Spago Nanomedical interim report January-June 2021

Continued good pace in the business despite Covid-19

APRIL – JUNE IN BRIEF

• Net sales for the quarter amounted to KSEK 267 (KSEK 0).
• The loss for the quarter amounted to KSEK -11,607 (KSEK -4,764).
• Operating expenses for the quarter amounted to KSEK -13,450 (KSEK -6,269).
• Earnings per share, before and after dilution, for the quarter amounted to SEK -0.28 (SEK -0.19).
• Cash and cash equivalents at the end of the quarter amounted to KSEK 76 873 (KSEK 41,421).

JANUARY – JUNE IN BRIEF

• Net sales for the half-year period amounted to KSEK 367 (KSEK 100).
• The loss for the half-year period amounted to KSEK -17,675 (KSEK -9,819).
• Operating expenses for the half-year period amounted to KSEK -20,889 (KSEK -13,039).
• Earnings per share, before and after dilution, for the half-year period amounted to SEK -0.47 (SEK -0.43).

SIGNIFICANT EVENTS DURING THE QUARTER

• No events to report

SIGNIFICANT EVENTS AFTER THE QUARTER

• Paul Hargreaves was appointed Chief Development Officer (CDO), starting in the third quarter. Paul will join the management team and have a key role in the clinical development of the company's project portfolio.

CEO STATEMENT

In the second quarter, we continued to notice the effects of the Covid-19 pandemic, which, among many other things, have resulted in significant difficulties in conducting clinical trials effectively. Despite this, we were able to keep up the pace of business and make important progress in the Tumorad^® project.

An important focus for us is the clinical development of SpagoPix, our contrast agent for increased precision in MRI of breast cancer and other cancers. The major advantage of SpagoPix is ​​the ability to provide possibilities for high resolution imaging of tumors with high precision, which can provide vital information for correct diagnosis and treatment. As such, we can combine the primary advantages of MRI (high sensitivity) and PET (high specificity) into one product. SpagoPix has promising potential to become the first tumor-selective contrast agent for MRI and thus meet the continuing increased need for improved diagnostic precision.

The primary goal of the clinical study SPAGOPIX-01 is to build a foundation for future clinical studies and strengthen our position in dialogue with potential partners. The results from the study have so far shown that SN132D provides clinically valuable images and is safe at current dose levels. It is noteworthy that the study thus, despite the slow recruitment pace caused by the pandemic, has already provided a very important basis for discussion with potential licensing partners for the continued development of the project.

The clinical results also show that our nanoparticles safely accumulate in human solid tumors, a fundament of our platform technology. This opens in the next stage for treatment of cancer with Tumorad.

We have previously shown that the Tumorad candidate drug SN201 can delay tumor growth and extend survival in a preclinical model of aggressive breast cancer. It is very satisfying that we successfully completed the production of materials for regulatory preclinical studies which will form the basis for clinical development. These studies are progressing well and will be completed in the fall. In parallel, preparations for the first clinical study are ongoing, including GMP production and compilation of regulatory documentation. The goal is to start the first clinical trial with SN201 in patients with advanced cancer next year.

It is well-established that the principle for accumulation in tumors, the EPR effect, becomes more pronounced in fast growing tumors. There are currently few effective pharmaceutical treatments against large groups of advanced cancers where mortality is driven by resistant and metastatic tumors. We see Tumorad becoming an important addition to the future treatment arsenal. We believe that Tumorad has great potential as a general treatment for advanced and aggressive cancer, and we are moving the project forward with full speed.We have an exciting time ahead of us and I look forward to updating you as our projects continue to progress.

Mats Hansen, CEO Spago Nanomedical AB

For further information, please contact Mats Hansen, CEO Spago Nanomedical AB, +46 46 811 88, mats.hansen@spagonanomedical.se. 

Spago Nanomedical AB is a Swedish nanomedicines company in clinical development phase. The company´s development projects are based on a platform of polymeric materials with unique properties for more precise diagnosis and treatment of solid tumors. Spago Nanomedical´s share is listed on Nasdaq First North Growth Market (ticker: SPAGO). For further information, see www.spagonanomedical.se.   

FNCA Sweden AB is the Certified Adviser of the company, +46 8 528 00 399, info@fnca.se.

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