By Amit Chowdhry Today at 5:27 PM

Allarity Therapeutics completed its Phase 3-ready manufacturing campaign for stenoparib ahead of schedule and says it does not currently anticipate additional cash outlays for active pharmaceutical ingredient manufacturing as the company prepares the cancer therapy for potential pivotal development.

The stenoparib API manufacturing campaign was completed in July 2026, ahead of the company’s original target of completion by the third quarter. The campaign used the more stringent manufacturing standards required for late-stage clinical development.

All manufacturing-related payments were completed during Q2 and recorded as prepaid expenses. As a result, Allarity said it does not currently anticipate any additional cash outlays associated with API manufacturing.

The manufacturing milestone is designed to support stenoparib’s continued development toward FDA approval following its Fast Track designation. Allarity is evaluating the drug in an ongoing Phase 2 study involving patients with advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer and is preparing for a potential pivotal registrational trial.

Stenoparib is an orally available small molecule that inhibits both PARP1/2 and tankyrase 1/2. The dual mechanism is intended to target PARP activity while also interfering with the WNT signaling pathway, which has been implicated in the development and progression of multiple cancers, particularly drug-resistant cancers.

The company has also strengthened the intellectual property surrounding the therapy. The U.S. Patent and Trademark Office granted a key patent covering Allarity’s stenoparib-specific Drug Response Predictor, or DRP, companion diagnostic, with protection extending into April 2042.

The patent covers methods for predicting clinical benefit using gene-expression profiles from tumor samples and selecting patients considered more likely to benefit from stenoparib. Allarity said the patent provides commercial exclusivity for using stenoparib in combination with the companion diagnostic.

Phase 2 data presented at AACR 2026 further supported the biomarker strategy. Allarity reported extended overall survival among patients with advanced platinum-resistant and refractory ovarian cancer, with the benefit particularly evident among patients whose tumors had the highest stenoparib DRP scores.

Allarity also obtained CLIA certification for its in-house laboratory in Hørsholm, Denmark. The certification enables the company to conduct DRP testing internally for U.S. clinical trials, including a potential registrational study, rather than relying entirely on external laboratories.

Management believes bringing the testing process in-house could shorten turnaround times, reduce costs, and give Allarity greater control over patient selection. The laboratory could also potentially provide CLIA-certified testing services to other companies pursuing U.S. clinical trials or commercialization programs.

Allarity ended Q2 with $26.9 million of cash and restricted cash, up from $14.7 million a year earlier. Operating cash usage was $2.6 million during the quarter. R&D expenses declined to $1.3 million from $2.3 million, while G&A expenses decreased to $1.3 million from $1.8 million.

The company is also evaluating stenoparib beyond ovarian cancer. A Phase 2 trial combining stenoparib with temozolomide for relapsed small cell lung cancer continues enrolling patients across multiple U.S. Department of Veterans Affairs medical centers and is fully funded by the VA. Preclinical findings presented at AACR also highlighted potential applications in colorectal cancer.

KEY QUOTES:

“Subsequent to quarter-end, we also successfully completed our manufacturing campaign for stenoparib, securing drug supply in accordance with the more stringent standards required for late-stage clinical development. Completion of this campaign represents an important step as we prepare for a pivotal, registrational trial.”

“We have also secured CLIA certification for our in-house laboratory, enabling us to do all of the necessary testing for the DRP® in-house, which will further secure our ability to control and accelerate the advance of stenoparib toward FDA approval.”

“Finally, I am pleased that we ended the quarter with almost $27 million in cash and restricted cash, providing us with the financial resources to continue the important work of advancing stenoparib.”

Thomas Jensen, Chief Executive Officer of Allarity Therapeutics