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]).

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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.

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]).

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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

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]).

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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

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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

On August 19, 2025 AbbVie (NYSE: ABBV) reported that it has completed its acquisition of Capstan Therapeutics (Press release, AbbVie, AUG 19, 2025, View Source [SID1234655379]). With the completion of the acquisition, Capstan is now a part of AbbVie.

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Capstan’s lead asset CPTX2309, currently in Phase 1 for the treatment of B cell-mediated autoimmune diseases, is a tLNP that generates CD19-specific, CD8+ in vivo CAR-T cells. The CAR-T cells are designed to achieve rapid and deep B cell depletion with the aim of achieving durable, drug-free remission. This can be accomplished without the need for lymphodepleting chemotherapy, while also avoiding other challenges associated with conventional ex vivo CAR-T therapies.

"With the acquisition now complete, we are excited to work together with the talented team at Capstan to advance our mission of transforming patient care," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "The addition of CPTX2309 and Capstan’s tLNP platform strengthens our ability to deliver new treatments aimed at resetting the immune system and enables application of Capstan’s proprietary technology more broadly for in vivo programming of cells."

On August 19, 2025 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that its self-developed CDH17-targeting ADC (R&D code: 7MW4911) received IND clearance from the U.S. Food and Drug Administration (FDA) (Press release, Mabwell Biotech, AUG 19, 2025, View Source [SID1234655378]). The clearance enables the initiation of Phase I/II study of 7MW4911 to evaluate the safety, pharmacokinetics, and efficacy in patients with advanced colorectal cancer and other advanced gastrointestinal tumors.

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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

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7MW4911 is an investigational CDH17-targeting ADC developed using Mabwell’s proprietary IDDC platform. Its highly optimized structure integrates three key elements:

Mab0727: A highly specific CDH17 monoclonal antibody with rapid internalization properties, cross-species (human/monkey) moderate affinity, and minimal off-target binding.
Novel cleavable linker: Ensures precise payload release in tumor tissues.
MF-6 payload: A proprietary DNA topoisomerase I inhibitor designed to overcome multidrug resistance (MDR), exhibiting superior plasma stability, controlled drug release, and potent bystander effects.
In July 2025, Mabwell published preclinical data in Cell Reports Medicine ("Overcoming multidrug resistance in gastrointestinal cancers with a CDH17-targeted ADC conjugated to a DNA topoisomerase inhibitor"), demonstrating 7MW4911’s tumor-selective cytotoxicity via CDH17-mediated internalization. Key advantages include:

Optimized molecular design: Homogeneous drug-to-antibody ratio (DAR=4, >95%) and stable linker confer exceptional plasma stability, while membrane-permeable MF-6 drives potent bystander killing.
Broad Antitumor Efficacy: Demonstrates robust tumor regression in colorectal, gastric, and pancreatic cancer PDX/CDX models, including tumors with RAS/BRAF mutations and diverse Consensus Molecular Subtypes (CMS).
MDR resistance: Outperforms MMAE/DXd-based ADCs in ABC transporter-mediated MDR models and reverses tumor progression post-ADC treatment.
Target versatility: Active even in tumors with low-to-moderate CDH17 expression, expanding potential patient eligibility.
Favorable safety profile: Limited tissue distribution in mice, controllable pharmacokinetics (moderate half-life, no accumulation), and a wide therapeutic window in cynomolgus monkeys, with no significant toxicity signals.
With this profile, 7MW4911 emerges as a promising therapeutic candidate for advanced gastrointestinal cancers. IND application of 7MW4911 has been accepted by China’s National Medical Products Administration (NMPA).

About CDH17

CDH17 is a pan-cancer validated target with restricted expression in normal intestinal epithelium but marked overexpression in gastrointestinal cancers (e.g., colorectal, gastric, pancreatic). Its aberrant expression correlates with tumor metastasis and poor prognosis, positioning it as an ideal therapeutic target.