Spago Nanomedical

 JANUARY – MARCH IN BRIEF

• Net sales for the quarter amounted to KSEK 88 (KSEK 211)
• The loss for the quarter amounted to KSEK –14,379 (KSEK -9,880)
• Operating expenses for the quarter amounted to KSEK -17,168 (KSEK -11,100)
• Earnings per share, before and after dilution, for the quarter amounted to SEK -0.16 (SEK -0.24)
• Cash and cash equivalents at the end of the quarter amounted to KSEK 45,106 (KSEK 40,992)

 SIGNIFICANT EVENTS DURING THE QUARTER

• The paper, titled "Characterization and Efficacy of a Nanomedical Radiopharmaceutical for Cancer Treatment", was published in the peer reviewed scientific journal ASC Omega. The results show that the candidate drug 177Lu-SN201 within the Tumorad program accumulates in tumors to the same extent as a comparable market approved benchmark and is well suited for systemic treatment of cancer. Furthermore, 177Lu-SN201 delays tumor growth and prolongs survival in a preclinical model of colon cancer.

 SIGNIFICANT EVENTS AFTER THE QUARTER

• The nomination committee proposed for the annual general meeting election of Hans Arwidsson as new chairman of the board and Alan Raffensperger as new board member to increase the commercial focus. Furthermore, the election committee proposed re-election of the board members Kari Grønås and Nicklas Westerholm.
• Principal investigator Dr Ligita Jokubkiene presented observations from the ongoing phase IIa clinical trial SPAGOPIX-02 in endometriosis at the scientific conference, 15th World Congress on Endometriosis.

CEO STATEMENT
 The start of 2023 was characterized by intensive preparations for the start of our first clinical study with the radionuclide therapy Tumorad® in cancer patients. In parallel, we worked on producing the final report for the completed SPAGOPIX-01 study in which the MRI contrast agent SN132D was evaluated in breast cancer.
 
The preparations for the planned phase I/IIa clinical study Tumorad-01 with our leading drug candidate 177Lu-SN201 has been intensified during the first quarter. The clinical study protocol has been finalized, as have contracts with CROs for conducting the study. Additionally, we have completed large-scale GMP-classified manufacturing of trial material for the study, a significant risk reduction in the project. Now remaining the formal approval process for the study with an Australian Human Research Ethics Committees, we expect this to begin in the next few weeks. The Phase I part of Tumorad-01 is a dose-escalation, first-in-human study intended to be conducted in up to 30 patients with advanced cancer. The study will initially be conducted at clinics in Australia with the primary objective of evaluating the safety, tolerability and dosimetry of 177Lu-SN201. In addition to competent clinics, Australia offers several regulatory and financial advantages that allow us to bring Tumorad to cancer patients quickly and cost-effectively. Not least, the possibility of substantial reimbursement of R&D costs is a great advantage. Moreover, authorities and hospitals are familiar with radiopharmaceuticals and have access to local manufacturing and distribution of the radioisotope lutetium-177.
 
The start of clinical development with Tumorad marks a crucial milestone for Spago Nanomedical. Following the positive results with the SpagoPix diagnostic project in breast cancer, which shows that our platform works well for targeting solid tumors, we are now placing a large and increasing focus on the development of drugs against cancer. Our belief in Tumorad as a promising new radionuclide therapy for physiological targeting and tumor-selective treatment of cancer was further confirmed at the beginning of the quarter by the publication of an article in the scientific journal ACS Omega showing that 177Lu-SN201 accumulates well in cancer tumors and slows tumor growth, which resulted in longer survival in preclinical tumor models. The published results provide further support for the start of clinical development with Tumorad.
 
At the end of last year, the initial clinical results from our completed phase I study SPAGOPIX-01 were presented at the San Antonio Breast Cancer Symposium 2022. The results showed that SN132D is well tolerated and provides clear contrast enhancement in MRI images of solid tumors of the breast, as well as in the pancreas and in the liver, which means that the primary objective of the study was achieved. Intensive work is now underway to complete the final report and we expect to be able to present full results from the study later this year. In addition, work is underway to evaluate and clearly define the commercial positioning in breast cancer.
 
Following the close of the quarter, the principal investigator Dr Ligita Jokubkiene presented early observations from the phase IIa study SPAGOPIX-02 evaluating the contrast agent SN132D in endometriosis at the 15th World Congress on Endometriosis scientific conference. The observations from patients examined so far support further study recruitment. Preliminary results are expected to be presented as planned around mid-year.
 
Following the close of the quarter, the nomination committee presented its proposal for the board’s composition for the 2023 annual general meeting. In the proposal, Hans Arwidsson and Alan Raffensperger are nominated as chairman and new member of Spago Nanomedical, respectively. With the proposed composition, we get a clearly commercially oriented board that is well-suited to drive important areas within company management, business development and financing. I am very much looking forward to continuing to develop the company together with the new board.
 
With continued positive momentum from the previous year within both of our leading development programs, I look forward to an eventful 2023.

Mats Hansen, CEO Spago Nanomedical AB

The interim report is available at the Company’s website; https://spagonanomedical.se/investor-relations/#financial-reports

Unless otherwise stated, this Interim report refers to the Group. Figures in parentheses refer to the parent company and to the corresponding period last year.