ANT01

ANeuroTech receives IND approval from the FDA for pivotal Phase IIIB trialof adjunctive anti-depression drug, ANT-01 ANT-01 in development as an adjunctive treatment for Major Depressive Disorder (MDD), with minimal side effectsPhase IIIB trial to begin later this year in the US, Europe and South AmericaCompany funding secured from international impact investing company, KOIS, as part of Series A round Alken, Belgium – 5 June 2022: ANeuroTech, a leader in the development of innovative mental health treatments with minimal or no side effects, today announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate a pivotal Phase IIIB trial of ANT-01 as an adjunctive anti-depression drug for Major Depressive Disorder (MDD). The Phase IIIB will include secondary endpoints of improvements in cognitive function and the ability to feel pleasure, the first time these have been included in an anti-depression drug clinical trial. ANeuroTech expects to begin the trial later this year. More than 60% of people with depression and associated cognitive problems are not helped by existing first-line treatments or experience challenging side-effects1. ANeuroTech is developing ANT-01 as an adjunctive anti-depression drug with minimal or no side-effects. ANT-01 is a low dose of an existing drug substance, pipamperone dihydrochloride, a typical antipsychotic developed and marketed at a high dose range for over 40 years in Europe for the treatment of psychotic disorders. Dr Erik Buntinx, CEO and Founder of ANeuroTech, discovered through his clinical practice that ANT-01 has a unique high selectivity and affinity for the serotonin 5-HT2A and dopamine D4DR brain receptors, and shows potential as an adjunctive treatment with fewer side effects. ANT-01 is being developed as a once-daily, orally administered drug to be taken in conjunction with a first-line antidepressant. The pivotal, double-blinded Phase IIIB trial will assess the safety and efficacy of a single low (15mg) dose of ANT-01 combined with a first-line antidepressant versus placebo in MDD patients with insufficient response to selective serotonin reuptake inhibitor (SSRI) or selective noradrenaline serotonin reuptake inhibitor (SNRI) treatment. The Phase IIIB trial follows positive clinical data generated from earlier trials which demonstrated clinical evidence of antidepressant activity of ANT-01 with a favourable safety profile. The data also showed an increased ability to feel pleasure and improvement in cognitive function, which has not been demonstrated by any other adjunctive antidepressant molecule. The trial plans to recruit more than 500 patients at sites in the US, Europe and South America, and is expected to begin in 2023. ANeuroTech has also secured funding from KOIS, an international impact investing company, as part of a Series A round. KOIS are experts in healthcare and life sciences investments, with a mission to turn projects with high societal and environmental impact into tangible investment propositions. Dr Erik Buntinx, CEO and Founder of ANeuroTech, commented: “We are delighted to welcome KOIS to the ANeuroTech family. Their experience and track record in the healthcare and life sciences sectors will help us achieve our goal of bringing new options to patients suffering with depression.” Dr Buntinx continued: “Globally, there are 190 million people with MDD who do not respond well to antidepressants and we must do more to help them. The FDA’s endorsement of the ANT-01 Phase IIIB development programme recognises the excellent safety profile and strong efficacy data shown in studies so far, which also support, for the first time, the investigation of an adjunctive antidepressant drug for improvements in cognitive function and the ability to feel pleasure.” Charles-Antoine Janssen, Founder and Managing Partner, KOIS, said: “We are excited to support ANeuroTech as it embarks on its Phase IIIB pivotal programme. We have been impressed by the Company’s data and the deep experience of its management team. We look forward to working closely with them as they develop effective mental health treatments so desperately needed in today’s world.” 1. Rush AJ, Trivedi MH, Wisniewski SR, et al., Am J Psychiatry 2006;163:1905–17 – END – For more information, please contact: ANeuroTechDr Erik Buntinx, CEO and FounderTel: + 32 11 94 91 15 Consilium Strategic CommunicationsTracy Cheung/Genevieve Wilson/Kris LamEmail: Aneurotech@consilium-comms.com Tel: +44 (0)20 3709 5813 About ANeuroTech ANeuroTech, based in Alken, Belgium, is a leader in the development of innovative mental health treatments with minimal or no side effects. The company is in late-stage clinical development of its lead asset, ANT-01, an adjunctive anti-depression drug which has been shown in late-stage clinical trials to improve depression and have a positive impact on cognitive function and anhedonia, with an excellent safety profile. ANT-01 is a low-dose of an existing drug substance, pipamperone dihydrochloride, a typical antipsychotic discovered by the late Dr Paul Janssen and marketed in Europe for the treatment of psychotic disorders. ANeuroTech plans to begin a pivotal Phase IIIB clinical trial of ANT-01 as an adjunctive anti-depression drug for Major Depressive Disorder (MDD) in 2023. ANeuroTech was founded by CEO, Dr Erik Buntinx, an experienced clinician, key opinion leader and global coordinating principal investigator on clinical trials for a number of CNS drugs including Spravato (esketamine). Many of the ANeuroTech team were previously at Johnson & Johnson where they gained extensive experience in the development of treatments for mental and other health disorders. For more information, please visit: https://www.aneurotech.com/

Positive clinical data from pharmaceutical companies Seagen and Anebulo were announced Tuesday, along with an announcement of support from the U.S. Food and Drug Administration for ANeuroTech’s innovative new treatment for major depressive disorder (MDD). Seagen’s Touts Positive Phase II Data in Colorectal Cancer Seagen's open-label Phase II MOUNTAINEER trial has produced positive full results. The trial was designed to investigate the safety and efficacy of Tukysa (tucatinib) when administered alongside trastuzumab, in patients with HER2-positive metastatic colorectal cancer (mCRC). The published results represent follow-up data from 84 patients who received the dual treatment. The patients showed a median duration of response at 12.4 months, and a 38.1% confirmed objective response rate. The median progression-free survival duration observed was 8.2 months. “This study has shown the benefits of dual-HER2 inhibition with tucatinib and trastuzumab in patients with HER2-positive metastatic colorectal cancer, including many whose cancer had spread to the liver or lungs before joining the trial,” Roger Dansey, M.D., Seagen’s interim CEO and chief medical officer said. “We believe this chemotherapy-free combination may play an important role in addressing the unmet needs of patients with this disease.” Patients with mCRC currently have limited treatment options. Seagen intends to supplemental New Drug Application for Tukysa to bring a chemotherapy-free option to patients. ANeuroTech’s MDD Drug Receives Positive FDA Feedback ANeuroTech also kicked off July with a bang. The company's Phase IIIb development trial of ANT-01, a drug being developed for MDD, has received positive feedback from the FDA after a pre-investigational new drug (IND) application meeting. The trial will assess the safety and efficicay of ANT-01 combined with a first-line antidepressant versus placebo. Existing treatments for this disorder come with the possibility of a wide range of negative side effects but if ANT-01 reaches the commercial market, patients would have access to a treatment that has little to no side effects. The treatment is a reduced dose of pipamperone dihydrochloride, an antipsychotic that is typically prescribed at a high dose for patients with psychotic conditions. Notably, this trial stands out with a unique secondary endpoint that tracks a participant’s improvement or decline in feelings of pleasure and cognitive function. “ANT-01 has the potential to change the treatment paradigm for the ~190 million patients worldwide with MDD who are not currently helped by initial treatment with antidepressants,” Dr. Rudi Pauwels, executive chairman of ANeuroTech said. An IND application filing for ANT-01 is anticipated in late 2022, and ANeuroTech intends to apply for Fast-Track Designation for the treatment. Anebulo Drug Succeeds in Reversing Acute Cannabinoid Intoxication As the United States moves slowly toward loosening restrictions on the use of cannabinoids, clinical trials investigating potential toxicity levels become more imperative. Anebulo Pharmaceuticals, Inc. is one such company taking an interest in this topic. An ongoing Phase II study is evaluating whether ANEB-001, one of the company’s treatment candidates, might be the answer needed in the event that a patient intakes toxic levels of psychoactive cannabinoids that lead to a condition called acute cannabinoid intoxication (ACI). Positive topline results for this trial were published Tuesday, demonstrating tolerability and efficacy as the treatment reverses feelings of “highness” in patients and a successful primary endpoint measurement. After treatment with 50 mg of ANEB-001, 90% of the patients no longer felt high. After a higher dosage of 100 mg, 70% of patients no longer felt high. These ratios have increased significantly compared to the placebo group, in which only 25% of participants had resolved symptoms of ACI. Additional measurements evaluated central nervous system functions such as alertness and heart rate. The trial is double-blinded and randomized. “The number of individuals with cannabinoid-related intoxication visiting our emergency departments is clearly on the rise,” Dr. Andrew Monte M.D., Ph.D., professor of emergency medicine & medical toxicology at the University of Colorado’s Denver-Anschutz Medical Center said. “Patients are coming from multiple settings including first-time users taking small doses of THC, adults and children inadvertently ingesting powerful THC gummies, and regular users unintentionally overdosing on new and more powerful THC products. Introducing an effective cannabinoid antidote into our treatment options would represent a significant improvement in how we can manage these patients.”