Alzinova

Three months, April – June 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 amounted to 44,531,265 (32,419,034).
• Average number of shares during the period after dilution amounted to 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).

Six months, January – June 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 amounted to 44,531,265 (32,419,034).
• Average number of shares during the period after dilution amounted to 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.
”the Company” or ”Alzinova” refers to Alzinova AB with corporate identity number: 556861-8168.

Significant events during the second quarter 2024

• All patients in the extension part (part B) of the phase 1b study were dosed with the last dose of the Alzheimer’s disease vaccine candidate ALZ-101 in April.
• An in-depth analysis of data from part A1 of Alzinova’s phase 1b study with the vaccine candidate ALZ-101 was conducted in April. The analysis indicated that patients with the higher antibody levels after vaccination have a positive effect on biomarkers associated with Alzheimer’s disease.
• Alzinova’s CEO, Kristina Torfgård, informed the Board of Directors at the end of April 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.
• In May, the first patient was dosed in the final cohort (part A2) of the phase Ib study. Part A2 aims to evaluate a higher dose of ALZ-101.
• The minutes of the Annual General Meeting were published. All proposals for resolutions were adopted by the meeting. Lena Degling Wikingsson left the Board of Directors in connection with the AGM and the Board subsequently consists of Julian Aleksov (Chairman), Anders Blom, Per-Göran Gillberg, Clas Malmeström, Carol Routledge and Anders Waas.
• Alzinova announced that a new external safety review of part A2 of the Company’s phase 1b clinical trial has been completed - with a positive assessment to continue the study as planned.
• Enrolment of patients in Alzinova’s part A2 of the phase 1b study was completed at the end of June.
• Alzinova announced a change of Certified Adviser and Liquidity Provider. The changes came into effect on 1 July 2024.
• Alzinova’s rights issue was oversubscribed with a subscription rate of approximately 106%. The company raised approximately SEK 34.4 million before deduction of issue costs. No underwriting commitments were utilized.

Significant events after the end of the second 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 have 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.

A word from acting CEO Carol Routledge

It has been an exceptional six months for Alzinova, filled with progress and events that strengthened our journey towards fighting Alzheimer’s disease. On June 17, the subscription period for our rights issue ended, resulting in a subscription rate of 106.2%. We raised approximately SEK 30.8 million after issue costs, providing us with the necessary resources to continue our clinical development without taking on any underwriter commitments. The support from our shareholders, in the current market climate, is a strong testament to the confidence in our strategy and our ability to deliver.

Alzinova presented promising phase 1b results
Several steps forward have also been taken in the ongoing phase 1b study. We have dosed all patients with the last dose of the vaccine candidate ALZ-101 in the extension cohort (part B). An in-depth analysis of the data from part A1 of the same study, conducted in April 2024, showed that patients with higher antibody levels following vaccination with ALZ-101, exhibited positive effects on biomarkers associated with Alzheimer’s disease. The results again highlight the potential of ALZ-101 and strengthen our position in partner dialogues.

In June, we presented the phase 1b results of ALZ-101 to senior executives from several Big Pharma companies at the Biotech International Convention, US Bio. Additionally, Henrik Zetterberg, Professor of Neurochemistry at University College London, UK and at Gothenburg University as well as Scientific Advisor to Alzinova, presented an abstract with the strong results from part A1 of the phase 1b study with ALZ-101 at the major Alzheimer’s conference AAIC in July.

The goal is to establish global partnerships through which our vaccine candidate is further developed to reach the market as quickly as possible. The timing is optimal after AC Immune’s lucrative out-licensing of the vaccine ACI-24, which like ALZ-101, targets amyloid beta. The critical and important difference between Alzinova’s treatment and AC Immune’s approach is that the vaccine candidate ALZ-101 is significantly more specific in targeting toxic oligomers vs other forms of amyloid beta. The specificity, together with the phase 1b results for ALZ-101, means that Alzinova offers an attractive treatment approach with their drug candidate. Alzinova is right on track with a potentially more efficient and safer product. With its novel treatment approach, ALZ-101 has the potential to be best in class, and I am convinced that we are and will be an valuable addition for Big Pharma’s Alzheimer’s portfolio. The demand for therapies that are easy and cost-effective for healthcare professionals to administer is high, which is also reflected in the potentially high sales value of such products.

Progress in the phase 1b study and positive safety review
On the clinical development front, we have made further progress. In May, the first patient was dosed in the last cohort (part A2) of the phase 1b study, and according to schedule, enrolment of all patients in part A2 was also completed. A new external safety review of our phase 1b study resulted in a positive assessment, allowing us to continue the study as planned. Shortly after the end of the quarter, we were also able to announce that all patients had received the first dose of ALZ-101 in part A2 of the phase 1b study. The treatment is administered a total of four times to each patient over a 16-week period, followed by a further four weeks of monitoring. Our goal is to present data from the high-dose cohort in the fourth quarter of 2024.

Strengthened position for Alzinova
At a corporate level, there have been important changes. CEO, Kristina Torfgård, announced her decision to step down before the summer. We thank Kristina for her invaluable contribution and wish her all the best in her future endeavors. I am grateful for the Board’s confidence in me to lead Alzinova as acting CEO until the Board has finalised the recruitment of a permanent CEO.

We have now completed six months that have strengthened Alzinova’s position as a leading actor in the research and development of treatments for Alzheimer’s disease. With the funds Alzinova has received from the successful share issue and the positive clinical results, the company is well equipped for the future and has a strengthened position in partnership dialogues.

Thank you to the Alzinova team for all the hard work and dedication, to all patients and their families for their trust, and to you, our shareholders, for your continued support. Together, we are taking important steps forward in the fight against Alzheimer’s disease.

Carol Routledge,
Acting CEO of Alzinova AB