Press release from Companies

Published: 2025-09-19 08:44:44

Aptahem AB: Aptahem Outlines Ongoing Preparations for Planned U.S. Listing and Announces Webinar Invitation

Aptahem AB (publ) ("Aptahem" or the "Company"), a clinical-stage biotech company listed on the Spotlight Stock Market that develops RNA-based treatments for acute thrombo-inflammatory conditions, today provides an update on the Company’s preparations for a planned U.S. listing and announces an upcoming webinar on Monday, September 22, to which all interested parties are invited (see details below).

The initiative to pursue a U.S. listing is part of the strategic direction announced on August 26, aimed at achieving a market valuation that more accurately reflects the Company’s scientific progress, securing the best possible access to financing for the Company’s planned Phase 2 trial, and ultimately creating the optimal conditions for successful commercialization of the Company’s drug candidate portfolio.

As part of this process, Aptahem is currently taking key steps to meet the requirements for attracting U.S. institutional investors and achieving a listing on a U.S. stock exchange:

  • Transition to IFRS accounting standards: The Company has initiated the process of realigning its financial reporting to IFRS (International Financial Reporting Standards), an essential step and a clear requirement from investors within the U.S. institutional investor community with which Aptahem has already established contact regarding their potential role as cornerstone investors backing the planned U.S. listing of Aptahem.
  • Preparation for U.S. auditor engagement: Upon completion of the IFRS transition, the Company will undergo review by a U.S.-qualified auditor. Aptahem is preparing the process for issuing a call and appointing an auditor who can provide U.S. investors with the necessary formal due diligence opportunities and ensure compliance with U.S. capital market requirements.
  • Legal and structural preparations: The Company is working closely with a U.S. capital markets legal advisor to evaluate and address the wide range of legal and regulatory requirements associated with a U.S. listing, ensuring the process is structured in a way that best supports both current shareholders and future institutional investors.

These financial, legal, and governance preparations follow several recent key initiatives by Aptahem, designed to strengthen its position and attractiveness to U.S. investors:

  • FDA PreCheck Program (August 13, 2025): The Company announced its application to the FDA’s PreCheck Program, which aims to streamline and accelerate inspections of pharmaceutical manufacturing. Participation would potentially enhance U.S. investors’ confidence in Aptahem’s development and production chain and represent a highly relevant milestone for the Company and its future U.S. investors.
  • U.S. intellectual property advancement (August 20, 2025): The Company filed a provisional U.S. patent application covering new indication areas for Apta-1, broadening its IP portfolio and expected to further increase interest among U.S. investors once Aptahem is U.S.-listed.
  • U.S. accelerated regulatory review initiatives (August 27, 2025): The Company submitted an application to the FDA’s CNPV Pilot Program (Commissioner’s National Priority Voucher), which, if granted, could significantly shorten FDA regulatory review timelines from normally around 10–12 months to around 1–2 months. Approval to participate would represent a major milestone for both the Company and prospective U.S. investors.

Together, these initiatives are expected to create a robust, U.S.-adapted platform that supports both clinical development and long-term commercial success.

CEO Mikael Lindstam comments:

"Securing a successful U.S. listing will be a transformative step for Aptahem. We are at a stage in the Company’s development where a change of market is both relevant and necessary, as we need to be able to attract investments from professional international life science investors on a scale that is not possible with our current listing on Spotlight. Over the past year, I have focused on building the relationships required to enable a U.S. listing, which we believe will provide the best environment for advancing our future clinical trials and ultimately creating commercial success based on our unique drug candidate portfolio. I am therefore very pleased that we are now moving swiftly from the planning phase into execution, and I look forward to keeping the market updated as we progress."

Webinar details:

Register for the event here: https://www.bigmarker.com/ir-live/Aptahem-webbinarium-om-strategiska-riktning-och-USA-notering

Time: Monday, September 22, 19.00-20.00 CEST

Language: Swedish

During the webinar, CEO Mikael Lindstam will provide insights into the Company’s recent advancements throughout August and September, as well as the ongoing preparations to make the Company ready for a U.S. listing.

Expected takeaways from the presentation:

  • A clearer understanding of the potential benefits of the FDA PreCheck Program for Aptahem.
  • Insights into the rationale behind the Company’s application to the FDA’s CNPV Pilot Program.
  • An update on the Company’s U.S. intellectual property strategy and how the new provisional patent strengthens Aptahem’s position.
  • An overview of the strategic reasons for pursuing a U.S. listing versus remaining listed in Sweden, and what concrete steps the Company is currently taking toward this listing.

The webinar will be moderated, and participants will have the opportunity to ask questions to the Company.

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.

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