InnoCare Releases 2025 Interim Results and Business Highlights

On August 19, 2025 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported the 2025 interim results as of 30 June 2025 (Press release, InnoCare Pharma, AUG 19, 2025, View Source [SID1234655384]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Significant Revenue Growth from Orelabrutinib

Total Revenue of InnoCare increased by 74.3% year-on-year (YoY) to RMB731.4 million1 for the six months ended 30 June 2025, primarily attributable to the robust sales growth of orelabrutinib and license-out revenue from Prolium. Drug sales increased by 53.5% YoY to RMB641.2 million in the first half of 2025, driven by coverage expansion, an increase in the number of patients treated by orelabrutinib, especially in marginal zone lymphoma, as well as strong commercial execution. Loss for the period decreased by 86.7% to RMB35.6 million for the six months ended 30 June 2025, attributed to revenue growth and improved cost efficiency.

Research and development expenses increased by 6.9% YoY to RMB449.7 million for the six months ended 30 June 2025 primarily due to increased investment in advanced technology platforms and a greater number of Phase III clinical trials.

Cash and related accounts balances2 stood at approximately RMB7.7 billion as of 30 June 2025. This robust cash position provides flexibility for the Company to expedite clinical development and invest in a competitive pipeline, including ADC programs.

Accelerating Innovation, Commercialization and Globalization

In the first half of 2025, InnoCare made substantial progress in advancing its pipeline with multiple key milestones achieved: Orelabrutinib received approval for first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), tafasitamab in combination with lenalidomide was approved for adult patients with relapsed or refractory DLBCL (R/R DLBCL), BCL-2 inhibitor Mesutoclax (ICP-248) entered two registrational clinical studies, the NDA for TRK inhibitor Zurletrectinib (ICP-723) was accepted and granted priority review, and the Company’s proprietary antibody-drug conjugate (ADC) platform reached a major milestone with IND approval.

Building on this R&D momentum, InnoCare further expanded its global footprint through strategic collaborations. In January, InnoCare partnered with Prolium to explore global potential for a CD3×CD20 bispecific antibody. InnoCare remains committed to advancing global partnerships that will enhance innovation, maximize the value of its pipeline, and support long-term growth.

Orelabrutinib drove significant revenue growth through strong commercial execution and broader market penetration. This momentum demonstrates the Company’s key abilities to translate scientific innovations into sustained business performance.

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "Over the past decade, we have built a fully-integrated platform encompassing original innovation, clinical development, commercialization, manufacturing, and BD, achieving a series of great milestones. As we embark on the next decade, we will accelerate our company’s rapid development of Stage 2.0, driving innovation, commercialization, and globalization. Over the next three to five years, we will launch multiple drugs into the market, significantly increasing commercial revenue. We will bring three to four products to the global market. We will also continue to deepen our innovation efforts and develop five to ten differentiated molecules. With our innovative and entrepreneurial spirit, the company is set to reach new heights."

Building A Leading Franchise in Hemato-Oncology

In the first half of 2025, InnoCare took major steps toward establishing a leadership position in hematology-oncology, driven by three cornerstone therapies – orelabrutinib, tafasitamab, and mesutoclax. With orelabrutinib’s approval in first-line CLL/SLL and tafasitamab’s approval in combination with lenalidomide for adult patients with R/R DLBCL, InnoCare’s commercial hematology portfolio has significantly expanded.

InnoCare’s novel BCL2 inhibitor, mesutoclax, further strengthens this franchise with two registrational trials now underway: a fixed-duration combination regimen with orelabrutinib in 1L CLL/SLL and a study for BTKi-treated mantle cell lymphoma (MCL). Additionally, InnoCare completed dose exploration in the first line acute myeloid leukemia (AML), with data to be presented at ASH (Free ASH Whitepaper) 2025, and received clearance to initiate a myelodysplastic syndromes (MDS) trials in both U.S. and China.

Tafasitamab

Tafasitamab (trade name: Minjuvi) is a potential best profile therapy for R/R DLBCL. In a pivotal Phase II study, it demonstrated a high overall response rate (ORR) with durable responses, achieving an ORR of 57.5%, a median duration of response of 43.9 months, and a median overall survival (OS) of 33.5 months. With a large patient base and significant unmet medical need, approximately 40-55% of DLBCL patients relapse or become refractory after standard treatment.
Mesutoclax (ICP-248)

The registrational Phase III trial of mesutoclax in combination with orelabrutinib as first-line treatment for CLL/SLL is advancing rapidly. This fixed-duration therapy is expected to provide deeper remissions for treatment-naïve CLL/SLL patients, while avoiding resistance mutations and offering the hope for clinical cure. Together, these benefits position the regimen as a highly promising therapeutic approach.
In a Phase II study of mesutoclax in combination with orelabrutinib, no tumor lysis syndrome (TLS) was observed. At week 36, data showed an ORR of 100%, target lesion complete response rate (CRR) of 57%, and undetectable minimal residual disease (uMRD) rate of 65%.
In R/R MCL patients who were refractory to prior BTKi treatment, ORR reached 84% with a 36% CRR.
In the dose-expansion study of mesutoclax in combination with azacytidine as first-line treatment for AML, the regimen demonstrated strong efficacy with a favorable safety profile, with a CRR of 70%, a uMRD rate of 57%, and a 60-day mortality rate of 0%.
Accelerating Multiple Phase III Clinical Trials in Autoimmune Diseases

Autoimmune diseases can affect almost every organ in the body and may arise at any stage of life. The global market for autoimmune disease therapeutics anticipated to reach $185 billion by 20293. The Company has fortified its powerful discovery engine to focus on cutting-edge targets for the development of autoimmune therapeutics through B-cell and T-cell pathways, with the aim of delivering first-in-class and/or best-in-class treatments to address the massive unmet medical needs and strong market potential in China and worldwide.

Orelabrutinib to Provide Novel Treatment for ITP Patients

The Company has completed patient enrollment of the Phase III registrational trail of orelabrutinib for the treatment of Immune Thrombocytopenia (ITP) and expects to submit the NDA application in the first half of 2026.

ITP represents hundreds of thousands of patients globally with a prevalence of 23.6 cases out of 100,000 in U.S. and a prevalence of 9.5 cases out of 100,000 in China. Current therapies, including corticosteroids and thrombopoietin receptor agonists, lack long-term tolerability or durable sustained responses. New safe and effective treatment options are needed for patients who have inadequate responses to previous lines of therapy.

BTK is a key kinase in the B cell receptor signaling pathway, which is essential for the activation of B lymphocytes, macrophages, and other immune cells as well as the production of antibodies in the pathological process of ITP. No BTK inhibitor has yet been approved for the treatment of patients with ITP. Orelabrutinib, with its high target selectivity and good safety profile, has the potential to become a novel treatment option for ITP patients.

InnoCare is accelerating the global Phase III studies for Primary Progressive Multiple Sclerosis (PPMS) and Secondary Progressive Multiple Sclerosis (SPMS). The Phase IIb clinical trial for orelabrutinib in SLE completed patient enrollment in 2024, with data readout expected Q4 2025.

InnoCare’s two in-house developed TYK2 inhibitors have demonstrated good efficacy with excellent safety profiles in Phase II studies. Soficitinib (ICP-332) is being developed for multiple autoimmune indications. Its Phase III trial for AD is expected to complete patient enrollment this year, while the phase II/III of clinical trial in vitiligo is advancing rapidly, and a global Phase II study in prurigo nodularis (PN) is about to be initiated.

The registrational Phase III trial of ICP-488 in psoriasis is also expected to complete patient enrollment this year, and its Phase II clinical data were presented as a high-impact oral report at the 2025 American Academy of Dermatology (AAD) Annual Meeting.

As oral small-molecule therapies for autoimmune indications, these drugs are expected to leverage convenient administration to better benefit patients.

Building Innovative Solid Tumor Assets

As part of InnoCare’s strategic focus on solid tumor therapeutics, the Company is building a competitive and diversified drug portfolio to address significant unmet medical needs across multiple tumor types.

Precision Medicine: Zurletrectinib

In March 2025, the new drug application of zurletrectinib for the treatment of adult and adolescent patients (12 to 18 years) with NTRK gene fusion-positive tumors was accepted by the CDE and granted priority review. The registrational trial for pediatric patients (2 to 12 years) is ongoing, with NDA submission later 2025.

Zurletrectinib was shown to overcome acquired resistance to the first generation TRK inhibitors, bringing hope for patients who failed prior TRKi therapy.

Zurletrectinib demonstrated outstanding efficacy with a good safety profile, achieving an ORR of 85.5%. Zurletrectinib has also shown a long duration of response, with longest beyond 36 months.

Proprietary ADC Platform with First ADC Drug Entering the Clinic

The Company has developed a cutting-edge ADC platform with proprietary linker-payload (LP) technologies, aimed at the delivery of potent and targeted therapies for cancer treatment. This platform allows for the creation of highly differentiated ADCs with improved efficacy and safety profiles. Key features of the platform include:

Novel connector: Irreversible connector to avoid linker detachment caused by instability.
Hydrophilic linker: Enhancing ADC stability and achieving high drug-to-antibody ratio (DAR).
Novel payload: Incorporating highly potent cytotoxic payloads with strong bystander killing effect.
The first in-house ADC candidate, ICP-B794, a B7-H3–targeting ADC, received IND approval in July 2025, and the Company expects first patient-in and clinical proof-of-concept later this year.

ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated to potent in-house developed payload via a protease-cleavable linker. This combination ensures precise targeting of tumor cells while minimizing off-target effects, offering a promising treatment for solid tumors such as lung cancer, esophageal cancer, nasopharyngeal cancer, head and neck squamous cell carcinomas, prostate cancer, and others. Currently, there are no B7-H3 targeted therapies approved for marketing globally. B7-H3 is a type I transmembrane protein that is highly expressed in a variety of solid tumors. Due to its specific expression in tumor cells, it is considered a highly promising anti-tumor target.

ICP-B794 has demonstrated superior anti-tumor activity in animal models compared to other ADCs, and exhibited significant tumor-killing effects even in large tumors. Upon achieving proof-of-concept, it is anticipated that multiple ADC-based molecules from this platform will have IND submissions next year, which will significantly expand the solid tumor pipeline.

Through these efforts, InnoCare aims to establish a robust and innovative oncology portfolio, positioning the Company as a future leader in innovative therapies for solid tumors.

To know more about the detailed financial data and business updates of InnoCare 2025 interim results, please log in to View Source .

Conference Call Information

InnoCare will host a conference call at 8:30 p.m. Beijing time on August 19 in English and at 9:00 a.m. Beijing time in Chinese on August 20, 2025. Participants must register in advance of the conference call. Details are as follows:

For English conference call, please register through the below link:
View Source

For Chinese conference call, please register through the below link:
View Source

Ategenos Emerges from Stealth to Debut First-Ever SmartPatch Platform Transforming the Economics of Medication Non-Adherence

On August 19, 2025 Following the announcement of its foundational U.S. patent allowance, Ategenos reported its investigational SmartPatch platform — a first-of-its-kind connected system in development to wirelessly detect and address medication non-adherence (Press release, Ategenos Pharmaceuticals, AUG 19, 2025, View Source [SID1234655383]). The public debut follows over three years of work in stealth mode advancing the technology toward future clinical evaluation and regulatory review.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Built on the company’s now-patented innovations, Ategenos SmartPatches contain reformulated oral solid dose (OSD) blockbuster drugs in a connected, transdermal SmartPatch that delivers sustained-release therapy over multiple days, while also detecting missed doses and automatically alerting caregivers to make interventions.

This marks the first time a drug delivery system has combined passive drug administration with active, cloud-connected intelligence, aiming to reduce the estimated $528.4 billion in U.S. healthcare costs ($1T globally) driven by medication non-adherence.

"We’re building a new layer of intelligence into the fabric of pharmacotherapy," said Don DeGolyer, CEO of Ategenos. "When medications go untaken, it’s not just dollars lost. It’s people’s lives unraveling through preventable relapses, hospital stays, and declining independence. Our SmartPatches enable early interventions, giving patients a better chance to stay well, at home, and in control of their lives."

A new vision for smart therapeutics, the Ategenos SmartPatch platform is being designed to deliver:

Next-generation transdermal drug delivery with multi-day sustained release
Integrated, low-cost, self-powered disposable electronics that connect wirelessly to Internet-of-Things community networks and a secure healthcare cloud
AI-powered reminders and alerts intended to notify caregivers of missed doses, supporting timely interventions that may help prevent hospitalizations
Simple, familiar application designed to be used like any other transdermal patch, with no special handling required to benefit from its planned IoT connectivity
On track to be the first and only solution with direct, real-time measurement of medication non-adherence in community populations
Ategenos is advancing a proprietary drug pipeline through the FDA’s 505(b)(2) regulatory pathway across behavioral health, cardiovascular, CNS, and oncology indications. At the same time, the company is exploring external development partnerships with pharmaceutical manufacturers in three key areas:

Lifecycle extension opportunities for therapies nearing the end of exclusivity
Reformulation of in-development compounds where patient compliance is a known challenge
Real-time, connected alternatives to existing OSD products facing commercial headwinds from non-adherence
Ategenos is partnering with a select group of pharma companies positioned to lead in connected therapeutics. A few strategic partner slots remain for those seeking first-mover advantage with the only scalable platform for connected drug delivery and real-time adherence monitoring.

Ategenos is also engaging select capital and strategic partners aligned with its mission to address the global crisis of medication non-adherence.

The Ategenos SmartPatch platform is an investigational device, currently under development. It has not been reviewed or approved by the U.S. Food and Drug Administration (FDA) and is not available for commercial sale. Any future availability will depend on successful regulatory review and approval.

Antengene’s ATG-022 (CLDN18.2 ADC) Granted Breakthrough Therapy Designation for the Treatment of Gastric/Gastroesophageal Junction Adenocarcinoma

On August 19, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, reported that its in-house discovered CLDN18.2 ADC, ATG-022,was granted a Breakthrough Therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of CLDN18.2-positive, HER-2 negative unresectable or metastatic gastric or gastroesophageal junction (GC/GEJ) in patients who have received at least two prior lines of therapy (Press release, Antengene, AUG 19, 2025, View Source [SID1234655382]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Breakthrough Therapy designation, introduced by the NMPA, is a key initiative aimed at accelerating the development and approval of innovative medicines that offer significant clinical benefits. With this designation, ATG-022 will receive priority review resources, reducing the overall research and development timeline and enabling faster access for patients in China. This follows the U.S. Food and Drug Administration’s (FDA) granting of Orphan Drug Designation (ODD) to ATG-022 for the treatment of gastric and pancreatic cancers, highlighting its strong clinical potential across multiple tumor types.

In the ongoing CLINCH Phase I/II clinical study, data show that ATG-022 demonstrated significant antitumor activity and a favorable safety profile in patients with gastric or gastroesophageal junction adenocarcinoma across high, low, and ultra-low CLDN18.2 expression levels.

CLDN18.2 Moderate-to-high expression (IHC 2+ > 20%)
2.4 mg/kg Cohort
Objective Response Rate (ORR): 40% (12/30), including 1 Complete Response (CR)
Disease Control Rate (DCR): 90% (27/30)
Median Progression-free Survival (mPFS): 6.97 months
6-month PFS Rate: 51.1%
9-month Overall Survival (OS) Rate: 82.7%
12-month OS Rate: 66.2%
1.8 mg/kg Cohort
ORR: 40% (10/25), including 1 CR
DCR: 84% (21/25)
CLDN18.2 Low and Ultra-low expression (IHC 2+ ≤ 20%)
Efficacious dose range of 1.8-2.4 mg/kg
ORR: 33.3% (6/18), including 1 CR
DCR: 50% (9/18)
Notably, some responding patients had CLDN18.2 expression levels below 5%, underscoring the robust antitumor activity of ATG-022 in both low- and ultra-low-expression populations.
To date, three patients in the study have achieved CR during treatment, with one case observed in each of the three aforementioned cohorts (i.e., both dose levels in the CLDN18.2 moderate-to-high expressor cohorts and the CLDN18.2 low and ultra-low expressor cohort). This broad-spectrum antitumor activity positions ATG-022 as a potential new treatment option for a wider patient population compared with other CLDN18.2-targeted therapies.

Antengene is currently conducting the Phase II dose-expansion stage of ATG-022 in the Mainland of China and Australia, with the program now entering mid-to-late stage of clinical validation. The company will continue to advance the clinical development of ATG-022 in gastric cancer while exploring its potential in other CLDN18.2-positive tumors. For gastric cancer indications, the development strategy spans first- through third-line treatment:

First-line treatment (CLDN18.2 IHC 1+ ≥1%, PD-L1 CPS ≥1%): ATG-022 in combination with pembrolizumab and chemotherapy (CAPOX/FOLFOX)
Second-line treatment (CLDN18.2 IHC 1+ ≥1%, PD-L1 CPS ≥1%): ATG-022 in combination with pembrolizumab
Third-line treatment (CLDN18.2 IHC 2+): ATG-022 monotherapy, covering patients across different CLDN18.2 expression levels, including CLDN18.2 moderate-to-high expressor (2+ >20%), and low and ultra-low expressors (2+ ≤20%)
In addition, the ongoing Phase II study includes a basket trial cohort covering multiple tumor types. In a certain subtype of gynecologic tumor, all 7 patients who had undergone at least one efficacy assessment demonstrated tumor shrinkage, indicating significant clinical potential for ATG-022 in other CLDN18.2-positive tumors. This cohort remains open for enrollment and follow-up, and the continued data generation is expected to further strengthen the robust value proposition of ATG-022 across multiple tumor types.

Nature Medicine Publishes Results of Phase II Study of Sacituzumab Tirumotecan Plus Tagitanlimab as First-Line Therapy for NSCLC

On August 19, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990) reported that clinical data from a Phase II study evaluating novel TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) in combination with PD-L1 monoclonal antibody (mAb) tagitanlimab for the first-line treatment of advanced or metastatic non-small cell lung cancer (NSCLC) have been published in Nature Medicine (Impact Factor: 58.7) (Press release, Kelun, AUG 19, 2025, View Source [SID1234655381]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The publication highlighted initial findings from the Phase II OptiTROP-Lung01 study, evaluating the efficacy and safety results of sac-TMT in combination with tagitanlimab as a first-line treatment of advanced or metastatic NSCLC patients without actionable genomic alterations. The study was led by Prof. Zhang Li’s team at the Center for Cancer Prevention and Control, Sun Yat-sen University, China. Patients in Cohort 1A received sac-TMT (5 mg/kg, Q3W) plus tagitanlimab (1200 mg, Q3W) in a three-week cycle, while patients in Cohort 1B were treated with sac-TMT (5 mg/kg, Q2W) plus tagitanlimab (900 mg, Q2W) in a four-week cycle. Patients received sac-TMT in combination with tagitanlimab in a non-randomized manner until disease progression or unacceptable toxicity. Median follow-ups for Cohort 1A and Cohort 1B were 19.3 months and 13.0 months, respectively (Data cutoff date: May 27, 2024).

The study results demonstrated promising anti-tumor activity, and manageable safety of sac-TMT in combination with tagitanlimab as a first-line treatment for advanced or metastatic NSCLC patients. A total of 40 patients in Cohort 1A and 63 patients in Cohort 1B were included in the full analysis set (FAS) for efficacy assessment. In Cohort 1A and Cohort 1B, respectively, the confirmed objective response rates (ORRs) were 40.0% (95% CI: 24.9–56.7) and 66.7% (95% CI: 53.7–78.0), and the ORRs were:

44.4% and 64.7% among patients with non-squamous carcinoma, 36.4% and 69.0% with squamous carcinoma;
41.7% and 57.1% among patients with PD-L1 tumor proportion score (TPS) <1%;
38.5% and 63.2% for TPS 1–49%;
40.0% and 78.3% for TPS ≥50%.
The median progression-free survival (mPFS) for Cohort 1A was 15.4 months (95% CI: 6.7–17.9) and not reached (95% CI: 9.6–NE) for Cohort 1B.

The most common grade ≥3 treatment-related adverse events (TRAEs) for both Cohorts 1A and 1B were decreased neutrophil count, decreased white blood cell count and anemia. No treatment-related deaths were observed.

Subgroup analyses showed consistent efficacy across PD-L1 and TROP2 expression levels, as well as in both squamous and non-squamous histological subtypes.

Dr. Michael Ge, CEO of Kelun-Biotech, commented: "The OptiTROP-Lung01 study supports the promising efficacy and safety of sacituzumab tirumotecan in combination with tagitanlimab as a first-line treatment for patients with advanced NSCLC. The results were observed across PD-L1/TROP2 expression levels and histological subtypes and support the advancement potential of sac-TMT from later-line to front-line therapy. The publication of results from several studies in top-tier international journals reflects the recognition of our innovation-driven development strategy. We will continue to work to address critical clinical challenges and unmet medical needs, striving to deliver more therapeutic options and improve quality of life for patients."

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).

To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the CDE, and were included in the priority review and approval process. As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 14 ongoing Phase III global clinical studies of sac-TMT as a monotherapy or with pembrolizumab[1] or other agents for several types of cancer. These studies are sponsored and led by MSD.

About Tagitanlimab

Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. Previously, the NMPA has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively.

Evogene Reports Second Quarter 2025 Financial Results

On August 19, 2025 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology and chemistry company aiming to revolutionize the development of life-science-based products, reported its financial results for the second quarter ended June 30, 2025 (Press release, Evogene, AUG 19, 2025, View Source [SID1234655380]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Mr. Ofer Haviv, Evogene’s President and CEO stated: "Evogene is entering a transformative phase, centered on the strategic repositioning of our business around ChemPass AI – a proprietary, cutting-edge platform for the AI-driven discovery and optimization of small molecules. With a renewed focus on high-impact innovation, cross-industry collaboration, and operational efficiency, Evogene is now uniquely positioned to unlock long-term value in two massive global markets- pharmaceuticals and agriculture.

Earlier this year, we outlined a bold strategic path, and we are now delivering results across five key priorities:

Enhance ChemPass AI as the core engine
Expansion of strategic collaborations in pharma
Integration of AgPlenus activities into Evogene
Enhanced cash flow from subsidiaries
Streamlined operations across the group
In line with these priorities, I’m excited to share with you the major achievements that took place during the second quarter and to date.

In June, we unveiled version 1.0 of our generative AI foundation model, developed in partnership with Google Cloud. Trained on a proprietary dataset of approximately 38 billion molecular structures, this model represents a leap forward in small molecule design, enabling us to address complex, multi-parameter challenges in pharma and ag-tech.

This technology solidifies ChemPass AI’s role as a best-in-class platform, capable of driving innovation at scale and speed.

Last week we announced a collaboration with Tel Aviv University. We partnered with Professor Ehud Gazit, a world-renowned expert in biomolecular self-assembly, to discover small molecule therapeutics targeting metabolic diseases like gout and PKU. This marks the beginning of a broader pharma ecosystem, leveraging ChemPass AI for next-generation drug discovery.

We are optimizing our agricultural offering around ChemPass AI through the integration of AgPlenus’ activity into Evogene, including a 40% workforce reduction at AgPlenus. This integration enhances ChemPass AI’s application in crop protection, unlocking deeper synergies and operational efficiency.

In July 2025, we completed the sale of most of Lavie Bio’s activity and the MicroBoost AI for Ag platform to ICL for a total of $18.71 million. As part of the transaction Lavie Bio redeemed the simple agreement for future equity investment, which was made by an ICL affiliate. This transaction:

Boosted our cash position through direct and indirect proceeds,
Maintained upside via Lavie Bio’s ongoing agreement with an existing partner and
Preserved strategic alignment while creating shareholder value.
As part of a streamlining process, in both Biomica and Evogene, we implemented major restructuring plans:

Biomica reduced staff and management overhead and is now focused on completing its clinical trial for BMC128, its immuno-oncology program (by early 2026) and pursuing potential partners to take the lead on its development programs.
Evogene executed a 30% workforce reduction, with cost savings to be reflected from the third quarter of 2025 onwards.
Another important event, which strengthened our financials and supports the execution of the new strategy, was raising $4.4 million through fully utilizing our existing at-the market facility in June 2025, at an average price of $2.31 per share, reflecting strong market confidence. Combined with the ICL transaction, Evogene now holds a solid 18-month operational runway."

Mr. Haviv continued: "Looking ahead, our unified corporate focus is ChemPass AI – a powerful computational AI engine that will serve two global verticals:

Pharma – Driving discovery of novel small molecule therapeutics.
Agriculture – Enhancing crop protection innovation via AgPlenus.
To accelerate the penetration of our technology into these verticals:

We are building a dedicated business development team in pharma.
We expect to expand our academic and industry collaborations in pharma globally.
AgPlenus will continue strategic engagements with Bayer and Corteva, with new collaborations expected in the future.
We will continue investing in the unique offering of our ChemPass AI’s cutting edge technology.
As to the activity forecast of our subsidiaries:

Lavie Bio: Post-asset sale, focused on maintaining a collaboration with its existing partner. Dividends are expected to flow to Evogene as the majority shareholder. No new initiatives are planned.
Biomica: Advancing toward completion of its clinical trial for BMC128 and exploring potential partners to take the lead on its current development programs. No new initiatives are planned.
Casterra – Although not directly linked to our core technology, it shows strong revenue potential and is expanding into new markets. We have a strong belief in Casterra’s potential as a growth engine and intend to support its continued development.
In summary, Evogene is now a leaner, more focused, and more AI-centric company. With a world-class platform, global partnerships, and a sharpened execution strategy, we are well-positioned to capture substantial value across multi-billion-dollar markets.

We invite investors to join us at this exciting inflection point, as we redefine small molecule innovation for both human health and sustainable agriculture".

Financial Highlights:

Cash Position: As of June 30, 2025, Evogene held consolidated cash, cash equivalents, and short-term bank deposits of approximately $11.7 million. The consolidated cash usage during the second quarter of 2025 was approximately $2.4 million. Excluding Lavie Bio and Biomica, Evogene and its other subsidiaries used approximately $1.0 million in cash during the second quarter of 2025.

Revenue: Revenues for the first half of 2025 were approximately $3.2 million, compared to approximately $2.3 million in the same period the previous year, reflecting an increase of approximately $0.9 million. This increase was primarily driven by higher revenues recognized by Casterra, attributed to seed sales in the first half of 2025, partially offset by a decrease in AgPlenus revenues. Revenues for the second quarter of 2025 were approximately $0.9 million; a slight increase compared to approximately $0.6 million in the same period last year.

R&D Expenses: Research and development expenses, net of non-refundable grants, for the first half of 2025 were approximately $4.8 million, a decrease of approximately $1.7 million compared to $6.5 million in the first half of 2024. The decrease was primarily due to reduced R&D expenses in Biomica and the cessation of Canonic’s operations at the beginning of 2024. In the second quarter of 2025, R&D expenses were approximately $2.3 million, down from $2.9 million in the same period of 2024. This decrease is mainly attributable to decreased expenses in Biomica and Casterra.

Sales and Marketing Expenses: Sales and marketing expenses for the first half of 2025 were approximately $0.8 million, a decrease of approximately $0.3 million compared to approximately $1.1 million in the same period last year. The decrease was mainly due to reductions in Evogene, AgPlenus and Biomica personnel costs. Sales and marketing expenses for the second quarter of 2025 were approximately $0.4 million, reflecting a decrease of approximately $0.2 million compared to approximately $0.6 million in the second quarter of 2024. The decrease was mainly attributable to reduced expenses in Evogene, Biomica and AgPlenus as mentioned above.

General and Administrative Expenses: General and administrative expenses for the first half of 2025 decreased to approximately $2.3 million from approximately $2.9 million in the same period last year. This decrease is mainly attributable to lower personnel costs in Evogene, a reduction in D&O insurance costs, and lower non-cash compensation expenses in Casterra, Biomica, and AgPlenus. General and administrative expenses for the second quarter of 2025 decreased to approximately $1.1 million compared to approximately $1.4 million in the same period of the previous year, primarily due to decreased expenses in Evogene as mentioned above.

Other expenses (income): Other income of approximately $191 thousand was recorded in the first quarter of 2025 as part of the accounting treatment related to a sub-lease agreement. The decision to cease Canonic’s operations in the first half of 2024 resulted in other expenses of approximately $0.5 million, primarily due to the impairment of fixed assets recorded in the first quarter of 2024.

Operating Loss: The operating loss for the first half of 2025 was approximately $6.1 million, a significant decrease from approximately $9.4 million in the same period of the previous year, mainly due to the decreased operating expenses mentioned above. The operating loss for the second quarter of 2025 was approximately $3.1 million, a decrease from $4.6 million in the same period of the previous year, primarily due to the decreased operating expenses mentioned above.

Financing income (expenses), net: Financing income, net for the first half of 2025 was approximately $732 thousand, compared to financing income, net of approximately $373 thousand in the same period of the previous year. The increase is mainly associated with accounting treatment of pre-funded warrants and warrants issued in August 2024 fund raising. As a result, during the first half of 2025 the Company recorded net financial income, related to pre-funded warrants and warrants of approximately $663 thousand. Financing expenses, net for the second quarter of 2025 were approximately $393 thousand, compared to financing income, net of approximately $97 thousand in the same period of the previous year. The decrease is mainly associated with accounting treatment of pre-funded warrants and warrants issued in August 2024 fund raising.

Loss from operations held for sale, net: Loss from operations held for sale, net for the first half of 2025 was approximately $2.2 million, compared to approximately $0.8 million in the same period of 2024. For the second quarter of 2025, the loss from operations held for sale, net was approximately $1.2 million, compared to approximately $1.4 million in the second quarter of the previous year. These amounts mainly reflect the financial results of Lavie Bio and expenses related to the development and maintenance of MicroBoost AI for Ag, which are presented as a single-line item in the consolidated statements of profit and loss. This accounting treatment follows the intention to sell the majority of Lavie Bio’s activities and the MicroBoost AI for Ag as of June 30, 2025. All prior period amounts were reclassified to conform to this presentation.

Net Loss: The net loss for the first half of 2025 was approximately $7.7 million, compared to approximately $9.8 million in the same period last year. The $2.1 million decrease in net loss was primarily due to decreased operating expenses and increased financing income, net, partially offset by increased loss from operations held for sale, net and reduced revenues. The net loss for the second quarter of 2025 was approximately $4.7 million, compared to approximately $6.0 million in the same period last year. The $1.3 million decrease in net loss was primarily due to decreased operating expenses, decreased loss from operations held for sale and increased revenues, partially offset by increased financing expenses, net as mentioned above.

For the financial tables click here.

Conference Call & Webcast Details: Tuesday, August 19, 2025, 9:00 AM EST 4:00 PM IDT

To join the Zoom conference, please register in advance here