Q4 2021 PDS Biotechnology Corp Earnings Call
[music].
Hello, and welcome to the Pds Biotechnology fourth quarter 2021 earnings call and webcast. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. Please press star zero on your telephone keypad as a reminder, this conference is being.
Recorded it's now my pleasure to turn the conference over to Gabby Jacobina. Please go ahead.
Good morning, and welcome to the PDF Biotechnologies fourth quarter and full year 2021 earnings conference call and audio webcast.
With me today from the company are Doctor, Frank Betty Waddell, Chief Executive Officer, Dr. <unk>, He was chief Medical Officer.
Matt Hill, Chief Financial Officer.
Earlier this morning P. D S biotech issued a press release announcing financial results for the quarter and year ended December 31st 2021.
We encourage everyone to read the press release as well as T. D. S. Biotechs report on Form 10-K , which was filed with the SEC earlier this morning.
The company's press release is available on the Pdf's web site at Tds biotech Dot com and the 10-K should be posted later today.
In addition, this conference call is being webcast and will be archived on the company web site for future reference.
Before we begin we need to remind everyone that on today's call. The company will be making forward looking statements regarding regulatory and product candidate development plans as well as research activities.
These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.
Descriptions of these risks can be found in the T. D. S. Biotechs. Most recent filings with the SEC you are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date of this conference call.
Except to the extent required by applicable law or regulation P. D. S. C undertakes no obligation to update the forward looking statements included today to reflect subsequent events or circumstances.
With that I would now like to turn the call over to doctors shrink they do Aldo and Lauren what Frank.
Thank you Debbie and thanks to all of you for joining us this morning.
We have undergone a period of incredible productivity and progress here at P. D. S by technology, and I would like to share some highlights from the past year as well as our more recent progress.
The National Cancer Institute, NCI presented promising preliminary safety and efficacy data from.
From the first 18 subjects in the Triple combination trial of the American Society of clinical oncology Osco meeting in June of 2021 .
This preliminary data demonstrated the potential to provide clinical benefit and extension of life in the majority of patients with advanced HPV associated cancers, who have failed all treatment options.
The N C I achieved their target recruitment up 30 patients in the checkpoint inhibitor refractory arm this quarter.
In 45 patients in total have been enrolled to date.
In Q2, Q3, we hope to have additional efficacy updates while this trial presented at a leading peer reviewed clinical conference.
Yeah.
The P. D. S. Biotech led versatile 002 trial is evaluating P. D. S. O 101 in combination with merck's keytruda in recurrent or metastatic HPV positive head and neck cancer.
Safety data was presented at the multi disciplinary head and neck cancers Symposium in February .
And successful achievement of the preliminary efficacy milestone was also reported this February .
Based on the successful attainment of the preliminary efficacy milestone in checkpoint inhibitor naive subjects.
We similarly anticipate presenting more detailed if it gets the results at an upcoming.
Upcoming peer reviewed conference in the coming months.
For the MD Anderson led trial evaluating PD L 101 in combination with chemo radiotherapy in locally advanced cervical cancer, we still remain on track to provide data late in Q2 or early Q3.
This quarter, we announced the initiation of the new P. B S O. One O one trial to be led by Mayo clinic.
This trial is studying the use of P. D. S. A one O one with and without Keytruda as a potential new adjuvant treatment for oral cancer and open to recruitment of this month.
We hope to see preliminary data in Q4 of this year or Q1 next year.
Dr Wood will take us through the more detailed clinical updates.
The Mayo clinic was selected to replace the previously projected P. D. S O one O two trial.
This decision was strategic to capitalize on the commercial opportunity to expand the target market for Pds, a one O one too early stage disease.
With the reported rapid increases in the incidence of HPV associated oral cancer.
There was a growing number of early stage cancer patients, who may benefit from treatment with an immunotherapy such as P. D. S O y to one.
It is noteworthy that all of our clinical programs are partnered with distinguished leaders in oncology and immuno oncology, which we believe provides strong validation of our science and approach.
In addition, these relationships through cost sharing agreements have also significantly mitigated the financial burden of advancing our expanding clinical pipeline.
P D S O one O two N P. D S. A one O three have completed preclinical development.
Our three Immunotherapies currently in development P. D. S. A one O one P D S. A one O two.
And P. D. S O one O three presents a multibillion dollar opportunity.
P D S O one O one addresses an approximate five to 6 billion dollar U S market.
P. S O one O too aggressive cancers containing protein we called top T. A R. P include.
Including prostate cancer breast cancer and acute myeloid leukemia.
It is estimated that there are over 300000, new cases of these TARP associated Kansas in the United States every year.
We believe the majority of obese patients may benefit from PD S O one O to immunotherapy.
This is an approximately 45 billion dollar addressable market.
P D S O one O three addresses cancers containing a protein called Mach one and you see one.
These include include colon breast ovarian and lung cancers, and that's a very significant market opportunity.
We anticipate initiating clinical evaluation of P. S O one O three during the second half of this year.
I will briefly discuss our infectious disease pipeline.
These products are based on our infect immune platform, which is designed to induce broadly acting neutralizing antibodies. In addition to T cells.
The most progressed of these programs are P. D. S O to O two which is a universal flu vaccine and tedious O to O three a second generation COVID-19 vaccine.
P D S O to O. One our tuberculosis vaccine was prioritized in 2020 in order to develop the COVID-19 vaccine.
P D S O to O. Two combines infect immune with novel computationally design proteins that were developed by Dr. Ted Ross a world renowned flu experts.
This program is funded by the National institutes of allergy and infectious diseases and I E I D.
With P. D S O to O. Two our goal is to develop a vaccine that unlike the current flu vaccines may provide robust protection against multiple strains of the flu.
Impressive data demonstrating the potential of our effect immune technology to induce high levels of broadly protective neutralizing antibodies was presented.
This led to effective protection against infection and thickness Doctor would will provide additional details on the study and results.
P D S O to O three our second generation COVID-19 vaccine is being developed under license from P. D. S biotech right the Brazilian company Pharmacology for Latin America.
We expect that our strong neutralizing antibody and C. D. H T cell activating vaccine may produce more durable or longer protection against multiple strains of the virus.
Pharma core is fully responsible for product development and is currently performing manufacturing development and scale up.
Clinical development is to be funded by the government in Brazil.
We will provide updates as they become available.
As part of our goal of successfully commercializing our pipeline products. We also completed a number of licensing transaction and continued to build partnerships not only securing intellectual property for our expanded pipeline.
But also enhancing our relationships with global organizations.
We announced the licensing of the top proteins expressed in prostate cancer breast cancer and acute myeloid leukemia from the National Cancer Institute in Q4 of 2021.
In addition, we announced an agreement to license the computationally optimized broadly reactive antigens also called Cobra used in our universal influenza vaccine tedious O to O two.
The University of Georgia.
And lastly, as you can see here, we strengthened our corporate leadership, adding distinguished immuno oncology experts to our scientific Advisory Board and welcoming Matt Hill, our Chief Financial Officer.
We also reported that the company was added to the Russell Microcap index in late 2021.
And importantly, we added more than $52 million to our balance sheet significantly extending our cash runway and ability to continue to advance our drug development programs.
As most of you already know our oncology and infectious disease pipelines based on two proprietary platforms.
Verse immune and infect immune respectively.
With our first immune platform, we are developing a new class of Molecularly targeted immunotherapies, which have demonstrated excellent potential to induce in vivo all within our bodies tumor attacking killer T cells also known as CD eight T cells.
Our ability to achieve this we believe presents strong potential to overcome one of the biggest limitations of immuno oncology.
The ability to induce T cells in vivo is neither novel no unique.
What is how roper unique about burst immune is this ability to first of all induce the right type of killer T cells.
So it can lead to promote powerful killing potency of the killer T cells and thirdly to generate large numbers of these induce potent killer T.
The right quantity and the right potency.
Verse immune also induces memory T cell responses, which are important in generating prolonged clinical efficacy.
Verse means method of T cell activation has presented early indications of potential for a combination of potency and safety.
With that introduction I will now hand over to Dr. Along with P. D. S Biotechs, Chief Medical officer to provide additional details on our ongoing clinical studies Lauren.
Thanks, Frank and thanks to all for joining us today.
Our most progressed clinical program is the National Cancer Institute sponsored Phase two trial studying P. D. S O. One O. One in combination with both better assist alpha or Ventura for short and N. 90, 241 also known as N H S. IL 12.
Two investigational immune modulating candidates owned by Merck K G. A a.
That is investigating the combination in patients with recurrent or metastatic HPV positive cancers, including AML cervical head and neck, Pino vaginal involved where cancers, who have failed prior treatment.
One cohort is evaluating patients who have not been treated with checkpoint inhibitors and have not responded to at least one standard of care therapy. These are CPI naive patients.
Almost all patients in this cohort have failed both chemotherapy and radiation treatments and it would be moving on to checkpoint inhibitor therapy as a potential treatment option.
The second cohort is evaluating the triple combination as a third line treatment in patients with recurrent or metastatic HPV positive cancers, who have failed checkpoint inhibitor therapy. These are the C. P I refractory patients today.
To date the study has recruited 45 patients.
As of December 31st 2021, 30 patients who were HPV 16 positive had at least one evaluation.
There's currently about a three to one ratio of CPI refractory patients to CPI naive patients enrolled in the trial. This means that we have a significantly larger number of patients who have failed all other treatment options being studied.
As reported at <unk> in 2021 by the NCI CPI naive patients historically have a median survival of.
Seven to 11 months on CPI monotherapy.
C P I refractory patients who have failed all three treatment approaches how about historical median survival of only three to four months.
As of December 31st 2021.
The median overall survival of these patients on the study exceeds 12 months and counting.
These results are extremely promising, especially given the limited treatment options for the majority of this population and presents a severe unmet medical need.
On treatment with the triple combination almost 70% of patients, including those who are CPI naive and CPI refractory experienced tumor shrinkage.
Preliminary results May suggest that these refractory cancer patients may not only be living longer but the majority also appear to be experiencing tumor shrinkage.
In this study an important observation was made with the patients whose tumors were not positive for HPV 16.
The HPV 16, <unk> negative patients.
Those these patients appear to have a potential survival benefit no tumor shrinkage was observed in this population because they do not express the HPV 16 protein target for P. D. S O one O one.
The contracting tumor shrinkage seen in HPV 16 positive patients is an important result, because it's strongly suggests that P. D. S. O. One O. One is effectively training killer T cells to specifically recognize and kill tumors in patients that express H P V 16 proteins.
The clinical results obtained in anal cervical head and neck vaginal and Volvo cancers suggests that the preliminary efficacy. That's been observed is independent of the type of cancer, where it's anatomic location. So long as the cancer meets the target molecular profile of HPV 16.
Ration.
We are hopeful that pending the updated results of the study the P. D. S N C I and Merck K G. A a well initiate discussions with the FDA on the expected clinical and regulatory strategy for our pivotal phase III trial and eventual regulatory approval pathway for.
It's a combination.
The versatile zero-zero Tuesdays to clinical trial studying P. D. S O. One O one in combination with U S Merck's checkpoint inhibitor keytruda.
Also known as Pampa lose a map and patients with HPV 16 positive recurrent and metastatic head and neck cancer and two study groups include checkpoint naive patients in checkpoint refractory patients. This past year, we successfully achieved the first safety benchmark and the checkpoint inhibitor.
<unk> naive arm of the trial, which allowed the study to advance to full enrollment we have since announced updated safety data from 18 patients in the CPI naive group. These data were presented at the multidisciplinary head and neck cancers Symposium in February and demonstrated that the combination treatment was well tolerated.
Rated without evidence of enhanced or significant toxicity accrual has progressed to stage two for the CPI naive cohort and is ongoing in stage one for the CPI refractory cohort.
More recently, we released preliminary efficacy data from this same group of 18 CPI naive patients.
Simon two stage clinical trial design requires the achievement of an objective response as measured by radiographic tumor responses. According to resist one one.
Its response requires a tumor reduction of 30% or more that is confirmed by two separate measurements among at least four or more of the first 17 patients in the CPI naive arm.
Treatment of this milestone allowed for progression to full enrollment of the CPI naive cohort with a targeted total of 54 patients. We expect that more mature results will be presented at a medical conference later this year.
In parallel we are enrolling into the CPI refractory cohort of the trial.
This cohort is similarly being evaluated using a Simon two stage design in this cohort we have to achieve an objective response in two out of the first 21 patients to proceed to full enrollment of the cohort with a targeted total of 41 patients.
Our third P. D S. A one on one trial is the immuno surf trial.
A phase two investigator initiated trial sponsored by MD Anderson to evaluate P. D. S. O 101 in combination with chemo radiotherapy in patients with locally advanced cervical cancer.
As we briefly discussed on our last call one of the more interesting aspects of this trial is that will be collecting both systemic and tumor specific biomarker data.
They help further elucidate understanding the immune response to the burst immune based immunotherapies and how early Biomarkers may correlate with clinical response preliminary results from immuno serve are still anticipated in mid 2022 .
And this trial is successful it could support further investigation of diverse immune based immunotherapies with chemotherapy or chemo radiotherapy to treat multiple cancers.
For phase two trial of P. D. S O. One O. One is being led by the Mayo Clinic. This trial is evaluating Pdf's Oh, one O one alone or P. D. S O. One O one with Keytruda and the neo adjuvant treatment of patients with oral pharyngeal cancer prior to trans oral robotic surgery.
We believe this study will provide invaluable data regarding potential expansion of the verse immune based immunotherapies into early stage cancer.
This trial is now open to enrolling patients.
Lastly, before passing it over to Matt I'd like to briefly focus on our in fact immune based infectious disease preclinical pipeline.
Our universal flu vaccine program P. D. S O to O. Two is being developed in partnership with the NIH Division of Yeah NIH.
This vaccine is being designed to protect against multiple strains of the flu and combined are infecting your technology with novel computationally optimize broadly reactive antigens known as Cobra.
Been designed by renowned influenza expert at the University of Georgia Doctor Ted Ross.
The antigens were selected following successful preclinical development work completed under a grant from the N I Aig's collaborative influenza vaccine innovation centers or civics program to progress the development of P. D. S O to O two.
Preclinical studies demonstrated the ability of P. D S O to O two to generate high levels of flu specific neutralizing antibodies.
D for helper and CD eight killer T cells as well as long acting memory T cells to potentially provide broad and long term protection against multiple influenza strains.
What has been demonstrated in preclinical studies.
Without in fact, you mean, there is ineffective neutralization of any viral strain.
Preclinical data suggests that with infecting the effective delivery of flu proteins activate the critical immune signals necessary to generate powerful neutralizing antibody responses to all of the flu strains that were tested this is a very important and highly encourage.
<unk> result.
It was also important to study the ability of P. D. S O to O two to protect from influenza infection and.
Standardized influenza challenge studies, a control group, where administered a vaccine that had no flu protein when they were challenged with the H one N. One flu strain. They all died.
The second group of mice received a dose of the novel flu proteins, but without infecting.
All animals got sick and only 30% survived.
However, in the mice vaccinated with P. D S O to O two 100% of the animals were completely protected and stayed healthy.
This was the case, even using a low dose of P. D. S O to O two which contains.
One five fold less flu protein.
These studies strongly suggest that a universal flu vaccine is possible P.
P D S biotech hooks to progress the P. D S O to O two vaccine into clinical development in collaboration with the Civics program network.
Data from these preclinical studies are being prepared for submission to a peer reviewed journal for publication.
With that I'll now turn it over to Matt forgive you of our financial results Matt.
Matt.
Thank you Lauren first I want to thank our shareholders for your patience with the rescheduling of our earnings call. Our auditors needed more time to complete their procedures and in order to give them that time it makes sense to reschedule this call today.
With that let's move to the financial discussion.
For the year ended December 31, 2021, the net loss was approximately $16 $9 million or 66 cents per basic and diluted share compared to a net loss of approximately $14 8 million or.
We're 89 cents per basic and diluted share for the year ended December 31 2020.
As of December 31, 2021 Pts biotech had $28 4 million common shares outstanding and 31.8 million common shares outstanding on a fully diluted basis.
For the year ended December 31, 2021 research and development expenses increased to approximately $11 $3 million compared to approximately $7 $9 million for the year ended December 31 2020.
The increase of $3.4 million was primarily attributable to an increase in regulatory and clinical costs of $2 $6 million.
Noncash stock based compensation of $1 $1 million personnel cost a point $4 million.
Partially offset by an overall decrease in manufacturing and facility costs are point $7 million.
For the year ended December 31, 2021 general and administrative expenses increased to approximately $10 $2 million.
Compared to approximately $7 million for the year ended December 31 2020.
The $3 2 million dollar increase was primarily attributable to an increase in personnel costs of $1 million.
Noncash stock based compensation of $2 $5 million.
And facility costs of $1 million, partially offset by a decrease in professional fees a point $4 million.
Total operating expenses for the year ended December 31, 2021, or approximately $21.4 million, an increase of approximately 44% compared to a total operating expenses of approximately $14 $9 million for the year ended December 31 2020.
The Companys cash balance as of December 31, 2021 was $65 $2 million.
Based on the company's available cash resources and cash flow projections. The company believes this balance is sufficient to fund the company operations and research and development program through the end of 2023.
Is that.
Why don't we open it up to questions operator.
Thank you well now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if he'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset.
Before pressing star one one moment. Please what would you poll for questions. Our first question today is coming from Louise Chen from Cantor Fitzgerald. Your line is now live.
Hi, congratulations on all the progress over the quarter and thanks for taking my questions here.
First question for you is if you could provide more color on the new adjuvant opportunity for P. D. S. O. One O. One is this part of that five to 6 billion that you mentioned earlier in the call or is this on top of that.
And then second question I had for you was on your flu platform impressive data, but I'm curious why you have confidence that you can move forward with your platform here, while others are many others have actually failed and then last question I had for you was if you could provide an update on your Mark one and TARP program. Thank you.
So Louise Thank you very much for that question. So all of those questions rather so let's start with the Mayo programs. So if you'll notice from with our PD is a one O. One programs P. S. O. One O. One is really designed to be a real demonstration program for the company and you'll notice that we have thought.
With the very late stage cancer patients, who have failed all treatment options and both with the checkpoint inhibitor refractory patients. We also doing trials in patients who have failed other options, but most of your checkpoint inhibitors. The checkpoint inhibitor naive population and then with the cervical cancer trial led by M. D. Anderson, We then looking at pre metastatic cancer.
So locally advanced and the Maia trial gets us even earlier so the strategy here is to cover the entire breadth of indications and also when you look at the NCI trial, we are not only looking at the specific type of cancer. We're looking at all types of HPV associated cancers and the early data has suggested.
That the biomarker pro to the Molecularly targeted approach is potentially viable for this program. So really the strategy here with P. D. S. O. One O one is to provide or attain as much coverage in this five to 6 billion dollar U S market.
Commercially feasible right to demonstrate potential superiority of to demonstrate superiority period. If we can achieve that across the board and for this range of broad range of HPV associated cancers, and all be incorporated within that $5 billion to $6 billion market right and so that's really the <unk>.
<unk> he has seen very promising data with the late stage late stage cancer programs.
It put patient safety and therefore, now coming earlier and earlier in the in the Kansas State.
So it's moving moving on from there to the infection.
In fact, a new program and our universal flu, so with universal flu.
The approach that has typically been taken has been to include.
Probably one two or three or three or four different strains of the flu virus into that formulation of the vaccine itself right in order to generate immune responses against those specific strengths of the virus that's incorporated in the vaccine.
Typically the focus hasn't been antibody responses. However, the approach that we're taking a slightly different.
So what's Dr. Ted Ross of University of Georgia has done is he has come up with a very different approach, which is not taking the specific viruses, but actually utilizing a computer designed approach what he calls the computational design proteins, where he has looked at strength of these viruses over the last couple of days.
It's really designed these programs to incorporate immunogenic regions from the strength over the last couple of decades right and so with this novel approach. We are we are hopeful that we can induce broadly reactive immune responses and very importantly, with our approach we are not only dealing.
With antibody responses, we also dealing with T cell responses and we have confirmed so our early preclinical studies are the preclinical studies that we just completed.
Completed demonstrate that if you take those broadly reactive proteins. The computation of design proteins, you can generate neutralizing antibody responses against a broad range of screens. However.
The neutralization levels don't reach what we would typically want to see in an effective vaccine for flu vaccine. However, when we take those same proteins and combined them with.
Ah reflecting platform at that point, you get highly effective presentation into the REIT parkways and activation of the right signals immunological signals to generally really powerful neutralizing responses and we see the protection too in the preclinical studies and so this is really the unique approach we've taken where we are not saying that.
Going to incorporate specific screens, but computationally designed protein, which should cover a number of immune immunogenic regions from multiple screens up these viruses over the last couple of decades. We believe provides a different approach, but strongly and potentially high effective based upon the results we've seen.
And we are hopeful that we will be able to take these into human clinical trials and really demonstrate.
Not only strong neutralizing antibodies, but we believe the long term protection also depends quite a bit on being able to induce the right kinds of T cell responses by the memory T cell responses, which could also help provide the durability of that immune response and provide the long protection right. So that's how what we are doing.
The person that's why we have a high confidence.
<unk> been successful with us with this approach.
And then moving onto P. S O one or two MPD is a one to three with PD one PD <unk> three we actually in manufacturing clinical manufacturing now in Pts or one or two is also in the manufacturing process.
We have limited resources and what we're doing here, what we decided to do was to capitalize on the opportunity with P. D. S. A one to one two.
To go into the earlier stage disease cancer disease, with the Mayo clinic and so based upon that what we said was let's replace PD, one or two with PD is a one to one for this year right and then progressed P. D. S O. One O three into the clinic hopefully by the end of this year and then the goal is hopefully to follow that up with PDL, one or two which is actually also going through.
The manufacturing process, but both of those programs have completed preclinical studies, we have demonstrated very similar types of CD eight T cell responses as we have demonstrated with pdfs of one to one and so with both programs. You're also very hopeful that we will be able to take a very similar approach looking at the small locally targeted approach.
As to immunotherapy with PD, one or two as Doron said prostate breast and AML and with PD <unk>. Three will also start the program looking at multiple types of cancer to really understand how that works across the board with those mock one positive cancers.
So Luis I Hope this answered your questions was there anything I left out.
No that was great. Thank you very much.
Youre welcome.
Thank you. Our next question is coming from even virtual from Oppenheimer. Your line is now live.
Hey, good morning, Frank and Laura and thank you very much for the comprehensive update a couple of questions for me.
First with respect to the recent rise in incidence of HPV driven cancers.
Clearly with HPV vaccines.
Those rates to go down and perhaps those are only.
You know active towards cervical HPV cancers, and not others, perhaps for Frank or lawn you could build on to that dynamic a bit more for us and then secondly.
But to kind of the cadence of trial data.
Reveals particularly with regard to the NCI Triple combo trial.
Perhaps you can share with us kind of the process in which decisions are made as to when to release data and who's really in charge of making those decisions. Thank you.
Okay. So thanks, a lot for those questions, so I'm going to stop and Loren regarding the HPV market and the H P. B disease and you you can jump in with any additional comments once I go through the first set of answers, but Linda with the HPV associated disease, one of the key things is that.
That's okay.
Portland in terms of the presence of these preventive vaccines out there today and what impact they could potentially have on the markets.
No there hasn't been a lot of epidemiology work done in there there are a number of reasons that have been presented as to why some of these some of these incidences are still on a significant rise in increase for example, head and neck cancer.
And the reason for this.
The current vaccines.
Only preventive in nature.
Oh, they are only effective if those vaccines are administered before the patient is actually infected with the virus and as we know the HPV is the most prevalent sexually transmitted agent worldwide. Today. So it's very highly prevalent and visa vaccines octave only if they are given a head.
About infection, secondly, visa very slowly progressing cancers, right and so sometimes it's been reported that this could take even a couple of decades from the time of infection to the time of actually getting guessing the cancer.
So those are very important in terms of the incidences and so what has been projected is that based upon these critical factors.
There you have the current vaccines that wont be effective before infection and the very high rates of infection that very likely most of the patients we will be treating over the next 20 or so years have already been infected with the virus and people are still getting infected with this virus and so head and neck cancer. It's a really good example, where the incidences.
Head and neck cancer are rising significantly and so.
And so it's actually been described as a silent epidemic and the vast majority of these cases are HPV positive head and neck cancer cases, right. So there is still a very significant unmet medical need to address these very debilitating cancers, which in many cases head and neck for example, anal.
On a significant rise in incidents over the last couple of years.
The last several years rather.
Okay. So moving from there on to the timing of our data releases I mean, that's something that we have considered quite good base and very seriously and we strongly believe that it is in the best interest of the company and our shareholders for our early data to be critically peer reviewed by experts and presented at the meeting.
Apology conferences right into lease doesn't borrow requires that the study be done with a certain amount of scientific and clinical rigor.
This also allows us to reach a much broader and highly relevant audience. In addition to our shareholders and so this is what we've recently done for example, with the safety results from diverse the towels. There was there were two study on.
Fortunately for many such conferences, making the data public precludes us from being able to present the data at the conference. But this is a really good question I'll say imagine many shareholders and prospective investors based upon our early promising data are anxious to learn more and so we anticipate presenting the data at a conference.
In late Q2 or early Q3.
Right. Okay. That's very helpful. Thank you very much.
Youre welcome. Thank you. Our next question today is coming from Jim Molloy from Alliance Global Your line is now live.
Hey, guys. Thanks for taking my questions I had a question on <unk>.
Got it.
Looking at the <unk> the expected timing for the next two.
Combination of adventure next interim look there and I want assurance to the correct timing on versatile O two combo with Keytruda for the next interim interim look and then.
I think you had mentioned in the past or indicated in the past that.
Likely be partnering, particularly the triple combo phase threes and launches.
Can you talk a little bit about the partnering environment and you know given the data is looking good but it's still pretty early but how does it how does the environment look at this point.
Hi, Jim Thanks, a lot for your question. So in terms of the data presenting the data and we anticipate that this would be at a conference either late Q2 or early Q3 and in terms of the well the NCI trial Triple combination we're looking at two specific groups of.
The data right in terms of the data on the patients the patients whose data was presented at Astro last year, how have those patients spirit over that period over the year since I spoke to date and also how have the how what does the new patient data look like compared to those patients whose data was prepared and presented at opco.
So essentially what is the durability of the.
Immune responses and what they think is he is it holding up similar to what we saw.
Our school last year, and so that we are hopeful that we will be able to present that data probably late Q2.
And the same with the versatile is there was there were two we've provided a top line data in terms of meeting that critical milestone of how many patients for at least four or more to progress. This into full enrollment. We are hopeful that we should be able to at the conference again, either late Q2 early Q3 present more details on this.
In terms of the objective response rates overall survival rates progression free survival. In addition to the safety data that has already been presented us provide more in depth analysis of the data that has been generated to date.
And so the.
The way we look at this if the PD is for 101 studies hopefully Q2 Q3, if we're able to achieve these goals will provide a very solid proof of concept for the personnel versatile platform right and so that's really the key go up with PD, one and one that as I said, it's the demonstration program to provide us with that.
Solid proof of concept of being able to generate these antigen specific powerful killer T cells in vivo.
Now as you know.
A lot of these T cell activating approaches havent really been successful over the last decade since province for example, like we haven't had any FDA approvals and so we believe that in order for us to successfully execute the next phase of our business program is going to require the solid proof of concept, which we are hoping we will be able to achieve.
By Q2, Q3 that will allow us to then start having very serious poker room conversations with prospective investors and partners to expand our programs and to profit to go into the other.
Platform programs also but in terms of timing once that data becomes available Q2 Q3, what we intend to do is to then sit down that having these discussions with the FDA and with our partners in terms of what would be the most rapid approaches to getting these through the pivotal trials and to commercialization and strategically how can we do.
Most efficiently right, but we believe we believe that being able to achieve the goal that we set for Q2 Q3, which we are hopeful that we should be able to meet would then be critical in executing the second the second base, whether it's going into pivotal trials deciding how we do that also initiating discussions with potential.
Potential partners moving forward.
Yes.
Jim I hope I hope that answered your question.
You did indeed did you. Thank you and maybe a quick follow up on the Covid program I know that Oh Covid has been waning in the U S, particularly throughout the world. There's two variants out there and then I guess I think you are.
And I have spoken there's no hard and fast rule. The next variance must be less deadly this happened to have been the last couple of times.
How do you see you have you have you seen the wind of interest.
In the Covid program.
Or what are your thoughts on you know the fact that this is a U S. Maybe you're doing with Covid. The Covid are certainly not done with the U S.
Yeah, So I mean, that's.
That's a tough one but I I think I mean, the way things are progressing with Covid, if you listen to the experts most of the experts believe that this is probably going to be with us for the long term and that we are probably going to have to be getting.
Vaccinations on it on a regular basis and I think the way we're looking at this is.
What are the opportunities today in the COVID-19 space and very likely we think it's a couple of things.
Safety robustness and durability of the immune response, meaning can we kind of vaccine developed that develop that provides long term protection. So quite nice a year right can we often use the kinds of immune responses that provide robust protection against multiple strains of COVID-19.
And based upon what the experts are projecting temps up how long COVID-19 is going to be here, we believe that if.
If vaccine can be developed that meet these characteristics right.
Long term protection.
A year or so and also hum.
Broader protection in terms of protecting against multiple screens that there was very strong potential for that vaccine to be commercially successful vaccine.
Right and to be able to do that we believe that T. Cell response. In addition to strong neutralizing antibodies provides the potential to do this successfully.
So based upon that and also based upon the fact that we are really not committing any of our resources to doing that and that's really being done by our partner in Brazil, who appear to be making some good progress right. So we've been in touch with them as we mentioned, we're going to revisit that program by the end of May we gave them extension through end of May and so we will be reversed.
Revisiting that looking at their progress and making a decision.
At that point, but they are making progress and we do believe that there is still a commercial opportunity for a vaccine that can be differentiated in terms of safety durability and breadth of response.
Great. Thank you for taking the questions.
Youre welcome thank.
Thank you. Our next question is coming from Joe Pan Janus from H C. Wainwright. Your line is now live.
Hi, good morning, everybody.
I wanted to focus my question more on the macro components of flu right now, but obviously with a focus on O to O two obvious.
As well so.
Do you feel that there can be an increased focus now or you know coming off a season, where the current flu vaccine really the data show that the efficacy was much lower because the predictions were there because flu hadn't been around do you feel that that can create.
Increased focus and the desire for universal flu vaccine.
Even though you know these approaches have been around for quite some time.
Well, Joe if you make a very good point that beef beef approaches have been around for quite some time right. So I think for at least a decade. There has been a lot of interest in developing a universal flu vaccine I think with what's happened with <unk>.
COVID-19.
And the rapid mutations I think he has brought into focus a little bit more the potential for pandemic flu for example.
Now whether there is going to be more interest dedicated to this by some of those agencies. The governmental agencies are not that that's really difficult to say.
But I think based upon what we've seen for example, our program as we mentioned is funded by the NIH I D. We are hopeful that we will be able to get the funding to take it into human clinical trials hopefully by the end of the year or early next year.
And I think it will be important there to be able to translate the preclinical data into human data and I think that will be very very important in being able to demonstrate the potential potential to do this but there there has been a lot of interest just based upon the very low reported efficacy of the flu vaccine from season to season to be able to have.
Something that's a little bit more effective and durable and I'll ask Lauren to add if there's anything loren wants to add to this.
Thanks, Frank and thanks, Joe for that question I think everyone is aware of the fact that.
Depending on which respiratory viruses maybe predominating.
Certain seasons, you then see impacts on other viral infections. So during the last two years, we've had a predominance and a focus on Sars Covid, two and we saw lower incidences of flu and RSV again as Sars Covid two now starts.
To recede, we're starting to see flu as well as RSV cases come up.
Ultimately people are believing that hopefully Sars COVID-19 two may become an endemic virus, which is going to still have the need because of its muted a little bit.
Eddie do you have an effective vaccination that addresses that we now have flu that is highly mutating and seasonal as well as potentially ongoing different ways of Sars cov, two and because of that I think youre actually seeing in the sector and the fact that.
Individuals' are still trying to address coming up with.
Vaccine approaches that would be broadly reactive universal vaccines, where not only flu, but also for COVID-19 .
And you're seeing attempts at developing dual agent vaccines that would protect against both flu as well as COVID-19 at the same time. So there is going to unquestionably be need there is unquestionably interest and again as Frank has highlighted during the call I think what's differentiating.
About the inspecting and base platform with the flu Cobra antigens from the University of Georgia that Ted Ross as it develops is we not only see neutralizing antibody responses, which is the end all be all historically of infectious disease vaccines, but we are also seeing the development of.
The T cell responses, which had the opportunity to provide long term memory and potentially greater duration of protection right. Now it's looking like everybody is going to need Covid boosters every six months.
So prolonging duration of protection, so that vaccines can be delivered once a year or longer as well as having broad protection across a range of viral strains and species its going to be very critical for both flu and for Covid.
That makes sense I appreciate that color. So maybe I'll just take it one more step because the way Frank put it.
Currently the hope is.
And in order to get it into the clinic or with getting it into the clinic.
Like to still have your collaboration with the NIH.
But maybe you could talk to your flexibility and Optionality that also brings Matt into the conversation since he is controlling your guys' checking accounts so.
With regard to maybe looking for external funding you know something like the gates foundation or anything along those lines or what you might want to or not want to throw behind it with company based funding.
No I think to date and I'll I'll, let mark must also join in but they will all options on the table in terms of partnering and looking at other non dilutive options, but at the moment, we're not we're not seeking to utilize any of our current cash.
In progressing that program at this point.
Martin do you want.
Yeah, Yeah absolutely.
Joe.
Great question and when we look at the size of the market is currently in it.
Oncology.
Five to 6 billion with in HPV related cancers.
$40 million over another $100 million when you get to Mark one the potential total available markets, we're focusing our dollars right now on on the oncology immuno oncology market.
We're seeking non dilutive financing to assist us with the infectious disease, which is why we went with form co. Originally and we're working with Dr. Ross on evaluating all aspects to help us get the universal flu vaccine into.
Into the clinic as quickly as possible.
Thank you guys.
Yeah.
Thank you as a reminder, that star one to be placed in the question queue. Our next question today is coming from Robert Leboyer from Noble capital. Your line is now live.
Yeah.
Good morning, My question has to do with the Universal flu vaccine and Dr. <unk> is a very nice description earlier in the call.
I was wondering if it's.
Appropriate to discuss the actual targets in the in the virus that the vaccine would be directed against as well as if you're seeing any any data that would predict the duration of this response, whether it's going to be one season multiple seasons or.
Italy many years.
Hi, Robert Thanks, a lot for the question I'll start and then I'll I'll hop Lauren to jump in but I think.
So the the way Dr. Ross has designed the east computation protein computational proteins. If he's looked at multiple strengths of the seasonal flu as well as multiple strains of the pandemic flu strains and so he has a number of proteins that are designed to either focus on the seasonal flu strains.
As well as the pandemic flu strains and so we have currently focused our initial studies on the seasonal flu strains, but we'll we'll very likely consider moving also to the pandemic flu strengths. Once we've demonstrated the transition of the results we have in preclinical to Q human clinical results.
In terms of the durability of those responses.
Very difficult to predict they have to actually be studied in humans and thats why we aren't just to be able to get into humans and begin to understand exactly what the durability of those responses could potentially be in in humans, but I think it is promising considering the fact that alone sets the induction of those T cell responses and memory T cells.
Our responses.
A really good indicator of the potential durability of that vaccine in the protective responses that could be generated but I think we will.
We will have to actually study it in in a human clinical trial, Lauren any any additional comments.
Yes, and the things that I would add is that regarding our in addition to the testing that ultimately needs to be done in humans. When you get to assessing the durability of the response and the breadth of the response against different flu strains I think what Frank its previously highlighted during our call is what we have.
Stratus preliminarily to date, so far by code delivering infective meetings with Doctor Ross's broadly reactive antigens that again are designed to induce immune responses across a broad range of strain.
Flu that had been detected over the years what appears to be differentiating is we not only see the neutralizing antibody responses that have historically been associated with all flu vaccines, but we're also seeing the induction of T cell specific responses both C.
D H and CD four T cell responses to these flu antigens and this ultimately may be what is differentiating about the Cobra antigens in terms of their broad reactivity, but their code delivery within factor again, the preclinical animal challenge studies certainly suggest that.
But again the definitive bar is going to be progression to testing in human clinical trials.
We also are in the process of submitting a publication detailing the.
Immune responses induced by intact immune co delivered with the flu and agenda and P. D. S O to O two as well as with Sars Covid two antigens.
And that we hope to have that in publication before at the end of the year, but that is being submitted for peer review.
Okay, great. Thank you very much and thanks for taking my question.
Youre welcome.
Thank you we reached end of our question and answer session I'd like to turn the floor back over to Frank for any further or closing comments.
Thank you very much.
Yeah.
So again, thank you very much for joining us today, our goal of Pds biotech is to be able to rapidly provide better therapeutic options to cancer patients and to fulfill a severe unmet medical need to offer effective treatments with extended survival to advanced cancer patients.
If successful we are optimistic this could provide renewed hope to patients and their families.
Look ahead to the rest of 2022 as we continue to advance our growing pipeline of promising oncology and infectious disease candidates. Thank you very much again and have a great rest of the day.
Thank you that does conclude today's teleconference and webcast you may disconnect. Your line at this time and have a wonderful day, we thank you for your participation today.
Thank you.