Q4 2021 HOOKIPA Pharma Inc Earnings Call
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? ? ? ? ? ? ? ? Good day and thank you for standing by. Welcome to the Hikipa 4th Quarter and 4th Year 2021 Financial Results and 2022 Outlook Conference Call. At this time all participants are in a listen only mode.
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In a listen only mode. After the speaker's presentation there'll be a question and answer session.
Speaker Change: After the speaker's presentation, there will now be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. To use the advice app, save conference is being recorded. If you require any services, please press star 0. I would now like to ask a question and answer session. To ask a question, please press star 1 on your telephone. Thank you, I'm Matthew Beck, Executive Director Investor Relations.
Fourth quarter and full year 2021 financial results.
On the phone.
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After the Speakers' presentation, there'll be a question and answer session.
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Oh, Thank you Matthew Beck executive director of Investor Relations.
Speaker Change: If you require any further assistance, please press star zero. I would now like to have the conversation speak to St. Matthew Beck. Please go ahead, sir. Thank you. I'm Matthew Beck, Executive Director, Investor Relations. The Hukipa Executive Team is here with me today, including Chief Executive Officer Jaron Aldack, Chief Financial Officer Ryan Hartman, Chief Medical Officer and Head of Research and Development, Igor Medoshansky, Chief Scientific Officer The Hukipa Executive Team is here with me today, including Chief Executive Officer Jaron Aldack, Chief Financial Officer Ryan Hartman, Chief Medical Officer and Head of Research and Development, Igor Medoshansky, Chief Scientific Officer Jaron Aldack, Chief Business Officer Christine Baker, Chief Financial Officer Ryan Hartman,
Food, if you acquire any sort of assistance.
Today's call is available through the webcast and in the events section of the who keep a web.
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I'm, Matthew Beck Executive Director Investor Relations.
Hum the who keep our executive team is here with me today, including Chief Executive Officer.
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Third Reinhart, Canada.
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Era of research and development Igor <unk>.
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Ara Chief Medical Officer, and global head of research and development Igor <unk>.
These statements May include statements regarding among other things the efficacy.
Ski Kristine Baker, and Chief Technology Officer.
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Matthew Beck: Our clinical and non-clinical plans. During today's call, we will present or report additional data. These statements include statements regarding, among other things, the efficacy, safety, and the intended utilization of investigational agents. Our clinical and non-clinical plans.
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Our clinical and non clinical plan.
During today's call, we will be making certain forward looking.
Lance.
Statement. These statements may include statements regarding among other things.
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Things safety and intended utilization of investigational agents.
While festival intended use of cash and investments.
Matthew Beck: These forward-looking statements are based on current information, the anticipated conduct and the sources that are subject to change, and involve risks and uncertainty that may cause the actual development to differ materially from those contained in the forward-looking statement.
Our plans to present or report additional data.
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Data the anticipated conduct and the source.
Asia are subject to change and involve risks and uncertainties.
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Cause the actual events to differ materially from those contained in the forward looking statements.
These forward looking.
Bribed and our periodic filings made with the security and Exchange Commission.
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Port are cautioned not to place undue reliance on these forward looking state.
And in the forward looking.
Today's.
Statements these and other.
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Risks the security and Exchange Commission.
Payments.
Including our quarterly and annual report.
Reinhard will offer a high level comments on our financial.
Forward looking.
This call to the Q&A.
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Statements.
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Q1 was a year of impressive continuous progress.
Remarks.
For us for.
And the call to the Q&A.
Keep up the year in which we have successfully navigated tumult.
Thank you for joining.
It has delivered on the need to drive scientific progress and financing strategy.
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G continued company.
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Growth into 2024.
It was a year in which we have successfully navigate.
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Kim can drive unprecedented levels of antigen specific T cells and humor.
Financing strategy.
Humans can you to expand the evidenced that our technology applied as a mono therapy helps control the disease and advanced line head and neck cancer patients.
So we can drive unprecedented levels of fountain.
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Along with a new oncology indication.
We continue.
The virally driven cancers, we've demonstrated the ability to break tolerance in animal.
Took some advanced line head and neck cancer patients.
Dermal space of cell phone to Jensen driver mutation based.
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We see incredible potential.
For this quarter.
Good for.
Virally driven cancers, we've demonstrated the ability to break tolerance in animals.
Overcome challenges of many immunotherapies in many different cancer types by providing the missing.
Matthew Beck: We see incredible potential for the future.
Animals, we see incredible potential for this.
Matthew Beck: We're pushing two high-value programs to work to connect with other oncologists, to overcome challenges of many immunotherapeutics and many different cancer types by providing the missing...
We're pushing to high value programs towards the.
Other oncology motor.
Clinic candidate H, B 300, HD 700 targeting.
And many different cancer.
Getting cross mutation.
Types from the missing, but essential T cell induction.
Matthew Beck: Our science is continuously validated through partnerships with leading pharma organizations. We progressed markedly on the partnering front by, one, renewing our collaboration with Gilead by taking responsibility for the clinical phase 1B of an HIV-fueled leading pharma organization, and two, markedly on the partnering front by, one, renewing our collaboration with Gilead. The FDA granted us the responsibility for the clinical phase 1B of an HIV Zomato Project.
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By renewing our collaboration with Gilead I'll come back to this by taking responsibility for the clinical phase one b.
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The FDA granted us fast track designation for this combination trial of <unk> 200, with Femara lose them up in the first line.
Matthew Beck: And two, we also advanced partnering discussions in oncology with other prospective collaboration partners. The FDA granted us fast-tracked as I mentioned earlier, Gilead, with botanics in their development area. And knowing the T cell data of our HIV development, partnering discussions on human biology models with other prospective collaboration partners, asked us to take responsibility for the development up to the end of Phase 1B, Gilead, of our HIV botanics in their development area. They wanted an option to take the program back after this Phase 1B, and in exchange, we received an unrefundable $50 million upfront at the end of Phase 1B of our HIV functional cure products. They wanted an option to take the program back after Phase 1B.
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We also advanced partnering discussions in oncology.
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Partner based with bottlenecks in their development area, knowing the T cell data of all HIV development candidates and nonhuman primate models.
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Model to take responsibility for the development up to the end of phase one.
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Knowing the T cell data of our HIV development candidates in nonhuman primate.
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$4 million milestone payment.
B cure collaborations.
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To us.
Matthew Beck: This transaction helps us execute a well-prepared financing in early 2022, securing $75 million and a follow-on offering extending our cash runway significantly for high-quality existing and new investors.
And in exchange, we received a nonrefundable $15 million upfront.
The early 2022.
$4 million milestone payment.
$2 million in a follow on offering extending our cash runway.
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To us this transaction helped us execute a well prepared financing in early 2022.
Matthew Beck: a well prepared financing body 2020-december 31st cash accruing $75 million plus the Gilead and Apollo 1 offering extending our cash runway of $157 million. Adding the additional $30 million from the drawdown facility by Gilead provides us a runway into mid-2024. We believe that these accomplishments speak to the strength of our data and adding the additional $30 million from the drawdown facility by Gilead provides us a runway
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Matthew Beck: into what's in store for 2022.
Same store for 2022 slide.
Matthew Beck: Next month at AACR, we will share four post-doc presentations that provide further preclinical and translational clinical evidence of the broad potential of arena virus platforms to address unmet needs in various types of cancer, either alone or in combination with other modalities. In mid-year, we will update our Phase 1 HP 200 MonoTherapy data.
MIT that these accomplishments.
Five months at ACR, we will share up four poster presentations that provide further preclinical translational and clinical evidence.
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At ACR, we will share.
Their combination with other modalities.
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We will update all phase one HP 200 monotherapy data.
And for them.
Matthew Beck: We will give a comprehensive overview of the HP 200 phase 1 dose escalation program, other modalities, including safety, anti-tumor activity, and additional translational data on HP 201 and HP 202. We will give a comprehensive overview of the HP 200 phase 1 dose escalation program.
Later, we will give a comprehensive.
And various types of cancer.
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Matthew Beck: We will update the status of phase 1 patients in the phase 1 program and present the selected phase 2 dose for the HP202, HP201, HP201, and HP202-21.
We will update the status.
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So the HB tool to HB, two or one or 2018 two vectors there.
The two to one.
Matthew Beck: And we will discuss the clinical path for HB200 in the advanced settings, knowing and present a third line or post-standard of care. To be clear, we will not provide at this time
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Matthew Beck: nor comment on any initial phase II data in combination with temporalism of urine in advanced settings.
Nor comment on any initial phase two data in combination with member leaves them up during the phase one.
Therapy knowing.
Matthew Beck: We will, however, report the initial safety and efficacy data results of the HB200 phase 2 combination trial, which combines HB200 and Pembroke-North Carnton in the first and second phase combined settings in the second half during the phase 1 trial.
Update we will however report initial safety and efficacy data results of the <unk> 200 phase II combination trial.
We will not provide.
While 200, Pember Elysium up in the first and second line setting.
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Matthew Beck: We aim to present an initial data set on 10 to 20 patients in total and seek to approximate a double of the current Pembrolizumab monotherapy response rate in the first line and the second line in the next setting.
This year, we aim to present.
We will however.
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Matthew Beck: We're also on schedule to present an initial data set on HP 20 patients in total and seek the first quarter of this term, then the third quarter of this year. Current immunotherapies target PAP, a key tumor agent. We're also on schedule to file the IV for people with cataract-related prostate cancer known as HP 300 in the first quarter of this year.
We're also on schedule.
The IND for our prostate cancer program.
And the patients in total.
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Matthew Beck: We're exploring incorporating additional tumor-targeted PSMAs to help address the unmet need and improve the standard of care for these patients. We aim to dose the first patient in the late fourth quarter of this year.
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To help address the unmet needs and improve the standard of care for these.
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Matthew Beck: Last but not least, we have started a KRAS program to help with targeting the main KRAS mutations relevant to several large tumor indications. We aim to do this program has attracted significant interest from pharma companies.
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Dose of this year or early 2000.
Matthew Beck: Finally, our infectious disease programs were committed to filing our HIV-IND in 2023, and Gilead tells us that they are on schedule to file the HbA1c-attractive hepatitis B virus functional cure IND by the end of 2022, though Fuquipa is not in control of their timeline to expect this is what we can expect. I reiterate that Fuquipa is now funded through all of these milestones and beyond. We have both promises for 2022, though Fuquipa team is in big ways to expect that is what we can expect. I reiterate that Fuquipa is now funded through all of these milestones and beyond.
Company, because these programs where commit.
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By the end of 2020.
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So funded through all of these milestones and beer.
Speaker Change: Good morning ladies and gentlemen. I want to give you a few highlights of our financial results for the year 2021, which actually reflect the clinical progress that we have made in the past year.
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2022.
A few highlights of our financial results for the year two.
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It's about for some brief comments on our financials.
Speaker Change: Our revenue line includes milestones morning, ladies and gentlemen, from our Gilead collaboration and the continued high level of revenue is evidence of the good progress that we have been making under this collaboration. Our revenue line includes milestones morning, ladies and gentlemen, from our Gilead collaboration and the continued high level of revenue is evidence of the good progress that we have been making under this collaboration. Our revenue line includes milestones morning, ladies and gentlemen, from our Gilead collaboration and the continued high level of revenue is evidence of the good progress that we have been making under this collaboration.
With our revenue line includes milestones and cost reimbursement from our Gilead collaboration.
But so far our financial results.
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Speaker Change: to $83 million in 2021 in our HB200. A significant portion of the 2021 R&D spending already relates to the overall increase of our R&D expenses from $85 million, so we expect to be able to maintain this spending level in the coming quarters.
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Speaker Change: while a significant proportion of the 2021 R&D spending already relates to general and antinatal activities.
One significant portion of the 2021 R&D spending already.
General and administrative costs.
Speaker Change: We were able to keep this well under control in 2021 and even to slightly decrease our income expenses year over year, executing on those programs. Other operating income, net, which in terms of general administrative costs and subsidies, we were able to keep this well under control in 2021 and even to slightly decrease our income expenses year over year, therefore below 2020 levels. Other operating income, our net loss for the year 2021 was 76 million dollars compared to 44 million dollars mainly in 2020. We see a 2021 increase being driven by R&D spending as a result of our clinical program. Our net loss for the year 2021, our cash outflow for operations in 2021 compared to 44 million dollars in 2020, and in addition, we made a 2021 increase being driven by R&D spending and equipment, mainly to prepare ourselves.
We were able to keep this well under control in 2021.
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One to slightly decrease in the expense year over year.
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Speaker Change: for GMP manufacturing requirements in our next growth phase was $66 million. Our year-end cash was $67 trillion and we were able to significantly strengthen this cash position in the bear out of 2022 by a $75 million follow-on offering and cash inflows from our year-end cash.
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Speaker Change: This proceed leads to a form of cash-in-position strength of 100% in 7.22 million dollars when added to our year-end cash. With that, we see our strength and cash inflows through the coming years.
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Speaker Change: But I would want to add that in a difficult funding environment, as we see it today, $170 million were drunk when adding the first year as well, and are making good progress in seeking collaboration to potentially increase our revenue. But I would want to add that in a difficult funding environment, as we see it today, we are putting greater emphasis on non-dilutive funding sources as well and are making good progress in seeking collaboration to potentially increase the revenue. And we are laser-focused to support the companies and our shareholders' objectives throughout this difficult market period, and we are laser-focused to produce and present to you our clinical data updates throughout the year.
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I am indeed, very proud of our people and their drive to support the companies and our shareholders objectives throughout this difficult market peer.
Good God overview.
It is a focus to produce and present to you our clinical data up.
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Speaker Change: As we said earlier, thanks a lot for listening and with this, I would like to open up for Q&A. Operator? Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound hash key. Once again, if you'd like to ask a question, please press star and 1.
Seven.
Thanks, a lot for listening.
Both people and their drive to.
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Q&A.
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As a reminder to ask a question you will need to press star one on your telephone.
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To withdraw your question press the pound husky.
Year and with.
And if you'd like to ask a question. Please press star one.
Speaker Change: Thank you. Your first question today comes from the line of Alex Planahan from Bank of America. Please go ahead to withdraw your question. Press the pound hash key. Hey, good morning everyone. This is John . I'm for Alex. Thanks for taking our question. So, I think my question is one question, but I think I have two parts to it. And it's about the Gilead partnership.
This thank you.
One question today comes from the line of.
Sure.
And from Bank of America.
Please go ahead your line is open.
Press the pound husky once again, if you'd like to ask a question.
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Question one.
Alex Thanks for taking my question.
One last question today comes from the line of.
Sure.
Just one question.
Ill.
Hello America.
But parts to.
Your line is open.
Gilead partnership.
Speaker Change: Hey, good morning everyone. This is John on Alex, and thanks for taking our question.
Hey, good morning every.
We'd be running one.
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Just one b trial for each wouldn't be.
Alex.
Speaker Change: It would be cool to get some outlook about what you're focusing on specifically for the FACE 1B and what kind of FACE 1 you're contemplating for the H1B and more specifically also could you also shed some light on what you're focusing on specifically for the FACE 1B and what kind of FACE 1 you're contemplating for the H1B.
Yourself.
I think my question.
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Kind of how to Gilead.
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Yeah.
We're contemplating.
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Running a phase one b trial for each one of them.
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Speaker Change: And for the first part of that question, we'll be running a Phase 1B safety immunogenicity trial. The endpoints will be clearly to assure that we have safety and, as I said before, re-efficiency and immunogenicity. The patient inclusion criteria will be a previously stated, will include HIV-positive individuals who are well-controlled on antiviral therapy and, as I said before, re-efficiency and immunogenicity. The patient inclusion criteria previously stated will include HIV-positive individuals
Thanks for the question.
So the first part of that question.
If you could shed some light on.
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And to your question.
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Patient inclusion criteria as we have previously stated we will include HIV positive individuals.
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On Xyrem therapy.
So as I said before.
These are the patients who will receive a planned limited number of doses followed by approximately six months of observation.
We'll include HIV.
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Speaker Change: the post-dose immunogenicity less. We are currently planning two doses and with a total number of patients somewhere in the 30 or 40 months of observation that are the current plan, but have not yet been finalized.
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Anti viral therapy.
Last two doses.
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Six months duration.
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Speaker Change: In terms of your second question, we are currently planning for two doses. We don't have a total number of patients on that, but again, as you can see from the way the trial is designed, what they will be looking for in general is a safety.
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Post the post dose immunogenicity.
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Last we are currently planning.
We would be looking for.
Mining.
We don't have specific clarifications on that but again as you can see from the way the trial design, what they will be looking for in generally is eight.
Safety and Immunogenicity.
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Speaker Change: And B, immunogenicity, it actually is lasting at the end point of six months after a lifetime. We don't have specific clarifications on that, but again, as you can see from the way the trial is designed, what they will be looking for in general is a safety and B, immunogenicity that actually is lasting at the end point of six months after a lifetime.
Question.
City.
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Is staying at the endpoint of six months after our last.
What specific clarifications on that but again as you can see from the way the trial design, what they will be looking for in generally as a safety.
Thank you.
Immunogenicity.
Dan comes from the line.
City, asking at the endpoint of six months after our last.
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Speaker Change: Thanks and good morning. This is Steve Onford, Brian . Congrats on all the progress and thanks for taking our questions. Thank you.
Thanks, and good morning. This is Steve on for Brian Congrats on all the progress and thanks for taking our questions.
Speaker Change: Your next question comes from the line of Brian Abrahams of RBC Capital Markets. Go ahead. Your line is open. Thanks, and good morning. This is Brian . Thanks for taking our question. As you think about HP300 targeting the tumor-associated antigens.
Your next.
Pick about H B 300 targeting.
The tumor associated antigens.
Next.
Perhaps.
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From them.
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Good morning, this is Steve on for Brian .
More advances in infiltration, where do you think.
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There are unique challenges with.
Question. So each grew 300 targeting.
Some additional.
Brian Abrahams: How much of the learnings from the HB200... Thanks for the question. So I'd say there is a fair amount of learnings from the 200 program that are being translated to the 300 program. First of all, you know, we have discussed with the FDA about whether or not we need extensive pre-IND studies.
James.
Nickel.
What are the learnings from HB 200 on Don Spector combination and checkpoint.
That's a fair amount of awareness to the 200 program data being translated to the 300 program.
So do you think.
First of all we have discussed with the FDA about whether or not we need extensive pre IND studies, well, whether or not if we can use the <unk>.
Brian Abrahams: or whether or not we can use the pre-R&D GLP technology from the 200 program to apply the 300 program. And they do believe that is appropriate, and are looking at our technology as a pre-R&D technology, or whether or not we can use the pre-R&D, or the majority of the pre-R&D technology from the 200 program to apply the 300 program, and they do believe that is appropriate. In the clinic itself, we actually do believe that we will actually see similar immunogenicity in terms of T-cells induced with the 300 as we did for the 200 program. Why do we believe this? Pre-clinically, when we looked at our technology comparing viral delta antigens to mouse cell antigens, we are actually able to induce equivalent amounts of tumor antigens to the CD8 T-cells, regardless of whether that antigen comes from a virus or a mouse self-antigen. Since our data for the viral program is translated so nicely from the pre-clinical to the clinical, we anticipate that the data would translate similarly from mouse self-antigens to human self-antigens.
<unk> for the 200 program there.
For the 200 program till planted 300 program and they do believe that as appropriate.
<unk> about whether or not we had extensive pre IND.
<unk> technology, where we don't have to repeat.
<unk>.
Pete all of.
<unk>.
The majority of the <unk> study.
For the 200 program to a plateau through Hunter program and they do believe that as appropriate.
<unk>.
Preet and are looking at our technology is sort of as a platform.
Given that we will actually see similar immunogenicity in terms of T cells and used for the 300 as we did for the 200 why do we believe.
102 actually.
This clinically when we looked at our technology comparing.
<unk> in the clinic itself, we actually do believe that we will actually see similar immunogenicity in terms of T cells induced a further 300 as we did for the 200 <unk> why do we believe.
<unk> CDA T cells, regardless of whether that ampligen comes from.
This.
Virus or a mouse.
I think the journey.
Miles antigen.
Gen two miles.
<unk> data for the viral program has translated so nicely from the clinic from the preclinical to clinical.
<unk> T cells.
State that.
Heartless and whether that ampligen comes from.
Similarly.
Hum.
Really from miles self antigens.
Louis antigen.
<unk> South antigens.
Brian Abrahams: Since our data are sort of viral program is translated from the preclinical to the clinical, we anticipate that we'll be seeing data which translates similarly.
Since our data for the viral program has translated so nicely from the clinic from the preclinical <unk> clinical.
For the 200 program will be seen for the 300 <unk> program as well there is I would say no rationale why it would not.
Brian Abrahams: There is, I would say, no rational way it would not, because the technology that drives these T-cells is the same. And we have shown that preclinically, it doesn't matter whether it's viral or self-antigen.
<unk>.
Not because the technology that drives these T cells is the same.
Is that the kinds of CDA T cell.
Same doesn't matter, whether it's viral of our south antigen.
100.
Brian Abrahams: The questions on dosing, we do believe we are actually know what is the appropriate dosing regimen, as well as the appropriate, I would say, dose level that we will be starting at and escalating with. Thank you.
Jim.
Graham will be seen for the 300.
Questions on dosing, we do believe we are actually no.
<unk>.
What's the appropriate.
Not only does it drive.
<unk> regimen.
<unk> is the same.
<unk> well as the appropriate I would say.
Same matter, whether it's viral of our south antigen.
We will be starting at an escalating with and we know the.
We do believe we are actually no.
He is the preferred.
Lifestyle.
Schedule, an intravenous as the preferred administration. So we do anticipate that these things, which we have learned from the dose escalation of the 200 program.
Brian Abrahams: The things which we have learned from the dose escalation of the 200 program will be applied to the 300 program, and so the dose escalation of that program, we anticipate should be significantly shorter.
Bret and escalating with and we know the.
Regardless of dose escalation of that program.
The preferred.
It should be.
<unk>, an intravenous as the preferred administration, so we do anticipate that.
Speaker Change: Does that answer your question? Yes, it does. Thanks for all that color. Thank you. Your next question comes from the line of Andrew Barrett from SBB, Warren, please go ahead. Your line is open. Yes, it is. Yeah. Thanks for that. All right.
Does that answer.
We have learned from the dose escalation of the 200 program.
Sure.
Ram will be applied to the 300 programs. So the dose escalation of that program.
The color your next.
So it should be.
Next is from the line of.
Sure.
But from SBB Walling. Please go ahead your line is open.
Sure, yes, thanks for that.
That color.
Oh.
Andrew Barrett: Just a couple for me. Thank you. It sounds like for the checkpoint combo, I just want to clarify that there'll be no more efficacy from the phase one portion. Your line is open. And it didn't sound like there was going to be any efficacy from the phase two. It sounded mostly just safety, probability, and detail. Just a couple for me. It sounds like for the checkpoint combo, you threw out a benchmark of no more efficacy head and neck from the phase one portion versus checkpoint alone. It didn't sound like there was going to be any efficacy from the phase two. It sounded mostly safety and probability. How does that compare to some of the... I know it sounded... You threw out a benchmark of no more efficacy head and neck versus checkpoint alone. Can you just give us a...
Just a couple for me.
Thank.
Like for the check.
No.
Check combo.
Next is from the line of.
There'll be no more efficacy.
CEB walling.
Please go ahead your line is open.
It sounds like there was going to be any efficacy from the phase II.
Well for me.
T K.
Very.
And then.
Bob.
Throughout.
There'll be no more efficacy.
Hey.
C.
Perfect.
Robert.
One portion.
Wasn't checkpoint alone.
Sure.
Just to give.
Mike.
That number would be.
That's a good phase.
<unk>.
How does that compare to some of them.
And then.
Targeted opportunity, but some of them about specific data that we've seen.
Third for Merit.
<unk>.
Okay.
Sure.
Activity so.
Good.
And a small number of patients.
Andrew Barrett: And how does that compare to some of the targeted opportunities that we've had in the last decade? Let me just clarify the 2022 update that we have previously commented on, just to be clear. In the middle of the year, we will be updating the kind of motor therapy or the advanced cancer patient population. Let me just clarify the 2022 update that we have previously commented on. In November ...
How does.
Hi, Andrew maybe I can.
We have targeted.
Can comment on a couple of things that were.
Good afternoon.
Just to clarify the 2022 update.
Sure.
As we have previously commented on just to be clear.
All right.
In the middle of the year, we will be updating the kind of mono therapy or the advanced cancer patient population focusing on updates on tool.
It's a 22.
One to 200.
But as we have previously commented on just to be clear.
Andrew Barrett: In the middle of the year, we will be updating the motor therapy or the advanced scans for patient populations, but we have not yet been on therapy long enough to where efficacy scans were yet attained.
In the middle of the year.
But that time, we have.
He kind of monotherapy or the advanced cancer patient population focusing on updates on two one.
Had on therapy long enough where efficacy scans.
One state in November .
<unk>.
Andrew Barrett: So, at the middle of the year, we would anticipate there will be approximately an additional 10 patients in total that were not yet ready for efficacy determination, because they have not been on therapy long enough. So, at the middle of the year, we would anticipate there will be approximately an additional 10 patients. So, in the middle of the year, there will be approximately 10 patients that we will talk about that are new or have not yet been on therapy since our November update. So, at the middle of the year, there will be approximately 10 patients that we will talk about that are new or have not yet been on therapy since our November update, because it was not yet available at the time of our last presentation. Okay.
<unk> presentation that we gave were at that time, we have.
Precipitated there'll be approximately an additional 10 patients.
Quinn or has it been.
<unk>.
Been long enough where efficacy.
Our efficacy determination.
Efficacy Kane.
<unk> not been on therapy long enough or had since.
<unk> anticipates that there will be approximately an additional 10 patients.
For update so in middle of this year, there will be approximately 10 patients that we will talk about.
<unk> determination.
<unk>, new or have not yet data has not yet been presented.
<unk> had.
It's available in some of our <unk>.
Since.
Last patient.
Pete.
Since our November update.
Patients with timber Elysium app in the first and our second line.
So.
<unk> setting that data.
Four have not yet data has not yet been.
<unk> 2000.
<unk> not yet available in some of our last presentation.
Two okay.
Andrew Barrett: In terms of the expected response rate that we are hoping to attain, we have stated before that we would like to double the response rate of checkpoint inhibitor 3 pembrolizumab in the front-line data. In terms of the expected response rate that we are hoping to attain,
<unk> the combinations with <unk>.
And the first and to our second line.
Thanks to our COO.
Line of data.
We have stated before that we would like to double the response rate of checkpoint inhibitors, typically pember Elizabeth the frontline data.
Data in terms of the expect.
The reason why a checkpoint inhibitor like <unk> has approximately 23%.
Spec double.
To receive it in a pre selected.
The risk points inhibitor, specifically <unk>, but the frontline data.
That is why it is only 23%.
Data reason why a checkpoint inhibitor like <unk> has.
Our missing significant tumor antigen specific CDA T cells.
In a pre select.
Our response.
<unk> PD Lone high patient population why it is only 23.
<unk>.
<unk>.
On top of <unk>, we should be able to double the 23% response rate and so we are constantly throwing out a number.
Does it put a lot of them to have.
I went to 50% range.
Ah receives thereby providing tumor antigen specific.
<unk>.
<unk> T cell.
Andrew Barrett: On top of femoralism, we should be able to double the 23 percent response rate that we have concentrated on, and now we're 15 percent, depending on which study you quote. We would like, for similar reasons, to believe that the 85 percent that are not responding, concurrent with our understanding of biology, is that they're missing too many response rates somewhere in the study. Again, we would like to bring those in and believe we can double that response rate. We would like, for similar reasons, to believe that the 85 percent that are not responding, concurrent with our understanding of biology, is that they're missing too many response rates somewhere in the study. Again, we would like to bring those in and believe we can double that response rate. And so the second line would like to get us somewhere in the 30 percent response rate.
That's.
On top of <unk>, we should be able to double the 23%.
A mid teen response rate somewhere in the probably 15% depending on which study quote.
We would like for similar reasons to believe.
<unk>.
<unk> 23.
That 5% that are not responding concurrent with our understanding.
Percent realism, App has an approximately mid teens.
In a specific CDA T cells and again, we would like to bring those in and believe we can double that we sponsor and so in the second line, we'd like to get us somewhere in.
And with 85% that are not.
Notwithstanding concurrent with our understanding of biology.
<unk> is.
So that would definitely be very.
Brad just specific CDA T.
Alright.
So, yes, we would like to bring those in and believe we can double that.
The year to give us response rates in both lines of therapy.
We tend to respond.
Perfect.
Speaker Change: We are anticipating that in totality we might have somewhere between 10 to 20 patients in total to support these assertations. We are anticipating that in totality we might have somewhere between 10 to 20 patients in total. Thank you. The next question comes from the line of R.K. from H.C. Wainwright. Please go ahead. Your line is open.
We are anticipating that into <unk>, we might have somewhere.
<unk> definitely do.
10 to 20 patients in total.
Very patient.
To support these expectations.
The year to give.
<unk>.
Give us some states in both lines of therapy.
Okay.
Thanks for the color of.
Arabic dissipating that in totality, we might have somewhere.
Thank you.
Sure.
So next.
<unk> 20 patients in total.
Next <unk>.
To support these expectations.
Please go ahead your line is open.
<unk> alright.
Speaker Change: Thank you. Thanks for the call, Igor. Good morning and good afternoon, folks. Thank you. Your next question comes from the line of R.K. from H.C. Wayne-Wright. Please go ahead. Your line is open. What to expect there? Thank you. Good morning and good afternoon, folks.
Thank you.
Thanks for the color of.
Good morning, and good afternoon folks.
Nancy.
Got it.
I see.
Sure.
He is from the line.
Line.
Don for coming up.
A couple.
Hey, <unk>.
Couple of weeks.
Please go ahead your line is open.
Ken what to expect there.
<unk> two.
Sure.
And so.
Good morning, and good afternoon folks.
Nancy.
R.K.: So, as you already commented on, they will focus predominantly on our preclinical, translational, and some biomarker data from our ongoing studies. We'll focus on updating on some of our prostate cancer work, and some of our 2 or 2.1 work, as well as some biomarker work from our ongoing clinical trial, which is your one.
The answer is.
The pre comments around they will focus predominantly on our.
Okay.
Our preclinical or translational and some biomarker data from our.
Four.
Our ongoing studies, we will focus on updating on some of our prostate cancer work in some of our <unk> hundred one work as well as additional biomarker.
Preclinical or translational and some biomarker data from our ongoing.
R.K.: ongoing studies. We'll focus on updating some of the prostate cancer work and some of our 2 or 2 to 1 work as well as additional biomarker work from our ongoing clinical trial with 2 to 1.
Thank you for.
<unk> focus on updating on some of our prostate cancer work in some of our COO of <unk> hundred one work as well as additional biomarker.
With that Gordon.
Our ongoing.
Me too.
Knowing that the trial.
<unk>.
While with two zero.
And to kind of gauge this program in defense do you need to get to a certain.
Speaker Change: age this program in a sense. And then for the HP 700 program, two questions. One more. One more. And the other is, is it going to get started much sooner in a sense, maybe to get to a late 2020? Alright. Thank you. I appreciate it. Thank you so much.
<unk> 700.
Development with that 203 hundred.
Graham.
Question one.
Got.
<unk> and <unk>.
Thanks.
<unk>.
Is it going.
<unk>.
Yes.
<unk>.
Much sooner in this sense maybe.
To get to a certain.
Maybe.
'twenty two.
200.
Okay.
Before you start.
Speaker Change: So let me ask the second question first, only because I didn't hear the first question well. The program, the KRAS 700 program, is not dependent on
So let me answer the second question first delinquency.
Doctor.
I didn't hear the first question.
Sure.
<unk>.
Okay.
The program the K Ras.
Okay.
<unk> hundred program is not dependent on.
Speaker Change: Any additional clinical data from those programs, so that program will start as soon as we are actually ready to manufacture that product and move that forward. We believe we have sufficient data from the 200 program, a sufficient pre-tube, and sufficient pre-clinical data with our KRS construct, then we are convinced that that program will have activity and move that forward. We do not need ways of further clinical data or additional clinical reason from the other programs to initiate that program. The only point regarding your timeline is that we are going to be 22 before the IV. It's going to be more like 23 or beyond. Perfect. Thank you very much for taking my question. Thank you.
Any additional clinical data from the from those programs to.
Scientists.
<unk>.
I didn't get to hear the first question well.
We are actually we're able ready to manufacture that product.
Well the K Ras.
<unk> forward, we believe we have sufficient data from the 200 program a sufficient return.
So clinical data from the from those programs.
And our <unk> construct.
<unk> as soon as we are actually we're able ready to manufacture that product.
<unk> in the clinic.
<unk> forward, we believe we have sufficient data from the 200 program a sufficient return.
Clinic clinical reasonably other programs to initiate that program.
Through <unk> <unk>.
Graham timeline thats not going to be <unk> 22 for the <unk>, it's going to be more like 23 or beyond.
<unk>.
A new way to further.
Beyond.
There are clinical.
<unk>.
<unk> data or additional clinical or either of the other programs to initiate that.
That's true.
Speaker Change: Ladies and gentlemen, as a reminder, if you would like to ask a question, please press star 1 on your telephone keypad.
Graham the only point regarding your timeline.
If you would like to ask a question.
<unk>, it's going to be more like 23.
Thing keep at Star one to ask a question.
Speaker Change: star and one to ask a question. Your next question comes from the line of
For taking my questions.
<unk> next question comes from the line of <unk> from JMP Securities.
Speaker Change: Roy Buchanan from JMP Security. As a reminder, if you would like to ask a question, please press star 1 on your telephone keyboard. Star 1 to ask a question. You're next. Your next question comes from the line of Roy Buchanan from JMP Security. Please go ahead, your line is open. Hi, thanks for taking the questions. I guess to start, maybe follow-up on the 700 program. So you mentioned in the prepared remarks that it's attracted significant interest from Pharma. Are you guys planning to partner this out, or maybe just ex-US, or what are you thinking about there? I guess to start, maybe follow-up on this. Hi, thanks for taking the questions.
As a reminder, if you would like to ask a question. Please.
Thanks for taking the questions I guess.
Paas keypad.
So up on.
Wanted to ask.
On the program. So you mentioned in the prepared remarks that it's attractive.
Quest.
With significant interest.
From JMP Securities.
From funding to partner this out.
So open.
Maybe just ex U S or what are you thinking about there.
Dan.
They're early.
On.
And then you just said.
Speaker Change: Igor, you just mentioned in the prepared remarks that you're able to manufacture it, I guess from pharma. Is it the kind of long capacity to manufacture at this point, or is it US, or what are you thinking about there? I know it's early, and then, thanks.
Graham So you mentioned in the prepared remarks that it's attract.
That manufacturer it I.
<unk> from farm.
I guess is it dependent on your capacity to manufacture at this point.
Maybe just ex U S or what are you thinking about that.
The time it takes to.
And.
A ramp up.
And then.
Igor Medoshansky: It's a question of standard timelines to ramp up the program, combined with CRO slots. You know, CROs for viral vector manufacturing are always in premium, you know, and a lot of them are currently booked up, you know, with vaccines or COVID and others. So I think it's a matter of standard ramp-up, combined with when we can get a time slot.
Igor you just said.
Thanks question first I mean, it's a question of standard timelines to ramp up the program.
Debt.
With combined with CRO slots.
Or.
<unk> four vials extra manufacturing are always at a premium.
Or is it.
Liam.
And.
So I'll answer the second question first I mean, it's a question of standard timelines to ramp up the program.
The ramp up times and when we can.
So <unk>.
Gas plant.
Igor Medoshansky: you know, CROs for viral vector manufacturing are always at a premium. And, you know, and a lot of them are currently booked up for vaccine for COVID and others. So I think it's kind of a standing ramp-up time, then, when we could get a time slot. We have looked at the possibility to put together a strain...
<unk> CFO .
<unk> four virals extra manufacturing are always at a premium.
And the first part of the question.
A lot of them are currently booked.
It's a very interesting.
Before COVID-19 and others. So I think it's a matter of standard ramp up times and when we can.
<unk> ability to.
Put together a string.
A beads.
Igor Medoshansky: and cooperating with the most common mutation, mutation, Section 5, if you want to play a role in the context of KRAS induced cancer. And combined with the strong T-cell responses that we're seeing, we do have pharma companies interested.
Get.
Cooperating.
Most common mutation.
And prices are very.
<unk> mutations actually buy.
Interesting.
<unk> play a role in the context of chaos.
<unk> ability to.
<unk>.
And combined with the strong T cell responses that we're seeing.
Creating the.
<unk> pharma companies.
<unk> mutation.
Igor Medoshansky: Actually, in the mutations, actually, five that play a role in the context of KRAS. It's clearly something that we're progressing internally and thinking is a high-value program. And combined with the strong TISA responses that we're seeing, we do have pharma companies interested, actually, in the approach. I just had a quick one on the CMV program. I know you guys are not focused on infectious disease, but are you actively seeking out partners for that program, and are you seeing any inbound interest?
<unk> actually in the approach.
Tons actually buy.
I cannot say more.
By context.
Sure.
Clearly.
Excellent.
Or do you think that we're progressing internally and think as a high value.
Sir so responses that we're seeing.
Okay.
We do have pharma.
Great I had a quick one on the CMV.
<unk> new approach.
I know you guys.
I cannot say more.
Focused on infectious.
More clearly.
So are you actively seeking out partners for that program.
<unk> internally and think as a high value.
Ram.
Okay.
Igor Medoshansky: It's early stages of partnering. We have committed to not investing our dollars into infectious disease programs and we're progressing through all of each of our companies to exceed the level of interest in the HB101 program. It's early stages of partnering. We have committed to not investing our dollars into infectious disease programs.
It's early stage.
Great I had a quick one on the CMV.
<unk> have committed to not investing our dollars into infectious disease programs.
But are you actively seeking out partners for that program.
<unk>.
Graham you are seeing any inbound interest.
<unk>.
The level of interest in the HB 101.
Interest stages partnering we have committed to not investing our dollars into infectious disease programs.
Igor Medoshansky: And we're progressing through an outreach to pharma companies to see the level of interest in the HB1. Thank you. There are no further questions.
And we're progressing through an outreach to pharma companies to see.
The level of interest in.
Program.
The HB 101.
Further questions.
Igor Medoshansky: This concludes today's conference call. Thank you for participating. You may now disconnect.
This concludes today's conference call. Thank you for participating you may now disconnect.
Speaker Change: Thank you. There are no further questions. This concludes today's conference call. Thank you for participating. You may now disconnect. Thank you for joining us. Thank you for joining us. Thank you for joining us. Thank you for joining us. Thank you for joining us. Thank you for joining us. Thank you for joining us. Thank you for joining us. Thank you for joining us. Thank you for joining us. Thank you for joining us. Thank you for joining us. Thank you for joining us. Thank you for joining us.
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