TuHURA Biosciences, Inc. Common Stock Canaccord Genuity's 46th Annual Growth Conference

Review the key takeaways and the transcript of this earnings call.

PeriodFY 0Duration26 minParticipants2

Key takeaways

The company is a phase three immuno-oncology firm focused on primary and acquired resistance to cancer immunotherapies.
They have a phase three trial ongoing for accelerated approval in frontline Merkel cell carcinoma, expecting enrollment completion in the second half of next year and top-line data by late 2027 or early 2028.
The trial design includes a key secondary endpoint to satisfy confirmatory trial requirements and has a special protocol assessment agreement with the FDA.
Their second asset is a Vista inhibiting antibody targeting molecularly defined subsets of AML, about to enter a phase 1b/2 study.
They also have a novel class of immune-targeting antibody drug conjugates in preclinical development with proof of concept data expected later this year.
The company secured a $50 million interest-only credit facility from a major shareholder owning 18% of the company, providing non-dilutive operating capital.
Merkel cell carcinoma is an aggressive, polyomavirus-driven skin cancer with about 3,900 new cases annually, where 75% present with advanced metastatic disease and about half of patients do not respond to frontline checkpoint inhibitors like Keytruda.
The company’s technology involves injecting plasmid DNA encoding a bacterial protein into tumors to activate an immune response and overcome primary resistance to checkpoint inhibitors.
In a prior study with 13 Merkel cell patients who were checkpoint inhibitor naive but progressed, the treatment showed durable clinical responses including complete and partial responses lasting up to 33 months.
The phase three trial is a randomized, placebo-controlled study of 118 patients comparing Ifex plus pembrolizumab versus pembrolizumab plus placebo, powered to increase response rate from 56% to 75% with progression-free survival as a key secondary endpoint.
The FDA encouraged the design with progression-free survival as a key secondary endpoint to support accelerated approval without a separate confirmatory trial, and the study is conducted under a special protocol assessment.
The Vista inhibiting antibody, acquired through Kineta, targets AML with Npm1 mutations which drive Vista expression and immunosuppression, representing an unmet medical need after menin inhibitor failure.
The phase 1b/2 trial in relapsed/refractory Npm1 mutated AML will use morphologic leukemia-free state, CR, and CRi as response criteria, with plans for dose optimization and combination studies.
The company is developing a bispecific bifunctional immune-modulating antibody drug conjugate targeting the delta opioid receptor on immunosuppressive cells, aiming to reprogram the tumor microenvironment and activate T cells.
Upcoming milestones include orphan drug designation for Ifex in Merkel cell carcinoma and Vista in AML, patent issuances in Q4, initiation of the AML phase 1b/2 study, preliminary data from the IR study in Merkel cell carcinoma, and proof of concept data for the ADCs.
The company plans to present data and hold a mini symposium at SMU and ASH conferences in the second half of the year.

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Transcript

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John NewmanManaging Director and Biotechnology Analyst0:00

Good afternoon, everybody. Thanks for joining us at the 46th Annual Canaccord Genuity Growth Conference here in Boston. I'm John Newman, one of the biotech analysts here at the firm. Very excited to have TuHURA with us today, and the CEO, Jim Bianco.

Jim BiancoPresident and CEO0:16

Jim? Thanks. Good afternoon. Before we get started, as typical with presentations of this variety, we will be making forward-looking statements, and we refer you to our SEC filings for more information on the company.

Jim BiancoPresident and CEO0:30

We are a phase III immuno-oncology company. We have three distinct technologies and therapeutics, and we're focused in two strategic areas: primary resistance and acquired resistance to cancer immunotherapies. Just by way of a summary, we have a phase III trial that's ongoing, accelerated approval, frontline Merkel cell carcinoma. I'll walk you through that, both the technology and where we are from the status. We expect to complete enrollment in the second half of next year and top-line data about the end of the year, early 2028. We'll show you the trial design that we worked out with the Oncology Center of Excellence. We do not need a confirmatory trial.

Jim BiancoPresident and CEO1:13

This has embedded a key secondary endpoint that would satisfy that requirement. Just to manage the risk of all of the changes at the FDA, we have a Special Protocol Assessment agreement with the agency for that study. Our second asset is a VISTA inhibiting antibody. We're the only company that is focusing that type of therapeutic in so-called molecularly defined subsets of AML. We're about to put that into a phase I-B/II study. Craig Tendler, who's one of our board members, Craig ran Global IO for Johnson & Johnson for 25 years. He brought bleximenib into clinical practice, clinical development before he left. So Craig is taking on the leadership for moving that program through his phase I/II effort. We'll close it out briefly talking about a really novel class of antibody-drug conjugates.

Jim BiancoPresident and CEO2:03

We're going to have proof of concept in the first set of animal models later this year. But we are the only immune targeting antibody-drug conjugate in pre-clinical development. We have a couple of meetings that we're presenting at in the second half of the year. Lastly, our largest shareholder stepped up for us, provided us with a $50 million credit facility. This is interest only. It's a five-year term. I'll go through a little bit more of detail, but clearly for us, a very non-dilutive source of operating capital from somebody that owns 18% of the company. Obviously, his interest is not to be diluted, but playing the equity play in the company in terms of the true value as this portfolio moves towards approval.

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