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November 24, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that the first patient has been enrolled in the pivotal phase III study CONCLUDE. The study will evaluate the efficacy and safety of the first-in-class TLR9 agonist cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis.
Ready to initiate patient recruitment in phase III study CONCLUDE
November 16, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that a new method of use patent for the drug candidate cobitolimod has been granted by the Canadian Intellectual Property Office (CIPO). The patent provides additional protection for the use of certain dosage regimens of cobitolimod for treating chronic active ulcerative colitis in patients that are not responding or are intolerant to anti-inflammatory therapy.
November 10, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced the composition of the Nomination Committee for the 2022 Annual General Meeting. The responsibility of the Nomination Committee is to present to the 2022 Annual General Meeting proposals regarding election of the Chairman of the Board and other members of the Board, fees and any other remuneration to the members of the Board as well as election and remuneration of the auditors.
November 9, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that a new method of use patent for the drug candidate cobitolimod has been granted by the United States Patent and Trademark Office (USPTO). The patent provides protection for the use of certain dosage regimens of cobitolimod for treating inflammatory bowel disease, including the 250 mg dose which was successful in the phase IIb study CONDUCT.
November 8, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that CEO Peter Zerhouni will present the company at Redeye Life Science Day 2021 on November 11 at 09.00 CET. The presentation will be livestreamed and can be followed at https://www.redeye.se/events/815899/redeye-life-science-day-2021.
First regulatory approvals to start the phase III study CONCLUDE
August 24, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has given clearance to start the phase III clinical study CONCLUDE in the United States. The study will evaluate the efficacy and safety of the first-in-class TLR9 agonist cobitolimod for the treatment of moderate to severe left-sided ulcerative colitis.
August 23, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that two new employees have been appointed in the clinical development organisation in preparation of the start of the phase III study CONCLUDE with cobitolimod.
August 19, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that the company will conduct a clinical pharmacokinetic study (PK study) with cobitolimod in Sweden. The Swedish Medical Products Agency has given approval to start the study.
July 21, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that the Swedish Medical Products Agency (MPA) has given approval to start the phase III clinical study CONCLUDE in Sweden. The study will evaluate the efficacy and safety of the first-in-class TLR9 agonist cobitolimod for the treatment of moderate to severe left-sided ulcerative colitis.
June 3, 2021 – The annual general meeting in InDex Pharmaceuticals Holding AB (publ) was held on Thursday June 3, 2021. The following resolutions, amongst others, were passed at the general meeting:
May 31, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that patient recruitment for the phase III study CONCLUDE is planned to initiate after the summer. The study will evaluate the efficacy and safety of the drug candidate cobitolimod for the treatment of moderate to severe left-sided ulcerative colitis.
May 27, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that CEO Peter Zerhouni will present the company at Redeye Growth Day 2021 on June 2 at 8.50 CET. The presentation will be livestreamed and can be followed at https://www.redeye.se/events/808637/redeye-growth-day-2021.
The crucial pieces of the puzzle in place for the start of phase III
May 4, 2021 – Shareholders in InDex Pharmaceuticals Holding AB, reg. nr 559067-6820 (the “Company”), are hereby summoned to the Annual General Meeting on Thursday 3 June, 2021 at 17.00 (CET) through advance voting. Attendance at the meeting is only possible via postal ballot.
April 23, 2021 – InDex Pharmaceuticals Holding AB (publ) today publishes the Annual Report for 2020. The Annual Report is attached as a PDF and is available on the company’s website, https://www.indexpharma.com/en/financial-reports-and-presentations/.
April 7, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that a patent covering 19 compounds from the company’s DIMS platform has been granted by the European Patent Office.
March 30, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that the company has entered an agreement for services with global clinical research organization (CRO) Parexel Biotech for the phase III study CONCLUDE. The study will evaluate the efficacy and safety of the drug candidate cobitolimod for the treatment of moderate to severe left-sided ulcerative colitis.
March 15, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced changes in the composition of the Nomination Committee for the 2021 Annual General Meeting due to changes in the ownership structure of the company.
March 12, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that the list of shareholders on the homepage has been updated with information as of February 26, 2021.
March 10, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that CEO Peter Zerhouni will present the company at Barclays Global Healthcare Conference on Thursday March 11, 2021 and at Carnegie Nordic Virtual Healthcare Seminar on Friday March 12, 2021, both at 13:30 CET.
Financing secured for phase III development of cobitolimod
NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, JAPAN, CANADA, HONG KONG, NEW ZEALAND, SWITZERLAND, SINGAPORE, SOUTH AFRICA, OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR ANY OTHER MEASURES.
9 February 2021 – The subscription period of the rights issue in InDex Pharmaceuticals Holding AB (publ) (”InDex” or the “Company”) ended on 5 February 2021. The subscription ratio in the rights issue amounted to 152.6 percent. Guarantee commitments made in connection with the rights issue will thus not be utilized. InDex will, through the rights issue, receive approximately SEK 533 million before deduction of costs related to the transaction.
NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR ANY OTHER MEASURES.
21 January 2021 – The board of directors of InDex Pharmaceuticals Holding AB (publ) (”InDex” or the “Company”) has prepared a prospectus in connection with the rights issue of approximately MSEK 533 announced through a press release on 14 January 2021 (the “Rights Issue”). The prospectus has today been approved and registered by the Swedish Financial Supervisory Authority and is available on the Company’s website.
NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR ANY OTHER MEASURES.
14 January 2021 – The board of directors of InDex Pharmaceuticals Holding AB (publ) (”InDex” or the ”Company”) has, with the support of the authorisation from the extraordinary general meeting held on 12 January 2021, resolved on a rights issue of approximately 444 million shares at a subscription price of SEK 1.20 per share (the “Rights Issue”). The Rights Issue is fully covered by subscription undertakings and guarantee commitments from existing shareholders and new investors, including amongst others HBM Healthcare Investments, Handelsbanken Funds, Linc and The Fourth Swedish National Pension Fund. At full subscription in the Rights Issue the Company will receive approximately MSEK 533 before deduction of costs related to the transaction.
12 January 2021 – The Extraordinary General Meeting in InDex Pharmaceuticals Holding AB (publ) was held on 12 January 2021 at the offices of Setterwalls Advokatbyrå at Sturegatan 10, Stockholm. Attendance at the meeting was solely possible via postal voting. The following resolutions were passed at the general meeting.
