LUND, SE / ACCESS Newswire / May 7, 2025 / Spago Nanomedical (STO:SPAGO.ST) (FRA:7UX.F)
OCTOBER - DECEMBER IN BRIEF
Net sales for the quarter amounted to KSEK 338 (KSEK 350)
The loss for the quarter amounted to KSEK -7,435 (KSEK -7,763)
Operating expenses for the quarter amounted to KSEK -8,964 (KSEK -9,497)
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 26,578 (KSEK 32,250)
SIGNIFICANT EVENTS DURING 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.
The independent data monitoring committee, DMC, recommended a dose increase in the ongoing phase I/IIa study Tumorad-01 with 177 Lu-SN201. The recommendation was based on the analysis of data from two patient groups, consisting of six patients with five different cancer types. Both groups show a similar acceptable safety profile. A total of eight patients with seven different tumor types have now been dosed, of which one on the new higher dose and one on the lower dose.
For the 2025 Annual General Meeting, the nomination committee proposes the election of current board member Alan Raffensperger as the new chairman of the board and the election of oncologist Dr. Mikael von Euler as a new board member. To better reflect the stage that Spago Nanomedical is in, the nomination committee assesses that the company is in need of a chairman of the board with a significant international background and contacts from major pharmaceutical companies. In addition, the board should be further strengthened with a specialist with extensive industrial experience in oncology. The nomination committee further proposes the re-election of board members Kari Grønås and Nicklas Westerholm.
SIGNIFICANT EVENTS AFTER THE QUARTER
Nothing to report
CEO STATEMENT The beginning of 2025 has been characterized by continued clinical development at a rapid pace, with important progress in our prioritized program Tumorad and the ongoing phase I/IIa study Tumorad-01. The independent data monitoring committee's (DMC) recommendation in March to proceed with a higher dose of the candidate drug 177 Lu-SN201 represents a clear validation of the safety profile we have observed so far in the first two patient groups in the study. At the beginning of the year, we also received approval to include patients in parallel on a lower dose. The objective is to gain additional knowledge and basis for various dosing regimes in the next steps. A total of eight patients with seven different tumor types have now been dosed, of which one on the new higher dose and one on the lower dose. Recruitment is actively underway at two clinics in Australia and our goal is still to be able to complete the phase I part of the study during 2025. We look forward to the next evaluation by the DMC at the end of May.
Preliminary imaging data from Tumorad-01 continue to indicate a biodistribution in line with previous preclinical data. These results strengthen our confidence in the composition and mechanism of 177 Lu-SN201. The methods for imaging and dosimetry calculations are continuously evolving as the study progresses, which is crucial to building the robust documentation required for future phases.
At the same time, we have continued to work on creating the conditions for the long-term development of the Tumorad program. Part of this is the proposal for a changed board composition that the nomination committee recently presented, where Alan Raffensperger is proposed as the new chairman and Dr. Mikael von Euler as a new member. Both have extensive experience from leading roles in global drug development and oncology, and we look forward to benefit from their expertise and networks in our continued journey towards clinical and commercial success.
While advancing Tumorad further into clinical development in a cost-effective and structured manner, we have also continued to develop our business dialogues related to our second development project SpagoPix, with the product candidate pegfosimer manganese. The publication of a paper with clinical results from SPAGOPIX-01 by the highly regarded peer-reviewed scientific journal Investigative Radiology marks an important validation of the platform and strengthens our position in discussions with potential partners. The article focuses on the results from the phase I study SPAGOPIX-01, where pegfosimer manganese demonstrated acceptable safety and good contrast enhancement in MRI images of primary tumors in breast cancer patients. Further development within SpagoPix requires external funding or partnerships. We are working to realize these opportunities and maximize the value of this asset.
Our main business development focus continues to exploring strategic opportunities for Tumorad. Our financial strategy involves optimizing costs while actively identifying and engaging potential partners who share our vision and see the medical and commercial value in our programs. As part of this work, we continuously participate in selected industry and partnering conferences.
In summary, we look back on a quarter in which Spago Nanomedical has taken clear steps forward both operationally and strategically. Our clinical program is developing in the right direction, our organization is highly focused, and we have strengthened our capabilities to build long-term value. We look forward to reaching more important milestones in Tumorad-01 during the year and continuing to develop the business opportunities that our programs represent.
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.
