Earnings call transcript Q4 2022

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Greetings. Welcome to PDS Biotechnology Fourth Quarter 2022 and Full-Year Earnings Conference Call. [Operator Instructions]. A question-and-answer session will follow the formal presentation.

As a reminder, this conference is being recorded.

turn Relations. over to CG Gabby pleasure Investor Capital my the to call DeGravina It's ahead. go Please

Gabrielle DeGravina

Good morning. webcast. to earnings And welcome conference year-end quarter call XXXX and and audio PDS Biotechnology's fourth

Dr. On from Dr. B. Chief Chief the Wood, Hill, Chief Officer; Matt Officer. the are Lauren and call Medical Financial Executive Frank company Officer; Bedu-Addo,

the well Earlier this the a website We and company's at PDS pdsbiotech.com. year full issued on everyone quarter available which on XX, encourage announcing Form XXXX. the as shortly. release press release with will morning, press PDS press to report Biotech's be PDS is read The ended as the Biotech for financial release December XX-K, results SEC filed

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

including begin, well everyone and Certain regarding research statements today's XXA need and that, statements, of making and PDS will as as we regulatory information Corporation of amended, concerning the of matters. company this States as we may remind XXXX Exchange XXE Section States plans, amended on as be development Section Securities the to Act United include of Act United the call, Biotechnology Securities XXXX forward-looking presentation forward-looking in activity. product the other of candidate within Before meaning

of operations, may and the management. management, These company's by, of or available intentions financial to, or future assumptions current the results and as discuss events, condition beliefs goals, based plans, currently statements expectations as as trends, to information made otherwise well on

results those with most A in to to the can PDS filings risks and Biotech's from description These SEC. be that forecasted. risks uncertainties cause subject statements actual found may are of recent these differ

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

that, Dr. call hand over I Frank? will to With the Frank Bedu-Addo.

Frank Bedu-Addo

you today. for us thank you, call all joining our And year-end on Thank Gabby.

We advance trial achieving Most PDSXXXX. our year, past our have to registrational a lead significant continue pipeline. to we importantly, candidate, made tremendous milestones progressing what's progress for as closer this oncology several

is human HPV, potent stimulates against targeted papilloma investigational a PDSXXXX immunotherapy HPV novel that or cell cancers. targeted virus, T a positive attack

with and of or ICI as Our well-designed to performing rapidly priority Phase HPV is goal PDSXXXX our immune to development trial our XXXX efficiently and key maximizes as possible the that speed cancer the is a treatment head for PDSXXXX checkpoint success. commercialize in X finalizing patients. potential for by and inhibitor, of Therefore, forward move both neck naive positive

I as we combination the to known Institute led, discuss and the NCI had triple move National into the registrational trials, Food like pathways to we and briefly quarter These would were US the Before meetings with recent led, our trial. FDA. advanced two the Cancer have phase VERSATILE-XXX fourth two the or most also Administration, Drug meetings mention updates, for held

transitioning guidance will data maturing ongoing X useful both VERSATILE-XXX. elements on provided we key trial from meetings, both In very designs. the and into this the development Therefore, be by informed FDA of year, clinical Phase

head in controlled will X or recurrent combination versus in trial Phase The HPV trial neck with This investigate VERSATILE-XXX. metastatic called Phase will randomized, alone and ICI patients PDSXXXX be X Positive naïve with KEYTRUDA cancer. KEYTRUDA XX

as PDSXXXX, with necessary continue NCI NHS we to formerly combination In immune approved inhibitor or IL-XX, triple or known parallel, MXXXX PDSXXXX, checkpoint led will progress ICI. the an activities of

safety KEYTRUDA, XXXX in and also trial ICI pembrolizumab, profiles The Interim ASCO refractory efficacy presented combination. combination Merck's on for X touch Phase now is the naïve results with patients. and in the at VERSATILE-XXX PDSXXXX Let's as update. known trial investigating demonstrated both promising

Data of with overall XX%, the nine-month survival At for imaging KEYNOTE-XXX KEYTRUDA study, monotherapy included months confirmed rate objective unconfirmed the responses. rate the showed XX%. was published overall of an of survival nine from approximately XX rate patients which and follow-up, was available response XX%. In

the parameter of relevance that OS. is or survival, overall translated objective FDA free in immunotherapies in the the many improved as believe or PFS, response have We highest not to to rate, and progression ORR, improvements overall or survival survival,

been It shown or as new drug has, becomes be cancer metastatic will most the survival, head neck such or drug approved should FDA noted and that an KEYTRUDA overall to which criteria in combination recurrent survival be where evaluated. the improve important by has

has reminder, this from Track the designation Fast received program a As FDA.

the Following our clinical our the initiated and of the to successfully quarter. of product for PDSXXXX VERSATILE-XXX. PDSXXXX we for selected was manufacturer X this Phase commercial manufacturing tech quarter FDA of process transfer successful, up third The XXXX, was in a and scale meeting transfer the completed production

as sections and VERSATILE-XXX. amended overall control design survival Most are in of free importantly, and our statistical progress. insight CMC, data and final of the that the manufacturing critical IND potential the mature data gaining into known PFS portion the The of are section, to the X Phase are continue study. also we progression to These survival from clinical chemistry, overall to ability survival

to us not it patients and are of encouraging, that insight it possible to these alive for progressing. duration signifies parameters rapidly as gain majority to the The highly endpoints has staying is taken critical begin and

important prefers products. by oncology the As to I is approval confirm parameter survival FDA the of which most typically mentioned, overall

We OS PDSXXXX/KEYTRUDA previously are hopeful, PFS presented ongoing results, and we to the will able upon that combination. and be improved based with show

and currently will other CMC agencies to of agencies be possible, intend and for the protocol in also this and review. year. If feedback their protocol incorporate design final into in the we section clinical European comments VERSATILE-XXX second submitted that regulatory on the the country-specific quarter are FDA also the expect communication to We with

IRBs, allow sites as us year, to present for amended should or We quarter which the file an process investigational therefore the various of perform to activation. expect to in the the third the of we site protocols review boards, IND this

Overall, typically take months. activities startup to these six four

year in fourth to to quarter opening global the of are at We the XXX sites. XX the run the up towards this and be working goal expect trial trial of

a we why of the triple progress reasons VERSATILE-XXX of have are ahead combination. to decided number the trial There

approval a all, other for PDSXXXX obtaining of as simplifies of of PDSXXXX First perspective. product specifically such an agents from combinations the our with development PDSXXXX future regulatory

regulatory program approved an IND-related the activities a combination progressed and product. this FDA earlier of to further with clear investigational for the agent also commercial are with meeting pathway due

to cancer. first design, with Importantly, we have HPV clinical fast having potential to approved for address our positive immunotherapy for program and PDSXXXX this good become track the

continue the we'll similar combination progress aggressively provide getting towards to we to parallel, work future. on In a updates triple the position, in and

X for Phase combination PDSXXXX transitioning PDSXXXX trial cancers. cancer. HPV with positive the or the FDA updates Last refractory the triple neck HPV and of So, combination on with recurrent positive ICI to month, and we metastatic with announced triple head advanced for meeting the FDA for patients ICI of approved a NCI-led XX an successful treatment

Our commercial triple ability a combination. the pathway to develop replace regulatory investigational ICI to the ICI with the simplifies

broader our conjugated It agent in potential has hurdles program acquire to Our strategic mitigated has novel moving forward. decision antibody pipeline. for operational in the use and IL-XX, PDSXXXX, unencumbered risk now also the the

simplified investigational current with combinations pertaining we and or to clarified and Importantly, by products. PDSXXXX future commercial ICI our of the the replacing products the a and commercial future with ICI economics acquiring other also pipeline PDSXXXX,

This important is also Darmstadt, of KGaA, are also clinical burden by includes ahead acquisition financially of as PDSXXXX due does product very Merck agreement note It payments to commercialization. successful the the deal not supply that product the the of Germany. development minimal PDSXXXX

you potential and This see, for as partnership, for maximizes therefore, parties. can the both financial development success

Merck with last updated results extremely quarter. we reported outcome the are triple survival We KGaA with from partnership pleased our combination the and with

therapy adverse the has the PDS in with patients events head neck triple data for to only X encouraging HPV patients selected be therapy triple grade X% in severity of Survival reported reported be has indication and advanced effective trial despite of no These reasonably XX% disease. of adverse developed. from the been tolerated, Biotech events the XX X refractory the treatment-related have grade well clear ICI combination few combination and and appears of will patients. as and the care initial cancer options standard which positive

note, the refractory and XX XX out of XX reported Institute Cancer data who the we reported XX National ICI December, triple was and months XX positive an ICI with interim in had overall survival XX those, Median three included refractory Of disease to Of HPV HPV four evaluable patients expanded patients. that the failed refractory. combination. median In patients only historical is patients were months. were ICI overall positive therefore and treated XX survival treatment in received with ICI the patients ICI

refractory our initially February median ICI head on date cancer refractory data meeting, combination XX head the overall triple in published announced to we As best months. trial XX, HPV after our neck X.X neck ICI and FDA positive survival will of is and cancer. The target

combination The in the HPV expanded positive data see and in to demonstrate the triple exciting continue data therapy is durability update. based and to with tolerability PDSXXXX advanced the cancers, of it each consistency

of combination care had trial. are or available. on The combination PDSXXXX patients additional data to with is a becomes treated in presented response IMMUNOCERV the being of the than size. X and no clinical to XX%. of tumors large XXX% These or disease with data biomarker encouraging with on XX%, a the study in therapy we the complete radiation demonstrated CR, performed of Remarkable Anderson XXXX. cancer chemo were at advanced Phase over results with standard with greater you clinical Moving MD look led treated the shrinkage nine and tumor forward locally of X evidence centimeters with updating XXX. and patients, when cervical SITC day eight response, patients

early hopeful to trial. recruited and cancer treated, continued X Mayo see data Phase we'll HPV of before stage, Patients year. end and XX Clinic in continue that in we are Positive studying The the this PDSXXXX a pre-metastatic oral be

we've timing Mayo treatment do trial, As study the progress, before, we have around readouts. the data and over investigator-initiated its enrollment an is control Clinic not meaning mentioned or

would is investigators when a study preliminary present at However, data that medical our congress. available expectation

on half year. PDSXXXXis hoping IND with Moving broader activities to progress. Pending file are second in initiating our the we for all manufacturing Tech the to VERSATILE-XXX, associated the transfer pipeline. of this of in oncology slots and availability

PDSXXXX for IND file We XXXX. the in expect to

I initiate this fourth Before Lauren, of I over to year. to by trial turn the call will we X reiterate VERSATILE-XXX that Phase the quarter the plan

protocol. is quarter. progress are in we make manufacturing third We the clinical continue the complete. as well program. with CMC activities of the to expect IND And Late amended stage finalization Clinical as the file significant to ongoing

to the updates. the call I to will now Lauren clinical us through turn walk

Lauren Wood

conducted research data some the to the peer recently like PDSXXXX clinical recap journal the I'd in the NCI several to was Frank. months. Immunopharmacology. of in Thanks, respect last reviewed exciting by published we With International monotherapy, announced

immune The also and clinical study XX Phase clinical The with dose assessed cancers receiving changes evaluated to in patients immune immunologic generated subset treatment-related responses. correlates dosing of Patients schedule X participated several the higher the study dose in changes level of the robust more who advanced Researchers of PDSXXXX. of a evaluated a trial with responses. PDSXXXX. relation of PDSXXXX

These Importantly, level. highlight supports immune dose date stronger in data seen responses immune PDSXXXX the which of immunological triple were NCI response seen the combination the activity study. the to higher at data

increase and exposure in the by limit constitutes immunotherapy. cytokine-based to significant development to of its the presence advancement tumors research circulating within a The The IL-XX's and published PDSXXXX the blood ability of in the microenvironment. its and the potential as immune a potentially the demonstrates ability responses overcome IL-XX that to of activation increase stimulate tumor-targeting tumor immunosuppressive NCI frequency immune the

treatment events associated in doses grade events were X monotherapy event adverse treatment-related cancer biologically studies published and Published occurred. was greater and This of XXXX grade research. these treatment-related XX% with PDSXXXX or adverse was all grade transient. active X and no in One to of observed in adverse equal Strauss of colleagues than clinical were by patients, X of related

improved cells Importantly, these outcomes. biologically active and in immune specific with clinical doses increases are associated

known well protein tumor or TARP, Association oncoprotein for of drug immunotherapy. our associated and development formulations on were also programs. frame protein immunology at preclinical tumor Research, is mucin-X as the on data AACR, also containing XXXX the and on epitope as sequences Versamune-based peptide cell modified known as moving poster conference special as presentation alternate Cancer to sequences American reading of presented T PDSXXXX both multi antigen The Recently, highlighted Now the gamma MUCX. which chain receptor of PDSXXXX the

breast, a the PDSXXXX research development MUCX as other colon, as foundation prostate the clinical lung, for potential cancers. for acute treatment cancers, and The preclinical myeloid associated of and a ovarian breast provided for PDSXXXX treatment associated potential leukemia, TARP and

to predominant PDSXXXX killer multiple with TARP seen high and T killer cell induction multifunctional Key PDSXXXX. findings against been were responses cells, antigens for similar of CDA of levels observed potent T and what's

to induction and Key multiple targeting MUCX responses the positive targets findings and of similar in multifunctional of PDSXXXX, T levels PDSXXXX for were, killer PDSXXXX effective again, of MUCX CDA and against high antigen vitro. killing

We're date PDSXXXX confirming the progress. biologic PDSXXXX pleased is to for their with clinical of research products complete, The activity. of and antigens manufacture in and is up these the preclinical compounds, manufacture scale

There's to mutation. of elicit advantage ability been viral infectious much less T strategies infectious CDX wide broadly regarding broadly as to agents. T is infection. area cells, be discussion also of develop can various to ability susceptible among effective effective is and key of be novel known cells acting disease the more providing helper against their One the immunologists protection important more cells, in and research to An experts development CDX vaccines that more against T

studies, Two were the peer journal utilizing in February in important published preclinical platform Infectimune the reviewed Viruses. XXXX

that to responses immune T immune vaccine that induced the two commercial evaluating study leading vaccine influenza performed research The potency cell a vaccination Immunology, and New responses Infectimune technology's leading CDX the studied the cells. of eliciting Rochester Infectimune comparing by focused cell Biology in following concluded T technologies Sant, preeminent T in researcher, against Dr. primary Vaccine The relative adjuvants. studies responses Infectimune laboratory CDX we're in enhanced at for and of Center University dramatically Andrea with approved study. induced demonstrated on CDX

protective The against in viruses, College generate to ability and of viral Woodward Infectimune and from multiple Kentucky University Siva Gandhapudi influenza. Viruses second of of including of protein Medicine from Gerald demonstrated immune publication Drs. the the strains with a response antigens broad

of of antibodies of The T the induction were flu neutralizing cell Infectimune against investigational influenza. cell flu and demonstrated virus. regions animal vaccine of strains also influenza. generated in was tested PDSXXXX universal models non-mutating responses T multiple against

challenges PDSXXXX NIAID for discussions vaccine. continue universal are we preclinical Importantly, consistent completely from studies two results These protected lethal influenza and our funding viruses. among the with animals clinical promising flu with regarding

you will move posted forward. We we as discussions keep

we To are today. summarize where

First program. Versamune oncology with based our

see consistency the clinical triple encouraged we the and We by IMMUNOCERV in are highly trial. the response combination and survival from coming VERSATILE-XXX, data

of correlated cells at infiltrating multifunctional The with results in by Phase biomarker type demonstrated XXXX study the which potent and quantity, right Anderson X SITC reported of clinical right both NCI the the tumor both responses induction in T MD killer cases.

independently program, based especially With two the our potential, Infectimune infectious about the disease journal studies Both we are similarly that the Infectimune potential of inducing Viruses induce only T also but month. excited in unique demonstrate the reported mutations, and last considering not are CDX reactive potentially CDX antibodies. more less neutralizing induce studies reactive to to also susceptible while to T cells, cells broadly multifunctional viral broadly

call the to review to At I'd Matt? to like this summary. financial turn our time, over Matt

Matthew Hill

Biotech. year PDS We at Lauren. extraordinary you, Thank an had

forward, business mitigate financial supporting while seek our strategy. risk financial overall the move to our to commercial we As strategy continues

select promising and progress combinations indications most rapidly to trials. the registrational into remains goal and Our

candidate, We're Phase trial. VERSATILE-XXX registrational excited to will PDSXXXX, our prepare for part our which X We approximately of our budget cost is trial lead currently operational million, and $XX projections. a estimate

quality primarily license approximately year $XX.X personnel and costs, higher million loss diluted December Now compared or XXXX. asset. cost share clinical for XXXX. let's December $XX.X ended our research XX, due loss to approximately to the year the basic per net PDSXXXX at $X.XX XX, and the net to $X.XX manufacturing financials Net basic costs for our and million, loss or share XXXX of diluted take was and look ended of summary for year per share ended a December XX, share a The was the

personnel of and the KGaA, of balance expenses and million, in the December XX, Darmstadt the the Research in million and $XX.X to costs for costs rights increased for million approximately increase year of the PDSXXXX $XX.X to our in clinical million, cash ended from development for year costs ended attributable $X.X million, was was compared XXXX $X.X common approximately $XX.X manufacturing million December shares The of increase XXXX. $X.X $X XX, Merck primarily an stock. Germany. Of to million to $XX million million, of $XX

and year approximately and increased General to XXXX the for personnel the primarily XX, $X.X million an ended XXXX. million million ended to professional attributable million. December of December approximately $X to year fees $X.X The compared costs administrative expenses for $XX.X of $XX.X in XX, was increase million increase

expenses ended to year operating XXXX. expenses XXXX December XX, the million approximately of $XX.X million $XX.X year December total Total were the XX, for for ended operating approximately compared

XXXX for ended as year in a be in to all PDSXXXX share $X.XX increase quarter. XX, loss primarily Loss of million and and in-license basic per and XXXX. diluted can loss XX, the per accounts and diluted year recorded loss share expensed the the for to December The per in $X.XX per $X.XX share compared approximately cents share. $XX basic R&D attributed ended was investment December It the basic to of for which fourth diluted was

We and which fund and our is to of million discipline sufficient $XX.X available is ended cash of flow continued development attributed in operations prudent the ATM. on approximately and cash this projections, the year third programs company's cash, to with XXXX. efficient the believes company, balance execution company the into the resources Based our research quarter and financial

operator the concludes like question-and-answer This call call and our the to portion turn Operator? for the of I'd my to session. over

Operator

[Operator Instructions].

from coming Gershell Leland Oppenheimer. from is today question first Our

Leland Gershell

the all Congratulations progress. on

Just a question maybe for Lauren.

the of size enrollment the As collecting statistical from I look a XXX you're you but we informing what the forward data XXX may of like? know to respect considerations, with sense of still trial, to look have VERSATILE-XXX do the

Lauren Wood

that's the informed sample ICI will maturing data of in VERSATILE-XXX naïve The be size design by the population. the VERSATILE-XXX total and

in for we updates to a size that additional And looking us spring sample data to finalize in protocol will give the and that anticipate we as trial are efficiently consistencies We possible. will us that allow the as the trends. have to conduct

Leland Gershell

you'll settle be study, With the ICI awaiting ICI choice you allow at are to Is you the to is? regard to will except learn a triple that that information any the or the of using that public to it'll that to available yet you identify have combo allow what be one. least commercially on know there

Lauren Wood

the data design in population and study, have an of refractory to the ICI from excellent terms maturing of combination triple VERSATILE-XXX. That's question. of the we also leverage Well, plan

know, iterated, that be to informing Frank focus As overall of would have trial. study. the survival, we And we to to the going since is be the will data triple ICI VERSATILE-XXX population refractory of the key design from like in that maturing combination

checkpoint on aware, indication. As we inhibitors more And from neck that in are two approval be informed head refractory patients. metastatic we recurrent overall the will and that you're there data determination ICI disease making survival immune as have get

Frank Bedu-Addo

two approved, OPDIVO neck what to said, for KEYTRUDA inhibitors little a head and right? to bit cancers. that checkpoint Just know, you have Lauren as and add commercial been there are

it's need. But two. those do also all strategy to we the in to in the want trial, to things of prudent is of terms information So, one one we to the be going be getting of the design

seen the and the And we based making technology in necessary preclinical results this the studies, clinical upon seen data trial we've how conditions, seen one why our go trials. So, of to reasons understand did that, studies, were we've all trials sure very optimal select consistent working, into is very that from trial. that kind exactly in we we've the our systematic today is clinical the of

Phase as checkpoint these gain to then the clinical the commercial VERSATILE-XXX. we since of we're that's possible with now all exactly as ICI these we going of in a evaluating trials, running And can reason much refractory why trials. inform PDSXXXX, information inhibitor are design what to That's are various right, that X arm

how some design terms could having really so, the trial. we how very in informative that's And performing be of information on

dual patient whether with few combination, lot maybe exactly reduce survival and with dramatically design XXX a we we up an in months design later, and a understand a but months cost speed much commercialization. that's actually a few which efficient, potentially improvement trial, to our assume see but wait a example, end For more starting we a would later smaller overall then

designed of So the doing we shareholders, provide, we our the final and that just sure trial. want to best that of to based information, trials get making in the progress interest design what's then information we're we sure upon make into that specifically that

Operator

from Next question Louise coming is Cantor from Chen Fitzgerald.

Louise Chen

I quarter. on a Congratulations wanted VERSATILE-XXX? for broadly could wanted XXX? design more details, XXX you you more maybe VERSATILE-XXX results And little of how your if then design thinking the versus how on all on study provide Phase study the progress speaking Phase did some the X that ask and bit the the see to this X inform you to

year? present Secondly, – new at so, where your are conferences medical Infectimune presenting any major what you even if be venues? or oncology your expecting from virus And this and to you data those platform would

is thinking to of good about just about starting study, you a about how so think XXXX. curious a for the for OpEx how the of fourth major And you're in cadence thinking starting things? R&D Lastly, point XXXX, build expense quarter XXXX

Frank Bedu-Addo

finish trial, and I'll to correct. then the Lauren of over Phase start in you X But in terms are up. terms hand to

as from to possible much information get looking the trial. VERSATILE-XXX are as We

is is us take power from would key trial the that what parameter mentioned, we also to understand. survival want as to information what we overall As design But be I the VERSATILE-XXX. the believe the want really trial we will also do to FDA

were For to with insight FDA with example, in approval. And design with PFS discussing those can than then us the that of PFS overall increase sooner like? key parameters potential we needed in our the do correlate could in a into for we we to what some points survival, certain data regarding the that that because, allow Does if look data increase get that's get later numbers that VERSATILE-XXX may interim case, then start example.

how and accelerated guidance terms look as trials the for of of for they would from single and at Right? So, that there look how example, accelerated approvals part has right the would control final FDA with that at things been all approval. So, they in we information, recent it's give the now, discussions key we positive, this start numbers, to be than ourselves data to opportunity later. the with having the to input the design, into the would do, other regulatory get from sooner but see able finalize if also countries want design, agency. And finalize

that's as parameters. key So, terms why to needed how numbers over really were in of overall KEYTRUDA of improvement well our sets and see look monotherapy the we of to survival as one published in reasons beginning understand PFS both if there was improvement data

I'll the additional Lauren hand questions. over to address to

Lauren Wood

In follow data at up to Louise, to updated Frank's VERSATILE-XXX scientific intention, comments, is meetings. our present from

VERSATILE-XXX. ESMO, targeting potentially of parameters to that ASCO, and population updated again, inform relates as also examination are it of the the immunogenicity SITC naïve clinical in present also We related not Frank and VERSATILE-XXX, PFS are either we design to the at to ICI overall data only survival, confirmation seeing and but which, in outcomes potentially will noted, our

course the I think during treatment experienced of the the patients. that T cells present looking to as potent the one XXXX. demonstration XX important things of was multifunctional induction data heavily these from that in last And see patients, we CDX well of patients, year killer most specific we're even in in HPV come to VERSATILE-XXX out

yes, presenting will So, that be data. we

of terms lethal I rest And to broad Infectimune year be from be CDXs CDX very, cells any based influenza indeed Infectimune are with trials. additional platform of I challenge. The presentations. protected clinical publications that that preclinical antigen goal studies progressing Viruses in presentations think guided scientific the our will pursuing regarding by may to the can't demonstrate human us the ability we really and for very during specific comment this were of impressive

And question third a had. repeat that? just you that there was you Could

Louise Chen

Yeah, financial question. it was a

expense wanted of a then cadence by ask about coming start the of about think XXXX quarter quarter fourth to the you this we VERSATILE-XXX So for with base this off of? fourth I XXXX. how good OpEx should R&D XXXX, build Is year? to And

Matthew Hill

I if related at trials, starting Merck think going into million looking in our KGaA. – I that's take step to that we've to costs we increase with obviously, spent fourth associated see think got in in the QX, the and up But continue the you're to $XX XXXX. and quarter numbers, you

– So after about well it. well. and a obviously, I'm sorry, also, as that's eliminating additional that, have way expenditures And administrative we're some R&D expenses good to think general to going as

Operator

Kalpit question coming B. Next is from Riley. from Patel

Andrew Fleszar

Fleszar final for Andy along had requiring the with FDA successful you on meeting the initial submitted be data on the is protocol protocol? with We is Congratulations This any progress. Kalpit. be to agency this the But more And should expect submitted? to a doublet. trial that know for the when we

Frank Bedu-Addo

that mentioned, also, the looking Hopefully, looking FDA. be in would information combination. contribution statistical of able the we pending is the want of think additional see PDSXXXX addition that think we triple get at And that provides that with things that in to of discuss something I data. be we PDSXXXX And one would of we to key want possible. with the may terms to we some quite to that agents. the times talked would inform that we is triple, that and as a mentioned We what anticipate so, in program. bit. things have may Right? us, go we a – to But that's We to will again, about the key do FDA how – to are that design the I the one portion of of number

PDSXXXX. to That's be been those critical if PDSXXXX – were found the for trial, be with those in there the us Right? because, triple agents the critical and also which you important combination recall, has are outcomes. three Both to outcomes of clinical two for found of

potentially of so, is number two part finalize that their bigger of again, that do stage we But patients trial. what to to small we registrational waiting look for And for as are those at [indiscernible] medium design. a information a are may things where we

able VERSATILE-XXX. design the going what until we all based the on to think detail we're But a information too know efficient be probably today, some things key be we it's are think I you're trial, than asking. to design what But to that that We the we come much wouldn't up have at smaller the design most to into with looking these provide of possible.

Andrew Fleszar

misspoke, was doublet but study. Sorry if I the actually questioning I

Frank Bedu-Addo

doublet study, okay. Oh, the

Andrew Fleszar

agency more requiring that initiating Yeah, correct. the If is data trial. before any

Frank Bedu-Addo

any require no. We before No, we don't trial. initiating that don't data more

Andrew Fleszar

the protocol will Do when have of timeline submitted? sense you a of be that

Frank Bedu-Addo

the the the feedback get design and then Right now, we then FDA. other that from to would put that EU in to regulatory agencies the their final we with are in the would discussions countries go order into

time And the anticipating that countries are that that's probably be we'll information ongoing. so QX all so, those other put early that into QX. that late we That from or have currently we will by protocol,

So once for IND we then the will final filed activating be various get the will in we QX. various the anticipate we amended investigational IRBs, then the feedback, review start that And boards, FDA sites.

into We we sites. we of that today, sites, working are to VERSATILE-XXX most sites of hopeful with will a the the convert number able the be

those four so, processes months. six to typically And from anywhere will take

considering get this and we With all to that that timeline, will is these running be activities. trial what up and hopeful other towards by QX, we're able working

manufacturing has clinical the mentioned, already. successfully been completed I As

section, trial by right? we'll of get and we IND get So, and So IRB that's finalizing the activated, we'll really the the sites get timeline of Right? anticipate later successfully the approval, CMC initiated all file those QX. activities progressing when are date. we when terms stage our in the the to are So,

Operator

Molloy James Partners. Next question is Alliance from from coming Global

James Molloy

Can a anticipate the Did some take IND way looks I run. quick point? gets we of Any to trial What going for to trial sort should what next the potential running trial. to be of little we had IND, looking once question a the bit interim of Phase sort there? X amending to data guide you're the up to out? of catalyst you The coming time through the and breakpoints the on anticipate? some exactly on amended amendments and at where walk is VERSATILE-XXX to

Frank Bedu-Addo

a be was for a you're single IND. trial, the updates the those amended arm But right? trial, was really IND into to going trial, now Phase X and X Phase called we're your We which if have IND, made. controlled initial So filed updating

update have We've manufacturer. to commercial process. going process. We're to update the transferred manufacturing process. selected the have We've now We manufacturing to the our

Phase raw to manufacturing manufacture the X. we CMC, that's updated have manufacture Phase the of the to those update be All those the the be the IND. R-DOTAP, X made Versamune, the for to have to scaled been up peptides, updates As in also of for process material

like. information, transitioning of the call as with Phase Really X the an it a and that's so, those with would the manufacturing at it we what And pertaining look amended the X, updated from package new look why lot the Phase to CMC IND all ind. to commercial

what we're doing So, there. that's really

James Molloy

for and we trial the Any thoughts here expectation or is be points on running? potential on once and up looks What coming interim timing [indiscernible] should data thinking out? data

Frank Bedu-Addo

at, that's when for looking example, we're with PFS. think I

have come to with, one up I think of overall are it is points indication whatever survival. you would you that data we give prolonging some interim So, things the key mentioned

As or response I recently. for survival the evaluating many really presentation, rates, the the been with immunotherapies most in mentioned immunotherapies during overall example, that objective FDA of correlated has haven't

so, as that overall delta and we the us what's based look. XXX survival and data And the our one between overall interim PFS survival, in that that we based for the both in KEYNOTE design improvement, VERSATILE-XXX KEYTRUDA data reported upon will with versus survival. then what's how VERSATILE-XXX we as the for monotherapy. in an could the and reasons inform with we an are use that what And the trial delta upon at determining see PFS PFS improvement as seeing we're what is looking overall of in that key And well

able terms to a on delta to numbers to we would looks survival, And with things discussions associated go we at the for through PFS, determine the with an the those get those trial. various and we why FDA. design have than before We're if are of design going us completion to have see also overall but waiting to to the little we increase population trial of wait that some we be statistics early important really being get the be what's in discussions waiting feedback we go is indication having this now able trial why so, of looking that absolutely to rather and that very seen we survival. least need FDA before the improved the to before trial an to the And entire the have were before going want the to very may that's with design. to that to tweak clarity But from that in to we're numbers increase cause That importantly, countries. in size patient an some bit finalize that's to overall PFS,

So we're that specifically in looking design. at our design

James Molloy

data it's highlighted would the out I question walk be know potentially your clear, triple with know future? point you on triple in how XXX through X hands study of The combo combo. running Phase here. data current the the somewhat trial. the final – or some the from a partner I But sort at expectations Can for on next focus a earlier you is any the this? of thoughts in expectations that

Frank Bedu-Addo

Absolutely.

acquired the think essentially now, PDSXXXX. is combination, NCI done is so we with trial out have triple triple is the what hands. our of we've Right combination The I completed. not

now So, really, with KGaA. the in designing of are partnership terms trial. we're Merck They it's control us material, the the our with providing in

looking KEYTRUDA these and which data, we're is treating, refractory though PDSXXXX However, to population in KEYTRUDA in sometime head commercial efficient IL-XX a and even at is exact neck we is see which to data PDSXXXX inhibitor trial, IL-XX, metastatic patient that cancer. complete looking inhibitor And, patients. we're checkpoint we recurrent critical know we're have that and to going this plus design an That QX. in checkpoint of also therefore, be at anticipate should without we that this trial

So anticipate be would be seeing trial, will the necessarily Phase that in but it what very X not data informative. will essentially we

in efficiently see then already population. overall us to allows That we information an clinical improvement Phase more of in that patient without that example, survival, IL-XX for even X If, design the trial. portion statistical

of key information are the those for. So, looking pieces we're

take same commercial we for We're time, it correct over. the also, product that the at doing needed as identify work to manufacturer the

in clinical So, look to Phase terms to want product. our into be make of commercial mitigates X to commercial do the what significantly. trials much manufacturing. speeds what the similar actually is risk BLA going go product producing to It sure that to is to as selling going we your That your like essentially, very and it's up we going from your pretty

and things of end. take same would key to we did process So, for once start beginning we like that with approach the much the efficient that VERSATILE-XXX it some to the those combination are triple make more to from

would and is are we up once happened, – and running. focus combination goal then prioritizing the getting our VERSATILE-XXX be currently, running. primary that's getting triple also up So, then But primary

is of Plus Our key here PDSXXXX commercialization PDSXXXX PDSXXXX. of commercialization and

the possible. we're we we risk make really to can most that's approach make efficient that sure So that mitigate and the much taking as as possible execute sure trial

Operator

[Operator Instructions].

question next Robert Noble Markets. Our from is from Capital coming LeBoyer

Robert LeBoyer

to or do been forward the plans question triple to out forward for whether indications. with you in all Mayo details look you've Anderson have My going given coming the the things trials. milestones to those data and the Thank trials or any the from that's has and MD include to therapy and VERSATILE Clinic you on those

Lauren Wood

both Anderson MD as Frank Mayo led well the trial, trial Clinic IMMUNOCERV As are investigator-initiated the mentioned, as studies.

presentation actually the from So, or we accrual the rates data of those publication or don't have control scientific trials. over

there IIT However, and accrual enrollment to significant trial. been and we Mayo has do interest know the that

is that or XX individuals prior HPV cancer. definitive presenting of and Just curative in PDSXXXX oral combination with reminding pharyngeal treatment this investigating to are who alone initial surgical KEYTRUDA resection for everyone using in

hopefully, going preliminary year us us to this Our surgery, in of able DNA. this that It's response investigators provide prior to regarding present study very is biomarker to also tumor tumor be be we that population. to examination findings insight tissues, circulating in an immunogenicity, from into XX but will because pathologic hope they'll important important data, hearing and this not only is some the shrinkage of HPV interim

undergone day The that MD have completed treatment, already on we're their IMMUNOCERV there nine are subjects know who We first of time end had the allow evaluations. Anderson presentation study the from patients XXXX. at data data not XXX to was at their point additional that but of this actually from that

as So, we additional that from matures to that look as well. data forward study

Frank Bedu-Addo

do of a translated Mayo be little Lauren, Clinic want randomized about trial? think help. may the into add and I to potential that bit how you a could it also

Lauren Wood

we disease. or in impact patients in earlier interested for whether outcomes very we're seeing that is things the of One not can differentiating

shrinkage has hope circulating potentially PDSXXXX so, whether tumor pathologic at setting in not published setting. addition see, declines with recurrence, treatment alone KEYTRUDA look this that. to And in combination randomized not we to KEYTRUDA improve tumor and and to design shrinkage whether evidence we versus examining DNA are alone the would trial treatment to hope minimal we would a studies disease in of on preliminary in neoadjuvant with Merck some and see response neoadjuvant those in or tumor PDSXXXX and we or of predictive

Frank Bedu-Addo

With both trials. opportunity of them, both there is a significant commercial in

And both getting from how do receive move the is it's design yes, move that that forward, will forward. we trials. based key information really And here okay, that basic say, that upon if so, we information the trial yes control

opportunity currently data significant commercial with provide the a next make both So decision. the to waiting us we for that are

Operator

Thank like you. closing end I'd further back the We've management or to over reached turn our to for floor the comments. of question-and-answer session. any

Frank Bedu-Addo

our very much Thank very Well, full and ended us much. joining you you conference on thank call. fourth today year quarter earnings for

our technologies in So, XXXX to clinical year our while XXXX poised progress is tremendous development for transformational be for programs, platform Biotech. was of preclinical PDS both the and

commercialization the of to this goal is that reiterate year will rapid prioritize VERSATILE-XXX PDSXXXX I in key study. first our

We our PDSXXXX commercial manufacturer of manufacturing have selected for at completed and VERSATILE-XXX. preferred

We in will also with combination to PDSXXXX. progress needed commercialize activities PDSXXXX

also to discussions PDSXXXX to plan with NIAID into flu progress universal getting continue PDSXXXX continue towards with to we necessary for progressing will activities year. We clinic. this the And IND hopefully

your advance We continued exciting we update you this continue through as we will very for thank interest. much. you journey. to Thank you And

Operator

you. That and today's conclude webcast. Thank does teleconference

day. and your You wonderful your have We disconnect thank today. participation this may line you at time for a

PDS Biotechnology (PDSB) 28 Mar 232022 Q4 Earnings call transcript