Coherus Oncology Conference Summary Company Overview - **Company**: Coherus Oncology (NasdaqGM:CHRS) - **Focus**: Transitioned from a biosimilar company to a commercial-stage innovative oncology company with a focus on immuno-oncology pipeline, particularly PD-1 inhibitors and novel therapies [3][4][5] Key Products and Pipeline - **Toripalimab**: FDA-approved next-generation PD-1 inhibitor, cornerstone of the oncology pipeline [4][5] - **Casdozokitug**: First-in-class anti-IL27 therapy showing promise in liver cancer and other tumor types [11][12] - **Tagmukitug**: Cytolytic antibody targeting CCR8, showing potential in various solid tumors [53][54] Clinical Data and Efficacy - **Casdozokitug**: - Phase 1 trial showed manageable safety profile with no dose-limiting toxicities (DLTs) [16] - Monotherapy activity observed in squamous non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC) [17] - In combination with Atizo and Bev for hepatocellular carcinoma (HCC), showed an overall response rate (ORR) of 38% and a complete response (CR) rate of 17%, compared to historical controls of 30% and 8% respectively [20][21] - Responses observed irrespective of viral etiology, indicating broad applicability [22] - **Tagmukitug**: - Demonstrated ability to deplete CCR8-positive T regulatory cells in tumors, leading to increased CD8 T cell activity [56] - Early data from head and neck cancer patients showed promising responses in heavily pre-treated individuals [62] Safety and Tolerability - **Casdozokitug**: Safety profile encouraging, with no significant increase in immune-related adverse events compared to standard treatments [26][27] - **Tagmukitug**: Selective targeting of CCR8 with a favorable safety profile, avoiding off-target toxicity seen in other CCR8 programs [58][59] Market Position and Future Outlook - **Market Strategy**: Coherus aims to leverage its innovative pipeline to establish a strong position in the oncology market, focusing on underserved patient populations [5][9] - **Upcoming Milestones**: - Initial data for the Casdozokitug triplet combination expected in mid-2026 [47] - Continued development of Tagmukitug across multiple tumor types with data anticipated throughout 2026 [65] Conclusion - Coherus Oncology is positioned for a data-rich 2026 with promising clinical trials and innovative therapies that could significantly impact cancer treatment, particularly in HCC and other solid tumors [71]

Coherus Oncology Conference Call Summary Company Overview - **Company**: Coherus Oncology - **Ticker**: NasdaqGM:CHRS - **Industry**: Oncology Key Points Company Value Proposition - Coherus Oncology's value proposition is summarized as "drugs, data, and deals" [2][28] - The company focuses on innovative oncology treatments, particularly in the PD-1 space with LOQTORZI and emerging therapies like CHS-114 and casdozokitug [2][3] Product Pipeline - **LOQTORZI**: A foundational PD-1 product approved for nasopharyngeal cancer, expected to generate revenue and expand its label with ongoing studies [4][6] - **CHS-114**: A highly selective Treg depleter, recognized as an important therapeutic approach, with studies in colorectal and gastric cancers [3][4][19] - **Casdozokitug**: An anti-IL-27 therapy being developed for liver and lung cancers, showing promising early data [3][21] Market Potential - The combined pipeline addresses a market opportunity of approximately **$30 billion** in the U.S. across multiple cancer indications [6] - LOQTORZI is projected to reach a revenue range of **$150-$200 million** by mid-2028, with a growth rate of **10%-15%** in recent quarters [9][10] Clinical Studies and Data - Ongoing studies for CHS-114 in colorectal and gastric cancers, with data expected in **2026** [5][19] - Casdozokitug has shown a **60%** tumor shrinkage rate and a **38%** overall response rate in initial studies, significantly outperforming standard care [24] Strategic Partnerships and Licensing - Coherus has a strong track record of divesting biosimilar assets, raising nearly **$800 million** and paying off **$480 million** in debt [25][26] - The company is focused on collaborations to enhance patient survival through combination therapies, leveraging its PD-1 and other products with partners [26][27] Scientific Innovations - LOQTORZI's mechanism involves high-affinity binding at the FG loop, leading to significant T cell signaling advantages [8] - CHS-114 targets CCR8 on Treg cells in the tumor microenvironment, aiming to enhance immune response against tumors [11][14] Future Outlook - Coherus is optimistic about the outcomes of ongoing studies and the potential for expanding its pipeline into additional cancer types [20][28] - The company is actively seeking to validate its pipeline through partnerships and collaborations, which will also help offset clinical trial costs [27][28] Additional Insights - The company emphasizes the importance of Treg depletion in treating "cold" tumors, which represent **70%** of certain cancer types [12][19] - The strategic acquisition of Surface Oncology for **$65 million** has positioned Coherus for innovative oncology advancements [26] This summary encapsulates the key insights from the Coherus Oncology conference call, highlighting the company's strategic direction, product pipeline, market potential, and scientific innovations.

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]