LUND, SE / ACCESS Newswire / August 20, 2025 / Spago Nanomedical (STO:SPAGO.ST)(FRA:7UX.F)
APRIL - JUNE IN BRIEF
Net sales for the quarter amounted to KSEK 81 (KSEK 459)
The loss for the quarter amounted to KSEK -6,964 (KSEK -8,152)
Operating expenses for the quarter amounted to KSEK -8,291 (KSEK -10,255)
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 18,517 (KSEK 47,700)
JANUARY - JUNE IN BRIEF
Net sales for the half-year period amounted to KSEK 419 (KSEK 809)
The loss for the half-year period amounted to KSEK -14,399 (KSEK -15,915)
Operating expenses for the half-year period amounted to KSEK -17,255 (KSEK -19,752)
Earnings per share, before and after dilution, for the half-year period amounted to SEK -0.04 (SEK -0.07)
SIGNIFICANT EVENTS DURING THE QUARTER
In June, the independent Data Monitoring Committee (DMC) recommended to continue the ongoing phase I/IIa study Tumorad-01 with the candidate drug 177 Lu-SN201 to recruit two further patients as per the current study protocol, at the highest dose to date. The recommendation was based on the analysis of the ten dosed patients dosed up to that point, which showed a continued acceptable safety profile. A total of twelve patients with ten different tumor types have now been dosed, three of whom received the highest dose level to date.
At the annual general meeting, Alan Raffensperger was elected as the new chairman of the board and the medical oncologist Dr. Mikael von Euler was elected as a new board member. Both have extensive experience from leadership roles in global pharmaceutical development as well as long industrial experience in oncology. Furthermore, board members Kari Grønås and Nicklas Westerholm were re-elected. The new board was elected to reflect the current needs of the company is in and to secure the continued clinical development of the Tumorad program.
SIGNIFICANT EVENTS AFTER THE QUARTER
Nothing to report
CEO STATEMENT
During the second quarter of 2025, we continued to take important steps forward in the clinical development of our candidate drug 177 Lu-SN201 in the Tumorad program. The ongoing Phase I/IIa study, Tumorad-01, is proceeding according to plan. In early June, the independent Data Monitoring Committee's (DMC) recommended to proceed according to the current study protocol with the recruitment of additional patients at the highest dose tested to date. This is a clear confirmation of the value of the consistent and acceptable safety profile we have seen so far. It allows us to confidently continue the study toward the primary goal of defining a clinically relevant dose in order to investigate the effect in one or more selected cancer types in the next phase.
According to DMC's report in June, which is based on an analysis of the 10 patients dosed to date, no dose-limiting toxicities have been reported. The generally mild side effects observed were related to the effect on blood platelets (thrombocytes), an expected effect of treatment with radioactive substances, being both asymptomatic and transient. The pace of patient recruitment has increased steadily during the study, and during the summer, two additional patients were dosed at both our clinics in Australia, Cancer Research SA in Adelaide and St Vincent's Hospital in Melbourne. The study now includes 12 patients with 10 different tumor types, three of whom are at the current highest dose level. We are now looking forward to the next DMC evaluation in early Q4.
The safety profile is crucial in the development of new cancer drugs as it practically determines whether a drug can be approved and used at all - even if it shows promising effects. An unsatisfactory safety profile is one of the most common reasons why promising drugs never reach the market. The relatively good safety profile observed to date across all three dose levels (5, 10, and 15 MBq/kg) evaluated in a diverse range of tumor types is very promising. In a preliminary comparison with other Lu 177 -based drugs, either launched or in development, our candidate drug in Tumorad, 177 Lu-SN201, shows similar impact on thrombocytes. However, 177 Lu-SN201 has not shown any effect on other critical organs, such as the kidneys, which some other Lu 177 -based drugs do.
Tumorad's design and mechanism of action offer the opportunity to address multiple tumor types compared to current radionuclide therapies (RNT), which primarily target prostate cancer and neuroendocrine tumors. In dialogues with investors, it becomes clear that they value Tumorad's potential to expand the RNT field and the ability to target other and multiple tumor types. If we maintain the good safety profile observed to date, this will provide a significant advantage for Tumorad and constitute a clearly differentiating factor compared to other RNT drugs, both launched and under development, which often have complex side effect profiles.
The market for RNT-based cancer treatment is significant and is estimated by several analysts to amount to 10 billion USD per year, with limited competition, due to complex barriers for new entry the field. There is a strong interest in the industry for the RNT field and M&A activity has been extensive with multiple completed licensing deals in recent years.
The observed and confirmed good safety profile, to date, means that the Tumorad program has taken an important clinical step forward. This, along with Tumorad's unique mechanism of action, enabling an expansion of the number of indications, and the increasing interest in RNT-based cancer treatments from major players, mean that we have already built substantial value in the program in Phase I.
With the data from the Tumorad study, we are building a solid documentation that is crucial for future clinical phases, where the focus will gradually shift more toward efficacy. In addition to the primary objective of evaluating safety, a key goal in the Phase I part of the study is to identify a possible maximum therapeutic dose for further testing in selected patient groups in the Phase IIa part, also known as the "maximum tolerated dose" (MTD). This is something that is highlighted in our ongoing dialogues with potential partners and specialist investors to facilitate upcoming clinical steps with Tumorad and secure the company's financial position in the long term.
We are also continuing to evaluate strategic alternatives to unlock the full potential of our second development program, SpagoPix, whose clinical results were published this spring in the leading scientific journal Investigative Radiology and further presented at the recent 16 th World Endometriosis Congress in Sydney, Australia.
In summary, the second quarter has confirmed that our clinical strategy is delivering results. What we have seen so far in the Phase I part of the Tumorad study strengthens our confidence in the clinical profile and belief in 177 Lu-SN201 as an effective future cancer treatment. We look forward to continuing to build value in the second half of the year by reaching the next milestones in Tumorad-01.
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.
Attachments
Spago Nanomedical interim report January-June, 2025
SOURCE: Spago Nanomedical
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https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/spago-nanomedical-interim-report-january-june-2025-1063191
