The Board of Directors and the Chief Executive Officer of Alzinova AB hereby present the year-end report for the period January - December, and the fourth quarter, 2024. 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, October-December 2024
- Net sales amounted to SEK 0 thousand (0).
- Loss after financial items amounted to SEK -6 563 thousand (-4,731).
- Average number of shares during the period amounted to 89,165,460 (44,531,265).
- Earnings per share amounted to SEK -0.07 (-0.11).
Twelve months, January- December 2024
- Net sales amounted to SEK 0 thousand (0).
- Loss after financial items amounted to SEK -20,553 thousand (-16,480).
- Average number of shares during the period amounted to 66,793,687 (40,383,241).
- Earnings per share amounted to SEK -0.31 (-0.41).
Amounts in brackets: Corresponding period in previous year.
Significant events during the fourth quarter 2024
- All patients in the high dose part (part A2) of the phase 1b study received their last dose.
- Alzinova announced that patient data from the extension part of the phase 1b study with ALZ-101 is being processed. Results are expected around the end of November-December 2024.
- The company participated in BIO-Europe 2024, one of Europe's largest partnering conferences in life science, where it met a large number of potential partners.
- Alzinova reported continued promising results from its phase 1b clinical trial with the vaccine candidate ALZ-101 in Alzheimer's disease. Analysis of data from patients who participated in the study for at least 84 weeks showed, among other things, that ALZ-101 continues to have a good tolerability and safety profile. The positive results provide strong support for continued clinical development of ALZ-101.
- Alzinova appointed Erik Kullgren as permanent CFO, after he served as interim CFO since March 2024.
Significant events after the end of the fourth quarter 2024
- Alzinova participated between January 13-16, 2025 at the J.P. Morgan Healthcare Conference in San Francisco, where 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 that a strategic decision has been made to appoint a CMO on site at the Company's head office in Gothenburg, primarily with the aim of being able to maintain even closer dialogue with the business R&D team and management team 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 then be processed, analyzed and compiled. The final results for the entire study period are planned to be communicated by the end of March 2025.
A word from CEO Tord Labuda
Strong position for the next phase
Dear Shareholders,
As we have now completed 2024 and looking ahead, I am pleased to report on significant progress in our clinical development and a strengthened position for Alzinova AB. With undiminished enthusiasm and strategic determination, we continue our journey towards phase 2 studies and further towards the market.
Alzinova is an innovative player in the treatment of Alzheimer's disease with a unique, oligomerspecific immunotherapy that represents a paradigm shift in the field. Our selective approach targets the most harmful amyloid-beta molecules, the oligomers, which distinguishes us from other antibody treatment methods. Our work during the year has cemented our role as a leading player in Alzheimer's research, and the results we have achieved strengthen our conviction in ALZ-101's potential as a breakthrough treatment for Alzheimer's disease.
Milestones and clinical progress
We are in the final phase of our phase 1b study with ALZ-101. The results from the extension part (B) after 42 weeks confirm our previous analysis, with an excellent safety profile and a strong immune response. In addition, our cognitive data indicate that ALZ-101 can have a real effect on the course of the disease, which would be revolutionary if verified in a larger phase 2 study.
The high-dose part (A2) of the study has now also been successfully completed, confirming the safety profile, the tolerability, and the robust immune respons, which gives us valuable insight for phase 2. The remaining analyses, including immune responses and biomarkers from the overall study and the results will be presented in a press release at the end of March 2025. We look forward to the opportunity to share our progress at the next major global scientific Alzheimerconference, AAIC in Toronto in July, which is an important platform to reach out to potential partners and investors.
Preparations for phase 2
Preparations for the phase 2 study are progressing according to plan. On the regulatory side, we expect to apply for an IND followed by Fast Track in the US, in parallel with PRiME (the European equivalent of Fast Track) in the EU in Q3. In the same way, we are in the final phase of the production of study substance in collaboration with our partners and expect to be ready well in advance of the start of the study. This work is critical to ensure a smooth transition to the next phase of our clinical program, thereby maximizing the chances of success.
Financial position and partnership
Through this summer's oversubscribed rights issue, we have been able to drive both clinical development and preparations for phase 2 forward during the autumn with a maintained pace. We are actively evaluating various financing options for the phase 2 study, including potential strategic partnerships and traditional capital raises. The J.P. Morgan conference in January, where we presented our latest clinical data, was a great success. This has led to follow-up meetings with several of the major pharmaceutical companies we met during the conference in San Francisco, and we have high hopes of finding a good partner in the near future who can support our continued development through phase 2 and further towards the market. Securing funding is also crucial to fully invest in conducting the crucial toxicological studies in the near future in order to be able to take ALZ-201 (our antibody treatment) into clinical studies.
ALZ-101: A potential game-changer
ALZ-101 continues to show great potential as a game-changer and best-in-class in Alzheimer's treatment. Its unique mechanism of specifically targeting the neurotoxic accumulations of amyloid-beta peptides, so-called oligomers, positions us well in a field where truly effective disease-modifying treatments are conspicuous by their absence. The current antibody treatments against amyloid-beta are struggling with low effectiveness, high costs and serious side effects. With its unique mechanism, ALZ-101 has the potential to open up completely new opportunities for the company and millions of patients worldwide. Positive results from our ongoing and future studies could revolutionize Alzheimer's treatment.
Future prospects and closing words
Our main priority going forward is to accelerate our clinical development program. We are facing exciting times with groundbreaking results and opportunities to make a real difference in the fight against Alzheimer's disease.
I look forward to building on Alzinovas success together with our dedicated and knowledgeable team. With our shared innovation and passion, we are ready to meet the challenges ahead and create long-term value for our shareholders, employees and above all for patients and their families living with Alzheimer's disease. 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 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 2025-02-27 07:30 CET.
