Ketamine Hydrochloride

Oral prolonged-release ketamine formulation (KET01) demonstrates minimal dissociation and cardiovascular effects with early antidepressant efficacy signals in treatment-resistant depression Results support further development of oral KET01 for at-home administration Phase 3-readiness activities underway MUNICH, Germany – July 07, 2026 – HMNC Brain Health ("HMNC" or the "Company"), a clinical-stage neuroscience company, today announced the publication of clinical data for Ketabon (KET01) in JAMA Network Open, demonstrating a differentiated tolerability profile and antidepressant properties that support further clinical development of this program for at-home administration. Entitled ‘Oral Prolonged-Release Ketamine for Treatment-Resistant Depression,’ the publication reports results from two clinical trials evaluating KET01, an oral prolonged-release ketamine formulation for treatment-resistant depression (TRD). The studies included a phase 1 crossover randomized clinical trial (RCT) contrasting KET01 to intranasal ketamine as an active comparator and a phase 2 randomized, placebo-controlled, double-blind trial in adult outpatients with TRD. Results from both trials demonstrated that KET01’s prolonged-release formulation addresses key limitations of currently available ketamine-based treatments, which commonly cause acute dissociation and blood pressure increases that require administration in specialized clinical settings. Conversely, KET01 exhibited minimal dissociation and cardiovascular effects at doses associated with clinically meaningful antidepressant effects. This favorable tolerability profile represents a significant advancement toward enabling at-home administration, which could significantly expand access to ketamine therapy. In the phase 2 trial, KET01 demonstrated early improvements in depressive symptoms, as measured by the Montgomery–Åsberg Depression Rating Scale (MADRS). In the efficacy analysis, treatment with KET01 240 mg/day produced rapid reductions in MADRS scores, with effects emerging as early as 7 hours and improvements versus placebo observed on Days 4 and 7 (p<0.05). Patients receiving KET01 240mg continued to improve throughout the treatment period, with an overall change from baseline of -13.15 MADRS points. Although the primary endpoint at Day 21 was not met because of substantial improvement in the placebo group, the early separation between treatment groups supports a rapid antidepressant effect. Together, these early efficacy signals indicating the potential of KET01 to provide rapid symptom relief in treatment-resistant depression, combined with its differentiated tolerability profile, provide a strong rationale for larger phase 3 studies with extended follow-up to evaluate the durability of response and the long-term maintenance of remission. Dr. Maximilian Doebler, Managing Director & Chief Business Officer, HMNC, said: “Publication of our Ketabon clinical data in JAMA Network Open represents a significant milestone, providing peer-reviewed validation of results that support our commitment to developing more accessible treatment options for the approximately 100 million patients worldwide living with treatment-resistant depression. Importantly, findings clearly demonstrate that the unique prolonged-release formulation delivers on its promise of minimal dissociation and cardiovascular effects while maintaining antidepressant properties. Such differentiated tolerability addresses key limitations of currently available ketamine-based therapies and supports our plans for scalable at-home use, providing a strong rationale for global phase 3 development.” Supported by proceeds from the successful $50 million first closing of a Series B financing, readiness activities are now underway to advance KET01 toward a phase 3 global program in TRD. HMNC Brain Health Dr. Maximilian Doebler, Managing Director & Chief Business Officer E-mail: maximilian.doebler@hmnc-brainhealth.com Dr. Dr. Jessica Burgstaller, VP Strategy & Corporate Development E-mail: jessica.burgstaller@hmnc-brainhealth.com Tracy Cheung / Ashley Tapp / Kris Lam E-mail: HMNCBrainHealth@icrhealthcare.com HMNC Brain Health (HMNC) is a clinical-stage neuroscience company pioneering new therapies for mental health disorders. Its pipeline includes Nelivabon (BH-200), a vasopressin V1b receptor antagonist being developed as a biomarker-guided precision therapy for biologically defined depressive disorders. Used with a genetic test to identify patients most likely to benefit, Nelivabon offers a precision neuroscience approach to treatment. HMNC is also developing Ketabon (KET01), an oral prolonged-release ketamine formulation for treatment-resistant depression, designed as a differentiated and scalable option for outpatient and at-home use. By advancing targeted and accessible treatment options, HMNC aims to address significant unmet needs of millions of patients who are not helped sufficiently by existing mental health therapies. The Company is headquartered in Munich, Germany. Find out more at www.hmnc-brainhealth.com and connect with us on LinkedIn. Ketabon is a joint venture between HMNC Brain Health and Develco Pharma focused on developing KET01, an oral prolonged-release ketamine formulation for treatment-resistant depression. Designed for safe and convenient at-home treatment, KET01 has demonstrated rapid antidepressant effects with minimal dissociative side effects in phase 2 studies, potentially offering an important differentiated alternative to existing ketamine-based therapies.

iStock, Kateryna Kovarzh New data from a Phase 3 trial will further support a rolling submission for Compass Pathways’ psilocybin treatment COMP360. Patients who saw a clinically meaningful benefit on depression severity maintained response through week 26. Compass Pathway’s psilocybin treatment worked quickly and durably in patients with treatment-resistant depression during a second late-stage trial, bolstering the psychedelic biotech’s run for an FDA approval. The new readout “paints a consistent picture” of COMP360’s durability, according to Stifel. The company will submit the data to the FDA to support an ongoing rolling submission for COMP360 in treatment-resistant depression (TRD). In the Phase 3 COMP006 trial, 39% of patients with TRD who received two fixed doses of COMP360 achieved a clinically meaningful reduction in depression severity by week six, according to Compass’ Tuesday release . The patients who saw relief maintained a durable response through week 26. At entry to the trial, these patients had depressive episodes lasting over three years on average. Of the patients who achieved the initial meaningful response at week six, 30% later went into remission, Compass said. The company had already revealed week six data in February showing clinically meaningful results. Today’s update provides a long-term look at how patients fared after their initial doses. A quarter of patients who received one dose achieved a clinically meaningful response. Compass said that the readout confirms the value of adding a second dose for some patients. The results appear to be “incrementally better” than what was seen in the earlier COMP005 study, according to Stifel. Safety was comparable to previous studies, with treatment-emergent adverse events that were transient and typically occurred on the day of dosing. However, the readout did disclose a suicide in a patient who had received Compass’ treatment. This was deemed by the investigator to be unrelated to the therapy, as the death took place 80 days after dosing, Stifel noted. The firm said that there were at least three suicides during clinical testing for Johnson & Johnson’s ketamine treatment Spravato. “While obviously very unfortunate, we don’t view this as concerning for ‘360 and deaths do happen in TRD programs as TRD can be a fatal condition,” Stifel wrote. The data collected to date supports the potential for COMP360 to usher in “a profound shift in mental health care,” Compass CEO Kabir Nath said in a statement. COMP360 could allow patients to receive just a few doses per year, rather than staying on chronic, daily treatment, he explained. Compass expects to complete the rolling submission in the fourth quarter, with a launch anticipated in the first half of 2027 if approved. Analysts have been bullish on COMP360’s success, with Jefferies “75-85%+ confident” in an FDA approval, according to a June 22 note. The firm anticipates peak sales of $1.5 billion for the therapy. The drug will face some stiff competition, as Big Pharma in recent years has reengaged with the neuropsych space, but Jefferies is confident that psychedelics players like Compass and rival Definium Therapeutics can carve out a piece of the market. “We believe the large depression market has historically proven it can support multiple new $1B+ blockbusters (e.g. Caplyta, Auvelity, Spravato, Vraylar), leaving ample room for both COMP360 and [Definium’s] DT120 as well as other psychedelic players,” Jefferies wrote. “Net-net, we do not necessarily foresee psychedelics competing against one another (albeit the availability of rooms may be a gating factor), but rather against existing drugs like SSRIs and antipsychotics (chronic dosing), which offer modest efficacy yet have safety liabilities.”