LUND, SE / ACCESS Newswire / October 29, 2025 / Spago Nanomedical (STO:SPAGO.ST)(FRA:7UX.F)
JULY - SEPTEMBER IN BRIEF
Net sales for the quarter amounted to KSEK 14 (KSEK 485)
The loss for the quarter amounted to KSEK -6,265 (KSEK -8,763)
Operating expenses for the quarter amounted to KSEK -7,568 (KSEK -10,650)
Earnings per share, before and after dilution, for the quarter amounted to SEK -0.02 (SEK -0.03)
Cash and cash equivalents at the end of the quarter amounted to KSEK 11,257 (KSEK 39,946)
JANUARY - SEPTEMBER IN BRIEF
Net sales for the year amounted to KSEK 433 (KSEK 1,294)
The loss for the year amounted to KSEK -20,664 (KSEK -24,679)
Operating expenses for the year amounted to KSEK -24,823 (KSEK -30,403)
Earnings per share, before and after dilution, for the year amounted to SEK -0.06 (SEK -0.09)
SIGNIFICANT EVENTS AFTER THE QUARTER
The independent Data Monitoring Committee (DMC) recommended a dose escalation in the ongoing phase I/IIa Tumorad-01 study with the drug candidate 177Lu-SN201 in radiotherapy. In addition, significant visible tumor uptake of 177Lu-SN201 has been observed in SPECT images. The DMC considers this observation to be proof-of-concept for Tumorad in humans, indicating that 177Lu-SN201 may be a potential new treatment for cancer. This provides strong support for continued development, as well as an important basis for exploring opportunities in indications with potential for orphan drug status.
CEO STATEMENT
During the fall, we took a decisive step forward in the development of our drug candidate ¹⁷⁷Lu-SN201 in the Tumorad program. The independent Data Monitoring Committee's (DMC) recommendation in October to increase the dose to 20 MBq/kg in the ongoing Phase I/IIa study, Tumorad-01, together with the observation of clearly visible tumor uptake in patients, marks a breakthrough for the program and, according to the DMC, can be considered Proof-of-Concept in humans. This confirms that our platform technology works as intended for the delivery of radiation to tumors and represents an important transition to the next phase in the company's clinical development.
Based on the DMC's review of data from all patients treated to date, the DMC concludes that the safety profile remains manageable and consistent and that the maximum tolerated dose (MTD) has not yet been reached. In addition to showing that Tumorad is safe at current dose levels, the DMC's recommendation to proceed and enroll a patient at a higher dose level is significant from a therapeutic and, in the future, commercial perspective. The higher the dose that is tolerated, the more potent a future drug could be. We now look forward to the DMC's next analysis and recommendation in early next year.
The main objective of phase I part of the study is to document safety and identify a dose for treatment in the next stage. As with all cancer treatments, but perhaps even more so in radiation therapy, an acceptable safety profile is crucial. It is therefore very gratifying to note that safety continues to be in line with previous observations, even at higher dose levels. The side effects we've seen are mainly temporary effects on blood platelets, which is expected with lutetium-based treatments, without any impact on other critical organs like the kidneys. Tumorad thus has a safety profile that could be a clear competitive advantage over other RNT drugs, both those already on the market and those in development, which often have complex side effect profiles.
The visible uptake of ¹⁷⁷Lu-SN201 in cancer tumors observed in several patients, with significant levels in one patient with the rare cancer adenoid cystic carcinoma (ACC), is a significant success for the program and a historic milestone for the company. It provides clinical confirmation of our mechanism for delivering radioactive isotopes to tumors and clear support for the effectiveness of our nanoparticle-based platform in humans. At the same time, it also provides a solid foundation for continued development towards efficacy studies in the Phase IIa part of the study.
The new observations may also open up development paths in indications with potential for orphan drug designation (ODD). We are exploring opportunities for faster development of Tumorad in rare types of cancer, with ACC as a clear example. ODD offers several advantages, such as regulatory guidance, fee reductions, and market exclusivity once a drug has been approved. Continued development in indications with the potential for orphan drug designation could facilitate both upcoming studies and future commercialization, while also making the project more attractive for partnerships.
We continue to work closely with our clinical partners in Australia, where recruitment for the Tumorad-01 study is proceeding according to plan. Our participating clinics continue to show strong commitment to the study, and the response from both investigators and patients is very positive. This continuity and confidence in the clinical work is crucial for us to be able to determine the optimal therapeutic dose and move on to the next clinical stage with Tumorad.
Interest in radiopharmaceuticals continues to grow globally, driven by medical advances and significant industrial investment. Our technology platform and the clinical data we are now generating differentiate Spago Nanomedical in this rapidly growing field. The combination of promising clinical safety and demonstrated tumor accumulation in cancer patients places Tumorad in an attractive position ahead of the next development phase, and we are very optimistic about the rest of the year and the period ahead.
Mats Hansen, CEO Spago Nanomedical AB
The interim report is available at the Company's website; https://spagonanomedical.se/investor-relations/#financial-reports.
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.
SOURCE: Spago Nanomedical
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