Diamyd Medical
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Diamyd Medical (DMYD) investor relations material

Diamyd Medical Q1 2026 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q1 2026 earnings summary28 Jan, 2026

Executive summary

  • Entered final stage of pivotal Phase 3 DIAGNODE-3 trial for retogatein in type 1 diabetes, with patient screening completed and 310-320 participants expected for interim and full efficacy analyses.

  • Interim readout for approximately 170 participants on track for March 2026, potentially supporting accelerated approval in the US.

  • FDA alignment allowed shortening of primary efficacy follow-up from 24 to 15 months, accelerating full readout by nearly a year.

  • Retogatein received global non-proprietary name and maintains Orphan Drug and Fast Track designations.

  • Biomanufacturing facility in Umeå progressing toward GMP certification, with expanded manufacturing partnerships.

Financial highlights

  • Net sales for the quarter: MSEK 0.2 (previous year: 0.0).

  • Net result: MSEK -48.8 (previous year: -36.2).

  • Cash flow from operating activities: MSEK -43.7 (previous year: -41.8).

  • Cash and short-term investments at period end: MSEK 233.2 (previous year: 152.9).

  • Research and development costs: MSEK -30.5 (previous year: -26.1).

Outlook and guidance

  • Interim analysis in March 2026 will provide early insights into retogatein's efficacy and may support accelerated US approval.

  • Focus remains on executing clinical and regulatory strategy, manufacturing, and pre-commercial preparations.

FDA alignment's impact on market approval
Detail commercial manufacturing strategy
Future pipeline beyond HLA DR3-DQ2
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Frequently asked questions

Diamyd Medical AB is a biotechnology company headquartered in Stockholm, Sweden, specializing in the development of immune modifying therapies for diabetes. The company is actively engaged in the pharmaceutical development field, focusing on two innovative disease-modifying drugs: Diamyd, an antigen-specific immunotherapy, and Remygen, an oral regenerative and immunomodulatory therapeutic. These drugs are undergoing clinical trials and are designed to address the underlying causes of diabetes, including dysfunction and loss of the pancreas's insulin-producing cells. Diamyd Medical operates a manufacturing facility in Umeå and leverages a global network of clinics, researchers, and production units for its development efforts. The company is headquartered in Stockholm, Sweden, and its shares are listed on the Nasdaq First North.

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