TYME - Earnings call transcript Q4 2019

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Operator

Good morning. And welcome to Tyme’s Fourth Quarter Fiscal 2019 Conference Call. I would like remind you this call is being recorded. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. now Corporate turn for Communications would to call Tyme. I Gill, Brian and Instructions] like the to over [Operator Investor Relations Thank you.

You begin. may

Brian Gill

quarter at for conference the of Operator. fiscal financial reporting going results you, And to to everyone Investor www.tymeinc.com. can and our Thank the the be addition presentation by welcome our operating section year webcast corporate The call. fourth XXXX in press today’s website release Relations to and access

remarks are Ben Giuseppe prepared our Hoffman, our and Joining Financial Business Officer; with me Officer, Korfin, Del and Steve Chief Executive our Chief Operating Officer, Taylor, Chief Dr. today and Chief Medical officer; President Jonathan our Priore; our Eckard. Officer; Michele Chief

forward-looking addition risks financial operational cause differ are that these As forecasted. a reminder, actual regulatory during to subject uncertainties The to description today’s plans. making regarding outlook to and statements call These in may product results be we development and and statements and those turn the risks date our our from of will SEC. now revise to can speak I’d XX-Q over filed call Steve any today’s statements of our with in them. only as Chief specifically to be Executive update These disclaim like obligation or recent to Officer, Hoffman. the we most found

Steve Hoffman

by about. Good my asked perspective and you, I’d key thanks call I’m everybody, start morning, often today’s showing Thank like on Brian. for joining to us. points three

and new help. third success financial ongoing from is our is trials, findings, second our first clinical the data The the is recent preclinical in encouraging our

following. to as X Phase results demonstrate pancreatic TYME-XX-Panc of our patients cancer. Part the XX-Panc continues available Preliminary XXXX of announced encouraging which using the with First, topline in today XX, demonstrated we from study, advanced ongoing April data overall from information survival II

of patient of patients double overall reported be First, approximately population. to is this the trending evaluable survival survival

months longer. from at still alive patients six were ASCO reported XX% at or Second, originally GI,

just longer correlate has and correlated survival. cancer. over addition achieved cells that response been tumor earlier progression fourth, in Circulating one learned remarkably patients we other with And of survival. a prognosis in cells Third, of type the of to have year tumor circulating

in So see These this pivotal it it prospects in to optimize significantly trial do well. good our are findings is NDA indicator is the surprising our and as FDA. power robust increase our as benefit pancreatic with filing a data to plan not and of successful everything to to

everybody ongoing our development that and Korfin interest medicines of over is cash through as data better to pivotal portfolio. study confidence development, study of And all in clearly and longer point planned safer XX-Panc support for of are approximately had in with of product all validates a single create cancer. our in recent continue multiply value in XXX, general demonstrating the pivotal to inhibition of the initiate results and will better Everyday Tyme Moreover, to research and us cash worldwide. third efforts, stakeholders of patients for in XXXX and cancer their discussion the to future drug and help Michele? This of to as safety the our works April thank and we our our XXXX. patients and our that cash Part pivotal proceed $XX.X demonstrates expand and on reinforces second in end the as trial our turn growth. The Tyme our agent preclinical X begin tumor To SM-XX patients million like prostate, call quarter substantial equivalents. we position regulatory for lives tolerability initiation ensures expect the in our strong patent cancer can X, Michele third-line of of XXXX to This planned sarcoma, results, passion pancreatic enrollment the metabolism-based platform live trial third-line working in data for Tyme. pancreatic and before I can our complete SM-XX at cancer transformational course,

Michele Korfin

Steve. Thank you,

at Our developing cancer is provide year and encouraging patients treatment tumors SM-XX the to survival different needs. we unmet patients therapies is a new GI, with hematologic for only Tyme X%. including the informative data has both focus our solid Based XX metabolism-based estimated and patients metastatic demonstrated progressing across safety about Phase has Tyme our XX oral SM-XX. of diagnosis had results months metastatic were we’ve unfortunately on for initiated a efficacy encouraging First well-tolerated medical will actively treated ASCO malignancies. XX% patients challenging types, passed Study had of who options away in such our with with Type Human of patients survival amongst an overall demonstrated These C is we these presented first five-year In study. reported the meeting also median a the approximately published FDA. Pancreatic that XX at study recently cancers. SM-XX cancer initial our Based profile. our within almost on all pancreatic II diagnosis, very tumor

these patients now These will patients be or the U.S. NCC for FDA no There on with no third-line. patients, are pancreatic recommended patients. focused amending trial Phase only third-line ASCO but options. We pivotal Over be to our reached cancer a II also therapies need treatment and study approved not XX,XXX in therapies.

to initial call committed Giuseppe advanced the are by pancreatic like with the provide turn and who Medical study. seen update. our the time, Del cancer, we’ve Chief Officer, encouraged will At SM-XX we data clinical Dr. would our and TYME-XX-Panc this I Priore, to the are over We to

Dr. Giuseppe Del Priore

obvious of period underrepresented many face emphasize patients patients XX-Panc where like trials ahead healthy the patients to in into unrealistic Thank almost cohort X are enrollment patients are representation allowed of prescreening I restricting you, Part trial of by real TYME-XX-Panc within that difficulties know the enrollment these died like Michele. of I these without so the concessive completed to the rarely would the the reflected of severely life Despite randomization. in unprecedented schedule. other situation an patients. no individuals before

the the design and using be as in guidance X survival trials overall We that agency. the of results are the have specified upcoming pivotal outcome primary randomized in communications with of to FDA and our will reflected Part as inform the

As just stated, consented, in of pre-specified XX with schedule patients resulting enrollment completed XX ahead as evaluable the in protocol.

reports evaluable overall trending previously patient of doubling the an towards populations. is As mentioned, other similar to compared survival approximate in patient

now months associated presented also as nine of at of relative an of reported treatment GI important The least significantly third-line XX ASCO group significantly with SM-XX cells survival. have one frail other the data worked Equally which months six that emerged disease. this longer trial. -- XXth be Also year overall updated identified with and we circulating as I the tumor believe The estimated similar is criteria instance, survival greater theoretical important, by enrollment. with lack that reported enough the all types tumor pivotal et Similarly, XXXX alive of other consistent and after but several toxicity spectrum treatments especially or explanation than alive across was prohibit April cross level and broad patients of patients. were of most in still tolerated options correlate here for or better patients We of still with. Manax to at having we our design screening the third-line of two-and-a-half reflected have For al. response therapies rapidly have nearly to with patients have two XXXX resistance as is efficacy GI in lack XX% months longer ASCO Once action, safety report early patients maybe women on mechanism at given survival. in will of for toxicity the declining in prognosis of multiple were

meetings. related will at these the We academic details present observations to upcoming

in Beyond cancer, for encouraging That advanced updated pancreas -- direct now SM-XX the encouraging of beyond details patients prostate is in hypotheses recurrent disease. results PSA metastatic also trial ready cancer. updating now are investigations concluded risk to future the in early and at trial we the

You metastasis, figure an PSA few progression doubling the have any studies, enrollment. more and and time upper patients even that left despite can on imaging aggressive importantly, develop patient see in remarkably had no

right, bottom I’d of of the like call in circulating the tumor and intriguing toxicity to tens continued cells, consequences now, the the favorable profile testosterone significant we cancer we facing for so XX-Panc. show the slide, in treatment in which thousands of prostate of are upper turn show the very At Michele. universal deprivation confirmed And deprivation. and the the reduction to has back hormone of important On again now been men

Michele Korfin

joined recently for FDA the PCAN Giuseppe. Cancer PCAN you, precision with Action protocol. promise, meeting adaptive Tyme Pancreatic a promise is Thank study. to to partner design Tyme or proud the innovative for finalize precision the with Network

first February amended finalizing patients. This physician the data The we chosen feedback protocol the therapy trial. control median our comparing Meeting the as final second-line the encouraging cancer patients standpoint. most these and in be versus the will X.X-month patients X.X-month to end We therapy Current received a of their study. for second-line our partnership confirmed could recently second for overall have choice, third-line. point experimental with look into to a pivotal overall safety also primary advance for There TYME-XX-Panc forward median in demonstrated are SM-XX XX,XXX We pancreatic is the study survival. second-line SM-XX feedback SM-XX half therapy. be from being of very control approved C PCAN care amended been from the are second-line This also for FDA saw survival and proud versus with Tyme this active registration seeking path second-line the limited with the arm. over the arm an open second-line is Type study for a incorporating advances treatments. There discussed protocol. will the at The SM-XX XXXX. was FDA We arm. initial are of FDAs studied design the for therapies challenging with the a

Tyme disease sarcoma. new cases accounts -- orphan sadly for children Viewing annually approximately only Another and U.S. is sarcoma five-year focus metastatic overall in of XX%. X area for with cancers clinical XX% are in an is of for Sarcoma’s XX,XXX the survival bone diseases rate the

partial encouraging a one study to We SM-XX response. a have patients the in two response SM-XX. we complete Based had this in and had approached on data sarcoma. were viewing had further initial One past treated with

we address to longer unmet cancer therapies loved partnering needs advanced treatments cancer life. patients metabolism-based help Tyme, better committed physicians patients proud next-generation At Sant cohort to SM-XX with with to the Chawla, the primary Ahmed of study viewing Dr. Joseph the Foundation endpoint with of this initiate first We and partnership sarcoma, study the on with are our response. being overall and and live ones focused their to are cancer through

over who Now, let call will President a our financial provide overview me turn and the update. CFO, Ben to corporate Taylor, and

Ben Taylor

burn fiscal guided Total you, $XXX,XXX quarter for The million. $X.X XXXX. operating operating the and below clinical first clinical focus cash quarterly to Approximately million into Thank of the was Michele. $X quarter the fell burn, quarter burn primarily expenses, XXXX a that annual fourth of due expense advancing associated was our reflecting pipeline. continued with XX% our of was company are of fiscal development the on research

As XXXX, and we in cash had $XX.X April of cash X, equivalents. million

the need appropriate believe to fiscal approximately to has fiscal availability operational of that represent currently we outside XX-Panc annual pathways. to been patients a in $X studies with XX communities oncologists But received meets well. Precision seek patients one-third all treatment burn annually types initiating and for core Through offset KOL standard is cash and therapy substantial mentioned the shown to commercial of over continue million pancreatic our the in clinical cancer the response annually expanding unmet XX,XXX and toxicity. patients second-line different new of need our of $X two SM-XX’s from pancreatic We is into efficacy burn earlier forward critical At received indications. better XXXX, Historically, XXXX we rapid paradigm. from development of in continue company has hear million related that outstanding same with that SM-XX option. quarter. care. expect as a pivotal that XX,XXX of cancer time, XX,XXX potentially third-line we treatment is per one-half cash significant Promise, and clinical cancer SM-XX approximately the want Looking to cancer network Michele guidance and limited Pancreatic financings. that investigators first-line existing SM-XX focus no operational Driving

in one-third Precision similar program more efficiency. Our The study we Promise reflect have Promise Precision cost expanded than with capital balance development sarcoma and doing tried both a patient how save trials internally. time to our compared

In completely on while principle TYME-XX the large to the with same would of cost forward, portion could in us using expect of partnership chemical most sarcoma different provide the the covers treat published to discussion Ideally, explore right capital. significant that hematology associated Phase breast, launched to leverages the XX-Panc Study localized We believe and difficult journal. conserving time a We first I FDA note our a the be treatment also Human connection trial. for with for in IND. large it’s would the SM-XX move focus address progress SM-XX, with disease. prostate the our initial is options of First trial. sarcoma as intra-tumoral to that but other in development we continue calendar important that addition, composition. our In JAF to an areas path patient’s that NDA an the in has to with study. results to on from XXXX, tumors, results we to the SM-XX, TYME-XX prostate the half injection or announce on a advancing made forward. so waiting but We TYME-XX and were pipeline We metastatic needed towards that II the we it move while peer-reviewed used SM-XX compelling we

initiate Looking studies. second are forward Part Promise. data XX-Panc in expect half we continue to X publications through trials for expected Precision the for II of Phase the the of and prostate results to of Part XXXX, pivotal this XX-Panc X half to including final Two and momentum, second both

agent also will on agent. the be from use especially results diving mechanism in action, conditioning into with We the single without in-vivo and as in-vitro of work, preclinical a SM-XX

That the the Lastly call our fiscal In TYME-XX’s a around end. closing, IND our to we’ll Q&A session. now provide we’re like transformational update would a an Tyme. over for remarks. pathway as year looking to on turn I ends forward year for XXXX an for to operator

Operator

[Operator H.C. first you. proceed. Sean with Our Instructions] Thank is question Lee from Please Wainwright.

Sean Lee

you taking months. the Look progress Thank a into of like my lot next Hi, for can XX questions. guys. expect we going

pivotal little study? maybe of pivotal the competitor could be the color, us you size the study, Regarding upcoming used? and part the the dose SM-XX provide more potential would What a to what’s -- be of going

Michele Korfin

the This Michele thank and question. is for Hi. Yes. you

study. an to So so in site to comparative, amendment the regards and is this the TYME-XX-Panc

the is of will [inaudible] So Precision and with so program. other interact the chance Giuseppe also leveraging we the Many be the sites under to leadership we positive the then clinical the participated through sites. in Promise from that’s sites that news operation X, Part a the side, positive, the of had and

on look been may we through that interacting with to we Medical add So other some Advisory Board. our sites

physician And would it so be will choice, have they this option do because X therapies amendment we amended population. is the a the news terms positive the for Part three approximately is physicians be using So arm, the that for protocol. that patient have sites third-line that the the would so comparative of will then ready be of in the

ASCO FDA therapy, as remarks, my Now, and in therapies. NCC mentioned there’s I no or prepared approved unfortunately recommended no

be feedback will So from we proceeding will appropriate medical the choice then we we felt XXX-milligram the proceed most based the on the of and from terms that was dose. FDA, dose, in the -- the daily comparative. advisors And physicians with

Sean Lee

upcoming in expect? on what’s second And you we what at from the Thank stuff previous data can different for half, new GU, the ASCO that. prostate updated study

Dr. Giuseppe Del Priore

This is Dr. Del Priore.

confidence data in increase an so see you’ll narrower intervals. points, think I

which now on message pretty little in think No the very XX-Panc. the I tumor course, It’s and any we’ve circulating imaging, clear. confirmed of cells, dramatic. it progress was metastases,

and going I follow-up studies. lead intervals, to that’s collaborations some think, tighter to So wonderful interesting

Sean Lee

right there Phase that as now Are any III plans well? to study move into a

Dr. Giuseppe Del Priore

We’ve great had a deal of interest.

meetings. at reflected it within also to some in those that community can we to will community. upcoming see pancreas and plans hope the add medical But You have our presentations prostate

Sean Lee

I the results on preclinical TYME-XX maybe and that it see. you us provide little bit see it? Could And more some newly from my is final we on can announce when color one? What program. question does

Jonathan Eckard

This Sean. morning, Jon. Good is

plan So, we TYME-XX models demographic showing release tumors in our completely a on did on animal we of appropriate for while gathering scientific package these dramatic a animals. doing effect occurring the what details the little put some and those initial that is into detailed -- on with meeting. what about scientific more have actually the mechanisms is of tumors, What some around of resolving more to press a them ago, XX% around had presentation in observations we

for course on at is the more look guidance be are that we that details the year forward as set, what we and the will program providing updates providing time. this plans over to of So, around

Sean Lee

Thank all I you questions. my see. for taking of

Operator

Please is Canaccord Genuity. next Arlinda from Our with Lee question proceed.

Unidentified Analyst

James the Congrats progress, to everyone. it guys out two with I is that’s question, [ph] of this morning, This one-year questions. little survivor Good about more have on on is us tell half. that bit anything patient Arlinda. for Can you X Part clinically? Jen on all stands and the looking My second XX-Panc forward

Dr. Giuseppe Del Priore

Yes.

So -- prior this is of Del is our with poor Priore. multiple extremely I prognosis lines. population us reflective

Unidentified Analyst

Okay.

Dr. Giuseppe Del Priore

within we meetings be able in actually will cancer all she publications. nearly at immune class This that alluded details agent, some or Despite long in complete pancreas oncology person to it in more therapy. to was that’s the we have investigational plus plus and described survival fact that hope had available additional every that either

Unidentified Analyst

disease and treatment? distinguishing is what women this the men hypothesize factor between you Can survival -- with

Dr. Giuseppe Del Priore

CTC mechanism and responders, of extremely looking the, in before host also I of the question want the which pancreas survival and the that, SM-XX cancer whole reasons. with we add other CTCs about at our your answer patient I important is did So, think to just one Jen, is longest

important, gender question certainly has been at it extensively is of looked diseases. pancreas cancer in and other Now the

underlying So phenotypic a But if we subgroup we’ve biomarker we’re there’s identified the in this are that or a extremely and for that difference implies encouraged explains that searching mechanism. genotype outcomes.

and pancreas wonderful the think actions I of and validation of benefits SM-XX mechanism and and ones. it’s of So a endorsement the other

Unidentified Analyst

Okay. -- that of given is of endpoint I the state potentially to mean what being today? the It’s clinical circulating just an cell diagnostics counts. possibility

Michele Korfin

Yeah.

thank you the for So, question.

that. cells comment prognostic different circulating we’ve been types, important make Sharon have number a tumor of very prostate on So in seen Dr. tumor in a a

FDA as efficacy exciting I So, the important It tumor the us it’s discussions of there’s an -- with the mark. was been cells with know circulating active SM-XX. use further how see around to for to very data

Now in seen our study Phase in both reduction study. tumor pancreatic prostate and cells those patient strong populations. in II we’ve The two different Phase our II circulating

Unidentified Analyst

Okay. very That’s Thank very you helpful. much.

Operator

Ladies and over conference session. to of the like question would to have closing turn end management our the reached for we I gentlemen, back remarks. and answer

Steve Hoffman

be will Thank you, and the management interest with to in the course The milestones and Operator. we appreciate the team throughout you achievements the year. the of available throughout have questions course additional our sharing We day, Tyme. if forward and of attention you look

thanks call. next our to So, forward and again look

Operator

conference. you. concludes This Thank today’s

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

Tyme (TYME) 29 May 192019 Q4 Earnings call transcript