Core Viewpoint - Bristol-Myers Squibb Company (BMY) is set to report its fourth-quarter and full-year 2025 results on February 5, 2026, with consensus estimates for sales at $12.25 billion and earnings per share (EPS) at $1.15. Recent earnings estimates for 2025 have decreased, while those for 2026 have increased slightly [1][4]. Estimate Movement - The current EPS estimates for Q1, Q2, FY 2025, and FY 2026 are $1.15, $1.51, $6.09, and $6.08 respectively, showing a downward trend from previous estimates [2]. - The earnings surprise history indicates that BMY has consistently beaten estimates in the last four quarters, with an average surprise of 20.05% [2][3]. Factors Influencing Q4 Results - BMY's revenue growth is likely supported by its growth portfolio, which includes drugs like Opdivo, Reblozyl, and Breyanzi, despite facing pressure from declining sales of legacy drugs due to generic competition [4][6]. - Opdivo's sales are projected at $2.6 billion, benefiting from label expansions in new indications [7][8]. - Other drugs such as Orencia and Yervoy are also expected to contribute significantly to sales, with estimates of $989 million and $727 million respectively [9]. Legacy Drug Impact - Legacy products accounted for 47% of total sales in the first nine months of 2025, and their decline has negatively impacted overall revenue growth [21]. - Sales from legacy drugs like Eliquis, Revlimid, and Pomalyst are under pressure from generic competition, although Eliquis continues to show strong demand [14][15]. Strategic Collaborations and Acquisitions - BMY's recent acquisition of Orbital Therapeutics adds a promising preclinical RNA immunotherapy candidate to its pipeline, enhancing its capabilities in autoimmune diseases [23]. - The collaboration with BioNTech for the co-development of pumitamig has shown positive interim results, indicating potential in treating various solid tumors [24][25]. Stock Performance and Valuation - BMY's shares have underperformed compared to the industry and the S&P 500, with a current price/earnings ratio of 9.09x, lower than the industry average [17][19]. - The company is viewed as a safe haven for investors in the biotech sector, with a dividend yield of 4.58% providing an incentive to hold shares [26][27].

Core Insights - Bristol Myers Squibb (BMY) showcased its promising pipeline at the 44th Annual J.P. Morgan Healthcare Conference, emphasizing multi-billion-dollar potential candidates [1][9] Pipeline Candidates - Key pipeline candidates include milvexian (oral factor XIa inhibitor), admilparant (LPA1 antagonist), pumitamig (PD-L1 x VEGF-A bispecific antibody), and iberdomide & mezigdomide (oral CELMoD protein degraders) [1] - Milvexian is being developed in partnership with Johnson & Johnson for atrial fibrillation and secondary stroke prevention, with data expected in 2026 [2] - Admilparant is under evaluation for idiopathic pulmonary fibrosis, with data from the ALOFT-IPF study anticipated later this year [3] - Pumitamig is being assessed for various solid tumor types and has received orphan drug designation for small-cell lung cancer, with eight registrational trials expected to start by year-end [4] - Iberdomide is being studied for relapsed or refractory multiple myeloma, showing significant improvement in minimal residual disease negativity rates in late-stage studies [5] Label Expansion and Market Strategy - BMY is expanding the label for schizophrenia drug Cobenfy, which has shown initial sales of $105 million in the first nine months of 2025, and is being evaluated for Alzheimer's-related psychosis and agitation [6][7] - The successful development of these pipeline assets and label expansions will significantly enhance BMY's portfolio amidst challenges from generic competition affecting legacy products [7] Competitive Landscape - BMY is focused on oncology, competing with major players like Merck and Pfizer, which have established oncology portfolios and are also developing bispecific antibodies targeting PD-1 and VEGF [8][10][12] Financial Performance - BMY shares have increased by 11.3% over the past six months, compared to the industry's growth of 16.3% [14] - The company is trading at a price/earnings ratio of 9.08x forward earnings, which is lower than the large-cap pharma industry's average of 17.74x [16] - The Zacks Consensus Estimate for 2025 EPS has slightly decreased to $6.48, while the estimate for 2026 has increased [17]

Group 1: Drug Pricing Agreement - AbbVie has signed an agreement with the Trump administration to lower drug prices in the U.S. to match those in comparable developed countries, supporting the Most Favored Nation (MFN) pricing proposal [2][4] - The agreement includes significant discounts on widely used medicines such as Alphagan, Combigan, Humira, and Synthroid, which will be available through the upcoming federal purchasing platform TrumpRx.gov [2][4] Group 2: Investment and Manufacturing Commitment - In exchange for the price reductions, AbbVie will receive a three-year exemption from import tariffs on pharmaceutical ingredients, contingent upon expanding its domestic manufacturing operations [3] - AbbVie has committed to investing $100 billion over the next decade to enhance its U.S. R&D and capital investments [3][8] Group 3: Licensing Deal for Cancer Treatment - AbbVie has entered into an exclusive licensing deal with RemeGen for the PD-1xVEGF bispecific antibody candidate, RC148, for a total of up to $5.6 billion [9][10] - The deal includes an upfront payment of $650 million and potential milestone payments of up to $4.95 billion, along with tiered double-digit royalties on future net sales [10] Group 4: Pipeline Expansion and Market Position - AbbVie plans to expand the development of RC148 as both a monotherapy and in combination regimens for various cancer indications, including non-small cell lung cancer and colorectal cancer [11] - The dual mechanism of RC148, targeting both PD-1 and VEGF, differentiates it from existing therapies, potentially offering a more effective treatment option for solid tumors [12][13] Group 5: Stock Performance - AbbVie's shares have gained over 24% in the past year, outperforming the industry growth of 18% [6]

Core Insights - ABL Bio has entered into a collaboration agreement with Eli Lilly, which includes a USD 40 million upfront payment and a USD 15 million equity investment [1][3] Group 1: Collaboration and Funding - ABL Bio and Eli Lilly are conducting joint research and development on multiple therapeutic candidates utilizing the Grabody platform [2] - The newly secured funding will be used to accelerate R&D on ABL Bio's core technologies, including bispecific antibodies and dual-payload ADCs [2][3] - ABL Bio aims to expand the indications of its Grabody platform into areas with high unmet needs, such as obesity and muscle disorders [3] Group 2: Clinical Development and Pipeline - ABL Bio is developing various clinical and non-clinical assets based on the Grabody platform, with 8 pipelines currently in clinical projects across multiple countries [4] - ABL301 (SAR446159) has completed Phase 1 clinical trials, with Sanofi set to conduct subsequent studies [4] - ABL001 (tovecimig) has received Fast Track designation from the FDA, and ABL111 (givastomig) has shown promising results in a Phase 1b trial [4]

The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Application Proof, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Application Proof. Application Proof of EpimAb Biotherapeutics Inc. 岸邁生物科技有限公司 (the "Company") (Incorporated in the Cayman Islands with limited liability) ...

Core Insights - NovaBridge Biosciences announced new data from the Phase 1 dosing study of ragistomig, a bispecific 4-1BB X PD-L1 antibody, showing consistent antitumor activity and improved safety profile with a new dosing schedule [1][2][3] Group 1: Study Results - The new Q6W dosing schedule demonstrated a disease control rate (DCR) of 58.8%, comparable to the 64.3% DCR observed with the previous Q2W schedule [7] - Only 5% of patients experienced Grade ≥3 liver function test (LFT) elevations with the Q6W regimen, compared to 40% with the Q2W regimen [13] - The study achieved its objective of extending the therapeutic window, supporting the advancement of ragistomig into combination studies [2][3] Group 2: Immunological Data - The Q6W dosing showed positive immunological data, including expansion of effector memory and CD8+ T cells, indicating durable immune engagement [7][13] - The study reported no cases of cytokine release syndrome (CRS) with either dosing schedule, highlighting the favorable safety profile [7][13] Group 3: Patient Characteristics - The study included 20 heavily pre-treated subjects receiving 3 mg/kg Q6W ragistomig, with 100% previously treated with immuno-oncology therapies [12] - Among the 17 evaluable patients on the Q6W regimen, the objective response rate was 11.8%, while the Q2W regimen had a 28.6% response rate [9] Group 4: Future Directions - The ongoing evaluation of the 5 mg/kg Q6W dosing cohort and future combination studies is anticipated to further assess the efficacy of ragistomig [8]

Core Viewpoint - Summit Therapeutics and Madrigal Pharmaceuticals have shown significant stock price increases over the past three years, with Summit rising 2,280% and Madrigal gaining 631%, indicating strong clinical and regulatory advancements in the biotech sector [1][2]. Group 1: Summit Therapeutics - Summit Therapeutics is developing ivonescimab, a bispecific antibody that has shown greater efficacy than Keytruda in a phase 3 study for non-small cell lung cancer, currently undergoing further studies in the U.S. [4][5]. - The market potential for ivonescimab is substantial, with analysts projecting worldwide sales of $4.4 billion by 2030 and peak sales of $53 billion, given its potential advantages over Keytruda, which generated $29.5 billion in revenue last year [7][8]. - The company’s market cap is currently $14 billion, and it has plans to target additional indications, with patent exclusivity for ivonescimab lasting until 2039, providing a long window for revenue generation [6][8][9]. Group 2: Madrigal Pharmaceuticals - Madrigal Pharmaceuticals received FDA approval for Rezdiffra, the first medication for metabolic dysfunction-associated steatohepatitis (MASH), addressing a significant unmet medical need linked to obesity [10]. - Rezdiffra generated $287.3 million in revenue in the third quarter, reflecting a 35% quarter-over-quarter increase and a 362% rise year-over-year, with 29,500 patients currently on the medication [11][12]. - The company is expanding its market reach and seeking label expansions for Rezdiffra, with patent protection lasting until 2045 in the U.S., indicating strong future growth potential despite competition [14][15][16].

Financial Data and Key Metrics Changes - Total revenue increased to $48.7 million in Q2 2025 from $19.2 million in Q2 2024, primarily due to a $20 million milestone from B1 and recognition of $80.3 million in deferred revenue [15][16] - Operating expenses decreased by 20% to $49.4 million in Q2 2025 from $62.1 million in Q2 2024, mainly due to a prior year impairment charge [17] - Net income was $2.3 million for Q2 2025, compared to a net loss of $37.7 million in Q2 2024 [17][18] - Cash resources increased to $333.4 million as of June 30, 2025, from $124.2 million at the end of 2024 [18] Business Line Data and Key Metrics Changes - The company has three product candidates in active Phase I trials in 2025, with two additional candidates expected to enter the clinic in 2026 [7][8] - Zanadatumab showed a median progression-free survival of 15.2 months and overall survival of 36.5 months in a study involving HER2 positive tumors [9][10] - The company recognized a $7.5 million option exercise payment related to a licensing agreement with BMS [14] Market Data and Key Metrics Changes - Conditional regulatory approvals for zanadatumab in China and Europe are expected to increase international patient access and potential future royalties [10][13] - The company anticipates an increase in royalty revenues from zanadatumab's international approvals for biliary tract cancer [13] Company Strategy and Development Direction - The company aims to leverage its proprietary technology platforms and strategic partnerships to enhance asset value and deliver long-term returns for shareholders [44][46] - The focus is on advancing a wholly owned pipeline of differentiated antibody drug conjugates and multi-specific antibodies across various therapeutic areas [46][48] - The company is committed to maintaining a science-first approach while exploring partnerships to share risk and resources [48][49] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of capital discipline and clarity in strategy to drive long-term value [44][51] - The company is focused on maximizing cash flow streams from royalties and other healthcare assets while maintaining flexibility in operations [51][52] - Anticipated growth in royalty and milestone income is not expected to trigger an automatic increase in operational expenditures [51] Other Important Information - The company presented data on its novel IL-4, IL-33 bispecific antibody for COPD at a recent conference, highlighting its potential in treating respiratory diseases [36][38] - The IND clearance for ZW251, targeting hepatocellular carcinoma, is seen as a significant advancement in the company's pipeline [28][29] Q&A Session Summary Question: Will PDL1 status be broken out for the triplet for arm C in the top line? - The inclusion of data in a top line press release will be determined by Jazz and B1, the sponsors of the studies [56][57] Question: How much of the ZANI $525 million regulatory milestone is weighted towards GEA versus other indications? - There is $500 million left in development milestones with Jazz, but no specific guidance on allocation has been provided [57] Question: How does ZW191 compare to other topoisomerase-based ADCs? - The company aims to create a differentiated asset with a novel mechanism and tolerability profile, which could allow for combinations with other treatments [60][63] Question: What is the approach for evaluating ZW251 in liver cancer patients? - The company will systematically study the tolerability and efficacy of ZW251 in appropriate patient subsets, considering liver impairment [68][69] Question: When can data from the Phase I trial of ZW191 be expected? - Initial data is anticipated to be shared at peer-reviewed meetings in 2025 or 2026, depending on abstract acceptance [74] Question: What is known about the expression of alpha in non-small cell lung cancer? - Analysis shows a subset of non-small cell lung cancer patients with BOLT receptor expression, encouraging further evaluation in this indication [78]

Core Insights - Aclaris Therapeutics has initiated a Phase 1a/1b clinical program for ATI-052, a bispecific antibody targeting TSLP and IL-4R, which is expected to be a best-in-class treatment for immuno-inflammatory diseases [1][2] Group 1: Clinical Development - The Phase 1a program will include single and multiple ascending dose (SAD/MAD) studies in healthy volunteers, followed by a Phase 1b proof of concept assessment in up to two undisclosed indications [2] - Completion of the Phase 1a SAD/MAD portion is anticipated by the end of 2025, with top line results expected in early 2026, and Phase 1b results in the second half of 2026 [2] Group 2: Mechanism of Action - ATI-052 is designed to exhibit high binding affinity and dual blockade of TSLP and IL-4R, inhibiting key proinflammatory pathways involved in Th2-mediated inflammation and allergic diseases [2][4] - The bispecific antibody's dual binding capability may enhance efficacy compared to traditional monoclonal antibodies, with potential applications for various immune-modulated diseases [3] Group 3: Product Profile - ATI-052 targets TSLP at the top of the inflammatory cascade and blocks downstream IL-4 and IL-13, which are critical cytokines in Th2-mediated inflammation [4] - The antibody utilizes the same TSLP antigen-binding fragment as bosakitug (ATI-045) but is engineered for tighter binding to the neonatal Fc receptor (FcRn), potentially extending its half-life [4] Group 4: Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, with a robust R&D pipeline [5]

Core Insights - Regeneron Pharmaceuticals is set to present new data from its oncology and hematology portfolio at the 2025 ASCO Annual Meeting, focusing on checkpoint inhibitors and bispecific antibodies for difficult-to-treat cancers [1][2][3] Oncology Developments - The company will showcase 18 presentations, including updates on the PD-1 inhibitor Libtayo and the investigational bispecific antibody linvoseltamab, which has shown promise in relapsed or refractory multiple myeloma [1][2] - Notable presentations include the Phase 3 C-POST trial results for Libtayo in high-risk cutaneous squamous cell carcinoma, scheduled for an oral session on May 31 [2][3] - Investigational combinations of linvoseltamab with proteasome inhibitors will also be highlighted in rapid oral presentations on June 2 [3] Hematology Insights - Regeneron will debut results from the LINKER-MM2 trial, exploring linvoseltamab combinations with carfilzomib or bortezomib in relapsed/refractory multiple myeloma [3][4] - The company will present findings from a randomized Phase 2 trial of vidutolimod in combination with anti-PD-1 therapy for stage 3 resectable melanoma on June 3 [4] Pipeline Overview - Regeneron's oncology pipeline includes a range of investigational therapies targeting over 30 types of solid tumors and blood cancers, with nearly half of its pipeline dedicated to oncology assets [11][26] - The company emphasizes its commitment to transforming cancer treatment through innovative therapies and collaborations [12][26] Regulatory Status - Libtayo is currently FDA-approved for several indications, while linvoseltamab and odronextamab are under review with target action dates of July 10, 2025, and July 30, 2025, respectively [9][11]