Spago Nanomedical interim report January-September 2023
Tumorad® in clinic
JULY – SEPTEMBER IN BRIEF
- Net sales for the quarter amounted to KSEK 271 (KSEK 397)
- The loss for the quarter amounted to KSEK –7,113 (KSEK -8,594)
- Operating expenses for the quarter amounted to KSEK -8,795 (KSEK -10,406)
- Earnings per share, before and after dilution, for the quarter amounted to SEK -0.08 (SEK -0.11)
- Cash and cash equivalents at the end of the quarter amounted to KSEK 25,974 (KSEK 71,234)
JANUARY – SEPTEMBER IN BRIEF
- Net sales for the year amounted to KSEK 472 (KSEK 912)
- The loss for the year amounted to KSEK -29,387 (KSEK -28,039)
- Operating expenses for the year amounted to KSEK -36,945 (KSEK -32,590)
- Earnings per share, before and after dilution, for the year amounted to SEK -0.32 (SEK -0.51)
SIGNIFICANT EVENTS AFTER THE QUARTER
- The company's application to start a clinical phase I/IIa study in Australia with the candidate drug in the radionuclide therapy program Tumorad, 177Lu-SN201, has been approved. The study is conducted in patients with advanced cancer and the first patient is expected to be included shortly.
- Four new patent applications have been filed with the European Patent Office (EPO) to expand the patent protection for Tumorad. If granted, Tumorad will receive protection in all strategically key markets, including the EU, US and Japan, until at least 2042.
- The Board decided, with the support from the AGM, to carry out a fully secured rights issue of approximately MSEK 30.6 for the continued development of Tumorad, including, among other things, the inclusion of patients and obtaining initial results in the first clinical study with Tumorad in cancer patients. The subscription period in the rights issue is November 9-23. For each unit subscribed for in the rights issue, the shareholder receives a warrant (TO12) that entitles the holder to subscribe for one new share during the period May 17-30, 2024.
After intensive preparations and anxious waiting, we now have received approval from the ethics review committee at St. Vincent's Hospital in Melbourne, and it has been registered with the Australian Therapeutic Goods Administration (TGA)" in Australia for starting our first clinical study within the Tumorad program, Tumorad-01. I am very happy to put this important milestone behind us and now focus on delivering results with the drug candidate 177Lu-SN201 in patients with advanced cancer. With a clinically validated and patented platform technology, together with a clearly differentiated profile in radioisotope drugs and imaging, we can enable effective treatment of larger groups of patients with severe disease.
Following the positive results from our SpagoPix diagnostic program in breast cancer, which clearly demonstrate that our platform works well for targeting solid tumors, we are now further increasing our focus on cancer drug development by starting our first clinical study within the Tumorad program – Tumorad-01. The start of the study marks a very significant milestone for Spago Nanomedical, transforming the company to be strongly focused on clinical development of our programs. Radioisotope drugs, also referred to as radionuclide therapy, is an area that has received significantly increased attention in recent years as a result of clinical and commercial progress and several major completed transactions by global pharma companies. The interest in the field is steadily increasing from investors as well as other pharmaceutical companies.
Tumorad is our leading development program and we see great value in now advancing and accelerating the clinical development with the phase I/IIa study Tumorad-01. There is still a great medical need for more effective methods to treat metastatic and aggressive cancer. Therefore, the Board of Directors of Spago Nanomedical recently decided on a share issue with preferential rights for existing shareholders with the main purpose of financing the Tumorad-01 study until initial results can be generated.
Tumorad-01 is initially conducted at clinics in Australia. The Phase I part is a dose escalation, first-in-human study, intended to be conducted in up to 30 patients with advanced cancer, with the primary objective of evaluating the safety, tolerability and dosimetry of the drug candidate 177Lu-SN201. The study received approval from an ethical review committee in October and we expect the first patient to be dosed shortly. With a study design that enables continuous data reporting, we expect initial results on the drug's safety and biodistribution during the first half of next year. These data are of great importance as they can provide an early indication of the possibility to reach a favorable benefit-risk ratio.
The rapid start of the study immediately after approval was made possible by extensive preparatory work completed in the third quarter. Among other things, the large-scale GMP-classified production of trial materials was completed, as well as the process for isotope labeling and delivery of radiopharmaceuticals to the clinics. Through a good network of CROs, we have ensured the delivery of drugs and implementation of the study at clinics in Australia. The goal is to gradually broaden the study to include clinics in Europe, and the preparations for this are in full swing.
Our strong belief in Tumorad as an opportunity for a new promising treatment for several types of aggressive and metastatic cancer is based on previous research results, and the significant medical need for more effective treatments. With modern targeted drugs, radioisotopes can be delivered to certain types of tumors inside the body and thus treat more patients, including those with metastatic cancer or with tumors that cannot be treated with external radiation. This is also reflected in the strong, increasing interest in new radioisotope drugs from both big pharmaceutical companies and specialist investors.
We see several clinical advantages of our technology compared to other radioisotope drugs, both launched and in development. The vast majority of these are designed to reach only a certain tumor type expressing a specific target protein. This is where our drug candidate 177Lu-SN201 differs, as its mechanism makes it possible to treat several different types of cancer, especially those where currently there are no targeted treatments.
In parallel with taking Tumorad into the clinic, development work has continued with the company's program for selective contrast agents, SpagoPix, where the product candidate SN132D has the potential to significantly improve the precision of magnetic resonance imaging (MRI). SN132D can provide visualization of tumors and other lesions with higher precision than what is possible with today's contrast agents, which increases the chances of successful treatment. Previous clinical results from patients with breast cancer demonstrate a selective accumulation of SN132D in breast tumors, as well as in the pancreas and liver. These data represent a clear first clinical validation that paves the way for broader use of the platform in both radioisotope drugs and additional imaging indications such as endometriosis.
The clinical phase IIa study SPAGOPIX-02, evaluating SN132D in patients with documented or suspected endometriosis, is now in the analysis phase and we expect topline data before year end. Endometriosis is a painful disease that affects up to 10% of all women of childbearing age and with a great need for improved diagnosis and treatment. If positive results in SPAGOPIX-02, we believe that this study will be key for the further development of the SpagoPix program and enable further discussions with potential license partners.
By means of the fully secured share issue of 30.6 MSEK with preferential rights for the company's existing shareholders and subscription period November 9-29, we potentiate delivery of meaningful results with Tumorad in cancer patients. I am very pleased by the major up-front support by several of our largest shareholders and I hope that both existing and new owners will join us on this exciting journey.
Thank you for your continued engagement in Spago Nanomedical, I look forward to keeping you updated as we progress.
Mats Hansen, CEO Spago Nanomedical AB (publ)