PDS Biotechnology Corporation

Q4 2022 Earnings Conference Call


spk_0: hello and welcome to the pts biotechnology fourth quarter twenty twenty two and four year earnings call conference call if anyone should require operator assistance please press sars euro and your telephone keypad a question answer session will follow the formal presentation as a reminder this province has been reported israel my pleasure to turn the pullover to gabby greener of city capitals us relations please go ahead
spk_1: the morning and welcome to pdf file technology fourth quarter and year and twenty twenty two earnings conference call and audio webcast on a call from the company or doctor saying that a lot of chief executive officer doctor of orange he was chief medical officer and that hell chief financial officer earlier this morning pdf file tech issued a press release announcing financial results for the quarter and sure your ended december thirty first twenty twenty two may hurt everyone to read that press release as well as pdf files tech support on form can chase after the fall with the fcc shortly the company's press release is a the album the pts let's say at pts file test dot com in addition with coffers have been webcast and will be archived on the company website for future reference before he became need some mind every one that on today's call the company will be making forward looking statements regarding regulatory and products candidate development plans as well as research activities certain information and the presentation include forward looking statements including within the meaning of section twenty one eat of the united states securities exchange act of nineteen thirty four as amended and section twenty seven eight of the united states security act of nineteen thirty three as amended concerning pts alcoholic he corporation and other matters he statements made a set goals intentions and execution as to choose your clients trend as then results of operations or financial condition or otherwise seats on families of the company's management as well as assumptions made by and information currently available to me
spk_2: management
spk_1: the statement are subject to arrest and uncertainties that may cause actual results to differ from those four classes and scripts and these read can be found in pdf files has most recent violence at the as he see you are clashing offices and you reliance on the for looking statements which speak only as of the date of this conference call set to the extent required by applicable law or regulation pts he undertakes no obligation to update the for looking statements included today turf like subsequent events or circumstances with that our him the columns over to doctor saints they do i know frank
spk_3: thank you gabby and thank you all for joining us on our year and call today we have made tremendous progress this past year achieving several significant milestone of we continue to advance our oncology pipeline most importantly progressing closer to was a registration or trial for our lead candidate pdf a one or one pdf or one or one is a novel investigational human papilloma virus or hpv targeted immunotherapy the stimulates a potent targeted t sell attack against hpv positive cancers
spk_1: our goal is to commercialize pts a one or one as rapidly as possible
spk_3: by performing a well designed faith three trials that maximizes our potential for both speed and success therefore i will key priority in twenty twenty three is to move forward efficiently with finalizing the development of pdf or one to one for the treatment of hpv positive head and neck cancer an immune checkpoint inhibitor oh i see i need patience before we move into the fourth quarter updates i would like to briefly mention the recent meetings we have had with the us food and drug administration also known as the f d a these meetings were held to discuss the registration pathways for our to most advanced face two trials
spk_4: versatile zero zero two
spk_3: and the national cancer institute lead or nc i lead a truffle combination trial in both meetings the ft a provided very useful guidance on key elements of both trial designs therefore we will be transitioning into faith three clinical development this year informed by the ongoing in maturing data from versatile zero zero two this randomized controlled faith three trial will investigate pts or wanna one in combination with cruder versus cut through the alone in i see i know you've patients with recurrent for metastatic hpv sixteen positive head and neck cancer the phase three trial will be called versatile zero zero three in parallel we will continue activities necessary to progress the m c i lead triple combination of pdf a wanna one pdf all three or one formerly known as and ninety two forty one for nhs i'll twelve with an approved immune checkpoint inhibitor or i see i
spk_0: let's not touch on the versatile zero zero two phase two trial update
spk_3: the trial is investigating pts a one a one in combination with merc's i see i could trudeau also known as and little from remove them up in both i see i naive and refractory patients interim results presented at go twenty twenty two demonstrated promised think if they could see and safety profiles for the combination data from seventeen patients with available imaging showed an objective response rate of forty one percent which included confirmed and unconfirmed responses at nine months of follow the overall survival rate was eighty seven percent in the publish keynote a zero for a study the nine month over overall survival rate for could food and mana therapy was approximately sixty percent we believe that the parameter of highest relevance to the sta if the overall survival
spk_1: as in many immunotherapy improvements in objective response rate for all our our and progression free survival or pf s have not translated to improve overall survival o s
spk_3: it should be noted that in were current or metastatic head and neck cancer
spk_1: where an f d a approved drugs has been shown
spk_3: to improve survival that's as good food a has
spk_1: overall survival becomes the most important criteria by which the new drug or combination of will be evacuated
spk_3: as a reminder this program has received fast track designation from the sta following our as the a meeting in the third quarter of twenty twenty two we initiated it tech transfer of the pts a one one manufacturing process to our selected commercial manufacturer for the scale up and production of pts or one oh one more versatile zero zero three the transfer was successful and the faith three clinical product was successfully completed this quarter the final sections of the chemistry manufacturing and control section also known as c m c of the amended i envy are in progress
spk_0: most importantly we are gaining insight into the potential progression free survival
spk_1: and overall survival data that continue to mature from versatile zero zero two
spk_3: these p s s an overall survival data are critical to our ability to design the statistical portion of the faith three clinical study the duration it has taken for us to begin to gain insight to be critical parameters and possible endpoints is highly encourage him as it signifies that the majority of patients are staying alive and not rapidly progressing as i mentioned overall survival is the most important parameter by which the the a typically prefers to confirm approval of oncology products we are hopeful based upon previously presented an ongoing resolve that we will be able to show improve pfs and o s with the pts a one or one intruder combination we are all for currently in communication with the european regulatory agencies and expect feedback on the versatile zero zero three clinical protocol and c m c section in the second quarter of the few
spk_5: if possible
spk_1: we intend to also incorporate their comments into the final protocol design that will be submitted to the ft a and other country specific agencies for with you
spk_3: we therefore expects to file an amended i envy in the third quarter of this year which should allow us to present the protocol to the investigation review was all hi our be for the various sites as we performed the process of fight activation overall the start activity typically take four to six months we are working towards the goal of opening up the trial in the fourth quarter of this year and expect the trial to be run of ninety to one hundred global size there are a number of reasons why we have decided to progress the versatile zero zero three trial ahead of the truffle combination
spk_4: first of all
spk_1: obtaining an approval for the pdf all one oh one product specifically
spk_3: simplified our development of future combinations of other agents that as pts or three along with pts oh one or one from a regulatory perspective i envy related activities are further progress with this program due to the earlier as the a meeting and also the key or regulatory pathway for combination of an investigational agent with on a commercial approved products importantly we have fast track for this program and with our clinical design haven't good potential for pdf a one wanna one to become the first approved immunotherapy to address hpv positive cancer
spk_1: in parallel we continue to aggressively work to with getting the triple combination to a similar position and will provide updates on progress in the future
spk_3: though transitioning to updates on the nc i lead face to triple combination trial for patients with advanced hpv positive cancers last month we announced a successful meeting with the sta for the triple combination of pdf a one a one and pts both three or one with an f d a approved i see i the treatment of recurrence for metastatic hpv sixteen positive i see i refractory head and neck cancer our ability to replace investigational i see i with the commercial i see i simplified the regulatory pathway to develop the triple combination our strategic decision to acquire the novel antibody conjugated i'll twelve now pdf all three or one have mitigated operational risk and potential hurdles in moving the program forward
spk_1: it has also on encumbered the agents from brought a youth in our pipeline
spk_3: importantly by replacing the investigational i see i with a commercial i see i in acquiring pdf oh three or one we also simplified and clarified the future economics pertaining to the current and for future commercial combinations of pts or three or one with our pipeline products
spk_6: for other products
spk_1: it is also important to note that the tedious or three or one acquisition deal does not financially burden development of the product
spk_3: as very minimal payments are you ahead of successful commercialization this agreement whole thing clues the supply of the clinical pdf oh three or one product by merck kg a dumpster germany this partnership as you can see therefore maximizes the potential for development and financial success for both parties we are extremely pleased with our partnership with mark kg a and with the updated survival outcome results we reported from the triple combination last quarter he the as biotech have selected advanced i see i refractory hpv sixteen positive head and neck cancer as the initial indications
spk_1: for which the triple combination of will be developed
spk_3: these patients have a few options and no clear effective standard of care therapy despite the severity of the disease the vital data from the trial has been encouraging and the triple combination therapy appears to be reasonably well tolerated with great three adverse events reported in forty three percent of patients and great for treatment related adverse events reported in only seven percent of patients in december we reported expanded national cancer institute interim data that included fifty patients of those thirty seven hpv sixteen profit patients were evaluable and twenty nine out of the thirty seven patients had failed i see i treatment and were therefore i see i refractory median overall survival was twenty one months in the twenty nine i see i was like for patients who received the triple combination of note the reported historical median overall survival in patients with hpv positive i see i refractory disease and treated with an icy i if only three to four months
spk_1: as we announced on february twenty seven after our ft a meeting
spk_3: i trial of the triple combination will initially target i see i refractory hpv sixteen positive head and neck cancer the best published median overall survival data to date in i see i refractory head and neck cancer it's eight point two months they expand the data continue to demonstrate did your ability and tolerability of the pdf oh my no one faith couple combination therapy in advanced hpv positive cancers and it is exciting to see consistency in the data with each update moving onto the md anderson lead immunotherapy phase two trial the study is being performed in patients with locally advanced cervical cancer with large tumors over five centimeters inside remarkable clinical and biomarker data were prevented act as i t c twenty twenty two one hundred percent of patients treated with the combination of pts a one a one and standard of care chemo radiation therapy had a clinical with bonds with too much shrinkage greater than sixty percent eighty nine percent for eight of the nine patients treated with the combination demonstrated a complete response or see our with no evidence of the disease on day one seventy
spk_1: these results are encouraging and we look forward to updating you when additional data becomes available
spk_3: the mayo clinic continue studying pts or one a one in early stage three metastatic hpv sixteen positive oral cancer in a phase two trial patients continue to be recruited and treated
spk_1: and we are hopeful that will see data before the end of this year
spk_3: as we've mentioned before the mayo clinic steady it's an investigator initiate a trial meeting we do not have control over it's progress enrollment and treatment for the tiny around data redoubts
spk_7: however
spk_3: our expectation is that steady investigators would present preliminary data when available at them medical congress moving onto our broader oncology pipeline
spk_1: that trump fair for pdf oh one oh three is in progress
spk_3: pending availability of manufacturing flops and all the activities associated with initiating versatile zero zero three we are hoping to file the i envy in the second half of this year we expect to fall but i n the for pdf a one o two in twenty twenty four before i turn the call over to lauren i will reiterate that we plan to initiate the versatile zero zero three phase three trial by the fourth quarter of the fear we continue to make significant progress with the program clinical manufacturing is complete late stage c and c activities are ongoing as well as finalization of the clinical protocol and we expect to file the amended i the in the third quarter i will now turned a call to learn to walk through the clinical updates
spk_8: thanks frank i'd like to recap some of the site eating as he announced in the last several months what respected pts out real one mana therapy clinical research conducted by dnc i was recently published peer reviewed journal international enough pharmacology the study as a new changes in relation to the dose level and guilty schedule a pts altria one the study
spk_1: also dilated the with of several treatment related logic changes with clinical responses researchers are dilated a success or twenty three patients with advanced sensors who participated in a phase one clinical trial or pts out three or one patients receiving the higher dose of tds altria one generated more robust and responses importantly stronger immune responses were seen as a higher dose level
spk_9: data highlight the logical activity at cbs ontario one which supports the new data seen today in the nc i triple combination daddy
spk_8: the ability to increase i'll twelve presence within the tumors and to limit it's exposure in the circulating blood constitutes a significant advancements in the development of cytokine based in therapy
spk_1: the research published by the want the i demonstrates the potential a pts oh trio one as a to my targeting i'll twelve and it's ability to simulate a activation an increase the frequency of a new sponsors that potentially overcome the immunosuppressive tumor microenvironment
spk_8: published study the biologically active does is a pdf out real one mana therapy for associated with greater than or equal to great three treatment related adverse events in twenty two sanitation and all of these were transients
spk_1: one great for treatment related adverse events with earth
spk_9: and no great five treatment related adverse events occurred
spk_1: it was published by strauss and college and twenty nine p and clinical cancer research importantly these biologically active doses are associated with increases in specific immune cells and improved clinical outcomes
spk_9: now moving on to our preclinical program
spk_1: recently data on both pts are one or two and pts or one or three were presented at it twenty twenty two american association for cancer research also known as a cr national conference on tumor immunology and a therapy the poster presentation highlighted the development of first taste drug formulations containing monkey apatow captain high urgent sequences of the tumor associated protein tart which is also known as piece always receptor damaging alternate reading frame protein as well as modified sequences of the nice in one uncle proteins or much one the pre clinical research presented provided the foundation for the clinical development of pts a one or two as a potential treatment so top associated a two mile away with cbs prostate and breast cancers and pts are one or three as a potential treatment for must one associated press one lung ovarian and other cancers defining to the pts a one or two were high levels of cd a killer cisa responses against multiple tart and a and predominates induction of multi functional potent killer t cells similar to what some seen an absurd with pts or one or one key findings for pts a one three were again somewhere to pts a one on one and pts or one or two
spk_9: the induction have high levels of see a killer to multi functional responses against multiple must one anuj and and had sex is targeting and chilling of must one positive targets in be trump
spk_1: we're pleased with the pre clinical research to gate for these compounds confirming their biologic activities the manufacture a p s o one to two engines is complete and the scale up and manufacturer pdf one or three clinical father is in progress there's been white discussion among immunologist an infectious disease experts were guarding the ability to develop more effective and more broadly as the vaccine against syria databases one key area of research and development of novel strategies to elicit city for cheap
spk_8: cells also known as she how for cells that can be much more broadly assesses in providing protection against infection
spk_1: and important advantage city for she sells is their ability to be less susceptible to viral mutation to important preclinical studies utilizing be infecting platform or published in february twenty twenty three in the peer reviewed journal viruses
spk_8: new research performed in a laboratory of pre eminence city for t soviets search your daughter andrea sand at the university of rochester center or vaccine biology immunology study kentucky and demonstrated the technologies potency in eliciting cd for cheap sell
spk_1: the study focused on comparing and setting induced scientists family primary vaccination against influenza with a new responses ages five leading commercial vaccine adjutant the study concluded that in saxony dramatically enhance city forty sell responses relative to to being approved vaccine technologies that we're evaluating study
spk_8: the second publication and viruses from doctors see that god had foodie and general woodward from the university of kentucky college of medicine demonstrated that was investigating protein bio agents to generate a abroad and could in respond to the viruses including multiple strains of influenza
spk_1: is that was tested in animal models of influenza he investigational universal flu vaccine pts of too old to demonstrated induction on t cells and neutralizing antibodies against multiple strain of influenza
spk_9: she tell responses were also generally against non mutated region
spk_10: of the flu virus
spk_8: importantly pts out you are two completely protected animals from legal challenges with influenza viruses
spk_1: these consistent preclinical results among the two studies are promising and we continue discussions with and i a ideas regarding clinical funding for universe universal flu vaccine we will keep you posted as we move discussion forward and summarize where we are today first with are voting and a psychology program you're highly encouraged by the consistency and the clinical responses survival data we see coming from the versatile zero zero two he has served and truffle combination trial
spk_8: the base to biomarkers study results were thwarted by both cnc i have any anderson
spk_9: and five ci see twenty twenty two demonstrated induction out the right type of potent tumor infiltrating multi functional killer t cells in the right quantities which quality with clinical responses in both cases
spk_1: with are in fact based in such as is each program we are similar only excited about the potential especially considering that she said he independently reported in the journal viruses last month
spk_8: both studies demonstrate unique potential of insect you mean not only to induce city a t cells
spk_1: to to induce multi functional fucking forty thousand a month was legally actors and potentially less susceptible to viral mutations lot also and you think broadly reactive neutralizing antibodies
spk_9: at this time i'd like to turn the call over the map to review of financial summary
spk_4: mattis
spk_3: thank you lord we had extraordinary year a pts biotech as we need the business for our financial strategy continue to seek to mitigate financial risk for supporting our overall commercial strategy
spk_1: our goal remains select the most promptly combinations as indications and rapidly progressed into a registration or trials we're excited to prepare or lead candidates idiots or want a one for registration or frau we currently estimates are phase three versatile zero zero three trial will cost approximately sixty million dollars which is part of our operational budget and project now let's take a look at our summary financials for the around it's december thirty one twenty twenty two net loss for the year ended december thirty one twenty twenty two was approximately forty point nine million dollars for one dollar
spk_11: and forty three cents per basic and diluted share the a net loss of approximately sixteen point nine million dollars or sixty six cents for basic into wheelchair for the year ended december thirty one twenty twenty one the higher net loss was primarily due to personal costs clinical research and quality manufacturing costs and the caught the license
spk_1: rps oh three or one assets research and development expenses for the early december thirty one twenty twenty to increase to approximately twenty nine point four million dollars compared to approximately eleven point three million dollars a year ended sept thirty one twenty twenty one
spk_11: the increase of eighteen point one million dollars was primarily a tribute to the increasing personal cost a two point three million dollars clinical costs and two point three million dollars manufacturing costs three point six million dollars and ten million dollars for the rights to p s o three old one for murky kg a dance def germany
spk_4: of the ten million dollars five million dollars was in cash and the balance and shares of our common stock general administrative expenses to the you're into seven december thirty one twenty two to increase to approximately twelve with two million dollars compared to approximately ten point two million dollars for the year ended december thirty one twenty twenty one the two million dollar increase was primary attributable to an increase in personal cost at one point three million dollars
spk_1: and professional fees
spk_4: a point seven million dollars total operating expenses for the and the some one twenty twenty two for approximately forty one point seven million dollars the parakeets elaborate fences approximately twenty one point four million dollars for year ended december thirty one twenty twenty one
spk_3: loss for basic and diluted share for your and it's december thirty one twenty twenty two was a dollar forty three had prepared to the lot of sixty six cents for president the with a chair for yards and the thirty one forty twenty one fifty increase loss for share can be primarily attributed
spk_1: he the investment in already and ten million dollars recorded in license tds oh three o one which is odd fenced in the fourth quarter the counselor approximately thirty five sense of loss for basically the literature
spk_3: we ended the you're probably seventy three point eight million dollars in cash which is attributed to our country private financial discipline and efficient execution of our hm
spk_0: based on the company's belt caf resources and cash flow projections the company believes this bounce is sufficient funny company operations research and belt and programs into the third quarter of a twenty twenty four it concludes my portion of the car and i'd like to turn the call over to the operator or question and answer session operator
spk_11: that you're not a conducting a question is recession if you like to be placed in the questions you please press star one under telephone keypad a confirmation tone when the cake or line is in the question to you may press start to feel like to move your question from the queue for participants using speaker equipment may be necessary to pick up her handset before pressing star one one moment please volleyball for questions her first questions raised me from leaving yourself not and hammer your line of allah
spk_8: as the morning or thanks for to my questions and document license on of foreigners just a question for i'm ugly for for line as we look for to the worst hello three carolina you're still collecting data from allowed to with respect to informing the that the other statistical considerations but you have a sense of the size
spk_3: oh the enrollment of what else we may look like thanks
spk_9: thanks for your question coming off go ahead strength not be long flowing off the family not directed that question to you are hundred with you
spk_1: oh okay thank you are trying to unleash thanks for your question leland i'm
spk_11: the
spk_4: the design and the total sample size a versatile or three will be informed by the versatile zero zero two data that's the change in the i see i need population and we're looking for consistency is entrenched and we anticipate that we will have
spk_12: have additional update to that data in the spring about allow us to finalize the protocol and give us a sample size to conduct a trial as efficiently as possible okay thanks then just with regard to i'm the the couple combo study feel you have yet to to identify the i see i will be using a little the mostly commercially available one are the only information you are willing to learn that will
spk_9: eliza settle on the choices or that i smile at least allow us
spk_8: the public to know that it's thanks
spk_9: and that's excellent question and thanks for that lunch wow
spk_3: in terms of the design of the triple combination study we plan to leverage and also has maturing data from the i see i was frankly population out versatile zero zero two am as friday aerated overall survival we know is going to be key to i'm informing the design of that while he was like to have maturing data from freestyle zero zero two in the i see i were factory population since that will be the focus of the triple combination daddy i'm as you're aware there are and to it each checkpoint a better that have approval in the had a knack for current managed static disease or education and we will be making that determination as we get more informed data on how to ah survival from i see irish applications
spk_1: the present with it either i just have to add a little bit to what long said as you know they're there to to commercial if checkpoint inhibitors that had been approved like a true that and a diva of for had an emphasis on be one of those two but oftentimes of the strategy to design that trauma things me want to do is to be pro
spk_3: you dent and getting all the information we need to my the reasons why we see seen the kind of data we see today in our clinical trials is that we were very systematic and our preclinical studies and making sure that we did all the necessary studies understand exactly how this technology is working for like the optimal conditions going to the clinical trials and based upon that we seem very consistent results from trout trial the same reason why we running all these various faiths to clinical trials right again as much information as possible that can then cm design of these trials and now since we're going to commercial checkpoint inhibitor with pts a one a one that's exactly what we're evaluating in the am i see have a factory
spk_11: on a burst out the receiver to and real having some information on how best performing could be very informative in terms of how we designed the trial so for example assume we design three hundred and fifty patients trial
spk_13: but wait a few months later and understand exactly whether we actually seen improvement in the were also vital potentially with the dual combination maybe we end up the a few months later but with a much smaller design that's a lot more efficient wicked then for matthew regions of course and speed to commercialization the we just want to make sure that we do what's in the best interest of ah
spk_0: our shareholders making sure we get the information that we specifically designed to trials to provide and then based upon that information progress into final design of that trial
spk_1: okay great that's that all make sense thanks for the for the out of fellas no problem they could expression is coming from the weekend from cats of his shoulder lot of my life
spk_3: hi congratulations and all the progress it's current thanks for taking my questions so i wanted to ask you what a bit wanna see three versatile oh three study and see if you could provide more details a profit in high you wanted to design that study iverson suffers that how to and that's how are the result of oh shit his inform know you're thinking on be safe design throw three and then secondly are you expecting a present any new data and major medical oncology conferences or even for the or virus on your afternoon and platform this year i nfl out in a where would you see
spk_1: you know our preventing those and and what the news and then lastly just thinking about our backs on for twenty twenty three is the fourth fourth quarter twenty twenty two a good starting point for to do about how to build things in in your starting a major sorry the period or you can give the cadence of argued expense and twenty twenty three thank you
spk_3: how can we thankful for the question all start and then handover to learn to to finish up but intent in to the phase three trial you you are correct we're looking to get as much information as possible from the burst out there is a retrial as i mentioned overall survival is what we believe will be the key parameter that the ft would want us to power the trial to to really understand but also what what we wanted to ask me designed the trial is also on take information from without the resume to for example what do i pfs number of look like to have
spk_1: pff nancy that's increase in pfs in versatile the reason to correlate with increase in overall survival for example and those with some the key parameters that we needed to get insight into because if that's the case then we can design that with sudden intern data points that may allow us to get data that we could dance that discussing the that fps so
spk_3: than later regarding a potential approval so right now for example down in recent guidance from the a in terms of how they would look at accelerated approval and how they would look at me sam single controlled trials for accelerated and final approval rating with all that information part of the key thing for me
spk_9: we would want to do is as we finalize the design get input from the from the other countries into the design finalize the numbers but also give ourselves opportunity to see day has sooner than later and if if positive be able to start having discussions with the regulatory agency so that that's what one of the key reasons why
spk_1: we need to react to stand how are pfs numbers were beginning to look as well as overall survival and see if there was a improvement over of it would publish good food i'm on a therapy data in terms of improvement in both both sets of and parameters like us our our hundred to lauren to to address the additional questions
spk_9: so and a far larger francs comments on our intention is to present updated data from versatile zero zero to add scientific leading should we are targeting to present data potentially either it has go as mouth arm
spk_1: and also potentially as i psyche see related not only to be updated clinical outcomes in the i see i nice population as it relates to pss and overall survival which again frank it all and for my design of versatile outreach but also confirmation and examination
spk_8: out be immediately city pet parameters that we're seeing can versatile zero zero two i think one of the most important things to come out last year was the demonstration that we see in patients on even in have retreated experience patients the induction of these hpv sixteen
spk_9: the subject multi functional of totally cdh okcular t cells in patience and were looking to do
spk_14: at present that data from versatile zero zero two ah as well during the course of twenty twenty two so yes we will be presenting that data am i can't really comment regarding arm
spk_9: in our infecting is presentations and the viruses publications were are very very impressive for us in terms of did the ability to demonstrate broad antigen specific city for his and city eight cells that can be protected from lethal and flinched challenge
spk_1: and i think i'm any scientific presentations during the wretched this year will be guided by additional preclinical studies that we may be pursuing with the goal of progressing are infected mean based platform to human clinical trials
spk_15: and there was a third
spk_3: question that you had could you just repeat that
spk_16: yeah we're a i actually yeah i was passing and some questions i and to ask you about our back for twenty twenty three as a fourth quarter twenty twenty two a good faith to build off of and then with the start of this versatile out three by fourth quarter twenty three house we think about the cadence and are indeed excess
spk_3: and this coming year
spk_0: some more i think that would be a good one for math to take operation expenses
spk_3: matt
spk_11: thanks frank
spk_17: thankfully pretty good question
spk_0: i dig in looking at you for you start started see the step up an increase in associated costs related to or trials and that's going to continue into twenty twenty four but i think of you take
spk_1: you're obviously in the fourth quarter numbers we got ten million dollars that we spent with mercator yeah yeah so after eliminating that that's a good way to think about it and some and also of the world than have some additional or the expenditures as well
spk_11: thinking of sorry general ministry expenses well
spk_3: i'll consider complex next question is coming from culpepper patel from be riley your line is alive the morning that is any pleasure and for cult thank you for taking questions and graduations on the progress we know that you had a successful initial beating that he asked the a for the douglas what is the agency requiring any more data to be some bed at a while with the file final trial protocol and blanchard we expect the throttle on this matter and finds a lot for the question by think with a triple as we mentioned we're looking to get some additional data hopefully that will inform how we designed to statistical portion of that program and also one of the key things that we would want to do as that the if he would want to see sweet i think once you think you mentioned a number of times is the contribution of agents we talked about that quite a bit right and so pending what that down for that information provided to us we may be able to go in in terms of looking at pts oh three one and pts and pts a one a one and pts or three one in addition to the couple combination we to say that that may be possible but again that's something that we would have to discuss with the the a does also important for us because if you recall with a triple combination trial there are two of the three agents which often found to be critical and the clinical outcomes pts a one to one and pts oh three or one right both of those were found to be critical for those outcomes
spk_12: as a part part of what we may potential do is a sign simon to state way we look at is a small number of patients as a median to their and bigger registration or file but again those those are things that we're looking waiting for information for to cut to finalize that design we think based on what we know today we we think it's go
spk_1: be a smaller design than there were sound zero zero three
spk_3: but until we have all the information to design the trial i probably wouldn't be able to provide too much detail into what you're asking but the for some the key things that we looking up to come up with the most efficient design design possible thank thanks frank i'm sorry sorry if i misspoke what i was actually on question the that doublet study on a the done nothing wrong guy or gal data before initiating that trapped there is no no we don't we don't require more data before initiating that trash okay and you have a a sense of the timeline of when separate elvis minutes yes we talked with so right now we're in discussions with their arm the even other the regulatory agencies from the other countries in order to get their feedback that we wouldn't put into the final design that would then go to the ft a and so we're anticipating that by the time we have all that information from those other countries that were put into that protocol for deaf currently ongoing that will probably be late to to or early que three so we anticipate that the final i and be amended i am will be filed in que three and then once we get the if the feedback will then start activating the various an investigation review was i are bees for the various sites we are hopeful that we will be able to convert a number of the sites most of the sites we working with today into the versatile zero zero three sites
spk_12: and so that those processes typically will take anywhere from four to six months so with that timeline
spk_6: luckily of work until it's an hopeful is that we will be able to get this trial up and running by cure for
spk_0: like considering all these other activities that as i mentioned the clinical manufacturing have been successfully completed already rights and we are finalizing that they later stage of the c m c section right the all those activities are progressing referee success me today
spk_11: my so that's that's our timeline terms of when we anticipate will filed a and the and one will get the i r be approvals get the site's activated and get the trial initiated by que
spk_4: that's up on thank you for taking questions
spk_3: no problem they next question is some of whom james malloy from allies global partners your why is allies figures are you think of course to a question on the on image that i didn't phase three person tells your zero three trump you what you will be remembered see id what exactly you're mending on there and then when what sort of break points you have to stay around the trial gonna take a little bit time to run into space rent from look at some point out anywhere to guys were so lax catalyst be looking for once drug that the running of digital data coming out well again thanks for the question why we caught an amended i indeed but it is he really update your eye and the the initial i idea with foul for the phase two trial which was a single on trial and now we're going into in a controlled face to face three trial rights of those those updates have to be made we have to update the manufacturing process with now selected our commercial manufacturer with transfer the process we don't have to update the manufacturing process as we are they the manufacturing process of a three manufacturer of the peptides those have to the updated data
spk_18: in the sea and see that on them manufacture of the our don't have the raw material for diversity and also be scaled up to their face three those all those updates have to be made to the i and the and so that's why we call them and id id it's it's really really look at it off an updated i and be with all the new information transitioning from the face
spk_3: nice to to the face through with a lot a lot of those pertaining to what the commercial commercial and manufacturing and cmc package would look like
spk_1: right so that that that's that's really what we're doing there
spk_19: james okay on it if it's a question
spk_3: he didn't it and then any thank you any thoughts on our expectation for potential interim looks or or data points here you want to try up and running which would be thinking a guy me and fit a certain season data coming up yeah so i think that that's when we're looking at for example with with pfs rights i think one of the key things you mentioned is whatever interim data points you come up with you it would have it would have to give some indication that you a prolonged the overall survival as i mentioned during the presentation objective response rate for example haven't really correlate it with overall survival in most immunotherapy some many of the immunotherapy said the as the has been evaluating recently and so what one the keep it that one key reasons we are looking at the data for pfs an overall survival is that inverse thousand resort to that do we see an improvement in pfs as well as overall survival and based upon death that improvements what's what's the sixth what's that delta between what we're seeing with ourselves in reserve to versus what's reported in keynote zero four eight with good food on a therapy and then based upon that delta for both a pfs and the overall survival
spk_4: that will inform us in determine how we designed a trial and what we could use that an interim data luck and so that that they'll face really going to determine the statistics right in terms of what what's the size of the patient population that we going to need before we see pfs if we have seen an increase in pf as my very importantly we would want
spk_11: the one that suits to be associated with an increase in overall survival at least and in indication that we improve proven overall survival rates that in that's why those numbers were very important and that's why we have to wait to get some clarity to those numbers before being able to design the trial we are now waiting for the feedback from the very
spk_3: countries countries and then that make that me costs us to tweet things a little bit before we finalize that times designed by we absolutely looking to do this and designed the strauss to get some early looks to be able to go and have discussions with the of the a rather than waiting to go through the entire trial to completion of the trial before before our huh having discussions with that the acer with we're we're looking specifically about design and our design exxon take his final question be are only triple combo and are you highlight earlier how it's and someone out are your hands with a partner running throughout can you want your expectations are the current of cases for said the data next data from this and then you know any and all three is clear focus here any thoughts on tinsel if a three starting the triple congo it some point the near it someone the future but absolutely i think with a triple triple combination arm totally the triple they of out of our hands right this the nc i probably successfully completed myself right now what we've done is we have acquired that pts or three a wants a release now in our control right in temple a partnership with more kgs they are providing us with the material we're designing the trial however to complete his i and of that route into have an efficient frau we also looking at pts a one to one plus the true that which is a commercial checkpoint inhibitor in the exact patient population we going to be treating which is recovering metastatic head and a cancer and therefore when we anticipate that we should see this data some timing que three that's the there even though we look at pts a one on one include a without i'll twelve we know that i'll twelve is critical in these checkpoint and hate to refracted patient so that data will not necessarily be essentially what we would anticipate seem to the phase three trial that will be very informative if for example we already see an improvement in overall survival even without i'll twelve and that patient population that information then allows us to more efficient he designed a statistical portion of that faith three clinical trial
spk_5: rights of those are the key pieces of information will looking for we also had the same time when the work needed to identify the correct amount of commercial manufacturer for that product ask me take it over right so you thank you what we want to do as we going to have three clinical trials is to make sure that
spk_18: it's going to be pretty much very similar to what the commercial product is gonna look like in terms of the manufacturing right that that mitigates your is significantly speeds up going from your be allay toxic producing and selling your commercial product rights of those was on the key things that we did for burst out zero zero three and would like to take the same
spk_20: approach with the triple combination to make that and process much more efficient once we started from beginning to answer currently we are prioritizing getting first aussi received zero three up and running for once that happened our then private primer risk amp primary am goal is all
spk_0: often find refocus focus would then be getting the triple combination of up and running our key here is commercialization of pts a one a one and commercialization of pts a wanna one plus pts all three a one right so that's that's really the approach we taking just to make sure that we mitigate risk as much as possible and make sure that we can execute the most efficient
spk_4: the trial possible
spk_21: great thank you taking the questions
spk_12: no problem
spk_3: thank you as a reminder that star one to be place in the question you are next question is coming from other the boyer from global capital markets a lot of
spk_22: good morning and thank you for all the details you've given on the versatile and the triple therapy trials
spk_9: my question has to do with the md anderson
spk_23: and the mayo clinic data that smoke coming out and with you have plans to include those in trials or any milestones going forward or things to look forward to from those indications
spk_9: thanks robot and you want to take this one first
spk_1: guess a thanks ebert
spk_8: i'm as mentioned the md anderson let in it has served trial as well as de mayo clinic trial or investigator initiated studies so we don't have control over at the equal rates or actually the publication or presentation of scientific data from those trials however
spk_9: we do know that there has been as
spk_1: interest and enrollment and a cruel to the mail i i to trial just reminding everyone that this is using and investigating pts oh i wanna one allows for the nation with to true that i'm prior to definitive sure it is surgical reception
spk_9: and individuals who are presenting for initial treatment of hpv sixteen are afraid you'll get cancer our hope is is that we will be hearing from investigators and that they'll be able to present an interim data on hopefully this year regarding preliminary findings
spk_24: in this population it's very important to ask because the study's going to provide us insight into i'm not only immunity this city to or shrinkage prior to surgery path logic response and issues but also an important examination of the biomarkers circulated
spk_3: humor hpv sixteen dna the image minister data from md anderson i was on the first nine subjects who had actually i'm completed their day one seventy evaluations we know that there are additional patients from the study armed and i'm already undergone treatment that we're not at that time point to allow presentation at the data
spk_25: i'm at the end of two thousand twenty two so we look forward to additional data
spk_1: as as that teachers from that study as well
spk_8: okay great thank you very much
spk_1: background you want to add a little bit up about the mayo clinic and how could be translated into a potential randomized trial
spk_9: and got me that may also help okay so one of the things that were very interested in is seeing whether or not we can impact on differentiating outcomes for patients earlier in disease and so we hope to see i'm in addition to out whether or not we see tumor shrinkage and decline and circulated humor dna
spk_3: and ah whether or not those are predicted of disease recurrence we would potentially design a randomized trials and look at pts a one a one alone versus pts a one a one in combination with key trudeau in this meal had you been treatment setting merck has published studies examining to trudeau alone in the neo i'd been treatment setting
spk_0: with some evidence of preliminary evidence of
spk_3: tumors shrinkage and minimal path logic response and we would hope to improve on that fine thanks a lot lauren the rubbish from ray he had with both of them there there is a significant commercial opportunity for both in both trials and so the key here's really getting that basic information that will say okay yes move forward and if he it's yes move forward how do we do to design that controlled trial based upon the information that we receive from both both trials the but both provide us with a significant permission of the kinky that we're we're currently waiting for the data to make that next decision thank you we reach and of our question and answer session college from a for that program management for further closing father's thank you very much well thank you thank you very much for joining us today on a fourth quarter and full year ended earnings conference call the while twenty twenty two was a year for mendis progress for both of clinical and preclinical development programs twenty twenty three poised to be transformational for our platform technologies and pdf by tech
spk_0: i will reiterate that our key goal this year is to prioritize rapid commercialization of pts a one a one first in the first hour zero zero three study we have selected incomplete had manufacturing a pts a one a one of our preferred commercial manufacturer from best our zero zero three we will also progress activities needed to commercial

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