Alzinova

Three months, October – December 2023

• Net sales amounted to SEK 270 thousand (0).
• Loss after financial items amounted to SEK -4,731 thousand (-4,735).
• Average number of shares during the period before dilution 44,531,265 (32,419,034).
• Average number of shares during the period after dilution 44,531,265 (32,578,199).
• Earnings per share before dilution amounted to SEK -0.11 (-0.15).
• Earnings per share after dilution amounted to SEK -0.11 (-0.15).

Twelve months, January – December 2023

• Net sales amounted to SEK 270 thousand (0).
• Loss after financial items amounted to SEK -16,480 thousand (-13,088).
• Average number of shares during the period before dilution 40,515,977 (24,364,688).
• Average number of shares during the period after dilution 40,515,977 (24,523,853).
• Earnings per share before dilution amounted to SEK -0.41 (-0.54).
• Earnings per share after dilution amounted to SEK -0.41 (-0.53).
• The board proposes that no dividends are paid for 2023.

Amounts in brackets: Corresponding period in previous year.

Events during the fourth quarter 2023

• On October 5, Alzinova announced that the Company would participate in Europe’s largest life science conference BIO-Europe during the autumn. The conference is a gathering place for partner meetings where the Company presented the vaccine candidate ALZ-101 and the antibody ALZ-201 to potential partners. The Company also announced that it would present at Redeye’s theme day on neurology, which was held on 11 October.
• On October 24, Alzinova announced that the Company has contracted Erik Penser Bank as liquidity provider from November 1, 2023.
• On November 29, Alzinova announced positive phase 1b results with the Alzheimer’s disease vaccine candidate ALZ-101. Top-line data show that the vaccine candidate ALZ-101 meets the study’s primary objectives regarding safety and tolerability. Furthermore, the patients treated with ALZ-101 responded to treatment with antibody levels increasing with the number of doses given.
• On 1 December, Alzinova announced that its CFO intends to retire in 2024 and that the recruitment of a replacement has been initiated.

Events after the end of the fourth quarter 2023

• On January 30, Alzinova announced that the full analysis of the data from part A of the Phase 1b clinical trial with the vaccine candidate ALZ-101 has confirmed the positive results previously reported. Given the favourable safety profile, the Company applied for an extension of the study to evaluate a higher dose level. The extension is made to optimise the design of the upcoming phase 2 study.
• On February 13, Alzinova announced that the Company received regulatory approval to evaluate a higher dose of the vaccine candidate ALZ-101 in the ongoing phase 1b study.

A word from the CEO

2023 was a year of many achievements in which we reached our goals. What I am particularly proud of is that we, in November, could report positive top-line data for Alzinova’s phase 1b study in Alzheimer’s patients. The full analysis of part A of the phase 1b study, that we presented in January, confirms that ALZ-101 is a promising vaccine candidate against Alzheimer’s disease. Strong safety and tolerability data and increased immune response with increased number of doses puts us in a good position for clinical development and continued partnering activities. Our main focus for 2024 is to sign a partnering agreement to accelerate the continued clinical and commercial development of ALZ-101.

Positive phase 1b results for the vaccine candidate ALZ-101
This year’s, and one of the company’s most important milestones so far, is the positive top-line results from our clinical phase 1b study with the vaccine candidate ALZ-101 in Alzheimer’s disease. The main goal of the study is to show that the vaccine candidate is well tolerated and safe, which we have confirmed with strong data. At the same time, the results show that we also achieved the study’s secondary goal of immune response where the results show a high frequency of immune response. In January, we finally received all the data from part A of the study and conducted a full analysis which confirmed the positive topline results from November. The fact that we have now reached the goals of the study is a sign of strength, and we are now taking the opportunity to gather further information for future studies.

In the phase 1b study, we also included exploratory measures of the treatment’s effect on biomarkers and cognition. These change slowly in Alzheimer’s disease and the likelihood of being able to detect something in the early clinical phase is therefore very low. It is only in phase 2 that we might be able to detect any effect on these endpoints, as it will be a larger study with more patients followed for a longer period of time. However, there is a value in including exploratory analyses in phase 1 studies because it allows for more analyses, and thus more can be learned about the candidate for later clinical phases.

With all the data and information we now have, we can proudly state that we have successfully reached the goal of the phase 1b study and obtained positive data that is crucial for the future development of our promising vaccine candidate. We look forward with excitement and anticipation to present these great results to potential partners and at upcoming international conferences, while continuing the preparations to initiate the next clinical phase.

Strong results allow for optimised treatment effect with ALZ-101
Both doses investigated in the phase 1b study, showed good safety and tolerability and stimulate the immune system. Based on these results, we want to investigate a higher dose to optimise the design of phase 2. We have therefore applied and received approval to make an addition to the study, part A2, where six patients will be treated with a higher dose for 16 weeks. This part of the study is planned to start in the spring of 2024.

I am very pleased with how we are working adaptively in this early phase, building on the ongoing study as new data emerges. This allows for us to gather a lot of valuable information which will enable us to gain a deeper understanding and knowledge about our drug candidate ALZ-101 and thereby optimise the design and implementation of future studies.

In parallel, the extension part (part B) of the study continues, which we have chosen to add to learn more about the vaccine candidate for phase 2. Our current view is that we can obtain information on safety and tolerability when applying to start the phase 2 study, i.e. before part B is fully reported.

Regulatory interactions in the US and Europe
As part of the preparations for the phase 2 study, we have during the year conducted a pre-IND meeting with the US Food and Drug Administration (FDA) and received scientific advice from the European Medicines Agency (EMA). With the positive and clear feedback we have received from the FDA and EMA regarding the planned development program for ALZ-101, we can now ensure that the development plan for ALZ-101 meets the regulatory requirements in both the US and Europe. In addition, we can more quickly reach important milestones in the development process with the goal of offering a new treatment for patients suffering from Alzheimer’s disease. These are also important steps for the commercial development and future partnerships for ALZ-101.

In the summer of 2023, we signed an agreement with PolyPeptide, a leading peptide manufacturer, which secures our production capacity for future clinical studies. A robust multi-manufacturer production of the peptide is important for drug development and, at a later stage, for commercial production. We will have a great advantage in having already secured and completed this.

Strengthened patent situation and “best in class” potential
In parallel with the vaccine candidate ALZ-101, we continue to develop the monoclonal antibody ALZ-201. This work resulted in a patent application for a further developed form of the antibody, and we continue with the preclinical development in order to bring the antibody into the clinic. Both of our drug candidates are oligomer-specific which makes them different from the competition and strong phase 1 data gives us ”best in class” potential. This means that our candidates are developed to specifically target what is believed to be behind the onset and progression of the disease, and are therefore expected to provide a more favourable efficacy and side effect profile compared to other amyloid-beta targeted therapies.

Expanded team and focus on visibility
During the year, Alzinova strengthened its organisation by recruiting Kirsten Harting to the role as Chief Medical Officer and Sebastian Hansson as Business Development Director. We have a strong focus on clinical development with the goal of starting phase 2. Furthermore, we have optimised our business development strategy and positioning of the company, which has been further intensified after positive data from the phase 1b study. We have strengthened our brand and increased our visibility with more investor meetings and partnering activities.

During the year, we participated in the international Alzheimer’s conference AD/PD, BIO US and BIO-Europe where we were able to present excellent data for ALZ-101 and also preclinical data for ALZ-201. Overall, we noted great interest in our project portfolio and the ongoing clinical study. Our top priority for 2024 is now to harness this interest with the main goal of signing a partnering agreement that takes the clinical and commercial development further.

I am very proud of everything we achieved in 2023. Alzinova’s progress gives me hope and a sense that we are on the way to solve the puzzle to stop, and even cure, this terrible disease. Alzheimer’s affects not only millions of people worldwide, but also so many loved ones.

With the great results we have with ALZ-101, a strengthened Alzinova team and the support of the Board of Directors, I look forward to taking our vaccine candidate into the next clinical phase and thus one step closer to the goal - a unique vaccine against Alzheimer’s disease.

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/