Three months, July – September 2023

• Net sales amounted to TSEK 0 (0).
• Loss after financial items amounted to SEK -3,549 thousand (-2,771).
• 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 -0.08 (-0.09).
• Earnings per share after dilution amounted to SEK -0.08 (-0.09).

Nine months, January – September 2023

• Net sales amounted to TSEK 0 (0).
• Loss after financial items amounted to SEK -11,749 thousand (-8,353).
• Average number of shares during the period before dilution 39,162,840 (21,650,403).
• Average number of shares during the period after dilution 39,162,840 (21,809,568)
• Earnings per share before dilution amounted to SEK -0.30 (-0.39).
• Earnings per share after dilution amounted to SEK -0.30 (-0.38).

Figures in brackets refer to corresponding period in previous year.

Events during the third quarter 2023

• Alzinova announced on August 3 that the Company has recruited Kirsten Harting to the role of Chief Medical Officer (CMO). Kirsten Harting, who began her new position on August 14, is also a member of the Company’s management team.
• On August 8, Alzinova announced that the Company had conducted a pre-IND meeting with the US Food and Drug Administration (FDA) and received positive feedback on the planned clinical development program for the vaccine candidate ALZ-101. This is a significant step in the preparations for including US study centers in future clinical studies.
• On August 25, Alzinova announced that the Company had signed an agreement with PolyPeptide Laboratories Holding (PolyPeptide) to manufacture Alzinova’s peptide (AβCC) for future clinical studies.
• On September 26, Alzinova announced that the Company has received a positive response from the European Medicines Agency (EMA) regarding the planned clinical development program for the vaccine candidate ALZ-101. This means significant steps in the preparation for the inclusion of European study centers in future clinical studies.

Events after the end of the third quarter 2023

• On October 5, Alzinova announced that the Company will participate in Europe’s largest life science conference BIO-Europe. The conference is a gathering place for partner meetings where the Company will present the vaccine candidate ALZ-101 and the antibody ALZ-201 to potential partners. Furthermore, the company announced that they will present at Redeye’s theme day on neurology, which was held on October 11.
• On October 24, Alzinova announced that the Company has contracted Erik Penser Bank as liquidity provider from November 1, 2023.

A word from the CEO

During the past quarter, we have continued to meet our goals to prepare the company for the next phase of clinical development. During this period, we have received positive feedback from the European and American regulatory authorities and initiated a collaboration with the peptide manufacturer PolyPeptide to secure production capacity for future clinical studies. Now we confidently look forward to top-line data for our vaccine candidate ALZ-101, which we expect to receive and present later this year.

The vaccine candidate ALZ-101 - preparing for top-line data
We are currently preparing top-line data for the phase 1 study in patients with Alzheimer’s disease, which is scheduled to be presented later this year. Based on all patients who participated in the study, the top-line data will give us an overall picture of especially safety and tolerability of treatment with ALZ-101 as well as essential information on the immune response for the two different dose levels 125 µg and 250 µg. Thereafter, the analysis of the study will continue, and we will receive a full analysis and report early next year. We will present the results in discussions with potential partners and at international conferences.

In parallel, the patients will continue into the extension part of the study where all will be offered treatment with additional doses of ALZ-101. The first patient was dosed in May and the last patient in the extension part is estimated to receive their last dose in early 2024. The results from the extension part will give us valuable information on the long-term effects of ALZ-101 for phase 2 and further strengthen our position in interactions with potential partners and regulatory authorities.

These are some of the many activities that, together with the full results from the phase 1b study, will lay the foundation for us to initiate phase 2 in 2024.

Significant progress towards phase 2
As part of the preparations for the Phase 2 study, earlier this year we applied for a pre-IND meeting with the FDA and an application for scientific advice from the EMA. During this period, we have received positive feedback from the FDA and EMA on the planned development program for ALZ-101. The regulatory interactions aim to ensure that the development plan for ALZ-101 meets the regulatory requirements in both the US and Europe. By interacting with the authorities early on, 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.

During the summer, we signed an agreement with PolyPeptide, a leading peptide manufacturer, which secures our production capacity for upcoming clinical studies. A stable production with several manufacturers of the peptide is important for drug development and future commercial production. We will have a great advantage in having already secured this.

Drug candidates with "best in class" potential
In parallel with the vaccine candidate ALZ-101, we continue to develop the monoclonal antibody ALZ-201. In addition to the work that led to a patent application for a further developed form of the antibody, we continue with the preclinical development to be able to take ALZ-201 into clinic. Both drug candidates are oligomer-specific, which differentiates them from the competition and gives us “best in class” potential. Top-line data for ALZ-101 will therefore be very important for the development of ALZ-201 as well.

We look forward to the eventful period ahead with top-line data for ALZ-101 as well as BIO Europe on November 6-8 where we will present the vaccine candidate ALZ-101 and the antibody ALZ-201 to potential partners.

We have delivered according to plan the phase 1 study, and we will soon be able to share data from the study. Our upcoming top-line data for ALZ-101 is of great interest to potential partners, shareholders, and investors alike. I look forward to sharing our progress with you!

Kristina Torfgård,
CEO Alzinova AB

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