Vaxcyte (PCVX) Conference June 05, 2025 09:55 AM ET Speaker0 Alright. Welcome, everyone, to twenty twenty five Jefferies Global Healthcare Conference. My name is Roger Song, one of the senior analysts covering mid cap biotech in The US. It's my pleasure to introduce next presenting company, Backside. So we have a whole crew here. We're gonna have a fireside chat with the CEO, Grant, president and CFO, Andrew, and then COO, Jim. Good morning, gentlemen. Speaker1 Good morning, Roger. Good morning. Speaker0 Aw ...

- Study will assess relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA comparator at 12 months - SOUTH SAN FRANCISCO, Calif., May 27, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced the first patient was dosed in the 10,000-participant portion of its ongoing Phase 2b clinical trial evaluating its oral pill COVID-19 vaccine candidate. “Initiating dosing in the 10,000-participant portion of this study is a significant st ...

NEW YORK, May 20, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, announced today that Mai-Britt Zocca, PhD, the company’s President and CEO, along with Amy Sullivan, the company’s CFO, and Qasim Ahmad, MD, the company’s CMO, will be participating in a fireside chat at the TD Cowen 6th Annual Oncology Summit: Insights for ASCO & EHA being held virtually May 27-28, 2025. Additionally ...

"We are pleased to receive BARDA approval to move forward with dosing in this large-scale study and expect to dose the first patient in this cohort in the second quarter of 2025," said Steven Lo, Chief Executive Officer of Vaxart. "We are deeply grateful for the continued support of our government partners at HHS and BARDA, whose collaboration is critical to advancing our clinical development program." The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study. It is designe ...

Summary of Vaxcyte (PCVX) Conference Call Company Overview - Vaxcyte is a clinical-stage biotechnology company focused on developing next-generation pneumococcal vaccines, particularly the PPD franchise [2][3][4] Core Points and Arguments Development Programs - The company is preparing to initiate a Phase III program for its adult pneumococcal vaccine, with positive data recently unveiled for the infant indication [4][8] - The Phase III program is expected to start by mid-2025, with a non-inferiority study reading out in 2026 and additional studies concluding by 2027 [8][9] Regulatory Environment - Vaxcyte is operating under a breakthrough therapy designation, allowing for more frequent discussions with the FDA [16][17] - The company does not anticipate the need for placebo-controlled trials for its vaccines, given established safety and efficacy [14][15] Competitive Landscape - Vaxcyte's 31-valent vaccine is positioned to be competitive in the market, with a focus on demonstrating expanded coverage for adults previously vaccinated with other pneumococcal vaccines [11][12][27] - The company believes that having the broadest serotype coverage (95% disease coverage) will provide a competitive advantage [27][30] Financial Position - As of March 31, Vaxcyte reported approximately $3 billion on its balance sheet, which is expected to support key milestones through 2027 [59][61] - The company is evaluating its investment priorities to further strengthen its financial position [61] Manufacturing Readiness - Vaxcyte plans to launch its adult vaccine from existing facilities and is building a new dedicated facility with Lonza, expected to be completed early next year [62][63] Important but Overlooked Content - The company is closely monitoring the macro environment, including potential policy changes in Washington, but asserts that these have not impacted its fundamental mission [5][6] - Vaxcyte is exploring higher doses in its ongoing studies to optimize the immune response for its vaccines [44][45] - The company is addressing enrollment dynamics for its trials, noting a slight decrease in infant enrollment but compensating by increasing the number of sites [57][58] This summary encapsulates the key points discussed during the Vaxcyte conference call, highlighting the company's strategic direction, competitive positioning, and financial health.

Moderna (MRNA) kicked off 2025 with mixed first-quarter results. While its streamlining efforts improved bottom-line numbers, the steep decline in revenues raises concerns.While sales of its COVID-19 vaccine continue to decline as expected in a post-pandemic market, Moderna is taking proactive steps to reshape its future. The company is swiftly advancing multiple pipeline candidates across late-stage development, with the intent to diversify its existing revenue base and launch multiple new products over th ...

- Topline data expected in mid-2025 - SOUTH SAN FRANCISCO, Calif., April 30, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it completed enrollment of its Phase 1 clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs. “Completing enrollment in this trial bring us one step closer in our development of a norovirus vaccine, where there is a significant unmet need,” said Steven Lo, Chief Executive Officer ...

Core Insights - IO Biotech is advancing novel immune-modulatory therapeutic cancer vaccines, with a focus on reshaping the tumor microenvironment and enhancing T cell activation [1][2][3] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company based in Copenhagen, Denmark, with a US headquarters in New York, specializing in off-the-shelf therapeutic cancer vaccines [3] - The company is developing its lead investigational cancer vaccine candidate, Cylembio® (IO102-IO103), which has received Breakthrough Therapy Designation from the FDA for advanced melanoma treatment [3] Scientific Contributions - Dr. Mads Hald Andersen, a co-founder of IO Biotech, presented at the 2025 AACR Annual Meeting, discussing advancements in cancer vaccine research and the dual mechanism of action of IO102-IO103 [1][2] - The vaccine targets both tumor cells and immune-suppressive cells, potentially reprogramming the tumor microenvironment to be more immune-permissive [2] Research and Development - The educational session at AACR highlighted key developments in RNA-based and immune-modulatory vaccines, showcasing the latest innovations in cancer immunotherapy [1][2] - IO Biotech's T-win® platform is designed to activate T cells against both tumor and immune-suppressive cells, representing a novel approach in cancer vaccine development [3]

Core Insights - Soligenix Inc. is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs [1][5] - The company has selected IBN to lead its corporate communications efforts, leveraging IBN's extensive distribution network to enhance visibility [1][4] Company Overview - Soligenix operates through two main segments: Specialized BioTherapeutics, which targets oncology and inflammation therapies, and Public Health Solutions, which focuses on vaccines and therapeutics for biothreats and infectious diseases [2] - The company is advancing multiple late-stage clinical programs, including HyBryte™ (SGX301) for cutaneous T-cell lymphoma, and other candidates for psoriasis (SGX302), oral mucositis (SGX942), and Behçet's disease (SGX945) [2][5] Public Health Initiatives - The Public Health Solutions segment includes development programs for vaccines against ricin poisoning (RiVax®), Ebola (SuVax™), and Marburg (MarVax™), supported by approximately $60 million in non-dilutive government grants and contracts [3][6] - The vaccine development utilizes proprietary heat stabilization technology known as ThermoVax® [6] Strategic Partnerships - IBN will utilize its investor-focused distribution network, which includes over 5,000 syndication outlets and a large social media following, to increase awareness for Soligenix [4][5] - IBN has over 19 years of experience and has assisted more than 500 client partners, positioning it to effectively reach a broad audience [5]

Core Viewpoint - The combination of the COVID adenovirus vaccine and CiVax™ shows broader protection against COVID-19 variants compared to a two-shot mRNA vaccination series, indicating potential advantages in vaccine efficacy and distribution logistics [1][2]. Group 1: CiVax™ Vaccine Development - CiVax™ is a heat-stable subunit vaccine candidate for COVID-19, demonstrating broad immune responses in preclinical studies with mice and non-human primates [2][4]. - The vaccine can be stored at ambient temperatures and requires only reconstitution with sterile water before use, simplifying global vaccination efforts [2][3]. - Development of CiVax™ was partially funded by a $1.5 million Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) [5]. Group 2: Technological Advancements - The ThermoVax® platform has successfully stabilized vaccines for various pathogens, enhancing the standard protein subunit vaccination technology [2][9]. - CiVax™ has shown efficacy as a booster after other primary vaccinations against COVID-19, providing broad immune coverage [4][2]. Group 3: Collaboration and Research - The development of CiVax™ is a result of collaboration with Axel Lehrer, PhD, from the University of Hawaiʻi at Mānoa, focusing on heat-stable vaccines for both COVID-19 and filoviruses [2][3]. - The research emphasizes the need for robust technology platforms to rapidly develop vaccines for emerging infectious diseases, as demonstrated by the COVID-19 pandemic [6].