Autoimmune diabetes vaccine (Diamyd)

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. For further information, please contact: Ulf Hannelius, President and CEO Phone: +46 736 35 42 41 E-mail: ulf.hannelius@diamyd.com Diamyd Medical AB (publ) Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68 E-mail: info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com The information was provided by the contact person above, for publication on November 14, 2024, 08.28 CET. Attachments: PDF version

STOCKHOLM, Nov. 6, 2024 /PRNewswire/ -- (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", says Ulf Hannelius, CEO of Diamyd Medical. "These insights together with the benign safety profile are central for positioning Diamyd® as a best-in-class immunotherapy and in our preparations ahead of a potential accelerated approval by the U.S. FDA." Summary of the detailed breakdown of the previously published meta-analysis that included data from 627 patients, with a focus on DR3-DQ2 positive patients and high dose (3 or 4 injections) group where available: D/P2/04/3 Trial: 34 out of a total of 70 patients, ages 10-18, were positive for HLA DR3-DQ2 and had received either 2 subcutaneous injections of Diamyd® or placebo. The results showed a 56.6 % improvement in C-peptide preservation (p = 0.0106). Original study published in New England Journal in 2008 (). D/P3/07/4 Trial: 109 out of a total of 334 patients, ages 10-20, were positive for HLA DR3-DQ2 and had received 4 subcutaneous injections of Diamyd® or placebo. The results showed a 37.4 % improvement in C-peptide preservation (p = 0.0235). Original study published in New England Journal of Medicine in 2012 (). TrialNet 08 Trial: 50 out of a total of 145 patients, ages 3-45, were positive for HLA DR3-DQ2 and had received 3 subcutaneous injections of Diamyd® or placebo. The results indicated a 48.0 % improvement in C-peptide preservation (p = 0.1458). Original study published in The Lancet in 2011 (). DIAGNODE-2 Trial: 49 out of a total of 109 patients, ages 12-24, were positive for HLA DR3-DQ2 and had received 3 intralymphatic injections of Diamyd® or placebo. The results showed a 55.7 % improvement in C-peptide preservation (p = 0.0078). Original study published in Diabetes Care in 2021 (). Combined analysis: Combined results encompassing 208 patients, ages 3-45, that were positive for HLA DR3-DQ2 and treated with 3-4 injections of Diamyd® or placebo showed a significant 48.3 % improvement in C-peptide preservation (p < 0.0001). The combined results also showed a significant reduction in HbA1c of -4.8 mmol/mol (p = 0.0044). The combined analysis published in Diabetes, Obesity and Metabolism 2022 (). These results demonstrate the effectiveness of Diamyd® compared to placebo on preservation of C-peptide across individual trials and support the robustness of the currently ongoing confirmatory Phase 3 trial DIAGNODE-3. DIAGNODE-3 is designed to confirm the efficacy and safety of 3 intralymphatic injections of Diamyd or placebo in approximately 300 recent-onset T1D individuals ages 12-28 who are positive for HLA DR3-DQ2. An earlier readout to support a potential accelerated Biologics License Application with C-peptide preservation as the primary endpoint, including approximately 170 patients followed for 15 months, is expected around March 2026. The presentation also includes insights from glucose monitoring data from the DIAGNODE-2 data, where the strongest correlation between treatment effect and glycemic control is seen for time in glycemic target range, time above the target range, number of severe hyperglycemic episodes and duration of hyperglycemic episodes. In addition to previously published treatment, the data show that Diamyd® significantly lowers both the number, duration and amplitude of hyperglycemic excursions. The insights will be presented by Anton Lindqvist, Chief Scientific Officer at Diamyd Medical during a Satellite Symposium organized by Abbott. The presentation is entitled: "Diamyd® Immunotherapy to Preserve ß-Cell Function and Improve Glycemic Control in Type 1 Diabetes Patients with HLA DR3-DQ2". 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. For further information, please contact: Ulf Hannelius, President and CEO Phone: +46 736 35 42 41 E-mail: [email protected] This information was brought to you by Cision The following files are available for download: SOURCE Diamyd Medical AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED