Arcus Biosciences, Inc. (RCUS): Business Model Canvas [Dec-2025 Updated]

You're digging into Arcus Biosciences, Inc. (RCUS) right now, trying to figure out if their late-stage pipeline justifies the current valuation, and honestly, the story isn't just about the science anymore; it's a strategic pivot. They are shifting from pure partnership reliance to driving their lead asset, casdatifan-which showed a compelling 12.2 months median PFS in late-line ccRCC-themselves, while still banking on the massive Gilead collaboration. With $841 million in the bank as of Q3 2025 and full-year GAAP revenue guidance landing between $225 million to $235 million, the runway is there, but execution is everything now. Let's break down exactly how this dual strategy-self-execution plus major partnerships-is structured across the nine building blocks of their business model below.

Arcus Biosciences, Inc. (RCUS) - Canvas Business Model: Key Partnerships

You're looking at the core alliances that fund and advance the Arcus Biosciences pipeline, which is definitely the engine room of their value proposition right now. These aren't just handshake deals; they involve significant financial flows and shared clinical execution, so let's break down the numbers we see as of late 2025.

The structure of Arcus Biosciences' Key Partnerships is critical for capital efficiency, especially given their late-stage trial load. Here's how the major players fit in:

The execution of the global Phase 3 trials is heavily reliant on external partners, which helps manage Arcus Biosciences' internal burn rate. Here are the operational statuses for the key trials mentioned:

• Enrollment has been completed for PRISM-1 (quemliclustat in pancreatic cancer) as of Q3 2025.
• PEAK-1 (casdatifan in IO-experienced ccRCC) is enrolling as of Q3 2025.
• Enrollment for STAR-221 (domvanalimab plus zimberelimab in upper GI cancers) has been completed.

The financial impact of these collaborations is clear in the expense reporting. For instance, Arcus Biosciences recognized gross reimbursements of $28 million for shared expenses from collaborations in Q3 2025, down from $37 million in Q3 2024. Anyway, Arcus expects Research and Development (R&D) expenses to decline starting in Q4 2025 as costs for the domvanalimab Phase 3 development program decrease significantly.

Arcus Biosciences, Inc. (RCUS) - Canvas Business Model: Key Activities

You're managing a complex, late-stage biotech pipeline, so the key activities for Arcus Biosciences, Inc. (RCUS) center on execution across clinical trials, regulatory pathways, and managing the critical Gilead partnership. Here's the breakdown based on late 2025 data.

Late-stage clinical development of lead assets (domvanalimab, casdatifan, quemliclustat)

The primary activity is driving the lead assets through pivotal trials. For casdatifan, the HIF-2a inhibitor, the Phase 3 PEAK-1 trial is actively enrolling. Data from the pooled ARC-20 monotherapy cohorts (121 patients, DCO August 15, 2025) showed a median PFS of 12.2 months and an 18-month landmark PFS of 43%. At the Phase 3 dose (100mg once-daily), the confirmed ORR was 35%, with 74% of confirmed responders remaining on treatment. You can expect further casdatifan readouts in 2026, including early-line data in the second half of 2026.

For quemliclustat, the CD73 inhibitor, the registrational Phase 3 study, PRISM-1, is expected to be fully enrolled by the end of this year (2025). Previous Phase 1 ARC-8 data showed a median OS of 15.7 months with 100mg quemliclustat-based regimens.

Domvanalimab, co-developed with Gilead, showed strong data in the Phase 2 EDGE-Gastric study, where the combination with zimberelimab and chemotherapy achieved a median OS of 26.7 months in Arm A1. The STAR-221 Phase 3 OS readout is targeted for 2026.

The intensity of these late-stage programs drove Q3 2025 Research and Development (R&D) Expenses to $141 million.

Discovery and preclinical research, including new programs in inflammatory/autoimmune diseases

Arcus Biosciences, Inc. is actively expanding beyond oncology. The company unveiled a portfolio of five programs targeting inflammatory and autoimmune diseases.

A key preclinical milestone is the small molecule targeting MRGPRX2, which is expected to enter the clinic in 2026.

The R&D spend reflects this work, though costs related to the domvanalimab Phase 3 program are expected to decrease starting Q4 2025.

Regulatory filings and preparation for potential first product approvals

The core regulatory activity involves compiling data packages for potential first product approvals, though as of late 2025, none of the investigational molecules-domvanalimab, quemliclustat, zimberelimab, or casdatifan-have received approval from any regulatory authority globally.

The company is managing ongoing compliance, with recent SEC filings including Form 4 and Form 144 activity in early December 2025, and a Form 424B5 filed on October 31, 2025.

Quemliclustat received Orphan Drug Designation for pancreatic cancer, which provides incentives like exemption from New Drug Application user fees.

Strategic collaboration management with Gilead and other partners

Managing the strategic collaboration with Gilead Sciences, Inc. is a major operational focus, involving cost-sharing and option management.

For Q3 2025, Arcus Biosciences, Inc. recognized gross reimbursements of $28 million for shared expenses from collaborations, down from $37 million in Q3 2024.

The collaboration structure dictates revenue recognition; Q3 2025 revenue was $26 million, compared to $48 million in Q3 2024, with the decrease partly due to lower Gilead collaboration revenues.

The original 2020 partnership provided an upfront payment of $175 million and a $200 million equity investment.

The May 2023 expansion for inflammation programs allows Arcus to be eligible for up to $420 million in option/milestone payments and tiered royalties per program if Gilead exercises the earlier option point.

The management of these programs directly impacts operating costs; Arcus expects R&D expenses to decline starting Q4 2025 as costs related to the domvanalimab Phase 3 program decrease.

The company maintains a strong balance sheet to support these activities, reporting $841 million in cash, cash equivalents, and marketable securities at the end of Q3 2025.

Here's a summary of key financial and operational metrics related to the collaboration and pipeline execution as of late 2025:

The company is focused on advancing its pipeline, which includes these three late-stage assets, while managing the financial dynamics of the Gilead agreement. Finance: draft 2026 R&D budget forecast by January 15th.

Arcus Biosciences, Inc. (RCUS) - Canvas Business Model: Key Resources

You need to know that Arcus Biosciences, Inc. has built its foundation on a few very specific, high-value assets, which is typical for a clinical-stage biopharma. These resources are what fund the science and what the whole enterprise is built around.

First, look at the balance sheet strength. As of the third quarter of 2025, Arcus Biosciences, Inc. reported $841 million in cash, cash equivalents, and marketable securities. That number is your primary indicator of near-term operational runway, supporting the ongoing and planned clinical trials through pivotal readouts.

The core value is locked up in the Intellectual Property (IP) portfolio. This is the science that matters. You're looking at differentiated molecules designed to hit targets in ways competitors haven't managed yet. Key assets here include:

• Investigational drug casdatifan, a HIF-2a inhibitor.
• Investigational antibody domvanalimab, which targets TIGIT.
• The portfolio also includes other programs targeting inflammatory and autoimmune diseases.

Here's a quick look at the hard numbers supporting the current operations and pipeline progression as of late 2025:

Financial stability is heavily underpinned by the strategic relationship with Gilead Sciences, Inc. Gilead's equity stake is significant; they own roughly 33 percent of Arcus Biosciences, Inc. This wasn't a small initial investment; Gilead made a $320 million equity investment in January 2024 at $21.00 per share, which definitely signals conviction in the pipeline. This partnership provides capital and governance alignment, giving Gilead three seats on the Arcus Board.

The engine driving the IP development is the experienced R&D team. This group is focused on immuno-oncology and small molecule development, pushing assets like casdatifan through late-stage trials. You can gauge the scale of their current work by looking at the burn rate; for instance, Research and Development Expenses for the third quarter of 2025 totaled $141 million. That level of spend reflects the intensity of the ongoing clinical programs, including the Phase 3 PEAK-1 trial for casdatifan.

Finance: draft 13-week cash view by Friday.

Arcus Biosciences, Inc. (RCUS) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Arcus Biosciences, Inc. (RCUS) is positioned to create value, grounded in their late 2025 pipeline and financial standing. Honestly, the value proposition hinges on hitting these clinical milestones with differentiated data.

The financial foundation supporting this development is solid for the near term. As of the end of the third quarter of 2025, Arcus Biosciences reported cash, cash equivalents and marketable securities totaling $841 million. This cash position is expected to fund operations through the PEAK-1 Phase 3 readout. For the full year 2025, Arcus expects to recognize GAAP revenue between $225 million and $235 million. The third quarter of 2025 revenue specifically came in at $26 million, while Research and Development Expenses for that same quarter were $141 million.

Here's a look at the key clinical value drivers:

• Potential best-in-class HIF-2$\alpha$ inhibitor, casdatifan, showing superior mPFS data in late-line ccRCC.
• Novel combination therapies to improve patient outcomes in major cancers.
• Expediting development of first- or best-in-class medicines against validated targets.
• Expanding pipeline into inflammatory and autoimmune diseases for future growth.

The data for casdatifan is definitely a cornerstone. In a pooled analysis of 121 patients with late-line clear cell Renal Cell Carcinoma (ccRCC) from the ARC-20 study, casdatifan monotherapy demonstrated a median Progression-Free Survival (mPFS) of 12.2 months. Furthermore, the 18-month landmark PFS was 43%. At the Phase 3 dose, the confirmed Overall Response Rate (ORR) was 35%.

The combination work is also showing compelling survival metrics. Consider the data from the Phase 2 EDGE-Gastric study:

Arcus Biosciences is actively expediting development, retaining full rights to casdatifan after Gilead's option expired. The Phase 3 PEAK-1 study, evaluating casdatifan plus cabozantinib in the IO-experienced setting, is underway. The company is also planning to initiate a Phase 3 study for casdatifan in early-line ccRCC in the second half of 2026.

For future growth, the expansion into non-oncology areas is a clear value driver. Arcus Biosciences has unveiled its portfolio of five programs targeting inflammatory and autoimmune diseases. Specifically, a small molecule targeting MRGPRX2 is in preclinical development, with an expected clinical study initiation in 2026.

You can see the focus on advancing these differentiated assets:

• Casdatifan (HIF-2$\alpha$ inhibitor) has Phase 3 PEAK-1 study evaluating casdatifan plus cabozantinib.
• Domvanalimab (anti-TIGIT) plus zimberelimab (anti-PD-1) has Phase 3 STAR-221 study ongoing.
• Quemliclustat (CD73 inhibitor) is advancing, having received Orphan Drug Designation.
• MRGPRX2 small molecule expected to enter clinic in 2026.

Finance: draft 13-week cash view by Friday.

Arcus Biosciences, Inc. (RCUS) - Canvas Business Model: Customer Relationships

You're looking at how Arcus Biosciences, Inc. manages its most critical external relationships, which are heavily weighted toward strategic alliances and scientific validation. These aren't transactional sales; they are deep, multi-year collaborations essential for global development and commercial reach.

High-touch, collaborative relationships with major pharmaceutical partners (Gilead, Taiho)

The relationship with Gilead Sciences, Inc. is a 10-year collaboration established in May 2020, granting Gilead time-limited exclusive option rights to most Arcus clinical programs. This requires constant, high-touch coordination for co-development activities. For instance, Arcus Biosciences and Gilead are co-developing investigational medicines including zimberelimab (anti-PD-1) and domvanalimab (anti-TIGIT). The financial structure of these relationships is key to Arcus Biosciences, Inc.'s operations; for example, Arcus Biosciences, Inc. recognized gross reimbursements of $28 million in the third quarter of 2025 for shared expenses from collaborations, down from $37 million in the third quarter of 2024. Similarly, Q2 2025 saw $33 million in reimbursements versus $40 million in Q2 2024. The relationship with Taiho Pharmaceutical Co., Ltd. covers exclusive development and commercialization rights in Japan and certain other Asian territories for five programs, including casdatifan. Taiho recently exercised its option for casdatifan, which triggers an option exercise payment, future milestone payments, and royalties on net sales. This deep integration means Arcus Biosciences, Inc. is building infrastructure to co-promote products in the U.S. with Gilead, having elected to do so for domvanalimab and zimberelimab.

Here's a look at the potential financial structure tied to these partner relationships:

Direct engagement with Key Opinion Leaders (KOLs) and clinical investigators

Direct engagement with the medical community is formalized through presentations at major medical congresses and dedicated events. Arcus Biosciences, Inc. hosted an Investor Event on October 6, 2025, where key opinion leaders with expertise in HIF-2a biology and treatment of clear cell renal cell carcinoma (ccRCC) were featured presenters. This direct scientific exchange is vital for validating clinical trial designs and data interpretation. Furthermore, Arcus Biosciences, Inc. is actively working with investigators on global registrational studies. For example, Taiho is operationalizing ongoing Phase 3 registrational studies for optioned molecules in Japan, including STAR-121, STAR-221, and PRISM-1. The company's cash position as of September 30, 2025, stood at $841 million, supporting the funding of these late-stage trials, which involve significant investigator site engagement.

• Featured KOLs at the October 6, 2025, Investor Event.
• Taiho operationalizing Phase 3 studies: STAR-121, STAR-221, and PRISM-1 in Japan.
• Enrollment expected to be completed for ARC-20 cohorts by the end of 2025.

Investor relations and public disclosures (e.g., 2025 ESMO and ASCO presentations)

The relationship with the investment community is managed through a steady cadence of public disclosures. Arcus Biosciences, Inc. reported expected GAAP revenue between $225 million and $235 million for the full year 2025. The company presented data from its Phase 2 EDGE-Gastric study at the 2025 European Society for Medical Oncology (ESMO) Congress in October. Also, initial data from the ARC-20 study was presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Management continues to engage directly, with planned fireside chats scheduled for December 2025 at the 8th Annual Evercore Healthcare Conference and Citi's 2025 Global Healthcare Conference. These disclosures provide the quantitative basis for investor trust.

Scientific communication through peer-reviewed publications (e.g., Nature Medicine)

Scientific credibility is cemented through publication in high-impact journals. The results from the domvanalimab plus zimberelimab and chemotherapy combination in advanced gastric, gastroesophageal junction or esophageal cancer were presented at the 2025 ESMO Congress and published in Nature Medicine in October 2025. Specifically, this publication detailed a median overall survival (OS) of 26.7 months in Arm A1 of the Phase 2 EDGE-Gastric study. This level of peer validation is a critical component of the relationship with the broader scientific customer base.

Arcus Biosciences, Inc. (RCUS) - Canvas Business Model: Channels

You're looking at how Arcus Biosciences, Inc. gets its data out and its potential products to the market, which is all about clinical sites and big pharma partners right now.

Global clinical trial sites and networks for patient enrollment

The channel for clinical data generation is a global network of trial sites. Arcus Biosciences, Inc. is running several key studies across different lines of therapy for its lead asset, casdatifan.

• The global, registrational Phase 3 PEAK-1 study, comparing casdatifan plus cabozantinib to cabozantinib monotherapy in IO-experienced metastatic clear cell renal cell carcinoma (ccRCC), was expected to initiate in the second quarter of 2025.
• The Phase 1/1b ARC-20 study evaluated casdatifan monotherapy across four cohorts, with data presented from a pooled analysis of 121 patients.
• Data presented as of August 2025 included results from over 125 patients treated with casdatifan monotherapy or in combination.
• Arcus expected to complete enrollment for three new early-line cohorts within the ARC-20 study by the end of 2025.
• The PRISM-1 Phase 3 trial for quemliclustat in pancreatic cancer was expected to complete enrollment by the end of 2025.
• The AstraZeneca-operationalized eVOLVE-RCC02 Phase 1b/3 study, combining casdatifan with volrustomig in IO-naive ccRCC, was expected to initiate in mid-2025.

Strategic partners (Gilead, Taiho) for global commercialization and distribution post-approval

Commercialization and distribution channels are heavily reliant on established global players like Gilead and Taiho, though the rights structure is specific for each program.

Arcus Biosciences, Inc. retains full rights to casdatifan outside of the Taiho territories.

Scientific conferences (ESMO, ASCO) to disseminate clinical data to oncologists

Dissemination of clinical evidence to the treating oncologist community happens through major medical meetings.

• Oral presentation data from the ARC-20 study for casdatifan were presented at the 2025 ASCO Genitourinary (GU) Cancers Symposium in February 2025.
• Data for casdatifan plus cabozantinib were presented at ASCO 2025 on June 1, 2025.
• Overall survival (OS) data from the Phase 2 EDGE-Gastric study for domvanalimab plus zimberelimab and chemotherapy were presented at the 2025 European Society for Medical Oncology (ESMO) Congress in October 2025.
• Arcus Biosciences, Inc. hosted an Investor Event on October 5, 2025, to include Casdatifan Monotherapy Data.
• The company planned participation in the 8th Annual Evercore Healthcare Conference on December 2nd, 2025, and Citi's 2025 Global Healthcare Conference on December 3rd, 2025.

Direct communication via Investor Relations for capital markets

The channel for capital markets access is managed directly through the Investor Relations function.

• Arcus Biosciences, Inc. announced the pricing of a $250 million Public Offering of Common Stock on October 30, 2025.
• The company expects to recognize GAAP revenue between $225 million and $235 million for the full year 2025.
• The VP of Investor Relations & Strategy is Pia Eaves, reachable at (617) 459-2006.
• The company reported $927 million in cash, cash equivalents, and marketable securities at the end of Q2 2025.

Arcus Biosciences, Inc. (RCUS) - Canvas Business Model: Customer Segments

You're looking at the core groups that Arcus Biosciences, Inc. targets to drive its clinical-stage biopharmaceutical business forward. Since they don't sell products directly to the public yet, their customers are the prescribers, the partners who fund development, and the capital markets that provide the runway.

Patients with advanced or metastatic solid tumors (NSCLC, ccRCC, GI cancers, pancreatic cancer)

This segment represents the ultimate beneficiaries whose medical needs drive the entire research and development effort. Arcus Biosciences, Inc. is focused on delivering data that convinces oncologists to adopt their novel combination therapies once approved. The clinical validation points are the key data they use to attract this segment.

Here are some of the latest efficacy numbers from the late 2025 data readouts that directly impact the perceived value for patients and their treating physicians:

The company is advancing registrational trials for its lead candidates, including domvanalimab for upper gastrointestinal and non-small cell lung cancer, and quemliclustat for pancreatic cancer. The cash position of $841 million as of September 30, 2025, is meant to sustain these costly trials through pivotal readouts.

Oncologists and specialist physicians who prescribe cancer immunotherapies

These are the key decision-makers. Arcus Biosciences, Inc. targets them by presenting compelling data at major medical congresses, like the 2025 European Society for Medical Oncology (ESMO) Congress, where the 26.7 months median OS for the domvanalimab combination was presented. Oncologists look for best-in-class profiles, and the company claims casdatifan shows a meaningfully higher response rate and longer PFS relative to the only marketed HIF-2a inhibitor.

The financial reality for the company, which incurred a net loss of $135 million in Q3 2025, underscores the high-risk, high-reward nature of convincing these specialists to adopt new standards of care.

Global pharmaceutical companies seeking to license or co-develop novel oncology assets

This B2B segment is a primary revenue source for Arcus Biosciences, Inc. as a clinical-stage company. These partners provide the capital and infrastructure to advance late-stage trials.

Key customer/partner activities in 2025 include:

• Gross reimbursements for shared expenses from collaborations in Q3 2025 totaled $28 million.
• Gilead Sciences provided over $700 million in upfront payments and milestones in 2024, showing the value of these deals.
• Taiho Pharmaceutical exercised its option for an exclusive license to casdatifan in Japan and certain territories in Asia in October 2025.
• The company expects to recognize GAAP revenue between $225 million and $235 million for the full year 2025, largely driven by these collaboration streams.

The net cash used in operating activities soared to $362 million for the nine months ended September 30, 2025, highlighting the reliance on these partners to offset the high R&D burn rate.

Institutional and retail investors focused on clinical-stage biotech

Investors are the financiers of the pipeline, buying into the potential future value of the drug candidates. As of November 2025, Arcus Biosciences, Inc. commanded a market capitalization of about $2.57 Billion. Their conviction is measured by ownership stakes and recent capital raises.

Key investor metrics as of late 2025:

• Total cash and marketable securities stood at $841 million as of September 30, 2025.
• Institutional Ownership was reported at 67.52%.
• BlackRock, Inc. held a significant stake, around 10.94%.
• The company executed a public offering of common stock on October 30, 2025, raising approximately $250 million.

This segment is keenly watching the expected R&D expense decline commencing in Q4 2025 as costs related to the domvanalimab Phase 3 development program decrease significantly.

Arcus Biosciences, Inc. (RCUS) - Canvas Business Model: Cost Structure

You're looking at the core expenses Arcus Biosciences, Inc. is managing to push its pipeline forward, which is heavily weighted toward clinical development. The cost structure is dominated by Research and Development (R&D) activities.

High Research and Development (R&D) expenses are the biggest component. For the third quarter of 2025, R&D Expenses totaled $141 million. This level of spending was driven significantly by the ongoing Phase 3 trials, particularly for domvanalimab, though the company guided that these costs would start to decrease beginning in the fourth quarter of 2025 as that program's Phase 3 development costs taper off.

The R&D spend is directly impacted by operational activities:

• Costs for clinical manufacturing (CMC costs) were noted as elevated through the third quarter of 2025.
• Purchasing standard-of-care therapeutics for use in combination studies is another variable cost factor within R&D.

General and Administrative (G&A) expenses represent a much smaller, but still significant, operational cost. For the third quarter of 2025, G&A Expenses were $27 million. This was slightly lower than the $30 million reported in the same period of 2024, primarily due to a decrease in compensation and personnel costs linked to lower stock-based compensation.

The financial impact of the Gilead collaboration is a key element in managing the net R&D cost. Arcus Biosciences recognizes gross reimbursements for shared expenses from this partnership. For the third quarter of 2025, Arcus recognized gross reimbursements of $28 million for these shared expenses. This reimbursement partially offsets the gross R&D spend, though the timing of clinical manufacturing and therapeutic purchases can cause quarterly fluctuations in both the gross R&D expense and the corresponding reimbursement amount.

Here's a quick look at the key reported operating expenses for Q3 2025:

Finance: draft 13-week cash view by Friday.

Arcus Biosciences, Inc. (RCUS) - Canvas Business Model: Revenue Streams

Collaboration revenue from Gilead Sciences, Inc. includes license and development services revenue and access fees.

For the third quarter of 2025, Arcus Biosciences, Inc. recognized $26 million in total revenue, which was driven by lower revenues from the Gilead collaboration compared to the prior year. For the first quarter of 2025, this revenue stream was detailed as:

Arcus Biosciences, Inc. expects to recognize GAAP revenue of between $225 million and $235 million for the full year 2025. This updated guidance includes a $143 million one-time catch-up recognized in the second quarter of 2025 related to the pausing of etrumadenant development and Gilead returning its license for that program.

Reimbursements for shared Research and Development (R&D) expenses from collaboration partners, primarily the Gilead collaboration, provide additional cash flow supporting operations. For the third quarter of 2025, Arcus Biosciences, Inc. recognized gross reimbursements of $28 million for shared expenses. For comparison, gross reimbursements for the first quarter of 2025 were $38 million.

Potential future milestone payments and royalties are tied to the progression of co-developed programs. Under the May 2023 expansion of the collaboration for inflammatory disease targets, Arcus Biosciences, Inc. is eligible to receive up to $420 million in option and milestone payments plus tiered royalties for each optioned program, should Gilead exercise its option at the earlier, prespecified time point.

The components contributing to revenue streams include:

• Collaboration revenue from Gilead (license and development services, access fees).
• Full-year 2025 GAAP revenue guidance of $225 million to $235 million.
• The $143 million one-time catch-up included in the 2025 guidance.
• Reimbursements for shared R&D expenses from collaboration partners, such as $28 million in Q3 2025.
• Potential future milestone payments upon regulatory approvals and commercial sales royalties, including up to $420 million per inflammation program option.