Alzinova AB interim report January – September 2020

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

Nine months, January – September 2020

• Net sales amounted to 0 SEK (0 SEK).
• Result after financial items amounted to -4,138,472 SEK (-3,345,629 SEK).
• Earnings per share amounted to -0.54 SEK (-0.44 SEK)
• Equity ratio amounted to 94.4% (96.3%).

Three months, July – September 2020

• Net sales amounted to 0 SEK (0 SEK).

• Result after financial items amounted to -1,240,085 SEK (-608,012 SEK).
• Earnings per share amounted to -0.16 SEK (-0.08 SEK)

Significant events during the third 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 was delayed due to additional analytical work. Delivery of the drug for the study was estimated to be the first quarter of 2021, and the study to commence with the first patient’s first dose during the second quarter of 2021.
• Alzinova has continuously engaged in an active risk analysis effort related to covid-19 and is working closely with its partners to minimize the impact of covid-19.

Significant events after the third quarter of 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.

CEO comments

Alzinova has had an important and productive quarter -  operations have developed successfully and proceed according to plan.

Our focus during the third quarter has been on the analysis of the technical batch of ALZ-101, alongside the continued work on the regulatory documentation that is required to initiate the clinical study with the therapeutic vaccine ALZ-101 in patients with Alzheimer’s disease.

As previously disclosed, the analysis of the technical batch caused a delay in the supply of study drug. This analysis has now been completed. The results indicate that the drug substance is of high quality, and the final steps of the purification of vaccine for the study have thus been established. Work on production for the Phase 1b study has therefore been resumed according to plan. The study drug for the planned clinical study is projected to be supplied during the first quarter 2021.

The preparatory effort for the clinical study has further encompassed a so-called request for scientific advice, which the company has sought from the Finnish Medicines Agency, Fimea. The advice regarded clinical and regulatory aspects of the Phase 1b clinical trial. It is very gratifying that the authority shares the company’s view that the pre-clinical package provides adequate support for an application to initiate the study in patients. The authority has further agreed with key aspects of the design and implementation of the study. This positive feedback allows us to make preparations to submit the application and initiate the clinical trial, with the aim of dosing the first patient during the second quarter of 2021.

ALZ-101 is a therapeutic oligomer-specific vaccine under development for the treatment of Alzheimer's disease. The vaccine is unique because its oligomer-specificity means that the body generates its own antibodies that target only the neurotoxic oligomers of amyloid-β, which are believed to be the cause of Alzheimer's disease.

Data from clinical studies conducted with other drug candidates, both those that bind non-specifically and others that bind to differing degrees to various forms of amyloid-β, show that oligomer-specificity is important to achieve efficacy as well as to avoid adverse side effects. 

We are now looking forward to initiating the clinical study of the therapeutic vaccine ALZ-101 which, through its unique oligomer-specificity, provides opportunities for developing both an effective and well tolerated product to treat Alzheimer's disease and thus substantially improve the lives of Alzheimer's patients.

Financially, during the fourth quarter, we significantly strengthened our position and our ability to make the drug candidate ALZ-101 even more attractive for partnerships, through the recent rights issue. It comprised units for initial proceeds of approximately MSEK 50 and attached warrants for additional proceeds of approximately MSEK 25-42 in January (upon full exercise). The capital raised will primarily be used to finance preparatory activities in the lead-up to Phase 2, which is the next stage of clinical development.

It is encouraging to see the considerable interest in Alzinova. The rights issue was oversubscribed to approximately MSEK 86, a subscription rate of 173 percent, and I would like to take this opportunity to sincerely thank both the new and existing owners that have invested for their trust. We are filled with confidence about the clinical phase, and moving forward, we hope to be able to deliver positive development outcomes that will convince our owners to in due time exercise their warrants.

Kristina Torfgård, CEO Alzinova

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

The information was submitted for publication, through the agency of the contact person set out above, at 08:01 a.m. CET on October 29, 2020.

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