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2022-11-01

Alzinova AB interim report January - September 2022

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

Three months, July - September 2022

  • Net sales amounted to 0 SEK (0 SEK).
  • Result after financial items amounted to SEK -2,771,286 (SEK -1,455,142).
  • Earnings per share amounted to SEK -0.09 (SEK -0.09).

Nine months, January - September 2022

  • Net sales amounted to 0 SEK (0 SEK).
  • Result after financial items amounted to SEK -8,353,042 (SEK -5,096,381).
  • Earnings per share amounted to SEK -0.26 (SEK -0.32).
  • Cash and cash equivalents at the end of the period amounted to SEK 38.9 million (SEK 34.3 million).
  • Equity ratio amounted to 95.9% (96.6%).

Events during the third 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 for Alzheimer's disease, can be scaled up to deliver the higher production volumes required for Phase 2 clinical trials.
  • The Company announced that the rights issue of units has been registered with the Swedish Companies Registration Office.
  • The company announced in August that 50% of patients in the ongoing Phase 1b study had been enrolled. The goal is to have all patients enrolled by 2022.
  • In September, the Company announced that an additional planned external review of the Phase 1b study's safety data, showed positive results and that the ALZ-101 study is therefore continuing as planned without adjustments.

Events after the end of the third quarter

  • In October, Alzinova announced that CSO Anders Sandberg was interviewed in Biostock where he shares his scientific reflections on the latest developments in the industry.
  • Alzinova announced in October that the Company will present at both Swedish and international investor meetings during the autumn. In October, the Company participated at one of the major biotech conferences in Europe, BIO-Europe, which is a gathering place for partner meetings where the Company presented the vaccine candidate ALZ-101 and the antibody ALZ-201 to potential partners.

A word from the CEO

Many exciting activities have taken place during the third quarter and more are planned for the autumn. Alzinova is focused on our Phase 1b clinical trial, but also very much on preparations for Phase 2 and on business development. Good news on the research front has bolstered the amyloid-beta hypothesis which also boosts the company. We continue to build the company and strengthen the organisation with a focus on presenting and positioning Alzinova in the market.  

Amyloid-beta theory strengthened with new clinical data

In September, as expected, we received positive data from the large phase 3 study in Alzheimer's patients conducted by the Japanese pharmaceutical company Eisai with the monoclonal antibody lecanemab, developed by BioArctic. I am very pleased with these first data that have now been presented, which is a very important milestone for the research field and means that the amyloid-beta hypothesis has been substantially strengthened. This makes it the leading theory and field for finding a cure for Alzheimer's disease. All this, together with our data showing "best-in-class" potential, is obviously contributing to an increased interest both in the research field itself and in Alzinova's unique portfolio of drug candidates.

Drug candidates with unique specificity - "best-in-class" potential

We already have indications that specificity is important for treating the disease and our drug candidates are unique in this field. Our candidates that can target the toxic accumulation of amyloid-beta to a greater extent than other candidates have "best-in-class" potential with the likelihood to be more effective and safer. In addition, our ALZ-101 vaccine, currently in phase 1b and being tested in Alzheimer's patients, will lead to a simpler treatment for the patient and will be better from a social and health economic perspective, as the treatment will need to be administered much less frequently than other drug candidates.

ALZ-101 - clinical data show a safe and well-tolerated vaccine

Our Phase 1b clinical trial continues on schedule and in September the second review of blinded safety data from the trial was completed. The external expert panel again recommended continuing the study, which was expected but still an important step in the development of ALZ-101. The expert panel will continue to conduct regular reviews in order to follow up on the safety data collected throughout the course of the study. Our goal is to have all patients enrolled in 2022 and then present top-line data in the second half of 2023.

Increased interest & business development - more attractive for partnerships

Following the release of the Eisai data, we have seen increased interest in Alzinova, both from investors and potential partners, which we are very pleased about. We continue to work on the business development of the company and are now strengthening the organisation with a focus on presenting and positioning the company. This is being done to, among other things, establish partnerships with a global pharmaceutical company. We are also very much looking forward to the various events we will be attending during the autumn. One of them is BIO-Europe which created many opportunities to meet existing contacts and new potential licensees to our programs. We want to ensure that we have contact with all suitable and willing potential partners well in advance of the ALZ-101 results, in the second half of next year, and build increased awareness and interest in the Alzinova brand and future commercialisation.

Bringing hope to Alzheimer's patients and their loved ones

Through our collaboration with the Alzheimer's Foundation, we can work together to increase awareness and interest in the disease and to support research with the ultimate goal - to end Alzheimer's disease. I had the privilege of presenting Alzinova at the Alzheimer's Foundation seminar in September. It was attended by both researchers and representatives from the pharmaceutical industry. I am really happy and proud to present the company and our innovative work to develop new effective drugs against Alzheimer's. The seminar was well attended by Alzheimer's patients and their families. Meeting people with Alzheimer's in this way and communicating that we and many others are working to break the code for Alzheimer's disease and develop effective treatments is a very important and hopeful experience for both patients and their loved ones.

Today, with the positive data recently presented reinforcing the amyloid-beta theory, I am even more convinced that our new Alzheimer's treatments will enable Alzheimer's patients to live independent and active lives.

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. CET on November 1, 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. For more information about Alzinova, please visit: www.alzinova.com

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