Q4 2019 Earnings Call

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Operator: Welcome to your conference call. Please continue to stand by.

Welcome to your conference call. Please continue to some by your confidence would begin in about two minutes.

Operator: Your conference will begin in about two minutes. One more time, your conference will begin in about two minutes. ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? Good morning and thank you for joining the Hookipa Pharma 4th Quarter and Full Year 2019 Earnings and 2020 Outlook Conference Call. At this time, all participants are in a listening only mode. If you wish to ask a question during the session, you will need to press star and one on your telephone. I will now pass the call over to Matthew Beck, Executive Director of Investor Relations. Please go ahead.

One more time your confidence with digging in about two minutes. Thank you.

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Matthew Beck: Thank you. Joining me today are our Chief Executive Officer, Joern Aldag, Chief Financial Officer, Reinhard Kandera, Chief Medical Officer, and Head of Global Research and Development, Igor Medeshchansky, and Chief Technology Officer, Roman Acina. 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 plans to present or report additional data, the anticipated conduct and source of future clinical trials, regulatory plans, future research and development, and possible intended use of cash and investment. 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 statement. These and other risks are described in our periodic file.

Good morning, and thank you for joining the hookup of farm <unk> fourth quarter I'm for year 2019 earnings 2020 outlook comfort in school.

Fine, but is it something I leave you didn't listen only mode. If you wish just a question didn't decision do we need to press Star then one month of telephone I would now plastic or although <unk> must feel bad executive director of Investor Relations. Please go ahead.

Matthew Beck: Transcription by Transcription Outsourcing, LLC. On today's call, Joern will provide opening remarks. Igor will detail the progress of our clinical programs. Reinhard will offer high-level comments on our financials, and then we'll open the call to Q&A. With that, I'll pass the call to Joern.

Thank you joining me today, our Chief Executive Officer, you're an L. dogs, Chief Financial Officer, Reinhard Kundera, Chief Medical Officer, and head of Global Research and development, You Guard Medicine ski and Chief Technology Officer roaming the Sina.

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.

Joern Aldag: Thanks, Matt. Thank you, everyone, for participating in today's earnings call. It's Hookipa's 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 two our safe harvest statement, and then switch to slide three.

Our clinical and non clinical plans our plan to present for 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.

Joern Aldag: We have 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 clinic in both the infectious disease and oncology areas. On the corporate side, as you see here on this slide, and Christine Baker.

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.

Joern Aldag: Our Chief Business Officer, who is also managing our Gilead Alliance and our U.S. Headquarters office. We also added Roman Nitsina as Chief Technology Officer in November. Roman is responsible for Hookipa's 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.

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 your and will provide opening remarks, eager will detail the progress of our clinical programs Reinhard Walker high level comments on our financials and then we'll open the call to QNX with that I'll pass the call to your.

Thanks, Matt.

Thank you everyone for participating in today's earnings call. It's will keep US first since our IPO in April of last year, and we're very happy to have this call with you today.

Joern Aldag: 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 two trial in kidney transplant patients. Before going public, we had completed our Phase 1 Healthy Volunteer Trials, 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 immunoecology trial in HPV-16 positive cancers in late December, 2019. You can imagine how excited we were about this.

Please see on slide two our safe Harbor statement.

And then switched to slide three.

We've had a strong year.

And have made great progress both in terms of building a team.

And on the clinical front.

We're now in the clinic in both the infectious disease and oncology areas.

On the corporate side. So you see here on this slide we expanded our executive team by hiring.

And Christine Baker.

How cheap business officer, who is also managing all Gilliat Alliance and all U.S. headquarter office.

We also added woman Encino as Chief Technology Officer in November.

Roman is responsible for keep us global manufacturing operations, including analytical and process development.

Joern Aldag: This is a Phase I-II trial of our CRT-based program, HP 201, a replication competent vector technology expressed the E6-E7 fusion protein from HPV16. That trial accrued the first dose cohort of intravenously treated patients, is completing a crew for intratumorally treated patients as we speak, and has begun accruing patients in the second intravenous dose cohort. We expect to submit the IND for our HB202 program in the first half of 2020. This product is carrying the same antigen as HP201, but it's based on a different vector backbone to be used in combination for a stronger immune response. EGLE will again provide more detail on these programs.

Key hires of rounded out our corporate needs for strategic growth and future in house manufacturing.

Switched to the next slide please.

H.B. want to one.

The program based on non replicating box wave technology.

Designed to stimulate the immune system against cytomegalovirus infection or reactivation.

Isn't its phase two trial and kidney transplantations.

Before going public we had completed phase one healthy volunteer trial.

Showing strong and durable T cell and anti body Immunogenicity.

We continue to enroll patients and time to report safety and Immunogenicity data from roughly one third of the told to patients.

In the first half of Twentytwenty.

Eagle will provide more detail shortly.

Flip over once.

We also dose first patient in immuno oncology trial in HPV 16 positive cancerous in late December 2019.

Joern Aldag: Slide 6, Our collaboration with Gilead seeking therapeutic cures for chronic hepatitis B and HIV is rapidly progressing. We were proud that, in January of 2020, Hookipa agreed with Gilead to expand and accelerate the development of both programs. As a result, Hookipa is adding staff that will be solely focused on the Gilead programs, the full cost of which is borne by Gilead themselves.

You can imagine how excited we worry about this this is a phase one two trial of Alistair T. based program HP tool one.

Hey, replication competent vector technology.

Expressing the 67 fusion protein from HPV 16.

That trial accrued the first dose cohort of intravenously treated patients.

Joern Aldag: Gilead internally approved what they call a request for development in the HPV program, triggering a significant milestone payment. The program is now progressing toward the clinic. We couldn't be more pleased working with Gilead as a development partner.

It's completing accrual for intra tumoral the treated patients as we speak.

And has begun accruing patients in the second intravenous dose cohort.

We expect to submit the R&D for H.B. tool to program in the first half of Twentytwenty. This product is carrying the same antigen is HP tool one.

Joern Aldag: Slide 7 is a summary of our clinical milestones. As communicated earlier, we will deliver preliminary efficacy data for CMV for preemptive patients at the end of 2020. Importantly, our Immune Oncology Program will show initial safety and efficacy data in late 2020 or early 2021, as guided before, and our combination of HB202 and HB201 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 It is difficult to provide timelines at this point for these programs as Gilead is controlling the timeline. Slide eight.

But it's based on a different vector backbone to be used in combination.

For a stronger immune responses.

Eagleville again provide more detail on these programs.

Slide six.

Our collaboration with galea seeking therapeutic cures for chronic hepatitis B and HIV is rapidly progressing.

We were proud in January of Twentytwenty, who keep agreed with gilliat to expand and accelerate the development of both programs.

As a result, who keep us adding stuff that will be solely focused on the gilliat programs.

The full cost of which is borne by gilliat themselves.

I would add 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.

Joern Aldag: Before I end my overview, I'd like to comment on the coronavirus 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.

We couldn't be more pleased working whiskey llyod as a development partner.

Slide seven as a summary of our clinical milestones.

As communicated earlier, we will deliver a preliminary efficacy data for CMV for preemptive patients at the end of Twentytwenty.

Importantly.

Oh immuno oncology program will show initial safety and efficacy data Lake Twentytwenty or early 2021 as guided before I know a combination of HP tool to and HP to a one to drive the highest T cell responses will provide important data in the middle of 2021.

Joern Aldag: Our employees have quickly adapted to the new circumstances, and the non-lab-based colleagues are trying to continue business from home as best they can. We are in close contact with our trial sites, with 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 immunosuppression during the coronavirus outbreak. Our HPV-16 positive patients are in the advanced metastatic setting and Post First and Second Line Treatments.

And I'll give you a collaboration as communicated earlier, we achieved one milestone following gileads decision to commit to preparations to advance the HIV and HCV vectrus towards development.

It is difficult to provide timelines at this point for these programs as Gilliat is controlling the timelines.

Slide eight.

Before I and my overview I'd like to comment on the Corona virus pandemic.

And how it's affecting people.

Our top priority is to health and safety of all 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.

Joern Aldag: So the risk is their ability and willingness to get to trial sites for continued treatment. We have to assume that recruitment for our trials will be impacted, though as of today, we remain on track with the disclosed milestone date. 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 is critically important with a cash reach to the end of 2021, 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, HP 201, HP 202, and the neoadjuvant 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 discussion. I will now pass the call over to Igor for a deeper dive into our CMV and HPV-16-positive cancer programs. Igor?

And I'm working with our lab technicians to sustain ongoing experiments in the company travelers reduced to zero.

Our employees of quickly adapt it to the new circumstances and a non lab based colleagues. So trying to continue business from home as best as they count.

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 they will be any clinical trial disruptions or delays.

For solid organ transplants, we believe it is unlikely that transplant centers will risk voluntary immunosuppression during the krona virus outbreak.

HPV 16 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 continue 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.

Why we are well funded and this at this current point in time is critically important with a cash reach to the end of Twentytwenty. One end of Twentytwenty. One. We're currently looking at the prioritization of although activities with a goal to extend the runway.

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

Our top priorities are the CMV program, our cancer programs HP tool, one HP tool to and Neoadjuvant studies that were running and Gilliat.

Igor Medeshchansky: Our CMV prophylaxis program, Hb101, dosed the first phase 2 patient in December of 2018 and continues to enroll patients. To review, the Phase II program is a randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of HB101, a bivalent prophylactic vaccine for cytomazovirus, in Omegalovirus negative patients awaiting kidney transplantation from living CMV positive donors. Based on HP 101's tolerability profile and the target patient population, and to gain further insights that will inform Phase 3 trial design, we recently added a new cohort 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 help 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.

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 our CMV and HPV 16 positive cancer programs category.

Thank you aren't Hello, this is eagle or Medicare landscape, Chief Medical Officer, and global head of research and development or keep up.

As Jordan mentioned, we're progressing through a proof of concept infectious disease and oncology trials, both with imported efficacy readouts at the end of Twentytwenty or early 2022 on.

Please see slide nine.

Our CMV portfolio access program, one or one dose the first phase two patients in December of 2018 and continues to accrue patients.

To review the Phase two program is a randomized placebo controlled clinical trial to evaluate the safety and efficacy of HB Wantto, one abides ailing prophylactic vaccine for cytomegalovirus.

Instead of medical virus negative patients awaiting kidney transplantation from living CMV positive donors.

Based on each people want to wants Tolerability profile and the target patient population and against further insights that both form phase three trial design.

Which has the added a new cohort 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 for also helps to expedite trials equipment.

Igor Medeshchansky: Also, in the first half of 2020, we expect to report on the immunogenicity of approximately one quarter, that is, 35 to 40 patients, of the total to be enrolled respect both CMV-specific antibody and CMV-specific CD8 T-cell response. For the placebo-controlled part of the trial, we expect to demonstrate an interpatient effect, that is, between those patients that received placebo versus those that received the vaccine. For the recipient-positive group, we will measure an intra-patient effect, that is, an increase over baseline in those patients that receive the vaccines.

In the first of a 2020 as Jordan mentioned, we expect to report on the safety of approximately one third that is 50 patients as a total 150 can be enrolled.

The safety monitoring pillar will include the period between the first dose and the date of transplantation.

Also in the first seven Twentytwenty at least Thats report on the new here in this city of approximately one quarter that is 35 to 40 patients of the total to being rolled.

We expect both seem to be specific antibody and CNB specific cdeight T cell responses.

Because the placebo control part of the trial, we expect to demonstrate an inter patient effects that is between those patients received placebo versus those who seem like a vaccine.

Igor Medeshchansky: We will view positively if T-cell and B-cell antibody values are in line or higher than those reported in the Phase I. Also, we expect 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 HB101 patients late in the second half of 2020. The data will be based on the quantity, quality, and number of complete data sets available.

For the recipient positive who will measure in truck patient effect that is an increase over baseline in those patients that received vaccine.

Ooh you positively if he cell and b cell antibody values are in line or higher than those reported in the phase one.

Also we expect to demonstrate no significant factor neutralizing antibody detection with repeat administration as we have also previously demonstrated in our phase one.

Additionally, we plan to released preliminary efficacy data from HP, one or one patients late in the second half Twentytwenty.

The data with based on the quantity quality and number of complete datasets available.

Igor Medeshchansky: The most important focus would be on the patients treated in the preemptive antiviral therapy post-transplant arm since these patients are tested often and only administer antivirals when evidence of CMV viremia presents. We will provide substantially more information about this data readout later in the year. Please, this is my chance.

The most important focus would be on the patients treated in the preemptive antiviral therapy post transplant are.

Since these patients a test that often only administered anti viral what evidence of CMV viremia presents.

We will provide substantially more information about these data read out later in the.

Please see slide 10.

Igor Medeshchansky: Moving on to our oncology program, we were excited to have submitted our HB201IND in July and dosed our first patient in December of 2019. HP201 is a theraT platform-based replication competence vector from the arena virus family expressing a non-oncogenic but highly antigenic E6-E7 fusion protein from HPV16.

Moving on to oncology programs.

We were excited to see that submitted our HB to a one I envy in July and dose the first patient in December of 2019.

He asked me to one is et cetera keep platform based replication competencies actor Sunday Arena virus family expressing a non oncogenic, but highly antigenic esix eseven fusion protein from HPV 16.

Igor Medeshchansky: The Mototherapy 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 who have progressed on standard of care. It is designed to evaluate the safety, tolerability, and preliminary efficacy of HB 201 as motor therapy and in combination with an immune checkpoint inhibitor. For phase one dose escalation, the patient population is divided into two groups of 20 patients each. The first group is enrolling locally advanced and or metastatic HPV 16 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 intratumoral administration of HB201 followed by intravenous administration of HB201 every three weeks as monotherapy.

The monotherapy phase one two trial is an open label dose escalation and dose expansion trial and 100 patients locally advanced and do our metastatic HPV 16 positive cancers with progressed as standard of care.

It is designed to evaluate the safety tolerability and preliminary efficacy of H.B. tool, one as we want to therapy and in combination with an immune checkpoint inhibitor.

For phase one dose escalation the patient population is divided into two groups of 20 patients. Each the first school is enrolling locally advanced and door metastatic HPV 16 positive head and neck squamous cell carcinoma patients progressing as standard of care, who will then receive intravenous administration of age.

The tool once every three weeks as monotherapy.

The second group is enrolling locally advanced and door metastatic HPV 16 positive cancers of any side of origin with an accessible tumor who receives the one intra tumoral administration as HP to a one followed by intravenous administration of HP tool. Once every three weeks as monotherapy.

Igor Medeshchansky: It is a standard 3 plus 3 dose escalation study design, and doses will go up on log scales. Importantly, we are not trying to compare intravenous to intratumoral 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 treatment would suggest a systemic approach. Other patients present with metastatic disease across the body with a central large tumor as well as additional systemic disease.

It is a standard three plus three dose escalation study design.

And does this 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 there on the body with no central NASS and treat them with suggests is that like approach.

The patients present with in metastatic disease across the body with essential a large tumor as well as additional systemic disease.

Igor Medeshchansky: In this latter case, we provide the option for investigators to inject HB 201 directly into the tumor, which may accelerate the response at that one tumor site while still providing an aposcopal-like effect. You mentioned earlier that the trial has already completed the accrual of the first dose level in the intravenous arm and is now currently already accruing patients at the second dose level. Ventral Tumoral Arm is completing a cool down of the first dose level as we speak. We plan to accrue and study backfill cohorts between dose levels 2 and 3 to test different dosing schedules. We anticipate dose level 3 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 resist 1.1 and immunogenicity. We expect preliminary data to be available in late 2020 or early 2021. Now, please see slide 11.

And this latter case, we provide the option for investigators to ingest HB tool one directly into the tumor.

Which may accelerate the response to that one tumor site, while still providing that scalpel like effect.

You had mentioned earlier that the trial has already completed their cool over the first in dose level and the intravenous arm and now it's currently already accrual patients at the second dose level.

The intra tumoral arm is completing a cool the first dose level asked me speak.

We plan to accrue and study backfill cohorts inbetween dose levels, two or three to test different dosing schedules.

We anticipate dose level through we will begin accruing patients late in the second half of this year.

The primary endpoint of the phase one portion of this trial will be to evaluate safety and tolerability to determine the recommended dose for the phase two portion.

Secondary endpoints will evaluate anti tumor activity as defined by resist 1.1 and immunogenicity.

We expect preliminary data to the available lay twentytwenty early 2020 to one.

Now please see slide 11.

We also expect to submit our HIV two or two I in d. in the first half of 2020.

Reinhard Kandera: We also expect to submit our HB202 ING in the first half of 2020. The IND submission will be an amendment to the current HB 201 IND, not a stand-alone submission. The benefit of this approach is that we will be able to amend our protocols on those patients at the same time as the currently ongoing HB 201 motor therapy trial. The HB 201-202 trial will be an alternating two-vector therapy using different arenaviral vectors derived from pachyndovirus and LCMV. It will follow a substantially similar trial design as HB 201 monotherapy, and we are very excited to get that going in the latter part of this year. With that, I'll turn it over to Reinhard for comments about finances. Reinhard?

The idea submission will be an amendment to the current H.B. to a one I Andy not a standalone submission.

The benefit of this approach is that we will be able to amend our protocols and dose patients at the same time as a currently ongoing HB tool one monotherapy trial.

They should be tool wanting to go to trial will be at alternating two's after therapy using different arena viral vectors derived from the tend to virus and how CMV.

And we'll follow essentially similar trial design as H.B. tool one monotherapy.

And we're very excited to get that going into later part of this year.

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

Probably hurt.

Reinhard Kandera: Thank you. Thank you, Igor. Good morning, ladies and gentlemen.

Thank you. Thank you your good morning, ladies and gentlemen, let me give your short overview on the financial restart. The three released this morning, and which are summarized on slide 12 book. Your presentation. These results and the year on year development reflects the significant progress that will keep us made and.

Reinhard Kandera: Let me give you a short overview of 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 reflect the significant progress that Hookipa has made in 2019 in advancing our clinical pipeline, delivering on our collaboration with Gilead, and in the transformation from a private to a publicly listed company. Since the fourth-quarter results were very much in line with the previous quarters, I will focus on the full-year results.

2019 in advancing our clinical pipeline and delivering on our collaborations with Gilead.

And in the transformation from a drive it took topic that this company.

Since the fourth quarter resides we are very much in line with previous quarters I will focus on the full year results.

Reinhard Kandera: Let me start with revenues, which resulted exclusively from our collaboration 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 toward clinical entry. R&D expenses increased by $24.3 million in 2019, and the main cost drivers were the Phase II clinical trials for our HP 101 program, the preparation costs for clinical trials for HP 201 and HP 202 programs, expansion of earlier stage programs, costs in connection with securing manufacturing capacity for production of clinical trial material, and the costs related to the general increase in our R&D capacities and personnel.

Let me start with revenues.

Recites exclusively from our corporation with Gilenya and increased by $4.3 million compared to 2018.

Below the 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 advantage.

We received another milestone of $4 million Threega cyclists decision to move to hepatitis B program total it's created get treated.

R&D expenses increased by $24.3 million in 2019.

And the main cost driver the phase two clinical trials HP one of them long program. The preparation costs of clinical trials for HP to along with HP, two or two programs expansion of earlier stage programs costs in connection with securing manufacturing capacity for.

Faction of clinical trial material and the cost related to the general increase of our R&D capacities and personnel.

Reinhard Kandera: The increase in 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, an increase in professional and consulting fees, and other expenses, such as insurance costs. Our other operating income mainly includes grant income of $6.7 million from the Austrian government and interest income on our cash balances, partially offset by interest expenses. Our combined cash outflow from operating activities and investments, sometimes referred to as cash burn, was 43.7 million US dollars. Between the February 2019 Series D financing and our IPO that closed in April 2019, we raised net proceeds of approximately 112 million US dollars, which provided us with a strong year-end cash balance of roughly 113 million dollars. Considering any coronavirus-related impacts, we expect our 2020 spending to only moderately increase compared to 2019. We expect our cash reserves to fund our operations to 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.

The increase of our T. and they cost by 9.9 million both substantial and it reflects the overall growth organization and the cost to operate the public company.

It was driven by an increase in personnel related expenses of $5.4 million, including stock compensation by the increase in professional and consulting fees.

And other expenses such as the Endo insurance costs.

Other operating income Manger includes grant income of 6.7 million thoughts from the Australian government and interest income and our cash balances, partially offset by interest expenses.

How combined cash outflow from operating activities and investments.

I was referred to as cash for both $43.7 million.

That being the February 2019 series, you financing and our IPO that closed in April 2019, we raised net proceeds of approximately 112 million U.S. dollar, which provides us with the strong yearend cash balance of roughly 100 within 15 million.

Startup.

Pending M&A Corona light with related impact, we expect our twentytwenty spending to only moderately increase compared to 2019, we expect our case reserves to fund operations through at the end of 2021 at least and most importantly beyond our key clinical labs.

Films.

Now with that I'd like.

To Europe.

In closing I'm, very pleased with who keep us corporate and clinical progress in 2019 and early Twentytwenty.

Joern Aldag: In closing, I'm very pleased with Hookipa's corporate and clinical progress in 2019 and early 2020. We remain focused on execution to produce compelling proof-of-concept data with our proprietary arena viral vector-based product, and I'm excited to see both our trials unfold and Hookipa continue to develop.

We remain 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 a continued to develop.

Joern Aldag: We will stay in close contact with you as the pandemic unfolds, and we'll 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 coronavirus pandemic period.

We will stay in close contact with you as dependent pandemic unfolds and anvil keep communicating.

If any of our ponds are impacted.

I'd like to leave you with one final thought we must ask ourselves what we us individual some company contributors can gain from working at home. During this unusual krona virus pandemic period.

Operator: In 1665, the Great Plague of London hit; the 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 professor. He produced papers that would become the bedrock of early calculus and made his famed observations about gravity. In fact, 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.

16, 65, the great plague of London hit University of Cambridge Coast and sent students home to continue their studies in practice today's version of social distancing.

One student had some of its greatest breakthroughs during that period without his professors. He produce papers that would become the bedrock of early cultures and made his famed observations about gravity.

It 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 from today.

Operator, Thank you once again, if you wish just a question. Please dial one on the first question is coming from that.

Andrew Scott Berens: Thank you. Once again, if you wish to ask a question, please press star and one, and the first question is coming from the line of Andrew Berens from SVV Leering. Please go ahead.

But buttons from.

The Leerink. Please go ahead.

Thank you can you hear me yes.

Unknown Executive: Thank you. Can you hear me? Yes.

Unknown Executive: Yes.

Yeah.

Andrew Scott Berens: 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 in the transplant program. Is it that the transplant centers are decreasing the number of transplants they're doing, or that these are still happening, but you think it's hard, potentially hard to introduce a novel adjuvant intervention into that sequence?

I want to thank.

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 go away the transplant program.

Isn't that the transplant centers are.

So the number of transplants are doing whether these are still happening, but you think it's hard potentially hard to introduce Inovalon Japan.

Intervention.

So that sequence.

Igor would you respond.

Igor Medeshchansky: Igor, would you respond?

Igor Medeshchansky: Of course. Thanks, Andrew, for the question.

Of course, thanks, Thats Azure for the question.

Igor Medeshchansky: I think it is too early to tell. Certainly, however, in the current environment, it is possible that surgery requiring immunosuppression will be delayed because hospital staff may be redirected to pandemic-related interventions. Hookipa is not unique in this.

I think it it is too early to tell.

Certainly however in the current environment. It is possible at surgery acquiring immunosuppression will be delayed hospital staff may be redirected to condemn escalate interventions.

People is not unique in this that they call clinical trials requiring hospital inpatient resources in the near to the pandemic what hospital resources are expected to be stretched.

Igor Medeshchansky: I think all clinical trials requiring hospital inpatient resources in the midst of the pandemic, when 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 are a difficult patients to accrue, but we believe what we know today we will be able to deliver on the milestones as stated. It's not a question of if but perhaps how many patients.

We'll be facing.

Similar challenges so I think you know.

You know the live don't understand transplant patients at high risk is a difficult patient to accrue, but listen we are what we know today, we'll be able to deliver on the milestones as stated its not a question.

It's the perhaps how many patients.

Joern Aldag: So Andy, we heard that in China

But we believe we are on track deliver the milestones.

As previously stated.

And Andy we heard.

Andrew Scott Berens: Okay. And just to remind us, your trials are not in China, though, right? No, we're not. We're not in China. Okay, and then, are you seeing any impact? Oh, potentially on the supply of the agents, any manufacturing impacts because of the pandemic?

Im kidney transplants are down significantly in the context off the the crisis that took place there so including Okay does impact things.

Okay.

And just news remind us I mean, you your trials amount in China there right.

No.

Were not and we're not in China.

Okay, and then are you seeing any impact.

Actually on the.

Supply.

Agents any manufacturing impacts pandemic.

At this point in time no I.

Joern Aldag: At this point in time, no. I would like to have Roman answer this question. We're obviously working very hard with our 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.

I would like to have Roman answered this question.

We're obviously working very hard with our arms heroes, who also have impact, but I'm trying to keep their own manufacturing sites up and running.

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

Hello, everyone Roman the thing that speaking.

Roman Acina: Hello everyone, this is Roman Messina speaking. We are very close.

Thank you all to our excel, Bob most poles to see animals as they this to a external lives because.

Roman Acina: to our external partners, both to CMOs as well as to our external labs because they face similar challenges as we do in our labs. They also have to make sure that they have sufficient people to execute on the GMP-relevant tasks. And so far, we have heard lots of solid business continuity plans. But, of course, as the situation evolves, they need to be constantly adapted. And we are very close.

They face similar challenges like we you know related to that has also.

To make sure that they have sufficient papers to execute on the GMP rather than.

And the so Oh, we have who have lots of solid business comes in is the planes for the because it's a situation evolves the need to be constantly.

And though we have a vehicle lines of communication updating each other on a regular.

We know that ours euros, or actually also prioritizing and clinical trial material and GMP seems to be very high on their priority list.

Joern Aldag: We know that our heroes are also prioritizing, and clinical trial material in GMP seems to be very high on their priority list, whereas other things are deprioritized, and there may be impacts. But at this point in time, we're not seeing anything impacting the material for our trials.

Yes, other things are de prioritized and then maybe impacts but at this point in time, we're not seeing anything impacting the material trial.

Andrew Scott Berens: Can you just remind us, Joern? 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?

Okay can you just for modeling Sean I don't remember what you guys have publicly announced about the supply chain, but.

Theres anything could you just remind us what what it is.

On do you mean, who were working with minutes heroes area.

Joern Aldag: Do you mean who we are working with in the CROs area?

Andrew Scott Berens: Right.

Right.

Joern Aldag: Yeah, Roman, just quickly, we have transferred to several CROs. All of our processes that we're using in clinical trials. We have good relationships with these people, and I would like to have Roman give a sort of brief summary of the relationships with these suppliers and also with our own manufacturing site which we're running in Sweden. Roman, just very brief.

Yeah Roman I'm just quickly you have transferred to several ciros.

All of our processes that were using in clinical trials.

We have good relationship with these people and I would like to have room and give a sort of brief summary on the relationships with these suppliers and also with our own manufacturing side, which were running in Sweden.

And just very brief.

We have a CMO both in Europe and you is.

Roman Acina: We have CMOs in Europe and in the U.S. for biotrack substance manufacturing. We have CMOs for drug product manufacturing in Europe, and we have eight external labs doing our testing and release relevant activities. And we are in the process of ramping up biotrack substance capacity at Varneva. Here we have a dedicated GMP plant for GMP manufacturing of phase one, and two clinical materials, 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 depends on the coronavirus. I hope so. And then, are you seeing any impact on regulatory interactions or progress with either the EMA or FDA?

Well, Mike drug substance manufacturing his foot drug product the animals in Europe and to have eight external lives doing our tasting and release rather than the if you do this and the we end the growth was of ramping up of like drug substance capacity at our neighbor.

You have you hit the dedicated to the GMB Brown, who GMP manufacturing of phase one to begin agreement through there and they have implemented or grows as the most recently.

With the ramp up GMP manufacturing.

In the second quarter, though this year, because everything depending on the Corona Lars.

Okay.

And then are you seeing any impact on regulatory interactions are progress with either.

Yeah.

Igor Medeshchansky: Igor, please comment.

I'm eager piece comments.

Igor Medeshchansky: No, we have not seen any delays, or we have not received any kind of guidance that indicates that there will be delays as yet. We are, of course, concerned and, you know, I would say being very conservative and realizing that there might be delays as the health authorities and the internal resources are diverted to deal with the current COVID-19 situation, but we have not had any communication or any indications that any kind of delays are forthcoming.

No we have not seen any delays or are we have now received any kind of guidance that indicates that there will be delays.

Coming as of yet we of course are concerned and and you know.

Let's say the very conservative enough and realizing that there of course might be delays asked the health authorities and internal resources are devoted to deal with a current coas 19 situation, but we we have not had any communications or any indications that any kind of.

Delays are forthcoming.

Andrew Scott Berens: Okay, maybe just one last question, and I'll stop hogging the bandwidth. In regards to the Gilead collaboration, they obviously made the milestone payment that you highlighted. But was there any other non-financial commitment that they made when they decided to go forward with the infectious disease program?

Okay and other just one last question I'll stop haagen the bandwidth.

In regards to the Gilliat collaboration.

This limited the milestone payment that you highlighted was there any other non financial.

Commitment that they've made when they decided to go forward would be infectious disease program.

Joern Aldag: Yes, the request for development means that they're doing everything possible to get a program into a phase one clinical trial, and there is a formal stage gate when they decide to move something into phase one. The RFD actually sort of unlocks the commitment, and then you know, manufacturing is a longer-term commitment, which costs money, and unlocks the commitment to actually go into a phase one 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 FDs, and accelerating the programs towards clinical trials is a very positive sign, which tells us with the commitments they make to reserve capacity at our manufacturing sites at the CROs. It's a very positive sign that they will take these programs into clinical trial within the normal time frame that you would expect for a biological to be manufactured for biodistribution tox studies and then go through the IND process and go into clinical trials.

Yes, they request for development means that they're doing everything possible to to get a program into phase one clinical trial.

Are there is a formal stage gate when they decide to move something in phase one the RF de actually sort of unlocks the commitment and you know manufacturing is a longer term commitment which costs money.

<unk> unlocks the commitment to actually go into phase one clinical trial.

And and we interpret <unk> the the fact that they have asked us to expand the collaboration we now have we had 15 people working on this is now 30, fts and and accelerate the programs towards clinical trials is a very.

Positive sign.

Which tells us with the commitments they make to Red reserve capacity at at all of our manufacturing sites at this heroes. So 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 talk studies and then go so the R&D process and go into clinical trial.

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

Andrew Scott Berens: Okay. Thanks a lot for all the questions, guys, and good luck with everything. Thanks. You too.

Thanks, you too.

Unknown Executive: Thanks, you too!

Yeah.

Next question is coming from that angle I like Shanahan from Bank of America. Please go ahead.

Alec Warren Stranahan: The next question is coming from the line of Alec Stranahan from Bank of America. Please go ahead.

Hey, guys, Oh, Hey.

Alec Warren Stranahan: Hey, guys. Hey, going on. So just a couple for me.

For for taking my questions I Hope you got sort of than say given everything that's going on.

So just a couple from me I'm first on H.B. went to one.

Igor Medeshchansky: First on HB101, could you just remind us as to the safety profile from phase one and if there are any factors that may change safety or the level of immune stimulation in phase two versus what we saw in healthy volunteers? And then maybe could you talk a bit more about the rationale for expanding the study into seropositive recipients? Is it primarily for accelerating enrollment, and then I've got a follow-up.

Could you just remind us as the safety profile from the phase one.

And if there any factors that may change safety or level.

Stimulation in the phase two versus what we saw in healthy volunteers and then.

Maybe could you talk a bit more about the rationale for extending a study into your positive recipient.

Primarily for accelerating enrollment.

Hello.

Yes, Thanks sure Yep, So I think in terms of mining of the safety of phase one.

Igor Medeshchansky: So, in terms of the safety of Phase I, what we saw in Phase I was, most importantly, certainly no systemic effect 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 in the saline placebo.

What we saw in phase one was most importantly, certainly no systemic effects from the intramuscular administration, we did see mainly.

Local reactions to the intramuscular administration, such as you would FEMA.

However, interestingly enough as they were very similar to what was observed in the feeling placebo.

Igor Medeshchansky: So overall, from the healthy volunteer phase one data, it was a very, I would say, safe and uninteresting kind of profile. In terms of immunogenicity and whether we will see similar immunogenicity in phase two as we saw in phase one, we do believe we will. The patients that 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 with our vaccine that will anyway differ from what we have seen in the healthy volunteer study. And the third part of your question was, you know, why did we add the R positive arm?

So overall from the healthy volunteer our phase one data was a very I would say safe.

Onyx non interest in kind of profile.

In terms of.

In terms of the Immunogenicity and whether we will see similar immunogenicity.

In the phase two as we saw under phase one we do believe we will the patients that are under a being treated as being treated perri transplantation.

Before any kind of immuno suppressants are on board and so we do not fundamentally biologically believes that there will be a difference in the immune response. This 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 you know deed why did we added the our positive on.

Igor Medeshchansky: It was basically in response to many of the investigators, having observed and had experience with our vaccine for over one year, and not noting any concerning safety signals, were more keen and much more interested in expanding this to their CMV positive recipients, who, of course, have a lower risk of post-transplant viremia, but still, the risk is in the order of 40%. And therefore, having demonstrated a very safe profile in a high-risk patient population, they were very keen for us to expand that to a lower-risk population. This, of course, serves our interests as well. It helps clearly with the implementation 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 comers, and this will give us additional data to support that argument.

It was basically in response to many of the investigators so having observed in hasn't 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 too is there in the positive recipients who of course have hello or.

Risk of post transplant viremia, but still the risk is on the order or 40% and therefore, having demonstrated very safe profile.

In a war at high risk patient population they were very keen to for us to expand that too.

More lower risk population. This of course service you know our interest as well it helps clearly as part when would the accrual of the program, but I think more importantly, it allows us.

Data to suggest to the FDA that our vaccination strategies, you 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 Yeah that makes a lot of side.

Alec Warren Stranahan: Okay, great. Yeah, that makes a lot of sense. And then, since coronavirus is obviously at the top of most people's minds right now, what will your plan be 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?

And then a.

Current a virus, it's obvious that at the top people wise right now what will your plan B for data dissemination is that the conference is contagious postponed.

Due to the virus, particularly for the planned.

On top 20 safety and immunogenicity updates or for one or one.

Joern Aldag: We will definitely have detailed press releases on the results that describe the results and the data. Igor, do you want to say something?

With that I'd like separately.

Press releases on on the results that describe the results and the data.

Igor Medeshchansky: I know. I mean, I agree with you on that.

You go do you want to say something.

I know I mean, I I agree with you on it will start with a press release I think the big.

Igor Medeshchansky: We'll start with a press release. I think the big and most interesting data will be the efficacy data that will come at the end of 2020. And I think at that point, that will also follow with a press release, and of course, a conference to come shortly after. As you know, most conferences now have three to four months in advance of submission. So any data that we submit in a press release by the end of 2020 will be ready for presentation at a 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 be presented on schedule.

And then more interesting data will be the efficacy to accommodate the end up on T. 20.

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

In advance submission so any data that we submitted a press release, but in a 2020, we'll be ready for presentation at a conference three to four months later.

Which point I am I being I would say.

Maybe realistic that all of this will be behind us and data will be built it presented our contract.

Alec Warren Stranahan: Okay, and last one for me, sort of along those same lines. You guys sort of alluded to this during your prepared remarks. But, you know, I know that you're laser focused on your core pipeline programs. But given the flexibility of your vaccine platforms, have you given much thought to developing a coronavirus vaccine yourselves? And perhaps you could just talk through the hypothetical strengths of such a vaccine built on your arena virus platform versus others, such as Moderna, beyond tech, etc.

Okay. Okay last one for me sort of along those same line.

Got it sort of alluded to that.

In your prepared remarks, but.

I know that you are laser focused on a core pipeline programs, but given the flexibility of your vaccine platform.

You have you given much thought into developing a credit by respective yourself.

Perhaps could you just talk through the hypotheticals strengths of such a vaccine built on your into virus platform versus others such as in the during a and B on tech et cetera.

Unknown Executive: [inaudible]

You are.

Igor Medeshchansky: So I think our technology is, in the long term, very suited to developing a vaccine for something like this, for the coronavirus and related strains. The only question is timing and a decision on where to prioritize. Currently, you know, we have decided, as you have already stated, to be laser focused on our core program. 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 prioritizing our core program.

Thank you. So I think our technology is in the long term very suited for developing a vaccine for for something like this for the corner virus and related strains.

The only question is timing and a decision our 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 prioritization.

At the moment then typically we just think we're prioritizing.

Alec Warren Stranahan: Thanks for taking our question.

Our core programs.

Okay. Thanks for taking your question.

The next question is comes from the language, Brian outcomes from RBC capital markets. Please go ahead.

Brian Corey Abrahams: The next question is coming from the line of Brian Abrahams from RVC Capital Markets. Please go ahead.

Brian Corey Abrahams: Hi guys, thanks very much for taking my call... Hi, can you hear me okay?

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

Can you hear me, Okay, Yeah sure.

Unknown Executive: Yeah, sure.

Brian Corey Abrahams: Great. Well, thanks so much for taking my questions and congrats on all the progress, and I 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, you know, how things are going with those initial cohorts. And then you mentioned the backfill cohorts. I'm curious about the types of dosing schedules you might test there and whether those, you know, what you're going to be testing is based on any sort of efficacy or safety findings from the cohorts dose so far.

Great well, thanks, so much for taking my questions and congrats.

All the progress and appreciate all the color on the potential October 19 impact I guess my first question is on two or two was wondering if you could talk a little bit more about sort of.

How things are going on with those initial cohorts and then you mentioned the backfill cohorts I'm curious the types of dosing schedules you My test there and whether those you know what you're gonna be testing is based on any sort of efficacy or safety findings from the cohorts dose so far.

Igor Medeshchansky: Thanks, Brian. I'm assuming you mean the 201 program, not the 202.

[laughter] us as Brian I'm, assuming you mean, the to a one program not the tool, yes, sorry I.

Igor Medeshchansky: Yes.

Meant to say two on sorry.

Igor Medeshchansky: Nope, nope, perfect. So first question: what are we seeing from dose level one? We have seen nothing from safety concerns and have escalated very smoothly to our dose level two. So, that remains completely on track. As I remind you, our preclinical toxicology package was completely safe. We had no dose-limiting toxicity or any kind of classical NOEL in the preclinical GLP studies. 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 1 to dose level 2. (Inaudible) And remember, we are escalating by log, so I think we're making quite rapid progress.

No no perfect.

So first question what are we seeing from.

Dose level, one we have seen nothing from a safety concerns.

And and escalated very smoothly to our dose level too.

So that remains completely on track this I remind you our preclinical toxicology.

Package was completely save for we had no.

No dose limiting toxicity or any kind of classes all Noel.

In the preclinical GLP studies, therefore, we did not and still do not anticipate that we will see any.

D. LTV.

In the human clinical trials. Therefore, I was no surprise that we went very smoothly with no safety concerns.

Dose level wanted dose level too.

And remember we are escalating bylaws, so I think we're making quite rapid product progress.

Igor Medeshchansky: In terms of what we expect to study in the Baxo 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 preclinical mouse and monkey work. However, we would like to actually explore more aggressive schedules in man, and by that, I mean, dosing more frequently, such as every two weeks or every one week, in order to try to quickly or much more quickly improve 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 CDAT responses up faster. So we'll actually be trying more aggressive schedules in the backfill cohort. Um, that is the plan there.

In terms of what do we expect the study in the backfill cohorts. We entered the trial as you know when the 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 preclinical mouse and monkey work.

However, we would like to actually explore more aggressive schedule.

Man and bought by data by what I mean, there as to dose more frequently purchase every two leases or every one week in order to try to quickly are much more quickly improve on our immunogenicity and responses. We have seen some recent data out internally that says if you do indeed.

[music].

Oh products more frequently you can actually get the CV T cell responses up faster through will actually be.

Trying more aggressive schedule by in the backfill cohort.

That is the plan there.

Brian Corey Abrahams: Got it. That's really helpful. And then on 101, you talked a lot about the potential impact of the coronavirus, 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.

Got it that that's really helpful. And then on one or one you talked a lot about the potential impact of of Corona virus, but.

Assuming that there might be some disruptions. There can you talk about any I guess contingency or or backup plans, whether they might be.

Shifting to different sites or any amendments to the protocol that might facilitate.

Adequate enrollment there over over the course of this outbreak and I'll hop back in the queue. Thanks.

Igor Medeshchansky: Yeah. Thanks, Joern. No, thanks, Brian, for the question. I think, you know, we need to kind of, first of all, comment on how this affects our current 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 first one-third of those old patients. The majority of those patients have already been accrued to the study, and the majority of the samples from that have already been collected. Therefore, we do not feel that the current situation will affect our ability to report on the current 2020 milestone.

Yeah, Yeah. Thank you I know thats, probably for the question I I think you know we need to kind of.

First of all comment on how does this affect our our current 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 20, Twond and even the efficacy endpoint at the end the year lead based on the on the first one third of those of patients. The majority of those patients have already been accrued to the study and the majority of the samples of problems that has already been collected.

Yeah.

Therefore, we do not feel that the current situation will affect our ability to report on the current twentytwenty milestones.

Igor Medeshchansky: Now, what happened beyond that? I think, you know, we need to see how the current situation has evolved. As you know, the current situation is equally evolving in the world. So we have caveats in our protocols that allow sites, of course, to get blood from patients on the CMV trial at local sites so that they do not need to come into their main center. We also are putting in place, you know, shelf life extension to make sure that we have sufficient drug products and at sufficient time in order to continue the trial if there are unexpected delays given the current situation.

Now what happens beyond that I think you know we need to see how the current situation evolve as you know is apparent situation is equally evolving involving the world.

So we have we have.

Caveats in our protocols that allows sites of course to.

Got blog App from patients for the CMV trial.

Local sites, which they do not need to come into their main center.

We also are putting in place their shelf life extension to make sure that we have sufficient truck product that sufficient time.

To continue the trial if there are unexpected delays given the current situation.

Brian Corey Abrahams: That's really helpful. Thanks again.

That's really helpful. Thanks again.

The next question is coming from the name of that Jeep Fiat.

Unknown Attendee: The next question is coming from the line of the kid, Shato Paya, from Wainwright. Please go ahead.

Yeah from.

Unknown Attendee: Thank you. Good afternoon. Thank you.

Wainwright. Please go ahead.

Hi, good afternoon guys.

Unknown Attendee: Good afternoon, guys. Thank you. Oh, hi. This is Aaron from DevJet. Good afternoon. So have you guys made any protocol amendments to screen for SARS-CoV-2 in patients prior to or during treatment with TheraT? And I'm wondering if you might expect to change the activity of TheraT in a patient with an active infection, and those patients might be

Oh, Hi, this is air and on for Debjit.

Good afternoon.

So have you guys made any protocol amendments to screen first stars coke to inpatient prior to or during treatment with therapy and I'm wondering if you might expect a change in activity a therapy in patients with an active infection as those patients might be.

Igor Medeshchansky: No, a great question. We specifically have not made any amendments or provisions.

Excluded from analyses.

No great question.

We specifically have not.

Any.

Amendments or provisions however, I will say you know that.

Igor Medeshchansky: However, I will say, you know, that I've spoken to all the investigators who are participating in our oncology program. And, as you can 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 per 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 would be required and would only complicate their already overburdened administrative staff if we were to, on top of their own institutional guidelines, start putting in amendments that require processing at their sites.

I have spoken to all the investigators who are participating in oncology program and as you could imagine.

Every single hospital at this point has instituted.

Perfect and guidelines for covert 19 screening, which of course means that anybody presenting with signs and symptoms set of suspicious for call. It 19 is undergoing specific covers 19 testing.

As part institutional guidance.

And speaking with the.

Investigators everybody feels at their own institutional guidelines are more than sufficient.

As a screening measure and therefore, no additional screening measures will be required and would only complicates.

They are already over burden administrative staff, we were two on top of their own institutional guideline start putting in illness that require processing that their sites everyone was quite comfortable at a recent call that they're all institutional and guidelines are more than sufficient to cover the screening of Covance 19 patients.

Igor Medeshchansky: Everyone was quite comfortable at a recent PI call that their own institutional guidelines are more than sufficient to cover the screening of COVID-19 patients. To the second part of your question, how do we feel that a COVID-19 infection affects the ability of patients to go on a therapy program? Standard oncology protocols cover these kinds of provisions, and I would say, you know, COVID-19 is perhaps somewhat no different than patients who have 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, quote-unquote, have other medical conditions that prevent them from either going on trial or from being treated. So we are all comfortable, and again, in a recent conversation with the investigators, that, you know, standard oncology guidelines for concomitant medical issues are, as built into the protocol, more than sufficient to cover the current situation.

Now.

The second part of your question, how do we feel that Akovaz 19 infection.

That said the ability of.

The patients to go on.

T program.

Thank you that's hologic protocols cover.

These lease kinds of provisions and I would say Covidien 19.

It is.

I have somewhat no different than patients so have advanced pneumonia or advanced the flu.

And are being actively treated in that regard.

And therefore investigators have to me sort of a specific decision as to whether or not the patients our quote unquote have other.

Medical conditions that prevent them from anything going on trial or from being treated.

So we're all comfortable and again in a recent conversation with investigators secondly, a standard oncology guidelines.

For concomitant medical issues are has built in the protocol are more than sufficient to cover the current situation.

Okay. Thank you that's interesting.

Unknown Attendee: Okay, thank you. That's interesting.

Igor Medeshchansky: So, are there any threshold levels of CD8 T cell proliferation that you're targeting, or any ratio of CD4 to CD8 T cells that you have internally goals for?

So are there any threshold levels of T T cell proliferation that you're targeting or any ratio activity for the CD eight T cells that you haven't internally goals for.

I think who would like to see in terms of Sydney T cells as extrapolated from other studies does that actually looked at.

Igor Medeshchansky: I think what we would like to see in terms of CD8 T-cells extrapolated from other studies that I 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 therapy. You can get a general pattern that numbers somewhere in the single digits, somewhere between 5 to 10 percent. You can actually demonstrate a peripheral CDT response in an indigent-specific manner, and there is indeed a correlation with efficacy. So, ideally, what we'd like to see is somewhere in the single-digit 5-10% response rate.

The impact of Sydney T cells on the control all the cancer and this is David and nearly council adaptive T cell therapies.

You can you can get a general pattern that number somewhere in the single digit somewhere between 5% to 10% is actually demonstrate a peripheral sitting here response antigen specific manner.

There was indeed, a showing a correlation with efficacy.

So ideally what we'd like to see it somewhere in the single digits positive, 10% response rate, we know from preclinical data that our therapy program, even as a monotherapy as about a 10 fold more potent that our wax life program, we know that I'll actually program into healthy volunteers.

Unknown Attendee: We know from preclinical data that our TheraT program, even as a mode of therapy, is about tenfold more potent than our WaxWave program. We know that our WaxWave program in the Healthy Volunteers study demonstrated antigen-specific CDAT cell levels that were on the order of about 0.3%. Therefore, and that was after two or three administrations. Therefore, we feel that two to three administrations of the THERA-T product should at least demonstrate a 3% peripheral CD8 T-cell response, and, of course, we will be giving more than two to three administrations, and we know that since we do not get vector neutralizing antibodies that our immunogenicity should increase with each administration. Therefore, we believe that we should be able to get into the high single digits with 2-0-1 alone. And, of course, the heterologous should be even a significant increase upon that.

Study demonstrated.

We see as is just as a cdeight T cell level set along the order about 0.3%.

Therefore, and that was after two or three administrations. Therefore, we feel that two or three administrations for the therapy product should at least demonstrate.

3% for Cdeight T cell response and of course, we will be giving more than two or three administration.

That yes, we do not get that commercializing antibodies that our immunogenicity should increase with each administration. Therefore, we are we believe that we should be able to get.

And to high single digits 201, along with of course, the at all of this should be even a significant.

Increase upon that.

Igor Medeshchansky: Right. And so last question, do you know of any correlation between CD8 cell expansion in purple blood and partitioning to the tumor or localizing to the tumor site?

This is right and ER. So last question do you.

Do you know if any correlation between TD cell expansion in peripheral blood.

And partitioning to the tumor or localizing to the tune their site.

Igor Medeshchansky: That's a great question. I think, you know, again, the majority of the data for this comes from adaptive T cell therapies or TCR-like approaches where they actually looked at the ratio between peripheral and tumor infiltrating lymphocytes. And the best we can say right now is that clearly there is a correlation between the more you have in the periphery, the more you will have in infiltrating the tumor. But certainly, there have not been enough studies to give kind of a standard correlation. All we can say is that more correlates with more. But more than that, I don't think anybody can say at this point.

That's a great question I think you know again the majority of the data for this comes from adaptive T cell therapy, Lasher, Oreo or TCR like approaches with Russia looked at though the ratio between.

Peripheral and tumor infiltrating lymphocytes.

And the best we can say less now is that clearly there is a correlation between the money has been the periphery. The more you will have in the infiltrating the too much but certainly there has not been enough study to give kind of standard correlation. All we can say is more correlates with more but more than that I still think anybody can say.

Unknown Attendee: Okay, great. Thank you, Igor.

This point.

Okay, great. Thank you.

Operator: The next question is coming from the line of Susan Van Bothrien from Kempen. Please go ahead. Hi.

Next question is coming from the language Hassan bomb both fan from kept them. Please go ahead.

Hi, Yes, this is and good afternoon.

Susan Van Bothrien: Hi, yes, this is Suzanne. Good afternoon or good morning.

Afternoon, or good morning, Thanks, a lot for any color on the potential growing up I was in fact, that's very helpful. I. Just one question. That's on the CMC program. So circling back to that third arm of lower risk patients that looks at it.

Susan Van Bothrien: Thanks a lot for the color on the potential coronavirus impact. That's very helpful. I have just one question left 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 of what you wish to see, I'm wondering if you have set some benchmarks of what you would like to see in this arm specifically?

Since you have communicated clear goals for the older arms, what do you wish to see I'm wondering if you set some benchmarks, but would you like to see in this arms specifically.

Igor Medeshchansky: No, thanks for the question. I think, you know, as I commented in our 10K, and as I think I mentioned earlier, what we're looking for in the R positive arm is kind of the intra-patient variation. In other words, we would like to see that the addition of the vaccine in that group significantly 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 an improvement of two to three-fold over the baseline in those patients would be a good barometer for success.

No. Thanks, a question I think you know as commented.

In our 10-K, you know as we had I think I mentioned earlier, what we are looking for in the are positive comp is kind of the in trough patient variation other which we would like to see that the additional off of the vaccine and that go significantly increases the TV specific antibody.

Do you tend to be specific cdeight T cell responses above the baseline of those patients.

As to what is the right level to correlate to we believe that at least an improvement of two to three fold over the baseline those patients would be a good.

Rommel for success.

Okay.

Susan Van Bothrien: Okay, that's very clear. Thanks a lot.

Very clear.

Operator: There are no more questions at this time; please continue.

Thanks, a lot.

There are no more questions at this time discontinued.

No more questions.

Operator: No more questions?

Operator: No, sir. No more questions.

No no more questions.

Then I think we can close the call.

Joern Aldag: 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.

I would like to thank everyone for participating in this call.

I hope we made it very clear that will keep up because of its financial strategy in the past isn't a very strong financial position.

To overcome this current problematic period.

Unknown Executive: And we're doing whatever we can in order to deliver in the middle of this year, and in particular, at the end of this year, efficacy data from our CMB and from our first immunoecology 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 program. Stay healthy, everyone, and take care. Bye-bye. This is a production of the U.S. Embassy in the Philippines U.S. Embassy in the Philippines U.S. Embassy in the Philippines

And we're doing whatever we can in order to deliver in the middle of this year and in particular at the end of this year efficacy data from our CMB and from our first immuno oncology trials. So thank you very much stay tuned and and we'll be in touch outs. As this crisis continues with some any news if there.

I knew that are impacting all programs.

Stay healthy everyone and take care Bye bye.

This does conclude that conference for today. Thank you for participation you may disconnect.

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