On April 23, 2020 Spago Nanomedical reported that Interim Report January-March 2020 (Press release, Spago Nanomedical, APR 23, 2020, View Source [SID1234556537])
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JANUARY-MARCH IN SUMMARY
• Profit for the quarter amounted to SEK -5,054,000 (-4,613,000).
• Operating expenses for the quarter amounted to SEK -6,769,000 (-9,665,000).
• Earnings per share, before and after dilution, for the quarter amounted to SEK -0.24 (-0.27).
• Cash and cash equivalents for the company at the end of the quarter amounted to SEK 6,938 thousand (SEK 7,859 thousand).
SIGNIFICANT EVENTS DURING THE QUARTER JANUARY – MARCH
• Data from the first dose group of six patients in the Phase 1 study SPAGOPIX-01 showed that the SN132D is well tolerated and the study continues to the next dose level.
• The company selected the lead compound in the Tumorad project and thus focused its development work on preclinical proof of concept studies.
• The Board of Directors decided on a fully guaranteed rights issue of SEK 47 million, before deduction of issue costs.
SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD
• Patient recruitment for the SPAGOPIX-01 clinical trial is paused in Uppsala following re-prioritization at the Academic Hospital as a result of covid-19.
• Extraordinary General Meeting approved the Board’s decision on a rights issue.
THE CEO HAS THE WORD
It has been a different beginning of the year, but despite the crippling effect that covid-19 has had on large sections of the community, our projects ran until mid-April when the patient recruitment for the clinical trial with SpagoPix was paused in Uppsala due to covid-19 priorities. Our second site, the Sahlgrenska Hospital, expects to be able to get started as soon as they have received clearance from the ethics review authority and to increase the pace of patient recruitment, we are also exploring the possibilities of getting more centers to participate in the study.
At the same time, we maintain a continuous dialogue with the clinics and our contract partners who handle the study, about covid-19 and the impact of the pandemic. In addition to the clinics’ priority needs, we have also looked at other possible consequences of the pandemic. Therefore, in order to broaden the base of patients for the study, we are working purposefully partly with the initiation of the Sahlgrenska hospital and partly with identifying other suitable centers that can participate in the studies. We have analyzed how our substance SN132D can affect patients and concluded that this in itself does not increase the risk of being infected or exacerbating the disease. We currently have no plans to slow down the study.
Recently, we were able to announce that analysis of data from the first dose group in the study was carried out as planned. The summary from the internal safety committee showed that there are no signs of safety problems and the study is thus continuing at the next planned dose level. In line with preclinical data, we expect the contrast effect to increase with increasing dose of SN132D.
In the Tumorad project, our lead compound is tested in a study program to document proof of concept in vivo. It is a solid program aimed at laying the groundwork for upcoming preclinical safety tests and clinical trials. We expect to be able to select a product candidate and start manufacturing materials on a larger scale after completed tests in the ongoing program.
We are also now conducting a rights issue to secure upcoming important milestones in the projects. I am grateful and humbled for the support shown to the company in these times by both major and minor shareholders. The Spago team and I look forward to continuing to drive projects forward, both internally and externally, with continued care for patients and staff.