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The Company’s Nelivabon Program Pairs Novel Compound with Companion Diagnostics to Treat MDD patientsMUNICH, Germany, June 20, 2023 (GLOBE NEWSWIRE) -- HMNC Brain Health (‘‘HMNC’’ or the ‘‘Company’’), a global clinical-stage biopharmaceutical company pioneering the development of personalized therapies in psychiatry, announced today that the first patient has been enrolled in the Olive trial, a randomized, double-blind, placebo-controlled trial in more than 300 patients with Major Depressive Disorder (MDD) conducted in eight countries in Europe. The Olive trial is a crucial component of the Nelivabon program, aimed at developing BH-200, a potent vasopressin V1b receptor antagonist, for improved treatment of patients with MDD who have underlying HPA-axis (Hypothalamus‐pituitary‐adrenal axis) dysfunction. The neuropeptide vasopressin plays a critical role in coordinating hormonal and behavioral adaptation to stress, and its elevated activity in the brain following repeated stressors may increase anxiety and depressive symptoms. BH-200 directly targets the HPA-axis dysfunction and has demonstrated promising tolerability in previous clinical trials. The Olive trial will evaluate the efficacy and safety of BH-200 in depressed patients. Moreover, it will test the predictive capabilities of the V1b polygenic score, which the company aims to eventually develop into a companion diagnostic for BH-200. As this genetic in-vitro diagnostic test is still under development, the Olive trial will recruit every patient regardless of genetic status, and a post-hoc analysis will be performed. The hypothesis is that patients with a high V1b polygenic score, which is estimated to be around 30% of the population, will benefit the most from BH-200. ‘‘The initiation of the Olive trial for the Nelivabon program marks an important milestone in our pursuit of providing innovative and personalized treatments for patients suffering from stress-axis-related MDD,’’ said Dr. Maximilian Doebler, Chief Business Officer of HMNC Brain Health. ‘‘We remain committed to advancing our clinical research pipeline to address unmet needs in mental health care and ultimately bring new treatment options to patients suffering from mental health disorders such as MDD.’’ ‘‘The development of the predictive companion diagnostic as part of the Nelivabon program reflects HMNC Brain Health's focus on targeted and personalized treatments. By identifying patients with a specific dysfunction of the HPA-axis, the program aims to provide tailored and efficient treatment options, furthering the company's goal of delivering personalized healthcare solutions,’’ said Dr. Hans Eriksson, Chief Medical Officer of HMNC Brain Health. ‘‘The commencement of our Phase 2 study is a crucial step in validating the safety and efficacy of this innovative treatment strategy. We are very confident that our precision psychiatry approach for the treatment of MDD will prove its noteworthy potential addressing a large patient population.’’ If the Nelivabon program receives clinical validation, it could represent a significant advancement in the treatment of stress-axis-related MDD, a potential breakthrough in mental health treatment, supporting HMNC Brain Health’s commitment to innovation. The initial results of the Olive trial are expected in H2 2024. ABOUT HMNC BRAIN HEALTH HMNC Brain Health (HMNC Holding GmbH) is a global precision psychiatry biopharma company pioneering the development of personalized therapies powered by predictive companion diagnostics, leading to higher remission rates. The Company develops a unique pipeline for targeting both Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD). The Company has presence in both Germany and the US and is backed by a renowned global VC, several family offices, and a strategic healthcare investor. The Company now enters the next stage of its development with a large-scale licensing and fundraising agenda. ABOUT THE NELIVABON PROGRAM The Nelivabon program is focused on developing BH-200, a vasopressin V1b receptor antagonist, to treat Major Depressive Disorder (MDD) related to dysfunction in the human body's stress system, called HPA-axis (Hypothalamus‐pituitary‐adrenal axis). BH-200 targets the elevated activity of vasopressin in the brain caused by repeated stressors, potentially reducing anxiety and depressive symptoms. The neuropeptide vasopressin coordinates hormonal and behavioral adaptation to stress, but repeated stressors can cause an overactive vasopressin system that leads to an increase in anxiety and the development of depressive symptoms. To identify depressed patients with underlying dysfunction of the HPA-axis, who may benefit from treatment with BH-200, the program includes a matching molecular diagnostic test. While the diagnostic test is still in early development, data stemming from this trial is expected to significantly improve its accuracy. BH-200 has shown to be well-tolerated in clinical trials. The program is entering a Phase-II proof-of-concept study in H1 2023 and once clinically validated, could represent an efficient treatment option for patients suffering from stress-axis-related MDD. Media contacts (U.S.):Anne Donohoe+1212.896.1265hmncbrain@kcsa.com Investor Contacts (U.S.):Sophia Bashford+1 347-487-6788sbashford@kcsa.com

VILLANOVA, Pa. and OAKLAND, Calif., Nov. 21, 2022 /PRNewswire/ -- EmbarkNeuro, a neuroscience-focused biotech company formerly known as Ancora Bio that was founded in 2021 by the venture firm Aditum Bio, today announced that the first patient has been dosed in its Phase 2 trial of ANC-501, a first-in-class vasopressin 1b (V1b) receptor antagonist for the treatment of major depressive disorder (MDD). This 8-week single-arm trial will assess the efficacy of ANC-501 when added to a standard antidepressant therapy in patients with biomarker-confirmed disruption in their stress-response system. "Rates of depression and anxiety have risen dramatically since the advent of the COVID-19 pandemic, which has spurred extreme stress due to social isolation and exacerbated health concerns," said Stephen Kanes M.D., Ph.D., Chief Executive Officer of EmbarkNeuro. "As people with a history of adverse childhood experiences, toxic stress or HPA axis disruption have been the hardest hit, it is more important than ever to rethink all aspects of mental health interventions and create targeted treatments with underlying conditions in mind for patients not responsive to standard therapies. We look forward to advancing ANC-501 and providing patients with depression and measurable disruption of their HPA axis with a treatment option. Our new name, EmbarkNeuro, represents our enthusiasm as we embark on the exploration of new pathways for the treatment of brain health disorders." The multi-center, open-label Phase 2 clinical trial is designed to evaluate the safety, tolerability, and efficacy of orally administered ANC-501 50mg over 8 weeks. The trial will enroll individuals aged 18-65 who are currently depressed and for whom standard treatments have not been effective. Patients with moderate to severe MDD who have confirmed baseline cortisol level elevations are eligible to participate. The primary efficacy endpoint is change from baseline at the end of 8 weeks of treatment using the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Participants will be followed for safety assessments for an additional 8 weeks following completion of dosing. For more information about the trial, please visit www.clinicaltrials.gov (identifier NCT05439603). A double-blind placebo-controlled trial of ANC-501 in patients with depression is planned for 2023 based on the outcome of this initial Phase 2 trial. ANC-501 is an investigational compound and not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. About Major Depressive Disorder (MDD) Major depressive disorder (MDD) is a common condition affecting over 20 million U.S. residents annually causing social, occupational, and educational impairment, along with depressed mood or loss of interest or pleasure in daily activities. The hypothalamic-pituitary-adrenal (HPA) axis plays a critical role in managing the body's response and adaption to stress. The peptide hormone vasopressin acting through the vasopressin 1b (V1b) receptors is a key regulator of the body's stress response. About EmbarkNeuro EmbarkNeuro, formerly known as Ancora Bio, is focused on bringing important new personalized treatments to patients with mental health disorders. Rates of major depression are rapidly rising, much of this attributable to the dramatic increase in stress brought on by the COVID-19 pandemic. The company is identifying depressed individuals with a potential biomarker linked to the stress response system (elevated cortisol) and developing ANC-501 as a new treatment specifically for these patients. For more information about EmbarkNeuro, please visit https://embarkneuro.com/.

Round Comprised of New and Former Investors, Including Dr. Josef Ackermann, Wilhelm Beier, Toni Kroos, and Carsten Maschmeyer First of Two Expected Closings of Round Increases Total Capital Raised to Date to EUR 42.3 Million MUNICH, Germany, Oct. 20, 2022 (GLOBE NEWSWIRE) -- HMNC Brain Health (“HMNC'' or the “Company”), a clinical stage biopharma company pioneering precision psychiatry, today announced it has raised an additional EUR 14.3 million in a funding series, bringing the total capital raised to date to EUR 42.3 million. The additional funding was raised from existing investors, including Carsten Maschmeyer, the Jahr Group and Guntard Gutmann. The round also included new investors Dr. Josef Ackermann (formerly CEO of Deutsche Bank), Toni Kroos (Real Madrid), Wilhelm Beier (Dermapharm) and Hans Kompernaß (Hans Kompernaß GmbH). The proceeds will be used to accelerate HMNC’s precision psychiatry programs, in which first-in-class pharmaceuticals are co-developed with proprietary genetic companion diagnostics to identify the patient groups most likely to benefit most from these treatments. HMNC’s flagship clinical trial, the Nelivabon program’s multi-national phase 2 study, is set to start enrollment in early 2023. In addition, the funds will advance the development of the Ketabon program, an oral prolonged release formulation of ketamine targeting treatment-resistant depression. The program entered a clinical phase 2 trial in June 2022 to assess the efficacy, safety, and tolerability of an add-on treatment with the compound KET01 in 117 patients suffering from treatment-resistant depression. “We are very pleased to receive support from both new and current investors. With this funding, we will advance the development of our personalized therapies to combat severe, unmet mental health challenges around the world. Raising additional capital is a tremendous vote of confidence in the promise of our clinical trial candidates, the power of precision medicine in psychiatry and our team’s ability to achieve its strategic priorities,” commented Dr. Maximilian Doebler, Chief Business Officer of HMNC Brain Health. "Mental health is a serious issue that affects millions of people around the world. I have witnessed how mental health is undervalued in competitive sports in particular, even though the physical and psychological pressure is incredibly high. The team at HMNC Brain Health are true pioneers in this field, combating mental illness with precisely tailored, individualized treatments, which is why I am delighted to be on board," added Toni Kroos, professional soccer player at Real Madrid. Dr. Josef Ackermann, former Chief Executive Officer of Deutsche Bank, said, “I have always been intrigued by breakthrough innovations that improve people's lives, especially when it comes to health. That's why I have decided to support HMNC as an investor and be part of the precision psychiatry revolution. Through investing in HMNC’s programs, I want to foster an important societal impact in the fight against anxiety disorders and depression." Carsten Maschmeyer, Co-Founder and Member of the Board of Directors at HMNC Brain Health added, “We are extremely encouraged by the progression of HMNC Brain Health’s activities to date, and equally confident in the team’s ability to achieve further success. Over the past few months, HMNC has recruited key experts to join the team, and made great progress in advancing its medications and companion diagnostics. Unsurprisingly, within a short period of time we attracted several new, renowned investors to support the maturation of HMNC Brain Health, who are as convinced as I am of the important role HMNC will play in treating mental health patients globally.” HMNC Brain Health expects to complete a second closing of this round by end of March 2023. About HMNC Brain Health HMNC Brain Health (HMNC Holding GmbH) is a clinical stage precision psychiatry biopharma company, pioneering the development of personalized therapies, powered by its AI platform and predictive companion diagnostics suite, bringing substantial therapeutic benefit to select patient populations suffering from mental health disorders. The company develops a unique pipeline for targeting both Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD). HMNC’s precision psychiatry franchise for MDD includes the Nelivabon program, in which it develops a V1bR antagonist with its companion diagnostic, and the Cortibon program, in which it develops a CRHR1 antagonist with its companion diagnostic. Additionally, in a joint venture with Develco Pharma, the Company is also developing an oral-prolonged release formulation of racemic ketamine that combines the rapid efficacy of ketamine with superior tolerability and convenience, to provide an enhanced treatment option for TRD. The Company has operations in both the US and Germany and is backed by a renowned global VC, several family offices, and a strategic healthcare investor. Media contactsAlexander Schmidt (Europe)+49 151 22 99 39 765alexander.schmidt@gaulyadvisors.com Anne Donohoe (U.S.)+1 212-896-1265hmncbrain@kcsa.com Investor Contact (U.S.)Sophia Bashford+1 929 246 7307hmncbrain@kcsa.com