Marker Therapeutics (MRKR) 15 Nov 172017 Q3 Earnings call transcript

Good afternoon. And welcome to the TapImmune Third Quarter 2017 Business Update Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note this event is being recorded. to Relations. conference like Drumm to now Investor with would turn over the Josh I ahead. go Please

Thanks Afton afternoon. XXXX [ph]. Good investor third the conference quarter TapImmune’s call. And welcome to

like forward-looking statements. call management, over Before the turning concerning I the would remarks following to to make

the we These projected goals in any statements statements plans uncertainties to its risks Securities the the of fact are set call, the cancer its future within historical regarding candidates. that costs meaning Act Any of product for statements following. and are Company’s the to make and subject of future will studies During Litigation the management’s not vaccine including include and statements Reform expectations, prospects market technology, forward-looking the beliefs, than advancement of position, PolyStart forth and Private XXXX. limited acceptance but of Company’s candidates, certain its about financial other clinical revenues

of the development any include future cash statements Forward-looking to to position, the nature expectations projections market the and regulatory spending for and and transactions, plans statements and any Company’s and product action, expectations, product business licensing the possible commercial other anticipated or candidates manufacturing as to our clinical expectations results development thereof, and as costs. as timing our plans, and projections timing product component about cost

Company’s described with from on and or approvals but in due Commission risks estimates update forward-looking regulatory Form as the the note on filings materially projections is place required described these intend statements. These may to XX, does filed to of in these clinical undue differ report the not that TapImmune available statements website. to limited Exchange law. greater plans not reliance including forward-looking these are XX-Q achieve the may at yesterday, uncertainties important commercialization. Securities as TapImmune detail including which goals variety results factors actual related TapImmune's quarterly and Our XXXX, by and should statements in well not or as investors tapimmune.com, not development, a to actually these SEC’s except November Please

on of to Richard Mr. and Loiacono, At today President Development Officer Mr. President Mr. Hoang, Hoang, Dr. Head turn the is over Kenney, Executive of of Officer Peter to Executive will this ahead. call Joining Peter TapImmune; Clinical Company’s now us Michael please Peter it and the time, my go pleasure and Chief be call TapImmune. CFO. Chief

and joining call pleased today. CEO afternoon Good quarterly of as Josh. for update TapImmune. first which is us my thanks I’m Thanks host this to

company As I of you the know joined September. at the end

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who currently patients avoid therapy. been seeking approval help area like to currently limited performed who a relatively complicated initial are remission not. to of therapies have further PARP work women by following do patients that those that but in these like subset are patients, relapse their have cancer in toxicities. significant example, And have approved Therapies in For poorly for this shown furthermore, ovarian mutations, inhibitors therapies in first best BRCA no tend

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and save and hope understand technologies that you deliver for our help extend appreciate the can that affected as my quality lives, enthusiasm I and as potentially of conviction my patients. So improved life can well

through from drive As discovery, to determined am we tribulation to regulatory [ph] clinical commercialization. execution, clinical to our continue explore TapImmune approval deep advance potential into pipeline, development I and

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over for Before I Head I'll call Company the and our of update, recent Development some Clinical Kenney, highlights. Richard overall to strategy our clinical hand go Dr.

Our studies lot so primary generate to is and is the as value continue we more My set in efficiently that In goal additional even milestone objective for trials each possible. for of candidates clinical ensure company. vaccine our we every we're a further their novel clinical company. trials that the for highlight executing X executing in of our efficiently potential our active to Phase we to order parallel expect cancer as achieve

believe and done I’m is two achievable months increasing goal deliver the recently to Phase achieved Mayo we it Something ahead have enrollment patient for cancer milestone committed collaboration triple-negative necessary our that XXX, in immuno-oncology I in competitive reality. is of this that Since TPIV landscape. the with Clinic. breast continued schedule. a was a believe quarterly making call, full I to almost achieving This study X last our in

patients help in the this enrollment contributing which months study TPIV to we forward dose but is who remain the to of and well the are want team’s the regimen every study and vaccine four-arm I as administered the maximize six completed thank this development immune So vaccine. diligence, as due continuing investigators they to XXX will to this Patients responses. our With comprehensive patient vaccination not receive in looking of patients’ progression-free. to designed optimal dose determine are

as in in study in the a this and Mayo quarter Clinic to when XXX-patient the survival is Later will placebo-controlled announce their first TPIV This at we will efficacy large disease-free XXX hope survival immune to triple-negative that trial addition double-blind, patient cancer. women with breast disease-free secondary advanced in X So vaccinates Phase evaluate trial planned endpoint. for same look response the randomized, indication. this

a Defense. study As Clinic sponsored fully Mayo by Department grant funded million a U.S. reminder, this the and from by of the is is $XX.X

patient a will potential virtually recurrence a us XXX study opportunity demonstrate this to take it tremendous large to in complete, to TapImmune. the cost TPIV at cancer vaccination very prevent for to While some no time of population represents

for excited this Mayo start important to in study. enrollment patient We’re

vaccine This is requirements HER-X+ Phase future HERXneu from of types carcinoma program a study is nice the year, by guidance planning complement DoD upon our use to U.S. our the by to may grant allow is our in new in at which Clinic covered end XXX for vaccine. the cancers or to based value is to completion the DCIS targeted us expect also study studies the expand successful another of from to Mayo DCIS on that the studies and being The XXXX. breast early breast study and with patients also the enrolling study us enable initiate on vaccine greater TPIV pipeline expect – cancer. successfully we vaccine in building women completed five-peptide X Mayo that by filing a cancer. ductal Before run the critical situ of in Mayo, in company. complete Conducting helps will predecessor Phase to to X we a Based collaborators

of study review X Additionally, XXX coming high we Phase is oncology TPIV expect to our the impact, currently results of description by under certain The in journal, publish pending a reviewed the completed weeks. revisions. peer

manuscript the As highlight is findings. to by make as will final announcement journal, we an soon available the the made key

effort As and I’ll portfolio through a and into do that With to opportunity share And a final say call pursuing and believe intend the that to like drive TapImmune. Rick some of I holder opportunities I'd Rick? comment development focus bolster to greater significant our significantly expand that clinical to opportunity market hand detail to on we programs. the these provide value pipeline had our we for to corporate business initiatives.

Thanks a Peter. lot

multi studies. of TPIV currently cancer receptor alpha. called being in four many candidate lead CDX XXX folate TPIV vaccine XXX is targeting a clinical Phase our active you evaluated peptide is vaccine a biomarker know X epitope As

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where sponsored The a therapy is vaccination to successful as therapies second in quarter. the evaluate paradigm was a strategic no to study in initial chemotherapy. a following Phase it double-blind to rate study point To TPIV give platinum-sensitive round shift on commitment focus to in randomized, first second in namely women exist, as of I a criteria TPIV treatment the remission to in to the XXX their women We controlled, the the approved amended as at study’s study study Enrollment study XXX TPIV opposed mentioned. is maintenance the track. started currently with of a XXX is the TapImmune earlier this that reduce this in and of recurrence. August made In platinum-based dose just case to – ovarian enrollment cancer the X

and We and is first interim from conduct expect safety of achieved XXXX responses to half the mature. a enrollment the once early blinded analysis futility in data

the completed Peter anti-tumor maximize randomized funded advanced Clinic X our on cancer. and receptor patients vaccine maintenance-phase women XXX, With We As hope completed help patients following recently these triple-negative two alpha for that study, multicenter treatment plans without from standard with at line mentioned that also triple-negative vaccination immune response disease collaborators DoD. $XX.X the enrollment our breast of who enrollment of free Peter of Similar in expect study this immune TPIV of breast we after triple-negative complete, to sponsored top report or to varying This other XXX and advance study in XXX anti-folate is can highlighted, X fourth dose focused the the cancer. cancer. TapImmune we correlate TPIV behalf study women TapImmune-sponsored patient for million TPIV breast study first with large Clinic XXXX, it survival. in regimen with Phase in to will care women with the now the the in surgery women for the in open with can our determine Phase chemotherapy immune in enrollment triple-negative cancer. interim grateful our to have to breast will data their XXX enroll also begin Between grant by are Mayo will that Mayo have responses doses half optimal responses which cyclophosphamide. which completely we the by to remain radiation prolonged studies generated vaccine with on be

each positioned DOD vaccine and filing as Xb/Xa us is an cancer product. is to breast the completing the U.S. with to requirement do TPIV early timing the five exciting year, one day a year to enrolling a that to as If into breast FDA the new about for Phase patients effective second our DCIS forward study that will updated for successful, vaccine the next from an we’re IMD And begin that TPIV peptide proposition fourth vaccine The funding targets For Phase setting, This standard HER-X+ our this immense soon now the clinical of surgery peptide they of candidate XXX, Mayo for grant dosing accounts required could cancers, with the start Clinic. be a DCIS which as chemotherapy the we version begins. of Clinic secured is vaccine, the complement peptide by one update been is Mayo providing four potential an studied breast in well. XXX that's cancer. stage X. chemotherapies. that as In in its study Xb/Xa in predecessor indication parallel well also driven this is already of study which breast and underscores planning cancers Phase women to called is allow in And patient look as

deep Finally, our DNA call vaccine stage clinical pipeline we completing is PolyStart. proprietary our that technology

they to compelling. as develop for expression a significant of TapImmune as CDA of and greater out up presented both the value in we licensing express to continuing to through development antigens can this on opportunity are T-cells. product generate cytotoxic In we've quantity further strategic quite ten-fold with show internal pipeline We antigen effectively to platform that which to cells immune enabling Results developers. surface vaccine activity are studies believe well last other been this able more the enhance them direct are

our with of we technology potential out on goal licensing that, to the to continue intellectual As pursue additional over financials. value to be turn and oncology studies, an validate Loiacono our update partners PolyStart to this and within demonstrate to call our of a infectious platform uses our additional broad CFO, to the for cover diseases. to Michael I'll vaccines With enhance property

you Thank I’m to our review financials. QX pleased XXXX Rick.

quarter by Firstly, in stock to net afternoon statements. the $X.XX quarter. a million read relating XXXX executed charges a you and per last more $X.X about the urge of and is filed loss of explanation This year. the in right net or of XX-Q of in net to to approximately our employment $X.XX a second compared compared impacted contained we during for for the a $X the results our a financial or We agreements the net you share. share $X.XX our quarter of XX-Q loss a to compensation yesterday complete quarter loss for XXXX for $X.X recorded loss and quarter share the information footnotes of the third third third or million of $X.X quarter million was million for of

have loss million expenses net share. for a XXXX million were XXXX Total share for the operating quarter quarter $X.X charges of second the those per the $X.XX Excluding the $X.X quarter would $X.X and compared cents quarter to of in of million, for been third third XXXX.

Excluding R&D clinical trials this $X.X spending expenses this expenses million the have patients the would relate quarter were $X.X quarter, million XXXX. as quarter increase to were booked triple-negative to R&D $X.X ovarian of and million in expenses increased $X.X continue trial and QX the for $X.X XX% year. versus QX $X.X in G&A compared or QX breast million, about million cancer expenses increase we of during during compensation second during last our of for the year. an $X.X to from trial. year been operating of compared continue our million increase the non-cash our cancer enroll in quarter expenses for in in million preparations and QX to

XXXX. $X Total of XX.X with nine expenses XXXX, $X.X of fair value that represents a R&D the Excluding to Clinic about quarter than net increased million was period the million increase the of results months stock $X.X for by of paid compensation our our million Mayo share. the loss of nine-month nine operating an $X.XX loss expenses have million, is $X.X about was XX, about million, September XXXX to of in paused spending months about This the loss year-over-year fees increased from would diluted a out this gain in of a Net million XXXX for $X.X and same to of The $XXX,XXX compared the With license to year. XX%. result XXXX compared ending period were of of the approximately by impacted incremental $X.XX nine or share clinical change for was a nine G&A $XXX,XXX $X were during of in during positively compared months XXXX. $X.XX liabilities. XXXX, the per for QX net recorded period which for for increase warrant non-cash respect million trials to net less expenses financial loss as for XXXX. $XXX,XXX nine-month our relating months of or basic

was approximately million to into XX normal compared the in this $X.X Our cash $X cash in increased nine-month are payable. cash with million primarily we and XX, nine-month XXXX. accounts our used the period had from sheet, that’s clinical At payable accounts million in operations of represents increase of resulted operations QX accrued used operating The of With balance our $X.X September trials. And of $X.X in our million liabilities which Phase for compares to $X.X December spending at XXXX regards XXXX. X $X.X period about of XXXX for we of to cash million million

quarter of million hand some remarks. we Lastly, million of working fiscal XXXX. the for Peter? the capital, $X.X will to I Peter back additional at with compares ended which of end $X.X the working capital call to and over closing now

its conclusion, underserved several Thank a clinical We're execution and the optimistic TapImmune years. with immuno-oncology and should lead deep for trials company company catalysts shareholders In our across you, leading indications. to cancer pipeline ongoing and quarters clinical-stage over Michael. in clinical coming the is important multiple and large continued significant that

oncology patient the are significant to collaborate therapies will with success. attract us drive therapies the and energy technologies others our that and which be also unique regulatory outcomes. believe on I'm strength people to and approach improve believe I commercial also space immuno through the we're in help approval potentially I want can and convinced compelling our they We our combinations that taking develop of

by to next to better In our value the and communicate addition execution to critical continuing new to mission space be market XXXX year. develop the be for line enables clinical the is immunotherapies Operator pursue is open update another we shareholders care. for understand Thank valued capital for the able you. quarterly is and proposition up changing continued investors our markets, which questions. headed. it’s of and who will TapImmune will to support to milestones we're of tracking standard I by ensure can objective capital and that to the to believe the efficient keeping on date We you thank of look where the to want nice company also appropriately to that your see forward in phase the drive what us to our rest into continue

will [indiscernible] may from Please [Operator begin Our with Jeffrey Mr. next question. proceed our is [ph] Instructions] your the go Private Private is And Investor. now We you you question comes go comes question-and-answer [indiscernible] ahead. first a from line ahead. Investor. Please session. live question Clark he

Thank you. Can about operational I for more some strategy your hear improving efficiency?

Look, [ph]. what’s about Clark of [indiscernible] are there been Much things assessing we're there be candid but these let well, working we first things that and not the done See in me company well of are effectively identifying those as that within things days my the done XX that aren’t. company many also has the company time historically.

issues. For to an the exceptional problem major the from But the historically milestones fact job that with example, need that not company the two done acknowledge comes we investor of I hitting it expectations think has regarded to.

timeframes, is, first provide we realistic properly through a to which failure forecast The guidance.

expectation thorough with and will to be achieve in done be what assess order experience. accomplished what industry to and industry to we realistic a to of on with the our upon goals rooted rigor, analysis focused of we could timelines with set projected and based very align from more be this in and a our needs The the I’ve in One point milestones that give guidance things timelines more is norms. lot line industry to be that analyze of standards a the

mean that When have the say frankly to we of more in execution. side crispy things problem by rooted two is I other execute that. I The

institutions allied know organization tend many academic with may move Firstly, has like cases working to we work commercially timelines in to the other really more academic TapImmune. need urgency. of us partners, urgency cases. which and the Historically well many of sense for TapImmune on with than you different our in different as focused But as along work a

So academic But force like for to with it to can in continue are our that cases partners, us. we by accomplish doing things the available resources faster that the we a multiplier we ourselves, work we’ll with us move driving will. in can where act who

going to hostage in to need our not so ways can internally to accomplish we're critical, the was remain move that so times control necessary, we find that going the outside we're speaking, broadly held marketplace. So the be where with to cases and to we competitive spin in developments if

completed to efficiently. going example. team development we get the the the I enrollment operational last work execution. have we of being more clinical Phase full announced Gerald over breast to rate enrollment. clinical volume really Rick, clinical on there to We with that the the think cancer at trial on almost our patients largely trial that, clinical period in that's that the that Secondly, at clinical ability trial blocking were the Almost two do on Phase much drive we that profile do. like the despite their by blocking efficiency. to therapies, we're quarter to cases operational the our administrative, had the sites you Merck obstacles do motivate an head enrollment make that patient is of to this pluses fact pembrolizumab them And and that's drive trials against individual how the tackling, Yesterday, then X over on logistically in effectively. enrollment year triple-negative to dependent basic And that rate I work high the X enroll our sites operations drive we his on prevent or to quadrupling few versus clinical look what along from When managed of of head months. and you no go and and many clinical we we because schedule. sure was to clinical primary focused months investigators of bureaucratic, that with clinical that mean first ahead trial we by are what patients done enrollment able it and that work operations and able is we to to intend give this I’ll tackling

you. thank Okay,

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assuming initial what twice month. is here withholds a tax that They the been grant held that in of as did. are the same stock I way referring that was to you company my So has standard company my that's XX% about salary withholding as

That you. Thank clarifies. Okay. Thanks.

$X.X my I guys your right have the million current cash balance sheet, that guess see I then so on question is So is, what last away?

is Hey Michael. thanks [indiscernible], this

for been two operations. a last the $X we've quarter using quarters, million about Over

would forward as you run math trial ovarian if XXXX. want into of to moving a going cancer some spending incremental So use us that our to rate forward, and that adding put QX

activities certainly we additional be planned. discussed While ideal slow in we QX enrollment late to not and trials that's certainly not early and timeframe or not waiting a always to that's the the until financing QX certainly have something will We've address. the ability

radar, something our and will So looking it's into. be actively we’re it's that on

right. Thanks. all That’s my questions. All

Thanks Clara.

from Investor. Karl go Our a Malden Private next Please ahead. is question [ph]

all so the call. thank Hey, for you much

pursuing types build out you're that in look what You you any interested the you going pipeline. go to into further of that on detail for? assets are opportunities to Can mentioned

I talk any think premature specific it's that asset. to about sort of

I think shareholder to that accretive portfolio we're the that are for are potentially immediately what looking assets value. and are to synergistic

background heavily shareholder in transactions As drive you value. and executing to is may strategic rooted my originating know

our that that now one cannot be that I that our right partnership, term a the So being technology think of of the actually strategic some prescribe actual that a in oncology immune happen through space short whether opportunities wealth or of leverage to and is capabilities. benefits on there’s add synergies opportunities,

assess are actually IO going and shareholder over course convinced frankly we to the I'm in be the that will to that to the opportunities We're actionable continue of development So some And accretive are across short medium strategic those to those opportunities. short significantly that of of can medium term. many strategic opportunities to spectrum opportunities, immediately value. there the where appropriate term, pursue

further regarding you the exciting. exciting, status at of Memorial trial? any very Sloan go Very Can Kettering in the details all

the trial commentary, remains Well, highlighted Rick Sloan Memorial in at open. as Kettering his

based so with investigators And our the primary conversations on there.

should we data I think update first in get an that of half based XXXX. their analysis on the

Fantastic.

and at be So results those the what’s reason guess, to published the delay? point, for can Phase expect we X this I

interesting. So it's

see aggressive I'm any continued the ovarian. an studies. in have indication [indiscernible] change either this the outcomes the like reported will And like that to commentary because more study last gene-modified from back T Let that there's Point I way, dressing from in cell me would to that therapies. a add the yet me. fact pretty checkpoint of setting have some field positive I ovarian. cell that the think are checkpoint, over an coming go cancers in question, and studies interesting therapy difficulties therapies even your think hoping TapImmune indication difficult step but therapy checkpoints has for combination the because I ovarian first failure historically in from primary probably the indication be coming I extraordinarily the the trial, – of ovarian time for by only that I even MSKCC the that meaningfully cells cell to that been think tumors seen the

standpoint eagerly is analysis over to study about talked So that from right. With waiting from data for my the coming I’m respect X X study our to Phase the Phase partners MSKCC. you

Correct.

Okay.

X update So me study, status. for the recent let most you give the an Phase on

one addressable. So the leading And submitted of the think actually have they're clinical our seen straightforward reasonable, lead journals in you paper. investigator the publication of they as comment reviewer a comments, to know the and for received that on I and a have oncology the field. Mayo Clinic I manuscript

process results announce a I reviewers, been is Well there, the by personally to be we have addressing review Our the at position response. highlighted items published. inherently editorial of the think, and have that of paper collaborators the in that subject when the are Mayo the that addressed data the the should

Great. Thank you.

is Private Roseman Investor. next go The Please Jack a from question ahead.

Hi, there and thanks for questions. taking the

First congrats completing enrollment on of all, in breast triple-negative cancer study.

mean if tracking data? expect when those are this also you be to would patients? we the addition the And to survival to in looking disease-free so, interim see that at analysis, for going In responses

typically disease disease-free different In little is question. less natural you Thank their pace scans a That’s study breast and history. much breast progress to a a in cancer with survival patients a ovarian don’t bit a cancer good have faster in a in propensity do CT these The than you. study like cancer.

And their progression. clinical so mostly that clinical on of you’re evaluation depending progression and

of database anything You patient really definitive. therefore need say, much larger to much

not exploratory won’t progression the analysis causing are And in got we’re looking we’ve study, this cyclophosphamide as of in sense analysis. this the the design not Really of be addition the conditions in it study interim for in themselves of dose so – that or vaccine. an in low addressed the the an and endpoint a or either the that case is high the peptides well the is is immune disease-free primary we’ve as really that interim or of whether part which what response

it. Thank you. Got

have enrolling patient is the my started Okay, XXX question second patients so yet? DOD

enrolling The that’s correct. Mayo currently study. is So the patients for Clinic

first dosed patient. We have the not yet

few and to we So them. last first dosing in their requested weeks that the provided that patient, drug they’ve provide we for

trial few in the position of result the in we be expect a patient next should first as the to that a I weeks. that dosing in So announce

is my Okay, the next is Track milestone Fast question ovarian great. study? for cancer And what the

TPIVXXX most get in for and we enrolled of going in of be be is, those we to be half patients we’ll probably study have done of this progression the So is sites platinum endpoint disease. and we analysis are one couple a getting which dozen The of about interim to enrolling next can sensitive said, year. about half starting patients like the of enroll,

XXXX that XXXX that early to of the the happen analysis can point. towards then We at expect do and end sometime

it. Got

study. Yes, only this milestone. That’s because the only it that’s milestone we at really is point can the a blinded predict

Thanks it. lot. Got a

Private next is Investor. The a Jerry Please go Logan question from ahead.

folks congratulations. just to I say Hey, want

are marvelous interested split? I a what that to my You I Are cell on said told what so And that they that’s million. ovarian always the I is you you me address investment is, few that’s with interesting job. and reverse viewing prior H&Q, guess question you that in doing I’ve – trying the problem $X.X heard for we’re with know like. and that guide folks. you of to got cash burn at trade cancer just a CFO

burn is stand far per that stock the to quarter Unfortunately about with disintegrated Polystart as out bit. potentially additional a potentially thing. do million as type has cash of of $X price licensing Your you Where little stock kind alleviate dilution?

Thanks, Jerry.

Let me address that.

modulate the very because the on that enrollment respect So think enroll patients. burden the do by have one speed based we burn I’m rate think rate a of to clinical little guiding to are here. cash with Currently, the to we which able towards it’s studies I is modulating in ability the a at thing, that of important that aggressive I the we out point date cash

we in for intend that of confidence one differently and are in good and quarter. here announce change. we better the past. with drive be development, position a that’s here we will we executing tell help that’s efforts than historically expect and increase shareholder should to that development not that value the milestones priority the investor I We things we the to the we are think initiatives will that completion Polystart, one be had you that are I to in to – that a coming priority our the With business corporate respect of a about

and of coming they major that about where five pharma a I from last we know I background that is one potential people think spent that to tend transactions with the I biotechs long is years that transactions benefits talking Polystart the space and of the have here in to other to – time. the mitigate my go interesting conversations. be licensing want we experience with to need take to lead that expectations

I expect to so conversations asset to ways us. will monetize in the And while help the that for be fully drive able

I Polystart. from with the at think look of the requirement to we in isolation capital question have the licensing

in what a I read bio like answer. you’ve Very you background your it do. and good looks got very extensive

that. applaud I So

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Thank you, Jerry.

a think hit I the you’ve of ahead. issues lot

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XXX%, you have I With the success. wish XXX%

very you much. Thank

for you questions. Thank taking my

Absolutely, too. happy

Peter question-and-answer conference to Hoang like remarks. any back would I over to This concludes turn our for session. closing the

to Thank support your want of you I your our investors all for and much thanking patients. Once again, historically by guys. very conclude

driving are I once our support all again our patients. call. you, and quarterly we hearing shareholder conference outcomes shareholders from said call, for and efficiency and towards for our for creating thank to value on you on look operational of driving again I focused intensely our forward drive to and investor As next on your transformative you

presentation. Thank today’s now concluded. The conference attending for has you

You now may disconnect.