Spago Nanomedical interim report January-March 2026

JANUARY – MARCH IN BRIEF

• Net sales for the quarter amounted to KSEK 22 (KSEK 338)
• The loss for the quarter amounted to KSEK -6,798 (KSEK -7,435)
• Operating expenses for the quarter amounted to KSEK -7,967 (KSEK -8,964)
• Earnings per share, before and after dilution, for the quarter amounted to SEK -0.01 (SEK -0. 02)
• Cash and cash equivalents at the end of the quarter amounted to KSEK 25,923 (KSEK 26,578)

SIGNIFICANT EVENTS DURING THE QUARTER

• Spago Nanomedical strengthened its management team by appointing Torsten Malmström as Director Chemistry, Manufacturing, and Controls (CMC) & Supply. With more than 20 years of experience from senior positions in pharmaceutical development, he brings strategic and operational expertise as the company prepares for the next step in the clinical development of the Tumorad program with the drug candidate ¹⁷⁷Lu-SN201.
• The independent Data Monitoring Committee (DMC) recommended that the ongoing clinical phase I/IIa trial Tumorad-01 with the drug candidate ¹⁷⁷Lu-SN201 should continue with parallel recruitment of two additional patients at the current dose level. The recommendation indicated a continued acceptable safety profile based on analysis of data from all patients enrolled at the time, across four dose levels and representing a broad spectrum of solid tumors.
• An abstract describing the ongoing clinical phase I/IIa trial Tumorad-01 with ¹⁷⁷Lu-SN201 was accepted for presentation at the 56th Annual Scientific Meeting of the Australian and New Zealand Society of Nuclear Medicine (ANZSNM), to be held in Canberra on May 15–17, 2026.

SIGNIFICANT EVENTS AFTER THE QUARTER

• The DMC of the Tumorad-01 study declared that a primary endpoint, identifying the maximum tolerated dose, has been met and recommends that an additional two patients are enrolled at the dose level of 15 MBq/kg to provide a basis for defining a recommended phase II dose and completing the phase I part of the study. Significant visible tumor uptake of ¹⁷⁷Lu-SN201 has been observed in an additional patient with head and neck cancer, strengthening proof-of-concept for the Tumorad program.

CEO STATEMENT

The start of 2026 has been one of the most significant periods in Spago Nanomedical’s clinical history. The phase I part of the Tumorad-01 study is progressing towards completion, we have obtained further evidence of tumor uptake of ¹⁷⁷Lu-SN201, and the radiopharma field continues to develop in a direction that strengthens Spago’s position in identifying the right partner for continued clinical development toward product approval.

The clearest message during the quarter came from the independent Data Monitoring Committee (DMC). Following a review of safety data, the DMC recommended in mid-March that the study should continue with parallel recruitment at the current dose level, an important recommendation based on a continued acceptable safety profile. Shortly thereafter, in early May, the DMC declared that a primary endpoint, identifying the maximum tolerated dose, has been met and recommended that an additional two patients are enrolled at the dose level of 15 MBq/kg to provide a basis for defining a recommended phase II dose and completing the phase I part of the study. Defining a recommended phase II dose represents another primary endpoint of the phase I part of the study and a decisive step ahead of the start of the upcoming phase II, while also constituting an important milestone in dialogues with regulatory authorities and potential licensing and development partners.

Equally encouraging is that visible tumor uptake of ¹⁷⁷Lu-SN201 has been observed in an additional patient, and with clearly visible uptake also in tumor-affected lymph nodes. This patient presented with tumors the same head and neck area where we previously observed strong uptake in a patient with adenoid cystic carcinoma (ACC). With this, a reproducible picture is potentially emerging, and strengthening proof-of-concept for Tumorad in humans. This provides further support for the program’s mechanism of action and, together with the observed acceptable preliminary safety file so far, a strong starting position as we plan for phase II, including preparations for regulatory interactions and the definition of development plans within both orphan drug and broader indications.

In parallel, we have strengthened the organization for the next stage of development. In March, Torsten Malmström joined as Director CMC & Supply and member of the management team. His extensive experience from senior roles at, among others, Camurus, Zealand Pharma, PolyPeptide and AstraZeneca will be central as we now scale up manufacturing and supply chains ahead of phase IIa and future commercialization.

During the quarter, our abstract was also accepted for oral presentation at a prominent scientific conference arranged by the Australian and New Zealand Society of Nuclear Medicine (ANZSNM) in Canberra on May 15–17, reflecting the growing scientific interest in Tumorad within the nuclear medicine community.

We are also closely monitoring developments in the field. The strategic alliance between Regeneron and Telix, announced after the end of the quarter, with USD 40 million upfront and up to USD 2.1 billion in development and commercial milestones in addition to royalties, confirms that leading global pharmaceutical companies are actively seeking next-generation radiopharmaceuticals and are willing to pay significant amounts to access the right platforms and programs. The transaction follows on a steadily growing number of radiopharma-deals, topped by the USD 4.1 billion acquisition of RayzeBio by Bristol Myers Squibb in phase 1. Transactions of this kind strengthen the conditions for our ongoing business development activities and place Tumorad in a field that is increasingly well financed and where interest from potential partners continues to grow.

Financially, we have a cash position sufficient to fund the planned activities, while securing financing for phase IIa remains a clear priority. We continuously evaluate different alternatives, including strategic partnerships and complementary financing solutions, to combine continued clinical development with responsible capital management.

Overall, the quarter has provided us with the most concrete basis to date for the next clinical phase – from a clinical, regulatory and organizational perspective. I would like to express my sincere gratitude to our shareholders, clinical partners and colleagues for their continued trust and commitment. With a recommended phase II dose within reach, reproducible observations of tumor uptake and a radiopharma field in strong development, I look forward to a continued eventful 2026.

Mats Hansen, CEO Spago Nanomedical AB

The interim report is available at the Company’s website; https://spagonanomedical.se/investor-relations/#financial-reports