OCTOBER – DECEMBER IN BRIEF
During the quarter, the company achieved net sales of KSEK 142, a significant increase from the KSEK 99 reported in the same quarter a year prior.
The quarter ended on a sour note, with a loss of KSEK -11,158 (KSEK -11,293).
During the quarter, operating expenses totaled KSEK -13,335, representing a slight increase from KSEK -13,078 in the same period the previous year.
In the quarter, earnings per share before and after dilution came in at SEK -0.12 (SEK -0.27), representing a decrease from the previous period.
At the close of the quarter, our cash and cash equivalents totaled KSEK 62,101, an increase of KSEK 9,461 compared to the previous quarter.
JANUARY – DECEMBER IN BRIEF
The company saw an impressive increase in net sales in the past year, with total revenue reaching KSEK 1,054, a substantial jump from the preceding year’s KSEK 660.
The year ended with a loss of KSEK -39,197, a decline of KSEK -39,071 from the previous year.
Operating expenses for the year were KSEK -45,925, a slight increase from the previous year’s KSEK -45,723.
For the year, earnings per share before and after dilution amounted to SEK -0.61 (SEK -0.99), indicating a decrease in profitability compared to the prior year.
SIGNIFICANT EVENTS DURING THE QUARTER
Spago Nanomedical is launching a Phase IIa clinical trial to evaluate the effectiveness of SpagoPix in treating endometriosis, a painful and debilitating condition experienced by up to 10% of women of reproductive age. The trial has already begun, with the first patient receiving a dose shortly after the start of the study and a total of 18 participants anticipated.
The Phase I clinical trial SPAGOPIX-01 in patients with confirmed breast cancer concluded during the quarter with 14 patients included and dosed. The results of this study, presented at the 2022 San Antonio Breast Cancer Symposium, showed that SN132D was well tolerated, providing clear contrast in MRI images of solid tumors in the breast, with good contrast enhancement in the pancreas and liver. This met the primary and secondary objectives of the study, and the final report is in preparation.
SIGNIFICANT EVENTS AFTER THE QUARTER
The recently published paper in the peer reviewed scientific journal ASC Omega, titled “Characterization and Efficacy of a Nanomedical Radiopharmaceutical for Cancer Treatment”, reveals exciting results on the efficacy of the candidate drug 177Lu-SN201 within the Tumorad project. The results show that this drug accumulates in tumors to the same extent as a comparable market approved benchmark and is an effective treatment for systemic cancer. Moreover, the study found that 177Lu-SN201 not only delays tumor growth but also extends life expectancy in a preclinical model of colon cancer.
CEO STATEMENT
The fourth quarter of 2022 was a momentous one for us, as we made tremendous strides in our leading imaging diagnostics development projects, SpagoPix and the radionuclide therapy Tumorad®. Our progress in these projects was a testament to the dedication and hard work of our team and promises to have a lasting impact on the health and well-being of many.
At the end of the fourth quarter, SpagoPix made a groundbreaking announcement: the start of the company’s first Phase II clinical trial with the MRI contrast agent SN132D in endometriosis. This groundbreaking trial is an essential step towards providing accurate and relevant diagnostics for this vastly undertreated disease, which affects up to 10 percent of women of reproductive age. By positioning SpagoPix in an indication where current contrast agents and other diagnostics do not work optimally, this study promises to revolutionize the way endometriosis is diagnosed and treated.
Our Phase IIa study of SN132D for the treatment of suspected endometriosis is underway at Skåne University Hospital in Malmö, Sweden. We are delighted to report that the screening process is progressing as planned, with several patients already enrolled in the study. We anticipate presenting the results of the study in mid-2023, and look forward to a potentially groundbreaking outcome.
At the end of 2022, we proudly announced the successful completion of the SPAGOPIX-01 trial in breast cancer at the San Antonio Breast Cancer Symposium. Our primary objectives of demonstrating the safety and contrast enhancement of SN132D in MRI images of solid breast tumors have been met. We are pleased to report that SN132D is well tolerated and provides clear contrast enhancement in these tumors. Furthermore, initial results show good contrast enhancement in the pancreas and liver regions. A final report is being compiled based on the successful outcomes. At the same time, we also announced the start of a Phase II trial.
Tumorad is revolutionizing the fight against cancer with its groundbreaking radionuclide therapy, which combines the effectiveness of radiation treatment with high-precision targeting to tackle tumors that were previously too difficult to access. We are on the brink of submitting an application to start a phase I/IIa trial in cancer patients, and are aiming to recruit the first patient by the start of summer. This is not just a breakthrough for the pharmaceutical industry and investors, but more importantly a breakthrough for those suffering from aggressive and metastatic cancers. With its mechanism based on physiological targeting, Tumorad is on the verge of unlocking opportunities to battle a much wider range of tumors and usher in a new era of hope.
Recent preclinical studies of 177Lu-SN201 have revealed that it is a promising radionuclide therapy for targeting and treating a variety of solid tumors. Based on the positive results achieved in these studies, a clinical study is set to begin in January 2023. The findings, published in the scientific journal ASC Omega, show that the therapy slows tumor growth and leads to longer survival in preclinical tumor models. Furthermore, toxicology studies have previously yielded favorable results, building confidence that this novel therapy could be a game-changer in the fight against cancer.
As we navigate the uncertain waters of our current financial climate, Spago Nanomedical is taking a careful, but strategic approach to our resources. Our platform technology and talented team give us a great foundation to build upon, and following an eventful 2022, we are optimistic about the potential for even greater progress in 2023. Now is an exciting time for our company, and the possibilities for long-term value are numerous.