About AlzeCure Pharma AB (publ)

AlzeCure® is a Swedish pharmaceutical company that develops new innovative drug therapies for the treatment of severe diseases and conditions that affect the central nervous system, such as Alzheimer’s disease and pain – indications for which currently available treatment is very limited. The company is listed on Nasdaq First North Premier Growth Market and is developing several parallel drug candidates based on three research platforms: NeuroRestore®, Alzstatin® and Painless.

NeuroRestore consists of two symptomatic drug candidates where the unique mechanism of action allows for multiple indications, including Alzheimer’s disease, as well as cognitive disorders associated with traumatic brain injury, sleep apnea and Parkinson’s disease. The Alzstatin platform focuses on developing disease-modifying and preventive drug candidates for early treatment of Alzheimer’s disease and comprises two drug candidates. Painless is the company’s research platform in the field of pain and contains two projects: ACD440, which is a drug candidate in the clinical development phase for the treatment of neuropathic pain, and TrkA-NAM, which targets severe pain in conditions such as osteoarthritis. AlzeCure aims to pursue its own projects through preclinical research and development through an early clinical phase, and is continually working on business development to find suitable outlicensing solutions with other pharmaceutical companies.

FNCA Sweden AB is the company’s Certified Adviser. For more information, please visit www.alzecurepharma.se.

About NeuroRestore®
NeuroRestore is a platform of symptom-relieving drug candidates for disease states in which cognitive ability is impaired, e.g. Alzheimer’s Disease, sleep apnea, traumatic brain injury and Parkinson’s disease. NeuroRestore stimulates several important signaling pathways in the brain, which among other things leads to improved cognition. Preclinical studies with NeuroRestore have shown that AlzeCure’s drug candidates enhance communication between the nerve cells and improve cognitive ability. The NeuroRestore substances are so called Trk-PAMs which stimulate specific signaling pathways in the central nervous system known as neurotrophins, the most well-known being NGF (Nerve Growth Factor) and BDNF (Brain Derived Neurotrophic Factor). The levels of NGF and BDNF are disturbed in several disease states and the signaling is reduced. The impaired function impairs communication between the synapses, i.e. the contact surfaces of the nerve endings, as well as reducing the possibility of survival for the nerve cells, which gives rise to the cognitive impairments. Neurotrophins play a crucial role for the function of nerve cells, and a disturbed function of BDNF has a strong genetic link to impaired cognitive ability in several different diseases, such as Alzheimer’s, Parkinson’s disease, traumatic brain injury and sleep disorders. There is also a link between BDNF signaling and depression, something that has been further strengthened in recent years. In addition to cognitive-enhancing effects, new preclinical data also show that NeuroRestore substances have a positive effect on mitochondrial function and cell survival, but also exhibit anti-inflammatory effects, which together could indicate potentially protective and disease-modifying effects. The leading drug candidate in the platform, ACD856, has recently completed clinical phase I studies and demonstrated positive effects there that support continued development of the program.

About Alzstatin®
AlzeCure’s disease-modifying research platform, Alzstatin, consisting of disease-modifying and preventive drug candidates, focuses on reducing the production of toxic amyloid beta (Aβ), such as Aβ42, in the brain. Aβ42 plays a key pathological role in Alzheimer’s and begins to accumulate in the brain years before clear symptoms develop. The drug candidates in the Alzstatin platform modulate the function of the enzyme gamma secretase. Gamma secretase acts like a pair of scissors and cuts Aβ42 out from a longer protein known as APP. The sticky Aβ42 clumps together giving rise to the amyloid plaque so typical of Alzheimer’s disease. aggregates of Aβ42 and appear to have protective properties. The candidates in the Alzstatin platform affect enzyme function so that it instead cuts out shorter forms of the Aβ peptide, Aβ37 and Aβ38, which in addition to them not being sticky and not forming aggregates, also have a restrictive effects on Aβ42 aggregates already formed and appear to have protective properties. This means the drug candidates in the Alzstatin platform have two separate but synergistic effects that together contribute to a stronger anti-amyloidogenic – and thus more potent – disease-modifying effect. This specific mechanism of action differentiates it from biological therapies, e.g. antibodies. Moreover, small molecules such as Alzstatin, have several other advantages, including easy and non-invasive administration as tablets or capsules. Small molecules will also generally pass more readily through the blood-brain barrier to reach its target, the brain.

About Alzheimer’s disease
Alzheimer’s disease is the most common form of dementia, affecting approximately 55 million people worldwide, and the number is estimated to triple in the next 30 years if nothing is done. Alzheimer’s disease is a lethal disorder that also has a large impact on both relatives and the society. Today, preventive and disease modifying treatments are missing. The main risk factors to develop Alzheimer’s are age and genetic causes. Even though the disease can start as early as between 40 and 65 years of age, it is most common after 65 years. Significant investments in Alzheimer research are being made because of the significant unmet medical need and the large cost of this disease for healthcare and society. The total global costs for dementia related diseases are estimated to about 1,300 billion USD globally in 2019. Given the lack of both effective symptomatic treatments and disease modifying treatments, including preventive treaments, the need for new effective therapies is acute. The few approved drugs on the European market today have only a limited symptomatic effect and can produce dose limiting side effects. A disease modifying treatment for Alzheimer’s disease is estimated to reach more than $15 billion in annual sales. In Sweden, approximately 100,000 people suffer from Alzheimer’s disease with a healthcare cost of about SEK 63 billion yearly, which is more than for cancer and cardiovascular diseases combined.

About neuropathic pain
Neuropathic pain affects approximately 7–8 percent of the total global adult population, approximately 600 million individuals. Some patients, with indications such as diabetes and HIV, are affected to a greater extent, where approximately 25 and 35 percent respectively of the patients experience neuropathic pain. Peripheral neuropathic pain is the result of various types of damage to the nerve fibers, such as toxic, traumatic or nerve compression injuries as well a metabolic and infectious diseases. Common symptoms are painful tingling that can be described as “pins and needles”, or choking or burning pain, as well as the feeling of getting an electric shock. Patients may also experience allodynia (pain caused by a stimulus that usually does not cause pain) or hyperalgesia (increased pain from a stimulus that normally provokes pain). The market for neuropathic pain is characterized by a major medical need in all indications and in all major markets, where about 70-80 percent of patients do not get effective pain relief with existing treatment. Due to the risk of abuse, overdose and secondary damage, people now try to avoid opiates as first-line treatment for pain conditions. Despite this treatment problem, these preparations are still used frequently, and therefore the need for new treatments that are not opiates is very great. The patient population will grow, among other things, due to an aging population and increased number of long-term cancer survivors and increasing prevalance of type-2 diabetes. The global market for neuropathic pain was valued at $11 billion in 2020 and is expected to grow to $25 billion by 2027.