On August 18, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel RNA splicing modulator payloads, reported new preclinical data demonstrating the potential of AKTX-101, the Company’s proprietary TROP2-targeted ADC utilizing its novel PH1 RNA spliceosome modulating payload, as a differentiated therapeutic approach for urothelial cancer in disease settings where currently available ADC therapies may have limited clinical benefit.

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The findings demonstrated meaningful anti-tumor activity across multiple clinically relevant urothelial cancer preclinical models including advanced urothelial cancer with limited response to currently approved ADC therapy, and tumors with acquired resistance following treatment with a first-generation TROP2-directed ADC. Collectively, the data provide additional validation for Akari’s strategy of developing ADCs with a differentiated payload mechanism designed to address emerging limitations associated with existing ADC payload classes, such as microtubule and topoisomerase 1 inhibitors.

"ADC therapies have transformed the treatment landscape across oncology, but the next wave of innovation will require advances beyond conventional payloads classes used with currently approved ADCs," said Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics. "As ADCs continue moving earlier in the treatment paradigm, more patients will ultimately require additional treatment following relapse, thus creating an urgent need for differentiated payload technologies capable of overcoming resistance and enabling effective ADC payload sequencing strategies. We believe our proprietary PH1 RNA spliceosome modulating payload has the potential to address this important challenge, and these new preclinical findings further strengthen our confidence in AKTX-101 as we advance the program toward Phase 1 development."

Urothelial cancer has become one of the fastest-growing categories for ADC therapy, with Padcev (enfortumab vedotin) representing > $3.5B in annual sales. Despite these advances, patients that relapse after receiving PADCEV continue to face significant unmet medical needs and limited treatment options. As the use of ADCs expands, developing novel payload mechanisms capable of maintaining anti-tumor activity following prior ADC exposure has become an increasingly important priority across the oncology field.

In Akari’s most recent preclinical studies, AKTX-101 demonstrated encouraging activity across multiple urothelial cancer models designed to evaluate its potential therapeutic profile across different clinical settings, including:

Demonstrated statistically significant anti-tumor activity in the UM-UC-14 advanced urothelial carcinoma model, which represents metastatic urothelial cancer, a setting where Padcev (enfortumab vedotin) is currently approved as first-line therapy. While Padcev had limited responsiveness on the tumor in this model, AKTX-101 achieved statistically significant tumor growth inhibition compared with vehicle, supporting the potential of its differentiated payload mechanism in settings where current ADC payloads may have reduced effectiveness.
Demonstrated encouraging activity following acquired resistance to the first-generation TROP2-directed ADC Trodelvy (sacituzumab govitecan). Tumors initially treated with Trodelvy subsequently developed resistance and resumed growth. When these resistant tumors were switched from Trodelvy to AKTX-101, tumor growth was again slowed, suggesting that resistance was associated with the Topoisomerase I payload, and that the AKTX-101 PH1 payload mechanism of disrupting RNA splicing can be effective in this resistant setting. These findings support the potential for AKTX-101’s novel PH1 payload to provide therapeutic benefit following prior treatment with first-generation TROP2 ADCs in several areas where these ADCs are currently approved, including potentially breast and lung cancers.
"One of the most important questions facing the ADC field today is how best to treat patients after progression on prior ADC therapies," said Satyajit Mitra, Ph.D., Head of Oncology R&D at Akari Therapeutics. "The activity we observed in tumors that have developed resistance to Trodelvy is particularly encouraging because it suggests resistance may be driven by the payload rather than loss of the TROP2 target itself. These findings provide compelling support for our hypothesis that introducing a differentiated payload mechanism may overcome payload-specific resistance while preserving target tumor engagement, reinforcing the potential of our PH1 platform to address an increasingly important unmet need in oncology."

Akari continues to advance IND-enabling activities for AKTX-101 with the goal of initiating a Phase 1 clinical trial in mid-2027. The Company is also expanding development opportunities for its proprietary PH1 payload platform through additional tumor-specific programs and strategic collaborations designed to maximize the platform’s long-term clinical and commercial potential.

(Press release, Akari Therapeutics, AUG 18, 2026, View Source [SID1234670205])

On August 18, 2026 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), the global leader in precision targeting of PRAME with multiple clinical-stage programs spanning cell therapies and bispecifics, reported a business update and announced financial results for the quarter ended June 30, 2026.

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"The Phase 3 SUPRAME trial continues to enroll patients on schedule across sites in North America and Europe. In parallel, the data from the Phase 1b anzu-cel study continue to mature. We are now observing that aggregate progression and death events in the SUPRAME trial are occurring more slowly than originally modeled. Based on these results and FDA feedback, we plan to proceed directly to a streamlined final analysis, while maintaining robust statistical power for the primary PFS endpoint," said Harpreet Singh, Ph.D., Chief Executive Officer and Co-Founder of Immatics. "We believe this approach provides the most efficient path to generating definitive data for regulatory approval and look forward to reporting topline results in the first half of 2027. We continue to build the foundation for the commercial launch to bring anzu-cel to patients who urgently need new treatment options, while advancing the PRAME franchise across our pipeline."

Second Quarter 2026 and Subsequent Company Progress

PRAME Franchise – Cell Therapy

Anzu-cel (IMA203) PRAME Cell Therapy – First Market Entry in Advanced Melanoma

Anzu-cel (anzutresgene autoleucel), previously called IMA203, is Immatics’ lead PRAME cell therapy and is expected to be the Company’s first PRAME therapy to enter the market in advanced melanoma. The current addressable patient population for anzu-cel’s first target indications, second-line or later (2L) advanced cutaneous melanoma, as well as metastatic uveal melanoma includes ~9,000 patients.

Phase 3 trial, SUPRAME, for anzu-cel (IMA203) in previously treated, advanced melanoma

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Immatics’ global, randomized, controlled, multi-center Phase 3 clinical trial, SUPRAME, is currently ongoing to evaluate the efficacy, safety and tolerability of anzu-cel PRAME cell therapy as monotherapy vs. investigator’s choice in patients with unresectable or metastatic melanoma who have received prior treatment with a PD-1 immune checkpoint inhibitor. Anzu-cel received FDA Orphan Drug Designation and FDA RMAT designation, which includes all benefits of FDA Breakthrough Therapy Designation.
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SUPRAME is designed to be an adequate and well-controlled clinical trial to generate the data supporting full regulatory approval of anzu-cel.
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The primary endpoint for SUPRAME is blinded independent central review ("BICR")-assessed (RECIST v1.1) progression-free survival (PFS). Key secondary endpoints include overall survival (OS), objective response rate (ORR), safety and patient-reported outcomes measuring quality of life.
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Enrollment in SUPRAME, currently ongoing in North America and Europe, remains on track to complete required randomizations by year-end to support final analysis for the primary endpoint.
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The aggregate number of PFS events (progressive disease or death) in the SUPRAME trial is occurring more slowly than originally modeled.
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As a result, Immatics intends to replace the previously planned interim and final PFS analyses with a single streamlined final analysis, now based on a lower prespecified number of PFS events while maintaining a robust power of 90% for the primary endpoint.
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At the same time, Immatics intends to increase the statistical power for the secondary endpoint of OS by enrolling approximately 90 additional patients, bringing the total trial size to approximately 450 patients. This aims to further strengthen the commercial product profile of anzu-cel. The increased number of events needed for the final OS analysis has no impact on the timing of the final PFS analysis.
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These planned protocol amendments are based on feedback from the FDA following recent interaction with the agency, with whom Immatics continues to engage.
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The Company expects to disclose topline data from the final PFS analysis in the first half of 2027, followed by a BLA submission in 2027.
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The Company continues to build the commercial infrastructure for the anticipated launch of anzu-cel after obtaining BLA approval.

Phase 1/2 trial for anzu-cel (IMA203) in previously treated, metastatic melanoma

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Updated Phase 1b clinical data presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting showed durable anti-tumor activity at longer follow-up in metastatic melanoma, including 56% confirmed ORR, 14.6 months mDOR, 6.1 months mPFS and 16.2 months mOS. The OS rate was 70% at 12 months and 46% at 24 months. Anzu-cel maintained a predictable and manageable tolerability profile. Explorative analyses focusing on predictors of durable response have been accepted for presentation at the ESMO (Free ESMO Whitepaper) Congress 2026.

Phase 2 cohort for anzu-cel (IMA203) PRAME cell therapy in patients with metastatic uveal melanoma

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A Phase 2 cohort to treat approximately 30 additional patients with metastatic uveal melanoma is ongoing and being conducted at select centers in the U.S. and Germany with expertise in uveal melanoma.
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Data from the ongoing single-arm Phase 1b trial as well as the Phase 2 cohort in metastatic uveal melanoma are intended to support a potential label expansion for anzu-cel following expected initial approval in unresectable or metastatic melanoma.

IMA203CD8 PRAME Cell Therapy – Expansion to All Advanced PRAME Cancers

IMA203CD8 is the Company’s PRAME cell therapy product candidate being developed with the goal of expanding into all advanced PRAME cancers. Given its enhanced pharmacology profile, the Company intends to pursue the clinical development of this product candidate with a tumor-agnostic approach, including gynecologic cancers (ovarian and uterine).

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Updated Phase 1 data in hard-to-treat gynecologic cancers presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrated anti-tumor activity at clinically relevant doses, including 63% ORR and 50% confirmed ORR, four complete responses and the longest ongoing response at 12 months. Additional data in synovial sarcoma showed a 67% ORR and 64% confirmed ORR, including one complete response and ongoing responses for up to approximately three years. IMA203CD8 demonstrated a manageable and consistent tolerability profile across patient populations.
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The clinical activity observed to date across tumor types (ovarian carcinoma, uterine cancer, melanoma, synovial sarcoma) with distinct biology and differing levels of PRAME expression supports the broad applicability of IMA203CD8 across solid tumors.
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The Company completed Phase 1a dose escalation as planned in mid-2026.
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Updated Phase 1 data from IMA203CD8 across multiple PRAME-positive solid tumors will be presented at ESMO (Free ESMO Whitepaper) Congress 2026.
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In addition to its broad expression across more than 50 adult cancer types, PRAME is highly prevalent in multiple pediatric cancers. A case report published in the New England Journal of Medicine3 highlights the therapeutic potential of PRAME TCR T-cell therapy in pediatric patients with solid tumors. Immatics intends to support further clinical evaluation in this population by manufacturing and supplying IMA203CD8 PRAME TCR T-cell therapy for the planned investigator-initiated Phase 1/2 PRAMEtime trial at Hopp Children’s Cancer Center Heidelberg (KiTZ), Germany.

PRAME Franchise – Bispecifics

IMA402 PRAME Bispecific – Expansion to Earlier-Line PRAME Cancers

To expand the PRAME opportunity to earlier-line PRAME cancers, the Company is developing its off-the-shelf, next-generation, half-life extended TCR bispecific, IMA402, as a monotherapy or in combination with standard of care, with a focus on melanoma and gynecologic cancers. In addition, Immatics is exploring the combination of IMA402 PRAME bispecific with IMA401 MAGEA4/8 bispecific in squamous non-small cell lung cancer (sqNSCLC) and potentially other solid tumor indications.

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IMA402 PRAME bispecific showed clinical proof-of-concept during the Phase 1a dose escalation trial in heavily pre-treated patients with solid tumors, including melanoma and ovarian cancer.
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As part of its strategy to maximize IMA402 opportunity, the Company opened additional Phase 1b cohorts in mid-2026 across both earlier and later treatment lines and is currently evaluating IMA402 as monotherapy and in combination with immune checkpoint inhibitors.
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Phase 1b data from IMA402 at the RP2D range across multiple cancers will be presented at ESMO (Free ESMO Whitepaper) Congress 2026.
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Based on the initial promising activity of IMA401 in head and neck cancer and sqNSCLC presented at ASCO (Free ASCO Whitepaper) 2026 and published simultaneously in Nature Medicine, Immatics has initiated a Phase 1b cohort evaluating IMA402 targeting PRAME in combination with IMA401 targeting MAGEA4/8 in sqNSCLC at multiple clinical trial sites. First data from the IMA402/IMA401 combination cohort are expected in 2027.Corporate Development:

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In collaboration, Moderna and Immatics discovered a cancer antigen therapeutic candidate (mRNA-4200) under the Database Program, incorporating targets identified using Immatics’ XPRESIDENT target discovery and validation platform and its bioinformatics and AI platform XCUBE. The first patient in the clinical trial sponsored by Moderna was dosed in July, 2026, marking a key clinical milestone and triggering a milestone payment to Immatics.
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Immatics’ General Counsel and Corporate Secretary, Edward Sturchio, has decided to transition out of the Company to pursue other opportunities after more than six years with Immatics. He played a key role in supporting the Company through its transition to a public company and pre-commercial growth stage.
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Effective July 20, 2026, Jim Pepin has been appointed as General Counsel and Corporate Secretary and joined Immatics’ Executive Team. Mr. Pepin brings more than 20 years of legal leadership experience across life sciences and consumer health industries, with expertise spanning public-company governance, compliance, transactions and intellectual property strategy. Most recently, he served as General Counsel of Legend Biotech, a global commercial-stage cell therapy company, and previously served as General Counsel and Corporate Secretary at Aimmune Therapeutics and Nestlé Health Science USA.

Second Quarter 2026 Financial Results

Cash Position: Cash and cash equivalents, as well as other financial assets, total $448.2 million1 (€393.4 million) as of June 30, 2026, compared to $534.7 million1 (€469.3 million) as of December 31, 2025. The decrease is the result of ongoing research and development activities, partially offset by the net proceeds of an at-the-market offering of $24.2 million1 (€21.2 million) as well as changes in net working capital and foreign exchange rate differences.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was $10.4 million1 (€9.1 million) for the three months ended June 30, 2026, compared to $5.4 million1 (€4.7 million) for the three months ended June 30, 2025. The increase is mainly due to a higher level of activity and proportion of costs incurred relative to the overall plan of collaboration activities within the quarter.

Research and Development Expenses: R&D expenses were $71.1 million1 (€62.4 million) for the three months ended June 30, 2026, compared to $51.4 million1 (€45.1 million) for the three months ended June 30, 2025. The increase mainly resulted from costs associated with advancing the product candidates in clinical trials, particularly the SUPRAME trial.

General and Administrative Expenses: G&A expenses were $15.8 million1 (€13.9 million) for the three months ended June 30, 2026, compared to $14.6 million1 (€12.8 million) for the three months ended June 30, 2025. The increase mainly results from activities in preparation for commercialization.

Net Profit and Loss: Net loss was $71.2 million1 (€62.5 million) for the three months ended June 30, 2026, compared to a net loss of $80.1 million1 (€70.3 million) for the three months ended June 30, 2025. The decrease is mainly driven by unrealized non-cash foreign exchange rate losses during the three months ended June 30, 2025, and to a lesser extent by higher collaboration revenue, partially offset by higher costs associated with the SUPRAME trial in the three months ended June 30, 2026.

Full financial statements can be found in our Report on Form 6-K filed with the Securities and Exchange Commission (SEC) on August 18, 2026, and published on the SEC website under www.sec.gov.

Upcoming Investor Conferences

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Jefferies Global Healthcare Conference, London, United Kingdom – November 16 – 19, 2026

To see the full list of events and presentations, visit: View Source

About PRAME

PRAME is a tumor-associated target expressed in more than 50 cancers. Immatics’ PRAME franchise includes multiple product candidates, therapeutic modalities, indications and combination approaches: anzu-cel (anzutresgene autoleucel; IMA203) and IMA203CD8, both PRAME-directed cell therapies, and IMA402, a PRAME-directed bispecific. Combination approaches include IMA402 with immune checkpoint inhibitors, IMA402 with the MAGEA4/8-directed bispecific IMA401, and anzu-cel in combination with Moderna’s PRAME mRNA therapy designed to enhance the cell therapy response.

(Press release, Immatics, AUG 18, 2026, View Source [SID1234670206])

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])

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 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])