On August 18, 2026 858 Therapeutics, a clinical-stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ETX-19477, the company’s internally discovered PARG inhibitor. The designation has been granted for the treatment of adult patients with BRCA-mutated, hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), unresectable or metastatic breast cancer.

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"For patients with advanced HR+/HER2- breast cancer, there is an urgent need for new treatment options that can delay disease progression," said Jeffrey Stafford, Ph.D., CEO of 858 Therapeutics. "We are pleased that the FDA has granted Fast Track designation to ETX-19477 and are committed to working closely with the agency to accelerate its development. The designation was supported by preclinical findings and emerging clinical data from our ongoing Phase 1/2 trial, including evidence of antitumor activity."

FDA Fast Track status is designed to facilitate the development and expedite the review of new therapies that are intended to treat serious conditions with unmet medical need. Under the Fast Track designation, the ETX-19477 development program will have access to more frequent interactions with the FDA and may be eligible for accelerated approval and/or priority review if certain criteria are met.

ETX-19477 is being evaluated in an ongoing Phase 1/2, open-label, multicenter study in patients with advanced solid tumors, designed to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity. The trial is currently enrolling patients in Phase 2 monotherapy cohorts in BRCA-mutated ovarian cancer and BRCA-mutated HR+/HER2- breast cancer.

About ETX-19477

Poly(ADP-ribose) glycohydrolase (PARG) is an enzyme that catalyzes the removal of poly-ADP-ribose (PAR) chains from proteins during the DNA damage response. PARG inhibition leads to selective cell death in tumors with underlying replication fork defects, including BRCAm tumors, through a mechanism distinct from PARP inhibition. ETX-19477 is an oral, potent, and selective PARG inhibitor that shows robust preclinical activity in mouse models of ovarian, breast, and gastric cancers. 858 Therapeutics is evaluating ETX-19477 in a Phase 1/2 study in patients with advanced solid tumors at multiple sites in the U.S. For more information on the Phase 1/2 study, please visit: View Source

(Press release, 858 Therapeutics, AUG 18, 2026, View Source;Unresectable-or-Metastatic-Breast-Cancer [SID1234670216])

On August 18, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that management will participate in the H.C. Wainwright 28th Annual Global Investment Conference being held September 14 – 16, 2026.

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Dr. Amit Kumar, Chairman and CEO of Anixa, will deliver a presentation that will be available to view beginning at 7:00 AM ET, Friday, September 11, 2026. Dr. Kumar’s presentation will highlight Anixa’s breast cancer vaccine, being developed in collaboration with Cleveland Clinic, which completed a Phase 1 clinical trial that was funded by the U.S. Department of Defense. The trial met all primary endpoints, including safety, and protocol-defined immune responses were generated in 74% of participants. Preparations are underway for a Phase 2 trial.

Dr. Kumar will also discuss Anixa’s ovarian cancer CAR-T therapy, liraltagene-autoleucel, or lira-cel, which is being evaluated in an ongoing Phase 1 clinical trial in collaboration with Moffitt Cancer Center. Participants in this trial are highly pre-treated, recurrent and resistant ovarian cancer patients, who have failed conventional therapies and are progressing. In the lira-cel trial, dosing has advanced to the fifth and highest cohort evaluated to date, which incorporates lymphodepletion for the first time. No dose-limiting toxicities have been observed in the study to date, and four patients have surpassed one year of survival following treatment, with the longest at approximately 28 months.

"This is an exciting time for Anixa, with our ovarian cancer CAR-T program now dosing at the highest level evaluated in the trial and our breast cancer vaccine advancing toward Phase 2," said Dr. Kumar. "We look forward to sharing our progress in the coming weeks."

Details to view the presentation are as follows:

Event: H.C. Wainwright 28th Annual Global Investment Conference
Date & time: Beginning at 7:00 AM ET, September 11, 2026, and will remain available for 90 days
Webcast: View Source

Management will be available for one-on-one meetings during the conference.

On August 18, 2026 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 autoimmune diseases, solid tumors and hematological malignancies, reported that the Company has been invited to participate in the Evercore 2nd China Biotech Summit, where it presented multiple key R&D highlights during a fireside chat. At the event, the Company presented updated clinical data for ATG–022 (CLDN18.2 antibody–drug conjugate [ADC]). Regarding T–cell engager (TCE) technologies, beyond its previously disclosed proprietary AnTenGager TCE platform, the Company showcased the TriGager TCE platform and multiple TCE functional modules for the first time. This further demonstrates the Company’s complete TCE engineering technology toolbox and illustrates the technical principles behind the TriGager TCE platform. In addition, the Company also introduced ATG–207, a first–in–class αCD3-TGF-β bifunctional fusion protein.

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1. ATG-022（CLDN18.2 ADC）

Latest data from the Phase II CLINCH study: As of June 26, 2026, among patients with moderate to high CLDN18.2 expression (IHC 2+ ≥ 20%) in the 2.4 mg/kg dose cohort, the objective response rate (ORR) was 42.4% (14/33) and the disease control rate (DCR) was 90.9% (30/33), with a median overall survival (mOS) of 12.85 months. In the 1.8 mg/kg dose cohort, the ORR was 46.7% (14/30), the DCR was 86.7% (26/30), and the mOS was not yet reached, with a median follow–up of 14.03 months. One patient in each of the two dose groups achieved a complete response (CR).

Favorable safety profile: Compared with the data cutoff of December 25, 2025, the incidence of Grade ≥3 treatment–related adverse events (TRAEs) in the 1.8 mg/kg dose cohort increased slightly from 19.4% to 21.0%, with only 9.7% of patients experiencing dose reduction due to TRAEs. These data demonstrate that despite more than six months of ongoing treatment follow–up and potential toxin accumulation in vivo, the incidence of Grade ≥3 TRAEs remained stable in the 1.8 mg/kg dose cohort. This favorable safety profile supports the combination of ATG–022 with chemotherapy and anti-PD-1 antibodies in the first–line setting, enabling the full therapeutic potential of ATG–022.

mOS not yet reached in the 1.8 mg/kg dose cohort: With a median follow–up of 14.03 months, mOS was not yet reached for the 1.8 mg/kg dose cohort, which further validates that ATG–022 can deliver durable long–term survival benefits for patients across all levels of CLDN18.2 expression.

Advancing clinical development across 1L to 3L gastric cancer: Antengene is currently conducting the Phase II CLINCH study, the Ib/II CLINCH–2 study, and the pivotal Phase III CLINCH–3 study of ATG–022 in Mainland of China and Australia. The Company continues to advance the clinical development of ATG-022 across different lines of gastric cancer treatment, including first-line therapy in combination with anti-PD-1 antibodies and chemotherapy (CAPOX/FOLFOX); second-line therapy in combination with anti-PD-1 antibodies; and third-line therapy as monotherapy. In addition, the CLINCH study of ATG-022 includes a basket trial cohort evaluating multiple tumor types, with the majority of patients continuing to receive treatment.
2. AnTenGager & TriGager TCE Platform

There is no universal template for designing TCE molecules across diverse targets and indications. Therapeutic potential can only be unlocked by striking a precise balance between efficacy and safety. To this end, the Company has built a comprehensive TCE engineering technology system, including proprietary platforms such as AnTenGager and TriGager, along with multiple functional modules, forming a flexible and customizable "technology toolbox". Leveraging this system, the R&D team can perform modular assembly and customized design of molecular structures based on the biological characteristics of different targets. This approach improves development efficiency while providing robust technical support for differentiated clinical strategies.

AnTenGager TCE platform: AnTenGager is Antengene’s proprietary, second-generation TCE platform featuring "2+1" bivalent binding for low-expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform’s broad applicability across autoimmune diseases, solid tumors and hematological malignancies indications. Leveraging this platform, Antengene has built a pipeline of multiple drug candidates, two of which have been out-licensed under exclusive license agreements:
ATG-201 (CD19 x CD3 TCE)：A global exclusive license agreement has been entered into with UCB. The Company has received USD 60 million upfront payment from UCB to date and is eligible to receive an additional USD 20 million near–term milestone payment, up to approximately USD 1.1 billion in additional milestone payments, as well as tiered royalties on future net sales.

ATG-106（CDH6×CD3 TCE）：An exclusive license agreement has been entered into with K2 Therapeutics, which was established by MPM BioImpact. Subject to satisfaction of certain near–term conditions, Antengene is entitled to upfront and near-term considerations of approximately USD 20 million, up to USD 960.5 million in additional milestone payments, as well as tiered royalties on future net sales.
TriGager TCE platform: TriGager is Antengene’s proprietary tri–specific TCE platform with steric hindrance masking technology, enabling the construction of diverse logic–gate molecules including AND–Gate, True AND–Gate and OR–Gate. AND–Gate and True AND–Gate molecules require target cells to co–express two disease–associated antigens before T–cell–mediated cytotoxicity can be triggered. This mechanism improves target specificity, reduces off–target toxicity, and expands the pool of druggable targets for TCE modalities. By contrast, OR–Gate molecules trigger T–cell–mediated killing upon recognition of either one of the disease–associated antigens, better addressing target–expression heterogeneity. Meanwhile, the platform supports incorporation of an engineered CD2 co–stimulatory moiety, which optimizes molecular developability, enhances TCE potency, and mitigates the risk of CRS, balancing efficacy and safety.
The Company also presented ATG–207, a globally first-in-class αCD3-TGF-β bifunctional fusion protein being developed for the treatment of T cell–mediated autoimmune diseases, and first disclosed its preclinical data at the 2026 European Congress of Rheumatology (EULAR 2026).

(Press release, Antengene, AUG 18, 2026, View Source [SID1234670214])

On August 18, 2026 Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other disease areas, reported that the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application for HBM7004 for the treatment of advanced solid tumors.

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HBM7004 is a novel B7H4xCD3 bispecific antibody developed using the Company’s HBICE platform. This bispecific antibody is designed to provide a differentiated approach to cancer immunotherapy with the potential to enhance both efficacy and safety. The development of HBM7004 further demonstrated the HBICE platform’s versatility and plug-and-play advantages. In preclinical studies, HBM7004 demonstrated an intratumor B7H4-dependent T cell activation manner. In multiple animal models, HBM7004 showed strong anti-tumor efficacy, remarkable in vivo stability, and reduced systemic toxicity. Additionally, in preclinical models, HBM7004 exhibited a strong synergistic effect when combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, indicating an encouraging therapeutic window.

"We are very pleased to receive NMPA approval of IND application for HBM7004, which marks another important milestone in our commitment to advancing novel immunotherapies for patients with advanced solid tumors," said Dr. Jingsong Wang, Founder, Chairman and Chief Executive Officer of Harbour BioMed. "This approval, together with the recent FDA clearance, underscores the strength of our HBICE platform and its ability to generate differentiated bispecific candidates with promising preclinical profiles. We are now one step closer to bringing HBM7004 into the clinic in China, and we look forward to advancing this program to address the needs of cancer patients with limited treatment options."

(Press release, Harbour BioMed, AUG 18, 2026, View Source [SID1234670213])

On August 18, 2026 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a pioneering company in computational chemistry, specializing in the generative design of small molecules for the pharmaceutical and agricultural industries, reported its financial results for the first half of 2026 and second quarter ended June 30, 2026, and provided an update on its strategic and operational progress.

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Strategic Transformation Delivering Measurable Progress

Over the past 18 months, Evogene has undergone a significant strategic transformation, focused on establishing the Company as a lean, AI-driven leader in computational chemistry for pharmaceutical and crop protection applications.

As part of this transformation, Evogene has significantly streamlined its operations, reduced its workforce from 117 employees in December 2024 to 38 in August 2026, substantially reduced operating expenses, and realigned its portfolio toward activities with significant commercial potential.

The Company expects full-year 2026 cash usage to be approximately $8.5 million to $9.5 million, compared with approximately $14.4 million in 2025 and approximately $20.5 million in 2024, with further reductions targeted for 2027.

Since the beginning of 2025, Evogene has also raised approximately $11.1 million in new capital, strengthening its financial position and providing additional resources to execute its strategic priorities.

Continued Commercial and Technological Momentum

Evogene’s Pharma division continues to demonstrate strong momentum. Since the beginning of 2026, the Company has entered four new drug development collaborations, bringing the total number of active collaborations to six with biotechnology companies and leading academic institutions.

Two of these programs have already completed the initial Hit Identification stage of Evogene’s ChemPass AI computational discovery process, with validation results exceeding partner expectations. Evogene is currently advancing these programs toward subsequent stages of development.

Across these programs, Evogene retains significant commercial rights to the resulting discoveries, providing the potential for future revenue generation as programs progress through development and toward commercialization.

In parallel, Evogene is advancing its internal drug discovery program. The program has successfully completed the Hit-to-Lead stage and progressed into Lead Optimization, where the Company is generating proprietary molecules with the potential to serve as candidates for future preclinical development.

In Agriculture, Evogene continues to advance its crop protection program targeting Septoria, a major fungal disease. The program is approaching completion of the Lead Optimization stage, with synthesized molecules currently undergoing advanced biological testing ahead of greenhouse and field trials.

Major Expansion of ChemPass AI

Evogene continues to substantially expand the capabilities of its core computational platform, ChemPass AI.

Following the Company’s second agreement with Google Cloud, In June Evogene has integrated advanced AI Agents into its computational workflow. These autonomous systems are designed to automate complex research tasks that traditionally required weeks or months of highly specialized scientific work, enabling the company to perform these activities in a matter of minutes.

In July, Evogene has also expanded its portfolio of predictive AI models. Among these is the recently announced Antifungal Potency Predictor (APP), designed to predict the activity of small molecules against fungal pathogens and provide an additional layer of biological prediction beyond target-level interaction.

In addition, this month Evogene has expanded its virtual chemical space from approximately 36 billion to approximately 110 billion molecules, significantly increasing the scope of chemical molecules that can be explored by its computational discovery platform.

Portfolio Optimization and Focus on Core Opportunities

Consistent with its revised strategy, Evogene has substantially reduced or transitioned its non-core activities.

Lavie Bio is no longer operational following the sale of the majority of its assets to ICL. Under the transaction, two additional payments remain due to Lavie Bio and Evogene, with the first received in July 2026 and the second expected in July 2027. In addition, Lavie Bio distributed a $4.25 million dividend to its shareholders during the second quarter, of which Evogene received approximately $2.9 million. Beginning in the second quarter of 2025, Lavie Bio’s results of operations have been presented separately as discontinued operations.

Biomica, following the successful completion of its Phase 1 clinical trial and the licensing of its lead oncology candidate BMC128 to Lishan Pharmaceuticals, is no longer conducting ongoing operations. During the second quarter, Biomica completed a $2.7 million dividend distribution to shareholders, of which Evogene received approximately $1.35 million. Beginning in the second quarter of 2026, Biomica’s results are presented as discontinued operations in the consolidated statements of profit or loss.

Casterra has significantly reduced and realigned its activities and is now focused exclusively on Brazil.

Management Commentary

"We have fundamentally transformed Evogene over the past 18 months," said Ofer Haviv, President and Chief Executive Officer of Evogene. "We have moved from a broad portfolio of activities to a highly focused organization centered on our AI-driven computational chemistry capabilities, while substantially reducing our cost structure and cash requirements."

"At the same time, we are seeing meaningful validation of our technology through new collaborations, progress in our internal drug discovery programs, and major advances in ChemPass AI. The expansion of our virtual chemical space to approximately 110 billion molecules and the integration of autonomous AI Agents represent important steps forward in our ability to discover novel molecules faster and more efficiently."

"Looking ahead, our priorities are clear: advance our existing pharmaceutical and agricultural programs, establish additional collaborations with leading biotechnology and pharmaceutical companies, advance our internal high-value programs, pursue strategic partnerships in agriculture, and continue to strengthen our computational platform."

Nir Nimrodi, Chairman of Evogene’s Board of Directors, added: "The second quarter reflects the significant transformation we have executed across Evogene. We have streamlined the organization, reduced our cash requirements, optimized our portfolio, and concentrated our resources on opportunities with substantial commercial potential."

"The combination of a significantly lower cost base, a stronger financial foundation, growing commercial validation, and rapid technological progress provides Evogene with a substantially more focused platform from which to execute its strategy and create long-term shareholder value."

First Half 2026 and Second Quarter Ended June 30, 2026, Financial Highlights

Cash Position – As of June 30, 2026, Evogene held consolidated cash and cash equivalents of approximately $9.3 million. Consolidated cash usage during the second quarter of 2026 was approximately $2.1 million.
Revenues for the first half of 2026 totaled approximately $0.7 million, compared to approximately $2.9 million in the same period of 2025, representing a decrease of approximately $2.2 million. The decrease is mainly attributable to lower revenue recognized by Casterra, which in the first half of 2025 included significant seed sales of approximately $2.0 million. Revenues for the second quarter of 2026 were approximately $0.3 million, representing a slight decrease compared to approximately $0.5 million in the same period last year, mainly attributable to the conclusion of AgPlenus’ agreement with Bayer in May 2026.
Research and development expenses, net of non-refundable grants, for the first half of 2026 were approximately $2.9 million, compared to approximately $3.5 million in the corresponding period of 2025, representing a decrease of approximately $0.6 million. The decrease is mainly attributable to lower R&D expenses in Casterra and AgPlenus, which were partially shifted to Evogene as the Company redirected its R&D efforts toward activities that are core to, and support the execution of, its new strategy. The decrease in R&D expenses was partially offset by the impact of exchange rate fluctuations between the U.S. dollar and the NIS of approximately $0.4 million. For the second quarter of 2026, R&D expenses were approximately $1.4 million, down from $1.7 million in the same period of 2025. This decrease is mainly attributable to decreased expenses in Casterra, partially offset by increased expenses in Evogene as mentioned above. In addition, the decrease was partially offset by the impact of exchange rate fluctuations between the U.S. dollar and the NIS of approximately $0.2 million.
Sales and marketing expenses for the first half of 2026 and 2025 were approximately $0.7 million, with no material change between the periods. Sales and marketing expenses for the second quarter of 2026 were approximately $0.3 million, a slight decrease from approximately $0.4 million in the second quarter of 2025.
General and administrative expenses for the first half of 2026 decreased slightly to approximately $2.0 million, compared to approximately $2.1 million in the corresponding period of 2025. The decrease in G&A expenses attributable to Evogene and its subsidiaries was substantially offset primarily by the impact of transaction costs related to the warrant inducement transaction and other legal expenses, totaling approximately $0.2 million, as well as by exchange rate fluctuations between the U.S. dollar and the NIS of approximately $0.2 million. General and administrative expenses for the second quarter of 2026 slightly decreased to approximately $0.9 million compared to approximately $1.0 million in the same period of the previous year.
Financing expenses, net, for the first half of 2026 were approximately $1.7 million, compared to financing income, net, of approximately $0.8 million in the corresponding period of 2025.
This change was primarily related to the accounting treatment and revaluation of warrants, including warrants issued in the August 2024 financing and the February 2026 warrant inducement transaction. As part of the February 2026 warrant inducement transaction, the Company recorded financing expenses of approximately $3.8 million during the first half of 2026. In addition, the Company recorded financing income of approximately $2.1 million related to the revaluation of warrants liability as of June 30, 2026. Financing income, net for the second quarter of 2026 was approximately $972 thousand, compared to financing expense, net of approximately $333 thousand in the same period of the previous year. The decrease is mainly associated with the warrants’ accounting treatment as mentioned above.

Loss from discontinued operations, net, for the first half of 2026 was approximately $0.5 million, compared to a loss from discontinued operations, net, of approximately $3.6 million in the corresponding period of 2025. For the second quarter of 2026, the loss from discontinued operations was approximately $0.2 million, compared to approximately $1.7 million in the second quarter of the previous year. These amounts primarily reflect the financial results of Lavie Bio’s and Biomica’s operations, as well as 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. Following the sale of the majority of Lavie Bio’s assets, as well as Evogene’s MicroBoost AI for Ag, to ICL in July 2025 and the licensing agreement with Lishan in February 2026, Lavie Bio’s and Biomica’s operating expense levels have decreased significantly.
Net loss for the first half of each of 2026 and 2025 was approximately $7.7 million, with no material change between the periods. The net loss for the second quarter of 2026 was approximately $1.8 million, compared to approximately $4.7 million in the same period last year. The $2.9 million decrease in net loss was primarily due to decreased operating expenses, decreased loss from discontinued operations and increased financing income, net as mentioned above.

(Press release, Evogene, AUG 18, 2026, View Source [SID1234670212])