stenoparib (2X-121) / Allarity Therap, Oncoheroes, Eisai - LARVOL DELTA

Allarity Therapeutics…announced that the Japan Patent Office (JPO) has granted a key patent covering Allarity’s proprietary stenoparib-specific Drug Response Predictor (DRP) companion diagnostic (GlobeNewswire) - "The newly granted patent, Japanese Patent No. 7917283, provides protection in Japan into 2039....This award of the patented patent is critical to securing stenoparib’s developability in one of the world’s most important pharmaceutical markets....Allarity has previously secured patent protection for the stenoparib DRP in the United States, with protection extending into April 2042, as well as in certain European jurisdictions and Australia. Related patent applications remain pending in additional international markets."

Patent • Oncology • Ovarian Cancer

Allarity Therapeutics…announced that it has obtained a Certificate of Registration under the Clinical Laboratory Improvement Amendments (CLIA) for its in-house laboratory (GlobeNewswire) - "With a wholly owned CLIA-certified facility located in Horsholm, Denmark, Allarity will now be able to do all necessary testing in-house to support the acceleration of stenoparib toward FDA registration. Importantly, Allarity will no longer need to rely on external partner labs to do this testing. This transition will significantly reduce turnaround times for DRP analyses, streamline communication with clinical trial sites, and create significant long-term cost savings for developing stenoparib....Positions Allarity Therapeutics Medical Laboratory as a preferred CLIA-certified partner for European companies pursuing U.S. clinical trials or commercialization."

Commercial • Ovarian Cancer

Allarity Therapeutics…announced that the United States Patent and Trademark Office (USPTO) has granted the key U.S. patent covering its proprietary stenoparib-specific Drug Response Predictor (DRP) companion diagnostic (GlobeNewswire) - "The granted patent covers methods for predicting clinical benefit from stenoparib based on gene-expression profiles derived from tumor samples, as well as methods for selecting patients most likely to benefit from stenoparib treatment using the stenoparib DRP test. The patent protects Allarity’s long-term commercial strategy, allowing exclusivity for stenoparib when used in concert with the stenoparib DRP companion diagnostic in the United States into April 2042. Allarity has also secured patent protection for the stenoparib DRP in Europe and Australia into 2039, with related applications pending in several additional international markets."

Diagnostic • Patent • Ovarian Cancer

NCT03878849: A phase II trial of stenoparib/2X-121, a novel dual inhibitor of PARP and the WNT pathway, in platinum resistant/ineligible ovarian cancer patients (ESMO-Gynae 2026) - P2 | "The optimal dose will be selected based on an integrated analysis of PK/PD, safety, and efficacy data. Enrollment is ongoing in the US and UK."

Clinical • P2 data • Platinum resistant • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • BRCA • BRCA1 • HRD

Allarity Therapeutics to Present Trial-in-Progress Poster on Phase 2 Stenoparib Trial at ESMO Gynaecological Cancers Congress 2026 (GlobeNewswire) - "The poster outlines the scientific background, study design, and clinical rationale for the Company’s ongoing Phase 2 trial evaluating stenoparib in patients with advanced platinum-resistant or platinum-ineligible ovarian cancer."

Platinum resistant • Trial status • Ovarian Cancer

Study of PARPi 2X-121 as Monotherapy and in Combination With Dovitinib in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=14 | Terminated | Sponsor: Allarity Therapeutics | N=40 ➔ 14 | Suspended ➔ Terminated; Sponsor decision.

Enrollment change • Monotherapy • Trial termination • Oncology • Solid Tumor

Allarity Therapeutics CEO to Present at Precision Medicine Forum Europe 2026 in Stockholm (GlobeNewswire) - "Mr. Jensen will discuss stenoparib’s dual mechanism of action and Allarity’s predictive biomarker, the Stenoparib DRP, based on a 414-mRNA gene expression signature, which is designed to identify patients who may be more likely to benefit from stenoparib, as well as the Company’s ongoing Phase 2 trials."

Clinical • Oncology

Allarity Therapeutics Advances Stenoparib Toward Pivotal Development with Phase 3 Manufacturing Campaign (GlobeNewswire) - "The CDMO site, located in Europe, operates in full compliance with GMP (Good Manufacturing Practice) standards set by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)...From a financial standpoint, the company has completed all payments for the manufacturing and no additional cash outlays for manufacturing are anticipated....The ongoing phase 2 trial continues to enroll patients under the new protocol, generating enthusiastic investigator engagement."

Commercial • New P3 trial • Platinum resistant • Trial status • Ovarian Cancer

A Drug Response Predictor (DRP®) is associated with enhanced overall survival in the phase 2 trial in advanced, recurrent ovarian cancer patients treated twice daily with 2X-121/ Stenoparib (NCT03878849) (AACR 2026) - P2 | "Prior treatment included PARP inhibitors, mirvetuxumab, bevacizumab and immunotherapy. These results indicate that the 2X-121 DRP may be a predictive- rather than prognostic- biomarker, highlighting extended OS in patients treated twice daily with 2X-121. A new ph2 clinical trial protocol is currently enrolling platinum-resistant Ovarian Cancer patients to further explore and delineate the relationship between 2X-121 DRP® score and clinical benefit."

Clinical • IO biomarker • Metastases • P2 data • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA

Allarity Therapeutics Announces that the Stenoparib DRP Test Has Received a Notice of Allowance from the US Patent and Trademark Office (GlobeNewswire) - "Importantly, this Notice of Allowance covers multiple claims and represents a major step in Allarity’s global strategy to expand and protect the commercial potential of stenoparib when selecting patients using its proprietary stenoparib DRP test. The patent is expected to be formally granted within three months, subject to standard administrative procedures and would provide exclusivity at least into 2039 for stenoparib when used in concert with the DRP as a companion diagnostic...The allowed claims include methods for predicting clinical benefit based on gene expression profiles derived from tumor samples and for selecting those patients most likely to benefit from stenoparib treatment."

Companion diagnostic • Patent • Platinum resistant • Colorectal Cancer • Ovarian Cancer • Small Cell Lung Cancer

Allarity Therapeutics Presents Two AACR 2026 Posters Highlighting Stenoparib's Potential in Colorectal Cancer as well as New Predictive Data Linking DRP and Overall Survival in Ovarian Cancer (Investing News Network (INN)) - "This poster highlights clinical data demonstrating that the highest stenoparib DRP scores are associated with enhanced overall survival in patients treated with stenoparib, reinforcing the value of DRP-based patient selection in ring-fencing those patients most likely to benefit from stenoparib...This poster presents new findings demonstrating stenoparib's unique mechanism of action to modulate the WNT/β-catenin signaling pathway and to inhibit the growth of colorectal cancer cell lines at clinically relevant concentrations."

P2 data • Platinum resistant • Preclinical • Colorectal Cancer • Ovarian Cancer

2X-121/ stenoparib - a novel, dual inhibitor of PARP and tankyrase in phase 2 clinical trials in advanced ovarian cancer- blocks the WNT signaling pathway and inhibits growth of human colorectal cancer cell lines at clinically relevant drug concentrations (AACR 2026) - "Importantly, these effects are evident at clinically relevant drug concentrations for 2X-121. Collectively, these data provide the foundation to explore the clinical potential of 2X-121 in colorectal cancers as well as other cancers where WNT pathway activation is prevalent."

Metastases • P2 data • Preclinical • Colorectal Cancer • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor • AXIN1 • BRCA

Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC (clinicaltrials.gov) - P1/2 | N=166 | Recruiting | Sponsor: VA Office of Research and Development | Not yet recruiting ➔ Recruiting

Biomarker • Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Allarity Therapeutics Closes $20 Million Financing to Accelerate the Advance of Stenoparib Toward FDA Approval and Commercialization (GlobeNewswire) - "The financing is expected to extend the Company’s cash runway into the summer of 2028. The Company intends to use the proceeds primarily to support key initiatives designed to accelerate the advance of stenoparib toward pivotal development, FDA approval and commercialization....Stenoparib has demonstrated durable clinical benefit in heavily pre-treated ovarian cancer patients, including previously reported extended overall survival."

Financing • Ovarian Cancer

Allarity Therapeutics Doses First Patients in VA-Funded Phase 2 Trial Focused on Small Cell Lung Cancer with High Unmet Need (GlobeNewswire) - "This trial is being conducted in collaboration with the U.S. Department of Veterans Affairs (VA) and is fully funded through the VA’s Special Emphasis Panel on Precision Oncology. Patient recruitment is ongoing across 11 VA medical centers throughout the United States."

Trial status • Small Cell Lung Cancer

Allarity Therapeutics announces that its collaborative Phase 2 trial with the United States Veteran’s Administration Combining Stenoparib with Temozolomide in Relapsed Small Cell Lung Cancer is Now Open for Enrollment (GlobeNewswire) - "The trial is being conducted in collaboration with the U.S. Department of Veterans Affairs (VA) and is fully funded through the VA’s Special Emphasis Panel on Precision Oncology."

Enrollment open • Small Cell Lung Cancer

Anticipated Clinical Milestones in 2025–2026 (GlobeNewswire) - "Enrollment continued in the new Phase 2 trial protocol evaluating stenoparib in recurrent, platinum-resistant or platinum-ineligible advanced ovarian cancer. The study has maintained steady investigator engagement and is expected to generate critical data by end of 2026....SCLC combination trial launch: U.S. Veterans Administration–funded Phase 2 trial of stenoparib plus temozolomide in recurrent small cell lung cancer expected to be open for enrollment by year-end 2025."

Enrollment status • P2 data • Platinum resistant • Ovarian Cancer • Small Cell Lung Cancer

Performance Comparison of the Illumina MiSeq i100 with Established Instruments for Amplicon-Based Somatic and Liquid Biopsy Sequencing Panels (AMP 2025) - "Libraries were sequenced across 6 MiSeq i100 runs in 2x121 to 2x251 bp configurations and benchmarked against MiSeq and NextSeq 550 runs using matched inputs... The MiSeq i100 supports rapid and accurate detection of somatic and liquid biopsy variants with comparable sensitivity and specificity to established Illumina platforms. Although slight differences in on-target efficiency and coverage depth for longer amplicons were observed, all panels performed as expected with no impact on variant detection. The MiSeq i100's ease of use, shorter runtimes, and reagent handling improvements make it an attractive option for clinical and translational NGS workflows."

Biopsy • Liquid biopsy • BRCA1 • BRCA2

Allarity Therapeutics Presents New Phase 2 Clinical Data for Stenoparib/2X-121 Showing Landmark Median Overall Survival Has Now Surpassed 25 Months (GlobeNewswire) - "The presentation showcased the first Kaplan-Meier analysis for median Overall Survival (mOS) from the Company’s ongoing Phase 2 trial that enrolled patients with advanced ovarian cancer, all of whom had either platinum-resistant or refractory disease and had tumors showing a Stenoparib-specific Drug Response Predictor (DRP) score above 50. Notably, these data provide the first evidence that stenoparib, when given twice daily, may extend patient survival. The mOS has not been formally reached yet and now exceeds 25 months. Two patients actively remain on therapy now more than 24 months, with one of these two patients carrying a wild-type BRCA gene—a genetic background that typically precludes benefit from PARP inhibitors."

P2 data • Platinum resistant • Ovarian Cancer

Allarity Therapeutics CEO to Present at Biomarkers & Precision Medicine 2025 (GlobeNewswire) - "In addition to his presentation, Mr. Jensen will be interviewed by Oxford Global’s editorial team to provide further insights into Allarity’s research and its innovative DRP companion diagnostic platform. The interview will be featured on Oxford Global’s online content portal."

Clinical • Solid Tumor

Anticipated Clinical Milestones in 2025:…SCLC combination trial launch (GlobeNewswire) - "U.S. Veterans Administration–funded Phase 2 trial of stenoparib plus temozolomide in recurrent small cell lung cancer should open for enrollment in Q3, with patient recruitment expected to begin during H2 2025."

Trial status • Small Cell Lung Cancer

Anticipated Clinical Milestones in 2025: Ovarian cancer trial progress (GlobeNewswire) - "Continued enrollment in new Phase 2 ovarian cancer trial protocol, with initial data expected in 2026."

P2 data • Platinum resistant • Ovarian Cancer

Analysis of 35 liquid biopsy samples from stage 3 and 4 newly diagnosed lung cancer patients using Pillar Biosciences OncoRevealTM Core and Fusion Next Generation Sequencing panels (ECP 2025) - "Sequencing of libraries was performed using paired-end read length of 121bp (2x121) and two indexing reads of 8 cycles each... We show here that we successfully implemented a NGS panel for ctDNA analysis in routine practice. We are initiating the use for other tumour types such as advanced breast carcinomas as well."

Biomarker • Biopsy • Clinical • Liquid biopsy • Next-generation sequencing • Breast Cancer • Lung Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Allarity Therapeutics Granted FDA Fast Track Designation for Stenoparib for the Treatment of Advanced Ovarian Cancer (GlobeNewswire) - "Allarity recently began patient enrollment under a new Phase 2 clinical trial protocol evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer."

Enrollment status • Fast track • Platinum resistant • Oncology • Ovarian Cancer

PREDICT 2X-121: Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Allarity Therapeutics | Active, not recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor