Announcement • Jun 30
Alzecure Pharma AB (Publ) Announces Board Changes AlzeCure Pharma AB at its annual general meeting held on June 29, 2026, announced Eggert Mörling was, in accordance with the nomination committee’s proposal, elected as a new member of the board, and as chairman of the board of directors. Thomas Pollare has declined re-election. 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. Announcement • Apr 24
AlzeCure Pharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 30.107587 million. AlzeCure Pharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 30.107587 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 22,982,891
Price\Range: SEK 1.31
Transaction Features: Rights Offering Announcement • Aug 26
AlzeCure Pharma AB (publ) to Report Q4, 2025 Results on Feb 26, 2026 AlzeCure Pharma AB (publ) announced that they will report Q4, 2025 results on Feb 26, 2026 Announcement • Jul 24
AlzeCure Pharma AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 48.56236 million. AlzeCure Pharma AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 48.56236 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 22,073,800
Price\Range: SEK 2.2
Transaction Features: Rights Offering Announcement • Jun 17
AlzeCure Pharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 48.5 million. AlzeCure Pharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 48.5 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 22,045,455
Price\Range: SEK 2.2
Transaction Features: Rights Offering Announcement • Apr 09
AlzeCure Pharma AB (publ), Annual General Meeting, May 14, 2025 AlzeCure Pharma AB (publ), Annual General Meeting, May 14, 2025, at 16:00 W. Europe Standard Time. Location: at synch advokat abs premises, at birger jarlsgatan 6, stockholm Sweden Announcement • Feb 17
AlzeCure Pharma AB (publ) Receives EU Grant for Phase 2 Clinical Trial of Neurorestore ACD856 for Alzheimer's Disease AlzeCure Pharma AB announced that its project NeuroRestore ACD856 has received GBP 2.5 million from the EU's European Innovation Council. This funding will support AlzeCure's planned Phase II,a study of NeuroRestore ACD856 in Alzheimer's patients. In addition, higher doses of ACD856 will be evaluated in humans, as the good safety profile allows for further dosing. ACD856 has the potential to be the first drug in a new category of Alzheimer's drugs - positive allosteric modulators of Trk receptors (Trk-PAMs), which increase BDNF and NGF signaling. ACD856 is a first-in-class drug candidate for Alzheimer's disease with possible positive effects on both memory function and the course of the disease. Phase I clinical studies have shown good safety and tolerability with the substance and that it enters the brain to a high extent and activates regions of the brain with relevance for both cognition and depression. Previous preclinical studies have also shown that AlzeCure's drug candidate ACD856 in the NeuroRestore platform strengthens communication between nerve cells and improves cognitive ability, including learning and memory functions. Furthermore, preclinical results also show neuroprotective, anti- inflammatory and disease-modifying effects in various models with these so-called Trk-PAM substances, which increase BDNF and NGF signaling in the brain. Announcement • Oct 28
AlzeCure Pharma AB (publ) Presents New Positive Data for the TrkA-NAM Pain Project Against Osteoarthritis AlzeCure Pharma AB (publ) announced that it has obtained new positive preclinical efficacy data supporting the continued development of the candidate drug ACD137 within the TrkA-NAM program. The new in vivo data, obtained in a rat model of osteoarthritis (OA) of the knee, show significant pain relief in both movement-induced and evoked pain as well as a significant anti-inflammatory effect. The analgesic effect of ACD137 is in line with the effect of the anti-NGF antibody Tanezumab, which have in several clinical trials demonstrated significant and robust pain relief, showing that ACD137 can reach the same efficacy as Tanezumab at the investigated doses. Repeated administration of ACD137 for 18 days was well tolerated and there were no clinical symptoms or histopathological findings of rapidly progressing OA (RPOA), a problematic side effect observed for anti-NGF antibodies, including Tanezumab, nor were any effects seen on neuronal ganglia. ACD137 was also found to display a protective effect towards articular cartilage damage. ACD137 treatment also significantly improved a number of cartilage and knee joint structural parameters suggesting a protective effect on knee-joint function in a model of osteoarthritis. ACD137 blocks NGF-mediated signaling via TrkA receptors, a biological mechanism with strong genetic, preclinical and clinical validation for its role in pain. The new preclinical data further strengthens previous positive analgesic results obtained with ACD137 in preclinical models of osteoarthritis, neuropathic pain and post-operative pain and further emphasizes its broad applicability in various severe pain states, including osteoarthritis. Announcement • Oct 01
AlzeCure Pharma AB (publ) Announces an Abstract with Preclinical Data on NeuroRestore ACD856 Demonstrating Its Anti-In-In-In-Class Drug Candidate for Alzheimer's Disease AlzeCure Pharma AB (publ) announced that an abstract with preclinical data on NeuroRestore ACD856 demonstrating its anti-inflammatory and immunomodulatory effects has been accepted for presentation at the annual Alzheimer's conference CTAD, Clinical Trials in Alzheimer's Disease, which this year is being held in Madrid, Spain, on October 29 - November 1. The abstract, titled Preclinical evidence for anti-inflammatory and immunomodulatory effects of NeuroRestore ACD856, a Trk-PAM in clinical development for the treatment of Alzheimer's disease, will be presented at the conference by Dr. Cristina Parrado-Fernández, Senior Scientist at AlzeCure. The other authors are Veronica Lidell, Azita Rasti, Maria Backlund, Gunnar Nordvall, Martin Jönsson, Johan Sandin and Pontus Forsell from AlzeCure Pharma, and Ruchi Gera, Sumonto Mitra and Prof. Maria Eriksdotter from Karolinska Institutet. The presentation includes new preclinical results with ACD856, the lead clinical drug candidate within the NeuroRestore platform. The data show that the substance shows both anti-inflammatory and immunomodulating properties, something that has been demonstrated after treatment in both aged animals and in Alzheimer's models. This indicates potentially disease-modifying properties of this class of molecules. Previous preclinical studies have shown that AlzeCure's drug candidates in the NeuroRestore platform strengthen communication between nerve cells and improve cognitive ability, including learning and memory functions. Preclinical results from AlzeCure also show neuroprotective, anti-inflammatory and disease-modifying effects in various models with these so-called Trk-PAM substances. The unique pharmacological mechanism of NeuroRestore also enables several indications, such as Alzheimer's and Parkinson's disease, but also depression. ACD856 is a first-in-class drug candidate for Alzheimer's disease and is now being prepared for upcoming phase II clinical studies in patients. Announcement • Aug 07
AlzeCure Pharma AB (publ) Announces New Results from Alzecure's Pain Project TrkA- NAM Presented At the Pain Conference IASP 2024 AlzeCure Pharma AB (publ) announced that its presentation about the preclinical project TrkA-NAM against osteoarthritis pain and other severe pain conditions, which is presented at the IASP 2024 World Congress on Pain on August 5-9, is now available in its entirety on the company's website. The poster presentation, which is given by Dr. Märta Segerdahl, Chief Medical Officer at AlzeCure, describes the development of ACD137, the lead drug candidate in the TrkA-NAM program, which exhibits very good potency and selectivity for the target mechanism. The substance has shown powerful pain-relieving effects in several different preclinical models, including neuropathic and nociceptive pain, which indicates a wide range of use for these substances. ACD137 has previously also shown anti-inflammatory effects, which can further strengthen the pain-relieving properties. The presentation, titled Pharmacological Effects of ACD137, a Potent and Selective Negative Allosteric Modulator of TrkA, was written by, among others, Pontus Forsell, project leader and Head of Discovery and Research at AlzeCure. The other authors include Gunnar Nordvall, Maria Backlund, Veronica Lidell, Azita Rasti, Cristina Parrado-Fernandez, Johan Sandin and Märta Segerdahl. The TrkA-NAM project, which is in research phase, is focused on the treatment of pain. The target mechanism, NGF /TrkA signaling, is well-validated both preclinically and clinically and provides a promising alternative to new analgesics without the side effects and addiction problems observed with opioids. Substances developed in the project have recently been shown to also have anti-inflammatory properties. For the TrkA-NAM drug project, the company have leveraged knowledge concerning the underlying biology for the NeuroRestore platform in order to develop new compounds that focus on providing pain relief in conditions associated with severe pain. The goal of the project is to develop a small-molecule TrkA-negative allosteric modulator for the treatment of osteoarthritis pain and other severe pain disorders. The global osteoarthritis market is expected to reach USD 11.0 billion by 2025, from USD 7.3 billion in 2020. Growth in this market is driven by factors such as the increasing occurrence of osteoarthritis, the growing aging population, and an increase in the number of sports injuries. Over 400 million people worldwide suffer from painful and activity-limiting osteoarthritis of the hip or knee. Many patients experience insufficient pain relief or side effects with current treatment, which usually consist of NSAIDs or opiates and there is a great need for more effective and better tolerated drugs in this field. New Risk • Jun 30
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 39% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (kr37m net loss next year). Shareholders have been diluted in the past year (39% increase in shares outstanding). Market cap is less than US$100m (€14.4m market cap, or US$15.5m). Announcement • Jun 14
Alzecure Pharma AB (Publ) Announces Positive Clinical Results with Painless ACD440 Against Neuropathic Pain AlzeCure Pharma AB (publ) announced that a scientific article has been published on the clinical phase Ib results that support the continued development of the lead drug candidate Painless ACD440. The article, titled Topically applied novel TRPV1 receptor antagonist, ACD440 Gel, reduces evoked pain in healthy, has been published online in the volunteers, a randomized, double-blind, placebo-controlled, crossover study European Journal of Pain and is written by Marta Segerdahl, MD, PhD and CMO at AlzeCure Pharma. Co-authors are Magnus Halldin, Matthias Rother, Traian Popescu and Klaus Schaffler. The article focuses on the clinical phase Ib study with ACD440. The results show that ACD440 had significant analgesic effects of laser-induced pain compared to placebo both when the individual was asked to rate their pain experience and when pain-related brain activity was measured. Furthermore, significant effects on mechanical pain sensitivity were also observed. The results also showed that the analgesic effects lasted for at least 9 hours and that the product was very well tolerated as a topical gel on the skin, which indicates good suitability for further clinical development, i.e. as a local treatment against nociceptive and neuropathic pain conditions. ACD440 is a first-in-class TRPV1 antagonist in clinical phase being developed as a new topical local treatment for peripheral neuropathic pain. The drug candidate, which was incorporated via a strategic in-licensing, originated in Big Pharma and is based on a strong scientific foundation, which in 2021 was awarded a Nobel Prize. The substance is developed as a gel for topical use, which keeps the systemic exposure very low while the concentration of the substance locally can be kept high to achieve a maximum analgesic effect, and over a long period of time. Announcement • May 16
AlzeCure Pharma AB (publ) Approves the Election of Jan Lundberg as New Ordinary Members of the Board of Directors AlzeCure Pharma AB (publ) at its annual general meeting held on 14 May 2024 approved the election of Jan Lundberg as a new ordinary members of the board of directors. Jan Lundberg has more than 25 years of experience in senior positions in global pharmaceutical companies, including as Global Head of Research at Astra and then AstraZeneca (1996-2009) and Global Head of Research and Development at Eli Lilly (2010-2018). He has led the development of more than 200 pharmaceutical candidates, with 30 approved products in several therapeutic areas, including Alzheimer's and pain, with 30 approved products in several therapeutic areas. Furthermore, Dr. Lundberg co-founded the medtech company Aerocrine, which was later acquired by British Circassia Pharmaceuticals for SEK 1.78 billion in 2015. Before joining Astra, Dr. Lundberg was professor of pharmacology at the Karolinska Institute in Sweden, where he also received his PhD. He also studied medicine at the University of Gothenburg for four years and his research has resulted in over 500 publications in peer-reviewed scientific journals. Dr. Lundberg is also an honorary doctorate at the Faculty of Pharmacology at Uppsala University, Sweden and has received both the Fernström and Jahre prizes. Over the years, he has also been active in several international authority committees. He is currently a board member of several different pharmaceutical and biotechnology companies, and his extensive experience in research and development with a strong interest in central nervous system diseases will be a great asset to AlzeCure. New Risk • Apr 26
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -kr35m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (22% average weekly change). Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr35m). Market cap is less than US$100m (€10.7m market cap, or US$11.5m). Announcement • Apr 03
AlzeCure Pharma AB (publ) Presents New Data Regarding the TrkA-NAM Pain Project at IASP 2024 AlzeCure Pharma AB (publ) announced that an abstract on its preclinical project TrkA-NAM against osteoarthritis pain and other severe pain conditions has been accepted for presentation at the IASP 2024 World Congress on Pain in Amsterdam on August 5-9. The abstract, titled Pharmacological Effects of ACD137, a Potent and Selective Negative Allosteric Modulator of TrkA, will be presented at the global pain conference IASP 2024 World Congress On Pain by Pontus Forsell, project leader and Head of Discovery and Research at AlzeCure. The other authors include Gunnar Nordvall, Maria Backlund, Veronica Lidell, Azita Rasti, Cristina Parrado-F Hernandez, Johan Sandin and Marta Segerdahl. The presentation includes new preclinical results describing the properties of the recently selected drug candidate for TrkA-NAM, ACD137. The data show that the substance is a potent and selective negative modulator of NGF/TrkA signaling in cell-based assays. New data in several different preclinical pain models also show clear and significant analgesic effects of ACD137. Interest in TrkA-NAM has also increased further after Asahi Kasei recently started its phase 2b study with AK-1830 against knee osteoarthritis, which validates AlzeCure's project, where developed molecules that are even more potent and selective than AK-1830. New Risk • Apr 02
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €9.16m (US$9.86m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (23% average weekly change). Earnings are forecast to decline by an average of 35% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (€9.16m market cap, or US$9.86m). Announcement • Mar 28
AlzeCure Pharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 52.77396 million. AlzeCure Pharma AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 52.77396 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 31,043,506
Price\Range: SEK 1.7
Transaction Features: Rights Offering Announcement • Mar 09
AlzeCure Presents New Preclinical Data with NeuroRestore ACD856 at Leading Alzheimer's Conference AlzeCure Pharma announced that the company's presentation at the Alzheimer's conference AD/PD 2024, regarding new preclinical data with its leading clinical drug candidate NeuroRestore ACD856, which is being developed with a focus on Alzheimer's disease, is now available on the company's website. Data from the study show that ACD856 functions as a so-called biased PAM (positive allosteric modulator), i.e. that the substance potentiates certain signaling pathways but not others, which means that the substance can have potent effects and at the same time maintain a good safety profile. The results show that ACD856 can stimulate nerve cell growth, something that is important for communication between nerve cells. In addition, the substance improves memory and learning ability in preclinical models. In contrast, pain signaling is not affected, which indicates a selective stimulation of specific signaling pathways. ACD856 is a Trk-PAM and enhances BDNF and NGF signaling, which among other things play an important role in normal nerve cell function and maintaining brain health. The substance is under clinical development as a symptom-relieving treatment for disease states where the cognitive ability is impaired, for example in Alzheimer's disease. New preclinical data also suggest that ACD856 has potential protective and disease-modifying effects. Announcement • Mar 07
AlzeCure Pharma AB (publ) Publishes Clinical Results Supporting Continued Development of NeuroRestore ACD856 Against Alzheimer's AlzeCure Pharma AB (publ) announced that another scientific article has been published on the phase I clinical results supporting the continued development of the lead drug candidate NeuroRestore ACD856. The article, titled ACD856, a Novel Positive Allosteric Modulator of Trk-receptors, Single Ascending Doses in Healthy Subjects: Safety and Pharmacokinetics, was published in the European Journal of Clinical Pharmacology and the responsible author is Märta Segerdahl, MD, PhD and CMO at AlzeCure Pharma. Co-authors are Boel Nilsson, Johan Bylund, Magnus Halldin, Matthias Rother, Erik Rein-Hedin and Kristin Önnestam. AlzeCure has previously published positive data from the subsequent clinical phase I MAD study. The article focuses on the results from the clinical phase I study (Single Ascending Dose, SAD) with ACD856, the primary drug candidate within the company's NeuroRestore platform, but also contains data from the previously performed microdose study in humans. The results of this study, which was the first clinical study of ACD856, demonstrated that the compound had suitable pharmacokinetic properties with a half-life in humans that allows for once-daily dosing. The subsequent SAD study was able to confirm the good pharmacokinetic properties with rapid absorption in the body and a linear increase in the concentration of the substance in the blood with increased oral dosage. Furthermore, it was observed that the substance has good tolerability and safety in humans. ACD856 is a Trk-PAM and enhances BDNF and NGF signaling, which play an important role in normal neuronal function. The substance is under development as a symptom-relieving treatment for medical conditions where the cognitive ability is impaired, for example in Alzheimer's disease. New preclinical data also suggest that ACD856 has potential protective and disease-modifying effects. New Risk • Feb 28
New major risk - Revenue and earnings growth Earnings have declined by 1.9% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Earnings have declined by 1.9% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (€12.3m market cap, or US$13.3m). Announcement • Feb 06
AlzeCure Pharma AB (publ) Gets Late Breaking Abstract of New Preclinical Data with ACD856 Accepted at AD/PD 2024 Conference AlzeCure Pharma AB (publ) announced that an abstract on preclinical data with its lead drug candidate NeuroRestore ACD856 has been accepted for a poster presentation at AD/PD 2024, which will be held in Lisbon on March 5-9. The abstract, titled ACD856 is a unbiased positive allosteric modulator of Trk-receptors - Enhances neurite outgrowth, will be presented at the international conference AD/PD 2024 on Alzheimer's, but do not affect pain signaling Parkinson's and Related Neurological Disorders by Pontus Forsell, Head of Discovery and Research at AlzeCure. Co-authors are Veronica Lidell, Azita Rasti, Gunnar Nordvall and Johan Sandin. The presentation includes study results showing that ACD856, the lead drug candidate in the NeuroRestore platform being developed with a focus on Alzheimer's disease, selectively appears to potentiate some signaling pathways, but not others. New preclinical data show that the substance stimulates the growth of nerve cell projections, which can promote nerve cell communication, but does not affect other functions, such as pain signaling. Previous studies have also been able to show that ACD856 improves memory, synaptic plasticity and has neuroprotective properties. Announcement • Jan 29
AlzeCure Pharma AB (publ) Selects Drug Candidate and Enters Next Phase of Development with Trka-Nam Acd137 Against Severe Pain AlzeCure Pharma AB (publ) announced that the company has selected a TrkA-NAM drug candidate, ACD137, and started the preclinical development phase with the compound. ACD137 is being developed within the TrkA-NAM project in AlzeCure's Painless platform, with the aim of developing a new pain-relieving drug for the treatment of osteoarthritis and other severe pain conditions. In the project, a drug candidate has now been selected to proceed into the preclinical development program, which includes safety and tolerability studies, as well as formulation work and stability testing. ACD137 blocks NGF-mediated signaling via TrkA receptors, a biological mechanism with strong genetic, preclinical and clinical validation for its role in pain. AlzeCure has already demonstrated that TrkA-NAM substances have a potent analgesic effect in preclinical pain models. Studies also show that they have a substantial anti-inflammatory effect, something that can enhance the analgesic effects in clinical contexts and open up further areas of use. Furthermore, effects have been seen on relevant biomarkers for inflammation and pain. Announcement • Oct 26
AlzeCure Pharma AB (publ) Presents Disease-Modifying Data with NeuroRestore ACD856 At Alzheimer's Conference CTAD AlzeCure Pharma AB (publ) announced that the company's presentation at the Alzheimer's conference CTAD 2023 is now available in its entirety on the company's website. The presentation contains new preclinical data with its leading clinical drug candidate NeuroRestore ACD856, which is being developed with a focus on Alzheimer's disease. The presentation, titled NeuroRestore ACD856, a Trk-PAM in clinical development for Alzheimer’s disease shows neuroprotective and neurorestorative effects, was held by Martin Jönsson, CEO at AlzeCure Pharma, and includes new preclinical data with ACD856, the lead clinical drug candidate in the NeuroRestore platform. The results from the new preclinical studies with ACD856 show, among other things, that the substance can protect nerve cells against toxic Ab42, the protein that forms amyloid plaques in the brains of Alzheimer's patients. Furthermore, growth-stimulating effects on neurons were observed with ACD856. These effects have specific relevance to Alzheimer's disease, where dysfunction and loss of neurons are important key findings in the disease. ACD856, which is a positive modulator of both NGF/TrkA- and BDNF/TrkB-mediated signaling, has been shown in previous preclinical studies to improve learning and memory and is being developed primarily for the treatment of Alzheimer's disease. The drug candidate has undergone phase I clinical studies, where both good safety and tolerability were demonstrated in humans, but also that the drug candidate crossed the blood-brain barrier and that the substance activated parts of the brain that are central to both cognition and depression treatment. Announcement • Oct 20
AlzeCure Pharma AB (publ) Announces Japenese Patent Office Grants Patent Covering its Leading Candidate Drug ACD856 AlzeCure Pharma AB (publ) announced that the Japenese Patent Office (JPO) has granted a patent covering the company's leading candidate drug ACD856, from the NeuroRestore platform, which is developed against Alzheimer's disease and other disorders with cognitive impairment. The company's patent application for ACD856 in Japan has been granted by the JPO. The patent number is 7350759 and the patent is expected to provide protection until 2039. ACD856 and other substances in the NeuroRestore platform stimulate several important signaling systems and signaling molecules in the brain, such as BDNF (Brain Derived Neurotrophic Factor) and NGF (Nerve Growth Factor), which can lead to improved cognition. The substance is under development as a symptom-relieving treatment for medical conditions where the cognitive ability is impaired, for example in Alzheimer's disease, and also for depression treatment. ACD856 has undergone phase I clinical studies, where both good safety and tolerability were demonstrated in humans, but also that the drug candidate crossed the blood-brain barrier and that the substance activated parts of the brain that are central to both cognition and depression treatment. Previous preclinical studies have shown that AlzeCure's candidate drugs strengthen communication between nerve cells and improve cognitive ability, including learning and memory functions. New preclinical data also suggest that ACD856 has potential protective and disease-modifying effects. Announcement • Oct 13
Alzecure Presents Clinical Phase Ii-Data with Acd440 for Neuropathic Pain At Pain Conference AlzeCure Pharma AB (publ) announced that the company's presentation at the pain conference held by the Swedish Pain Society is now available in its entirety on the company's website. The presentation contains clinical data from the phase II study with the company's leading drug candidate in pain, ACD440, which is being developed for the treatment of peripheral neuropathic pain. The presentation, titled "Topical ACD440 Gel reduces pain induced by temperature-stimulation in patients with was held by Dr. Segerdahl and contains results from the recent neuropathic pain with sensory hypersensitivity", phase II clinical trial with ACD440. Other co-authors of the material are Magnus Halldin, Rolf Karlsten, Karin Ellstrom and Adriana Miclescu. The Phase II study included fourteen patients, men and women aged 50-85 years with moderate to severe peripheral neuropathic pain. On average, the patients had pain for 4.75 years. The results showed that after 7 days of treatment with ACD440, the temperature-triggered pain was reduced by about 50%, a significant and clinically relevant effect. No treatment-related side effects were reported, indicating that the product is safe and well tolerated by patients. AlzeCure's drug candidate ACD440 is a TRPV1 antagonist for the local treatment of patients with peripheral neuropathic pain. The discovery of TRPV1 that underlies the project was awarded the Nobel Prize in Physiology or Medicine in 2021. There is thus a strong scientific basis for this biological mechanism, including its relationship to pain signaling. ACD440 completed a positive phase Ib study in 2021. It showed both very good tolerability and safety, but also a potent, long-lasting pain-relieving effect of the substance that is applied as a gel to the skin. Announcement • Sep 27
AlzeCure Gets Presentation Accepted on Disease-Modifying Effects of Acd856 At Alzheimer's Conference AlzeCure Pharma AB (publ) announced that an abstract with preclinical data on NeuroRestore ACD856 demonstrating its potential disease- modifying effects has been accepted for presentation at the annual Alzheimer's conference CTAD, Clinical Trials in Alzheimer's Disease, which this year is being held in Boston on October 24-27. The abstract, titled NeuroRestore ACD856, a Trk-PAM in clinical development for Alzheimer's disease shows neuroprotective and neurorestorative effects, will be presented at the international Alzheimer conference CTAD 2023 by Martin Jönsson, CEO at AlzeCure. Other authors are Pontus Forsell, Veronica Lidell, Azita Rasti, Gunnar Nordvall and Johan Sandin. The presentation includes new preclinical results with ACD856, the lead candidate drug within the NeuroRestore platform. The data show that the substance exhibits both protective and regenerative effects on nerve cells, indicating potentially disease-modifying properties of this class of molecules. Previous preclinical studies have shown that AlzeCure's drug candidates strengthen communication between nerve cells and improve cognitive ability, including learning and memory functions. ACD856 has undergone phase I clinical studies, where both good safety and tolerability were demonstrated in humans, but also that the candidate drug crossed the blood-brain barrier and that the substance activated parts of the brain that are central to both cognition and depression treatment. Announcement • Sep 21
AlzeCure Pharma AB (publ) Presents Positive Phase II Clinical Data with ACD440 Against Neuropathic Pain at EFIC 2023 Conference AlzeCure Pharma AB (publ) announced that the company's presentation at the pain conference EFIC 2023 is now available in its entirety on the company's website. The presentation contains clinical phase II data with the company's leading clinical candidate drug in pain, Painless ACD440, which is being developed with a focus on neuropathic pain. The presentation, entitled A study of ACD440 gel for the treatment of patients with peripheral neuropathic pain with was given by Dr. Marta Segerdahl, project manager and CMO at AlzeCure, and contains sensory hypersensitivity, results from the phase II clinical study with ACD440, the lead candidate drug in the Painless platform. The presentation showed the results of the completed phase II clinical trial of ACD440 in patients with peripheral neuropathic pain. The study was a double-blind, placebo-controlled, randomized study aimed at evaluating the efficacy, safety and pharmacokinetics of AlzeCure's lead candidate drug in pain, ACD440. The patients, who were treated for 7+7 days in a cross over design, were between 50-85 years old and suffered from chronic neuropathic pain. The majority of them also were on existing pain treatment. Data from the study showed a clear and significant effect (p=0.0166) of ACD440 gel on temperature-induced pain in the patients. A very good safety and tolerability of the product in the patients was also observed. AlzeCure's non-opioid drug candidate ACD440 is a TRPV1 antagonist for the local treatment of patients with peripheral neuropathy pain. The discovery of TRPV1 that underlies the project was awarded the Nobel Prize in Physiology or Medicine in 2021. There is thus a strong scientific basis for this biological mechanism, including its relationship to pain signaling. ACD440 has previously completed a positive phase Ib study in 2021. It showed both very good tolerability and safety, but also a potent, long-lasting pain-relieving effect of the substance that is applied as a gel to the skin. New Risk • Aug 25
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -kr47m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (14% average weekly change). Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr47m). Shareholders have been diluted in the past year (22% increase in shares outstanding). Market cap is less than US$100m (€25.0m market cap, or US$27.0m). Announcement • Aug 24
AlzeCure Pharma AB (publ) to Report Q4, 2023 Results on Feb 27, 2024 AlzeCure Pharma AB (publ) announced that they will report Q4, 2023 results on Feb 27, 2024 Announcement • Aug 09
AlzeCure Pharma Publishes the Positive Clinical Results from the Phase I Trial of NeuroRestore ACD856 Against Alzheimer's AlzeCure Pharma announced that a new scientific article has been published on the Phase I clinical results supporting the continued development of the lead candidate drug NeuroRestore ACD856. The article, titled Safety, Tolerability, Pharmacokinetics and Quantitative Electroencephalography Assessment of ACD856, a Novel Positive Allosteric Modulator of Trk-Receptors Following Multiple Doses in Healthy Subjects, was published in The Journal of Prevention of Alzheimer's Disease and the corresponding author is Märta Segerdahl, MD, PhD and CMO at AlzeCure Pharma. Co-authors are Kristin Önnestam, Boel Nilsson, Matthias Rother, Erik Rein-Hedin, Johan Bylund, Peter Anderer, Manuel Kemethofer, Magnus Halldin and Johan Sandin. The article focuses on the results from the clinical phase I study (Multiple Ascending Dose, MAD) which shows that ACD856, the primary drug candidate within the company's NeuroRestore platform, has good tolerability and safety. Furthermore, it was observed that the substance has suitable pharmacokinetic properties with rapid absorption in the body and relevant and dose-dependent exposure in the CNS. In addition, AC856 was shown to increase EEG activity in the brain, indicating that the substance reaches and activates regions of the brain that are central for cognitive-enhancing and antidepressive therapies. ACD856 is a Trk-PAM and enhances BDNF and NGF signaling, which play an important role in normal neuronal function. The substance is under development as a symptom-relieving treatment for medical conditions where the cognitive ability is impaired, for example in Alzheimer's disease. New preclinical data also suggest that ACD856 has potentially protective and disease-modifying effects. Announcement • Jul 12
AlzeCure Pharma AB (Publ) Publishes New Disease Modifying Data with Neurorestore ACD856 Against Alzheimer's and Cognitive Disorders AlzeCure Pharma AB (publ) announced that a new scientific article has been published on NeuroRestore ACD856 and preclinical results supporting its disease-modifying effect. The article, titled "Neuroprotective and disease modifying effects of the triazinetrione ACD856, a positive allosteric modulator of Trk-receptors for the treatment of cognitive dysfunction in Alzheimer's disease", is published in the International Journal of Molecular Sciences and is written by Pontus Forsell, Head of Research and Discovery. Co-authors are Cristina Parrado-F Hernandez, Sanja Juric, Maria Backlund, Marta Dahlstrom, Nather Madjid, Veronica Lidell, Azita Rasti, Johan Sandin and Gunnar Nordvall. The article focuses on the characterization of ACD856, the leading clinical drug candidate in the NeuroRestore platform which, being a Trk-PAM, increases BDNF and NGF signaling. ACD856 was tested in various preclinical models to investigate its potential disease-modifying effects. The results show that ACD856 has positive effects on neurite outgrowth, has protective effects against amyloid-beta induced nerve damage and has positive effects on the synapses - the contact surfaces between nerve cells where the exchange of information takes place. Announcement • May 25
Alzecure Announces Positive Phase IIa Clinical Study Data in Neuropathic Pain with the Non-Opioid ACD440 AlzeCure Pharma AB announced that the company has received positive data from the Phase IIa clinical study with the non-opioid drug candidate ACD440, which is developed against peripheral neuropathic pain. The phase II data show that ACD440 was able to demonstrate positive proof-of-mechanism (PoM) results in patients with chronic peripheral neuropathic pain, i.e. the drug candidate has an effect on the intended target mechanism. A significant analgesic effect was observed on pain induced by cold and heat. This temperature hypersensitivity is very common in the skin area, where the patients have their neuropathic pain, and is a major problem in everyday life for these individuals. These positive phase II results are in line with previously reported Phase I results. ACD440 was well tolerated as a topical gel on the skin, which shows good suitability for continued clinical development, i.e. as a local treatment against neuropathic pain conditions. ACD440 is a TRPV1 antagonist and first-in-class local treatment for patients with peripheral neuropathic pain. The discovery of TRPV1, which is the basis of the project, was awarded the Nobel Prize in Physiology or Medicine 2021. ACD440, which is applied as a gel, is the company's leading drug candidate within the Painless platform and completed a positive phase Ib study in 2021. Announcement • May 20
AlzeCure Pharma AB (publ) Appoints Janet Hoogstraate to its Board AlzeCure Pharma AB (publ) announced that Janet Hoogstraate is newly elected to AlzeCure's board. Dr Janet Hoogstraate has many years' experience in life science, with leading roles at Astra Zeneca, among others. She has a PhD in Biopharmaceutical Sciences from the University of Leiden in the Netherlands and an eMBA from Hult International Business School. Janet has a great interest and knowledge in neuroscience research and has been, among other things, chairman of the board of the Stockholm Brain Institute. Janet is CEO of Valneva Sweden AB, and her extensive experience in preclinical research, the pain area and biotech will be a great asset for AlzeCure. Breakeven Date Change • May 09
Forecast to breakeven in 2025 The analyst covering AlzeCure Pharma expects the company to break even for the first time. New forecast suggests the company will make a profit of kr216.0m in 2025. Average annual earnings growth of 109% is required to achieve expected profit on schedule. Announcement • Jan 31
Last Patient Included in Alzecure's Phase II Clinical Trial in Peripheral Neuropathic Pain with The Non-Opioid ACD440 AlzeCure Pharma announced that the last patient has now been included in the ongoing Phase II clinical study with ACD440, the lead non-opioid drug candidate in the Painless platform, which is being developed against peripheral neuropathic pain. This double-blind, placebo-controlled, randomized cross-over study, which is carried out in collaboration with LINK Medical Research in Uppsala, is aimed at evaluating the efficacy, safety and pharmacokinetics of AlzeCure's lead drug candidate in pain, ACD440. The main results from the study are expected by the summer of 2023 at the latest. AlzeCure's drug candidate ACD440 is a TRPV1 antagonist for the local treatment of patients with peripheral neuropathic pain. The discovery of TRPV1 that underlies the project was awarded the Nobel Prize in Physiology or Medicine in 2021. There is thus a strong scientific basis for this biological mechanism, including its relationship to pain signaling. ACD440, which is also the company's leading drug candidate within the Painless platform, completed a positive phase Ib study in 2021. It showed both very good tolerability and safety, but also a potent, long-lasting pain-relieving effect of the substance that is applied as a gel to the skin. The medical need in neuropathic pain is very great, not least to find alternatives to opioids. The neuropathic pain market is the single larger market segment in pain management with annual sales exceeding $11 billion. Up to 80% of patients do not get a satisfactory effect with their current treatments. Announcement • Jan 12
AlzeCure Pharma AB (publ) Selects CD and Enters Next Development Phase with Alzstatin ACD680 against Alzheimer's AlzeCure Pharma AB (publ) announced that the company has chosen a candidate drug (CD) and started the preclinical development phase with the company's preventive and disease-modifying candidate drug Alzstatin® ACD680. ACD680 is being developed within AlzeCure's Alzstatin platform, with the aim of developing a preventive and disease-modifying drug for the early treatment of Alzheimer's disease. In the project, a CD has now been selected which will continue into the preclinical development program, which includes preclinical safety and tolerability studies, as well as formulation work and stability testing. In Alzheimer's disease, a protein, amyloid beta (Aß42), accumulates into larger aggregates, such as plaques, which have a harmful effect on nerve cells and their function. ACD680 is a so-called gamma-secretase modulator (GSM), which constitutes a promising class of small-molecule Aß42-lowering anti-amyloidogenic substances for preventive and disease-modifying treatment of Alzheimer's disease. The GSM thereby affects the production of the very building block of the harmful amyloid aggregates and exhibits several key properties that distinguish it from antibody treatments, including that it can be taken in tablet form, easily crosses the blood-brain barrier and can be produced more cost-effectively. Announcement • Dec 16
AlzeCure Pharma AB (publ) Gets Late-Breaking Abstract on New Data with Alzheimer Project AlzeCure Pharma AB (publ) announced that an abstract with new preclinical Alzstatin data has been accepted for presentation at the Alzheimer conference AD/PD 2023, which will be held in Gothenburg, Sweden, on March 28 -April 1. The abstract, titled In vitro and in vivo profile of AC-0027875, a novel gamma-secretase modulator for the prevention and treatment of Alzheimer's disease, will be presented at the international Alzheimer conference AD/PD 2023 by Dr. Johan Sandin, CSO at AlzeCure. The other co-authors are Gunnar Nordvall, Märta Dahlström, Lotta Agholme, Johan Lundkvist, Maria Backlund, Veronica Lidell, Azita Rasti, Sanja Juric, Magnus Halldin, Pontus Forsell and Henrik Zetterberg. The presentation includes new preclinical results with AlzeCure's compound AC-0027875, which is a new potent small molecule gamma-secretase modulator (GSM) and part of AlzeCure's research platform Alzstatin. In the studies, the substance exhibits a high concentration in the brain which results in powerful effects on the production of the protein amyloid-beta, where the amount of toxic A42 is reduced by over 50%. AlzeCure's GSM exhibits several key properties that make it suitable as a preventive or disease-modifying treatment for Alzheimer's disease. Announcement • Dec 03
Alzecure Pharma AB (Publ) Announces New Data on Alzstatin for Preventive Treatment Against Alzheimer's Presented At Alzheimer's Conference CTAD AlzeCure Pharma AB (publ) announced that the company's presentation of its research platform Alzstatin, which was presented at the scientific conference CTAD in San Francisco, is now available in its entirety on the company's website. The abstract, titled AC-0027875, a novel gamma-secretase modulator for the treatment of Alzheimer's disease, was presented by Dr. Johan Sandin and includes new preclinical results with AC-0027875 which show the substance's potent effects on amyloid production, indicating that compounds in the Alzstatin®-platform are promising as a preventive and disease-modifying treatment for early Alzheimer's disease. The presentation included results with AC-0027875, a new potent small molecule gamma-secretase modulator (GSM) and part of AlzeCure's research platform Alzstatin, which exhibited potent effects on toxic Aß42 production in cells and animals. Data showed reductions of over 50% in vivo with a rapid onset of effect and good duration. AC-0027875 also had good pharmacokinetic properties with high penetration across the blood-brain barrier resulting in high concentration of the substance in the target organ, the brain. GSM's represents a promising class of small molecular Aß42-lowering anti-amyloidogenic substances for preventive or disease-modifying treatment of Alzheimer's disease. A GSM exhibits several key properties that distinguish it from antibody treatments, including that it can be taken in tablet form, easily crosses the blood-brain barrier and can be produced more cost-effectively. Announcement • Dec 01
Alzheimer Announces New Data Strengthening the Continued Clinical Development of NeuroRestore ACD856 AlzeCure Pharma announced that the company's presentations at the scientific conference CTAD 2022 are now available in their entirety on AlzeCure's website. They include new clinical and preclinical data with the company's leading drug candidate NeuroRestore ACD856, which is being developed with a focus on Alzheimer's disease The abstracts, titled Quantitative EEG results from a multiple ascending dose study in healthy volunteers with NeuroRestore ACD856, a positive modulator of Neurotrophin Trk-receptors, and Preclinical characterization of ACD856, a cognitive enhancer in clinical development for the treatment of cognitive dysfunction in Alzheimer's disease, demonstrates increased plasticity, neuroprotection and a possible disease modifying effect, were presented by Johan Sandin, CSO, and Martin Jönsson, CEO at AlzeCure Pharma. The results include new clinical and preclinical data with ACD856, the lead drug candidate in the NeuroRestore project. The clinical data come from the recently completed phase I MAD study, where the substance, in addition to good safety and tolerability, was also shown to cross the blood-brain barrier effectively and in relevant quantities. The new EEG data, which measures brain activity, also showed that ACD856 activates relevant neuronal pathways in the brain with relevance for cognition and depression, something that strengthens the continued clinical development of the substance. In addition to memory-enhancing and symptom-relieving properties, the preclinical data presented show that ACD856, also has potentially disease-modifying properties with both neurorestorative and neuroprotective properties. The substance also shows positive long-term effects after repeated administration, which indicates an enhanced plasticity in relevant neuronal pathways. A positive modulator of both NGF/TrkA- and BDNF/TrkB-mediated signaling, ACD856 has been shown in preclinical studies to improve cognition and memory and is poised for Phase 2 clinical trials, where it is being developed primarily for the treatment of Alzheimer's disease . Announcement • Oct 25
AlzeCure Pharma AB (publ) Gets Abstract Accepted on Positive Clinical EEG Results with Alzheimer's Project NeuroRestore ACD856 AlzeCure Pharma announced that an abstract on NeuroRestore ACD856 and its positive effects on brain activity in the MAD clinical trial has been accepted for presentation at the annual Alzheimer's conference CTAD, Clinical Trials in Alzheimer's Disease, which this year is being held in San Francisco, November 29 - December 2. The abstract, titled Quantitative EEG results from a multiple ascending dose study in healthy volunteers with NeuroRestore ACD856, a positive modulator of Neurotrophin Trk-receptors, will be presented at the international Alzheimer conference CTAD 2022 by Dr. Johan Sandin, CSO at AlzeCure. The other co-authors are Kristin Önnestam, project leader, Boel Nilsson, Dr. Matthias Rother, Dr. Erik Rein-Hedin, Dr. Peter Anderer, Manuel Kemethofer, Dr. Magnus Halldin, Director of Discovery DMPK & Safety assessment, Dr. Gunnar Nordvall, Director of Medicinal Chemistry at AlzeCure, Dr. Pontus Forsell, Head of Discovery & Research at AlzeCure, and Dr. Märta Segerdahl, Head of Development and CMO at AlzeCure. The presentation contains results from the clinical phase I MAD study with ACD856, the leading drug candidate within the NeuroRestore platform, which exhibits both good tolerability and good pharmacokinetic properties in humans. The substance was also shown to pass over the blood-brain barrier in high and relevant concentrations where it activates relevant neuronal pathways in the brain, something that is reflected in EEG measurements in the test subjects. Announcement • Oct 11
AlzeCure Pharma AB (publ) Announces New Data from AlzeCure Demonstrate Potential Disease-Modifying Effects of NeuroRestore ACD856 AlzeCure Pharma announced that the company's presentation at the scientific conference ISMND 2022 is now available in its entirety on the company website. The abstract demonstrates new preclinical data with the company's leading drug candidate NeuroRestore ACD856, which is being developed with a focus on Alzheimer's disease. The abstract, titled The Trk-PAM ACD856 improves mitochondrial function and increase BDNF levels in primary cortical neurons, was presented by Pontus Forsell, Head of Research and Discovery på AlzeCure, and includes new preclinical data on ACD856, the lead drug candidate in the NeuroRestore project. Data from the study show that ACD856 has a potential neuroprotective effect in a cellular model of nerve injury. These protective properties are believed to be mediated by an improved mitochondrial function and a protective effect on the structure of the cell, which has been demonstrated in the presented studies. Furthermore, ACD856 also increases the release of Brain Derived Neurotrophic Factor, BDNF, from the cells, something that is believed to further enhance these positive effects. ACD856, which is a positive modulator of both NGF/TrkA and BDNF/TrkB mediated signaling, has demonstrated in preclinical studies to improve cognition and memory and is ready for phase 2 clinical studies, where it is being developed primarily for the treatment of Alzheimer's disease. Announcement • Sep 23
AlzeCure Presents New Data on the Anti-Inflammatory Effects of its TrkA-NAM Pain Project at IASP 2022 AlzeCure Pharma AB (publ) announced that the company's presentation from the pain conference IASP 2022 is now available in its entirety on the company's website. The abstract includes new results from the company's preclinical project TrkA-NAM, which is developed with a focus on osteoarthritis pain and other severe pain conditions. The results show that the substance, AC-0027838, has a potent analgesic effect in a model of nociceptive pain. The substance blocks NGF-mediated signaling via TrkA receptors, a biological mechanism with strong genetic, preclinical and clinical validation regarding its role in pain. The data also show that AC-0027838 has a powerful anti-inflammatory effect, something that may potentiate its analgesic effects in clinical contexts. Analysis of the inflamed tissue also demonstrated significant effects on CGRP, which is a relevant biomarker of inflammation and pain. These positive data further strengthen the project and contribute to increased commercial interest. That this is also a mechanism that is not linked to the side effects and addiction problems observed with opioids is important in the context as the medical need for alternative treatments is very great. Announcement • Sep 16
AlzeCure's Alzheimer’s Project NeuroRestore ACD856 Shows Positive Effect on Brain Activity in Clinical Trial AlzeCure Pharma AB (publ) announced that the company has received new data from the clinical phase I study (multiple ascending dose, MAD) with repeated dosing of the drug candidate ACD856, which is being developed against Alzheimer's disease and other indications with cognitive dysfunction. New data from a planned exploratory analysis of the MAD study show that ACD856 increases EEG activity in the brain. A clear difference can be seen after vs. prior to administration of the substance. This result combined with previously reported data show that the substance not only crosses the blood-brain barrier, but also reaches and activates neural pathways in the brain, with the potential of having positive effects on cognition. The MAD phase I study is AlzeCure's third clinical study with ACD856, the company's leading drug candidate within the NeuroRestore platform. The substance is under development as a symptom-relieving treatment for medical conditions where the cognitive ability is impaired, for example in Alzheimer's disease. The primary study objective was to evaluate the drug candidate's tolerability and safety after repeated dosing. As previously reported, ACD856 shows good safety and tolerability in both the SAD and MAD studies. ACD856 and the other substances in the NeuroRestore platform stimulate several important signaling systems and signaling substances in the brain such as BDNF (Brain Derived Neurotrophic Factor) and NGF (Nerve Growth Factor), which can lead to improved cognition, something that has been demonstrated in previous preclinical studies. New preclinical results also show potential neuroprotective and disease-modifying effects with these substances. The biological mechanism behind NeuroRestore enables several indications, such as Alzheimer's and Parkinson's disease, but also traumatic brain injury and depression. Announcement • Sep 08
AlzeCure Pharma AB (publ), Annual General Meeting, May 17, 2023 AlzeCure Pharma AB (publ), Annual General Meeting, May 17, 2023. Announcement • Aug 31
AlzeCure Pharma AB (publ) Gets Abstract Accepted on Potential Neuroprotective Effects of NeuroRestore ACD856 AlzeCure Pharma AB (publ) announced that an abstract about the research platform NeuroRestore and its role in neuroprotection has been accepted for a presentation at ISMND 2022, which this year will be held in Athens, Greece, on October 10-12. The abstract, titled The Trk-PAM ACD856 improves mitochondrial function and increase BDNF levels in primary cortical neurons, will be presented at the international conference organized by the International Society for Molecular Neurodegeneration (ISMND 2022) by Pontus Forsell, Head of Research and Discovery at AlzeCure. Other Co-authors include Cristina Parrado, Sanja Juric, Märta Dahlström and Johan Sandin, CSO at AlzeCure. The presentation includes study results showing that the leading drug candidate in the NeuroRestore platform, ACD856, has a potential neuroprotective effect. New preclinical data show that the substance, in addition to strengthening the signaling, also increases the release of Brain Derived Neurotrophic Factor, BDNF, a so-called neurotrophin that has a very central role in memory formation, but also in maintaining normal nerve cell function and protecting them from damage. Moreover, ACD856 has a positive effect both on mitochondrial function and on cell survival, which could indicate potential disease-modifying effects of the substance. Announcement • Jul 06
AlzeCure Pharma AB Gets Abstract on New Clinical Study Data with NeuroRestore Accepted At the Alzheimer's Conference Aaic AlzeCure Pharma AB announced that an abstract on clinical study data with its leading drug candidate NeuroRestore ACD856, which is being developed with a focus on Alzheimer's disease, has been accepted for a poster presentation at AAIC 2022, which this year will be held in San Diego, USA, from July 31 to August 4. The abstract, titled Results From a Multiple Ascending Dose Study in Healthy Volunteers of ACD856, a Positive Modulator of Neurotrophin Trk-Receptors, will be presented at the international Alzheimer's conference AAIC by project leader Kristin Önnestam. Co-authors include Boel Nilsson, Project leader & Clinical Trial Manager, Dr. Johan Sandin, CSO at AlzeCure, Dr. Matthias Rother, Medical Program Director, and Dr. Märta Segerdahl, CMO at AlzeCure. Announcement • Jun 30
AlzeCure Pharma AB (Publ) Announces Update on Clinical Phase I Study AlzeCure Pharma AB (publ) announced that the company has completed the clinical phase I study (multiple ascending dose, MAD) with repeated dosing of the drug candidate ACD856, with a focus on Alzheimer's disease. Data show that ACD856, the primary drug candidate within the company's NeuroRestore platform, has good tolerability and safety. Furthermore, the results demonstrate that the substance has suitable pharmacokinetic properties with rapid uptake into the body as well as relevant and dose-dependent exposure in the CNS. The MAD Phase I study is AlzeCure's third clinical study with ACD856, the company's leading drug candidate in the NeuroRestore platform. The substance is being developed as a symptom-relieving treatment for disease states where cognitive ability is impaired, for example in Alzheimer's disease. The primary objective of the study was to evaluate the tolerability, safety and pharmacokinetics of the drug candidate after repeated dosing. The company started the study in September 2021 and is now presenting according to plan results from this clinical study with ACD856. Preparations are now being made to initiate further clinical trials. These upcoming studies are focused on evaluating early effect-signals in humans. Announcement • Jun 22
AlzeCure Pharma AB (publ) Announces First Patient Included in its Phase II Clinical Trial in Neuropathic Pain with Non-Opioid ACD440 AlzeCure Pharma AB (publ) announced that the first patient has been included in a Phase II clinical trial with ACD440, the leading non-opioid drug candidate in the Painless platform which is being developed for peripheral neuropathic pain. This follows the recent approvals from regulatory authorities to begin the study. The Phase II clinical trial is a double-blind, placebo-controlled, randomized cross-over study evaluating the efficacy, safety, and pharmacokinetics of AlzeCure's leading drug candidate in pain, ACD440. Results from the study are expected in mid-2023. ACD440 is a TRPV1 antagonist and first-in-class local treatment for patients with peripheral neuropathic pain. The discovery of TRPV1, which is the basis for the project, was awarded the Nobel Prize in Physiology or Medicine in 2021. ACD440, which is applied as a gel, is the company's leading drug candidate in the Painless platform and conducted a positive phase Ib study in 2021. The medical need in neuropathic pain is very great, not least to find alternatives to opioids. The market for neuropathic pain is the single large market segment in pain treatment, with annual sales of over USD 11 billion. Up to 80% of patients do not get a satisfactory effect with their current treatments. Announcement • Jun 02
Alzecure Pharma AB (Publ)'s Abstract on Pain Project TrkA-NAM Accepted for Presentation At IASP 2022 AlzeCure Pharma AB (publ) announced that an abstract of its preclinical project TrkA-NAM against osteoarthritis pain and other severe painconditions has been accepted for presentation at the IASP 2022 World Congress on Pain in Toronto, Canada. The presentation includes preclinical results showing how TrkA-NAM substances were identified as potent and selective negative modulators of NGF/TrkA signaling in cell-based assays. New important data in a preclinical pain model show, in addition to significant analgesic effect, also a potent anti-inflammatory effect. "The results show that AlzeCure has identified unique, potent and selective TrkA-NAM molecules that show both analgesic and anti-inflammatory effects in a relevant preclinical model - something see as a strength for the further development of the program. In addition, identification of selective and potent small molecule TrkA-NAM substances can potentially avoid some of the side effects observed for anti-NGF antibodies due to a more selective mechanism of action, while maintaining the analgesic effect," said Pontus Forsell, project manager of the TrkA-NAM program. Announcement • May 26
AlzeCure Pharma AB (publ) Gets Approval to Start Phase II Clinical Trial with Non-Opioid Pain Project ACD440 AlzeCure Pharma AB (publ) announced that it has received approval from the regulatory authorities in Sweden to initiate its clinical phase IIa study with the drug candidate ACD440 in patients with peripheral neuropathic pain. The Phase IIa study is AlzeCure's second clinical study with ACD440, the company's leading drug candidate in the Painless platform. ACD440 is under development as a local treatment for peripheral neuropathic pain, such as long-term pain after shingles and diabetic neuropathy. The aim of the study is to evaluate the analgesic effects of the drug candidate in patients with peripheral neuropathic pain, but also its tolerability after repeated dosing. ACD440 is a TRPV1 antagonist that originated in Big Pharma and is based on a strong scientific foundation. The discovery and insight into TRPV1, the biological system that underlies ACD440 and is central to, among other things, temperature regulation and pain, was awarded the Nobel Prize in Physiology or Medicine 2021. ACD440 is developed for local treatment as a gel and has previously been studied in a clinical phase Ib study, which showed both good tolerability and good pain-relieving effect. Announcement • Apr 23
AlzeCure Pharma AB (publ) Publishes New Data on Alzstatin from Alzheimer Conference AlzeCure Pharma AB (publ) announced that the company's presentation regarding the research platform Alzstatin at the Alzheimer's conference 2nd Swedish Meeting for Alzheimer Research, is now available in its entirety on the company's website. The presentation, entitled Development of novel gamma-secretase modulators for the treatment of Alzheimer's disease, was given by Maria Backlund, Senior Scientist, and contains preclinical data from studies with a newpotent small-molecule -secretase modulator (GSM) which is part of AlzeCure's research platform Alzstatin. The results show that the substance, AC-0027875, effectively crosses the blood-brain barrier and reaches the target organ, i.e. the brain, in high concentrations, which is essential for a good pharmacological effect. Furthermore, data show that the potent effect of the substance on -secretase led to a reduction in the amount of harmful A42 by more than 50%. Small-molecule GSMs is a class of drugs that exhibit several important properties that make them suitable as a disease-modifying or preventive treatment for presymptomatic Alzheimer's disease. Announcement • Apr 22
AlzeCure Publishes New Data on NeuroRestore and Acd856 from Alzheimer's Conference AlzeCure Pharma AB announced that the company's presentations at the Alzheimer's conference 2nd Swedish Meeting for Alzheimer Research, regarding the research platform NeuroRestore and its primary drug candidate ACD856, are now available in their entirety on the company's website. The presentations, entitled Results From a Single Ascending Dose Study in Healthy Volunteers of ACD856, a Positive Modulator of Neurotrophin Trk Receptors, and A Positive Modulator of Neurotrophin Receptors Improve Cognition and Mitochondrial Function, were given by Kristin Önnestam, Clinical Project leader, and Cristina Parrado-Fernández, Senior Scientist. The results presented include new data from the clinical phase I Single Ascending Dose study which shows that ACD856 shows a good safety and tolerability profile in humans as well as suitable pharmacokinetic properties, which supports the further clinical development of the substance. ACD856, which is primarily developed for the treatment of Alzheimer's disease, is being tested in an ongoing clinical phase I Multiple Ascending Dose study that is expected to be read out in the summer of 2022. Results from the conference also exhibited new preclinical data showing a dose-dependent positive effect of the NeuroRestore substance AC-0027136 on mitochondrial function, which is particularly interesting as impaired mitochondrial function is common in disorders such as Alzheimer's disease. The results also showed that AC-0027136, like ACD856, had a positive effect on long-term memory in aged animals. Recent Insider Transactions • Mar 24
Chief Executive Officer recently bought €16k worth of stock On the 22nd of March, Martin Jönsson bought around 41k shares on-market at roughly €0.38 per share. This was the largest purchase by an insider in the last 3 months. This was Martin's only on-market trade for the last 12 months. Recent Insider Transactions • Mar 24
Chief Executive Officer recently bought €16k worth of stock On the 22nd of March, Martin Jönsson bought around 41k shares on-market at roughly €0.38 per share. This was the largest purchase by an insider in the last 3 months. This was Martin's only on-market trade for the last 12 months. Announcement • Mar 10
Alzecure Pharma AB (Publ) Receives Positive Indicative Clinical Data with Acd856 in Development for Alzheimer's Disease AlzeCure Pharma AB (publ) announced new indicative data from the ongoing clinical phase I MAD study with ACD856 showing that the substance reaches the brain, the target organ for the substance which is developed as a treatment for Alzheimer's disease. ACD856, which is the company's leading drug candidate in the NeuroRestore platform, is currently undergoinga clinical phase I MAD study (Multiple Ascending Dose). The purpose of the study is to evaluate safety and tolerability after repeated dosing of different doses of the substance, but also to study the concentration of the substance in the body. AlzeCure has now received key data showing that ACD856 reaches the brain in relevant concentrations, something that supports the further development program for the drug candidate as oral treatment of, among other things, Alzheimer's disease. ACD856 and the other substances in the NeuroRestore platform stimulate several important signaling systems in the brain, which can lead to improved cognition. Preclinical studies have shown that AlzeCure drug candidates strengthen the communication between nerve cells and improve cognitive ability including learning and memory functions. Announcement • Feb 09
Alzecure Pharma AB (publ) Announces Moving Towards Phase IIa Clinical Trial with ACD440 Based on Guiding Response from the FDA AlzeCure Pharma AB (publ) announced that it has received a response from the US Food and Drug Administration (FDA) regarding the preIND application that was submitted prior to the planned phase IIa study with ACD440 in neuropathic pain. ACD440, which is the company's leading drug candidate in the Painless platform, completed a positive phase Ib study in 2021 and the company now plans to initiate a clinical phase IIa study in patients with peripheral neuropathic pain. Prior to this clinical development step, a preIND application was submitted to the FDA. AlzeCure has now received indicative answers that support the continued development program for ACD440, as well as the preparatory work for the upcoming clinical phase IIa study. ACD440 is a TRPV1 antagonist for the topical treatment of patients with neuropathic pain. The discovery of TRPV1, which is the basis for the project, was awarded the Nobel Prize in Physiology or Medicine in 2021. Announcement • Aug 13
AlzeCure Pharma AB (publ) to Present Abstract at ECNP Conference on NeuroRestore Project's Potential in Depression AlzeCure Pharma AB (publ) announced that an abstract about the neurology platform NeuroRestore, its link to BDNF/TrkB signalling and potential therapeutic role in depression, has been accepted for presentation at the ECNP 2021 conference, which this year will be held in Lisbon, Portugal, on October 2-5. The abstract, titled Characterization of positive allosteric modulators of TrkB for the treatment of depression, will be presented at the major international conference European College of Neuropsychopharmacology 2021, by Dr. Johan Sandin, Chief Scientific Officer at AlzeCure. Other authors include Dr. Pontus Forsell, Head of Discovery, Dr. Gunnar Nordvall, Head of Chemistry, and Magnus Halldin, Head of DMPK & Safety at AlzeCure. The presentation includes results from studies that show how substances from the NeuroRestore project have had potent effects in various preclinical models linked to depression. Furthermore, the results show that these substances bind to the receptors for the neurotrophin BDNF, so called TrkB receptors, and stimulate the signaling of this system. This biological system has been linked to depression, and the support for this hypothesis has recently been further strengthened, and new scientific findings indicate that many of the classic antidepressant drugs available actually mediate their effect via BDNF/TrkB. Announcement • Mar 04
AlzeCure Pharma AB (publ) to Report Fiscal Year 2021 Results on Feb 24, 2022 AlzeCure Pharma AB (publ) announced that they will report fiscal year 2021 results on Feb 24, 2022 Is New 90 Day High Low • Feb 17
New 90-day low: €0.74 The company is down 14% from its price of €0.86 on 19 November 2020. The German market is up 11% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 13% over the same period. Is New 90 Day High Low • Jan 30
New 90-day low: €0.77 The company is down 2.0% from its price of €0.78 on 30 October 2020. The German market is up 18% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 15% over the same period. Announcement • Nov 13
AlzeCure Pharma AB (publ) Receives Approval to Start Clinical Phase I Trial with ACD856 in Alzheimer's Disease AlzeCure Pharma AB (publ) announced that the company has received approval from the regulatory authorities in Sweden to initiate a clinical Phase I study with the drug candidate ACD856. The Phase I study is AlzeCure's second clinical study with ACD856, the lead drug candidate within the company's NeuroRestore platform, which is developed as a symptom-relieving treatment for disease states where cognitive ability is impaired, such as in Alzheimer's disease. The primary study obejective in the phase I study is to evaluate the drug candidate's tolerability and safety. Recent Insider Transactions • Oct 21
Chief Executive Officer recently bought €92k worth of stock On the 16th of October, Martin Jönsson bought around 102k shares on-market at roughly €0.90 per share. This was the largest purchase by an insider in the last 3 months. This was Martin's only on-market trade for the last 12 months. Announcement • Oct 14
Alzecure Gets Abstract on the Neurorestore Platform Against Alzheimer's Accepted for Poster Presentation At CTAD AlzeCure Pharma AB (publ) has received an abstract approved for poster presentation at the annual Alzheimer's conference CTAD, Clinical Trials in Alzheimer's Disease, which this year will be held completely digitally on November 4-7. The abstract, titled Gamma-secretase modulators show selectivity for gamma-secretase-mediated amyloid precursor protein intramembrane processing, describes how the mechanisms in AlzeCure's disease-modifying research platform Alzstatin work and shows that the substances are well suited for early treatment of Alzheimer's disease. The study was conducted in collaboration with Helena Karlström at Karolinska Institutet (Principal Investigator for the study) and Erik Portelius at the University of Gothenburg. Other authors include Professor Henrik Zetterberg, Professor Kaj Blennow and Professor Bengt Winblad, as well as Johan Lundkvist, Johan Sandin and Gunnar Nordvall at AlzeCure. Announcement • Sep 29
AlzeCure Pharma AB Provides Scientific Update on Alzheimer's Disease and the Alzstatin Project Platform AlzeCure Pharma AB that develops a broad portfolio of drug candidates for diseases affecting the central nervous system, with projects in both Alzheimer's disease and pain, will hold a live business update focused on the company's Alzheimer's platform 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 (Aß) in the brain. Aß 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 platfrom modulate the function of the enzyme gamma secretase. Gamma secretase acts like a pair of scissors and cuts Aß42 out from a longer protein known as APP. The sticky Aß42 clumps together giving rise to the amyloid plaque so typical of Alzheimer's disease. The candidates in the Alzstatin platform affect enzyme function so that it instead cuts out shorter forms of the Aß peptide, Aß37 and Aß38, which in addition to them not being sticky and not forming aggregates, also have a restrictive effects on Aß42 aggregates already formed. 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. Alzheimer's disease is the most common form of dementia, affecting approximately 45 million people worldwide. 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 is estimated to about 1,000 billion USD globally in 2018. Given the lack of both effective symptomatic treatments and disease modifying treatments, the need for new effective therapies is acute. The few approved drugs on the market 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 10 billion USD in annual sales. In Sweden, approximately 100,000 people suffer from Alzheimer's disease with a healthcare cost of about 63 billion SEK yearly, which is more than for cancer and cardiovascular diseases combined. Announcement • Aug 25
AlzeCure Pharma AB (publ) to Report Fiscal Year 2020 Results on Feb 28, 2021 AlzeCure Pharma AB (publ) announced that they will report fiscal year 2020 results on Feb 28, 2021