JANUARY – MARCH IN BRIEF

• Net sales for the quarter amounted to KSEK 350 (KSEK 88)
• The loss for the quarter amounted to KSEK –7.763 (KSEK -15.573)
• Operating expenses for the quarter amounted to KSEK -9.497 (KSEK -17.168)
• Earnings per share, before and after dilution, for the quarter amounted to SEK -0.03 (SEK -0.17)
• Cash and cash equivalents at the end of the quarter amounted to KSEK 32,250 (KSEK 45,106)

SIGNIFICANT EVENTS DURING THE QUARTER

• Nothing to report

SIGNIFICANT EVENTS AFTER THE QUARTER

• Spago Nanomedical strengthens management by the appointment of Birgitta Rembratt Svensson as Head of CMC & Supply. Birgitta, an experienced CMC project manager with several leading positions at development and commercial stage pharmaceutical companies, will join Spago Nanomedical on June 1 and serve as a member of the management team.
• 177Lu-SN201 demonstrates significant anti-tumor effect in a non-clinical triple-negative breast cancer model compared to several cancer drugs with a low and acceptable level of radiotoxicity observed.

CEO STATEMENT
2024 has begun in the same positive spirit as we ended last year. The phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201 is progressing according to plan with a continued satisfactory safety profile. New and promising non-clinical effect data in a triple-negative breast cancer model further strengthens our belief in Tumorad in the treatment of several different types of cancer. As we take Tumorad further into the clinic, we have also strengthened the management team with an experienced Head of CMC & Supply.

Our ongoing phase I/IIa clinical study Tumorad-01 is a first-in-human study with the primary aim of evaluating safety, tolerability, dosimetry and initial effect of 177Lu-SN201 in cancer patients with the aim of identifying a possible therapeutic dose for further studies. In January, we announced that the first patient was successfully treated with the initial dose and the study has since continued as planned.

The phase I part of the study aims to, based on safety and biodistribution, identify a possible therapeutic dose for further testing in selected patient groups in the phase IIa part. Based on preclinical results, we assess that there is a good chance of a favorable benefit-risk profile in humans. Using different methods to measure radioactivity in the body, even at low doses, we expect to be able to get an early idea of the possibilities for therapeutic usefulness in cancer patients. Patient recruitment continues and our ambition is to further update the market regarding the study before mid-year.

In parallel with the clinical study, an extensive non-clinical program is also underway to explore Tumorad as both a monotherapy and combination therapy in triple-negative breast cancer, a very aggressive and difficult-to-treat form of cancer in which the tumor cells often have resistance to chemotherapy even before the chemotherapy treatment has begun and which makes up approximately 15 percent of all breast cancer cases. It was therefore very gratifying that in April, after the end of the period, we were able to report favorable data from the initial non-clinical study with 177Lu-SN201 as monotherapy showing superior tumor inhibitory effect compared to drugs used in standard treatment with only a low and acceptable level of radiotoxicity being observed. The findings we have seen in this model are very promising and support continued non-clinical development, with evaluation of combination therapy as the next step.

The interest in the radiopharma area continues to be high among pharmaceutical companies and specialist investors with several completed transactions of significant size. In March, AstraZeneca strengthened its radiopharma portfolio with the acquisition of the US based Fusion Pharmaceuticals, a transaction worth up to $2.4 billion. Another current example is Bristol Myers Squibb which, at the end of last year, acquired RayzeBio and its radiopharma platform for around USD 4.1 billion.

We also see continued interest in our second development program, SpagoPix, and especially in endometriosis where at the end of last year we reported positive topline data from the phase IIa clinical study SPAGOPIX-02 with the contrast agent pegfosimer manganese. The study was an open-label proof-of-concept study with the primary objective of evaluating contrast enhancement in patients with endometriosis. Analysis of study data showed that contrast enhancement could be observed in the majority of lesions confirmed by ultrasound, and thus the primary efficacy objective had been met. The results show the potential of pegfosim manganese in medical imaging of endometriosis lesions and enable further evaluation in the next step.

The increasing interest in women’s health in general, and endometriosis specifically, was clearly evident during the annual J.P. The Morgan Health Care conference in January that we attended in order to create new contacts. We participated in several productive meetings with possible future partners.

Given the progress within both of our development programs, we have seen a need to strengthen the company’s organization and I am very pleased with the recruitment of Birgitta Rembratt Svensson as the new Head of CMC & Supply. Birgitta is an experienced CMC project manager with senior positions at pharmaceutical companies in the commercial phase, and will join Spago Nanomedical’s management team in June. Procurement, planning and execution of production and distribution will become increasingly important to supply our clinical studies with drugs and, in the longer term, prepare for commercial scale. The recruitment to this key position is thus an important part in building a strong team with a focus on later development phases and commercialization.

2024 will be a very important year for Spago Nanomedical with the greatest focus on the clinical study with our leading program Tumorad. I look forward to continuing to update you on our progress and upcoming milestones .

Mats Hansen, CEO Spago Nanomedical AB

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