Comments by CEO
Dear Shareholders,
The recent granting of Fast Track designation by the
In the wake of receiving the Fast Track designation for
The precision medicine Phase 3 trial DIAGNODE-3 remains a cornerstone of our efforts to advance the field of Type 1 Diabetes treatment through antigen-specific immunotherapy. We are poised for an interim analysis this summer based on approximately 70 patients and their progression in C-peptide, the marker for endogenous insulin producing capacity, at 6 months. The analysis is blinded to not interfere with the pivotal nature of the trial but will provide information about the progression of the trial and thereby the likelihood of the trial meeting its endpoints. In parallel, we anticipate reaching another significant milestone with 100 patients randomized this April and associated milestone payments from our partnership with JDRF. A few days ago, the clinical team also reported that we have now screened more than 300 patients, which underlines the operational momentum in the study.
The collaboration with JDRF not only underscores our commitment to pioneering innovative treatments but also highlights the collective drive to address the complexities of Type 1 Diabetes.
Last week I had the opportunity and privilege to present new genetic data from DIAGNODE-3 as well as how they align with data from our previous trials at the Antigen Specific Immune Tolerance Summit in
Furthermore, the progress at our biomanufacturing facility in Umeå is another key pillar of our strategy. In parallel to the work aiming to have the biomanufacturing facility GMP ready during this year, the team is actively working with engineering runs, technical batches that are critical before transitioning into manufacturing of clinical batches. The expansion of our team, where several positions are currently advertised, is also central to scaling up our production capabilities, ensuring that we can meet the future demand for
The last months have been marked by noteworthy achievements and strategic decisions that pave the way for an exciting future. As CEO, I am profoundly optimistic about what lies ahead for
Together, we are making strides towards transforming the landscape of Type 1 Diabetes treatment.
The reporting period in summary
- Operating income: MSEK 2.1 (2.6) second quarter: MSEK 1.2 (1.6)
- Net result: MSEK -62.0 (-57.9), second quarter: MSEK -29.3 (-25.0)
-
Result per share:
SEK -0.7 (-0.8), second quarter:SEK -0.3 (-0.3) - Cash flow from operating activities: MSEK -63.2 (-52.4), second quarter: MSEK -35.4 (-25.4)
-
Cash and short-term investments at
February 29, 2024 : MSEK 137.1 (101.6)
Significant events during the second quarter,
Diamyd Medical received FDA Fast Track designation forDiamyd ®
Other events during the second quarter
Diamyd Medical announced presentation of new genetic data at ASIT summit inBoston, MA - Publication in Diabetologia highlighted AI's potential for Type 1 Diabetes screening
-
In-depth analysis of
Diamyd Phase II trial further supported value of preserved insulin secretion Diamyd Medical gained market research findings to guideU.S. commercial strategyDiamyd ® Phase 3 trial key interim analysis was announced to be presented in July-
Precision Medicine patent for the prevention and treatment of autoimmune diabetes was granted in
South Korea
Significant events after the second quarter
- The Board resolved on a rights issue of approximately
SEK 114 million
INVITATION TO PRESENTATION OF THE QUARTERLY REPORT 2 2023/2024
The presentation will be held in Swedish
When:
Live webcast: https://www.youtube.com/watch?v=of5wTS4ydFo.
The YouTube chat is open for questions.
The broadcast is produced by
The presentation will also be made available on www.diamyd.com
About
.
Further information is available on https://www.diamyd.com
For more information, please contact:
Phone: +46 8 661 00 26 E-mail: info@diamyd.com Reg. no: 556242-3797
The information was submitted for publication, through the agency of the contact person set out above,
at 08.15 CET on
https://news.cision.com/diamyd-medical-ab/r/quarterly-report-ii-23-24,c3952952
https://mb.cision.com/Main/6746/3952952/2698616.pdf
https://news.cision.com/diamyd-medical-ab/i/diamyd--vials,c3283590
(c) 2024 Cision. All rights reserved., source