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])

On August 18, 2026 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported its 2026 Interim Results.

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Business Highlights

Cash and cash equivalents were around RMB1,400 million as of June 30, 2026. Cash and cash equivalents at the end of 2026 are expected to be not less than RMB1,200 million. In light of operational factors, we expect to have adequate cash into 2030.
During H1, 2026, CARsgen has received a total of 110 confirmed orders of zevor-cel from its commercialization partner Huadong Medicine.
Satri-cel receives NMPA approval in June 2026 as world’s first and only CAR-T for solid tumors. Data of satri-cel as sequential therapy after 1L treatment in patients with G/GEJA have been presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting.
Multiple allogeneic CAR T-cell products are under development based on the proprietary THANK‑u Plus platform. Among them, research results for CT0596 in the treatment of R/R MM and PCL, as well as for CT1190B in the treatment of R/R B‑NHL, have been presented at the EHA (Free EHA Whitepaper)2026 Congress. In August 2026, both products successively received IND approvals from the NMPA.
In vivo CAR T-cell products are under development based on the proprietary CARvivo platform. An IIT of KJ‑C2529, which targets CD19/CD20 for the treatment of B‑cell malignancies, has been initiated.
Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "In the first half of 2026, CARsgen achieved a historic breakthrough—satri-cel became the world’s first approved CAR‑T product for solid tumors. This milestone not only validates our decade‑long dedication and persistence in the solid tumor field, but also underscores our leading position in the global CAR T-cell therapy landscape. Meanwhile, the commercialization of zevor-cel is progressing steadily, with continuous improvements to the diversified payment system and increasing product accessibility. The Company maintains a sound financial position, and our ample cash reserves provide a solid foundation for our ongoing global expansion, advancement into earlier lines of treatment, and development of next‑generation allogeneic/in vivo CAR‑T technologies. Looking ahead, we will remain true to our founding mission of ‘Making Cancer Curable,’ accelerate forward‑looking therapeutic explorations, and actively expand into both domestic and international markets, bringing more innovative CAR T-cell therapy products to cancer patients worldwide."

Financial Highlights

CARsgen’s revenue was around RMB62 million for the six months ended June 30, 2026 mainly from zevorcabtagene autoleucel (an autologous BCMA CAR T-cell product), in which the primary revenue of zevorcabtagene autoleucel was calculated on the basis of ex-works price, rather than on the basis of end-of-market prices. Our revenue is recognized upon completion of ex-works delivery of products. Due to the inherent time cycle of CAR-T manufacturing, there is a discrepancy between the number of orders obtained from Huadong Medicine and number of ex-works deliveries. CARsgen’s gross profit was around RMB42 million for the six months ended June 30, 2026. In the commercialization stage, we are demonstrating a strong cost competitive advantage, which is mainly due to self-manufacture for plasmids and vectors with stable output and high yield per batch.

Cash and cash equivalents were around RMB1,400 million as of June 30, 2026. Cash and cash equivalents at the end of 2026 are expected to be not less than RMB1,200 million. In light of operational factors, we expect to have adequate cash into 2030.

Steady Commercialization Progress of Zevor-cel

Zevorcabtagene autoleucel (zevor-cel, R&D code: CT053) is an autologous fully human CAR T-cell product against B-cell maturation antigen (BCMA) approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent) in 2024. In December 2025, zevor-cel was included in China’s Commercial Health Insurance Innovative Drug Catalogue (2025).

CARsgen entered into a collaboration agreement with Huadong Medicine (000963.SZ) for the commercialization of zevor-cel in Chinese Mainland. In terms of commercialization, Huadong Medicine has established a dedicated, professional, and comprehensive commercial team to promote the use of zevor-cel and has been utilizing China’s multi-layered insurance system to improve patient accessibility. During the first half of 2026, certification and regulatory filings for zevor-cel have been completed in more than 20 provinces or cities and we have received a total of 110 confirmed orders from Huadong Medicine.

Satri-cel Receives NMPA Approval as World’s First CAR-T for Solid Tumors

Satricabtagene autoleucel (satri-cel, R&D code: CT041) is a world’s first-in-class, autologous humanized CAR T-cell product against Claudin18.2. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on gastric/gastroesophageal junction cancer (G/GEJA) and pancreatic cancer (PC).

The New Drug Application (NDA) for satri-cel was approved by NMPA for patients with Claudin18.2-positive, HER2-negative advanced G/GEJA who have failed at least two prior lines of therapy in China in June 2026. This marks the world’s first and only approved CAR T-cell therapy for solid tumor treatment. The approval is supported by confirmatory Phase II trial (CT041-ST-01, NCT04581473) data, published in The Lancet and presented as an oral presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting in June 2025.

The latest clinical data of a case report on long-term peritoneal metastasis control in 3 patients with advanced gastric cancer treated with satri-cel monotherapy has been published in the Journal of Hematology & Oncology in July 2026. All patients achieved both clinical and radiographic benefits post-treatment, with durable control of peritoneal disease observed. The maximum follow-up period reached 48 months, significantly outperforming the historical survival data for patients with gastric cancer and peritoneal metastasis and demonstrating remarkable potential to fundamentally alter the natural course of the disease.

To translate this landmark clinical value into commercial impact, we have established a competitive in-house commercial team to lead domestic sales. Backed by deep oncology domain expertise and proven clinical promotion experience, the team is well positioned to drive efficient hospital access and product commercialization. In the early commercialization phase, we will prioritize satri-cel rollout across leading oncology hospitals and cell therapy centers at top-tier general hospitals nationwide. Leveraging expert collaborations, we will rapidly set clinical benchmarks and build market recognition.

Satri-cel has been included in 2026 China Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Gastric Cancer issued by CSCO, and China Anti-Cancer Association (CACA) Guidelines for Commercial Insurance Application of Innovative Oncology Diagnosis and Treatment Technology issued by the CACA. Satri-cel also passed preliminary formal review for 2026 National Commercial Insurance Innovative Drug Catalogue. The multi-payment system is to be established to reduce the financial burden of Chinese patients.

After satri-cel received marketing approval from the NMPA, the Company persistently pushes forward its global development strategy. Prioritizing key regions with high unmet medical needs and accessible regulatory pathways, the Company will adopt diversified overseas development models, with core overseas markets and major regional hubs listed as the top priorities for registration expansion. The Company plans to conduct well-planned marketing authorization filings in selected regional hub markets, aiming to harness the radiating advantages of these hubs to establish a firm foundation for commercial launches in various regions going forward.

Building on its proven clinical benefit in later-line populations, satri-cel is being actively advanced into earlier lines of therapy and perioperative care to unlock deeper therapeutic value. The Company is actively expanding satri-cel application in early-line treatment and perioperative treatment of cancer: including an ongoing Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an IIT for consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786) and an IIT for sequential therapy following first-line treatment for G/GEJA (CT041-CG4011, NCT07179484).

Promising data for early line treatment have been presented at top global oncology congresses. The long-term analysis results of satri-cel, as sequential therapy after first-line treatment in patients with advanced G/GEJA, have been presented as a poster presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting. Two patients received satri-cel infusions following first-line sequential therapy and subsequently underwent surgery; one had an OS of more than 58 months, and the other had an OS of more than 51 months. We believe satri-cel has tremendous room for value growth as it moves into earlier lines of care, with the potential to redefine standard of care and bring long-term survival benefits to a wider patient population.

Robust Pipeline of Allogeneic CAR T-Cell Products

In addition to autologous products, CARsgen has also been advancing differentiated allogeneic CAR-T-cell products utilizing the THANK-u Plus platform, an update version of THANK-uCAR technology platform.

CT0596 is a BCMA-targeting allogeneic CAR T-cell product candidate deploying our THANK-u Plus technology. IITs have been initiated in China to evaluate the safety and efficacy of CT0596 for the treatment of R/R MM and plasma cell leukemia (PCL). In August 2026, the IND clearance was achieved from NMPA in China for R/R MM. CT0596 will initiate a Phase I registrational trial. Updated IIT results have been presented at the 2026 Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) ("EHA") in June 2026.

CT1190B (KJ-C2219) is an allogeneic CAR T-cell product candidate targeting CD19/CD20 deploying our THANK-u Plus technology, for B-cell malignancies. IITs for refractory/relapsed B-cell non-Hodgkin lymphoma (R/R B-NHL) have been initiated. In August 2026, the IND clearance was achieved from NMPA in China for the treatment of patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) who have failed at least two prior lines of standard therapy. CT1190B will initiate a Phase I registrational trial. Updated IIT results have been presented at the 2026 Annual Congress of the EHA (Free EHA Whitepaper) in June 2026.

In addition, multiple products against different targets are currently under development: CT1390B against CLL1 for AML; KJ-C2526 against NKG2DL for AML, other malignancies and senescence; KJ-C2527 against Claudin18.2 for G/GEJA, etc.; KJ-C2630 against GPC3 for hepatocellular carcinoma (HCC), etc.

Development of In Vivo CAR T-Cell Products

CARsgen is developing a portfolio of differentiated in vivo CAR T-cell product candidates based on the proprietary CARvivo platform, featuring self-developed, patent-protected viral envelopes and T-cell-specific promoters. The platform achieves exceptionally high transduction efficiency and robust cell-type specificity, which reduces the risk of off-target transduction in tumor cells and lowers the incidence of antigen masking and therapeutic resistance.

KJ-C2529 is an in vivo CAR T-cell product candidate against CD19/CD20 deploying our CARvivo platform for the treatment of B-cell lymphoma. An IIT has been initiated in 2026 for the treatment of R/R B-NHL.

Other in vivo CAR T-cell products currently being developed include KJ-C2632 against BCMA/GPRC5D for R/R MM; KJ-C2633 against CD19/BCMA for R/R MM and autoimmune disease; KJ-C2634 against Claudin18.2 for G/GEJA, etc.; KJ-C2635 against GPC3 for HCC, etc.

(Press release, Carsgen Therapeutics, AUG 18, 2026, View Source [SID1234670211])

On August 18, 2026 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, reported it has commenced finalization of a clinical trial protocol and will conduct a feasibility assessment for its First-In-Human (FIH), Phase 1b clinical study of PRP in up to 40 advanced cancer patients suffering from solid tumors. Preparatory activities for the multi-trial center investigation will be led by Avance Clinical Pty Ltd and will consist of a detailed review of the Company’s Investigator’s Brochure (IB), preparation of a Briefing Document from the IB, as well as finalization of a Clinical Trial Protocol using the jointly prepared Clinical Trial Synopsis which summarizes the design of the 40-patient study. The documents will be provided to Investigators in Clinical Trial Centers located across Australia for the world-first study to obtain detailed and thorough feedback as part of a feasibility assessment prior to the submission of a Clinical Trial Application planned for Q4 this year.

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The world-first clinical study is a Phase 1b, open‑label, dose escalation and dose expansion study of PRP in patients with advanced solid tumors. It will consist of a multicenter, open-label, two-part (dose escalation, Part A, and dose expansion, Part B) study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of PRP in participants with advanced solid tumors. PRP will be administered as a weekly intravenous (IV) infusion (Days 1, 8, 15 and 22 of every 28-day treatment cycle). Treatment with PRP may continue until a withdrawal criterion is met. Part A will use a Bayesian Optimal Interval (BOIN) design with target dose limiting toxicity (DLT) probability, with backfill (BF) allowed (BF-BOIN), to identify the maximum tolerated dose (MTD), if reached, and/or up to two recommended doses for optimization/expansion (RDO) of PRP. Up to 5 dose levels are planned for escalation. Following determination of the RDO(s) in Part A, Part B will further evaluate the safety, tolerability, and preliminary antitumor activity of PRP at the selected doses into one or more tumor specific expansion cohorts.

"The Feasibility Assessment in preparation of our FIH, Phase1b clinical study for PRP is a major step towards a significant, transformative milestone for the Company in the advancement of a first-in-class therapy for the treatment and prevention of metastatic cancer from solid tumors, such as pancreatic, ovarian and refractory prostate cancers," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "The design of the Phase 1b study has been undertaken with the Company’s research and development team, our partners, and will be ably led by the Company’s appointed CRO, Avance Clinical, who have extensive experience in this field. Many hours have been spent so far preparing the Company’s supporting documents and it reflects the hard work and dedication for nearly two decades incorporating scientific research, non-clinical and clinical evidence, formulation development and API (active pharmaceutical ingredient) purification, and manufacturing process development to be ready for the Phase 1b study. We look forward to further announcements as we advance towards the submission of the CTA (Clinical Trial Application) and commencement of the GMP manufacture of PRP this year. I have every confidence these activities will result in significant anticipatory interest among the medical and scientific communities with a world-first therapeutic that reverses the malignancy of cancer cells and leaves healthy cells intact, free from side effects often observed with standard treatment regimen, whilst preventing cancer from returning and spreading. Metastatic cancer remains the single most common cause of death among sufferers from solid tumors."

(Press release, Propanc, AUG 18, 2026, View Source [SID1234670208])

On August 18, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported that it has received written feedback from the U.S. Food and Drug Administration ("FDA") regarding the design of a potential pivotal Part B expansion of REO 033, the Company’s ongoing randomized study evaluating pelareorep in second-line RAS-mutant, microsatellite stable ("MSS") metastatic colorectal cancer ("REO 033").

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The Company submitted a Type D meeting request to the FDA regarding the potential expansion of REO 033 into a pivotal study. Specifically, Oncolytics sought FDA feedback on the validity of the currently designed REO 033 (Part A) to support expansion of a pivotal Part B, and whether a Part B could support a potential accelerated approval pathway based on objective response rate and duration of response, with progression-free survival serving as the basis for full approval.

The FDA provided written responses that the Company believes represent important alignment regarding the proposed pivotal study design. The FDA also suggested that the Company hold an End-of-Phase meeting to reach final agreement on key elements of the registration program. Based on the substantive written feedback and alignment with the FDA regarding the Company’s immediate development plans for pelareorep in colorectal cancer, Oncolytics elected to forego its scheduled Type D meeting and intends to pursue an End-of-Phase meeting with the FDA as the program advances.

"We are thrilled with the response provided by the FDA and believe this feedback could support a highly efficient path to potentially transition REO 033 from its ongoing randomized Part A directly into a pivotal Part B," said Jared Kelly, Chief Executive Officer of Oncolytics. "Importantly, the feedback provides alignment around the potential use of response rate to support an accelerated approval pathway and progression-free survival to support full approval. We appreciate the FDA’s thoughtful and clear guidance, which allows us to efficiently plan the next stage of development while continuing to generate the Part A clinical data that will inform our decision to launch Part B."

REO 033 is currently evaluating pelareorep in combination with standard-of-care therapy in patients with second-line RAS-mutant, MSS metastatic colorectal cancer. The study was designed to allow for expansion into a pivotal Part B if supported by the clinical results observed in Part A and regulatory feedback. Based on the FDA’s written feedback, Oncolytics plans to minimize the time between the generation of supportive Part A data and initiation of Part B by launching Part B start-up activities as soon as positive interim Part A data are available.

Prior clinical data with pelareorep in metastatic colorectal cancer, including results from REO 022, demonstrated encouraging improvements in objective response rate, duration of response, progression- free survival and overall survival in patients receiving pelareorep-containing therapy combined with the current standard of care. Pelareorep combination therapy has received Fast Track designation from the FDA in this patient population.

About REO 033
REO 033 is a randomized controlled clinical trial evaluating pelareorep in combination with folinic acid, fluorouracil and irinotecan ("FOLFIRI") and bevacizumab versus FOLFIRI and bevacizumab alone in patients with second-line RAS-mutant, microsatellite stable metastatic colorectal cancer (link to study on ClinicalTrials.gov). The study is designed to confirm the encouraging efficacy signals observed in REO 022 while generating the controlled clinical data necessary to support future regulatory interactions and potential registration.

The ongoing Part A (n=60) is designed to evaluate the clinical activity of pelareorep and provide data to inform the potential transition into a pivotal Part B. Following the FDA’s written feedback, the Company intends to continue preparations for Part B and expects to determine whether to launch the pivotal expansion following the availability of initial clinical data from Part A.

About Pelareorep
Pelareorep is an intravenously delivered, systemically active, investigational immunotherapy with a dual mechanism of action that selectively replicates in tumor cells while activating both innate and adaptive anti-tumor immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes. It has been administered to over 1,200 patients, and clinical studies have demonstrated pelareorep’s potential to enhance the activity of checkpoint inhibitors and other anti-cancer therapies across multiple solid tumor types.

(Press release, Oncolytics Biotech, AUG 18, 2026, View Source [SID1234670207])