OCTOBER – DECEMBER IN BRIEF

• Net sales for the quarter amounted to KSEK 731 (KSEK 142)
• The loss for the quarter amounted to KSEK –9,417 (KSEK -12,616)
• Operating expenses for the quarter amounted to KSEK -12,060 (KSEK -13,335)
• Earnings per share, before and after dilution, for the quarter amounted to SEK -0.08 (SEK -0.14)
• Cash and cash equivalents at the end of the quarter amounted to KSEK 45,217 (KSEK 62,101)

JANUARY – DECEMBER IN BRIEF

• Net sales for the year amounted to KSEK 1,203 (KSEK 1,054)
• The loss for the year amounted to KSEK -42,223 (KSEK -42,892)
• Operating expenses for the year amounted to KSEK -49,005 (KSEK -45,925)
• Earnings per share, before and after dilution, for the year amounted to SEK -0.43 (SEK -0.67)

SIGNIFICANT EVENTS DURING THE QUARTER

• The first cancer patient was successfully dosed in the phase I/IIa clinical study Tumorad-01 with the drug candidate in the radionuclide therapy program Tumorad, 177Lu-SN201. The study is being conducted on patients with advanced cancer. Initial data regarding safety and biodistribution are expected to be reported in the first half of 2024.
• The analysis of data from the phase IIa clinical study SPAGOPIX-02 with the contrast agent pegfosimer manganese (formerly SN132D) confirms that the primary endpoint of measuring the MRI enhancing effect in endometriotic lesions was met, with an overall acceptable safety profile.
• Four new patent applications have been filed with the European Patent Office (EPO) to expand the patent protection for Tumorad. If granted, Tumorad will receive protection in all strategically key markets, including the EU, US and Japan, until at least 2042.
• The company received approximately MSEK 26 after issuance costs in the rights issue, in which the subscription period expired on November 23. The net proceeds are intended to be used for the continued development of Tumorad, including the inclusion of patients and the summation of initial results in the first clinical study with Tumorad in cancer patients. Full allocation and registration with the Swedish Companies Registration Office was completed after the required approvals were obtained from the Inspectorate for Strategic Products (Sw: Inspektionen för strategiska produkter, “ISP”).

CEO STATEMENT
The fourth quarter was successful with several important milestones achieved. At the beginning of the quarter, we received the approval to start our first clinical study within the Tumorad program in Australia, and in December we announced the dosing of the first patient. At the end of the quarter, we also announced progress in our second clinical program SpagoPix with positive Phase IIa data with pegfosimer manganese in patients with endometriosis. To ensure optimal progress of our clinical programs, we carried out a fully guaranteed rights issue during the quarter that provided the company with approximately SEK 30.6 million before issue costs.

The need for new, more effective methods to treat metastatic and aggressive cancer is still significant, as evidenced by the steadily increasing interest in radionuclide therapies among major pharmaceutical companies and specialist investors. According to a survey by analyst firm GlobalData, transactions in the field have increased significantly in recent years. The total value of venture capital deals in radiopharmaceuticals has increased by 550% between 2017 and 2023, from USD 63 million to USD 408 million. Several major transactions in 2023 have contributed to a significant increase in attention to the field. In the fall, for example, Eli Lilly invested USD 175 million in Mariana Oncology’s preclinical project MC-339 for small cell lung cancer, and at the end of December they acquired all shares in the radiopharmaceutical company Point Biopharma for approximately USD 1.4 billion. Another example is Bristol Myers Squibb, which has previously invested in the field. At the end of December, Bristol Myers Squibb announced that it was acquiring the company RayzeBio and its radiopharmaceutical platform for approximately USD 4.1 billion.

We at Spago Nanomedical are also experiencing greater interest in our development programs, especially in Tumorad with the drug candidate 177Lu -SN201, which has now entered the clinical development phase. In mid-October, we received approval to start our first clinical study, Tumorad-01, in patients with advanced cancer. Patient recruitment started immediately and in early December the first cancer patient was successfully treated with the initial dose.

Tumorad-01 is a Phase I/IIa study with the primary objective to evaluate the safety, tolerability, dosimetry and initial efficacy of 177Lu-SN201 in cancer patients with the goal of identifying a potential therapeutic dose for further studies. With a study design that enables continuous data reporting, we expect initial safety and biodistribution data from the Phase I part of the study already in the first half of 2024. This data will be of great importance as it can give an indication of the product’s usefulness in the treatment of cancer patients.

We have also seen a significant increase in interest in our second development program, SpagoPix, after we reported positive topline data in December from the clinical Phase IIa study SPAGOPIX-02 with the contrast agent pegfosimer manganese, formerly known as SN132D. The study was an open-label proof-of-concept study with the primary objective of evaluating contrast enhancement in patients with endometriosis. Analysis of the study data showed that contrast enhancement could be observed in the majority of lesions confirmed by ultrasound, and that the primary endpoint had thus been reached. The results show the potential of pegfosimer manganese in medical imaging of endometriosis lesions and enable further evaluation in the next step.

We also see an increasing interest in women’s health in general, and endometriosis specifically, among pharmaceutical companies. Women suffering from endometriosis are a severely under-diagnosed and under-treated patient group and the need for improvement is very high. This interest was clearly evident during the annual J.P. Morgan Health Care conference in January in San Francisco which we attended. We enjoyed several fruitful meetings with potential future partners.

In December, we also announced that the fully guaranteed new share issue was completed and that the company received a total of approximately SEK 30.6 million before issue costs. I am very humbled and pleased with the confidence that existing and new owners have shown the company. With secured financing, we are taking the Tumorad program further into clinical development. We continue the important work of giving more cancer patients the opportunity to be treated with effective radionuclide therapy and to create value for our shareholders.

With Spago Nanomedical now fully in clinical development, I look forward to another eventful year.

Mats Hansen, CEO Spago Nanomedical AB