Q3 2024 PDS Biotechnology Corp Earnings Call and Business Update
[music].
Good morning, ladies Sunshine and won't come cheap P. D. S biotechs third quarter 'twenty 'twenty four results and clinical strategy update conference call.
All participants.
Speaker Change: Currently in a listen only mode.
Speaker Change: Following the formal presentation, we will open up the call for question and answer session.
Speaker Change: Okay I'll have to turn the conference over to Tom Johnson.
Tom Johnson: Last time it advances. Please go ahead sir.
Tom Johnson: Thank you operator, and good morning, everyone. Welcome to P. P. D S biotech third quarter 2024 results and clinical strategy update call.
Tom Johnson: I'm joined on the call today by the following members of the company's management team Dr. Frank better window, Chief Executive Officer, Dr. Curt Shepherd, Chief Medical Officer, and large both garden Chief Financial Officer, Dr. A bit of a Doe will begin with an overview of the company's recent interactions with investors and investigators and others regarding this clinical development plans.
Tom Johnson: Mr. Bose Guard will review our financial results for the third quarter and Dr. Sheppard will then join the call to help address questions from our covering analysts.
As a reminder, during this call we will be making forward looking statements, which are subject to various risks and uncertainties that could cause our actual results to differ materially from these statements any such statements should be considered in conjunction with the cautionary statements in our press releases and risk factors discussed in our filings with the SEC, including our quarterly reports on.
Tom Johnson: Our Form 10-Q and annual report on Form 10-K.
Tom Johnson: Cautionary statements made during this call we assume no obligation to update any of these forward looking statements or information now.
Speaker Change: Now I'd like to turn the call over to Dr.
Tom Johnson: Right.
Dr. Right: Thank you Tom and good morning, everyone.
Dr. Right: It's our pleasure to speak with you again and to provide an update on our progress in advancing our clinical programs.
Dr. Right: Our third quarter has been a very busy and productive period.
Dr. Right: Since the update we provided in August the first we have been actively engaged with investors and clinicians to discuss our funding requirements and strategy for our breast health through a three phase III trial.
Speaker Change: First the towels. There was there were three evaluating burst immune HPV, plus penguin lithium up compared to <unk> alone.
Speaker Change: Potential treatment for first line recurrent or metastatic HPV 16 positive head and neck squamous cell carcinoma, or H M. S. D C.
Speaker Change: I'll refer to this simply as head and neck cancer.
Speaker Change: I am very pleased to report that both investor and investigator interest in our first how's the residual three trial is strong.
Speaker Change: Based on our assessment of the clinical data to date.
Speaker Change: Feedback we received from investors.
Speaker Change: As well as discussions we held with key opinion leaders involved with the study and Arthur experts.
Speaker Change: We have made minor modifications to the burst styles. There were zero three trial design to reduce the overall cost and the time required to achieve an interim data readout and trial completion.
The update adverse tells you we're sitting with three trial design will now include approximately 350 patients.
Speaker Change: The trial retain statistical power.
Speaker Change: It maintained at 221 randomization.
Speaker Change: And remains within the confines of our discussions with the FDA on a registrational trial design.
Speaker Change: Median overall survival remains as the primary endpoint.
Speaker Change: And with the mission of the updated protocol to our investigational new drug application with the U S food and drug administration FTA. This week.
Speaker Change: We expect FDA clearance decision by mid December.
The updated design.
Speaker Change: By them therapy durability of the clinical responses in all risk policy reserve.
Speaker Change: There were two studies seen over the last year with.
Speaker Change: With the most recent data presented at the ESMO Congress in September.
Speaker Change: Before we dig into the burst out there as they were three study.
We would like to review some of the key data points from the first out there was there were two study.
Speaker Change: <unk> showed improvement and responses over the last year.
Speaker Change: Were taken into consideration and the updates to the burst tells there is zero three study design.
Speaker Change: The data demonstrated the following.
Speaker Change: Median overall survival has remained at 13 months over the last two data crops.
Speaker Change: And the lower limit of the 95% confidence interval improved to approximately 20 months.
Speaker Change: The best published median overall survival for Pampa listen Bob It's approximately 18 months.
Speaker Change: Objective response rates improved from 26% to 36%.
Speaker Change: Published objective response rate for Penn Burleson is 19% to 25%.
Speaker Change: Disease control rate improved from 70% to 77%.
Speaker Change: The number of patients with complete or near complete responses of 90% to 100% tumor shrinkage increased from 6% to 21%.
Speaker Change: 9% of patients had a complete response versus 3% a year earlier.
Speaker Change: Treatment related adverse events for T. R. H E a grade three or higher.
Speaker Change: And nine out of the 87 patients with.
Speaker Change: With one out of 87 patients have a great pool T.
Speaker Change: T R E and no grade five D R. A T.
Speaker Change: The T R ae's with predominantly transient injection site reactions.
Speaker Change: We are very encouraged to see that the data from our first half. There was there were two clinical trial have mature risk.
Speaker Change: Responses continue to improve suggesting durability of the birth of immune HPV induced anti tumor immune response.
The encouraging patient survival and clinical responses.
Speaker Change: Coupled with promising Tolerability I've seen in diverse styles diversity with two trial.
Speaker Change: Underscoring our belief and investigate the belief in the potential of the combination to beat Hurst H P V targeted immunotherapy for head and neck cancer and a significant advancement in the treatment of the growing population of patients with HPV 16 positive head and neck cancer.
Speaker Change: The consistent and maturing data from her style diversity with too.
Speaker Change: Also supports the reduction of the trial size, while maintaining a favorable risk profile.
In making these revisions we were also mindful that the clinical trial landscape in head and neck cancer, it's evolving.
Speaker Change: Merck last month announced topline data from the keynote six eighty-nine trial, evaluating new adjuvant and adjuvant treatment of head and neck cancer patients with Keytruda.
Speaker Change: This prompted us to perform the necessary analysis to understand how a potential approval for keytruda in early treatment of head and neck cancer may impact our target population.
Speaker Change: Recurrent and metastatic immune checkpoint inhibitor naive patients.
Speaker Change: It was also our goal to ensure alignment with key opinion leaders on our approach.
Speaker Change: We had meetings with.
Speaker Change: And solicited feedback from an array of key thought leaders in the HPV 16 positive head and neck cancer space.
Speaker Change: Including several key opinion leaders and clinical investigators who intends to take part in diverse styles. The residual three trial.
Speaker Change: We also conducted an independent survey of over 50 U S based oncologist, who regularly treat head and neck cancer patients along the entire treatment paradigm.
Speaker Change: Findings from this outreach include the following.
Speaker Change: At least 50% of head and neck cancer patients are HPV positive and the percentage of HPV positive cases is increasing.
Speaker Change: Separately.
Speaker Change: Key opinion leaders in the United States, and Europe reported that over 70% of the new patients. They see all HPV 16 positive.
Speaker Change: Information the rapid increase in the population.
Speaker Change: Okay.
Speaker Change: Most HPV positive patients do not meet the inclusion criteria for the keynote 689 study.
Speaker Change: And therefore, the potential use of keytruda in the new adjuvant adjuvant setting is not expected to significantly impact the growing population of immune checkpoint inhibitor naive recurrent or.
<unk> metastatic HPV 16 positive head and neck cancer.
Speaker Change: HPV positive head and neck cancers are virally, driven cancers and are increasingly seen as a different disease from HPV negative head and neck cancer.
Speaker Change: With a different tumor theology.
Speaker Change: And H P. V targeted approach is believed to be the best potential for more effective therapy.
Primary surgery, which is an inclusion criteria for the new adjuvant and adjuvant treatment in the keynote 689 study.
Speaker Change: It's more common in HPV negative disease than in HPV positive.
Speaker Change: And survey respondents do not expect significant impact on diverse styles. The residual three target population and enrollment even if keytruda is approved based on the results of keynote 689.
Speaker Change: T D S biotech as you know.
Speaker Change: Investigating versus mean HPV, both as a monotherapy and in combination with Keytruda in the new adjuvant setting in HPV 16 positive head and neck cancer in the ongoing phase II trial being conducted by the Mayo clinic.
Speaker Change: This is being studied both in patients receiving chemotherapy and in patients receiving surgery.
Speaker Change: Investigators believe that we are uniquely positioned to address the HPV positive disease state and are urging us to initiate diverse styles diversity with three trial at the earliest opportunity.
Speaker Change: Accordingly, we have decided to stop the trial with a targeted subset of sites to be financed from our existing resources and we intend to ramp up the number of sites as the additional capital becomes available.
Speaker Change: With the F D. A decision expected on our updated protocol in mid December.
Speaker Change: We expect to initiate the first site shortly after in the first quarter of 2025.
Speaker Change: Yeah.
Speaker Change: Elsewhere in our pipeline, we were pleased with the data from the immunotherapy phase II clinical trial.
Speaker Change: Found waiting versus me in HPV with chemo radiation to treat locally advanced cervical cancer.
Speaker Change: This data was presented at the American Society for radiation oncology Ostrow annual meeting.
Speaker Change: The presented data demonstrated promising clinical activity and a compelling safety profile.
Speaker Change: Based on continued research.
Speaker Change: Various HPV positive cancers conducted by tedious biotech.
Speaker Change: Independent researchers who recognize its potential.
Speaker Change: First in an H P V appears to work in combination with a variety of therapeutic agents.
Speaker Change: To generate clinical responses and promote improved survival in patients with favorable toxicity.
Speaker Change: We are exploring the next steps in the development diverse mean HPV for cervical cancer.
Speaker Change: In October.
Speaker Change: We also announced that the rationale and trial design for study evaluating P. D. S O one a D C in combination with external.
Speaker Change: Versus extending alone for the treatment of recurrent prostate cancer.
As discussed during an oral presentation at the 12 on all meeting of the international cytokine and into parents Society.
Speaker Change: Italians 'twenty 'twenty, four and so South Korea.
Speaker Change: The presentation was given by Dr. Rodney aid my Dad M D head.
Speaker Change: The prostate cancer clinical research section Genitourinary Malignancies Branch Center for cancer Research National Cancer Institute part of the U S National Institutes of health.
Speaker Change: Now I will turn it over to Lars for a review of our results for the third quarter.
Speaker Change: Lars.
Lars: Thanks, Frank and good morning, everyone.
Lars: Turning to our financial results the net loss for the quarter was approximately $10 $7 million or <unk>.
Lars: 29 cents per basic and diluted share for the three months ended September 32024.
Lars: Payers to a net loss of $10 $8 million or <unk> 35 cents per basic share and diluted share for the three months ended September 32023.
Lars: This decrease was primarily due to lower operating expenses.
Lars: Research and development expenses increased to approximately $6 8 million for the three months ended September 32024.
Lars: That's up from $6 4 million for the three months ended September 32023.
Lars: The increase of <unk> 4 million was primarily attributable to higher manufacturing expenses, which was partially offset by lower clinical costs and personnel expenses.
Lars: General administrative expense decreased to approximately $3 $4 million for the three months ended September 32024 from approximately $4 1 million for the three months the preceding year.
Lars: The decrease of <unk> 7 million was primarily attributable to lower personnel costs and professional fees.
Lars: The overall operating expenses decreased to approximately $10 2 million for the three months ended September 32024 down from $10 5 million for the three months ended September 32023.
Lars: Net interest expenses increased to approximately <unk> 5 million for the three months ended September 32024.
Lars: And that's up from <unk> 3 million for the three months ended September 32023.
Lars: Our cash and cash equivalents at September 32024, total approximately $50 million.
Speaker Change: And with that I'll turn the call over to the operator for a Q&A session.
Speaker Change: Thank you, Sir ladies and gentlemen, good will now be conducting the question and answer session.
Speaker Change: Christian Please press star one on your telephone keypad.
Speaker Change: A confirmation tone will indicate that demand is in the question queue.
Speaker Change: You May press Star two.
Speaker Change: The question queue.
Speaker Change: All participants, making use of speak equipment, it may be necessary to pick up your handset before pressing just shocking.
Speaker Change: Our first question comes from.
Speaker Change: Louise Chen of Cantor Fitzgerald. Please go ahead.
Hi, Thanks for the updates today and taking my question here. So I have two questions for you just wanted to ask you when would you expect an interim look at your versatile 003 data.
And then what's your latest thinking on the opportunity for versatile Oh, what's the reasons I think the landscape has changed a little bit since when you first started the program. Thank you.
Speaker Change: Hi, Louise Thanks, a lot for your question. So I will start with the second part of your question there.
The landscape I'm, considering keynote 689.
Speaker Change: Do we like that.
Speaker Change: That's the correct question, what's what is how do we view that impacting change in the landscape with regards to 689.
Speaker Change: That's correct. Thank you.
Speaker Change: Yeah. So you know.
Speaker Change: 689.
Speaker Change: Very interesting early data they are looking primarily at new adjuvant and adjuvant treatment of head and neck cancer right. I think when we saw that initial data. We felt was very important to take a step back and really analyzed how would that could potentially impact our population of patients as you know.
Ill reverse means there was there were three trial is looking at patients who are recurrent or metastatic, but also checkpoint inhibitor naive.
Speaker Change: Right and so if patients are getting treated with checkpoint inhibitors early in the treatment.
<unk> process, it could potentially impact the number of patients who are recurrent metastatic and checkpoint naive.
Speaker Change: So the first thing we did was to put together a steal in comedy of key opinion leaders, who treat b specific patients some of whom were actually on this trial and really understood that keynote six eight to nine trial design are very well run.
Speaker Change: And so the other thing we did separately from that.
Speaker Change: Two independently have.
Speaker Change: Our firm perform.
Speaker Change: Survey of 50, additional head and neck cancer experts, who typically treat these patients.
Speaker Change: In short the feedback we got from the experts in this study there was a very small population of patients who could be allowed to be HPV positive, but those patients would have to one of the key criteria for this particular approach what the patients have to be eligible for surgery.
Speaker Change: Yeah.
Speaker Change: The HPV positive population those patients are typically not candidates for surgery and very few of those patients would be recommended for surgery.
Speaker Change: So as a result the feed.
Speaker Change: But we got from the experts wasn't that our population of HPV 16 positive patients.
Speaker Change: It's not it does not appear.
Speaker Change: To be potentially impacted with the keynote 689 study right and that's what the same response, we got from the key opinion leaders, who we actually met with them.
Speaker Change: And those who are also surveyed in.
Speaker Change: Independently and so those responses were consistent.
Speaker Change: Now what we also found out from these surveys and lease discussions with as we have mentioned in the past based upon the literature reports the population of HPV 16 positive patients appears to be increasing significantly right, so head and neck cancer.
Speaker Change: You know how it's been described that's a silent epidemic with these incidents is increasing significantly projected over the next 10 to 2030 years.
Speaker Change: This is being driven predominantly by HPV 16, specifically.
Speaker Change: And what we found out from these key opinion leaders both in the United States and Europe is that today at least about 70% of the patients are actually HPV 16 positive.
Speaker Change: It aligns very well with what the literature House project it would be the change in the landscape and head and neck cancer. So overall the feedback. We received was that this population is the right population for us to be looking at for this population of patients is increasing significantly and the keynote 689 study even if keytruda.
Speaker Change: It is approved in that early stage setting would not have any significant impact on our specific population. This would impact mainly HPV negative patients not HPV positive.
Speaker Change: So basketball basketball are favorable and an important outcome for US to then proceed have the comfort to proceed with the study based upon that that thorough analysis that had been done.
Speaker Change: Now in terms of in terms of the timing. So what we expect we will provide some updates hopefully next quarter. Once we start the trial and open the site to start enrolling because the time the time to read out is primarily dependent upon enrollment rates. What we estimate today is that it's probably going to.
Speaker Change: Take us about 18 months to complete the enrollment and shortly after that maybe about six months. After that we expect the first interim data readout, but that's that will be confirmed in terms of what we anticipate those enrollment rates will be once we open up these sites next next quarter and stop and stop enrollment process.
Speaker Change: Before I hand over I'll go to Kirk and see Kirk if there's anything I missed there or anything you would like to add to that response.
No that's correct the enrollment duration, which we're very close to it up because.
Speaker Change: I would emphasize is the number of sites that were in the versatile zero-zero two previous study almost all of them have wanted to be a part of this deal was you were three study.
Speaker Change: It really increases our confidence that the enrollment duration will be around 18 months and with that first interim analysis coming six months after that and that of course was driven as Craig said by how fast we enrolled but also by the number of deaths.
Speaker Change: That's that occur.
Speaker Change: Yeah.
Speaker Change: Thank you.
You're welcome.
Speaker Change: Yeah.
Speaker Change: The next question comes from Mike I'm, Tony of B Riley. Please go ahead.
Speaker Change: Hi, Good morning, Thanks for taking my question. This is Ellie on for my own.
Speaker Change: So I had a couple of glitch and the first question is.
Speaker Change: You showed promising data from our immuno curve at Astro.
Speaker Change: Expecting to see if you have if youre planning any phase III in near future.
Speaker Change: And also I was curious to know how you position yourself with the mirrors Egfr bio specific and first line head and neck cancer, which they should.
Speaker Change: Pretty 75% of all of our initiatives at positive patient and they already have started their phase III dog I noticed sample number was not it was a small but I just wanted to see.
Speaker Change: So your view on that thank you.
Thanks Ali for the questions, let's start with the second portion again in terms of how we position ourselves versus Maryland.
Speaker Change: I think medicines data is quite impressive they are focusing.
Speaker Change: Very differently from Pts we are specifically looking at HPV 16 specific head and neck cancer, which is.
Speaker Change: The largest and grow it most rapidly growing population of these patients their approach is very different from pdfs approach, it's a biased bi specific antibody targeting targeting.
Speaker Change: The Egfr antibodies right so.
Speaker Change: In today's it picks them up as the Egfr antibody.
Speaker Change: If you compare the results that.
Speaker Change: Keynotes 048 presented.
Speaker Change: But you know what they were for a study where they looked at keytruda.
Speaker Change: Keytruda plus chemotherapy and the Egfr antibody.
Speaker Change: The results from that study show very clearly that you have the highest.
Speaker Change: Objective response rate with the Egfr antibody how river.
Speaker Change: You had the lowest median overall survival with Egfr antibody that's published.
Speaker Change: Is that it's one of the key reasons why the FDA made it very clear to us.
In this specific indication.
Speaker Change: They are only going to approve a product based on median overall survival because objective response rates do not translate to survival.
Speaker Change: Right. So that that's very important if you look at our data some of the data that I just walked through looking at how the that.
Speaker Change: The results have progressed and matured over the last year.
Speaker Change: And compare it to some of their results for example, if you look at the patients who have.
Speaker Change: Deep <unk>.
Speaker Change: Tumor regression, 90% to 100% tumor shrinkage.
Speaker Change: Do you see with P. D. S. S responses, we have 21% of those patients. So after one out of five patients past the near almost complete elimination of their tumors.
That is unparalleled what ever.
Speaker Change: Pierre you look at.
Speaker Change: Whether it's HPV negative HPV positive combined those results are clearly outstanding versus anybody else's results right. So you're looking at just when you took out objective response rates you're looking at one specific powermeter. What we haven't done is to get comfortable and what our Kols have done is to look at the bar.
Speaker Change: Off responses overall, what's the objective response rates remember objective response rate when he looks at it.
Speaker Change: <unk>, who have 30% or more tumor shrinkage right. That's what the objective responses looking athletes one narrow evaluation of those patients' responses. We look at that we look at 90% to 100% tumor shrinkage and very importantly, when you look when you compare our data in terms of the durability.
Speaker Change: And the robustness.
Speaker Change: Largest number of patients treated to date among our peers.
Speaker Change: 53 patients reported.
Speaker Change: 16 months median follow up duration. So we have not only the largest number of patients but also the longest follow up. So we have the durability of these responses showing that the responses are actually getting better with time, which is very important.
Compare and contrast, and immuno therapeutic approach versus tumor killing.
Speaker Change: If you are generating the right type of immune responses.
Speaker Change: What do you want to see if you are not going to get an initial burst of killing.
Speaker Change: Immune response is being generated and its being generated with time you have the memory T. Cell response. So you are arming the body with the ability and potential to continue that long term attack on the cancer and provide that patient long term survival right and that's one reason why it was very encouraging for us to be able to.
Speaker Change: Evaluate these results over the last year and see the consistent improvement in these results across the board.
Speaker Change: That was also very important in informing this updated design given us the comfort to be able to do this while continuing backed risk mitigated approach to the clinical design right and so again, we have to look at the results in their entirety right to be able to really understand exactly what this immunotherapy is doing.
Speaker Change: As the more traditional approaches and we have every confidence we've got very encouraging feedback from the experts regarding the results and the need to move this.
Speaker Change: Forward quickly to provide that opportunity for these this growing population of patients.
So I hope I hope that answers the second part of your question and before I go to the first thing.
I'll go to Kirk again before I go to the first part to see if he has anything to add to that to that part.
Kirk: No I think you've covered everything except for the fact, the specificity of our treatment of HBV positive.
Speaker Change: <unk> data, although as Frank went through somewhat impressive on responses with no survival data.
Only treated for HPV positive patients so that the bulk of their results are in HPV negative patients at this time.
Speaker Change: Again, that's the sizing the lack of overall survival in these patients because the FDA knows that the past large trials of leap can and also keen 848, you did have good responses, but it did not translate into a improvement in overall survival. That's why they emphasized that this should be the end.
All of these trials, including ours.
Speaker Change: Thank you thanks, a lot Kirk.
Speaker Change: And so I'll leave to go to the first part of your question with immunotherapy.
Speaker Change: So as you mentioned, we were extremely encouraged with the results from the immunotherapy trial, so immunotherapy as you recall compared.
Speaker Change: Our verse immune H P V plus chemo radiotherapy.
Speaker Change: Chemo radiotherapy in and locally.
Speaker Change: <unk> advanced cervical cancer.
Speaker Change: The standard of care today allows for a good a good evaluation in terms of comparing with where they stand up carries today. The standard of care is the same C. R T combined with Keytruda.
Dr. Right: Right. So so.
Dr. Right: That gives people a really good reference point in terms of how how this is performing quite tank potentially and what we reported.
Dr. Right: That in our study the patients get five doses averse mean HBV.
Dr. Right: And the patients who got all five doses averse mean HPV. The 36 month overall survival rate was 100%.
Dr. Right: We have never seen that in any of the studies to date in.
Dr. Right: And the patients who had at least two doses of bursting in HPV.
Dr. Right: The 36 month overall survival rate was 84.2% again very encouraging when you look at Keytruda plus the same chemo radiotherapy. The 36 month overall survival rates reported in published today, It's 82, 6%.
Dr. Right: So very encouraging results when we go to.
Dr. Right: Progression free survival again.
Dr. Right: They're very similar results when you look at the 36 month PFS rate in the patients who took all five doses of verse HPV.
Dr. Right: That is six month PFS rate was 100%.
Dr. Right: If you look at.
Dr. Right: The published keynote a 18 study with Keytruda plus <unk> plus <unk>.
Dr. Right: R T.
Dr. Right: Again, I think that's in the high 60 and the <unk>.
Dr. Right: High 60% range again, so very encouraging results we saw complete responses.
Dr. Right: 88% in patients, who got to a more doses of diversity in HPV.
Dr. Right: So based upon that data what we have done is we've assembled gone too again key opinion leader because we always want to make sure we're making we're very informed decisions.
Dr. Right: Putting together an advisory board to discuss the results and determine what the next steps should be and getting this out to hopefully an approval in the near future for cervical cancer, but that process of talking to the experts reviewing the data would be on the landscape and looking at the right positioning.
Dr. Right: This particular product in the cervical cancer space is currently ongoing and we will provide an update on back once that decision is made.
Speaker Change: Thank you so much.
Speaker Change: You're very welcome.
Speaker Change: The next question comes from Robert Leboyer.
Capital markets. Please go ahead.
Good morning, the previous design of the versatile <unk> three trial had.
Speaker Change: Armed with.
Speaker Change: The combination of.
Speaker Change: First immune HPV and releasing that and.
Speaker Change: Eight and P. D. S O one a D C similar to the Triple therapy Phase two trial, what is the status of that arm and plans.
Speaker Change: Plans to develop a D C O one.
Speaker Change: Hi, Robert Thanks, a lot for your question.
Speaker Change: So you have you're probably remembering.
Number of iterations that go so we have actually proposed initially to the FDA that we would have if three arm trial.
Speaker Change: The F D. A in principle was in agreement.
Speaker Change: However, as you recall you may recall that the FDA also agreed that the fastest approach to an approval would be to focus on the two arm study first.
Speaker Change: We proposed a dose optimization for the IL 12, with PD L. One ADC, which the FDA agreed with her.
Speaker Change: However, the FDA also requested a couple of additional safety studies that we felt could potentially extend the duration before we get to that data readout right and so both Pts and the FDA agreed that the fastest approach would be to focus on the double and do that dose optimization in parallel right and so that's.
Speaker Change: The approach we've taken today moving forward as quickly as we can with the double get that double to the finish line and then we will do that dose optimization of the triple of the PD one ADC in parallel and then determine what the best timing would be to add that to the doubling.
Speaker Change: Yeah.
Speaker Change: Robert.
Speaker Change: To answer your question.
Speaker Change: Yeah.
Speaker Change: Any timing on the development of those safety studies.
Speaker Change: No today to date, all our focus is on getting the birth thousands of received with three up and running once we get burst of 003 up and running the next quarter. We will then get back to that dose optimization study by the current the current focus is primarily on getting first how's the residual three up and running.
Speaker Change: Okay, great. Thank you very much.
Welcome.
Speaker Change: Okay.
Speaker Change: Ladies and gentlemen, we have reached the end of our question and answer session.
Speaker Change: Got it.
Speaker Change: Okay remarks.
Speaker Change: Thank you very much operator.
I will close by saying that we are very eager to get back into the clinic with Albert's styles. They receive a free trial early in 2025.
We are confident that the updated trial design can enroll in a timely fashion.
Speaker Change: And that's our fast track designation mature and durable survival data.
Speaker Change: And cost effective plan for breast meat HPV can position us well to be the first product of its kind on the market in head and neck cancer.
Speaker Change: Our engagement with investors and clinical investigators has validated our approach and the long term opportunity. We believe burst mean HPV presents in the HPV positive head and neck cancer indication.
Speaker Change: We look forward to keeping you updated on our progress. Thank you very much again.
Speaker Change: Thank you, Sir ladies and gentlemen, thank you for attending and you may now disconnect your lines.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Yeah.
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Speaker Change: Uh huh.
Speaker Change: [music].