Spago Nanomedical

JULY – SEPTEMBER IN BRIEF

• Net sales for the quarter amounted to KSEK 485 (KSEK 271)
• The loss for the quarter amounted to KSEK -8,763 (KSEK -7,755)
• Operating expenses for the quarter amounted to KSEK -10,650 (KSEK -8,795)
• Earnings per share, before and after dilution, for the quarter amounted to SEK -0.03 (SEK -0.09)

JANUARY – SEPTEMBER IN BRIEF

• Net sales for the year amounted to KSEK 1,294 (KSEK 472)
• The loss for the year amounted to KSEK –24,679 (KSEK -32,806)
• Operating expenses for the year amounted to KSEK -30,403 (KSEK -36,945)
• Earnings per share, before and after dilution, for the year amounted to SEK -0.09 (SEK -0.36)
• Cash and cash equivalents at the end of the quarter amounted to KSEK 39,946 (KSEK 25,974)

SIGNIFICANT EVENTS DURING THE QUARTER

• The independent Data Monitoring Committee (DMC) recommended to proceed the clinical phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201 according to plan. The recommendation is based on an analysis of data from the first three treated patients in the study that the DMC considers shows a satisfactory safety profile. The study proceeds according to plan with recruitment of patients at the two hospitals activated so far.

SIGNIFICANT EVENTS AFTER THE QUARTER

• The Board decided that all available resources will be focused on the development of Tumorad with the company's primary priority being the execution of the ongoing clinical study Tumorad-01. To ensure that crucial clinical milestones can be reached and to position the company well for the future, organizational changes have been made. As part of our strategic focus on the Tumorad program, any continued clinical development within SpagoPix will take place in collaboration with a partner, through out-licensing or commercial partnership, or be financed by grants.

CEO STATEMENT
The third quarter of 2024 has been an important period for Spago Nanomedical where we have taken crucial steps forward in the clinical development of our prioritized Tumorad program with the candidate drug 177Lu-SN201. The single most important event during the quarter was that the independent Data Monitoring Committee (DMC) gave us a positive recommendation to continue the phase I/IIa study Tumorad-01 according to plan. The Committee's decision was based on data from the first three treated patients who demonstrated a satisfactory safety profile in the study with no serious adverse events reported. This is an important step in the continued development of 177Lu-SN201 and strengthens our confidence in the candidate drug as a potentially promising treatment for cancer.

To ensure that crucial clinical milestones can be reached and enable faster progress, we have conducted a strategic review and decided that all available resources will be focused on the Tumorad program and the ongoing phase I/IIa study. As part of this positioning, we have decided that all internal preclinical discovery will be terminated. This gives us the financial space to generate results from the study's phase I part with existing funds and advancing the study towards phase IIa. We are convinced that this is the right way to better structure the company for current and future phases and to create long-term shareholder value.

Our goal is that the next cohort of patients in the Tumorad-01 study is ready for evaluation by DMC in the beginning of next year. The results from this patient cohort, which is expected to include patients with different tumor types, will provide us with additional valuable data on safety and biodistribution. The data is crucial for decisions on the phase IIa part of the study and determining which group or groups of patients we should proceed with to generate the first efficacy results. We continue to work intensively to meet all of the study's objectives and get closer to results that can support continued clinical development of 177Lu-SN201.

The interest in the radionuclide therapies continues to be high in the industry and several of the major global pharmaceutical companies are making significant investments in the field. We are also noticing the increasing interest and our candidate drug, 177Lu-SN201, has the potential to meet a major medical need in several cancer indications. As the clinical development progresses, we increase the pace of business development and have, among other things, met and had several fruitful discussions with potential partners at the partnering conferences Bio Japan and BIO Europe during the autumn. We are confident about the opportunities to strengthen our position in this growing field.

In parallel, active business development work continues to find potential partners for the SpagoPix development program. The product candidate pegfosimer manganese has shown in clinical studies that our technology platform for the selective accumulation of nanoparticles in solid tumors via the EPR effect works and thereby provides support for Tumorad as a treatment concept. As part of our strategic focus on the Tumorad program, any continued clinical development within SpagoPix will take place in collaboration with a partner, through out-licensing, commercial partnership, or be financed by grants. With favorable clinical data in both breast cancer and endometriosis, together with a growing interest in women's health in the industry, we are optimistic about the possibilities of moving the program forward in some form.

In summary, we have strengthened the foundation for our continued development during this quarter. By focusing our resources on Tumorad-01 but at the same time continuing to explore commercial opportunities for the SpagoPix program, we are working purposefully towards creating both medical and financial success. We are well equipped to take on the challenges ahead and look forward to continuing the development of our programs.

Mats Hansen, CEO Spago Nanomedical AB

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