Prescient Therapeutics Ltd (ASX:PTX) earlier this week opened a share purchase plan targeting up to $7 million as the company continues advancing its lead cancer therapy, PTX-100, through an ongoing Phase 2a clinical program.
Chief Executive James McDonnell told Proactive the funding would support continued progression of the study as Prescient Therapeutics approaches an important dose optimisation review expected later in 2026.
The Phase 2a program currently has clinical sites operating in Australia, the United States and Italy, while the company is hoping to bring France into the study in early 2027.
McDonnell said 28 patients had so far been enrolled. The dose optimisation committee will start reviewing the study once 10 evaluable patients are available in each of its two arms.
He described that point as a significant milestone because it will provide Prescient Therapeutics with its first substantive look at how the Phase 2a study is progressing.
“That’s the first time we’re really getting a look at how the study is progressing,” McDonnell said.
The committee is tasked with reviewing safety and helping define the dose that could be taken forward into the next stage of the clinical program. McDonnell said Prescient Therapeutics expects the review around November or December.
That assessment represents a key potential catalyst for investors, as it could provide an indication of study progress and help shape the next stage of development for PTX-100.
The current program follows earlier Phase 1b data which, according to McDonnell, demonstrated a 43% objective response rate and no serious adverse events attributed to PTX-100.
He said those results provided the basis for moving into the ongoing Phase 2a study.
McDonnell stressed that the company’s immediate focus remained on executing the clinical program effectively, noting that patient outcomes and emerging data themselves were outside the company’s control.
He said Prescient Therapeutics’ role was to implement the study “as well as we can” and prepare for the upcoming review.
Beyond the anticipated year-end committee assessment, further milestones are expected as the clinical data matures, while the prospective addition of France would also broaden the study’s international footprint.
Interview highlights
- Prescient Therapeutics has launched a share purchase plan targeting up to $7 million.
- Proceeds are intended to support the continued development of PTX-100 through its ongoing Phase 2a clinical program.
- The Phase 2a study currently has clinical sites in Australia, the US and Italy.
- Prescient Therapeutics is hoping to add France in early 2027.
- The study has enrolled 28 patients.
- The dose optimisation committee will begin reviewing progress once there are 10 evaluable patients in each of the two study arms.
- Prescient Therapeutics expects that review to take place towards the end of 2026, with November or December highlighted as the likely period.
- The committee will assess safety and help define a dose for the next phase of the clinical program.
- Previous Phase 1b data demonstrated a 43% objective response rate.
- McDonnell said there were no serious adverse events attributed to PTX-100 in the Phase 1b study.
- The upcoming dose optimisation review represents the first substantial opportunity for Prescient Therapeutics to assess how the Phase 2a program is progressing.
Proactive: Prescient Therapeutics has opened its share purchase plan, targeting up to $7 million to help advance its lead cancer therapy, PTX-100, through an ongoing Phase 2a clinical program. Here to discuss the raise and what it means for the program is Chief Executive James McDonnell. James, good to see you.
James McDonnell: Good to see you, Jonathan. I’m happy to be here.
Proactive: It’s a pleasure to have you. Let’s talk about this raise, targeting $7 million. Talk us through the details.
James McDonnell: We’re running an SPP looking to raise $7 million. It’ll help us continue the progression of PTX-100 through the Phase 2 program. We’ve got a near-term milestone coming up, with the first review of the study happening later this year.
That’s a significant point for us, and there will be more of those as the data matures. Then we’ll be heading into something a bit more exciting as well, so there’s plenty to look forward to.
Proactive: Can you talk us through the progress you’ve seen with patient recruitment and the expansion of the clinical trial sites?
James McDonnell: We’re running a Phase 2a study. We’ve currently got sites in Australia, the US and Italy, and we’re hoping to bring France on board in the early part of next year.
We’ve seen 28 patients enrolled in our study, and the dose optimisation committee starts reviewing progress in the study when it has 10 evaluable patients in each of the two arms. We expect that to be towards the end of this year, and that’s a milestone for us.
Proactive: Could you explain a little more about why that is a milestone?
James McDonnell: The dose optimisation committee is there to assess safety and to define a dose that we can take into the next phase of the clinical program.
Halfway is 10 patients in each arm, so that’s the first time we’re really getting a look at how the study is progressing. The committee will provide a report, and that’ll give us an indication of progress.
That’s why it’s a milestone. All our focus is on the Phase 2a study at the moment and really implementing the program. We don’t have as much control over the results, and the data is all about the patient. Our role is to make sure we implement the study as well as we can and prepare for that time.
Proactive: James, you’ve probably touched on it already, but there are only a few months left of 2026. What can we expect as we come towards the end of the year?
James McDonnell: It is about the dose optimisation committee. We have Phase 1b data which demonstrated a 43% objective response rate and no serious adverse events attributed to PTX-100.
On those data, we moved forward into this Phase 2a program and, towards November or December, we’ll see how we’re progressing on the Phase 2 program.
Proactive: James, good luck with it all. I’m sure we’ll speak again as it unfolds. Thanks very much.