Spago Nanomedical Q1 2024 Interim Report

LUND, SWEDEN - May 2, 2024 - Spago Nanomedical has reported a promising start to the year, marked by positive financial and operational developments for the period of January to March. The company, listed on the Stockholm Stock Exchange (STO:SPAGO.ST) and Frankfurt Stock Exchange (FRA:7UX.F), showcased a notable improvement in its quarterly net sales, which amounted to KSEK 350, a significant increase from KSEK 88 in the same period last year.

Despite the recorded net loss of KSEK -7,763, the figure is an improvement over the previous year’s KSEK -15,573. Operating expenses also saw a reduction, amounting to KSEK -9,497 compared to KSEK -17,168 in the corresponding quarter of the previous year. Earnings per share stood at SEK -0.03, a marked improvement from SEK -0.17. The company ended the quarter with cash and cash equivalents totaling KSEK 32,250, down from KSEK 45,106 at the same point last year.

After the quarter ended, Spago Nanomedical announced a significant strengthening of its management team with the appointment of Birgitta Rembratt Svensson as Head of CMC & Supply. Svensson brings extensive experience from her previous senior roles in pharmaceutical companies and will join the company on June 1.

In an important development for Spago Nanomedical’s drug candidate, 177Lu-SN201, significant anti-tumor effects were demonstrated in a non-clinical triple-negative breast cancer model. This effect was compared to several existing cancer drugs, showing a low and acceptable level of radiotoxicity.

CEO Mats Hansen expressed optimism in his statement, citing the ongoing progress of the phase I/IIa Tumorad-01 study. This first-in-human study focuses on evaluating the safety, tolerability, dosimetry, and initial effects of 177Lu-SN201 in cancer patients, aiming to identify a therapeutic dose for further studies. The study has already successfully treated its first patient, and patient recruitment is ongoing, with plans to update the market before mid-year.

Parallel to the clinical study, Spago is conducting a robust non-clinical program to investigate Tumorad as both a monotherapy and combination therapy for triple-negative breast cancer. This aggressive cancer type is resistant to chemotherapy and constitutes about 15% of all breast cancer cases. Recent non-clinical trials have shown promising results for 177Lu-SN201, displaying superior tumor inhibition compared to standard treatment drugs and minimal radiotoxicity.

The radiopharma sector has seen increased interest and significant transactions, such as AstraZeneca’s acquisition of Fusion Pharmaceuticals for up to $2.4 billion and Bristol Myers Squibb’s purchase of RayzeBio for around $4.1 billion. This trend highlights the growing recognition of the potential of radiopharmaceuticals.

Additionally, Spago Nanomedical’s second development program, SpagoPix, continues to garner attention, particularly for its application in endometriosis. The phase IIa clinical study, SPAGOPIX-02, reported positive topline data, demonstrating the potential of the contrast agent pegfosimer manganese in medical imaging of endometriosis lesions. The study met its primary efficacy objective, showing observable contrast enhancement in most lesions confirmed by ultrasound, paving the way for further evaluation.

Given the advancements in both development programs, Spago Nanomedical has bolstered its organization with the strategic recruitment of Birgitta Rembratt Svensson. Her expertise in procurement, planning, and execution will be crucial as the company prepares for later-stage development and potential commercialization.

2024 is set to be a pivotal year for Spago Nanomedical, with a primary focus on advancing the clinical study of Tumorad. The company is committed to updating stakeholders on its progress and achieving key milestones throughout the year.