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Allarity Therapeutics, Inc.

CIK: 18606572 Annual ReportsLatest: 2025-03-31

10-K / March 31, 2025

Revenue:N/A
Income:-$24,515,000

10-K / April 29, 2024

Revenue:N/A
Income:-$11,901,000

10-K / March 31, 2025

Company Summary - Allarity Therapeutics, Inc.

Overview:
Allarity Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing precision medicine anti-cancer therapeutics. The company leverages its proprietary Drug Response Predictor (DRP®) platform to create drug-specific companion diagnostics that identify patients most likely to benefit from specific cancer treatments, thereby enabling personalized cancer therapy.

Core Technologies and Focus:

  • DRP® Platform: A bioinformatics system that analyzes cancer cell gene expression signatures to predict sensitivity or resistance to anti-cancer drugs. It uses data from cancer cell line panels (such as the NCI-60) and clinical biopsy samples to develop predictive biomarkers.
  • Companion Diagnostics: The company develops and seeks approval for diagnostic tests that can identify suitable patients for particular therapies using DRP signatures. These diagnostics aim to streamline clinical trials and improve success rates.
  • Therapeutic Candidate: The primary focus is on Stenoparib, a dual inhibitor of PARP1/2 enzymes involved in DNA repair, and tankyrases involved in the WNT pathway. Stenoparib is in Phase 2 clinical trials targeting advanced ovarian cancer, with promising preliminary data showing durable clinical responses in heavily pre-treated patients.

Assets and Intellectual Property:

  • Developed over 70 patents related to DRP® companion diagnostics for dozens of cancer drugs, with patent protection extending into the 2030s–2040s.
  • Own patents protecting stenoparib, with expiration dates around 2028–2032.
  • In-licensed rights to stenoparib from Eisai Pharmaceuticals, with an existing license agreement including milestone payments and royalties linked to sales and development progress.

Business Strategy and Operations:

  • Focused solely on the development of stenoparib; terminated other assets like LiPlaCis, dovitinib, and Irofulven.
  • Working to validate and develop stenoparib as a potential new cancer therapy, especially for ovarian cancer, using DRP® diagnostics to select responsive patients.
  • Relying on third-party manufacturers for drug production and external partners for clinical trial conduct.
  • Planning to commercialize primarily via partnerships, not own sales infrastructure.

Financial and Operational Details:

  • Number of Employees: 7 (as of December 31, 2024) — 6 full-time and 1 part-time, mainly in research and development, located mostly in Hoersholm, Denmark, with some management in the U.S. and Sweden.
  • Market Capitalization: As of June 28, 2024, the company’s estimated market value (excluding affiliates) was approximately $7.46 million.
  • Shares Outstanding: About 17,014,737 shares as of March 31, 2025.
  • Revenues: No revenue has been generated from product sales; income to date has come from research grants and biomarker/license agreements.
  • Cash and Marketable Securities: $19.5 million as of December 31, 2024; in early 2025, the company raised an additional $9.7 million through stock offerings.

Legal and Licensing Details:

  • License agreements with Eisai involved milestone payments up to $94 million and tiered royalty payments based on sales.
  • Patents cover both the drug (stenoparib) and its companion diagnostics, with legal protections in the U.S. and international markets.

Summary:
Allarity Therapeutics is a small, biotech company solely dedicated to advancing stenoparib and its personalized biomarker platform for cancer treatment. It has a limited operating history, no product revenues to date, and a strategic focus on using DRP® diagnostics to improve the success and targeting of its key therapeutic candidate, stenoparib.