Core Viewpoint - Karolinska Development AB's portfolio company OssDsign successfully completed a directed share issue, raising approximately SEK 158 million, and announced an updated strategy and revised financial targets for 2025–2028 [1][3]. Group 1: Directed Share Issue - OssDsign's directed share issue attracted both existing and new institutional investors, including Adrigo Asset Management and La financiere de L'Echiquier, with the subscription price determined through an accelerated bookbuilding procedure [2][3]. - The successful share issue is expected to strengthen OssDsign's efforts in accelerating sales growth and building a long-term profitable business [3]. Group 2: Updated Strategy and Financial Targets - The new strategy, "ScaleToProfit," focuses on investments in four main areas: sales and marketing, research and development, clinical studies, and production [3][8]. - Revised financial targets include achieving sales of over SEK 400 million by 2028, which represents a compounded annual growth rate of over 30% during 2025–2028, and becoming EBIT profitable and cash flow positive in the second half of 2025–2028 [8]. Group 3: Company Overview - Karolinska Development holds a 3% ownership stake in OssDsign [4]. - 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 [5][6]. - Karolinska Development has a portfolio of eleven companies targeting innovative treatments for serious diseases [7].

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]

Core Viewpoint - Karolinska Development AB held its Annual General Meeting on May 15, 2025, where several key resolutions were passed regarding financial statements, board composition, remuneration, and authorizations for share transactions and new issues of shares [1][2][3][4][5][9][10]. Financial Resolutions - The profit and loss statement and balance sheet for the financial year 2024 were adopted, with a total of SEK 1,235,972,877 to be carried forward [1][2]. - The Board of Directors' remuneration report for 2024 was approved in accordance with Swedish regulations [8]. Board Composition and Remuneration - The number of directors was set to five without deputies, and one auditor was appointed without a deputy [3]. - The chairman will receive a fixed remuneration of SEK 400,000, while other directors will receive SEK 200,000, both paid in proportion to board meetings attended [4]. - Ben Toogood was re-elected as Chairman of the Board, and four other directors were re-elected, with Anders Härfstrand newly elected [5]. Nomination Committee - A Nomination Committee consisting of five members was established, appointed by the five largest shareholders based on voting power [6][7]. - The committee is responsible for proposing candidates for the Board of Directors and auditor, as well as evaluating its own instructions annually [7]. Shareholder Authorizations - The Board of Directors was authorized to transfer all shares of series B held by the Company, with transfers to occur on Nasdaq Stockholm or otherwise, at market terms [9]. - The Board was also authorized to issue new shares of series B up to 20% of the total share capital, with conditions to ensure compliance with the Company's maximum allowed share capital [10].

Core Insights - OssDsign has successfully treated 10,000 patients with its innovative nanosynthetic bone graft, OssDsign Catalyst, in the US market [1][2] - The product has shown rapid and robust bone formation, even in poorly vascularized environments, and has significantly penetrated the American orthobiologics market since its launch in August 2021 [2][3] - The usage of OssDsign Catalyst has doubled from 5,000 patients reported last year, indicating strong demand from American surgeons and hospitals [3] Company Overview - Karolinska Development AB is a Nordic life sciences investment company focused on identifying and developing breakthrough medical innovations [4][5] - The company has a portfolio of eleven companies targeting innovative treatments for serious diseases, supported by experienced management teams and a strong global network [6]

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].

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].

Group 1 - Karolinska Development's portfolio company OssDsign is undergoing a leadership change to enhance its focus on the US market [1][2] - OssDsign has transitioned to a pure-play orthobiologics company since launching OssDsign Catalyst in the US in August 2021, experiencing high double-digit growth [2] - Current CEO Morten Henneveld will ensure a smooth transition to new leadership and will leave his position by year-end or upon the appointment of a new CEO [3] Group 2 - Karolinska Development holds a 3% ownership stake in OssDsign [3] - The company focuses on identifying and investing in breakthrough medical innovations in the Nordic region, aiming to create and grow companies that develop these innovations into commercial products [4][5] - Karolinska Development has a portfolio of eleven companies targeting innovative treatments for serious diseases, supported by experienced management teams and a strong global network [6]

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]