Company: HURA
Filing Date: 2025-05-15
Form Type: 425
Source: 0000950170-25-072703
Chunk: 7

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-15
Form: 425
Chunk 7
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 lifting the partial clinical hold relating to completion of certain CMC requirements.

Q2 2025 : Initiation of Phase 3 accelerated approval trial in first line Merkel cell carcinoma

VISTA Inhibiting Monoclonal Antibody

Q2 2025 : TuHURA expects to close its acquisition of Kineta, Inc. and Kineta’s VISTA inhibiting mAb.

Q3 2025 : Initiation of Phase 2 trial of VISTA inhibiting mAb in combination with a menin inhibitor for the treatment of NPM1 -mutated AML.

ADC and APC Development Candidates

TuHURA continues to advance its bi-specific, bi-functional immune modulating ADCs and APCs that target the DOR on MDSCs, inhibiting their immune suppressing effects in the tumor microenvironment while localizing a checkpoint inhibitor like the VISTA inhibiting antibody.

In 2025 , TuHURA anticipates presenting non-clinical data at relevant medical meetings.

Financial Results for the Three Months Ended March 31, 2025

Research and development expenseswere $4.6 million and $3.6 million for the three months ended March 31, 2025, and 2024, respectively.

General and administrative expenseswere $2.4 million and $1.0 million for the three months ended March 31, 2025, and 2024, respectively.

As of March 31, 2025, TuHURA’s total shares outstanding was approximately 43.7 million.

As previously announced, on December 11, 2024, TuHURA entered into a definitive agreement with Kineta, Inc. (OTC Pink: KANT) in which, as amended, TuHURA agreed to acquire Kineta, including the rights to Kineta’s novel KVA12123 antibody, for a combination of cash and shares of TuHURA common stock via a merger transaction upon the terms and conditions described in TuHURA’s Form 8-Ks filed on December 12, 2024 and May 7, 2025. The merger is currently targeted to close in Q2 2025 pending the satisfaction of certain financing and other closing conditions.

About TuHURA Biosciences, Inc.

TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immun