Company Strategy - Bavarian Nordic's CEO believes the buyout offer highlights the capital requirements for its global vaccine powerhouse ambitions [1] Financial Implication - The proposed buyout indicates the significant investment needed to support Bavarian Nordic's growth strategy [1]

Summary of Candel Therapeutics (CADL) FY Conference Call - August 13, 2025 Company Overview - **Company**: Candel Therapeutics (CADL) - **Industry**: Biotechnology, specifically focused on cancer immunotherapy Key Points and Arguments Vaccine Approach - Candel's approach involves a novel vaccine strategy that immunizes patients against their own tumors without needing to identify specific antigens [3][4] - Utilizes a replication-defective adenovirus to deliver the HSV thymidine kinase gene, leading to localized enzyme expression and subsequent tumor cell death [4][5] - The process induces a strong pro-inflammatory response, creating optimal conditions for T cell activation against tumors [5][6] Pipeline Focus - Current focus on three main indications: - Early localized nonmetastatic prostate cancer - Borderline resectable pancreatic cancer - Therapy-resistant non-small cell lung cancer (NSCLC) [7][8] Prostate Cancer Data - Positive Phase 3 trial results with a primary endpoint of disease-free survival, showing a 30% improvement in disease-free survival rates [10][12] - Secondary endpoint showed a 38% improvement in prostate cancer-specific disease-free survival [13] - Plans to submit a Biologics License Application (BLA) by 2026 [9][10] Commercial Launch Preparation - Scaling up commercial manufacturing with partner SAFC in California [16][17] - Positive feedback from urologists and radiation oncologists regarding the adoption of CAN 2409 in combination with standard care [18][20] - Initial payer feedback has been favorable, indicating potential cost savings for healthcare systems [21] Non-Small Cell Lung Cancer (NSCLC) Data - Focus on patients with unresectable stage 3 or stage 4 NSCLC who have failed standard treatments [23] - Median overall survival of over 24 months in treated patients, doubling the expected survival [24] - Fast track designation received from the FDA based on these results [26][27] Pancreatic Cancer Data - Conducted a small randomized trial showing a median overall survival of over 32 months compared to 12.5 months in the control group [34] - Fast track and orphan drug designations received from the FDA and EMA [35] Manufacturing and Capacity - Manufacturing process involves replication-defective adenoviruses, similar to COVID-19 vaccines, with established industry capacity [38][39] - Product stability confirmed for over ten years under refrigeration [40] Future Directions - Candel is preparing for a potential registrational Phase 3 trial in therapy-resistant NSCLC and pancreatic cancer [27][35] - Ongoing exploration of CAN 3110, a next-generation oncolytic virus for glioblastoma, showing promising early results [42][45] Financial Position - Current cash runway extends into Q1 2027, with upcoming data announcements expected [53] Additional Important Information - Candel emphasizes the importance of a strong scientific rationale and unmet clinical needs in prioritizing its pipeline [36] - The company aims to advance multiple programs in parallel to maximize commercial value [37]

Vinay Prasad, who was ousted as the top vaccine and gene therapy regulator at the US Food and Drug Administration, is returning to his role https://t.co/snfLbLJi9Y ...

Funding & Policy Changes - HHS (美国卫生与公众服务部) 决定 mRNA 技术对呼吸道病毒的风险大于收益，因此 BARTA (生物医学高级研究与发展管理局) 已开始终止总额近 5 亿美元（约合 5 亿美金）的 22 份合同 [2] - 美国卫生部长 Robert F Kennedy Jr 宣布撤回 5 亿美元（约合 5 亿美金）的联邦资金，这些资金原本用于 mRNA 疫苗的研究和开发 [1] - Kennedy 采取了一系列措施，包括解雇数千名公共卫生部门的员工，在 HHS (美国卫生与公众服务部) 安排反疫苗盟友，削减州和地方卫生部门数十亿美元的资金，取消数十亿美元的疫苗研究资金，解散联邦疫苗咨询小组，并退出一项拯救了数百万儿童生命的全球疫苗计划 [6] Scientific & Public Health Concerns - 科学家和医生谴责了这一举动，指出 Kennedy 错误地认为 mRNA 疫苗不能预防呼吸道疾病 [2] - 公共卫生专家警告说，现在停止资助将使美国在未来面临更大的健康威胁 [4] - mRNA 疫苗在疫情期间拯救了数百万人的生命，降低了 COVID 的严重程度，并防止了住院 [3] - Kennedy 散布关于 COVID 疫苗的谎言，声称它们无效，会改变 DNA，导致不孕，并导致广泛的伤害和死亡 [5] Organizational Impact - Kennedy 成立的美国最大的反疫苗组织 Children's Health Defense 正在庆祝 Kennedy 的最新举动 [7] - HHS (美国卫生与公众服务部) 内部的科学家和研究人员对 Kennedy 的最新举动感到震惊 [6]

Vaccine Development - NIH is developing a universal vaccine that mimics natural immunity, potentially effective against various mutations, including coronaviruses and flu [1][2] - mRNA vaccines may be useful for some illnesses, including cancers, but trials for upper respiratory infections were cancelled [1] Political Implications - Extremist views on both sides regarding COVID-19 vaccines may alienate moderate voters [3][4] - Gutting funding for vaccine development could confuse middle America voters who saw the COVID-19 vaccine as a good idea [4]

Funding & Research - The health department is pulling \$500 million (half a billion dollars) in funding specifically for mRNA vaccine development [1] - The terminated contracts are focused on mRNA technology for COVID and flu shots [6] - \$2 million was pulled from a vaccine program for vulnerable children [8] Scientific & Expert Opinions - Experts state mRNA vaccines have been extremely effective against hospitalizations and deaths, even if they don't prevent infections [4] - Scientists and vaccine experts are coming out against the decision to cut mRNA vaccine research, stating it could put people at more risk during public health emergencies [2] - Experts worry about the secretary trying to undermine the US vaccine infrastructure under the guise of safety [8] Potential Risks & Concerns - Concerns exist regarding the potential for the next pandemic and the lack of resources needed to address it [10] - There are long-term concerns about sowing doubt in the safety of vaccines and potentially preventing scientists from developing newer, better vaccines [9]

Public Health & Policy - The Health and Human Services Department (HHS) is removing thimerosal from flu shots [1] - This action is considered a victory for antivaccine activists [1] Vaccine Safety Concerns - Antivaccine activists claim the mercury-based preservative thimerosal causes autism [1]

Public Health Impact - Withdrawal of US funding from the global vaccine initiative could lead to a vast number of child deaths [1] Policy & Funding - RFK Jr's decision involves withdrawing US funding from the global vaccine initiative [1]

Immunizations “are not all good or bad,” says the chair of the vaccine committee that has been overhauled by Health and Human Services Secretary Robert F. Kennedy Jr. https://t.co/oxv657Q4wD ...

Market Trends & Economic Policy - The Nasdaq 100 climbed over 4% in June, indicating a strong performance in the tech sector [1] - Nvidia reclaimed its position as the most valuable company after a dip in January [1] - Senator Warren believes Trump's economic chaos, particularly tariffs, hinders interest rate cuts [2][3] - The Fed's inflation forecast increased from 25% to 31%, while GDP growth prediction decreased from 21% to 14%, attributed to Trump's tariffs [3] - Oil prices are back down to $64, influencing decisions to wait and see what happens [1] Federal Reserve & Monetary Policy - President Trump is considering naming a new Fed chair as early as this summer, potentially influencing investor expectations [1] - Potential Fed chair candidates include Kevin Walsh, Kevin Hasset, Scott Bessent, David Malpass, and Christopher Waller [1] - The dollar has slid about 10% this year [1] - The Fed acknowledges fiscal policy can theoretically add to inflation [3] Legal & Regulatory Issues - A mediator proposed a $20 million settlement between President Trump and Paramount Global over a 60 Minutes interview [2] - Paramount offered $15 million to settle the suit, but Trump's team seeks $25 million and an apology [2] - FCC Chairman Brendan Carr indicated a third-party complaint about the interview's edit could affect the Paramount Sky Dance merger review [2] - The Federal Housing Finance Agency is directing Fannie Mae and Freddie Mac to consider crypto assets in mortgage loan risk assessments [2] Vaccine & Public Health - Robert F Kennedy Jr's new vaccine advisory panel includes members with unabashed antivaccine views [1][19] - The panel is focusing on the MMR and varicella vaccine, with concerns about febrile seizures [20] - There are discussions about removing thyarasol, currently in 4% of vaccines, and alum from vaccines [23][24] - MMR vaccination rates are declining, with over 50% of states below herd immunity [41]