The Board of Directors and the Chief Executive Officer of Alzinova AB hereby present the interim report for the period January - September 2025. The full report, which is attached in the press release, can also be downloaded from the company's English website, www.alzinova.com/investors/financial-reports/.
Three months, July-September 2025
- Profit/loss after financial items amounted to SEK -6,960 thousand (-4,152).
- Cash flow for the period amounted to SEK 11,025 thousand (-22,687).
- Cash and cash equivalents at the end of the period amounted to SEK 485 thousand (27,674).
Nine months, January-September 2025
- Profit/loss after financial items amounted to SEK -20,375 thousand (-13,988).
- Cash flow for the period amounted to SEK -15,011 thousand (-5,649).
- Cash and cash equivalents at the end of the period amounted to SEK 1485 thousand (27,674).
Amounts in brackets: Corresponding period in previous year.
Significant events during the third quarter 2025
- Alzinova announced that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for its planned Phase II study with ALZ-101. At the same time, Alzinova has also applied for Fast Track Designation (FTD) from the FDA.
- Alzinova announced that the US Food and Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application for its planned Phase II clinical trial with the vaccine candidate ALZ-101 for Alzheimer's disease.
Significant events after the end of the third quarter 2025
- Alzinova announced that the US Food and Drug Administration (FDA) has granted Fast Track status to the company's vaccine candidate ALZ-101 for Alzheimer's disease.
- Alzinova announced that the company has entered into loan agreements with two external lenders for short-term financing totaling SEK 11 million. The loan agreement has been entered into to secure the company's working capital requirements for its ongoing operations during the current financial year and into the first quarter of 2026.
- Alzinova announced that two abstracts on the vaccine candidate ALZ-101 have been accepted for presentation at the Clinical Trials on Alzheimer's Disease (CTAD) 2025, to be held December 1-4 in San Diego, USA.
A word from CEO Tord Labuda
Steady progress towards the next phase
Dear Shareholders,
The third quarter of 2025 has been marked by important progress for Alzinova, both scientifically and strategically, as we continue advancing our lead vaccine candidate ALZ-101 toward the upcoming Phase II study.
The U.S. Food and Drug Administration (FDA) has approved Alzinova's Investigational New Drug (IND) application and granted Fast Track designation - decisions that confirm the quality of our scientific and regulatory work. Together, these milestones demonstrate that Alzinova is well positioned to advance ALZ-101 to the next clinical phase in the U.S., while also underscoring the FDA's recognition of the program's potential as a new disease-modifying treatment for Alzheimer's disease, an area where the need for effective therapies remains substantial.
Fast Track designation further enables more frequent interactions with the FDA and a more efficient review process, strengthening both the scientific and commercial positioning of ALZ-101.
Regulatory and clinical progress
The FDA's approval of our IND application provides Alzinova with clearance to initiate the Phase II study in the U.S., where a significant portion of the trial will be conducted. This global multicenter study will include approximately 240 patients with early Alzheimer's disease and will evaluate safety, tolerability, and treatment effect through established clinical and functional endpoints.
The study will be conducted in collaboration with Worldwide Clinical Trials, a global contract research organization with extensive experience in large-scale neuroscience programs. The production of GMP-grade material is progressing, and quality controls are being finalized to ensure readiness ahead of study initiation.
The complete results from the phase 1b study have been finalized and work on the manuscript is in its final stages. The results will shortly be submitted for publication in a leading scientific journal, which will give the results wide dissemination and ensure that they are presented with high scientific credibility and long-term relevance.
Financial flexibility and strategic progress
To maintain momentum and ensure financial flexibility during this critical phase, Alzinova has entered into a short-term loan agreement of SEK 11 million with two external lenders. The loan provides necessary working capital into 2026 on commercially balanced terms, allowing us to manage operations responsibly while continuing to focus on partnerships and long-term financing initiatives.
Our priority is clear: to initiate the Phase II study once financing is secured, ensuring that the trial can be conducted to the highest quality standards. This is a deliberate and responsible decision - one that best serves patients, regulators, and shareholders alike.
Strengthened partner and investor dialogue
Recent scientific and regulatory achievements have continued to drive growing interest in Alzinova and our candidate ALZ-101. During the quarter, our team held meetings with international pharmaceutical companies and institutional investors, including organizations with a strong presence in neurology and neurodegenerative diseases. These interactions have strengthened ongoing dialogues and opened new opportunities for future collaborations.
Following the quarter, Alzinova also participated in BIO-Europe 2025, one of Europe's leading partnering events in life science, where we took further steps to establish strategic relationships and strengthen international interest in ALZ-101. As a next step, Alzinova will participate in Clinical Trials on Alzheimer's Disease (CTAD) 2025, December 1-4 in San Diego, USA, where the company will present two scientific abstracts with data that further strengthen the understanding of ALZ-101's mechanism of action and the company's research platform.
Our key strategic objective remains to establish a partnership with a leading pharmaceutical company that shares our ambition to develop and deliver disease-modifying treatments for Alzheimer's disease. Such a partnership would contribute both resources and expertise, enabling ALZ-101 to reach patients more quickly and efficiently. At the same time, we continue to evaluate alternative structured solutions to support the continued advancement of the program.
Outlook
As we enter the final quarter of 2025, Alzinova stands on a solid scientific, regulatory, and operational foundation. The recent milestones - from the FDA's IND approval and Fast Track designation to a strengthened financial base and deepened partnership discussions - have brought the company into a new phase of development.
We remain firmly committed to our mission of developing effective, disease-modifying treatments that can change the future for people living with Alzheimer's disease. In the months ahead, our focus is on completing preparations for Phase II, continuing constructive partnership discussions, and securing the long-term financing required to drive the next stage of Alzinova's growth.
Thank you for your continued trust and support as we work to make a meaningful difference for 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 AßCC 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
This information is information that Alzinova is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-11-13 07:45 CET.