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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 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

    Recruitment milestone reached in Diamyd® Phase 3 trial

    Diamyd Medical’s precision medicine Phase 3 trial for Type 1 Diabetes, DIAGNODE-3, has enrolled 100 patients. To date, no serious adverse events have been reported, and no patients have discontinued the trial.“This is an important milestone in our Phase 3 trial and the notable zero dropout rate confirms our insights from previous trials regarding the safety and convinience of the treatment,” says Ulf Hannelius, President & CEO of Diamyd Medical. “We are deeply grateful to our participants for their continued commitment to the trial and to the dedicated staff at our participating clinics for

    Diamyd Medical led ASSET innovation partnership organizes a workshop on the future treatment of Type 1 Diabetes

    The workshop will gather patient organizations, medical experts, clinical practitioners, researchers, regulatory authorities, professional associations, and drug developers to discuss screening, early diagnosis and monitoring of Type 1 Diabetes. The workshop will take place on Monday the 15th of April 2024 in Stockholm and will be moderated by the Leading Healthcare Foundation.“We are experiencing a paradigm shift in medicin,” says Hans Winberg, Secretary General, Leading Healthcare Foundation. “We see however only a few signs of this in our current health care system. We need to develop

    Diamyd Medical's main Shareholders announce their subscription commitments in the ongoing 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 announces that its main shareholder

    Diamyd Medical publishes prospectus with regards to the 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. The prospectus with regards to Diamyd Medical AB’

    Quarterly Report II 23/24

    September 2023 – February 2024, Diamyd Medical AB (publ), Fiscal year 2023/2024Comments by CEO Ulf Hannelius Dear Shareholders, The recent granting of Fast Track designation by the U.S. FDA for our flagship product Diamyd[®] is a milestone that both accelerates the path to bringing our innovative treatment to patients with Type 1 Diabetes and validates the urgent need for our therapy. This status enhances our ability to work closely with the FDA to expedite the review process, bringing us closer to making a tangible impact on the lives of those diagnosed with Type 1 Diabetes. In

    The Board of Directors in Diamyd Medical have resolved on a rights issue of approximately SEK 114 million

    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. The Board of Directors in Diamyd Medical AB (publ)

    Diamyd Medical to present new genetic data at the ASIT summit in Boston, MA

    Diamyd Medical is invited as a speaker at the 7[th] Antigen Specific Immune Tolerance summit to be held in Boston, MA, on March 18-20, 2024. CEO Ulf Hannelius will  present up-to-date HLA haplotype frequency data in Type 1 Diabetes collected as part of the ongoing precision medicine Phase 3 trial DIAGNODE-3. The antigen-specific immunotherapy Diamyd[®] was recently, as previously announced,  awarded Fast Track designation by the FDA.“Genetic data that have been collected from the ongoing Phase 3 trial confirm the previously estimated prevalence of the genetic patient population we are

    Diamyd Medical receives U.S. FDA Fast Track designation for Diamyd®

    Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd[®] (rhGAD65/alum) that is being investigated to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2. 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 designation is intended to bring promising medicines to patients sooner.“We are very pleased with the FDA's decision to grant Fast Track

    Publication in Diabetologia highlights AI's potential for Type 1 Diabetes screening

    The article is the result of a conference organized in Malmö in May 2022 by the ASSET consortium (www.asset.healthcare) where key factors and opportunities around the integration of Artificial Intelligence (AI) in early Type 1 Diabetes screening were discussed. The publication highlights the need for precision in risk assessment and individualized monitoring plans. The article also highlights the overall feasibility and cost-effectiveness of screening. The ASSET consortium is financed by the Swedish innovation agency VINNOVA and coordinated by Diamyd Medical.“With Diamyd Medical’s

    In-depth analysis of Diamyd® Phase II trial further supports value of preserved insulin secretion

    An in-depth analysis of the continuous glucose monitoring data from the phase 2b trial DIAGNODE-2 with Diamyd[®] sheds new light on the importance of residual beta cell function in individuals recently diagnosed with Type 1 Diabetes. Most notably, the results show highly statistically significant and positive associations between residual beta cell function measured as stimulated C-peptide and reduction of the number and severity of hyperglycemic events, in other words episodes of high blood glucose levels, as well as improvments in glucose control during meal time. The results lend further

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