Akari Therapeutics, Plc (AKTX) Earnings Call Transcript & Summary

We've always said we believe our payload can be attached to many different types of antigen targets and molecules and create a library or pipeline of ADC molecules. And so this is the power of the payload coming to fruition.

Welcome back, and thank you for joining us for another virtual investor What This Means segment. My name is Jenene Thomas. I am CEO of JTC IR, and I will be the moderator for today's segment. I am very excited to welcome back Akari Therapeutics to our virtual investor platform. And I am very pleased to be joined by Abizer Gaslightwala. He is Director, President and CEO of Akari Therapeutics. Welcome back, Abizer.

Thanks, Jenene. Thanks for having me here today.

Always happy to have you. And before we get started, I just want to inform our audience that Akari Therapeutics is listed on NASDAQ and trades under the ticker AKTX. And during today's discussion, the company will be making forward-looking statements, and I encourage everyone to view the company's website at akaritx.com or the SEC's website for their latest filings and information.

Okay, Abizer. So just to set the stage for why we're here today, Akari recently announced the filing of a key new patent and unveiled its second ADC pipeline candidate, which you're calling AKTX-102, targeting CEACAM5 expressing solid tumors. So today, we'll discuss what this announcement means for Akari's expanding ADC pipeline, its rapidly growing patent estate and the company's path towards the clinic with its lead program, AKTX-101. So that was a mouthful there. I first want to congratulate you. Lots of progress, Abizer. And so I'm just going to dive right in, if that's okay?

Sure. Happy to dive in.

To start, your recent patent filing introduced AKTX-102 as a second ADC program. What does this milestone say about the scalability of Akari's PH1-powered ADC platform and its ability to generate multiple differentiated pipeline assets?

Yes. Well, thanks for the question, Jenene, and the time here to give some context and perspective. It's a really exciting development for us on AKTX-102, the second product candidate we want to move forward, second antigen target for the ADC. In particular, this shows the power of the payload. We are a novel payload company. We've always said we believe our payload can be attached to many different types of antigen targets and molecules and create a library or pipeline of ADC molecules. And so this is the power of the payload coming to fruition. Obviously, our lead ADC, AKTX-101, a TROP2 ADC is moving well along its way to potentially get to the clinic soon. This shows that our biology, our research continues across other novel antigen targets. In particular, we'll speak to in a minute, we think the CEACAM5 target is very unique, very differentiated and very difficult for some interesting biological reasons. And so when we take our novel biological insights and then are able to kind of create a next-generation best-in-class antibody, and then couple that with what we believe is the best-in-class payload, that's going to be really a transformational kind of molecule opportunity we have to attack certain types of cancers.

So Abizer, my next question is CEACAM5 has been a long-standing but challenging oncology target. So how does Akari's novel antibody construct combined with PH1 spliceosome modulating payload enable a differentiated approach compared to prior CEACAM5-directed therapies?

Yes, great question. So this is where we're really excited about the novel biological insights we have around this target. So you mentioned CEACAM5. It's not new new, but it's been a very difficult target, very relevant, in particular in some of these cancers like stomach cancer, colon cancer, pancreatic cancer, super high unmet need in those cancers. And this target is a really relevant way to attack those cancers with an ADC. The problem is CEACAM5 is what we call a target that sheds. It means is it expressed in the tumor, but it often sheds into the blood. And so when you try to make a molecule targeting it, it's a little confusing. It's like is it targeting the blood or the tumor? And the way the target antigen set up, just the complexity of the biology, where you actually target to be most effective? So knowing that, that's some of the problems that we encounter that are there with this target, even though it's a really good target. So we figured out certain ways to circumvent that. I can't speak to all the details, and that's covered in the patent about how we're doing this. So essentially, we have found a way to kind of engineer around those constructs and those problems in a new novel antibody that we believe will address those problems that others have not been able to address, and that gives us a competitive advantage as we move this high-value target into an ADC. So you take the antibody design, that's half of it, and you combine it with what we believe is the best payload moving forward potentially, and we have a really unique ADC construct, not only on the payload side, but in this case, also on the antibody side that is differentiated to any CEACAM5 ADC that's put into the clinic today.

Excellent. It sounds like this could be an important breakthrough in the space. So we'll definitely keep an eye on your progress there, Abizer. So next, as Akari expands its pipeline with AKTX-102, how are you prioritizing execution on your lead program, AKTX-101, as it advances towards IND or CTA submission and first-in-human clinical studies?

Sure. Great question in terms of where we're spending our effort, where do we spend our resources. And so first and foremost, AKTX-101, our lead TROP2 ADC is our primary focus and our key area of attention and highest priority this year. As we mentioned in our press release last year, we started IND-enabling activities with our high-quality partner, WuXi. That is work underway. We're targeting a very tight time line to get to an IND CTA filing by the end of this year to hopefully start a clinical trial soon after that, our first in-human study. That is the focus and attention of our team. That being said, we're able to move along a product in a program like AGTX-102 on -- in a very limited budget way and limited resource way because it's still earlier in discovery. So it doesn't require the heavy lifting of big scale manufacturing, nonclinical GLP tox. Those are things that 101 is going through. The 102 asset, we can move along at a much lower kind of investment and resource base because it's a little earlier. So it's a way of kind of walking and chewing your gum, but we can do both as long as we make sure we're walking and walking pretty fast and paying attention to where we're going.

Excellent. And so you're so talented to be able to do both.

I try everyday.

Absolutely. That's great Abizer. Thanks for that background there. Another question I have, and I think this is going to be top of mind for investors. So this latest patent filing further expands Akari's IP estate across payloads, antibody design and ADC architecture. How should investors think about the role of this growing IP portfolio supporting long-term value creation and potential partnering opportunities?

Sure. Great. So what I would say is this patent portfolio continues to grow. The ADC patent we just filed on the CEACAM5 is a unique extension of our novel biology and our ability to build really high-quality unique antibodies, that falls on top of our novel payload IP estate that we're building. And so as a reference, we filed 3 patents last year. In particular, we already have patent protection on the composition of matter for the payload, which is very unique, our RNA splice targeting payload PH1. But what we did last year to supplement that is really patenting around the modes of action and how the payload works. Those are more general that are outside the actual composition of matter because we've seen unique modes of action of this payload. We are filing intellectual property to protect that so that others can infringe on that. And so this is where we think our payload has a lot of legs, not just on the actual structure of the molecule, but how it actually works and it works in many different ways. It has a cytotoxic ability. It affects what we call splice-driven variant cancers, that's the RNA splicing. It has unique immuno-oncology properties, either as a single agent or with checkpoint inhibitors, the most successful class of immunotherapies. So that's the bedrock of our IP and the CEACAM5 IP is just adding on top of that around a great antibody that can be coupled with this novel payload.

Excellent. So Abizer, I know you love this question, why Akari, why now? I feel like you answered that throughout this entire discussion that we've had so far. But let's go more directly and kind of have a succinct response here. What key milestones should investors be watching across both AKTX-101 and Akari's broader ADC platform over the next 12 to 18 months?

Sure. So I'll kind of highlight there are big milestones and there are going to be milestones along the way. Some of them I can't speak to because they're a little bit confidential under embargo. So we -- in terms of what we outlined and it's in our corporate deck and materials, what we speak to is that we would like to have an IND or CTA filing by the end of 2026. That is our target. That would enable us to actually open up a clinical trial in a region of the world to initiate our first-in-human Phase I study. So we think within 12 months, that's a big target for us. It's a corporate goal. It's a big area of focus, high priority, as I mentioned. And then subsequently after that, we hope within the 6-month time frame, so a total of 18 months out, we hope to get our first read of initial clinical data in our Phase I data. That would be safety, the dosing and potential activity -- clinical activity of efficacy if we can get some reads in certain tumor types. So think about that 12- to 18-month time line of getting all the filings ready and starting a clinical trial and getting some initial safety, potential efficacy activity data, that's what's going to happen in this next 12 to 18 months. Now there are going to be milestones along the way. We are continuing to develop a robust package to file the IND that encompasses new preclinical data that will read out. We will talk about that throughout the year. We're going to present other really compelling preclinical data on our TROP2 ADC that we believe establishes as a best-in-class ADC. So keep an eye out for our press releases when we say we're going to present data at either research conferences throughout the year. And then we also will be continuing to talk to regulators around our strategy. We might make some public announcements of what those outcomes are as we continue to get data for the filing to get to the clinical trial, we might release more aspects of that. So those could be these interim kind of milestones throughout the year as we get to those 2 big milestones, both in end of '26 and '27.

Excellent. Well, Abizer, 2025 certainly was an important year for the company, a lot of activity, really setting the stage for what seems to be an action-packed 2026. So congratulations. I cannot wait to have you back, and thanks for your time today. And with that, this does conclude the Virtual Investor Meet segment featuring Akari Therapeutics. I'd like to thank Abizer for joining us today. And as a reminder, Akari Therapeutics trades on NASDAQ under the ticker AKTX. And if you like what you saw today, I encourage you to visit akaritx.com for more information on the company and to sign up, to follow the company, to receive their alerts, as well as follow their social channels to stay current on the latest information. And you can also visit virtualinvestorco.com for our latest segments and events calendar. I would like to thank everybody for joining and like to wish you a great rest of your day.