Optimizing Diagnostics and Treatment

Spago Nanomedical AB (publ) is a Swedish nanomedicine company in clinical development phase, developing products for diagnostics and treatment of life-threatening and debilitating diseases.

More Accurate Diagnosis and Treatments

The company's operations are based on a patented material for the design of functional nanoparticles that accumulate physiologically in tumors, which could enable higher diagnostic and therapeutic precision. The current pipeline projects have the potential to improve patient care in diseases with urgent medical needs.

The SpagoPix project aims to launch a ground-breaking gadolinium-free MRI contrast agent for visualization of cancer and similar serious conditions. Unlike the conventional low molecular-weight MRI contrast agents, which enhance healthy tissue as well as diseased tissue, and therefore results in a relatively high proportion of false positive findings, Spago Nanomedical’s proprietary contrast agent is designed to selectively accumulate in tumor tissue. This improves the precision of MRI scans for suspected cancers. With better cancer diagnostics, the chances of successful and cost-efficient treatment of cancer patients improve. The Tumorad® project aims to develop a novel therapeutic radiopharmaceutical targeting solid tumors based on functional nanoparticles with radioactive isotopes. The design of Tumorad® could make tumor selectivity possible even in the case of small, difficult-to-reach and aggressive tumors, which enables efficient radiation treatment of the cancer while minimizing the risk of adverse effects.

Spago Nanomedical´s share is listed on Nasdaq First North Growth Market in Stockholm  (ticker: SPAGO).

Spago Nanomedical's vision is to engage in competitive and successful development of products for increased survival and quality of life for patients and thereby create long-term profitability for the company and its owners.

Spago Nanomedical's objective is to become a leading company within diagnostics and therapy based on nanomedicine through the development of products that benefit patients and provide good health economics.

Spago Nanomedical's overall strategy is to conduct development of medical projects based on the company's proprietary and patented nanomaterial. The business strategy builds on commercializing the company's development projects through strategic collaboration and outlicensing to industrial partners who have the resources to bring the product to market and clinical use. This reduces the capital need and the time before revenue is received, and increases the potential for successful market penetration.

Comments from the CEO

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

Board of Directors

Hans Arwidsson

Chairman of the Board

Born: 1958

Member of the board since: 2023

Holdings (related parties included): 497,000 shares and 212,000 TO12

Education and experience: Hans Arwidsson is CEO and board member at Eurocine Vaccines AB as well as chairman of the board and chief consultant at Healthy Bizniz Europe AB. Hans has broad experience from the pharmaceutical industry through several leading positions in research, business development, marketing and production within the AstraZeneca group, board assignments for Nanexa AB and XSpray Pharma AB as well as CEO at LipoCore AB. Hans is a pharmacist and doctor of pharmaceutical science from Uppsala University and has an MBA from Stockholm School of Economics.

Other appointments: Hans is CEO and board member of Eurocine Vaccines AB and chief consultant at Healthy Bizniz Europe AB.

Independent in relation to the company’s major shareholders, the company and its management.

Alan Raffensperger

Board Member

Born: 1960

Member of the board since: 2023

Holdings (related parties included): 808,667 shares and 528,667 TO12

Education and experience: Alan Raffensperger works as vice chairman of the board at Inceptua Group and is a member of Karolinska Institutet’s Steering Committee, Rolf Luft Research Center for Diabetes and the Department of Molecular Medicine. Alan has long and solid experience in life science through leading positions in both SOBI – Swedish Orphan Biovitrum AB (publ), Amgen, Roche Pharmaceuticals and Pharmacia / Pfizer, as well as smaller companies. Alan has in his roles of CEO and board member experience from the entire development chain from early research through to commercialization, licensing, and sale of entire companies. He holds an MBA from the George Washington University School of Business and a bachelor’s degree in Emergency Health Services Management from the University of Maryland, Baltimore (UMB).

Other appointments: Alan is vice chairman of the board at Inceptua Group and is also a board member of the Rolf Luft Foundation as well as Karolinska Institutet’s Steering Committee, Rolf Luft Research Center for Diabetes and the Department of Molecular Medicine.

Independent in relation to the company’s major shareholders, the company and its management.

Kari Grønås

Board Member

Born: 1965

Member of the board since: 2018

Holdings (related parties included): 199,999 shares and 116,666 TO12

Education and experience: Kari Grønås is pharmacist and has long experience of industrial contrast agents and drug development from Bayer AS, Algeta ASA, PhotoCure ASA, and Amersham Health. She worked as a project leader for Xofigo, where the job included applications for marketing approval at EMA and FDA but also responsibility for CMC in the contacts between Algeta and Bayer. Kari has also been the project leader for developing the contrast agent Hexvix until market approval in EU/EEA.

Other appointments: Kari is a consultant for start-up companies in the pharmaceutical and biotech industry. Owner and CEO of K og K AS, owner and board member of Ultimovacs ASA, board member of Arxx AS and owner of Oncopeptides AB.

Independent in relation to the company’s major shareholders, the company and its management.

Nicklas Westerholm

Board Member

Born: 1976

Member of the board since: 2019

Holdings (related parties included): 72,432 shares and 64,167 TO12

Education and experience: Nicklas Westerholm is the CEO of  Egetis Therapeutics AB (publ) since 2017. Before that, he worked within the AstraZeneca Group in a number of global roles in various business areas, most recently as Vice President of Project & Portfolio Management, Cardiovascular and Metabolic Diseases, Global Medicines Development Unit. Prior to that, Nicklas has held positions such as Executive Officer & Vice President Japan Operations and Director Investor Relations. He has studied analytical and organic chemistry at Stockholm University and chemical engineering at the Royal Institute of Technology. He has also studied at the University of Warwick, INSEAD and Harvard Business School.

Other appointments: Chairman of the board and CEO of Rare Thyriod Therapeutics International AB.

Independent in relation to the company’s major shareholders, the company and its management.

Management Team

Mats Hansen

Chief Executive Officer (CEO)

Born: 1971

CEO since: 2015

Holdings (related parties included): 385,252 shares and 224,730 TO12

Education and experience: Mats Hansen holds a Ph.D. in plant biochemistry and a Master in biology. He has extensive experience in project management, clinical
development and business development within oncology pharmaceuticals. His prior roles include director of Project Management and Head of Knowledge Management at Active Biotech AB, where he previously also has held various positions within information management, IP and business development.

Other appointments: Member of the board of Ekoscandica Naturguide AB

Oskar Axelsson

Chief Scientific Officer (CSO)

Born: 1962

In the management team since: 2007

Holdings (related parties included): 167,812 shares and 97,890 TO12

Education and experience: Oskar Axelsson holds a Ph.D. in organic chemistry and has extensive experience primarily from contrast agent research at Nycomed Innovation, Amersham, GE Healthcare and other companies. Oskar is leading the research department of Spago Nanomedical and is responsible for the Company’s patent issues. He has participated in over 50 patent applications and co-authored several scientific publications.

Other appointments:

Hanna Olsson

Chief Financial Officer (CFO)

Born: 1980

CFO since: 2019

Holdings (related parties included): 67,500 shares and 39 375 TO12

Education and experience: Hanna holds an MSc. in Business Administration and has long experience from different roles in auditing, analysis, financial control and business planning, in both small and large national and international groups such as Deloitte, Schneider Electric and most recently from a role as CFO at System Verification.

Other appointments:

Paul Hargreaves

Chief Development Officer (CDO)

Born: 1969

CDO since: 2021

Holdings (related parties included): 60,000 shares and 35,000 TO12

Education and experience: Paul holds both an MSc. in clinical pharmacology and an MBA. He has extensive experience in international drug development across multiple therapeutic areas. His prior roles include Development Team Lead at Pfizer, Vice President Phase I for Quintiles and Global Head of Clinical Operations at LEO Pharma. Most recently he has been working as an independent consultant and CDO.

Other appointments: –

Medical Advisors

Per Hall

Per Hall is Professor at the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet and Senior physician at the Department of Oncology at Södersjukhuset, Stockholm. Dr Hall has a long experience in clinical cancer research and randomized controlled trials. He has coordinated six research projects funded by the EU and three research projects funded by NIH.

Timothy Roberts

Timothy Roberts is Professor of Radiology and Vice-chair of Research at the Department of Radiology at the Perelman School of Medicine, University of Pennsylvania, where he also holds the Oberkircher Family Endowed Chair in Pediatric Radiology. Prof. Roberts’s research is focused on translational development of medical imaging technologies.

Peter Leander

Peter Leander is an associate professor and specialist in medical radiology. He is Head of Radiology at the Peritus Clinic and has conducted research on contrast agents for MRI and CT. Peter has extensive experience in radiology, including many years of experience as radiologist in Malmö as well as Regional Chief Radiology Officer in the Skåne Region, and is a member of the Swedish Society of Radiology (SMFR), and chairman of the Swedish contrast agent group within SMFR.

Sten Nilsson

Sten Nilsson is a specialist and professor emeritus in oncology, as well as a specialist in nuclear medicine. Sten was responsable for the study design and led the early clinical program Xofigo™ (previously Alpharadin™). Sten was previously the chairman of the Swedish Oncology Association (SOF) and the Swedish Association for Nuclear Medicine (SFNM) and member of EANM’s Radionuclide Therapy Task Force. He has published over 200 scientific articles.

Kristian Pietras

Kristian Pietras is a professor in Molecular Medicine at Lund University, specializing in translational cancer research as a hub between basic science, clinical science and the pharmaceutical industry. Kristian has made important contributions in defining tumors as communicating organs comprising multiple cell types that collectively sustain cancer progression. He has received numerous awards for his research, most notably the Anders Jahre’s Medical Prize for young scientists by Oslo University, The Fernström Award for Young Scientist by Lund University, and the Göran Gustafsson Award by the Royal Swedish Academy of Sciences. Kristian has been a member and chairman of the Young Academy of Sweden, and is an elected member of the Royal Physiographic Society. He has published over 100 research articles and patents.

Austin Smith

Austin Smith is trained and qualified in Medical Oncology and Pharmaceutical Medicine. He has a solid background in all aspects of Oncology and Malignant Hematology, along with Regulatory Science experience across Europe, the US and Asia-Pacific regions, acting in senior and executive positions in biopharma companies. Austin is also a member of the Expert Group for Oncology, representing the Faculty of Pharmaceutical Medicine in the UK.

Corporate Governance

Corporate governance within Spago Nanomedical is based on applicable laws, rules and recommendations, such as the Swedish Companies Act (2005:551), the Annual Accounts Act (1995:1554), Nasdaq First North Growth market's regulations and Spago Nanomedical's articles of association and internal rules and guidelines. As Spago Nanomedical's share is not admitted to trading on a regulated market, the company is not obliged to apply the Swedish Code of Corporate Governance (the Code) but has adapted to the Code in parts where the Code is deemed to be relevant to Spago Nanomedical and its shareholders.

BOLAGSORDNING FÖR SPAGO NANOMEDICAL AB (PUBL), Org. nr. 556574­5048

 

§ 1      Företagsnamn

Bolagets företagsnamn skall vara Spago Nanomedical AB. Bolaget är publikt.

 

§ 2      Styrelsens säte

 Styrelsen skall ha sitt säte i Lund.

 

§ 3      Verksamhet

 Bolaget skall bedriva forskning, utveckling, tillverkning, försäljning och licensiering av substanser som används för tillverkning av läkemedel, kontrastmedel och medicinsk utrustning samt därmed sammanhängande verksamhet.

 

§ 4      Aktiekapital

 Aktiekapitalet skall utgöra lägst 9 000 000 kr och högst 36 000 000 kr.

 

§ 5      Antal aktier

 Antalet aktier skall vara lägst 90 000 000 och högst 360 000 000 stycken.

 

§ 6      Styrelse

 Styrelsen skall bestå av 3­7 ledamöter med lägst 0 och högst 7 suppleanter.

 

§ 7      Revisor

 1-2 revisorer med eller utan revisorssuppleant eller ett registrerat revisionsbolag skall utses. Revisors uppdrag gäller till slutet av den årsstämma som hålls under det första, andra, tredje eller fjärde räkenskapsåret efter det senast gjorda revisorsvalet.

 

§ 8      Kallelse till bolagsstämma

 Kallelse till bolagsstämma skall ske genom annonsering i Post­ och Inrikes Tidningar samt på bolagets webbplats. Upplysning om att kallelse har skett skall annonseras i Svenska Dagbladet. Om utgivningen av Svenska Dagbladet skulle upphöra att vara rikstäckande, skall i stället sådan annonsering ske i Dagens Nyheter.

Bolagsstämma kan hållas i Stockholm förutom på den ort där styrelsen har sitt säte.

 

§ 9      Anmälan om, samt rätt till deltagande i bolagsstämma

 Aktieägare som vill delta i bolagsstämma skall göra en anmälan till bolaget senast den dag som anges i kallelsen till stämman.

 

§ 10   Årsstämma

 Årsstämma hålls årligen inom sex månader efter räkenskapsårets utgång.

På årsstämman skall följande ärenden förekomma:

 Val av ordförande vid stämman;

  • Upprättande och godkännande av röstlängd;
  • Val av en eller två justeringsmän;
  • Godkännande av dagordning;
  • Prövning av om stämman blivit behörigen sammankallad;
  • Framläggande av årsredovisning och revisionsberättelse, samt, i förekommande fall, koncernredovisning och koncernrevisionsberättelse;
  • Beslut om:
    1. fastställande av resultaträkning och balansräkning, samt, i förekommande fall, koncernresultaträkning och koncernbalansräkning,
    2. dispositioner av bolagets resultat enligt den fastställda balansräkningen,
    3. ansvarsfrihet åt styrelseledamöter och verkställande direktör.
  • Fastställande av styrelse­ och, i förekommande fall, revisorsarvoden
  • Val av styrelse och, i förekommande fall, revisionsbolag eller revisorer samt eventuella revisorssuppleanter
  • Annat ärende, som ankommer på stämman enligt aktiebolagslagen (2005:551) eller bolagsordningen.

 

§ 11   Fullmaktsinsamling och poströstning

Styrelsen får samla in fullmakter enligt det förfarande som anges i 7 kap. 4 § andra stycket aktiebolagslagen (2005:551).

Styrelsen får inför en bolagsstämma besluta att aktieägarna ska kunna utöva sin rösträtt per post före bolagsstämman.

 

§ 12   Räkenskapsår

 Kalenderår skall vara bolagets räkenskapsår.

 

§ 13   Avstämningsförbehåll

 Den aktieägare eller förvaltare som på avstämningsdagen är införd i aktieboken och antecknad i ett avstämningsregister enligt lagen (1998:1479) om värdepapperscentraler och kontoföring av finansiella instrument eller den som är antecknad på avstämningskonto enligt 4 kap. 18 § första stycket 6­8 nämnda lag skall antas vara behörig att utöva de rättigheter som följer av 4 kap. 39 § aktiebolagslagen (2005:551).

                                    _

Antagen vid årsstämman den 10 maj 2023

2023

EGM
2023 Kallelse till extra bolagsstämma
2023 Notice to Extra General Meeting
2023 Bilaga 1 – Villkor för teckningsoptioner av serie TO12 avseende nyteckning av aktier
2023 Anmälan och formulär för poströstning
2023 Notification and postal voting form
Fullmaktsformulär mall
AGM
2023 Kommuniké från årsstämman
2023 Kallelse till årsstämma
2023 Förslag till ny bolagsordning
2023 Anmälan och formulär för poströstning
2023 Form for notification of participation and postal voting

2022

2022 Kommuniké från årsstämman
2022 Kallelse till årsstämma
2022 Förslag till ny bolagsordning

2021

2021 Kommuniké från årsstämma
2021 Kallelse till årsstämma
2021 Poströstningsformulär inför årsstämma
2021 Förslag till ny bolagsordning
2021 Kommuniké från extra bolagsstämma

2020

2020 Kallelse till extra bolagsstämma (jan 2021)
2020 Poströstningsformulär inför extra bolagsstämma (jan 2021)
2020 Kommuniké från årsstämma
2020 Kallelse till årsstämma
2020 Förslag till ny bolagsordning
2020 Poströstningsformulär inför årsstämman
2020 Kommuniké från extra bolagsstämma
2020 Kallelse till extra bolagsstämma (apr 2020)

2019

2019 Kommuniké från extra bolagsstämma
2019 Kallelse till extra bolagsstämma
2019 Kommuniké från årsstämma
2019 Kallelse till årsstämma

2018

2018 Kommuniké från årsstämma
2018 Kallelse till årsstämma

2017

2017 Kommuniké från extra bolagsstämma
2017 Kallelse till extra bolagsstämma
2017 Kommuniké från årsstämma
2017 Kallelse till årsstämma

2016

2016 Kommuniké från årsstämma
2016 Kallelse till årsstämma

Fullmaktsformulär

Fullmaktsformulär mall

The nomination committee for the 2024 AGM has been established based on the largest owners as of September 30, 2023, who wish to participate in the nomination committee. The nomination committee has the following composition:

  • Peter Lindell, represents Cidro Förvaltning AB and own holding, chairman of the Nomination Committee
  • Mikael Lönn, represents own holding
  • Eva Redhe, represents own holding

The nomination committee’s tasks are, among other things, to submit proposals to the AGM for the chairman of the AGM, election of chairman and other members of the board of directors, as well as remuneration to each of the board members. The nomination committee shall also submit proposals for the election and remuneration of auditors.

Shareholders who wish to submit proposals to the nomination committee are welcome to send them by e-mail to valberedning2024@spagonanomedical.se. Proposals shall be submitted no later than January 31, 2024.

Instructions to the nomination committee

The company’s auditor is appointed by the Annual General Meeting. At the Annual General Meeting 2023, the auditing firm BDO Mälardalen AB was re-elected as auditor for a term of one year.

Jörgen Lövgren is the auditor in charge.

Career

The future of Spago Nanomedical is dependent on the know-how, creativity and skills of its employees. The company has an informal and flexible working environment offering employees good possibilities to professional and personal development.

Are you interested in working with us or want to explore the possibilities for Degree Projects (primarily within chemical synthesis, analysis and simulation of nanomaterials, but also biologically oriented projects involving cell culture and immunochemistry), please submit the below form.

    By registering your personal data, you agree that Spago Nanomedical saves this. Spago Nanomedical will handle the data according to current Data Protection Regulation (GDPR). We protect your privacy and do not give your personal data to any external part. If you want further information about how your personal data is processed or want to delete your personal data from our system, please contact us: Personal Data Manager, Spago Nanomedical AB (publ), Scheelevägen 22, 223 63 Lund Sweden E-mail: info@spagonanomedical.

    * Obligatory