Alzinova

Three months, January – March 2024

• Net sales amounted to SEK 30 thousand (0).
• Loss after financial items amounted to SEK -4,963 thousand (-4,272).
• Average number of shares during the period before dilution 44,531,265 (32,419,034).
• Average number of shares during the period after dilution 44,531,265 (45,545,811).
• Earnings per share before dilution amounted to SEK -0.11 (-0.13).
• Earnings per share after dilution amounted to SEK -0.11 (-0.09).

Amounts in brackets: Corresponding period in previous year.

Events during the first quarter 2024

• Alzinova announced the full analysis of the data from part A of the phase 1b clinical trial, with the vaccine candidate ALZ-101. The analysis confirmed the positive results previously reported. Given the favourable safety profile, the Company applied for an extension to the study to evaluate a higher dose level. The extension was included to optimise the design of the upcoming phase 2 study.
• In February, the Company received regulatory approval to evaluate a higher dose of the vaccine candidate ALZ-101 in the ongoing phase 1b study.
• Erik Kullgren was appointed interim CFO and the process of recruiting a permanent CFO is ongoing.

Events after the end of the first quarter 2024

• All patients in the extension part (part B) of the phase 1b study had been dosed with the last dose of the Alzheimer’s disease vaccine candidate ALZ-101.
• An in-depth analysis of data from part A of Alzinova’s phase 1b study with the vaccine candidate ALZ-101 was conducted in April. The analysis indicated that patients with higher antibody levels after vaccination had a positive effect on biomarkers associated with Alzheimer’s disease.
• Alzinova’s CEO, Kristina Torfgård, informed the Board of her wish to step down as CEO of the Company.
• Alzinova’s Board of Directors decided, with the support of authorisation from the Annual General Meeting 2023, on a rights issue of shares of approximately SEK 34.4 million.
• Notice of the Annual General Meeting to be held on 29 May 2024 at 13:00 at Chalmersska Huset in Gothenburg was published.
• Alzinova’s annual report for 2023 was published.
• The Company announced planned presentations at both Swedish and international investor meetings and partnering meetings during the spring.
• The first patient was dosed in the Company’s high-dose part of the phase 1b study.

A word from the CEO

I would like to start by highlighting the most important thing that has happened in the company, namely the excellent results we obtained from the full analysis of the data from the first part of the phase 1b clinical trial, with the vaccine candidate ALZ-101. With these strong data from the phase 1b trial and with upcoming important milestones, I am convinced that the company has an exciting future with the goal of being able to offer a therapeutic vaccine against Alzheimer’s disease through strategic partnering.

ALZ-101 vaccine candidate - results & biomarkers
In January, we received impressive results from the full analysis of the data from part A of the phase 1b clinical study. The primary and secondary objectives of the study were met, i.e. ALZ-101 has a favourable safety and tolerability profile. In addition, the results showed a positive response to the vaccine with a high frequency of immune responses. The excellent safety profile allows for the evaluation of a higher dose level which started in the first quarter. In the new part, six additional patients will be treated with a higher dose for 16 weeks. The addition is made to optimise the design of the upcoming phase 2 study.

We reached another important milestone in the first quarter when all patients in the extension part (part B) received their fourth and final dose. For phase 2, an analysis of the data is planned for the fall of 2024, before part B is fully reported.

An in-depth analysis of the data from part A has also been conducted and from these new analyses we see very promising results. The results, indicate that there are patients who already, after 16 weeks of treatment with our vaccine candidate respond positively with vaccine-induced changes to biomarkers associated with Alzheimer’s disease. Seeing results this early is fantastic and we now look forward to the upcoming evaluation of data from longer treatment time and higher dose with ALZ-101. The results are also important for our partner dialogues and preparations for the phase 2 study. The new documentation shows that ALZ-101 has the potential to be a better treatment than competing products, i.e.”best in class”.

Focus on partnering agreements to accelerate the development of ALZ-101
From a strategic perspective, we have been working diligently to evaluate potential partners. We focus on their pipeline capacity, business flow and ability to acquire our vaccine candidate as a project for further development and then commercialisation. A priority area for 2024 is to sign a partnering agreement to accelerate the further clinical and commercial development of ALZ-101. The recently announced major licensing deal between the biopharmaceutical company AC Immune and the Japanese pharmaceutical company Takeda Pharmaceuticals for the Alzheimer’s vaccine candidate ACI-24.060 reinforces this strategy and can be seen as a benchmark for the enormous potential value and demand that exists for a vaccine treatment for Alzheimer’s. The main difference between AC Immune’s candidate and our vaccine candidate ALZ-101 is that ours is more specific, targeting just the toxic oligomers. This, together with the fact that we have already proven at an early stage of development that our candidate has strong potential, sets us apart in the market.

With promising results from part A of the phase 1b clinical trial, the intention is to continue the clinical development of ALZ-101 in a phase 2 study, a study that we believe can best be financed through a partnership. The proposed share issue aims to advance the development of ALZ-101 and thus strengthen the company for a partnership, which can provide the best possible terms for shareholders in such a contract negotiation.

With strong data from the phase 1b study and with upcoming important milestones, I am convinced that the company has an exciting future with the goal of offering a therapeutic vaccine for Alzheimer’s disease through strategic partnering.

It has been a fantastic journey, and I am very proud of what we at Alzinova have achieved during my time as CEO. I have been involved in building the company during an important part of the company’s development and with the great data we have obtained in the phase 1b clinical trial, as well as ongoing strategic partnering discussions, we have come to a point where I think the company is now ready for a change of CEO. I look forward to following the company as an engaged shareholder in the future.

Kristina Torfgård, CEO of Alzinova AB