Alzinova AB Year end report 2021
The Board of Directors and the Chief Executive Officer of Alzinova AB hereby present the year end report for the period January - December 2021
Twelve months, January – December 2021
- Net sales amounted to 0 SEK (0 SEK).
- Result after financial items amounted to -7,552,006 SEK (-6,499,557 SEK).
- Earnings per share amounted to -0.48 SEK (-0.41 SEK).
- Equity ratio amounted to 96.5% (95.2%).
Three months, October – December 2021
- Net sales amounted to 0 SEK (0 SEK).
- Result after financial items amounted to -2,455,624 SEK (-2,361,085 SEK).
- Earnings per share amounted to -0.16 SEK (-0.15 SEK).
Significant events during October – December 2021
- Alzinova announced in October that the first patient with Alzheimer’s disease had been recruited in the phase 1b study with the vaccine candidate, ALZ-101.
- Alzinova announced in December that the research project evaluating Alzinova’s monoclonal antibody, ALZ-201, had been successfully completed in collaboration with Amsterdam University Medical Centers. Data from the project confirm the unique specificity and preclinical effect of the antibody.
Significant events after end of the period
- Alzinova announced in January 2022 that the company had completed work on adapting the antibody to humans and selected a main candidate for its monoclonal antibody for ALZ-201 and that several backup candidates with promising profiles had also been developed.
- Alzinova announced in February 2022 that the Company will receive approximately SEK 2.8 million through the exercise of warrants of series TO2 2020/2022. The exercised warrants corresponded to an exercise rate of approximately 11%.
CEO comments
In October, the first patient was recruited in our clinical study with the therapeutic vaccine, ALZ-101. This is an important milestone and means that Alzinova is a pioneer in the field and the first company with an oligomer-specific vaccine in the clinical phase.
The fact that we are now testing our vaccine candidate, ALZ-101, in the clinic i.e. in patients, inspires hope for Alzheimer’s patients, as well as their friends, family and care givers, who suffer from this terrible disease. It has been both touching and inspiring to receive questions from people all over the world who want to know more about our unique therapeutic vaccine. Many of them want to know how they can participate in the study.
The study is the first of its kind. Never has a vaccine specifically targetting the neurotoxic oligomers of the amyloid beta peptide been tested to treat Alzheimer’s disease. The study is being performed in Finland (Turku and Helsinki) by Alzinova’s partner, Clinical Research Services Turku (CRST), on patients with early Alzheimer’s disease. People are being recruited into the study now and throughout 2022. We expect to see the first results (so-called ”topline data”) from the study in the second half of 2023. The goals of the study are: to document that the vaccine does not cause unexpected side effects; to study the immune system response to repeated dosing; as well as to study biomarkers linked to Alzheimer’s disease.
We are currently planning a long term study to follow-up the patients in the Phase 1b study. The study will provide additional information about the safety and tolerability, as well as the treatment effects, of ALZ-101 over a longer time period. The study will be started to ensure that all patients who have undergone the phase 1b study can be included.
Of course, we want to conduct international studies with ALZ-101 so that more patients in the world are given the opportunity to participate in our clinical studies; with the goal that the vaccine will reach a global market. Therefore, we are already working on preparatory activities for the next clinical development phase, which makes the candidates even more attractive for strategic partnerships.
During the fourth quarter, we made significant progress in documenting mechanisms and effects of our monoclonal antibody (ALZ-201). Data from the project, carried out in collaboration with Amsterdam University Medical Centers (a leading medical center with expertise in neurodegenerative diseases), confirms the unique oligomer specificity and preclinical effect of ALZ-201, and that its binding profile in clinical use can provide specific efficacy with a beneficial tolerability profile. This leads to ”Best in Class potential” and opportunities to stop or slow down the progressive deterioration of cognition seen in patients with Alzheimer’s disease.
During the fourth quarter, there has also been a strong focus on the antibody, aducanumab, developed by Biogen and Eisai. Aducanumab, which received conditional approval in the United States for the treatment of Alzheimer’s, did not get approval in Japan nor Europe. The clinical efficacy data were not sufficiently convincing, and the benefits of aducanumab did not outweigh its risks. Moreover, the connection between the removal of plaque and improved cognition was not sufficiently demonstrated.
Aducanumab, like other current late stage antibodies, is primarily targeted towards plaques. Although a certain slowdown in cognition decline occurs when the amount of plaque decreases, the patients remain ill and continue to deteriorate at the same rate. In addition, all the antibodies appear to have a limited effect over time. These antibodies also show side effects in the form of ARIA-E, a form of brain edema (swelling of the brain tissue), which means that the benefit compared to the risk can be difficult to justify.
We believe that antibodies against amyloid beta for the treatment of Alzheimer’s are a viable way forward, but to obtain the best possible effect with the least possible side effect profile, they must specifically target the neurotoxicity. We are therefore convinced that our oligomer-specific treatments with both our vaccine and our antibody will show a greater clinical benefit compared to risk.
As in many other areas of therapy, I am convinced that several different types of drugs and combinations of drugs will be needed to treat Alzheimer’s disease. There is a sizeable place and opportunity for Alzinova’s treatments, the vaccine, ALZ-101, and the antibody, ALZ-201; both of which can fight the disease. We look forward to continuing to document our vaccine and our antibody, and thereby developing effective ”Best in Class” products that can give Alzheimer’s patients a better life.
Kristina Torfgård, CEO Alzinova
The full report, which is attached in the press release, can also be downloaded from the company’s English website, www.alzinova.com/investors/financial-reports/
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 February 24, 2021.
About Alzinova AB
Alzinova AB is a Swedish clinical-stage biopharma company specializing in the treatment of Alzheimer’s disease targeting neurotoxic amyloid beta oligomers. The lead candidate, ALZ-101, is being developed 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 beta 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 is in early preclinical development, 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