Spago Nanomedical Year-End Report January-December, 2021

LUND, SWEDEN / ACCESSWIRE / February 2, 2022 / Spago Nanomedical (STO:SPAGO.ST) (FRA:7UX.F)

Good progress in the projects

OCTOBER – DECEMBER IN BRIEF

• Net sales for the quarter amounted to KSEK 99 (KSEK 175).
• The loss for the quarter amounted to KSEK -11,293 (KSEK -4,624).
• Operating expenses for the quarter amounted to KSEK -13,078 (KSEK -7,161).
• Earnings per share, before and after dilution, for the quarter amounted to SEK -0.27 (SEK -0.15).
• Cash and cash equivalents at the end of the quarter amounted to KSEK 52,460 (KSEK 28,448).

JANUARY – DECEMBER IN BRIEF

• Net sales for the year amounted to KSEK 660 (KSEK 342).
• The loss for the year amounted to KSEK -39,071 (KSEK -18,928).
• Operating expenses for the year amounted to KSEK -45,723 (KSEK -26,207).
• Earnings per share, before and after dilution, for the year amounted to SEK -0.99 (SEK -0.70).

SIGNIFICANT EVENTS DURING THE QUARTER

• The regulatory preclinical program with Tumorad® (177Lu-SN201) were completed and show a good safety margin for clinically relevant doses.
• All patients in the second dose group in the company’s ongoing Phase I clinical trial SPAGOPIX-01 with the tumor-selective contrast agent SpagoPix (SN132D) were recruited.
• Agreement was signed with the global CRO Cmed Group Limited for the development of the first clinical study with the company’s therapy project Tumorad.

SIGNIFICANT EVENTS AFTER THE QUARTER

• Interim results from the second dose group in SPAGOPIX-01 show that SN132D is well tolerated and provides clear contrast enhancement in MRI images of solid tumors in the breast, as well as in the pancreas and liver. Based on the results, the company has decided to continue the study in breast cancer and in addition, to expand to also include patients with pancreatic and liver cancer.
• Results from a preclinical model for colorectal cancer show that 177Lu-SN201 reduces tumor growth and prolongs survival by 39% compared to the control group.

CEO STATEMENT

In 2021, we continued to make good progress with our projects, despite the still ongoing Covid-19 pandemic, and the fourth quarter turned out to be a particularly busy period, where we passed a few important milestones with both SpagoPix and Tumorad. We could in fact start the new year with some further exciting news around both projects. This makes me believe we have an exciting year ahead of us.

In early December, we completed the recruitment to the second dose group in our clinical phase I study SPAGOPIX-01 with the tumor-selective contrast agent SN132D in patients with confirmed breast cancer. Shortly after, in January 2022, we presented the interim results from the second dose group which show that SN132D is well tolerated and provides clear contrast enhancement in MRI images of solid tumors in the breast, as well as in the pancreas and liver. Based on the results, we decided to proceed the study in breast cancer and in addition, to expand to also include patients with pancreatic and liver cancer, where there is a large clinical need.

It is very rewarding that we, also in the second dose cohort, can show that SN132D clearly accumulates in cancerous tumors and provide images that with both high precision and positive contrast show the tumor against a clean background. Strengthened by these positive results, together with previously presented data, we are continuing the project at full speed, both in breast cancer and in the new indications.

The interim results from SPAGOPIX-01 show that our platform technology makes it possible to clinically and precisely accumulate functional nanoparticles in solid tumors. This is also of great importance for our therapy project Tumorad, which aims to develop a precision treatment for several different cancers. Tumorad, with the candidate drug code 177Lu-SN201, has previously demonstrated a positive effect by slowing tumor growth in a preclinical model for aggressive breast cancer.

In the last quarter, we completed the regulatory preclinical, IND-enabling studies for Tumorad. We see a good safety margin to clinically relevant doses, as the results show that the nanomaterial is safe to give in doses that widely exceed planned clinical doses and that radiation is distributed in a manner that allow dosing according to plan. This is a major risk reduction in the project.

Recently we could also communicate new preclinical results showing that 177Lu-SN201 significantly reduces tumor growth and prolongs survival by 39% in a preclinical model for colorectal cancer. These new results provide additional support for the company’s unique platform technology with nanoparticles for use in several different cancer indications.

Data from the preclinical studies, together with other documentation, will form the basis for the first clinical trial application for Tumorad. The plan is to submit the application and start the studies in humans in 2022. The aim of the first in human trial is to document safety at different doses of 177Lu-SN201 in cancer patients as well as to evaluate signs of early proof-of-concept.

The preparations for Tumorad clinical development are ongoing at full speed, and a key person in this process is of course Paul Hargreaves, who joined as Chief Development Officer. With almost 30 years of experience in clinical development from Pfizer and Quantiles, among others, Paul significantly strengthens the team to allow further acceleration of our critical work going forward.

Earlier in the year, our share started trading on Nasdaq First North Growth Market, which provides an opportunity for increased exposure and sends an important signal of our long- term ambitions to become a leading company in the development of nanomedicine. During the year, we were busy presenting the company and our exciting project portfolio at conferences and industry events. We will continue to do so in 2022.

Strengthened by these important milestones, I believe we have an exciting year ahead of us. At the same time, we continue to carefully monitor the development of the Covid-19 pandemic, and we take every precaution to ensure that patients, healthcare staff and our organization are safe and well, and that our operations continue according to plan. I look forward to updating you as our projects continue to progress.

Mats Hansen, CEO Spago Nanomedical AB

For further information, please contact Mats Hansen, CEO Spago Nanomedical AB, +46 46 811 88, mats.hansen@spagonanomedical.se

Spago Nanomedical AB is a Swedish nanomedicines company in clinical development phase. The company´s development projects are based on a platform of polymeric materials with unique properties for more precise diagnosis and treatment of solid tumors. Spago Nanomedical´s share is listed on Nasdaq First North Growth Market (ticker: SPAGO). For further information, see www.spagonanomedical.se.

FNCA Sweden AB is the Certified Adviser of the company, +46 8 528 00 399, info@fnca.se.

Attachments

Spago Nanomedical year-end report January-December, 2021

SOURCE: Spago Nanomedical

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