Q3 2021 PDS Biotechnology Corp Earnings Call
Greetings welcome to P. T S. Biotechnologies third quarter 2021 earnings call and webcast at this time all participants are in a listen only mode.
A question answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero from your telephone keypad.
Please note this conference is being recorded.
At this time I'll now turn the conference over to Deanne Randolph Vice President of commercial development.
You may now begin.
Good morning, and welcome to PDL.
Energy third quarter, 2021 earnings conference call and audio webcast.
With me and Frank Milano, Chief Executive Officer, Pascal anything Blake Chief Medical Officer.
Hill, Chief Financial Officer.
Earlier this morning, PTO issued a press release announcing financial results for the quarter.
32021.
We encourage everyone to read the press release as well as <unk>.
Our quarterly report on Form 10-Q, which was filed with the F E. Early get this money.
Company's press release is available on PDF.
Right.
I thought com.
Quarterly report will be posted later today.
In addition, this conference call is being webcast through the company's website and will be archived there for future reference.
Before we begin I would like to caution listeners that comments made by management. During this conference call will include forward looking statements within the meaning of securities laws, including the Safe Harbor provision.
Geraghty litigation reformer at 1995.
These forward looking statements involve material risks and uncertainties and the company's actual results may differ materially.
For a discussion of these risk factors, including among others the risks related to COVID-19.
This pandemic may have on the company's business operations and financial operational results of operations and the company's ability to respond to the related colleagues, including those noted in this mornings press release.
Please refer to PDF biotech at island.
Investors potential investors and other listeners are urged to consider these pocket carefully in evaluating the forward looking statements.
You're cautioned not to place undue reliance on such forward looking statements.
Please note that the contents of this conference call contains time sensitive information that is accurate only as of the date. The live broadcast November 10 2021.
Except as required by law the company undertakes no obligation to revise or update any statements to reflect events.
Our circumstances that take place after the date of this call.
Following today's prepared remarks, we will open it up for a question and answer session.
With that I would now like to turn the call over to Doctor Thank value auto.
Thank you, Dan and thanks to everyone on the call today.
Last year, our Pds biotech, we initiated execution of our oncology clinical strategy and outlines key milestones that we have plans to achieve in 2021 and 2022.
P. D. S. Biotech is still on track to achieve each of these milestones on schedule.
With added progression of pipeline programs.
2021 has been an extraordinary year for Pds biotech.
We shared extremely promising interim results of Pdfs of 101 from ongoing clinical trials and this quarter have continued to progress our pipeline programs towards commercialization of what we believe are transformative treatments for cancer.
As we begin to see the positive human impact versus mean based treatments are hopping on terminally ill patients who previously had very few if any options our team of P. D. S. Biotech is highly encouraged.
We continue our strong relationship with the National Cancer Institute.
A key goal of the National Cancer Institute is to make and to promote significant advancements in the treatment of cancer.
Last quarter interim data for the National Cancer Institute that they used to study.
Up in novel Triple combination, including our lead candidates P. D. S. A one O one.
<unk> reported at the American Society of clinical oncology also known as the <unk> annual meeting.
This clinical strategy is based on an immuno therapeutic combination targeting a specific molecular marker HPV 16 present in six different cancers.
This represents a paradigm shift in cancer treatment as we evolve from treating tumors by location to treatment based on molecular profiles.
The strength of the data across all HPV 16 tumor types is extraordinary and immuno oncology.
One arm of this ongoing clinical trial.
Validating the novel P. D. S O one O one based combination in patients with anal cancer cervical cancer head and neck cancer penile cancer vaginal involve a cancers, who have failed at least one standard of care treatment.
In a second the trial studying the combination in patients with the same six cancers, who have failed one or more standard of care therapies, including checkpoint inhibitor therapy.
The interim data from both arms of the study.
Strengthen evidence of diverse mean platforms potential ability to recruit train and activate large numbers of critical cancer attacking killer T cells.
Even in very ill patients and may overcome a key limitation of cancer immunotherapy.
The strong proof of concept data suggests potential utility of vers immune in the development of Molecularly targeted cancer Immunotherapies that are agnostic to the location of the cancer in the body.
And have the potential therapeutic efficacy across multiple types of cancer.
During the third quarter, we significantly progressed several pipeline products towards clinical development.
We are focused on executing our P. D. S. O 101 phase II trials and rapidly progressing our pipeline products into clinical development in order to understand the potential.
Our molecularly targeted immunotherapies in treating a broad range of cancers.
Let's begin with the Pds biotech initiated versatile zero to do with two trial conducted in collaboration with Merck.
The versatile zero-zero two study is designed to evaluate <unk> hundred one in combination with Keytruda also known as <unk>.
In the treatment of advanced HPV 16 associated head and neck cancer.
This September we announced the successful recruitment of the initial cohort of checkpoint inhibitor naive patients.
First line treatment of recurrent or metastatic head and neck cancer.
We also announced the achievement of the trials preliminary safety benchmark demonstrating no dose limiting toxicities.
This positive safety data strengthens confidence in P. D. S. O 100 one's potential to address a significant unmet medical need in the treatment of advanced HPV 16 associated head and neck cancer as well as other HPV associated cancers.
We also completed stage one enrollment of the Simon two stage design for this cohort of the study.
Yeah.
In addition to this we initiated accrual into the checkpoint inhibitor refractory arm, which addresses second line treatment of recurrent or metastatic head and neck cancer.
Moving onto Pds or one O two.
<unk> Oh, one O two combined diverse new platform technology with our proprietary T cell receptor gamma alternate reading frame protein T. A R. P also known as TARP.
This is a tumor associated protein identified by the National Cancer Institute.
This week, we announced a licensing agreement with the National Cancer Institute, all intellectual property related to their proprietary top protein.
It is important to note that TARP has already been studied by the National Cancer Institute in men with prostate cancer.
And been shown to be safe and recognized by the immune system.
Administration of the National cancer Institutes TARP based immunotherapy was associated with a significant slowing of tumor growth rates in the published clinical trial.
Based on our preclinical results. We are excited about the potential of PD, one or two as the second molecularly targeted immunotherapy addressing tariff associated cancers, including prostate cancer breast cancer, and acute myeloid leukemia or AML.
We are now preparing to move into the clinic with our next two oncology products PD.
<unk>, which we just discussed and Pds or one O three which targets the Mach one protein present in multiple solid tumors.
We have requested a pre IND meeting with the FDA for Pds <unk> III.
Diverse immune technology is propelling our molecularly targeted immunotherapies into a broad range of cancers.
It is the potential adverse immune that allows for six different cancers with the same will look low profile to be studied in just one trial as is being done in the National Cancer Institute led P. D. S O one O one trial.
We believe our approach will lead to quicker and broader medical and commercial impact.
Now moving to our infectious disease pipeline.
Based on exciting preclinical data, we announced last week that Pds biotech has obtained the option to license the novel computationally optimized broadly reactive antigens or Cobra designed by renowned influenza experts Dr. Ted Ross of the universe.
City of Georgia.
Dr. Ros lease one of the N I Aig's collaborative influenza vaccine innovation centers civics based at U G E.
These novel proteins are being used in the development of Pds O to O two our universal flu vaccine candidates.
The flu has touched all of us in some way, resulting in hundreds of millions of illnesses and hundreds of thousands of deaths every year worldwide.
Yeah.
Reverse immune based universal flu vaccine could provide significantly enhanced protection and may eliminate the need to manufacture a new seasonal flu vaccine each year.
Compared to the current antibody focus flu vaccine P. S O to O two could present, a huge advancement in the development of the new generation of more broadly active antibody and T cell influenza vaccines.
Preclinical work on PD S O to O. Two is almost complete and the data has been very encouraging.
Lauren will walk through the top line data.
We are finalizing formulation work and are exploring funding opportunities to move the product into human clinical testing.
For our second generation COVID-19 vaccine P. D. S O to O. Three we have completed a strategic review of the pharma core program.
And have aligned on key manufacturing and regulatory milestones that must be met in the short term.
Pharma core has made some progress on the protein manufacturing and supply issues that have delayed their program.
Based on this progress in our program review, we plan to extend our contract with pharma call, which is scheduled to end on November 30th by six months through May 2022.
We will be closely monitoring their progress through this period.
As a result of last quarter's capital raise Pds biotech has a strong cash position with funding to support planned activities over the next two years.
Tedious biotech is very well positioned for the future.
We are preparing for the next phase of growth and continued progression of our exciting product pipeline.
We have several catalysts expected over the next three to 12 months as we advance our current studies and initiate new clinical trials.
Last month, we welcomed Matt Hill, our Chief Financial Officer.
Matt has decades of experience as a financial leader in publicly traded life science companies.
We are pleased to have Matt on board as we move into our next stage of growth.
Now I'd like to pass the call to Dr. Laurent <unk> Wood, Pds Biotechs, Chief Medical Officer, who will provide more comprehensive clinical updates on our development programs Lauren.
Thank you Frank and thanks to everyone for joining us this morning.
As Frank just highlighted we've continued to progress both our oncology and infectious disease pipeline since our second quarter call.
I'll begin with our ongoing oncology clinical trials and our lead candidate Pds wintered one.
Versatile 002 is the phase two study evaluating two groups of HPV 16 positive head.
And neck cancer patients, whose cancer has returned or spread.
The first group has not been previously treated with a checkpoint inhibitor.
Also known as checkpoint inhibitor naive patients.
The second group of patients have failed multiple treatments, including checkpoint inhibitor therapy and are considered checkpoint inhibitor refractory.
As Frank discussed during his remarks. This September we announced that the versatile <unk>. Two study had achieved its preliminary safety benchmark in its first 15 patients.
P D F O 101 treatment related adverse events generally appeared to be limited to transient manageable local injection site reaction.
Importantly, the combination also did not appear to exacerbate known keytruda related side effects.
The achievement of this important milestone anniversary titled 002 trial strengthens the evidence regarding the safety of P. D. S. O 101 in combination with other agents.
Less than two weeks later, we achieved completion of enrollment of stage one for the checkpoint inhibitor naive cohort in the versatile <unk> two study.
As specified in the clinical dessert trial design enrollment is now cars for the checkpoint inhibitor naive cohort until the earliest achievement of at least four or more objective responses. Among the first 17 patients in this stage.
According to standard resist one one imaging criteria. The achievement of an objective response requires tumor reduction of 30% or more and must be confirmed on repeat imaging.
Versatile zero zero to imaging. It's performed every nine weeks during the first year.
In the first stage of the trial at least for the first 17 patients in the checkpoint inhibitor naive on and at least two of the first 21 patients in the checkpoint inhibitor refractory arm.
<unk> achieved an objective response.
Achievement of these milestones for each cohort will trigger advancement to the second stage of the study for both arms and full enrollment of the planned 95 patients.
We anticipate the preliminary efficacy evaluation from the checkpoint inhibitor naive arm in Q1 of 2022.
Recruitment to the checkpoint inhibitor refractory cohort is ongoing ongoing with a planned efficacy evaluation of the first 21 patients expected in the second half of 2022.
It's been noted that our objective response language a reference to the versatile 002 study changed from objective response rate to best overall response in accordance with our revision to a Simon two stage design.
In this type of clinical trial design Best objective response is the industry standard and does not change or eliminate the use of objective response criteria herb resist one one in the study.
For reference generally only about one in five checkpoint inhibitor naive patients respond to initial treatment with checkpoint inhibitors.
With the Pds or 101, Keytruda combination we are seeking to improve objective responses to at least one in three patients.
The situation in Egypt.
Patients who have failed checkpoint inhibitors used.
Usually less than one in 10 checkpoint inhibitor refractory patients respond to treatment.
We're seeking to double that with the P. D. S O wildlife Keytruda combination so that one in five or more of these patients with very advanced refractory disease respond to treatment.
We were pleased to have achieved the safety benchmark with no evidence of new or unanticipated toxicity related to the combination.
Moving onto the NCI led phase II study evaluating Pdf's, Oh 101 in combination with two investigational immune modulating agents in advanced HPV cancers.
Highly encouraging interim data from this study was presented in early June at the <unk> annual meeting from twenty-five patients roughly.
Roughly half of the 56 patients planned to enroll in this trial.
Recruitment into the trial was paused at the end of October due to an administrative issue.
Namely the need to update the National Cancer Institute informed consent form for this study.
This issue is not specific to the P. D. S. O 101 combination trial and its unrelated to any safety or efficacy concerns with the specific triple combination being studied.
Only the recruitment of new patients to the trial was impacted patients.
Patients enrolled on the trial through the late October Pos has continued to receive treatment on schedule.
The updated informed consent form is now working its way through the MTI administrative approval process. Once it has been approved recruitment in this trial will resume.
The timing of clinical data, resulting from this trial is not expected to be affected by the recruitment. This budget, we still anticipate the completion of recruitment by the end of Q1 2022 and updated data from this study will be available in mid 2022.
Moving onto the third trial, the MD Anderson led immuno serve trial.
This trial is a phase two study evaluating P. D. S. O 101 in combination with standard of care chemo radiotherapy or see our T for the treatment of locally advanced cervical cancer.
One of the interesting aspects of this trial will be the collection of Immunogenicity as potential biomarker data, which may help further elucidate the immune response to P. D. F 101, and how early markers may translate to clinical response.
Preliminary results from immuno serve are still anticipated in mid 2022.
Moving now to Pds or one or two.
Our recent licensing agreement with the NCI for the TARP tumor antigen is the next step in progressing the development of our burst immune based oncology pipeline product P D F or wanted to.
Similar to PD, one PDL one two will include vers immune plus a mixture of TARP peptide antigens.
Preclinical studies performed by Pts biotech the administration of Pds, Oh, why don't you lead to effective induction of large numbers of killer T cells targeting TARP expressing tumors and preclinical development is near completion.
The license agreement allows P. D S biotech to freely execute on clinical regulatory and commercial development plans to address cancers expressing TARP.
Including prostate cancer breast cancer, and acute myeloid leukemia or AML.
We anticipate requesting a pre IND meeting with the food and drug administration by the end of the year.
Now moving on to <unk>, <unk>, three which combines the first new platform technology with novel highly immunogenic.
Mr peptides of the tumor antigen Mark one.
Agonist peptides are specifically designed and engineered to better stimulate and immune response.
Importantly, Mark one is highly expressed in multiple solid tumor types and has been shown to be associated with drug resistance and core disease prognosis.
Tds is developing P. D. S O one three for the treatment of breast colorectal lung ovarian and other cancers.
Similar to Pds <unk> two preclinical work for Pds <unk> three is near completion with final studies being conducted at the NCI as we continue to progress our pipeline products into human clinical trials.
We have already requested a pre IND meeting with the FDA to align on our clinical development plan for the Pds a one O three program.
High level synopsis of our proposed trial and different advanced solid tumors known to express my one wasn't included in the pre IND meeting request.
We anticipate a finalized study design and fully develop protocol and preparation for the meeting with the F. D. A.
We have also made great progress with our infectious disease pipeline.
As Frank noted P. D S O to O two combined diverse immune with novel Cobra flu antigens developed by pre eminent infectious disease expert Dr. Ken Ross at the University of Georgia.
These antigens are designed to stimulate broadly reactive flu specific antibody responses that can protect against both seasonal.
And pre pandemic influenza strains.
In combination.
Binding these unique images with bursting a T cell activating technology in P. D. S O to O. Two we have an opportunity to develop a universal flu vaccine that potentially induces.
Broadly reactive antibodies as well as T cells that target different flu strains.
Preclinical results generated by P. D S biotech and the University of Georgia completed over the summer were highly encouraging.
And documented a significant differentiating breath of immune responses to influenza as well as significant flu specific neutralizing antibody and T cell responses.
These flu responses parallel early results obtained with bursty, meaning plus Sars COVID-19, two antigens and a publication date.
Detailing both of these results is being prepared.
In addition, pdfs biotech announced earlier this month and agreement with U G E to license. These Cobra antigens for the use in a clinical trial.
An important step in continuing to advance our infectious disease pipeline.
We're now finalizing formulation work and are exploring funding opportunities to lose the universal flu vaccine product into human clinical testing I would like to expand on Franks earlier point and summarize the potential threat of indications being <unk>.
<unk> and current and upcoming trials by P. D S biotech.
Each vers immune based immuno therapeutic pipeline product is designed to attack on molecular target expressed in different types of cancer.
Oh, one O one targets HPV 16 present in cervical anal.
<unk> head and neck.
Over vaginal.
P&L cancer.
P S O one or two.
TARP.
And prostate and breast cancers, as well as acute myeloid leukemia or AML.
Finally P D S O one O three targets Mark one.
Present in non small cell lung breast colorectal ovarian and multiple other cancers.
As a consequence P. D S biotechs burst immune based platforms have development potential for the treatment of at least 12 or more advanced solid tumors.
Many of which are responsible for a substantial burden of death due to cancer.
Specifically in 2019 lung colorectal and pancreatic breast and prostate cancers accounted for 52% cancer death.
P. D. S. Biotech we will continue to embrace the challenge of these diseases as we seek to impact improved the lives of as many cancer patients as possible.
I would now like to turn the call over to our New Chief Financial Officer, Matt Hill to review, our third quarter 2021 financials Matt.
Matt.
Thank you Lauren and good morning, everyone.
I'm very excited to have recently joined Pds biotech well.
Typically it is only day 18 for me here as CFO I've known Frank and some of the board members for over five years.
I've been following the company and its success as a shareholder and a supportive of the technology.
Frankly has put together a top notch team.
Had great preliminary clinical data results and with upcoming milestones Tds biotech is re ready to take the next step in its evolution.
For me it's a.
Accessible company is one with a solid science and Frank and Greg Tom and the rest of the team.
He can be measured.
Methodical approach to the science and when I was able I jumped at the opportunity to join the company.
With my background.
And glad to have the chance to contribute to the team's success, leading the company's financial strategy in the next phase of growth.
Now, let's turn our discussion to review of our financial results.
For the third quarter of 2021, we reported a net loss of approximately $7 million or 24 cents per basic and diluted share as.
As compared to a net loss of approximately $3 $9 million or 21 cents per basic and diluted share.
For the three months ended September 32020.
Research and development expenses increased to $3 $7 million for the three months ended September 32021.
From $2 1 million for the three months ended September 32020 the.
The increase of $1 $6 million was primarily attributable to an increase.
A $7 million of personnel costs of which $5 million with stock compensation costs and.
$9 million and costs related to clinical studies.
General and administrative expenses increased to $3 2 million for the three months ended September 32021 from $1 8 million for the three months ended September 32020.
The increase of $1 $4 million is primarily attributable to an increase in the personnel cost of $1 $6 million of which $1.0 million was related to stock compensation costs.
In point $4 million.
With severance.
This was partially offset by a decrease in professional fees of <unk> $2 million.
<unk> cash and cash equivalents at September 32021 were approximately $69 $7 million with our current plans.
We have over two years of cash on hand, we will continue to manage our cash prudently to maximize the return and investments to advance both our oncology and infectious disease programs.
Creation of a share prices at the beginning of this year along with a significant increase in the average daily trading volume has greatly improved liquidity for existing and future shareholders.
Thank you for your time today I'd like to now turn the call back to Frank for final remarks.
Thank you Marty and Loren.
I would also like to thank our extremely diligent and innovative team here at P. D S biotech and all of our clinical partners for their continued dedication.
The expertise and creativity demonstrated by our teams and collaborators continues to enable execution of our highly ambitious preclinical and clinical development strategies.
I would also like to thank the patients who are the reason why we have dedicated our lives to this work.
Our continued positive results and pipeline advancements this year have driven significant shareholder value.
Year to date PDF biotech, it's among the highest performing stocks on Nasdaq.
We still have significant upcoming milestones, which if achieved we believe will continue this momentum.
The ground work has now been laid for the execution of multiple programs across the P. B S biotech pipeline into 2023.
We have secured the financial runway and partnerships to work towards the achievement of our value creating milestones.
In the short term, we expect to receive top line data for multiple Pds or 101 trials between the fourth quarter of this year and first half of next year.
We expect completion of recruitment of the National Cancer Institute led trial addressing.
And third line treatment of <unk>.
Angel cervical head and neck penile vaginal involve of cancers in the first quarter.
We also expect preliminary data from our broker towels zero-zero two trial by the first quarter of 2022.
Preliminary data from our MD Anderson that immunotherapy trial is expected during the second quarter of 2022.
Interim data from the PD is a one O one of Molecularly targeted immuno therapeutic approach demonstrated clinical efficacy in all the advanced HPV related cancers studied to date.
We continue to progress towards additional milestones.
We have multiplied shareholder value and demonstrated the potential of the company and technology to be in the forefront of immuno oncology advancement and we are impacting patients' lives.
We look forward to sharing with you our future accomplishments as milestones are achieved.
That concludes our prepared remarks.
Operator, please begin our question and answer session.
Thank you at this time, we'll be conducting a question and answer session.
Like to ask a question today. Please press star one on your telephone keypad and a confirmation tone will indicate your line is in the question queue.
You May press Star two if you would like to move your question from the queue.
Just consider using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
One moment, please while we poll for questions.
Thank you and our first question comes from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your questions.
MS. Chen Your line is open. Please proceed with your question, perhaps you're on mute.
Yeah.
Hi can you hear me.
Yes, because yes, okay. Thank you sorry about that so congratulations on all the progress this quarter had a few questions for you. So could you give any more color on the economics for your NCI TARP collaboration and what is the market opportunity here that you see circa.
Question I had for you is can you elaborate more on your universal flu vaccine or you took I know you talked about it on your call, but how does your technology broadly compare to others in development because there are a few projects I'm here on the Universal flu vaccine front and then can you provide any more color on P. D. S O one O three and your rationale.
Hi, This is mark one target. Thank you very much.
Thanks, a lot for those questions. So let's start with the NCI, so with it and with the NCI and the licensing of the top antigen.
And a lot of that has been specific T. Redacted by the National Cancer Institute, specifically, but this would be a typical typical licensing agreement with very reasonable economics.
And with regards to the market opportunity for the top program I think as Laura mentioned and this is present in three three very large market cancers actually two very large market, Kansas breast and prostate as well as AML. So with AML. For example, they are approximately 20000 cases annually in the United.
States.
And we talk a supported expressed in 100% of these patients tumors.
With prostate cancer in the United States alone, we have almost 175000 cases.
Yeah.
And the top protein is expressed in about 90% of these breast and prostate cancers at all stages of the disease and.
And with breast cancer again, we have more than 270000 cases annually in the United States alone and TARP as expressed in about 50% of these cancers. So when you look at these Kansas.
The market opportunity is significant.
Unmet need is extreme.
Extremely significant and so we see significant potential.
For the <unk> program right just based upon the need and the size of the markets.
And with with Pdfs or one or three.
Again, we're looking at the Mark one related cancers and the rationale for this.
Broach is mark want US you know how it's been studied.
And.
Cancer vaccines over the last decade or so.
The initial approaches to evaluating Mach one have not been successful.
Now with a P. D S O one O to O. One O. One O. Three program. There are two very significant differences between what has been done in the past and what's being done today.
With PD, one or three.
First of all the specific antigens. So what we are using are not the native mark one antigens, which were shown to be very weakly immunogenic.
Pdfs of one O. Three is based on novel <unk> agonist epitopes of the Mark one.
Each have been designed and patent Ted by the law Bulked up the Jeff Sloan I've been National Cancer Institute.
These novel Epitopes of Mach one have been shown to be dramatically more immunogenic than the native Mark one right. So that's what our PD one <unk> based on now secondly, what's different is diverse immune technology itself.
For the first time, what we've seen is the technology that actually activates the critical immunological pathways, that's unnecessary to induce a powerful antigen specific immune response by the effective presentation to the immune system presentation into the MHC class, one and class two pathways as well.
Upregulation of the type one interferons and so with these combined both diverse immune MBS novel highly immunogenic epitopes, what we've demonstrated is that in preclinical models, we can generate very powerful.
CD eight T cell responses similar to what we see with Pds for 101.
And we've also characterize these T cells to show that they are highly polyfunctional, which means that they are the phenotype of T cell, but it's much more highly potent and active and it's killing capability right.
And so this is really different and that's why we believe Pds <unk> III is all fixed really important and why are we so excited about the potential of <unk> hundred three and as you know the market. That's Loren mentioned these are very significant markets with huge unmet needs colorectal cancer non small cell lung.
Cancer breast cancer ovarian cancer, and a number of other solid tumors.
So Louise I hope this answered your questions.
It does thank you very much.
Thanks, a lot.
As a reminder to ask a question today you May press star one from your telephone keypad.
The next question comes from the line of Leland Gershon with Oppenheimer. Please proceed with your question.
Great. Good morning, Thank you and I'm glad to hear on the continued progress.
Frank a couple of questions for me first on the NCI trial with the with the pause it sounds like timelines are still intact, but just wanted to know if there's any further color you can provide on what may change.
You know as as that trial.
You know resumes.
Would it be a change in.
Simply consent forms would there be anything that might be more.
More involved and then also wanted to ask Matt.
Obviously, you've got a couple of years of cash, but just wanted to ask with respect to our modeling on an R&D expense, how we might want to.
Think about that.
For 2022, just given.
The various programs that you're deploying capital and two versus this past year. Thank you.
Okay. So Linda I'll answer the first question and then I'll hand over to Matt to address the cash runway over the next year or two.
So with the NCI program I think.
What Loren Express is the extent of our knowledge today. It if they have assured US asked me. He said that this is purely administrative.
It's an updating of the patient informed consent, we've been informed US last week that that had been completed and it's working its way through the administrative process at the National Cancer Institute. The patients currently on the trial are still receiving treatment on schedule nothing has changed.
And once once that updates to the informed consent is approved in there given the green light again nothing will change. It is just that informed consent document that will be provided to the patients that would have requested updates included in it.
So as of today, we do not expect any any.
Any delays to the tightened timeline that we proposed initially were still on schedule to complete recruitment during the first quarter of next year. So as of today everything is still on schedule and based on our discussions with the National Cancer Institute. They do not appear to have any concerns that bill encountering any delays.
Sure enough emphasis on administrative process.
That is working its way through through the various departments at the NCI and hopefully they will get started in there in the near term.
And so I will hand over to Matt.
Good morning, Leland. Thanks for your questions. Good question. When you were looking at and I'll walk you through it. So that you can back into R&D. So essentially we've got two years of cash on hand.
That means there's at least.
<unk> nine quarters of cash on hand.
You can assume that that's going to be the burn of cash will be weighted more in 2022.
We had about $3.3 million worth of administrative expenses.
<unk>.
In Q3, you can expect that too to.
Increased slightly and level off and then the difference in the cash burn will be will be R&D costs.
Terrific. Okay. That's very helpful. Thanks, so much for taking the question.
Youre welcome no problem.
Great day.
Thank you. Our next question is from the line of Emmanuel a French heavy with H C. Wainwright. Please proceed with your questions.
Good morning, everyone and thank you for taking my question, we'd like I still P. D. S. Oh, one or two I was hoping you could tell us more about your thoughts on the path forward.
You're thinking about prioritizing one indication that ops prostate cancer well there.
There are still or could you potentially baked in in the clinic with the back basket study and.
Related to this question, obviously, you have the NCI data in prostate cancer, but could you remind me for cleaning to leave money indications stands out as the most promising at the moment.
That's what I want to thank you very much for that question. That's a really good question and lots of consideration has been given to the specific question within Pds.
Based upon our approach to risk mitigation and potential for success based upon the fact that the National Cancer Institute has performed the clinical trial in prostate cancer specifically.
And shown this antigen antigen to be immunogenic in these patients and actually provide anticancer benefits to the patients very likely in this specific with a specific.
Program will very likely start with prostate cancer that has not been finalized yet but that is the direction in which we are heading is more likely to go to go buy just based upon the current data available to us and what the NCI has already demonstrated in these patients.
Got it got it thank you for that and so if this is the case would you be able to start to read a safe two since you I believe you already have phase one data from.
From the Sci.
Yes, we believe that in this case very likely based upon the fact that we already have data in humans with vers immune and the protein. The top antigen has already been in humans that we may have to do it we can do a combined phase <unk>, two where we demonstrated the first few patients at that safe and transition seamlessly.
Into the into.
Due to the phase II trial, but I'll hand over to Loren to confirm this for us.
Yeah right, yes, okay. Thank you Frank that's exactly our expectation that because of the prior human experience with TARP peptides, specifically in the prostate cancer setting that we would be able to do a combined phase one two study with very limited.
Immunogenicity and safety confirmation before proceeding into phase two aspect of studying the agent.
The other got it.
The other reason for going into prostate cancer is as Frank previously highlighted we know TARP is expressed and approximately 90% of prostate cancers. Since it's only expressed in 50% of breast cancers, we anticipate that the agency the FDA might require co.
Development of a companion diagnostic for a breast cancer indication again, another reason for us to target going into prostate cancer initially.
Yeah, Yeah that makes sense. Thank you very much.
Thank you.
Our next question is from the line of Florida, Fearon with Alliance Global Partners. Please proceed with your questions.
Hello. This is Laura staring at all in my presentation of Jim Malloy.
Congratulations on the progress you made this corner and regarding the HPV Triple Combo trial me. Please talk about a little bit more of the data that you need to see in this trial in order to apply for a specific or non location specific to maintain and regarding this charlie's wildly. Please talk about the number of patients.
You need to see or are anticipating in this trial by the next interim look in a scope for the upcoming year 2022, and my last question is just regarding your partnership so besides Merck do you have any plans to bring on any other partnerships to partner.
Your first and your platform.
Thanks, a lot so I'm quite a few topics here so with <unk>.
The initial data about the preliminary data was generated in two patient types. The first one with HPV sorry, this checkpoint inhibitor naive patient population.
And with these patients typically what youll see is approximately 15% to 20% response rates with the standard of care, which are the checkpoint inhibitor. So that is what we were comparing to in the statistical analysis will be done based upon those specific patients. So.
We needed to achieve.
Three out of the first eight positive responses as the benchmark for that.
Continuing the study.
And as you can as you know we have achieved five out of the first six.
The.
The frequency rate and the checkpoint inhibitor naive.
It's much much higher than has been generated before in any trial with a specific patient population.
On the next second arm of the trial is evaluating patients who are in addition to chemo and radiation also failed checkpoint inhibitor therapy.
As you May know with this patient population. These patients have extremely few options available to them and their response or efficacy rates in this patient population is.
We're between the range of 5% to 10% maximum Reits are very very few drugs have any effect on a very small percentage of these patients and we're seeing response rates around the 50% range with these patients and so what we want to do now is even though these patients are still being recruited and still being evaluated.
We will be having discussions with both the national Cancer Institute, and <unk> Serono, who own the two other agents, but I'd been evaluated in this triple combination.
And we would we would like to have a discussion with the FDA to find out from the FDA, what they would want to see in a pivotal trial design.
The data the data is so compelling that we believe that the earlier, we can have these discussions with the FDA the better and understanding from the FDA, what they would want to see because what we know the FDA is looking for new approaches and approaches to treating cancer or they're looking for novel combinations that can significantly move the needle.
That's exactly what we've demonstrated with this novel Triple combination VSAT three different agents each of which acts by a different anti tumor mechanism and we can see that if these numbers hold up or anywhere close to what we have generated today. This will be a significant advancement in the treatment of these patients right and so these are discussions that we.
We anticipating beginning to have with them with the FDA very soon.
And discussing what the pathway would be and how rapidly we can take this end to.
And to commercial development.
Okay.
Okay and in terms of the partnerships. So currently as you know with this triple combination even though the trial was led by the National Cancer Institute. The three agents are owned by Pdf's biotech and <unk> serono.
So we are also in communication with with the <unk> Sirona team.
And with the second trial the Brookdale Zero-zero two trial. This is a collaboration with with with Merck.
Mark.
The other trials, we still collaborating with the National Cancer Institute with the PD is a one O three and PD is a one or two and we anticipate that.
The second portion of our business strategy would then be the partnership and potential licensing opportunities for the platform, but we believe that what's what's really important to successfully execute on the second arm of our strategy is to clearly demonstrate proof of concept and to really demonstrate that we have been able to.
Conflict with a number of technologies have not been able to do in the past, which is the in vivo generation of these powerful tumor attacking T cells and so the additional data that's coming out of the NCI Triple combination trial as well as the data that we should be hopefully seen from diversified zero-zero two trial will be very.
Morten and really establishing the solid proof of concept and demonstration of diverse immune technologies potential.
Potential in treating these kinds of patients and we believe that will be important for the second piece that you were asking about which is partnering with with a broader range of pharmaceutical companies and also out licensing this technology to other companies, but you know.
In cancer, specifically over 50 antigens have been identified Pdfs will never have the resources to be able to develop every single one of those tumor antigens.
So we anticipate that we will we will work it stepped selectively and strategically with other potential cancer immunotherapy companies, who may want to utilize our technology and indications, which may not be off.
Pdf's might not have initially targeted and which in which we can work with those companies to address some of those indications.
Did that answer your questions.
Yes. Thank you so much.
Thanks, a lot.
Thank you at this time refresh at the end of the question and answer session. I will now turn the call over to Frank what do I do for closing remarks.
Thank you very much. So thank you very much to all of you for your continued interest in Pts biotech, we believe that 'twenty 'twenty. One we will continue to be an exciting year for the company.
We have multiple ongoing clinical trials of <unk> hundred one in various advanced HPV associated cancers, and we are preparing to advance additional products into the clinic.
We appreciate your ongoing support in this pursuit.
For more information about the company and our ongoing clinical trial. Please visit our website or Pds biotech dot com.
Thank you very much again.
Thank you. This will conclude today's conference you may disconnect. Your lines at this time. Thank you for your participation.
Thanks, a lot.