Announcement • Jun 16
AlzeCure Pharma Completes Phase Ib Clinical Study Of NeuroRestore ACD856 With Positive Results AlzeCure Pharma AB (publ) announced that the Phase Ib clinical study of ACD856, the lead drug candidate in the NeuroRestore platform being developed for Alzheimer's disease and other indications, has been completed on schedule with positive results. Consistent with previous clinical data, the results show that ACD856 was well-tolerated and no substance-related safety findings were observed. Furthermore, an expected increase in the concentration of ACD856 was seen in both blood and cerebrospinal fluid. The Phase Ib clinical study aimed to evaluate the safety and tolerability of ACD856 following repeated administration of higher doses than previously studied, as well as to measure the substance's concentration in the body. This could broaden the opportunities for ACD856, including in depression. AlzeCure has previously obtained key clinical data showing that ACD856 crosses into the brain at relevant concentrations and activates neural pathways important for both cognition and depression. Preclinical studies have previously shown that AlzeCure’s drug candidates in the NeuroRestore platform strengthen communication between nerve cells and improve cognitive function, including learning and memory. Previous preclinical results from AlzeCure also demonstrate neuroprotective, anti-inflammatory, and disease-modifying effects in various models with these so-called Trk-PAM substances, which enhance BDNF and NGF signaling. Furthermore, NeuroRestore’s unique pharmacological mechanism enables its use across several different indications, such as Alzheimer's and Parkinson's disease, as well as depression. ACD856 is a first-in-class drug candidate for Alzheimer's disease and is currently being prepared for upcoming Phase II clinical studies in patients; it was also awarded a major EU grant from the European Innovation Council (EIC) in 2025. This study is expected to start in 2026. 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 display neuroprotective as well as anti-inflammatory effects, which could indicate potential 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. ACD856 is in preparation for Phase II clinical trials, funded by a substantial EIC grant from 2025. Breakeven Date Change • Jun 10
Forecast breakeven date moved forward to 2026 The analyst covering AlzeCure Pharma previously expected the company to break even in 2027. New forecast suggests the company will make a profit of kr70.9m in 2026. Earnings growth of 132% is required to achieve expected profit on schedule. New Risk • Jun 09
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Swedish stocks, typically moving 71% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (71% average weekly change). Shareholders have been substantially diluted in the past year (30% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (kr14m net loss next year). Market cap is less than US$100m (kr551.6m market cap, or US$58.2m). 
