Core Insights - Valneva SE reported consolidated financial results for the first nine months of 2025, showing total revenues of €127.0 million, an increase of 8.9% compared to €116.6 million in the same period of 2024 [2][10][17] - The company experienced a net loss of €65.2 million in the first nine months of 2025, contrasting with a net profit of €24.7 million in the same period of 2024, primarily due to the absence of one-time proceeds from the sale of a Priority Review Voucher [2][28] - Valneva's financial position was strengthened through successful debt refinancing, which improved financial terms and reduced operating cash burn [2][10] Financial Performance - Total revenues for the first nine months of 2025 were €127.0 million, up from €116.6 million in 2024, driven by product sales of €119.4 million, which increased by 6.2% from €112.5 million [2][18] - Adjusted EBITDA loss was €37.7 million in the first nine months of 2025, compared to a profit of €48.6 million in the same period of 2024, influenced by the previous year's one-time sale of the Priority Review Voucher [27][28] - Cash and cash equivalents stood at €143.5 million as of September 30, 2025, down from €168.3 million at the end of 2024 [32] Product Sales and Portfolio - Valneva's commercial portfolio includes three travel vaccines: IXIARO/JESPECT, DUKORAL, and IXCHIQ, with IXIARO/JESPECT sales increasing by 12.5% to €74.3 million in the first nine months of 2025 [3][6] - DUKORAL sales decreased slightly to €21.5 million, impacted by currency fluctuations and a transition in distribution to CSL Seqirus [7][20] - IXCHIQ sales rose significantly to €7.6 million, aided by supply for a chikungunya outbreak, although U.S. license suspension affected traveler segment sales [8][9] Research and Development - Valneva is advancing its Lyme disease vaccine candidate, VLA15, with the Phase 3 VALOR study on track, and results expected in the first half of 2026 [11][12] - The company is also developing a tetravalent Shigella vaccine candidate, S4V2, which has received Fast Track designation from the FDA, indicating its potential to address unmet medical needs [13][14] - Positive Phase 1 results were reported for the Zika vaccine candidate, VLA1601, although further development will depend on securing funding [15][16] Cost Management - Operating expenses were managed effectively, with research and development expenses increasing to €59.7 million, primarily due to costs associated with the Shigella vaccine candidate [22] - Marketing and distribution expenses decreased to €28.6 million, reflecting reduced advertising and promotional spending [23] - General and administrative expenses were reduced to €29.5 million, attributed to lower recruitment and insurance costs [24]

Accessibility StatementSkip Navigation EMERYVILLE, Calif., Nov. 19, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that the Company will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Tuesday, December 2nd at 2:10 p.m. ET. The presentations will be webcast and may be accessed through the "Events & Presentations" page on the "Investors" ...

Core Insights - Elicio Therapeutics (ELTX) has been recognized for its promising development of a vaccine targeting KRAS, a significant area in cancer research [1] Company Overview - Elicio Therapeutics has been under observation for approximately five years due to its advancements in vaccine development [1] - The company focuses on the scientific aspects of biotechnology and aims to educate investors about the underlying science [1] Industry Context - The development of vaccines targeting KRAS is crucial in the biotechnology sector, particularly in cancer treatment [1]

Financial Performance & Strategy - Total revenue for Q3 2025 was $70 million, a decrease of 18% compared to $85 million in Q3 2024[25] - The company achieved $1.1 billion in non-dilutive funding over the past 8 quarters[14] - Novavax is aiming for Non-GAAP profitability as early as 2028, driven by diversified revenue streams[15] - Combined R&D and SG&A expenses for Q3 2025 decreased by 18% compared to Q3 2024[22] - The company anticipates combined R&D and SG&A expenses less partner reimbursement of approximately $350 million for FY 2026 and $250 million for FY 2027[35] Sanofi Partnership - Sanofi revenue in Q3 2025 was $48 million, including $4 million in COVID-19 royalties[23, 28] - Novavax expects $60 million in cash from Sanofi by Q1 2026 related to the COVID-19 commercial role transition[23] - The Sanofi partnership is projected to result in $230 million in operating cost savings over 11 years[23] 2025 Financial Outlook - Adjusted Total Revenue for full year 2025 is projected to be between $1040 million and $1060 million[39] - Nuvaxovid product sales are expected to be $610 million for full year 2025, including $603 million from the termination of the Canada and New Zealand Advance Purchase Agreements[39] Pipeline Development - The company is advancing an early-stage pipeline focused on diseases with high unmet medical needs, including Varicella Zoster Virus (Shingles), C difficile, RSV combinations, and Pandemic Flu[14, 19]

Financial Data and Key Metrics Changes - Dynavax reported net product revenue of approximately $90 million for Q3 2025, representing a 13% increase year over year, and total revenues of approximately $95 million, up 18% year over year [18][19] - GAAP net income for Q3 2025 was $27 million, compared to $18 million in Q3 2024, while non-GAAP adjusted EBITDA improved to $36 million from $25 million year over year [20] - The company ended Q3 2025 with cash and equivalents of $648 million, down from $714 million at the end of 2024, primarily due to a completed $200 million share repurchase program [21] Business Line Data and Key Metrics Changes - Heplisav-B generated approximately $90 million in net product revenue, achieving a 46% market share in the U.S. adult hepatitis B vaccine market, up from 44% in the prior year [10][11] - The retail segment market share for Heplisav-B grew to 63%, compared to 59% in Q3 of the previous year, indicating strong performance in this critical growth segment [10][11] Market Data and Key Metrics Changes - The adult hepatitis B vaccine market is expanding under the ACIP universal recommendation, with a large catch-up cohort of over 100 million unprotected adults [10] - The overall market for adult hepatitis B vaccines is expected to peak at over $900 million in the U.S. by 2030, with Dynavax targeting at least 60% market share [12][13] Company Strategy and Development Direction - Dynavax is focused on maximizing and growing Heplisav-B, advancing its internal pipeline, and executing strategically aligned business development transactions [59] - The company has entered into a strategic license agreement with Vaxart for a novel oral COVID-19 vaccine program, which is expected to provide improved protection through intestinal delivery [22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the long-term goal of at least 60% market share for Heplisav-B by 2030, supported by ongoing growth in the retail segment and increased awareness of the ACIP recommendation [12][13] - The company anticipates continued growth and progress in its pipeline, with key milestones expected in the second half of 2026 [23][24] Other Important Information - A new $100 million share repurchase program was authorized, reflecting the company's commitment to enhancing shareholder value [21][24] - R&D expenses for Q3 2025 were $19 million, up from $14 million in the same quarter last year, reflecting advancements in the pipeline [19] Q&A Session Summary Question: Why license a COVID vaccine now? - Management believes this is a strategic opportunity to grow the market with improved vaccine options, despite recent challenges in the COVID vaccine landscape [26][27] Question: What is the power of the trial with 5,400 patients? - The study is adequately powered to demonstrate improvement over the comparator mRNA vaccine, despite the reduction in size [28] Question: Will the company be able to conduct registrational studies for both shingles and the oral COVID-19 vaccine simultaneously? - Management confirmed that they are capable of managing the staging of activities for both programs [30][31] Question: What is needed to advance the oral vaccine program? - The goal is to demonstrate an improved option compared to the mRNA vaccine, with a focus on both efficacy and tolerability [35][36] Question: How does seasonality affect Heplisav-B revenue in Q4? - Management acknowledged that seasonality exists but expects stronger fourth quarters as retail continues to grow in adult immunizations [38][39] Question: What is the long-term outlook for Heplisav-B market share? - Management is confident in achieving the 60% market share target by 2030, with ongoing progress expected [52][54]

Financial Performance - HEPLISAV-B net product revenue reached $90 million in Q3'25, a 13% year-over-year increase compared to $79 million in Q3'24[5, 81] - The company anticipates HEPLISAV-B net revenue to be between $315 million and $325 million for the full year 2025[78] - Adjusted EBITDA for FY 2025 is expected to be at least $80 million, revised up from the previous guidance of at least $75 million[9, 79, 85] - Cash, cash equivalents, and marketable securities totaled approximately $648 million as of September 30, 2025[7, 83] - Total revenues for Q3'25 were $949 million, an 18% increase from $806 million in Q3'24[77] Market Position and Strategy - HEPLISAV-B's total U S market share reached 46% at the end of Q3'25, compared to 44% in Q3'24[5, 81] - The U S adult Hepatitis B vaccine market is projected to peak at over $900 million by 2030, with HEPLISAV-B expected to achieve at least 60% of the total U S market share[5, 25] - The company is focused on maximizing HEPLISAV-B's commercial potential, advancing its diversified vaccine pipeline, and continuing a balanced capital allocation strategy[12] Pipeline Development - The company's plague vaccine program received approximately $14 million in additional funding from the U S DoD, bringing the total funding to approximately $44 million through the first half of 2027[11, 87] - Dynavax entered into an exclusive license agreement for Vaxart's oral COVID-19 vaccine candidate, involving a $25 million upfront payment and a $5 million equity investment[68] - The global shingles vaccine market size was approximately $42 billion in 2024[33]

Core Insights - Valneva SE announced positive results from its Phase 1 clinical trial for VLA1601, a second-generation vaccine candidate against the Zika virus, demonstrating improved immune response and safety [1][5][7] Group 1: Clinical Trial Details - The Phase 1 trial, VLA1601-102, involved approximately 150 participants aged 18 to 49 in the U.S., who received two doses of the vaccine at varying dosages [2] - The trial evaluated the safety and immunogenicity of VLA1601, which is an aluminum-adjuvanted inactivated vaccine, with additional adjuvants tested in the low-dose group [2][4] - Data up to Day 57 indicated that VLA1601 was generally safe and well tolerated across all treatment arms, with no safety concerns identified [3] Group 2: Immunogenicity Results - VLA1601 induced an immune response across all treatment arms, with the strongest response observed in the double-adjuvanted groups, showing significantly higher neutralizing antibody titers compared to the single-adjuvant group [4] - The second-generation vaccine candidate showed higher peak seroconversion rates (>93% vs 86%) and a greater peak Geometric Mean Fold Increase of titers (>56 fold vs >7 fold) compared to the first-generation vaccine [5] Group 3: Development Context - VLA1601 is developed using the manufacturing platform of Valneva's licensed Japanese encephalitis vaccine IXIARO®, which has been optimized for other vaccine candidates [6][9] - The Chief Medical Officer of Valneva highlighted the growing public health challenge posed by Zika virus due to climate change, but noted that further development of VLA1601 will depend on securing significant funding opportunities [7]

Core Insights - Valneva SE, a specialty vaccine company, is engaging with institutional investors through presentations and 1-on-1 meetings at upcoming conferences in the U.S. and Europe [1][4] Group 1: Upcoming Events - Valneva will host moderated "fireside chat" presentations to discuss key value drivers and upcoming catalysts, particularly the Phase 3 trial outcomes for VLA15, its Lyme disease vaccine candidate partnered with Pfizer [2] - If the Phase 3 trial is successful, Pfizer plans to submit applications for U.S. and European market authorization in 2026, with a potential vaccine launch in the second half of 2027 [2] - The company will participate in several conferences, including the Guggenheim 2nd Annual Healthcare Innovation Conference on November 10, Stifel 2025 Healthcare Conference on November 11, and Jefferies London Healthcare Conference on November 19 [3] Group 2: Company Overview - Valneva specializes in developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, focusing on unmet medical needs [5] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [6] - Valneva's commercial business revenues support the advancement of its vaccine pipeline, which includes the only Lyme disease vaccine candidate in advanced clinical development and the world's most clinically advanced Shigella vaccine candidate [7]

Core Insights - Moderna's experimental CMV vaccine failed in a Phase 3 study, showing only 6% to 23% effectiveness, significantly below the target of 49.1% [2][3] - The company plans to continue a Phase 2 study for patients who have undergone bone-marrow transplants but will discontinue the congenital CMV study [4] - Moderna reiterated its expectation to achieve cash break-even by 2028, but the failure of the CMV program is expected to negatively impact cash flow [5] Company Performance - Following the study results, Moderna's stock fell approximately 2% to $26.34, potentially pushing it below its 50-day moving average [3] - Analysts have expressed low expectations for the CMV study, noting that it had previously missed an interim analysis [2] - The company is likely to report revenue at the lower end of its guidance of $1.5 billion to $2.2 billion for the full year 2025 due to reduced COVID-19 vaccination volumes [5] Analyst Ratings - William Blair analyst Myles Minter has a market perform rating for Moderna stock and has removed the CMV opportunity from his financial model [3][6] - Needham analyst Joseph Stringer has rated Moderna stock as a hold, indicating uncertainty about the reasons behind the trial's failure [4]

Core Insights - Dynavax Technologies Corporation will report its third quarter 2025 financial results on November 5, 2025, after U.S. financial markets close [1] - A conference call and live audio webcast will be held on the same day at 4:30 p.m. ET/1:30 p.m. PT [1][2] Company Overview - Dynavax is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines to combat infectious diseases [3] - The company has two commercial products: HEPLISAV-B® vaccine, approved in the U.S., EU, and UK for hepatitis B prevention in adults aged 18 and older, and CpG 1018® adjuvant, used in HEPLISAV-B and various adjuvanted COVID-19 vaccines [3]