Good morning, and thank you for joining the HOOKIPA Pharma Fourth Quarter and Full Year 2019 Earnings and 2020 Outlook Conference Call. At this time, all participants in listen-only mode. [Operator Instructions]. I’ll now pass the call over to Matthew Beck, Executive Director for Investor Relations. Please go ahead..

Thank you. Joining me today our Chief Executive Officer, Joern Aldag; Chief Financial Officer, Reinhard Kandera; Chief Medical Officer and Head of Global Research and Development, Igor Matushansky and Chief Technology Officer, Roman Necina. During today's call, we will be making certain forward-looking statements.

These statements may include statements regarding, among other things, the efficacy, safety and intended utilization of investigational agents, our clinical and non-clinical plans.

Our plan to present or report additional data, the anticipated conduct and the source of future clinical trials, regulatory plans, future research and development and possible intended use of cash and investments.

These forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve risks and uncertainties that may cause the actual results to differ materially from those contained in the forward-looking statements.

These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements, which are only made as of today's date. The Company disclaims any obligation to update such statements.

For today's call, Joern will provide opening remarks. Igor will detail the progress of our clinical programs. Reinhard will offer a high level comments on our financials, and then we'll open the call for Q&A. With that, I'll pass the call to Joern..

Thanks, Matt. Thank you, everyone, for participating in today's earnings call, and to keep us first since our IPO in April of last year. And we're very happy to have this call with you today. Please see on Slide 2, our safe harbor statement. And then switch to Slide 3.

We've had a strong year and have made great progress, both in terms of building our team and on the clinical front. We're now in the clinic in both the infectious disease and oncology areas.

On the corporate side, you see here on the slide, we expanded our executive team by hiring Christine Baker, our Chief Business Officer who is also managing our Gilead Alliance, and our U.S. headquarter office. We also added Roman Necina as Chief Technology Officer in November.

Roman is responsible for -- who keep us global manufacturing operations, including analytical and process development. These key hires have rounded out our corporate needs for strategic growth and future in-house manufacturing. Switch to the next slide please.

HB-101, a program based on our non-replicating VaxWave technology designed to stimulate the immune system against cytomegalovirus infection or reactivation is in its Phase 2 trial in kidney transplant patients. Before going public, we had completed our Phase 1 healthy volunteer trial showing strong and durable T cell and antibody immunogenicity.

We continue to enroll patients and plan to report safety and immunogenicity data from roughly one-third of the total patients in the first half of 2020. Igor will provide more detail shortly. Flip over once. We also dosed our first patient in our immune-oncology trial in HPV16 positive cancers in late December 2019.

You can imagine how excited we were about this. This is a Phase 1/2 trial of our TheraT-based program HB-201 a replication competent vectors technology expressing the E6/E7 fusion protein from HPV16. That trial accrued the first dose cohorts of intravenously treated patients.

It's completing accrual for intratumoraly treated patients as we speak and has begun accruing patients in the second intravenous dose cohorts. We expect to submit the IND for HB-202 program in the first half of 2020. This product is carrying the same antigens HB-201.

But it's based on a different vector backbone to be used in combination for a stronger immune responses. Igor will again provide more detail on this progress. Slide 6, our collaboration with Gilead seeking therapeutic cures for chronic Hepatitis B, and HIV is rapidly progressing.

We were proud in January of 2020, will keep agreed with Gilead to expand and accelerate the development of both programs. As a result, we keep us adding staff that will be solely focused on the Gilead programs, the full cost of which is borne by Gilead themselves.

Gilead internally approved a -- what they call request for development in the HBV program, triggering a significant milestone payment. The program is now progressing towards the clinic. We couldn't be more pleased working with Gilead as a development partner. Slide 7 is a summary of our clinical milestones.

As communicated earlier, we will deliver preliminary efficacy data for CMV for pre-emptive patients at the end of 2020.

Importantly, our immune-oncology program will show initial safety and efficacy data late 2020 or early 2021 as guided before, and our combination of HB-202 and HB-201 to drive the highest T Cell responses will provide important data in the middle of 2021.

In our Gilead collaboration as communicated earlier, we achieved one milestone following Gilead’s decision to commit to preparations to advance the HIV and HBV vectors towards development. It is difficult to provide timelines at this point for these programs, as Gilead is controlling the timelines.

Slide 8, before I end my overview, I'd like to comment on the Corona virus pandemic and how it's affecting HOOKIPA. Our top priority is the health and safety of our employees followed by business continuity. We have instituted a work from home policy for both the U.S.

and Vienna offices for the foreseeable future, and are working with our lab technicians to sustain ongoing experiments in the company. Travel is reduced to zero. Our employees have quickly adapted to the new circumstances and the non-lab based colleagues are trying to continue business from home as best as they can.

We are in close contact with our trial sites, with the clinical research organizations and development partners. However, at this time, it is difficult to say with any certainty whether there will be any clinical trial disruptions or delays.

For solid organ transplants, we believe it is unlikely that transplant centers will risk voluntary immune-suppression during the Corona virus outbreak. Our HPV16 positive patients are in the advanced metastatic setting and post first and second line treatments.

So the risk is their ability and willingness to get to trial sites for continued treatments. We have to assume that recruitment of our trials will be impacted, though as of today, we remain on-track with the disclosed milestone dates. We will communicate updates to our milestones once there is more clarity on the effects and duration of this slowdown.

While we are well funded and this -- at this current point in time, it is critically important with a cash reach to the end of 2021, we are currently looking at the prioritization of all our activities with a goal to extend the runway.

Our top priorities are the CMV program, our cancer programs, HB-201, HB-202 and new adjuvant studies that we're running and Gilead. And everything else is second priority. We will communicate the results of this effort, the moment we have more clarity, both on the developments outside and the outcome of our internal discussions.

I’ll now pass the call over to Igor for a deeper dive into all CMV and HPV16 positive cancer programs. Igor..

Thank you, Joern. Hello, this is Igor Matushansky, Chief Medical Officer and Global Head of Research and Development of HOOKIPA. As Joern mentioned, we're progressing through a proof-of-concept infectious disease and oncology trials, both as important efficacy readouts at the end of 2020 or early 2021. Please see Slide 9.

Our CMV Prophylaxis program HB-101 dose the first Phase 2 patient in December of 2018 and continues to accrue patients. To review, the Phase 2 program is a randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of HB-101 a bivalent prophylactic vaccine for cytomegalovirus.

In cytomegalovirus negative patients awaiting kidney transplantation from living CMV positive donors.

Based on HB-101 tolerability profile in the target patient population and to gain further insights that will inform Phase 3 trial design, we recently added a new cohorts of CMV positive recipients awaiting kidney transplantation from either CMV positive or negative donors to the trial in early 2020.

We believe the addition of CMV positive patients will also helps to expedite trial recruitment. In the first half of 2020, as Joern mentioned, we expect to report on the safety of approximately one-third that is 50 patients of the total 150 to be enrolled.

The safety monitoring period will include the period between the first dose and the date of transplantation. Also in the first half of 2020, we expect to report on the immunogenicity of approximately one-quarter that is 35 patients to 40 patients of the total to be enrolled. We expect both CMV specific antibody and CMV specific CD8 T Cell responses.

For the placebo-controlled part of the trial, we expect to demonstrate an inter-patient effect that is between those patients that received placebo versus those who received vaccine. For the recipients positive group, we will measure an intra-patient effect that is an increase over baseline in those patients that receive vaccine.

We [will leave] positively if T Cell and B Cell antibody values are in line or higher than those reported in the Phase 1. Also, we [spoke to] demonstrate no significant vector neutralizing antibody detection with repeat administration, as we have also previously demonstrated in our Phase 1.

Additionally, we plan to release preliminary efficacy data from HB-101 patients late in the second half of 2020. The data we based on the quantity, quality and number of complete data sets available. The most important focus would be on the patients treated in the pre-emptive antiviral therapy post-transplant ARM.

Since, these patients are tested often and only administered antivirals when evidence of CMV viremia present. We will provide substantially more information about this data readout later in the year. Please see Slide 10.

Moving on to our oncology programs, we were excited to have submitted our HB-201 IND in July and dosed our first patient in December of 2019. HB-201 is a therapy platform based replication competent vector from the arenavirus family expressed in a non-oncogenic, but highly antigenic E6/E7 fusion protein from HPV16.

The monotherapy Phase 1/2 trial is an open label dose escalation and dose expansion trial in 100 patients with locally advanced and/or metastatic HPV16 positive cancers with progressive standard-of-care.

It is designed to evaluate the safety, tolerability and preliminary efficacy of HB-201 as monotherapy and in combination with an immune checkpoint inhibitor. For Phase 1 dose escalation, the patient population is divided into two groups of 20 patients each.

The first group is enrolling locally advanced and/or metastatic HPV16 positive head and neck squamous cell carcinoma patients progressing on standard-of-care, who will then receive intravenous administration of HB-201 every three weeks as monotherapy.

The second group is enrolling locally advanced and/or metastatic HPV16 positive cancers of any site of origin with an accessible tumor who will receive one into a tumor or administration of HB-201 followed by intravenous administration of HB-201 every three weeks as monotherapy.

It is a standard three-plus-three dose escalation study design, and doses will go up in log scales. Importantly, we are not trying to compare intravenous to intra-tumoral administrations, but rather to develop both approaches as therapeutic options depending on how patients present.

Some patients present with cancer with numerous tiny tumors around the body with no central mass and treat them with suggested systemic approach. Other patients present with a metastatic disease across the body with a central large tumor as well as additional systemic disease.

In this latter case, we provide the option for investigators to inject HB-201 directly into the tumor, which may accelerate the response that one tumor site while still providing an [indiscernible] like effect.

Joern mentioned earlier, that the trial has already completed the accrual of the first dose level in the intravenous ARM, and now is currently already accruing patients at the second dose level. The intra-tumoral ARM is completing accrual the first dose level [asmispeak].

We plan to accrue and study backfill cohorts in between dose levels two and three to test different dosing schedules. We anticipate dose level three will begin accruing patients late in the second half of this year.

The primary endpoint of the Phase 1 portion of this trial will be to evaluate safety and tolerability to determine the recommended dose for the Phase 2 portion. Secondary endpoints will evaluate anti-tumor activity as defined by RECIST 1.1 and immunogenicity. We expect preliminary data to be available in late 2020 or early 2021.

Now, please see Slide 11. We also expect to submit our HB-202 IND in the first half of 2020. The IND submission will be an amendment to the current HB-201 IND, not a standalone submission. The benefit of this approach is that, we will be able to amend our protocols and dose patience at the same time as the currently ongoing HB-201 monotherapy trial.

The HB-201/202 trial will be an alternating two vector therapy using different arena-viral vectors derived from Pichinde Virus and LCMV. It will follow substantially similar trial design as HB-201 monotherapy and we are very excited to get that going in the later part of this year.

With that, I'll turn it over to Reinhard for comments about financials. Reinhard..

Thank you. Thank you, Igor. Good morning, ladies and gentlemen. Let me give you a short overview on the financial results that we released this morning and which are summarized on Slide 12 of your presentation.

These results, and the year-on-year developments reflects the significant progress that HOOKIPA has made in 2019, in advancing our clinical pipeline, in delivering on our corporation with Gilead, and in the transformation from a private to a publicly listed company.

Since the fourth quarter results, we are very much in line with previous quarters, I will focus on the full year results. Let me start with revenues, which resulted exclusively from our corporation with Gilead and increased by $4.3 million compared to 2018.

Gilead revenue included $3.2 million in milestone payments, $4.4 million from the partial recognition of the upfront payments that we received in 2018 and $4.3 million from reimbursement of research and development expenses.

In early 2020, we received another milestone of $4 million triggered by Gilead’s decision to move the Hepatitis B program towards clinic entry.

R&D expenses increased by $24.3 million in 2019 and the main cost drivers were the Phase 2 clinical trial for HB-101 program, the preparation costs of clinical trials for HB-201 and HB -202 program, expansion of earlier stage programs costs in connection with securing manufacturing capacity for production of clinical trial material and the cost related to the general increase of our R&D capacities and personnel.

The increase of our G&A costs by $9.9 million was substantial and it reflects the overall growth of our organization and the cost to operate as a public company.

It was driven by an increase in personnel related expenses of $5.4 million, including stock-compensation by an increase in professional and consulting fees and other expenses such as the and/or insurance costs.

Our other operating income mainly includes grant income of $6.7 million from the Austrian government and interest income in our cash balances partially offset by interest expenses.

Our combined cash outflow from operating activities and investments, sometimes referred to as cash burn was U.S.$43.7 million between the February 2019 Series D financing and our IPO that closed in April 2019. We raised net proceeds of approximately U.S.$112 million, which provided us with a strong year-end cash balance of roughly U.S.$113 million.

Spending any Corona virus related impacts, we expect our 2020 spending to only moderately increase compared to 2019. We expect our cash reserves to fund our operations through the end of 2021 at least and most importantly beyond our key clinical milestones. Now with that, I'd like to pass back to Joern..

In closing, I'm very pleased with who keep us corporate and clinical progress in 2019 and early 2020 we remained focused on execution to produce compelling proof-of-concept data with our proprietary arena-viral vector based products. And I'm excited to see both our trials unfold and to keep continue to develop.

We will stay in close contact with you as the pandemic unfolds and we'll -- and keep communicating if any of our plans are impacted. I'd like to leave you with one final thought. We must ask ourselves, what we as individuals and company contributors can gain from working at home during this unusual Corona virus pandemic period.

In 1665, the great plague of London hit University of Cambridge closed and sent students home to continue their studies and practice today's version of social distancing. One student had some of his greatest breakthroughs during that period without his professors.

He produced papers that would become the bedrock of early calculus and made his famed observations about gravity. There was indeed an apple tree outside of his bedroom window. You may have heard of him. His name was Isaac Newton. With that, I'd like to open the line for Q&A. Operator..

Thank you. [Operator Instructions]. And the first question is coming from the line of Andrew Berens from SVB Leerink. Please go ahead..

Thank you.

Can you hear me?.

Yes..

Well, I want to thank you for all the color and for hosting the call, despite everything that's going on.

Just wanted to get a little more color on the hypothetical delays the transplant program, is it -- that the transplant centers are decreasing the number of transplants they're doing or if this -- are still happening, but you think it's hard potentially hard to introduce a novel adjuvant intervention into that sequence?.

Igor, would you respond?.

Of course, thanks Andrew for the question. I think it is too early to tell. Certainly, however, in the current environment it is possible that surgery requiring immunosuppression will be delayed.

Hospital staff may be redirected to pandemic related interventions, whose keep is not unique in this I take all clinical trials requiring hospital in-patient resources in the midst of the pandemic, what hospital resources are expected to be stretched will be facing similar challenges.

So, I think you know, the live donor kidney transplant patients at high risk is a difficult patient to accrue. But, we believe in what we know today, we'll be able to deliver on the milestones as stated it's not a question of -- if the perhaps many patients, but we believe we are on-track to deliver the milestones as previously stated..

And Andrew, we heard that in China kidney transplants are down significantly in the context of the crisis that took place there. So clearly that does impact things..

Okay. Okay.

And just -- can you just remind us and your trials are not in China though right?.

No..

We're not in China..

Okay.

And then, are you seeing any impact potentially on the supply of the agents, any manufacturing impacts due to the pandemic?.

At this point in time, no. I would like to have Roman answered this question. We're obviously working very hard with our -- on CROs, who also have impacts, but are trying to keep their manufacturing sites up and running.

Roman maybe you want to give a little bit more color here?.

Hello, everyone. Roman Necina speaking. We are very close to our [indiscernible] to CMOs as well as to external [indiscernible] because they face similar challenges like we in our labs, they have also to make sure that they have sufficient people to execute on the GMP relevant tasks. And so far, we have lots of solid business continuity plans.

But of course, if the situation evolves they need to be constantly updated, and we have the actual line of communication, updating each other on a regular basis..

Okay..

We know that our CROs are actually also prioritizing and clinical trial material in GMP seems to be very high on their priority list. Whereas other things are de-prioritized and there maybe impacts, but at this point in time, we're not seeing anything impacting the material for our trials..

Okay.

Can you just remind the show and I don't remember what you guys have publicly announced about the supply chain, but if there's anything, could you just remind us what it is?.

You mean, who we're working within the CROs area?.

Right?.

Yes, Roman, and just quickly you have transferred to several CROs of processes that we're using in clinical trials. We have good relationship with these people. And I would like to have Roman give a sort of brief summary on the relationships with these suppliers, and also with our own manufacturing side, which we're running in Sweden.

Roman, just very brief..

We have CMOs in Europe and in U.S. For our BiTEs drug substance manufacturing. We have for drug product CMOs in Europe. And we have eight external labs doing our testing and release relevant activities. And, we are in the process of ramping up of BiTEs drug substance capacity at Vienna.

Here we have a dedicated GMP plan for GMP manufacturing of Phase 1 to clinical material and they have implemented our process most recently and they will ramp up GMP manufacturing in the second quarter of this year, of course everything depending on the Corona virus situation..

Okay.

And then, are you seeing any impact on regulatory interactions or progress with either BMA or FDA?.

Igor, please comment..

No, we have not seen any delays or we have not received any kind of a guidance that indicates that there will be delays coming as of yet.

We of course are concerned and you know, I would say being very conservative in this and realizing that there of course might be delays as the health authorities and the internal resources are diverted to deal with the currently COVID-19 situation, but we have not had any communications or any indications that any kind of delays are forthcoming..

Okay, maybe just one last question and I'll stop hogging the bandwidth. In regards with Gilead collaboration and they obviously made the milestone payment that you highlighted.

Was there any other non-financial commitment that they've made when they decided to go forward with the infectious disease program?.

Yes. They request for development means that they're doing everything possible to get a program into the Phase 1 clinical trial. There is a formal stage gate, when they decide to move something in Phase 1. The RFT actually sort of unlocks the commitment.

And then manufacturing is a longer term commitment, which costs money that unlocks the commitment to actually go into the Phase 1 clinical trial. And we interpret the fact that they have asked us to expand the collaboration we now have -- we had 15 people working on this.

It's now 30 FTEs, and accelerate, the program's towards clinical trials is a very positive sign, which tells us with the commitments they made to reserve capacity at all manufacturing sites at the CROs.

It's a very positive sign that they will take these programs into clinical trial within the normal timeframe that you would expect for a biological to be manufactured for bio-distribution tox studies and then go through the IND process and go into clinical trial..

Okay. Thanks a lot for all the questions, guys. And good luck for everything..

Thank you too..

Next question is coming from the line of Alec Stranahan from Bank of America. Please go ahead..

Hey, guys..

Hey..

Hey..

Thanks for taking our questions and hope you guys are staying safe given everything that's going on.

So just a couple from me, first on HB-101, could you just remind us as to the safety profile from the Phase 1 and if there are any factors that may change safety or level of immune stimulation in the Phase 2 versus what we saw in healthy volunteers? And then maybe could you talk a bit more about the rationale for expanding the study into still positive recipients, is it primarily for accelerating enrollment? And then I've got a follow up?.

Igor..

Thanks, sure. Yes. So, I think in terms of reminding you the safety of Phase 1, what we saw in Phase 1 was most importantly, certainly no systemic effects from the intramuscular administration. We did see mainly local reactions to the intramuscular administration such as erythema.

However, interestingly enough, they were very similar to what was observed the [indiscernible] placebo. So overall, from the healthy volunteer our Phase 1 data was a very -- I would say safe and it’s -- an interesting kind of profile.

In terms of the immunogenicity and whether we will see similar immunogenicity in the Phase 2, as we saw on the Phase 1, we do believe we will, the patients that are under are being treated are being treated pre transplantation before any kind of immunosuppressants are on board.

And so, we do not fundamentally biologically believe that there will be a difference in the immune response that will be seen to our vaccine that will anyway differ from what we have seen in the healthy volunteer study. And the third part of your question was, why did we add our positive ARM.

It was basically in response to many of the investigators having observed and having had experience with our vaccine for over one year and not noting any concerning safety signals or more keen and much more interested on expanding this to their CMV positive recipients who of course have a lower risk of post transplant viremia.

But still, the risk is on the order of 40%. And therefore, having demonstrated a very safe profile at a high risk patient population they were very keen to -- for us to expand that to a more lower risk population. This of course serves our interest as well. It helps a clearly as a part -- would be accrual of the program.

But, I think more importantly, it allows us data to suggest to the FDA that our vaccination strategy should be much more broadly applicable, which was, of course, our plan all along to vaccinate all commerce, and this will not provide us additional data to support that argument..

Okay. Great, yes, that makes a lot of sense. And then to Corona virus is obviously at the top of most people's minds right now.

What will be your plan B for data dissemination in the event that conferences continue to be postponed due to the virus, particularly for the planned One half ‘20, safety and immunogenicity updates for HB-101?.

We will definitely…...

All right, as we…...

Detailed press releases on the results that described the results and the data.

Igor do you want to say something?.

No, I mean, I agree with you. And we'll start with a press release. I think the big and the more interesting data will be the efficacy will come at the end of 2020.

And I think at that point, that will also follow with a press release and of course, the conference to come shortly after, as you know, most conferences now have three to four months in advance submission.

So any data that we submitted in press release by the end of 2020 will be ready for presentation at conference three to four months later, by which point I am being I would say, maybe realistic that all of this will be behind us, and data will be able to present on track..

Okay. Okay, and last one for me, sort of along those same lines. You guys sort of alluded to this during your prepared remarks.

But, I know that you're later focused on your core pipeline programs, but given the flexibility of your vaccine platforms, if you -- have you given much thought into developing a Corona virus vaccine yourself and perhaps could you just talk through the hypothetical strengths of such a vaccine built on your antivirus platform versus others such as [indiscernible], etc? Thanks..

Igor..

Thank you. So, I think our technology is in the long-term very suited for developing a vaccine for something like this for the corona virus and related strains. The only question is timing and decision of where to prioritize. Currently, we have decided, as you have already stated to be laser focused on our core programs.

Certainly in the future, we think we are well suited to do this. And it's simply a matter of prioritization at the moment and currently, we're just simply prioritizing our core programs..

Okay. Thanks for taking the questions..

The next question is coming from the likes of Brian Abrahams from RBC Capital Markets. Please go ahead..

Hi, guys. Thanks very much for taking my --..

Hi..

Can you hear me okay?.

Yes, sure..

Great. Well, thanks so much for taking my questions and congrats on all the progress and appreciate all the color on the potential COVID-19 impact. I guess my first question is on 202, I was wondering, if you could talk a little bit more about -- sort of how things are going with those initial cohorts.

And then you mentioned the backfill cohorts, curious the types of dosing schedules, you might test there and whether those, what you're going be testing is based on any sort of efficacy or safety findings from the cohorts dose so far?.

Thanks Brian. I'm assuming you mean the 201 program. Not the 202..

Yes. Sorry. I -- yes. I meant to say 201, sorry..

Nope, no, perfect. So first question, what we are seeing from the dose level one, we have seen nothing from safety concerns and escalated very smoothly to our dose level two.

So that remains completely on-track as I remind you, our pre-clinical toxicology, package was completely safe, we had no dose limiting toxicity or any kind of classes of know well, in the pre-clinical GLP studies therefore, we did not and still do not anticipate that we will see any DLTs in the human clinical trials.

Therefore, it was no surprise that we went very smoothly with no safety concerns from dose level one to dose level two. And remember, we are going – escalating by logs. So I think we're making quite rapid progress.

In terms of what do we expect to study in the backfill cohorts? We enter the trial, as you know, with a dosing schedule of every three weeks, that three weeks was somewhat of an arbitrary number based on extrapolation from what we have seen in our pre-clinical mouse and monkey work.

However, we would like to actually explore more aggressive schedules in man and by that -- by what I mean there is to dose more frequently, such as every two weeks or every one week, in order to try to quickly or much more quickly improve on our immunogenicity responses.

We have seen some recent data internally that says if you do indeed give our products more frequently, you can actually get the CD T cell responses up faster. So we will actually be trying more aggressive schedules in the backfill cohorts. That is the plan there..

Got it. That's really helpful. And then on 101, you talked a lot about the potential impact of Corona virus, but assuming that there might be some disruptions there.

Can you talk about any I guess contingency or backup plans, whether they might be shifting to different sites or any amendments to the protocol that might facilitate adequate enrollment there over the course of this outbreak. And I'll hop back in the queue. Thanks..

Yes. Thanks, you are [indiscernible] for the question. I think we need to kind of -- first of all, comment on, how does this affect our chronic milestones.

As you know, most of the relevant samples and other data for the analysis that will contribute to our reporting of data at both the first half of 2020 and even the efficacy endpoint at the end of the year, will be based on the on the first one-third of those patients.

The majority of those patients have already been approved to the study and the majority of the samples from that has already been collected. Therefore we do not feel that the current situation will affect our ability to report on the current 2020 milestones. Now, what happens beyond that? I think, we need to see how the current situation evolves.

As you know, the current situation is equally evolving the world. So we have caveats in our protocols that allow sites of course to get blood from patients on a CMV trial at local sites who actually do not need to come into their main center.

We also are putting in place shelf life extension to make sure that we have sufficient drug products and sufficient time in order to continue the trial if there are unexpected delays, given the current situation..

That's really helpful. Thanks again..

The next question is coming from the line of Debjit Chattopadhyay from Wainwright. Please go ahead..

Hi, Debjit..

Good afternoon guys. Oh, hi, this is Aaron on for Debjit. Good afternoon.

So, have you guys made any protocol amendments to screen for SARS-CoV-2 in patient prior to or during treatment with therapy? And I'm wondering if you might expect to change in activity of therapy in a patient with an active infection as those patients might be excluded from analysis?.

Igor..

Yes, great question. We specifically have not made any amendments or provisions.

However, I will say you know that I've spoken to all the investigators who are participating in our oncology program and as you could imagine, every single hospital at this point has instituted specific guidelines for COVID-19 screening, which of course means that anybody presenting with signs and symptoms that are suspicious for COVID-19 is undergoing specific COVID-19 testing as part of institutional guidance.

In speaking with the investigators, everybody feels that their own institutional guidelines are more than sufficient as a screening measure and therefore no additional screening measures will be required and what only complicate they are already overburdened administrative staff, we were to on top of their own institutional guidelines start putting in amendments that require processing at their sites.

Everyone was quite comfortable at a recent [PI] call but their own institutional guidelines are more than sufficient to COVID-screening of COVID-19 patients.

Now, to the second part of your question, how do we feel that a COVID-19 infection affects the ability of the patients to go on a [therapy] program? Standard oncology protocols cover these kinds of provisions.

And I would say, COVID-19 is perhaps somewhat no different than patients who have an advanced pneumonia or advanced flu and are being actively treated in that regard.

And therefore investigators have to make sort of a specific decision as to whether or not the patients are “have other medical conditions that prevents them from either going on trial or from being treated.” So we are all comfortable and again, in a recent conversation with investigators that made a standard oncology guidelines for concomitant medical issues are as built in the protocol are more than sufficient to cover the current situation..

Okay, thank you. That's interesting.

So are there any threshold levels of CD T Cell proliferation that you're targeting or any ratio of CD4 to CD8 T Cells that you haven't internally goals for?.

I think we would like to see in terms of CD8 T cells as extrapolated from other studies does actually looked at the impact of CD8 T Cells on the control of cancer.

And this is data that mainly comes from adaptive T Cell therapies, you can get a general pattern that number somewhere in the single-digit, somewhere between 5% to 10% could actually demonstrate a peripheral CD8 response and antigen specific manner. There is indeed showing a correlation with efficacy.

So ideally what we'd like to see is somewhere in the single-digit 5% to 10% response rate. We know from pre-clinical data that our therapy program even as monotherapy is about a tenfold more potent than our VaxWave program.

We know that our VaxWave program in the healthy volunteers study demonstrated, we see as a specific CD8 T Cell levels that were on the order of about 0.3%. Therefore and that was after two or three administrations.

And therefore, we feel that two to three administrations for therapy products should at least demonstrate 3% for CD8 T Cell response that of course, we will be giving more than two to three administrations. And we know that since we do not get back to neutralizing antibodies that our immunogenicity should increase with each administration.

Therefore, we are -- we believe that, we should be able to get into the high single-digit with 201 alone, and of course, the heterologous should be even a significant increase upon that..

Right. And so, last question.

Do you know if any correlation between CD8 T Cell expansion in peripheral blood and partitioning to the tumor or localizing to the tumor site?.

That's a great question. I think, again, the majority of the data for those comes from adaptive T Cell therapies or [indiscernible] like approaches where they've actually looked at the ratio between peripheral and tumor infiltrating lymphocytes.

And the best we could say right now is that clearly there is a correlation between the more you will have in the periphery and the more you will have in the infiltrating the tumor. But, certainly there's not been enough studies to give kind of a standard correlation.

All we can say is more correlates with more, but more than that, I don't think anybody can say at this point..

Okay, great. Thank you, Igor..

Next question is coming from the line of Suzanne van Voorthuizen from Kempen. Please go ahead..

Hi. Yes, this is Suzanne. Good afternoon or good morning. Thanks a lot for the color on the potential Corona virus impact. That's very helpful. I've just one question that's on the CMC program.

So circling back to that third ARM of lower risk patients that was added, since you have communicated your goals for the other ARMs, what you wish to see, I'm wondering if you have set some benchmarks of what would you like to see in this ARM specifically?.

Thanks for the question. I think -- as commented in our 10-K, as we kind of -- I think I’ve mentioned earlier, what we're looking for in the -- our positive ARM is kind of intra patient variation.

Otherwise, we'd like to see that the additional of the vaccine and that go and [indiscernible] increases the CMV specific antibody and CMV specific CD8 T cell responses above the baseline of those patients.

As to what is the right level to correlate to, we believe that is an improvement of two to three fold over the baseline on those patients would be a good barometer for success..

Okay. That’s very clear. Thanks a lot..

There are no more questions at this time. Please continue..

No more questions..

No sir, no more questions..

Then, I think we can close the call. I would like to thank everyone for participating in this call. I hope we made it very clear that HOOKIPA because of its financial strategy in the past is in a very strong financial position to overcome this current problematic period.

And we're doing whatever we can in order to deliver in the middle of this year and in particular the end of this year efficacy data from our CMV and from our first immune oncology trials. So thank you very much. Stay tuned and we'll be in touch as this crisis continues with any news if there are any that are impacting our programs.

Stay healthy everyone. And take care. Bye-bye..

That does conclude our conference for today. Thank you for participating. You may now disconnect..