“During the second quarter 2025, Kancera has made several important steps forward in the clinical development of our fractalkine program, during which we have:

• received positive feedback from the FDA on the planned clinical development program for KAND567 in acute myocardial infarction,
• reported positive top-line results in the KANDOVA study with KAND567 in ovarian cancer, and
• announced the International Non-proprietary Names for our candidate drugs KAND567 and KAND145.

In May, the annual general meeting also made the decision to change the company name to Novakand Pharma, planned to be implemented during September. However, the highest priority during the period has been to, within the framework of the letter of intent entered into in March, together with Recardio Inc. identify and meet potential investors with the objective to secure financing of a joint business plan that would advance both companies’ clinical programs to the next development phase. The very challenging capital markets environment has however made external financing not possible and after the reporting period the decision was made to terminate the letter of intent.

In the beginning of June, we reported that we had conducted a successful pre-IND meeting with the US FDA and received positive feedback on our planned clinical development program for KAND567 in acute myocardial infarction. FDA stated that our planned clinical development plan, which e.g. includes the planned phase IIb study FRACTIVE, can support a future market approval and Fast Track Designation. The positive feedback from the FDA is a quality stamp on our clinical development work.

We have also, earlier than forecasted, reported positive top-line results from the KANDOVA study, a phase Ib/IIa study of KAND567 in combination with standard of care carboplatin therapy in ovarian cancer, in patients with relapse from carboplatin therapy. The study met its primary objective – to define the recommended dose and evaluate safety and tolerability – without clinically significant side effects. We also assess that the secondary objective was met – to show signals of anti-tumor effect when administering KAND567 in combination with carboplatin.

In addition to once more having demonstrated that administration of KAND567 in patients is safe and tolerable, we find it promising that the secondary and exploratory endpoints indicate that KAND567 may have an additive effect to standard of care in patients having high levels of CX3CR1 (the fractalkine receptor) in their cancer cells. If this signal can be re-confirmed in a larger and placebo controlled clinical trial, there is a potential for KAND567 to improve outcomes in a very hard-to-treat patient population. We now have extensive PK, safety and biomarker associations data, that are very valuable for upcoming regulatory interactions and clinical study design.

In June we also announced the International Non-proprietary Names (INN) rugocrixan and fosrugocrixan that our candidate drugs KAND567 and KAND145 have been granted by the WHO. The INNs granted are the first made by the WHO for small molecule CX3CR1 antagonists, which demonstrates that we are a leading pioneer in this new class of drugs.

In March, 2025, Kancera announced that the company had signed a letter of intent with the private US biotech company, Recardio Inc. with the objective of combining both companies’ assets and resources through a transaction in which Recardio would in-license Kancera’s candidate drugs KAND567 and KAND145. The collaboration aimed at forming a cardiovascular-focused specialty care company and jointly seek external capital to finance the joint business plan, including a phase IIb study with Kancera’s rugocrixan and a phase III study with Recardio’s, both in acute myocardial infarction (STEMI).

The transaction with Recardio was already from the beginning subject to securing new external financing, which was the reason for why we decided to enter into a letter of intent and not a complete license agreement. The challenging capital markets environment has however caused us to believe that it will not be possible to raise the targeted amount of capital near-term, in order to close the transaction. Based on this, and despite that we continue to see a strong business rationale for the transaction, we decided to terminate the letter of intent with Recardio, in order to be able to explore other options. These options, which we now are able to fully explore without being restricted by the letter of intent, include other licensing and business development opportunities.

We are convinced that our program can make a difference for many patients in a number of disease conditions and we are now conducting a comprehensive review of the strategy and business plan, including considering structural transactions. In this review we are considering both the data we have generated in our pre-clinical and clinical studies and the global business development trends we see – with specific attention to in which areas licensing deals are being made.”

Solna, August 28, 2025