Earnings call transcript Q2 2023

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Operator

Hello and welcome to the PDS Biotechnology Second Quarter 2023 Earnings Call and Webcast.

If anyone should require Operator assistance, please press star, zero on your telephone keypad. A question and answer session will follow the formal presentation.

You may press star, one at any time to be placed into question queue.

As a reminder, this conference is being recorded.

pleasure DeGravina, the Investor my your over now Gabby host, Relations. is to call turn to It Please go ahead, Gabby.

Gabby DeGravina

webcast. Good morning earnings audio XXXX second Biotechnology’s and welcome conference to call PDS quarter and

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

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

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

everyone United of PDS Corporation activities. may concerning need the as beliefs on operations development of well assumptions this of will information other or remind based available Act as amended, States condition, XX(e) otherwise regulatory Biotechnology to statements we company the of and statements to of States Securities research information on as currently discuss current trends, matters. the we amended, the candidate These United expectations presentation management. made intentions management, and include results events, Securities and goals, the as the XXXX, making statements, plans, Act clinical call, of as Certain and by Section future and or company’s financial Before be well begin, XXXX, Section including of today’s forward-looking Exchange within plans, forward-looking meaning in as may XX(a) as regarding that to

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

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

now hand Frank to Dr. Frank? will I over the call Bedu-Addo.

Frank Bedu-Addo

thanks our second morning. for Thank quarter you all XXXX this Gabby, and call joining to

this are we We so far progress the have year. made pleased with

to Our treatment. significantly create can revolutionize is therapies cancer goal groundbreaking that primary

on Our lead commercializing current cancers. T-cell stimulates for a primary precise HPVXX-positive investigational focus HPVXX-positive designed and recurrent attack and neck on candidate, therapy treatment immunotherapy PDSXXXX, an HPVXX cancer. or is our is and of PDSXXXX advancing head clinical the targeted metastatic innovative potent that

will PDSXXXX Merck’s neck treatment supporting In information of protocol Phase line the cancer. planned mention previously and or CMC which our or to upcoming we examine our that PDSXXXX. care with chemistry, week another controls, announced. final existing III the we path congratulate to of the or Biotech milestone trial, metastatic I head on achieving to VERSATILE-XXX key with recurrent anti-PDX of in team schedule, therapy, current IND combination and pembrolizumab PDS controlled I on as last compared is first to Keytruda, filed commercialization manufacturing and for pleased VERSATILE-XXX randomized monotherapy, the standard am and Keytruda on

moves fourth us the filing quarter in of the year. This III Phase significant upcoming trial to initiation of closer milestone, the a this step another

are the biologic available in us PDSXXXX and commercialized get BLA, need eagerly As the looking VERSATILE-XXX. patients towards license who and we and move effective safer will can This or of head increased and imagine, hopefully filing all neck application, to the therapies. desperate of potential you are forward more to a cancer commencement to of successfully

is with low rates devastating of and current one the as to and unfortunately may Advanced response of head and cancers most debilitating rates highest neck you cancer, of treatments. know, many one suicide the already

a data II was ASCO annual and Phase our an year’s discussion on progress selected this featured adverse grade significant expert at survival provide head or meeting. positive Dr. and demonstrated of and made XX-month data panel neck patients of details of treatment-related events data interim more we X the rate toxicities. session severe X the and more reports trial. data grade no X XX% X% cancer presented The quarter, Wood momentarily. ASCO experiencing grade This with will VERSATILE-XXX at on We only

significant of of The best on Additionally, threshold per threshold response, registrational VERSATILE-XXX achieved suggests this assessment. tumor trial. for objective when inhibitor shrinkage gives the the for based immune statistically PDSXXXX more naïve III into efficacy is inhibitor efficacy to a of confirmed Phase that over XX% checkpoint or a naïve investigator these immune indicating confidence response, patients patients. achievement us as XX arm effect reached there the objective This XX checkpoint was and additive achieved more in move its monotherapy,

HPVXX-targeted for Just Oncology presentation Medical cancer relevant for data treatment cancer. T-cells responses will last T-cell or Moreover, showcase killer challenging at generate patients. combination immunotherapy the patients ESMO potential in Society the and of HPVXX-specific month, European to biomarker this approach treat this has minimal as demonstrating demonstrated immunological advanced effective induction its data accepted in been helper multi-functional the we further clinical and head to Congress underlining an Keytruda toxicity, this clinically potential and neck has October. the announced the multi-functional of combination treatment that The XXXX, receiving PDSXXXX

and will will detail National three program We Annual an the that led Cancer investigating PDSXXXX at clinical investigator being SD-approved This meeting. for National cytokine successfully study prostate cancer multiple The progress clinical we’ve trial, castration-sensitive or ILXX therapy, and conjugated PDSXXXX, the Institute II in of programs of cancer. first National recently results conjugated of for prostate development metastatic studies. of Cytokine NCI-led care study presentation chemotherapy, novel other an is by continued the lead our by as castration-resistant at VERSATILE-XXX oral the prostate antibody our II activity is clinical Cancer the docetaxel standard presentation Institute, in Beyond and the to Institute combination in as XXXX ongoing the antibody responses announced in the is achievement, ILXX combination safety, the metastatic Phase on docetaxel take Phase cancer of place the patients. with immunocytokine clinical immune Cancer well prostate the which with our clinical cancer the

As readouts we of to the look remainder a the next the milestones. and of of expect year data we year, half key first number and

inhibitor updates quarter. For the VERSATILE-XXX, late providing naïve data checkpoint immune this both anticipate additional checkpoint cohorts immune and we inhibitor refractory on

late anticipate arm trial initiation As our Institute-led later immune With the and this Cancer an targeted XXXX. National the been that mentioned, project second the the completed, be inhibitor. as is recruitment PDSXXXX, antibody High already of of our year. we list of combination checkpoint study the of naïve will data we reported ILXX in quarter on has triple final also VERSATILE-XXX,

head well triple We VERSATILE-XXX combination statistical combination among expect data from updated survival arm refractory immune data as as neck patients the triple the the to of checkpoint registrational inform cancer study. and inhibitor intended of design

to also highly late last combination encouraging providing the We updates triple with survival that year. data the anticipate we reported

II conference preliminary the investigator-initiated end cancer MD with also the is is in cervical centimeters of are from PDSXXXX IMMUNOCERV progress we have more Dr. Anderson X Clinic. Mayo trial the a expect HPVXX-related Phase tumors trial and provided data as an year. patients a and large in of the over neo-adjuvant to This The data of before the exciting we little an on Cancer investigator-initiated trial is in near or in of high releases; that at presentation SITC cancer at control in scientific oral risk of meeting the hopeful have we Ann occur timing treatment at Klopp a data XXXX. trial This will study trial future. November of the update however,

year. primary the our our targeted focus also is working for our file we to of IND are end Although before on MUCX immunotherapy, VERSATILE-XXX, PDSXXXX, this

to through time, Lauren? I the this will data. walk Lauren hand us recent to over At

Lauren Wood

Thank you Frank.

Let’s level stabilization or inhibitors The PDLX in immune recurrent checkpoint with tumor patients as monotherapy. discussion The XX.X of panel XX% document defined results poster combination high Published and as cancer poster of as their checkpoint advocacy tumors. rate, report median months include receiving and Meeting survival used metastatic The ASCO months. now Annual XX% head in progress-free which a disease presented shrinkage, to disease on or to months Katharine neck cancer featured survival therapy. overall patients was monotherapy immune two at XX-month rates a following: three approved expression the Price for as similar in was interim the XXXX in highlights head used seen in Dr. a progression-free overall patients. inhibitors turn is XX and with Mayo session. rate neck when XX% XX% reviewed level of survival of the by results included by the Clinic, an expert survival approved the control to data in median Published

addition the additive that In monotherapy. has with that July responses effect PDSXXXX results in an over checkpoint we suggesting we had published immune achieved data, inhibitor XX ASCO announced seen confirmed

mentioned Phase with with the to the moving addition this XX-month rate survival further previously confidence overall In XX%, us of provided trial. III forward randomized

achieve be prioritized for VERSATILE-XXX to of plus Phase survival response, the improved FDA alone over PDSXXXX trial BLA rather the efficacy that our Phase III has Keytruda endpoint objective have overall will than our approval; approval. to we in to opportunity the primary overall III show endpoint Importantly trial, maximize the designed consequently, survival Keytruda

respect XX%. the grade safety, grade X Keytruda patients, treatment-related there finding rate were known approximately combination TRAEs, only to to having events for The XX events, events adverse of or treatment-related adverse With time the adverse or higher of also we published monotherapy the be with well is treatment-related at are observed. no ASCO. X.X% four tolerated Furthermore, X as

the trial. initiation ramp the continue VERSATILE-XXX We through to up of

During global the to registrational related Phase to quarter, a III multi-center activities the CMC PDSXXXX trial. initiate required we completed

We agencies some the received from study on VERSATILE-XXX European regulatory have also feedback design.

previously, mentioned of and the initiate to CMC the submission the Frank the study end of this preparation protocol the to package in the year. by we clinical announced FDA As morning

Phase active design starting Keytruda Biotech powered accelerated the arm. in quarter data We XX Initiating to to comparator readout. in to is sites this interim combination analysis planned the a fourth to as the PDSXXXX VERSATILE-XXX PDS of we globally. arm, control Keytruda the with approval milestone the look and for potential be trial for overall conduct this with XXX controlled trial will pending significant III intend a will forward trial year. study monotherapy randomize for survival This at subjects and The an for as

the investigational inhibitor-naïve and triple immune the of from for checkpoint to trial is ILXX as positive with inhibitor. combination HPV vaginal VERSATILE we anal, in the pleased II both all tumor and addition of targeting This patients. cytokine, as head cervical, in checkpoint cancers, checkpoint have PDSXXXX, the well combination types evaluated In an penile, cancers our has neck, including Phase and been immune programs, immune ongoing which PDSXXXX, vulvar results refractory inhibitor been

this As to we’ve continue develop approved plan immune in mentioned refractory patients. we inhibitor commercialize previously, an checkpoint combination using checkpoint and inhibitor to

neck and transformative treatment PDSXXXX HPV-related Versamune HPVXX-positive The We most approach for is from and advanced this rapidly cancer head different overcomes mechanism patients solid tumor checkpoint by and the believe largest multiple cancer across technology a proprietary inhibitors represents that’s growing markets. of suppression immune of alone. potentially the tumors. combination cancer immune a

the like I PDSXXXX our led ILXX by advancement would to of NCI. programs antibody highlight also the being conjugated

clinical are continue multiple and trials our in potential of both NCI and advanced the with combination cancers. relationship We PDSXXXX monotherapy the exploring a of with to agents other as expand in now

are We leading of to with immuno-oncology. be experts evaluate the some able the pleased in field to PDSXXXX of

first-in-human the on meeting trial. based data of II in This Madan Ravi annual evaluate with chemotherapy. study docetaxel Phase XX designed interim patients will the During Dr. and safety XXXX to involved October, provide a in in immune PDSXXXX conjunction Cytokine is NCI

other potential of it also chemotherapy opportunity sensitive metastatic with about findings solid We combinations to the offer improved to prostate castration and in have The castration resistant are benefits the combining potential treatment shed possibilities to opportunity on the light tumors. chemotherapy for trial excited a and this represents as treating of with cancer. understand patients PDSXXXX PDSXXXX significant forms

to financial Matt? summary. turn to over With the now Matt discuss that, the I’d like to call

Matthew Hill

Thank you Lauren.

June Now XX, financial share, to $X.X our loss the to per the for turning development, in $XX.X loss diluted ended was for connection The basic net June a research, costs loss XX, XXXX, months million approximately ended compared million for XXXX. VERSATILE higher three the or due to and results in share quarter diluted XXXX per with months and this of basic $X.XX same was net net three programs. and period $X.XX or clinical the incurred

for an period expenses the clinical development increase which ended and and compared quarter to same Research $X.X June $X for increased the the in XXXX. include XXXX approximately include is million in in increase attributable million to costs, trials, expenses. $X.X to compensation, The manufacturing million million XX, primarily million in $X.X $X.X $X.X $X.X which personnel million of million stock-based of and costs manufacturing in clinical non-cash

quarter fees. administrative second XXXX. million increase and million compared $X.X personnel to and million attributable same million expenses non-cash the in million period of of XXXX $X.X for to for $X.X General compensation The an primarily increase including of costs, to in increased $X.X in the in professional $X.X $X.X approximately million stock-based is

for June of XXXX expenses million in approximately $X.X total operating XX, $XX.X the were XXXX. expenses quarter million ended operating compared period Total the same for approximately to

this the believe June company’s balance on our the will following research clinical the as which sufficient cash of months Form resources our filing and equivalents approximately quarterly and to report XX and based projections, operations programs development for cash fund of is and be million XX, $XX.X XXXX we totaled cash today. June XX-Q, filed on XXXX Our of and

continue and will cash be to We development prudently. opportunities engaged manage continue to business in our

this would session. Q&A to the I call Operator? like for time, hand my back discussion, and the concludes to This the Operator at

Operator

you. Thank

instructions] We question be will and [Operator conducting now a session. answer

question Wainwright. first coming Our Joe HC today Pantginis is from from

Your line live. is now

Joe Pantginis

for everyone. summer. question, happy Thanks morning taking Good and the

get already it quarter Wanted supply’s ready the for to so far not all all just a mean, a operational one-to-one, everything targeted with the the start Lauren the then diagnostic, First, obviously the that. lot. enrolment readiness I III assuming wanted is what and to set. course go, is, - too the benchmarks. randomization, get a discussed of of probably sense away, is Thanks to Phase We’ll of is sense fourth

Frank Bedu-Addo

Hey number of just to are are readiness, the ongoing IND. respect question. your beyond there Joe, the actively actually that thanks IND as you submission have operational happen to currently. those know, number a the A amendment of things lot With to the update a and for of

We have to sites. activate clinical the

clinical the as looking sites sites, XXX so process at, currently running. We’re Lauren and to up those XX said, of getting in

in XXX as ASCO, very data, We have indicated that response, III We we the presented directly overall than actually expected. to data related have believe the sites interest participating the have as higher is that already and the good who clinical had at well survival in about Phase was safety.

neck that than live so really longer looking head something patients can largely quality responsible know, higher help As interest to and really you life have larger we’re seeing and the for their the cancer oncologists well of with up start are that we’re institutional for in that’s these expected review the we that’s at tolerated, sites, waiting actually various trials. these sites we for clinical and ready, those the light believe FDA boards green so to the approve then getting from sites also getting all

and CMC is so what was The been manufactured, to The terms the done. has thing section. that the good all update is that utilized is manufacturing of in product manufacturing, information

a anywhere between feedback to between--I the say of XXX target final pending enrolment for patients, XXX we’re We’re looking waiting the from would at FDA.

documents always we for we final to to this know, those IND, so want that’s the final say, any protocol anticipate protocol Phase absolute trial. make but light the we then feedback the could the get before we you everyone, feedback FDA’s moving have week and to final from we’ve the but into green III As we once what available final be actual the the we the submitted wait can is FDA, submitted protocol or either last

protocol we excited trial, that took the FDA, this received upon we in are all feedback and is going, that we into this this as going developed control really pleased was inputs to and far, the based a right, get be from so this we so consideration think with arm. control is FDA’s the together we’re as Keytruda actually to very putting protocol a solid But

Joe Pantginis

you Thank Frank. helpful, very that. That’s for

for quickly Lauren of you’re and very discuss what and that benefit docetaxel, I that of study, have then data taking Schlom with just XXXX Then you’re are that because docetaxel, docetaxel the more regard can ago info to Gulley the to concomitant with guess back intriguing, just--well, you or what talked translational levels to on maybe or I say, you, to, get I years looking lack labs best maybe--well, out was the going curious so gather or approach what’s and info. or translational even also, on here, guess about in approach combination data immune the or the sequencing looking that with thereof, with with study the talking do to the dosing

curious discussed Thanks forefront it’s but is always minds a people’s today not to lastly, lot. influenza? regard in Then percolating what’s the in world, since with of the just background it’s the in

Frank Bedu-Addo

good Lauren the studies translational with influenza then Joe. Really to I’ll address questions, the to PDSXXXX. I’ll and hand over address

these centers, progress. now provide ferret with in in these do to currently studies, With to vaccines typical know, upon tested intend and ferrets and gold considered are NIAID the the mouse this program, and studies we you human the as PDSXXXX also are results, successful relevant as studies progress once most going confirmed on based Those NIAID. clinical are those continues CIVICs Joe, flu vaccines studies are flu at so results CIVICs-selected then and ferrets, after program, ongoing the the studies, with and to are under what’s are standard in an is so update ferrets by usually available program so the when to the continuing

Lauren, the I’ll for with translational and to discuss to PDSXXXX hand studies you over docetaxel.

Lauren Wood

your and Great. question, thanks Good Joe. morning for

out that also immunocytokine, PDSXXXX of of one, safety dosing together, concurrent we immune responses The magnitude different of looking both study that in doses we and that’s really castration is ensure of importantly combination ILXX here to, is PDSXXXX there targeting Madan’s one we of prostate different the differences cancer. want one, tumor is clinical specifically there dose levels well with docetaxel castration and of when excellent the in they’re coming NHS translational if of an of examination the see since relevance the and actually docetaxel, with as Dr. sensitive really combination delivered more and to combination, is are in the metastatic as terms it’s co-delivery is at want of see Your docetaxel. question there a is resistant things the outcomes

to is also augmenting responses natural XXXX, once we’re this would really hope but responses, the this building tumor forward targeting that induces standpoint, lead that tumor that possibility so presentation augmentation this of cell T-cell Madan’s immunocytokine translational know we we since is as that specific clinical actually docetaxel see our to at PDSXXXX on combination what a therapy, Our is PDSXXXX outcomes responses. killer augment T-cell of immune we necrosis. further to the Cytokine interest as necrosis, and looking tumor the could far co-delivery fact a of only Dr. in we From know tumor these studies not and see the

Joe Pantginis

thanks Great, color. the for all

Operator

Thank today Fitzgerald. Cantor next you. question Louise coming from from The Chen is

line Your is live. now

Lucas Duffy

questions, is thank on questions. morning Louise guess taking for you I on picture strategy-slash-vision Lucas quick for have Good quarter. from I questions. they’re two the and Chen Cantor. and Duffy more big This congratulations my

your regards platform. with to is question First Versamune

for to date? date of XXXX, you leveraging the to or PDSXXXX is success developing to the your or of XXXX, the expand lot had What with platform, platform how a vision do future success on hope it You’ve etc.

a forward. and the about there’s important you how see Then or you question you. Thank NIH progressing the little if that talk moving your there, any could with if partnership developments is second

Frank Bedu-Addo

two very Thanks a good questions. lot,

developed first PDSXXXX. is concept platform really for as a Versamune of study proof see we being PDSXXXX, the platform. The with

upon what’s of industry potential strong T-cell really the based us happened last we Just very the concept this really for proof the for over the understand important to PDSXXXX. of demonstrate decades, believe with activating technologies couple of it’s to

PDSXXXX, cancer studies As these with same is the address would performed cancer. TARP-specific prostate and so pre-clinical you know, breast in also platform tumors, we’ve which utilizing

PDSXXXX also cancer lung performed that ovarian MUCX non-small have addresses We cancer, and these so cancers are with positive cancer, preclinical those studies breast colon like cancer, cell cancer.

of studies, the this that of T-cells cancers; tumor commercialization. the HPV-associated with to addresses as goal neck preclinical targeted you into products, levels our multi-functional of is demonstrated indications. each we focus largest an really head have can generate PDSXXXX PDSXXXX, on we know, with same cancer, and the these growing we HPV most have these and types so now, is of all initial get In killer rapidly which however, rapidly really

mentioned, FDA into the the we call, to had which neck also a intend the I As last meeting regarding initially and cancer. on move think triple I head combination, with we

metastatic a studies and from Institute, adjuvant ahead early the the that looking achieve through stage neck at be recurrent and first stage we Mayo cancers to a position, based Mayo the therapy patients. really have surgical which on be we National product, cancer also in looking we’re We so the their PDSXXXX, for strongly Clinic, successfully want all have of believe treatment, oral Cancer to patients is to head which able We ongoing Clinic with as PDSXXXX partnerships of new with cancer head will neck with doing the and at our this. who and removal Versamune-based what currently lesion, refractory treatment is as early way we’re position checkpoint synonymous treatment

all broadly you far HPV-associated HPV-associated of Cancer as just in head neck at have studies types cancers. applied also, we beyond actually so then The has We Institute cancer have but started PDSXXXX evidence very National looked that potential cancer. know, cancers, strong and in cervical

positive to to be the related after--so into XXXX would rapidly this the on and that MUCX also PDSXXXX, that IND study, the cancers do As mentioned to clinic. as move allow after of clinic addresses also into PDSXXXX. file I coming we we call, go a to which the second we is mentioned, for cancers--MUCX intend PDSXXXX this product proof concept intend and PDSXXXX

and are some these a of the strategy, them have partner rapidly also to into commercialization selectively business we move programs we to development looking path. advantageously so Also,

with think partnerships MD one Institute, onto the often doesn’t partnerships Anderson with second you have really of very Moving is I These become partnership partnerships obvious of which folks after independently the with of the that our antibody many the that convincing these things several question tumor of is asked, and come Cancer NIH, our Mayo National the key importance partners as very like preclinical conjugated and clinical in actually years as independent potential PDS, technologies, to oncology. technology, technology these science has studying about ILXX, of our themselves completely the studies well our of Versamune significantly advance the Clinic.

that for looking science. to are confidence wants such can to technology what experts our our PDS regarding technology PDS’ they as we the our and technology we find what with thinking whatever independent do science when we completely They that their reporting to our clinical These advance from PDS to Anderson or see, and them experts, and is comfortable technologies our Mayo science. NIH, hand enough have in MD are perspective, that going over Clinic, are have so of studies

So far, to very these opinion trials of science this the is science oncology. we from the the putting validation, of significantly in this clinical that strong being trials from have into own interested a these potential progressing opinion and validation advance they some leaders has the the studies capital experts in into the results, independent key of technology, and science strong of clinical of interest provided and their experts can preclinical and key validation the see as transitioning the of human and

eight see we clinical science these progress National ongoing PDS have a more Phase would five that we the are partnered buy-in PDS cost trials Cancer are this and these based a partnerships lot what of date, to is here lower developing, is typically upon trials that To and to so the clinical Biotechnology. Institute, with at we you II and can able than Biotechnology significantly trials to

in solid dealing really advance for understand programs, these ILXX, able tumor certain standard with now allows is do PDSXXXX, targeted and tumors, chemotherapy our example, us how example, docetaxel. We behaves technologies, it so how are of what to this care to to for with synergizes

We’re allows also indications the with at us have combinations which II this data, same and these products. then at the best combinations look we’re the doing monotherapies, we’re Phase to combination, commercialize which radiation, chance with looking the looking determining to at rapidly so and we triple

We so also expert trials They key experts these indications Cancer a they we this National in see a Biotechnology. what provide to look that’s has strong are Institute a the fields oversight in in PDS that’s Cancer through all of and of in with gone oncology technology guidance every National actually really have valuable and how relationship the these lot things, They with seen--almost we design successful been specific for. it’s validation. very Institute, relationship terms PDS

Lucas Duffy

Okay, follow-up and very for the thank you much answers the thank you. color. No questions from me,

Frank Bedu-Addo

You’re welcome.

Operator

question Patel B. Securities. from next Kalpit Riley The you. from is Thank coming

live. now is line Your

Kalpit Patel

for thanks questions. taking and morning good the Yes,

you the should expect this believe said, for report trial? we expect you for quarter, how more many months I that additional follow-up updates to [indiscernible] the later First, of

Frank Bedu-Addo

VERSATILE-XXX talking is trial, that PDS--you’re Kalpit, about the With correct?

Kalpit Patel

Correct, yes.

Frank Bedu-Addo

Those that III also have survival. on later privy on provide the two this overall not will clinical survival since but updates when of those trial. be I key quarter, update have I and the design the an hopefully the hopefully key for updates Yes, so clinical am XX-month to I am the we overall were would hopeful especially we’ll updates that XX-month data, expect, Phase the

be key powered, know, before that’s been would be that As so has FDA would hopeful interested this the the overall that the those we you two get survival, and how quarter. updates I trial in is the of most end

Kalpit Patel

when in XX XXX as analysis your start of well? III, the interim on hit, expectations in Okay, the endpoint assuming--let’s assume enrolling you the to sites the primary you then and and would based expect fourth to Phase quarter,

Frank Bedu-Addo

enrollment be events for occurred. CRO of initial the after and events. and an will period the trial trial, endpoint death endpoint were endpoint accrual after actual estimate occur, between the for that a feasibility survival. projections meet events conducted period. Really, to enrollment the to primary overall when events and pre-specified these so XX-month the and about analysis pending after will completed right will our occur endpoint analysis, time enrolment be be occurrence exactly accrual planned number It’s actual they anywhere the enrolment number interim of have easy a of death the or the but to interim XX overall predict is complete XX that very final to either an The could certain is survival, by rate interim this will events, be to The Since is informed the has XX-month not endpoint. the

Kalpit Patel

very Frank, for taking perfect. the questions. Okay, Thanks much,

Frank Bedu-Addo

You’re welcome.

Operator

you. Thank

one As to a the star, reminder, placed in be queue. question that’s

Our Leland Gershell coming Oppenheimer. is next question from from

now line is live. Your

Leland Gershell

wondering, may be Hi, PDSXXXX VERSATILE-XXX approval for in thanks for Lauren, taking Frank your what on study. our the potential accelerated questions. I’m and view

you VERSATILE-XXX be for Following approval. of development oncology, as drugs out approval use as the that came submissible accelerated draft in could FDA on accelerated in randomized as with guidance trials ORR for March, endpoint may aware, such recommendations a the

from there responses data, of in wondering earlier, and the efficacy. Thanks. if an may use ahead of opportunity for population, confirmation then you’ve that the the OS Given you be so as data submit XXX robust far to OS seen mature

Frank Bedu-Addo

also a take hand I’ll Lauren I’ll then stab to and add Leland, response. to to at my over it

that an know, close We the opportunity as that the we data we to becomes get we’ll are data the to to have with you and the if approval to VERSATILE-XXX, extremely as what designation, points, like I the if we data FDA understand interim frequent discuss as that available. discussions currently we’re that currently, seeing do the accelerated take hopeful with think to FDA. fast-track and is would have looks anything the encouraging, of VERSATILE-XXX have advantage data more with do we

as that have emerge. the track to Even and specifically, head powered have as data take do FDA monitoring, overall also endpoint, primarily have objective trial and survival we for secondary begins will in made the with in of interested continues very cancer primary clear really neck overall is and survival, response But earlier on it we’ll are PFS, since definitely though they overall overall we the rates correlated that’s us and rates to not so discussions FDA fast cancer, we to response the neck the why endpoints such advantage survival but that in objective survival. and be this head with specifically

Lauren, anything that? add you’d to to like

Lauren Wood

accelerated echo, like that is powered we have you be for only a for approval mentioned, opportunity so cut year required, next survival, VERSATILE-XXX primary for XX and ultimately accelerated while is once as to Yes, those months as final data and in confirmatory the from XX trial response with overall will well discussions. rates, discussions I’d like months, the survival additional Agency thing final of Leland, with approval VERSATILE-XXX have is overall of objective follow-up the our endpoint terms that another the rates and also

Leland Gershell

Okay, the data that’s respect see we helpful. initial from MUCX Then with might MUCX, study? when to

Frank Bedu-Addo

actually Well, we I when have as going started not timelines not to data. to so that at any we’re point, yet, this see study provide will

call, clinical will we which of end next that going like, We the are calendar design Hopefully next to the allow year, clinical and data. the so when on more we by that early information on what the this question. is have look trial be able to expect more we more file clarity probably IND some will around going by see should to hopeful provide year, we’ll on have it’s--once exactly we will to clarity us get the

Leland Gershell

the thanks for right, All taking questions.

Frank Bedu-Addo

You’re welcome.

Operator

question next is from Robert The you. Capital LeBoyer from Noble Thank coming Markets.

line Your now is live.

Robert LaBoyer

Good morning.

have that follow-up or mentioned design been FDA? PFS PFS question still on the of Is interim with going VERSATILE-XXX. and analysis, the analysis Just discuss be one you more previously. interim endpoint can an to factor In the OS

Frank Bedu-Addo

endpoints be the overall We but survival. powered the been the information, collecting have interim final certainly PFS for both and will

Robert LaBoyer

the you for on triple mentioned One - that, combination question had the Phase that the start of design progress. III the timing the of in on an III? IND Phase the submission of Okay. was for Any

Frank Bedu-Addo

and refractory specifically, going survive. we That we continue the obtaining and to patients to that quarter, together from how head refractory triple cancer the who treated, first we I what with the last the second the and call, mentioned to Keytruda neck the so to study. and overall on hope and we’re initial we head respond and patients first trial checkpoint cancer critical information combination patients refractory neck are waiting in study, design to With head it trial. and registrational that are impacts, final, in is to for get--this may will is is XX have to expect going mentioned, be, XX VERSATILE-XXX be checkpoint is survival the a being information indication as be the arm how we of as VERSATILE-XXX this the information and and those from evaluating trial in we trial additional neck the intend from patients that to we’re cancer, Primarily looking what checkpoint PDSXXXX allow be

would to exactly to protocol down we then those FDA with probably upon One FDA’s key year. then do would to those--get registrational, very a project allow that’s Keytruda, did like is see see the be maximize start a feedback. really of trial be the the in our with so start like would We understand Based something to what this initiating like with those start, initial and trial, of to like good make this able will end year. design interactions we and will starting we of to that having we with to with what FDA interactions the trial we expect get that getting the elements what we that but understanding it interactions things before it they similar FDA when the be the to to that registrational to interaction FDA, later the would in really

Robert LaBoyer

you very thank much. Okay,

Frank Bedu-Addo

welcome. very You’re

Operator

question Alliance The is from Molloy Partners. you. next coming from Global James Thank

Your now line is live.

Laura Suriel

for calling questions. Laura is Thank for Molloy. you taking this Suriel the Jim Hello,

For be first of VERSATILE-XXX the might set to do end or or with by it here the Phase look the being early think initiated it’s enrollment complete announce you III data? to trial, too not a interim you tell, when if year,

Frank Bedu-Addo

anticipate enrollment projected analysis. timing, of sites upon take discussed enrollment what various will that earlier, XX we could we are, be to At to events the months the that between potential the the looked upon projections based occurrence we see we we expect potentially so have CRO that completed. anywhere trial, enrollment it that be also and As the then for at to actual what based could accrual and point, for expect we our interim XX first the our

Laura Suriel

here Got it, for and held of then II also might well? of the data following Cytokine when for be this get this some that’s Phase other going the trial XXXX, to trial October, we meeting and the as timelines additional NCI-led

Frank Bedu-Addo

I’ll trial. since hand that to question she over more that has Lauren, information on

Lauren Wood

As PDSXXXX, triple and-- it relates combination XXXX to NCI the examines study that

Frank Bedu-Addo

I think, asking that about. think I she Lauren, was docetaxel was trial the

Lauren Wood

be additional expansion terms of XXXX. of study the well as survival yielded and responses discussions in there presented thought in updated will I there data. to PDSXXXX that of the will and then docetaxel following be at that examined dose updated immune this being that the okay. end think meeting the are highlight there before further will tolerability, was optimum just fact wanted interest I Cytokine the levels presentation, of quarter, and as I data at that Oh, be Cytokine

Laura Suriel

questions. Got you taking it. the Thank for

Operator

Thank you.

any to closing have our floor over turn like the for of comments. end question We I’d back the or session. and further reached answer

Frank Bedu-Addo

much much very very today. to Lauren earnings we you joining quarter second thank and call conference appreciate Matt, and you our attendees, our Well,

and quarter’s year. rest the about truly we This has progress been enthusiastic what lies remain of the exciting ahead for

are the leader out we who PDSXXXX, Please will like to the more any cancer. event. will include to neck of in perspectives details a provide on treatment near for and the potential its mention we call, I data the concluding planning event updates, The would their and experts closer Before future. key opinion webcast get that look head advanced in as

and many that here releases are significant hold reiterated investors. this are As you data promise have the have excited call, seen share the horizon on our I and readouts value from our and potential that to on as we to press

path head achieve a head goal of great cancer effective neck potentially that made have in the neck and the treatment treated advanced our is safe We and strides shift paradigm extends advancing and to tolerated, on survival cancer way well of the with patients. a

need a will believe in that We we’re future, result medical longer who doing quality and higher as a very unmet critical the today. life near of live have have strongly a work here these the patients of

Thank your forward our you very a much look updating we and for lot. to on support, progress. Thanks continued you

Operator

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

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

PDS Biotechnology (PDSB) 14 Aug 232023 Q2 Earnings call transcript