This study aims to compare the efficacy and safety of lumateperone and cariprazine as adjuncts in patients with depression associated with bipolar I using standardized efficacy assessment tools such as the Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impression bipolar severity scale (CGI-BP-S) and recording treatment emergent adverse effect.
Participants will undergo baseline assessment on day 0 using these scales. Follow-up assessments using MADRS and CGI scales will be conducted at Day 15, Day 30 and Day 45. Safety analysis will be performed for all participants who receive at least one dose of study medication. Vitals and treatment-emergent adverse events (TEAEs) will be recorded at every visit

Start Date01 Dec 2026

Sponsor / Collaborator-

NCT07747389

/ Not yet recruitingPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Fixed Doses of Lumateperone Administered as Monotherapy in Participants With Major Depressive Disorder and an Open-label Long-term Extension Treatment With Lumateperone

The purpose of the study is to assess how well each dose of lumateperone (Dose 1 and 2) works when given alone as compared to placebo in participants with major depressive disorder (MDD; a medical condition characterized by a persistent feeling of deep sadness, hopelessness, and a loss of interest in activities for a prolonged period of time and interfere with ability to function).

Start Date20 Oct 2026

Sponsor / Collaborator

Intra-Cellular Therapies, Inc.

NCT07623135

/ RecruitingPhase 3IIT

Lumateperone for Late-Life Depression

The purpose of this research study is to examine how well a medication called lumateperone (Caplyta) works to relieve depression in older adults with treatment-resistant depression. Lumateperone (Caplyta) is approved by the U.S. Food and Drug Administration to treat Major Depressive Disorder in adults who are also taking another antidepressant medication. This study will compare lumateperone (Caplyta) to placebo (a sugar pill without medication).

Start Date01 Aug 2026

Sponsor / Collaborator

Washington University School of Medicine

[+2]

100 Clinical Results associated with Lumateperone Tosylate

100 Translational Medicine associated with Lumateperone Tosylate

100 Patents (Medical) associated with Lumateperone Tosylate

147

Literatures (Medical) associated with Lumateperone Tosylate

01 Nov 2026·JOURNAL OF AFFECTIVE DISORDERS

Efficacy, acceptability, and related outcomes of pharmacological interventions for acute bipolar depression: A systematic review and dose-related network meta-analysis across different age groups

Review

Author: Vieta, Eduard ; Oliva, Vincenzo ; De Prisco, Michele ; Di Lorenzo, Chiara ; Fornaro, Michele

BACKGROUND:

Acute bipolar depression poses a significant burden and socioeconomic costs. We investigated the comparative efficacy/response/acceptability of pharmacological interventions for acute bipolar depression, considering dose effects across different age groups.

METHODS:

We conducted a network meta-analysis (NMA), searching for randomized controlled trials (RCTs) comparing pharmacological interventions against each other/or placebo in patients with acute bipolar depression (Type-I/Type-II/other), indexed in PubMed/MEDLINE, Embase, Web-of-Science/and Scopus (database inception up to 2025.11.25). Co-primary outcomes were change in depressive symptoms/response/and acceptability. Tolerability/remission/change in anxious symptoms/and risk-of-manic/hypomanic switches were secondary outcomes. Confidence-In-Network-Meta-Analysis was likewise appraised.

RESULTS:

103 RCTs, encompassing 71 distinct treatment combinations, included 20,941 participants. Sensitivity analysis including low-risk-of-bias studies only and excluding outliers for possible effect modifiers indicated that lamotrigine 50 mg/day or 200 mg/day, quetiapine extended-release 150 mg/day and 300 mg/day, and lumateperone 42 mg/day outperformed placebo for depressive symptoms, with estimates ranging from -1.53(95%C.I. = -2.13;-0.93) for lamotrigine 50 mg/day, to -0.36(95%C.I. = -0.68;-0.04) for lumateperone 42 mg/day. Several additional drugs might be efficacious, although they emerged as outliers for either mean age of participants/proportion of females/BD-II participants/psychotic features/rapid cycling/baseline severity of depression/and trial duration. No treatment outperformed placebo for response/remission/acceptability/tolerability/and manic/hypomanic switches.

CONCLUSIONS:

Our findings are consistent with previous NMAs and current guidelines, thereby expanding knowledge by concurrently appraising different drugs, doses, and age groups.

14 Sep 2026·XENOBIOTICA

A high-throughput LC-MS/MS method for simultaneous determination of lumateperone and its four metabolites in human plasma: application to a clinical trial

Article

Author: Wang, Rui ; Zhao, Yunli ; Ding, Chenxin ; Ding, Hongjie ; Zhang, Pengfei ; Ding, Juefang ; Wu, Bingda ; Ding, Li

Lumateperone is an antipsychotic metabolised to four active metabolites IC200131, IC200161, IC200565 and IC201308, which are closely related to its clinical efficacy and safety.For evaluating the clinical pharmacokinetics of lumateperone and its active metabolites in Chinese subjects, a high-throughput LC-MS/MS method was developed and validated for the simultaneous quantification of lumateperone and its four metabolites in human plasma. Chromatographic separation was achieved using an alkaline mobile phase and a bidentate silane column (Zorbax Extend-C18) with two-step gradient elution, which overcame peak tailing and carryover while enabling rapid analysis. The calibration ranges were 0.100-80.0 ng/mL for lumateperone and IC200131, 0.0400-32.0 ng/mL for IC200161 and IC201308, and 0.150-30.0 ng/mL for IC200565.The validated method was successfully applied to a pharmacokinetic study of lumateperone tosylate capsules. The clinical trial was registered at the Chinese Clinical Trial Registry (identifier: CTR20242699). Under fasting conditions, the mean C_max values were 30.6 ng/mL for lumateperone, with corresponding AUC_0-t values of 72.8 h·ng/mL. Under fed conditions, food delayed absorption and decreased C_max for all analytes.This study reports the first comprehensive pharmacokinetic profiles of lumateperone and its four active metabolites in Chinese subjects. The validated method provides a robust foundation for pharmacokinetic research of lumateperone in humans.

01 Jul 2026·EUROPEAN NEUROPSYCHOPHARMACOLOGY

Long-term adjunctive lumateperone 42 mg treatment in major depressive disorder: Results from a 6-month open-label extension study

Article

Author: Cutler, Andrew J ; Kozauer, Susan G ; Lakkis, Hassan ; Earley, Willie R ; Durgam, Suresh ; Chen, Changzheng

This Phase 3 open-label extension study (NCT05061719) investigated long-term safety of lumateperone 42mg (simultaneous modulator of serotonin, dopamine, and glutamate neurotransmission) adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) with inadequate ADT response. Eligible adults (18-65years) completed 6-week double-blind treatment (NCT04985942; NCT05061706) and had DSM-5-defined MDD with inadequate response to 1-2 ADTs in the current depressive episode, Montgomery-Åsberg Depression Rating Scale (MADRS) Total score ≥24, and Clinical Global Impression-Severity (CGI-S) score ≥4 at lead-in study entry. Patients received 26-week, open-label, oral lumateperone 42mg+ADT once-daily. The primary endpoint was safety/tolerability, assessed by adverse events (AEs), vital signs, and laboratory parameters. The secondary endpoint was efficacy, assessed by MADRS Total score and CGI-S score changes from double-blind baseline to open-label Week 26. Of 809 patients treated, 84.5% completed open-label treatment; 67.7% experienced ≥1 treatment-emergent AE (TEAE). Most common TEAEs (≥5%) were headache (16.6%), dizziness (10.6%), dry mouth (8.0%), nausea (7.7%), somnolence (7.2%), diarrhea (6.2%), and nasopharyngitis (5.2%). The majority (98.9%) of TEAEs were mild-to-moderate severity. Rate of extrapyramidal symptom (EPS)-related TEAEs per broad standardized MedDRA query was low (3.8%). No notable changes in EPS scales, body morphology, or cardiometabolic parameters occurred from double-blind baseline to end of open-label treatment. No emergence of suicidal behavior occurred during treatment. Symptoms of depression improved with lumateperone+ADT from double-blind baseline to open-label Week 26 (mean change: MADRS Total score=-22.9, P<.0001; CGI-S score=-2.7, P<.0001). Overall, lumateperone 42mg+ADT was safe and effective during 26-week treatment in patients with MDD with inadequate ADT response.

165

News (Medical) associated with Lumateperone Tosylate

18 Aug 2026

·www.biospace.com

Helus Pharma Appoints Regina Donohue as Chief People Officer and Suresh Durgam, M.D., to its Scientific Advisory Board

Former Intra-Cellular Therapies, Inc. (“Intra-Cellular”) executives bring complementary experience in organizational scale-up, central nervous system (“CNS”) drug development, regulatory approvals and commercialization Ms. Donohue is the former Chief Human Resources Officer of Intra-Cellular, where she led the company’s people strategy and human resources infrastructure as it transitioned from a clinical to a commercial stage organization of 1,000+ employees Dr. Durgam is a recognized CNS drug-development leader who played a pivotal role in securing multiple U.S. Food and Drug Administration (“FDA”) approvals for CAPLYTA® (lumateperone), including in schizophrenia, bipolar depression and adjunctive major depressive disorder Appointments support Helus Pharma’s continued growth, scientific leadership and preparation for potential commercialization This news release constitutes a “designated news release” for the purpose of the Company’s prospectus supplement dated December 30, 2025, to its short form base shelf prospectus dated September 17, 2025, as amended on December 19, 2025. NEW YORK and TORONTO, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Helus Pharma (Nasdaq: HELP) (Cboe CA: HELP) (the “Company” or “Helus Pharma”), a clinical-stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists (“NSAs”), today announced the appointment of Regina Donohue as Chief People Officer and the appointment of Suresh Durgam, M.D., to the Company’s Scientific Advisory Board (“SAB”). “I had the pleasure of working with both Regina and Suresh at Intra-Cellular, and I am delighted to welcome them to Helus Pharma,” said Michael Halstead, Chief Executive Officer of Helus Pharma. “As we execute against our upcoming clinical, regulatory and commercial milestones, Regina’s experience thoughtfully scaling organizations and building high-performing teams will be instrumental. Suresh’s deep expertise in CNS clinical development, regulatory strategy and scientific leadership will further strengthen our SAB as we advance our pipeline toward potential commercialization.” Chief People Officer Appointment Ms. Donohue has extensive human resources leadership experience working with life sciences companies amidst their transition from clinical platforms through commercialization by building scalable human resources functions through periods of rapid growth. Most recently, at Intra-Cellular, Ms. Donohue served as Chief Human Resources Officer, where she built the company’s people strategy and infrastructure, and managed its rapid growth as it transitioned into a commercial-stage organization, launched its first product, and grew to 1,000+ employees. Intra-Cellular was acquired by Johnson & Johnson in April 2025. Previously, Ms. Donohue was among the first five executives hired to build LEO Pharma’s U.S. subsidiary, establishing its human resource function and supporting the organization through the rapid growth necessary to launch two products in the U.S. During her tenure at LEO Pharma, she also served as the interim Global Head of Human Resources. “I am thrilled to join a company so deeply committed to advancing innovative treatments for people living with mental health conditions,” said Ms. Donohue. “Mental health is a cause that is personally meaningful to me, and I am particularly excited to bring my experience and passion for building strong, purpose-driven organizations to Helus Pharma. The Company is at an exciting stage of its growth, and I look forward to helping build a patient-centric culture and developing the strong people strategy Helus Pharma will need as it advances towards potential commercialization of its programs.” Ms. Donohue holds a Bachelor of Science from the University of Scranton and professional human resources designations from the HR Certification Institute and Society for Human Resources Management. SAB Appointment Dr. Durgam is a CNS drug-development executive with more than two decades of experience spanning clinical development, medical affairs, regulatory strategy and pharmacovigilance. Most recently, he served as Executive Vice President and Chief Medical Officer of Intra-Cellular, where he provided strategic oversight across global clinical development and operations, data science, regulatory affairs, drug safety and medical affairs. He played a pivotal role in securing FDA approvals for CAPLYTA across multiple indications, including schizophrenia, bipolar depression, as both a monotherapy and adjunctive therapy, and adjunctive major depressive disorder. Earlier in his career, Dr. Durgam held senior clinical-development leadership roles at Allergan, Forest Laboratories and Solvay Pharmaceuticals, with responsibility for programs across major depressive disorder, bipolar disorder, schizophrenia and anxiety disorders. His development experience includes lumateperone, cariprazine, vilazodone, levomilnacipran and other CNS therapies. He has led or supported numerous interactions with regulatory authorities worldwide and authored or co-authored more than 50 peer-reviewed publications and over 200 abstracts and posters. “Helus Pharma is advancing a differentiated CNS pipeline with the potential to address significant unmet needs in mental health,” said Dr. Durgam. “I look forward to working with the Company’s leadership team and fellow SAB members to provide scientific and clinical guidance as Helus Pharma advances its programs through late-stage development.” Dr. Durgam received his psychiatry residency training at Scott & White Memorial Hospital within the Texas A&M University System College of Medicine and earned his medical degree from Siddhartha Medical College in India. He is a member of the Scientific Committee of the International Society for CNS Clinical Trials and Methodology and received the 2026 International Society for CNS Drug Development Leadership Award. About Helus Pharma Helus Pharma™, the commercial operating name of Cybin Inc. is a clinical stage pharmaceutical company committed to helping minds heal by developing proprietary NSAs, synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The Company’s proprietary NSAs are intended to address the large unmet need for people who suffer from depression, anxiety, and other mental health conditions. With class leading data, Helus Pharma aims to improve the treatment landscape through the introduction of NSAs that aim to provide durable improvements in mental health. Helus Pharma is currently developing HLP003, a proprietary NSA, in Phase 3 clinical development for the adjunctive treatment of MDD that has received Breakthrough Therapy Designation from the FDA and HLP004, also a proprietary NSA in Phase 2 for GAD. Additionally, Helus Pharma has an extensive research portfolio of investigational NSAs. The Company operates in Canada, the United States, the United Kingdom, and Ireland. For Company updates and to learn more about Helus Pharma, visit or follow the team on X, LinkedIn, YouTube and Instagram. Helus Pharma™ is a trademark of Helus Pharma Corp. Cautionary Notes and Forward-Looking Statements Certain statements in this news release relating to the Company are forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, “forward-looking statements”) and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “potential”, “possible”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the anticipated contributions of Ms. Donohue and Dr. Durgam; the Company’s continued growth and commercialization of the Company’s programs; execution against clinical, regulatory and commercial milestones; and plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions. These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the NSA market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the three months ended June 30, 2026, and the Company’s annual information form for the year ended March 31, 2026, which are available under the Company's pro SEDAR+ at and with the U.S. Securities and Exchange Commission on EDGAR at Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The FDA, Health Canada or other similar regulatory authorities have not evaluated claims regarding NSAs or HLP003, HLP004 and other programs of the Company. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of NSAs, HLP003, HLP004 or other programs of the Company can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Helus Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations. Neither Cboe Canada, nor the Nasdaq Global Market stock exchange, have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein. Investor Contact: Matthew Beck astr partners Managing Partner (917) 415-1750 Matthew.beck@astrpartners.com Gabriel Fahel Chief Legal Officer Helus Pharma 1-866-292-4601 irteam@helus.com – or – media@helus.com Media Contact: Victoria Verdeja RXMD Public Relations Director (212) 537-9495 cwray@rxmedyn.com

Executive ChangeDrug ApprovalPhase 2

10 Aug 2026

·www.biospace.com

As BMS’ Cobenfy struggles to gain traction, MapLight knocks on the door

iStock, PCH-Vector Despite the recent emergence of a new drug class, schizophrenia remains one of the most challenging neuropsychiatric diseases to treat—and Cobenfy’s first steps into the market indicate there is still room to grow. When the FDA greenlit Bristol Myers Squibb’s Cobenfy in 2024 as the first novel drug for schizophrenia in 35 years, it was widely seen as a turning point in treating the intractable neuropsychiatric disease. But with the drug struggling out of the gate and a still imperfect side effect profile, there is plenty of room for improvement—and competitors. “The magnitude of our effect is deep,” Laura Gault, senior vice president and head of neuroscience development at BMS, told BioSpace in an interview . “Cobenfy is a novel [mechanism of action] with a very different side effect pro to what people have been using for the last 75 years.” Cobenfy—formerly KarXT—is a combination of xanomeline, a muscarinic agonist, and trospium chloride, also a muscarinic antagonist, that came to BMS in the $14 billion acquisition of Karuna Therapeutics in 2023. ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); However, side effects are still a part of the Cobenfy story, particularly with regard to pro-cholinergic symptoms that impact the gastrointestinal system, according to Christopher Kroeger, CEO of MapLight Therapeutics, which is also developing a muscarinic receptor agonist and hopes to compete with BMS’s first-to-market entry. “The challenge with Cobenfy has been that it is not proven to be particularly tolerable,” Kroeger told BioSpace . Because the components of the drug “have to be in exquisite balance, you can have high interpatient variability.” Two years in, however, BMS has already heard a lot of success stories, Gault said, where even after a short time on treatment, patients are seeing “very meaningful changes in terms of a reduction in symptoms, but also their ability to engage in life in a way that they had been unable to do.” Sales numbers, however, reflect a smaller splash. Cobenfy brought in $155 million in sales for BMS in 2025, well below some analysts’ predictions during the drug’s late phase development at Karuna. Early sales forecasts for Cobenfy were more than double this number, Mizuho analyst Graig Suvannavejh told BioSpace . Still, Gault said BMS isn’t concerned with the slow start. Since re-entering the neuroscience space with its $74 billion mega-merger with Celgene in 2019, the company has built up its acumen in the arena, which has enjoyed something of a Big Pharma renaissance over the past few years. “Anytime you bring a new drug, especially a drug with a new [mechanism of action], into the field … [doctors] need to take some time to get to know it,” Gault said.“They need to see those first few experiences with their own eyes before they feel confident to prescribe it regularly.” Suvannavejh agreed that with schizophrenia in particular, requiring a “Goldilocks approach” to balance side effects and efficacy, Cobenfy has strong potential. “I do think Cobenfy can be a good drug,” he said. Schizophrenia FDA Approves First Novel Schizophrenia Drug in 35 Years BMS’ KarXT targets muscarinic receptors and “is at least 2-3 years ahead of the competition” including AbbVie and Neurocrine Biosciences, Truist Securities wrote in a note to investors. September 27, 2024 · 8 min read · Heather McKenzie Read more A balancing act In schizophrenia, decades of treatment have laid bare the challenges inherent in the disease—and the tightrope drug developers must walk between efficacy and tolerability. Older drugs that primarily affect the brain’s dopamine receptor leave patients with “very potent, very harsh side effects,” Suvannavejh said. From earlier medicines like Eli Lilly’s Zyprexa to Johnson & Johnson’s Risperdal to next generation antipsychotics such as BMS’ Abilify and more recently, AbbVie’s Vraylar and J&J’s Caplyta, the mechanism of action remained the same despite differences in potency. “These are just different mousetraps with the same biology, trying to optimize efficacy and safety tolerability,” Suvannavejh said. Enter muscarinics. Marked by sizable acquisitions, including BMS’s purchase of Karuna and AbbVie’s $8.7 billion pick-up of Cerevel Therapeutics in 2023 and emraclidine—which ultimately led to a high-pro failure in schizophrenia—muscarinic receptor inhibitors gained a good deal of attention for their potential to avoid some of the worst side effects of drugs targeting the dopamine receptors. In addition to MapLight, AbbVie continues to progress emraclidine in Phase 2 , while smaller biotechs like Neurocrine BioSciences and Neumora Therapeutics are also hoping to challenge BMS in the muscarinic space. Because muscarinic receptors are not expressed in key brain regions, patients avoid many of the side effects associated with the classic dopamine-based drugs, Carlos Dortrait, senior vice president of neuroscience commercialization and global commercial strategy, told BioSpace prior to Cobenfy’s approval. But Cobenfy’s main muscarinic agonist xanomeline comes with other adverse effects, primarily gastrointestinal, which require an additional ingredient to balance them out and avoid conditions that can lead to poor patient compliance—already a challenge among those with schizophrenia or Alzheimer’s disease psychosis, Suvannavejh said. MapLight hopes to differentiate and challenge Cobenfy on a couple of fronts. MapLight posted mixed trial results from a Phase 2 trial of its candidate earlier this month, garnering significant scrutiny from analysts. The results for ML-007-MA “muted” the competitive threat to Cobenfy, BMO Capital Markets said in a note to investors on July 27. Neuroscience MapLight’s schizophrenia pill remains in Cobenfy’s shadow after mixed Phase 2 readout While MapLight Therapeutics’ oral schizophrenia candidate reached the main endpoint of a Phase 2 trial, analysts say Bristol Myers Squibb’s Cobenfy is likely to hold its market share. July 27, 2026 · 2 min read · Michael Gibney Read more A twice-daily formulation of MapLight’s ML-007C-MA met the Phase 2 ZEPHYR trial’s primary endpoint, reducing symptoms of schizophrenia on the Positive and Negative Syndrome Scale (PANSS) at five weeks, with patients seeing a 4.5-point improvement. However, a once-a-day version of the pill that the company hoped would rival Cobenfy’s twice-daily regimen failed to meet the same expectation. Cobenfy demonstrated an 8-to-10-point reduction in a pair of Phase 3 trials dubbed EMERGENT, according to BMO. Still, Kroeger believes MapLight showed what it needed to earn a place next to Cobenfy on the market. He additionally argued that the results have been “misinterpreted” in the public sphere. The misinterpretation, he said, stems from trying to compare specific PANSS scores across trials and ignoring aspects that are important in the real world, such as cognition and a secondary endpoint measuring clinicians’ global impression of disease severity. MapLight’s drug also demonstrated important signals in cognition, according to Kroeger. While PANSS measures alleviation of so-called positive symptoms such as hallucination, delusion and disordered thinking and negative symptoms including apathy, withdrawal and lack of engagement with the world, 80% of patients with schizophrenia also suffer from cognitive challenges that have a meaningful impact on quality of life, the CEO noted. Unlike Cobenfy—whose cognitive signal data were drawn from post-hoc pooled analyses, according to a MapLight spokesperson—ML-007C-MA hit a prespecified secondary endpoint in the ZEPHYR trial, which looked at cognitive performance. Cobenfy’s market challenges are an opportunity for MapLight to showcase “significant differences in safety we’ve seen in the clinic [that are] going to be even larger when we get to real-world experience,” Kroeger said. “The whole idea was to develop a drug that can give you the same kind of efficacy that Cobenfy delivered in a way that patients can tolerate,” Kroeger said. “And that’s what we showed in the study.” Rates of discontinuation in MapLight’s program were lower than with Cobenfy, Kroeger said, attributing this result to fewer moderate and severe adverse events despite instances of mild side effects such as nausea and vomiting. BMO in its note conceded this point, writing that MapLight’s pill could be more impactful in older adults with schizophrenia alongside Alzheimer’s disease due to lower rates of symptoms such as dry mouth, blurry vision and constipation. MapLight saw a GI discontinuation rate of just 2% in ZEPHYR, the biotech reported. However, BMO said the effect will likely not be enough to derail Cobenfy’s leadership from a market share perspective. Comparing across clinical trials from different drugmakers is messy at best, Suvannavejh said. While acknowledging that MapLight’s “efficacy seemed to fall short of what was shown in the Karuna clinical trials,” the analyst said that given the high unmet need in schizophrenia, there’s room for more than just one or two of the same kind of drug. “Just because we have one muscarinic right now in Cobenfy doesn’t mean there can’t be another five more,” Suvannavejh said.

Clinical ResultPhase 2AcquisitionPhase 3

03 Aug 2026

·www.biospace.com

Helus Pharma Appoints Michael Halstead as Chief Executive Officer

Former President of Intra-Cellular Therapies, Inc. was instrumental in building and scaling the company, which was subsequently acquired by Johnson & Johnson Experienced executive with a proven track record of guiding pharmaceutical companies through late-stage clinical development and commercialization Appointed as Helus Pharma prepares for topline data readout from APPROACH, the first pivotal Phase 3 Study of HLP003 as an adjunctive treatment for Major Depressive Disorder (“MDD”), expected in Q4 2026 This news release constitutes a “designated news release” for the purpose of the Company’s prospectus supplement dated December 30, 2025, to its short form base shelf prospectus dated September 17, 2025, as amended on December 19, 2025. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); NEW YORK and TORONTO, Aug. 03, 2026 (GLOBE NEWSWIRE) -- Helus Pharma (Nasdaq: HELP) (Cboe CA: HELP) (the “Company” or “Helus Pharma”), a clinical-stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists (“NSAs”), today announced the appointment of Michael Halstead as Chief Executive Officer, effective immediately. Mr. Halstead’s appointment comes as Helus Pharma advances HLP003 through late-stage clinical development and prepares for potential commercialization. Enrollment is complete in APPROACH, with topline data expected in Q4 2026, while enrollment continues in EMBRACE, the second pivotal study in the Phase 3 PARADIGM program. Participant rollover is ongoing into EXTEND, the long-term extension study. Mr. Halstead brings 25 years of industry experience, most recently serving as President of Intra-Cellular Therapies, Inc. (“Intra-Cellular”). During his tenure at Intra-Cellular, he played a pivotal role in transforming the company from an early-stage clinical development organization into a fully integrated commercial biopharmaceutical enterprise. He was instrumental in the successful development, launch, and commercialization of CAPLYTA® (lumateperone), which has received approvals across multiple indications, including schizophrenia, bipolar depression and the adjunctive treatment of major depressive disorder. Mr. Halstead also supported the advancement of the company’s pipeline programs in generalized anxiety disorder and neuropsychiatric symptoms associated with Alzheimer’s disease. In addition, he managed multiple equity offerings and led the company’s US$14.6 billion sale to Johnson & Johnson in 2025. “Mr. Halstead’s leadership and operational experience guiding pharmaceutical companies through late-stage development, infrastructure buildout, and commercialization will be invaluable as we execute against our upcoming HLP003 and HLP004 clinical, regulatory, and commercial milestones,” said Eric So, Co-Founder and Executive Chairman. “I’m honored to join the Helus Pharma team at this crucial stage in the Company’s evolution,” said Mr. Halstead. “HLP003, a potential differentiated new option in the adjunctive treatment landscape for MDD, and HLP004, a compelling short-acting compound in development for generalized anxiety disorder, position Helus Pharma to pursue a unique approach focused on the outcomes that matter most to patients.” “The clinical results in the HLP003 program to date suggest the potential to transform the treatment paradigm for MDD. I am impressed with the program’s rigor and focus on providing the optimal solution for patients, providers, and payors. The Company’s intellectual property portfolio of more than 350 patent applications and more than 100 granted patents worldwide provide a solid foundation for continued growth,” concluded Mr. Halstead. Prior to his time at Intra-Cellular, Mr. Halstead held senior leadership roles at Warner Chilcott plc where he oversaw major strategic initiatives, including the US$3 billion acquisition of Procter & Gamble’s pharmaceutical business in 2009 and the integration of its approximately 2,000 employees across multinational operations and Warner Chilcott’s US$8.5 billion sale to Actavis in 2013. Mr. Halstead holds a J.D. from Villanova University Charles Widger School of Law and a B.A. in International Relations from Boston University. About Helus Pharma Helus Pharma™, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company committed to helping minds heal by developing proprietary NSAs, synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The Company’s proprietary NSAs are intended to address the large unmet need for people who suffer from depression, anxiety, and other mental health conditions. With class-leading data, Helus Pharma aims to improve the treatment landscape through the introduction of NSAs that aim to provide durable improvements in mental health. Helus Pharma is currently developing HLP003, a proprietary NSA, in Phase 3 clinical development for the adjunctive treatment of MDD that has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration and HLP004, also a proprietary NSA in Phase 2 for GAD. Additionally, Helus Pharma has an extensive research portfolio of investigational NSAs. The Company operates in Canada, the United States, the United Kingdom, and Ireland. For Company updates and to learn more about Helus Pharma, visit or follow the team on X, LinkedIn, YouTube and Instagram. Helus Pharma™ is a trademark of Helus Pharma Corp. Cautionary Notes and Forward-Looking Statements Certain statements in this news release relating to the Company are forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, “forward-looking statements”) and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “potential”, “possible”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company’s plan to readout HLP003 topline data in the fourth quarter of 2026; the Company’s expectation that HLP003 will be a differentiated new option in the adjunctive landscape for patients living with MDD; the potential of HLP003 to transform the treatment paradigm for MDD; the potential of HLP003 to meaningfully improve outcomes for patients living with MDD; the commercialization of HLP003; the Company’s continued growth; and plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions. These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the NSA market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the year ended March 31, 2026, and the Company’s annual information form for the year ended March 31, 2026, which are available under the Company's pro SEDAR+ at and with the U.S. Securities and Exchange Commission on EDGAR at Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The FDA, Health Canada or other similar regulatory authorities have not evaluated claims regarding NSAs or HLP003, HLP004 and other programs of the Company. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of NSAs, HLP003, HLP004 or other programs of the Company can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Helus Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations. Neither Cboe Canada, nor the Nasdaq Global Market stock exchange, have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein. Investor Contact: Matthew Beck astr partners Managing Partner (917) 415-1750 Matthew.beck@astrpartners.com George Tziras Chief Business Officer Helus Pharma 1-866-292-4601 irteam@helus.com – or – media@helus.com Media Contact: Charlotte Wray RXMD Chief Client Services Officer cwray@rxmedyn.com

Executive ChangePhase 3Phase 2Drug Approval

100 Deals associated with Lumateperone Tosylate

External Link

KEGG	Wiki	ATC	Drug Bank
D11170	Lumateperone Tosylate	N05A	DB06077

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bipolar I disorder	United States	Intra-Cellular Therapies, Inc.	24 Apr 2026
Bipolar II disorder	United States	Intra-Cellular Therapies, Inc.	24 Apr 2026
Depressive Disorder	United States	Johnson & Johnson	07 Nov 2025
Depressive Disorder, Major	United States	Intra-Cellular Therapies, Inc.	05 Nov 2025
Bipolar Disorder	United States	Intra-Cellular Therapies, Inc.	17 Dec 2021
Schizophrenia	United States	Intra-Cellular Therapies, Inc.	20 Dec 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder, Treatment-Resistant	Phase 3	United States	Intra-Cellular Therapies, Inc.	01 Aug 2026
Irritable Mood	Phase 3	United States	Intra-Cellular Therapies, Inc.	22 Nov 2024
Mania	Phase 3	United States	Intra-Cellular Therapies, Inc.	19 Jun 2024
Mania	Phase 3	Bulgaria	Intra-Cellular Therapies, Inc.	19 Jun 2024
Mania	Phase 3	Croatia	Intra-Cellular Therapies, Inc.	19 Jun 2024
Mania	Phase 3	India	Intra-Cellular Therapies, Inc.	19 Jun 2024
Mania	Phase 3	Serbia	Intra-Cellular Therapies, Inc.	19 Jun 2024
Autism Spectrum Disorder	Phase 3	United States	Intra-Cellular Therapies, Inc.	25 Jan 2024
Autism Spectrum Disorder	Phase 3	Colombia	Intra-Cellular Therapies, Inc.	25 Jan 2024
Autism Spectrum Disorder	Phase 3	Serbia	Intra-Cellular Therapies, Inc.	25 Jan 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05061706 \| NCT04985942 (Pubmed \| CNS Drugs)	Phase 3	Depressive Disorder, Major	964	Lumateperone 42 mg + ADT	vjonhebadf(qsnxxgeloi) = kjxzhlikcy kagkxuwjqf (pjmnacfrto ) View more	Positive	15 Jul 2026
				Placebo + ADT	vjonhebadf(qsnxxgeloi) = tvpagziatv kagkxuwjqf (pjmnacfrto ) View more
NCT05356013 (CTgov)	Phase 2	Borderline Personality Disorder	60	Placebo (Placebo)	mqewbraqjf(mhmyramlvb) = tktypxnoai jticcdjztn (hvduzjnvbm, 6.8) View more	-	23 Apr 2026
				Caplyta (Caplyta)	mqewbraqjf(mhmyramlvb) = ulszjhdfwz jticcdjztn (hvduzjnvbm, 4.06) View more
NCT04779177 (CTgov)	Phase 1	Schizoaffective disorder \| Schizophrenia	26	Lumateperone 42 mg	iaqefluttl(bhkikkfxgc) = wnrjwiyyco jjhdgumgxy (bcdwevxdhm, 11.21) View more	-	12 Nov 2025
NCT02600494 (CTgov)	Phase 3	Bipolar Disorder \| Bipolar II disorder \| Depressive Disorder, Major	554	Placebo	zjpnfhnpze(zypeyahgmm) = ptipbsmtcs lesmskzmsh (rvrnoxhgib, 1.11) View more	-	03 Nov 2025
NCT05061719 (CTgov)	Phase 3	Depressive Disorder, Major	812	Lumateperone	knukhtoddx = qxejpipsjf txuzowebzb (dwcsjkxsoe, brnctlvakh - urymwkmzxi) View more	-	03 Nov 2025
NCT01499563 (CTgov)	Phase 2	Schizophrenia	335	Placebo	iiydzhydqj(ctqbewjgua) = ahdbycebpb zlhacpwnzt (cdogrdubcy, 1.7) View more	-	03 Oct 2025
NCT02469155 (CTgov)	Phase 3	Schizophrenia	696	ITI-007 (Lumateperone 14 mg (ITI-007 20 mg Tosylate))	ljjsqjpnzw(ultraaocma) = srpsgpztft recresztkb (sotphcujrr, 1.27) View more	-	02 Oct 2025
				ITI-007 (Lumateperone 42 mg (ITI-007 60 mg Tosylate))	ljjsqjpnzw(ultraaocma) = nxjxutlkxp recresztkb (sotphcujrr, 1.23) View more
NCT02282761 (CTgov)	Phase 3	Schizophrenia	450	ITI-007 (Lumateperone 28 mg (ITI-007 40 mg Tosylate))	hkkfpsxckw(gduyvujeyt) = kkozopapvj grsjbjrlxn (ozhtkmdkvv, 1.27) View more	-	02 Oct 2025
				ITI-007 (Lumateperone 42 mg (ITI-007 60 mg Tosylate))	hkkfpsxckw(gduyvujeyt) = vnuvrqgqum grsjbjrlxn (ozhtkmdkvv, 1.25) View more
NCT04985942 (CTgov)	Phase 3	Depressive Disorder, Major	485	Lumateperone (Lumateperone 42 mg)	mgyjtghyov(vetvxodyyh) = yvmissxqpy zfkcuvyhjj (ufsgeegone, 0.54) View more	-	02 May 2025
				Placebo (Placebo)	mgyjtghyov(vetvxodyyh) = opdltymytl zfkcuvyhjj (ufsgeegone, 0.53) View more
NCT05061706 (ITI-007-502, CTgov)	Phase 3	Depressive Disorder, Major	480	Lumateperone (Lumateperone 42 mg)	cbdamnadut(qplbuwwztd) = utbgbzapcm idepzadlia (ogkaahrsio, 0.56) View more	-	25 Mar 2025
				Placebo (Placebo)	cbdamnadut(qplbuwwztd) = vtsnhuvieq idepzadlia (ogkaahrsio, 0.54) View more

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