Optimizing Cancer 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 diseases.

More Accurate Diagnosis and Treatments

The company's operations are based on a patented material for the design of functional nanoparticles that accumulate physilogically in tumors, thus enabling higher precision and improved cancer patient care. The current pipeline projects have the potential to facilitate diagnostics and improve the treatment of cancer indications with urgent medical needs.

The SpagoPix project aims to launch a ground-breaking gadolinium-free MRI contrast agent for visualization of tumors and metastases. Unlike the conventional low molecular-weight MRI contrast agents, which enhance healthy tissue as well as tumor 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 nanoparticles loaded with radioactive isotopes. The design of Tumorad® makes 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

The positive and intense spirit that characterized last year continued during the first quarter of this year with good news from both our projects, SpagoPix (SN132D) and Tumorad® (177Lu-SN201). Of course, we are also following developments with regard to both Covid-19 and the tragic war in Ukraine; we do not currently see any immediate impact of these on our operations.

A priority area for us is to maximize the value of SPAGOPIX-01 - our Phase I clinical trial with the contrast agent SN132D. To this end, we have amended the study so that it can also include patients with pancreatic cancer. This is a cost-effective way to show the potential of SN132D in another cancer indication, thus enabling increased value. The recruitment of patients for the study with suspected or confirmed pancreatic cancer that has spread to the liver is ongoing.

At the same time, I would like to emphasize that there is no doubt that the study is positive. The interim results from the second dose group show that SN132D is well tolerated and provides clear contrast in MRI images of breast tumors, as well as in the pancreas and liver tissue. The study's internal safety committee has found that SN132D is safe at both dose levels.

The results also confirm that SN132D accumulates in solid tumors in humans, which, in addition to safety, has been our main goal of the study. We have thus confirmed that the principle on which we have built our platform - physiological enrichment of nanoparticles in tissue with EPR effect - works in the body and with the equipment available in hospitals. The very good correlation between preclinical and clinical results is of great importance and strengthens our confidence about the possibilities of using the platform also for therapy with Tumorad.

After showing that SN132D clearly accumulates in cancerous tumors and provides images with both high precision and positive contrast, additionally showing the tumor without background noise, we continue the dialogue with potential licensees. Our conclusion from these dialogues so far is that the study program should be expanded to more indications for a deal to be interesting. By including patients with cancer of the pancreas, we can demonstrate the greater potential of SN132D. We are also evaluating the possibilities in other indications where the EPR effect is well documented, both within and outside the cancer area. With the results we have achieved so far, we see good opportunities to position SN132D in important indications with a great clinical need for improved imaging diagnostics.

With the knowledge from the SpagoPix project, Tumorad has been able to develop at a very high pace. Now that we have confirmed that our materials accumulate in malignant tumor tissue in humans as well, our main focus is to enter into clinical trials as soon as possible with the drug candidate 177Lu-SN201, our nanoparticle SN201 loaded with the clinically proven radioisotope Lutetium-177 (177Lu). We plan to initiate the first study in humans during the year.

The work of optimizing the clinical development and the path to market approval for 177Lu-SN201 is in an intensive phase. We intend to apply for orphan drug status for 177Lu-SN201 for the treatment of ovarian cancer, provided that preclinical studies show strong results here as well. At the same time, we are also evaluating other ways to develop the 177Lu-SN201 in both broad and more niche indications.

In parallel with developing a clinical program, we continue to build the preclinical package around the candidate drug. In January, we were able to show that 177Lu-SN201 delays tumor growth and prolongs survival by 39% compared to the control group in a model for colorectal cancer, a statistically significant improvement. The results broaden our previous positive results with the drug candidate in a preclinical model for aggressive breast cancer. 177Lu has been clinically validated for long. With this, we show the strength and breadth of the technology and lay the foundation for clinical development.

Overall, we see a very large potential in the Tumorad project. Already at the current stage of development, we see a value for 177Lu-SN201 which in the orphan drug indication ovarian cancer alone is significant and, with an optimized development strategy, rapidly increasing. To this can be added the value in other, larger indications.

In step with the positive development, several new patent applications have recently been submitted to extend patent protection and strengthen Tumorad's future position.

Tumorad is unique, and we see a clear interest for the project. In preparation for clinical trials, we have initiated dialogues with specialist investors. In this context, we can observe a great interest in radionuclide therapy among both investors and pharmaceutical companies, which has recently resulted in a number of investments and acquisitions in this area.

Strengthened by these important milestones, I see that we have an exciting year ahead of us, and I look forward to updating you as our projects continue to develop.

Mats Hansen, CEO Spago Nanomedical AB

Board of Directors

Eugen Steiner

Chairman of the Board

Born: 1954

Member of the board since: 2019

Holdings (related parties included): 253,125 shares, 60,000 warrants in program TO10

Education and experience: Eugen is a medical doctor and a specialist in Clinical pharmacology, holding a Ph.D. from Karolinska Institutet. Eugen has over 30 years of experience from CEO and board assignments within several Swedish, Norwegian, English and American life-science companies in various development phases. He has been a venture partner in HealthCap since 1997.

Other appointments: Chairman of the Board of Empros Pharma AB. Board member of BioArctic AB, Apotek Produktion & Laboratorier AB, Inbox Capital AB, Inbox Intressenter 1 AB, Inbox Intressenter 2 AB, Inbox Intressenter 3 AB, Inbox Intressenter 4 AB Karolinska Institutet Holding AB. Karolinska Institutet Innovation and A3P Biomedical AB (publ). Board member and CEO of Setraco AB and deputy board member of Doctrin AB.

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

Peter Leander

Board Member

Born: 1957

Member of the board since: 2012

Holdings (related parties included):

Education and experience: 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.

Other appointments: Member of the board of Lument AB.

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

Sten Nilsson

Board Member

Born: 1948

Member of the board since: 2013

Holdings (related parties included): 18,324 shares.

Education and experience: 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.

Other appointments: Board member of Dextech Medical AB, owner and member of the board of DETRUSOR AB. Co-founder of Micropos Medical AB (publ) and board member and chairman of Rehnman & Partners Asset Management AB’s scientific advicery board.

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): 20,000 warrants in program TO10

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): 8,265 shares, 4,000 warrants in program TO10

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): 110,522 shares, 60,000 warrants in program TO11

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

VP and Chief Scientific Officer (CSO)

Born: 1962

In the management team since: 2007

Holdings (related parties included): 69,922 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): 28,125 shares, 25,000 warrants in program TO11

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): 25,000

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.

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 40 000 000 kr och högst 160 000 000 kr.

§ 5      Antal aktier
Antalet aktier skall vara lägst 40 000 000 och högst 160 000 000 stycken.

§ 6      Styrelse
Styrelsen skall bestå av 3-­7 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 istället 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:

  1.  Val av ordförande vid stämman;
  2. Upprättande och godkännande av röstlängd;
  3. Val av en eller två justeringsmän;
  4. Godkännande av dagordning;
  5. Prövning av om stämman blivit behörigen sammankallad;
  6. Framläggande av årsredovisning och revisionsberättelse, samt, i förekommande fall, koncernredovisning och koncernrevisionsberättelse;
  7. Beslut om:
    • fastställande av resultaträkning och balansräkning, samt, i förekommande fall, koncernresultaträkning och koncernbalansräkning,
    • dispositioner av bolagets resultat enligt den fastställda balansräkningen,
    • ansvarsfrihet åt styrelseledamöter och verkställande direktör.
  8. Fastställande av styrelse­ och, i förekommande fall, revisorsarvoden
  9. Val av styrelse och, i förekommande fall, revisionsbolag eller revisorer samt eventuella revisorssuppleanter
  10. 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 18 maj 2022

The Nomination Committee for the 2022 Annual General Meeting has been established based on the largest owners as of September 30, 2021, who wished to participate in the Nomination Committee’s work. The Nomination Committee has the following composition:

  • Peter Lindell, represents Cidro Förvaltning AB and own holding
  • Mikael Lönn, represents own holding
  • Eva Redhe, represents own holding

The Nomination Committee has elected Peter Lindell as Chairman.

The Nomination Committee’s assignment is to present proposals for the Annual General Meeting regarding the Chairman of the Annual General Meeting, election of Chairman and other members of the Board, 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 can do so by e-mail to: valberedning2022@spagonanomedical.se

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

The company’s auditor is appointed by the Annual General Meeting. At the Annual General Meeting 2022, 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.

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