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]

Financial Data and Key Metrics Changes - Revenue reached $1.3 billion in Q2 2025, representing a 42% year-on-year growth [5][17] - GAAP earnings per ADS grew by $2 compared to Q2 of the previous year [5] - Free cash flow generated in Q2 was $220 million, an increase of over $400 million year-on-year [5] - Gross margin improved to approximately 87% from 85% in the prior quarter [21] - Non-GAAP net income reached $253 million, reflecting an increase of $230 million compared to the previous year [23] Business Line Data and Key Metrics Changes - Brukinza global revenues were $950 million, growing 49% year-on-year, driven by strong performance across all geographies [17] - Tovembra reported a 22% increase in revenue, reflecting continued market leadership in China [19] - In-licensed products showed continued strength, growing 27% year-on-year [19] Market Data and Key Metrics Changes - The US market generated $685 million with a year-on-year growth of 43% [20] - China revenue totaled $429 million, a 23% increase [20] - Europe contributed $152 million with 87% year-on-year growth [20] - Rest of world markets grew by 168% driven by market expansions and new launches [20] Company Strategy and Development Direction - The company aims to maintain leadership in the hematology franchise and expand its solid tumor pipeline [6][15] - Plans to combine assets in multiple phase three trials to improve outcomes for CLL patients [15] - The company is focused on serial innovation in CLL and aims to build a deep pipeline across various disease areas [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in long-term market leadership for Brukinza despite competitive pricing pressures [18] - The company anticipates stable pricing for the remainder of the year [46] - Future impacts from potential US tariffs are expected to be manageable within the context of the P&L [73] Other Important Information - The company is preparing for the initial global approval of Sonro and anticipates pivotal data for its BTK CDAC by 2026 [15] - The tablet formulation of Brukinza is expected to achieve a lower cost of goods and improve patient convenience [24] Q&A Session Summary Question: Update on Brukinza's US net pricing and inventory changes - Management anticipates stable pricing for the remainder of the year and has no significant inventory levels to comment on [46][47] Question: Reaction to Bruin CLL 314 data for PERTO versus IMBRUVICA - Management noted that the OR superiority was not formally tested and emphasized the importance of PFS data [48][49] Question: Delay in starting the second line phase three trial for CDK4 - Management stated that the delay is modest and aims to let data mature for better dose level selection [53] Question: Impact of US tariffs on gross margin - Management indicated that current guidance contemplates known tariffs and that impacts have been mitigated through supply chain strategies [73] Question: Specifics on access to Brukinza and revenue mix - Management confirmed that Brukinza continues to be listed on all Medicare Part D formularies and access is strong [99][100]

Financial Data and Key Metrics Changes - Revenue for Q2 reached $1.3 billion, representing a 42% year-on-year growth [4][16] - GAAP earnings per ADS increased by $2 compared to Q2 of the previous year [4] - Free cash flow generated in Q2 was $220 million, an increase of over $400 million compared to last year [4] Business Line Data and Key Metrics Changes - Brukinza's global revenues were $950 million, growing 49% year-on-year, driven by strong performance across all geographies [16] - Tovembra reported a 22% increase in revenue, reflecting continued market leadership in China [18] - In-licensed products grew 27% year-on-year, with the launch of zanadatumab in China [18] Market Data and Key Metrics Changes - The US market generated $685 million with a year-on-year growth of 43% [19] - China revenue totaled $429 million, a 23% increase [19] - Europe contributed $152 million with 87% year-on-year growth [19] - Rest of the world markets grew by 168% driven by market expansions and new launches [19] Company Strategy and Development Direction - The company aims to maintain leadership in the hematology franchise and expand its solid tumor pipeline [5][14] - Plans to run over 20 phase three trials and anticipate more than 10 proof of concept data readouts by 2026 [14] - Focus on serial innovation in CLL to address unmet patient needs across all lines of therapy [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in long-term market leadership for Brukinza despite competitive pricing pressures [17] - The company is optimistic about the prospects for its pipeline and upcoming milestones [14][27] - Management noted that the current guidance reflects known factors, including potential impacts from US tariffs [72] Other Important Information - Gross margin improved to approximately 87% from 85% in the prior quarter, reflecting favorable product mix and production cost efficiencies [20] - Non-GAAP net income reached $253 million, reflecting an increase of $230 million compared to the previous year [22] Q&A Session Summary Question: Update on Brukinza's US net pricing expectations - Management anticipates stable pricing for the remainder of the year and no significant inventory changes [46] Question: Reaction to Bruin CLL 314 data - Management noted that the study did not formally test OR superiority, and emphasized the importance of PFS data [47][48] Question: CDK4 trial timeline - Management updated the timeline for the second line phase three trial to early 2026 to allow for data maturation [52] Question: Market dynamics for CELESTIAL trial - Management expressed optimism about the Xanin plus Sonro combination and its potential market impact [58] Question: Gross margin improvements - Management attributed gross margin improvements to production efficiencies and a favorable product mix [71] Question: Access to Brukinza - Management confirmed that the majority of patients have access to Brukinza, with a successful appeals process for new patients [96] Question: Revenue guidance drivers - Management indicated that the updated revenue guidance reflects confidence in execution across the portfolio [80]

Financial Data and Key Metrics Changes - The company has maintained a 100% success rate in clinical studies, with the recent approval of zanadatumab for second-line biliary tract cancer, indicating strong validation of its scientific approach [4][10][12] - Future cash flow projections are expected to be healthy due to structured arrangements with partners Jazz and Beijing, which include milestone payments and royalties [18][19] Business Line Data and Key Metrics Changes - The company has focused on developing bispecific antibodies and antibody-drug conjugates (ADCs), with two programs entering clinical studies in the past year [20][22] - The five by five strategy aims to build a diverse portfolio of agents, including three ADCs and T cell engagers, to enhance clinical data and create partnering opportunities [21][22] Market Data and Key Metrics Changes - The company is exploring the potential of its products in various markets, including solid tumors and autoimmune diseases, with a focus on innovative therapeutic approaches [24][48] - The upcoming Phase III study for gastric esophageal adenocarcinoma (GEA) is seen as a significant opportunity for both patients and financial returns [6][12] Company Strategy and Development Direction - The company has adopted a partnership model for commercialization, allowing it to share in the success of its innovations without bearing the full risk and cost of commercialization [5][17] - The focus remains on maintaining a strong R&D portfolio while ensuring that innovations translate into shareholder value on a per-share basis [52][54] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming clinical readouts and the potential for significant financial impact from successful trials [12][19] - The company is committed to a capital strategy that emphasizes partnerships and innovative R&D to ensure sustainable growth and shareholder returns [56][57] Other Important Information - The company is exploring the development of a bispecific therapeutic for COPD, which combines mechanisms from existing therapies to address a broader patient population [45][48] - The company has a strong focus on engineering multifunctional therapeutics, which is expected to differentiate its products in crowded markets [34][60] Q&A Session Summary Question: Can you discuss the long-term outcomes from the phase two study of zanadatumab? - Management highlighted impressive median overall survival (OS) data from the study, indicating strong clinical responses and quality of life improvements for patients [9][11] Question: How does the company prioritize resources across its various programs? - Management emphasized the importance of reallocating resources based on clinical responses and potential returns, ensuring a focus on high-quality innovations [51][53] Question: What are the expectations for the upcoming GEA readout? - The company is optimistic that the GEA readout will provide significant revenue potential and validate its innovative approaches in the HER2 space [12][19]

Summary of Conference Call Company and Industry - The conference call discusses ALX Oncology, focusing on their drug development programs, particularly in the oncology sector, including anti-CD47 antibodies and antibody-drug conjugates (ADCs) targeting EGFR. Core Points and Arguments 1. **Current Drug Development**: ALX Oncology is developing an anti-CD47 antibody, aboricept, which is unique due to its dead Fc mechanism, showing no on-target related issues that have affected similar drugs in the past [6][10][12]. 2. **Clinical Studies**: The company has five positive clinical studies supporting their initial hypothesis from 2015, with ongoing studies in breast and colorectal cancers [9][17]. 3. **New ADC Program**: ALX is working on a new ADC targeting EGFR, which is still in early stages but shows promise. The company aims to be first and best in class against this validated target [3][10]. 4. **Breast Cancer Study**: A randomized study is being launched for patients post-HER2 treatment, showing a 55% overall response rate (ORR) in previous studies. The study will compare the combination of vorprecept and Herceptin with chemotherapy [19][33]. 5. **Colorectal Cancer Study**: The company is initiating a study combining their drug with cetuximab in colorectal cancer, addressing a significant unmet need in this area [60][61]. 6. **EGFR ADC Development**: ALX is innovating in the ADC space by optimizing the payload, linker, and antibody to minimize on-target toxicity, particularly skin toxicity, which has plagued previous EGFR ADCs [82][84]. 7. **Preclinical Success**: In non-human primate studies, ALX has dosed up to 10 mg/kg without observing skin toxicity, indicating a potential therapeutic window for their ADC [86][102]. 8. **Financial Position**: The company reported approximately $100 million in cash at the end of Q1, with plans to manage expenses effectively while executing their studies [110][111]. Other Important Content 1. **Patient Selection**: The company emphasizes the importance of selecting HER2 positive patients for their studies, utilizing ctDNA as a surrogate marker for patient eligibility [51][53]. 2. **Market Strategy**: ALX is focused on executing their studies while exploring potential partnerships for their drugs, particularly after positive data presentations at ASCO [117][118]. 3. **Future Data Readouts**: Interim data for the breast cancer study is expected in the second half of 2026, while colorectal study data may be available in the first half of 2026 [80][115]. This summary encapsulates the key points discussed during the conference call, highlighting ALX Oncology's strategic focus on innovative cancer therapies and their clinical development pipeline.

Financial Data and Key Metrics Changes - The company reported a net loss of $22.6 million for Q1 2025, a decrease from a net loss of $31.7 million in Q1 2024, primarily due to increased revenue [11] - Revenue for Q1 2025 was $27.1 million, significantly up from $10 million in Q1 2024, driven by milestone revenues and development support [11][12] - Operating expenses increased to $52.7 million in Q1 2025 from $47.3 million in Q1 2024, reflecting a 10% rise [12][13] Business Line Data and Key Metrics Changes - Milestone revenue included $14 million from GSK and $3.1 million from Daiichi Sankyo, contributing to the overall revenue growth [11] - Research and development expenses rose to $35.7 million in Q1 2025 from $32 million in Q1 2024, mainly due to increased costs associated with ZW251 and other preclinical research [12] Market Data and Key Metrics Changes - The company anticipates increased royalty revenue from the potential approval of zanadatumab for advanced HER2 positive biliary tract cancer, with a final decision expected soon [10] - The company is also looking forward to presenting data at several upcoming medical conferences, which may enhance its market presence [9] Company Strategy and Development Direction - The company emphasizes a disciplined approach to cash burn and pipeline management, focusing on evidence-based decisions tied to clinical validation [8] - The R&D strategy includes advancing a diverse pipeline of ADCs and T cell engagers, with a focus on unmet needs in oncology and immunology [36][40] - The company plans to submit an IND for ZW251 by mid-2025, marking a significant milestone in its development strategy [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the dynamic biotech environment while delivering shareholder value [7][8] - The company remains well-capitalized with $321.6 million in cash and equivalents, projected to fund operations into the second half of 2027 [14][38] - Management highlighted the importance of clinical progress and disciplined capital allocation in creating long-term shareholder value [40] Other Important Information - The company presented six posters at the AACR annual meeting, showcasing advancements in its R&D pipeline [16][35] - The recent appointment of Dr. Sabine McCann as Senior VP of Clinical Development is expected to enhance the company's clinical strategy [37] Q&A Session Summary Question: What are the base case assumptions regarding milestone royalty revenues? - Management emphasized the importance of capital allocation and expressed excitement about the progress made by partners Jazz and Beijing, which could impact future revenues [44][46] Question: Can you provide details on the cytokine induction data for ZW209? - The design of ZW209 allows for localized T cell activation, which may limit cytokine release syndrome, presenting a favorable safety profile compared to other approaches [50][52] Question: How do you view the impact of ex-US patients in the Horizon GEA trial? - Management noted that there is generally no significant difference in efficacy across ethnicities, but they are monitoring the data closely [58][60] Question: What is the expectation for the KLK2 bispecific update at ASCO? - Management indicated that they are looking forward to the data presentation and highlighted the financial interest in the partnership with J&J [63][64] Question: How many internal programs can the company support? - The company can handle approximately five internal programs through phase one and about ten preclinical programs at any one time [87]