On January 26, 2022 Diamyd Medical reported it’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B (Press release, Diamyd Medical, JAN 26, 2022, View Source;ClipID=4167222 [SID1234607387]).

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September 1, 2021 – November 30, 2021

Net result: MSEK -37.8 (104.9). The previous year contains a one-off effect of corresponding MSEK 117.5 from divestment of shares in Companion Medical, Inc.
Result per share: SEK -0.5 (1.5)
Cash flow from operating activities: MSEK 0 (-14.0)
Cash and cash equivalents at November 30, 2021: MSEK 240.7 (173.0)
Significant events during the first quarter, September 1, 2021–November 30, 2021

Diamyd Medical paused start of Phase III trial pending additional evaluations of manufacturing process
Diamyd Medical announced to initiate its type 1 diabetes Phase III trial in Europe as discussions continue with FDA regarding partial clinical hold in the US
Diamyd Medical and partners were awarded SEK 40 million in VINNOVA funding
First regulatory approval to start the Phase III trial was received
Start of the Phase III trial in the US was paused pending clarification of FDA questions
Property with manufacturing facility in Umeå was acquired
SEK 150 million was raised via a directed share issue
Other events during the first quarter

Clinical results with Diamyd Medical’s study drug Remygen were published in a scientific journal
A new analysis supporting the effect of Diamyd was elected to be presented at the ISPAD scientific conference
Significant events after the first quarter

Interim report indicated similar immunological response in LADA-patients treated with intralymphatic Diamyd as in type 1 diabetes patients
Other events after the first quarter

Diamyd Medical patent for intralymphatic Diamyd to be granted in China
Australia granted Diamyd Medical a broadening of patent for intralymphatic injection of antigens in autoimmune diabetes
Comments by CEO Ulf Hannelius
We are very much looking forward to the upcoming Phase III precision medicine trial DIAGNODE-3, approved so far by Competent Authorities and Ethical Review Boards in the Czech Republic, the Netherlands, Spain and Poland. To get started with the trial soon – and since we do not compromise on safety anywhere – we have been working hard to rule out that a potential contamination early in the process could in any way affect the drug product. Indeed, we have a safe and robust process that encompasses several purification steps designed to remove contaminants of this nature and additional analyses are ongoing with the goal of being able to initiate DIAGNODE-3 and other trials in the development pipeline soonest possible.

Our investment in the Umeå manufacturing facility is central to securing long-term access and control over our Diamyd flagship asset. The experimental small-scale manufacturing process is in place and the large-scale process equipment have been installed. Next, the plan is to have the process in Umeå tested, validated and GMP certified later this year and to get the facility approved and production ready in the second calendar quarter of 2023.

It was rewarding to see the interim results in December from GADinLADA, the pilot trial in LADA evaluating intralymphatic injections of Diamyd. No safety issues were observed, and the immune response appears similar to what has been observed in type 1 diabetes patients treated with Diamyd. This is the first time this administration mode of Diamyd is evaluated in individuals diagnosed with LADA, providing important additional support for the safety and convenience of the therapy in a new indication as well as data that support the use of intralymphatic administration in individuals that are up to 70 years of age. A more thorough analysis of the clinical course, immune response and next steps including a potential pivotal trial in LADA will be possible once we have the 12 months results from GADinLADA trial later during 2022.

The quarter has seen advances in our patent portfolio where the Chinese patent office recently informed that they will approve patent claims that protect the intralymphatic administration mode of Diamyd. These key patent claims have already been approved among other countries, in Europe and Japan and provide protection until 2035. The Australian patent office also informed that they approve, as the first region, intralymphatic administration of other beta cell antigens beyond GAD, most importantly insulin. These broadened patent claims provide incentives to develop antigen specific therapies that complement GAD, which given the importance of precision medicine in type 1 diabetes, is of high interest. Insulin-based immunotherapies should likely be targeted to individuals that carry the HLA DR4-DQ8 haplotype while GAD-based therapies like Diamyd will be targeted to individuals that carry the HLA DR3-DQ2 haplotype.

With all activities ongoing that further strengthen the foundation of Diamyd Medical, we are fortunate to have a strong financial position; more than SEK 200 million in cash as of today will carry us well into 2023. I would like to thank the team and collaborators for your hard work and enthusiasm and our shareholders for helping us breaking new ground.

Stockholm, January 26, 2022
Ulf Hannelius, President and CEO

Significant events during the first quarter
September 1 – November 30, 2021

Diamyd Medical paused start of Phase III trial pending additional evaluations of current manufacturing process
Diamyd Medical decided to pause the start of the precision medicine Phase III trial DIAGNODE-3 with the diabetes vaccine Diamyd (GAD/alum) in recent onset type 1 diabetes, as well as the initiation of other clinical trials with Diamyd pending additional evaluations of the current manufacturing process. A new analysis has shown the potential presence of a contamination early in the manufacturing process of the drug substance (GAD65) used in the existing study drug. Diamyd Medical will evaluate its specific removal before additional clinical work is conducted. The potential contamination is not connected to the new manufacturing facility being established in Umeå.

Diamyd Medical announced to initiate its type 1 diabetes Phase III trial in Europe as discussions continue with FDA regarding partial clinical hold in the US
The FDA requested additional data to support Diamyd Medical’s IND application for DIAGNODE-3. Outstanding questions largely pertained to manufacturing of the study drug and needed to be addressed before FDA’s partial clinical hold for the Phase III trial in the US can be lifted. Given the delay this may entail, Diamyd Medical announced commence its initiation of the Phase III trial in Europe, while interactions with the FDA continue.

Diamyd Medical and partners were awarded SEK 40 million from VINNOVA for the prevention of autoimmune diseases
The Swedish governmental innovation agency VINNOVA awarded SEK 40 million in financing for an innovation milieu in sustainable precision health that will be led by Diamyd Medical. The project aims to develop and evaluate new algorithms based on artificial intelligence (AI) for preventive precision medical treatments for type 1 diabetes and other autoimmune diseases. The innovation milieu also includes Mainly AI AB, Lund University, Sahlgrenska University Hospital, the National Diabetes Register and the Leading Healthcare Foundation. Diamyd Medical’s part of the five- year grant amounts to approximately SEK 18 million.

First regulatory approval received to start the DIAGNODE-3
The Swedish Medical Products Agency gave approval for the start of DIAGNODE-3. The trial is designed to confirm the efficacy and safety of Diamyd in individuals recently diagnosed with type 1 diabetes, who carry the genetically defined haplotype HLA DR3-DQ2.

FDA paused the start of DIAGNODE-3 in the US
The start of DIAGNODE-3 in the United States was paused by the US Food and Drug Administration (FDA) to clarify certain outstanding questions regarding the study drug.

Acquisition of property with manufacturing facility in Umeå
Diamyd Medical announced the acquisition of the property in Umeå, Sweden, where production of the recombinant protein GAD65, the active component in the therapeutic diabetes vaccine Diamyd is being established. The property is acquired for a purchase price of SEK 24.5 million and comprises approximately 20 000 square feet including the 10 000 square feet Diamyd Medical AB rents, as well as 90 000 square feet of land area.

Proceeds of SEK 150 million were raised via a directed share issue
A directed share issue of 5 357 143 B-shares at a price of SEK 28 per share was completed. Through the directed share issue, the Company received gross proceeds of SEK 150 million. The directed share issue was subscribed by qualified investors.

Other events during the first quarter

Clinical results with Diamyd Medical’s study drug Remygen were published in a scientific journal
The clinical results from the dose-escalation part of the investigator-initiated clinical Phase I/II trial ReGenerate-1 evaluating Remygen (GABA) in individuals with long-standing type 1 diabetes, have been published in the scientific journal BMJ Open Diabetes & Care. The patent-pending findings showed, as previously announced, that Remygen established a counter-regulatory response to severely reduced blood sugar levels (hypoglycemia), indicating its potential use as a hypoglycemia-preventing treatment.

Analysis that supports the effect of the diabetes vaccine Diamyd was presented at the ISPAD conference
An analysis showing the effect of the diabetes vaccine Diamyd (GAD-alum) in reducing the time a patient has high blood glucose, was presented at the ISPAD conference (The International Society of Pediatric and Adolescent Diabetes), by Professor Johnny Ludvigsson, Principal Investigator of the clinical trial DIAGNODE-2.

Significant events after the first quarter

Interim report indicated similar immunological response in LADA-patients treated with intralymphatic Diamyd as in type 1 diabetes patients
An initial interim report from the open-label investigator-initiated clinical trial GADinLADA, in which the diabetes vaccine Diamyd is administered directly into the lymph node in 14 patients aged 30 to 70 years with the autoimmune form of diabetes called LADA (Latent Autoimmune Diabetes in Adults), showed that treatment after five months is safe and tolerable. Preliminary analyses indicated that the immunological response to the treatment is similar to what has been observed in individuals with type 1 diabetes treated with Diamyd.

Other events after the first quarter

Patent for intralymphatic injection of GAD in autoimmune diabetes to be granted in China
The patent that will be granted by the Chinese Patent Office is valid until 2035. The patent primarily protects the administration method of Diamyd (GAD/alum) which has shown positive results in the Phase I/II and Phase IIb trials DIAGNODE-1 and DIAGNODE-2 and will be evaluated in the Phase III trial DIAGNODE-3.

Australia granted as first region Diamyd Medical a broadening of a patent for intralymphatic injection of antigens in autoimmune diabetes
The patent covers intralymphatic injection of beta cell antigens including insulin for the treatment and prevention of autoimmune diabetes. The approval is a division of the patent application previously approved in Australia on intralymphatic injection of GAD, the active component in the diabetes vaccine Diamyd that Diamyd Medical is developing for type 1 diabetes and Latent Autoimmune Diabetes in Adults (LADA).

Two drugs in clinical development

Diamyd and Remygen are drugs in clinical development that focus on the underlying disease mechanisms of diabetes; the dysfunction and loss of insulin-producing beta cells in the pancreas.

Diamyd is an antigen-specific immunomodulating precision medicine diabetes vaccine for the treatment and prevention of autoimmune diabetes (type 1 diabetes and LADA, Latent Autoimmune Diabetes in Adults).

Clinical data indicate the potential of the diabetes vaccine Diamyd to halt or stop the autoimmune destruction of insulin-producing beta cells in individuals that carry the HLA DR3-DQ2 haplotype. The effect is achieved by antigen-specific reprogramming of immune cells by administration of low doses of Diamyd in superficial lymph nodes. By maintaining the endogenous insulin production, Diamyd has the potential to make a significant difference in the daily life of patients as well significantly reduce the complications of type 1 diabetes. Topline results from the Phase IIb trial DIAGNODE-2 demonstrated a significant treatment effect of Diamyd in the predefined genetic patient group.

Remygen is an oral regenerative and immunomodulatory drug candidate for the treatment of autoimmune- and type 2 diabetes. By stimulating the growth of insulin-producing cells, Remygen has the potential to reverse the disease progression in autoimmune- and type 2 diabetes. Based on clinical data, Remygen has also the potential to protect against hypoglycemia by improving the hormonal response. Remygen is now being investigated in a clinical Phase I/II trial (ReGenerate-1), where clinical efficacy is evaluated with the aim of optimizing the treatment regimen ahead of registration-based trials.

Clinical trials
Type 1 diabetes is a devastating disease which requires daily treatment with insulin to sustain life. The importance of finding a drug that improves the prospects for patients with diabetes is of utmost importance. The effect of intralymphatic administration of Diamyd, an antigen-specific precision medicine immunotherapy aimed at stopping the immune system’s attack on insulin-producing beta cells in autoimmune diabetes, will be evaluated in the Phase III trial DIAGNODE-3 and is evaluated in the Phase II trial GADinLADA.

Remygen, which aims to stimulate the growth of beta cells in patients with diabetes, is evaluated in patients in a Phase I/II trial.

Upcoming clinical trial

Trial with Diamyd in lymph node

DIAGNODE-3 – DIAMYD IN LYMPH NODES WITH ORAL SUPPLEMENTATION OF VITAMIN D
The placebo-controlled Phase III trial DIAGNODE-3 will include approximately 330 individuals aged 12 to 28 who have been recently diagnosed with type 1 diabetes and who carry the genetically defined haplotype HLA DR3-DQ2. The trial will be conducted at approximately 50 clinics, where almost half of all individuals with type 1 diabetes are estimated to carry the current haplotype. After an initial month in which all trial participants receive vitamin D, the individuals will be randomized 2:1, ie two out of three trial participants will receive three intralymphatic injections of Diamyd and one in three will receive the corresponding placebo at one month intervals, with one primary reading 24 months after trial start. The design provides, based on efficacy data from previous studies on the HLA-restricted patient population, a high probability of reaching the primary endpoints; preservation of stimulated C-peptide and lower HbA1c. The Coordinating Investigator for the trial is Professor Johnny Ludvigsson at Linköping University. The Sponsor of the trial is Diamyd Medical.

Ongoing clinical trials

Trial with Diamyd in lymph node

GADinLADA – DIAMYD IN LYMPH NODES WITH ORAL SUPPLEMENTATION OF VITAMIN D
The main aim of the trial is to evaluate the safety of intralymphatic treatment with Diamyd in patients with LADA (Latent Autoimmune Diabetes in Adults). The patients have been recruited in Norway at the Norwegian University of Science and Technology (NTNU) in Trondheim, in collaboration with St. Olavs Hospital, University Hospital in Trondheim, and in Sweden at the Center for Diabetes, Akademiskt specialistcentrum, an academic specialist unit run in collaboration between Stockholm County’s healthcare area, Karolinska Institutet and Karolinska University Hospital. The patients included in the trial are between 30 and 70 years old, have been diagnosed with LADA within the last 18 months and are not yet on insulin therapy. The Sponsor of the trial is the Norwegian University of Science and Technology with Ingrid K Hals as Sponsor’s representative. Diamyd Medical contributes with study drugs, expertise and some financial support for immunological analyzes and determination of HLA haplotypes. 12 month results are expected later in 2022.

Trial with Remygen (GABA)

REGENERATE-1 – REMYGEN /ALPRAZOLAM
An open-label, investigator initiated clinical trial with Remygen. The trial includes approximately 36 patients aged 18-50 who have had type 1 diabetes for more than five years with low to non-existing insulin production. Safety and initial efficacy results from the dose escalation section of the trial have paved the way to initiate the main trial and have also demonstrated a potential effect of Remygen to improve the hormonal response to hypoglycemia. The main trial evaluates whether the insulin-producing cells can be regenerated and if the hormonal response to hypoglycaemia can be improved using Remygen and the combination of Remygen and Alprazolam. The trial is led by Professor Per-Ola Carlsson at Uppsala University, Sponsor of the trial.

Manufacturing of GAD65 in Umeå
A new facility for vaccine manufacturing is being set up in Umeå, the Capital of Västerbotten County in Sweden, for the manufacture of recombinant GAD65, the active pharmaceutical ingredient in the therapeutic diabetes vaccine Diamyd currently in late-stage clinical development. The 10 000 square feet site, comprising of clean rooms, laboratory facilities and office space, will facilitate full control, predictability and scalability of the manufacturing technology of the active ingredient. Diamyd Medical has chosen Cytiva’s configurable single-use bioprocess manufacturing platform FlexFactory for the process. Small-scale experimental production of GAD65 is now established at the manufacturing facility. Large-scale production is being set up primarily using Cytiva equipment.