Accessibility StatementSkip Navigation GAITHERSBURG, Md., Sept. 30, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced progress on its collaboration and license agreement (CLA) with Sanofi regarding Novavax's Matrix- M adjuvant. The companies have amended their CLA to expand Sanofi's license to include use of Novavax's Matrix-M adjuvant in Sanofi's pandemic influenza vaccine candidate program. Sanofi recently received funding from the Biomedical Advanced Research and Development Author ...

Core Viewpoint - Pfizer is attempting to reposition itself after a decline in COVID-related revenues, with a focus on oncology and other therapeutic areas to drive future growth [1][2]. Group 1: Financial Performance - Pfizer's stock has decreased by 19.3% over the past 52 weeks and 9.7% year-to-date, largely due to declining sales of its COVID-19 products Comirnaty and Paxlovid [1]. Group 2: Oncology Portfolio - Pfizer's oncology portfolio is showing significant progress, with a focus on increasing research and development productivity by 2025 [4]. - Braftovi and Mektovi have achieved a 23% year-over-year operating growth in the second quarter, indicating strong momentum in cancer-targeted treatments [4]. - The investigational antibody-drug conjugate Sigvotatug vedotin (SV) is advancing in Phase 3 trials for non-small cell lung cancer (NSCLC), which is projected to reach a market size of $60 billion by 2030 [5]. Group 3: Strategic Collaborations - Pfizer's collaboration with 3SBio provides access to SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, in the $55 billion immunotherapy market [5]. Group 4: Hematology and Vaccines - In hematology, HYMPAVZI has shown promising Phase 3b findings, with potential to capture market share in the hemophilia industry, expected to reach $10 billion by 2030 [6]. - Pfizer is nearing the end of its Phase 3 trial for a Lyme disease vaccine and plans to file for approval next year, addressing significant unmet needs in the vaccine market [6].

Core Insights - Novavax is an innovative biotech company focused on vaccine development, having undergone significant transformation post-pandemic to enhance its technology and create value [2][3] - The company has shifted from a single product focus during the pandemic to a more diversified approach, aiming to strengthen its financial position while exploring multiple value creation opportunities [3] Company Overview - Novavax has developed a vertically integrated structure that initially incurred high expenses but also presented substantial opportunities [3] - The leadership team has worked on reducing the expense base, improving the balance sheet, and extending the cash runway while maintaining operational capabilities [3]

Core Viewpoint - Novavax's Nuvaxovid™ has been approved by the U.S. FDA for the 2025-2026 vaccination season, making it the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for high-risk adults aged 12 to 64 and seniors aged 65 and older [1][4]. Group 1: Vaccine Approval and Target Population - The FDA approval allows Nuvaxovid to be administered to adults 65 years and older, or individuals aged 12 to 64 with at least one underlying condition that increases their risk for severe COVID-19 outcomes [1][4]. - Novavax plans to collaborate with Sanofi to ensure access to the vaccine for eligible individuals this fall [2]. Group 2: Clinical Data and Efficacy - Clinical and preclinical data indicate that Nuvaxovid is safe and effective against COVID-19, particularly the JN.1 strain, which is responsible for the majority of global infections as of July 2025 [3]. - The vaccine induces immunity across various circulating strains within the JN.1 lineage, including NB.1.8.1, LP.8.1, XFG, XFC, LF.7, and XEC [3]. Group 3: Commercialization and Royalties - Sanofi is leading the commercialization efforts for Nuvaxovid, while Novavax is set to receive ongoing tiered royalties from the vaccine sales [3]. Group 4: Vaccine Composition and Technology - Nuvaxovid is a protein-based vaccine that targets the JN.1 variant, utilizing Novavax's recombinant nanoparticle technology to create copies of the SARS-CoV-2 spike protein [8][9]. - The Matrix-M® adjuvant enhances the immune response and allows for a lower dose of the antigen while maintaining effectiveness [10]. Group 5: Company Overview - Novavax, Inc. focuses on addressing significant health challenges through its expertise in vaccines and technology platforms, including protein-based nanoparticles and the Matrix-M adjuvant [11]. - The company's growth strategy includes optimizing existing partnerships, expanding access to its technology, and pursuing research and development innovations [11].

HEPLISAV-B Performance and Market Outlook - HEPLISAV-B achieved a quarterly sales record of $92 million, a 31% increase year-over-year compared to $70 million in Q2'24[5] - HEPLISAV-B's total U S quarter-end market share reached approximately 45%, up from approximately 42% in Q2'24[5] - The U S adult Hepatitis B vaccine market is expected to peak at over $900 million by 2030, with HEPLISAV-B projected to reach at least 60% of the total U S market share[5, 25] - In 2024, the HEPLISAV-B total market share was ~$615M and is expected to increase from 44% in 2024 to at least 60% by 2030[25] Financial Highlights - The company's cash, cash equivalents, and marketable securities totaled $614 million as of June 30, 2025[7] - Adjusted EBITDA for FY 2025 is expected to be greater than $75 million[8] - Dynavax completed repurchases under the previously announced $200 million share repurchase program as of June 30, 2025[9] - Total revenues for Q2'25 were $95.4 million, a 29% increase from $73.8 million in Q2'24[53] Pipeline Development - The company expects to report top-line data results for the Shingles vaccine program in August 2025[10] - The U S DoD partnership provides approximately $30 million through 1H'27 to fund additional clinical & manufacturing activities for the Plague vaccine program[10] - The company plans to initiate a Phase 2 clinical trial for the Plague vaccine program in the second half of 2025[10]

NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) -- via InvestorWire — Soligenix Inc. (NASDAQ: SNGX) today announces its placement in an editorial published by NetworkNewsWire ("NNW"), one of 70+ brands within the Dynamic Brand Portfolio@IBN (InvestorBrandNetwork), a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. To view the full publication, “Clinical Progress in Rare Disease Signals Long-Term Revenue Potent ...

The health department is pulling the plug on a half a billion dollars in funding specifically for mRNA vaccine development. Health Secretary Robert F. Kennedy Jr.. calling the technology behind current COVID and RSV vaccines quote ineffective. mRNA vaccines don't perform well against viruses that infect the upper respiratory tract. mRNA only codes for a small part of the viral proteins, usually a single antigen.one mutation and the vaccine becomes ineffective. Scientists and vaccine experts are now coming o ...

Financial Data and Key Metrics Changes - Novavax reported total revenue of $239 million for Q2 2025, down from $415 million in Q2 2024, which included a $175 million milestone from Sanofi related to the BLA approval for Nuvaxibid [30][32] - The company achieved a net income of $107 million or 62 cents per diluted share for Q2 2025 [35] - Combined R&D and SG&A expenses were reduced by 41% year-over-year, with SG&A expenses down 57% due to the transition of commercial activities to Sanofi [31][34] Business Line Data and Key Metrics Changes - Product sales for Q2 2025 were $11 million, consisting of $13 million from supply sales and a negative $2 million from Nivaxibid product sales due to market activity closeout [33] - Year-to-date sales of the R21 Matrix M malaria vaccine reached 14 million doses, exceeding the total of 6 million doses sold in 2024 [33] Market Data and Key Metrics Changes - The partnership with Sanofi is expected to enhance commercialization efforts for Nuvaxibid in select global markets, with additional milestone payments anticipated [9][10] - The company is actively pursuing new partnerships to leverage its technology platform and expand its market presence [13] Company Strategy and Development Direction - Novavax's strategy focuses on optimizing partnerships, enhancing existing collaborations, and advancing its technology platform and early-stage pipeline [7][40] - The company aims for potential non-GAAP profitability as early as 2027, driven by its partnerships and technology advancements [7][32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of combination vaccines and the ongoing discussions with partners, particularly Sanofi [10][45] - The company is committed to maintaining a lean operational model while driving value creation through targeted investments in R&D [37][40] Other Important Information - The company is exploring the utility of its Matrix M adjuvant in oncology and has signed material transfer agreements with three pharmaceutical companies [14][27] - A post-marketing commitment study is planned for 2025 and 2026, with costs expected to be reimbursed by Sanofi [35][36] Q&A Session Summary Question: Will Novavax file for approval for the COVID vaccine for the upcoming season? - Management confirmed that they are working on regulatory filings to improve the shelf life profile of their vaccine for the fall season [43] Question: What is the interest level in the combination vaccine partnership? - Management indicated ongoing discussions with multiple potential partners and noted positive feedback from Sanofi regarding combination assets [45] Question: What is the confidence level in the post-marketing Phase four trial efficacy data? - Management stated that the design and timing of the post-marketing commitment study are being finalized, with expectations to start by the end of the year [72] Question: Is the company open to acquiring or in-licensing clinical stage candidates? - Currently, the focus is on external partnerships and internal development rather than acquiring clinical stage candidates [66] Question: How does the shifting FDA funding landscape impact Novavax? - Management sees continued investment in vaccines by peer companies and believes there is a growing interest in alternative technology platforms like theirs [76][80]

GAITHERSBURG, Md., July 30, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced it will report its second quarter 2025 financial results and operational highlights at 8:30 a.m. Eastern Time (ET) on Wednesday, August 6, 2025. Details of the event and replay are as follows: | Conference call details: | | | --- | --- | | Date: | August 6, 2025 | | Time: | 8:30 a.m. U.S. ET | | URL to register phone: | Register Here | | Dial-in number: | (888) 880-3330 (Domestic) or | | | (+1) (646) 357-8766 (Inte ...

Financial Data and Key Metrics Changes - For the six months ended June 30, 2025, the company reported revenues of $2.5 million compared to $301,000 in 2024, primarily due to the BARDA Project NextGen contract that began in June 2024 [16] - Research and development expenses increased to $10 million in 2025 from $8.7 million in 2024, representing a 16% increase, mainly associated with the BARDA contract and other programs [17] - General and administrative expenses rose to $3.2 million in 2025 from $2.5 million in 2024, a 27% increase attributed to higher investor relations consulting costs and stock-based compensation [18] - The net loss for the six-month period in 2025 was approximately $10.7 million or $0.79 per share, compared to a net loss of $10.9 million or $4.68 per share in 2024 [18] Business Line Data and Key Metrics Changes - The company is focused on advancing its product candidates, including GEO MVA, GEO CM04S1, and Gideptin, which address significant unmet healthcare needs [5][14] - The advanced MVA manufacturing process is expected to provide a competitive advantage in the production of MVA-based vaccines and therapies [6] Market Data and Key Metrics Changes - The company anticipates significant governmental interest in U.S.-based supply chains, particularly in light of the current overdependence on non-U.S. suppliers [9] - The company is engaged in discussions with various stakeholders, including the White House and WHO, regarding the progress of GEO MVA [9] Company Strategy and Development Direction - The company aims to develop innovative cancer therapies and infectious disease vaccines, focusing on expedited registration pathways and establishing partnerships for worldwide development and commercialization [14] - The strategic focus for 2025 includes advancing GEO MVA to clinical evaluation readiness, progressing GEO CM04S1 for immunocompromised patients, and enhancing the advanced MVA manufacturing process [14] Management's Comments on Operating Environment and Future Outlook - Management remains confident in the progress and outlook for its product portfolio, particularly in light of recent guidance from the European Medicines Agency for GEO MVA [5][6] - The company is committed to addressing the medical needs of immunocompromised patients with its COVID-19 vaccine candidate, GEO CM04S1, which is expected to provide a more robust immune response [10][11] Other Important Information - The company completed CGMP production and quality release of the clinical batch of GEO MVA vaccine material, with plans to produce additional product for potential emergency use distribution [8] - The company has initiated discussions for potential collaborations in the long-term development and commercialization of Gideptin [14] Q&A Session Summary Question: Regarding the new patch method for the MDA vaccine - The company does not intend to use the patch for the clinical program and plans to utilize the standard vaccine delivery method [24] Question: Is the making of enough vaccine product a limiting step for the trial start? - The vaccine is largely manufactured, and various components need to come together before the trial can start [26] Question: What is the expected start date for the Gideptin trial? - The target start date for the Gideptin trial is the second half of 2026 [51] Question: Can you elaborate on the major pathological response endpoint for Gideptin? - The major pathological response is defined by the extent of response in the resected tumor tissue, with a primary endpoint focused on pathological response [45] Question: What is the status of the BARDA manufacturing proposal? - The company was selected for funding but is currently in a holding pattern pending funding availability [65]