CHS-114 Overview - CHS-114 is a highly selective anti-CCR8 mAb with the potential to augment I-O therapy by depleting Treg-mediated tumor immune suppression[16] - CHS-114 specifically binds and preferentially depletes CCR8+ tumor Tregs, with no off-target binding[17,23] - Preclinical data shows that anti-CCR8 with anti-PD-1 treatment demonstrates antitumor activity and a significant increase in tumoral CD8+ T cells[27,29] - *In vitro* data shows CHS-114 demonstrates dose-dependent Treg depletion and activation of NK and myeloid cells[37] Clinical Trial Design and Results - The Phase 1/1b study is an open-label single-agent and combination dose trial evaluating CHS-114 in patients with advanced solid tumors and HNSCC, with safety and tolerability as the primary endpoint[50,63] - In the monotherapy dose escalation (Stage 1a), 20 patients with advanced solid tumors were enrolled and evaluated seven dose levels (5 mg – 1200 mg) of CHS-114[54] - In HNSCC patients, treatment-emergent adverse events (TEAE) were observed in 85.7% of patients receiving CHS-114 monotherapy (n=14) and 100% of patients receiving CHS-114 + Toripalimab (n=7)[68] - One heavily pretreated PD-1 refractory patient with HNSCC treated with CHS-114 (DL6) + Toripalimab achieved a confirmed partial response with a 40% reduction in target lesions[73,88] Biomarker Analysis and Conclusions - CHS-114 administration leads to a substantial increase in CD8+ T cells in the TME, providing a strong rationale for combining with other drugs such as T cell engagers and bispecifics[102] - In on-treatment tumor biopsies, CHS-114 depleted CCR8+ Tregs and increased CD8+ T cells in the TME, indicating favorable TME remodeling and establishing proof of mechanism[102]

Coherus BioSciences (CHRS) Conference Call Summary Company Overview - **Company**: Coherus BioSciences - **Event**: Jefferies Global Healthcare Conference - **Date**: June 04, 2025 Key Industry Insights - **Focus Areas**: Coherus Oncology is concentrating on three main areas: - Lactorsi (proprietary PD-1 asset) for nasopharyngeal cancer - CHS-114 (anti-CCR8 cytolytic antibody) - Casdozo ketog (IL-27 antagonist) [4][6][40] Core Product Highlights - **Lactorsi**: - Launched in 2024, it is the only preferred treatment for both first-line and follow-on lines in nasopharyngeal cancer - Expected revenue of $40 to $50 million in 2025 [12][40] - Targets a market of approximately $150 to $200 million annually [11] - Demonstrated a 15% increase in overall demand from the previous quarter [12] - **CHS-114**: - Targets T regulatory cells, aiming to selectively deplete them in tumors to enhance immune response - High expression of CCR8 in various solid tumors, including head and neck, gastric, and colorectal cancers [18][23] - Anticipated data readouts in the first half of 2026 [6][8] - **Casdozo ketog**: - First-in-class IL-27 antagonist showing promise in liver cancer with a 38% overall response rate and a 17% complete response rate [33][36] - Expected to enter a global study comparing it with standard care [35] Financial Overview - **Debt Reduction**: Successfully reduced debt to approximately $38.7 million annually after divesting $800 million worth of assets [7][42] - **Cash Position**: Ended Q1 2025 with $82 million in cash, bolstered by a $250 million increase post-divestiture [42][44] - **Cost Management**: Plans to reduce workforce from 225 to about 50 employees, yielding $25 million in savings [42] Strategic Partnerships and Market Opportunities - **Partnerships**: Actively seeking partners for ex-US licensing of pipeline assets [40][41] - **Market Potential**: Combined market opportunity for pipeline assets exceeds $15 billion [6][40] Additional Insights - **Mechanistic Differentiation**: Lactorsi's unique binding mechanism allows for internalization of the PD-1 receptor, enhancing T cell signaling, particularly in low PD-L1 states [9][10][43] - **Clinical Development**: Robust clinical programs with expected results in 2026, focusing on large indications with multibillion-dollar market potential [43][44] - **Regulatory Engagement**: Positive alignment with the FDA regarding the development approach for CHS-114 and Casdozo ketog [28][41] This summary encapsulates the critical points discussed during the conference call, highlighting the strategic direction, product pipeline, financial health, and market opportunities for Coherus BioSciences.

Core Viewpoint - Coherus Oncology has rebranded itself to emphasize its commitment to innovative immuno-oncology therapies, focusing on combination therapies to enhance cancer treatment outcomes [1][2]. Company Overview - Coherus Oncology is a commercial-stage innovative oncology company with a focus on proprietary immuno-oncology medicines [1][10]. - The company has an approved next-generation PD-1 inhibitor, LOQTORZI, which is the only FDA-approved treatment for recurrent or metastatic nasopharyngeal carcinoma in combination with chemotherapy [5][10]. Pipeline and Development - Coherus is developing a portfolio of novel combination therapies aimed at overcoming immune resistance to existing treatments [4]. - LOQTORZI serves as the foundation of the company's immuno-oncology franchise, with ongoing development for additional tumor types [5][10]. - CHS-114, a selective cytolytic CCR8 antibody, is in Phase 1b studies in combination with toripalimab for advanced solid tumors [6]. - Casdozokitug, an IL-27 antagonist, is being evaluated in a randomized Phase 2 study for advanced metastatic hepatocellular carcinoma [7]. Scientific Expertise - The company is supported by a world-class team with deep expertise in oncology drug development, including members from prestigious institutions and companies [8]. - The Scientific Advisory Board includes experts in Treg immunology and cytokine biology, providing valuable insights for navigating the oncology landscape [8].

Coherus BioSciences (CHRS) FY Conference Summary Company Overview - Coherus BioSciences has transitioned into an innovative oncology company, divesting its biosimilar assets, including Lucentis, Yosemir, and UDENYCA, generating approximately $800 million in total from these divestitures [3][4] - The company has paid off $480 million in long-term debt and added $250 million to its balance sheet [3] Key Developments Loktorzi - Loktorzi is a central asset in Coherus' strategy, with ongoing pivotal trials for additional indications [4][5] - The launch for nasopharyngeal carcinoma (NPC) showed good growth in Q4, but Q1 was flat due to supply interruptions and sales team distractions [10][11] - The focus is on increasing the breadth of physician prescriptions, depth of market penetration, and ensuring patient duration on the product [12][13] Partnerships and Clinical Studies - Coherus announced a partnership for combination studies with STC 15 from Storm Therapeutics, targeting RNA methyltransferase activity, which has shown promise in solid tumors [16][17] - The goal is to drive label expansion for Torapalumab, a next-generation PD-1 inhibitor, through these partnerships [20][21] CHS 1 114 (Treg Depleter) - CHS 1 114 targets CCR8 to selectively deplete tumor-resident Tregs, showing promising early clinical data with significant Treg depletion and CD8 T cell infiltration [23][25][26] - The combination with Torapalumab in late-line head and neck cancer patients has shown early signs of activity, with ongoing studies to evaluate its efficacy further [27][28] Casdozoketug - Casdozoketug is an IL-27 antagonist showing promising results in liver cancer, with a 17% complete response rate in early studies, which is significantly higher than reported rates in phase three studies [41][42] - The company is planning to progress with studies in both liver and lung cancers, with data expected next year [44][46] Financial and Strategic Outlook - Coherus is focused on execution and leveraging its strong track record in development, regulatory affairs, and commercial success [48][49] - The company anticipates promising results from ongoing clinical trials and partnerships, positioning itself for growth in the oncology market [8][49] Additional Insights - The company is actively exploring other tumor types for CHS 1 114, indicating a broadening of its clinical focus [29] - The strategic emphasis on enhancing the commercial story and execution capabilities is expected to drive future success [48][49]

Core Insights - Coherus BioSciences has initiated a Phase 1b/2 clinical study to evaluate STC-15, a METTL3 inhibitor, in combination with LOQTORZI, a next-generation PD-1 inhibitor, targeting various cancers including non-small cell lung cancer (NSCLC) and melanoma [1][2] Company Overview - Coherus is a commercial-stage oncology company with an approved PD-1 inhibitor, LOQTORZI, and a pipeline that includes mid-stage candidates for liver, lung, and head & neck cancers [3] - The company aims to expand LOQTORZI's indications beyond nasopharyngeal carcinoma through strategic collaborations and cost-efficient drug supply agreements [2][3] Clinical Study Details - The Phase 1b/2 study will assess the safety and efficacy of the STC-15 and LOQTORZI combination, with up to 188 patients enrolled in the United States [2] - STORM Therapeutics is the sponsor of the trial, while Coherus will supply LOQTORZI, retaining commercial rights for both compounds [2] Immuno-Oncology Pipeline - Coherus' pipeline includes multiple antibody immunotherapy candidates designed to enhance immune responses against tumors [4] - Notable candidates include Casdozokitug, an IL-27 antagonistic antibody, and CHS-114, a selective anti-CCR8 antibody, both in various stages of clinical trials [4]

Financial Data and Key Metrics Changes - The company has transitioned from a biosimilars focus to an innovative immuno-oncology (IO) company, indicating a significant strategic shift [1] - The launch of Lactorsi as a preferred therapy in NCCN guidelines is a notable development, with the team reportedly hitting their stride in Q2 after overcoming earlier disruptions [33] Business Line Data and Key Metrics Changes - The company presented encouraging data for its CCRA antibody, CHS 114, showing a partial response in a patient with advanced refractory disease, highlighting the potential of targeted therapies [2][5] - The combination of CHS 114 with toripalumab has shown marked depletion of T regulatory cells, leading to significant immune cell infiltration, which is a positive indicator for its efficacy [10][11] Market Data and Key Metrics Changes - The company is aware of the looming loss of exclusivity (LOE) for Keytruda in 2028 and is strategically positioning Lactorsi to differentiate itself in the market [15][16] - The competitive landscape is evolving, with the company focusing on novel mechanisms and combinations that could provide advantages over existing PD-1 therapies [17][29] Company Strategy and Development Direction - The company aims to develop both CHS 114 and casdosakitug in combination with toripalumab, seeking to maximize the potential of its pipeline [17][24] - The strategy includes forming partnerships that focus on novel mechanisms of action while maintaining a capital-efficient approach [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical data flow and the potential for upcoming collaborations, particularly in liver cancer, head and neck, and lung cancer [22][24] - The company is excited about the differentiated mechanism of action of Lactorsi, which has shown activity in PD-L1 low patients, setting it apart from competitors [28][30] Other Important Information - The company has divested from its biosimilar business to focus on innovative oncology, which is seen as a space with greater potential for value creation [40][41] - The safety profile of castosakitug has been well tolerated, with promising early results in lung and liver cancers, indicating a strong potential for future studies [36][38] Q&A Session Summary Question: What was encouraging about the data for the CCRA antibody? - The data showed a partial response in a patient with advanced refractory disease, which is significant given the patient's history of treatment failures [2] Question: How does the company view the competition with Keytruda? - The company is aware of the LOE for Keytruda and believes that their differentiated therapies will maintain a competitive edge despite the upcoming biosimilars [15][16] Question: What is the strategy for partnerships moving forward? - The company is focusing on collaborations that will yield interesting clinical data and is prioritizing partnerships that involve novel mechanisms of action [24][22]

Coherus BioSciences (CHRS) came out with a quarterly loss of $0.35 per share versus the Zacks Consensus Estimate of a loss of $0.31. This compares to loss of $0.32 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -12.90%. A quarter ago, it was expected that this drug developer would post a loss of $0.23 per share when it actually produced a loss of $0.28, delivering a surprise of -21.74%.Over the last four quarters, the company ...

Financial Data and Key Metrics Changes - The net loss from discontinued operations for Q1 2025 was $9.2 million compared to a net income of $170.9 million in Q1 2024, primarily due to a $153.6 million gain on the sale of the Similee ophthalmology franchise in March 2024 [49][50] - Revenue for Q1 2025 was flat at $7.3 million, attributed to a seasonal inventory drawdown despite a 15% growth in patient demand [39][40] - Cost of Goods Sold (COGS) from continuing operations increased to $2.7 million from $1.4 million in Q1 2024 due to increased sales of Lactorsi [48] Business Line Data and Key Metrics Changes - Lactorsi is projected to grow to approximately $150 million to $200 million annually over the next three years, providing non-dilutive funding for the development pipeline [10] - The commercial team reported a 15% growth in patient demand for Lactorsi, with an increase in new patient starts and duration of treatment [39][40] Market Data and Key Metrics Changes - The market for nasopharyngeal carcinoma (NPC) is estimated to be valued at $150 million to $200 million, with expectations for Lactorsi to achieve a dominant share [43] - The restructuring of the sales force was completed, and the team is now focused on driving growth in the NPC patient population [38] Company Strategy and Development Direction - The company is focused on innovative oncology, with three core pillars: Torapalumab (Lactorsi), CHS-114 (a selective CCR8 cytolytic antibody), and casdosoketogue (an anti-IL-27 antibody) [7][14] - A key part of the strategy includes partnerships for indication expansion, where the company supplies drugs to partners who fund clinical trials [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to adapt to changes in the FDA and emphasized the importance of strong development expertise [54][57] - The company anticipates that Q2 and Q3 will be times for growth, following the restructuring of the sales force [69] Other Important Information - The company expects to achieve approximately $25 million in annualized savings from lower headcount following the divestiture of UDENYCA [47] - The company has received $483 million in upfront cash from the UDENYCA divestiture and plans to repurchase remaining convertible notes [45] Q&A Session Summary Question: What needs to happen for a significant inflection point for Lactorsi? - Management noted that awareness among providers is increasing, and they expect to see an acceleration in growth following the restructuring of the sales force [53][58] Question: Can you clarify what you meant by patient demand for Lactorsi? - Demand refers to actual patient growth as indicated by clinics purchasing the product from wholesalers, which is distinct from revenue [66][67] Question: Will there still be an impact from the sales force restructure in Q2? - Management believes the impact was primarily in Q1, and they expect Q2 and Q3 to be times for growth [69] Question: Are PD-1s like Keytruda still being used off-label in NPC? - Yes, off-label use of PD-1s is prevalent, especially in community settings, despite NCCN guidelines recommending Lactorsi [73][79] Question: Can you discuss the Type D meeting with the FDA for CHS-114? - The meeting focused on aligning on Project Optimus, and the FDA found the company's approach acceptable [84][86]

Financial Data and Key Metrics Changes - The company reported a revenue of $7.3 million for Q1 2025, which remained flat due to a seasonal inventory drawdown despite a 15% growth in patient demand [38][39] - Cost of Goods Sold (COGS) from continuing operations increased to $2.7 million from $1.4 million in Q1 last year, attributed to increased sales of Lactorsi [47] - Research and Development (R&D) expenses decreased by 14% to $24.4 million, reflecting savings from reduced co-development with Junshi [48] - Selling, General and Administrative (SG&A) expenses decreased by 35% to $26 million, primarily due to lower headcount and non-recurring charges from the previous year [48] Business Line Data and Key Metrics Changes - The company is now focused solely on its innovative oncology business, with Lactorsi being the only FDA-approved treatment for metastatic recurrent locally advanced nasopharyngeal carcinoma [6][8] - Lactorsi is projected to grow to approximately $150 million to $200 million annually over the next three years, providing non-dilutive funding for the development pipeline [8][9] - The commercial team has successfully remapped territories and updated customer assignments post-UDENYCA divestiture, with a focus on driving growth in appropriate NPC patients [37][38] Market Data and Key Metrics Changes - The company noted a significant number of patients still receiving non-preferred chemotherapy and off-label immuno-oncology treatments, indicating a market opportunity for Lactorsi [38] - The NCCN guidelines now place Lactorsi in a preferred position for recurrent and metastatic patients, which the company is actively promoting to healthcare providers [38][41] Company Strategy and Development Direction - The company’s strategy is anchored around three core pillars: Lactorsi, CHS-114 (a selective CCR8 cytolytic antibody), and casdosoketogue (an anti-IL-27 antibody) [6][12][13] - The company aims to expand Lactorsi's indications through partnerships and combination therapies, enhancing its market presence and revenue potential [10][11] - The focus on innovative oncology is expected to drive long-term value for shareholders while addressing significant unmet medical needs in cancer treatment [50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company’s ability to navigate recent FDA changes and emphasized the importance of strong development expertise in adapting to regulatory environments [52][56] - The company anticipates that the restructuring of the sales force will lead to accelerated growth in Q2 and beyond, despite transitional challenges faced in Q1 [60][68] - Management highlighted the promising clinical data for CHS-114 and its potential to address PD-1 resistance, which could significantly impact treatment paradigms in oncology [30][36] Other Important Information - The company completed the divestiture of UDENYCA, receiving $483 million in upfront cash and repurchasing $170 million of convertible notes [43][44] - The net cash from these transactions is expected to provide substantial liquidity for ongoing operations and development initiatives [44] Q&A Session Summary Question: What needs to happen for a significant inflection point for Lactorsi? - Management noted that increased awareness among providers and ongoing clinical trials will be crucial for driving adoption and market share [51][56] Question: Can you clarify patient demand for Lactorsi? - Demand is defined as actual patient growth, with a 15% increase in end-user demand reported, indicating strong physician engagement [65][66] Question: Will the Salesforce restructure impact future projections? - The impact of the restructure was primarily felt in Q1, but management expects Q2 and Q3 to be growth periods for the brand [68] Question: Are there any competitor molecules that have proven the efficacy of CCR8 targeting? - Management indicated that while selectivity is a challenge, there are emerging data points suggesting the relevance of CCR8 targeting in certain tumor types [72][75]

Financial Performance - Net revenue for the three months ended March 31, 2025, was $7.6 million, a significant increase from $2.3 million in the same period of 2024, representing a growth of approximately 229%[13] - The net loss from continuing operations for Q1 2025 was $47.4 million, compared to a loss of $68.0 million in Q1 2024, indicating an improvement of approximately 30%[13] - The company reported a net loss of $56.6 million for Q1 2025, compared to a net income of $102.9 million in Q1 2024, reflecting a significant shift in financial performance[13] - Coherus reported a net loss of $56.569 million for the three months ended March 31, 2025, compared to a net income of $102.875 million for the same period in 2024[18] - The Company reported a basic and diluted net loss per share of $0.49 for the three months ended March 31, 2025, compared to a net income per share of $0.91 for the same period in 2024[108] Expenses and Cost Management - Total costs and expenses decreased to $53.0 million in Q1 2025 from $70.1 million in Q1 2024, a reduction of about 24%[13] - Research and development expenses for Q1 2025 were $24.4 million, down from $28.4 million in Q1 2024, a decrease of about 14%[13] - Selling, general and administrative expenses also decreased to $26.0 million in Q1 2025 from $40.2 million in Q1 2024, a reduction of approximately 35%[13] - Stock-based compensation expense totaled $5,046,000 for the three months ended March 31, 2025, down from $6,816,000 for the same period in 2024[106] Cash and Assets - Cash and cash equivalents decreased to $82.4 million as of March 31, 2025, down from $126.0 million at the end of 2024, a decline of about 35%[12] - Total assets decreased to $371.1 million as of March 31, 2025, from $448.5 million at the end of 2024, a reduction of approximately 17%[12] - The company had cash, cash equivalents, and restricted cash of $82.674 million at the end of March 31, 2025, down from $260.227 million at the end of March 31, 2024[18] - Total current assets were $310.175 million as of March 31, 2025, compared to $341.583 million at December 31, 2024, reflecting a decrease of approximately 9%[12] Liabilities and Deficits - The company has a total stockholders' deficit of $183.5 million as of March 31, 2025, compared to a deficit of $132.0 million at the end of 2024[12] - The company has total liabilities of $554.536 million as of March 31, 2025, slightly down from $580.523 million at December 31, 2024[12] - The total stockholders' deficit increased to $183.470 million as of March 31, 2025, from $131.990 million at the end of December 31, 2024[18] Divestiture and Future Payments - Coherus completed the divestiture of the UDENYCA business to Intas Pharmaceuticals for an upfront cash consideration of $483.4 million, including $118.4 million for product inventory[20] - The company anticipates potential future payments of $37.5 million related to the divestiture of the UDENYCA franchise, contingent on post-closing net sales[7] - The company is eligible for two additional earnout payments of $37.5 million each based on UDENYCA's net sales performance post-divestiture[20] Clinical Development and Pipeline - LOQTORZI was approved by the FDA for the treatment of metastatic or recurrent locally advanced nasopharyngeal carcinoma, with the launch in the U.S. on January 2, 2024[21] - The company is developing casdozokitug, which received orphan drug designation for hepatocellular carcinoma, currently in three ongoing clinical studies[22] - CHS-114, another clinical-stage candidate, is being evaluated in combination with LOQTORZI for advanced solid tumors and head and neck squamous cell carcinoma[25] - Coherus plans to initiate a first-in-human clinical study for CHS-1000, an investigational antibody targeting human ILT4, subject to further evaluation[26] Revenue Recognition and Sales - LOQTORZI generated net product revenue of $7.348 million in the first quarter of 2025, compared to $1.988 million in the first quarter of 2024[48] - McKesson Corporation accounted for 46% of total gross product revenues in Q1 2025, up from 29% in Q1 2024, indicating a shift in customer revenue distribution[48] - The company recognizes revenue from vaccine sales to the U.S. federal government for stockpiling, which allows for revenue recognition even if other criteria are not met[40] Inventory and Reserves - The balance of chargebacks and discounts for prompt payment as of March 31, 2025, was $68.915 million, down from $110.778 million at the end of 2024[51] - The company recorded a total of $216.653 million in reserves for chargebacks, co-pay assistance, and other fees as of March 31, 2025, compared to $275.645 million at the end of 2024[51] - Inventory of continuing operations decreased from $4.2 million as of December 31, 2024, to $3.5 million as of March 31, 2025[60] Debt and Interest Expenses - The 2029 Term Loan, entered on May 8, 2024, has a principal amount of $38.7 million, accruing interest at 8.0% per annum, with interest-only payments until maturity on May 8, 2029[84] - Interest expense on the 2029 Term Loan was $1.3 million for the three months ended March 31, 2025[85] - The company repaid $79.6 million of the 2027 Term Loans on May 8, 2024, which included principal repayment, accrued interest, and a prepayment premium[93] - The company repurchased approximately $170 million of its 2026 Convertible Notes on April 15, 2025, at a cash repurchase price equal to 100% of their principal amount[97] - The annual effective interest rate for the 2026 Convertible Notes is 2.1%, with total interest expense for the three months ended March 31, 2025, amounting to $1,203,000, compared to $1,195,000 for the same period in 2024[98]