The Board of Directors and the Chief Executive Officer of Alzinova AB hereby present the interim report for the period January - September, and the third quarter, 2024. 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/.
Three months, July - September 2024
- Net sales amounted to SEK 0 thousand (0).
- Loss after financial items amounted to SEK -4,151 thousand (-3,549).
- Average number of shares during the period amounted to 88,462,793 (44,531,265).
- Earnings per share amounted to SEK -0.05 (-0.08).
Nine months, January - September 2024
- Net sales amounted to SEK 30 thousand (0).
- Loss after financial items amounted to SEK -13,990 thousand (-11,749).
- Average number of shares during the period amounted to 59,281,997 (38,985,372).
- Earnings per share amounted to SEK -0.24 (-0.30).
There are no dilution effects regarding the number of shares.
Amounts in brackets: Corresponding period in previous year.
"the Company" or "Alzinova" refers to Alzinova AB with corporate identity number: 556861-8168.
Significant events during the third quarter 2024
- All patients in part A2 of the phase 1b study had received the first dose of ALZ-101 by July.
- The Board of Directors decided to appoint Board member Carol Routledge as acting CEO of Alzinova from August 1, 2024, until a permanent CEO is recruited.
- Alzinova published further details of the data presented in a poster presentation at AAIC in July 2024.
- Alzinova updated the market that the Company has accelerated the partnering process. Among other things the Company has engaged with a renowned US Adviser, covering life sciences consulting, M&A and investment banking, to assist the company in identifying and subsequently signing a partner agreement.
- In August, the Company updated the market on the status of the various parts of Alzinova's phase 1b study.
- In September, the first study participant had successfully completed the entire phase 1b study with ALZ-101.
- The Board appointed Tord Labuda as the new CEO of Alzinova, effective 1 October 2024.
Significant events after the end of the third quarter 2024
- All patients in the high dose part (part A2) of the phase 1b study have 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.
A word from CEO Tord Labuda
- A new era for Alzinova
Dear shareholder,
It is with great enthusiasm and humbleness that I have taken on the role as the new CEO of Alzinova AB. Having taken office on 1 October, I now have the exciting task of leading this innovative company into the next phase of our clinical development and growth.
Our unique position in Alzheimer's research
Alzinova is a pioneer in the development of treatments for Alzheimer's disease, and I am deeply impressed by the strong scientific foundation laid by my predecessors and our entire dedicated team. Our unique approach focusing on an amyloid-beta oligomer-specific immunotherapy positions us as a pioneer in Alzheimer's research, and the progress we have made so far, both preclinically and in the first patient studies, is very promising for our further journey.
Insights and potential
During my first six weeks, I have spent a lot of time understanding our ongoing projects and listening to our employees, partners and shareholders. It is clear that we have significant potential to build on, especially considering the results from our phase 1b study with ALZ-101, which targets the neurotoxic amyloid-beta oligomers, as well as with ALZ-201, our antibody therapy against the same toxic oligomers, currently in the preclinical phase.
Key milestones ahead
Our main priority going forward will be to accelerate our clinical development programme and we are looking at some key milestones in the next six months:
- In Q4, we expect to present long-term data (up to week 42) from the extension part (part B) of our phase 1b study, i.e. patients have been in the phase 1b study for at least 84 weeks. Provided that these data are in line with our analysis earlier in the year, from part A1 where we saw good safety and tolerability, a dose-dependent immune response and excellent biomarker data, we will be able to strengthen our position in the ongoing discussions for further funding and potential partnerships.
- Recently, the last patient in the high dose part, A2 of the phase 1b-study, was dosed, where patients received 400ug in 4 doses over 16 weeks. This will be followed by a 4-week follow-up and we expect to report data early in the new year. The focus here is safety, tolerability and immune response, which will give us valuable insight for future phase 2 studies.
- Looking ahead, we are working intensively on the important preparatory steps for a phase 2 study including protocol development, manufacturing of study drugs and selection of a contract research organisation (CRO). This work is crucial to ensure a smooth transition to the next phase of our clinical programme and thereby maximise the chances of success.
Financial strength and outlook
Financially, we have strengthened our position through the successful rights issue earlier this year, giving us the resources to drive our clinical development forward in the near term. However, we recognise that the continued development of ALZ-101 will require significant investment. As we approach phase 2, we are of course carefully evaluating different options - from strategic partnerships that can provide both financial resources and expertise to more traditional capital raising that can enable us to run the phase 2 study on our own - to ensure that we have the resources needed to realise the full potential of our pipeline. Our goal is to make the best informed decisions to position Alzinova for success in the challenging but promising world of Alzheimer's research.
Our results so far have attracted significant industry interest and we look forward with confidence to the world's largest pharmaceutical conference, JP Morgan, in January. There, with new clinical data, we will hopefully be in a stronger position to continue our discussions with the major pharmaceutical companies. This conference represents an important opportunity for us to present our results from the phase 1b study with ALZ-101 to potential partners and investors.
ALZ-101: A potential game-changer
Financial strength is crucial for us to fully develop our main asset - the vaccine candidate ALZ-101. With its unique mechanism of specifically targeting the toxic oligomers of amyloid-beta, ALZ-101 has the potential to be a game-changer in Alzheimer's treatment. Positive results from our ongoing studies could open up entirely new opportunities for the company and millions of patients worldwide.
Lastly, I would like to thank you for the warm welcome I have received from the entire Alzinova family. I look forward to working with our fantastic team to take Alzinova to new heights. We have an exciting journey ahead of us, and I am convinced that with our innovation, commitment and expertise, we will continue to deliver value to our employees, shareholders and not least to our Alzheimer's patients and their families.
Thank you for your confidence,
Tord Labuda
CEO Alzinova AB
For more information, please contact:
Tord Labuda, CEO
E-mail: tord labuda@alzinova.com
Erik Kullgren, Interim CFO
E-mail: erik.kullgren@alzinova.com
Please note that this is an English translation of a press release written in Swedish by Alzinova AB (publ), in the event of any inaccuracies, the Swedish version applies.
About Alzinova
Alzinova AB is a Swedish clinical-stage biopharma company specializing in the treatment of Alzheimer's disease targeting toxic amyloid beta oligomers. The lead candidate, ALZ-101, is being developed as a therapeutic vaccine for the treatment of Alzheimer's. Alzinova's proprietary AßCC peptide technology enables the development of disease-modifying treatments that target the toxic amyloid beta oligomers involved in the onset and progression of the disease with high precision. Alzheimer's is one of the most common and devastating neurological diseases globally, with of the order of 40 million people afflicted today. In addition, the antibody ALZ-201 is in preclinical development, and the ambition is to expand the pipeline further. 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
