Core Insights - Transgene's TG4050, an individualized neoantigen therapeutic vaccine, shows promising immunogenicity data in preventing cancer relapse, with results to be presented at SITC 2025 [1][2][3] - The company is advancing its clinical trials, with the first immunogenicity data from the ongoing Phase II trial expected in H2 2026 [1][6] - Financial updates indicate a positive trend in research tax credits and a strategic funding plan to support operations until the end of December 2026 [12][14][15] Clinical Development - TG4050 has demonstrated the ability to induce neoantigen-specific cytotoxic CD8+ T-cell responses, which can target and eliminate tumor cells, with effects detectable up to two years post-treatment [3][4] - The ongoing Phase I/II trial evaluates TG4050 as a single agent in the adjuvant treatment of HPV-negative head and neck squamous cell carcinoma (HNSCC) [4][6] - Transgene is exploring efficient regulatory pathways to expedite TG4050's development for operable HNSCC patients [7] Financial Position - For Q3 2025, Transgene reported a research tax credit of €5.8 million, up from €4.8 million in Q3 2024, reflecting ongoing clinical trial progress [12] - As of September 30, 2025, the company had €12.8 million in cash, down from €16.7 million at the end of 2024, with a net cash burn of €28.8 million for the first nine months of 2025 [13] - A new amendment to the account advance agreement with major shareholder TSGH has increased funding to €48 million, allowing the company to sustain operations through December 2026 [14][15] Future Plans - Transgene plans to present additional immunological data profiling the neoantigen-specific T-cell response at the SITC Annual Meeting [2][5] - The company is initiating start-up activities for a potential new Phase I trial in a second indication, aiming to begin once all conditions are met [8]

Core Insights - CytomX Therapeutics announced initial Phase 1 data for CX-801, indicating activation of tumor-selective interferon signaling in advanced melanoma patients [1][2] - The data supports the ongoing Phase 1 combination study of CX-801 with KEYTRUDA, addressing significant unmet medical needs in melanoma treatment [3] Company Overview - CytomX Therapeutics is a clinical-stage biopharmaceutical company focused on developing conditionally activated, masked biologics for cancer treatment [5] - The company utilizes its PROBODY therapeutic platform to create localized therapies, including CX-801, which is a masked interferon alpha-2b cytokine [5] - CytomX's pipeline includes other candidates like CX-2051, aimed at treating various epithelial cancers [5] Clinical Study Details - Initial biomarker data from the Phase 1 study of CX-801 suggest it induces tumor-localized activation of immune cell populations and interferon-stimulated genes [2] - CX-801 has shown to be generally well tolerated and can modulate the immune tumor microenvironment in patients with metastatic melanoma who are refractory to prior therapies [3] - The poster presentation for CX-801 will take place at the Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 8, 2025 [4]

Core Insights - Merck & Co Inc. reported third-quarter 2025 sales of $17.3 billion, reflecting a 4% increase year-over-year [1] - The company expects full-year sales to be between $64.5 billion and $65 billion, and has raised its non-GAAP EPS forecast to $8.93–$8.98 [3] Sales Performance - KEYTRUDA generated $8.1 billion in sales, marking a 10% increase [2] - WINREVAIR sales surged to $360 million, while CAPVAXIVE contributed $244 million [2] - GARDASIL sales decreased by 24% to $1.7 billion, and Animal Health sales grew by 9% to $1.6 billion [2] Earnings and Financials - Earnings per share were reported at $2.32 (GAAP) and $2.58 (non-GAAP), which included a $0.10 charge related to a tech transfer deal [3] - The company received FDA approval for a new KEYTRUDA injection and shared promising cancer trial data [3] - Merck completed its acquisition of Verona Pharma [3] Company Overview - Merck & Co. Inc. is a global healthcare company focused on scientific innovation to develop health solutions, including prescription medicines, vaccines, biologic therapies, and animal health products [4] - The company's primary focus areas include oncology, vaccines, and infectious diseases [4]

Third-Quarter 2025 Sales and Earnings Merck & Co., Inc., Rahway, N.J., USA October 30, 2025 Strategy and Business Update Robert M. Davis Chairman and Chief Executive Officer Financial Results and Outlook Caroline Litchfield Executive Vice President and Chief Financial Officer Research Update Dr. Dean Y. Li Executive Vice President and President, Research Laboratories Question & Answer Session 2 Agenda Agenda Forward-looking statement of Merck & Co., Inc., Rahway, N.J., USA This presentation of Merck & Co., ...

Company Overview - Merck & Co. Inc. (NYSE:MRK) is recognized as one of the best value stocks in Goldman Sachs' portfolio [1] - The company is a global healthcare provider delivering medicines and vaccines across various therapeutic areas, including oncology, infectious diseases, immunology, and cardiometabolic conditions [3] Product Development - On September 19, Merck announced FDA approval for KEYTRUDA QLEX injection, the first subcutaneous version of its cancer drug KEYTRUDA [1] - QLEX can be administered subcutaneously in as little as one minute, offering a faster and more convenient option compared to the traditional intravenous (IV) form [1] Market Impact - The approval of QLEX strengthens Merck's leadership in oncology, where KEYTRUDA already has approvals across 38 cancer indications [2] - The new subcutaneous format is expected to enhance adoption in community clinics and smaller practices, improving patient experience with three-week and six-week dosing schedules [2] Financial Performance - KEYTRUDA is already generating multi-billion-dollar sales annually, and the introduction of the subcutaneous version provides Merck with a new opportunity to defend and grow its oncology franchise [3]

本研究一项多中心、随机、双盲、平行对照的1期临床研究，旨在评估HLX17与KEYTRUDA(美国市售) 在多种已切除实体肿瘤(包括非小细胞肺癌、黑色素瘤或肾细胞癌)受试者中的药代动力学(PK)特徵、有 效性、安全性和免疫原性相似性。合格的受试者将按1:1的比例随机分配至A组和B组，A组受试者每3周 接受一次HLX17治疗;B组受试者前8个周期(24周)每3周接受一次KEYTRUDA治疗，随后转为接受 HLX17治疗，所有受试者持续接受治疗至随机化后12个月(约17个周期)或研究者评估的疾病复发、死 亡、开始新抗肿瘤治疗、出现不可耐受的药物毒性、撤回知情同意书或研究终止(以先发生者为準)。本 研究的主要研究终点为首次给药后从0到21天血清药物浓度-时间曲线下面积(AUC0-21d)以及第6次给药 后稳态下单个给药间隔内的血清药物浓度-时间曲线下面积(AUCss)。次要研究终点包括其他PK参数、 有效性、安全性和免疫原性。 复宏汉霖(02696)公布，近日，公司自主研发的帕博利珠单抗生物类似药HLX17(重组抗PD-1人源化克隆 抗体注射液)(HLX17)在多种已切除实体瘤患者中开展的国际多中心1期临床研究于中国 ...

Core Viewpoint - The company has completed the first patient dosing in an international multicenter Phase 1 clinical study of its self-developed biosimilar HLX17, aimed at evaluating its pharmacokinetics, efficacy, safety, and immunogenicity compared to KEYTRUDA in patients with various resected solid tumors [2] Group 1 - The clinical study is a multicenter, randomized, double-blind, parallel-controlled Phase 1 trial [2] - The study focuses on patients with multiple resected solid tumors [2] - HLX17 is a recombinant humanized monoclonal antibody targeting PD-1 [2]

mRNA-4157/V940 in combination with KEYTRUDA - At ~3 years of follow-up, the recurrence-free survival rate of mRNA-4157/V940 in combination with KEYTRUDA was 74.8%, compared to 55.6% for KEYTRUDA alone[12] - At a median planned follow-up of 34.9 months, mRNA-4157/V940 in combination with KEYTRUDA reduced the risk of recurrence or death by 49%[14] - At ~3 years of follow-up, mRNA-4157/V940 in combination with KEYTRUDA demonstrated a 62% reduction in the risk of developing distant metastasis or death compared to KEYTRUDA alone[17] Safety and Tolerability of mRNA-4157/V940 - In the adjuvant melanoma trial, any treatment-related adverse event occurred in 100% of patients (n=104) receiving mRNA-4157 (V940) + pembrolizumab, with Grade ≥ 3 events in 25% of patients[18] - Serious adverse events occurred in 14.4% of patients (n=15) receiving mRNA-4157 (V940) + pembrolizumab[18] - Immune-related adverse events occurred in 37.5% of patients (n=39) receiving mRNA-4157 (V940) + pembrolizumab, with Grade ≥ 3 events in 10.6% of patients[18] - 94.2% of patients (n=98) experienced mRNA-4157 (V940)-related adverse events, with 33.7% Grade 1, 49% Grade 2, and 11.5% Grade 3[18] Development Programs - The Phase 3 study for adjuvant melanoma with mRNA-4157/V940 is fully enrolled[21, 22] - mRNA-4359 is ongoing in Phase 1/2 study; now enrolling Phase 2 with additional indications planned[27] - mRNA-2808 is in Phase 1 development[41] - mRNA-4203: IND open, in combination with Immatics' IMA203[49]

Core Insights - Merck & Co., Inc. is recognized as one of the 13 best Fortune 500 dividend stocks to invest in, highlighting its appeal to income-focused investors [1] - The company received FDA approval for KEYTRUDA QLEX™ injection, which is expected to enhance its market position and attract further investor interest [3][4] Financial Performance - For Q2 2025, Merck reported an Adjusted EPS of $2.13, exceeding the consensus estimate of $2.03, indicating strong operational efficiency [2] - Worldwide sales reached $15.8 billion, reflecting a slight decline of 2% year-over-year, primarily due to decreased Gardasil sales in China [2] - Sales of KEYTRUDA increased by 9% to $8.0 billion, showcasing the drug's continued strong performance in the oncology market [2] Regulatory Developments - The FDA approval for KEYTRUDA QLEX™ allows for subcutaneous administration in adults for most solid tumor indications, marking a significant advancement in treatment options [3] - The approval is viewed positively by healthcare providers, emphasizing the importance of immunotherapies in cancer treatment [4] Dividend Appeal - Merck offers a dividend yield of 4%, which is attractive to investors seeking income-generating stocks [4]

Group 1: Company Overview - Pfizer Inc. is a global pharmaceutical leader focusing on mRNA vaccines, oncology, immunology, and infectious diseases, with notable recognition for its COVID-19 vaccine collaboration with BioNTech [1][2] - The company is advancing its mRNA vaccine portfolio, recently announcing progress with its LP.8.1-adapted COMIRNATY 2025-2026 formula [1] Group 2: Vaccine Development - In September 2025, Pfizer reported positive Phase 3 topline data showing a fourfold increase in neutralizing antibodies in adults aged 65+ and high-risk adults aged 18–64, supporting FDA approval [2] - The adaptive vaccine targets emerging SARS-CoV-2 sublineages, reinforcing Pfizer's strategic direction to maintain vaccine efficacy amid changing pandemic conditions [2] Group 3: Oncology and Specialty Medicines - Pfizer is advancing oncology and specialty medicines, with combination therapy PADCEV plus KEYTRUDA showing improved survival rates in bladder cancer [3] - The company is also progressing with HYMPAVZI for hemophilia treatment, demonstrating its commitment to high-need therapeutic areas [3] Group 4: Research and Development Focus - Despite facing regulatory challenges and patent litigation over Paxlovid, Pfizer continues to invest in R&D and strategic partnerships [4] - The company's focus on adaptive mRNA technology, AI-driven development, and precision medicine highlights its leadership among biotech innovators [4]