Core Viewpoint - Helus Pharma has appointed Michael Cola as CEO at a pivotal moment for the company, as it advances its next-generation mental health therapies and approaches critical clinical milestones [2][3]. Company Developments - Helus Pharma is progressing its clinical pipeline, with HLP004 Phase II data expected to be released this quarter and HLP003 Phase III topline data anticipated in Q4 2026 [2][6]. - The company has submitted over 350 patent applications globally and has received more than 100 patents, indicating a strong intellectual property portfolio [2]. - Helus Pharma is focused on addressing severe mental health disorders through differentiated projects and is transitioning from early clinical development to late-stage execution [2][6]. Leadership Appointment - Michael Cola brings over 30 years of experience in neuroscience, rare diseases, and specialty pharmaceuticals, making him a suitable leader for Helus [3][4]. - Cola's previous achievements include transforming Shire into a leader in the CNS field and significantly increasing its market value from $5 billion to $20 billion [4][5]. - Cola has also held leadership roles in various companies, contributing to successful clinical transitions and product launches [5][6]. Company Background - Helus Pharma, established in 2019, focuses on developing proprietary new serotonin agonists (NSAs) aimed at improving mental health recovery [8]. - The company is currently developing two proprietary NSAs: HLP003, in Phase III for major depressive disorder, and HLP004, in Phase II for generalized anxiety disorder [8]. - Helus Pharma aims to address the significant unmet treatment needs of patients with depression, anxiety, and other mental health disorders [8].

Core Viewpoint - Helus Pharma has appointed Michael Cola as CEO to lead the company through pivotal clinical milestones in its mental health therapy pipeline, focusing on novel serotonergic agonists [2][3][4]. Company Overview - Helus Pharma, a clinical stage pharmaceutical company, is dedicated to developing novel serotonergic agonists aimed at treating mental health disorders such as depression and anxiety [8][9]. - The company has filed over 350 patent applications globally and holds more than 100 granted patents, indicating a strong intellectual property position [3]. Leadership Appointment - Michael Cola's appointment as CEO is seen as crucial for advancing Helus's pipeline, particularly with upcoming Phase 2 data for HLP004 and Phase 3 topline data for HLP003 [3][6]. - Cola has over 30 years of experience in neuroscience and pharmaceuticals, having previously led significant growth initiatives at Shire and other companies [4][5]. Clinical Development - Helus is advancing HLP003, which is in Phase 3 for major depressive disorder and has received Breakthrough Therapy Designation from the FDA, and HLP004, currently in Phase 2 for generalized anxiety disorder [9]. - The company aims to improve treatment outcomes for serious mental health disorders through its differentiated pipeline of NSAs [9]. Market Position and Strategy - The company is focused on global regulatory engagement and long-term commercial planning as it transitions from early clinical development to later-stage execution [3]. - Cola's leadership is expected to enhance the company's ability to translate scientific advancements into effective therapies and shareholder value [4][5].

Summary of Phathom Pharmaceuticals Conference Call Company Overview - **Company**: Phathom Pharmaceuticals - **Product**: VOQUEZNA, a first-in-class P-CAB approved for gastroesophageal reflux disease (GERD) treatment - **Market Focus**: Targeting patients who are refractory to traditional PPI therapies Key Points and Arguments Commercial Strategy and Market Focus - Phathom has pivoted its commercial strategy to focus more on the gastroenterology (GI) community, which is where the majority of patients experiencing significant GERD symptoms are referred [4][6] - The company aims to target the 20 million PPI prescriptions written within GI practices, with a current penetration of approximately 3% [10][11] - The goal is to increase penetration to 20%-30% within the GI community, potentially generating $1 billion in revenue from this segment alone [12] Financial Performance - Revenue growth has been significant, with $10 million increases from Q1 to Q2 and Q2 to Q3, reaching $49.5 million in Q3 [7][8] - Operating expenses were reduced from $98 million in Q1 to $49 million in Q3, achieving a 50% cut in cash operating expenses [8] - The company expects to reach positive operating profit by 2026, focusing on cash basis excluding stock compensation and interest expenses [9] Sales Force Realignment - The sales force has been realigned to focus 70% of their time on gastroenterologists, shifting from a previous 70/30 split favoring primary care [20][27] - Territories have been remapped to optimize call frequency on gastroenterologists, allowing for better engagement and education about VOQUEZNA [29] Adoption and Utilization - Adoption patterns among physicians are gradual, with initial focus on patients who have failed multiple PPI therapies [18][19] - The company tracks physician prescribing frequency to reinforce habits and increase script volume [45][46] - There is a strong emphasis on patient feedback to encourage physician adoption, as patients report significant improvements in their symptoms [32][66] Medicare and Patient Access - The introduction of Medicare coverage has positively impacted prescription volumes, with a notable increase in cash prescriptions due to the availability of the Blink patient assistance platform [48][56] - The company is tracking both covered and cash prescriptions separately, with cash prescriptions growing since the Medicare rollout [49][56] Future Opportunities - Phathom is initiating a clinical trial for eosinophilic esophagitis (EOE), which could lead to additional market opportunities and an extension of exclusivity for VOQUEZNA [67][70] - Successful trials could result in a six-month exclusivity extension, potentially delaying generic competition until late 2033 or 2034 [70] Additional Important Insights - The company has implemented financial discipline in its spending, which is expected to support future profitability [72] - The transformative effect of VOQUEZNA on patient quality of life is a key selling point that is expected to drive further adoption among physicians [33][66]