DENVER, CO / ACCESS Newswire / January 20, 2026 / Aytu BioPharma, Inc. (the "Company" or "Aytu") (Nasdaq:AYTU), a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients, today provided a summary of the Company's Investor Day, held today, Tuesday, January 20, 2026, at 11:00 a.m. Eastern time in New York City. The Investor Day was conducted both in-person and via webcast. A replay of the event can be found on the ...

Introduction Josh Disbrow Co-Founder & Chief Executive Officer Forward Looking Statements EXXUA™ Launch Aytu BioPharma Investor Day January 20, 2026 Actor portrayals. This presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended ("Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended ("Exchange Act"). All statements other than statements of historical facts contained in this presentation, are forward-looking s ...

Core Insights - BrainsWay's strategic investment in Neurolief has led to the FDA granting Premarket Approval for the Proliv™Rx system, the first at-home neuromodulation device for major depressive disorder (MDD) patients who have not responded to previous antidepressants [1][2][3] Company Overview - BrainsWay is a leader in noninvasive brain stimulation technologies, focusing on advanced treatments for mental health disorders [5] - The company utilizes its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform to provide effective treatments for various mental health conditions, including MDD, obsessive-compulsive disorder, and smoking addiction [5] Neurolief Overview - Neurolief is a pioneering company in neuromodulation, known for developing the first wearable, non-invasive, multi-channel brain neuromodulation system designed for home use [4] - The Proliv™Rx device is indicated for adults with MDD who have not achieved satisfactory improvement from at least one prior antidepressant [4] Regulatory Milestone - The FDA's approval of Proliv™Rx marks a significant advancement in the treatment landscape for refractory MDD, allowing for treatment in both home and clinical settings [2][3] Strategic Positioning - BrainsWay's investment in Neurolief, which includes an option to acquire the company, aims to enhance its market value and expand its addressable market by providing access to patients who may struggle to visit clinics [3]

Core Insights - Biohaven Ltd. reported results from a Phase 2 proof-of-concept study for BHV-7000 targeting major depressive disorder (MDD), which did not meet its primary endpoint of reducing depressive symptoms compared to placebo [1] Study Results - The study showed trends favoring BHV-7000 in clinically relevant subgroups, particularly among participants with more severe depression at screening and baseline [2] - BHV-7000 was found to be safe and well-tolerated, with adverse events primarily mild to moderate and largely resolving spontaneously [3] Strategic Focus - The company views the subgroup analyses as hypothesis-generating but plans to prioritize resources on key areas such as immunology, obesity, and epilepsy, foregoing additional psychiatric clinical trials [4] Analyst Commentary - Analysts consider the Phase 2 miss a setback but not unexpected, citing ongoing challenges in MDD trials, including execution risk and rising placebo response [5] - Concerns remain regarding the efficacy of the extended-release formulation of opakalim, as no efficacy signal was observed and adverse event rates were similar between BHV-7000 and placebo [6] - Caution is advised against overinterpretation of favorable signals in severely depressed patients due to the small sample size in the analysis [7] Market Reaction - Following the news, Biohaven shares fell by 15.45% to $9.14 in premarket trading [8]

Summary of Aytu Biopharma Conference Call Company Overview - Aytu Biopharma is a specialty pharmaceutical company founded in 2015, focusing on ADHD and pediatric products, with a revenue of approximately $66 million, of which $58 million is from ADHD products [4][5] - The company has a program called Aytu Rx Connect, partnering with 1,000 pharmacies to ensure patients have access to prescriptions at a maximum cost of $50 [6] New Product Launch - Aytu Biopharma is preparing to launch a new product, ExuA, for major depressive disorder (MDD), which is a $22 billion market [8] - ExuA is a novel treatment that targets the 5-HT1A receptor, differentiating it from existing SSRIs and SNRIs that often cause side effects like sexual dysfunction and weight gain [9][10] - The product is expected to launch by December 2025, with initial sales to wholesalers and a more significant revenue impact anticipated by June 2026 [32] Market Dynamics - The MDD market sees 340 million prescriptions annually in the U.S., with SSRIs and SNRIs accounting for about 60% of these [12] - Competitors like Trintellix, Avelity, and Spravato have seen growth but share similar side effects that ExuA aims to avoid [13][14] - Government payers are required to cover depression treatments, which could account for 30-40% of the market for ExuA [19] Financial Performance - For the fiscal year 2025, Aytu reported $66.4 million in revenue and an adjusted EBITDA of $9.2 million, marking three consecutive years of positive adjusted EBITDA [36] - The company raised $15 million in June 2025 to support the launch of ExuA, with a cash balance of $31 million as of June 30, 2025 [39][40] Strategic Initiatives - Aytu is focusing on refining sales territories and engaging with psychiatrists, as 60% of their current psychiatrist contacts overlap with the target market for ExuA [18] - The company is also working on branding and promotional strategies to effectively communicate the benefits of ExuA to clinicians [20] Investor Outlook - The management believes ExuA could quickly become a $50 million business within a year of launch, based on the number of prescriptions and the product's unique selling points [42] - The company is exploring ways to extend the patent life of ExuA, which currently has a five-year runway [52][53] Key Takeaways - Aytu Biopharma is positioned for growth with the upcoming launch of ExuA, targeting a significant market opportunity in MDD while leveraging its existing ADHD business [5][8] - The company has a solid financial foundation and strategic plans in place to maximize the potential of its new product [36][39]

Financial Data and Key Metrics Changes - For fiscal year 2025, net revenue was $66.4 million, a slight increase from $65.2 million in the previous year [28] - Adjusted EBITDA for the year was $9.2 million, marking the third consecutive year of positive adjusted EBITDA, down from $10.8 million in the prior year [34][33] - Gross margin decreased to 69% from 75% in the previous year, primarily due to increased cost of sales in ADHD inventory [29][30] Business Line Data and Key Metrics Changes - ADHD portfolio net revenue was $57.6 million, slightly down from $57.8 million, attributed to a decrease in the number of prescriptions written [28] - Pediatric portfolio revenue increased to $8.8 million from $7.3 million, reflecting a successful return-to-growth plan [29] Market Data and Key Metrics Changes - The U.S. market for major depressive disorder (MDD) is over $22 billion, with Exua targeting a significant portion of this market [7][9] - SSRIs and SNRIs represent over 60% of all antidepressants prescribed, indicating a competitive landscape for Exua [9][10] Company Strategy and Development Direction - The company is focusing on the launch of Exua, a novel treatment for MDD, which is expected to transform its business model [4][7] - Aytu BioPharma plans to leverage its psychiatry-focused sales force and proprietary patient access platform to drive product acquisitions aligned with its focus [6][19] - The company aims to minimize coverage barriers and enhance patient access through strategic payer contracting [17][52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming launch of Exua, highlighting positive feedback from psychiatrists regarding the product [41][43] - The company anticipates that the Exua launch will position it as one of the fastest-growing CNS-focused companies in the industry [44] Other Important Information - The company has launched an authorized generic of Adzenys to maintain market share amid potential competition from Teva [21] - Aytu BioPharma has successfully raised $16.6 million through a public offering to support the Exua launch [35] Q&A Session Summary Question: Will there be a national sales meeting for Exua? - Management confirmed that a sales meeting is planned before the full launch in the first calendar quarter of 2026 [47] Question: Will promotional materials be pre-cleared? - Management stated they do not plan to pre-clear promotional materials but will follow the traditional submission process [48] Question: What is the strategy for engaging with payers? - Management indicated a selective approach to payer engagement, focusing on ensuring favorable contracting without undermining margins [50][52] Question: What are the expectations for ADHD and pediatric portfolio contributions? - Management expects the ADHD and pediatric portfolios to cover general and administrative expenses, with a break-even target of approximately $13 million quarterly [60][62] Question: What is the medical affairs strategy for Exua? - Management outlined plans for extensive medical affairs efforts, including presentations at medical conferences and educational programs [63]

Summary of Acadia Pharmaceuticals FY Conference Call Company Overview - **Company**: Acadia Pharmaceuticals (NasdaqGS:ACAD) - **Event**: FY Conference held on September 18, 2025 Key Points on Prader-Willi Syndrome (PWS) Program - **Upcoming Data**: Top line phase 3 COMPASS data for ACP-101 (carbetocin) expected in early Q4, possibly October [3][4] - **Mechanism of Action**: ACP-101 is a modified version of oxytocin, designed to enhance pharmacokinetics and selectivity for the oxytocin receptor, which is relevant for treating hyperphagia in PWS [4][5] - **Animal Studies**: Evidence suggests that oxytocin replacement can mitigate hyperphagic behaviors in animal models of PWS [5] - **Clinical Trials**: Previous oxytocin studies showed mixed efficacy results but consistent safety and tolerability [7] - **Inverse Dose Response**: Prior phase 3 trial indicated an inverse dose response, with a significant p-value of 0.016 for the lower 3.2 mg dose compared to placebo [12] - **Safety Profile**: No serious adverse events reported in previous studies; some nosebleeds observed at higher doses [16][17] COMPASS Study Design - **Enrollment**: Target of 170 patients, randomized 1:1 between 3.2 mg dose and placebo [20] - **Primary Endpoint**: HQ-CT to measure hyperphagia-related behaviors [20][21] - **Secondary Endpoints**: Include clinician global impressions and caregiver burden assessments [21] ACP-204 Development - **New Compound**: ACP-204 is a next-generation 5HT2A inverse agonist aimed at treating Alzheimer's disease psychosis and Lewy body dementia [27][28] - **Study Design**: Phase 2 study with 318 patients, operationally seamless with phase 3 [29] - **Primary Endpoint**: SAPS-H and D at week six [29] - **Biomarker Confirmation**: Required for Alzheimer's disease psychosis patients, but not for Lewy body dementia [36][37] ACP-211 Overview - **New Compound**: ACP-211 is a noradrenaline compound for major depressive disorder (MDD) [38] - **Phase 2 Study**: Set to start in Q4 with 150 patients, focusing on moderate response [40] - **Safety Profile**: Aims for ketamine-like efficacy without sedation or significant dissociation [39][41] Business Development Strategy - **Focus Areas**: Emphasis on neuropsychiatry and rare diseases, particularly phase 2 assets [42] - **Pipeline Catalysts**: Key upcoming data includes ACP-101 in early Q4 and initiation of several new trials [43] Additional Insights - **Stakeholder Engagement**: Positive feedback from KOLs and caregivers regarding the potential treatment options for PWS [25] - **Regulatory Considerations**: FDA's focus on HQ-CT as a primary efficacy endpoint for approval [24] This summary encapsulates the critical insights and developments discussed during the Acadia Pharmaceuticals FY Conference, highlighting the company's ongoing research and strategic direction in neuropsychiatry.

Core Insights - Tonix Pharmaceuticals is advancing TNX-102 SL, a potential first-in-class treatment for major depressive disorder (MDD), with an IND application expected in Q4 2025 [1][3] - TNX-102 SL is already FDA-approved for fibromyalgia and is being explored for its effects on sleep quality and depressive symptoms [1][2] Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates [5] - The company recently received FDA approval for Tonmya™, a non-opioid analgesic for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [6] - Tonix's development portfolio focuses on central nervous system disorders, immunology, immuno-oncology, and infectious diseases [6] Product Development - TNX-102 SL is a patented sublingual formulation designed for rapid absorption, bypassing first-pass metabolism, and is currently approved for fibromyalgia [4] - The drug is also being developed for other indications, including acute stress reaction, PTSD, and Long COVID [4] - The FDA provided positive feedback during the Pre-IND meeting, indicating a reasonable long-term safety data collection plan [2][3] Clinical Data - In the Phase 3 RESILIENT study, TNX-102 SL showed significant improvement in depressive symptoms among fibromyalgia patients compared to placebo, with a p-value of less than 0.05 [3] - The biological relationship between depressive symptoms in fibromyalgia and MDD remains unclear [3] Intellectual Property - Tonix holds multiple patents related to TNX-102 SL, providing market exclusivity until at least 2034, with potential extensions until 2044 for method of use [4]

Core Points - New York State Medicaid will cover Transcranial Magnetic Stimulation (TMS) services for adults diagnosed with major depressive disorder (MDD) starting October 1, 2025, for fee-for-service members and November 1, 2025, for those in Managed Care Plans [1][2] - This policy change will benefit nearly 1 million individuals with fee-for-service Medicaid and over 4.4 million individuals with Managed Care Organizations in New York [2] - Major depressive disorder affects 21 million adults in the U.S., with 6.4 million unable to tolerate or receiving inadequate relief from antidepressants [3] Company Overview - Neuronetics, Inc. is a medical technology company focused on neurohealth disorders and is the maker of NeuroStar Advanced Therapy, the leading provider of TMS [1][5] - NeuroStar Advanced Therapy is a non-drug, non-invasive treatment that has shown an 83% response rate and a 62% remission rate for MDD patients [3] - Neuronetics operates Greenbrook TMS Inc. treatment centers across the U.S., providing NeuroStar Advanced Therapy and has delivered over 7.6 million treatments [5] Industry Context - The decision by New York State Medicaid reflects a growing recognition of TMS as an evidence-based treatment for depression [2] - Neuronetics is the only TMS company with a dedicated health policy team advocating for health policy updates [4] - The NeuroStar Advanced Therapy System is FDA-cleared for various indications, including MDD and anxiety symptoms in adults [6]

Core Insights - The FDA has approved the Magstim Horizon 3.0 and Inspire Transcranial Magnetic Stimulation (TMS) Systems for treating major depressive disorder (MDD) in adolescents aged 15-21, providing a non-invasive treatment option [1][2] - Major depression affects over 5 million adolescents in the U.S. annually, with 20% of those aged 12 to 16 experiencing at least one major depressive episode [1][3] - TMS is a non-invasive procedure that stimulates nerve cells in the brain, improving symptoms of MDD without the systemic side effects associated with traditional antidepressants [2][5] Company Insights - Magstim is the only TMS system capable of treating MDD, Anxious Depression, OCD, and Adolescent Depression with a single treatment coil [4] - The company has delivered over 400 million treatment pulses using the Horizon 3.0 system, demonstrating its extensive application in mental health treatment [5] - Magstim has a long history in TMS technology, having developed the first system over 30 years ago, with over 16,000 studies published worldwide citing its stimulators [5] Industry Insights - The approval of TMS for adolescents reflects a growing need for innovative treatment options in mental health, particularly for young patients who may not respond to or prefer not to use antidepressants [2][4] - The WHO emphasizes the importance of addressing untreated depression during adolescence, as it is a leading cause of illness and disability [3] - The advancement in TMS technology aligns with the increasing demand for non-pharmacological treatment methods in mental health care [4]