NanoGroup is strategically expanding its portfolio to include the Value Added Medications (VAM, value-added drugs) segment, by financing a PLN 7.5 million new share issue of Auxilius Pharma S.A. in an investment round worth a total of PLN 15 million. The investment is part of NanoGroup’s long-term plan to build a strong, integrated biotechnology group.

Funding Objective

The funds will enable Auxilius, a Polish pioneer in the area of VAM drugs, to conduct a Phase 1b clinical trial of an improved drug for chronic angina (AUX-001).

Strategy

Auxilius specializes in VAM drugs, utilizing proven active substances in modern formulations that enhance treatment effectiveness and patient comfort. This includes a proprietary drug release modification technology, which reduces dosing frequency and improves therapeutic efficiency in chronic diseases.

US market

The main objective is to secure a partnering agreement and introduce the AUX-001 drug to the strategic US market. The company maintains continuous cooperation with the FDA and plans to submit a New Drug Application (NDA) in the US in 2028, with the drug expected to launch commercially in 2029.

Regulatory Pathway

Auxilius is leveraging the simplified FDA 505(b)(2) regulatory pathway, which significantly shortens project development time, reduces costs, and mitigates risk. Thanks to agreements with the FDA, it is possible to bypass Phase 2 and substantially simplify Phase 3 in the development of AUX-001.

Vision and Synergies

Przemysław Mazurek, CEO of NanoGroup, emphasizes that Auxilius Pharma is an exceptional partner with significant growth potential. Participation in this funding round is another step towards building a group focused on achieving regular and repeatable revenues, not only through capital investment but also by sharing in the future revenues of its partners.

Jedrzej Litwiniuk, CEO of Auxilius Pharma, points out that the funds raised are a watershed moment, opening the next stage of the company’s development. After the successful completion of the next clinical phase in 2026, the AUX-001 project will gain traction for future partners. It is possible to conclude a partnership agreement with a global player as early as early 2027.

Additional information

Investors: PLN 7.5 million comes from the ffVC ASI II fund, which is making the transaction on behalf of NanoGroup S.A. The remaining PLN 7.5 million is being contributed by NCBR Investment Fund ASI S.A. as part of a co-investment. The total investment will amount to PLN 15.0 million and will include 23.08% of Auxilius Pharma shares.

Other NanoGroup projects: among others, NanoGroup is developing the NanOX system for normothermic organ perfusion, which has the potential to fundamentally change transplantation. The company also acquired the aptamer platform and DOTO Medical from Pure Biologics in 2025.