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]

Company Overview - Soligenix Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs [5] - The company is advancing its HyBryte(TM) platform, a novel therapy for cutaneous T-cell lymphoma (CTCL), primarily affecting older adults [4][5] - Soligenix has established U.S.-based manufacturing for HyBryte's active ingredient, showcasing domestic innovation [4] Industry Context - The aging American population is leading to an increase in chronic and rare diseases, with over 30 million Americans affected by rare diseases [3] - There is a growing need for accurate diagnoses and effective treatments, particularly as many rare conditions lack FDA-approved therapies [3] - The Trump administration's initiatives aim to improve access to treatments and accelerate medical innovation in this sector [4] Product Development - The Specialized BioTherapeutics segment is moving towards potential commercialization of HyBryte(TM) after successful completion of the second Phase 3 study [5] - Other development programs include synthetic hypericin for psoriasis and dusquetide for inflammatory diseases [5] - The Public Health Solutions segment includes vaccine candidates for ricin toxin, filoviruses, and COVID-19, supported by government grants [6]

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]

Core Points - Novavax, Inc. will report its second quarter 2025 financial results and operational highlights on August 6, 2025, at 8:30 a.m. ET [1] - The company utilizes a scientific expertise in vaccines and a proven technology platform, including protein-based nanoparticles and Matrix-M® adjuvant [2] - Novavax's growth strategy focuses on optimizing existing partnerships, expanding access to its technology platform, and fostering new collaborations [2] Conference Call Details - The conference call is scheduled for August 6, 2025, at 8:30 a.m. U.S. ET, with a registration link provided for participants [1] - A replay of the call will be available starting at 11:30 a.m. U.S. ET on the same day until August 13, 2025 [2] - Participants can join the call via a direct dial or by registering online for an automated callback [4]

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]

Group 1: Canopy Growth - Canopy Growth has been a disappointing investment over the past five years, with a significant decline in net revenue and increased losses per share [3][4] - The cannabis industry faces challenges such as legal and regulatory issues, competition from illicit markets, and oversupply, particularly in Canada [5][6] - Despite cost-cutting efforts and a focus on in-demand products, the long-term outlook for Canopy Growth remains bleak, with expectations of further stock decline [6][7] Group 2: Novavax - Novavax reported substantial revenue growth in the first quarter, with revenue of $666.7 million and a net income of $518.6 million, a significant improvement from the previous year [8] - The company has positive results from phase 3 studies for its influenza and combination COVID-19 vaccines, along with partnerships with major pharmaceutical companies [8][9] - However, the long-term sustainability of Novavax's performance is questionable due to market unpredictability, competition from leaders like Moderna and Pfizer, and reliance on external funding for future trials [10][12][13]

Core Insights - Tonix Pharmaceuticals announced that its vaccine candidate TNX-801 provides durable protection against monkeypox after a single dose [1][3] - The vaccine is well tolerated in immunocompromised animals, showing no evidence of spreading to blood or tissues even at high doses [2][3] - TNX-801 is designed to generate both humoral and cellular immunity and serves as a platform for delivering multiple protective antigens against various viral pathogens [3][4] Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on developing therapies for pain management and vaccines for public health challenges [6] - The company has a diverse development portfolio, including TNX-102 SL for fibromyalgia, which has a PDUFA goal date of August 15, 2025 [6] - Tonix's infectious disease portfolio includes TNX-801 for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million with the U.S. Department of Defense [6]

William Blair 45th Annual Growth Stock Conference Using Proven, Innovative Adjuvant Technology to Help Protect the World Against Infectious Diseases June 2025 Nasdaq: DVAX Forward-Looking Statements Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about Dynavax's expected financial results and market share as of and for the quarter ended M ...

Novavax's Corporate Strategy - Novavax is shifting its business model to focus on R&D and diversified partnerships[7, 8] - The company aims to drive value through in-house early-stage R&D and strategic partnerships[6, 9] - Novavax is establishing a lean operating model to drive shareholder value[59] Sanofi Partnership - Sanofi made a minority equity investment (less than 5%) in Novavax[16] - Novavax received a $500 million upfront payment from Sanofi in Q2 2024, with $424 million recognized in 2024 and $76 million amortized through 2026[18] - Novavax is eligible for up to $700 million in milestones from Sanofi[18] COVID-19 and Influenza Vaccines - COVID-19 hospitalization rates are approximately 4 times higher than those for influenza[20] - COVID-19 vaccine coverage rates are less than half of influenza vaccine rates among US adults 18+ in the 2023-24 season (22% vs 45%)[22, 23] - Nuvaxovid recipients experienced approximately 39% fewer symptoms compared to mRNA vaccine recipients[25] Matrix-M Adjuvant and Partnerships - Novavax is eligible to receive up to $200 million in launch and sales milestones plus mid-single digit royalties under the Matrix-M license agreement[19] - Novavax's COVID-Influenza Combination (CIC) vaccine and stand-alone flu vaccines are in Phase 3 trials, with initial cohort data showing robust immune responses and good tolerability[45, 54]