Three months, April – June 2023

• Net sales amounted to SEK 0 (SEK 0)
• Loss after financial items amounted to SEK -3,928,458 (SEK -3,299,600)
• Average number of shares during the period before dilution 40,405,120 (16,387,646)
• Average number of shares during the period after dilution 40,619,993 (16,546,811)
• Earnings per share before dilution amounted to SEK -0.10 (SEK -0.20)
• Earnings per share after dilution amounted to SEK -0.10 (SEK -0.20)

Six months, January – June 2023

• Net sales amounted to SEK 0 (SEK 0)
• Loss after financial items amounted to SEK -8,199,961 (SEK -5,581,756)
• Average number of shares during the period before dilution 36,434,138 (16,176,845)
• Average number of shares during the period after dilution 36,649,011 (16,336,010)
• Earnings per share before dilution amounted to SEK -0.22 (SEK -0.34)
• Earnings per share after dilution amounted to SEK -0.22 (SEK -0.34)

Figures in brackets refer to corresponding period in previous year.

Events during the second quarter 2023

• In April, the utilization period for the Company’s series TO3 warrants commenced, with an exercise price set at 2.17 SEK per share and a subscription period from April 11th to April 21st. The warrants were exercised to a utilization rate equivalent to approximately 93.4%, resulting in the Company receiving approximately 26.3 million SEK before issuance costs.
• On April 12, Alzinova announced that all patients participating in the phase 1b study with the vaccine candidate ALZ-101 against Alzheimer’s disease had received their fourth and final dose of the vaccine ALZ-101 or placebo.
• Alzinova announced on April 18 that the Company had received regulatory approval from the Finnish Medicines Agency, Fimea, and the Finnish National Ethics Committee to initiate an extension of the phase 1b study. The extension part aims to provide information on long-term safety and tolerability, immune response and also information on effects of ALZ-101 on biomarkers and cognitive functions.
• On April 24, Alzinova announced that the Company had terminated the agreement with Mangold Fondkommission AB on the assignment as liquidity provider. The last day for liquidity support trading of Mangold was April 28, 2023.
• On April 27, Alzinova announced a change in the management team, Chief Medical Officer (CMO) Anders Bylock will leave the Company for personal reasons, with his last day on May 28, 2023. The Company has previously initiated a recruitment process to find a replacement.
• On May 4, the Company announced that a second planned interim analysis was conducted of the ongoing clinical phase 1b study with the vaccine candidate ALZ-101 against Alzheimer’s disease. The analysis showed positive data with continued good safety and tolerability and a clear immunological response, i.e. that specific antibodies have been formed following dosing with ALZ-101. Based on this positive second interim analysis, the Company made the decision to conduct an extension part of the study.
• On May 29, the Company announced that the extension part of the phase 1b study with the vaccine candidate ALZ-101 had been initiated by dosing the first patient.
• The Company convened an annual general meeting, which was held on May 30, 2023, and all proposed resolutions were adopted by the meeting. The minutes of the meeting are available on the Company’s website, www.alzinova.com.
• At the AGM, Björn Larsson resigned as Chairman of the Board and the AGM thanked him for his far-reaching commitment and efforts during his 10 years as Chairman for Alzinova. Julian Aleksov was elected as the new Chairman of the Board.
• On June 13, the company announced that it has submitted an application for a pre-IND meeting with the US Food and Drug Administration (FDA) and an application for EMA Scientific Advice from the European Medicines Agency (EMA).

Events after the end of the second quarter 2023

• Alzinova announced on August 3 that the Company has recruited Kirsten Harting to the role of Chief Medical Officer (CMO). Kirsten Harting will be part of the Company’s management team and will assume her position on August 14.
• On August 8, Alzinova announced that the Company has conducted a pre-IND meeting with the US FDA and received positive feedback on the planned clinical development program for the vaccine candidate ALZ-101.

A word from the CEO

The year has continued at a high pace with important events that have enabled us to reach several milestones. The development of our vaccine candidate ALZ-101 is proceeding according to plan with promising interim data that we obtained in May. Through regulatory agency interactions and partnering activities, we are working towards the goal of entering clinical phase 2 next year.

ALZ-101 vaccine - new positive interim data strengthens our position
The development of our vaccine candidate ALZ-101 is proceeding according to plan. In May, the second planned interim analysis was conducted in the clinical phase 1b study in Alzheimer’s patients. The analysis again showed positive data with continued good safety and tolerability and a clear immunological response, i.e. that specific antibodies have been formed following dosing with ALZ-101. In addition, the new analysis showed that patients treated with ALZ-101 responded to treatment with antibody levels increasing with the number of doses given. We now look forward to topline data later in the year, likely during the fourth quarter.

Based on these positive data, we decided to initiate the extension part of the study and the first patient was dosed in May. The extension part will give us information about the immune response, safety and tolerability after a longer period of treatment. In addition, we have the opportunity to obtain information about the effect on biomarkers and cognitive functions. This is something that we believe further strengthens our position and is valuable for future interactions with potential partners and regulatory authorities.

Regulatory interactions ahead of phase 2
Based on the promising interim results with ALZ-101, we submitted an application for a pre-IND meeting with the US Food and Drug Administration (FDA) and an application for scientific advice from the European Medicines Agency (EMA).

During the summer, the meeting with the FDA was held where we received positive feedback on the planned clinical development program for the vaccine candidate ALZ-101. This validation of the quality of the project is a significant step for potential partner discussions, as well as the path towards the submission of an application to include US study centers in future phase 2 studies. We are now looking forward to receiving a response from the EMA in the autumn.

ALZ-101 and ALZ-201 with “best in class” potential

In June, the company participated in the major US biotech conference, BIO, held in Boston. BIO serves as an important forum for partnership meetings, where we presented our vaccine candidate ALZ-101 and the antibody ALZ-201 to potential partners. Attending BIO gave us an excellent opportunity to network, establish and deepen valuable contacts in the industry. We also had the chance to showcase our progress and innovations to a wide audience of experts and stakeholders. We are pleased to see significant interest in our vaccine. This is partly due to the positive progress seen with our specific approach and the benefits of using a vaccine as a treatment. Moreover, the amyloid hypothesis has been further strengthened by a third antibody, donanemab, showing positive phase 3 data. However, it is our oligomer-specific approach that sets us apart from the competition and gives us best-in-class potential.

Preparing the company for successful clinical development and future market introduction
The Company’s organization has been further strengthened by our recruitment of Kirsten Harting as Chief Medical Officer with many years of experience in medicine, clinical trials and drug development as well as in business development and taking products to market.

Later this year, we will receive our long-awaited top-line data for the vaccine candidate ALZ-101. Based on all patients who participated in the study, it will give us an overall picture of the safety and tolerability of treatment with ALZ-101 as well as information on the immune response for the two different dose levels 125 μg and 250 μg. We also hope to get an early indication of whether ALZ-101 has an effect on biological markers involved in the disease. During the autumn, we will continue to prepare for a new and exciting phase in Alzinova’s history - through regulatory interactions and partnering activities with the goal of entering clinical phase 2 next year and taking the company to phase 3 readiness.

We look forward to sharing the continued journey with your shareholders!

Kristina Torfgård, CEO Alzinova AB

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/