Allarity Therapeutics

Company purpose and focus

Clinical-stage, precision medicine pharmaceutical company focused on developing stenoparib, a dual inhibitor of PARP1/2 and tankyrases.
DRP® (Drug Response Predictor) platform defines gene expression signatures that predict cancer cell sensitivity to therapies and supports a companion diagnostic to identify patients most likely to benefit.
Current strategic emphasis is on stenoparib development and the stenoparib DRP® companion diagnostic. Other assets previously in the portfolio (e.g., dovitinib, Irofulven, LiPlaCis) were terminated in 2024.

Lead therapeutic candidate: stenoparib, a dual PARP1/2 and tankyrase inhibitor with potential to exploit synthetic lethality in DNA-damage repair–deficient cancers and to affect WNT signaling via tankyrase inhibition.
Stenoparib is in-licensed from Eisai Co., Ltd. (exclusive worldwide rights).
A DRP® companion diagnostic for stenoparib is under development; prior programs received FDA IDE approvals for DRP® use in retrospective validation.
External partnerships and out-licensing exist for other DRP companions (for example, LiPlaCis® with Chosa/Smerud) to advance non-core assets while resources remain focused on stenoparib.

DRP® platform develops drug-specific companion diagnostics from transcriptional profiles of treated cancer cell lines (including the NCI-60 and proprietary panels). It uses gene expression signatures to identify responsive patient subgroups and applies a biological relevance filter based on >3,000 human biopsy samples to reduce noise.
Intellectual property: 18 granted DRP® patents covering 70 cancer drugs and 9 DRP® patents pending covering 3 drugs (including stenoparib and 2X-111), with coverage in the US, EU, and other major markets.
Value proposition: the DRP® approach is intended to enable enriched clinical trial populations, potentially smaller and faster trials, and an improved benefit/risk profile by targeting likely responders.

Stenoparib is in a Phase 2 program for advanced ovarian cancer; DRP-guided patient selection was used in retrospective validation showing activity signals (including a complete response in a heavily pre-treated ovarian cancer patient).
Ovarian cancer program: a newly designed Phase 2 protocol targets platinum-resistant or platinum-ineligible ovarian cancer (PROC) with restricted prior therapy; two dose levels are being studied.
SCLC program: a trial combining stenoparib with temozolomide in relapsed small cell lung cancer (SCLC) is fully funded by the US VA and open for enrollment as of January 2026.
Earlier programs (LiPlaCis, dovitinib, Irofulven) were terminated in 2024 to streamline focus and reduce costs.

Initiated: June 2025; currently enrolling.
Design: randomized, biomarker-driven, two-dose-level Phase 2 trial.
Dose levels:
- 600 mg total per day given as two doses (200 mg morning, 400 mg evening).
- 800 mg total per day given as two doses (400 mg morning, 400 mg evening).
Enrollment: planned 40 patients total, with 20 patients per dose level.
Patient population: platinum-resistant or platinum-ineligible ovarian cancer with no more than one line of chemotherapy beyond PROC designation; fresh tumor biopsy required to assess the stenoparib-DRP® score.
Objective: define the DRP® score that best predicts durable clinical benefit to support DRP® as a patient selection tool in subsequent pivotal trials.

Corporate structure: reorganized from Allarity Therapeutics A/S into Allarity Therapeutics, Inc. (Delaware) in 2021; Nasdaq-listed since December 20, 2021 after a Recapitalization Share Exchange.
Regulatory path: the FDA has accepted retrospective DRP® validation in support of IDE applications for stenoparib and LiPlaCis; a PMA would be required to market a DRP companion diagnostic with stenoparib in the U.S. if commercialization occurs.
Fast-track status: FDA fast-track designation granted for stenoparib in advanced, recurrent ovarian cancers (Q3 2025).
Orphan drug status: possible for certain indications and is part of the regulatory strategy.

Stenoparib is in-licensed from Eisai under exclusive worldwide rights; the license includes amendments and a milestone/royalty framework.
Key licensed IP: stenoparib composition and use patents (US, EU, Canada, China, Japan, South Korea; basic stenoparib patents expire around 2028). The stenoparib-DRP® patent family is projected to expire around 2039.
Dovitinib/LiPlaCis out-licenses: LiPlaCis DRP companion diagnostics are licensed to Chosa, with an ongoing collaboration framework with Smerud/Chosa; Allarity retains certain DRP IP rights for these programs but no longer develops LiPlaCis in-house.

2025 revenue: $0.3 million from DRP analysis and related lab/test services with external biotech clients.
2025 operating results: net loss of $11.2 million; 2024 net loss of $24.5 million.
Accumulated deficit: approximately $130.2 million as of December 31, 2025.
Cash runway: $14.7 million in cash and cash equivalents as of December 31, 2025; management projects funds sufficient to operate into the second quarter of 2027 under current plans.
Headcount: eight employees as of December 31, 2025 (7 full-time, 1 part-time); by March 24, 2026, seven full-time and one part-time.
Revenue model: primarily DRP analytic services and assays for external clients; no product revenues to date.

Core business: develop stenoparib and advance the stenoparib-DRP® companion diagnostic to guide patient selection in trials, while using the DRP® platform to create drug-specific or multi-drug panels for biomarker-guided cancer treatment approaches and pursuing strategic partnerships and out-licensing for non-core assets.
Market position: no approved products yet; DRP® platform has retrospective validation across multiple drugs and prior IDE support. The primary drivers of value are stenoparib development and the companion diagnostic strategy.