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 ...

Dynavax (DVAX) FY Conference June 03, 2025 03:40 PM ET Speaker0 Analyst here at William Blair. Thank you all for coming, part of our forty fifth Annual Growth Stock Conference. Happy to introduce Dynavax and Ryan Spencer, CEO. We're to talk a little bit about the continued growth of HEPLISAV. It's been becoming a great business for the company and also, I think, a little bit of expansion opportunities that they're evaluating. Please visit williamblair.com for any and all disclosures. And with that, I'll tur ...

Saint-Herblain (France), May 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and hold investor meetings at several upcoming investor conferences in the United States and Europe in June 2025. Key topics for discussion include Valneva’s commercial stage vaccines and its differentiated portfolio of vaccine candidates, including VLA15, the world’s leading Lyme disease vaccine candidate. VLA15 is partnered with Pfize ...

Novavax (NVAX) 2025 Conference Summary Company Overview - **Company**: Novavax (NVAX) - **Event**: 2025 Bank of America Healthcare Conference - **Date**: May 14, 2025 Key Points Industry and Company Developments - Novavax has transitioned from a small biotech to a more structured organization post-pandemic, focusing on leveraging its technology platform for growth through partnerships and R&D [3][4] - The company has launched four new R&D programs in the last quarter, indicating a robust pipeline for future growth [3] Financial Guidance and Performance - Novavax raised its revenue guidance based on BLA milestones from its partnership with Sanofi, with expectations of breakeven and profitability as early as 2027 [6][7] - The company anticipates receiving $2.25 billion in cash from BLA approvals and license transfers to Sanofi, which includes a $1.75 billion milestone and two $25 million license transfers [39][40] Regulatory and Approval Pathways - Novavax is in discussions with the FDA regarding post-marketing commitments, which are expected to be less stringent than requirements, allowing for potential approval in the near term [9][10][14] - The company has a robust dataset from a placebo-controlled trial involving 30,000 individuals for its COVID vaccine, Nuvaxavid, supporting its approvability [17][18] Market Dynamics and Vaccine Strategy - The company is observing a shift in consumer choice towards vaccines with better tolerability, which could favor Novavax's offerings [58][59] - The COVID vaccine market is expected to grow significantly, with Novavax aiming to capture a substantial share through its innovative technology and partnerships [77] Partnerships and Collaborations - Novavax has expanded its partnership with Sanofi and signed new agreements with top pharmaceutical companies to explore the utility of its Matrix M adjuvant in various vaccine platforms [4][48][50] - The updated agreement with Takeda includes a $20 million upfront payment and a shift to a traditional royalty model, enhancing the partnership's economic viability [44][46] Future Outlook - The company is focused on reducing liabilities and costs, aiming for an 80-85% reduction in R&D and SG&A expenses by 2027, which will enable a stronger focus on value creation [76][77] - Novavax is positioned to capitalize on the growing vaccine market, projected to increase from $50 billion to $75 billion, leveraging its technology across multiple vaccine categories [77] Additional Insights - The company is actively monitoring the evolving landscape of COVID variants and the need for seasonal vaccine updates, which is critical for maintaining market relevance [26][28] - Novavax's strategy includes developing combination vaccines and exploring new markets, such as oncology, to diversify its product offerings [48][52] Conclusion - Novavax is strategically positioned for growth through innovative partnerships, a strong pipeline, and a focus on cost reduction, aiming to capture a significant share of the expanding vaccine market while ensuring product safety and efficacy.

Vaxart (VXRT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Edward Berg - Senior Vice President and General CounselSteven Lo - CEO , President & DirectorJames Cummings - Chief Medical OfficerSean Tucker - Founder & Chief Scientific OfficerPhillip Lee - Chief Financial OfficerCheng Li - Director - Equity ResearchMayank Mamtani - Senior Managing Director & Group Head of HealthcareLiang Cheng - Senior Research Associate Operator Greetings. Welcome to Vaxart Business Update and First Quart ...

Vaxart (VXRT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Speaker0 Greetings. Welcome to Vaxart Business Update and First Quarter twenty twenty five Financial Results Conference Call. A question and answer session will follow management's opening remarks. Individual investors may submit written questions to vaxart.com. As a reminder, this conference is being recorded. I would now like to turn the webcast over to your host, Ed Berg, Senior Vice President and General Counsel. Speaker1 Good afternoon, and w ...

FDA PDUFA goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia; if approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years Announced positive topline results from Phase 1 study of TNX-1500, a next generation anti-CD40L mAb candidate in development for prevention of kidney transplant rejection and treatment of autoimmune disorders Cash and cash equivalents of $131.7 million reported as of March 31, 2025; Current cash sufficient to fund o ...

Core Viewpoint - HilleVax, Inc. reported its financial results for the first quarter of 2025, highlighting a significant reduction in net loss and ongoing development of norovirus vaccine candidates [1][3]. Financial Performance - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $159.5 million, down from $171.4 million as of December 31, 2024 [2][8]. - Research and development expenses for Q1 2025 were $2.0 million, a decrease from $26.0 million in Q1 2024, primarily due to lower clinical development costs [2][7]. - General and administrative expenses for Q1 2025 were $5.6 million, down from $8.5 million in Q1 2024, mainly due to reduced personnel-related costs [3][7]. - Other income for Q1 2025 was $1.5 million, compared to $3.0 million in Q1 2024, driven by lower accretion of marketable securities [3]. - The net loss for Q1 2025 was $6.1 million, significantly reduced from $46.8 million in Q1 2024 [3][7]. Company Overview - HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, specifically targeting norovirus with its candidates HIL-214 and HIL-216 [4]. - Norovirus is responsible for over 700 million cases of acute gastroenteritis globally and results in approximately 200,000 deaths annually, leading to over $4 billion in direct health system costs and $60 billion in societal costs [4].

Total revenues of €49.2 million compared to €32.8 million in the first quarter of 2024Cash and cash equivalents of €153.0 million at end of March 2025Further clinical and regulatory progress2025 financial outlook confirmed Saint-Herblain (France), May 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2025, provided key corporate updates and confirmed its 2025 financial guidance. The condensed co ...

Total revenues of €49.2 million compared to €32.8 million in the first quarter of 2024Cash and cash equivalents of €153.0 million at end of March 2025Further clinical and regulatory progress2025 financial outlook confirmed Saint-Herblain (France), May 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2025, provided key corporate updates and confirmed its 2025 financial guidance. The condensed co ...