Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 475

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 475
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 FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of TuHURA’s financial condition and results of operations should be read together with TuHURA’s consolidated financial statements and the related notes appearing elsewhere in this joint proxy statement/prospectus. This discussion and other parts of this joint proxy statement/prospectus contain forward-looking statements that involve risks and uncertainties, such as statements regarding TuHURA’s plans, objectives, expectations, intentions and projections. TuHURA’s actual results could differ materially from those described in or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the “TuHURA Risk Factors” section of this joint proxy statement/prospectus.

In this section, TuHURA discusses its financial condition, changes in financial condition and results of TuHURA’s operations for the year ended December 31, 2024 compared to the year ended December 31, 2023. References to “TuHURA” refers to Legacy TuHURA for periods prior to the closing of the Kintara Merger, and to TuHURA Biosciences, Inc. (formerly Kintara Therapeutics, Inc.) for all other periods, as the context requires.

Overview

TuHURA is a clinical stage immuno-oncology company developing novel technologies designed to overcome primary and acquired resistance to cancer
immunotherapies. TuHURA’s lead product candidate, IFx2.0, is an innate immune agonist designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration
trial of IFx-2.0 administered as an adjunctive therapy to Keytruda (pembrolizumab) in first line treatment for patients with advanced or metastatic Merkel cell carcinoma who are checkpoint
inhibitor naïve, utilizing the FDA’s accelerated approval pathway. In addition to TuHURA’s innate immune agonist candidates, TuHURA is leveraging its Delta receptor technology to develop tumor microenvironment modulators in the form
of first-in-class bi-specific antibody-peptide conjugates (“APCs”) and antibody-drug conjugates (“ADCs”) targeting Myeloid Derived Suppressor Cells (“MDSCs”). TuHURA’s APCs and ADCs are being developed to inhibit
the immune-suppressing effects of MDSCs on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies