A word from the CEO

The first quarter of 2022 was yet another extremely active period for AlzeCure. We strengthened our financial position through a rights issue, with both current and new shareholders, which raised SEK 48.5 million before expenses for the company. In addition, we received feedback from the US Food and Drug Administration (FDA) regarding our Painless ACD440 project for neuropathic pain, which was in line with our expectations so that we can now move forward, as planned, and begin our Phase IIa clinical trial as soon as possible. We presented positive Alzstatin data for a new molecule during the quarter. We also published data showing the positive effect of Neuro Restore on mitochondrial activity. Moreover, the company reported that ACD856 crosses the blood-brain barrier in healthy volunteers, an important finding that supports continued development work. The ongoing MAD study with ACD856 is proceeding according to plan and is expected to be completed during the summer.

 

“The first quarter was a very eventful quarter with many positive achievements in the projects and a new share issue which strengthened our financial position.”

  CEO Martin Jönsson 

 

AlzeCure continues to make good progress. To support this development, during the quarter we completed a rights issue that we announced on February 10 and that was guaranteed to 80%. This issue occurred during a turbulent and financially unstable period that culminated with Russia’s invasion of Ukraine. During this time, both current and new shareholders subscribed, and we are happy that we managed to secure approximately SEK 48.5 million before expenses. The capital will be invested in our Alzheimer’s and pain projects. The funds will primarily be used to f inance our Phase IIa clinical trial for Painless ACD440 for peripheral neuropathic pain. We will also invest resources in Alzstatin, our disease-modifying and preventive treatment for Alzheimer’s, as well as NeuroRestore, our treatment for cognitive disorders with a focus on Alzheimer’s.

Our Alzstatin project platform aims to develop a preventive disease-modifying treatment for Alzheimer’s disease by reducing production of harmful amyloid-beta and thereby preventing accumulation of pathological amyloid in the brain. In the Alzstatin program, we have preclinical studies that have previously shown that we can reduce the quantity of harmful amyloid-beta by 50 percent. The Alzstatin project ACD679 is currently in the preclinical development phase. Meanwhile, research continues in the ACD680 follow-up project. With multiple preclinical projects, we can ensure that we have the best possible compound when we move into clinical trials. During the first quarter, we also presented new positive preclinical Alzstatin data from a series of molecules that are expected to be advantageous from a patent perspective. These data showed that a molecule from the series can lower the harmful amyloid-beta levels by 50–60%, which is extremely positive and promising. Interest in gamma-secretory modulators such as Alzstatin is also receiving increasing attention as potentially important treatments for Alzheimer’s (Example: Luo et al, Turning the tide on Alzheimer’s disease: modulation of γ-secretase, Cell & BioScience, 12:2, 2022). This trend is of course positive for our business development work with Alzstatin since few companies, as far as we know, have active gamma-secretase modulator projects.

ACD856, our leading drug candidate, is part of the innovative NeuroRestore platform with a primary focus on treatment of Alzheimer’s disease to improve learning and to counteract memory and other cognitive problems. The ongoing Phase I MAD (Multiple Ascending Dose) study is progressing according to plan and the results are expected to be available during the summer. During the quarter, we also received positive data showing that ACD856 crosses the blood-brain barrier and can be measured in the spinal fluid, which means that the drug reaches the organ it intends to affect – data supporting continued development work and we look forward to presenting them in more detail in the future. During the quarter, we also presented new NeuroRestore data indicating that the compound AC- 0027136 improves mitochondrial function. We will continue to work on these important f indings as they are relevant in numerous neurodegenerative diseases, including Alzheimer’s. These findings could increase interest and potentially also the use of NeuroRestore compounds, with regard to potential disease-modifying properties.

We also see continued promising progress in our pain platform Painless, which consists of two projects, ACD440 and TrkA-NAM. ACD440 is a TRPV1 antagonist for topical use aimed at treating peripheral neuropathic pain. The project is based on discoveries that were awarded the Nobel Prize in Medicine in 2021. The groundbreaking discovery of TRPV1 and its link to pain perception is of great significance and we have used it in our ACD440 clinical program. Based on the results from the Phase Ib clinical trial of ACD440, we reported both positive effects on pain and good outcome on safety and tolerability.

During the last quarter, we received feedback from the FDA on the material and documentation we submitted for a pre-IND meeting. Pleased with the feedback from the FDA, we can now proceed and soon initiate the Phase IIa clinical trial in patients suffering from chronic neuropathic pain, which we planned for and have now financed through the issue we just completed. Drugs for the treatment of neuropathic pain represent the single largest market for pain medication, with sales of over USD 11 billion (GlobalData 2021). Nevertheless, as many as 80 percent of patients with neuropathic pain currently do not achieve adequate pain relief, which indicates the potential within the field and for our ACD440 project.

Our TrkA-NAM pain project, with a focus on arthritis of the knee, is also making good progress. The project has drawn the attention of several external parties with whom we have regular meetings, even though the project is in the early stages.

During the quarter we continued to have a strong focus on marketing communication and participated in several meetings and events, both in Sweden and internationally. 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.

I am pleased and proud to report that AlzeCure continues to make good progress together with our dedicated, motivated and ambitious employees. We continue to make good progress with several promising projects that are under development within fields with great unmet medical need, which is incredibly satisfying and motivating. We view the growing interest in the field of Alzheimer’s and in AlzeCure as a company as an acknowledgement that we are on the right path. I continue to be confident about the future and look forward to the development of AlzeCure in the near future into a Phase II company, according to plan.

Stockholm, May 2022

Martin Jönsson