A Late-Stage Company With a Global Oncology Pipeline PACC Update June 23, 2025 Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. These statements include, but are not limited to, implied and express statements about our strategy, business plans and objectives for our programs; plans and timelines for the preclinical and clinical development of our product candidates, i ...

思宇年度活动回顾： 首届全球眼科大会 | 首届全球骨科大会 | 首届全球心血管大会 | 首届全球医美科技大会 即将召开： 2025年7月17日，第二届全球医疗科技大会 2025年9月3-5日，第三届全球手术机器人大会 2025年6月， 精准肿瘤学企业Caris Life Sciences 正式向美国证券交易委员会（SEC）提交招股说明书，计划在纳斯达克上市，股票代码为"CAI"。 本次IPO预计募资约 4.235亿美元（约合30亿人民币），发行约2,350万股股票，定价区间为每股16-18美元。 上市完成后，公司估值或将超过 52亿美元。 这家总部位于德克萨斯州的分子诊断企业，过去十年累计融资已近20亿美元。2025年初，公司刚完成一笔 1.68亿美元增长资本融资 ，由Braidwell LP领投。 本次IPO是其资本路径中的又一关键节点，也标志着其在精准肿瘤学平台商业化、全球化布局方面的进一步推进。 # 四 大 产 品 构 成 精 准 诊疗 平 台 骨 架 ， 覆 盖 组 织 、 血液 与 多 重 突 变 维 度 Caris当前围绕肿瘤样本分析构建了四大主力产品线，分别针对不同样本来源与检测深度需求展开布局 ...

Black Diamond Therapeutics (BDTX) 2025 Conference June 04, 2025 04:20 PM ET Speaker0 Good afternoon. My name is Farzin Hak, one of the biotech analysts at Jefferies. I'm happy to introduce Mark Vileka, CEO of, Black Diamond Therapeutics. This is a fireside chat format. Thank you for joining us today. Speaker1 Thanks Farzan. Pleasure to be here. Speaker0 For those who are new to the story, can you provide a short overview of your program? Speaker1 Sure. So Black Diamond is a precision small molecule oncology ...

Enliven Therapeutics (ELVN) 2025 Conference June 04, 2025 03:45 PM ET Speaker0 It's your Speaker1 day. Just grinding through this. Speaker0 It's fine. Yeah. It's gonna run around. It's like a barn. But it's good though. All set? Yeah. Okay. Hi, everyone. My name is Maury Raycroft and one of the biotech analysts at Jefferies. I'm happy to introduce Sam Kintz, the CEO of Enliven Therapeutics. Thanks for joining us today, Sam. And we're gonna do fireside chat format. So maybe for those who are new to the story ...

IDEAYA Biosciences (IDYA) 2025 Conference June 04, 2025 08:10 AM ET Speaker0 Hi everyone. My name is Maury Raycroft and one of the biotech analysts at Jefferies. So it's a great pleasure that I'd like to welcome the IDEA team. We've got Yajiro Hata, CEO, and Josh Blaharski, the CFO. Thanks so much for joining us today. Speaker1 Great. Thanks so much Maury and thank you to Jeffries for the opportunity to participate this year and Josh and I will be talking today. Thanks again. Speaker0 And we're going do fir ...

Core Viewpoint - BioNTech and Bristol Myers Squibb have entered into a collaboration for the global co-development and co-commercialization of BioNTech's investigational bispecific antibody BNT327, targeting various solid tumor types [1][3]. Company Overview - BioNTech is a biopharmaceutical company focused on developing novel immunotherapies for cancer and other serious diseases, utilizing a range of therapeutic modalities including mRNA cancer immunotherapies and antibody-drug conjugates [9]. - Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines for serious diseases [15]. Product Details - BNT327 is a next-generation bispecific antibody that targets PD-L1 and VEGF-A, currently in trials with over 1,000 patients treated, including Phase 3 trials for extensive stage small cell lung cancer and non-small cell lung cancer [2][8]. - The mechanism of BNT327 aims to restore T cell function against tumor cells while neutralizing VEGF-A to counteract the tumor's immunosuppressive environment [5][7]. Financial Terms of Collaboration - Bristol Myers Squibb will make an upfront payment of $1.5 billion to BioNTech, with a total of $2 billion in non-contingent anniversary payments through 2028, and BioNTech could receive up to $7.6 billion in additional milestone payments [4][6]. - The development and manufacturing costs will be shared equally between BioNTech and Bristol Myers Squibb, with profits and losses also split 50:50 [4][6]. Clinical Development Plans - The collaboration will involve a broad clinical development program for BNT327 across multiple solid tumor types, with plans for additional trials in triple-negative breast cancer by the end of 2025 [2][8]. - More than 20 clinical trials are ongoing or planned to evaluate BNT327 as a monotherapy or in combination with other treatments targeting various oncogenic pathways [8].

Summary of IO Biotech (IOBT) FY Conference Call - May 27, 2025 Company Overview - **Company**: IO Biotech (IOBT) - **Lead Asset**: Xilenvio (IL-102, IL-103) - **Focus**: Immuno-oncology, specifically targeting advanced melanoma Key Points Upcoming Data and Trials - **Pivotal Phase III Trial**: Expected readout in Q3 2025 for advanced melanoma patients, with 407 patients fully enrolled as of December 2023 [4][7] - **Primary Analysis**: Based on 226 progression-free survival (PFS) events, with a target of achieving this by Q3 2025 [10][11] - **Event Rate**: Slower than anticipated, leading to a revised guidance for PFS events [8][11] Trial Design and Expectations - **Trial Design**: Randomized 1:1 comparison of Xilenvio plus pembrolizumab (pembro) versus pembro alone [7][17] - **Response Rate**: Previous studies indicated an 80% response rate with 50% complete responses (CRs) and a median PFS of approximately 26 months [13] - **Statistical Power**: The study is powered at 89% with a hazard ratio of 0.65, indicating a 35% improvement in PFS over Keytruda [26][27] Safety and Efficacy - **Safety Profile**: Favorable safety profile with no significant added systemic toxicity compared to pembrolizumab [31][32] - **PD-L1 Status**: The trial includes both PD-L1 positive and negative patients, which may provide a broader efficacy profile compared to emerging treatments that target only PD-L1 negative patients [40] Financial Position - **Cash Position**: Ended Q1 2025 with over €37 million, with a recent drawdown of €10 million from a financing tranche [63][64] - **Future Financing**: Eligible for additional tranches totaling €20 million, contingent on product approval [65][66] Manufacturing and Logistics - **Manufacturing**: Secured manufacturing capabilities in Europe with multiple suppliers for drug substance and product [44][46] - **Adjuvant Used**: Monostinide, which allows for slow release of antigens upon injection [49] Future Developments - **Neoadjuvant Melanoma Study**: Preliminary data expected by the end of 2025, focusing on major pathological response (MPR) as a primary endpoint [74][76] - **Head and Neck Cancer Data**: Encouraging response rates observed, with updates on PFS and durability expected in the second half of 2025 [61][62] Regulatory Interactions - **FDA Communication**: Ongoing interactions with the FDA, including feedback and review meetings, with breakthrough status confirmed [58][59] Additional Insights - **Market Context**: The competitive landscape in immuno-oncology is evolving, with IO Biotech positioning itself to address both PD-L1 positive and negative patient populations [40][78] - **Clinical Relevance**: Emphasis on not just statistical significance but also clinical relevance and quality of life for patients [31][32] This summary encapsulates the critical aspects of IO Biotech's current status, upcoming milestones, and strategic positioning within the immuno-oncology sector.

Financial Data and Key Metrics Changes - The company reported a revenue of $7.3 million for Q1 2025, which remained flat due to a seasonal inventory drawdown despite a 15% growth in patient demand [38][39] - Cost of Goods Sold (COGS) from continuing operations increased to $2.7 million from $1.4 million in Q1 last year, attributed to increased sales of Lactorsi [47] - Research and Development (R&D) expenses decreased by 14% to $24.4 million, reflecting savings from reduced co-development with Junshi [48] - Selling, General and Administrative (SG&A) expenses decreased by 35% to $26 million, primarily due to lower headcount and non-recurring charges from the previous year [48] Business Line Data and Key Metrics Changes - The company is now focused solely on its innovative oncology business, with Lactorsi being the only FDA-approved treatment for metastatic recurrent locally advanced nasopharyngeal carcinoma [6][8] - Lactorsi is projected to grow to approximately $150 million to $200 million annually over the next three years, providing non-dilutive funding for the development pipeline [8][9] - The commercial team has successfully remapped territories and updated customer assignments post-UDENYCA divestiture, with a focus on driving growth in appropriate NPC patients [37][38] Market Data and Key Metrics Changes - The company noted a significant number of patients still receiving non-preferred chemotherapy and off-label immuno-oncology treatments, indicating a market opportunity for Lactorsi [38] - The NCCN guidelines now place Lactorsi in a preferred position for recurrent and metastatic patients, which the company is actively promoting to healthcare providers [38][41] Company Strategy and Development Direction - The company’s strategy is anchored around three core pillars: Lactorsi, CHS-114 (a selective CCR8 cytolytic antibody), and casdosoketogue (an anti-IL-27 antibody) [6][12][13] - The company aims to expand Lactorsi's indications through partnerships and combination therapies, enhancing its market presence and revenue potential [10][11] - The focus on innovative oncology is expected to drive long-term value for shareholders while addressing significant unmet medical needs in cancer treatment [50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company’s ability to navigate recent FDA changes and emphasized the importance of strong development expertise in adapting to regulatory environments [52][56] - The company anticipates that the restructuring of the sales force will lead to accelerated growth in Q2 and beyond, despite transitional challenges faced in Q1 [60][68] - Management highlighted the promising clinical data for CHS-114 and its potential to address PD-1 resistance, which could significantly impact treatment paradigms in oncology [30][36] Other Important Information - The company completed the divestiture of UDENYCA, receiving $483 million in upfront cash and repurchasing $170 million of convertible notes [43][44] - The net cash from these transactions is expected to provide substantial liquidity for ongoing operations and development initiatives [44] Q&A Session Summary Question: What needs to happen for a significant inflection point for Lactorsi? - Management noted that increased awareness among providers and ongoing clinical trials will be crucial for driving adoption and market share [51][56] Question: Can you clarify patient demand for Lactorsi? - Demand is defined as actual patient growth, with a 15% increase in end-user demand reported, indicating strong physician engagement [65][66] Question: Will the Salesforce restructure impact future projections? - The impact of the restructure was primarily felt in Q1, but management expects Q2 and Q3 to be growth periods for the brand [68] Question: Are there any competitor molecules that have proven the efficacy of CCR8 targeting? - Management indicated that while selectivity is a challenge, there are emerging data points suggesting the relevance of CCR8 targeting in certain tumor types [72][75]

Core Insights - ITM Isotope Technologies Munich SE has elected Dr. Barbara Weber to its Supervisory Board, effective May 01, 2025, enhancing the board's expertise in advancing its radiopharmaceutical pipeline [1][2] - Dr. Weber brings over 25 years of experience in biotech and pharmaceutical industries, having held leadership roles at major companies and founded Tango Therapeutics [1][4] - The company is focused on developing its lead Phase 3 candidate, n.c.a. 177Lu-edotreotide (ITM-11), and expanding its pipeline of radiopharmaceuticals [1][3] Company Overview - ITM is a leading radiopharmaceutical biotech company dedicated to developing therapeutics and diagnostics for hard-to-treat tumors, aiming to improve patient outcomes through precision oncology [5] - The company has a broad pipeline that includes multiple Phase 3 studies, leveraging high-quality radioisotopes combined with various targeting molecules [5] Leadership and Expertise - Dr. Weber's background includes significant achievements in oncology drug development, including leading clinical studies that resulted in FDA approvals for several drugs [4] - As a physician-scientist, Dr. Weber emphasizes the potential of targeted radiopharmaceutical therapy to enhance precision oncology treatment [3]

Coherus BioSciences, Inc. (NASDAQ:CHRS) Q4 2024 Earnings Conference Call March 10, 2025 5:00 PM ET Company Participants Jodi Sievers - Head of IR Denny Lanfear - CEO Paul Reider - CCO Sameer Goregaoker - SVP, Immuno-Oncology Marketing Theresa LaVallee - CDO Rosh Dias - CMO Bryan McMichael - CFO Conference Call Participants Srikripa Devarakonda - Truist Securities Yigal Nochomovitz - Citigroup Colleen Kusy - Baird Michael Nedelcovych - TD Cowen Brian Cheng - JPMorgan Douglas Tsao - H.C. Wainwright Operator H ...