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  • Ulf Hannelius

    CEO


    Box 7349, SE-103 90 Stockholm
    +46 8 661 00 26
    +46 8 661 63 68
    https://www.diamyd.com

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    The collected genetic and immunological insights support the possibility that we may be able to truly individualize the treatment.
    Ulf Hannelius, CEO
    Our top strategic priority is to prepare for a marketing application for Diamyd®
    Ulf Hannelius, CEO
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    Diamyd Medical Aligns with FDA on Key Elements for an Accelerated Approval Process

    Diamyd Medical today announced a positive in-person Type C meeting with the U.S. Food and Drug Administration (FDA), where alignment was achieved on key components of the planned early readout and an accelerated approval pathway for the antigen-specific immunotherapy, Diamyd[®] (rhGAD65/alum). Additional details of the FDA interaction will be disclosed upon receipt of the final meeting minutes, expected in January 2025.“We are very pleased with the positive and constructive dialogue and the alignment achieved with the FDA on key elements of the accelerated readout procedure,” says Ulf

    Bulletin from Annual General Meeting of Diamyd Medical AB

    The Annual General Meeting of Diamyd Medical AB (publ) was held on December 5, 2024. The Company's income statement and balance sheet were adopted, and the Board members and the Chief Executive Officer were discharged from liability for the fiscal year 2023/2024. The Annual General Meeting approved the Board's proposal that no dividend shall be paid for the fiscal year 2023/2024. Anders Essen-Möller, Erik Nerpin, Maria-Teresa Essen-Möller, Torbjörn Bäckström, Mark A. Atkinson, Karin Hehenberger and Karin Rosén were re-elected to the Board. Anders Essen-Möller was elected as

    Article published by ASSET, coordinated by Diamyd Medical, advocates for national screening programs in Sweden for early detection of Type 1 Diabetes

    An opinion piece article published by members of the ASSET steering group in Göteborgs-Posten, western Sweden’s largest daily morning paper, underscores the need for early detection of Type 1 Diabetes through national screening programs. The article discusses recent advances in disease understanding that enable intervention before symptoms appear, potentially preventing or delaying its onset. The innovation milieu ASSET (AI for Sustainable Prevention of Autoimmunity in the Society), coordinated by Diamyd Medical, is an industry-healthcare partnership financed by the Swedish innovation agency

    Diamyd Medical hits a recruitment milestone in DIAGNODE-3 Phase 3 trial

    180 patients have now been recruited in the precision medicine Phase 3 trial DIAGNODE-3, exceeding the recruitment target set for the planned early readout in March 2026. The readout is designed to support a potential accelerated Biologics License Application (BLA).“We are proud to have reached the 180-patient milestone, which is critical for the planned accelerated readout”, says Ulf Hannelius, CEO of Diamyd Medical. “This progress reflects the engagement and the strong support from our clinical sites and the Type 1 Diabetes community in advancing innovative, precision-based therapies.

    Conference on the future of Type 1 Diabetes screening organized as part of the ASSET partnership coordinated by Diamyd Medical

    As part of the ASSET innovation partnership led by Diamyd Medical, the Leading Healthcare Foundation organizes a conference on November 26, 2024, in Stockholm, Sweden, on the future of Type 1 Diabetes screening and treatment. The conference is co-sponsored by Sanofi.The event gathers key stakeholders, including patient organizations, healthcare professionals, researchers, and regulators, to explore the practical implementation of precision and preventive medicine in Type 1 Diabetes care. The conference will feature a keynote lecture by Prof. Chantal Mathieu, President of the European

    Diamyd Medical recognizes World Diabetes Day

    In connection with World Diabetes Day and Diamyd Medical's publication of the annual report for 2023/2024 on 14 November, CEO Ulf Hannelius will present at 3:00 pm CET in a live broadcast arranged by Direkt Studios. The broadcast also features the Company's Director of Business Development, Manufacturing Site in Umeå, Sofia Mayans and Board member Karin Rosén. Diamyd Medical also announces that Principal owner and Chairman of the Board Anders Essen-Möller today has acquired 40,000 Class B shares in Diamyd Medical. The broadcast can be followed via link:https://www.youtube.com/live/

    Information about the Annual Report 2023/2024

    Diamyd Medical today publishes its Annual Report for 2023/24. The Company is in an expansive phase where positive feedback has been received from the US Food and Drug Administration (FDA) regarding the possibility of earlier market approval. The Annual Report is published in Swedish. The English version is expected to be published around December 6, 2024.“The past year has exceeded our highest expectations; fast track status, a successful interim analysis of the Phase 3 trial and the go ahead from the FDA for an accelerated approval procedure for Diamyd[®], says Ulf Hannelius, CEO of Diamyd

    In-depth analysis showing robust Diamyd[®] treatment effects across clinical trials to be shared at the 2024 IDS Diabetes Congress

    Diamyd Medical will present new analysis results on November 7 at the 20th Immunology of Diabetes Society (IDS) Congress in Bruges, Belgium. The analysis will be presented at a Satellite Symposium organized by Abbott. The results support the robustness of the treatment effects and underscore the potential for precision medicine to slow and delay disease progression in Type 1 Diabetes.”These analyses clarify the robustness of our previous treatment results across trials in our genetically defined responder patient group, and further characterize the effect of Diamyd[®] on glycemic control”,

    Diamyd Medical and INNODIA partner for Type 1 Diabetes awareness and patient recruitment for the DIAGNODE-3 precision medicine trial

    Diamyd Medical has entered a strategic partnership with INNODIA, an international non-profit organization dedicated to advancing research on disease modifying therapies for Type 1 Diabetes. The partnership will leverage INNODIA’s extensive EU-based clinical network with the aim to further amplify patient enrolment and the visibility of the precision medicine Phase 3 trial DIAGNODE-3 ahead of a potential accelerated Biologics Licensing Application in the U.S.“We are delighted to work with INNODIA to spread the awareness of Type 1 Diabetes and Diamyd[®], as well as to ensure that we meet

    Diamyd Medical highlights precision medicine approach for Type 1 Diabetes at the scientific conferences ISPAD and IDS

    Diamyd Medical will participate in two major conferences in the coming weeks: the 50th Annual Meeting of the International Society for Pediatric and Adolescent Diabetes (ISPAD) in Lisbon, Portugal, on October 16-19, 2024, and the 21st Immunology of Diabetes Society (IDS) Congress in Bruges, Belgium, on November 4-8, 2024. At these conferences, data and insights will be presented that underscore the potential of precision medicine to delay and slow down disease progression in Type 1 Diabetes.”These presentations highlight our data-driven strategy in preventing and treating type 1 diabetes,

    Year-End Report 23/24

    September 2023 – August 2024, Diamyd Medical AB (publ), Fiscal year 2023/2024Precision Medicine for Autoimmune DiabetesAiming for Accelerated Market Approval Diamyd Medical’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B.Further information is available on https://www.diamyd.com September 1, 2023 – August 31, 2024 · Net result: MSEK -151.8 (-116.1), fourth quarter: MSEK -49.7 (-37.5). The higher costs compared to previous year is mainly due to that all 60 clinics in Europe and U.S. in the Phase III trial DIAGNODE-3 are activated and recruiting

    Diamyd Medical announces final outcome of the exercise of series TO 3 warrants

    Diamyd Medical AB (publ) ("Diamyd Medical" or the "Company") issued a total of 9,165,682 series TO 3 warrants in 2023 as part of a rights issue of units. During the exercise period, which ran from September 2, 2024, to September 30, 2024, a total of 4,365,200 shares have been subscribed for by exercise of warrants TO 3, corresponding to an exercise rate of approximately 95 percent. The Company will thereby receive issue proceeds of approximately SEK 48 million before deduction of related issue costs.”We are of course very pleased with the broad utilization of the warrants”, says Ulf

    The last day of trading in Diamyd Medical's warrants of series TO 3 is today

    Today, Wednesday, September 25, 2024, is the last day of trading in Diamyd Medical AB’s (publ) (“Diamyd Medical” or the “Company”) warrants of series TO 3, which were issued in 2023 as part of a rights issue of units. The exercise period for the warrants began on September 2, 2024, and continues until and including September 30, 2024. Two (2) warrants of either series TO 3 A or TO 3 B entitle the holder to subscribe for one (1) new share, of the corresponding share series, in the Company at a subscription price of SEK 11.00 per share. Several of the Company's board members and senior

    Diamyd Medical to pursue accelerated approval pathway for Type 1 Diabetes precision medicine

    Diamyd Medical will pursue an accelerated approval pathway in the U.S. for its antigen-specific immunotherapy, Diamyd[® ](rhGAD65/alum), aimed at preserving endogenous insulin production in patients with Stage 3 Type 1 Diabetes. An earlier interim study readout from the ongoing Phase 3 trial, DIAGNODE-3, is planned to serve as the basis for a Biologics License Application (BLA) under the accelerated approval pathway. Results from the interim readout are expected around March 2026.“We are committed to working at full speed with our partners and in close dialogue with the FDA to seize this

    The exercise period for Diamyd Medical's warrants of series TO 3 begins today

    In 2023, Diamyd Medical AB (publ) (”Diamyd Medical” or the ”Company”) issued a total of 9,165,682 warrants of series TO 3 as part of a rights issue of units. The exercise period for the warrants will begin on September 2, 2024, and will continue until September 30, 2024. Two (2) warrants of either series TO 3 A or TO 3 B entitle the holder to subscribe for one (1) new share of the corresponding series, in the Company at a subscription price of SEK 11.00 per share. Chairman of the Board and major shareholder Anders Essen-Möller and CEO Ulf Hannelius have in advance announced their intention to

    Diamyd Medical Announces Positive Interim Analysis Results for Phase 3 Trial in Type 1 Diabetes

    Diamyd Medical today announced a successful interim analysis (non-futility test) for its ongoing precision medicine Phase 3 DIAGNODE-3 trial. The interim analysis, reviewed by an independent Data Safety Monitoring Board (DSMB), resulted in a favorable recommendation to continue the trial without any modifications.“We are extremely pleased with the DSMB's recommendation to continue the DIAGNODE-3 trial as planned,” says Ulf Hannelius, CEO of Diamyd Medical. “This positive outcome reaffirms our confidence in the potential for Diamyd[®] to address an unmet medical need in Type 1 Diabetes. We

    Diamyd Medical receives positive feedback from FDA on potential Accelerated Approval for Diamyd® in Type 1 Diabetes

    Diamyd Medical received encouraging feedback from the U.S. Food and Drug Administration (FDA) regarding an Accelerated Approval pathway for its immunotherapy, Diamyd[®,] for treating patients with Stage 3 Type 1 Diabetes carrying the genotype HLA DR3-DQ2.In a recent in-person Type C Meeting the FDA acknowledged that C-peptide could be used by Diamyd Medical as a surrogate endpoint reasonably likely to predict the clinical benefit of preservation of endogenous insulin production. As such, Accelerated Approval could be sought based on a demonstration of significant treatment-related benefits

    Diamyd Medical receives second U.S. FDA Fast Track designation for Diamyd® - for the prevention of Type 1 Diabetes

    Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd[®] (rhGAD65/alum) to treat Type 1 Diabetes in pediatric patients with Stage 1 or Stage 2 Type 1 Diabetes carrying the genotype HLA DR3-DQ2. Earlier this year, Diamyd[®] received Fast Track designation for the treatment of individuals with Stage 3 Type 1 Diabetes carrying the HLA DR3-DQ2 genotype. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track

    Quarterly Report III 23/24

    September 2023 – May 2024, Diamyd Medical AB (publ), Fiscal year 2023/2024Comments by CEO Ulf Hannelius Dear Shareholders, The recent share issue, including warrants, has strengthened our financial position at this pivotal time. This capital infusion supports our efforts in advancing clinical programs and scaling operations. Importantly, this was achieved with minimal dilution for existing shareholders and at a cost substantially below prevailing market rates. With the cash position end of May of approximately 162 MSEK and a warrant structure including warrants in September this year

    Diamyd Medical updates on the registrational Phase 3 trial; upcoming interim analysis and enrollment

    Interim Analysis outcome scheduled for beginning of AugustThe Interim Analysis will be conducted in July by ICON plc, the appointed global CRO for the Phase 3 trial, and will be assessed by an independent Data Safety and Monitoring Board (DSMB). The DSMB is currently scheduled to convene on July 30[th] to evaluate the Interim Analysis outcome. The DSMB has approximately a week to inform Diamyd Medical of the conclusion of their meeting. As previously announced, an Interim Analysis of the ongoing precision medicine Phase 3 trial DIAGNODE-3 in Type 1 Diabetes will assess 6-month data

    Diamyd Medical announces final outcome in the company’s rights issue

    THIS PRESS RELEASE MAY NOT BE RELEASED, PUBLICATED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, BELARUS, CANADA, HONGKONG, JAPAN, NEW ZEALAND, RUSSIA, SINGAPORE, SOUTH AFRICA, SWITZERLAND, THE UNITED STATES OR ANY OTHER JURISDICTION IN WHICH SUCH ACTION IN WHOLE OR IN PART, IS SUBJECT TO LEGAL RESTRICTIONS. THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER, OR A SOLICITATION OF ANY OFFER, TO BUY OR SUBSCRIBE FOR ANY SECURITIES IN DIAMYD MEDICAL AB IN ANY JURISDICTION. PLEASE REFER TO THE “IMPORTANT INFORMATION” SECTION BELOW. On April 16, 2024, Diamyd Medical AB (publ) (“

    Diamyd Medical announces preliminary outcome in the company’s rights issue

    THIS PRESS RELEASE MAY NOT BE RELEASED, PUBLICATED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, BELARUS, CANADA, HONGKONG, JAPAN, NEW ZEALAND, RUSSIA, SINGAPORE, SOUTH AFRICA, SWITZERLAND, THE UNITED STATES OR ANY OTHER JURISDICTION IN WHICH SUCH ACTION IN WHOLE OR IN PART, IS SUBJECT TO LEGAL RESTRICTIONS. THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER, OR A SOLICITATION OF ANY OFFER, TO BUY OR SUBSCRIBE FOR ANY SECURITIES IN DIAMYD MEDICAL AB IN ANY JURISDICTION. PLEASE REFER TO THE “IMPORTANT INFORMATION” SECTION BELOW. Diamyd Medical AB (publ) (“Diamyd Medical” or the

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