Alzinova AB : interim report January - June 2021

The Board of Directors and the Chief Executive Officer of Alzinova AB hereby present the interim report for the period January -June 2021. 

Six months, January -June 2021

• Net sales amounted to 0 SEK (0 SEK).
• Result after financial items amounted to -3,641,239 SEK (-2,898,387 SEK).
• Earnings per share amounted to -0.23 SEK (-0.38 SEK).
• Equity ratio amounted to 93.7% (92.6%)

Three months, April -June 2021

• Net sales amounted to 0 SEK (0 SEK).
• Result after financial items amounted to -2,179,986 SEK (-1,123,481 SEK).
• Earnings per share amounted to -0.14 SEK (-0.15 SEK).

Significant events during April - June 2021

• Alzinova announced in April that the documentation required for the application to start the planned Phase 1b clinical study with the drug candidate ALZ-101 will be ready during June. The study is planned to start during the third quarter, with the first patient first dose (FPFD) administered during third quarter. 
• Anders Blom was elected as a new Alzinova board member in May. Anders brings valuable experience from business and corporate development.

Significant events after the second quarter of 2021

• In July, Alzinova presented preclinical data on Alzheimer's disease candidates at the Alzheimer's Association International Conference (AAIC). The preclinical data support the continued develop­ment of Alzinova's lead candidate, ALZ-101.

 

CEO comments

Alzinova is entering the clinical development phase with the vaccine, ALZ-101, specifically targeting the neurotoxic oligomers of amyloid-ß in Alzheimer's disease. This is an important step for the company in an area with significant medical need for new treatments.

The second quarter has been intensive and very inspiring, and Alzinova has made great progress. We have achieved a number of important mile-stones in the work to start the first clinical Phase 1b study with our oligomer-specific therapeutic vaccine in Alzheimer's patients:

• In May, we received the final ethical approval of the study from the national ethics committee in Finland.

• The documentation required for the application to start the clinical study was finalised and was sent in June to the Finnish regulatory authority, Fimea, for approval to start the study.
• The clinical study material for the Phase 1b study was manufactured and is ready to be delivered ahead of the recruitment of the first patients.

We are now awaiting approval from Fimea to enter the clinical phase, which will be an important milestone for the company. We are very much looking forward to this and it feels extremely gratifying and encouraging to soon be able to treat patients with ALZ -101.

During the summer, the US Food and Drug Administration (FDA) approved the first antibody against amyloid-ß (Biogen's aducanumab) for the treatment of Alzheimer's disease. The announcement of a conditional approval gives hope to the millions of patients, care givers and their families who are suffering from Alzheimer's disease. It also marks the beginning of a new era in research and clinical progress relating to Alzheimer's disease. The decision demonstrates the opportunities to register a disease-modifying drug in the field of amyloid-ß (Aß). We believe that a therapy such as ALZ-101 that causes the body to generate its own antibodies that are specifically targeted against the neurotoxic oligomers of Aß will prove to be more effec­tive against the most damaging causes of Alzheimer's disease.

In July, together with researchers from the University Medical Center (UMC) Amsterdam, Alzinova presented data for the company's Alzheimer's disease candidates at the Alzheimer's Association International Conference 2020 (AAIC). The monoclonal antibody, ALZ- 201, which specifically targets amyloid-ß42 oligomers, neutralises the neurotoxicity effect although it only targets a very small fraction of all Aß. The data presented indicate that ALZ-201 has very high selectivity for the toxic form of the Aß peptide and a binding profile that differs from other known antibodies in the field. The selecti­vity may be a critical attribute for achieving a true specific therapeutic effect with favourable tolerability in patients with Alzheimer's disease.

The Phase 1b clinical study that we are about to start with ALZ-101 will be in patients with mild Alzheimer's disease. The study will evaluate the vaccine candidate's tolerability and safety. It will study the immunological response to the vac­cine after multiple doses, as well as a number of biomarkers that are associated with Alzheimer's disease.

At the AAIC conference, improved diagnostic tools under development were also presented, including blood biomarkers. This provides hope for early diagnosis of Alzheimer's disease, which in turn creates better opportunities for earlier treatment with a disease-modifying therapy

Besides our focus on ALZ-101 and the start of the clinical study, we have continued the develop­ment of our antibody, ALZ-201. We are working to humanise the antibody as a first step to making it our next candidate to be tested in humans.

Our financial situation remains stable and the cost of development for our R&D activities is according to plan. We forecast that our current liquidity, together with the capital we expect to raise in the beginning of next year through the ongoing subscription warrants programmes, will ensure the delivery of the Phase 1b clinical study and the continued development work with ALZ-101. Besides this, we are continuously working to evaluate different financing opportunities with the aim to develop our product portfolio.

The Covid-19 situation seems to be improving inside and outside Sweden. We do not currently foresee any negative impact on our business activities nor our clinical study. We continue to work closely with our suppliers and collaboration partners to minimise any effects on our business. We continue our work to minimise the risk for our employees.

I am very proud to see our therapeutic vaccine shortly will enter the clinical phase and I'm looking forward to continue our important work to treat and prevent the onset and progression of Alzheimer's disease.

Our long-term goal to develop a long-acting and effective therapy that enables patients to live an active and independent live without any impact of Alzheimer's disease has now come that little bit closer.

Finally, I would like to warmly welcome our new board member, Anders Blom, to the company. With his experience in business and corporate development, Anders brings valuable skills at a time when the company is now entering the clinical phase.

Kristina Torfgård, CEO Alzinova

 

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: [phone]
E-mail: [e-mail]

Håkan Skogström, CFO
tel: [phone]
E-mail: [e-mail]

The information was submitted for publication, through the agency of the contact person set out above, at 08:01 a.m. CEST on August 26, 2021.

 

About Alzinova AB
Alzinova AB is a Swedish biopharma company specializing in the treatment of Alzheimer's disease targeting neurotoxic amyloid-β oligomers. The lead candidate, ALZ-101, is a therapeutic vaccine for the treatment of Alzheimer's. Alzinova's proprietary AβCC peptide(TM) technology enables the development of disease-modifying therapies that target the toxic amyloid-β 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, in early preclinical development, was generated with the AβCC peptide(TM) technology and the ambition is to expand the pipeline further. The company's Certified Advisor on Nasdaq First North Growth Market is Corpura [e-mail] [phone]. For more information about Alzinova, please visit: www.alzinova.com

 

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