Good afternoon, everyone, and welcome to H.C. Wainwright 26th Annual Global Investment Conference. My name is Arthur He, senior biotech analyst at H.C. Wainwright. So thanks for joining us for a conversation with the management of HOOKIPA Pharma. So a little bit about the HOOKIPA. HOOKIPA is a clinical stage biopharmaceutical company focused on developing novel cancer therapies based on its proprietary arenavirus platform.
The company also has an ongoing partnership with Gilead to develop immunotherapies against chronic HPV and HIV infections. So joining me here are Dr. Malte Peters, Chief Executive Officer, and Ms. Terry Coelho, Chief Financial Officer. Malte and Terry, welcome. So I guess to first, for the audience who are not so familiar with the company, Malte, could you help to give an overview of HOOKIPA Pharma's pipeline?
Yes, happy to. Thanks for having us, by the way. HOOKIPA was founded in 2011 based on an arenavirus technology, as you said. The principle is that the arenavirus is modified in a way to overexpress tumor-associated antigens or viral antigens in a way to elicit a very strong antitumor or antivirus T-cell response in the human body. Basically, the technology induces and stimulates and activates the own immune system of the body to fight against the tumor or the virus disease. That's the common principle. The pipeline consists of three major areas of activities.
We have a product called HB-200, which is now called eservivec, which is a product that overexpresses two tumor-associated antigens that are found in head and neck cancer, and this program is clinically the most advanced. We have robust phase two data in patients suffering from head and neck cancer, and that's clearly where the current development and also financial focus is for the company.
There are two very important points that I would like to make about this program. One is the data is very strong. We have a very strong support from U.S. FDA regarding our development and regulatory strategy that could bring this product to an approval stage-
Mm
... in 2027. The second point that I would like to make about this program is that it's not only head and neck cancer, it's HPV-16-positive disease, and HPV-16-positive disease is relevant in head and neck cancer, in cervical cancer, in anal cancer, in vaginal cancer. So the opportunity of this space is much larger than head and neck cancer alone.
The second bucket we are excited about are the programs we develop in collaboration with Gilead. There are two programs, HB-400 in Hepatitis B virus, and HB-500 in HIV. These programs are exciting and move forward very rapidly. And the last bucket is HB-700, which is a program targeted at mutated KRAS tumors.
For this program, we have endorsement of an IND submission by FDA, and this program is ready to go into clinical development very soon. We are currently allocating all of our financial resources to HB-200 or eservivec, and do not allocate currently resources to HB-700. So this is an area where we are currently looking into opportunities of continuing our development.
Right. Thanks, Malte. So you touched upon the arenavirus platform.
Mm-hmm.
So I guess, what's the advantage for arenavirus platform compared to other delivery method of kind of cancer vaccine part of the drug modality?
We are very excited about the degree of T-cell activation we observe. It's actually phenomenal amounts of T-cell activated T-cells that we are seeing, both in preclinical, but more importantly in clinical experiments. Our data show that the compounds are extremely well-tolerated.
Mm.
We do not observe significant safety signals, and associated to that, these products work without any adjuvant booster to the immune system. So they're very easy to use, they're very well-tolerated for patients, and the level of T-cell responses we can see in the clinic are very high.
I see. So both of you recently took the helm for the company leadership. And especially you, Malte, you had an interesting experience with both at the MorphoSys and the Novartis. So I'm just curious, what attracted you to join HOOKIPA? And based on what you have onboarding in a short time, what could be a challenge you're kind of facing right now for the-
So both Terry and I were members of the supervisory board of HOOKIPA. So I started in January 2023, I think Terry a couple of months after me. And I came because I was really intrigued by the science.
Mm.
It's a novel approach that hasn't been tested before. The data are extremely encouraging and promising, and I'm personally convinced that this could present another shot on goal or another therapeutic opportunity for patients who have extremely difficult-to-treat cancers. So that's really the bottom line of what attracted me to HOOKIPA. After having started our board roles, it became clear that the supervisory board wanted more focus on operational excellence.
Mm.
... execution, and financial innovation-
I see
... I would say. And that's why we were asked if we could help the company at this transition point-
Mm
... of moving it from a science organization into a development and potentially commercial organization, which is not unfrequent for biotech companies at this stage, right?
I see.
Everything starts with science.
Right
... but eventually, companies evolve from the scientific stage into a development and commercial stage.
Mm.
In terms of challenges, I think, I'm or we are really concentrated and focused on moving with a very fast pace.
Mm.
We are concentrated on executing and delivering on the promises, and delivering on the milestones we share with the public.
I see.
That's really one thing we are concentrated on, and we are also concentrated on finding enough, funding for the organization to actually allow for our front-runner program, at the minimum, to see the light of day.
I see. So, let's take a little bit deep dive into the pipeline. And you mentioned your leading program is HB-200. And so far it has generated very encouraging data, both in the monotherapy and, also especially in combo with the pembro. So could you help highlight the clinical data from the HB-200 program so far?
Yes. So what we are extremely excited about is that we are seeing a very robust, data situation. So we are seeing, a situation where the clinical responses and the duration of the responses, are constant over time. So the more often we look and analyze our data, the more often we see that the data actually remain the same, which is not normal for early-stage, clinical data. Secondly, we observe, a response rate that's higher than 52% in frontline patients with head and neck cancer.
Mm
... which are treated with a combination of pembrolizumab and eservivec or HB-200, and that's compared to somewhere between 20%-24% for patients treated with pembrolizumab alone. So we are kind of doubling the response rates. Of course, this comparison is based on cross-trial comparison, which is always a situation that's not super accurate, and that's why we are now running a randomized study-
Mm
... where we have two arms comparing pembrolizumab alone against pembrolizumab plus HB-200.
Wow, thanks, Malte. So I guess another question for the 200 program is... Let's see, 'cause we know the head and neck space is. There's a lot of players getting there because the pembro is kind of not that great in terms of the response. And so if the HB-200 get approved, could you give us more color on how these treatment can fit into the treatment landscape if get approved?
Yeah. We think that this is an opportunity for patients to have a completely different way of how their frontline head and neck cancer could be treated.
Mm.
If this combination of pembrolizumab and HB-200, eservivec, is approved, it will could become the standard of care, how every patient who is diagnosed with head and neck cancer will be treated in the future. So, and I mentioned it earlier, that we are based on the feedback we received from the U.S. FDA-
Mm
... we are quite optimistic to have a product on the market in 2027, which is not too far out from today. So it could be relatively soon that this combination could really be a game changer of how patients are treated, who present with frontline head and neck cancer to their doctor.
I see. And in terms of market opportunity there, you touched a little bit earlier, what beyond the head and neck-
Yeah
Do you have a kind of a rough number, or, like, how large this market potential for HB-200, beyond what are you currently pursuing in the, in later-stage program?
Yeah. So, as you may know, so head and neck cancer is a very rapidly evolving field. Unfortunately, we will see many more patients presenting with head and neck cancer over the next years.
Mm.
So currently, today, we estimate that approximately between 1,500 and 2,000 patients could be benefiting from this kind of treatment. But that number, unfortunately, could grow to somewhere in the range of 4,000 patients per year in the U.S.
I see.
Yeah, so that's one benchmark of a number that I can give. And as you know, the market size is approximately similar for the five big European countries, and also for the Asia Pacific region. So, we have an opportunity here that I think would be in the blockbuster range if you combine all the HPV- 16- positive opportunities.
I see. So let's switch gear a little bit for when we look at the HB-700. I know it's everything is ready for getting to clinic, so what's your strategy there for to push this asset forward?
We are open to consider partnerships, collaborations at the moment. As I said earlier, in order to increase our focus and probability of success for HB-200, we have decided to put all of our financial strength behind that lead program, and that's why we are currently not investing any dollars into HB-700. But the program is far advanced in terms of having a package available that could enable us or someone with us to take this program into clinical trial immediately.
I see. Speaking of the Gilead partnership, could you give us an overview about the setting of the partnership, and as well as what's the current status for both HB-400 and HB-500 program?
Yeah. Yeah, so HB-400 is the program in hepatitis B virus.
Mm.
That study is fully run by Gilead. They have basically incorporated that program into their own organization after HOOKIPA started it. That program is fully funded by Gilead. HB-500 is operationalized by HOOKIPA, but we are reimbursed, and the economics involve royalty payments and milestone payments based on certain clinical and regulatory items.
I see. Yeah. So, to close our conversation, so could you remind us the major catalyst for HOOKIPA for the next 12 month?
Yeah. So I think the biggest catalyst is clearly the start and initiation of our pivotal study, which is now called AVALON-1. We are in very good discussions with FDA regarding moving the program into a fast regulatory track. So that could be something we could be speaking about. And then obviously, the maturation of the Phase 2 study would also be something that we will publicly share at the right moment. We have presented data at ASCO, and we will give updates as soon as we have more meaningful clinical updates available.
I see. I see, so Terry, what's the current cash position for the company, and how about the cash runway? Yeah.
So we ended the second quarter with about $77 million. We have about 12 months of cash on hand as of the time we filed our 10-Q. We're working and spending a lot of time together with our management team to really dig into the costs and look for opportunities. We're prioritizing spend, as Malte shared, and obviously looking at what partnerships we could also bring on board.
I see. All right. I think, thank you both for coming down to talking to our audience, and, thank you.
Thank you for having us.
Thank you.
Yeah.
Thank you for having us.