Alzinova AB interim report January – June 2020

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

Six months, January – June 2020

• Net sales amounted to 0 SEK (0 SEK).
• Result after financial items amounted to -2 898 387 SEK (-2 737 617 SEK).
• Earnings per share amounted to -0,38 SEK (-0,36 SEK)
• Solidity amounted to 92,6% (95,5%).

Three months, April – June 2020

• Net sales amounted to 0 SEK (0 SEK).
• Result after financial items amounted to -1 123 481 SEK (-1 567 023 SEK).
• Earnings per share amounted to -0.15 SEK (-0.21 SEK)

Significant events during the second quarter of 2020 

• The Alzinova strengthened its Board of Directors with two new members, Lena Degling Wikingsson and Per-Göran Gillberg, both of whom will add pharmaceutical development skills to the Company. 
• The annual general meeting held on May 14 resolved to establish long-term incentive schemes for the Board of Directors and key personnel by issuing subscription warrants. Upon full exercise of the issued warrants, the dilution effect on Alzinova's shares and votes will be approximately 2.1 percent.
• During the period, Alzinova initiated an active risk analysis effort of COVID-19-related hazards. The Company is working closely with its partners to minimize the impact of COVID-19.

Significant events after the second quarter of 2020

• Alzinova presented preclinical data on the Company's candidates at the Alzheimer’s Association International Conference (AAIC). The preclinical data support the continued development of the Company's lead candidate, ALZ-101.
• The manufacture of the ALZ-101 vaccine drug substance for the Phase 1b clinical trial in Alzheimer's disease patients has been delayed, as additional analytical work must be performed.  Delivery of the drug for the study is now estimated to be the first quarter of 2021, and the study is expected to commence with the first patient’s first dose during the second quarter of 2021.

CEO comments

Alzinova’s operations have proceeded according to plan for the past quarter, despite the ongoing COVID-19 pandemic which affects both us and the wider world.

Our long-term goal is to develop a disease modifying therapeutic vaccine for the treatment and also the prevention of progression of Alzheimer's disease.  A long-acting and effective drug will make it possible for patients to lead an active and independent life without impact from the disease. 

In the second quarter, we received delivery of a technical batch of ALZ-101 which was found to be of higher purity than the drug substance manufactured by the previous supplier. This is positive. The ongoing analysis of the technical batch has, however, not been completed in time, and the production and supply of material for the planned clinical Phase 1b study in Alzheimer's disease patients is thus delayed. On a positive note, the delay is likely to facilitate patient recruitment for the clinical study as the availability of patients is set to improve in the second quarter 2021 in light of the anticipated covid-19 development.  

In July, Alzinova presented preclinical data on the Company’s candidates at the Alzheimer’s Association International Conference 2020 (AAIC), together with researchers from the University Medical Center (UMC) Amsterdam and Gothenburg University. Data shows that the monoclonal antibody ALZ-201, which specifically targets amyloid-β42-oligomers, is able to neutralize the neurotoxic effect of these oligomers as effectively as an antibody that binds to all forms of amyloid β. The findings demonstrate that oligomers are present in low levels in the brain of patients, and that targeting these with high specificity is likely required to achieve therapeutic efficacy.

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 neuro toxic oligomers of amyloid-β, which are believed to be the cause of Alzeimer’s disease.

Based on the documented preclinical properties of both the monoclonal antibody ALZ-201 and the clinical candidate ALZ-101, we are looking forward to the clinical development of the therapeutic vaccine ALZ-101, which gives opportunities to development effective well tolerated products.

At AAIC, data were presented from clinical trials with other drug candidates that bind non-specifically and to differing degrees to various forms of amyloid-β. These results indicate that the specificity matters, to achieve efficacy as well as to avoid adverse side effects. 

During summer, the US Food and Drug Administration (FDA) announced that another clinical drug candidate for treatment of Alzheimer’s disease (Biogen's aducanumab) had been accepted for Priority Review. We welcome this news, which indicates a new era for the research and clinical progress in Alzheimer’s disease. This demonstrates that it is possible to register a disease modifying therapy in the amyloid-β field as well as to shorten the development times and fast track the market approval process - a promising development for patients with Alzheimer's disease.

Our financial position remains stable.

I would finally like to welcome two new board members to the company – Lena Degling Wikingsson and Per-Göran Gillberg. With their experience, they will contribute valuable skills, particularly in pharmaceutical development, as the Company now makes the transition into a new phase.

For more information, please contact

Kristina Torfgård, VD

tel: +46 708 46 79 75

E-mail: kristina.torfgard@alzinova.com

Håkan Skogström, CFO

tel: +46 705 85 08 59

E-mail: hakan.skogstrom@alzinova.com

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 August 26, 2020.

AboutAlzinova AB

Alzinova AB is a Swedish biopharma company specializing in the treatment of Alzheimer’s disease targeting  neurotoxic amyloid-β oligomers. The lead candidate, ALZ-101, is in late preclinical development as a therapeutic vaccine for the treatment of Alzheimer's. Alzinova’s proprietary AβCC peptide™ technology enables the development of disease-modifying therapies that target the toxic amyloid-β oligomers involved in the onset and progression of the disease with high precision. Alzheimer’s is one of the most common and devastating neurological diseases globally, with of the order of 40 million people afflicted today. In addition, the antibody ALZ-201, in early preclinical development, was generated with the AβCC peptide™ technology and the ambition is to expand the pipeline further. The company’s Certified Advisor on Nasdaq First North Growth Market is Corpura info@corpura.se +46 768-532 822. For more information about Alzinova, please visit: www.alzinova.com