Alzinova AB interim report January – June 2022

The Board of Directors and the Chief Executive Officer of Alzinova AB hereby present the interim report for the period January - June 2022

Three months, April – June 2022

• Net sales amounted to 0 SEK (0 SEK).
• Result after financial items amounted to -3,299,600 SEK (-2,179,986 SEK).
• Earnings per share amounted to -0.10 SEK (-0.14 SEK).

Six months, January – June 2022

• Net sales amounted to 0 SEK (0 SEK).
• Result after financial items amounted to -5,581,756 SEK (-3,641,239 SEK).
• Earnings per share amounted to -0.17 SEK (-0.23 SEK).
• Equity ratio amounted to 96.5% (93.7%).

Significant events during the second quarter

• In April, Alzinova’s board decided on a preferential issue of units corresponding to SEK 42.5million if fully subscribed. The issue proceeds will primarily be used to finance the completion of the phase 1b-study and extension of the study for the vaccine candidate ALZ-101 as well as to prepare for the phase 1b study of the antibody ALZ-201.
• The Company announced that an external review of the phase 1b study of the safety data shows positive results and the study for ALZ-101 therefore continues according to plan.
• In May, Alzinova published a prospectus due to the preferential issue of units.
• The Company called for an annual general meeting, which was held on May 18, 2022, and all proposals for decisions were adopted by the general meeting. The minutes for the meeting are available on the company’s website, www.alzinova.com.
• The Company announced continued preclinical development of the antibody candidate ALZ-201 which was part of the preparations for clinical studies.
• Alzinova published the results of the rights issue. Subscription rate of 80%, the company received SEK 34 million before issue costs.
• Alzinova engaged Mangold Fondkommission as liquidity provider for the company share.

Significant events after the end of the second quarter

• In July, Alzinova announced that it has successfully verified that the manufacturing process for vaccine doses of ALZ-101, the Company’s vaccine candidate against Alzheimer’s disease, can be scaled up to deliver the larger production volumes required for phase 2 clinical trials.
• The Company announced that the preferential issue of units was registered with the Swedish Companies Registration Office.
• The Company announced that 50% of the patients for the ongoing phase 1b study had been recruited to the study. The goal is for all patients to be recruited in 2022.

A word from the CEO

During an eventful quarter, Alzinova has continued to build a stable foundation for the further development of the Company’s pharmaceutical portfolio, which has strong potential to be “best-in-class”. Recruitment to the Company’s phase 1b study is proceeding according to plan with the goal of recruiting all patients to the study in 2022.

ALZ-101 – Half of the patients recruited in the phase 1b study
During the summer, we reached the important milestone of having recruited half of the patients in the ongoing phase 1b clinical study. We are well on our way to our goal of recruiting all patients to the study by end of 2022.

The study therefore continues according to plan and in April the first review of blinded safety data from the study was carried out. The external expert group recommended continuing the study, which was an important step in the development of ALZ-101. The expert group now conducts regular reviews to follow up the safety data accumulated during the conduct of the study.

The vaccine can be scaled up for larger production volumes
Preparations for clinical phase 2 studies are progressing according to plan, and it is encouraging that we have now ensured that the manufacturing process can produce larger volumes of our vaccine candidate ALZ-101. We have already optimized the manufacturing of the active ingredient in the vaccine and have now in the second quarter also validated that the manufacturing process for the drug can be scaled up for larger production volumes. These are important steps for the long-term goal of cost-effectively produce and offer a vaccine against Alzheimer on the global market. In addition, these will be important elements that potential partners review and contributes also to increased interest in partnership.

ALZ-201 – being developed to enter into clinical phase
During the second quarter, work began on developing a stable manufacturing process for large-scale production of the antibody ALZ-201 in preparation for upcoming clinical studies. Unlike other antibodies that are being developed today, this antibody is more specific and targeted against the toxic peptides that break down brain cells, so-called oligomers. Protecting the brain cells from the toxic action of the oligomers could result in a treatment with better efficacy and a more favourable safety profile. We see several possible uses for ALZ-201. It can be further developed both as a stand-alone treatment against Alzheimer, and as a complement to the vaccine ALZ-101 for patients who, for various reasons, need higher levels of antibodies.

Strengthened financial position and more attractive for partnerships
Financially, we strengthened our position and the possibilities to make our drug candidates more attractive for partnerships, through the recent rights issue. The new capital ensures the financing of the vaccine candidate ALZ-101, the completion of the clinical study, strategic marketing and IP, as well as preparations for the next clinical development phase - phase 2. For the antibody ALZ-201, the preclinical development work is funded, thereby preparing the antibody so that we can take also this drug candidate into the clinic.

We have ongoing dialogues with potential partners who are established pharmaceutical companies in one way or another. These companies follow our development projects with great interest and look forward to the data that we are currently generating in the clinical study, which will strengthen both the clinical and commercial interest in the vaccine ALZ-101 and the antibody ALZ-201.

We are very grateful for the interest in our rights issue and I would like to thank both our existing shareholders for their trust and all interested parties who have chosen to invest in Alzinova. We now look forward to completing recruitment for the phase 1b study, continuing dialogues with potential partners and preparing for phase 2. If we achieve the results we expect to achieve with our clinical program, Alzinova and its shareholders face a very exciting future. 

Kristina Torfgård, CEO Alzinova AB

The full report, which is attached in the press release, can also be downloaded from the company’s English website, www.alzinova.com/investors/financial-reports/

For more information, please contact:
Kristina Torfgård, VD
tel: +46 708 46 79 75
E-mail: kristina.torfgard@alzinova.com

Håkan Skogström, CFO
tel: +46 705 85 08 59
E-mail: hakan.skogstrom@alzinova.com

The information was submitted for publication, through the agency of the contact person set out above, at 08:01 a.m. CEST on August 25, 2022.

About Alzinova AB
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 AβCC 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 Advisor on Nasdaq First North Growth Market is Corpura info@corpura.se +46 768-532 822. For more information about Alzinova, please visit: www.alzinova.com