On April 24, 2020 Spago Nanomedical reported half-year report January-June 2020 (Press release, Spago Nanomedical, AUG 24, 2020, View Source [SID1234563962])
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APRIL-JUNE IN SUMMARY
• Profit for the quarter amounted to SEK -4,764 thousand (SEK -4,547 thousand).
• Operating expenses for the quarter amounted to SEK -6,269 thousand (SEK -9,062 thousand).
• Earnings per share, before and after dilution, for the quarter amounted to SEK -0.19 (SEK -0.22).
• Cash and cash equivalents for the company at the end of the quarter amounted to SEK 41,421 thousand (SEK 33,157 thousand).
JANUARY-JUNE IN SUMMARY
• Profit for the half-year amounted to SEK -9,819 thousand (-9,161 thousand).
• Operating expenses for the half year amounted to SEK -13,039 thousand (-18,729 thousand).
• Earnings per share, before and after dilution, for the half-year amounted to SEK -0.43 (SEK -0.48).
SIGNIFICANT EVENTS DURING THE QUARTER APRIL-JUNE
• The recruitment of subjects for the clinical study SPAGOPIX-01 was temporarily paused in Uppsala during parts of the second quarter after reprioritisations at the University Hospital as a result of covid-19.
Preclinical studies have shown that Tumorad accumulates in tumors to an extent that implies that the substance has good potential to become clinically useful. The results confirmed that the company’s nanomedical platform can with good precision generate materials that accumulate in tumors.
• Tumorad patents were approved in Japan and means that Spago Nanomedical has product protection for Tumorad in the largest markets for radionuclide therapies. Tumorad already has patent protection in several strategically important regions, including the USA and the EU.
• The company received approximately SEK 47 million before deductions for issue costs through a heavily oversubscribed rights issue with a subscription ratio of 222 percent. A total of 10,514,839 new shares were issued.
SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD
• The company showed in a preclinical mouse model for breast cancer that Tumorad statistically significantly reduces tumor growth and prolongs survival. Based on this and previously communicated progress in the project, the company decided to appoint a product candidate ("candidate drug") and prepare the preclinical safety tests with Tumorad required before patient studies can be initiated.
Inclusion of patients to the next dose level in the SPAGOPIX-01 clinical trial has begun.
CEO’S SPEECH
During the quarter, it was clear that our, like many other companies’, clinical activities were delayed due to covid-19. The number of patients at the clinics dropped drastically during the period and the redistribution of hospital resources meant that recruitment to the SPAGOPIX-01 study was paused. As the covid 19 pressure on healthcare has since decreased, we can state that the second dose group in the study is underway. We are very pleased with the safety of the first dose group and look forward to the results of the three patients who make up the next dose group, with the aim of subsequently increasing the dose further to maximize the potential for objective contrast and to gather additional safety data.
The Tumorad project has also made important progress. During the summer, we successfully conducted tests in a preclinical mouse model for aggressive breast cancer. We have shown that Tumorad inhibits tumor growth and prolongs survival at a clinically relevant dose. This result is very positive and forms the basis for the decision to formally appoint a product candidate in the project. It also marks that we have completed the exploratory study program and are now moving on to the regulatory development phase. A clinic preparation program with a few preclinical studies in accordance with guidelines from both European and American authorities, has been agreed with the Medical Products Agency. Preparations for internal production of materials for these regulatory toxicology and dosimetry studies have begun.
We are experiencing autumn strengthened by the lightening in the SpagoPix study and with Tumorad, which has taken a decisive step towards clinical development and thus once again shows the strength of Spago Nanomedical’s development platform.