Core Insights - Karolinska Development AB is approaching a period where several portfolio companies will conclude their clinical studies, which is expected to yield exciting data readouts [1] Significant Events During the Third Quarter - Organon announced the discontinuation of the clinical development of drug candidate OG-6219 following phase 2 study results [4] - Modus Therapeutics completed patient enrollment for part 1 of its ongoing phase 2a study with sevuparin for chronic kidney disease with anemia [4] - Umecrine Cognition raised SEK 24.6 million through a convertible loan for its ongoing clinical study of golexanolone in Primary biliary cholangitis [4] - Modus Therapeutics raised SEK 28.3 million in a unit issue with a subscription rate of 189% to finance the development of sevuparin [4] - Umecrine Cognition presented data supporting golexanolone's mechanism in alleviating Parkinson's disease symptoms [4] - AnaCardio completed enrollment in the phase 2a study of drug candidate AC01 for heart failure, with results expected by year-end [4] - Dilafor was granted a US patent for tafoxiparin, which will support its phase 3 clinical development [4] - PharmNovo received approval to initiate a phase 2a clinical trial of PN6047 for neuropathic pain [4] - SVF Vaccines presented positive preclinical study results for SVF-001 targeting chronic hepatitis B and D [4] - Karolinska Development participated in BOOST Pharma's financing, contributing SEK 7.5 million to support phase 3 development of BT-101 for Osteogenesis imperfecta [4] - BOOST Pharma presented new long-term data from the BOOSTB4 trial for BT-101 at an international conference [4] - Modus Therapeutics received regulatory approval to initiate the second part of its phase 2 study with sevuparin [5] Financial Update - The net profit/loss for Q3 2025 was SEK -66.8 million, compared to SEK -10.9 million in Q3 2024 [8] - Earnings per share for Q3 2025 totaled SEK -0.25, down from SEK -0.04 in Q3 2024 [8] - The total fair value of the portfolio at the end of September 2025 was SEK 1,346.7 million, a decrease of SEK 38.2 million from the previous quarter [8] - Net asset value at the end of September 2025 was SEK 1,085.4 million, or SEK 4.0 per share, down from SEK 1,224.4 million or SEK 4.5 per share at the end of September 2024 [8] - Net sales for Q3 2025 totaled SEK 0.3 million, compared to SEK 0.4 million in Q3 2024 [8] - Karolinska Development invested SEK 28.4 million in portfolio companies during Q3 2025, up from SEK 19.8 million in Q3 2024 [8] - Cash and cash equivalents decreased by SEK 26.6 million, totaling SEK 44.5 million on September 30, 2025 [8]

Core Viewpoint - PharmNovo has received approval from Spanish regulatory authorities to initiate a phase 2a clinical trial for its drug candidate PN6047, aimed at treating neuropathic pain, with plans to expand the study to other EU countries [1][2]. Company Overview - Karolinska Development AB holds a 20% ownership stake in PharmNovo, which is focused on developing innovative medical treatments [5]. - The company specializes in identifying and investing in breakthrough medical innovations in the Nordic region, aiming to create and grow companies that advance these innovations into commercial products [6][8]. Clinical Development - The phase 2a clinical trial will assess the safety and efficacy of PN6047 in patients with neuropathic pain, with patient enrollment expected to start by mid-2026, contingent on securing necessary funding [2]. - The current study is fully aligned with the requirements set by the U.S. FDA, following a successful pre-IND Type B meeting in January 2025 [3]. Drug Candidate Details - PN6047 is a selective delta-opioid receptor agonist (DORA) being developed as a new treatment for complex pain conditions, potentially addressing severe pain without the addiction issues associated with traditional opioids [4][5].

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]