Aankondiging • Jun 19
Spago Nanomedical AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 15.048808 million. Spago Nanomedical AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 15.048808 million.
Security Name: B Shares
Security Type: Common Stock
Securities Offered: 136,807,342
Price\Range: SEK 0.11
Transaction Features: Rights Offering Aankondiging • Jun 11
Spago Nanomedical AB (Publ) Announces Board Appointments Spago Nanomedical AB at its Annual General Meeting held on June 10, 2026, announced that Peter Lindell, Mikael Lönn and Tiel Ridderstad were elected as directors of the board for the period until the end of the next AGM. Bile Daar and Carolina Lönn were elected as deputy board members. Aankondiging • May 22
Spago Nanomedical AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 16.171779 million. Spago Nanomedical AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 16.171779 million.
Security Name: B Shares
Security Type: Common Stock
Securities Offered: 147,016,174
Price\Range: SEK 0.11
Transaction Features: Rights Offering Board Change • May 20
High number of new directors Independent Director Mikael Von Euler-Chelpin was the last director to join the board, commencing their role in 2025. Aankondiging • May 12
Spago Nanomedical AB (publ), Annual General Meeting, Jun 10, 2026 Spago Nanomedical AB (publ), Annual General Meeting, Jun 10, 2026, at 15:00 W. Europe Standard Time. Location: advokatfirman cederquist premises, hovslagargatan 3, in stockholm, stockholm Sweden Aankondiging • Oct 29
Spago Nanomedical AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 25.070126 million. Spago Nanomedical AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 25.070126 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 313,376,580
Price\Range: SEK 0.08
Transaction Features: Rights Offering Aankondiging • May 17
Spago Nanomedical AB (Publ) Approves Board Elections Spago Nanomedical AB (publ) at its AGM held on May 14, 2025, approved election of Mikael von Euler as director of the board for the period until the end of the next AGM and Alan Raffensperger as chairman of the board of directors. Aankondiging • Mar 21
Spago Nanomedical AB (publ), Annual General Meeting, May 14, 2025 Spago Nanomedical AB (publ), Annual General Meeting, May 14, 2025. Location: stockholm Sweden Aankondiging • Mar 20
Spago Nanomedical AB (publ) Announces Hans Arwidsson Declines Re-Election to the Board Spago Nanomedical AB (publ) announced that Hans Arwidsson has informed the nomination committee that he declines re-election to the board, at the 2025 Annual General Meeting. Aankondiging • Mar 04
Spago Nanomedical AB (publ) Announces Increased Dose in the Phase I/IIa Study Tumorad-01 Spago Nanomedical AB (publ) announced that the independent Data Monitoring Committee (DMC) recommends a dose increase in the ongoing phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201. The recommendation is based on analysis of data from two patient groups, consisting of six patients with five different cancer types. Both groups show similar acceptable safety profile. The clinical phase I/IIa studyTumorad-01 is a first-in-human study with the purpose of evaluating the safety, tolerability, dosimetry and initial efficacy of 177Lu-SN201 in cancer patients. The phase I part of the study aims to identify a possible therapeutic dose for further testing in selected patient groups in the phase IIa part of the study. The second patient group in the study, consisting of three patients, two women with lung and throat cancer, respectively, and one man with rectal cancer, has now been treated with at least one dose-cycle of 177Lu-SN201. Aankondiging • Jan 15
Spago Nanomedical AB (publ) Announces Publication in the Peer Peer Reviewed Scientific Journal Investigative Radiology Spago Nanomedical AB (publ) announced that a manuscript on product candidate pegfosimer manganese has been accepted for publication in the highly regarded peerreviewed scientific journal Investigative Radiology. The publication provides further scientific support for the SpagoPix development program. The article, entitled 'Safety, Tolerability, Efficacy and Pharmacokinetics of Pegfosimer manganese (SN132D) for Contrast Enhanced MRI of Breast Cancer', has been accepted for publication in The article focuses on results from the clinical study SPAGOPIX-01 in which NCT04080024 the product candidate pegfosimer Manganese (formerly SN132D) demonstrated acceptable safety and clinically relevant contrast enhancement in magnetic resonance imaging (MRI) of primary tumors in patients with breast cancer. The SpagoPix development program, with pegfosimer mangan cheese, aims to improve the precision of MRI of suspected cancers and endometriosis by launching a selective contrast agent for more precise visualization of tumors and other lesions. Initial clinical results show that pegfosimer manganee provides clinically relevant contrast in malignant breast tumors while maintaining good safety. Selective contrast enhancement has also been observed in endometriosis lesions in a Phase IIa clinical study. Continued clinical development within the SpagoPix NCT05664828 program will take place in collaboration with a partner, which will require out-licensing, commercial partnership, or by means of other external financing. Aankondiging • Dec 18
Spago Nanomedical AB (Publ) Announces All Patients in the Second Patient Group Have Been Dosed According to Plan in the Company's Phase I/IIa Study Tumorad-01 with the Candidate Drug 177Lu-SN201 Spago Nanomedical AB (publ) announced that all patients in the second patient group have been dosed according to plan in the company's Phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201. The study's independent Data Monitoring Committee (DMC) is expected to be able to present its analysis of the patient group during the first quarter. A total of six patients have so far been included and dosed in the study. The Phase I/IIa clinical study Tumorad-1 is a first-in-human study with the primary purpose of evaluating the safety, tolerability, dosimetry and initial efficacy of 177Lu-SN201 in cancer patients. The Phase I part of the study aims to identify a possible therapeutic dose for further testing in selected patient groups in the Phase IIa part of the study. In August 2024, the company announced that the first patient group in the Phase I part of the study, consisting of three patients, two men with lung and rectal cancer and one woman with throat cancer, has also been treated with at least one dose/cycle of 177Lu-SN201. Reported Earnings • Nov 07
Third quarter 2024 earnings released Third quarter 2024 results: Net loss: kr8.76m (loss widened 23% from 3Q 2023). Revenue is forecast to grow 116% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in Europe. Aankondiging • Oct 22
Spago Nanomedical AB (Publ) Appoints Nomination Committee for Annual General Meeting 2025 Spago Nanomedical AB (publ) appointed Nomination committee for Annual General Meeting 2025. The nomination committee for the 2025 AGM has been established based on the largest owners as of September 30, 2024, who wish to participate in the nomination committee. The nomination committee has the following composition, which together represent approximately 60% of all shares in Spago Nanomedical: Peter Lindell, represents Cidro Forvaltning AB and own holding, chairman of the Nomination Committee. The nomination committee's task is, 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. Aankondiging • Aug 27
Spago Nanomedical AB (publ)'s Phase I/IIa Study Tumorad-01 Continues Following Successful Treatment Completion of First Patient Group Spago Nanomedical AB (publ) announced that the independent Data Monitoring Committee (DMC) recommends to proceed the clinical phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201, with inclusion of patients with different tumor types. The recommendation is based on an analysis of data from the first three treated patients in the study that the DMC considers shows a satisfactory safety profile. The study proceeds according to plan with recruitment of patients at the two hospitals activated so far. Tumorad-01 is a phase I/IIa first-in-human study in patients with advanced cancer with the primary objective of evaluating the safety, tolerability, dosimetry and initial efficacy of the candidate drug 177Lu-SN201. The first patient group of three patients, two men with metastatic prostate cancer and one woman with metastatic breast cancer, has been successfully treated with at least one dose/cycle of 177Lu-SN201 (10 MBq/kg). The DMC has evaluated all available data for the patient population regarding safety, tolerability, biodistribution and dosimetry. No serious adverse events (SAEs) have been reported. Further, the DMC considers the safety to be satisfactory in this patient group and recommends the study to continue according to plan with inclusion of patients with different tumor types. The Phase I part of the study aims to identify a possible therapeutic dose for further testing in selected patient groups in the Phase IIa part of the study based on safety and biodistribution. Patient recruitment is proceeding according to plan and additional patients have been identified and are expected to be included shortly. The next DMC evaluation is expected to occur after 3 additional patients complete a first treatment cycle. Clinical evidence for selective tumor accumulation of Spago Nanomedical's functional nanoparticles has previously been generated with the MRI contrast agent pegfosimer manganese (SN132D) in breast cancer patients. In the Tumorad candidate drug 177Lu-SN201, the same type of carefully optimized polymeric nanomaterials is combined with the clinically effective radioisotope lutetium-177 (177Lu), which is already used in market-approved drugs. This makes 177Lu-SN201 a promising new radionuclide therapy for tumor-selective treatment of cancer with potential use in multiple tumor types. If a favorable biodistribution of radiation to tumors compared to other organs can be demonstrated, 177Lu-SN201 has good potential to become an effective drug against cancer. Reported Earnings • Aug 22
Second quarter 2024 earnings released Second quarter 2024 results: Net loss: kr8.15m (loss widened 3.6% from 2Q 2023). Revenue is forecast to grow 110% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. New Risk • Aug 14
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €9.08m (US$9.99m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr39m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Shareholders have been substantially diluted in the past year (283% increase in shares outstanding). Revenue is less than US$1m (kr6.0m revenue, or US$575k). Market cap is less than US$10m (€9.08m market cap, or US$9.99m). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (kr30m net loss in 2 years). New Risk • Jul 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr39m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr39m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Shareholders have been substantially diluted in the past year (283% increase in shares outstanding). Revenue is less than US$1m (kr6.0m revenue, or US$567k). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr30m net loss in 2 years). Market cap is less than US$100m (€10.2m market cap, or US$10.9m). New Risk • Jun 07
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 10% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (10% average weekly change). Shareholders have been substantially diluted in the past year (283% increase in shares outstanding). Revenue is less than US$1m (kr6.0m revenue, or US$578k). Market cap is less than US$10m (€9.16m market cap, or US$9.98m). Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr39m). Currently unprofitable and not forecast to become profitable over next 2 years (kr30m net loss in 2 years). New Risk • Jun 01
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -kr39m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (147% increase in shares outstanding). Revenue is less than US$1m (kr6.0m revenue, or US$571k). Market cap is less than US$10m (€5.77m market cap, or US$6.26m). Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr39m). Currently unprofitable and not forecast to become profitable over next 2 years (kr30m net loss in 2 years). Share price has been volatile over the past 3 months (10% average weekly change). Aankondiging • May 08
Spago Nanomedical AB (publ), Annual General Meeting, Jun 10, 2024 Spago Nanomedical AB (publ), Annual General Meeting, Jun 10, 2024, at 16:00 Central European Standard Time. Location: Advokatfirman Cederquist's premises Hovslagargatan 3 Stockholm Sweden Agenda: To consider the annual report and the auditor's report, as well as the consolidated financial statements and the auditor's report on the consolidated financial statements; to consider determination of the number of directors and deputy directors of the board; to consider determination of remuneration to the directors of the board and the auditors; to consider election of directors and chairman of the board of directors; to consider election of auditor; to consider authorisation for the board of directors to resolve to issue new shares and/or warrants; to consider amendment on the articles of association; and to consider reduction of the share capital for allocation to unrestricted shareholders' equity. Aankondiging • Apr 24
Spago Nanomedical AB (publ) Reports Favorable Data in Breast Cancer Model with Tumorad Spago Nanomedical AB (publ) announced data from a non-clinical study exploring 177Lu-SN201 in a model for triple-negative breast cancer. In the model, 177Lu-SN201 demonstrates superior anti-tumor effect compared to standard cancer drugs with a low and acceptable level of radiotoxicity observed. Spago Nanomedical's leading candidate drug within the radiopharmaceutical program Tumorad, 177Lu-SN201, is progressing in clinical development. In parallel to the ongoing phase I/IIa clinical trial in patients with advanced cancer, an extensive non-clinical study is underway to explore 177Lu-SN201 as monotherapy and combination therapy in a 4T1 orthotopic triple-negative breast cancer model. Data from the initial part of the study with 177Lu-SN201 as monotherapy demonstrates statistically significant anti-tumor effect compared to standard cancer drugs including anti PD-1 and anti-CTLA-4 (immune checkpoint inhibitors), Niraparib (PARP-inhibitor), Paclitaxel (taxanes), and Carboplatin (platinum-based chemotherapy). 177Lu-SN201 reduces tumor growth and significantly increases survival rate compared to animals treated with standard cancer drugs. A low and acceptable level of radiotoxicity was observed based on body weight and general appearance. Aankondiging • Apr 17
Spago Nanomedical AB (publ) Announces Appointment of Birgitta Rembratt Svensson as Head of CMC & Supply, Effective June 1, 2024 Spago Nanomedical AB (publ) announced the appointment of Birgitta Rembratt Svensson as Head of CMC & Supply. Birgitta, an experienced CMC project manager with several leading positions at development and commercial stage pharmaceutical companies, will join Spago Nanomedical on June 1 and serve as a member of the management team. Birgitta joins from the Danish commercial stage pharmaceutical company MC2 Therapeutics where she was CMC Project Manager since 2021. Previous positions include e.g. Head of Development at Sever Pharma Solutions AB and Bioglan AB, respectively. Birgitta holds a Ph. D. in physical chemistry and a M. Sc. in chemistry from Lund University. Reported Earnings • Feb 09
Full year 2023 earnings released: kr0.43 loss per share (vs kr0.61 loss in FY 2022) Full year 2023 results: kr0.43 loss per share. Net loss: kr42.2m (loss widened 7.7% from FY 2022). Revenue is forecast to grow 63% p.a. on average during the next 2 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Aankondiging • Jan 10
Spago Nanomedical Proceeds to the Next Dose Level in the Phase I/IIa Study Tumorad-01 Spago Nanomedical announced that the independent data monitoring committee has recommended a dose escalation in the company's clinical phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201. The recommendation is based on an analysis of data from the first dosed patient in the study showing that the safety profile of their first treatment cycle held no concerns. The study continues according to plan. Tumorad-01 is a phase I/IIa first-in-human study in patients with advanced cancer with the primary objective of evaluating safety, tolerability, dosimetry and initial efficacy of 177Lu-SN201. The first patient was successfully treated with the initial dose of 10 MBq/kg. Following a recommendation from the data monitoring committee, the company has decided to proceed to the next planned dose level of 25 MBq/kg. The phase I part of the study aims to identify, based on safety and biodistribution, a possible therapeutic dose for further testing in selected patient groups in the phase IIa part of the study. Patient recruitment is proceeding according to plan and initial data from the phase I part of the study is expected to be reported later in the first half of 2024. New Risk • Dec 22
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 147% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (15% average weekly change). Shareholders have been substantially diluted in the past year (147% increase in shares outstanding). Revenue is less than US$1m (kr8.6m revenue, or US$854k). Market cap is less than US$10m (€6.01m market cap, or US$6.61m). Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr44m). Currently unprofitable and not forecast to become profitable over next 2 years (kr32m net loss in 2 years). Aankondiging • Dec 20
Spago Nanomedical Announces Positive Top Line Data from a Clinical Phase IIa Study in Patients with Endometriosis Spago Nanomedical has announced positive top line data from a clinical phase IIa study in patients with endometriosis. SPAGOPIX-02 study is evaluating the MRI-enhancing effect of the contrast agent pegfosimer manganese. The data confirms that the primary endpoint was met, without compromising safety. Aankondiging • Dec 15
Spago Nanomedical Reports Positive Top Line Data from Clinical Phase IIa Study SPAGOPIX-02 in Patients with Endometriosis Spago Nanomedical AB (publ) announced that the analysis of data from the phase IIa clinical study SPAGOPIX-02 with the contrast agent pegfosimer manganese (formerly SN132D) confirms that the primary endpoint of measuring the MRI enhancing effect in endometriotic lesions was met, with an overall acceptable safety profile. The analysis of MR- images from the SPAGOPIX-02 clinical study shows that the primary endpoint of measuring The MRI enhancing effect in endometRIotic lesions that was identified by the treating gynaecologist was met.rast enhancement with pegfosimer mangan cheese was observed in the majority of lesions confirmed by unenhanced ultraound. In addition, the overall safety was considered acceptable, confirming the previously announced preliminary conclusion by the study Data Monitoring Committee (DMC). Exploratory analysis is suggestive of enhancement in active inflammatory lesions but not of indolent fibrotic lesions, suggesting the clinical relevance of pegfosimer mananese-enhanced MRI, which may be of great importance for disease staging and treatment planning. SPAGOPIX-02 is an open-label, proof-of-concept study with the primary objective to evaluate the MRI enhancing properties of the novel lesion selective MRI contrast agent pegfosimer Manganese in patients with suspected endometriosis. Secondary objectives included evaluations of the diagnostic value of pegfosimer manganee for detection of endometriosis lesions, specifically deep pelvic endometriosis lesions, and safety. The full analysis of results continues along with compilation of the clinical study report. Final results will be published later in one or several appropriate scientific journals and at scientific conferences. The contrast agent, previously known only as SN132D, has been granted the official generic name (International Nonproprietary Name (INN)) pegfosimer manganals by the World Health Organisation (WHO). From now on, the generic name will be used in all external communications.egfosimer manganese has previously been evaluated in the phase I clinical study SPAGOPIX -01 in patients with confirmed breast cancer. Results from the study show that the contrast agent is well tolerated and provides clear contrast in MRI images of solid tumors in the breast, as well as in the pancreas and liver. Aankondiging • Dec 07
Spago Nanomedical AB (publ) Announces First Patient Dosed in Spago Nanomedical's Clinical Phase I/IIA Study Within the Tumorad(R) Program Spago Nanomedical AB (publ) announced that the first cancer patient has successfully been dosed in the clinical phase I/IIa study Tumorad-01 with the candidate drug 177Lu-SN201. Initial data regarding safety and biodistribution from the phase I part of the study is expected to be reported already in the first half of 2024. Tumorad-01 is a phase I/IIa first-in-human study in patients with advanced cancer with the primary objective of evaluating safety, tolerability, dosimetry and initial efficacy of 177Lu-SN201. The phase I part of the study was designed for up to 30 cancer patients and aims to, based on safety and biodistribution, identify a possible therapeutic dose for further testing in selected patient groups in the phase IIa part of the study. The study is initially run at a number of clinics in Australia and as the study progresses, clinics in other countries may also be included. Clinical evidence of selective tumor accumulation of Spago Nanomedical's functional nanoparticles has previously been generated with the MRI contrast agent SN132D in breast cancer patients. In the Tumorad candidate drug 177Lu-SN 201, the same type of carefully optimized polymeric nanomaterial is combined with the effective radioisotope lutetium-177 (177Lu), which was previously used in market approved drugs. This makes 177Lu-SN201 a promising new radionuclide therapy for tumor-selective treatment of cancer with potential use in multiple tumor types. The Tumorad-01 study is designed to enable early data demonstrating safety, biodistribution and accumulation of 177Lu-SN201 in tumors in cancer patients. With a favorable distribution of radiation to tumors compared to other organs, 177Lu-SN201 has good potential to become an effective drug against cancer. Reported Earnings • Nov 04
Third quarter 2023 earnings released Third quarter 2023 results: Net loss: kr7.11m (loss narrowed 17% from 3Q 2022). Revenue is forecast to grow 49% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Germany. Aankondiging • Oct 26
Spago Nanomedical AB (publ) Announces Publication of Four New Patent Applications Filed with the European Patent Office Spago Nanomedical AB (publ) announced the publication of four new patent applications filed with the European Patent Office (EPO) to expand and extend the patent protection for the company's radionuclide therapy Tumorad. If granted, Tumorad will receive protection in all strategically key markets, including the EU, US and Japan, until at least 2042. The applications relate to composition patents and together they cover the various key components of the drug candidate 177Lu-SN201. Recently, Spago Nanomedical received approval to start a first clinical phase I/IIa study with the drug candidate 177Lu- SN201 in cancer patients and the first patient is expected to be included shortly. Aankondiging • Oct 24
Spago Nanomedical Announces Cancer Therapy Approved for Phase I/IIa Spago Nanomedical has achieved a significant milestone in its cancer therapy development journey. The company's drug candidate, 177Lu-SN201, has received approval to initiate the clinical phase I/IIa study, Tumorad-01, in Australia. Board Change • Oct 19
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 2 experienced directors. No highly experienced directors. Independent Director Kari Gronas is the most experienced director on the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Aankondiging • Oct 19
Spago Nanomedical AB (publ) Receives Approval to Initiate the Clinical Phase I/IIa Study with Tumorad in Australia Spago Nanomedical AB (publ) announced that the company's application to start the clinical phase I/IIa study, Tumorad-01, with the candidate drug 177Lu-SN201 in cancer patients has been approved. The first patient is expected to be included shortly. Full approval to start the study has been obtained from the ethics review committee at St. Vincent's Hospital in Melbourne, and it has been registered with the Australian Therapeutic Goods Administration (TGA). Site initiation is being conducted immediately and patient recruitment is expected to follow immediately thereafter. In addition to competent clinics, Australia offers several regulatory and financial advantages that allow the company to bring Tumorad to cancer patients quickly and cost-effectively. The possibility for substantial reimbursement of R&D costs is a great advantage, as is the familiarity of authorities and hospitals with radiopharmaceuticals and access to local manufacturing and distribution of the radioisotope lutetium-177. The approved clinical study is a phase I/IIa, dose escalation and dose expansion, first-in-human study in patients with advanced cancer. The primary aim of the entire study is to evaluate safety, tolerability and initial efficacy of 177Lu-SN201. The phase I part of the study will include up to 30 cancer patients with the aim to identify a possible therapeutic dose based on safety and biodistribution, to be further tested in selected groups of patients during the phase IIa part. A favorable distribution of radiation to tumors versus the rest of the body provides good conditions for 177Lu-SN201 to become an effective pharmaceutical against cancer. The study will initially be conducted at number of sites in Australia and as the study progress, sites in other countries may also be included. The aim is for the first patient to be included in the fourth quarter of 2023. Clinical evidence of selective tumor accumulation of Spago Nanomedical's functional nanoparticles has previously been generated with the MRI contrast agent SN132D in patients with breast cancer. The radioisotope lutETium-177 (177Lu) is clinical effective against cancer and is used already in market approved drugs. Combined with Spago Nanomedical's carefully designed polymeric nanomaterial, the candidate drug 177Lu- SN201 provides for a promising new radionuclide therapy for tumor selective treatment of cancer with potential use in several different tumor types. The Tumorad-01 study is designed to enable early results showing biodistribution and accumulation of 177Lu-SN201 in tumors in cancer patients. With a favorable distribution of radiation to tumors compared to other organs, 177Lu-SN201 has good potential to become an effective drug against cancer. Board Change • Sep 20
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 2 experienced directors. No highly experienced directors. Independent Director Kari Gronas is the most experienced director on the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. New Risk • Aug 15
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr42m Forecast net loss in 2 years: kr26m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Revenue is less than US$1m (kr8.9m revenue, or US$820k). Market cap is less than US$10m (€3.60m market cap, or US$3.94m). Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr50m). Currently unprofitable and not forecast to become profitable over next 2 years (kr26m net loss in 2 years). Breakeven Date Change • Aug 15
No longer forecast to breakeven The 2 analysts covering Spago Nanomedical no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr14.9m in 2024. New consensus forecast suggests the company will make a loss of kr37.6m in 2025. Reported Earnings • Aug 01
Second quarter 2023 earnings released Second quarter 2023 results: Net loss: kr7.87m (loss narrowed 18% from 2Q 2022). Revenue is forecast to grow 46% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Germany. Aankondiging • Jun 28
Spago Nanomedical Updates on the Clinical Phase IIa Study SPAGOPIX-02 Spago Nanomedical AB (publ) announced that a preliminary analysis of data from the phase IIa clinical study SPAGOPIX-02 shows that SN132D has a good safety profile in patients with endometriosis. Further evaluation of the MRI contrast enhancing properties, particularly in lesions indicative of deep endometriosis, is ongoing. SPAGOPIX-02 is an open-label, proof-of-concept study to evaluate the safety and MRI-enhancing properties of SN132D in patients with suspected endometriosis. The first preliminary results have been compiled and analysed by the study Data Monitoring Committee. It was concluded SN132D is well tolerated in patients with endometriOS and that further analysis is needed before conclusions about efficacy can be made. The Committee further concluded the number of recruited patients (n=8) at this point is sufficient to provide for a meaningful assessment and recruitment is therefore paused. The contrast agent SN132D has previously been evaluated in the phase I clinical study SPAGOPIX -01 in patients with confirmed breast cancer. Initial results from the study show that SN132D is well tolerated and provides clear contrast in MRI images of solid tumors in the breast, as well as in the pancreas and liver. Final report of the study is in preparation. Aankondiging • Jun 13
Spago Nanomedical AB (Publ) Announces Establishment of A Scientific Advisory Board Spago Nanomedical AB (publ) announced the establishment of a Scientific Advisory Board (SAB) comprised of scientific and clinical leaders in oncology and nuclear medicine. The SAB will provide support and guidance in the clinical development of the radiopharmaceutical program Tumorad with the candidate drug 177Lu-SN201. At the outset the SAB consists of three prominent members; Professor Sten Nilsson, Professor Kristian Pietras and Dr. Austin Smith.The current members of the Tumorad SAB are: Professor Sten Nilsson; Sten is a specialist and professor emeritus in oncology at the Department of Oncology-Pathology, Karolinska, as well as a specialist in nuclear medicine. Sten was responsible 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. Professor Kristian Pietras; Kristian 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. 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.Dr. Austin Smith; Austin is trained and qualified in Medical Oncology and Pharmaceutical Medicine. Austin is a graduate of the Royal College of Surgeons, Ireland and 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. Board Change • Jun 02
High number of new and inexperienced directors There are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 2 experienced directors. No highly experienced directors. Independent Director Kari Gronas is the most experienced director on the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Aankondiging • May 23
Spago Nanomedical AB (publ) Submits Application to Start Tumorad(R) Clinical Phase I/IIa Study Spago Nanomedical AB (publ) announced that the final step in the preparations for the clinical phase I/IIa trial in cancer patients, Tumorad-01, with its leading candidate drug 177Lu-SN201 has begun in Australia. The application to start the study has been sent to the ethics committee and patient enrollment is expected to start in the summer 2023. The application process includes submission to an Australian Human Research Ethics Committee (HREC), followed by a Clinical Trial Notification (CTN) to the Australian Therapeutic Goods Administration (TGA). Patient recruitment is expected to start immediately following approval. Spago Nanomedical plans to commence clinical development of 177Lu-SN201 with a phase I/IIa, dose escalation and dose expansion, first-in-human study in patients with advanced cancer. The primary aim of the study is to evaluate the safety, tolerability and early efficacy of 177Lu-SN201 The Phase I part of the study will include up to 30 patients. Clinical evidence of selective tumor accumulation of Spago Nanomedical´s functional nanoparticles has previously been generated with the MRI contrast agent SN132D in patients with breast cancer. The radioisotope lutetium-177 (177Lu) is clinically effective against cancer. Combined with Spago Nanomedical´s carefully designed polymeric nanomaterial, the candidate drug 177Lu-SN201 provides for a promising new radionuclide therapy for physiological targeting and tumor selective treatment of cancer with potential use in several different tumor types. Reported Earnings • May 15
First quarter 2023 earnings released: kr0.16 loss per share (vs kr0.24 loss in 1Q 2022) First quarter 2023 results: kr0.16 loss per share. Net loss: kr14.4m (loss widened 46% from 1Q 2022). Revenue is forecast to grow 85% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in Germany. Aankondiging • May 11
Spago Nanomedical AB (Publ) Elects New Directors Spago Nanomedical AB (publ) at its Annual General Meeting held on May 10, 2023, Hans Arwidsson and Alan Raffensperger were elected as new directors of the board for the period until the end of the next AGM. Hans Arwidsson was elected as chairman of the board of directors. Reported Earnings • Feb 05
Full year 2022 earnings released: kr0.61 loss per share (vs kr0.99 loss in FY 2021) Full year 2022 results: kr0.61 loss per share. Net loss: kr39.2m (flat on FY 2021). Products in clinical trials Phase I: 1 Phase II: 1 Revenue is forecast to grow 79% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in Europe. Aankondiging • Jan 11
Spago Nanomedical AB (Publ) Publishes Scientific Paper on Positive Preclinical Data with Tumorad(R) as Treatment of Solid Tumors Spago Nanomedical AB (publ) announced the publication of data on the composition, stability, and mode of action for its leading candidate drug 177Lu-SN201. The preclinical results shows that the candidate drug accumulates favorably in tumors, inhibits tumor growth, provides prolonged survival compared to control, and is suitable for systemic treatment of cancer. The paper was published in the scientific journal ACS Omega. The paper, titled "Characterization and Efficacy of a Nanomedical Radiopharmaceutical for Cancer Treatment", was published in the peer reviewed scientific journal ASC Omega. The results shows that the candidate drug accumulates favorably in tumors and is suitable for systemic treatment of cancer. Treatment with 177Lu-SN201 inhibited tumor growth and resulted in 37% longer survival compared to the control group in a preclinical model of colon cancer. The relative accumulation of 177Lu-SN201 in tumor, analyzed by single-photon emission computed tomography (SPECT), was 19.4% of the injected dose per gram tumor tissue. This is somewhat higher than has been previously reported for the Novartis drug Lutathera, a radionuclide therapy approved by the EMA and the FDA for treatment of patients with neuroendocrine tumors. Previous preclinical results from regulatory studies shows good safety of the nanoparticle SN201 in doses that widely exceeds the anticipated clinical dose. In summary, results indicate that 177Lu-SN201 is a promising new radionuclide therapy for physiological targeting and tumor selective treatment of cancer with potential use in several different tumor types. Preparations for clinical trials proceeds according to plan and the aim is to initiate a phase 1/2a trial in cancer patients within shortly. Aankondiging • Dec 10
First Patient Dosed in Spago Nanomedical’S Endometriosis Phase Iia Clinical Study Spago Nanomedical AB (publ) announced that the first patient in the Phase IIa clinical study with SpagoPix in endometriosis, SPAGOPIX-02, has been successfully dosed with the contrast agent SN132D and undergone magnetic resonance imaging (MRI). This open label, proof-of-concept study is conducted at the Department of Obstetrics and Gynecology at Skåne University Hospital in Malmö, Sweden, and led by Associate Professor Dr. Ligita Jokubkiene. It will evaluate the safety and MRI enhancing properties of the novel intravenous contrast agent SN132D in up to 18 patients with suspected endometriosis. Comparisons will be made to transvaginal ultrasound and conventional MRI in order to consider the diagnostic potential of SN132D in endometriosis. SN132D in endometriosis Endometriosis is a chronic disease of the female reproductive system in which cells similar to those in the endometrium, the layer of tissue that normally covers the inside of the uterus, grows outside the uterus, causing menstrual pain, pain at defecation and sexual intercourse, chronic pelvic pain and infertility. Like cancer, endometriosis is an angiogenesis-dependent disease that could be targeted by means of optimized functional nanoparticles. It is estimated that at least 176 million women of reproductive age are affected worldwide and endometriosis accounts for societal healthcare costs of a similar order as diseases such as type 2 diabetes or rheumatoid arthritis. Aankondiging • Dec 07
Spago Nanomedical Initiates Clinical Trial with Spagopix in Endometriosis and Concludes SpagoPix -01 Spago Nanomedical AB (publ) announced that the company has received regulatory approval to initiate a Phase IIa clinical study with its MRI contrast agent SN132D in endometriosis – a chronic, debilitating condition that affects up to 10% of women of reproductive age. Patient recruitment has started, and the first patient is expected to be dosed shortly. The ongoing SPAGOPIX-01 study in breast cancer has now been concluded and a final report is in preparation. The Phase IIa clinical trial in endometriosis is an open label, proof-of-concept study concerning efficacy of the novel intravenous contrast agent SN132D in patients with suspected endometriosis. The study will include up to 18 patients and led by Associate Professor Dr. Ligita Jokubkiene, Senior Consultant at the Department of Obstetrics and Gynecology at Skåne University Hospital in Malmö, Sweden. The study will evaluate the safety and MRI enhancing properties of SN132D in participants with suspected endometriosis. Comparisons will be made to transvaginal ultrasound and conventional MRI in order to consider the diagnostic potential of SN132D in endometriosis. The SPAGOPIX-01 study in breast cancer was conducted at two hospitals in Sweden with the primary objective of studying safety at different doses of SN132D. A total of 14 patients with confirmed breast cancer were enrolled and dosed. The initial results from the study will be presented at the 2022 San Antonio Breast Cancer Symposium and the final report of the study is in preparation. SN132D in endometriosis:- Endometriosis is a chronic disease of the female reproductive system in which cells similar to those in the endometrium, the layer of tissue that normally covers the inside of the uterus, grows outside the uterus, causing menstrual pain, pain at defecation and sexual intercourse, chronic pelvic pain and infertility. Like cancer, endometriosis is an angiogenesis-dependent disease that could be targeted by means of optimized functional nanoparticles. It is estimated that more than 176 million women of reproductive age are affected worldwide and endometriosis accounts for societal healthcare costs of a similar order as diseases such as type 2 diabetes or rheumatoid arthritis. Access to early diagnosis and effective treatment of endometriosis is important. Currently, the average time to diagnosis is 7 years and the clinical need for improved diagnostic technologies is high. Breakeven Date Change • Nov 25
Forecast to breakeven in 2023 The 2 analysts covering Spago Nanomedical expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr8.80m in 2023. Aankondiging • Sep 21
Spago Nanomedical Gets SpagoPix Abstract Accepted At Breast Cancer Conference Spago Nanomedical AB (publ) announced that an abstract, concluding the initial results from the First-In-Human Phase I clinical trial SPAGOPIX-01, has been accepted for poster presentation at the 2022 San Antonio Breast Cancer Symposium® (SABCS) on December 6-10, 2022. The abstract, titled Safety, tolerability, and efficacy of the novel intravenous manganese-based contrast agent SN132D in patients with breast cancer: initial results of a Phase I, First-In-Human clinical trial SPAGOPIX-01, will be presented at the 2022 San Antonio Breast Cancer Symposium by the coordinating investigator Dr. Fredrik Wärnberg, professor and breast surgery specialist at Sahlgrenska University Hospital. The initial results from the open-label, non-randomized and non-placebo-controlled Phase I study SPAGOPIX-01, evaluating the drug candidate SN132D, demonstrate an acceptable safety profile and PoC for SN132D in breast cancer patients. Physiological targeting with functional nanoparticles appears to be suitable for tumor MRI imaging and the data generated to date are in agreement with preclinical data in rodent tumor models. The data is based on 12 female breast cancer patients enrolled in the study between September 2019 and December 2021. Aankondiging • Sep 13
Spago Nanomedical Announces Process of Entering Clinical Phase with Its Drug Candidate [177]Lu-SN201 Spago Nanomedical is in the process of entering clinical phase with its drug candidate [177]Lu-SN201, which is expected to have wide use in this particular area. Reported Earnings • Apr 28
First quarter 2022 earnings released First quarter 2022 results: Net loss: kr9.88m (loss widened 63% from 1Q 2021). Over the next year, revenue is forecast to grow 195%, compared to a 43% growth forecast for the industry in Germany. Breakeven Date Change • Apr 27
Forecast breakeven date pushed back to 2023 The analyst covering Spago Nanomedical previously expected the company to break even in 2022. New forecast suggests the company will make a profit of kr7.40m in 2023. Reported Earnings • Feb 04
Full year 2021 earnings: EPS in line with expectations, revenues disappoint Full year 2021 results: kr0.95 loss per share (down from kr0.70 loss in FY 2020). Net loss: kr39.1m (loss widened 106% from FY 2020). Revenue missed analyst estimates by 5.7%. Over the next year, revenue is forecast to grow 970%, compared to a 67% growth forecast for the pharmaceuticals industry in Germany. Aankondiging • Jan 26
Spago Nanomedical AB (publ) Announces New Results Spago Nanomedical AB (publ) announced new results which show that the company's leading candidate drug Tumorad (177Lu-SN201) significantly reduces tumor growth and prolongs survival in a preclinical model for colorectal cancer. Together with previously communicated clinical and preclinical results, the new results provide additional support for the company's unique platform technology with nanoparticles foruse in several different cancer indications. The new results show that SN201 loaded with the clinically validated isotope lutetium 177(177Lu) delays tumor growth and prolongs survival by 39% in a preclinical model of colorectalcancer compared to the control group. The results reinforce previous preclinical results with177Lu-SN201 from a mouse model in aggressive breast cancer. Together with the recentlycommunicated interim results from the company's ongoing phase 1 study with SpagoPix(SN132D), the results show the strength and breadth of the company's platform technology.A first clinical trial with SN201 in humans is planned to start in 2022. Work is underway toproduce study protocols and documentation for applications to relevant authorities, as well asidentification of suitable hospitals for the study. In parallel, the production of GMP materialscontinues at an external contract manufacturer (CMO). The clinical study will be carried out incancer patients and is designed to document safety of 177Lu-SN201 at different doses, as wellas evaluating early proof of concept of its anti-tumor effects. The clinical need for new types of cancer treatment is great. 177Lu-SN201 is being developedas a new type of radionuclide therapy for the treatment of cancer, where tumors are radiatedlocally inside the body. Because the material accumulates in fast-growing tumors, the treatmenthas the potential to reach both aggressive and disseminated tumors. 177Lu-SN201 isconsidered to be able to treat tumors alone or in synergy with other types of therapies. Theproject is protected by approved patents in several strategically important regions, including theUS, the EU and Japan. Aankondiging • Jan 18
Spago Nanomedical Announces Positive Interim Results from Phase I Study with SpagoPix Spago Nanomedical announced interim results from their phase I study with SpagoPix, the tumour selective contrast agent in cancer diagnostics with magnetic resonance imaging. The results show that the candidate is safe, that it accumulates into the tumours, and that it provides clear contrast enhancement in the image analysis. Based on these results the company has decided to expand the study to new indications, in addition to breast cancer. Aankondiging • Jan 14
Spago Nanomedical AB (Publ) Announces Interim Results from the Second Dose Group in Ongoing Clinical Phase I Study SPAGOPIX-01 Spago Nanomedical AB (publ) announced that interim results from the second dose group in the company's ongoing clinical phase I study SPAGOPIX-01 show that SpagoPix (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. A total of 12 patients with confirmed breast cancer have been included in the phase I study SPAGOPIX-01 with the tumor-selective contrast agent SpagoPix (SN132D). After analyzing the data, the internal safety committee for the study has concluded that SN132D is safe at the second, higher dose level. The MRI images from the 6 patients in the second dose group show that SN132D provides clear contrast enhancement in breast tumors as well as in the pancreas and liver. The results thus confirm previously presented interim results that SN132D accumulates in solid tumors. The primary endpoint of the study is to study safety at different doses of SN132D. Secondary endpoints include how the contrast agent can enhance MRI images in clinical use in patients with solid breast tumors, and how the contrast agent can enhance MRI images of the pancreas and liver. Based on analysis of the interim results, the company will continue evaluating SN132D in breast cancer and has decided to broaden the indication area to include patients with documented pancreatic cancer with metastases in the liver. An application for an amendment to the current study protocol is being submitted to the Swedish Medical Products Agency. Spago Nanomedical is also evaluating SN132D in additional indications areas of clinical need. The interim results presented so far show that Spago Nanomedical's platform technology makes it possible to clinically and precisely accumulate functional nanoparticles in solid tumors. This is also of great importance for the company's project Tumorad®, which aims to develop a precision treatment for several different cancers. Tumorad, with the candidate drug code SN201, has demonstrated a positive effect by slowing tumor growth in a preclinical model for aggressive breast cancer. Further preclinical studies in other cancer models are ongoing. Aankondiging • Dec 03
Spago Nanomedical AB (Publ) Announces That Second Dose Group Fully Recruited in Spago Nanomedical's Phase 1 Study with Spagopix Spago Nanomedical AB (publ) announced that all patients have been recruited in the second dose group in the company's ongoing clinical phase I study SPAGOPIX-01 with the tumor-selective contrast agent SpagoPix (SND132D). New interim results are expected to be reported in early 2022. A total of 6 patients with confirmed breast cancer have been included in the second dose group in the phase I study SPAGOPIX-01, which has been performed at two hospitals in Sweden. A number of adjustments to the study protocol have been made during the course of the study to, among other things, broaden the patient base and simplify the inclusion of patients. Including the 6 patients included in the first dose group, a total of 12 patients were evaluated in the study. The primary endpoint of the study is to study safety at different doses of SN132D. Secondary endpoints include initially investigating how the contrast agent can enhance MRI images in clinical use in patients with solid tumors of the breast, as well as the liver and the pancreas. Previous interim results from the study have shown a good safety profile and clear contrast in MRI images of breast tumors at the current dose. Furthermore, all images in the study showed a very good contrast in the pancreas and in the liver. Reported Earnings • Nov 12
Third quarter 2021 earnings released Third quarter 2021 results: Net loss: kr10.1m (loss widened 125% from 3Q 2020). Breakeven Date Change • Aug 26
Forecast to breakeven in 2022 The analyst covering Spago Nanomedical expects the company to break even for the first time. New forecast suggests the company will make a profit of kr19.8m in 2022. Reported Earnings • Aug 25
Second quarter 2021 earnings released Second quarter 2021 results: Net loss: kr11.6m (loss widened 144% from 2Q 2020). Reported Earnings • Apr 17
Full year 2020 earnings released: kr0.70 loss per share (vs kr1.01 loss in FY 2019) Full year 2020 results: Net loss: kr18.9m (loss narrowed 6.3% from FY 2019). 
