University of California, Irvine

-6 Years Long-term survival data reinforce potential benefit to patient survival in treating recurrent or metastatic nasopharyngeal carcinoma with LOQTORZI in combination with chemotherapy -REDWOOD CITY, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Coherus Oncology, Inc. (NASDAQ: CHRS) today announced compelling six-year overall survival (OS) follow-up results from the Phase 3 JUPITER-02 trial evaluating LOQTORZI® (toripalimab-tpzi) plus chemotherapy in recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). The findings reveal a striking and durable survival advantage that underscores the urgent clinical need to incorporate LOQTORZI with chemotherapy as first-line treatment. In this exploratory post-hoc analysis, patients receiving LOQTORZI plus gemcitabine and cisplatin achieved a median OS of 64.8 months, nearly double that of chemotherapy alone (33.7 months), representing a 31-month improvement and an observed 38% reduction in risk of death (HR 0.62; 95% CI, 0.45–0.85). These results, presented at ESMO Asia 2025, signal a step change in cancer patient survival, reinforcing LOQTORZI’s role in transforming outcomes for people living with RM-NPC. JUPITER-02 is a randomized, double-blind, placebo-controlled Phase 3 study evaluating LOQTORZI with chemotherapy in first-line RM-NPC, and this long-term follow-up provides additional context for the previously reported survival outcomes. A Meaningful Shift for Patients Who Need It Most RM-NPC is an aggressive cancer, and long-term survival with standard chemotherapy can be limited for many patients. The multi-year survival observed in the LOQTORZI arm suggests a potential for meaningful clinical benefit, which may translate into longer survival for patients who typically face a challenging prognosis. “The new 6-year overall survival follow up data gives us even greater confidence to use toripalimab in patients with NPC that is recurrent or metastatic,” said Victoria Villaflor, MD, Professor and Director, Head and Neck Oncology Program, Division of Hematology-Oncology, Department of Medicine, UC Irvine School of Medicine. For many patients, the difference between 33 months and nearly 65 months represents the possibility of more time with family and more milestones. This meaningful extension highlights why oncologists may consider adding LOQTORZI to chemotherapy upfront, as delaying or omitting a therapy associated with improved survival outcomes could reduce a patient’s opportunity to achieve longer-term benefit. A Standard of Care Reinforced by Long-Term Evidence “These data suggest a significant long-term overall survival benefit for patients living with RM-NPC,” said Rosh Dias, MD, Chief Medical Officer, Coherus Oncology. “With these long-term data, LOQTORZI, in combination with chemotherapy, reinforces the data supporting this regimen as the standard of care for patients living with RM-NPC.” Coherus Oncology is advancing a pipeline built on deep scientific expertise and strategic collaborations designed to deliver first- and best-in-class therapies. LOQTORZI, Coherus’ next-generation PD-1 inhibitor, is an important part of this vision, with data indicating its potential to enhance survival outcomes when used with chemotherapy. ESMO Asia 2025 Presentation DetailsAbstract # 1279: Long Term Overall Survival Follow-up of Toripalimab versus Placebo in Combination with Gemcitabine and Cisplatin as First-line Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma Date: Friday, December 5, 2025, 5:00 p.m. – 6:30 p.m. PST INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS LOQTORZI® (toripalimab-tpzi) is indicated: In combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC).As a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. IMPORTANT SAFETY INFORMATION Severe and Fatal Immune-Mediated Adverse ReactionsImmune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions. Immune-mediated adverse reactions, which can be severe or fatal, occur in any organ system or tissue, affect more than one body system simultaneously, and occur at any time after starting PD-1/PD-L1 blocking antibody. While immune-mediated adverse reactions usually manifest during treatment, they can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.Withhold or permanently discontinue LOQTORZI based on severity and type of reaction (see Dosage and Administration in Prescribing Information). In general, If LOQTORZI requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated PneumonitisLOQTORZI can cause immune-mediated pneumonitis. In patients receiving LOQTORZI in combination with cisplatin and gemcitabine, immune-mediated pneumonitis occurred in 2.1% (3/146) of patients, including Grade 2 (1.4%) adverse reactions. Pneumonitis resolved in 67% (2/3) of these patients.In patients receiving LOQTORZI monotherapy, immune-mediated pneumonitis occurred in 2.6% (22/851) of patients, including fatal (0.2%), Grade 3 (0.7%), and Grade 2 (1.1%) adverse reactions. Systemic corticosteroids were required in 82% (18/22) of patients with pneumonitis. Pneumonitis led to permanent discontinuation of LOQTORZI in 1.2% (10/851) of patients. Pneumonitis resolved in 23% (5/22) of these patients. Immune-Mediated ColitisLOQTORZI can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving LOQTORZI monotherapy, immune-mediated colitis occurred in 0.4% (3/851) of patients, including Grade 3 (0.2%) and Grade 2 (0.1%) adverse reactions. Colitis resolved in all 3 patients. Hepatotoxicity and Immune-Mediated HepatitisLOQTORZI can cause immune-mediated hepatitis. In patients receiving LOQTORZI in combination with cisplatin and gemcitabine, immune-mediated hepatitis occurred in 0.7% (1/146) of patients, which was a Grade 3 (0.7%) adverse reaction. The patient with immune-mediated hepatitis required systemic corticosteroids.In patients receiving LOQTORZI monotherapy, immune-mediated hepatitis occurred in 3.3% (28/851) of patients, including Grade 4 (0.8%), Grade 3 (2.1%), and Grade 2 (0.4%) adverse reactions. Hepatitis led to permanent discontinuation of LOQTORZI in 1.1% of patients and withholding of LOQTORZI in 0.8% of patients. Hepatitis resolved in 54% (15/28) of these patients. Immune-Mediated EndocrinopathiesAdrenal InsufficiencyLOQTORZI can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold or permanently discontinue LOQTORZI depending on severity. In patients receiving LOQTORZI monotherapy, adrenal insufficiency occurred in 0.5% (4/851) of patients, including Grade 2 (0.4%) and Grade 1 (0.1%) adverse reactions. Systemic corticosteroids were required in 75% (3/4) of the patients with adrenal insufficiency. Adrenal insufficiency led to withholding of LOQTORZI in 0.1% (1/851) of patients. In the one patient in whom LOQTORZI was withheld, LOQTORZI was reinitiated after symptom improvement. HypophysitisLOQTORZI can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effects such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue LOQTORZI depending on severity. In patients receiving LOQTORZI monotherapy, hypophysitis occurred in 0.4% (3/851) of patients receiving LOQTORZI, including Grade 3 (0.2%) and Grade 2 (0.1%) adverse reactions. All three patients received systemic corticosteroids. Hypophysitis led to permanent discontinuation of LOQTORZI in 0.1% (1/851) of patients and withholding of LOQTORZI in 0.1% (1/851) of patients. The one patient in whom LOQTORZI was withheld reinitiated LOQTORZI. Thyroid DisordersLOQTORZI can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue LOQTORZI depending on severity. In patients receiving LOQTORZI in combination with cisplatin and gemcitabine, thyroiditis occurred in 2.1% (3/146) of patients receiving LOQTORZI, including Grade 2 (1.4%). Three patients required thyroid hormone replacement therapy. Thyroiditis resolved in one of the 3 patients. Hyperthyroidism occurred in 1.4% (2/146) of patients receiving LOQTORZI in combination with cisplatin and gemcitabine. Hyperthyroidism resolved in these 2 patients. Hypothyroidism occurred in 30% (44/146) of patients receiving LOQTORZI in combination with cisplatin and gemcitabine, including Grade 2 (24%) and Grade 1 (6%). Eighty percent of the 44 patients required thyroid hormone replacement therapy. LOQTORZI was withheld in 2.1% (3/146) of the patients. Of the 3 patients in whom LOQTORZI was withheld, 2 patients reinitiated LOQTORZI.In patients receiving LOQTORZI monotherapy, thyroiditis occurred in 0.6% (5/851) patients receiving LOQTORZI, including Grade 2 (0.1%). Two of these 5 patients received systemic corticosteroids and 2 required thyroid hormone replacement therapy. Thyroiditis resolved in 2 of the 5 patients. Hyperthyroidism occurred in 7% (55/851) of patients receiving LOQTORZI, including Grade 2 (1.9%). Hyperthyroidism resolved in 85% (47/55) of the patients. Hypothyroidism occurred in 15% (128/851) of patients receiving LOQTORZI, including Grade 2 (8%). Sixty three percent of the 128 patients required thyroid hormone replacement therapy. LOQTORZI was withheld in 0.5% of patients. Of the 4 patients in whom LOQTORZI was withheld, 3 patients reinitiated LOQTORZI. Type 1 Diabetes Mellitus, which can present with Diabetic KetoacidosisMonitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue LOQTORZI depending on severity. In patients receiving LOQTORZI monotherapy, diabetes mellitus occurred in 0.9% (8/851) of patients receiving LOQTORZI, including Grade 4 (0.1%), Grade 3 (0.7%), and Grade 2 (0.1%). Diabetes mellitus led to permanent discontinuation in 0.4% of patients. Six of the 8 (75%) patients with diabetes mellitus required long-term insulin therapy. Immune-Mediated Nephritis with Renal DysfunctionLOQTORZI can cause immune-mediated nephritis. In patients receiving LOQTORZI in combination with cisplatin and gemcitabine, immune-mediated nephritis occurred in 0.7% (1/146) of patients receiving LOQTORZI. The one patient with immune-mediated nephritis (Grade 4) required systemic corticosteroids and nephritis led to discontinuation of LOQTORZI. Nephritis resolved in this patient.In patients receiving LOQTORZI monotherapy, immune-mediated nephritis occurred in 0.5% (4/851) of patients, including Grade 3 (0.5%) adverse reactions. Nephritis resolved in 75% (3/4) of these patients. Immune-Mediated Dermatologic Adverse ReactionsLOQTORZI can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Withhold or permanently discontinue LOQTORZI depending on severity. In patients receiving LOQTORZI in combination with cisplatin and gemcitabine, immune-mediated dermatologic adverse reactions occurred in 8% (12/146) of patients, including Grade 3 (3.4%) and Grade 2 (1.4%) adverse reactions. Systemic corticosteroids were required in 25% (3/12) of the patients with immune-mediated dermatologic adverse reactions. Immune-mediated dermatologic adverse reactions led to permanent discontinuation of LOQTORZI in 2.1% (3) of patients. Immune-mediated dermatologic adverse reactions resolved in 92% (11/12) of these patients.In patients receiving LOQTORZI monotherapy, immune-mediated dermatologic adverse reactions occurred in 4% (34/851) of patients, including Grade 3 (0.4%) and Grade 2 (1.4%) adverse reactions. Immune-mediated dermatologic adverse reactions led to withholding of LOQTORZI in 0.4% (3) of the patients. Systemic corticosteroids were required in 12% (4/34) of the patients with immune-mediated dermatologic adverse reactions. Immune-mediated dermatologic adverse reactions resolved in 71% (24/34) of these patients. Other Immune-Mediated Adverse ReactionsThe following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received LOQTORZI or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis, pericardial effusionNervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathyOcular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitisMusculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis, polymyalgia rheumatica, dermatomyositisEndocrine: HypoparathyroidismHematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection Infusion-Related ReactionsLOQTORZI can cause severe or life-threatening infusion-related reactions including hypersensitivity and anaphylaxis. In patients receiving LOQTORZI in combination with cisplatin and gemcitabine, infusion-related reactions have been reported in 4.1% of patients, including Grade 2 (0.7%) reactions.In patients receiving LOQTORZI monotherapy, infusion-related reactions occurred in 2% of 851 patients, including Grade 3 (0.1%) and Grade 2 (0.6%). LOQTORZI was withheld for one Grade 3 infusion related reaction. Monitor patients for signs and symptoms of infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. For severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions, stop infusion and permanently discontinue LOQTORZI. Complications of Allogeneic Hematopoietic Stem Cell Transplant (HSCT)Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT. Embryo-Fetal ToxicityLOQTORZI can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LOQTORZI and for 4 months after the last dose. LactationThere are no data on the presence of toripalimab-tpzi in human milk; its effects on the breastfed child, or on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to toripalimab-tpzi are unknown. Because of the potential for serious adverse reactions in breastfed children, advise lactating women not to breastfeed during treatment with LOQTORZI and for 4 months after the last dose. Serious Adverse Reactions In JUPITER-02, when LOQTORZI was administered in combination with cisplatin and gemcitabine for the first-line treatment of recurrent, locally advanced or metastatic nasopharyngeal carcinoma, serious adverse reactions occurred in 43% of patients. Serious adverse drug reactions in ≥2% were thrombocytopenia (14%), neutrophil count decreased (10%), pneumonia (10%), anemia (9%), abnormal hepatic function (2.7%), and rash (2.1%). There were three fatal adverse reactions (2.1%): one due to epistaxis; one due to intracranial hemorrhage associated with immune-related thrombocytopenia and coagulopathy; and one due to pneumonia. Permanent discontinuation of LOQTORZI, due to an adverse reaction occurred in 12% of patients. Adverse reactions resulting in permanent discontinuation of LOQTORZI in ≥1% were pneumonia (2.1%), pulmonary tuberculosis (1.4%), rash (1.4%), and vomiting (1.4%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (58%), decreased lymphocytes (57%), decreased hemoglobin (50%), decreased platelets (33%), decreased potassium (10%), decreased sodium (9%), increased alanine aminotransferase (6%), increased or decreased magnesium (4.2% each), decreased calcium (3.5%), increased aspartate aminotransferase (2.7%), and increased bilirubin (2.1%).In POLARIS-02, when LOQTORZI was administered as a single agent to patients with previously treated, unresectable or metastatic nasopharyngeal carcinoma, serious adverse reactions occurred in 24% of patients. Serious adverse drug reactions in ≥2% were pneumonia (4.7%), abnormal hepatic function (2.6%), and hyperbilirubinemia (2.1%). Fatal adverse reactions occurred in 3.7% of patients who received LOQTORZI, including death not otherwise specified (1.6%), tumor hemorrhage (0.5%), hepatic failure and thrombocytopenia (0.5%), hyponatremia (0.5%), and sudden death (0.5%). Permanent discontinuation of LOQTORZI due to an adverse reaction occurred in 9% of patients. Adverse reactions resulting in permanent discontinuation of LOQTORZI in ≥1% included pneumonia (1.1%), abnormal hepatic function (1.1%), and hyperbilirubinemia (1.1%). The most common Grade 3 or 4 laboratory abnormalities (≥2%), were decreased sodium (11%), decreased lymphocytes (9%), decreased hemoglobin (6%), increased aspartate aminotransferase (3.8%), decreased phosphate (3.2%), and increased alkaline phosphatase (2.2%). Common Adverse Reactions In JUPITER-02, the most common adverse reactions (≥20%) were nausea (71%), vomiting (68%), decreased appetite (55%), constipation (39%), hypothyroidism (38%), rash (36%), pyrexia (32%), diarrhea (31%), peripheral neuropathy (30%), cough (26%), musculoskeletal pain (25%), upper respiratory infection (23%), insomnia (23%), dizziness (21%), and malaise (21%).In POLARIS-02, in patients with previously treated, unresectable or metastatic nasopharyngeal carcinoma, the most common (≥20%) adverse reactions were hypothyroidism (27%), fatigue (22%), and cough (20%). LOQTORZI® Injection: 240 mg/6 mL (40 mg/mL) solution in a single-dose vial Please see prescribing information for LOQTORZI. About Coherus Oncology Coherus Oncology is a fully integrated commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI® (toripalimab-tpzi), and a pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, colorectal and other cancers. The Company’s strategy is to grow sales of LOQTORZI in NPC and advance the development of new indications for LOQTORZI in combination with both its pipeline candidates as well as through its partners, driving sales multiples and synergies from proprietary combinations. Coherus’ innovative oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor response and enhance outcomes for patients with cancer. CHS-114 is a highly selective cytolytic anti-CCR8 antibody currently in Phase 1b/2a studies in patients with advanced solid tumors, including head and neck squamous cell carcinoma, colorectal cancer, gastric cancer, and esophageal cancer. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in a Phase 2 study in patients with first-line hepatocellular carcinoma. For more information about LOQTORZI, including the U.S. Prescribing Information and important safety information, please visit www.loqtorzi.com. Forward-Looking Statements The statements in this press release include express or implied forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended about Coherus that involve risks and uncertainties relating to future events and the future performance of Coherus. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity,” “likely,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. You can also identify forward-looking statements by discussions of strategy, plans or intentions. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding: the ability of Coherus’ pipeline to enhance outcomes for cancer patients; expectations about future synergies; projections about growth in sales; expectations for future enrollment in clinical trials; projections about the expansion of indications for LOQTORZI; and the assumptions underlying or relating to such statements. These forward-looking statements are based on Coherus’ current plans, estimates and projections. Such forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those contemplated in any forward-looking statements. Such risks and uncertainties include, without limitation: uncertainties about the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, economic performance, indebtedness, financial condition and losses on Coherus’ prospects, business and operations in the future; risks and uncertainties in executing collaboration agreements and other joint ventures; risks and uncertainties of conducting clinical trials; the risks of Coherus’ dependence on an ability to raise funds, which may not be available on acceptable terms or at all; and risks and uncertainties of any litigation, regulatory actions and other legal proceedings. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further discussion of these and other factors that could cause Coherus’ future results to differ materially from any forward-looking statements see the section entitled “Risk Factors” in Coherus’ Quarterly Report on Form 10-Q for the period ended September30, 2025, filed with the Securities and Exchange Commission (SEC) on November 6, 2025, as updated by Coherus’ subsequent reports filed with the SEC. LOQTORZI® is a registered trademark of Coherus Oncology, Inc. ©2025 Coherus Oncology, Inc. All rights reserved. Coherus Oncology Contact Information:For Investors:Carrie GrahamVP, Investor Relations & AdvocacyIR@coherus.com US-LOQ-0283.1 12/2025

New Data Shows TRUE-See’s Color Calibrated Technology Significantly Increases the Accuracy of Routine Medical Photographs and Enables Development of AI-Assisted Medical Photographic Imaging for Wound Care and Other ApplicationsNEW ORLEANS, La., Nov. 12, 2025 (GLOBE NEWSWIRE) -- TRUE-See Systems, the New Orleans-based, global leader in color-calibrated photographic medical imaging and image authentication, today reported that it is hosting two presentations on November 13 at the International Post-Acute Wound Care Society (IPAWS) Summit, November 12–14, 2025, at The Ritz-Carlton, New Orleans. Together, the posters highlight the inadequacies of current clinical photographic imaging and show how TRUE-See’s proprietary color calibration technology can greatly improve the accuracy of the photographs while also increasing their utility in the development of AI-enhanced diagnostic tools. TRUE-See’s first poster, titled “A Deep Learning Model for Predicting Wound Healing Using Color-Calibrated Imaging,” describes how AI models trained on medical photographs of wounds that used TRUE-See technology to produce standardized, color-accurate images were able to predict the risk of wound worsening with high precision. The study analyzed more than 18,000 longitudinal wound images across 11 causes, demonstrating that the robust color calibration achieved with TRUE-See significantly improves diagnostic consistency and predictive accuracy. Peter Chang, MD, is lead author of the study and a leading expert in AI-driven medical imaging. He is Director, Center for Applied AI Research (A2IR) and Associate Professor of Radiological Sciences & Computer Science at the University of California, Irvine. Dr. Chang noted, “Color fidelity is not optional in medical photography—it’s foundational. Without standardized color data, AI models of clinical photographs risk misinterpretation and bias. TRUE-See’s approach ensures that predictive algorithms for increasing the accuracy and utility of medical photography are trained on clinically reliable images, which is critical for scaling AI in healthcare.” TRUE-See’s second poster, “A Medical Photo Color Accuracy Score,” introduces a first-of-its-kind metric to objectively measure color fidelity in clinical photography using the international CIE Delta E standard. This innovation addresses a critical gap in wound care and telemedicine, where inaccurate color can lead to misdiagnosis and delayed treatment for patients as well as compromised performance in the AI models increasingly used to inform medical imaging. Key study findings included: Analysis of more than 8,000 wound photographs captured under uncontrolled lighting conditions across multiple facilities showed that color calibration technology improved accuracy scores from 77% to over 94%.Almost all of the color-calibrated images (99%) achieved an accuracy score of 90% or better, compared to only 77% of photographs that had not been calibrated.Objective color calibration reduced color error by more than half, enhancing diagnostic accuracy and confidence and enabling the use of accurate AI-driven predictive analytics. Alisha Oropallo, MD, is a lead author of this study and a Professor of Surgery at the Zucker School of Medicine at Hofstra/Northwell and the Feinstein Institutes for Medical Research. She is Director of the Comprehensive Wound Healing Center and Program Director of the Wound and Burn Fellowship program at Northwell Health. Dr. Oropallo commented, “Color accuracy in medical photographic imaging goes far beyond the cosmetic, impacting critical clinical decision-making. Our research demonstrates that standardized color imaging improves diagnostic reliability and provides the foundation for AI models that can predict wound deterioration and optimize care.” Why These Studies Matter For Clinicians and patients: Reliable color calibration improves wound assessment and patient outcomes, telemedicine consultations, and diagnostic and documentation accuracy. Early detection of wound deterioration via imaging accuracy and AI guidance can prevent severe complications, enhancing patient care, increasing provider efficiency and saving thousands in per patient treatment costs.For AI development: Standardized color data reduces bias and enhances predictive performance in machine learning models.For AI in wound care: When accurate, predictive algorithms can identify high-risk wounds days before deterioration, reducing complications and hospital readmissions.TRUE-See’s role: By automatically embedding color calibration and image authentication into routine clinical photography, TRUE-See provides user and device-independent accuracy, regulatory compliance, and AI-readiness.AI enablement: TRUE-See’s dataset of over 80,000 color-calibrated wound images positions the company as a foundational partner for AI-driven healthcare imaging.Scalable solution: TRUE-See integrates seamlessly with EHR systems and mobile workflows, making adoption practical and hassle-free for clinicians and health systems.Commercial opportunity: TRUE-See’s proprietary color calibration technology addresses a $96 billion wound care market and positions the company as a critical enabler of AI-driven healthcare imaging. Dr. Shaun Carpenter is a nationally recognized expert in wound medicine who helped develop the TRUE-See technology. He leads a team of over 100 wound specialist physicians and nurse practitioners throughout the southeast region of the US and has authored multiple publications regarding the science of wound healing. Dr. Carpenter commented, “True-See color calibration is the future of wound medicine. Accurate Ai clinical decision support can not be accomplished without it.” “This research further validates our mission to transform wound care and more broadly, increase the accuracy and utility of the photographic imaging used by thousands of healthcare providers across multiple specialties in the US every day,” said Ben Favret, CEO of TRUE-See Systems. “The average color accuracy score for medical photographs reported in the medical literature shows that about half are just unusable, and even worse, could cause AI diagnostic support tools to make errors in more than half of the clinical photographs they analyze. By embedding our proprietary color calibration and image authentication into routine clinical workflows, we’re not only improving patient outcomes but also enabling the next generation of AI-enhanced diagnostics with the potential to provide system-wide benefits.” The IPAWS Summit is a premier global event for wound care innovation. TRUE-See invites clinicians, researchers, investors, and media representatives attending the meeting to visit its poster session during the “Wine & Wounds” networking reception on November 13 and learn more and explore collaboration opportunities to advance the future of wound care and medical imaging. About TRUE-See SystemsNew Orleans-based TRUE-See Systems is a medical technology company committed to improving clinical outcomes through standardized, color-accurate medical photography by increasing the accuracy, utility and efficiency of clinical photography through its patented color calibration technology, secure workflows, and AI-powered diagnostic tools. Designed for any healthcare setting and any mobile device, TRUE-See’s patented system delivers significant improvements in diagnostic accuracy and reimbursement rates, simplifies physician workflows, ensures HIPAA compliance, and establishes legal admissibility. With a growing library from its more than 2 million calibrated medical photographs and integrations across leading EHR platforms, TRUE-See empowers clinicians to make faster, more accurate medical decisions for patients while improving confidentiality, legal defensibility and reimbursement outcomes. TRUE-See holds multiple issued and pending patents. Learn more at TRUE-See.com Contacts: CorporateBen FavretCEObfavret@TRUE-See.com407 488-0920 MediaBarbara LindheimBLL Partners for TRUE-Seeblindheim@bllbiopartners.com917 355-9234

ANN ARBOR, Mich., Nov. 10, 2025 (GLOBE NEWSWIRE) -- ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced that the company will deliver podium presentations at EYENOVATE and the FLORetina-ICOOR Congress 2025. This is the inaugural year for EYENOVATE, which will be held on December 4, 2025. The FLORetina-ICOOR Congress 2025 will be held from December 4-7, 2025. Both meetings will be located at the Fortezza da Basso in Florence, Italy. Details of the EYENOVATE presentation:Title:Fas Inhibition with Xelafaslatide: A Novel Approach for the Treatment of Geographic Atrophy Presenter:David N. Zacks, M.D., Ph.D. Chief Scientific Officer ONL Therapeutics, Inc. Session:We Are in the Midst of a New Treatment Category: Dry AMD Innovation Update Date/Time:Thursday, December 4: 9:45 - 10:30 a.m. Central European Time (CET) Location:Fortezza da Basso Details of the FLORetina-ICOOR presentation: Title:Advancing Geographic Atrophy Treatment with ONL1204 (xelafaslatide): Insights from the Phase 1b Study and Phase 2 Launch Presenter:Baruch D. Kuppermann, M.D., Ph.D. Chair, Department of Ophthalmology Director, Gavin Herbert Eye Institute University of California, Irvine Session:Retina Futura: Highlights in Geographic Atrophy (GA): Current Clinical Updates and Emerging Therapies Date/Time:Saturday, December 6: 4:15 - 5:45 p.m. CET Presentation: 4:29 p.m. CET Location:San Giovanni Room The company will also have conference booth space to host meetings with attendees, including representatives from clinical sites for ONL’s global Phase 2 GALAXY clinical trial. The GALAXY trial is designed to evaluate the efficacy and safety of xelafaslatide in patients with GA associated with dry AMD. About Xelafaslatide (ONL1204 Ophthalmic Solution)Xelafaslatide (ONL1204) is an investigational first-in-class small molecule Fas inhibitor designed to protect key retinal cells, including photoreceptors, from cell death that occurs across a range of retinal diseases and conditions. Death of these retinal cells, through both direct and inflammatory signaling pathways, is the root cause of vision loss and the leading cause of blindness. The company’s later stage clinical development program for xelafaslatide includes a Phase 2 study for the treatment of GA associated with AMD (NCT06659445) and a completed Phase 2 study in the U.S. for the treatment of macula-off retinal detachment (RD) (NCT05730218), a condition for which the compound has been granted orphan drug designation by the United States Food and Drug Administration (FDA). The company has also completed a Phase 1b clinical trial in patients with GA associated with AMD (NCT04744662), a Phase 1b clinical trial in patients with progressing open-angle glaucoma (NCT05160805) and a Phase 1 clinical trial in macula-off RD patients at sites in Australia and New Zealand (NCT03780972). About Geographic Atrophy (GA) Associated with Dry Age-related Macular Degeneration (AMD) AMD has become a major cause of visual disability and legal blindness globally. Although generally affecting only the central retina (macula), this region of photoreceptors provides the visual acuity necessary for reading, driving, and the performance of fine vision-related tasks. Associated with aging, cigarette smoking, obesity, diets low in certain nutrients, a lifestyle related to cardiac risk, and a growing list of genetic factors, AMD is becoming an increasingly prevalent public health concern, especially as the global population ages. GA, also called atrophic AMD, is an advanced form of AMD. About ONL TherapeuticsONL Therapeutics (ONL) is a clinical-stage biopharmaceutical company committed to developing first-in-class therapeutics to protect and improve the vision of patients with retinal disease. By advancing a breakthrough technology designed to protect key retinal cells from Fas-mediated cell death, ONL is pioneering a new approach to preserving vision. For more information about ONL Therapeutics, please visit www.onltherapeutics.com. Company Contact: Linda Kemnitz ONL Therapeutics, Inc. lkemnitz@onltherapeutics.com