo received positive feedback from the FDA regarding its drug candidate PN6047 in a pre-IND meeting [4] - Umecrine Cognition faced delays in its clinical trial for golexanolone due to production issues but reported no safety concerns [4] - Umecrine Cognition presented preclinical data on golexanolone at an international conference [4] - Viktor Drvota took over as CEO of Umecrine Cognition while remaining CEO of Karolinska Development [4] Financial Update for Q1 - The net profit/loss for Q1 was SEK -14.2 million, compared to SEK 0.2 million in Q1 2024 [4] - Earnings per share were SEK -0.05, down from SEK 0.00 in Q1 2024 [4] - Change in fair value of shares in portfolio companies was SEK -3.5 million, influenced by a downturn in Modus Therapeutics' share price [4] - Total fair value of the portfolio was SEK 1,434.2 million, a decrease of SEK 17.3 million from the previous quarter [9] - Net asset value was SEK 1,230.4 million, with a per-share value of SEK 4.6 [9] - Net sales were SEK 0.5 million, unchanged from Q1 2024 [9] - Karolinska Development invested SEK 15.5 million in portfolio companies during Q1 2025, up from SEK 12.0 million in Q1 2024 [9] - Cash and cash equivalents increased by SEK 9.0 million, totaling SEK 51.1 million by March 31, 2025 [9]