Coherus Oncology Conference Call Summary Company Overview - Coherus Oncology transitioned to being solely an innovative oncology company after divesting its biosimilar business in Q2 2025, marking Q3 2025 as its first quarter focused exclusively on oncology [6][13] - The company reported $198 million in cash on its balance sheet at the end of Q3 2025, indicating strong financial management [13] Pipeline Programs Toripalimab (LOQTORZI) - Toripalimab is a next-generation PD-1 inhibitor with unique binding sites, demonstrating activity in low PD-L1 states [7] - Approved for front-line and second-line nasopharyngeal carcinoma in 2023, generating $11 million in revenue in Q3 2025, a 12% increase from Q2 2025 [17][19] - The drug has shown a strong hazard ratio, extending survival from 22 months to over 48 months in nasopharyngeal cancer patients [18] - The company aims for 10-15% revenue growth, targeting $150-$200 million by 2028 [20] - Adoption is strong among academic physicians, but community physicians require more education about the drug [21][22] - Combination strategies with other therapeutics are being explored to enhance treatment efficacy [15][16] CHS-114 (CCR8 Targeting) - CHS-114 is a highly selective molecule targeting CCR8, which plays a significant role in Treg cells within the tumor microenvironment [26][28] - The drug is designed to deplete Tregs, potentially allowing CD8 positive T cells to infiltrate tumors, which is crucial for effective immunotherapy [30][34] - The clinical program is strategically designed to evaluate efficacy across various cancers, including head and neck, gastric, and colorectal cancers [32][35] - The company is optimistic about the potential for CHS-114 to show significant activity in underserved tumor types [32] Casdozokitug - Casdozokitug is an anti-IL-27 molecule showing promising efficacy in liver cancer, with a focus on improving overall response rates and progression-free survival [50][51] - The company anticipates data from ongoing studies in the first half of 2026, which will inform the design of future phase two and three trials [47][48] Strategic Partnerships and Deals - Coherus has global rights to its products, allowing for flexibility in forming partnerships, particularly in Asian markets for liver cancer treatments [12][53] - The company is open to collaborations with other biotech firms to enhance the development of its products [40][41] - Upcoming deals are expected to validate the value of its assets and provide upfront funding to offset clinical costs [53][54] Key Catalysts and Future Outlook - The company is focused on delivering data in 2026 that will support the advancement of its pipeline products [34][46] - Coherus is positioned to leverage its scientific leadership and partnerships to enhance patient outcomes and drive growth [45][46] - The next 12-18 months are expected to be pivotal for the company, with significant updates anticipated from ongoing studies and potential partnerships [52][55]

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]

Core Viewpoint - Junshi Biosciences has received FDA approval for its investigational new drug application for JS207, a bispecific antibody targeting PD-1 and VEGF, aimed at treating resectable non-small cell lung cancer (NSCLC) in a phase 2/3 clinical study [1][3][4] Industry Overview - Lung cancer is the most prevalent and deadly malignant tumor globally, with approximately 2.48 million new cases and 1.82 million deaths reported in 2022 [2] - Non-small cell lung cancer (NSCLC) accounts for about 85% of lung cancer cases, with 20%-25% being surgically resectable at diagnosis; however, 30%-55% of these patients experience recurrence post-surgery [2] Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery and commercialization of novel therapies, with over 50 drug candidates in its R&D pipeline [8][9] - The company has five therapeutic focus areas, including cancer, and has received approvals for five products in China and international markets, including toripalimab, China's first domestically produced anti-PD-1 monoclonal antibody [8] Product Details - JS207 is a recombinant humanized anti-PD-1/VEGF bispecific antibody developed by Junshi Biosciences, currently approved for phase 2/3 clinical studies and being explored in various cancers [5][6] - The drug can bind to PD-1 and VEGFA, blocking their interactions and improving the tumor microenvironment, which enhances anti-tumor activity [6][7] Clinical Study Insights - The phase 2/3 clinical study is an open-label, two-arm, randomized, active-controlled trial comparing JS207 to nivolumab for neoadjuvant treatment in patients with stage II/III, resectable, AGA-negative NSCLC [3][4] - Professor Yilong WU from Guangdong Provincial People's Hospital will lead the study as the principal investigator [3]

Core Viewpoint - Junshi Biosciences has received FDA approval for the IND application of JS207, a bispecific antibody targeting PD-1 and VEGF, for a phase 2/3 clinical study in patients with resectable NSCLC [1][4]. Industry Overview - Lung cancer is the most prevalent and deadly malignant tumor globally, with approximately 2.48 million new cases and 1.82 million deaths reported in 2022. NSCLC accounts for about 85% of lung cancer cases, with 20%-25% being surgically resectable at diagnosis. Despite surgical treatment, 30%-55% of patients experience recurrence and death [2]. Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery and commercialization of novel therapies. The company has over 50 drug candidates in its R&D pipeline, with five products approved in China and international markets, including toripalimab, China's first domestically produced anti-PD-1 monoclonal antibody [8][9]. Product Details - JS207 is a recombinant humanized anti-PD-1/VEGF bispecific antibody developed by Junshi Biosciences for advanced malignant tumors. It is currently approved for phase 2/3 clinical studies and is being explored in combination with other therapies for various cancers, including NSCLC and triple-negative breast cancer [5][6]. Clinical Study Design - The phase 2/3 clinical study is an open-label, two-arm, randomized, active-controlled trial comparing the efficacy and safety of JS207 to nivolumab for neoadjuvant treatment in stage II/III, resectable, AGA-negative NSCLC. This study is significant as JS207 is the first PD-1/VEGF dual-target drug approved for such a study [3][4]. Mechanism of Action - JS207 binds simultaneously to PD-1 and VEGFA, blocking their interactions and enhancing anti-tumor activity. It combines the effects of immunotherapeutic and anti-angiogenic drugs, improving the tumor microenvironment and increasing cytotoxic T lymphocyte infiltration [6][7].

Core Insights - HUTCHMED will present new and updated data from several studies at the ESMO Congress 2025, scheduled for October 17-21, 2025, in Berlin, Germany [1][2] Group 1: Study Presentations - Results from the FRUSICA-2 study on the combination of fruquintinib and sintilimab for second-line treatment of advanced renal cell carcinoma will be presented in a Mini Oral session [2] - Additional analyses from the FRUSICA-1 study in endometrial cancer and the SACHI and SAVANNAH studies in non-small cell lung cancer will be showcased during poster sessions [2] - Specific presentations include a phase 3 study comparing fruquintinib plus sintilimab against axitinib or everolimus for renal cell carcinoma [2] Group 2: Drug Information - Fruquintinib is a selective oral inhibitor of VEGFRs and is co-developed by HUTCHMED and Eli Lilly, marketed as ELUNATE® in China [4] - Savolitinib is a selective MET tyrosine kinase inhibitor developed by AstraZeneca and HUTCHMED, commercialized as ORPATHYS® [5] - Surufatinib is an oral angio-immuno kinase inhibitor marketed in China as SULANDA® and retains all rights with HUTCHMED [8]

Company Overview - Junshi Biosciences is a leading innovation-driven biopharmaceutical company focused on the discovery, development, and commercialization of novel therapies [1][8] - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas: cancer, autoimmune, metabolic, neurological, and infectious diseases [8] - Junshi Biosciences has received approvals for five products in China and international markets, including toripalimab, the first domestically produced anti-PD-1 monoclonal antibody in China [8] Product Development - The recombinant humanized anti-IL-17A monoclonal antibody, JS005, has shown positive results in a Phase 3 clinical study for treating moderate to severe plaque psoriasis [1][3] - The study met both co-primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful improvements compared to the placebo group [1][4] - JS005 is designed to block IL-17A, a cytokine involved in autoimmune diseases, thereby alleviating symptoms of conditions like psoriasis [6] Clinical Study Insights - The Phase 3 study was conducted at 60 clinical sites across China, led by Professor Jianzhong ZHANG from Peking University People's Hospital [3] - Results indicated that a higher proportion of participants achieved a sPGA score of 0 or 1 with JS005 compared to the placebo, along with good safety profiles [4][5] - The study results will be presented at future international academic conferences, highlighting the significance of JS005 in psoriasis treatment [4] Market Context - Psoriasis affects approximately 125 million people globally, with a prevalence of 2.0% to 3.0% worldwide and 0.47% in China [2] - Patients with moderate to severe psoriasis face increased risks of metabolic syndrome, cardiovascular disease, and mental health issues, underscoring the need for effective treatments [2] - The successful Phase 3 study of JS005 represents a significant milestone in addressing the treatment gap for patients suffering from this chronic condition [5]

Core Insights - TREOS Bio Ltd. has entered into clinical collaboration agreements with Charité – Universitätsmedizin Berlin and Junshi Biosciences to initiate the OBERTO-202 Phase II clinical trial, evaluating PolyPEPI1018 in combination with toripalimab for treating microsatellite stable metastatic colorectal cancer [1][2] - The company has successfully completed a $2.1 million bridge financing, raising the total financing to $47 million, excluding non-dilutive support [1] Company Overview - TREOS Bio is a clinical-stage biotechnology company focused on developing precision cancer immunotherapies using its proprietary PASCal platform [5] - The lead program, PolyPEPI1018, is designed to target shared tumor antigens and has shown clinical activity in advanced microsatellite stable colorectal cancer [5] Clinical Trial Details - The OBERTO-202 study will be conducted at Charité – Universitätsmedizin Berlin, involving 14 leading academic hospitals and approximately 140 patients with relapsed/refractory microsatellite stable colorectal cancer [2] - The trial will compare the combination of PolyPEPI1018 and toripalimab with standard care (Lonsurf + Avastin) against standard care alone [2] Market Context - Microsatellite stable colorectal cancer accounts for about 85% of all colorectal cancer cases, affecting an estimated 130,000 new patients annually in the US and over 1.6 million globally [4] - Current immunotherapies have shown limited efficacy in this patient population, indicating a significant unmet medical need [4] Leadership Insights - The collaboration with Charité Berlin and Junshi Biosciences is viewed as a significant milestone in demonstrating the potential of TREOS Bio's precision immunotherapy approach [3] - The randomized controlled trial is seen as a logical next step in the development of PolyPEPI1018, aiming to overcome resistance to immunotherapies in microsatellite stable colorectal cancer [3]

Core Viewpoint - Junshi Biosciences announced the acceptance of a supplemental new drug application for toripalimab in combination with disitamab vedotin for treating HER2-expressing locally advanced or metastatic urothelial carcinoma, marking toripalimab's 13th marketing application in mainland China [1] Group 1: Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company focused on discovering, developing, and commercializing novel therapies, with a diversified R&D pipeline of over 50 drug candidates [11] - The company has five therapeutic focus areas: cancer, autoimmune, metabolic, neurological, and infectious diseases, and has received approvals for five products in China and international markets [11] - Toripalimab is China's first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in 40 countries and regions, including China, the US, and Europe [11][10] Group 2: Industry Context - Urothelial carcinoma (UC) is one of the ten most prevalent malignant tumors globally, with rising incidence and mortality rates in China; in 2022, there were 92,900 new cases and over 40,000 deaths [2] - The treatment landscape for advanced UC has been reshaped by the emergence of PD-(L)1 monoclonal antibodies and novel antibody-drug conjugates (ADCs), offering significant improvements in survival benefits and tolerability compared to conventional chemotherapy [3] - The RC48-C016 study demonstrated that toripalimab combined with disitamab vedotin significantly improved progression-free survival (PFS) and overall survival (OS) compared to traditional chemotherapy regimens [5][4]

Core Viewpoint - Junshi Biosciences has received approval from the National Medical Products Administration (NMPA) for two supplemental new drug applications for ongericimab, marking it as China's first domestic PCSK9-targeted drug approved for statin-intolerant patients [1][10]. Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery, development, and commercialization of novel therapies [13]. - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas, including cancer, autoimmune, metabolic, neurological, and infectious diseases [13]. - Junshi Biosciences has received approvals for five products in China and international markets, including toripalimab, China's first domestically produced anti-PD-1 monoclonal antibody [13]. Product Details - Ongericimab is a recombinant humanized anti-PCSK9 monoclonal antibody injection, approved for three indications in China: 1) adult patients with primary hypercholesterolemia (non-familial) and mixed dyslipidemia; 2) adult patients with heterozygous familial hypercholesterolemia (HeFH); 3) statin-intolerant patients with non-familial hypercholesterolemia and mixed dyslipidemia [11]. - The approved specifications for ongericimab are 150 mg (1 ml) in a single dose, available in pre-filled syringes and autosyringes [11]. Clinical Trials - The approval of ongericimab is based on two registered clinical trials: JS002-005 and JS002-007 [6]. - JS002-005 involved 135 patients with HeFH and demonstrated significant LDL-C reductions of 69.4% and 80.6% compared to placebo [8]. - JS002-007 is focused on statin-intolerant patients with primary hypercholesterolemia and mixed dyslipidemia, with results to be published soon [9]. Market Context - Cardiovascular disease is the leading cause of death in China, with atherosclerotic cardiovascular disease (ASCVD) being the predominant subtype [2]. - Lowering LDL-C levels is crucial for reducing the incidence of ASCVD and associated mortality [2]. - Approximately 9.1% of patients exhibit statin intolerance, which is more prevalent in Asian populations, leading to suboptimal LDL-C levels and increased cardiovascular risk [4].