Net sales for the quarter amounted to KSEK 617 (KSEK 731)
The loss for the quarter amounted to KSEK -7,830 (KSEK -9,417)
Operating expenses for the quarter amounted to KSEK -10,223 (KSEK -12,060)
Earnings per share, before and after dilution, for the quarter amounted to SEK -0.02 (SEK -0.08)
JANUARY - DECEMBER IN BRIEF
Net sales for the year amounted to KSEK 1,911 (KSEK 1,203)
The loss for the year amounted to KSEK -32,509 (KSEK -42,223)
Operating expenses for the year amounted to KSEK -40,626 (KSEK -49,005)
Earnings per share, before and after dilution, for the year amounted to SEK -0.11 (SEK -0.43)
Cash and cash equivalents at the end of the year amounted to KSEK 32,470 (KSEK 45,217)
SIGNIFICANT EVENTS DURING 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 milestones can be reached and to position the company well for the future, with focus on clinical development, 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 by means of other external financing.
All patients in the second patient group have been dosed according to plan in the company's Phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201. The study's independent Data Monitoring Committee (DMC) is expected to be able to present its analysis of the patient group during the first quarter. A total of six patients have so far been included and dosed in the study.
SIGNIFICANT EVENTS AFTER THE QUARTER
A manuscript on product candidate pegfosimer manganese has been accepted for publication in the highly regarded peer reviewed scientific journal Investigative Radiology. The publication provides further scientific support for the SpagoPix development program.
CEO STATEMENT
The fourth quarter of 2024 has been another important period for Spago Nanomedical where we continued to make substantial progress in the clinical development of our Tumorad program with the candidate drug 177Lu-SN201. A significant milestone during the quarter was that all patients in the second patient group were successfully dosed in the phase I/IIa study Tumorad-01. The three patients in the group, two men with lung and rectal cancer and one woman with throat cancer, respectively, have all been treated with at least one dose/cycle of 177Lu-SN201. In total, we now have patients with five different cancers included in the study, creating the conditions for early evaluation of the candidate drug in various tumor types.
We look forward to the independent DMC's analysis of the second patient group during the first quarter of 2025. To avoid losing valuable time while awaiting the DMC's analysis and recommendation, the recruitment of additional patients continues in parallel. To further increase the momentum of the study, we have applied for, and received, ethical approval to include patients also on a lower dose of 177Lu-SN201. This allows multiple patients to be recruited concurrently at multiple clinics and to multiple dose groups.
At the beginning of the quarter, we announced that a strategic review had been carried out of Spago Nanomedical's entire business. It was decided that all available resources would be focused on the Tumorad program and the ongoing phase I/IIa study, and that all internal preclinical discovery activities would be terminated. Intensive work has been underway to implement the new strategy, and several operational and organizational changes have already been implemented. The measures have included staff reductions, which is of course unfortunate, but it is a natural consequence of the company now entering a new phase where we choose to focus our resources on areas where we see the greatest potential in the near term.
In addition to the focus on Tumorad, we continue to seek partners to advance the SpagoPix development program to the next phase. In early 2025, we announced that our article with clinical results from SPAGOPIX-01 has been accepted for publication in the reputable, peer-reviewed scientific journal Investigative Radiology. We see this as a strong validation of our development work within the SpagoPix program that further supports our ongoing business development work.
We are convinced that focusing our resources on Tumorad is the right way to better structure the company for current and future phases. By terminating all internal preclinical discovery activities, we have freed up financial resources, which has enabled us to accelerate our clinical development efforts. We are committed to reaching crucial clinical milestones and getting closer to results that can support continued clinical development of 177Lu-SN201.
In summary, we have strengthened the foundation for Spago Nanomedical's continued development during this quarter combined with seeing good progression of Tumorad. We are well equipped to take on the challenges ahead and look forward to an intense and successful 2025.
For further information, please contact Mats Hansen, CEO Spago Nanomedical AB, +46 46 811 88, mats.hansen@spagonanomedical.se
Spago Nanomedical AB is a Swedish company in clinical development phase. The company´s development projects are based on a platform of polymeric materials with unique properties for more precise treatment and diagnosis of cancer and other debilitating diseases. Spago Nanomedical´s share is listed on Nasdaq First North Growth Market (ticker: SPAGO). For further information, see www.spagonanomedical.se.
FNCA Sweden AB is the Certified Adviser of the company.
