Diamyd® vials
Comments 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 and March 2025, there is an opportunity to finance our operations well into 2026.
An important milestone in our Phase 3 trial, DIAGNODE-3, was reached with the recruitment of 100 patients. This is a significant achievement given that these patients are recently diagnosed with Type 1 Diabetes and carry the specific genetic profile associated with a high likelihood of a positive clinical response to Diamyd®. Notably, no serious adverse events or dropouts have been reported to date. With nearly all clinical sites operational and an accelerating screening rate, this milestone underscores both the safety and convenience of Diamyd® treatment and the dedication of our clinical teams.
The ASSET consortium that Diamyd Medical is coordinating is also making progress. A recent workshop was arranged in Stockholm that brought together experts to discuss screening programs for T1D. This and other similar activities highlight our commitment to advancing preemptive medicine and integrating predictive analytics with targeted immunotherapies like Diamyd®. Additionally, our partner MainlyAI that also participates in ASSET is making strides in artificial intelligence and machine learning. Their collaborative AI platform is especially relevant as large-scale generative AI models continue to gain traction and fuel the adoption of AI across all industries including pharma and biotech. At Diamyd Medical, we are leveraging AI in our DIAGNODE-3 project to reach underserved patient communities. As also demonstrated at the recent international diabetes conference, the ADA Scientific Sessions in Orlando, we utilize avatars that communicate trial information in the patient’s native language, ensuring better understanding and engagement.
At our biomanufacturing facility in Umeå, we have been diligently working on the production of technical batches. This facility is crucial for ensuring the supply of high-quality GAD65 protein, the active ingredient in Diamyd®. As we move towards the manufacturing of clinical batches and eventually commercial production, we are also in the process of employing a Business Development Director in Umeå to focus on commercial opportunities beyond GAD manufacturing.
Our partnership with Breakthrough T1D (formerly JDRF) is instrumental in supporting our phase 3 clinical trial and increasing our visibility. We are further strengthened by the regulatory advancements with Diamyd®, where we have been granted both Fast Track Designation and Orphan Drug Designation by the U.S. FDA. These designations facilitate expedited review and approval processes, and the granting of these underscores the critical need for new treatments in Type 1 Diabetes.
Looking ahead, the upcoming interim analysis expected in early August is a significant milestone. It will provide insights into the progression of DIAGNODE-3, specifically informing whether the trial is still on track to reach its key endpoint. We are also pursuing discussions with regulatory agencies regarding C-peptide as a reasonably likely surrogate endpoint, which may open up accelerated approval pathways.
To conclude, this quarter has been marked by significant advancements in our ongoing projects, strategic collaborations, and financing activities, setting the stage for an exciting and transformative period ahead.
Stockholm, June 26, 2024
Ulf Hannelius, President and CEO
Significant events during the third quarter
March 1, 2024 – May 31, 2024
The Board of Directors in Diamyd Medical resolved on a rights issue of approximately SEK 114 million
The Board resolved, pursuant to the authorization granted by the Company's annual general meeting held on November 30, 2023, on a rights issue of a maximum of 9,494,799 units, consisting of shares and warrants, corresponding to approximately SEK 114 million. The subscription price in the rights issue was set to SEK 12.00 per unit, corresponding to SEK 12.00 per share (the warrants are issued free of charge). Each A-unit contained one share of series A and one warrant of series TO 4 A. Each B-unit contained one share of series B and one warrant of series TO 4 B. Shareholders in Diamyd Medical on the record date have for each ten (10) held shares, regardless of share class, preferential right to subscribe for one new unit of the same share class in the rights issue.
Diamyd Medical announced the outcome in the company’s rights issue
The final outcome showed that 4,216,203 units, corresponding to approximately 44 percent of the rights issue, had been subscribed for with unit rights. Additionally, applications for subscription of 558,779 units without unit rights, corresponding to approximately 6 percent of the offered units, had been received. In aggregate, the subscriptions by exercise of unit rights and the applications for subscription without unit rights corresponded to approximately 50 percent of the offered units. The Company received issue proceeds from the rights issue of approximately SEK 57 million before the deduction of costs attributable to the rights issue. Subscribers in the rights issue included the Chairman of the Board of Directors and founder Anders Essen-Möller (approximately SEK 1 million), the Company’s largest shareholder Bertil Lindkvist (approximately SEK 1 million), and other Senior Executives and members of the Board of Directors (approximately SEK 0.6 million).
Other events during the third quarter
March 1, 2024 – May 31, 2024
Diamyd Medical updated on the registrational Phase 3 trial; upcoming interim analysis and enrollment
Diamyd Medical informed that the 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 30th to evaluate the Interim Analysis outcome. The DSMB has approximately a week to inform Diamyd Medical of the conclusion of their meeting.
Recruitment milestone reached in Diamyd® Phase 3 trial
Diamyd Medical’s precision medicine Phase 3 trial for Type 1 Diabetes, DIAGNODE-3, had enrolled 100 patients. No serious adverse events had been reported, and no patients had discontinued the trial.
Diamyd Medical led ASSET innovation partnership organized a workshop on the future treatment of Type 1 Diabetes
The workshop gathered 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 took place on Monday the 15th of April 2024 in Stockholm and was moderated by the Leading Healthcare Foundation.
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 (Feb-2024) by the U.S. FDA. DIAGNODE-3, a confirmatory Phase III trial is actively recruting patients with recent-onset Type 1 Diabetes 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 IIb 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 is intended to optimize the immune 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 as well as 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.
Further information is available on https://www.diamyd.com
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