Core Insights - Arcus Biosciences has a promising oncology pipeline, supported by positive clinical data and a strong balance sheet, positioning it as a potential high-upside growth stock [1][2] - The company faced a significant setback with the cancellation of its Phase 3 STAR-221 trial due to inefficiency, which has raised questions about its investment case [2][6] - Despite the challenges, Arcus is focusing its resources on its key programs, particularly casdatifan, which shows potential as a leading treatment for kidney cancer [7] Company Overview - Arcus Biosciences is valued at $2.7 billion and operates as a clinical-stage biopharmaceutical company, developing treatments for cancer and autoimmune diseases [4] - The company does not currently sell any approved medicines, with its main oncology programs including casdatifan for clear cell kidney cancer and quemliclustat for pancreatic cancer [4] STAR-221 Trial Details - The STAR-221 trial was a large Phase 3 study involving over 1,000 participants across approximately 30 countries, aimed at improving survival rates in advanced upper gastrointestinal cancers [5] - The trial was discontinued after an interim review indicated no overall survival improvement compared to standard therapy [6] Future Focus - Following the discontinuation of STAR-221, Arcus will concentrate its capital and R&D efforts on casdatifan and its immuno-oncology portfolio [7] - Positive results from the Phase 1/1b ARC-20 study have strengthened the company's belief in casdatifan's potential as a best-in-class medication for kidney cancer [7]

Core Viewpoint - Arcus Biosciences is facing challenges following the discontinuation of the Phase 3 STAR-221 study, which has led to a significant decline in its stock price, but the company remains committed to its research and development efforts in cancer therapies and immunology [2][5]. Group 1: Company Overview - Arcus Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative cancer therapies, collaborating with Gilead Sciences in the field of immuno-oncology [1]. - The company is recognized for its pioneering work in the oncology space despite competition from other biotech firms [1]. Group 2: Recent Developments - Citigroup has maintained a "Buy" rating for Arcus Biosciences, adjusting its price target from $56 to $44 due to the recent discontinuation of the Phase 3 STAR-221 study [2][5]. - The STAR-221 study evaluated a combination of anti-TIGIT antibody domvanalimab, anti-PD-1 antibody zimberelimab, and chemotherapy, but did not show improved overall survival compared to nivolumab plus chemotherapy, leading to its discontinuation [3]. Group 3: Stock Performance - Following the discontinuation of the STAR-221 study, Arcus Biosciences' stock price dropped approximately 14.38%, closing at $21.53 [4][5]. - The stock fluctuated between $20.35 and $23.98 during the trading day, with a market capitalization of approximately $2.32 billion and a trading volume of 7.16 million shares [4]. - Over the past year, the stock reached a high of $26.40 and a low of $6.50 [4]. Group 4: Future Focus - Despite recent setbacks, Arcus Biosciences continues to focus on its research and development efforts, particularly in its inflammation and immunology portfolio [4][5].

Core Insights - Arcus Biosciences has announced the discontinuation of the Phase 3 STAR-221 study due to futility, following a recommendation from the Independent Data Monitoring Committee after an interim analysis of overall survival [1][2]. Study Discontinuation - The STAR-221 study evaluated the combination of anti-TIGIT antibody domvanalimab and anti-PD-1 antibody zimberelimab with chemotherapy against nivolumab plus chemotherapy for untreated patients with advanced gastric and esophageal cancers [2]. - The interim analysis revealed that the domvanalimab-based combination did not improve overall survival compared to nivolumab plus chemotherapy, with a similar safety profile and no new safety findings [3]. Future Directions - Arcus will focus its R&D efforts on casdatifan, a potential best-in-class HIF-2α inhibitor, which has shown strong single-agent activity in over 120 late-line clear cell renal cell carcinoma (ccRCC) patients in the ARC-20 Phase 1/1b study [5]. - Key milestones for casdatifan include additional analyses in early 2026, more mature combination data by mid-2026, and potential initiation of a Phase 3 trial in late 2026 [6][7]. Oncology Pipeline - Arcus is advancing quemliclustat, a small-molecule CD73 inhibitor, with the Phase 3 PRISM-1 trial in first-line metastatic pancreatic ductal adenocarcinoma having completed enrollment earlier this year, with results expected in 2027 [8]. Immunology and Inflammation Pipeline - The immunology and inflammation portfolio includes several oral small-molecule programs, with two candidates expected to enter clinical trials in the near future [10][11].

Business Highlights - OmniAb has 104 active partners as of September 30, 2025 [13] - The company has 399 active programs as of September 30, 2025, a net addition of 36 programs year-to-date [16, 18] - There are 32 active clinical programs and approved products as of September 30, 2025 [26] - OmniAb is launching OmniUltra in December, a new technology for antibody and peptide therapeutics discovery [11, 41] Financial Performance - Q3 2025 total revenue was $22 million, compared to $42 million in Q3 2024 [65] - License and milestone revenue decreased to $06 million in Q3 2025 from $14 million in Q3 2024 [65] - Service revenue decreased to $12 million in Q3 2025 from $25 million in Q3 2024 [65] - Royalty revenue increased to $04 million in Q3 2025 from $03 million in Q3 2024 [65] - Research and Development expenses decreased to $104 million in Q3 2025 from $133 million in Q3 2024 [65] - Net loss was ($165) million in Q3 2025, compared to ($164) million in Q3 2024 [65] Financial Guidance - The company expects 2025 revenue to be in the range of $18 to $22 million [67] - The company expects 2025 operating expense to be in the range of $82 to $86 million [67]

Core Insights - Arcus Biosciences Inc. announced the first overall survival results from Arm A1 of the Phase 2 EDGE-Gastric study for patients with advanced gastric cancer [1] - The study evaluates the safety and efficacy of domvanalimab plus zimberelimab and chemotherapy [1][2] Study Details - The Phase 2 EDGE-Gastric study is a multi-arm global trial conducted in partnership with Gilead Sciences Inc. [2] - Patients in Arm A1 received a regimen of domvanalimab (1600mg IV every four weeks), zimberelimab (480mg IV every four weeks), and FOLFOX chemotherapy every two weeks [3] - The cohort demonstrated a median overall survival of 26.7 months [3] Efficacy Results - The study reported a confirmed overall response rate of 59% and a median progression-free survival of 12.9 months [4] - Richard Markus, chief medical officer of Arcus, emphasized the differentiated efficacy and safety of the anti-TIGIT-based combinations [4] Safety Profile - No unexpected safety signals were observed, and the treatment regimen was generally well tolerated [5] Market Reaction - Following the announcement, Arcus Biosciences' stock increased by 6.58%, reaching $15.56 [5]

Summary of Arcus Biosciences Investor Event - October 2025 Company Overview - **Company**: Arcus Biosciences - **Focus**: Development of innovative cancer therapies, particularly in renal cell carcinoma (RCC) and immunology - **Key Programs**: Castadafen (HIF2 inhibitor), domvanalimab (anti-TIGIT), quemliclustat (CD73 inhibitor) - **Financial Position**: Over $900 million in funding to support late-stage programs and clinical trials [7][8][14] Key Points on Castadafen - **Priority Program**: Castadafen is the highest priority program due to its scientific, clinical, and commercial validation [3][4] - **Market Potential**: The clear cell RCC market opportunity is estimated at approximately $5 billion, with additional potential in other cancers leading to a total market exceeding $10 billion [15][18] - **Clinical Data**: - Castadafen shows approximately twice the progression-free survival (PFS) compared to belzutifan, with a 50% lower rate of primary progression [17][43] - Confirmed overall response rate (ORR) for castadafen is 35%, compared to 22% for belzutifan [32][43] - Median PFS for castadafen is projected to exceed 12 months, with 60% of patients remaining progression-free at 12 months [40][41] - **Safety Profile**: Castadafen has a comparable safety profile to belzutifan, with serious adverse events (SAEs) at 31% and treatment-related SAEs at 6% [43][44] Other Programs - **Domvanalimab**: Focused on upper GI cancers, with an oral presentation at ESMO expected to provide overall survival data [5][6] - **Quemliclustat**: CD73 inhibitor showing unprecedented overall survival of 16.4 months in combination with gemcitabine/nab-paclitaxel [6][14] Clinical Trials and Collaborations - **PEAK-1 Study**: Ongoing phase 3 study for castadafen in frontline clear cell RCC, with strong enrollment expected due to investigator enthusiasm [12][14] - **Collaboration with AstraZeneca**: Cost-sharing arrangement while maintaining 100% commercial rights to castadafen [13][14] - **Taiho Collaboration**: Potential decision from Taiho regarding participation in the castadafen program [13] Market Competition - **Competitive Landscape**: Competing against major players like Merck and Roche, with a focus on addressing significant medical needs in large markets [14][15] - **Strategic Positioning**: Arcus aims to leverage its well-funded status and strong data to capture market share in the competitive landscape of RCC treatments [14][15] Insights from Key Opinion Leaders - **Dr. Raina McKay**: Emphasized the need for improved treatment options in RCC, highlighting the limitations of current therapies like belzutifan [48][52] - **Patient Journey**: Discussed the typical RCC patient journey and the importance of long-term treatment strategies [49][50] Conclusion - **Future Outlook**: Arcus Biosciences is well-positioned to capitalize on its innovative therapies, particularly castadafen, with strong clinical data and a robust financial foundation to support ongoing and future studies [7][8][15]

TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Table of Contents As filed with the Securities and Exchange Commission on February 6, 2023 Registration No. 333-268613 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 2 OMNIAB, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 8731 98-1584818 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identif ...