PDSB - Earnings call transcript Q3 2021 | PDS Biotechnology Corporation

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Operator

Greetings and welcome to PDS Biotechnology’s Third Quarter 2021 Earnings Call and Webcast. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] please note, this conference is being recorded. At this time, I would now turn the conference over to, Deanne Randolph, Vice President of Commercial Development. begin. now may you Deanne,

Deanne Randolph

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

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Frank Bedu-Addo

Biotech, for an cancer. to of initiated year PDS milestones achieve this Deanne, have schedule has are have on clinical pipeline we We with you, of strategy, interim XXXX the oncology call Biotech ongoing of extremely track continued programs, of been our extraordinary transformative promising progress audit Biotech. we believe commercialization these programs to trials what PDS year everyone on to results and and quarter milestones achieve our and each pipeline its execution outlined to on from of treatments is shared for PDSXXXX progression XXXX. XXXX at clinical and plans Thank thanks today. key in still to PDS Last we that

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Matt our over experience we current catalysts advance companies. Chief publicly month, financial we in clinical as XX-months our to as and leader of We have trials. several Matt welcome a new Officer. expected has Hill life science initiate decades next to as studies the Financial Last traded new three

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Lauren Wood

Thank And us everyone joining this thanks to for Frank. you, morning.

PDSXXXX. clinical whose As infectious is HPVXX-positive of II our quarter head candidate second will call. we Frank neck since has Phase VERSATILE-XXX spread. oncology study and a patients continued disease or cancer our our ongoing and to returned and oncology both evaluating I pipeline with begin highlighted, lead groups two cancer our just have trials progress

been also checkpoint previously The first a not has patients. inhibitor, checkpoint inhibitor treated naive group with known as

multiple considered group have checkpoint checkpoint including inhibitor second therapy patients failed refractory. inhibitor treatments of and The are

transient, the its first manageable in local events discussed benchmarks reactions. PDSXXXX preliminary to generally we this his related to As safety September, VERSATILE-XXX Frank type XX announced during study adverse injection that remarks, be achieved patients. its appeared had limited treatment

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respond naive inhibitors. reference, For generally in checkpoint one five to about patients with treatment checkpoint only inhibitor initial

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respond refractory that related to achieved in We with combination. five are new seeking of or the no treatment. one We evidence to disease pleased benchmark were double advanced PDSXXXX patients combination, unanticipated the KEYTRUDA of to so more or safety toxicity have these with that very to with the

the was study. specific trial continued to this in was is updated the clinical Form anticipate treatment Consent was unrelated through The PDSXXXX way Annual the trial. schedule. paused efficacy immune of from its to the still this be This Meeting on issues, in the trial it being study updated the concerns cancers. safety approval and combination expected advanced II evaluating to in with now recruitment the recruitment process. administrative Consent patients will of patients early namely specific XX plan to the or receive administrative impacted, enrolled resume. trial on will is have of triple to study the pause with from to this the not Only studied. it of approved, any of enroll The led Highly presented need the at trial, mid-XXXX. from recruitment the new late patients two timing through the of NCI to NCI trial to combination National issue Informed an Form on working Recruitment Roughly October HPV is XXXX the not the in into agents, XX from June available by We update combination data modulating affected been has Moving Phase October, the due in to Informed the for this the Institute’s and is patients. encouraging study half ASCO PDSXXXX interim Cancer end trial data data completion end resulting at be in this by recruitment QX, suspension. Once investigational

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mid to and anticipated in further which be One immune translate Immuno will are potential of the interesting still XXXX. may to immunogenicity Preliminary to clinical response. aspects the collection trial Serve data, biomarker of of from and may help elucidate this the results early PDSXXXX markers response how

Moving now to PDSXXXX.

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stimulate response. technology on agonist with to PDSXXXX, highly the to peptides antigen designed which Agonist engineered moving Now, an combines specifically peptides better MUCX. tumor platform immune Versamune the immunogenic, and novel of are

work solid to associated pipeline Similar lung, poor colorectal, PDSXXXX human the cancers. products continue trials. shown resistance clinical other being Importantly, MUCX be is to PDSXXXX tumor is of to completion as NCI, we been in with at breast, studies into and and drug and disease treatment PDSXXXX is highly the PDS conducted for prognosis. our expressed multiple with final types, near has ovarian, preclinical for progress developing

a IND in included have the the tumors meeting fully the developed a all requests. clinical the pre-IND was and known pre We a MUCX the with the anticipate requested in high-level meeting PDSXXXX different already protocol We for express advanced finalized to design FDA. on to FDA program. preparation a plan with study trial meeting for A and of proposed align development synopsis

also with our progress have great made pipelines. infectious We disease

publication PDSXXXX well protect is preeminent obtained University as Ross responses flu of induces immune responses significant Frank and flu generated Georgia. antibody T-cells antigens immune diverse combined strains. detailing infectious as being antigens, T-cell at that Georgia differentiating parallel of pre have antigens both by Versamune’s flu as PDS documented encouraged prepared. completed results target as responses strains. and flu well Preclinical SARS-CoV-X the that highly summer to PDSXXXX, as we the universal can are COBRA pandemic over results University potentially Versamune unique both plus and breadth reactive were stimulate an broadly vaccine a activating Biotech neutralizing by disease In results early T-cell As influenza, These these with specific of in These of against designed a different reactive combination significant flu antibodies, responses. and develop noted, Ted developed opportunity with seasonal technology - to these antibody Dr. with the expert, in novel broadly antigens specific that combining influenza and to flu

these COBRA in this Biotech agreement our important license earlier PDS use UGA a step trial in clinical for with advance disease announced the antigens an continuing to month, and to infectious pipeline. addition, In

well finalizing and vaccine and human into are expand based vaginal Myeloid the on immunotherapeutic the Leukemia exploring HPVXX cancer. in different is testing. now indications TARP molecular targets to anal, in flu being expressed trials neck, breadth types Versamune cancer. attack as of work and in targeted designed are upcoming clinical cervical, I PDSXXXX move product We PDSXXXX targets Frank’s Biotech. formulation and vulvar, opportunities current summarize product present PDS breast point universal and like of cancers penile potential targets a to earlier as to funding pipeline Acute by and would Each in or AML. head prostate present

present Finally, targets is colorectal, cell cancers. other breast, MUCX that PDSXXXX and in ovarian, non-small lung, multiple

a or As of XX Versamune for burden which consequence, are Many of the to PDS cancer. treatment platforms death Biotech more have tumors. the for based potential advanced a solid due least at substantial development of responsible

turn Specifically these prostate cancers colorectal, XXXX, to we for of Chief Hill XX% third PDS many patients breast Officer, deaths. to now over Matt. pancreatic, as review Matt possible. XXXX Financial would quarter to call of of continue as diseases I the our Biotech and the in cancer accounted improve impact our financial. lives to like seek new embrace the challenge as lung, to will cancer

Matthew Hill

and Frank preliminary the evolution. supporter together take results Biotech top as Lauren its you, I I put some success has as upcoming and step to have to excited had known has technology. next years. me CFO. Thank in PDS a have the and very clinical Biotech. in recently and five it been ready shareholder, PDS team following only company of the day a is XX Well, I’m data great is for have from technically, morning, members with and of milestones. the everyone. Board good joined here a Frank notch

my team I next in company glad successful Company’s science success rest jumped With the the when to methodical of have join the solid able, the opportunity time measured of Frank I And to approach the taken science. with in financial phase at the to the background, contribute the leading the a growth. have to Company. the is me, and I’m the great to strategy For was chance one team’s and

of results. turn financial discussion our let’s Now to review our

and Frank invest with the the since infectious and share average both return year, of oncology increase of volume personnel disease in liquidity daily $X.XX your improved at we maximize $X.X XX, in continue XXXX. million price programs. September was increased for related PDS increase $X.X XX, clinical as the and to was a increase a have related XX, million. increase we or for now partially and million we and to XXXX, greatly approximately the The compared The to of of final three studies. XXXX, which to cash months XXXX the decrease would for loss is reported $XX.X significant The cash of of costs ended diluted the back $X.X to quarter million million. September million on-hand, million to our investments months ended over third was of for beginning per XX, September to and the ended the for the our expenses stock the approximately from cash along fees primarily With in $X.X Frank. Thank September XXXX months months share loss attributable $X.X professional to offset remarks. Research months compensation million $X.X turn net basic three cost million September has manage personnel XXXX. diluted or trading $X.X $X.X $X.X of like and $X.X General development costs expenses million $X.X you costs, of of in basic the current future million to an prudently appreciation by I to our XX, ended This our for for this shareholders. cash for net increased and share of a plans, For was three million years $X.X costs existing $X.X compensation to ended $X will approximately severance. an attributable for XXXX. in stock of to of million were two three Biotech’s XX, equivalents administrative million $X.X increase was for which September today. and call three time primarily $X.XX million million

Frank Bedu-Addo

continues Biotech Matt also demonstrated team all our sign our by extremely you, here continued at I Lauren. to patients diligent would Thank of would also PDS The our expertise I teams who the we and like clinical to our the collaborators preclinical our their like to clinical thank partners and for this are reason execution highly creativity and and strategies. to ambitious and enable of have dedicated lives and work. development why innovative dedication.

pipeline driven achieved continued among advancements results been Our will continue shareholder still positive laid we momentum. significant this year performing and is Biotech now believe across have multiple have significant if highest execution value. upcoming Year-to-date the NASDAQ. PDS pipeline of the PDS on for The We has into the we Biotech XXXX. this stocks programs groundwork milestones

year secured and achievement milestones. between of value this and next expect quarter year. PDSXXXX to to creating work In partnerships receive of towards financial short-term, We of first trials the fourth half the runway data the we the for have our top-line multiple

vulvar Institute We completion quarter. of Cancer and led treatment and head third in penile, addressing trial second anal, the the and expect vaginal cervical, of of first neck, National cancers recruitment line

molecularly from We data data from first in of expected the targeted PDSXXXX the is studied all led second immunotherapeutic our Interim approach, also trial efficacy XXXX. MD quarter demonstrated XXXX. Serve clinical of trial Anderson by Immuno our expect to-date. from during the VERSATILE-XXX Preliminary quarter HPV-related the cancers advanced preliminary data

milestones. additional towards progress to continue We

to achieved. the and patient’s accomplishments demonstrated our oncology shareholder session. please impacting advancements technology you immuno sharing the of multiplied That begin milestones of question-and-answer are we forefront Company with potential concludes have lives. value We are prepared as and future our our Operator, and remarks. the look We in forward

Operator

Louise Please proceed first with Instructions] Cantor Fitzgerald. comes [Operator of question. from line question you. your our with Thank the And Chen

Louise Chen

Okay. Thank you.

Sorry about that.

So progress the all I questions for few quarter. this congratulations on a had you.

few I collaboration give on flu about the universal your your you it can the market on more But then, your on any in any And talked much. I the question your on are that PDSXXXX here you flu more broadly had you NCI on technology compare target. because is front. you and behind development, vaccine, call. Second to Thank how you here color see? TARP more you economics provide rationale opportunity and what a can vaccine your for does is, for elaborate could there universal know very others projects So, this you MUCX color

Frank Bedu-Addo

those questions. Louise for thanks

let’s with So, the NCI. start

market the specifically but NCI antigen, that cancers, Cancer agreement to TARP by reasonable actually specifically, as And has this regards the large and market redacted a program, with to So, in of this lot is TARP AML. very as with of economics. be cancers, as the present the and three opportunity I large Institute for would a market licensing and very mentioned, National with think licensing Lauren the typical the breast prostate, well two

prostate protein cancer the alone, expressed at expressed So in than States And cancers. these of is breast patient’s the these expressed these With XX,XXX and for in there United are cancer, of with in And TARP AML, United States with in again, about almost the is cancers cases the more annually TARP cases in example, approximately cases the TARP XX% is reportedly tumors. XXX,XXX of we annually annually in United disease. alone. all prostate have States XX% stages XXX% about have of we XXX,XXX and

So, when significant, significant. the you opportunity look the at is extremely these cancers market need unmet is

and vaccines in so, MUCX approaches last the to you MUCX know And need rationale successful. been or have for related is as for again, the based decade cancer potential the the evaluating the PDSXXXX steady we upon cancers, with PDSXXXX the this has at And program the MUCX size the so looking are we initial and over of see approach just significant markets. not been

done differences significant being programs, two very are the PDSXXXX. today and in has what Now is with there the PDSXXXX between what been with done past

immunogenic were be than First native our and not what of Schlom Institute. the to PDSXXXX is have shown at so the patented agonist National MUCX, what are using of been more novel very on native MUCX to The Dr. MUCX novel on. the specific based been immunogenic. antigens, designed These we of that dramatically epitopes so of Cancer which weekly all, is based antigens, is MUCX, the have are the shown PDSXXXX the lab by epitopes Jeff be which

Now, the Versamune is secondly, technology what different itself. is

time, antigen interference. effective seen well a X is are into induce presentation what the we necessary system actually Class critical the Class For the MUC first the pathways by immunological presentation to regulation the Type-X specific X response immune of have the that pathways, activates as technology powerful that proper as and to immune the

we these preclinical novel these with combined highly epitopes, that T-cells And potent show active similar CDX see which capability. have very demonstrated what powerful much so models, to in that are is characterize these in both T-cell functional, and the we and is can of highly T-cell means Versamune And phenotype have more poly we its with immunogenic they highly responses, killing that generate to PDSXXXX. we that what also

so And why tumors. of this about the is PDSXXXX. markets lung cancer, PDSXXXX other also the extremely important cancer, excited Dr. significant cell needs, is know, different so Lauren we cancer, number and huge as very unmet and markets ovarian a are non-small that and with you breast is these believe of we solid why mentioned, really colorectal potential And cancer,

questions. your hope I answered So this

Louise Chen

does. you It Thank very much.

Frank Bedu-Addo

lot. a Thanks

Operator

your question from comes with The next proceed with question. Leland line Oppenheimer. Gershell the Please of Instructions] [Operator

Leland Gershell

your modeling ask that how to about provide change on also wanting would in year. be still as of timelines color to would Great, like you of just what questions NCI change good with pause, trial a with various ask any want Thank couple to there our it capital just wanted just or resumed, gap, then might trial hear years we R&D given know for more the couple glad expense, deploying Obviously, it further on that the to if on in this may to want versus but of you. involved. think Matt. on two a XXXX, And can but might you the me, are that first have got intact, there be anything you morning. Frank, forms are past to sounds simply And programs for contend be is progress. continued that respect

Frank Bedu-Addo

Okay.

I year will runway the then to and question or two. hand first next Matt over the over address answer will I to Leland the So cash

the I process they have requested assured program, said administrative, So purely that consent, Lauren working of week the of is had been completed the expressed knowledge green National once on document light, that it. has treatment changed. is administrative our nothing this nothing Cancer and receiving and update the again, patients of what informed informed patient’s in included also that have be to us consent patient it of NCI to trial given on an will And It if is that informed that been last through way today, just that as informed with The the is the is and its think extent would we the it updating approved have updates the consent is the Institute. be that that change. provided schedule currently will

the schedule complete first do to as the so, are not recruitment to of initially, quarter still of during on we year. expect today, any delays we And we next proposed that timeline

and today, they will NCI. any encounter appear they on us various everything its on Cancer of with our do get have this process not in is delays, the to there departments started will they National hopefully, concerns near-term. schedule they an of administrative have that through the the any working discussions in that assured as is way And the that is So Institute, still based

over will I So Matt. hand to

Matthew Hill

R&D. Leland. looking that Thanks into walk were your morning, through Good back questions. will Good you questions. for at it and We so you I can

cash two on of quarters nine we at have hand. of hand, means years So on cash essentially, got least that

that QX. be burn administrative expenses $X.X of weighted assume more that about cash We had worth in million - going the will of in to can XXXX. is be You

the expect to level off increase can difference and then the in and R&D burn that slightly be cash You will costs.

Leland Gershell

Terrific, helpful. is very okay that questions. much very for taking Thanks the

Frank Bedu-Addo

no problem. welcome, are You

Matthew Hill

day. great a Have

Operator

Thank you.

Our next Emanuela proceed with from with your C. of line Please the H. questions. Branchetti question is Wainwright.

Emanuela Branchetti

cancer about everyone. I And my was past forward, you Good your for taking morning, prioritizing us could prostate thoughts more hoping With in thank the other. has over about are tell questions. you to thinking indication the that regards you PDSXXXX,

with as but you clinically could indication sided. if out beginning the you moment? you NCI the question, stands promising one could And prostate where remind baskets in potentially related the data obviously, me So this most the have at to cancer,

Frank Bedu-Addo

upon That for not NCI actually based to antigen we and available approach these the the top potential antigen, will demonstrated are but data is shown yet, the specifically that much in risk it with and to patients consideration the benefits performed specific anti-cancer to based you to in And has lightly is very our lots specific for clinical has the question what success, which this patients immunogenic finalized question. program really given fact likely And the current very start in within cancer. thank prostate go mitigation Institute based upon Yes has upon this the been and to more with that a direction Emanuela, has already of National patients. Cancer to or that That good I PDS. been very question. provide these heading by think different this likely cancer in us trial is and be prostate

Emanuela Branchetti

you Thanks that. Got it. for

And is to believe start have so, if Phase a I able data case II with Phase this you NCI? you the be the you, from already since I would

Frank Bedu-Addo

has and humans to I that Yes. already could have over can patients But this the the into that we fact we Lauren humans. this us. II Phase safe seamlessly combined confirm very trial. where top that to do the believe the demonstrated I/II, hand may Versamune will Phase first - it Lauren. a the very we data few a it transition to But case, in have with been protein, upon in based antigen and we already in likely We do for

Lauren Wood

TARP Frank. the because into confirmation of That with before agent. to would II Yes. experience immunogenicity exactly setting specifically studying peptides, expectations the aspect Thank proceeding combined is prior a that Phase be do the of Phase cancer that our prostate you, study limited safety and in able we very human with I/II

Frank of - going prostate reason approximately of in prostate TARP the the cancers, that target of diagnostic companion into for a to XX% anticipate know is, us is expressed for going XX% require breast The in we only as highlighted, expressed Again, cancer indication. we cancer previously reason into breast other prostate initially. cancers. Since cancer for is might agency FDA another it co-development

Emanuela Branchetti

sense. you Yes. That Thank much. makes very

Operator

Thank you.

[Laura with Ferrin] (Ph) Our your next Global Alliance Please question of with Partners. proceed question. from line

Unidentified Analyst

Molloy. Hello. This is Jim in representation [indiscernible] of

for So tumor talk this maybe apply a year congratulations in that made to maybe the about to And HPV as the non-location patients progress for see triple partnerships. just need ASCO my child little And in question is this order this data please XXXX? trial you more anticipating in well, please on talk to trial intern bit by your quarter regarding a see of regarding last the and about and number of you upcoming the next are type. specific regarding need this or all that combo, the the

So on besides your you. to Merck, you Versamune other do partnerships plans have to bring partner any platform? Thank any

Frank Bedu-Addo

a Thanks lot.

So, quite here. topics a few

initial with data the So, types. two preliminary was data, though, in the generated patient

response with first checkpoint approximately typically HPV you patients, what and rates inhibitor. to a a these sorry, with without checkpoint this is were population, patient the one the see - The inhibitor naive standard-of-care, XX% XX%

the statistical those So, And will comparing is patients. what done upon to. be analysis specific that based you were

benchmark three the eight have of needed six. first out you as to we five as the achieved And So, know we of the for the responses continuing first positive out study. achieve

before a inhibitor has much population. the any been higher in than patient much, So is efficacy rate specific checkpoint in naive generated trial arm with the

about second next also checkpoint of trial the in and inhibitor arm failed, radiation who are see addition waking chemo to patients therapy. the to On

extremely percentage as around them. response Now, these population, are patients effects maximum, very know, we population with very this patients. may range to rates XX% the between have these XX% in you this a so the available on of patient to options somewhere range the small And response rates with patient patients. seeing efficacy few any these X% of few drugs And have is

if these novel of this we acts three for understanding find discussions would the I want we be FDA, and have looking the patients evaluated to numbers hold move be have for know and a to discussion we the combination. pivotal can approaches would, with we though are triple is what FDA is triple significant combinations and the treatment earlier they a FDA, we even up recruited And anti-tumor mechanism. EMD a that FDA Serono The we with want with are is that what been these believe these today, that in we different needle. cancer. two different can what advancement compelling with novel so that Institute so this These National that owned we have is the And still demonstrated evaluated, to see And the because having still patients. agents, combination. They like from the trial the they we of would looking to from close Cancer significantly out would now the what other data discussions being which see who both to each this will have agents do will better being the want by are in in treating can see, generated to we FDA new the that what And these exactly to have with a design.

the discussions what development. into with are commercial beginning how have these and so and would the to that be anticipating And this discussing we soon pathway rapidly can we very FDA take

as owned three In Institute, terms trial partnerships, of the Biotech with know the and triple this the even Cancer led EMD by by that you PDS though National combination, Serono. agents the

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with But second of we, been have number of and demonstrate really the is the accomplish strategy that execute been to and believe concept, is what to proof in the these successfully on technologies powerful of to we strategy a able of the arm we second then that have With to And the the still past, T-cells. partnership the portion licensing do attacking not able the is and to tumor which demonstrate PDSXXXX. the in-vivo clearly are generation important the business for we National PDSXXXX, be trails, collaborating platform. of our Institute we would really other opportunities anticipate with Cancer potential what

as important every And antigens really out-licensing also in the proof data XX will for see that patients. of the to treating this range broader able have be in one will of that be MCI a the companies, Versamune hoping cancer data additional with triple establishing be that second about will so those believe over technology we that have as demonstration of these coming we very potential trial to partnering the out develop of resources PDS but technologies of should to the to solid trial, asking VERSATILE-XXX important and the combination And single cancer be well from specifically concept other is never tumor pharmaceutical you and antigens. were in of companies, because identified. piece the been

those in will strategically work your anticipate may PDS to immunotherapy want And so indications. to indications, we might in potential targeted of collectively that not can answer with that address utilize companies which which work may and technology have which we with questions? initially off other who we - those some our not Did cancer be companies

Unidentified Analyst

Thank so much. Yes. you

Frank Bedu-Addo

lot. a Thanks

Operator

will of to Bedu-Addo have Frank call question-and-answer Thank now end the over time, the and remarks. closing we turn session, for you. the I reached this At

Frank Bedu-Addo

Thank much. you very

the of PDS year Company. to for thank continued very to all be We you much will for interest Biotech. in your believe exciting that So XXXX you continue an

preparing products We pursuit. PDSXXXX and ongoing appreciate We this various in support advanced into your advance cancers, have multiple to clinic. are clinical HPV-associated ongoing the trials we with in additional

website For much visit our information ongoing pdsbiotech.com. clinical Thank our more and very please you about the Company at trial, again.

Operator

will you. Thank conference. today’s This conclude

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

PDS Biotechnology (PDSB) 10 Nov 212021 Q3 Earnings call transcript