Live from Washington, D. C. This is balance of power with Joe Matthew.Congress prepares probes into the drug boats. Welcome to the Monday edition. As Republican led committees in both the House and Senate investigate a report that the Secretary of Defense issued a kill everybody order on alleged drug smugglers coming out of Venezuela.We're going to have a lot more on this when we sit down with Bloomberg's Wendy Benjamin, seen here in Washington with insights today from retired four star General Wesley Clark ...

Core Insights - Autolus Therapeutics has appointed Ryan Richardson to its Board of Directors, bringing over 20 years of experience in strategy and corporate development within the healthcare and investment banking sectors [1][4]. Group 1: Company Growth and Strategy - Autolus is entering a new growth phase as a commercial-stage company, with a focus on expanding the reach of its product obe-cel in new indications [2]. - The company is well-positioned with strong clinical data and proven CAR T manufacturing expertise, which supports its growth in current and future indications [3]. Group 2: Ryan Richardson's Background - Prior to joining Autolus, Mr. Richardson served as Chief Strategy Officer at BioNTech, where he played a key role in the company's global expansion and transition to a commercial stage [4]. - Mr. Richardson has extensive experience in strategic transactions, having worked as an Executive Director in J.P. Morgan's Global Healthcare Investment Banking team [4]. Group 3: Company Overview - Autolus Therapeutics is focused on developing next-generation T cell therapies for cancer and autoimmune diseases, utilizing proprietary T cell programming technologies [6]. - The company has a marketed therapy, AUCATZYL, and a pipeline of candidates for treating hematological malignancies, solid tumors, and autoimmune diseases [6].

Group 1 - The Extraordinary General Meeting of Shareholders of CureVac N.V. was convened in connection with BioNTech's public exchange offer for all outstanding shares of CureVac N.V. [2] - Shareholders will vote on resolutions related to the proposed transaction with BioNTech, including corporate reorganization and the appointment of new members to CureVac's Management and Supervisory Board [2] - Key attendees at the meeting include CureVac's CEO, CBO, General Counsel, and representatives from Dutch Legal Counsel [3]

Core Viewpoint - The report from Xingzheng International initiates coverage on InnoCare Pharma (09606) with a "Buy" rating, highlighting its focus on the ADC field and strategic collaborations with leading global pharmaceutical companies like BioNTech to expedite clinical development globally [1] Recent Events - The company will host a R&D day on October 23, 2025, to present recent advancements in its ADC product pipeline and future directions [2] - BioNTech will hold its R&D day on November 11, 2025, showcasing InnoCare's original ADC pipeline in combination with immune antibodies like PD-L1/VEGF [2] - The clinical phase 2a of the autoimmune ADC pipeline DB-2304 (BDCA2 ADC) for systemic lupus erythematosus has completed its first patient dosing [2] - Results from the single-dose escalation phase of DB-2304 will be presented at the AIC 2025 conference, and data for DB-1310 targeting HR+/HER2- breast cancer will be disclosed at the SABCS 2025 [2] Global Clinical Progress - The BLA submission for DB-1303 (HER2 ADC) targeting HER2+ endometrial cancer is expected in 2026, with ongoing phase 3 trials for HR+/HER2 low-expressing breast cancer and plans for a BLA submission in China by the end of 2025 [3] - DB-1311 (B7H3 ADC) is currently in a global phase 2 basket trial for various solid tumors, with potential frontline treatment opportunities for SCLC through combination with PD-L1/VEGF dual antibodies [3] - The ADC pipeline in collaboration with BioNTech opens new market opportunities for ADC combination therapies, while DB-2304 shows promising tolerability and pharmacokinetic characteristics, positioning it as a potential first-in-class ADC drug in the autoimmune field [3]

Core Viewpoint - The report from Xingzheng International initiates coverage on Ying'en Bio-B (09606) with a "Buy" rating, highlighting the company's focus on the ADC sector and its strategic collaborations with leading global pharmaceutical companies like BioNTech to accelerate clinical development globally [1] Recent Events - The company will host a R&D day on October 23, 2025, to present recent advancements in its ADC product pipeline and future directions [2] - BioNTech will hold its R&D day on November 11, 2025, showcasing clinical plans for Ying'en Bio's original ADC pipeline in combination with immune antibodies such as PD-L1/VEGF [2] - The clinical phase 2a portion of the DB-2304 (BDCA2ADC) for systemic lupus erythematosus has completed its first patient dosing [2] - Results from the single-dose escalation phase of DB-2304 were selected for oral presentation at the AIC2025 conference [2] - The company plans to present global phase 1/2a data for the DB-1310 HER3ADC pipeline at the SABCS2025 [2] Global Clinical Progress of ADC Pipeline - The BLA for DB-1303 (HER2ADC) targeting HER2+ endometrial cancer is expected to be submitted in the U.S. in 2026, with ongoing global phase 3 trials for HR+/HER2 low-expressing breast cancer [3] - The company aims to submit the Chinese BLA for this indication by the end of 2025 [3] - DB-1311 (B7H3ADC) is currently in a global phase 2 basket trial for various solid tumors, including SCLC and CRPC, with potential frontline treatment opportunities being explored [3] - The collaboration with BioNTech on PD-L1/VEGF dual antibodies opens up future market opportunities for ADC combination therapies [3] - The clinical progress of the self-immune ADC pipeline DB-2304 has shown good tolerability and pharmacokinetic characteristics, positioning it as a potential first-in-class ADC drug in the autoimmune field [3]

Group 1 - The German Federal Cartel Office has cleared the planned transaction between BioNTech and CureVac, which is a significant step towards the expected closing later this year [1] - The offer period for BioNTech's public exchange offer for all outstanding CureVac N.V. shares began on October 21, 2025, and is set to expire on December 3, 2025 [1] - Ongoing German litigation involving Pfizer/BioNTech related to mRNA-based COVID-19 vaccines has been paused pending the completion of BioNTech's public exchange offer [1] Group 2 - CureVac has received Clinical Trial Application (CTA) clearance from the European Medicines Agency (EMA) for its CVHNLC squamous non-small cell lung cancer (sqNSCLC) [1] - The Phase 1 Part B trial for CVGBM (glioblastoma) remains on track [1] - As of September 30, 2025, CureVac reported a strong cash and cash equivalents position of €416.1 million, confirming an expected cash runway into 2028 [1] Group 3 - CureVac received the final audit report related to the Advance Purchase Agreement with the European Commission for its first-generation COVID-19 vaccine candidate [1]

Summary of Genmab's Conference Call Company Overview - **Company**: Genmab - **Event**: Jefferies London Healthcare Conference - **Key Speakers**: CEO Jan van de Winkel, CFO Anthony Pagano Key Focus Areas Late-Stage Programs - Genmab is focusing on late-stage programs including: - **Epkinly** - **Rinatabart sesutecan** - **Acasunlimab** - **Patu Centamab** (acquisition of Merus) [2][3][4] Patu Centamab - **Description**: A bispecific antibody targeting EGFR, showing significant tumor shrinkage in clinical trials. - **Clinical Data**: - In frontline head and neck cancer, a **63% overall response rate** when combined with Pembrolizumab, tripling the benchmark response [9]. - In second-line settings, a **36% overall response rate** with impressive median progression-free survival of **11.4 months** [9]. - **Safety Profile**: New dosing schedules have improved infusion-related reactions, and a subcutaneous version is in development to further mitigate these issues [11]. - **Potential**: Beyond head and neck cancer, Patu Centamab is expected to have applications in other EGFR-positive tumors [6][12]. Epkinly - **Launch Performance**: Launched in May 2023, with potential to become a **$3 billion-plus global brand**. - **Recent Developments**: Positive data in second-line follicular lymphoma, with a significant hazard ratio of **0.21**, indicating a **79% risk reduction** for disease progression [21]. - **Commercial Strategy**: Focus on subcutaneous delivery and maintaining a balance of safety and efficacy [20]. Rinatabart sesutecan - **Characteristics**: Combines a good antibody with a hydrophilic linker, allowing for multiple toxin attachments without compromising pharmacodynamics [23]. - **Clinical Data**: Expected to have a clean safety profile with no ocular toxicity or interstitial lung disease observed [24]. - **Market Potential**: Peak year sales guidance upgraded to **$2 billion**, with a launch expected in **2027** [28]. Acasunlimab - **Clinical Development**: Ongoing studies in second-line plus lung cancer, with follow-up data expected to bolster confidence in its efficacy [30]. - **Sales Guidance**: Projected peak sales of around **$1 billion**, reflecting a conservative approach due to competition in the lung cancer market [31]. Financial Considerations - **Investment Strategy**: 2026 is expected to be an investment year, focusing on late-stage pipeline and commercialization capabilities [14][15]. - **EBITDA Growth**: Anticipated meaningful growth in EBITDA by **2027**, with projections of over **$1 billion** in sales for Patu Centamab by **2029** [16][17]. Other Considerations - **Pipeline Focus**: Genmab remains primarily focused on oncology, with over **90%** of activities in this area, while maintaining some preclinical work in immunology and inflammation [34][35]. - **Future Developments**: Plans to advance two bispecifics and one ADC from the organic pipeline by the end of the year [36]. Conclusion - Genmab is strategically positioned with a robust late-stage pipeline and a clear focus on maximizing the potential of its key assets, particularly Patu Centamab, Epkinly, and Rinatabart sesutecan, while managing investments and operational efficiencies to drive future growth.

Core Insights - Elicio Therapeutics has appointed Marc J. Wolfgang as Chief Technology Officer, bringing over 30 years of biopharmaceutical leadership experience [1][2][3] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers [4] - The company aims to leverage its Amphiphile ("AMP") technology to enhance cancer-specific T cell responses, promoting durable cancer immunosurveillance [4] - Elicio's lead program, ELI-002, targets common KRAS mutations found in approximately 25% of all solid tumors and is currently in a randomized clinical trial for mKRAS-positive pancreatic cancer [4] Leadership and Expertise - Marc J. Wolfgang has extensive experience in manufacturing, CMC strategy, and operations across various modalities, including cell therapy and RNA-based medicines [2][3] - His previous roles include Senior Vice President at Sail Biomedicines and Vice President of U.S. Manufacturing at BioNTech, where he oversaw critical manufacturing and supply chain operations [2] Strategic Goals - The company is preparing for late-stage development and commercial-scale execution of ELI-002, with a primary disease-free survival analysis expected in the first half of 2026 [3] - Elicio plans to expand ELI-002 to other indications, including mKRAS-positive lung cancer, and is developing additional off-the-shelf immunotherapy candidates targeting BRAF-driven cancers and p53 hotspot mutations [4]

Core Insights - The company, Ying'en Biotech, recently held a R&D day to update on several pipeline developments and progress in their clinical trials [1][2]. Group 1: Pipeline Developments - Ying'en Biotech is advancing in IO 2.0 combination therapies, with three ADCs (DB-1303, DB-1311, DB-1305) partnered with BioNTech, currently in four global clinical trials, all of which have completed the first patient enrollment [1]. - DB-1311 is exploring treatment potential in small cell and non-small cell lung cancer under various conditions, while DB-1303 is covering different HER2 expression levels in breast cancer [2]. - DB-1305 is progressing the fastest, with early efficacy and safety data expected to be released at the 2025 AACR, showing a low overlapping toxicity rate of only 4.5% among 67 patients with advanced/metastatic solid tumors [2]. Group 2: New Drug Candidates - The second dual-antibody ADC, DB-1419, has been introduced, utilizing an innovative target combination and a self-developed toxin, P1003, with a DAR of 8, showing superior tumor suppression effects in preclinical studies compared to B7-H3 ADC [2]. - DB-1317, a new member of the DITAC platform, shows significant drug potential in gastrointestinal tumors, with ADAM9 expression being 20 times higher than HER2 and 3 times higher than CLDN18.2 in these cancers [3]. Group 3: New Toxin Mechanism - The new toxin DUP5 from the DUPAC platform has been revealed to block the translation initiation of oncogenic mRNA through its action on the eIF4F complex, demonstrating broad-spectrum anti-tumor activity [3]. Group 4: Financial Outlook - Due to the company's extensive layout and leadership in IO 2.0 combinations, along with the continuous introduction of new molecules, the target price has been raised to 496.89 HKD based on DCF valuation, maintaining a "buy" rating [3].

Summary of Pfizer's 2025 Conference Call Company Overview - **Company**: Pfizer Inc. (NYSE:PFE) - **Event**: 2025 Conference Call - **Date**: November 19, 2025 Key Points Industry Context - Pfizer is navigating a period of significant change with a focus on returning to growth by 2029 and 2030, amidst a wave of loss of exclusivity (LOE) for several products [2][22] Financial Performance and Cost Management - Pfizer has identified approximately **$7.7 billion** in cost improvements to be implemented over the next several years to enhance its cost structure [3] - By the end of 2025, Pfizer expects to achieve **$4.5 billion** of the targeted savings, with further opportunities for operational efficiencies in manufacturing and commercial operations [39][40] Research and Development (R&D) Strategy - Pfizer has restructured its R&D focus, promoting Chris Boshoff to lead the R&D organization, emphasizing oncology, vaccines, internal medicine, and inflammation & immunology (I&I) [3] - The company is actively pursuing business development transactions, including a partnership with **3SBio** to enhance its oncology portfolio and a recent acquisition of **Metsera** to enter the obesity treatment market [3][4] Obesity Market Entry - Pfizer's acquisition of Metsera is seen as a strategic move to compete in the obesity market, leveraging its strong commercial engine and manufacturing capabilities [6][8] - The Metsera platform offers a differentiated approach with a potential monthly dosage, which is critical for market competitiveness [9][11] - Pfizer anticipates that the recent Medicare coverage for obesity treatments could positively impact market dynamics [13] Future Growth and Product Pipeline - Pfizer is preparing for a significant LOE period, with **$17 billion** of products losing patent protection by the end of the decade, primarily between 2026 and 2028 [22][23] - The company aims to ensure that investments are appropriately allocated to support growth aspirations for 2029 and 2030 [24] Capital Allocation and M&A Strategy - Pfizer has set a **$15 billion** external capital commitment for acquisitions, with approximately **$5 billion** remaining after the Metsera deal [32] - The company is focused on enhancing its oncology and I&I portfolios, with a particular interest in identifying additional molecules or projects in I&I [33][34] Operational Efficiencies and Cash Flow Management - Pfizer has improved its working capital, achieving a free cash flow increase of **$3-$4 billion** in 2025 through better inventory management across its global operations [41][42] - The company expects to see a reduction in cash outflows related to cost-saving measures, which will enhance future cash flow [43][44] Conclusion - Pfizer is strategically positioning itself for future growth by managing costs, enhancing its R&D capabilities, and entering new markets such as obesity treatment, while navigating the challenges posed by upcoming LOEs. The focus remains on operational efficiencies and prudent capital allocation to support long-term growth objectives [2][24][32]