27 Apr, 2022

Spago Nanomedical interim report January-March 2022

Several important milestones in the first quarter

· Net sales for the quarter amounted to KSEK 211 (KSEK 100).
· The loss for the quarter amounted to KSEK –9,880 (KSEK -6,068).
· Operating expenses for the quarter amounted to KSEK -11,100 (KSEK -7,439).
· Earnings per share, before and after dilution, for the quarter amounted to SEK -0.24 (SEK -0.18).
· Cash and cash equivalents at the end of the quarter amounted to KSEK 40,992 (KSEK 85,225).
· Interim results from the second dose group in SPAGOPIX-01 show that SN132D is well tolerated and provides clear contrast enhancement in MRI images of solid tumors in the breast, as well as in the pancreas and liver. Based on the results, the company has decided to continue the study in breast cancer and in addition, to expand to also include patients with pancreatic cancer.
· Results from a preclinical model for colorectal cancer show that 177Lu-SN201 reduces tumor growth and prolongs survival by 39% compared to the control group.
· Extended patent protection for SpagoPix in Japan until at least 2038.

The positive and intense spirit that characterized last year continued during the first quarter of this year with good news from both our projects, SpagoPix (SN132D) and Tumorad® (177Lu-SN201). Of course, we are also following developments with regard to both Covid-19 and the tragic war in Ukraine; we do not currently see any immediate impact of these on our operations.
A priority area for us is to maximize the value of SPAGOPIX-01 – our Phase I clinical trial with the contrast agent SN132D. To this end, we have amended the study so that it can also include patients with pancreatic cancer. This is a cost-effective way to show the potential of SN132D in another cancer indication, thus enabling increased value. The recruitment of patients for the study with suspected or confirmed pancreatic cancer that has spread to the liver is ongoing.
At the same time, I would like to emphasize that there is no doubt that the study is positive. The interim results from the second dose group show that SN132D is well tolerated and provides clear contrast in MRI images of breast tumors, as well as in the pancreas and liver tissue. The study's internal safety committee has found that SN132D is safe at both dose levels.
The results also confirm that SN132D accumulates in solid tumors in humans, which, in addition to safety, has been our main goal of the study. We have thus confirmed that the principle on which we have built our platform – physiological enrichment of nanoparticles in tissue with EPR effect – works in the body and with the equipment available in hospitals. The very good correlation between preclinical and clinical results is of great importance and strengthens our confidence about the possibilities of using the platform also for therapy with Tumorad.
After showing that SN132D clearly accumulates in cancerous tumors and provides images with both high precision and positive contrast, additionally showing the tumor without background noise, we continue the dialogue with potential licensees. Our conclusion from these dialogues so far is that the study program should be expanded to more indications for a deal to be interesting. By including patients with cancer of the pancreas, we can demonstrate the greater potential of SN132D. We are also evaluating the possibilities in other indications where the EPR effect is well documented, both within and outside the cancer area. With the results we have achieved so far, we see good opportunities to position SN132D in important indications with a great clinical need for improved imaging diagnostics.
With the knowledge from the SpagoPix project, Tumorad has been able to develop at a very high pace. Now that we have confirmed that our materials accumulate in malignant tumor tissue in humans as well, our main focus is to enter into clinical trials as soon as possible with the drug candidate 177Lu-SN201, our nanoparticle SN201 loaded with the clinically proven radioisotope Lutetium-177 (177Lu). We plan to initiate the first study in humans during the year.
The work of optimizing the clinical development and the path to market approval for 177Lu-SN201 is in an intensive phase. We intend to apply for orphan drug status for 177Lu-SN201 for the treatment of ovarian cancer, provided that preclinical studies show strong results here as well. At the same time, we are also evaluating other ways to develop the 177Lu-SN201 in both broad and more niche indications.
In parallel with developing a clinical program, we continue to build the preclinical package around the candidate drug. In January, we were able to show that 177Lu-SN201 delays tumor growth and prolongs survival by 39% compared to the control group in a model for colorectal cancer, a statistically significant improvement. The results broaden our previous positive results with the drug candidate in a preclinical model for aggressive breast cancer. 177Lu has been clinically validated for long. With this, we show the strength and breadth of the technology and lay the foundation for clinical development.
Overall, we see a very large potential in the Tumorad project. Already at the current stage of development, we see a value for 177Lu-SN201 which in the orphan drug indication ovarian cancer alone is significant and, with an optimized development strategy, rapidly increasing. To this can be added the value in other, larger indications.
In step with the positive development, several new patent applications have recently been submitted to extend patent protection and strengthen Tumorad's future position.
Tumorad is unique, and we see a clear interest for the project. In preparation for clinical trials, we have initiated dialogues with specialist investors. In this context, we can observe a great interest in radionuclide therapy among both investors and pharmaceutical companies, which has recently resulted in a number of investments and acquisitions in this area.
Strengthened by these important milestones, I see that we have an exciting year ahead of us, and I look forward to updating you as our projects continue to develop.

Mats Hansen, CEO
Spago Nanomedical AB