Quarterly Report II 17/18

September 2017 – February 2018, Diamyd Medical AB (publ), Fiscal year 2017/2018

September 1, 2017 – February 28, 2018

  • Net result amounted to MSEK -20.0 (-10.9), of which the second quarter constituted of MSEK -9.1 (-6.4). The change compared with the previous year relates to the DIAGNODE-2 trial which started this financial year and production of GAD-65
  • Result per share, before and after dilution, amounted to SEK -0.4     (-0.4), of which the second quarter constituted of SEK -0.2 ( -0.2)
  • Cash flow from operating activities amounted to MSEK -22.9 (-10.5) of which the second quarter constituted of MSEK -10.8 (-5.9)
  • Liquid assets and short-term investments amounted as of February 28 to MSEK 62.6 (20.6)

Significant events during the second quarter, December 1, 2017 – February 28, 2018

  • The GABA/Diamyd® trial in the US expected to be fully recruited this summer
  • High interest from patients to participate in the DIAGNODE-2 trial
  • Continued positive clinical course was shown in DIAGNODE-1 when four patients had been followed for 30 months and all patients for six months

Significant events after the reporting period

  • Diamyd® subcutaneously continued to show weaker results than when administered intralymphatically
  • Continued positive clinical course was shown in DIAGNODE-1 when nine patients had been followed for 15 months

CEO comments

Dear Shareholders and Readers,

So far, patient enrollment for DIAGNODE-2 has exceeded our expectations. A total of 48 patients have been screened, which corresponds to nearly half of the number planned. Of these 48 patients screened, 29 have started the trial. To be able to respond to the considerable interest being shown in the trial, we increased the number of clinics in March. The most recent clinic to join the trial is the pediatrics clinic at the University Hospital of Umeå, which is now open for patient enrollment.

The other week, we announced new results from the ongoing DIAGNODE-1 trial, where a total of nine patients have completed their 15-month follow-up period. In connection with this, we met with potential partners. The results from DIAGNODE-1 remain positive, and confidential discussions are under way with some players regarding licensing of the Diamyd® diabetes vaccine for certain countries. The outcome of these discussions will largely depend on whether an agreement can be reached regarding the financial terms and on the prospective partners’ expertise and involvement in the field of diabetes and pharmaceutical marketing. The progress we have made in the development of the diabetes vaccine has also made an impression on investigators, and we have identified an interest in initiating a trial involving a patient population with latent autoimmune diabetes in adults (LADA). Since our existing resources are primarily focused on the DIAGNODE-2 trial, we are currently proceeding with the application for grants for the trial together with collaboration partners. LADA patients represent a large and often incorrectly treated group of diabetics, who are often misdiagnosed as having type 2 diabetes but actually have a diagnosis that more closely resembles type 1 diabetes, where the disease progression involves an autoimmune attack on the insulin-producing cells.

Regarding Remygen™, our proprietary patent-pending GABA formulation, we are seeing growing interest in our program, partly from companies that have indicated an interest in entering into partnership at an early phase and thereby contributing to the design of the clinical development program. Intellectual property rights, meaning patents and trade secrets, play a very important role in such collaborations, since GABA is a previously known substance. We have a strong and growing patent portfolio; with our own applications and with the patent application we licensed from UCLA in early autumn 2017 where we have chosen to proceed in the US, Canada, Australia, Europe, China, Japan and South Korea. The application covers the combination of GABA and allosteric modulators to increase the efficacy in terms of growth and survival of insulin-producing cells, a highly attractive area for Diamyd Medical.

It may also be interesting to note that, in addition to the above-mentioned patent applications, Diamyd Medical has so far applied for a further seven proprietary patents, including a) antigen-specific treatment of individuals with certain genetic predisposition for type 1 diabetes, b) biomarkers to measure the effect of antigen-specific therapies and c) antigen-specific treatment of autoimmune diseases with concomitant inhibition of complement activation.

I would like to thank all shareholders and others for your interest in our struggle to change the paradigm for the treatment of diabetes.

Stockholm, March 28, 2018

Ulf Hannelius,
President and CEO


Significant events during the second quarter
December 1, 2017 –February 28, 2018

The GABA/Diamyd® trial in the US fully recruited this summer
In the placebo-controlled combination trial GABA/Diamyd®conducted at University of Alabama at Birmingham, US, 82 patients had been included, of which 48 had completed the entire trial. No serious side effects had been reported and the treatment appeared to be safe. The trial is expected to be fully recruited this summer.

High interest from patients to participate in the DIAGNODE-2 trial
Diamyd Medical reported that five patients had been enrolled in the European phase II trial DIAGNODE-2 and several patients were scheduled for screening during the forthcoming weeks. Out of these first five patients, one patient had had the first intralymphatic injection of the diabetes vaccine Diamyd®(or its placebo) after a 30-day period of oral treatment with vitamin D (or its placebo).

Continued positive clinical course was shown in DIAGNODE-1 when four patients had been followed for 30 months and all patients for six months
Positive effects such as lower insulin requirements and improved blood glucose levels were observed for the first four diabetes patients that had been followed for 30 months in the DIAGNODE-1 trial. Safety looked good and no serious side effects had been reported. Positive results were also reported from the trial when all patients have been followed for 6 months. A clinically relevant and positive progression was demonstrated in terms of the body’s own capacity to produce insulin, as well as long-term blood sugar and insulin dose. No serious adverse events had been reported.

Significant events after the reporting period

Diamyd® subcutaneously continued to show weaker results than when administered intralymphatically
A preliminary 15-month interim report from EDCR IIa, an investigator initiated pilot trial where the diabetes vaccine Diamyd®is administered subcutaneously in combination with etanercept and vitamin D showed, when all 20 patients have been followed for fifteen months, that the treatment is safe and tolerable. No serious side effects had been reported. Results pertaining to the patients’ own insulin production, HbA1c and external insulin requirements were, however, weaker in EDCR IIa than from the ongoing DIAGNODE-1 trial where the diabetes vaccine is administered directly into the lymph node.

Continued positive clinical course was shown from DIAGNODE-1 when nine patients had been followed for 15 months
A sixth interim report from the investigator initiated DIAGNODE-1 trial, an open label clinical pilot trial in which the diabetes vaccine Diamyd®is given directly into the lymph node, showed a continued positive clinical course in terms the patients’ own ability to produce insulin as well as long-term blood sugar and insulin dose when nine patients had been followed for 15 months.

On-going clinical trials with Diamyd®
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 diabetes vaccine Diamyd® has been used in clinical trials with more than 1 000 patients and has shown a good safety profile. Diamyd® is easy to administer in any clinical setting. The potential annual market is estimated to several billion dollars per year. Five clinical trials are ongoing combining Diamyd® with various other immunomodulatory compounds; etanercept, vitamin D and GABA.

  • DIAGNODE -1 – DIAMYD® IN LYMPH GLANDS IN COMBINATION WITH VITAMIN D

An open label trial, where Diamyd® is administered directly into lymph nodes 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. The trial was fully recruited in June 2017. 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, Sweden.

  • DIAGNODE -2 – DIAMYD® IN LYMPH GLANDS IN COMBINATION WITH VITAMIN D

DIAGNODE-2 is a follow-up double-blind randomized trial where Diamyd® is administered directly into lymph nodes in combination with treatment with vitamin D. The trial encompasses approximately 80 patients from Sweden, the Czech Republic and Spain, aged 12–24 years that have recently been diagnosed with type 1 diabetes and will continue for a total of 15 months. 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. Diamyd Medical is the Sponsor of the trial.

  • GABA/ DIAMYD® – COMBINING DIAMYD® WITH GABA

A placebo-controlled 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. 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.

  • EDCR IIa – COMBINING DIAMYD® WITH ETANERCEPT AND VITAMIN D

An open label 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. 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, Sweden.

  • DiAPREV-IT 2 – COMBINING DIAMYD® WITH VITAMIN D

A placebo-controlled 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. 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 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 28, 2018.

Note: This document has been prepared in both Swedish and English. The Swedish version shall govern in case of differences between the two documents. The document contains certain statements about the Company’s operating environment and future performance. These statements should only be regarded as reflective of prevailing interpretations. No guarantees can be made that these statements are free from errors.

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Diamyd Medical is a Swedish diabetes company dedicated to finding a cure for autoimmune diabetes through pharmaceutical development and investments in stem cell- and medical technology.

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