Q2 2022 Immunocore Holdings PLC Earnings Call
Operator: Greetings.
Greetings and welcome to the immuno Corps second quarter 2022 earnings call.
Operator: Welcome to the Immunocore second quarter 2022 earnings call.
Operator: At this time, all participants are in a listen-only mode.
At this time all participants are in a listen only mode.
And answer session will follow the formal presentation.
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Operator: A question and answer session, will follow the formal presentation.
Please note this conference is being recorded.
I will now turn the conference over to your host Clay Robertson head of Investor Relations. Thank you you may begin.
Operator: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.
Thank you Alex welcome to our Q2 earnings call.
As Clayton Robertson head of Investor Relations at immuno Corp.
Operator: Please note this conference is being recorded.
During today's call, we will be making forward looking statements, including about financial projections development activities business strategy, and the timing and impact of future events.
Actual results could differ materially from those projected by these statements, which are based on management's views as of today and subject to risks and uncertainties, including those noted in our most recent form 20-F and A&H six case, we filed with the FCC and the earnings press release, we issued this morning, you are cautioned not to place any undue line.
These statements and disclaims any obligation to update them.
We will also discuss certain non <unk> measures on today's call, which are reconciled to comparable <unk> measures in todays slides.
Im pleased to introduce <unk>, Chief Executive officer, Dr. But he's your jaw.
Thank you clay good morning, and good afternoon, everyone.
Operator: I will now turn the conference over to your host, Clay Robertson,
We are very happy to be here and to share our strong Q2 results with you.
Clay Robertson: head of investor relations.
With me today are Brian D Donato, our Chief Financial Officer, and head of strategy roster Bay, our head of commercial and Dr. David Berman, our head of R&D.
Clay Robertson: Thank you.
Clay Robertson: You may begin.
Our platform is an off the shelf solid ball bi specific T cell receptor that was validated in a positive phase III trial.
Clay Robertson: Thank you, Alex.
This was the first ever T. Seven gave her to show overall survival in solid tumors.
In January we received the approval of our first product can track.
With that we have pioneered the new therapeutic modality, but most importantly, we have opened a new chapter in the treatment of cancer.
Having launched the world's first TCR therapeutic and with an industry, leading pipeline and platform the potential for what we can deliver for patients and investors is tremendous.
Thanks to the dedication of our teams we have had an exceptional first half of 2022, and we aren't that they bring and I could not be more proud.
Clayton Robertson: Welcome to our Q2 earnings call.
Of all of them.
So now let's focus on the second quarter their 2022.
Clayton Robertson: My name is Clayton Robertson, head of, investor relations at Immunocore. During today's call, we will be making forward-looking statements, including about financial projections, development activities, business strategy, and the timing and impact of future events.
We have had an outstanding performance as we continued to execute across each of our objectives.
Clayton Robertson: Actual results could differ maturely from those projected by these statements, which are based on management's views as of today and subject to risks and certainties, including those noted in our most recent form 20-F and in H-6Ks we filed with the SEC and in the earnings press release we issued this morning. You are cautioned not to place any undue reliance on these statements, and Immunocore disclaims any obligation to update them.
If you look at the executive executing on commercial launch.
Clayton Robertson: We will also discuss our non-IFRS measures on today's call,
I am so proud of the commercial team and the medical teams.
They took the baton from R&D and thanks to their efforts we are off to a strong start.
Clayton Robertson: which are reconciled to the comparable IFRS measures in today's slides.
Following this fall in the U S launch we received a positive <unk> opinion in February with an EU approval that's foremost in April .
The team was prepared and ready to go and we immediately launched in Germany and in France.
Actually within the first two weeks post EU approval, we had transitioned all EAP patients in Germany to commercial supply.
In June Kim truck was approved in the U K, Australia and Canada.
Commercial launch is expected in 2023.
I'm happy to report that we have generated over 45 million years, two data and our revenue from Kim track, but most importantly, we are reaching new patients who are facing this devastating disease.
Clayton Robertson: I am now pleased to introduce Immunocore's Chief Executive Officer, Dr. Bahidja Jalloh.
Bahija Jallal: Thank you, Clay.
Ralph will give you more details in a few moments.
Bahija Jallal: Good morning and good afternoon, everyone.
This wouldn't be an impressive list of achievements for any pharma company, but I think you'll agree with me, but it is even more so for our biotech launching its first product.
So moving now to the pipeline, we are executing against our plan to expand beyond the Uveal melanoma.
I'd ask why this year, we presented data in both cutaneous and Uveal melanoma, and we are making progress in the plans for Kim tracking cutaneous melanoma and David will give you more details on the innovative trial design that he got the agreement with the FDA on.
We are on track and we will be sharing frame phase one data at an oral presentation at ESMO in September in Paris, and then in the fourth quarter. We are on track to presenting an updates on major Florida data.
Yeah.
Outside of oncology, we are advancing our infectious disease program in HIV and HBV.
We recently dosed the first patient in phase one HIV trial and presented early HBV data it's ESAU.
David again, it will share more details on this exciting but preliminary data.
And finally last month, we solidify our financial runway through 2025, with 100 or $40 million.
Transaction, which gives us an adjusted cash position of 393 million.
So now I'll ask Brian to share more details on this exciting financial results.
Thank you Felicia.
Bahija Jallal: We are very happy to be here and to share our strong, Q2 results with you.
Today I will focus on the highlights for the second quarter did you see on slide eight.
Please refer to the press release, we issued this morning for our full financial results.
Please note that as a foreign private issuer. We're currently reporting actual results under IRS.
For convenience, we converted the summary financials to U S dollars.
Bahija Jallal: With me today are Brian DiDonato, our Chief Financial Officer and Head of Strategy, Ralph Torbay, our Head of Commercial, and Dr. David Berman, our Head of R&D.
Bahija Jallal: Our platform is an off-the-shelf, soluble bispecific T-cell receptor that was validated, in a positive Phase III trial.
I'm excited to report that our teams continue to execute to deliver contracted patients in the United States, Germany and France.
Bahija Jallal: This was the first ever T-cell engager to show overall survival in solid tumors.
Bahija Jallal: In January, we received the approval of our first product, ChemTrack.
Bahija Jallal: With that, we have pioneered the new therapeutic modality, but most importantly, we have opened, a new chapter in the treatment of cancer.
Within property site expansion and seamless reimbursement.
Bahija Jallal: Having launched the world's first TCR therapeutic, and with an industry-leading pipeline and platform, the potential for what we can deliver for patients and investors is tremendous.
All while continuing to manage our global early access programs.
Highlights from the quarter include.
Total second quarter net revenue of $33 $7 million when converted to U S dollars.
The second quarter marked our first full quarter of sales in the United States with contract revenue of $22 $1 million.
Since may we added $7 1 million in sales for Europe , which primarily consisted of converting 100%.
Our early access patients in Germany.
Additionally, we continue to grow to think about us net revenue in France with $4 5 million of estimated reimbursement.
We expect to have full marketing authorization.
Bert to the contract level.
September .
For the year, we expect our product revenue to be based primarily in the United States, Germany and France.
We expect to gain final reimbursement agreement for Germany, and France in the first half of 2023.
In addition, we expect reimbursement agreements with additional European countries in 2023 and 2024.
On the expense side SG&A expenses increased $5 million in the quarter due to increased commercialization costs before we credit $8 million of U S dollar currency gains.
R&D expenses for the quarter were in line with Q1.
However, as announced where the recent pipe financing, we do expect development costs to increase into 2023, as we expand and accelerate our clinical development portfolio.
In July we were pleased to report that we had a significant reverse inquiry for additional equity investment.
We will across four of our largest and best long term shareholders and executed a pipe transaction with $140 million of equity proceeds.
When combined with a 253 million of cash reported at the end of the quarter was $393 million.
Along with anticipated contract revenue in Uveal melanoma.
Enable us to further accelerate our current clinical and research operating plan. This.
Capital should fund the company through 2025 and enter 2026.
I'm thankful for the seamless execution from our commercial and clinical teams, who have enabled us to bring <unk> to patients so quickly.
Both with our global early access program and now commercialization and a disease with such a significant unmet need.
We also appreciate our shareholders okay.
We will continue to allow us to fund and accelerate our development pipeline, even in a challenging biotech market.
I'll now turn the call over to Ralph who will review some of our launch metrics for Q2 and objectives for the year Ralph Thank you Brian .
I'm delighted to be here today to provide you with an update on what has been an amazing first half of the year.
Bahija Jallal: Thanks to the dedication of our teams, we have had an exceptional first half of 2022, and we are delivering, and I could not be more proud of all of them.
In Q1, following our successful approval and launch in the U S. We transitioned all 69 patients from EAP to commercial supply.
Bahija Jallal: So now, let's focus on the second quarter of 2022.
In Q2.
We received EU approval in April reimbursement in Germany in May and transitioned all 50 patients from EAP to commercial supply in a matter of weeks.
Bahija Jallal: We have had an outstanding performance as we continue to execute across each of our objectives.
The outstanding launches in U S, Germany, and France have delivered $46 5 million in revenue for the first half of the year.
In addition.
These great achievements, we remain steadfast in our ambition of delivering <unk> to patients across the globe.
We are now approved in over 30 countries, including recent approvals in the U K, Australia and Canada.
The medical team continues to build clinical confidence and Kim track and I was delighted to see end CCN and ethical guidelines recommending it as a standard of care for metastatic Uveal melanoma.
Bahija Jallal: Let's look at executing on commercial launch.
Now, let's review on Slide 11, the details of our U S launch performance.
Yeah.
I am pleased to report that 124 counts have infused patients with Kim truck.
We believe these accounts capture around 40% of the <unk> patient opportunity in the U S.
As the team continues to focus on activating priority accounts we.
We are also supporting the transition and the initiation of patients closer to home and into the community.
So far one of every four patients on camp truck is being treated in the community setting.
Feedback from community physicians to date has been very positive and speaks to the predictable and manageable profile of contract.
From an access perspective, our teams have secured formal policy coverage for approximately 60% of all potential <unk> patients in the U S.
In addition, I am pleased to report that as well.
At June 30th 99% of Kim truck prescriptions were covered.
We continue to work toward our goal of supporting access for every single patient that needs can truck.
Turning to new patient starts today, 40% of patients are in first line.
We're seeing positive momentum in our ability to displace entrenched checkpoint inhibitor competition.
It is still too early for us to guide on what to expect from a duration of therapy perspective. However, this continuation data remains in line with our expectations.
Bahija Jallal: I am so proud of the commercial team and the medical teams.
I'm very grateful for the excellent launch execution, though our U S team has delivered.
Bahija Jallal: They took the baton from R&D, and thanks to their efforts, we are off to a strong start. Following the solid U.S. launch, we received the positive CHMP opinion in February, with an EU approval that followed in April.
Their efforts are for many patients a chance with longer survival.
Now, let's transition to Europe , where the launches are going equally as well.
In Germany we've.
We've had a strong start since reimbursement of Kim truck in May and the transition of all patients with <unk>.
In fact, our first patient was infused with commercial Kim track the same week, we received price listing.
Across Germany, and France, 45 accounts have infused patients with Kim truck.
We're seeing strong momentum in Germany was 30% of patients coming from first line. This only two months post launch.
We are providing axis in 10 additional countries through the expanded access program.
Our value access team is prosecuting reimbursement across these geographies with many expected to launch in 2023.
We remain determined in our ambition of delivering <unk> to patients across Europe .
A little more than a year ago. The team was challenged with creating a multinational commercial infrastructure to deliver the amazing innovation that has kept track.
Bahija Jallal: The team was prepared and ready to go, and we immediately launched in Germany and in France. Actually, within the first two weeks post-EU approval, we had transitioned all EAP patients in Germany to commercial supply.
Today, we have successfully launched in the U S, Germany and France.
Bahija Jallal: In June, ChemTrack was approved in the UK, Australia, and Canada, with commercial launches expected in 2023.
Together these countries represent the majority of the value opportunity for Kim track and have delivered so far $46 5 million in the first half of the year.
Bahija Jallal: I'm happy to report that we have generated over 45 million years to date in revenue from ChemTrack.
It remains early for us to guide after the final ERP numbers, the impact of bolus or the expected duration of therapy. However, we will continue to deliver strong execution engagement and growth in these markets.
Bahija Jallal: But most importantly, we are reaching new patients who are facing this devastating disease.
I am very proud of the highly dedicated team that is laser focused on helping patients with Kim track two.
To that end, we're committed to the ambition of reaching over 1000, new patients by 2025.
We look forward to delivering this lifesaving medicines to more patients globally.
With that I. Thank you and now I'll invite David to provide a portfolio update.
Bahija Jallal: Ralph will give you more details in a few moments.
Thank you very much Ralph.
Our clinical program builds on the success of Chem track and today I am going to update you on three other pillars first we are expanding contract beyond uveal melanoma by studying other types of melanoma.
Bahija Jallal: This would be an impressive list of achievements for any pharma company, but I think you'll agree with me that it is even more so for a biotech launching its first product.
Bahija Jallal: So, moving now to the pipeline, we are executing against our plan to expand beyond uveal melanoma.
Including cutaneous melanoma second we are expanding beyond keep your 100 to larger indications with our programs targeting frame and major.
And finally, we are expanding beyond oncology and our clinical programs for functional cure in HBV and HIV.
Bahija Jallal: At ASCO this year, we presented data in both cutaneous and uveal melanoma, and we are making progress in the plans for ChemTrack in cutaneous melanoma, and David will give you more details on the innovative trial design that he got the agreement with the FDA on.
I will first provide an updates on advanced melanoma.
As co two months ago, we presented a survival update on our study of <unk> plus anti PD L. One.
In metastatic cutaneous melanoma patients who progressed on a prior anti PD one.
As we saw in Uveal melanoma survival was the best endpoint for capturing all the benefits and cutaneous melanoma and here, we see a very promising one year survival of 75% for the combination.
Now to put this in context, the historical one year survival for this population is approximately 55% and that's seen across several recent benchmark trials.
This differential gives us confidence to design a registrational program.
Dance melanoma, including cutaneous melanoma with a survival endpoint.
Okay.
Bahija Jallal: We are on track, and we will be sharing PRAME Phase I data at an oral presentation at ESMO in September in Paris.
Following discussions with global melanoma experts and with the U S FDA.
We are excited to announce our new Registrational phase two three trial in patients with any histologic type of melanoma, excluding only uveal melanoma.
These patients have progressed on a prior anti PD, one and received prior ethylamine map and if appropriate a prior.
Prior tyrosine kinase inhibitor.
This population is one of high unmet need and the best option for these patients is to enroll on clinical trials.
The study will randomize patients to three arms, including number one <unk> number two contract with an anti PD, one and number three a control arm.
The control arm is innovative and then patients go straight to survival follow up.
And this enables the investigator discretion to choose any therapy, including even enrolling the patients and other clinical trials.
Therefore, we are randomized them essentially to a real world treatment option, rather than offering chemotherapy, which is generally considered ineffective.
The FDA has accepted this design since the primary endpoint is overall survival, which is standard data collection and follow up from any clinical trial.
The primary endpoint of the phase II is reduction in C. T DNA and overall survival and data from the phase II provides us optionality to inform changes to the phase III, including moving into earlier lines of therapy, dropping an arm or even re powering the study to make it smaller.
<unk>.
As the pioneer in TCR Therapeutics I am proud that we have published extensively on the science of Kim track from the mechanism.
Safety.
Yes.
And with over 500, Uveal melanoma patients treated in clinical trials. We now have the insights that provide a blueprint for how we develop our other impacts including major frame.
And this blueprint is summarized here first we must demonstrate that the impact is activating T cells and redirecting them to the tumor.
Second.
A hallmark of crack was durable clinical benefit which include durable tumor shrinkage shown in green and durable partial responses shown in yellow with some ongoing for over one year.
Third we see survival benefit regardless of where the patients have high or low expression of the parent GP 100 protein, which is reflected by the H score now we do note that there was an enrichment for resist partial responses at the higher rate score.
And fourth.
Early <unk> reductions was a strong and early surrogate of survival and for Uveal melanoma, and Kim track indicate up to 70% of patients may be having benefit based on Cte D. N. A decrease of course the ultimate goal for all patients is overall survival and this is where we are.
Ultimately well look.
Beyond <unk>, we have two clinical impact targeting larger cancer indications.
F 160, <unk> targets frame, which has the potential for 150000 patients.
The phase one data was accepted for oral presentation at ESMO next month.
And there will be more than 20 patients who are <unk> positive treated at active doses and who are efficacy evaluable.
So you want a three C targets may Jay for which has the potential for 60000 patients.
The phase one dose escalation continues as is the expansion in ovarian carcinoma, and we will update the progress later this year.
This platform can be applied beyond oncology to infectious disease and I am pleased to update you on our progress here.
Chronic viral infections, such as HIV and HBV May result in a reservoir that is not eradicated by currently available direct acting anti virals.
Our platform should be applicable to eliminating this reservoir to achieve functional cure.
We initiated all of our phase one studies, including our HBV functional cure program at what are called <unk> doses, which are intended to be sub therapeutic.
However, we find that our molecules are so potent than even as the Mabel dose for the HBV program, we see the exact target biomarkers that we expect to see <unk>.
Including a transient decrease in HBV surface antigen, which is a marker of disease with a concomitant increase in L. T.
Now the changes we see are small, but one must remember that this initial dose was below one micrograms and it's remarkably seen after only a single dose and we certainly look forward to seeing what happens at higher doses.
And finally I am pleased to announce that we have achieved first patient dosing in our HIV functional cure this program and now im going to hand, it back to Asia.
Bahija Jallal: And then in the fourth quarter, we are on track to presenting an update on MAI-J4 data.
Thank you David and thank you Brian .
As you have heard it has been a very successful quarter, there and I could not be more proud and also thankful to this team's leadership.
So looking into the rest of the year are we still have more work to do and we're very happy about that we will be there from the milestones. We are on track. So we will continue the commercial launch and continue to.
It gets approval in other countries.
Looking into Q4, we expect to have the first patient enrolled in the advanced melanoma trial that David just shared with you.
Bahija Jallal: Outside of oncology, we are advancing our infectious disease program in HIV and HBV. We recently dosed the first patient in Phase I HIV trial and presented early HBV data at ESO.
We are on track of presenting the data in Q3, our four frame in Paris.
And in ESMO and then we're on track to presenting data for me Jay for and updates on major Florida in Q4, and then continuing with the enrollment of HIV and HBV programs.
Bahija Jallal: David, again, will share more details on this exciting but preliminary data.
Just wanted to reflect before we take your questions.
At the beginning of 2022 I said this would be a year of execution and the team did just that they were laser focused and so far we have achieved everything we said we would.
Bahija Jallal: And finally, last month, we solidified our financial runway through 2025 with $140 million per transaction, which gives us an adjusted cash position of $393 million.
I feel and we all feel really privileged to be in the business of bringing medicines with meaningful benefits to patients and benefit that's what truly impact their lives.
I'm humbled by the efforts of my team and our employees.
Our patients are counting on us and we take this responsibility very seriously.
So we have few minutes left and well be happy to answer your questions. Thank you.
Yeah.
Bahija Jallal: So now I'll ask Brian to share more details on these exciting financial results.
Thank you at this time, we will be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad.
Brian DiDonato: Thank you, Benicia.
Brian DiDonato: Today, we'll focus on the highlights for the second quarter that you see on slide 8.
Brian DiDonato: Please refer to the press release we issued this morning for our full financial results. Please note that as a foreign private issuer, we are currently reporting financial results under IFRS. For convenience, we converted the summary financials to U.S. dollars.
A confirmation tone will indicate your line is in the question queue.
You May press star two if you'd like to remove your question from the queue.
For participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys.
Our first question comes from the line of Michael Yee with Jefferies. Please proceed with your question.
Oh, Hey, good morning.
Thanks for the questions and congrats on the progress on the great quarter, We had a commercial question on the pipeline question.
Brian DiDonato: I'm excited to report that our teams continue to execute and to deliver ChemTrac to patients in the United States, Germany, and France, with impressive site expansion and seamless reimbursement, all while continuing to manage our global early access programs.
On the commercial front, although it is early in the launch in U S and Europe .
Do you expect a steady continuous growth and in the following quarters are beyond just a a P people that have come on both from new patients coming on but also you get the sense early on that people are staying on duration of therapy beyond just five months based on your experience what you're seeing in the commercial setting and then.
From a pipeline question maybe for David.
No that people are focused on as you might not know will get the data as shown on one hand.
G. P 100 has shown lower response rates, but much longer.
Wes and I think there's a question whether its mechanism or just a target thing how do you think about framing expectations for prime.
Brian DiDonato: Highlights from the quarter include total second quarter net revenue of $33.7 million when converted to U.S. dollars. The second quarter marked our first full quarter of sales in the United States, with ChemTrac revenue of $22.1 million.
Given what we know without preempting pretty active target. Thank you.
Thank you Michael all the great questions and we'll start with.
Brian DiDonato: Since May, we added $7.1 million in sales for Europe, which primarily consisted of converting, 100% of our early access patients in Germany.
Brian DiDonato: Additionally, we continue to grow Teventafast's net revenue in France with $4.5 million of, estimated reimbursement.
Ralph maybe to take the question on commercial sure. Thank you. Thank you Michael for the question. So look I mean, you spoke of the EAP and the patients coming from the AP. So there's that piece of bolus that.
Brian DiDonato: We expect to have full marketing authorization and convert to the Chemtract label in September.
Brian DiDonato: For the year, we expect our product revenue to be based primarily in the United States, Germany and France, and we expect to gain final reimbursement agreement for Germany and France in the first half of 2023. In addition, we expect reimbursement agreements with additional European countries in 2023, and 2024.
Brian DiDonato: On the expense side, SG&A expenses increased $5 million in the quarter due to increased, commercialization costs before we credit $8 million of U.S. dollar currency gains.
Brian DiDonato: R&D expenses for the quarter were in line with Q1. However, as announced with the recent PIPE financing, we do expect development costs, to increase into 2023 as we expand and accelerate our clinical development portfolio.
Brian DiDonato: I'm thankful for the seamless execution from our commercial and clinical teams who have, enabled us to bring Chemtract to patients so quickly, both with our global early access program and now commercialization in a disease with such a significant unmet need.
Brian DiDonato: In July, we were pleased to report that we had a significant reverse inquiry for additional, equity investment. We wall-crossed four of our largest and best long-term shareholders and executed a PIPE, transaction with $140 million in equity proceeds. When combined with the $253 million of cash reported at the end of the quarter, this $393, million, along with anticipated Chemtract revenue in uveal melanoma, will enable us to further accelerate our current clinical and research operating plan. This capital should fund the company through 2025 and into 2026.
Brian DiDonato: We also appreciate our shareholders who continue to allow us to fund and accelerate our development, pipeline, even in the challenging biotech market.
We're proud that the team has executed so well that all patients transitioned into commercial supply.
Weeks within approval.
However, we're still the first medicine to launch in this space in over four decades. So really we don't have a good analog to base. This on.
I expect the team will continue to do great work. It is still too early however for us to really comment given that we have five months of launch in the U S. Two months in Germany.
<unk>.
And duration of therapy really has not materialized, but as I mentioned discontinuation rates are in line with what we expected.
Brian DiDonato: I will now turn the call over to Ralph, who will review some of our launch metrics for
Great David do you want to comment on that or.
Ralph Torbay: Q2 and objectives for the year.
So Michael we know that frame is a good target we've.
Seen that before it tends to be homogenous in the peptide density is high and we've seen from others that it is an active targets. So where we know it's I'd say a good target from our platform. What we've seen is we've seen durable benefits we've seen prs, we've seen tumor shrinkage and we've seen <unk> reduction those are the.
The hallmarks of what we've seen with our platform. So we're one month away from the data and I think we'd be happy to discuss more of it after we shared the data.
Ralph Torbay: Ralph?
Okay. Thank you guys.
Ralph Torbay: Thank you, Brian.
Thank you. Our next question comes from the line of Jessica Fye with J P. Morgan. Please proceed with your question Hey.
Ralph Torbay: I'm delighted to be here today to provide you with an update on what has been an amazing, first half of the year.
Hey, guys good morning, nice quarter and thanks for taking my question.
Couple on Kim track and a couple on train.
Ralph Torbay: In Q1, following our successful approval and launch in the U.S., we transitioned all 69, patients from EAP to commercial supply. In Q2, we received EU approval in April, reimbursement in Germany in May, and transitioned all 50, patients from EAP to commercial supply in a matter of weeks.
Ralph Torbay: The outstanding launches in U.S., Germany, and France have delivered $46.5 million in, revenue for the first half of the year.
First in the U S. How many legacy EAP patients were still on Kim track at the end of Q O Q.
Ralph Torbay: In addition, these great achievements, we remain steadfast in our ambition of delivering, Kim Tractor patients across the globe.
Ralph Torbay: We are now approved in over 30 countries, including recent approvals in the U.K., Australia, and Canada.
And appreciating that it's a bit early to talk definitively about duration of treatment.
Can you talk directionally about what you're seeing emerging with Kim track for example, with five months of experience in the U S. Can you say, whether it might be tracking.
Ralph Torbay: The medical team continues to build clinical confidence in ChemTrack, and I was delighted, to see NCCN and ASCO guidelines recommending it as a standard of care for metastatic uveal melanoma.
Better than or at least no worse than the 5.3 months median treatment duration observed in the phase III trial.
And then moving on to frame what tumor types should we expect to see represented in the ESMO update and how should we think about the length of follow up for those premium positive patients who are treated at relevant doses.
Thank you Jess asked several questions in here. So we'll start with the first one maybe.
You can take it to Ralph and then we'll go to David.
Ralph Torbay: Now let's review on slide 11 the details of our U.S. launch performance.
Have you been thinking about Asia and thank you for the question so starting with the U S. You spoke of the legacy EAP patients. So it really allows these patients were in second line today, what we see that 40% of our patients are coming from first line.
Ralph Torbay: I am pleased to report that 124 accounts have infused patients with ChemTrack.
The team continues to activate accounts are with him. So far about 124 accounts. So really what you can expect is more of a as good execution and.
I can't really comment currently on D O T. Because we're too early in the launch. However, this continuations are in line with what we expect as I said thank you.
And David do you want to talk about the tumor types and ESMO. Yes. So this is a basket trial Jackson so are we.
No we don't control the types of cameras, it's up to the investigators to enroll and so there is a variety of different tumor types.
In terms of length of follow up.
There.
We do have a follow up on patients over months. So I think we'll have a samsung.
Sufficient durability.
Thank you great can I, just clarify that Kim track comment is that 40% of the new patients that you are picking up our first line or 40% of the overall U S patients now on keeping track our first line.
Ralph Torbay: We believe these accounts capture around 40% of the MUM patient opportunity in the, U.S. As the team continues to focus on activating priority accounts, we are also supporting, the transition and initiation of patients closer to home and into the community. So far, one of every four patients on ChemTrack is being treated in a community setting. The feedback from community physicians to date has been very positive and speaks to, the predictable and manageable profile of ChemTrack.
Ralph Torbay: From an access perspective, our teams have secured formal policy coverage for approximately, 60% of all potential MUM patients in the U.S.
Yeah.
Ralph Torbay: In addition, I am pleased to report that as of June 30th, 99% of ChemTrack prescriptions, were covered.
Suggest it's 40% of the now patients on <unk> are in first line.
Great. Thank you.
Okay.
Thank you. Our next question comes from the line of Tyler Van Buren with Cowen and company. Please proceed with your question.
Ralph Torbay: We continue to work toward our goal of supporting access for every single patient that needs, ChemTrack.
Hey, guys good morning, and congratulations on the stellar Kim truck results.
Ralph Torbay: Turning to new patient starts, today, 40% of ChemTrack patients are in first line.
I guess I'll ask you about cutaneous melanoma, given the newly announced trial design are.
Requiring patients to be previously treated.
Since it requires patients to be both.
Betsy treated with both a checkpoint inhibitor and it would be does the one year survival benefit analysis that you presented at Astro separate more if you just look at the patient population with checkpoint.
Check point and it'd be experience as it might be more severe and just.
Just a follow up to that is the control arm.
I believe you said patients.
It'd be switched to Kim track. So how do you expect that to impact the survival analysis.
Mhm.
So for.
Ralph Torbay: We are seeing positive momentum in our ability to displace entrenched checkpoint inhibitor, competition.
Ralph Torbay: It is still too early for us to guide on what to expect from a duration of therapy perspective. However, this continuation data remains in line with our expectations.
So the first question the historical one year survival is mostly in patients who progressed on prior PD one.
Ralph Torbay: I'm very grateful for the excellent launch execution that our U.S. team has delivered.
Ralph Torbay: Their efforts offer many patients a chance at longer survival.
Yeah.
5% is also even seen it flips Nemo and patients who progressed on prior PD, one patients who were enrolling here who have progressed on PD, one and if you might even have a lower one year survival and in fact thats part of the reason to do the phase II part to see the should be the actual treatment effect, which might be.
The same are larger in terms of the control arm.
It is straight to survival follow up and investigators can choose whatever they want to enroll the patients and we believe most of the patients will be enrolled on other investigational agents clinical trials.
Don't think that that will really impact the powering of the study.
Thank you.
Okay.
Thank you. Our next question comes from the line of Patrick Tokyo with H C. Wainwright. Please proceed with your question.
Thanks, Good morning, and congrats on all the progress in the quarter.
Ralph Torbay: Now let's transition to Europe, where the launches are going equally as well.
Just a clarification question just in terms of the Kim track launch in European markets.
Just as much and whats European markets would you expect to be launching in 2023 and 2024.
And how many patients would be expected to be transitioned to a commercial supply at the times of those launches and then just in terms of the HBV program.
Can you discuss the sad trial results a bit more in terms of reduction in surface antigen was this in line with your expectations. How would you characterize the L. T elevations that we're seeing.
What can we expect as that service level increases and finally do you envision moving the HBV program you know eventually.
Forward in combination with.
[noise] other antiviral or immune stimulatory mechanisms or where would you be moving it forward on its own.
Yes. Thank you Patrick I think you have several questions here, maybe we can we can start with the Kim trek launches in the EU.
Ralph Torbay: In Germany, we've had a strong start since reimbursement of ChemTrack in May and the, transition of all patients with AAP. In fact, our first patient was infused with commercial ChemTrack the same week we received, price listings. Across Germany and France, 45 accounts have infused patients with ChemTrack.
Thank you Patrick for the question so look in the EU.
Ralph Torbay: We are seeing strong momentum in Germany with 30% of patients coming from first line, this, only two months post-launch.
The launches will depend on reimbursement.
Actively engaged and so have submitted those seems to a lot of these countries are.
Ralph Torbay: We are providing access in 10 additional countries through the expanded access program.
At the moment I can't really comment on when the launches will happen because as you know these are negotiations what I can tell you. Though is that you can expect the same level of execution from the team and all of the geographies, where we have an EAP ongoing.
Ralph Torbay: Our value access team is prosecuting reimbursement across these geographies with many expected, to launch in 2023.
Ralph Torbay: We remain determined in our ambition of delivering ChemTrack to patients across Europe.
Ralph Torbay: A little more than a year ago, the team was challenged with creating a multinational commercial, infrastructure to deliver the amazing innovation that is ChemTrack. Today, we have successfully launched in the U.S., Germany, and France. Together, these countries represent the majority of the value opportunity for ChemTrack and, have delivered so far 46.5 million in the first half of the year.
Okay.
In terms of the HBV questions Patrick so.
There were three markers, we were really looking for when we.
Ralph Torbay: It remains early for us to guide us to the final epi numbers, the impact of bolus, or, the expected duration of therapy.
Ralph Torbay: However, we will continue to deliver strong execution, engagement, and growth in these markets.
Part of the program, but frankly don't expect to see them until we get to higher doses, we were expecting it to eventually to see increases because we would potentially be killing hepatocytes and releasing A&P. We expect it to see IL six increase and we expected to see.
Lymphocyte trafficking those.
That is really all we expected to see in <unk> and.
And that is why it was remarkable in the first initial dose at such a low dose as I mentioned that we saw an increase in A&P and increase in IL six and even a few patients having lymphocyte trafficking what was totally unexpected for me is to see even at this initial dose any surface antigen change I really didn't expect to see that until the <unk>.
And I think Thats why we were so excited in terms of your second question. The current study is in the background of nukes and this is a platform that can be combined with anything so we do see it as combinable with any other therapy.
Great. Thanks, David.
Thank you.
Thank you.
Yeah.
Thank you. Our next question comes from the line of Justin Kim with Oppenheimer <unk> Company. Please proceed with your question.
Hi, good morning, and congrats on the progress maybe just on Kim truck has the team observed any pattern between first line or second line treated patients just wondering if the physician experience as a driver here and whether we might expect this to change over time.
Thank you Justin.
Take that truck sure so Justin.
You would expect second line patients and really when we're talking about second line patients. We're talking about second line plus so you have patients who have seen three lines of therapies and so on so second line patients tend to be.
Sicker overall, so we do see a better experience in first line and obviously this is where we've seen the U S benefit so our focus and commitment is to really establish contract as a center of care first line and that's what the team is focusing on.
Ralph Torbay: I am very proud of the highly dedicated team that is laser-focused on helping patients, with ChemTrac.
Ralph Torbay: To that end, we are committed to the ambition of reaching over 1,000 new patients by 2025.
Okay got it.
And in terms of sort of that 60% of remaining patients in the U S. But you know the.
The team is hopefully to get on treatment.
Do you see these as more accessible.
Can you the community setting just kind of trying to understand what sort of steps from an execution standpoint.
Enable reaching these patients more easily.
So as you said in your question a lot of these patients are in the community. So we're accessing the community patients in several ways. One is through obviously, what what you usually do with the Omnichannel approach digital approaches so long because the community space is so large.
Really we have our field force going after the community we see one in four patients now transitioned into the community.
Feedback from physicians in the community has been very positive to date.
Let's talk about the predictable manageable profile with <unk>. So we do expect to have good penetration in the community as the launch goes on.
Okay. Thanks for taking the question.
Thank you thank you Justin.
Ralph Torbay: We look forward to delivering this life-saving medicine to more patients globally.
Our next question comes from the line of Justin Zelman with BTG. Please proceed with your question.
David Berman: With that, I thank you, and now invite David to provide a portfolio update.
David Berman: Thank you very much, Ralph.
Hi team congrats on the strong quarter here I wanted to ask about any expectations for the upcoming prime data at ESMO next month, or if you're not able to give any color here would be great too.
Hi, David talk about how your modality is differentiated from other approaches in the field.
Yeah. Thank you Justin I think it is only one month, but we can David can comment on what are the data that we'll be bringing David yeah.
Comment on the.
On what differentiates our platform first.
David Berman: Our clinical program builds on the success of ChemTrac, and today I'm going to update you on three other pillars.
David Berman: First, we are expanding ChemTrac beyond uveal, melanoma by studying other types of melanoma, including cutaneous melanoma.
Validated shown a survival benefit with <unk>, we've shown the durability of that benefit if you see the Kaplan Meier curve remain separated patients who have tumor shrinkage or prs have very durable tumor shrinkage of Prs. We've shown very rapid onset of effect that you see the Kaplan Meier curves separate to very early and we have shown a good safety profile.
For me, Jay four and four for TC 100.
David Berman: Second, we are expanding beyond GP100 to larger indications with our programs targeting PRAME and MAJOR-A4.
David Berman: And finally, we are expanding beyond oncology in our clinical programs for functional care, in HPV and HIV.
We feel this is the first mechanism that's shown for for bi specifics that's shown such.
Promising data in solid tumors, and we believe it can be applicable.
Broadband.
Thanks for taking the question.
Thank you.
Our next question comes from the line of Matt Phipps with William Blair. Please proceed with your question.
Thanks, and congrats on the quarter. That's really my question two quick ones for Ralph I assume Ralph you, specifically said the discontinuation data is kind of in line with expectations do you have any sense of treatment beyond progression and the kind of a real world setting at this point and then secondly, you know have 10 countries where EAP.
He is open I wonder if you can maybe give us a sense of how many patients are on <unk> T in those countries beyond Germany and France.
Okay Ross do you want to take the first one and then maybe Brian you can comment on the second got it sounds good. Thank you Matt for the question. So when you think about trillium beyond progression. The practice was already established with checkpoint inhibitors, but it's not at the level, where we needed with Kim track to maximize patient outcomes as we've seen them into.
This is why we made sure that this made it into our label and we continue to educate on it. So it's still a little bit early to comment on where that will land, but the team is actively working at building.
The education here.
But as I said.
Yeah, I think I would add like in academic centers is not going to be.
Often issue, they're used to seeing better I think in the community setting where you have to do more and.
More of education, and that's exactly what the <unk> are doing well in our comments on the EAP Brian Yes.
Include France and Germany.
Matt.
You still have 10 countries, there's still enrolling on the EAP.
We now have over 100 patients still on the EAP.
As Ralph mentioned as we move into 2023, and 2024 and seek reimbursement in those countries, we expect to transition those patients.
Okay.
Thank you Bob.
Thank you. Our next question comes from the line of Gil Blum with Needham <unk> Company. Please proceed with your question.
David Berman: I will first provide an update on advanced melanoma.
David Berman: At ASCO two months ago, we presented a survival update on our study of ChemTrac plus an antipedial, one in metastatic cutaneous melanoma patients who progressed on a prior antipedial one.
David Berman: As we saw in uveal melanoma, survival was the best endpoint for capturing all the benefits, in cutaneous melanoma. And here, we see a very promising one-year survival of 75% for the combination.
David Berman: Now, to put this in context, the historical one-year survival for this population is approximately 55%, and that's seen across several recent benchmark trials. This differential gives us confidence to design a registrational program in advanced melanoma, including cutaneous melanoma, with a survival endpoint. Following discussions with global melanoma experts and with the U.S. FDA, we are excited, to announce our new registrational Phase 2-3 trial in patients with any histologic type of melanoma, excluding only uveal melanoma. These patients have progressed on a prior antipedial one and received prior ifilimumab and, if appropriate, a prior tyrosine kinase inhibitor.
David Berman: The study will randomize these patients to three arms, including number one, ChemTrac alone, number two, ChemTrac with an antipedial one, and number three, a control arm.
David Berman: This population is one of high unmet need, and the best option for these patients is to enroll on clinical trials.
David Berman: The control arm is innovative in that patients go straight to survival follow-up, and this enables the investigator discretion to choose any therapy, including even enrolling the patients on other clinical trials.
Thank you for taking our questions.
David Berman: Therefore, we are randomizing essentially to a real-world treatment option, rather than, pre-chemotherapy, which is generally considered ineffective.
David Berman: The FDA has accepted this design, since the primary endpoint is overall survival, which is standard data collection in follow-up from any clinical trial.
So I'd like to add my congratulations on your quarter. So you mentioned about 124 accounts of Oh.
David Berman: The primary endpoint of the phase two, is reduction in ctDNA and overall survival.
David Berman: And data from the phase two provides us optionality, to inform changes to the phase three, including moving into earlier lines of therapy, dropping an arm or even repowering the study to make it smaller.
David Berman: As the pioneer in PCR therapeutics, I am proud that we have published extensively on the science of ChemTrac from the mechanism to safety to efficacy.
David Berman: And with over 500 UVL melanoma patients treated, in clinical trials, we now have insights that provide a blueprint for how we develop our other IMTACs, including MAGE and PRAME. And this blueprint is summarized here. First, we must demonstrate that the IMTAC, is activating T cells and redirecting them to the tumor.
David Berman: Second, the hallmark of ChemTrac, was durable clinical benefit, which include durable tumor shrinkage shown in green and durable partial responses shown in yellow with some ongoing for over one year.
David Berman: Third, we see survival benefit, regardless of whether the patients have high or low expression of the parent GP100 protein, which is reflected by the age score.
Sure capturing about 40%.
Hum.
Thank you have the potential for higher penetration in the accounts you already have relationships with and then I have a follow up right.
Yeah, Rob.
Sunil.
We're currently working on.
On those accounts to get them trained to get all the stocks trading I mean, when you think of an accounts do you think about several physicians being in that account.
So we do have great penetration or market share with the physicians that are familiar with Debbie and Kim truck. However of course, where we're still working through making sure that everyone in those accounts prescribing <unk> as first line treatment.
Thank you that's very helpful and that's maybe a bit of a follow on on Michael's question from before.
How relevant is or are for a study like this.
Given that the real benefit only shows up.
Later, I mean with patients that have responses that can last a long time, but maybe you don't get it you know a big or our upfront. Thank you.
Are you just a clarification are you talking about the keep tracking in continuous or are you talking about the frame right.
David Berman: Now we do note that there was an enrichment, for resist partial responses at the higher age score.
David Berman: And fourth, early ctDNA reductions, was a strong and early surrogate of survival.
Great.
David Berman: And for UVL melanoma and ChemTrac indicates, up to 70% of patients may be having benefit based on ctDNA decrease.
Yeah.
David Berman: Of course, the ultimate goal for all patients, is overall survival.
Okay. Thank you yeah, yeah. So first I would just say that our largest dataset is website Kim track. That's that's point number one and there we see the survival benefit at both high and low H score, but we do see resist prs at the higher rate score and it's really an open question that we've been trying to ask is we go to other.
David Berman: And this is where we ultimately will look.
David Berman: Beyond ChemTrac, we have two clinical IMTACs, targeting larger cancer indications.
David Berman: F106C targets PRAME, which has the potential for 150,000 patients. The phase one data was accepted, for oral presentation at ESMO next month.
David Berman: And there will be more than 20 patients, who are PRAME positive, treated at active doses and who are efficacy are valuable.
Bahija Jallal: I'm going to hand it back to Bahija.
David Berman: C103C targets MAI-J4, which has the potential for 60,000 patients.
Bahija Jallal: Thank you, David, Ralph, and thank you, Brian.
David Berman: The phase one dose escalation continues, as is the expansion in ovarian carcinoma.
Bahija Jallal: As you have heard, it has been a very successful, quarter, and I could not be more proud and also thankful to this team's leadership.
David Berman: And we will update the progress later this year.
Bahija Jallal: So looking into the rest of the year, we still have more work to do, and we're very, happy about that.
David Berman: This platform can be applied beyond oncology, to infectious disease.
Bahija Jallal: We will be, from the milestones, we are on track.
David Berman: And I am pleased to update you on our progress here.
Bahija Jallal: So we'll continue the commercial launch and continue to get approval in other countries.
Operator: A confirmation tone will indicate your line is in the question queue.
David Berman: Chronic viral infections, such as HIV and HPV, may result in a reservoir that is not eradicated by currently available direct acting antivirals. Our platform should be applicable, to eliminating this reservoir to achieve functional care.
Bahija Jallal: Looking into Q4, we expect to have the first patient enrolled in the advanced melanoma trial that David just shared with you.
David Berman: We initiate all of our Phase I studies, including our HPV functional care program, at what are, called Mabel doses, which are intended to be sub-therapeutic. However, we find that our molecules are so potent that even at the Mabel dose for the HPV program, we see the exact on-target biomarkers that we expect to see, including a transient decrease in, HPV surface antigen, which is a marker of disease, with a concomitant increase in ALT.
Bahija Jallal: We are on track of presenting the data in Q3 for PRAME in Paris, in ESMO.
David Berman: Now the changes we see are small, but one must remember that this initial dose was below, 1 micrograms, and it's remarkably seen after only a single dose.
Bahija Jallal: And then we're on track to presenting data for MEJ-4 and update on MEJ-4 in Q4, and then continuing the enrollment of HIV and HVB programs.
David Berman: And we certainly look forward to seeing what happens at higher doses.
Bahija Jallal: I just want to reflect before we take your questions.
David Berman: And finally, I am pleased to announce that we have achieved first patient dosing in our HIV functional cure program.
Bahija Jallal: At the beginning of 2022, I said, this would be a year of execution, and the team did just that. They were laser-focused, and so far we have achieved everything we said we would. I feel, and we all feel, really privileged to be in the business of bringing medicines with meaningful benefits to patients, a benefit that will truly impact their lives.
Operator: You may press star 2 if you'd like to remove your question from the queue.
David Berman: And now
Bahija Jallal: I'm humbled by the efforts of my team and our employees.
Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Bahija Jallal: Our patients are counting on us, and we take this responsibility very seriously.
Bahija Jallal: So we have a few minutes left, and we'll be happy to answer your questions.
Bahija Jallal: Thank you.
Operator: Thank you.
Operator: At this time, we will be conducting a question-and-answer session.
For other targets is whether this is going to be at the same pattern, we see R. R.
Operator: If you'd like to ask a question, please press star 1 on your telephone keypad.
Operator: Our first question comes from the line of Michael Yee with Jeffries.
Michael Yee: Please proceed with your question.
Michael Yee: Hey, good morning, Bahija.
Or not and so I think between MAGE.
Bahija Jallal: Thanks for the questions and congrats on the progress in the great quarter.
And frame, which tends to have a higher H score and more homogenous staining I think will begin to answer the question or actually I should just basically is it a platform effect alright.
Michael Yee: We had a commercial question and a pipeline question.
Michael Yee: On the commercial front, although it's early in the launch in the U.S. and Europe, do you expect steady, continuous growth in the following quarters beyond just EAP people that have come on, both from new patients coming on, but also do you get the sense early on that people are staying on a duration of therapy beyond just five months based on your experience of what you're seeing in the commercial setting?
Michael Yee: Thank you.
Michael Yee: And then from a pipeline question, maybe for David, you know, I know that people are focused on Esmoyn, and we'll get the data soon.
Bahija Jallal: Thank you, Michael.
Michael Yee: On one hand, you know, GP100 has shown lower response rates, but much longer OS.
Bahija Jallal: Great questions.
Michael Yee: And I think there's a question whether it's mechanism or just a target thing.
Ralph Torbay: We'll start with Ralph, maybe, to take the question on commercial.
Michael Yee: How do you think about framing expectations for PREEM, given what we know that PREEM is a pretty active target?
Dependent on the targets and I think hopefully you would have an answer.
Ralph Torbay: Sure.
Okay excellent that's very helpful and thank you for taking my questions.
Ralph Torbay: Thank you, Behija, and thank you, Michael, for the question.
No. Thank you.
Ralph Torbay: So, look, I mean, you spoke of the EAP and the patients coming from the EAP.
Ralph Torbay: But as I mentioned, these continuation rates are in line with what we expect.
Ralph Torbay: So there's that piece of bolus that we're proud that the team has executed so well, that all patients transitioned into commercial supply weeks within approval.
Ralph Torbay: Great.
Ralph Torbay: However, we're still the first medicine to launch in this space in over four decades.
David Berman: David, do you want to comment on the ORR?
Thank you ladies and gentlemen, we have reached the end of our question and answer session. I will now turn the call back over to management for closing remarks.
Ralph Torbay: So, really, we don't have a good analog to base this on.
David Berman: Yeah, so, Michael, we know that PREEM is a good target. We've seen that before. It tends to be homogenous, and the peptide density is high.
Ralph Torbay: You know, I expect the team will continue to do great work.
David Berman: And we've seen from others that it is an active target, so we know it's a good target.
Ralph Torbay: It is still too early, however, for us to really comment, given that we have five months of launch in the U.S., two months in Germany, and duration of therapy really has not materialized.
David Berman: From our platform, what we've seen is we've seen durable benefits.
David Berman: We've seen PRs, we've seen tumor shrinkage, and we've seen ctDNA reduction.
Bahija Jallal: So we'll start with the first one, maybe,
David Berman: Those are the hallmarks of what we've seen with our platform.
Ralph Torbay: you can take it to Ralph, and then we'll go to David.
David Berman: So we're one month away from the data, and I think we'd be happy to discuss more of it after we share the data.
Ralph Torbay: Happy to.
David Berman: Okay.
Ralph Torbay: Thank you, Bahija, and thank you, Jess, for the question.
David Berman: Thank you, guys.
Ralph Torbay: So starting with the U.S., you spoke of the legacy EAP patients.
David Berman: Thank you.
Ralph Torbay: So really, a lot of these patients were in second line.
Operator: Our next question comes from the line of Jessica Fye with J.P. Morgan.
Ralph Torbay: Today, what we see is that 40% of our patients are coming from first line.
Well great operator, thank you so much for everyone and we look forward to seeing.
Jessica Fye: Please proceed with your question.
Ralph Torbay: The team continues to activate accounts with ChemTrac. So far, we have 124 accounts.
Jessica Fye: Hey, guys.
Ralph Torbay: So really, what you can expect is more of this good execution, and I can't really comment currently on DOT because we're too early in the launch.
Jessica Fye: Good morning.
Ralph Torbay: However, these continuations are in line with what we expect, as I said.
Jessica Fye: Nice quarter, and thanks for taking my questions.
Ralph Torbay: Thank you.
Jessica Fye: A couple on ChemTrac and a couple on PREEM.
David Berman: David, do you want to talk about the tumor types in ESMO?
Jessica Fye: First, in the U.S., how many legacy EAP patients were still on ChemTrac at the end of QQ?
David Berman: Yeah, so this is a basket trial, Jess, and so we don't control the types of tumors.
Jessica Fye: And appreciating that it's a bit early to talk definitively about duration of treatment, can you talk directionally about what you see emerging with ChemTrac?
David Berman: It's up to investigators to enroll us.
C C N Q, maybe at the ESMO. Thank you bye.
Jessica Fye: For example, with five months of experience in the U.S., can you say whether it might be tracking?
David Berman: So there is a variety of different tumor types.
Bahija Jallal: Thank you, Jess.
David Berman: In terms of length of follow-up, we do have follow-up on patients over months, so I think we'll have a sense of sufficient durability.
Bahija Jallal: Several questions in here.
David Berman: Great.
Jessica Fye: Can I just clarify the ChemTrac comment?
Operator: Ladies and gentlemen, we have reached the end of the question and answer session.
Ralph Torbay: Is that 40% of the new patients that you're picking up are first line, or 40% of the overall U.S. patients now on ChemTrac are first line? Jess, it's 40% of the now patients on ChemTrac are in first line.
This concludes today's conference and you may disconnect your lines at this time.
Bahija Jallal: I will now turn the call back over to management for closing remarks.
Ralph Torbay: Great.
Bahija Jallal: Well, great, operator.
Jessica Fye: Thank you.
Bahija Jallal: Thank you so much for everyone, and we look forward to seeing you, maybe at ESMO.
Jessica Fye: Thank you.
Bahija Jallal: Thank you.
Operator: you for your participation, and have a wonderful day.
Operator: Our next question comes from the line of Tyler Van Buren with Cowan & Company.
Operator: Bye.
Tyler Van Buren: Please proceed with your question.
Thank you for your participation and have a wonderful day.
Operator: This concludes today's conference, and you may disconnect your lines at this time.
Tyler Van Buren: Hey, guys.
Operator: Thank
Tyler Van Buren: Good morning, and congratulations on the stellar ChemTrac result.
Tyler Van Buren: I guess I'll ask about cutaneous melanoma, given the newly announced trial design requiring patients to be previously treated.
Yeah.
Tyler Van Buren: Since it requires patients to be both previously treated with both a checkpoint inhibitor and IPI, does the one-year survival benefit analysis that you presented at ASCO separate more?
[music].
Tyler Van Buren: If you just look at the patient population with checkpoint and IPI experience, they might be more severe.
Tyler Van Buren: And just a follow-up to that is the control arm, I believe you said patients, could be switched to ChemTrac.
Tyler Van Buren: How do you expect that to impact the survival analysis?
David Berman: For the first question, the historical one-year survival is mostly in patients who progressed on prior PD-1. And it's also even seen for IPI plus NEVO in patients who progressed on prior PD-1.
David Berman: Patients who we're enrolling here who have progressed on PD-1 and if you might even have a lower one-year survival.
David Berman: And in fact, that's part of the reason to do the phase two part, to see the actual treatment effect, which might be the same or larger.
David Berman: In terms of the control arm, it is straight to survival follow-up, and investigators can choose whatever they want to enroll the patients on.
David Berman: We believe most of the patients will be enrolled on other investigational agent clinical trials.
David Berman: So I don't think that that will really impact the powering of the study.
David Berman: Thank you.
Operator: Operator Thank you.
Operator: Our next question comes from the line of Patrick Trucchio with H.G.
Patrick Trucchio: Wainwright.
Patrick Trucchio: Please proceed with your question.
Patrick Trucchio: Patrick Trucchio Thanks.
Patrick Trucchio: Good morning and congrats on all the, progress in the quarter.
Patrick Trucchio: Just a clarification question, just in terms of the ChemTrack launch in European markets, just in which European markets would you expect to be launching in 2023 and 2024?
Patrick Trucchio: And how many patients would be expected to be transitioned to commercial, supply at the times of those launches?
Patrick Trucchio: And then just in terms of the HBV program, can you discuss the SAD trial results a bit more in terms of reduction in surface antigen?
Patrick Trucchio: Was this in line with your expectations?
Patrick Trucchio: How would you characterize the ALT elevations that, we're seeing?
Patrick Trucchio: What can we expect as this dose level increases?
Patrick Trucchio: And finally, do you envision moving the HBV program, you know, eventually forward in combination with other antiviral or immune stimulatory mechanisms?
Patrick Trucchio: Or, you know, would you be moving it forward on its own?
Naureen Quibria: Naureen Quibria Yes.
Patrick Trucchio: Thank you, Patrick.
Naureen Quibria: I think, you have several questions here.
Naureen Quibria: Maybe we can start with the ChemTrack launches in the EU.
Naureen Quibria: Thank you.
Ralph Torbay: Thank you, Patrick, for the question.
Ralph Torbay: So, look, in the EU, as you know, the launches, will depend on reimbursement.
Ralph Torbay: And we're actively engaged and have submitted those cases to a lot of these countries.
Ralph Torbay: At the moment, I can't really comment on when the launches will happen because, as you know, these are negotiations.
Ralph Torbay: What I can tell you, though, is that you can expect the same level of execution from the team in all of the geographies where we have an EAP ongoing.
David Berman: In terms of the HBV questions, Patrick, so there were three markers we were really looking for, when we started the program, but frankly, didn't expect to see them until we got the higher doses. We were expecting to eventually to see ALT increases because we would potentially be, killing hepatocytes and releasing ALT. We expected to see IL-6 increase, and we expected to see lymphocyte trafficking.
David Berman: That is really all we expected to see in the SAD.
David Berman: And that is why it was remarkable in the first initial dose, at such a low dose, as I mentioned, that we saw an increase in ALT, an increase in IL-6, and even a few patients having lymphocyte trafficking.
David Berman: What was totally unexpected for me is to see, even at this initial dose, any surface antigen change. I really didn't expect to see that until the MAD. And I think that's why we were so excited.
David Berman: In terms of your second question, the current study is in the background of NUCCS, and this is, a platform that can be combined with anything.
David Berman: So we do see it as combinable with any other therapy.
David Berman: Great.
David Berman: Thanks, David.
David Berman: Thank you.
Operator: Thank you.
Operator: Our next question comes from the line of Justin Tim with Oppenheimer and Company.
Justin Tim: Please proceed with your question.
Justin Tim: Hi.
Justin Tim: Good morning, and congrats on the progress.
Justin Tim: Maybe just on Kimtrack, has the team observed, any patterns between first-line or second-line treated patients?
Justin Tim: Just wondering if physician experience as a driver here and whether we might expect this to change over time.
Bahija Jallal: Thank you, Justin.
Ralph Torbay: I'm going to take that, Ralph.
Ralph Torbay: Sure.
Ralph Torbay: So, Justin, I mean, you'd expect second-line patients, and really when we're talking about second-line patients, we're talking about second-line plus.
Ralph Torbay: So you have patients who have seen three lines of therapies and so on.
Ralph Torbay: So second-line patients tend to be, you know, sicker overall.
Ralph Torbay: So we do see a better experience in first-line, and obviously this is where we've seen the U.S. benefit.
Ralph Torbay: So our focus and commitment is to really establish ChemTrack as a center of care in first-line, and that's what the team is focusing on.
Ralph Torbay: Okay, got it.
Justin Tim: And in terms of sort of that 60% of remaining patients in the U.S. that, you know, the team is hoping to get on treatment, do you see these as more accessible, you know, through the community setting?
Justin Tim: Just kind of, you know, trying to understand what sort of steps from an executive standpoint will enable reaching these patients more easily.
Ralph Torbay: So as you said in your question, a lot of these patients are in the community.
Ralph Torbay: So we're accessing the community patients in several ways. One is through obviously what you usually do with the omni-channel approach, digital approaches and so on, because the community space is so large.
Ralph Torbay: But really we have our field force going after the community.
Ralph Torbay: We see one in four patients now transition into the community. Feedback from physicians in the community has been very positive to date.
Ralph Torbay: You know, they do talk about the predictable, manageable profile of ChemTrack.
Ralph Torbay: So we do expect to have good penetration in the community as the launch goes on.
Justin Tim: Thanks for taking the question.
Justin Tim: Thank you.
Justin Tim: Thank you, Justin.
Operator: Our next question comes from the line of Justin Zelen with BTIG.
Justin Zelen: Please proceed with your question.
Justin Zelen: Hi, team.
Justin Zelen: Congrats on the strong quarter here.
Justin Zelen: I wanted to ask about any expectations for the upcoming PRAME data at ESMO next month.
Justin Zelen: Or if you're not able to give any color here, it would be great to have David talk about how your modality is differentiated from other approaches in the field.
Justin Zelen: Yeah, thank you, Justin.
Justin Zelen: I think it is only one month, but David can comment on what are the data that we'll be bringing.
David Berman: David?
David Berman: Yeah, I mean, I'll comment on what differentiates our platform.
David Berman: First, we have validated and shown a survival benefit with ChemTrack. We've shown the durability of that benefit.
David Berman: If you see the Kaplan-Meier curves remain separated, the patients who have tumor shrinkage or PRs have very durable tumor shrinkage or PRs.
David Berman: We've shown very rapid onset of effect.
David Berman: If you see the Kaplan-Meier curves separate very early.
David Berman: We've shown a good safety profile both for MAGE-A4 and for GT100.
David Berman: So we feel this is the first mechanism that's shown for bi-specifics that's shown such promising data in solid tumors.
David Berman: And we believe it can be applicable broadly.
David Berman: Thanks for taking the question.
Operator: Thank you.
Matt Phipps: Our next question comes from the line of Matt Phipps with William Blair.
Matt Phipps: Please proceed with your question.
Matt Phipps: Thanks.
Matt Phipps: Encounters on the Core, thanks for taking my question.
Matt Phipps: Two quick ones for Ralph, I assume.
Matt Phipps: Ralph, you specifically said that this continuation data is kind of in line with expectations.
Matt Phipps: Do you have any sense of treatment beyond progression in the kind of real-world setting, at this point?
Matt Phipps: And then secondly, you now have 10 countries where EAP is open.
Matt Phipps: I wonder if you can maybe give us a sense of how many patients are on EAP in those countries, beyond Germany and France.
Matt Phipps: Okay, Ralph, you want to take the first one, and maybe Brian, you can comment on the second.
Ralph Torbay: Go ahead.
Ralph Torbay: Sounds good.
Ralph Torbay: Thank you, Matt, for the question.
Ralph Torbay: So when you think about treatment beyond progression, the practice was already established with, checkpoint inhibitors.
Ralph Torbay: But it's not at the level where we needed with ChemTrack to maximize patient outcomes, as we've seen them in the trial.
Ralph Torbay: This is why we made sure that this made it into our label, and we continue to educate, on it.
Ralph Torbay: I think it's still a little bit early to comment on where that will land.
Ralph Torbay: The team is actively working at building the education here.
Ralph Torbay: But as I said, it's a...
Ralph Torbay: Yeah, I think I would add, like, in academic centers, it's not going to be of an issue.
Ralph Torbay: They're used to seeing that.
Ralph Torbay: I think on the community setting, we have to do more of education, and that's exactly, what the MSLs are doing.
Ralph Torbay: You want to comment on the EAP, Brian?
Brian Donato: Yeah.
Brian Donato: If you don't include France and Germany, Matt, we still have 10 countries that are, still enrolling on the EAP.
Brian Donato: So we now have over 100 patients still on the EAP.
Brian Donato: And as Ralph mentioned, as we move into 2023 and 2024 and seek reimbursement in those countries, we expect to transition those patients.
Matt Phipps: Great.
Matt Phipps: Thank you both.
Matt Phipps: Thank you.
Operator: Our next question comes from the line of Gil Bloom with Needham & Company.
Gil Blum: Please proceed with your question.
Gil Blum: Thank you for taking our questions, and also I'd like to add my congratulations on your, quarter.
Gil Blum: So you mentioned about 124 accounts of capturing about 40% AUM.
Gil Blum: Do you think you have the potential for higher penetrations in the accounts you already have, relationships with?
Gil Blum: And then I have a follow-up on France.
Gil Blum: Okay.
Ralph Torbay: Ralph?
Ralph Torbay: So, Gil, we're currently working on those accounts to get them trained, to get all the, staff trained.
Ralph Torbay: I mean, when you think of an account, you think about several physicians being in that, account.
Ralph Torbay: So we do have great penetration or market share with the physicians that are familiar, with Tevi and Chemtrail.
Ralph Torbay: However, of course, we're still working through making sure that everyone in those accounts, is prescribing Chemtrail as first-line treatment.
Ralph Torbay: Thank you.
Ralph Torbay: That's very helpful.
Gil Blum: And as for Perry, maybe a bit of a follow-on on Michael's question from before.
Gil Blum: How relevant is ORR for a study like this, given that the real benefit only shows up, a lot later?
Gil Blum: I mean, with patients that have responses that can last a long time, but maybe you don't, get a big ORR up front.
Gil Blum: Thank you.
David Berman: Are you – just a clarification, are you talking about Chemtrail in cutaneous, or are, you talking about PREIM?
David Berman: PREIM.
David Berman: Okay, thank you.
David Berman: Yeah.
David Berman: Yeah, so first I would just say that our largest data set is with, ChemTrac, so that's point number one.
David Berman: And there we see the survival benefits at both high and low age score, but we do see resist PRs at the higher age score.
David Berman: And it's really an open question that we've been trying to ask as we go to other targets, is whether this is going to be the same pattern we see or, you know, or not.
David Berman: And so I think between MAGE and PRAME, which tends to have a higher age score and more homogenous staining, I, think will begin to answer the question.
David Berman: Correct.
David Berman: It's just basically, is it a platform effect or if it's dependent on the targets, and I think hopefully we'll have an answer.
David Berman: Okay, excellent.
Gil Blum: That's very helpful.
Gil Blum: And thank you for taking our questions.
Gil Blum: Thank you.
Operator: Thank you.