Comments from the CEO

During the second quarter of 2025, we continued to take important steps forward in the clinical development of our candidate drug 177Lu-SN201 in the Tumorad program. The ongoing Phase I/IIa study, Tumorad-01, is proceeding according to plan. In early June, the independent Data Monitoring Committee's (DMC) recommended to proceed according to the current study protocol with the recruitment of additional patients at the highest dose tested to date. This is a clear confirmation of the value of the consistent and acceptable safety profile we have seen so far. It allows us to confidently continue the study toward the primary goal of defining a clinically relevant dose in order to investigate the effect in one or more selected cancer types in the next phase.

According to DMC's report in June, which is based on an analysis of the 10 patients dosed to date, no dose-limiting toxicities have been reported. The generally mild side effects observed were related to the effect on blood platelets (thrombocytes), an expected effect of treatment with radioactive substances, being both asymptomatic and transient. The pace of patient recruitment has increased steadily during the study, and during the summer, two additional patients were dosed at both our clinics in Australia, Cancer Research SA in Adelaide and St Vincent's Hospital in Melbourne. The study now includes 12 patients with 10 different tumor types, three of whom are at the current highest dose level. We are now looking forward to the next DMC evaluation in early Q4.

The safety profile is crucial in the development of new cancer drugs as it practically determines whether a drug can be approved and used at all – even if it shows promising effects. An unsatisfactory safety profile is one of the most common reasons why promising drugs never reach the market. The relatively good safety profile observed to date across all three dose levels (5, 10, and 15 MBq/kg) evaluated in a diverse range of tumor types is very promising. In a preliminary comparison with other Lu177-based drugs, either launched or in development, our candidate drug in Tumorad, 177Lu-SN201, shows similar impact on thrombocytes. However, 177Lu-SN201 has not shown any effect on other critical organs, such as the kidneys, which some other Lu177-based drugs do.

Tumorad's design and mechanism of action offer the opportunity to address multiple tumor types compared to current radionuclide therapies (RNT), which primarily target prostate cancer and neuroendocrine tumors. In dialogues with investors, it becomes clear that they value Tumorad's potential to expand the RNT field and the ability to target other and multiple tumor types. If we maintain the good safety profile observed to date, this will provide a significant advantage for Tumorad and constitute a clearly differentiating factor compared to other RNT drugs, both launched and under development, which often have complex side effect profiles.

The market for RNT-based cancer treatment is significant and is estimated by several analysts to amount to 10 billion USD per year, with limited competition, due to complex barriers for new entry the field. There is a strong interest in the industry for the RNT field and M&A activity has been extensive with multiple completed licensing deals in recent years.
The observed and confirmed good safety profile, to date,means that the Tumorad program has taken an important clinical step forward. This, along with Tumorad's unique mechanism of action, enabling an expansion of the number of indications, and the increasing interest in RNT-based cancer treatments from major players, mean that we have already built substantial value in the program in Phase I.

With the data from the Tumorad study, we are building a solid documentation that is crucial for future clinical phases, where the focus will gradually shift more toward efficacy. In addition to the primary objective of evaluating safety, a key goal in the Phase I part of the study is to identify a possible maximum therapeutic dose for further testing in selected patient groups in the Phase IIa part, also known as the “maximum tolerated dose” (MTD). This is something that is highlighted in our ongoing dialogues with potential partners and specialist investors to facilitate upcoming clinical steps with Tumorad and secure the company’s financial position in the long term.

We are also continuing to evaluate strategic alternatives to unlock the full potential of our second development program, SpagoPix, whose clinical results were published this spring in the leading scientific journal Investigative Radiology and further presented at the recent 16th World Endometriosis Congress in Sydney, Australia.

In summary, the second quarter has confirmed that our clinical strategy is delivering results. What we have seen so far in the Phase I part of the Tumorad study strengthens our confidence in the clinical profile and belief in 177Lu-SN201 as an effective future cancer treatment. We look forward to continuing to build value in the second half of the year by reaching the next milestones in Tumorad-01.

Mats Hansen, CEO Spago Nanomedical AB