Kazia Therapeutics Limited (KZIA) Earnings Call Transcript & Summary

Excellent. So we've talked a lot about glioblastoma, but you're also evaluating several other indications.

So perhaps could you talk a little bit more about this? And any upcoming data we can expect from some of these studies?

So I'll talk about maybe some of the ongoing investigator-initiated trials and some of the other collaborations we have put in place here over the last couple of years. As James mentioned, the mechanism of action with the PI3K and dual inhibition, both with PI3K and mTOR affords us a lot of opportunities and a lot of other indications outside of the traditional PI3K. And the reason for this is it's unique factor or a unique nature of being able to cross the blood brain barrier. So obviously, our lead indication is in glioblastoma, but it affords a lot of opportunity to push into development outside of that, including patients with brain mets, but also primary and secondary central nervous system tumors. So we essentially have ongoing 7 investigator-initiated trials across several different indications. We can divide it up into adults and pediatrics within the pediatric program. We're finishing up on investigator-initiated trial in DIPG, which is just a terrible pediatric brain primary tumor with no approved agents in the U.S. So that trial is actually finishing up, and we're hoping to have some results towards the end of this year. The other is a large cooperative group study being run with PNOC. So the pediatric neuro-oncology consortium group, they're based at UCSF. And they launched a large cooperative group study in diffuse midline gliomas. Again, this is, generally speaking, mostly young pediatric, but it also does somewhat blend into young adults. And that trial is also ongoing now and is recruiting very well. The other 3 investigator-initiated trials, one in glioblastoma that we actually was just launched out of Cornell. And this research is based off of Dr. Howard Fein and Professor Lew Cantley, and this is using paxalisib in newly diagnosed and recurrent glioblastoma patients in combination with metformin and the ketogenic diet. It's really taking the whole approach to the patient treatment. And there's a lot of literature that these professors have done that really demonstrate the improvement of the PI3K inhibition in a ketotic state. The other 2 trials, again, with a really strong academic center base, is one in combination with HERCEPTIN, which is a very standard therapy in breast cancer. So this is actually in HER2-positive breast cancer patients. It's in combination with HERCEPTIN. That trial is actually also finishing up, and we're hoping to have some results sometime later this year. And the final trial is in combination with whole brain radiation. And so that's essentially in patients with metastatic brain cancer, and it's in combination with radiation therapy. That side of Sloan Kettering, and we're hoping to see some results or preliminary results, at least from a safety, futility perspective sometime this year as well. So a lot of activities and a lot of trials ongoing now. And that's one of the things that's really been driving me in terms of both, I think, our interest from a scientific perspective and joining Kazia, but also benefiting patients. The final trial within brain met patients is another cooperative group program based out of Dana-Farber. This is an alliance trial line is a cooperative group doing a lot of research in neuro-oncology, but also other oncology indications. This is a genomically guided brain met trial. Essentially, what they're doing is looking at brain met patients and assessing their genomics to determine which drug would be best to treat that potential genomic and genetic mutation. So within the paxalisib arm, we have 3 cohorts of patients, lung cancer, breast cancer and then a general category of other tumor types. This is an extremely exciting program. Again, another huge cooperative group program that we are supporting and super excited about and has been enrolling very well and hope to see some data here over the next 12 months.

And James, what are the commercialization plans for the asset? You mentioned partnering, but is going solo in the U.S., the potential option to consider?

I think everything is an option. We really just want to get the drug to patients. And of course, we want to return best value for our shareholders. And I think whatever path leads us to that is the one we'll choose. I think certainly for markets outside of the U.S., it makes an incredible amount of sense to look for partners to commercialize it in territories like Japan, Latin America, Middle East and Africa, where we clearly couldn't do justice to the drug. In the United States, it's not crazy to think about doing it ourselves. And when we look at some of the companies we think of as role models, companies like Tesaro and Array Biopharma, but very successful businesses out of licensed assets. the way they've been able to do that has been to commercialize themselves in the U.S. I would say that nothing is off the table. I think all options are open. And at the end of the day, we're going to do whatever really does the most justice to paxalisib's potential.

Kazia Therapeutics, thank you so much.

Thank you.

And if you'd like to learn more about the company or access our research, which is fully available online, please visit the Edison website or e-mail me directly at [email protected]. Thank you.