Announcement • Jul 08
Allarity Therapeutics Obtains CLIA Certification For In-House DRP Testing And Advances Stenoparib Toward FDA Registration Allarity Therapeutics, Inc. has obtained a Certificate of Registration under the Clinical Laboratory Improvement Amendments (CLIA) for its in-house laboratory. 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. 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. Allarity Therapeutics Medical Laboratory will now be positioned as a preferred CLIA-certified laboratory partner in Northern Europe, capable of providing DRP and additional laboratory services for potential partner companies seeking to conduct clinical trials in the U.S. or support products commercialized in the U.S. market. Allarity has sought to develop this capability in-house to control DRP testing in advance of a potential pivotal, registrational trial of stenoparib in advanced, platinum-resistant or platinum-ineligible ovarian cancer. The CLIA initiative also represents an important step toward the potential future commercialization of the DRP companion diagnostic in the U.S.—both as part of Allarity’s internal clinical programs and as a potential regulated service offering to other biopharmaceutical companies interested in leveraging the Company’s DRP platform in the development of precision oncology therapies in U.S.-based clinical trials. CLIA certification, administered by the U.S. Centers for Medicare & Medicaid Services (CMS), is a regulatory requirement for laboratories conducting diagnostic testing on human samples for use in U.S.-based clinical trials. Under its CLIA Certificate of Registration, Allarity’s Danish laboratory is authorized to perform DRP testing for U.S. studies, including a pivotal, registrational trial of stenoparib in advanced ovarian cancer. Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/ß-catenin signaling has been implicated in the development and progression of numerous cancers, especially drug-resistant cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, small cell lung cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has completed its first Phase 2 trial for stenoparib in advanced ovarian cancer patients. That trial showed promising and durable clinical benefit in ovarian cancer patients who had 2+ lines of therapy and were given stenoparib twice daily. The updated data from this study were presented at the AACR special conference on advances in ovarian cancer in September 2025. Note that analyses may change as the study fully matures. A new protocol was designed expressly to capitalize on this emerging clinical experience with stenoparib in platinum resistant patients and began enrolling patients in the summer of 2025. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval. In parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC) began enrolling patients in early 2026 and is currently enrolling patients across multiple VA sites in the US. Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature. Live News • Jul 02
Allarity Therapeutics Gains Key US Patent for Ovarian Cancer Diagnostic Tool Allarity Therapeutics announced that the U.S. Patent and Trademark Office has granted a key patent for its stenoparib-specific DRP companion diagnostic, providing protection until April 2042 for methods that predict which ovarian cancer patients are likely to benefit from stenoparib based on tumor gene-expression profiles.
The patent extends Allarity Therapeutics’ intellectual property around stenoparib and its DRP technology, creating a longer-term framework for pairing the drug with a patient-selection tool as the company advances toward potential FDA review in ovarian cancer.
Allarity Therapeutics’ stock last traded at $1.33, with the share price up 16.7% year to date, which frames this patent grant against a backdrop of higher returns for 2026 so far.
The key read-through is that stronger IP protection for the companion diagnostic could be important if stenoparib progresses through clinical and regulatory steps, while any setbacks in that process would limit the value of this patent on its own. Price Target Changed • Jun 08
Price target increased by 7.9% to US$10.25 Up from US$9.50, the current price target is provided by 1 analyst. New target price is 549% above last closing price of US$1.58. Stock is up 79% over the past year. The company is forecast to post a net loss per share of US$0.92 next year compared to a net loss per share of US$0.78 last year. 
