A word from the CEO

AlzeCure continues to progress our portfolio according to our 2021 plan. During the first quarter we focused on advancing our ongoing clinical trials with ACD856 and ACD440 with the goal to announce data from them during the summer. In addition, we continued to focus on our preclinical pain project, TrkA-NAM, so that we will be able to choose a drug candidate for the project during the second half of 2021. We also strengthened our development organization by employing a Chief Medical Officer with expertise and experience from our core areas, Alzheimer’s disease and pain. Thus AlzeCure has once again closed the books on yet another positive and very active quarter.

”AlzeCure continues to develop according to plan and has once again had a positive and very active quarter.”

CEO, Martin Jönsson

ACD856 is part of the innovative NeuroRestore platform with a primary focus on symptomatic treatment of Alzheimer’s – in other words, improving the memory and cognitive problems that are so characteristic for the disease. There is currently a high unmet medical need for new symptomatic drugs for the treatment of Alzheimer’s disease. Over the next 30 years, the number of patients with dementia is expected to triple to 150 million. In the ongoing clinical trial for ACD856 we are studying its safety and tolerability, where we expect to obtain the initial results during the summer of 2021. Our other drug candidate in the NeuroRestore platform, ACD857, is in the preclinical development phase. We plan to use this compound for an indication within the field of cognitive dysfunction, such as Alzheimer’s disease.

Our innovative Alzstatin project platform, which includes ACD679, aims to develop preventive “disease-modifying” treatments for Alzheimer’s by reducing production of harmful amyloid-beta (Aβ) and thereby preventing the accumulation of pathological amyloid in the brain. Dementia diseases are estimated to cost society SEK 10,000 billion worldwide every year – a cost that is expected to triple over the next 30 years, as life expectancy increases. This demonstrates the tremendous and growing need for effective new medications, as well as the potential for the new Alzstatin program, which has compounds in preclinical studies that have shown that they can reduce the quantity of harmful amyloid-beta by 50 percent.

ACD679 is in preclinical toxicological studies and research continues in the ACD680 follow-up project. This parallell development will ensure that we can choose the best possible Alzstatin compound for future clinical trials. During the quarter additional data were  published that strengthen the evidence for the amyloid hypothesis  on which Alzstatin is based. Among other things, new data were presented with antibody treatment at the AD/PD 2021 conference in March, which increases the interest in projects like Alzstatin.

We also see continued promising progress in our pain platform Painless, which consists of two projects, ACD440 and TrkA-NAM. ACD440 is a VR1 antagonist for local topical use to treat neuropathic pain, and in December 2020 we initiated a phase 1b clinical trial, which will provide us with safety and tolerability data, as well as with early effect signal data. We expect to receive the results from this study during the summer of 2021. Global sales for medications with the indication of neuropathic pain are currently worth over SEK 70 billion each year. It is assessed that half of the estimated 25–30 million patients with neuropathic pain do not achieve adequate pain relief. This indicates the great unmet medical need, as well as the potential in this field and for our ACD440 project.

TrkA-NAM is a highly interesting pain project that focuses on discovering drugs to treat severe pain in conditions such as osteoarthritis, which currently affects an estimated 250 million patients, for whom healthcare providers would like new treatment options as an alternative to existing treatment (e.g. opioids, which are addictive narcotic drugs). The project is based on a biological mechanism with strong preclinical and clinical validation. As a result of these efforts and in combination with our advanced progress related to the development of potent and selective compounds, interest among potential partners is strong. After having received positive efficacy data from the first preclinical pain studies, we are now actively working to select a drug candidate for the project, which we expect to do during the second half of 2021.

During the quarter we continued to have a strong focus on marketing and communication and participated in several different meetings, including Business Sweden, Redeye and Aktiespararna. We are constantly working on reaching out to both private and institutional investors, as well as other pharmaceutical and research companies that may be interested in investing in or in-licensing our development projects, or alternatively in entering into a partnership. During the quarter we participated in the partner meetings at SwissNordicBio in February and at BioEurope in March. We were also recognized as one of the Stockholm region’s most promising companies in the field of Alzheimer’s in a report by InvestStockholm. Regarding the ongoing COVID-19 situation, we have retained the previously implemented measures to protect our employees, and we are working with our suppliers and partners to minimize the impact of the situation on AlzeCure’s operations.

As a natural consequence of having more projects in the clinical development phase, we continued to strengthen our development department during the quarter by hiring more key people, thereby strengthening internal competencies and enabling us to conduct development work faster and more cost-effectively. The most recent addition is Märta Segerdahl Storck, MD/PhD, as Chief Medi-cal Officer with responsibility for our clinical development activities. Märta has extensive experience from several senior positions in the pharmaceutical industry, including from AstraZeneca, Lundbeck and Grünenthal. Her past experience with development projects within AlzeCure’s core areas, Alzheimer’s and pain, was crucial during the recruitment process. We are very pleased that Märta has now joined the AlzeCure team and she will be a key player for our continued development of the project portfolio.

I am pleased to report that AlzeCure continues to make good progress. This progress would not be possible without our motivated, talented and ambitious employees. We have several promising projects under development, all within fields with great unmet medical need, which is incredibly motivating. The performance we achieved to date strengthens our conviction that we should be able to deliver as stated in our communicated objectives during the year.

Stockholm, May 2021

Martin Jönsson