Coherus Oncology, Inc.

Coherus Oncology, Inc. is a fully integrated commercial-stage innovative oncology company focused on proprietary immuno-oncology medicines, a strategic shift completed in May 2025 with the change of its corporate name from Coherus BioSciences, Inc. ¹. The company's core business model revolves around growing sales of its approved next-generation programmed death receptor-1 (PD-1) inhibitor, LOQTORZI® (toripalimab-tpzi), and advancing new indications for LOQTORZI in combination with its pipeline candidates and partners ². Revenue is generated primarily through product sales to wholesalers and distributors in the United States, with a significant portion of revenue from a limited number of wholesalers ³.

The company's primary product, LOQTORZI, is an anti-PD-1 antibody developed in collaboration with Junshi Biosciences Co., Ltd. ⁴. It was approved by the U.S. FDA on October 27, 2023, for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC) in combination with cisplatin and gemcitabine, and as monotherapy for recurrent unresectable or metastatic NPC with disease progression after platinum-containing chemotherapy ⁵. LOQTORZI is currently the only immune checkpoint inhibitor approved by the FDA for these indications commercially available in the United States, having launched on January 2, 2024 ⁶. The company estimates the market opportunity for LOQTORZI in RM-NPC patients to be up to 2,000 eligible patients, translating into a $250 million market opportunity ⁷. NCCN guidelines were updated on November 26, 2024, to specify LOQTORZI as the only preferred category 1 first-line treatment option for adults with metastatic or recurrent locally advanced NPC when used in combination with cisplatin and gemcitabine, and as the only preferred monotherapy in subsequent lines of therapy ⁸.

Coherus Oncology's pipeline includes two mid-stage clinical candidates. Casdozokitug (CHS-388, formerly SRF388) is an investigational antagonist antibody targeting IL-27, an immune regulatory cytokine overexpressed in certain cancers like hepatocellular, lung, and renal cell carcinoma ⁹. It received orphan drug designation from the FDA for hepatocellular carcinoma (HCC) in October 2020 and is currently in a randomized Phase 2 study in HCC in combination with toripalimab and bevacizumab ¹⁰. Tagmokitug (CHS-114, formerly SRF114) is an investigational human afucosylated IgG1 monoclonal antibody targeting CCR8, a chemokine receptor highly expressed on regulatory T cells in the tumor microenvironment ¹¹. It is being evaluated in a Phase 1b clinical study in second-line HNSCC in combination with toripalimab, and in an ongoing Phase 1b/2a clinical study in advanced solid tumors, including upper GI adenocarcinoma, esophageal squamous cell cancer, and microsatellite stable colorectal cancer ¹².

For the fiscal year ended December 31, 2025, Coherus Oncology reported total net revenue of $42.172 million ¹³, an increase from $26.389 million in 2024 ¹⁴. Cost of goods sold was $13.814 million ¹⁵, resulting in a gross margin of 67% ¹⁶. Operating loss was $181.134 million ¹⁷. Net income for the period was $168.024 million ¹⁸, with basic and diluted EPS of $1.43 ¹⁹. Cash, cash equivalents, and marketable securities totaled $172.125 million as of December 31, 2025 ²⁰. Total financial liabilities were $51.200 million ²¹, down from $293.670 million in 2024 ²². The accumulated deficit as of December 31, 2025, was $1.382 billion ²³.

Comparing 2025 to 2024, LOQTORZI net revenue increased by $21.705 million ²⁴, driven primarily by volume growth following its January 2024 launch ²⁵. Cost of goods sold increased by $5.087 million ²⁶ due to this volume growth, while the gross margin remained stable at 67% ²⁷. Research and development expense increased by $17.055 million to $108.888 million ²⁸, primarily due to increased development costs for tagmokitug ($19.9 million, including $1.1 million in milestones) ²⁹ and casdozokitug ($14.5 million) ³⁰, partially offset by decreases in other programs and employee-related costs ³¹. Selling, general and administrative expense decreased by $24.878 million to $100.604 million ³², mainly due to lower average headcount and a net impairment charge in 2024 ³³. Interest expense decreased by $1.733 million to $9.001 million ³⁴ due to debt prepayments ³⁵. Net income from discontinued operations, net of tax, increased by $107.247 million to $351.148 million ³⁶, primarily driven by a $161.7 million favorable change in gain on Sale Transactions, including the UDENYCA Sale gain of $338.3 million in 2025 ³⁷.

Significant operational developments during the period include the completion of the divestiture of the UDENYCA Business on April 11, 2025, for upfront cash consideration of $483.4 million, including $118.4 million for inventory ³⁸. The company is eligible for two additional Earnout Payments of $37.5 million each based on UDENYCA net sales thresholds ³⁹. A portion of these proceeds was used to repay substantially all of the $230 million aggregate principal amount of the outstanding 2026 Convertible Notes and to buy out royalty rights on UDENYCA net sales for $47.7 million ⁴⁰. In February 2026, the company completed a public offering of 28,600,000 shares of common stock at $1.75 per share, generating net proceeds of approximately $47.0 million ⁴¹. The company also entered into a Canada License Agreement with Apotex, Inc. on June 27, 2024, granting exclusive rights to commercialize toripalimab in Canada, for which Apotex paid an upfront payment of $6.3 million USD and is eligible for up to $51.5 million CAD in milestone payments ⁴². Health Canada approved LOQTORZI for recurrent unresectable or metastatic NPC in October 2025 ⁴³.

Management expects net revenue from continuing operations in 2026 to be higher than in 2025 due to the continued growth of LOQTORZI ⁴⁴. Fixed research and development expenses in 2026 are anticipated to be lower than in 2025, primarily as a result of rebalancing manufacturing-related development activities and reduced headcount ⁴⁵. Total overall research and development expenses, including external clinical costs, will be a function of data readouts and the ongoing portfolio prioritization process ⁴⁶. Selling, general and administrative expense from continuing operations for the full year 2026 is also expected to be lower than the full year 2025, primarily due to decreased operating costs and headcount ⁴⁷. Interest expense from continuing operations is projected to be slightly lower in 2026 than in 2025, mainly due to a downward trend in market interest rates relative to the 2025 period ⁴⁸.

The company's growth strategy is anchored on accelerating new patient share for LOQTORZI through strong healthcare professional engagement and patient identification, ensuring LOQTORZI educational messaging is delivered at the time of treatment decision, and optimizing the duration of LOQTORZI treatment ⁴⁹. Educational efforts are focused on communicating the proven superior overall survival benefit of LOQTORZI to physicians who still treat RM-NPC with chemotherapy alone, and reinforcing LOQTORZI's position as the only approved and available IO treatment for these patients ⁵⁰.

In terms of pipeline growth, further evaluation of LOQTORZI is expected through multiple current and planned clinical studies by the company, Junshi Biosciences, and biopharma partners ⁵¹. This includes a post-marketing commitment study actively enrolling patients in the U.S. and Canada to further evaluate the safety and efficacy of toripalimab in combination with chemotherapy in advanced NPC ⁵². Junshi Biosciences has an active multiregional Phase 3 clinical study evaluating LOQTORZI with its investigational anti-BTLA antibody in LS-SCLC ⁵³. INOVIO Pharmaceuticals, Inc. plans a randomized Phase 3 study of INO-3112 and toripalimab in locally advanced, high-risk HPV16/18+ oropharyngeal squamous cell carcinoma ⁵⁴. Cancer Research Institute is evaluating toripalimab in combination with ENB Therapeutics' investigational agent ENB-003 in a Phase 2 trial for platinum-resistant high-grade serous ovarian cancer ⁵⁵. STORM Therapeutics, Ltd. is evaluating its METTL3 inhibitor STC-15 in combination with LOQTORZI in a Phase 1b/2 study for non-small cell lung cancer, head and neck squamous cell carcinoma, melanoma, and endometrial cancer ⁵⁶.

For casdozokitug, the lead indication is 1L HCC, and it is currently being studied in a randomized Phase 2 study in HCC evaluating casdozokitug in combination with toripalimab and bevacizumab ⁵⁷. For tagmokitug, the company is enrolling patients with head and neck squamous cell carcinoma (HNSCC) in the U.S. in a clinical trial evaluating safety and pharmacokinetics of tagmokitug with and without LOQTORZI ⁵⁸. A multiregional Phase 1b clinical study of tagmokitug in combination with toripalimab and/or other treatments in participants with advanced solid tumors is also ongoing, with initial cohorts evaluating upper GI adenocarcinoma, esophageal squamous cell carcinoma (ESCC), 1L ESCC, and a Phase 2a cohort evaluating 4L+ colorectal cancer ⁵⁹. A clinical study evaluating tagmokitug in combination with pasritamig in metastatic castrate-resistant prostate cancer is also planned ⁶⁰.

Operationally, Coherus is executing a coordinated initiative to onshore the biomanufacturing process for LOQTORZI, casdozokitug, and tagmokitug to the United States ⁶¹. The company has scientific expertise, manufacturing capabilities, and U.S.-based experience across oncology clinical development, regulatory affairs, sales, and medical affairs, which it expects to leverage to advance its immuno-oncology franchise ⁶².

Regarding capital allocation, the company received approximately $47.0 million in net proceeds from a public offering of common stock in February 2026 ⁶³. As of December 31, 2025, approximately $64.9 million of common stock remained available for sales under the Sales Agreement with TD Cowen ⁶⁴. The company has obligations to make future payments to third parties upon the achievement of certain development, regulatory, and commercial milestones, including $355.0 million to Junshi Biosciences for LOQTORZI (of which $65.0 million relates to regulatory milestones for non-clinical trial indications and $290.0 million to sales milestones) ⁶⁵, $10.5 million to Adimab LLC for casdozokitug ⁶⁶, $13.5 million to Vaccinex, Inc. for tagmokitug ⁶⁷, and $7.2 million to Memorial Sloan Kettering Cancer Center for tagmokitug ⁶⁸. A $1.0 million milestone payment to Vaccinex related to a clinical milestone was accrued as of December 31, 2025, and paid in January 2026 ⁶⁹. The company's non-cancelable purchase commitments as of December 31, 2025, were $8.1 million ⁷⁰, with $2.1 million of these obligations due within twelve months ⁷¹.

Management explicitly flagged several structural headwinds and execution risks to the growth plan. There is no guarantee of receiving either of the two $37.5 million Earnout Payments from the UDENYCA Sale, which are contingent on UDENYCA net sales thresholds ⁷². The company is also subject to risks and uncertainties associated with the UDENYCA Transition Services Agreement (TSA), including expending management and employee time, providing significant support services, exposure to Intas's financial status for payments, and potential unanticipated costs ⁷³. The company faces intense competition from larger, better-funded pharmaceutical and biotechnology companies with greater resources and established market positions ⁷⁴. Competitors may develop therapies that are similar, more advanced, less costly, easier to administer, or more effective, or obtain regulatory approval more rapidly ⁷⁵. The company is highly dependent on its key executives and personnel, and the inability to retain or recruit qualified management, product development, and scientific staff could harm the business ⁷⁶. Managing changes in employee numbers, particularly due to divestitures, reductions in force, and turnover, could disrupt operations ⁷⁷. The company relies on third parties for manufacturing and clinical studies, and failure by these third parties to meet contractual duties, deadlines, or regulatory requirements could substantially harm the business ⁷⁸.

Geographic, regulatory, and macro factors identified as constraints include the extensive regulation by numerous government authorities in the United States and other countries, with regulatory requirements subject to change and potentially impacting operations ⁷⁹. Healthcare reform measures, including the IRA and the OBBBA, may increase the difficulty and cost of obtaining marketing approval and commercializing products, affect prices, and materially adversely affect business and results of operations ⁸⁰. The OBBBA, enacted in July 2025, imposes significant reductions in Medicaid program funding, which is expected to decrease enrollment and covered services, potentially affecting LOQTORZI sales ⁸¹. The Trump administration's two-fold strategy to reduce drug costs, including potential tariffs and mandatory payment models based on most favored nation pricing, could also significantly impact the U.S. pharmaceutical sector ⁸². The continuation of the war in Ukraine and conflicts in the Middle East may exacerbate certain risks, such as disruptions to supply arrangements or clinical operations due to expanded sanctions or adverse impacts on countries where the company has operations or relationships ⁸³.

The company faces material risks including a limited history of profitability and dependence on a single approved product, LOQTORZI, with multiple product candidates still in development, leading to an accumulated deficit of $1.4 billion ⁸⁴. Commercial success is uncertain and depends on market acceptance, pricing, and third-party reimbursement, which are subject to increasing cost-containment measures and legislative changes like the Inflation Reduction Act of 2022 (IRA) and the One Big Beautiful Bill Act (OBBBA) ⁸⁵. The OBBBA, enacted in July 2025, is expected to significantly reduce Medicaid funding, potentially decreasing enrollment and covered services, which could adversely affect LOQTORZI sales ⁸⁶. The company is highly dependent on key executives and personnel, and the inability to retain or recruit qualified staff could harm the business ⁸⁷. Reliance on single third-party manufacturers and CROs for critical supplies and clinical studies exposes the company to risks of supply disruptions, quality issues, and delays, exacerbated by the initiative to onshore biomanufacturing processes ⁸⁸. Product candidates may cause undesirable side effects, leading to delays or denial of regulatory approval, restrictive labeling, or product liability claims ⁸⁹. The company operates in a highly competitive environment with larger, better-funded competitors, and faces risks of intellectual property infringement claims, which could result in substantial costs, litigation, and diversion of management attention ⁹⁰. There is no guarantee of receiving the two $37.5 million Earnout Payments from the UDENYCA Sale, which are contingent on specific net sales thresholds ⁹¹. Geopolitical tensions, such as the war in Ukraine and conflicts in the Middle East, may exacerbate existing risks, including supply chain disruptions and increased cybersecurity threats ⁹².

Management's overall tone emphasizes a strategic pivot to an exclusive focus on proprietary innovative immuno-oncology medicines, following the divestiture of biosimilar businesses and the corporate name change to Coherus Oncology, Inc. ⁹³. Key strategic priorities include growing sales of LOQTORZI in nasopharyngeal carcinoma (NPC) and advancing the development of new indications for LOQTORZI in combination with pipeline candidates and partners, aiming to drive sales multiples and synergies from proprietary combinations ⁹⁴. Management expects net revenue from continuing operations in 2026 to be higher than in 2025 due to continued LOQTORZI growth ⁹⁵, and anticipates fixed research and development expenses and selling, general and administrative expenses to be lower in 2026 compared to 2025, primarily due to rebalancing manufacturing-related development activities and reduced headcount ⁹⁶. The company believes its existing cash and cash equivalents, investments, product sales, and proceeds from the UDENYCA Sale will be sufficient to fund current operations for at least the next twelve months ⁹⁷.