PDSB - Earnings call transcript Q2 2022 | PDS Biotechnology Corporation

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Operator

Greetings. Welcome to PDS Biotech Second Quarter 2022 Earnings Call and Webcast. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions]. conference recorded. this that note is being Please At Gabby DeGravina I'll turn over to the conference with this time, Investor Relations. Gabby, you begin. may now

Gabrielle DeGravina

XX, And for as are Hill, shortly. results be Officer. PDS encourage B. the on financial Dr. Wood, XXXX. announcing Biotechnology's available June press Chief PDS well We the Bedu-Addo, Chief The call Financial to ended as Form With release welcome is Medical pdsbiotech.com. Dr. release PDS XXXX issued Frank on today Biotech morning. the read SEC Lauren Officer, press me press company conference filed webcast. and with morning, will everyone Officer, second the PDS quarter the at Earlier report company's XX-Q, from release Chief this Executive which Biotech's website earnings a audio Good quarter to and Matt

company on In future reference. addition, be will this archived conference and call website for webcast being the is

found matters. the within may results today's the PDS subject Act Biotech's management. XXXX, of everyone recent be and as management, uncertainties and meaning with beliefs currently differ including XXE States intentions research as those Before amended, XXA condition company's as otherwise events, of Section XXXX we description and filings include financial well results These development of the most as and can begin, information on Corporation or of of regarding made cause plans, statements making product we company statements, as remind as These forward-looking assumptions statements Exchange trends, plans, current from on operations, statements other candidate Securities to regulatory SEC. risks available United A Biotechnology Act forecasted. expectations the as activity. need by, well of to, that, may and in Section the actual in these Securities amended discuss be United to to information goals, future forward-looking based are will of that this call, States may presentation in PDS to Certain or of the concerning

cautioned conference included date reliance to which applicable to subsequent Except only today forward-looking the reflect these the this update is PDSB statements of circumstances. as to speak place law not You to of call. required undertakes are extent on regulation, statements, the or no obligation events or undue forward-looking by which

We want summarize and you as As the as help presentation our we're a to your commodity, Q&A. and precious know we milestones updates. is aiming slides can see, and for of much streamline utilizing to time and possible time information programs leave background to

welcome. over would call on feedback be to to now like Frank? With this Your turn Dr. I would structure Bedu-Addo. Frank the that,

Frank Bedu-Addo

this Biotech Gabby. for our and past PDS morning. the has us you, to advance on quarter, infectious you worked of and joining team pipelines, And all fronts. progress have development these made diligently of oncology we tremendous disease to Thank thanks This the

HPVXX of Here PDSXXXX, immunotherapy associated to papilloma cancers. lead designed human candidate, can broad or investigational an the treat overview virus see you our Versamune-based

cells tumors positive. of with tumor are also antigen-specific induce As system that kill technology T a killer and to proteins, induction delivery target PDSXXXX called killer Versamune the the positive HPVXX reminder, cells. our CDA immune to activates that simultaneously therefore of promotes combines platform the and antigens antigens, immune system the Versamune and promotes T associated HPVXX

a allow who broader that beyond advanced suggests checkpoint respond the us treat the reduction such Our cytokines in leads Versamune second proprietary population Versamune cytokines also with with suppressor suppressive This oncology data Preclinical this those IL-XX. inhibitors. to to cancer MDSC. cells, may called platform cells, such to myeloid immune of of combination of as combines platform population derived this technology with as patients

agents are four ongoing we treatment and the evaluating various PDSXXXX most a We three anti-cancer cancers. trials. Phase combination advanced across PDSXXXX with In as studies, X are in clinical progressed refractory evaluating

the We terminally are diseases with studying metastatic these ill combinations advanced of different disease stages disease. and checkpoint patients to cancer locally from HPV multiple in recurrent associated inhibitor at refractory

We important that are most a or of the the KEYTRUDA leading to better in PDSXXXX indications indications in this oral to in collaboration It every of Mayo work This trial, be combination world. cancer respected and stage performing to performing development disease enable to product into rapidly understand studies know in of centers studies risk some most is broad the to a which our we every promising In study range us for combinations with to broad us as early indication. the allows pivotal that approach these mitigate combination progress to in to evaluate with approach monotherapy various not note at cancer. as are allow may select is promising fourth investigators is the the us as of Clinic to and combinations likely trials.

accurately date be of generated indications preclinical and which As beginning we trials. safety The efficacy encouraging. we advance to have patients reported To the studies. our and/or could which for in we are the And demonstrate key highly is results to promising fact selected highly priority by elucidate to continue to look These is studies, have as to data as been pivotal and results safety predicted rapidly PDSXXXX. our commercialization. is date, combinations data that two the clinical efficacy possible encouraged ahead, XX by also PDSXXXX potentially from

failed study have prior inhibitor who combination and study therapy advanced patients KEYTRUDA with neck trials. Phase cancer we of HPVXX and National recurrent and positive Merck's Importantly, cancer. very our ASCO head Cancer in anti-PD-X The inhibitor pembrolizumab or checkpoint led naïve from checkpoint in metastatic X encouraging June combination and/or at PDSXXXX both therapy. clinical PDSXXXX inhibitor presented refractory in triple with data IL-XX a combination positive The Institute ongoing in VERSATILE-XXX evaluating in with a patients is NHS in of is checkpoint two HPV range patients evaluating

I and treat refractory presentations Wood As shortly. very broader us inhibitor highlights treat and Dr. covering combination to Lauren Versamune, of to enable the the data earlier, population will from IL-XX ASCO difficult mentioned of this checkpoint a be may patients.

In related the the we have presentations, to announcements VERSATILE during data news to quarter. the trial addition exciting also some

As the we in CTA, May, the the announced or UK. trial we of study of the received clinical of notification into allow application, expansion acceptance to VERSATILE

trial Due trial we various with familiar time getting various regulatory This goal VERSATILE-XXX to accounted of Union the an is development. efficiently recent for expanding our pivotal outside is the financial trial the data to believe of accelerate United approach into the our to strategy product the to could the the in prepare facilitate of rapid European transition taken to on States. international projection. Our agencies trial, sites for enrolling based into this expand that sites

on from during for We cancers. will quarter, positive so begins. combination we for PDSXXXX with Europe treatment HPVXX based of VERSATILE-XXX enrollment the provide FDA results track far Also the the were the pembrolizumab in updates trial, granted neck fast the as head in designation by and

aid conditions track address potentially the to As and potential designation you know, treat drug the need. FDA's and medical that development of expedite the life serious to could program in threatening is an unmet designed or demonstrate candidates review that fast the to

review independent KEYTRUDA. from review in appear administration The and the both combination with our monitoring and doubles VERSATILE-XXX, of safe than refractory checkpoint data groups. of the data KEYTRUDA in XX included with Democrats, its in committee, on checkpoint Lastly, in at safety committee's scheduled to data This safety whose inhibitor patients well inhibitor presented PDSXXXX continues for or the naïve patients combination met ASCO more was PDSXXXX XX tolerated. June.

were attributed The as the trial recommended not KEYTRUDA Specifically, to three more profile the Versamune combination. therapies. safety hold to related to related drug of based may DMC continue safer continuing believe DMC of the and The effective therapies, we the events and PDSXXXX immunotherapies no better grade enable to no review, also no plus up, and discontinuations treatment adverse higher cancer tolerated continues only with or modifications. there but that toxicity

tumors clinical PDSXXXX be advanced either may biomarkers, study both which combination In care standard responses, well is blood cancer, the the avoid ongoing CRT, their as evaluating X working with have immunologically and Phase immunological the trial well PDSXXXX third embargo tumor meeting in an cervical MD led jeopardizing for Anderson lymph the trial at chemoradiotherapy, abstract submitted is or team with X patients of informed data. how have Our environment abstract, MD the Society and far, in locally been than size will metastasis in we as greater in the wait who been clinical is IMMUNOCERV or we PDSXXXX as node have immunological how understand evaluating study has until centimeters. November. standard This for circulation may better as been so results, of Immunotherapy data generated. of to improve to promising And presentation in lifted been of by that acceptance To present Cancer, it has or SITC, care. the Anderson this of

investors, experts is for peer our potential to key be to of and in interest shareholders continue scrutinized, a it data believe partners audience that all We best field. the in to the larger reviewed of presented and

to and to simply in monotherapy with and This in trial As has PDSXXXX they relationship Clinic. now being site investigator-initiated Enrollment for newly previously, being Mayo combination established pharyngeal with from ongoing, updates provide is study where evaluated thrilled ongoing we've conducted available. the cancer. as HPVXX as have KEYTRUDA. being a a we will the a study progressed VERSATILE-XXX oral diagnosed relationship associated both is This discussed is are with patients become we include the

FDA Finally, year PDSXXXX are plan FDA the in a for on with with the discuss expecting We path to meet to note discuss and in combination to regulatory KEYTRUDA with the quarter forward quick the triple later study. combination also the NCI-led registrational meeting here. this

focus address combination indications meetings into these patients of greenlight We progression suppressive that trials current that on could hopeful checkpoint on refractory breadth results, are dual inhibitor the project, will to triple due programs. inhibitor naïve We both activity. and based for will a anti-immune combination the checkpoint pivotal greater

to commercialization to could, we leverage programs to Our currently our on Ross we for of the advancing at universal National vaccine team, data timelines his progressing PDSXXXX outlay. us and results, PDSXXXX PDSXXXX is continue presented of minimal on and to PDSXXXX of studies. and PDSXXXX collaborator, and pipeline, collaborations Society Similar Meeting. with Infectious the also are and promising the advance Versamune known in strategic continue to American disease NIAID are as cause continue stage the according flu prioritize capital Based into initiation to our Infectimune work with advocate our schedule therefore, PDSXXXX manufacturing. this clinical the to to Discussions adjust with for XXst infectious goal the Last to oncology of Allergy and Institute these Diseases, preclinical Ted progress. month, Dr. NIAID, Virology clinic. clinical

data PDS of efficacy part Ted this Professor presented safety turn preclinical group. Lauren, Woodward, Lauren? the School process discuss Kentucky staff. As call the NIAID universal and clinical in Last of Dr. last Biotech's will University at collaborator, data of Ross flu Medicine, to larger month, in-human NIAID Infectimune who detail. program to manufacturing the week, presented PDS over I'll the to these the data Jerry

Lauren Wood

And you, Thank us of joining the to today. you Frank. call on all thanks for

strains was full of body the flu or full vaccinated Ted just These American the compared were it in its multiple PDSXXXX to to strains optimized Animals COBRA, types Virology vaccine of of with potential higher for program computationally a XXX% the from influence was vaccine with survived PDSXXXX at evaluated encouraging of neutralizing preclinical Infectimune influenza lethal the vaccinated a against broadly antigens, lower influenza of that also significant demonstrated animals laboratory strains multiple PDSXXXX virus equally against poster against animals antigens. without Ross. Frank showed survived antibodies. and we of Infectimune. study, As vaccinated mentioned, XX% loss demonstrated the animals virus. found the Meeting. protection challenge. effective group XX-fold only weight doses lethal None influenza and sick and expert the nanoparticles antibodies formulated COBRA this The In poster overall animals. by our in COBRA renowned survived. presented sickness. broadly influenza antibody Dr. neutralized provided animals without PDSXXXX reactive be levels against contains lethal ability recently vaccine lethal with data and dose the infection developed of to flu PDSXXXX flu Highlights multiple antigen-only was effective, the protection antigens untreated influenza influenza induce significantly All The included: universal of Society the using of in provided doses of got and diverse

virus with detectable was PDSXXXX. lungs vaccinated from animals Importantly, found in no

is Another no strains of World to influenza. provide result X cases the multiple each million vaccine cells T the provides Organization, advantage against Currently, to antibodies Health illness against severe disease. about of and to the there is in to XXX,XXX protection According flu PDSXXXX robust up to to of in of induction is X addition broad flu protection estimated that year. universal million deaths

pleased We universal these that the achieve broad influenza by the to a are which of protection providing PDSXXXX vaccine. potential data goal suggest has sought the in

to Let's ASCO XXXX now our turn data.

to reported study. The XX% seen in update The trial, vaccine refers tumor the is with trial of the ORR, data over of Here, in or X that the which presented the or objective KEYTRUDA XX% Phase XX we arm being of to response XX.X%. checkpoint naïve KEYNOTE-XXX or into get about An VERSATILE-XXX X reduction more. data presented in mind, patients. monotherapy, providing Keeping the let's the clinical to an is patients response from double in was study conducted rate, summarize VERSATILE-XXX at ORR the of ASCO. size be objective our goal on first inhibitor

administered benefit, confirmed the alive PDSXXXX the of of disease Clinical of months, two benefit at note a have X include Please KEYTRUDA. of had that a evidence those data and PDSXXXX have plus had or Additionally, a and response. of patients seven who both who nine no patients doses stable of X were received these treated XX% KEYTRUDA. of suggesting cut survival At responses. unconfirmed of XX of median as with with was X responses, complete percentage disease, is which XX.X%. objective time experienced of data patients off, the out doses out the of patients median

a there greater The compares events efficacy reported Committee This side, appears related were data toxicity. adverse observed confirms equal treatment no recent study from to PDSXXXX synergy demonstrate in Data included in patients the or was same patients The with safety checkpoint or Monitoring three grade in and XX% of than result events no in discontinued studies. three where interim inhibitors adverse clinical monotherapy, grade the XX the as and On the treatment-related to patients were treatment patients. KEYTRUDA this of favorably greater documented XX the of to in preclinical the review.

with mentioned, As development. a the our we'll be path to discussing data potentially FDA soon forward determine further Frank these begin to of registrational phase

the now to XXXX Turning data. triple trial combination

become the positive, PDSXXXX being IL-XX. investigational to NCI-led alfa to HPV As studied to the Merck cancers. Median by Bintrafusp XX%. in only inhibitor KGaA, will with less survival usually is range refractory a inhibitor is combination is MXXXX, progress for these have two patients triple and also rates checkpoint evaluating as reminder, triple objective which patients treated and with checkpoint difficult patients therapy The combination of than Historically, with combination continue treat owned is generally inhibitor in three four and NHS checkpoint known advanced, extremely been months. agents, in Ultimately, response refractory relapsed patients this in study refractory. immune-modulating most

As number Versamune may cancer the data of the greater to system and greater resulting Understanding is helps IL-XX this of a better context. kill proprietary cells, Frank achieved mentioned, This in clinical put outcomes. in into to of be inhibitors findings cells to can allow T survival expose population killer induced PDSXXXX checkpoint HPVXX combination our alone. difficult-to-treat the positive historical with and tumors a NHS immune expected population

patients response inhibitor are were This we an is cancer. or HPV-related of a follow-up had observed date Now moving at to XX% refractory aware checkpoint XX% recurrent objective of in any evidence patients highest alive XX was that into of the the inhibitor of months. naïve of response. data. checkpoint It median refractory

grade of no patients durability four a plus alive As again median events. checkpoint expected promising KEYNOTE-XXX months. great favorably There follow-up XX mentioned, patients to live these study. response. I of in would XX% suggesting treatment-related chemotherapy only events. were the XX% median events terminally of historically were in naïve and at X a been immune three have of months, grade for related the XX% inhibitor ill to grade X% patients safety experiencing of X treatment-related compares were adverse adverse of treatment where profile higher events, adverse X This very grade experienced pembrolizumab three with reported patients with generally

vaginal the not inhibitors that only HPVXX the Importantly, it to to both head outcomes reported associated of Matt? the results refractory subjects, provide cancers. positive proprietary cervical. a of anal, of has Versamune showing is immune suggests patients checkpoint similar tumor IL-XX Matt survival that, PDSXXXX cancers, from by HPV The in Versamune cancers. and this that occurred I'll this that for review the occurred the and entire combination data trial, positive ability vulvar combined combination responses With The presented that trials. range HPVXX overcome data across over ASCO neck, of improved shrinkage potential suggests at potency also alone. financial across suggest to and IL-XX results, now clinical turn and overall the with novel additional for addressed previously results. have tumor suppression may These with including our

Matthew Hill

And thanks you Thank on the today. to you, Lauren. of all call

of in cash for to to our partners leveraging of the We and prudent HPVXX warmly a to platform. Versamune cancers. all associated thank wish continue have of to carefully and the confidence investigation with range partners and fiscally costs their interest allocate PDSXXXX our manage We cover been strategy, clinical wide those

Moving summary financials. our into

up in brought In support functions. in to from fees. a strong ended increase $X.X as licensing three open to in personnel legal Sanjay let's nearly quarter months veterans million Brown and our of company's of General manage $X this June business clinical Business partnering our continuous for as the our $XX XX, increased as and and pharma legal the We to ended decrease in administrative our Counsel. million expect expenses June, research in General welcomed months XXXX XX, President business Vice key has the pipeline. cash, was stage model development Development team expanded facilities, of lead up to million our up that, and result $X.X growth. million million we welcomed to Vice months President, of finished second million we million million Senior expenses million is of will and months May, in $X.X addition June three and the the biotech to For lead million and $X.X operations fund set it three XXXX, and our personnel million ourselves with XX, by With XX, and $X.X We've June XXXX. increase Zaveri a opportunities XX, million in primarily and PDS experienced the which And three for in of financial to for also $X.X we and and Senior was increased discipline, increase XXXX. partnering position questions. potential resources strategy next increase the into Spencer Operator? development The to study $X.X million for of a XXXX. an of $X.X costs partially in manufacturing ended The $X.X development quarter costs, June attributable offset primarily June services. $X ended research $X.X attributable in an the ended costs, of XXXX, and for the with

Operator

[Operator Instructions].

Chen of is Cantor first line Fitzgerald. the from Our question Louise with

Louise Chen

I this Congratulations few on a progress quarter. for all here had the you.

wanted about opportunity. to ask talked was you I the EU question you First

and size at question the you the or was if is, And could data? your Thank have with we've pipeline presented for think what last some the vaccine. from? that you opportunity ASCO curious you. And then data I you your for about about us for I'm help compare here? seen on platforms you you. physician mRNA next platform your thinking are feedback you when your And flu steps So, that What could contrast the

Frank Bedu-Addo

also Lauren additional comments. I will over to and hand add start any answering I'll to

our opportunity, components know, to an trial going the spread. head trial into trial the With the efficient as and efficiently. key believe that And EU recruitment. you to of to neck ability I the enroll think, EU is of expanding is one is and patients We run significantly widely cancer clinical enhance

And getting sites, if looking very Now into EU even we beneficial we getting feedback will we a moving those we have data pending a those and FDA. in trial the pivotal to regulators transition are forward that are potentially trials running to familiar our to outside the into products from date, our States. with be United getting trial, anticipate the pivotal the

even ex-US it a sometimes As you sometimes months up running. those to close of get may be aware, and several takes year sites some and to

sooner be getting efficiently. enroll so, going executed potentially get And those important than efficiently and in allowing very later, the we trial activities believe, in trial the could us to

going. And EU in up financial And mentioned, I as account taken activity of so, we and are in is, that a that It's sites projections. not currently. key our was new one undertaking that getting goals our the

agents, for the example. their have Moving on platforms agents, vaccines viral been impressive against in multiple extremely flu rapidly the ability to Yes, in to the mRNA generate vaccine.

the flu data showing think announced Fluzone, vaccine, result is recently the for to what's has seen I comparable been that with some flu example. there seasonal vaccine current

so, Professor try has COBRA to couple in particular different. COBRA those last strains to Now, Right? the particular is of And we particular it vaccine the neutralizing show that been several evaluate multiple strains. would is is the with a be you an Right? think and approach has by broadly is universal the with what current new have induce hand a trying Ted goal vaccine of able the be incorporate and obsolete. multiple over strains a are because flu will feedback antibodies. broadly goal. flu. reactive the The and see be the flu those so, has today. going over against we goal that to would make approach against the to year update flu computational And effective that's flu Right? becomes effective Right? what is be successful or that vaccine, rapidly will universal us vaccine, physician a of of been rapidly the more decades going can immunogenic that current I the doing these of developing proteins. the that And And of and develop Infectimune, what a every universal to of the an flu of generate be Lauren to proteins strain a What approach, into on multiple for And of active effective to we against flu combining flu Lauren, Ross we more year to taken strains flu vaccine less that I approaches a that would the to regions physician that's ultimate is of vaccine potent vaccine understand a now less or we're are And strain with strains give what feedback, to very prevalent trying the universal vaccine a is that flu. that having way obsolete

Lauren Wood

greater from rate the a than the the significant. the with poster, poster as combination KEYNOTE-XXX. response objective ASCO is objective feedback NCI historically response VERSATILE-XXX well only feedback seen was The The doubling not at rate XXXX XX% on of XX%, of VERSATILE-XXX was regarding triple which physicians as

was that. of that. a commentary lot impressed There were they So, by regarding

no treatment-related that This were no events and regimen The tolerability was XX% with and combination associated grade we of reported to equal than X of than second were that comments discontinuations regimen. focus adverse the therapy events, there of the KEYNOTE-XXX. contrast the greater drug to there specifically greater that with got the grade X or of

combination. very physicians the differentiating tolerability So, that impressed by were of

Regarding dose, CPR survival commentary very more was even up the the impressed lot data, subjects received a was but naïve or combination, and up, was approximately was had XX%. in refractory on there follow in extended, was follow survival CPI of combination, months not triple only patients where the that the low everyone fact high whether the the triple that very, of dose the it XX that

So, survival combination tolerability it VERSATILE-XXX differentiating as really about dual profile was the in triple the as of combination, with the study. associated well the

Operator

next The question Jim Alliance with Global from Partners. of Malloy comes the line

James Molloy

characterization obviously, in wondering I had was know, data for a some you've talk potential KEYTRUDA partnership about partnerships, you've quick a the seen, if data of the you and elephant I so given the you seen how far? Merck, potential But strong could question. room. characterize markets. bit obvious I opportunities of little would

Frank Bedu-Addo

Merck, That also, a ultimately at trials, I in pivotal becomes to think from is a even understanding progress to decisions their we critical broad move important generate, or stronger But whose know, I at to continue data and in partnering opportunities focus the of So, potential us Merck the development continue I the we really partnering FDA we And more attractive the pharma that the you strong business are to more looking right? becomes. becomes, data data partnering. right? beyond internal very data green stronger a the think with story creates I And the we for get light the on generation. of is more into and we companies, for the think to with as and will as generate, stronger the our also generating and start importantly, business development also key strategy. the strategy. business senior partnering compelling their is what different that vice category, puts PDS president development have opportunities. those And large and that make for continue strategies, them we we they brought to think think believe more also, one us our but I PDS, makes And if story

across looking believe the HPV strong across that trials We indications both The certainly I XX already from we both across generated working been of spectrum data has PDSXXXX trials. to patients the broadly. data as date So, entire indications from data and are is that trials both cancers. have both we provide of – mentioned,

data. compelling caused have a number believe what We discussions. XX has significant development those that's that's a very So we to patients And very patients. strong data. of business very is us package approach this of beginning of activate

Jim, of we're very that's business we're focused an beyond something that And piece So, partners. just broadly it is our our looking and yes, strategy, on. current important

James Molloy

the quick and I Phase talk pivotal VERSATILE of Phase a potential potentially of the on bit X of flu? then a for the X, Can you could. a Maybe follow-up, X for Phase a with timing start end little KEYTRUDA for if starting combo universal timing program,

Frank Bedu-Addo

Jim, part first question? repeat please you of could the the

James Molloy

and timing of FDA expectations KEYTRUDA starting X for an X potentially and the Phase pivotal combo. the with end for Current Phase

Frank Bedu-Addo

regarding We're the and this talking trial quarter. that to proposal a pivotal trial our anticipating for FDA

year. so, If FDA be by whether anticipate of we could trial trial or green quarter, strong do move have terms that the not we to the we from we this started hopefully, can the forward what that response pivotal. That we end be our feedback would are of half that's into the so, do again, should And first in next a But, year. that do. we of pivotals light move get from the contingent able next that that into we to be get is early the in to sometime on hope, FDA. preparing And, and will the

part during flu the the universal we call, think of with are NIAID. working earlier I the as I With the vaccine, mentioned

as so project will to I a NIAID clinical And working that very met trials. program. to we The them forth. the Dr. with team to mentioned, and the attract the has It's NIAID them also with difficult strong opportunity that the make timing to data, to the for be. non-dilutive move And that with hopeful the would are exact he's himself PDS Ted would is be really to and present the information Ted Ross have human what hopefully advocate decision. Ross met. the that also need some into provide funding NIAID And they We

not So we are been hopeful. the finalized But that yet. at has NIAID decision

that and next this the it so, program everything clinical if earliest my the is will that could will potentially funded by human out but lighted I green we go say updated is and be would sometime anticipation on trials progress. works NIAID, year into And

Operator

the line question next Oppenheimer. Our with comes of Leland Gershell from

Leland Gershell

the for me. A on progress. Congratulations couple questions

positive of between science analysis show done on VERSATILE-XXX if there's the at presented you to there the that. any and at look an complete that sort in you've regimen. I'm response the question. wondering kind the It CPS, further analysis one score. of Frank, just of based with sort clear levels data correlation didn't was any Just ASCO, those

Frank Bedu-Addo

to want Lauren, do you that? take

Lauren Wood

the and score at specifically between KEYTRUDA that call, all greater everyone score, reinforce, have seen CPS than they composite the all tissue, measuring in this patient's than For on At entry the have composite XX%. greater scores this correlation X, VERSATILE-XXX But subjects study preliminary on is Leland, have to a or to any XX. CPS are score, not In that small presented stage, CPS we're we we individuals not must a than the greater PD-LX criteria see current outcomes. ASCO to the has clinical score that greater look the is not than characterize score care on PD-LX the going the any of we equal just at to CPS the That doing is to subjects look continue receive requirement for whether tumor whether or impact or monotherapy. and to standard of correlation X. also at with characterization, number and

are with today. studies that's But We outcomes whether or regarding HPVXX immunogenicity that see clinical we have and characterizing planned responses that not as to have well. specific correlates what additional

Leland Gershell

Obviously cervical be with side. data cancer. to and plans respect beyond data need how Frank, IMMUNOCERV of in up. ask I your on Phase add to well. question development coming that those candidate forward want the cancer Obviously, XXXX continued a looking will the as may in huge or change just Just cancer the cervical in to X to a

you So, and deploy how ask combo just pending look and IMMUNOCERV to alongside KEYTRUDA neck the as resources the set. head data want to may

Frank Bedu-Addo

an That's question. important

taken I understanding at very is of multiple the provide in most one think multiple combinations which in of looking we've important bear really of currently in strategy mind things that our rapidly combinations the which in indications benefit is the to indications. strategy

standard one improve we the also can what care. how at of of and standard have to the is that of we think to the the potential quickly improve or would care to is I do look things

or with Anderson later very think are MD I the been been more also compelling it's combination triple patients. generated Those very that's today. that's data is data generated in still VERSATILE are less the by The stage and early it's but compelling, early. still

have I standard over So, to full compelling at see data that compelling. the very data some package, I care compounding available. make we If toxicity, the a will we think I again, like, with think no decision. the see and, we we improvement be, see would of of what would as when that point, VERSATILE-XXX, like to And the looks it's think

move real think bit we once determine we'll little pivotals data trials whole that to But package available, what studies, dual. have terms and we're to ones of sit interesting how prioritize to But determine the planning will the with specific the into those triple very We opportunity a behind down we is date. now that's and to the do and want the and as indication. I is in which

Operator

comes next with Wainwright. Pantginis of H. from line question Joe Our C. the

Joseph Pantginis

further, get least you on a that on NIH. you I more broad flu this and know constantly question do money to this and its How do competitive say, the of asset? program. well. provided by to differentiate teased field I years to grant universal And wanted I what's obviously today you you or Frank, saying from Because been would process over data details vaccine the you're I the seemed want PDS potential non-dilutive position said looking and my capital with market you balance at the the think has take own the advance look rapidly presented can beyond that is? to potentially to you how view flu the at question to your potential What guess quickly?

Frank Bedu-Addo

discussing things lot we been the A of internally. that have

and we is towards diseases oncology, programs infectious universal those some non-dilutive key to data approaches. as overall get looking versus desire currently, why early I funding at the as the program And and our that that's flu trying commercialization really the approach today. we've the the for flu resources to efficient. on been things think do want vaccine, to via one of oncology to possible with That's at be least to accomplish the rapidly financially really of universal move our taken focus

In terms of the here differences, are the that I utilized. unique think antigens is being what's

You're of the differently those have with together flu been different been probably against has single right. or What's three into okay, viruses, of the flu those been been vaccines typically to a discussed have have of of that has over a strains together consistent is in regions Universal how several been And this into of the be done into can for hopes that approach changed have here modeled over a flu put two have strains vaccine seen they of taken generating what of, the broader where years, the vaccine. specific antigen. strains consideration that antibodies approach incorporated flu decade. that last we the particular over decade, are terms of much the number design over last the a antigen in decades computational into strains strains been that what terms taken specific

what the that when is to presentation its a get vaccine, you as antigens that is studies, response, protection generate seen very we viral after And the into and time but of immunological is powerful pathway. animal see together, they give are that antigens COBRA you Infectimune. not with cells. T complete vaccination highly potent as which combine done, Infectimune, the flu responses, immune well When can protective vaccine. when right processing we've that without activating presentation immune neutralizing as is that lungs broadly in of you antibodies, two even novel well with those signaling when as Infectimune ability you some the as beauty Now, critical to first put the pathways, for broadly presence necessary you those do importantly, The as, see in

significant there I a So, think opportunity. very is

we I only, the our on infectious focus diseases not is oncology very think just of opportunities, business that things will one too. will at much development activities look will do

while to early safety as we data, human as allowing infectious additional it space those believe done human space. disease those believe confirming partners. key things clinic, significant humans, in early the the talking similar in are generated in compelling with potential that data, and to But on PDS very could on will results. disease that clinical key be well some too, bring generate goals demonstrating response get working also we're However, be that We potentially that partners significant like showing, important are just the really the to in hopefully generated infectious to confirming data breadth potentially data that and attracting into that we've partnerships very oncology, immune of having for in us prospective date,

Operator

Robert question next The coming is of with Markets. from line Capital the Noble LeBoyer

Robert LeBoyer

year. keep and short could pivotal trial next my question I'll just potentially start the about ask that

to whether any out-licensing have specific have as stage certain of to related number you're licensed, trial? projections you or to point to or and secondly, early patients collaborations strategy any going do In things be parameters entirely of these any are products? as terms a what in terms the or of milestones development to length those the any you And seeing, business of opportunities, do

Frank Bedu-Addo

them to also see want the with on we have hand feedback I give stab the and is it trials, to in and additional on some we're trial. first think that they one trial But to also what you Lauren that things the would that the the of do in strategy. what of take I'll get thinking discussion to some like have FDA, understand information over terms to key

pivotal as would table. – want partnering the and options potential will evaluating move the want available the what going, are have, case, to really make you be those now options and would we what opportunities company's But, our would of trials? for would in and the potentially We're the own independently. how the what least anything would preparing, them In just company. and Currently, to on partner clinical and we when are trials typically all trial, we are currently, hopefully the opportunities understand At want options we strive do we all would could look to the best add both those at terms move to we we also to Lauren, and forward, be to forward have one we or to the goal between shareholders. that decision company on be get them. do of we all on

Lauren Wood

XXX regionally population We at looking we rates would as XXX studying require that as KEYTRUDA well PDSXXXX that estimate a to This can globally, combination, monotherapy is involve the exact in trial pivotal vary as which plus KEYTRUDA HPVXX. same well the as would subjects. screen incidence versus that on of are approximately field the currently VERSATILE-XXX dependent VERSATILE-XXX

and about design had half strategy Frank with this and FDA the regarding FDA going end from would we And quarter, start concurrence mentioned, the the that the is of the before with XXXX. that the will As we hopes hear first the be the advice to the pivotal study of trial critical. in

believe, approximately is during the our XX of a initiation following The to call, projected the The expansion other the global study enrollment would up but issue study. not that Frank Europe, that, rates. mentioned depending from VERSATILE-XXX for on also window of set enrollment is only months anywhere groundwork as our introduce infrastructure we be also into laying ex-US,

Operator

closing remarks. you. the reached session. Thank floor of the our management for We've end question-and-answer I'll to hand back

Frank Bedu-Addo

very you thank Again, on call. for joining us today's Thank much. you

our XX both progress the continue and and administered To in of the patients trials is update has all and you combination. And progress date, we'll both can summer. efficacy data patients We during clinical the we to over concept. appear preclinical be and We of believe programs. to very look progressing triple PDSXXXX first and fact as support. the that well safety provided recruitment significant from proof Institute appreciate have and and The for combination and year. the is six months remainder provides see, we to in led that of KEYTRUDA your success the wish encouraging, Cancer been strong National We during PD-LX you extremely we've XXX progress As you we made next you half forward ongoing the much. to continued the the validation the best continued Thank ahead.

Operator

This will conference. conclude today's

participation. you for You may disconnect time. at your lines your Thank this

PDS Biotechnology (PDSB) 8 Aug 222022 Q2 Earnings call transcript