Alzinova AB Year-end Report 2020

The Board of Directors and the Chief Executive Officer of Alzinova AB, hereby present the report for the period January-December 2020.

Twelve months, January–December 2020

• Net sales amounted to 0 SEK (0 SEK).
• Result after financial items amounted to -6,499,557 SEK (-6,189,903 SEK).
• Earnings per share amounted to –0.41 SEK (-0.81 SEK).
• Equity ratio amounted to 95.2 % (93.0 %).

Three months, October–December 2020

• Net sales amounted to 0 SEK (0 SEK).
• Result after financial items amounted to -2,361,085 SEK (-2,844,273 SEK).
• Earnings per share amounted to –0.15 SEK (-0.37 SEK).

Significant events during October–December 2020

• Alzinova carried out a 95 percent guaranteed preferential rights issue of units of MSEK 49.6 with attached warrants. The warrants can provide additional proceeds of approximately MSEK 25-42 in January 2022 (upon full exercise).
• The rights issue was oversubscribed to approximately MSEK 86 including subscription commitments, corresponding to a subscription rate of 173 percent, 95 percent of which with preferential rights. Alzinova was provided MSEK 49.6 in proceeds before issuance and guarantee costs.
• Alzinova received positive feedback in scientific advice from the Finnish Medicines Agency Fimea, for the forthcoming clinical trial application of the Alzheimer’s vaccine ALZ-101

Significant events after the end of the period

• Alzinova announced in January that the drug substance for the vaccine ALZ-101 is manufactured and meets the requirements for the upcoming Phase 1b clinical study in patients with Alzheimer's disease, expected to start during the second quarter of 2021. 

CEO comments

2020 was an important year and, our goal-oriented work has ensured that we are well prepared for the start of our upcoming clinical study in 2021 in patients with Alzheimer’s disease, despite the challenges of the Covid-19 pandemic.

During the fourth quarter, we progressed the work on the manufacturing of the drug substance for the ALZ-101 vaccine and, at the start of 2021, we secured materials for the Phase 1b clinical study. The drug substance has a high purity and meets the requirements of the clinical study. For us, this is an important milestone ahead of the study start and the continued development of the vaccine. We are now working to optimize the drug substance manufacturing process to ensure we can meet the requirements of the next stage of the development process, which is a Phase 2 study.

Preparations for the start of the Phase 1b clinical study in Finland have, during the year, featured two important regulatory interactions. As previously communicated, we received positive feedback in scientific advice from the Finnish Medicines Agency Fimea. During 2020, we also submitted an application to the National Ethics Committee in Finland and received their favorable opinion in February 2021. With these positive outcomes and according to plan, we will now submit our application to Fimea to obtain approval to start the clinical study with our therapeutic vaccine, ALZ-101, during the second quarter 2021. 

ALZ-101 is a therapeutic oligomer-specific vaccine being developed to treat patients with Alzheimer’s disease. The vaccine is unique because its oligomer-specificity means that the body generates its own antibodies that only target the neurotoxic oligomers of amyloid-β, which are believed to be one of the causes of Alzheimer’s disease.

During the year, data from clinical trials conducted with a number of other amyloid-ß drug candidates were presented. The results show that high oligomer-specificity is important both to obtain a good effect, and to avoid side effects. This supports our strategy to develop oligomer-specific treatment of Alzheimer's and that ALZ-101 can succeed in clinical trials.

In November, Alzinova presented the study design for the vaccine candidate ALZ-101 at the scientific congress, Clinical Trials in Alzheimer’s Disease (CTAD). The planned study will be conducted in patients with early Alzheimer’s disease. The study is the first in humans and the aim is to demonstrate if the vaccine candidate, ALZ-101 is well tolerated and doesn’t result in any unexpected side-effects. Moreover, the study will also include analyses of the immune response, i.e. levels of antibodies generated by the vaccine after repeated dosing, as well as a number of biomarkers that are linked with Alzheimer’s disease.

As part of the ongoing preparations for the upcoming clinical study, Alzinova has established a research collaboration with Sahlgrenska University Hospital in Gothenburg, Sweden, focused on biomarkers that are used to track neurodegenerative change related to Alzheimer’s disease.

We strengthened our financial position during the fourth quarter through a preferential rights issue of units of MSEK 49.6 with attached warrants. The warrants can provide additional proceeds of approximately MSEK 25-42 in January 2022 (upon full exercise). The new capital will primarily be used to finance preparations for clinical Phase 2 and thereby strengthen our ability to make ALZ-101 even more attractive to potential partners.

During the year, we have been affected by Covid-19, but thanks to actively implementing safety precautions, the pandemic hasn’t had any major impact on our operations.

I am proud to lead this innovative company and, together with colleagues, board members and collaboration partners, to be developing a therapeutic vaccine that can potentially improve the lives of people suffering from Alzheimer’s disease. We are now looking forward to starting our first clinical study with patients.

Kristina Torfgård, CEO Alzinova

Read the full report at:
https://www.alzinova.com/investors/financial-reports/

For more information, please contact:
Kristina Torfgård, CEO
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

The information was submitted for publication, through the agency of the contact person set out above, at 08:01 a.m. CET on February 25, 2021.

About Alzinova 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