Diamyd Medical AB: 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 Medical. "This strong momentum means that we are now entering an intensive period of preparation for potential market approval. We are proud to lead the development of antigen-specific immunotherapy for Type 1-Diabetes and work tirelessly towards our goal of making Diamyd[®] available to patients worldwide."[ ]
At the end of the financial year, Diamyd Medical had SEK 132.4 million in cash and cash equivalents, which during September and October was further strengthened through milestone payments and the redemption of warrants, and the cash on November 12 amounted to SEK 157.5 million. Diamyd Medical's expansive phase is expected to lead to increased activities, which may mean a need for additional financing in the coming year, something that is also commented on by the Company's Auditor in the Audit report.
The Annual Report in Swedish is available on www.diamyd.com/se. The Annual Report in English is expected to be published around December 6, 2024 .
About Diamyd Medical
Diamyd Medical develops precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd[®] is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production that has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 1, 2 and 3 Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase 3 trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company's prospective European Phase 2b trial, where Diamyd[®] was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. Injections into a superficial lymphnode can be performed in minutes and are intended to optimize the treatment response. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd[®]. Diamyd Medical also develops the GABA-based investigational drug Remygen[®] as a component in the treatments of metabolic diseases. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.
Diamyd Medical's B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser.