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2022-04-19

Alzinova AB interim report January - March 2022

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

Three months, January - March 2022

  • Net sales amounted to 0 SEK (0 SEK).
  • Result after financial items amounted to -2,282,156 SEK (-1,461,253 SEK).
  • Earnings per share amounted to -0.14 SEK (-0.09 SEK).
  • Equity ratio amounted to 91.4% (93.6%).

Significant events during January - March 2022

  • Alzinova announced in January 2022 that the company had completed work on adapting the antibody to humans and selected a main candi­date for its monoclonal antibody for ALZ-201 and that several backup candidates with promising profiles had also been developed.
  • Alzinova announced in February 2022 that the Company will receive approximately SEK 2.8 million through the exercise of warrants of series TO2 2020/2022. The exercised warrants corres­ponded to an exercise rate of approximately 11%.
  • Alzinova announced in March that the manu­facturing process for the active substance in ALZ-101 had been improved, thus enabling supply of ALZ-101 in the amounts required for Phase 2 clinical trials. Furthermore, a more robust manu­facturing process is beneficial for future reliable, cost-effective and GMP (Good Manufacturing Practice) compliant manufacturing.

Significant events after end of the period

  • No significant events

CEO comments

Our continued focus is on the vaccine candi­date, ALZ-101, and the ongoing clinical study in patients with Alzheimer's disease. It is pleasing that a Swedish biopharma company such as Alzinova is now on the international map of companies that have ongoing studies in Alzheimer's patients.

ALZ-101 - recruitment for the Phase 1b study is ongoing
The recruitment of patients for the phase 1b study is ongoing and we are proud to now have patients being treated with our therapeutic vaccine, ALZ-101, which is being developed into a disease-modifying treatment against Alzheimer's disease. The study is blinded and being managed by our partner, Clinical Research Services Turku, in Finland so we cannot provide any detailed updates, but patients are being continuously recruited into the study and we have not received any reports that the vaccine is harmful to or not well tolerated in humans.

Improved manufacturing process ahead of Phase 2
Preparing for the next clinical development phase - Phase 2 - is also an important part of the development of ALZ-101. We have just finished work on improving the manufacturing process of the active peptide in the ALZ-101 vaccine. The new manufacturing process meets the higher quality requirements placed on therapies in clinical phase 2. It generates representative material with higher purity and in larger quanti­ties, which is promising for future cost-effective manufacturing ahead of Phase 2.

ALZ-201 - humanised lead candidate
During the first quarter, we selected a huma­nised lead candidate for the oligomer-specific antibody, ALZ-201. The monoclonal antibody has a unique and specific binding profile and strong preclinical efficacy data. The fact that it has now been modified to be tolerated by humans now makes it possible to develop further as a poten­tial treatment for patients with Alzheimer's.

We see several potential uses for the antibody, ALZ-201. For example, as adjunctive therapy to the vaccine ALZ-101 in patients who, for some reason, initially need high levels of antibodies, as well as in Alzheimer's patients with weakened immune systems who have difficulties producing antibodies themselves.

Strengthened portfolio with best-in-class potential
I am pleased that we now have a new can­didate in the form of a monoclonal antibody that we can progress and prepare for clinical development. This also means that we have a stronger product portfolio in dialogue with potential partners. I am convinced that both the vaccine, ALZ-101, and the antibody, ALZ-201, have "best-in-class" potential and that they could make a signifi­cant impact in future disease treatments for Alzheimer's disease.

I look forward to an exciting new year where our most important goal is to complete patient recruitment for the ongoing clinical study with ALZ-101 before the end of this year so we can finalise the study in the second half of next year.

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 07:46 a.m. CEST on April 19, 2022.

About Alzinova AB
Alzinova AB is a Swedish clinical-stage biopharma company specializing in the treatment of Alzheimer's disease targeting neurotoxic 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 therapies 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 early 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

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