AC01

Search documents
Karolinska Development’s portfolio company AnaCardio completes patient recruitment in phase 2a study of its drug candidate AC01
Globenewswire· 2025-09-16 07:05
Group 1 - Karolinska Development's portfolio company AnaCardio has completed enrollment in the phase 2a part of its clinical study GOAL-HF1, which evaluates the drug candidate AC01 in patients with heart failure and reduced ejection fraction, with results expected by the end of the year [1][4] - The phase 2a study includes 26 patients and aims to assess safety, tolerability, pharmacokinetics, and pharmacodynamics after 28 days of treatment, conducted at 13 specialized heart failure centers across Sweden, the Netherlands, Italy, and the UK [3] - Karolinska Development holds a 10 percent ownership stake in AnaCardio, indicating a vested interest in the success of the clinical study and the advancement of the drug candidate [4] Group 2 - AnaCardio AB is a privately held Swedish biopharmaceutical company focused on developing novel drugs for heart failure, with its lead asset AC01 currently in a clinical phase 1b/2a study [2] - Karolinska Development is a Nordic life sciences investment company that identifies and invests in breakthrough medical innovations, aiming to create and grow companies that develop these innovations into commercial products [5][6] - The company has a portfolio of eleven companies targeting innovative treatments for serious diseases, supported by a team of experienced investment professionals and a strong global network [7]
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]