Marker Therapeutics (MRKR) 12 Nov 192019 Q3 Earnings call transcript

Greetings, and welcome to the Marker Therapeutics’ Third Quarter 2019 Operating and Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to our host, Tony Kim, Chief Financial Officer. you. Thank

begin. may You

at welcome press our results release News corporate in and earnings is quarter call. the website our of The reporting section everyone you third to XXXX available markertherapeutics.com. Thank our financial

Joining Officer; President Dr. Chief our Peter and Development. Mythili Dr. the Koneru, me Chief President Executive Development of call Clinical for Vera, are Hoang, today Juan and Officer; Senior Vice

uncertainties subject of that forecasted. statements As cause during making today’s XX-Q to with SEC. we risks in statements These A can on reminder, to and a results the Form found forward-looking are may those actual most materially these will call. from recent our file be be differ risks description

I call now would to Hoang. turn like the Peter over to

thanks and for everyone afternoon, joining Good Tony. you, us. Thank

years meaningful our durable at quarter. partner-sponsored In the over virtually Medicine, early by College results we’re disease solid therapies encouraged particularly such progress to various across good T-cell areas. treatment while and And ongoing challenging patients the responses the it’s experiencing We continue delivered in five related MultiTAA tumor Baylor make in promising T-cell with MultiTAA by T-cell cancers toxicities. immunotherapy, of are days, studies advancing some with novel clinical hematologic no

time to In months to Marker-sponsored expand months exciting anticipation the to and and clinical support be of continue our our XX productive build-out anticipate and XX future for next infrastructure trials, we our We an company. team.

first the trial. collected Marker recently patients X the acute active disease leukemia our drug myeloid post-allogeneic As stem study for lead as Phase a part you on transplant selected settings. both application of as company-sponsored we’ve new and USFDA investigational cell We’ve adjuvant may Baylor-sponsored or or studies, in in of hematopoietic clinical based a breadth our across IND AML the recall, with with new filed the AML data indication planned

for regarding technical are products not two vendors third-party ancillary additional our quality that submission, used reagents Upon in and certain product. are reagents requested specifications by manufacturing reviewing the These FDA final used are and the in information our supplied process. in present manufacturing

data to the and or products to our quality clear questions satisfactory Because are questions technical we placed the agency’s were third-party is IND, the than respective rather until response address to complete own directed the manufacturers on been at needed the with the because hold request. our to the the However, being the trial regulatory to FDA. groups FDA’s process worked has product

them, regulators for submitted After late the days October, response to in required we receiving our from complete information agency and the have XX respond.

and will been once plans update We have addressed. forward questions to communicate these move our and

this the scenarios, new initiate provide Given population, for our T-cell We this later priority. remains confident of on candidate, top novel the which hope therapies treatment are improved various we year. trial precise that resolution need timelines believe can our a in impact patient XXXX significant the to more can AML have the recognize in and we advancing we and

rapidly and with a progresses also risk chemotherapy, marrow to carry the are graft sometimes necessitating transplants bleeding, the carry marrow of infertility. Current treatment. treatments a Both of these for is with also disease, with as and risk our risk GVHD. options patients permanent mostly fact, treatments. need a of and limited versus poor bone improved rate acute leukemia relapse survival most is prognosis in of host In infections, The combination AML XX%, a common high adults for transplant. Bone known in five-year life-threatening

more in epitope as MultiTAA recognize development. standard MultiTAA to potent stays, over unlike five for up is transplants administered to and in response, hospital other therapies that durable have We setting. require may an therapy approaches anti-tumor T-cells outpatient antigens T-cell to a mono-specific MultiTAA that allow believe well our contrast advantages In and several as spreading T-cells, leading

in therapy our continuing a the trial progression shown breast XX, triple-negative including immune but date, meaningful XX sites, trials date, also focus, cancer To is treatment preliminary TPIV cancer have MultiTAA vaccine-based vaccine in based XX have XXXX, breast of on showed XXX. our progress we cell central analysis based enrolled clinical treated with XX of are at advancing September showed treatment results have responses XX legacy of patients patients following to disease to clinical XX several programs. as

however, interim an to advanced on ovarian the discontinue from of platinum-sensitive an Monitoring or review Board in with Phase made study DSMB. decision conducted have the Safety our independent We by of results unblinded patients based Data cancer development cancer X vaccine and

anticipate DSMB Although express for in the in have ovarian closing respect did trial, is concerns pre-specified based and formal data, to elected not as trial. interim on breast that results which the we threshold in will trial Unlike product. patient the XXXX. we safety upon not suspend of cancer the at XXXX; complete make to a TPIVXXX, trial full decision we quarter time, review first for the there QX with our communicate last the the probability analysis of Pending success cancer our the the no next The steps did trial it any of criteria. meet will

review taking financials. will to Tony forward to over we questions. After that, I your look that, turn With to the call

Peter. XX, a the September loss Thanks, $X.X for XX, for of $X.X Net million the net September million, to ended loss XXXX, ended quarter XXXX. compared was quarter

development during to months the was during of of build-up attributable $X.X personnel-related the to infrastructure. increases million, increase million XX, September September expenses, relating internal Research $X.X months our The $X.X XXXX. was primarily three million in three and to ended costs XX, ended XXXX, the compared

three offset months expenses the months million and during as during million was headcount-related XX, increased other and expenses $X.X General were The administrative professional $X.X XX, during XXXX. September $X.X in XXXX, legal expenses. XX, ended ended decrease XXXX, primarily the three attributable three merger-related expenses million compared to the months ended September of to incurred September by

turn I remarks. will over final to now Peter presentation back for the

Thanks, Tony. I’ll open questions. for the call Operator?

with Christopher Please question. first Marai [Operator comes you. your question Nomura/Instinet. Thank Instructions] from state Our

Hello, this I’m to resolves you start response Marai. is the the to patients? technical curious the quickly just Jackson be clinical on able FDA concerns, after will dosing for their hold how Christopher with Harvey

Hi, for the question. That’s Jackson. still stood in question. thanks a great meantime. the We’ve not

think In fact, fully are that of I preparations the trial initiation for underway.

with date, plan. get we the who IND fact, have In site sites. now sites, number. in ahead IRB To of XX accepted we’re started we and contracting have over progressing visited the for can IND plan waiting an are number, Once enrollment accepted an we those process

that able start IND. to promptly trial be after I do acceptance of anticipate we the so, the should And

Great. Thank you very much.

Our Ted Tenthoff with next Piper Please question comes Jaffray. question. from your state

you very Thank much. Great.

are steps to the outstanding the hold I some that. exactly? respect what and Just want following What up understand IND issues are just be I Peter. a the on timing. to on of with make clearer next little that, Thanks, bit sure

Yes, absolutely, Ted.

Let am I Head turn Mythili the Medical our to question Koneru, of over Operations.

Mythili. Hi,

the reagents but a we To and Hi, question, fuse – use quality product two supplied the information manufacturing in address Thank process, for it’s the certain third-party technical your you, FDA your there. of part and in vendor final first were to specifications Peter. additional that not by specifically present that our patients. actually requested regarding

on until IND, of FDA plans complete these because holds the FDA. forward satisfactory or the was with this response placed which So, allowing studies this technical to planning, the clinical to IND requires any data questions move our the that’s before

response respective So, these regulatory the idea to on the manufacturers is and at FDA’s and these release, to the was the that FDA communicated with working that XXXX. press quality in we’ve request, raised groups October a XX, the as issues complete we we’ve submitted been by address

XX receiving lifted complete then So, and trial. indicate whether and whole FDA is clinical the is responses the if why days going the respond is to actually specifically not, the the reason after within

puts it That’s says minor because really, maybe, the just how, hopefully helpful, for that really into perspective I IND. think

all the in more the So, going, excited there getting hear studies? up about to we’re and best

a at therapy. in really what seeing in We Ted. not right atypical industry now cell a do sort from of we’re biologics across – the Thanks, see

it. appreciate So

you. Thank

Biegler comes state question. & from Our Company. Oppenheimer next with question Matt your Please

Hey delay? those with scenario testing? long be taking require I new would really the mean, for might a FDA do questions. estimate guys, think worst if you mentioned? Peter, how IND think equivalence reagents would find here what that vendor for do it thanks you case to you my Do so, you this you could to a And take

Yes, matt. That’s a good question.

FDA start. anything Like me From again for better is I to Mythili gone, think say, gating at I has than enrollment Let the acceptance said, that point this really can the item to refer site if us here. the I expected. what once

Mai, acceptance. to able start add? think further we we fast And get anything do as so be do as that, you I get to soon pretty have should

been that. reiterate the our program to these we manufacturers in to working then would XXXX. very closely trial confident have response FDA’s do for clinical X We just that, And the post-transplant the expect Yes, phase treatment questions. of the to like have AML MultiTAA with of prospective initiate submitted we and feel about

for helpful. Okay. That’s that. Thanks

And concerns design moving still that AML planning trial you’re the forward as any so design on maintenance with as is and well the with patients. looking agency correct? refractory both same didn’t relapse at have that actual the of

disease setting study be phase we is unchanged adjuvant the an that of an as X That and setting. active will correct. is both Yes. portion exploring well as

one last just for if one I it. then me Got maybe, And may.

any yet? early do this cell you the has get separately, maybe we’ll AML think the if updated began you end data Baylor testing XXXX? So, Baylor patients with higher And year, of dose know by from do

providing has the regarding doses additional AML obviously; as as which We the the AML some Yes. in on Baylor studies. information year higher will The pancreatic plan include studies, do study well begun. next the

for the Thanks taking Great. question.

Thanks, Matt.

Please you. next with question. question from Butler capital. Roth Tony Thank your state comes Our Instructions] [Operator

Clearly, trials Other could – therapy Thanks albeit questions registration that you may deal are cell other a phase trial? – itself. what much, generally be you great move cells at, information in that than give looking parameters trials. clinical give forward could trial you within our very dosing on of opportunity Two in sets design you four X Peter. the the a

So, – to I do you what just actually accomplish? will want you what to understand hope

In then And Do begin ClinTrials participants. a setting – you ClinTrials when particular finally, then AML? will actually this Phase post-transplant then that in X? and I about much. enrollment. and MDS patients of the number the correct? AML gauged thinking Would for has dosing is be you’re patients? with And guess present very is around How XX those that for will generally that in second question be one fulminant words more that Thanks other would recorded

questions. your for you Thank

them can address me at if Let see time. one I a

either receive and is question, a we study at it planned adjuvant be is in this relapse Regarding setting both care study. be we is We The the feel part have MultiTAA actually fact X to do of interim move looking and to or the phase portion population. sufficient. analysis. the very active that there your treatments of single-arm going the the given portion randomized because first an for disease adjuvant observation, but T-cells forward, randomized disease a to is study of standard that active would limited there’s the study a that single-arm opportunity is also post-transplant feel And

standard and the In XX accurate. be total arm active the of the study, in looking The each obviously XXX phase arm. have arm. disease for care at you TAA saw study, larger study the is in observation actual patients of phase terms to in for we’ll the of the adjuvant a X in patients of of you enrollment what that X XX and part is versus part T-cells ClinTrials.gov patients be

Tony, that AML. you a about question think asked I presentation And of

nine therapy mark, three-month into one active active the disease-free thus their will trial. be month around that a relapsed about probably them will the thus feed patients refractory maintenance three single-arm as arm patients the our be is adjuvant has for XX that disease and in be active of into judged information At disease. will XX cells of patients will of best feed a to disease and arm follow-up, the Our XX and receiving without that

cells will in complete as patients we said, adjuvant in arm. in those moment get randomized the of once they arm, be XXX who rather will thus patients held at total, XXX receiving their to Now, disease cells looking transplant, enrolled bolstering them of enrollment active that relapse, for the days the than XX enrollment after Mai the patients aggregate. continue But until you’re their the

Peter, in just plus – sorry, the XXX that… in those I’m the XX

It’s arm. XXX with XXX with in randomized XX one, to control the XX so aggregate, patients – at one patients patients drugs,

of arm for trial. the XX be active the will in there addition, In patients the disease

Thank you very much. I appreciate it.

Sure.

Our Please comes Janney. Yun from next question. Zhong your with question state

Hi. Thanks. Thanks the question. for taking

Baylor clinical curious, study? study IND package the conducted at the include investigator-sponsored from that just did So,

question. great and perspective, I company-sponsored transitioning question. Hey, for academic That’s for is this sort my a for commercialization. is from of part into thanks trial think the and It Yun, pivotal a did. process appropriate process of that that in parcel a

here So, agency that higher therapy. what I Really all profile looking is that the are the surprised overall are that reagents proposed of has particularly there’s don’t safety looking the for. they’re think potentially be that of of scrutiny specification we’ve on process used level been of ensure but the that they for to to the the that meet reagents, some the noted a in

you. Thank Okay.

to to be further Thank appears there And this ladies and management no back I’ll at questions you. to time. it turn conclude. gentlemen,

call wish if our your good out Please to additional any a have you today. appreciate all evening. for joining hours you Thank you after We questions. us and attention reach again,

Thank may conference. you. All Have a day. concludes disconnect. today’s This parties great