Spago Nanomedical

APRIL – JUNE IN BRIEF

• Net sales for the quarter amounted to KSEK 459 (KSEK 114)
• The loss for the quarter amounted to KSEK –8,152 (KSEK -9,449)
• Operating expenses for the quarter amounted to KSEK -10,255 (KSEK -10,982)
• Earnings per share, before and after dilution, for the quarter amounted to SEK -0.03 (SEK -0.10)

JANUARY – JUNE IN BRIEF

• Net sales for the half-year period amounted to KSEK 809 (KSEK 201)
• The loss for the half-year period amounted to KSEK –15,915 (KSEK -25,051)
• Operating expenses for the half-year period amounted to KSEK -19,752 (KSEK -28,150)
• Earnings per share, before and after dilution, for the half-year period amounted to SEK -0.07 (SEK -0.28)
• Cash and cash equivalents at the end of the half-year period amounted to KSEK 47,700 (KSEK 31,392)

SIGNIFICANT EVENTS DURING THE QUARTER

• 177Lu-SN201 demonstrates significant anti-tumor effect in a non-clinical triple-negative breast cancer model compared to several cancer drugs with a low and acceptable level of radiotoxicity observed.
• The company received MSEK 24.7 before transaction costs through the utilization of warrants series TO12. In total, approximately 97% of the warrants were exercised for subscription of 123,480,752 new shares. The proceeds are intended to mainly be used to secure results from the phase I part of Tumorad-01, which may support decisions regarding the focus and commencement of the phase IIa part of the study.
• Tumorad-01 is progressing and the first group of three patients has been treated with the candidate drug 177Lu-SN201.
• Spago Nanomedical strengthens management by the appointment of Birgitta Rembratt Svensson as Head of Chemistry, Manufacturing, and Controls (“CMC”) & Supply. Birgitta, an experienced CMC project manager with several leading positions at development and commercial stage pharmaceutical companies, joined Spago Nanomedical on June 1 and serve as a member of the management team.

CEO STATEMENT
The second quarter of 2024 has been another intensive period for Spago Nanomedical with the continued main focus being on the Tumorad program and the ongoing phase I/IIa study Tumorad-01 in cancer patients. The study is progressing and the first group of three patients has been treated with the candidate drug 177Lu-SN201.

Tumorad-01 is a Phase I/IIa first-in-human study in patients with advanced cancer with the primary objective of evaluating the safety, tolerability, dosimetry and initial efficacy of the candidate drug 177Lu-SN201 with the aim of identifying a possible therapeutic dose for further studies.

During the quarter, we announced that two patients, both men with metastatic castration-resistant prostate cancer (mCRPC), successfully completed initial dosing. No serious adverse events were reported in those patients, which is encouraging as the main objective of the Phase I part of the study is to demonstrate that the treatment is safe and tolerated by patients.

A further patient, a woman with metastatic breast cancer, has since been treated and we are now awaiting the evaluation and recommendation of the independent Data Monitoring Committee (DMC), which will be made after all three patients have completed their first cycle of treatment according to the study protocol.

In parallel with clinical development, our extensive non-clinical program continues to explore Tumorad as both monotherapy and in combination with other treatments in triple-negative breast cancer, a highly aggressive cancer with a poor prognosis. During the quarter, we reported favorable data from the initial non-clinical study of 177Lu-SN201 as monotherapy showing significant anti-tumor effect compared to several cancer drugs. This effect was achieved with a low and acceptable level of radiotoxicity. The observations are very promising, which support continued non-clinical development, with evaluation of combination therapy as the next step.

Within the SpagoPix development program we see great opportunities to improve imaging for women with endometriosis with the product candidate pegfosimer manganese. The positive topline results from the clinical phase IIa study SPAGOPIX-02 reported at the end of last year show this potential. As such we are now preparing for the next step in this program, focusing on evaluating the possibilities of financing a larger clinical study in patients with endometriosis through out-licensing, commercial collaborations or different types of grants.

During the quarter, we received a capital injection via warrants issued in connection with a rights issue at the end of 2023. In total, the company received net proceeds just under SEK 25 million before issue costs. This capital is important to ensure continued progress in the phase I part of the Tumorad-01 study and support decisions on the direction and start of the phase IIa part of the study.

To support our continued development, we have also strengthened our organization with the recruitment of Birgitta Rembratt Svensson, who joined us in June as new Head of CMC & Supply. Birgitta's extensive experience and expertise from senior positions in the pharmaceutical industry will be invaluable in our continued journey.

2024 is, and will continue to be, a very important year for Spago Nanomedical. With a strengthened financial position, we are equipped and determined to move our programs forward, with a primary focus on Tumorad-01. We look forward to the rest of the year with confidence.

Thank you for your continued support and trust.

Mats Hansen, CEO Spago Nanomedical AB

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