Spago Nanomedical interim report January-September 2022
Intensive preparations to bring Tumorad into clinic
JULY –SEPTEMBER IN BRIEF
· Net sales for the quarter amounted to KSEK 397 (KSEK 195)
· The loss for the quarter amounted to KSEK –8,594 (KSEK -10,103)
· Operating expenses for the quarter amounted to KSEK -10,406 (KSEK -11,756)
· Earnings per share, before and after dilution, for the quarter amounted to SEK -0.11 (SEK -0.26)
· Cash and cash equivalents at the end of the quarter amounted to KSEK 71,234 (KSEK 65,987)
JANUARY – SEPTEMBER IN BRIEF
· Net sales for the year amounted to KSEK 912 (KSEK 561)
· The loss for the year amounted to KSEK -28,039 (KSEK -27,778)
· Operating expenses for the year amounted to KSEK -32,590 (KSEK -32,645)
· Earnings per share, before and after dilution, for the year amounted to SEK -0.51 (SEK -0.67)
SIGNIFICANT EVENTS DURING THE QUARTER
· Spago Nanomedical raised MSEK 51.7 after issue costs in the rights issue, in which the subscription period expired on June 28, 2022. The net proceeds are planned to be used to start the first part of a clinical phase I/IIa study in cancer patients with the company’s radionuclide therapy project Tumorad.
· An abstract covering the initial results from the company's Phase I study SPAGOPIX-01 was accepted for poster presentation at the 2022 San Antonio Breast Cancer Symposium® (SABCS) on December 6-10, 2022
SIGNIFICANT EVENTS AFTER THE QUARTER
· No events to report
Thanks to a successful rights issue at the end of June, we were able to enter the third quarter with strengthened finances. It gives us room to take our radionuclide therapy project Tumorad® (177Lu-SN201) further into clinical development, while within the framework of the previous budget, we can finish the ongoing phase I study with SpagoPix and prepare the project for the next step.
I am very happy and proud of the trust that existing and new shareholders have shown us. Through the capital raising, which added just over SEK 58 million to the company before issue costs, we now have the conditions to focus fully on continuing to build future value for both patients and shareholders.
Above all, we see great potential shareholder value in the development of the Tumorad project, with its unique treatment principle and significant market potential, as well as the increasing interest in radionuclide therapy among both pharmaceutical companies and investors. 177Lu-SN201 belongs to a new generation of radionuclide treatments that provide the opportunity to treat cancer with precision, either as monotherapy or in combination with other drugs. Given that we can demonstrate a good clinical effect in our studies, 177Lu-SN201 can thus become a welcome addition in cancer care.
Our primary focus is now to start clinical studies of 177Lu-SN201 in cancer patients, and as previously announced, we aim to apply for approval for a phase I/IIa clinical study. At the same time as we focus on the preparatory work for the study, intensive preclinical activities are ongoing to demonstrate the breadth of Tumorad's potential treatment area within indications with major medical needs, both as monotherapy and in combination with other drugs. We consider these data to be of great importance for the positioning of the project as well as for laying the foundation for the continued clinical and regulatory strategy.
Another prioritized area for us is the completion of the phase I clinical trial SPAGOPIX-01 with the MRI contrast agent SN132D. We have already seen that SN132D clearly accumulates in cancer tumors and provides images that with both high precision and positive contrast show breast cancer tumors without background noise. A clear evidence of the scientific interest in SN132D is that the abstract covering the initial results from SPAGOPIX-01 has been accepted for poster presentation at the 2022 San Antonio Breast Cancer Symposium® (SABCS), a well respected symposium providing state-of-the-art information on the biology, diagnosis, and therapy of breast cancer to an international audience of 8,000 academics, researchers and physicians from more than 80 countries.
We see good opportunities to position SN132D in additional indications with great clinical need for improved imaging diagnostics. Here we mainly focus on areas with high market potential where the EPR effect (Enhanced Permeability and Retention effect) is well documented, both within and outside the cancer area. With strong clinical results and good prospects for SpagoPix, we continue the dialogue with potential development partners.
Strengthened by both the outcome of the rights issue and the continued positive development in our projects, I look forward to updating you on upcoming milestones.
Mats Hansen, CEO
Spago Nanomedical AB
The interim report is available at the Company’s website; https://spagonanomedical.se/investor-relations/#financial-reports