Coherus Oncology (NasdaqGM:CHRS) 2025 Conference November 18, 2025 05:30 AM ET Company ParticipantsDennis Lanfear - CEOOperatorIt is now my pleasure to introduce Dennis Lanfear, CEO of Coherus Oncology.Dennis LanfearThank you. Thank you to the organizers for the opportunity to talk to you about Coherus Oncology, an emerging innovative oncology company based in the Bay Area in Northern California. Let me first apprise you of the company's forward-looking statements and direct you to the requisite SEC filings ...

Core Insights - Coherus Oncology's CHS-114 shows promising results in selectively depleting CCR8+ Tregs and enhancing immune response in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][2][3] Clinical Trial Results - The Phase 1b clinical trial of CHS-114 demonstrated a greater than 50% increase in intratumoral CD8 T cells, indicating a shift towards a "hot" tumor microenvironment [1][2] - CHS-114 treatment resulted in a 74% reduction in CCR8+ Treg density and a 73% increase in CD8+ T cell density, showcasing effective immune remodeling [5][6] Safety and Efficacy - The combination of CHS-114 with toripalimab has shown a manageable safety profile and early signs of antitumor activity in HNSCC patients [2][3] - A partial response was observed in a refractory head and neck cancer patient during initial safety testing of the combination therapy [3] Development Strategy - The data supports advancing CHS-114 in combination with toripalimab or other immune activators, aligning with the company's development plan [3][4] - Ongoing enrollment in the dose optimization arm aims to address the FDA's Project Optimus and define a phase 2 dose for CHS-114 [3][7] Company Overview - Coherus Oncology is focused on developing innovative oncology therapies, including the next-generation PD-1 inhibitor LOQTORZI and CHS-114, targeting various cancers [9][10]

Core Insights - Coherus Oncology announced new multiomic tumor and blood-based biomarker data from the Phase 1b clinical trial of CHS-114, a selective anti-CCR8 antibody, presented at the SITC Annual Meeting [1][2] - The data indicate that CHS-114, both as a monotherapy and in combination with toripalimab, shows promising early antitumor activity and a manageable safety profile in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [2][3] Clinical Trial Findings - The interim analysis shows significant immune activation enhancement with CHS-114 and toripalimab, including selective depletion of CCR8+ Tregs and increased CD8+ T cells in the tumor microenvironment [2][5] - CHS-114 treatment resulted in a 74% decrease in CCR8+ Treg density and a 73% increase in CD8+ T cell density, indicating effective tumor microenvironment remodeling [6][5] - A partial response was observed in a refractory HNSCC patient during initial safety testing of the combination therapy [3] Development Strategy - The data support advancing CHS-114 in combination with toripalimab or other immune activators, with ongoing enrollment in the dose optimization arm of the study [3][8] - The study aims to define a phase 2 dose and address the FDA's Project Optimus [3] About CHS-114 - CHS-114 is designed to selectively target and deplete CCR8+ Tregs while preserving CD8+ effector T cells, showing potential for enhanced antitumor activity [9][10] - The drug is currently being evaluated in multiple Phase 1b clinical trials for various advanced solid tumors, including HNSCC, colorectal cancer, gastric cancer, and esophageal cancer [9][11] Company Overview - Coherus Oncology is a commercial-stage oncology company with an approved PD-1 inhibitor, LOQTORZI, and a promising pipeline targeting various cancers [10][11] - The company's strategy focuses on growing sales of LOQTORZI and advancing new indications in combination with its pipeline candidates [10]

Financial Data and Key Metrics Changes - Coherus Oncology reported Q3 2025 net revenue of LOQTORZI at $11.2 million, reflecting a 12% increase quarter-over-quarter and a 92% increase year-over-year, although this is a decline from the 35% growth seen in Q2 [26][32] - The total cash and investments at the end of Q3 was $192 million, with total liabilities of $429 million, of which $254 million related to transition service agreements [33][34] - R&D expenses for the quarter were $27.3 million, up 24% from Q3 last year, while SG&A expenses were $24.9 million, down 11% compared to last year [35] Business Line Data and Key Metrics Changes - LOQTORZI's growth was driven by new patient starts and increasing duration of treatment, with a total number of accounts purchasing LOQTORZI growing over 15% [26][28] - The average growth for three out of four regions was 21%, with one region experiencing flat demand due to staffing issues [27][30] Market Data and Key Metrics Changes - The addressable market for LOQTORZI in nasopharyngeal cancer (NPC) is estimated to be between $150 million and $200 million, with expected average demand growth of 10%-15% over the next three years [28][29] - Approximately 2,000 LOQTORZI eligible patients are seen each year, with key differences in treatment dynamics between hospital-based specialists and community physicians [29][30] Company Strategy and Development Direction - The company aims to achieve a step change in patient survival through drug combinations and is focusing on expanding its pipeline with LOQTORZI and CHS-114 [6][10] - Coherus is pursuing partnerships to offset ongoing clinical development costs and is focused on global rights for its pipeline products [10][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue targets and highlighted strong execution across all business dimensions [5][37] - The company is well-positioned to continue scientific leadership in TREG depletion and is excited about the potential of its pipeline assets [9][18] Other Important Information - The company has transitioned to focus solely on novel oncology after exiting the biosimilar business, using divestiture proceeds to pay off near-term debts [33][34] - The clinical program for CHS-114 is designed to explore its utility across multiple tumor types, with a focus on colorectal cancer and other solid tumors [22][80] Q&A Session Summary Question: Potential for bispecific format targeting CCR8 and PD-1 - Management acknowledged the interest in bispecifics but emphasized the challenges in combining mechanisms and suggested traditional combination therapy may yield stronger clinical responses [40][44] Question: Trajectory and inflection points for LOQTORZI - Management indicated that with a consistent growth rate of 10%-15% per quarter, the company could reach its sales target of $150 million-$200 million earlier than mid-2028, emphasizing the importance of physician education [47][50] Question: Expectations for colorectal cancer study benchmarks - Management highlighted the need to exceed current response rates in the fourth-line setting and emphasized the importance of durability and disease stability in evaluating outcomes [51][53] Question: Justification for moving to pivotal studies for casdozokitug - Management stated that they would look for solid overall response rates and durability in the upcoming data readouts to justify moving forward with pivotal studies [62][63] Question: Increase in duration of therapy for LOQTORZI - Management noted that duration of therapy is increasing each quarter, although they have not yet reached the average seen in clinical trials [67][69] Question: Expectations around dose optimization data for CHS-114 - Management expressed optimism about the ongoing study and the importance of biopsy data in determining the recommended phase two dose [70][74]

Core Insights - Coherus Oncology is focused on enhancing the lives of cancer patients and aims to deliver significant improvements in survival rates [4] - The company's growth strategy consists of three distinct components, including existing and upcoming drugs [4] Company Overview - Coherus Oncology is dedicated to developing innovative therapies for cancer treatment [4] - The company is led by a team of experienced executives, including the CEO Dennis Lanfear and Chief Development Officer Theresa Lavallee [2][3] Pipeline and Strategy - The company is advancing its pipeline, which includes LOQTORZI, a next-generation PD-1 therapy [5] - Coherus believes it has the right strategy to drive growth and achieve its objectives in the oncology market [4]

Coherus BioSciences Conference Call Summary Company Overview - **Company**: Coherus BioSciences (NasdaqGM:CHRS) - **Focus**: Enhancing the lives of cancer patients and improving survival rates through innovative therapies [5][6] Pipeline and Strategy - **Key Products**: - **LOQTORZI**: Next-generation PD-1 inhibitor - **CHS-114**: Anti-CCR8 antibody T-reg depletor - **Casdozokitug**: Anti-IL-27 antibody - **Development Programs**: - Data expected around mid-2026 for CHS-114 in various cancers including head and neck, gastric, esophageal, and colorectal [6][12] - Active in liver cancer with casdozokitug, showing promising results [6][12] - **Partnerships**: Seeking ex-US partners for pipeline validation and monetary support [6][12] Market Dynamics - **LOQTORZI**: - Approved for frontline and second-line nasopharyngeal carcinoma - Generated approximately $10 million in revenue last quarter, with expectations of substantial market growth [11][12] - Anticipated peak sales between $150 million and $200 million by mid-2028, with a growth rate of 10% to 15% per quarter [12] - **Market Size**: The nasopharyngeal market is estimated at $250 million [12] Competitive Advantages - **LOQTORZI**: - Higher binding affinity (>10x) compared to other PD-1 inhibitors, with unique epitope binding [9][10] - Approved irrespective of PD-L1 status, unlike competitors [9][10] - **CHS-114**: - Selective targeting of CCR8, a key marker in regulatory T cells, with a mechanism that enhances immune response [19][20] - Potential to be a best-in-class asset in immuno-oncology [22][30] Clinical Data and Expectations - **CHS-114**: - Ongoing studies in head and neck cancer, gastric cancer, and esophageal squamous cell carcinoma [25][26] - Early data shows promise with partial responses in late-line patients [24] - **Casdozokitug**: - Demonstrated a 38% overall response rate and a 17% complete response rate in combination with atezolizumab and bevacizumab for hepatocellular carcinoma [39] - Ongoing study with LOQTORZI, aiming to further characterize efficacy and safety [40] Future Outlook - **Data Readouts**: Anticipated results for various studies in mid-2026, with a focus on combination therapies and their contributions to overall efficacy [32][40] - **Strategic Positioning**: Coherus aims to leverage its unique product offerings and partnerships to drive growth and improve patient outcomes [45] Conclusion - Coherus BioSciences is positioned uniquely in the oncology space with a strong pipeline and strategic focus on combination therapies, aiming to deliver significant advancements in cancer treatment and patient survival [45]

Coherus BioSciences FY Conference Summary Company Overview - Coherus BioSciences has transitioned from a biosimilar company to a full immuno-oncology (IO) company, divesting its biosimilar business over the past year and acquiring Surface Oncology in 2023, which added key assets CHS-114 and Casdozokitug to its pipeline [4][6] Core Strategies and Differentiation - The company focuses on combining its PD-1 agent, Toripalimab, with other agents like CHS-114 and Casdozokitug to enhance patient outcomes in various cancers [5][6] - Coherus emphasizes partnerships and collaborations, aiming to validate its platform, generate income, and share costs for pivotal trials [6][7] - The company plans to focus on ex-U.S. partnerships and licensing, with global rights to its assets acquired through recent acquisitions [6][8] Product Performance and Market Position - LOQTORZI, the company's product, has been positioned at the top of NCCN guidelines, leading to a 36% increase in utilization from Q1 to Q2 2025 [12] - The company anticipates reaching $150 to $200 million in revenue by mid-2028, although early adoption may be uneven due to the nature of the patient population [12][13] - 90% of NCCN institutions have ordered LOQTORZI, indicating strong performance in academic centers, while community settings require more educational efforts [14][15] Pipeline Developments - Casdozokitug, an IL-27 antagonist, is in a phase 2 study for first-line HCC, showing promising early responses and safety profiles [16][18] - CHS-114, a CCR8 antibody, is in several phase 1 studies, targeting T-regs in solid tumors, with early data showing immune activation and robust T-reg depletion [22][23] Competitive Landscape and Market Dynamics - The company does not foresee significant impact from the potential loss of exclusivity for Keytruda, as its products are differentiated and will not be directly affected by biosimilars [25][26] - Coherus is positioned to collaborate with other biotechs, especially in underserved tumor types, enhancing its development capabilities [28] Future Milestones - Upcoming milestones include top-line results from the HCC study on Casdozokitug and further progression of CHS-114 in head and neck and gastric cancers [33] - The company expects to pursue transactions to offset development costs and anticipates earnout payments from its partner Accord Healthcare, which has gained significant market share [34]

Core Insights - Coherus Oncology reported a net revenue of $10.0 million for LOQTORZI, marking a 36% increase from Q1 2025, driven by higher patient demand and inventory restocking [1][6][11] - The company has a cash position of $238 million as of Q2 2025, providing a runway through 2026 for ongoing clinical programs [1][22] - Upcoming data readouts for CHS-114 and casdozokitug are expected in the first half of 2026, indicating progress in the oncology pipeline [1][2][7] Financial Performance - LOQTORZI net revenue increased from $7.3 million in Q1 2025 to $10.0 million in Q2 2025, compared to $3.8 million in Q2 2024 [6][11] - Total net revenue from continuing operations was approximately $10.3 million for Q2 2025, consistent with Q2 2024 [11] - The net loss from continuing operations for Q2 2025 was $44.9 million, a reduction from a net loss of $54.9 million in Q2 2024 [16] Pipeline Development - CHS-114, a cytolytic CCR8 antibody, is in Phase 1b studies, with initial data readouts expected in 1H 2026 [2][7] - Casdozokitug, an IL-27 antagonist, is being evaluated in multiple studies, with a focus on solid tumors [5][25] - The combination of LOQTORZI with internal pipeline candidates is aimed at expanding treatment indications [4][24] Recent Business Highlights - The divestiture of UDENYCA was completed in April 2025, generating $483.4 million in cash, which has been used to pay off significant financial obligations [9][10] - The company is focusing on maximizing LOQTORZI's potential in nasopharyngeal carcinoma, supported by a recent revision in NCCN guidelines granting it preferred status [6][24] Cash Position and Financial Obligations - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled $237.6 million, up from $126.0 million at the end of 2024 [22][33] - The company has settled a majority of UDENYCA-related obligations, which are expected to be resolved in a front-loaded manner over the remainder of 2025 and into 2026 [22]

Core Insights - Coherus BioSciences has completed its strategic transformation to focus on innovative oncology, particularly through the commercialization of LOQTORZI and the advancement of its immuno-oncology pipeline [1][2] Recent Business Highlights - The divestiture of UDENYCA in April 2025 allows Coherus to concentrate on its oncology portfolio, with LOQTORZI revenues expected to be maximized [2] - LOQTORZI net revenue for Q1 2025 was $7.3 million, with patient demand increasing over 15% compared to Q4 2024 [5][9] - The National Comprehensive Cancer Network (NCCN) has designated LOQTORZI as the only treatment with Preferred status for nasopharyngeal carcinoma (NPC) [5] Financial Performance - Net revenue from continuing operations for Q1 2025 was $7.6 million, up from $2.3 million in Q1 2024, primarily due to higher LOQTORZI sales [9] - Research and development expenses decreased to $24.4 million in Q1 2025 from $28.4 million in Q1 2024, attributed to reduced co-development costs and personnel savings [11] - The company reported a net loss from continuing operations of $47.4 million, or $(0.41) per share, compared to a loss of $68.0 million, or $(0.60) per share, in the same period last year [15][16] Pipeline Development - Coherus is advancing its next-generation immuno-oncology pipeline, including CHS-114, which is currently in Phase 1 clinical trials [4][12] - Promising early clinical data for CHS-114 was presented at the AACR Annual Meeting, showing potential for treating various solid tumors [12] - Enrollment is ongoing for a Phase 2 trial of casdozokitug in combination with toripalimab and bevacizumab for first-line hepatocellular carcinoma (HCC), with data readout expected in 1H 2026 [4][12] Cash Position - As of March 31, 2025, cash and cash equivalents totaled $82.4 million, down from $126.0 million at the end of 2024 [18] - The company received an upfront payment of $483.4 million from the divestiture of the UDENYCA franchise, which will be reflected in Q2 2025 financials [18]

Core Insights - Coherus BioSciences has completed its strategic transformation to focus on innovative oncology, with significant advancements in its product pipeline and financial performance [1][3][24] Recent Business Highlights - The company reported positive Phase 1b data for CHS-114, an anti-CCR8 antibody, at the 2025 AACR Annual Meeting, indicating potential for treating various solid tumors [1][3] - LOQTORZI, a next-generation PD-1 inhibitor, generated net revenues of $7.3 million in Q1 2025, with patient demand increasing over 15% compared to Q4 2024 [5][11] - The divestiture of UDENYCA was completed in April 2025, allowing the company to concentrate on its oncology portfolio [3][10] Financial Performance - Net revenue from continuing operations for Q1 2025 was $7.6 million, up from $2.3 million in Q1 2024, primarily driven by higher LOQTORZI sales [11] - The company reported a net loss from continuing operations of $47.4 million, or $(0.41) per share, compared to a loss of $68.0 million, or $(0.60) per share, in the same period last year [17][18] - Cash and cash equivalents decreased to $82.4 million as of March 31, 2025, down from $126.0 million at the end of 2024 [20] Pipeline Development - Ongoing studies for CHS-114 include Phase 1b trials in second-line gastric cancer and head and neck squamous cell carcinoma (HNSCC), with data readouts expected in 2026 [1][13] - Enrollment is ongoing in a Phase 2 trial of casdozokitug in combination with toripalimab and bevacizumab for first-line hepatocellular carcinoma (HCC), with initial data expected in the first half of 2026 [1][13] Strategic Focus - The company aims to maximize LOQTORZI revenues and advance its immuno-oncology candidates, including CHS-114 and casdozokitug, through strategic partnerships and label expansions [3][6][24] - Coherus is positioned to leverage its innovative oncology pipeline to enhance treatment options for cancer patients and drive future growth [3][25]