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BioArctic announces results from interim analysis of the Phase 1/2 study of SC0806 in patients with complete spinal cord injury

Stockholm, Sweden, November 18, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today the results of an interim analysis of a Phase 1/2 study of SC0806 in patients with complete spinal cord injury. In this analysis, none of the patients showed an effect as measured by electrical impulses passing through the injured area after treatment. Electrical impulse passage is considered a prerequisite to restore motor function. This means that the study did not meet the primary efficacy endpoint. In addition, the results did not show convincing efficacy on secondary endpoints

BioArctic’s partner Eisai initiates the confirmatory Phase 3 study of BAN2401 in early Alzheimer’s Disease

Stockholm, Sweden, March 22, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that its partner Eisai has initiated the global Phase 3 confirmatory study of BAN2401 in patients with early Alzheimer´s disease. The Phase 3 study (named Clarity AD/Study 301) that is now initiated is a global placebo-controlled, double-blind, parallel-group, randomized study in 1566 patients with early Alzheimer’s disease i.e. mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s disease with confirmed amyloid pathology in the brain. Patients are allocated in a 1:

BioArctic’s product candidate SC0806 for treatment of patients with complete spinal cord injury is now in Phase 2

Stockholm, Sweden, February 13, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the first patient in the second panel of the Phase 1/2 study now has been treated with SC0806. This means that the study with the product candidate SC0806 for complete spinal cord injury has progressed into Phase 2. BioArctic develops a new innovative treatment for patients with complete spinal cord injury. The product candidate SC0806 is a combination of a biodegradable medical device and a drug substance (FGF1). SC0806 is designed to support nerve regeneration across the injured

BioArctic receives European patent protection for a medical device for treatment of patients with Complete Spinal Cord Injury

Stockholm, Sweden, October 3, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the European Patent Office (EPO) has issued a decision to grant the company’s patent application in Europe, EP12815796.3, for a medical device, which is one of the main components in the product candidate SC0806. The product candidate is a combination of a medical device (implant) and a medicinal product (FGF1) for patients with complete spinal cord injury. The decision states that the European patent, EP 2 787 900 B1, will enter into force on October 24, 2018. The patent will provide

BioArctic receives regulatory approval in Finland for a clinical study in patients with Complete Spinal Cord Injury

Stockholm, Sweden, July 10, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company has received approval by Fimea, the Finnish Medicines Agency, and Valvira, the Finnish authority for medical device, as well as the local ethics committee for inclusion of Finnish patients in BioArctic’s ongoing clinical Phase 1/2 study with SC0806. The candidate product is a combination of a medical device (implant) and a medicinal product (FGF1) for patients with complete spinal cord injury. This approval means that BioArctic has received approvals in all the countries

Inclusion completed of patients with complete spinal cord injury in the first panel of BioArctic’s ongoing study

Stockholm, Sweden, April 25, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the inclusion of patients with complete spinal cord injury in the first panel has been completed in the company’s ongoing clinical Phase 1/2 study. BioArctic develops a new innovative treatment for patients with complete spinal cord injury. The product candidate, SC0806, is a combination of a medical device and a drug. Due to the novelty of the treatment, patients have been included sequentially, in order to monitor the effect and safety. The last patient in the first panel has now

BioArctic receives regulatory approval in Norway for a clinical study in patients with Complete Spinal Cord Injury

Stockholm, Sweden, March 21, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company has received approval by the Norwegian Medicines Agency (NOMA) departments for medicinal products and medical device and the local ethics committee for inclusion of Norwegian patients in BioArctic’s ongoing clinical Phase 1/2 study with SC0806. The candidate product is a combination of a medical device (implant) and a medicinal product (FGF1) for patients with complete spinal cord injury. The Norwegian patients will undergo treatment with SC0806 at the Karolinska University

BioArctic receives patent protection in Japan for a medical device for treatment of patients with Complete Spinal Cord Injury

Stockholm, Sweden, March 19, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the Japanese Patent Office (JPO) issued a notification to grant the company’s patent application in Japan, 2014-545410, for a medical device, which is one of the main components in the product candidate SC0806. The product candidate is a combination of a medical device (implant) and a medicinal product (FGF1) for patients with Complete Spinal Cord Injury. The notification states that the Japanese patent (derived from 2014-545410) will enter into force no later than April 13, 2018. The

BioArctic receives regulatory approval in Estonia for a clinical study in patients with Complete Spinal Cord Injury

Stockholm, Sweden, February 21, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company has received approval by the Estonian State Agency of Medicines, the Estonian Health Board for medical device and the local ethics committee for inclusion of Estonian patients in BioArctic’s ongoing clinical Phase 1/2 study with SC0806. The candidate product is a combination of a medical device (implant) and a medicinal product (FGF1) for patients with Complete Spinal Cord Injury. The Estonian patients will undergo treatment with SC0806 at the Karolinska University

BioArctic receives US patent protection for a method with a medical device for treatment of patients with Complete Spinal Cord Injury

Stockholm, Sweden, February 2, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the US Patent and Trademark Office (USPTO) published an Issue of Notification of granting the company’s patent application US 14/361,650 for a method with the medical device, which is one of the components in the product candidate SC0806. The notification states that the US patent 9,895,234 will be granted and enters into force on February 20, 2018. The patent will provide important protection for methods of treatment of patients with Complete Spinal Cord Injury. The patent

BioArctic presents Nomination Committee and publishes financial calendar 2018

Stockholm, Sweden, November 9, 2017 – According to the resolution of the Annual General Meeting in BioArctic AB (publ) on May 31, 2017 the members of the Nomination Committee for the 2018 Annual General Meeting shall be appointed through a procedure where the three largest shareholders in terms of voting power according to Euroclear’s transcription of the share register as of September 30, 2017 are contacted by the Chairman of the Board and asked to appoint one representative each to the Nomination Committee. If any of the three largest shareholders does not wish to appoint a member of the

Invitation to presentation of BioArctic’s Interim Report January – September 2017 on November 8

Stockholm, Sweden, November 3, 2017 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) publishes the company’s Interim Report for the period January – September 2017 on November 8, 2017 at 08:00 a.m. CET.BioArctic invites you to an audiocast with teleconference (in English) for investors, analysts and media on November 8, at 09:30 – 10:30 a.m. CET. Gunilla Osswald, CEO, and Jan Mattsson, CFO, will present BioArctic and comment on the Interim Report for the period January – September 2017 followed by a Q&A-session. To attend, see below: Please dial-in at one of the numbers below, from:

Change in the number of shares and votes in BioArctic AB (publ)

Stockholm, Sweden, October 31, 2017 – BioArctic AB (publ) (“BioArctic” or the “Company” ) today announced that the number of shares and votes in BioArctic has increased during the month of October due to the new share issue carried out in connection with the listing of BioArctic’s B-share on Nasdaq Stockholm. A total of 25,000,000 B-shares have been added. At October 31, 2017 the number of A-shares, each representing ten (10) votes, amounts to 14,399,996 and the number of B-shares, each representing one (1) vote, amounts to 73,659,989. The total number of votes thus amounts to 217,659,

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