Three months, January – March 2023

• Net sales amounted to 0 SEK (0 SEK)
• Loss after financial items amounted to SEK -4,271,503 (-2,282,156).
• Number of shares outstanding: 32,419,034 (16,209,519).
• Average number of shares during the period before dilution 32,419,034 (15,963,702).
• Average number of shares during the period after dilution 45,545,811 (16,135,352).
• Earnings per share before dilution amounted to SEK -0.13 (SEK -0.14).
• Earnings per share after dilution amounted to SEK -0.09 (SEK -0.10).

Figures in brackets refer to corresponding period in previous year.

Events during the first quarter 2023

• Alzinova announced on January 3 that a new scientific article had been published in the prestigious journal Alzheimer’s Research & Therapy presenting preclinical results demonstrating that the antibody ALZ-201 has specificity for the toxic oligomers believed to be the cause of Alzheimer’s disease.
• On January 24, Alzinova announced that the Company had strengthened its management team by appointing Sebastian Hansson as the new Business Development Director.
• On March 16, Alzinova announced that a planned external safety data review had been conducted of the Company’s clinical phase 1b study – with a positive assessment to continue the study as planned.
• Alzinova announced on March 21 that the Company had filed a new patent application for a further developed form of the Company’s monoclonal antibody ALZ-201. The patent application is part of Alzinova’s strategic development of the patent portfolio for pharmaceutical candidates.
• On March 29, Alzinova announced that the Company presented data and studies regarding the Company’s vaccine candidate ALZ-101 at the international conference AD/PD™ held in Gothenburg on March 28 – April 1.

Events after the end of the first quarter 2023

• On April 5, Alzinova announced that the subscription price for the exercise of warrants of series TO3 was set at SEK 2.17 per share.
• On April 11, Alzinova announced that the exercise period for the Company’s warrants of series TO3 began.
• 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.
• On April 13, Alzinova announced signed subscription commitments corresponding to 26.6 percent of outstanding warrants of series TO3 from larger holders, including members of the Company’s Board of Directors and management group as well as founders of the Company.
• 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 21, Alzinova announced the last day of trading in warrants of series TO3.
• 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 that the Company will receive approximately 26.3 MSEK before issuing costs, through the exercise of warrants of series TO3. The exercised warrants corresponded to an exercise rate of approximately 93.4%.
• 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. Based on this positive second interim analysis, the Company made the decision to conduct an extension part of the study.

A word from the CEO

We had an eventful first quarter that included a positive safety review and all patients receiving their last dose in the clinical phase 1b study. With positive data in May from the latest interim analysis, we are increasing the pace further in 2023!

The ALZ-101 vaccine - positive data and favorable safety profile
Our phase 1b study in Alzheimer’s patients continues as planned. In March, a new planned safety data review was conducted by the expert group Data Safety Monitoring Board (DSMB) where safety data was also evaluated in relation to a planned extension of the study. Based on the positive safety data from all patients participating in the study, the DSMB recommended that the study should proceed as planned and that the study may also be extended.

The last patient enrolled into the study received their last dose in mid-April. This is an important milestone for the company and meant that, as planned, we could conduct a second interim analysis based on all 26 patients in early May. The response from this analysis was very positive. First, it again showed that the treatment is safe and well tolerated. In addition, we received data showing a clear immunological response, through the formation of antibodies, which is an important sub-goal of the study and for future evaluation of efficacy in phase 2!

I am very pleased that we see continued good safety and tolerability of the treatment, which is also the primary goal of this first clinical study. These positive results strengthen our position for future interactions with regulatory authorities, partnering activities and for the next step in clinical development, i.e. the phase 2 study. We now look forward to top-line data from the ongoing study in the second half of 2023.

Confidence in vaccine with long-acting effect
At the end of March, Alzinova participated in the highly regarded international Alzheimer’s conference AD/PD™ held in Gothenburg, this conference was extra exciting for us as it was held at home. The conference was characterized by optimism, and we noted a great interest in vaccines and their advantages compared to the antibodies that are currently approved or under development. In particular, it highlighted that vaccines are more patient-friendly and cost-effective treatments, which could allow many more people to receive an effective treatment for Alzheimer’s. At the conference, the Company presented preclinical data showing that the vaccine candidate ALZ-101 has a long-acting effect and that antibodies can be observed six months after the last dose of ALZ-101. In addition, the study shows that the antibodies that are formed can reach the brain in relevant amounts. Results that generated great interest in Alzinova!

Increased interest in Alzinova – Vaccine with better side effect profile provides opportunities for more people to receive treatment
Today, there are two antibodies that have received accelerated approval in the United States for the treatment of Alzheimer’s disease. This is, of course, very positive and gives hope to all those suffering from Alzheimer’s and their loved ones. However, it has been discussed how society will cope with the high costs that come with this type of antibody treatment. Here we see that Alzinova with its vaccine approach has the opportunity to make a big difference with an effective treatment that, compared to antibody treatment, can reduce healthcare and societal costs. This creates the opportunity for more people to receive treatment.

Research results support that oligomer-specific treatments (ALZ-101 and ALZ-201) have the potential to be “best-in-class” with good efficacy and a more favorable side effect profile than observed for other therapies. This too could contribute to lower nursing costs for society.

Strengthens the patent portfolio
In March, we filed a new patent application for a further developed form of our monoclonal antibody ALZ-201. The patent strategy and application are important parts of our work to position Alzinova as a leading player in the development of treatments for Alzheimer’s disease. We work continuously to strengthen our patent portfolio, which is value-creating and is very important, not least in future partner discussions.

Focus on business development and strengthened financial position
We are pleased that the organization is expanding and that we, in January, welcomed Sebastian Hansson as Business Development Director. We have a strong focus on business development and are positioning the Company where the work with partnering activities has now intensified after further positive interim data.

We strengthened our financial position through the warrants in April. A big thank you to all of you who have subscribed for shares in the warrant program. It is delightful to see a subscription rate of about 93.4% in the current market climate, which is proof of your interest and confidence in Alzinova! Through the capital injection of approximately SEK 26 million, we can continue the development of the vaccine ALZ-101 and the antibody ALZ-201 with the goal of developing the new generation Alzheimer’s drugs.

Alzinova accelerates further in 2023
With positive data from the latest interim analysis, the differentiation that shows that we have potential to become ”best-in-class” and with an increased focus on business development, we increase the pace further in 2023! We are convinced that our candidates can make a big difference in future treatments for Alzheimer’s disease.

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/