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Spago Nanomedical interim report January-June 2021

Continued good pace in the business despite Covid-19 APRIL – JUNE IN BRIEF · Net sales for the quarter amounted to KSEK 267 (KSEK 0). · The loss for the quarter amounted to KSEK -11,607 (KSEK -4,764). · Operating expenses for the quarter amounted to KSEK -13,450 (KSEK -6,269). · Earnings per share, before and after dilution, for the quarter amounted to SEK -0.28 (SEK -0.19). · Cash and cash equivalents at the end of the quarter amounted to KSEK 76 873 (KSEK 41,421). JANUARY – JUNE IN BRIEF · Net sales for the half-year period amounted to KSEK 367 (KSEK 100). ·

Spago Nanomedical appoints Paul Hargreaves as Chief Development Officer

Spago Nanomedical AB (publ) announced today that Paul Hargreaves has been appointed Chief Development Officer (CDO), starting September 13. He will join the management team and have a key role in the clinical development of the company´s project portfolio.The appointment of Paul Hargreaves as CDO marks an important step for Spago Nanomedical as the company continues to make progress with its unique project portfolio, with the Tumorad[®] candidate drug SN201 rapidly advancing towards clinical trials. This is an opportunity to provide potential treatment for advanced cancers of different

Bulletin from the 2021 Annual General Meeting of Spago Nanomedical AB (publ)

The Annual General Meeting (AGM) of Spago Nanomedical AB (publ) was held today, May 5, 2021, at which the AGM resolved to approve the income statement and balance sheet for 2020 and discharge the Board members and the CEO from liability for the financial year 2020.The following resolutions were also passed at the AGM: Disposition of results In accordance with the Board's proposal, no dividend will be paid and KSEK 47,966 are carried forward. Election of board and board fees The Board shall consist of five ordinary members and no deputies. Peter Leander, Sten Nilsson, Kari Grønås,

Spago Nanomedical interim report January-March 2021

Successful rights issue strengthens project development JANUARY – MARCH IN BRIEF ·Net sales for the quarter amounted to KSEK 100 (KSEK 100). · The loss for the quarter amounted to KSEK -6,068 (KSEK -5,054). · Operating expenses for the quarter amounted to KSEK -7,439 (KSEK -6,769). · Earnings per share, before and after dilution, for the quarter amounted toSEK -0.18 (SEK -0.24). · Cash and cash equivalents at the end of the quarter amounted to KSEK 85,225 (KSEK 6 938). SIGNIFICANT EVENTS DURING THE QUARTER ·Spago Nanomedical was provided with MSEK 69 in an

Trading of Spago Nanomedical shares on Nasdaq First North Growth market starts today

Commencing today, Spago Nanomedical AB (publ) shares are traded at the Nasdaq First North Growth Market under the ticker “SPAGO”.“Facilitation of healthcare and saving lives should always be a good investment. At Spago Nanomedical we are committed to improving treatment and diagnostics of life-threatening diseases as we continue to build our business. The listing at Nasdaq First North Gorwth Market is a stepping stone for continued value creation for our owners and eventually for patients with cancer. It marks the beginning of the next chapter of Spago Nanomedical”, says CEO Mats Hansen.

Extended SpagoPix patent protection in Europe

Spago Nanomedical AB (publ) has received notice from the European Patent Office (EPO) that it intends to grant the company´s patent application including a critical component of the SpagoPix candidate drug SN132D. The granted patent will extend protection of SpagoPix in Europe until at least 2038.EPO has issued an Intention to grant-notification which means the patent will be granted following confirmation of Spago Nanomedical and payment of applicable fees. The granted patent, ”Chemical compounds for coating of nanostructures” (EP18700364.5) provides Spago Nanomedical with additional

Invitation to webcast

In connection to the interim results of the clinical study SPAGOPIX-01, the company invites to a live webcast today at 13:00. CEO Mats Hansen will present and comment the results, and provide opportunity for questions. The webcast can be reached by: https://www.finwire.tv/webcast/spago-nanomedical/q3/. The webcast will be available afterwards at the home page of Spago Nanomedical. For further information, please contact: Mats Hansen, CEO Spago Nanomedical AB (publ), +46 46 811 88, mats.hansen@spagonanomedical.se

Distinct images in clinical study with SpagoPix

Interim results from the phase I study SPAGOPIX-01 show that SN132D provides MRI contrast enhancement in breast tumors. In line with previous preclinical data the clinical results confirm accumulation of the unique nanomaterial in solid tumors. In addition, unexpectedly good contrast in the pancreas has been observed in all images from the study so far, representing an opportunity the company will explore further.Spago Nanomedical CEO Mats Hansen will provide comments on the results in a webcast, today at 1 pm, which can be reached by the following link: https://www.finwire.tv/webcast/spago-

Spago Nanomedical appoints candidate drug in the Tumorad® project

Spago Nanomedical AB (publ) has demonstrated, with statistical significance, that Tumorad® reduces tumor growth and extends survival in a mice model for breast cancer. Based on this result and previously communicated progress in the project, the company has decided to formally appoint candidate drug (“CD”) and prepare the preclinical safety program with Tumorad® required in preparation for clinical trials.”This is an important step for the company and for Tumorad® on its way to becoming an integral part of the treatment arsenal against cancer. It also marks the entry of our second project

Tumorad[®] patent approval in Japan

Spago Nanomedical has received notice of allowance for the company´s patent application including Tumorad[®] product protection in Japan.”The patent covers the nanomaterial that is central for the Tumorad[®]-project. As Japan represent a potentially large market for radionuclide therapies, this approval is important. It also underscores the quality of our innovation and strengthens the commercial prospects of the project”, says Spago Nanomedical CEO Mats Hansen. The patent, titled ”Nanostructures and applications thereof” (application no. 2017-501494), is valid until 2035. With the

SpagoPix phase I study to next dose level and expansion to additional site

Data from the first dose group in the phase I trial show that SN132D is well tolerated, and provide valuable information for optimization of MRI in the next step. Now that the study continues into the next dose level the company intend to up the pace in patient recruitment by engaging an additional study center.The internal safety review committee (iSRC) has analysed data of the first six patients of the clinical study SPAGOPIX-01 and concluded that the initial dose of SN132D is safe. The iSRC further conclude that the dose should be increased in order to optimize contrast enhancement of

Lead compound appointed in the Tumorad® -project

Spago Nanomedical has appointed lead compound in the Tumorad® -project and is now proceeding development into pre-clinical proof-of-concept validation in tumor models.”Nomination of lead compound is an important step marking that we now hold a material that fulfills our strict requirements on pharmacokinetic and chemical properties for selective accumulation in solid tumors, as well as clinical use”, says Spago Nanomedical CSO Oskar Axelsson. The immediate aim is to initiate preclinical proof of concept studies in suitable tumor models. The design of the lead compound particle also

Spago Nanomedical to present preclinical data for SpagoPix at ECR

Spago Nanomedical AB (publ) will present preclinical data for SpagoPix at the conference European Congress of Radiology (ECR) this week.The presentation, in the form of a poster with the title ”Efficacy and safety profile of SN132D, a novel nanoparticle MRI contrast agent”, includes preclinical data that collectively show that the product candidate SN132D is safe and efficient at dose levels corresponding to clinically relevant doses. The poster can be viewed here https://posterng.netkey.at/esr/viewing/index.php?module=viewing_poster&task=&pi=146808&

Spago Nanomedical receives approval to initiate the clinical trial SPAGOPIX-01

Spago Nanomedical AB (publ) has received approval from the Swedish Medical Products Agency to initiate the first clinical trial with the contrast agent SpagoPix (SN132D) in patients with breast cancer.SpagoPix is a nanomedical contrast agent with potential to significantly improve cancer diagnostics with magnetic resonance imaging (MRI). Spago Nanomedical will initially focus on imaging of breast cancer, a disease that affects approximately 2.1 million people annually. MRI is used regularly for screening, diagnosis, or tumor staging in 15-30% of all breast cancer patients but the need for

New data on SpagoPix published in European Journal of Inorganic Chemistry

Study results show that the signal strength of SpagoPix is among the highest reported for MRI contrast agents and far higher than those of the clinically used gadolinium based contrast agents currently in clinical use.The article, titled ”Characterization of a manganese-containing nanoparticle as MRI contrast agent”, is the result of a collaboration with researchers at the University of Turin led by professor Silvio Aime. The paper describes physicochemical studies where the signal strength of SpagoPix has been documented. ”We have shown that, overall, the per-manganese relaxivity of

Spago Nanomedical submitted application for initiation of the phase I clinical trial SPAGOPIX01

Spago Nanomedical AB (publ) applied today with the Swedish Medical and Pharmaceutical Agency for initiation of a phase I clinical trial of the contrast agent SpagoPix (SN132D) in patients with breast cancer. The study is planned to be conducted in Sweden at Uppsala University Hospital. The intention is to start patient recruitment as soon as possible following regulatory approval.The primary aim of the clinical trial is to document safety in patients with breast cancer. Another key aim is to investigate the contrast enhancement in MRI of primary and secondary tumors. ”The SpagoPix

Tumorad® patent granted in Europe

Spago Nanomedical AB (publ) announce today that the European Patent Office (EPO) has granted the company´s patent application comprising product protection for Tumorad®.Tumorad® is based on nanoparticles loaded with a radioisotope and holds potential to become a new treatment of cancer. Earlier this year the patent was approved in the USA. The patent, with the title “Nanostructures and applications thereof” (patent number 3122383) is valid until 2035. The approval means that Spago Nanomedical holds product protection for Tumorad® in the two largest markets for radionuclide therapies,

US patent granted for Tumorad®

Spago Nanomedical AB (publ) announce today that the United States Patent and Trademark Office (USPTO) has granted the company´s patent application comprising product protection for Tumorad® in the USA.Tumorad® is based on nanoparticles loaded with a radioisotope and holds potential to become a new treatment of solid tumors. Earlier this year the USPTO issued a preliminary approval by means of a Notice of Allowance. The USPTO has now informed Spago Nanomedical that the patent was approved on June 19. The patent, with the title “Nanostructures and applications thereof”, has been assigned

Spago Nanomedical select CTC for the first clinical trial with SpagoPix

Spago Nanomedical AB has signed an agreement with the Swedish clinical CRO CTC Clinical Trial Consultants AB for the conduct of the first clinical study with SpagoPix.The aim of the clinical trial is to document safety and MR images in cancer patients. Compilation of clinical study protocol and material for the application for clinical trial with the Swedish Medical Products Agency is in progress. The study will include approximately 20 cancer patients and be conducted at a small number of centers.   ”Following on the recently communicated positive preclinical results the agreement with

SpagoPix shows good safety in regulatory preclinical studies

Spago Nanomedical AB (publ) has completed the in-life part of the regulatory preclinical program with SpagoPix. The product candidate SN132D displays a good safety margin to clinically relevant doses.Data from the preclinical studies will be included in the regulatory application for the first clinical trial with SpagoPix. The aim is to submit the application in order to allow a study in humans to start during this year. The planned clinical study will be performed in cancer patients and is being designed to document safety and MR images of tumors. ”We are currently working with the

Spago Nanomedical receives grant from Vinnova for the development of SpagoPix

Spago Nanomedical has been granted 500 000 SEK by Sweden's government agency for innovation, Vinnova, to support the clinical development and commercialization of SpagoPix.Spago Nanomedical applied in February for the first level of financing from Horizon 2020, EU´s framework program in research and innovation for small and medium sized enterprises (SMEs). The project received strong scoring in the ranking system and was awarded a “Seal of Excellence”, a designation that allowed application for grants through Vinnova´s program "Runner-up SME instrument 2018". Vinnova has now granted 500

SpagoNanomedical select ChemConnection for SpagoPix production to supply clinicaltrials

Spago Nanomedical AB has signed an agreement with ChemConnection BV, a well-established contract manufacturer with extensive experience in the GMP-production of nanomedical products, for the manufacture of the SpagoPix product candidate SN132D for clinical trials.The SpagoPix project is advancing towards clinical trials and the product candidate SN132D is currently undergoing regulatory preclinical tests to generate the toxicity and safety data required to initiate human studies. The production of material will commence in the first half of 2018. Tech transfer in which Spago Nanomedical

Spago Nanomedical and Charles River Laboratories announce agreement forpreclinical studies of SpagoPix

Spago Nanomedical has selected Charles River Laboratories, a leading global CRO, to conduct regulatory preclinical toxicology and safety studies of SpagoPix before clinical trials.The SpagoPix project is advancing towards clinical trials and the product candidate SN132D has shown good effect and safety in pilot tests. The agreement with Charles River covers GLP-studies aiming for generation of regulatory toxicity and safety data that are required for initiation of first-in-man studies. Production of SN132D to cater for the amounts needed in the regulatory preclinical program is ongoing.

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