Alzinova AB interim report January – March 2020

The Board of Directors and the Chief Executive Officer of Alzinova AB hereby present the interim report for the first quarter 2020. 

Three months (2020-01-01 – 2020-03-31) 

• Net sales amounted to SEK 0 (SEK 0). 
• Result after financial items amounted to SEK -1,774,906 (SEK -1,170,594).  
• Earnings per share amounted to SEK -0.23 (SEK -0.16). 
• Solidity amounted to 91.8% (95.4%).

Significant events during the first quarter of 2020

• The Company announced in January that it had ensured a robust and validated process to manufacture API that meets the quality standards required to conduct the clinical trial with the vaccine ALZ-101 on Alzheimer’s disease patients. It was further announced that the study would commence during the fourth quarter with the initial dosing of the first patient planned for the turn of the year 2020/2021.
• In February, Alzinova AB made changes to the composition of the Board of Directors, as Björn Löwenadler stepped down from the board on personal grounds.
• An extraordinary general meeting was held on 27 February 2020. The general meeting passed resolutions regarding the number of board members of the Company and the appointment of Pernilla Sandwall as new board member.
• In March, Håkan Skogström took up appointment as Chief Financial Officer.
• Alzinova is actively conducting risk analysis with regard to covid-19, and is working closely with its partners to reduce any negative impact of covid-19 to a minimum. Alzinova will provide the market with relevant and timely updates of significant effects of covid-19 on Alzinova’s operations.

Significant events after the first quarter of 2020

• No significant events.

CEO comments

Our goal is to initiate the first clinical trial with a therapeutic vaccine that specifically targets the toxic oligomers of amyloid-β in patients with Alzheimer’s disease at the turn of the year, 2020/2021.

The ALZ-101 drug candidate is in late preclinical phase, and during the first quarter of 2020, we have continued our effort to develop and manufacture API in order to be able to deliver GMP material and clinical trial material for the upcoming study in the fall. We have prepared and worked on the regulatory documentation required to initiate the clinical phase 1b study on Alzheimer’s disease patients in Finland. This marks the first study with ALZ-101 on humans, and will thus be a so-called safety study, where the objective is to demonstrate safety and good tolerability of the therapeutic vaccine ALZ-101 in Alzheimer's disease patients. In the clinical study, we will also examine the patients’ immune response, as well as a number of different biological markers that are associated with Alzheimer’s disease.

The drug candidate ALZ-101 and the ALZ-201 antibody differ from previously tested candidates against Alzheimer’s disease, which bind non-specifically and to differing degrees to various forms of amyloid-β. Completed clinical trials on other candidates indicate that the specificity matters, to achieve efficacy as well as to avoid adverse side effects.

A therapeutic oligomer-specific vaccine against Alzheimer’s disease is specific and unique and entails that the body generates its own antibodies that target only the toxic oligomers of amyloid-β, which are believed to be the cause of Alzeimer’s disease.

For more information, please contact

Kristina Torfgård, VD

tel: +46 708 46 79 75

E-mail: kristina.torfgard@alzinova.com

Certified Adviser

Corpura Fondkommission AB

E-mail: ca@corpura.se

tel: 0768-532822

Home page: www.corpura.se

This information is information that Alzinova AB  is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the contact person set out above at 8:01 CEST on May 15, 2020.

About Alzinova AB 

Alzinova AB is engaged in pharmaceutical research and development for treatment of Alzheimer’s disease – one of our major health scourges, without efficient treatment options. The Company's patented technology enables the development of novel therapies, that with high precision could target the substances involved in the formation of the disease and render them harmless. Alzinova's focus is to develop a vaccine as a long-acting therapy for treatment and prevention of Alzheimer's disease. The vaccine is under preclinical development, in preparation for human clinical trials. Alzinova was founded by researchers from the MIVAC research center at the University of Gothenburg, and by GU Ventures AB.