Pfizer (PFE) has reportedly decided to sell its entire remaining stake in BioNTech (BNTX), showing a lack of confidence in BioNTech’s Covid-19 vaccine and in BNTX stock. Meanwhile, BioNTech has generally been generating relatively steep losses and its shares are not cheap. Finally, while its two most prominent drug candidates show some potential, they both have significant weaknesses and consequently may very well not end up generating large amounts of revenue for the firm. More News from Barchart In li ...

映恩生物于近期开展研发日活动，并在研发日上更新了若干管线信息与进展。 全面拥抱IO 2.0 联用进展领先。公司与BioNTech 合作的三款ADC：DB-1303(HER2 ADC)、DB- 1311(B7-H3 ADC)以及DB-1305(TROP2 ADC)已与PDL1/VEGF 双特异性抗体BNT327 联用，开展四项全 球临床实验，并均已完成首例患者入组。其中：（1）DB-1311 开展两项联用研究，分别为肺癌和多种 实体瘤。 机构：麦高证券 研究员：辛家齐 在胃肠道肿瘤中，ADAM9 的阳性率比 HER2 高 20 倍、比 CLDN18.2 高 3 倍。 DB-1317 临床前数据优异，成药潜力大。 DUPAC 平台新毒素DUP5 公布分子机制。DUP5 通过作用于eIF4F 复合物介导的mRNA 翻译起始阶段， 阻断一系列致癌 mRNA 翻译过程，进而发挥强效且广谱的抗肿瘤活性。与Dxd 相比，DUP5 体外活性 相当,均具有旁观者效应，但可以作用于非分裂的癌细胞，在实体瘤和血液瘤都有杀伤效应，具备潜在 更优的疗效。 盈利预测与投资建议：鉴于公司在IO 2.0 联用的广泛布局和领先，以及新分子的陆 ...

Core Insights - Bristol Myers (BMY) has decided to discontinue the late-stage Librexia study for milvexian, an investigational oral factor XIa inhibitor, due to an interim analysis indicating it is unlikely to meet its primary efficacy endpoint [1][2][3] - Following the announcement, BMY's stock fell by 4%, and year-to-date, shares have decreased by 17.5%, contrasting with the industry growth of 14.9% [1] Group 1: Study Discontinuation - The Librexia ACS study was halted after the Independent Data Monitoring Committee (IDMC) found it unlikely to achieve its primary efficacy goal, which is the time to the first occurrence of stroke and non-CNS systemic embolism [3][6] - Despite the discontinuation, the IDMC did not identify any new safety concerns related to milvexian [3][6] Group 2: Other Clinical Trials - BMY and JNJ will continue with two other late-stage studies: Librexia AF for atrial fibrillation and Librexia STROKE for secondary stroke prevention, with top-line data expected in 2026 [4][6] - The IDMC recommended the continuation of these trials, noting they differ from Librexia ACS in patient groups, endpoints, and background therapy [6][7] Group 3: Portfolio Diversification - The discontinuation of the Librexia ACS study is viewed as a setback, but successful development of milvexian for AF and SSP could enhance BMY's cardiovascular portfolio, which includes Camzyos, a cardiac myosin inhibitor [8][9] - BMY is actively seeking to diversify its pipeline, especially as its legacy portfolio faces challenges from generic competition on drugs like Revlimid and Pomalyst [10] Group 4: Recent Acquisitions - BMY announced the acquisition of Orbital Therapeutics for $1.5 billion, which will add OTX-201, a preclinical RNA immunotherapy candidate, to its pipeline [10][11] - This acquisition aims to strengthen BMY's position in the market and expand its therapeutic offerings [11][12]

Core Insights - Goldman Sachs highlights the promising preliminary Phase 1 data for CS2009, a tri-specific antibody targeting PD-1, VEGF, and CTLA-4, presented at the ESMO 2025 conference, indicating good safety and early tumor response signals across various cancer types [1][2] Group 1: Safety and Tolerability - CS2009 demonstrated good tolerability during the Phase 1 dose escalation study involving 72 patients across six dosage levels (1/3/10/20/30/45 mg/kg) [2] - In comparison, the HARMONi-2 trial showed that ivonescimab (PD-1/VEGF dual antibody) had a 29% incidence of grade 3 or higher treatment-related adverse events (TRAE) and 7% for immune-related adverse events (irAE) [2] - Higher dose groups of CS2009 reported fewer adverse reactions, potentially due to shorter observation periods, with the median observation time being 1.9 months [2] Group 2: Competitive Potential in NSCLC - Among 49 patients who underwent at least one tumor assessment, partial responses were observed in seven patients across five cancer types, suggesting CS2009's broad potential [3] - Notably, in 12 IO-treated NSCLC patients without prior anti-angiogenic therapy, CS2009 exhibited a 25% objective response rate (ORR) and an 83% disease control rate (DCR) [3] - The initial ORR signals are viewed positively, although further data is needed to assess CS2009's potential differentiated efficacy due to the small sample size and short follow-up [3] Group 3: Future Development Plans - The management plans to select the recommended Phase 3 dose from 20 mg/kg and 30 mg/kg based on Phase 1 data, aiming to initiate a global Phase 3 trial by the end of 2026 [4] - The ongoing Phase 2 trials in Australia and China have commenced with over 30 clinical centers, and patient enrollment is expected to begin soon [4] - Goldman Sachs has upgraded its earnings forecasts for the company, reflecting an increased view on CS2009's success probability from 30% to 49%, and revised the 12-month target price to HKD 7.05 [4]

Summary of Clinical Trial Pipeline Tracker Industry Overview - **Industry**: Biopharma - **Region**: North America - **Industry View**: In-Line for Major Pharmaceuticals, Attractive for Biotechnology [7][7] Key Changes in Clinical Trials New Trials - **Alector**: Initiated a Phase 2 trial (NCT07105709) for an Open-label Extension Study in Participants With Early Alzheimer's Disease [9] - **BioNTech**: Advancing BNT327 (PD-L1xVEGF bispecific) combinations, including a new Phase 1/2 trial in combination with BNT326 (HER3 ADC) in NSCLC (NCT07111520) and a Phase 1/2 trial of BNT327 with BNT314 and chemotherapy in advanced CRC (NCT07079631) [9][9] - **Bristol-Myers Squibb**: Initiated a Phase 2/3 trial (NCT07106762) of Izalontamab Brengitecan (EGFRxHER3 bispec) vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer [9] - **Gilead Sciences**: Initiated a Phase 1 trial (NCT07115368) of GS-1219 in people with HIV, indicating progress in its next-gen HIV pipeline [9] - **Neurocrine**: Initiated a Phase 3 trial (NCT07114874) for Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia [9] Withdrawn Trials - **Sarepta**: The Phase 3 trial (NCT06952686) of SRP-9005 in Limb Girdle Muscular Dystrophy Type 2C/R5 Pediatric and Adult Participants was withdrawn [4][24] Recruitment Updates - **BioNTech**: Currently recruiting for a Phase 1/2 study (NCT07079631) to test the combination of BNT314 and BNT327 with chemotherapy in advanced colorectal cancer [10] - **Merck**: Recruiting in a Phase 3 study (NCT07044297) to prevent HIV-1 [11] Completed Trials - **Amgen**: Completed recruitment for a Phase 3 trial (NCT06104124) evaluating Dazodalibep in participants with Sjögren's Syndrome [17] - **Ionis**: Completed recruitment for a Phase 3 trial (NCT04768972) in Amyotrophic Lateral Sclerosis participants [17] Other Important Information - The report includes a comprehensive list of clinical trials, their stages, and statuses, providing insights into the ongoing research and development efforts within the biopharma sector [2][7][21] - The document emphasizes the potential conflicts of interest due to Morgan Stanley's business relationships with the companies covered in the research [7] This summary encapsulates the critical updates and insights from the clinical trial pipeline tracker, highlighting the dynamic nature of the biopharma industry in North America.

Core Insights - The collaboration between the company and Merck focuses on the global development of TROP2 ADC, specifically the drug SKB264, which is recognized for its potential as a blockbuster product [1] - SKB264 is currently in the phase III global multi-center registration clinical trials for over ten solid tumor indications, with significant data expected to be disclosed in 2027 [1] - SKB264 has demonstrated superior efficacy in various patient populations, particularly in NSCLC, outperforming competitors in terms of median progression-free survival (mPFS) [2][3] Group 1: Product Development and Clinical Trials - SKB264 has entered the phase III clinical trial stage for multiple solid tumors, with Merck planning to disclose nine clinical trial data points in 2027 [1] - The drug has shown promising results in the first-line wild-type NSCLC population, achieving an mPFS of 15.0 months when combined with PD-1 monoclonal antibody KL-A167, surpassing other TROP2 ADCs [2] - In the PD-L1 TPS≥1% population, SKB264 achieved an mPFS of 17.8 months, and in the PD-L1 TPS<1% group, it reached 12.4 months, indicating its efficacy across different expression levels [2] Group 2: Competitive Landscape - SKB264 is positioned in the first tier of the global TROP2 ADC competition, alongside Gilead's Trodelvy and AstraZeneca/Daiichi Sankyo's Dato-DXd [1] - The molecular design of SKB264 provides it with better plasma stability and a longer half-life compared to Trodelvy, while being slightly shorter than Dato-DXd [1] Group 3: Future Directions and Market Potential - The rise of next-generation immunotherapy drugs suggests that IO+ADC combination therapies may become a key focus in the treatment of solid tumors [3] - The collaboration between BMS and BioNTech to develop a dual-specific antibody candidate highlights the commercial potential of combining IO with ADC therapies [3] Group 4: Financial Projections - The company forecasts revenues of 2.084 billion, 2.876 billion, and 4.663 billion yuan for the years 2025 to 2027, respectively, with net profits expected to improve significantly by 2027 [4]

Investment Rating - The report maintains a "Buy" rating for the company [5][7]. Core Insights - The company's core product, SKB264, is positioned as a promising ADC targeting TROP2, with significant clinical trial progress and potential for commercialization [1][14]. - SKB264 has shown superior efficacy in various clinical settings, particularly in NSCLC, outperforming competitors in terms of mPFS [2][24]. - The collaboration with Merck enhances the global development strategy for SKB264, indicating strong commercial potential [1][15]. Summary by Sections Section 1: Collaboration and Clinical Development - The company has partnered with Merck to develop SKB264, which is currently in multiple Phase III clinical trials for various indications, including NSCLC and triple-negative breast cancer [14][15]. - SKB264 is recognized as a candidate with "blockbuster potential" by Merck, reflecting confidence in its market value [16]. Section 2: Efficacy in NSCLC - In the first-line treatment of wild-type NSCLC, SKB264 demonstrated a median progression-free survival (mPFS) of 15.0 months, significantly better than other TROP2 ADCs [2][24]. - In patients with PD-L1 TPS ≥1%, the mPFS reached 17.8 months, showcasing its effectiveness in this subgroup [2][24]. - SKB264 also exhibited promising results in EGFR-mutated NSCLC patients, with a notable reduction in tumor size compared to standard treatments [3][36]. Section 3: Future Potential and Market Position - The report highlights the potential of combining next-generation immunotherapy with ADCs, positioning SKB264 as a key player in this evolving treatment landscape [4][19]. - The competitive landscape for TROP2 ADCs is intensifying, with SKB264 among the leading candidates, necessitating close monitoring of upcoming clinical data [19][21]. Section 4: Financial Projections - Revenue forecasts for the company are optimistic, with projected revenues of 2.084 billion, 2.876 billion, and 4.663 billion CNY for 2025, 2026, and 2027 respectively [5][7]. - The company is expected to achieve profitability by 2027, with a projected net profit of 561 million CNY [5].

Financial Data and Key Metrics Changes - For Q2 2025, total revenues reached approximately €261 million, a significant increase from €129 million in Q2 2024, primarily driven by higher revenues from the COVID-19 vaccine collaboration [40] - Research and development expenses decreased to approximately €585 million from €709 million in the prior year, reflecting a reprioritization of clinical trials [41] - The company reported a net loss of €387 million for Q2 2025, compared to a net loss of €88 million in the same period last year [42] - Basic and diluted loss per share improved to €1.6 from €3.3 year-over-year [42] - Cash and cash equivalents stood at €16 billion, providing flexibility for long-term strategy execution [42] Business Line Data and Key Metrics Changes - The company is focusing on two priority pan-tumor programs: mRNA cancer immunotherapies and bispecific antibody BNT327, with significant investments in clinical development [9][10] - The acquisition of BioThese has fully integrated BNT327 into the pipeline, enhancing its clinical development capabilities [10] - The collaboration with Bristol Myers Squibb (BMS) aims to establish BNT327 as a new standard of care across multiple tumor types [11][16] Market Data and Key Metrics Changes - The company is preparing for the global commercial rollout of a new variant-adapted COVID-19 vaccine, pending regulatory approvals, indicating ongoing market engagement [13] - The partnership with the UK government aims to invest up to £1 billion over the next decade to accelerate clinical trials for personalized mRNA immunotherapies [13] Company Strategy and Development Direction - The overarching vision is to build an immunotherapy powerhouse and become a fully integrated biopharmaceutical company with multiple approved therapies [7] - The strategy includes developing combination therapies that address various cancer stages, focusing on both early and late-stage cancers [8] - The company is enhancing its commercial infrastructure and manufacturing capabilities to support future launches in key markets [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of BNT327 to improve patient outcomes in high unmet medical need areas, with ongoing clinical trials expected to yield meaningful data [20][21] - The company anticipates lower COVID-19 vaccination rates compared to previous years but remains optimistic about maintaining market share and pricing [47] - Future growth is expected to be driven by the oncology pipeline and the ongoing development of combination therapies [49] Other Important Information - The company reaffirmed its financial guidance for 2025, expecting revenues between €1.7 billion and €2.2 billion, with R&D expenses projected between €2.6 billion and €2.8 billion [46] - The collaboration with BMS is expected to significantly strengthen the company's cash position and P&L for the coming years [43][45] Q&A Session Summary Question: Clarity on vaccine development and vaccination rates - Management acknowledged lower vaccination rates but emphasized the ongoing priority of the COVID-19 vaccine business alongside oncology development [56][57] Question: Details on BNT327 trial doses and data release - Management confirmed that details on doses for the Phase II portion will be shared later this year, with top-line data expected before year-end [62][63] Question: BNT327 in frontline triple-negative breast cancer - Management highlighted the potential of BNT327 in combination with ADCs and the encouraging data generated so far [66] Question: R&D spending post-Bristol collaboration - Management indicated that R&D spending will increase in priority areas while decreasing in less prioritized programs [71] Question: COVID-19 vaccination revenue guidance - Management expects lower vaccination rates but maintains that pricing and market share will remain stable [78]

Core Insights - BioNTech reported significant advancements in its oncology strategy, including collaborations and acquisitions aimed at enhancing its product pipeline and capabilities [2][6][30] - The company experienced a substantial increase in revenues for the second quarter of 2025, driven primarily by its COVID-19 vaccine collaboration [3][4] - BioNTech's financial position remains strong, with substantial cash reserves and expected cash inflows from strategic partnerships [10][11][14] Financial Performance - Revenues for Q2 2025 reached €260.8 million, up from €128.7 million in Q2 2024, while total revenues for the first half of 2025 were €443.6 million compared to €316.3 million in the prior year [3][4] - The net loss for Q2 2025 was €386.6 million, a significant reduction from a net loss of €807.8 million in Q2 2024, with a total net loss of €802.4 million for the first half of 2025 compared to €1,122.9 million in the same period last year [7][8] - Basic and diluted loss per share improved to €1.60 for Q2 2025 from €3.36 in Q2 2024, and for the first half of 2025, it was €3.33 compared to €4.67 in the prior year [8][41] Research and Development - R&D expenses for Q2 2025 were €509.1 million, down from €584.6 million in Q2 2024, with total R&D expenses for the first half of 2025 at €1,034.7 million compared to €1,092.1 million in the previous year [4][5] - The company is focusing on its oncology pipeline, including the development of BNT327, a bispecific antibody candidate, and has initiated several clinical trials for various cancer treatments [6][23][27] Strategic Developments - BioNTech entered a collaboration with Bristol Myers Squibb (BMS) for the co-development of BNT327, which includes an upfront cash payment of $1.5 billion and potential milestone payments totaling up to $7.6 billion [10][11][12] - The acquisition of CureVac is expected to enhance BioNTech's capabilities in mRNA technology, complementing its existing product offerings [2][6][30] - The company has received approval for a new variant-adapted COVID-19 vaccine, with preparations for launch underway [6][22] Financial Guidance - BioNTech reaffirmed its revenue guidance for the full year 2025, expecting revenues to be between €1,700 million and €2,200 million, with a focus on late-stage development and commercialization in oncology [14][16] - Planned expenses for 2025 include R&D expenses of €2,600 million to €2,800 million and SG&A expenses of €650 million to €750 million [15][16]

Financial Data and Key Metrics Changes - Total company revenues for Q2 2025 were approximately $12.3 billion, reflecting strong demand across the business [19] - The growth portfolio saw a 17% year-over-year increase in sales, primarily driven by demand for key brands [5][19] - Gross margin was approximately 73%, primarily due to product mix, with operating expenses down by approximately $260 million compared to the same period last year [29][30] - Diluted earnings per share was $1.46, which includes a $1.5 billion charge related to the BioNTech strategic partnership [30][34] Business Line Data and Key Metrics Changes - Opdivo global sales were approximately $2.6 billion, up 7%, driven by demand in the U.S. and international markets [20] - REBLOZYL global sales were $568 million in the quarter, with U.S. revenue growth up 30% year-over-year [22] - BRYANZI revenues were $344 million, reflecting a 122% increase due to strong demand across all indications [25] - Kamsiyos global sales were $260 million, growing 86% due to robust demand [26] - Eliquis global sales were $3.7 billion, growing 6% primarily due to strong demand [27] Market Data and Key Metrics Changes - In the U.S., Opdivo revenues were approximately $1.5 billion, largely driven by a strong launch in MSI high colorectal cancer [20] - Outside the U.S., Opdivo revenues grew 7%, driven by volume growth and one-time favorable adjustments [20] - REBLOZYL sales outside the U.S. grew 46%, reflecting continued demand across newly launched markets [23] Company Strategy and Development Direction - The company is focused on reshaping for long-term sustainable growth, optimizing its cost structure, and enhancing its growth portfolio [5][19] - Strategic partnerships with BioNTech and Philochem aim to strengthen immuno-oncology and radiopharmaceutical capabilities [6][11] - The company is prioritizing investments in areas with the strongest potential for high-value assets [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential despite some studies not meeting expectations, emphasizing the importance of upcoming data readouts [39] - The company is entering a data-rich period with seven registration assets and seven lifecycle management opportunities expected in the next 12 to 24 months [13] - Management raised full-year revenue guidance by $700 million, reflecting strong performance and better-than-expected legacy sales [32][34] Other Important Information - The company announced a direct-to-consumer offering for Eliquis in partnership with Pfizer, aimed at increasing patient access and affordability [45][49] - A new Executive Vice President, Chief Medical Officer, and Head of Development will join the company, indicating a focus on pipeline advancements [17] Q&A Session Summary Question: Upcoming data-heavy period and Phase III results - Management acknowledged the importance of upcoming studies and their limited impact on long-term growth, emphasizing confidence in future opportunities [39] Question: Macro pressures and direct-to-consumer offering - The direct-to-consumer offering was implemented to cut out middlemen and provide patients with lower costs and increased transparency [46][49] Question: Launch dynamics for COBENFI - COBENFI is performing in line with expectations, with steady growth anticipated as the company expands its prescriber base [56] Question: Competitive dynamics for Kamsiyos - Management remains confident in Kamsiyos' growth despite upcoming competition, citing strong real-world data and positive feedback on label changes [86] Question: Differentiation of MILVEXIAN - Management believes there is an underappreciation of MILVEXIAN's differentiated dosing and its potential in multiple indications [90][92]