Quarterly Report II 18/19

September 2018 – February 2019, Diamyd Medical AB (publ), Fiscal year 2018/2019

DIAGNODE-2 towards full recruitment
Diamyd Medical’s B-share is traded on Nasdaq First North under the ticker DMYD B.
Further information is available on https://www.diamyd.com

Figures in parentheses relate to the corresponding period previous financial year. 

September 1, 2018 – February 28, 2019

•  Net result: MSEK -19.0 (-20.0), whereof second quarter MSEK -10.4 (-9.2)
•  Result per share: SEK -0.3 (-0.4), second quarter SEK -0.2 (-0.2)
•  Cash flow from operating activities: MSEK -19.5 (-22.9), second quarter MSEK -8.7 (-10.8)
•  Liquid assets and short-term investments as of February 28, 2019:          MSEK 79.6 (62.6)

Significant events December 1, 2018 – February 28, 2019

• 75 percent of the patients enrolled in DIAGNODE-2, the European Phase II trial with Diamyd®
• Diamyd Medial raised SEK 58.4 million through redemption of warrants

Significant events after the reporting period

• Diamyd Medical announced strategic activities for 2019 and 2020
• DIAGNODE-2 close to full recruitment
• New publication supports Diamyd Medical’s patent rights around GABA

Comments by CEO Ulf Hannelius

Dear Shareholders and Readers,

Our European phase IIb trial DIAGNODE-2, where the diabetes vaccine Diamyd®is administered three times in a superficial lymph node is close to being fully recruited. Currently, 93 out of 106 patients have been randomized and in the beginning of March we were able to give the green light to the clinic in Rotterdam in the Netherlands to start recruiting. This together with high patient retention rate ensures that we keep our timelines and will close the trial for recruitment during the spring. Results are expected in the third quarter in 2020, and as previously communicated our aim is to file for a conditional marketing authorization in Europe end of 2020.

There are certain requirements for a therapy to be aligned with conditional marketing authorization in Europe. Firstly, the positive effects need to out-weigh the risks and there should be a clear public health benefit to making the product immediately available. Secondly, the applicant should be able to provide comprehensive data following conditional authorization in order to convert it to a full marketing authorization. And finally, the product needs to address a significant unmet medical need. Given the above, there is a clear case supporting an early market introduction for Diamyd®.

Today, there are no disease-modifying therapies available for type 1 diabetes patients. Recent reports both in Europe and in the US show that treatment goals are met by only a minority of patients despite an increased use of modern assistive devices and improvements in insulin technologies. The disease is associated with a significant decrease in life-expectancy due to short- and long-term complications as well as significant health economic costs.

Diamyd®is a therapeutic that has demonstrated very good safety in trials with more than 1,000 patients and there is strong support of a positive biological effect of the therapeutic. Most importantly, recent results based on intralymphatic administration of Diamyd®support an efficacy profile that is both clinically highly relevant as well as unique, and the treatment regimen is simple and therefore aligned with high patient acceptance.

Supported by these key insights we are moving forward with confidence and we are seeing increased international visibility highlighting the work we are doing. Recently an interview by the US non-profit T1DExchange was published featuring our efforts to cure type 1 diabetes. Diamyd Medical has also been invited to present the diabetes vaccine Diamyd®at the international scientific conference Vaccines Forum in Valencia in May.

As announced yesterday, regulatory meetings in Europe and the US are planned for 2019 and 2020. We also announced that we are planning for commercial activities including pricing and market access, designing a Phase III program, as well as making sure the commercial manufacturing capacity is aligned with market launch and expansion. Existing resources will be used for finalizing DIAGNODE-2 and for regulatory meetings, while activities associated with a Phase III program and commercial manufacturing and will be financed through with future partnerships and/or institutional investors.

Based on current results and the progress we are making it seems ever more likely that we will be able to make a significant positive impact in the lives of those affected by type 1 diabetes.

Stockholm, March 27, 2019
Ulf Hannelius,
President and CEO

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 immunotherapy for the treatment of autoimmune diabetes (type 1 diabetes).

Clinical data indicate the potential of the diabetes vaccine Diamyd®to halt or stop the autoimmune destruction of insulin-producing beta cells. The effect is achieved by antigen-specific reprogramming of immune cells by administration of three 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.

Intralymphatic treatment with Diamyd®is now being investigated in a clinical phase IIb trial (DIAGNODE-2), with the aim of confirming the previously demonstrated clinical effect from a pilot trial in type 1 diabetes patients (DIAGNODE-1).

Remygen® is an oral regenerative and immunomodulatory therapy for the treatment of autoimmune diabetes and type 2 diabetes.

Preclinical data indicate GABA's potential to stimulate growth and function of insulin-producing beta cells. Increased GABA concentrations activate GABA-specific cell surface receptors leading to effects on the cells in the pancreas.

By stimulating the growth of insulin-producing cells, Remygen®has the potential to reverse the disease progression in autoimmune diabetes and type 2 diabetes.

Remygen®is now being investigated in clinical phase I/II trial (ReGenerate-1), where clinical efficacy is evaluated with the aim of optimizing treatment ahead of registration-based trials.

Significant events during the second quarter

December 1, 2018 – February 28, 2019

75 percent of patients enrolled in Diamyd Medical’s European Phase IIb trial DIAGNODE-2
Three quarters, 80 out of 106 patients had been included in DIAGNODE-2, where the diabetes vaccine Diamyd®is administered directly into the lymph node with the aim to preserve the patients’ endogenous insulin production

Diamyd Medical raised SEK 58.4 million in funds through redemption of warrants
During 1 to 30 November 2018, holders of warrants of series TO 1 B and TO 2 A of Diamyd Medical AB were able to subscribe for shares through warrants. A total of 426 037 A shares and 12 409 855 B shares were subscribed for, which means a subscription rate of 95.6 percent. Diamyd Medical raised approximately SEK 58.4 million before issue costs. After registration with the Swedish Companies Registration Office of the new shares, the number of shares in Diamyd Medical amounts to a total of 69 159 726, of which 2 556 223 A shares and 66 613 573 B shares.

Significant events after the reporting period

Diamyd Medical announced strategic activities for 2019 and 2020
The Company announced that preparations for a Conditional Marketing Authorization Application in Europe end of 2020 are underway, including regulatory, manufacturing and commercial activities as well as preparations for a Phase III clinical trial in Europe and the US, to be completed post-approval in support of an accelerated approval process.

DIAGNODE-2 close to full recruitment
Diamyd Medical announced that 91 patients were included in the DIAGNODE-2 trial. Results from the trial are expected during the third quarter of 2020.

Publication supports Diamyd Medical’s patent rights around GABA
A scientific article published in Journal of Diabetes Research supports previous findings that form the basis of patent applications that Diamyd Medical exclusively licenses from University of California, Los Angeles (UCLA). The study shows that treatment with GABA in combination with the GABA receptor modulating agent Alprazolam provides increased effect on the survival and growth of insulin-producing cells in animals.

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 diabetic patients is of utmost importance. The effect of intralymphatic administration of Diamyd®, an antigen-specific immunotherapy aimed at stopping the immune system's attack on insulin-producing beta cells in autoimmune diabetes, is evaluated in the Phase IIb trial DIAGNODE-2. Remygen®, which aims to stimulate the growth of beta cells in patients with diabetes, is now evaluated in patients in a Phase I/II trial. In addition to these, Diamyd®is evaluated in various combinations and modes of administration in ongoing investigator-initiated trials.

Trials with Diamyd® intralymphatically

• DIAGNODE -2 – DIAMYD® IN LYMPH NODES IN COMBINATION WITH VITAMIN D
  A follow-up double-blind randomized clinical trial where Diamyd®is administered directly into a lymph node in combination with treatment with vitamin D. The trial encompasses approximately 106 patients from Sweden, the Czech Republic, Spain and the Netherlands, aged 12–24 years that have recently been diagnosed with type 1 diabetes and will continue for a total of 15 months. Results are expected to be presented in the third quarter of 2020. The trial is a follow up of DIAGNODE-1. The aim of the trial is to evaluate the patients’ remaining insulin producing capacity. Coordinating Investigator is Professor Johnny Ludvigsson at Linköping University, Sweden. Diamyd Medical is the Sponsor of the trial.

• DIAGNODE -1 – DIAMYD® IN LYMPH NODES IN COMBINATION WITH VITAMIN D
  An open label clinical trial, where Diamyd®is administered directly into a lymph node in combination with treatment with vitamin D. The trial comprises twelve patients between the ages of 12 and 30 newly diagnosed with type 1 diabetes and will continue for a total of 30 months. 30 months results are expected to be presented in the first quarter of 2020. The aim of the trial is to evaluate the safety of the combination treatment and the effect on the immune system and the patients’ insulin producing capacity. The trial is led by Professor Johnny Ludvigsson at Linköping University.

Trials with Remygen® and GABA/Diamyd®

• REGENERATE-1 – REMYGEN®
  An open-label, investigator-initiated clinical trial with Remygen®. The trial includes approximately 30 patients aged 18-50 who have had type 1 diabetes for more than five years with low to non-existing insulin production. The primary aim of the trial is to in a smaller dose escalation section evaluate the safety of Remygen®. The main trial also evaluates whether the insulin-producing cells can be regenerated using Remygen®. The trial is led by Professor Per-Ola Carlsson at Uppsala University.

• GABA/DIAMYD® – COMBINING DIAMYD® WITH GABA
  A placebo-controlled clinical trial, where Diamyd®is given subcutaneously and being tested in combination with GABA. In accordance with agreement with Jansen Research & Development and JDRF the trial has expanded to comprise 95 patients between the ages of 4 and 18 recently diagnosed with type 1 diabetes. The trial will continue for a total of 12 months and results are expected to be presented in the last quarter of 2019. The aim of the combination treatment is to preserve the body’s residual capacity to produce insulin. The trial is led by Professor Kenneth McCormick at the University of Alabama at Birmingham, USA.

Other ongoing trials with Diamyd®

• EDCR IIa – COMBINING DIAMYD® WITH ETANERCEPT AND VITAMIN D
  An open label clinical trial, where Diamyd®is given subcutaneously and being tested in combination with etanercept and vitamin D. The trial comprises 20 patients between the ages of 8 and 18 who have been newly diagnosed with type 1 diabetes and will continue for a total of 30 months. 30 months results are expected to be presented in the spring of 2019. The aim of the trial is to evaluate the safety of the combination treatment and the effect on the immune system and the patients’ insulin producing capacity. The trial is led by Professor Johnny Ludvigsson at Linköping University.

• DiAPREV-IT 2 – COMBINING DIAMYD® WITH VITAMIN D
  A placebo-controlled clinical trial, where Diamyd®is given subcutaneously and being tested in combination with vitamin D in children at high risk of developing type 1 diabetes, meaning that they have been found to have an ongoing autoimmune process but do not yet have any clinical symptoms of diabetes. The trial includes 26 children and results are expected in the beginning of 2020. The aim of the trial is to evaluate whether Diamyd®can delay or prevent the participants from presenting with type 1 diabetes. The trial is led by Dr. Helena Elding Larsson at Lund University, Sweden. 

  
  *** The above is an excerpt from the report. To read the complete report, please visit https://www.diamyd.com, or see attached PDF ***

For more information, please contact:
Ulf Hannelius, President and CEO, phone: +46 736 35 42 41
Diamyd Medical AB (publ), Kungsgatan 29, SE-111 56 Stockholm, Sweden
Phone: +46 8 661 00 26 Fax: +46 8 661 63 68 E-mail: info@diamyd.com Reg. no: 556242-3797

This information is information that Diamyd Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 08.15 CET on March 27, 2019.

Tags: