Invivyd (IVVD) FY 2025 Conference May 20, 2025 11:00 AM ET Speaker0 Not ready. Okay. Hello, everyone, and welcome to the third annual, HC Wainwright BioConnect Conference. I'm Patrick Trucchio, a senior health parent at HC Wainwright. It's my pleasure to, introduce you to the management of InVivid. I'm Katie Falzoni, senior vice president of finance and Robert Allen, CSO. So first, I think it'd be good to start out with, some background on Invivid platform and on the validation of this antibody platform. Sp ...

Summary of ALX Oncology Holdings (ALXO) Conference Call Company Overview - **Company**: ALX Oncology Holdings (ALXO) - **Focus**: Development of ALX2004, a differentiated antibody-drug conjugate (ADC) targeting EGFR Key Points and Arguments Industry and Product Development - **ADC Focus**: ALX2004 is designed to maximize therapeutic window and overcome historical toxicity challenges associated with EGFR-targeted ADCs [5][6][10] - **Clinical Pipeline**: The company is advancing its ADC in combination with anti-cancer antibodies, specifically targeting breast and colorectal cancers [4][5] - **IND Clearance**: ALX2004 has received Investigational New Drug (IND) clearance, with plans to launch a Phase I trial in mid-2025 [5][7] Scientific Rationale - **Payload and Linker Design**: ALX2004 utilizes a proprietary topoisomerase one inhibitor payload, designed to minimize off-target toxicity while maximizing tumor cell killing [17][20] - **Immunogenic Cell Death**: The payload triggers immunogenic cell death, potentially enhancing long-term tumor control through adaptive immune response [18][28] - **Optimized Antibody**: The antibody component is designed to block EGFR signaling and bind to a unique epitope, potentially overcoming resistance to existing therapies [30][32] Clinical Development Plans - **Phase I Study**: The study will focus on four tumor types: head and neck squamous cell carcinoma, colorectal cancer, non-small cell lung cancer, and esophageal squamous cell carcinoma, targeting patients with relapsed or refractory disease [40][41] - **Safety and Efficacy Goals**: Initial safety data is expected in the first half of 2026, with an emphasis on establishing a recommended dosing schema [42][43] Competitive Landscape - **Market Positioning**: ALX Oncology aims to be a leader in the ADC space targeting EGFR, which currently lacks an approved drug [43][85] - **Comparison with Competitors**: The company is aware of other ADCs in development, such as MRG003, but believes its optimized design gives it a competitive edge [85] Additional Important Insights - **Preclinical Data**: Robust preclinical data supports the efficacy and safety profile of ALX2004, with encouraging results in various tumor models [14][34] - **Toxicity Management**: The design aims to avoid common toxicities seen in previous EGFR-targeted ADCs, such as skin toxicity and interstitial lung disease [14][72] - **Funding and Capital Allocation**: The company has sufficient cash to fund its ongoing studies into 2024, with plans to explore additional capital options as needed [51][52] This summary encapsulates the critical aspects of ALX Oncology's conference call, highlighting the company's strategic focus on developing ALX2004 and its potential impact on the oncology market.

Core Insights - Merck and Daiichi Sankyo have initiated the phase III IDeate-Esophageal01 study for the B7-H3 directed ADC, ifinatamab deruxtecan (I-DXd), targeting advanced or metastatic esophageal squamous cell carcinoma (ESCC) patients [1][2] - The study aims to compare the safety and efficacy of I-DXd against an investigator's choice of chemotherapy in patients who have progressed after platinum-based therapy and immune checkpoint inhibitors [2] - The primary endpoint is overall survival, with secondary endpoints including progression-free survival and objective response rate [3] Company Developments - Merck's stock has decreased by 22.3% year-to-date, while the industry has seen a decline of 5.2% [6] - Merck acquired global co-development and co-commercialization rights for I-DXd and two other ADCs from Daiichi Sankyo for a potential total of up to $22 billion, retaining exclusive rights for Daiichi in Japan [8] - Merck has expanded its collaboration with Daiichi to co-develop MK-6070, a T-cell engager targeting DLL3, following its acquisition of Harpoon Therapeutics [9] Industry Context - ADCs are viewed as a disruptive innovation in the pharmaceutical industry, enhancing cancer treatment by using antibodies to deliver cytotoxic drugs directly to tumors [11] - Daiichi Sankyo is developing several ADCs across various cancer types, including Enhertu, which is marketed in partnership with AstraZeneca [12] - Pfizer has entered the ADC market by acquiring Seagen for $43 billion, adding three ADCs to its portfolio that have significantly contributed to its revenues in 2024 [13][14]

Core Insights - ALX Oncology is advancing ALX2004, a potential best- and first-in-class antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumors, designed to maximize therapeutic efficacy while minimizing toxicity [1][2] - The U.S. FDA has cleared the IND application for ALX2004, with clinical studies set to begin in mid-2025 and initial safety data expected in the first half of 2026 [1][6] - The company plans to initiate trials for its lead therapy, evorpacept, in breast and colorectal cancers around the same time, with significant milestones anticipated in 2026 [1] ALX2004 Development Overview - ALX2004 is developed using a proprietary linker-payload platform, featuring an affinity-tuned EGFR antibody and a stable linker-Top1i payload, aimed at enhancing anti-tumor activity and reducing toxicity [3][4] - Preclinical data indicates that ALX2004 has superior stability and a favorable safety profile compared to other ADCs, showing dose-dependent activity across various tumors and EGFR expression levels [5] Clinical Trial Plans - The Phase 1 clinical trial for ALX2004 will target EGFR-expressing solid tumors, including non-small cell lung cancer and colorectal cancer, focusing on patients with relapsed or refractory cancers [6] - The trial is expected to begin in mid-2025, with initial safety data anticipated in the first half of 2026 [1][6]

Core Viewpoint - Zymeworks Inc. is advancing its clinical-stage pipeline with the presentation of new preclinical data for ZW1528, a bispecific molecule targeting IL-4Rα and IL-33, aimed at treating respiratory inflammation, particularly chronic obstructive pulmonary disease (COPD) [1][2]. Group 1: Product Development - ZW1528 demonstrates high affinity binding to IL-4Rα and IL-33, effectively blocking IL-4, IL-13, and IL-33 signaling pathways, which are critical in respiratory inflammation [5][6]. - The bispecific design of ZW1528 shows promising manufacturability and stability, supporting high dosing concentrations and subcutaneous administration [5][7]. - Zymeworks is also developing ZW1572, another bispecific inhibitor targeting IL-4Rα and IL-31 for atopic dermatitis, as part of its expanding IL-4Rα program portfolio [3][5]. Group 2: Preclinical Data and Findings - Preclinical data presented at the ATS conference indicate that ZW1528 can suppress both Type 2 and non-Type 2 immune responses in primary human immune cells from COPD patients [6][7]. - In vivo studies in murine models of lung inflammation show efficacy for ZW1528, with extended pharmacokinetics observed in rodent and non-human primate models [6][7]. - The bispecific antibody's blockade of cytokine-driven activation in human epithelial cells is superior to that achieved with monoclonal antibodies targeting either IL-4Rα or IL-33 [7]. Group 3: Company Overview - Zymeworks is a global biotechnology company focused on developing multifunctional biotherapeutics for difficult-to-treat conditions, including cancer and autoimmune diseases [8]. - The company has a robust pipeline of product candidates and has entered into strategic partnerships to enhance its therapeutic platforms [8].

Compugen (CGEN) Q1 2025 Earnings Call May 19, 2025 08:30 AM ET Company Participants Yvonne Naughton - VP, Head of Investor Relations & Corporate CommunicationsAnat Cohen-Dayag - CEO, President & DirectorDavid Silberman - Chief Financial OfficerMichelle Mahler - Chief Medical OfficerEran Ophir - Chief Scientific OfficerRohan Mathur - Biopharma Equity Research Associate Conference Call Participants Daina Graybosch - Senior Managing Director, Biotechnology AnalystAsthika Goonewardene - Analyst Operator Ladies ...

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had approximately $103.7 million in cash, cash equivalents, total bank deposits, and investments in marketable securities [14] - Revenues for Q1 2025 were approximately $2.3 million, a decrease from approximately $2.6 million in Q1 2024 [15] - R&D expenses for Q1 2025 were approximately $5.8 million, down from approximately $6.4 million in Q1 2024 [15] - The net loss for Q1 2025 was approximately $7.2 million, or $0.08 per basic and diluted share, compared to a net loss of approximately $7.3 million in the same period of 2024 [15] Business Line Data and Key Metrics Changes - The company is advancing its clinical immuno-oncology pipeline, particularly focusing on the anti-PVRIG antibody COM701, with a sub-trial initiated for patients with relapsed platinum-sensitive ovarian cancer [6][7] - The study aims to demonstrate a clinically meaningful improvement in median progression-free survival over placebo, targeting a three-month improvement [8] Market Data and Key Metrics Changes - AstraZeneca has initiated multiple Phase III trials in the TIGIT space, with significant potential revenue opportunities estimated at over $5 billion in lung cancer alone [10] - The eligible lung cancer patient population across G7 countries is estimated to exceed 500,000 patients based on 2025 epidemiological data [10] Company Strategy and Development Direction - The company is focused on advancing its early-stage and clinical immuno-oncology pipeline, with a strong emphasis on innovative therapies and strategic collaborations [4][12] - The leadership transition aims to ensure a solid foundation for the company's next phase of growth, with a commitment to addressing significant unmet medical needs in cancer treatment [4][5] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential impact of their clinical trials on cancer patients' lives and highlighted the importance of their cash runway extending into 2027 [12][14] - The evolving clinical trial landscape, particularly in the context of ADCs and TIGIT studies, presents both challenges and opportunities for the company [9][10] Other Important Information - The company has a robust foundation with a talented management team and a commitment to advancing its innovative pipeline [4][12] - The cash runway is expected to support the advancement of key clinical trials and early-stage research without additional cash inflows [14] Q&A Session Summary Question: Impact of Merck's KEYNOTE B96 trial success on ovarian cancer strategy - Management noted that the success of Merck's trial indicates benefits from adding immune checkpoint inhibitors to standard care, which could open opportunities for COM701 in similar settings [17][19] Question: Interpretation of Roche's Skyscraper one data regarding TIGIT - Management discussed the challenges faced by the trial and emphasized the importance of patient population and study design in interpreting the results [20][24] Question: Data collection on tumor microenvironment features from the COM701 study - The company confirmed plans to collect data on tumor microenvironment features, although specific details were not disclosed [29][30] Question: Activity in PD-L1 positive patients and combinability with other treatments - Management indicated that COM701 has shown activity in both PD-L1 positive and negative patients, suggesting potential for combination therapies [33][35]

Core Insights - Genmab A/S is a biotech innovator focusing on antibody engineering and has a strategy that includes direct commercialization of its products Tivdak and Epcoritamab, as well as monetizing through partnerships and licensing drugs like Darzalex and Kesimpta [1] Group 1 - The company retains its value through innovative antibody engineering [1] - Genmab's strategy involves both direct product sales and partnerships for drug monetization [1]

Syndax Pharmaceuticals (SNDX) 2025 Conference May 15, 2025 12:20 PM ET Speaker0 Here on this our third day of, Bank of America's twenty twenty five health care conference in Las Vegas. My name is Jason Zemanski. I'm one of the SMID cap analysts here at the bank. With me on the stage, my associate, Cameron Bozog. And for this slot, I'm very pleased to have join us Mike Mechsger, CEO of Syndax Pharmaceuticals and the rest of the Syndax team. Mike, thank you so much for joining us. Speaker1 Yes, Speaker2 Jason ...

Core Insights - Mersana Therapeutics, Inc. provided a business update and reported financial results for Q1 2025, focusing on the development of its antibody-drug conjugates (ADCs) targeting cancers with high unmet medical needs [2][15]. Business Update - The company is advancing the development of Emi-Le, a B7-H4-directed Dolasynthen ADC, with promising preliminary data presented at ESMO Breast Cancer 2025 [3][4]. - Encouraging clinical activity data showed an objective response rate (ORR) of 31% among evaluable patients with B7-H4 high tumors receiving intermediate doses of Emi-Le, an increase from 23% previously reported [5][7]. - The focus remains on triple-negative breast cancer (TNBC) patients, with ongoing enrollment in dose expansion cohorts [6][10]. Clinical Data - Updated clinical data from Emi-Le's Phase 1 trial indicated a median progression-free survival (PFS) of 16.0 weeks and a median overall survival (OS) of 5.7 months for patients with B7-H4 low TNBC [8]. - The company plans to report initial clinical data from the expansion portion of its Phase 1 trial in the second half of 2025 [11]. Financial Results - As of March 31, 2025, Mersana had cash and cash equivalents of $102.3 million, with net cash used in operating activities amounting to $29.3 million for Q1 2025 [15][20]. - Collaboration revenue for Q1 2025 was $2.8 million, a decrease from $9.2 million in the same period in 2024, primarily due to reduced revenue from collaboration agreements [15][16]. - The net loss for Q1 2025 was $24.1 million, or $0.19 per share, compared to a net loss of $19.3 million, or $0.16 per share, for the same period in 2024 [20][25]. Future Plans - Mersana is set to present at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, with two presentations regarding Emi-Le planned [12]. - The company continues to support collaborations with Johnson & Johnson and Merck KGaA, focusing on the development of its ADC platforms [14].