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

2024 has begun in the same positive spirit as we ended last year. The phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201 is progressing according to plan with a continued satisfactory safety profile. New and promising non-clinical effect data in a triple-negative breast cancer model further strengthens our belief in Tumorad in the treatment of several different types of cancer. As we take Tumorad further into the clinic, we have also strengthened the management team with an experienced Head of CMC & Supply.

Our ongoing phase I/IIa clinical study Tumorad-01 is a first-in-human study with the primary aim of evaluating safety, tolerability, dosimetry and initial effect of 177Lu-SN201 in cancer patients with the aim of identifying a possible therapeutic dose for further studies. In January, we announced that the first patient was successfully treated with the initial dose and the study has since continued as planned.

The phase I part of the study aims to, based on safety and biodistribution, identify a possible therapeutic dose for further testing in selected patient groups in the phase IIa part. Based on preclinical results, we assess that there is a good chance of a favorable benefit-risk profile in humans. Using different methods to measure radioactivity in the body, even at low doses, we expect to be able to get an early idea of the possibilities for therapeutic usefulness in cancer patients. Patient recruitment continues and our ambition is to further update the market regarding the study before mid-year.

In parallel with the clinical study, an extensive non-clinical program is also underway to explore Tumorad as both a monotherapy and combination therapy in triple-negative breast cancer, a very aggressive and difficult-to-treat form of cancer in which the tumor cells often have resistance to chemotherapy even before the chemotherapy treatment has begun and which makes up approximately 15 percent of all breast cancer cases. It was therefore very gratifying that in April, after the end of the period, we were able to report favorable data from the initial non-clinical study with 177Lu-SN201 as monotherapy showing superior tumor inhibitory effect compared to drugs used in standard treatment with only a low and acceptable level of radiotoxicity being observed. The findings we have seen in this model are very promising and support continued non-clinical development, with evaluation of combination therapy as the next step.

The interest in the radiopharma area continues to be high among pharmaceutical companies and specialist investors with several completed transactions of significant size. In March, AstraZeneca strengthened its radiopharma portfolio with the acquisition of the US based Fusion Pharmaceuticals, a transaction worth up to $2.4 billion. Another current example is Bristol Myers Squibb which, at the end of last year, acquired RayzeBio and its radiopharma platform for around USD 4.1 billion.

We also see continued interest in our second development program, SpagoPix, and especially in endometriosis where at the end of last year we reported positive topline data from the phase IIa clinical study SPAGOPIX-02 with the contrast agent pegfosimer manganese. The study was an open-label proof-of-concept study with the primary objective of evaluating contrast enhancement in patients with endometriosis. Analysis of study data showed that contrast enhancement could be observed in the majority of lesions confirmed by ultrasound, and thus the primary efficacy objective had been met. The results show the potential of pegfosim manganese in medical imaging of endometriosis lesions and enable further evaluation in the next step.

The increasing interest in women's health in general, and endometriosis specifically, was clearly evident during the annual J.P. The Morgan Health Care conference in January that we attended in order to create new contacts. We participated in several productive meetings with possible future partners.

Given the progress within both of our development programs, we have seen a need to strengthen the company's organization and I am very pleased with the recruitment of Birgitta Rembratt Svensson as the new Head of CMC & Supply. Birgitta is an experienced CMC project manager with senior positions at pharmaceutical companies in the commercial phase, and will join Spago Nanomedical's management team in June. Procurement, planning and execution of production and distribution will become increasingly important to supply our clinical studies with drugs and, in the longer term, prepare for commercial scale. The recruitment to this key position is thus an important part in building a strong team with a focus on later development phases and commercialization.

2024 will be a very important year for Spago Nanomedical with the greatest focus on the clinical study with our leading program Tumorad. I look forward to continuing to update you on our progress and upcoming milestones.

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): 709,000 shares

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): 1,337,334 shares

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: 1964

Member of the board since: 2018

Holdings (related parties included): 316,665 shares

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, board member of Ultimovacs ASA and Oncoinvent AS.

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): 136,599 shares

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): 609,982 shares

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): 265,702 shares

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): 106,875 shares

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): 95,000 shares

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: –

Birgitta Rembratt Svensson

Head of CMC & Supply

Born: 1971

Head of CMC & Supply since: 2024

Holdings (related parties included):

Education and experience: Birgitta holds a Ph.D. in physical chemistry and a M.Sc. in chemistry. She has experience in pharmaceutical development, regulatory CMC, and IMP/commercial supply. Previous positions include CMC Project manager at MC2 Therapeutics A/S and Head of Development at Sever Pharma Solutions AB and Bioglan AB.

Other appointments: –

Medical Advisors

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 papers.

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 at Region Skåne, and is a member of the Swedish Society of Radiology (SMFR), and chairman of the Swedish contrast agent group within SMFR.

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.

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. Tmothy’s research is focused on translational development of medical imaging technologies.

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.

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.

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

2024

2024 Kallelse till årsstämma
2024 Notice to Annual General Meeting
2024 Anmälan och formulär för poströstning
2024 Notification and postal voting form
Fullmaktsformulär mall

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

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