Alzinova AB interim report January – March 2021

The Board of Directors and the Chief Executive Officer of Alzinova AB hereby present the interim report for the first quarter 2021. 

Three months, January - March 2021

• Net sales amounted to 0 SEK (0 SEK).
• Result after financial items amounted to -1,463,253 SEK (-1,774,906 SEK).
• Earnings per share amounted to -0.09 SEK (-0.23 SEK).
• Equity ratio amounted to 93.6 % (91.8 %).

Significant events during January – March 2021

• Alzinova announced 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. 
• As part of the ongoing preparations for the upcoming Phase 1b clinical study, Alzinova announced in February that it has initiated a collaboration with the Clinical Neurochemistry Laboratory at Sahlgrenska University Hospital in Gothenburg to track markers of neurodegenerative change in Alzheimer’s disease.

Significant events after the end of the period

• Alzinova announced in April that the documentation required for the application to start the planned Phase 1b clinical study with the drug candidate ALZ-101 will be ready during June. The study is planned to start during the third quarter, with the first patient first dose (FPFD) administered during third quarter. 

CEO comments

Alzinova has reached a very exciting phase in the company's history. We are now approaching the start of the first clinical study with a vaccine - ALZ-101 – specifically targeting the neurotoxic amyloid-β oligomers in patients with Alzheimer's disease.

The study in Alzheimer's patients will investigate if the vaccine candidate ALZ-101 is well tolerated and does not cause any unexpected side effects. We will also study the immune response that the vaccine generates upon multiple dosing, as well as a number of biological markers that are associated with Alzheimer's disease. The biomarker work will be done in the context of a research collaboration together with Sahlgrenska University Hospital in Gothenburg.

The documentation required for the application to start the clinical phase 1b study will be ready in June, with the aim to start the study during the third quarter. We plan to give the first patient a first dose during the same quarter.

During the first quarter, we received the drug substance for the vaccine ALZ-101, and the clinical study material for the Phase 1b study is now also manufactured. We continue to work on optimizing the manufacturing process of the drug substance, as well as with the pharmaceutical development to be able to meet the necessary requirements for a future phase 2 study.

The field of dementia, to which Alzheimer's disease belongs, is a hot research area where significant progress is currently being made in both desease diagnostics and drug development. This became apparent in March, when the international Alzheimer's disease and Parkinson's disease conference (AD/PD) was held.

At the conference, there was great interest in data presentations from clinical studies, especially those that showed a disease-modifying effect. These drug candidates are in the form of antibodies against amyloid-ß. The studies show that these antibodies can reduce the harmful forms of amyloid-ß, providing further support for and validation of the amyloid-ß hypothesis. Together, the data also shows that the binding profile of these antibodies is a crucial factor, where a high selectivity for aggregated Aβ is important to obtain a good effect. This further supports our strategy to develop oligomer-specific treatments for Alzheimer's, and that the therapeutic vaccine ALZ-101 is expected to result in positive clinical studies.

A number of improved diagnostic tools that are now under development with the hope of being able to diagnose the disease early were presented at the conference. This creates even better future possibilities for early treatment with a long-acting and cost-effective vaccine such as ALZ-101.

In addition to our strong focus on ALZ-101, we have continued to strengthen our organisation with key people in communications and intellectual property rights & patents, which further improves the company's position and its capabilities.

Our financial situation remains stable. We have reassuring liquidity and the cost development for R&D operations is progressing according to plan.

Regarding the covid-19 situation, we continue to work together with suppliers and partners to minimise the impact on our operations, and not least the risks for our employees.

During the first quarter of 2021, we have carried out several important activities to prepare the start of the Phase 1b clinical study. I look forward with confidence to the continued work with the patient study, which has the highest priority. Taking our therapeutic vaccine, ALZ-101, into the clinical phase and continuing our important work to treat and prevent the progression of Alzheimer's disease is a very important and fantastically inspiring milestone in the company's history.

The long-term goal to develop a long-acting and effective drug that enables patients to live an active and independent life free from the effects of Alzheimer's disease has now come a bit closer.

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. CEST on May 19, 2021.

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