Three months, January–March 2025

• Net sales amounted to SEK 0 thousand (0).
• Loss after financial items amounted to SEK -5,731 thousand (-4,963).
• Average number of shares during the period amounted to 89,165,460 (44,531,265).
• Earnings per share amounted to SEK -0,06 (-0.11).

Amounts in brackets: Corresponding period in previous year.

Significant events during the first quarter 2025

• Alzinova participated from January 13–16, 2025, in the J.P. Morgan Healthcare Conference in San Francisco, where the management met with a large number of potential partners and investors to present the company’s latest positive clinical Alzheimer’s data and strong results from the Phase 1b study with the vaccine candidate ALZ-101.

• The company announced a strategic decision to appoint a Chief Medical Officer (CMO) based at the company’s headquarters in Gothenburg. This aims primarily to enable closer dialogue with the R&D team and management group as Alzinova enters the next development phase.

• Alzinova announced that all study participants have completed the final visit in the Phase 1 study. All data points will now be processed, analyzed, and compiled.

• Alzinova received data for the treatment arm where patients were treated with 400 μg in the company’s Phase 1b study. This treatment arm also shows good safety and tolerability. In this part of the study, a total of six patients were openly treated with 400 μg of ALZ-101 on four occasions over 16 weeks.

• Alzinova announced that the final analysis of data from the clinical Phase 1b study with the vaccine candidate ALZ-101 is now complete. The study’s primary and secondary objectives – safety, tolerability, and immunogenicity – have been achieved. Additionally, the exploratory efficacy measures show a stable disease profile without signs of deterioration.

Significant events after the end of the first quarter 2025

• Alzinova’s board decided to carry out a rights issue of shares, which, upon full subscription, will provide the company with approximately SEK 35.7 million before issue costs. Ahead of the rights issue, the company received subscription commitments and entered into guarantee agreements totaling approximately SEK 30.3 million, corresponding to 85 percent of the rights issue. The main purpose of the issue is to raise capital to finalize preparations for the vaccine candidate ALZ-101 ahead of the upcoming clinical study, while ongoing partnership dialogues with Big Pharma companies continue. At a later date it was announced that that members of the company’s board and management and certain other existing shareholders had submitted declarations of intent to subscribe in the issue of approximately SEK 1.0 million in total.

• Alzinova announced that the long-term incentive program LTIP 2025:1 has been implemented, and the board resolved to transfer 3,250,000 warrants to the participants according to market terms.

• Alzinova announced that the active pharmaceutical ingredient is now produced for the upcoming Phase 2 clinical study of the vaccine candidate ALZ-101. This milestone enables the production of the final drug product, allowing for the study to commence in the second half of 2025.

• Alzinova announced the outcome of the rights issue which was subscribed to 85 percent and provides Alzinova with approximately 30.3 MSEK before issue costs.

A word from CEO Tord Labuda

Continued strong momentum

Dear Shareholders,

2025 has begun with continued strong momentum for Alzinova. After a transformative 2024, where we took decisive steps in our clinical development and strengthened our strategic position, we have in the first quarter completed the phase 1b study with positive results and continued to build on this foundation.

Clinical progress and key milestones
The past quarter has been characterized by an important breakthrough in our clinical development. We have now completed our Phase 1b study with the vaccine candidate ALZ-101 - a crucial step towards a new treatment for patients with early Alzheimer’s disease. The study has met its primary and secondary endpoints of safety, tolerability and immunogenicity, while exploratory endpoints show a stable disease profile with no signs of deterioration. The results exceeded our expectations and strengthen our confidence in ALZ-101 for the next phase of the development program.

Another significant milestone this quarter is that the active drug substance is now available for the upcoming clinical Phase 2 study of our vaccine candidate ALZ-101. This enables production of the final drug product and allows us to stay on track for initiating the study during the second half of 2025. Our collaboration with PolyPeptide Laboratories has been crucial in securing GMP-grade production and quality. We are now continuing to optimize processes ahead of future, larger clinical trials and eventual commercialization.

Strengthened financial position and Phase 2 preparations
After the end of the quarter we have successfully completed the rights issue that the Annual General Meeting 29 May 2024 authorized the Board of Directors to carry out. The issue was subscribed to a total of approximately 85 percent, of which approximately 51.1 percent subscription rights, 1.8 percent without subscription of subscription rights and the remaining 32.1 percent by underwriters. Through the issue, the company approximately SEK 30.3 million before issue costs. This means that we now have the financial stability and the resources required to complete the preparations for our upcoming phase 2 study with ALZ-101.

Partnerships and strategic opportunities
Our strengthened financial position gives us increased flexibility in ongoing dialogues with potential global partners and investors. There is strong interest in our clinical progress and our selective oligomer-based treatment approach. We are also exploring opportunities for further capital raising to accelerate the development of our pipeline, including ALZ-101 as well as our antibody-based treatment ALZ-201, and to further expand our pipeline. We are focused on creating long-term value for our shareholders and on establishing partnerships that can bring ALZ-101 closer to market.

Increased employee engagement and incentives
During the second quarter, we implemented the incentive program. This program is an important part of our efforts to attract, motivate, and retain talent. By offering our employees the opportunity for ownership, we strengthen engagement and the shared ambition to achieve our long-term goals. The strong interest in participating in the program is encouraging and contributes to building a committed and long-term workforce and leadership at Alzinova.

Summary and Looking Ahead
Q1 2025 has been marked by continued progress in our clinical and financial activities. We are well-prepared for the next steps and look forward to initiating the Phase 2 study with ALZ-101 in the second half of 2025. Our goal is clear: to contribute to a better future for patients and loved ones affected by Alzheimer’s disease through groundbreaking treatments.

Thank you for your continued support and trust.

Tord Labuda, CEO of Alzinova AB

For further information, please contact:
Tord Labuda, CEO
E-mail: info@alzinova.com

About Alzinova AB
Alzinova AB is a Swedish biopharmaceutical company in clinical development specializing in the treatment of Alzheimer's disease, where the starting point is to attack toxic amyloid-beta oligomers. The lead candidate ALZ-101 is a therapeutic vaccine against Alzheimer's disease. Alzinova's patented AβCC peptide technology makes it possible to develop disease-modifying treatments that target the toxic amyloid-beta oligomers that are central to the onset and development of the disease with great accuracy. From a global perspective, Alzheimer's disease is one of the most common and devastating neurological diseases, with around 40 million affected today. Based on the same technology, the company is also developing the antibody ALZ-201, which is currently in preclinical development, and the goal is to further expand the pipeline. The company's Certified Adviser on Nasdaq First North Growth Market is Mangold Fondkommission AB. For more information about Alzinova, please visit: www.alzinova.com