Aptahem AB

Aptahem AB (publ), a biotech company developing RNA-based treatments for acute thrombo-inflammatory conditions, announces that the company has submitted an application for participation in the U.S. Food and Drug Administration’s (FDA) Commissioner’s National Priority Voucher (CNPV) Pilot Program – “Accelerated Drug Review for Companies Supporting U.S. National Interests.” The application is made as a next step after Aptahem’s previous application to FDA PreCheck on August 13, 2025. It complements the company’s application to FDA PreCheck and strengthens the U.S.-focused regulatory strategy. About the CNPV Program CNPV is a new pilot program where the FDA, for a limited number of companies, can award a “voucher” that provides significantly shortened regulatory review processing times – from normally around 10–12 months to around 1–2 months – while maintaining applicable safety and efficacy requirements. The selection is directed at development programs that are in line with US national health priorities (e.g., high unmet medical needs, innovation level, crisis management, onshoring, and supply chain robustness). In the first round of the pilot year, a maximum of five participants are intended to be selected. To qualify, it is required, among other things, that the manufacturing part and proposed labeling are submitted at least 60 days before the final application and that the company can maintain a close dialogue with the FDA’s cross-functional review team. Read more at: U.S. Food and Drug Administration. Strategic importance for Aptahem A decision to participate in CNPV could – when the time is right for future regulatory filings – provide Aptahem with a more predictable and time-efficient path through the review process. Together with the previous PreCheck application, which aims to provide faster and more predictable inspections of pharmaceutical manufacturing in the US, this strengthens Aptahem’s long-term goal of building a high-quality, US-adapted development and production chain. CEO Mikael Lindstam comments: ”The CNPV application is a natural next step in our US-focused regulatory plan. If selected, the program could, at the right stage, contribute to significantly more efficient processing – without compromising quality and safety requirements.” Next steps FDA is processing CNPV applications on an ongoing basis and contacting selected companies for further dialogue. Aptahem will return when there is new information to communicate. For further information: Aptahem AB Mikael Lindstam, CEO Tel: +46 (0)766-33 36 99 E-mail: ml@aptahem.com About Aptahem Aptahem AB (APTA) is a clinical stage biotechnology company that develops RNA-based pharmaceuticals for the treatment of acute, life-threatening conditions in which a combination of coagulation, inflammation and tissue damage are involved. The company’s lead candidate, Apta-1, is currently in early clinical phase. Apta-1 has in preclinical studies, by its anti-thrombotic, immunomodulating and tissue repairing characteristics, shown very positive and promising results as treatment for sepsis and critical conditions associated with sepsis. For more information, please visit www.aptahem.com. Press release

Aptahem AB (publ) (“Aptahem” or the “Company”), currently listed on Spotlight Stock Market, today announces that the Company has initiated a strategic process to pursue a listing of the Company’s shares on a U.S. stock exchange, such as Nasdaq in the United States. The purpose of this strategic initiative is to create improved conditions for financing the Company’s planned Phase 2 clinical trial with its drug candidate Apta-1 – a program with significant potential that requires substantial capital resources. In ongoing discussions with investors and partners, the Company has identified that its current marketplace and valuation do not adequately reflect its scientific progress or long-term potential. A capital raise of the scale required to conduct the planned full-scale patient study is not considered feasible under current conditions. Strategic rationale for a U.S. listing The Board of Directors of the Company, following a thorough evaluation of the Company’s strategic alternatives, has identified several reasons why a listing of the Company’s shares on a U.S. stock exchange could be beneficial for both the Company and its shareholders: Access to capital: The U.S. capital market provides greater access to venture capital, particularly for innovative life science companies. Valuation potential: A U.S. listing may enable a market valuation that, in the Board’s view, more accurately reflects the Company’s scientific progress and commercial potential. Life Science Hub: The U.S. is an attractive and leading hub for global life science investments, with strong institutional and strategic investor interest. Institutional investors and partners: A U.S. listing opens up new opportunities for international institutional investors, as well as new potential investor partners. Therapeutic alignment: Interest in innovative anti-inflammatory drugs such as Apta-1 is particularly high in the U.S. clinical and regulatory environment. Shareholder interest: A U.S. listing would be designed to strengthen the Company’s financing capabilities, support pipeline advancement, and thereby serve the long-term interests of all shareholders. Next steps The Company is currently assessing various options for a U.S. listing in order to determine the structure most beneficial for all shareholders. Aptahem has initiated tentative dialogues with advisors, U.S. investors and potential partners to assess how a U.S. listing could be structured in the most beneficial way. Together with its appointed advisor, the Company is currently reviewing the regulatory, legal, and financial implications of different alternatives. Further updates will be communicated as the process develops. CEO Mikael Lindstam comments: ” Our team has taken Apta-1 through extensive preclinical development and FIM studies with very promising results. We are now ready to take the step towards clinical validation in patients. To make this possible, we need capital that we see can only realistically attract through a broader, international investor base – something that a U.S. listing can make possible. We are humbled by the process, but also determined that this may be the right path for the company and the technology.” For further information: Aptahem AB Mikael Lindstam, CEO Tel: +46 (0)766-33 36 99 E-mail: ml@aptahem.com This contains such information that Aptahem AB is obliged to make public according to the EU Market Abuse Regulation. The information was provided through the agency of the above contact person for publication on 26 August 2025. About Aptahem Aptahem AB (APTA) is a clinical stage biotechnology company that develops RNA-based pharmaceuticals for the treatment of acute, life-threatening conditions in which a combination of coagulation, inflammation and tissue damage are involved. The company’s lead candidate, Apta-1, is currently in early clinical phase. Apta-1 has in preclinical studies, by its anti-thrombotic, immunomodulating and tissue repairing characteristics, shown very positive and promising results as treatment for sepsis and critical conditions associated with sepsis. For more information, please visit www.aptahem.com. Press release

Aptahem AB (publ), a biotech company developing treatments for patients suffering from acute inflammatory diseases, today announces that the company has received patent pending status through a provisional patent application in the USA. The application aims to protect the company’s lead RNA aptamer Apta-1 in new indication areas, based on detailed evaluation of data generated from previous studies with Apta-1. These groundbreaking new insights are based on the detailed evaluation of data generated from Apta-1 by the Company’s Co-Founder and CSO Dr. Luiza Jedlina. Dr. Jedlina has identified entirely new indications for the Company’s lead RNA aptamer, Apta-1. These discoveries are now protected by a provisional patent application in the United States, further strengthening Apta-1’s position as a first-in-class, innovative therapy option. Some of the identified indications include: Neurodegenerative diseases: Apta-1 blocks interactions of Amyloid-β and tau, with the potential to slow progression in Alzheimer’s, Parkinson’s, frontotemporal dementia, and Huntington’s disease. Viral infections: Effective against HSV, CMV, Dengue, Zika, SARS-CoV-2, MERS, HIV, and HPV by preventing viral cell entry. Cancer and metastasis: Inhibits growth factors, slowing angiogenesis and tumor cell spread in aggressive cancers such as breast cancer, melanoma, and glioblastoma. Fibrotic diseases and infectious conditions: Interesting indications for idiopathic pulmonary fibrosis, liver and kidney fibrosis, as well as in certain infectious diseases Dr. Jedlina’s evaluation of the study results shows that Apta-1 has the potential to stop disease-driving mechanisms at multiple levels – from protein aggregation and pathogen entry to tissue damage and fibrosis – making Apta-1 a potential game-changer in these indication areas. CEO Mikael Lindstam comments: ”Apta-1 opens an entirely new frontier in tackling diseases where there are currently no effective therapies. With Dr. Jedlina’s discoveries, we are at the cusp of something truly transformative, and it is an exciting moment to be part of Aptahem’s journey.” Aptahem is actively engaging with potential partners across these indication areas to fully realize the therapeutic potential of Apta-1. For further information: Aptahem AB Mikael Lindstam, CEO Tel: +46 (0)766-33 36 99 E-mail: ml@aptahem.com This contains such information that Aptahem AB is obliged to make public according to the EU Market Abuse Regulation. The information was provided through the agency of the above contact person for publication on 20 August 2025. About Aptahem Aptahem AB (APTA) is a clinical stage biotechnology company that develops RNA-based pharmaceuticals for the treatment of acute, life-threatening conditions in which a combination of coagulation, inflammation and tissue damage are involved. The company’s lead candidate, Apta-1, is currently in early clinical phase. Apta-1 has in preclinical studies, by its anti-thrombotic, immunomodulating and tissue repairing characteristics, shown very positive and promising results as treatment for sepsis and critical conditions associated with sepsis. For more information, please visit www.aptahem.com. Press release