Three months, April–June 2025

• Profit/loss after financial items amounted to SEK -7,684 thousand (-4,876).
• Cash flow for the period amounted to SEK 7,918 thousand (-8,020).
• Cash and cash equivalents at the end of the period amounted to SEK 11,510 thousand (4,987).

Six months, January–June 2025

• Profit/loss after financial items amounted to SEK -13,415 thousand (-9,838).
• Cash flow for the period amounted to SEK -3,986 thousand (-17,039).
• Cash and cash equivalents at the end of the period amounted to SEK 11,510 thousand (4,987).
  

Amounts in brackets: Corresponding period in previous year.

Significant events during the second quarter 2025

• Alzinova resolved to carry out a rights issue, which was subscribed to 85% and provided the company with approximately SEK 30.3 million before issue costs. The proceeds will finance the final preparations for the Phase II study of ALZ-101 while partnership discussions continue. Members of the Board, management, and certain shareholders also made subscription commitments amounting to approximately SEK 1.0 million.
• Alzinova implemented the LTIP 2025:1 incentive program and transferred 3,250,000 warrants to participants on 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.
• Alzinova presented new data showing that the vaccine candidate ALZ-101 generates stable antibody levels in plasma and detectable levels in cerebrospinal fluid. These results strengthen the therapeutic potential of ALZ-101 by demonstrating central nervous system exposure.
• Alzinova announced a strategic collaboration with Worldwide Clinical Trials, a global leader in neuroscience studies, appointing them as the Contract Research Organization (CRO) for the company’s upcoming phase 2 study with the vaccine candidate ALZ-101.
• Alzinova announced a collaboration with Rx Securities, a UK-based investment firm specialized in healthcare analysis, to provide institutional investors with in-depth research and continuous updates on the company.
• Alzinova announced new clinical results showing that ALZ-101 raises protective antibody levels in Alzheimer’s patients to levels comparable with healthy elderly individuals, indicating a new approach to addressing immune deficiencies in Alzheimer’s disease.
• Alzinova presented a market update highlighting several key milestones that mark a successful first half of 2025. The company also disclosed its own sales forecasts and market simulations for ALZ-101.
  

Significant events after the end of the second quarter 2025

• Alzinova announced that the company has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for the planned Phase II study of ALZ-101. At the same time, Alzinova has also applied for Fast Track Designation (FTD) to the FDA.

A word from CEO Tord Labuda

Progress on several fronts

Dear Shareholders,

The second quarter of 2025 has delivered key milestones that move Alzinova closer to initiating the pivotal Phase II study for ALZ-101. We submitted our Phase II trial application to the US FDA, advanced manufacturing of the final drug product, and generated new data confirming ALZ-101’s ability to reach the central nervous system. Together, these achievements strengthen our scientific foundation and keep us firmly on track for the next phase of development.

Clinical milestones and regulatory progress
ollowing the successful completion of our Phase 1b study with ALZ-101, the second quarter was marked by several clinical milestones and key regulatory steps, moving us closer to the planned initiation of the pivotal Phase II study later this year.

Among the most important findings, new data confirmed that vaccination with ALZ-101 stimulates the body to generate antibodies that can reach the central nervous system. In addition, and importantly, plasma antibody levels in Alzheimer’s patients after vaccination were normalized to levels seen in healthy individuals. This result aligns with our goal of targeting the underlying disease process and reinforces the scientific rationale for advancing ALZ-101 into the next stage of development.

The Phase 1b results have attracted strong interest from peers and potential partners, and active discussions are ongoing. Our international presence also continued during the quarter, including participation at the BIO International Convention in Boston, which generated renewed attention from global pharmaceutical companies and investors.

To ensure that the results from the Phase 1b study gain maximum scientific impact and lasting relevance, we have chosen to prioritize publication in a leading peer-reviewed scientific journal. This path will secure maximum scientific credibility, create a long-term reference for the Alzheimer’s research community, and support value creation for Alzinova and its shareholders. Submission of the manuscript is planned for the third quarter of 2025, with publication following the journal’s review process. In this way, both researchers and market stakeholders will have access to the most authoritative and widely available presentation of the study results.

Alongside regulatory preparations, manufacturing has been a critical focus to ensure readiness for Phase II. Through our collaboration with PolyPeptide Laboratories, the GMP-grade drug substance was delivered earlier this year, and manufacturing and quality control of the final drug product are now in their final stages.

During the quarter, after a thorough evaluation of several contract research organizations with Alzheimer’s trial expertise, Alzinova selected Worldwide Clinical Trials as its CRO partner for the upcoming Phase II study. Worldwide brings deep experience in neuroscience clinical development, having managed over 9,000 dementia trial participants in the past five years and contributing to regulatory approvals, including the first disease-modifying treatment for Alzheimer’s disease.

After the close of the quarter, Alzinova submitted its IND application for the ALZ-101 Phase II study to the FDA and simultaneously applied for Fast Track Designation. This represents a crucial regulatory step enabling study initiation in the US later in 2025, pending regulatory feedback. If granted, Fast Track status could shorten the time to market through a more efficient review process and closer collaboration with the FDA, supporting the advancement of ALZ-101 as a potential disease-modifying treatment for Alzheimer’s disease, where the need for effective therapies remains urgent.

Secured capital and strategic decision-making drive future growth
Following previously announced commitments, we completed our rights issue in May, which was subscribed to 85% and raised approximately SEK 30.3 million before issue costs. This capital secures our ability to finalize preparations for the Phase II study and supports ongoing partnership and licensing discussions.

We see partnerships or structural deals as the way to secure the long-term financial and expertise resources needed to drive projects forward. At the same time, we must prepare and optimize everything for the next step in as efficient and business-minded a way as possible.

At the same time, confidence in Alzinova’s future is strong within the company. All members of the management team and other employees invested in warrants during the quarter, committing their own capital to Alzinova. This clearly demonstrates our shared confidence in the company’s strategy and future potential, and it means we stand side by side with our shareholders on the journey ahead.

Summary and looking Ahead
The second quarter of 2025 was defined by clear regulatory, clinical, and operational progress, with the strong results from the Phase 1b study being a particular highlight. With the IND and Fast Track applications submitted, the final Phase II product nearing release, and operational partners in place, we are well positioned to initiate the clinical Phase II trial with ALZ-101.

We remain focused on creating long-term value for our shareholders by advancing scientific innovation and building strategic partnerships that strengthen our path to market. Thank you for your continued support as we work to deliver meaningful new treatments to patients and families affected by Alzheimer’s disease.

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