Spago Nanomedical interim report January-June 2026
APRIL – JUNE IN BRIEF
- Net sales for the quarter amounted to KSEK 0 (KSEK 81)
- The loss for the quarter amounted to KSEK -7,331 (KSEK -6,964)
- Operating expenses for the quarter amounted to KSEK -8,418 (KSEK -8,291)
- Earnings per share, before and after dilution, for the quarter amounted to SEK -0.01 (SEK -0.02)
- Cash and cash equivalents at the end of the quarter amounted to KSEK 32,508 (KSEK 18,517)
JANUARI – JUNE IN BRIEF
- Net sales for the half-year period amounted to KSEK 22 (KSEK 419)
- The loss for the half-year period amounted to KSEK -14,128 (KSEK -14,399)
- Operating expenses for the half-year period amounted to KSEK -16,385 (KSEK -17,255)
- Earnings per share, before and after dilution, for the half-year period amounted to SEK -0.02 (SEK -0. 04)
SIGNIFICANT EVENTS DURING THE QUARTER
- The Data Monitoring Committee (DMC) of the Tumorad-01 study declared that one of the primary endpoints, identifying the maximum tolerated dose, has been met and recommends that an additional two patients are enrolled at the dose level of 15 MBq/kg (fractionated) to provide a basis for defining a recommended phase II dose and completing the phase I part of the study. Significant visible tumor uptake of 177Lu-SN201 has been observed in an additional patient with head and neck cancer, strengthening proof-of-concept for the Tumorad program.
- The Principal Investigator and Associate Professor Kim Taubman of St. Vincent's Hospital in Australia, presented the ongoing clinical phase I/IIa study Tumorad-01 with ¹⁷⁷Lu-SN201 at the 56th Annual Scientific Meeting held by the Australian and New Zealand Society of Nuclear Medicine (ANZSNM). The conference took place in Canberra on 15–17 May 2026.
- At the Annual General Meeting, Alan Raffensperger was re-elected as Chairman of the Board, along with Mikael von Euler, Kari Grønås, and Nicklas Westerholm re-elected to the board, and Peter Lindell, Mikael Lönn, and Tiel Ridderstad newly elected to the board.
- The company completed a rights issue, which subscribed to approximately 93.1 percent and provided the company with approximately SEK 15.0 million before issue costs, intended to finance the completion of phase I of Tumorad-01 and preparations for phase IIa.
CEO STATEMENT
During the second quarter, we continued building the foundation – clinically, regulatorily, and financially – for the next phase of the Tumorad program. The phase I portion of the Tumorad-01 study is approaching its conclusion, and we have taken further important steps toward a clear strategic direction for continued development.
The clinical picture which has emerged during phase I so far remains unchanged and forms an important part of a foundation we are now continuing to build on. In early May, we reported that a total of 15 patients with advanced cancer had been dosed in the Tumorad-01 study, with dose escalation up to 20 MBq/kg. Based on these data, the study's independent Data Monitoring Committee (DMC) determined that one of the primary endpoints, establishing the maximum tolerated dose (MTD), had been reached, and recommended that an additional two patients be treated at the 15 MBq/kg (fractionated) level. Focus is now on completing the phase I portion and establishing a recommended phase II dose (RP2D). Identifying a recommended phase II dose constitutes a further primary endpoint in the phase I portion of the study and is a decisive basis for the next clinical phase, while also being an important milestone in the dialogue with regulatory authorities and potential licensing and development partners.
Given the above, we intend to advance Tumorad with a primary focus on head and neck cancer. This is the indication area where we have generated our strongest clinical data and observed repeated instances of tumor uptake, which also strengthens Tumorad's proof-of-concept in humans. We view adenoid cystic carcinoma (ACC), a tumor type where we observed significant uptake early on, as a well-defined starting point for continued development.
ACC is a rare but aggressive tumor type that primarily arises in the salivary glands within the head and neck region. The disease often grows slowly but has a high rate of recurrence and spreads to other organs. For patients with recurrent or metastatic disease, there is currently no approved systemic treatment, and the medical need is significant. With Tumorad, we see the potential to offer a new type of treatment, alongside opportunities to expand into additional tumor types within the head and neck area, which could progressively broaden the commercial potential.
ACC is a typical orphan drug indication, which opens several important development and market advantages. In the US, Orphan Drug Designation provides seven years of market exclusivity after approval, tax credits for clinical trials, and exemption from significant FDA application fees. Collectively, this strengthens our competitive advantages and the conditions for out-licensing, while the orphan drug pathway can be combined with the expedited regulatory procedures we are working toward. Operating within a well-defined indication with high medical need also provides a focused and capital-efficient path to market.
In addition to clinical progress, we have strengthened the company's position in several other ways. At the Annual General Meeting in June, a partially renewed and strengthened Board of Directors was elected, bringing additional breadth and experience for the next phase of development. During the quarter, we also completed a rights issue that subscribed to approximately 93 percent and raised approximately SEK 15 million for the company before issue costs. The rights issue secures the working capital needed to complete the phase I portion of Tumorad-01 and the necessary preparations for phase IIa. Continued financing of phase IIa remains a clear priority area, where we are continuously evaluating strategic partnerships and complementary solutions to combine clinical development with responsible capital management.
Overall, Spago Nanomedical is well positioned. We have achieved a primary endpoint with a recommended phase II dose within reach, secured financing to complete the phase I portion of Tumorad-01, and a clear strategic direction toward an attractive orphan drug indication. All of this is supported by a strengthened organization and board. With reproducible observations of tumor uptake, an established regulatory direction, and a radiopharmaceutical field continuing to develop strongly, I look forward with confidence to a continued eventful second half of the year.
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.