This presentation by Contineum Therapeutics, Inc. ("Contineum", "We" or "Our) contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including without limitation statements regarding our future results of operations and financial position, future revenue, timing, progress and expected results of our clinical trials and our product development efforts, business strategy, prospects, research and development costs, timing and likelihood of ...

SeaStar Medical Holding (ICU) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Company Participants Jackie Cossmon - ConsultantEric Schlorff - CEOTim Varacek - SVP - Commercial & Business OperationsKevin Chung - Chief Medical OfficerDavid Green - CFONicholas Sherwood - Equity Research Associate Operator Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the SeaStar Medical First Quarter Financial Results Con ...

SeaStar Medical Holding (ICU) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Speaker0 Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the SeaStar Medical First Quarter Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. Thank you. I would now like to turn the call over to Jackie K ...

NEW YORK, May 09, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody, today announced results of a PET scan showing a marked reduction in microglia activation associated with neuroinflammation in a patient suffering from moderate Alzheimer's disease (AD) who was treated for three months ...

Reviva Pharmaceuticals Holdings (RVPH) 2025 Conference May 08, 2025 10:30 AM ET Speaker0 Here this morning at the Citizens Life Science Conference. Excited to be joined next by Reviva Pharmaceuticals. Reviva is a company focused on novel treatments for neuropsychiatric diseases. Really glad to be joined by the company's CEO, Laxbot. Lax, thank you for being here. Lax is going to run through a few slides and then we'll jump into Q and A. Speaker1 Yep, thanks. Thanks, Jason. Thanks for having me here. So I re ...

Blueprint Medicines (BPMC) 2025 Conference May 07, 2025 12:00 PM ET Speaker0 Pleasure to welcome the next presenting company, Blueprint Medicines. Joining us here on stage is CEO, Kate Havlund, as well as Fuad Nimani, president and president of research and development. Thank you both for for being here. For all of you in the audience and those in the webcast, you know, this is this has been one of our top picks from soup to nuts, the company that developed drugs, got it to commercialization, and now is on ...

Core Viewpoint - BioVie Inc. is advancing its clinical-stage drug candidate bezisterim (NE3107) for the treatment of early Parkinson's disease, with a Phase 2 clinical trial named SUNRISE-PD set to present findings at the IAPRD 2025 conference in New York City [1][2]. Company Overview - BioVie Inc. (NASDAQ: BIVI) focuses on developing innovative drug therapies for neurological and neurodegenerative disorders, including Alzheimer's disease, Parkinson's disease, and long COVID, as well as advanced liver disease [13]. - The company's lead candidate, bezisterim, is designed to modulate inflammation and enhance insulin sensitivity without immunosuppressive effects, potentially addressing multiple disease indications [8][13]. Clinical Trial Details - The SUNRISE-PD trial is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study lasting 20 weeks, evaluating bezisterim's safety and efficacy in patients with early Parkinson's disease [3][4]. - Patients can participate either from home or at clinical sites, with remote supervision by neurologists during assessments [4]. Parkinson's Disease Context - Parkinson's disease is characterized by the loss of dopamine-producing neurons, leading to motor and non-motor symptoms that significantly impact patients' quality of life [5]. - Traditional treatments like levodopa have limitations, including long-term complications such as motor fluctuations and dyskinesia [6]. Mechanism of Action - Bezisterim targets chronic inflammation and insulin resistance, which are linked to the progression of Parkinson's disease, by modulating neuroinflammation and metabolic dysfunctions [7][8]. Expected Outcomes - Topline data from the SUNRISE-PD trial is anticipated in late 2025 or early 2026, with previous studies indicating bezisterim's potential to improve motor control and reduce adverse events when combined with levodopa [9][10].

MoonLake Immunotherapeutics (MLTX) 2025 Capital Markets Day April 29, 2025 02:15 PM ET Speaker0 Good morning. Good afternoon. Welcome to the capital markets update of Moon Lake Immunotherapeutics. My name is Matthias Bodenstadt. I'm the chief financial officer of the company. With me here today are CEO and co founder, Georges Santos Dasilva and our CSO and co founder, Professor Christian Reich. It's a pleasure to have you here today for the capital markets update. We have a very exciting agenda. We will pro ...

Financial Data and Key Metrics Changes - The base business, excluding Veclury, grew 4% year over year, primarily driven by growth in the HIV business [6][50] - Total product sales, including Veclury, were down by 1% from last year, reflecting fewer COVID-19 related hospitalizations [8][50] - Non-GAAP diluted EPS was $1.81, with a product gross margin flat year over year at 85% [52][54] Business Line Data and Key Metrics Changes - HIV sales were up 6% year over year, with Biktarvy sales increasing by 7% [7][22] - Livedelzi achieved first-quarter sales of $40 million, reflecting early momentum in its launch [27] - Veclury sales were down 45% year over year, reflecting lower rates of COVID-19 related hospitalizations [28] - Trodelvy sales were down 5% year over year, impacted by inventory dynamics and lower average realized price [29][98] - Cell therapy sales were down 3% year over year, with Yescarta sales up 2% year over year [31] Market Data and Key Metrics Changes - The HIV treatment market continues to grow at an expected rate of 23% annually [22] - Descovy sales increased by 38% year over year, driven by higher average realized price and demand [23][78] - The liver disease segment saw sales of $758 million, up 3% year over year [26] Company Strategy and Development Direction - The company is focused on multiple upcoming launches, including lenacapavir, anetocel, and Trodelvy [13][34] - Gilead Sciences, Inc. has no major loss of exclusivity (LOE) until the end of 2033, positioning itself for top-line growth across therapeutic areas [14] - The company is increasing investment in US manufacturing and R&D infrastructure [15][89] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming FDA decision on lenacapavir for PrEP, with a potential launch immediately following [9][38] - The company remains well-positioned to adapt to potential policy outcomes in the US [14] - Management noted that the first quarter was lighter than expected but emphasized the variability of the business [54][93] Other Important Information - Gilead Sciences, Inc. received an upgrade in its long-term debt rating from BBB+ to A- [58] - The company returned $1.7 billion to shareholders in the first quarter of 2025 through dividends and share repurchases [58] Q&A Session Summary Question: Expectations for lenacapavir for PrEP and reimbursement dynamics - Management is excited about the upcoming PDUFA date and expects around 75% access within the first six months post-launch, reaching about 90% at the twelve-month mark [62] Question: Impact of HHS and CDC cuts on launch dynamics - Management has not seen anything that would alter plans for the lenacapavir launch and is actively engaging with policymakers [68] Question: Implications of COVID-19 on Descovy and lenacapavir - Descovy saw a 38% growth year over year, driven by market development initiatives, which supports the opportunity for lenacapavir [78] Question: Tariff risks and US market supply - Management indicated that the majority of Gilead's IP is in the US, which suggests lower value for pharmaceutical imports, and they have invested significantly in US manufacturing [86][89] Question: Cannibalization of Descovy by lenacapavir - Management believes lenacapavir will attract both switch patients from daily orals and naive patients, potentially accelerating market growth [124]

InMed Pharmaceuticals (INM) Update / Briefing November 12, 2024 02:00 PM ET Speaker0 Hello, everyone. Thank you for attending today's Fierce Biotech webinar, Alzheimer's Outlook, The Next Step. I understand we have a great number of attendees on today's webinar, and I want to thank InMed Pharmaceuticals for sponsoring this presentation. My name is Phyllis Fearle, and I will be moderating today's conversation. But before we get started, here's a few quick housekeeping notes. You can access closed captions fr ...