Alzinova

Three months, October – December 2022

• Net sales amounted to 0 SEK (0 SEK).
• Result after financial items amounted to SEK -4,734,807 (SEK -2,455,624).
• Number of outstanding shares 32,419,034 (15,775,724).
• Average number of shares during the period 32,419,034 (15,775,724).
• Earnings per share before dilution amounted to SEK -0.15 (SEK -0.16).

Nine months, January – December 2022

• Net sales amounted to 0 SEK (0 SEK).
• Result after financial items amounted to SEK -13,087,849 (SEK -7,552,006).
• Number of outstanding shares 32,419,034 (15,775,724).
• Average number of shares during the period 24,364,688 (15,775,724).
• Earnings per share before dilution amounted to SEK -0.40 (SEK -0.48).
• Cash and cash equivalents at the end of the period amounted to SEK 32.0 million (SEK 28.8 million).
• Equity ratio amounted to 94.5% (96.5%).
• The board proposes that no dividends are paid for 2022.

Events during the fourth quarter 2022

• On October 4, Alzinova announced that CSO Anders Sandberg was interviewed in Biostock where he shared his scientific reflections on the latest developments in the industry.
• Alzinova announced on October 10 that the Company would present at both Swedish and international investor meetings and partnering meetings during the autumn.
• On November 23, Alzinova announced that the Company will change Certified Advisor to Redeye AB as of December 1, 2022.
• On November 29, the Company announced that CSO Anders Sandberg gave a presentation about the ALZ-201 antibody’s unique binding profile at the major international Alzheimer’s conference Clinical Trials in Alzheimer’s Disease (CTAD).
• On December 12, Alzinova announced that the Company has received a new positive safety review and interim data from the ongoing phase 1b study with the vaccine candidate ALZ-101. The result indicates an immunological response, i.e. antibodies have been formed, and the study is proceeding as planned.
• On December 19, Alzinova announced that the phase 1b trial had been fully recruited and that the target of completing recruitment by the end of the year had been achieved.

Events after the end of the fourth quarter 2022

• Alzinova announced on 3 January 2023 that a scientific article has been published in the prestigious journal Alzheimer’s Research & Therapy with preclinical results demonstrating that the ALZ-201 antibody has specificity for the toxic oligomers thought to be the cause of Alzheimer’s disease. Furthermore, the research shows that ALZ-201 has the potential to be “best-in-class” in the clinic, with good efficacy and a more favourable side effect profile than other antibodies.
• Alzinova announced on January 24 that Sebastian Hansson has been recruited to the newly created role of Business Development Director.

A word from the CEO

2022 was a year of many successes, with several important milestones achieved. Enrolment in the ongoing clinical trial was completed on schedule in December and we now look forward to study results in the second half of 2023. In addition, the past year has seen interesting and important research results that have strengthened the Company’s strategy - to develop effective and safe amyloid-beta treatments for Alzheimer’s disease.

ALZ-101 vaccine - favourable safety profile and indications of immune response
During the year, the independent Data Safety Monitoring Board has continuously reviewed safety data from our ongoing phase 1b clinical trial. I am very pleased that the study shows continued good safety and tolerability of the treatment, which is also the goal of the first clinical trial. We also conducted a first interim analysis of blinded efficacy and safety data from patients in the study in December. The information we received from this early interim analysis was very positive, again showing that the treatment is safe and well tolerated. In addition, we received data indicating an immunological response, i.e. antibodies have been formed and one could say that this is a sign that ALZ-101 is doing its job!

Furthermore, we ended the year by announcing that the study is fully recruited. The fact that the last patient started treatment in December was a very important milestone for the study to continue as planned where we look forward to further interim safety and immunological data in the spring and top-line data in the second half of 2023. During the year we have also demonstrated that larger volumes of our vaccine candidate ALZ-101 can be produced. Taken together, this lays the foundation for the next step in the clinical development of ALZ-101 i.e. phase 2 trials. In parallel, we are preparing for interactions with regulatory authorities. With the progress we have made during the year, it strengthens our position in the market and it increases the interest of other companies to partner with us.

Unique binding profile - “best in class” potential
This autumn, the unique binding profile of our antibody ALZ-201 was presented at the major international Alzheimer’s congress CTAD. These data have attracted great interest, as have the research results recently published on this antibody. In a comparative analysis between the oligomer-specific antibody ALZ-201 (which we developed from the vaccine ALZ-101) and copies of the antibodies lecanemab, aducanumab, and gantenerumab, it was found that ALZ-201 binds to a greater extent to the toxic accumulations of amyloid-beta, so-called oligomers.

We are convinced that an oligomer-specific treatment with an antibody such as ALZ-201 or the ALZ-101 vaccine with “best in class” potential has the potential to provide significantly better efficacy with a more favourable side effect profile than observed for other therapies. In addition, our ALZ-101 vaccine can be administered much less frequently than other drug candidates in development for the treatment of Alzheimer’s. This also contributes to better health economics, as a more effective and simpler treatment is more convenient and less burdensome for the patient and requires less from both the patient and society.

Alzinova’s strategy strengthened - increased interest in the Company
In the autumn, data were presented from the large phase 3 study in Alzheimer’s patients conducted by the Japanese pharmaceutical company Eisai with the monoclonal antibody lecanemab - developed by BioArctic. We see this as positive for both the Alzheimer’s field and Alzinova as it re-enforces our strategy to develop novel, effective and safe amyloid-beta treatments for Alzheimer’s disease. This of course also contributes to an increased interest in Alzinova and our unique portfolio of drug candidates that have strong potential to be “best in class”, which we are very excited about.

Strengthened organisation and financial position
Alzinova has also strengthened the organisation through recruitments in clinical development and regulatory affairs as part of the preparatory work for the phase 2 clinical trial. We are focusing on business development and building up the area to position the Company and intensify partnering activities. As part of this work, we have recruited a Business Development Director. During the autumn, we participated in BIO-Europe where we met with potential licensees of our programmes. We noted strong interest in our pipeline and the upcoming milestones from our ongoing clinical trial.

We strengthened our financial position through the rights issue that was completed in the second quarter of 2022. We are very grateful for the interest in the Company and I would like to thank both our existing shareholders for their confidence and all interested parties who have chosen to invest in Alzinova. Through this financing and with the upcoming warrants in April 2023, we expect to have funding to complete the ongoing clinical trial and preparations for phase 2.

Alzinova develops next generation Alzheimer’s drug
Over the past year, I have seen first-hand how Alzheimer’s breaks people down and how it affects the lives of loved ones. I am deeply committed and passionate about my work to develop medicines for this terrible disease. I am proud to lead this innovative Company with my amazing Alzinova team, partners and board of directors who are all helping to make the development of the next generation of Alzheimer’s drugs possible. We now look forward to continuing to accelerate the Company’s progress and delivering a strong 2023.

Kristina Torfgård, CEO Alzinova AB

The full year-end report, which is attached in the press release, can also be downloaded from the company’s English website, www.alzinova.com/investors/financial-reports/