About Us: Overview

Allarity Therapeutics: Personalized Cancer Care. Realized.

Allarity Therapeutics is a late clinical-stage, precision medicine company actively advancing a pipeline of in-licensed oncology therapeutics for patients with difficult-to-treat cancers.

Allarity’s clinical program includes five anti-cancer assets in mid- to late-stage clinical development. Our programs and partnerships leverage our proprietary, highly accurate Drug Response Predictor (DRP®) technology to refine patient selection and improve clinical outcomes. Our DRP® technology has been broadly validated across an extensive array of therapies and tumor types with a high degree of accuracy for matching the right patient to the right drug. By identifying those patients who will and who will not respond, the DRP® companion diagnostics have the potential to transform cancer therapeutic development across many indications by increasing clinical success rates with trials involving a fewer number of patients, and improve patient outcomes by matching them to the right drug. Publicly traded on NASDAQ, Allarity Therapeutics (ALLR). Allarity Therapeutics (ALLR) is headquartered in Boston, MA, while maintaining an R&D facility in Hoersholm, Denmark. Allarity is committed to enhancing patient outcomes through improved decision-making and personalized cancer care.

Our Approach to Value Creation

Step 1: Identifying clinical drug candidates with hidden potential

We start the journey of value creation by scouting for drug candidates with a documented acceptable safety profile and clinical efficacy data, but that failed to meet defined clinical trial endpoints as a result of study protocols failing to select the right patients. There are many options for drug candidates that meet these criteria, as the vast majority (95%) are placed on the shelf during development. Our search focuses on drugs or drug types for which we’ve already developed, or can easily develop, a DRP® companion diagnostic.

Step 2: In-licensing candidates with clear signals of efficacy and favorable safety profiles

So far, Allarity has been able to acquire five drug candidates for our portfolio with terms including low upfront fees, reasonable milestone and royalty payments, and access to existing clinical-grade drug supply. Many of our drug programs come from world-leading pharmaceutical companies, which we regard as an acknowledgment of the external trust in our ability to create significant
value based on drug candidates that have previously failed to be matched against an optimal patient group.

Step 3: Focused further development

After acquiring a new drug candidate, we employ a drug-specific DRP® companion diagnostic to focus the continued development for those patients who are expected to benefit most. We then
conduct a Phase 2 proof-of-concept (POC) study using the DRP®
 companion diagnostic to select and enroll patients most likely to respond to the drug. If the data supports advancing the program, we proceed to a DRP®-guided Phase 3/pivotal trial. 

Step 4: Exiting programs with significant upside potential

In the final step of our business model, we exit drug programs through out-licensing, asset sale transfer, or M&A activity to global or regional pharmaceutical companies based on the results of DRP®guided clinical trials. As a result of our proven ability to utilize a DRP® companion diagnostic to improve patient benefit for a drug program, we expect to receive substantial upside from program exit, which could include cash payments, royalties, etc.

History of Allarity Therapeutics

 

Allarity was initially founded as Medical Prognosis Institute A/S in 2004 by then-Professor Steen Knudsen, Ph.D., who has a background in computational biology. Since 1996, Knudsen has been part of building the Center for Biological Sequence Analysis at the Technical University of Denmark (DTU). Based on bioinformatics, his research explored the potential of using gene chips in fighting cancer.

In order to bring the potential benefit of this discovery to cancer patients, marketing approval was needed. Knudsen founded the Medical Prognosis Institute A/S (MPI) for this purpose in 2004 as a spin-out from DTU and with DTU Innovation A/S as the primary investor.

The first focus of MPI was to identify which specific clinical uses of gene chips were most promising to be commercialized. Supported by surveys among oncological experts and the need for a sufficient number of patients, Steen Knudsen chose in 2005 to focus on prognostics for lung cancer. In further research, Steen Knudsen made an important discovery. By comparing data from the U.S. National Cancer Institute (NCI), MPI could predict which patients would get a positive effect from chemotherapy. In 2006, MPI submitted a patent application, which was approved by the American patent authorities in 2013.

Since 2012, the company has become still more focused on commercialization. The initial strategy was to act as a service provider to sell DRP® to pharma/biotech to be used for their drug development.

The company was eventually renamed Oncology Venture A/S and started to focus on drug development, including strategy and business model for establishing cooperation agreements with drug development and biotech companies regarding research, development, and commercialization of drug candidates.

In 2019, a new Executive Management team came into office. Steve Carchedi joined the company as the new CEO and was also elected to the Board of Directors. The change of the Executive Management team was accompanied by strategic refocusing of the company’s pipeline and development work towards the advancement of its three priority programs, as well as monetization and a near-term return on investment for these assets. In 2020, the company was renamed Allarity Therapeutics.

At the end of 2021, the company completed a reorganization transforming the company from being a Danish entity listed in Sweden to becoming a U.S. corporation listed on the Nasdaq stock market in the U.S.