TYME - Earnings call transcript Q2 2020

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Operator

Greetings, and welcome to the Tyme Technologies Second Quarter 2020 Earnings 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.

to conference like host, to now Mr. would turn over the your I Corporate Relations and Gill Communications Brian of Investor for Technologies. Tyme you. Thank Mr. Gill, begin. may you

Brian Gill

XXXX going updates Web and Thanks, second and the operating press everyone corporate welcome be financial Investor reporting investor accessed Relations can fiscal of by release business Tim, www.tymeinc.com. The the conference site our to on at results call. to and quarter our section

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

operational during As uncertainties regulatory making we to to statements These outlook and today’s product be those development and cause are may will differ and in call risks a from subject to forecasted. plans. addition regarding reminder, results forward-looking actual statements that financial to our

recent in of these as date description A disclaim statements and speak update revise we SEC. any of them. most risks file only today’s or specifically be found with the to These obligation our XX-Q can on

like to and Executive call Steve over turn to Chief our Hoffman. Chairman the Officer, now I’d

Steve Hoffman

everyone, everyone, Thank you, joining progress Those us today. have thanks Brian. Good been that has and in reached history. point our for Tyme who know our following the transformative

treatment cancer. of for pancreatic enrollment studying designed the to for trials ready two now are We of pivotal SM-XX be

to increases that efficacy It these where company data have for value in We the many the believe prospects safety has forward. bring brought point goes for create and without and that our value potential, saying we believe failed. success encouraging tremendous will milestones before this going us Tyme that

their having groups key series oncologists a expressed Those leaders Tyme’s medical compelling Furthermore, our prostate leaders for Key resulted to have both the FDA, optimism. which central with in they SM-XX opinion approval. share communities in by the and have has guys major advisory enthusiasm led and driven of at have told pancreatic data study constructive international that IRB presented instrumental in us protocol meetings. interactions the pivotal opinion

We and Moreover, hear Tyme’s we our soon you patients this as enroll have are prostate, ready are expect data plans trial XXXX. as also pivotal breast morning, as sarcomas, now in and hematology. to advancing to

as fact, In addition O’Brien to to delighted hematologist Medical Susan the Advisory our we renowned Dr. are have Board. newest

cancer cancers. metabolism-based demonstrated of have Our across therapies a activity spectrum broad

release preclinical expect data We XXXX the be developments. other by marked SM-XX of more and regulatory to clinical

enable to adequate to expect advance to have trials other and our to access us resources pivotal Importantly, initiatives. we key

now I’d that, in I just like leadership over With perspectives you more outlined. call the their with team on our the detail to to share points to turn

Michele Korfin

Thank you, Steve.

using We about pancreatic of pivotal the are truly excited cancer trials SM-XX. in launch

and received have central we quarter. mentioned, as clearance Board Importantly, are Institutional IRB ready enrolling Review we to start or this patients

our key company’s results discuss focus, our I summary point critical provide have SM-XX wanted I that to brief brought to regulatory in the clinical aspects this history. Before us of and a on

cell such acids cancer SM-XX most then healthy to SM-XX is hypothesized tyrosine. disrupt is it need Cancer leading take amino tyrosine. takes non-essential oral, as cell. to The the dysfunctional modified synthesis cells, and unlike into cells, sees protein SM-XX in an to cells death.

XX almost comprising CMBTs and profile the SM-XX or a different demonstrated platform. types in tumor XXX well-tolerated SM-XX four patients studies. across lead safety cancer therapies efficacy is our therapy in investigational has metabolism-based separate Tyme encouraging

these malignancies. These and initiated Based II include tumors trials sarcoma. solid pancreatic results, on and data hematologic patients both in treated cancer encouraging cancer, Tyme Phase with prostate

pancreatic SM-XX Phase and in TYME-XX-Panc trial cancer. actually patients progressing have open evaluating dose label, randomized II multi-center, cancer, to included required This radiographically For pancreatic Tyme pancreatic conducted advanced a optimization, study, cancer.

cancer. aggressive were Over advanced was study This very XX,XXX extremely cancer about a prognosis. third-line the pancreatic an or cases XX% with patients in with poor in were annually There patients this of U.S. population alone. of plus patient a the

For the who therapy. seeing over actively in pancreatic U.S. there patients third-line cancer are with are treatment, XX,XXX

There population two and for guideline patient Unfortunately, only on medicines patient no based no a these half for published the recommendations for a months. two approved ASCO FDA this NCCN literature, survival were expected patients, for therapies. or is active to third-line and

first these part I who can’t better, medicines poor prognosis. safer need has very TYME-XX-Panc and for the is on patients a fully still study patients enrolled of for emphasize enough the study. have This

presentation expect We in and/or to in publication data XXXX. present final the

at pivotal trial presented for clinical second a launched cancer. data SM-XX potential as the quarter, in Based pancreatic patients Tyme the third-line has on with evaluating multiple medical meetings own encouraging its therapy

this Enrollment is have closer XXXX. enrollment pivotal and This we lead commercialization data to year brings of by step having from full of expect quarter fourth expected in this We SM-XX. one quarter to candidate anticipate potential our study begin calendar XXXX. to the CMBT us

this with are guidance believe productive There incorporated treatments. treatments had to third-line the We patients current We discussions have seeking into design. approval these FDA very no path study a with study. the pivotal have have their and we for

are our experience have be ready SM-XX therapies confident commercialize broad upon of that the disease team cancer and of completion into the market expertise multiple U.S. Members and to we trial. launching and altering successful we will

monotherapy. track the therapy in of as end to adaptive trial experimental be with Action cancer in we this and open Pancreatic This Promise second SM-XX to by be trial this Network, first pivotal. design year. trial is Precision the partnership designed will the patients in is remain pancreatic on studied in the In a line first close addition, the study working site Cancer

to and not world’s who SM-XX examined this the PanCAN, on the learn about line It therapy familiar organization. to chosen are pancreatic be upcoming is For you second in exceptional I advocacy was those focused we encourage with that group honored of largest are you first its as trial. cancer

at conducted trial As highly be on the regarded around see will country. institutions you can the the slide,

XX,XXX without good year and each a are Ewing’s patients treatment need. represents sarcoma, diagnosed teenagers Sarcoma options. often arms, treatment of also our great unmet There one young approximately medical afflicts adults.

the trial protocol the our is quarter. enrolling is advancing with start Joseph this about passionate trial and and The to Chawla partnership Dr. through also approved IRB expected Foundation. are SM-XX Ahmed We

I who Del multiple perspective in prostate meetings Now, positive he well will share Dr. pancreatic turn Giuseppe data cancers. to medical at the leaders both has Priore in second the his as he quarter will key reception presented and received call clinical opinion on as the over that has from the

Giuseppe Del Priore

oncologists Michele. regarding I the like start prognosis you experienced nearly with core the want unprecedented start to excited by Thank world TYME-XX-Panc from reports. ESMO, very emphasizing I’d the of for be the the back to innovative over you, these patients study. at leading share that I I’m trial. from venue to international of a the enthusiasm

status into metastases performance predicted evidenced tumor no in the these tolerable of by ECOG heavily of size, demographic number the restrictions specificity is of actively tumor our a poster this, locations permissive patients and regimen by leverage with mechanism even that patients. the and we Despite on two. This enrollment table criteria for action progressing were the to able or the frail, pretreated allowed

was can derived approximately overall submission see On Kaplan-Meier that population for median preliminary evaluable deadline. abstract the survival Slide spring of the the X.X XX, months as we

months GI similar third to being line two group. et a half only al expected of For their an ASCO two XXXX on reported comparison, chemotherapy a and in survival at patients as Manax patient in for

to course, robust to with than to Of data better to others. benefit we are experience appear responses more define SM-XX patients the analyze clinical continuing from who subsets identify a

shown efforts on come of reduction beginning the the of to these XX. saw Slide association percent CTCs We survival fruition overall as with and

in Here, of half towards reduction the patients X.X. with a Overall, about an had the at of all consistent achieved greater least reduction risk at which with ratio of control. believe CTC our reduction overall improved with death in contributes seen XX% disease of of patients and CTC hazard mechanism least and survival is XX% trended to a survival an action XX% we hypothesized burden,

here survival or the a now curve further with which related PET-based of in will second right-side for shows to XX, patients PERCIST on Slide as a shown have surrogate audience metabolism. as We response, trend a tumor Kaplan-Meier the recognize that also observed,

XX XX as Slide and pancreas trials It stable and death is patients patients rate are evaluable our ESMO in do of so important we patients PERCIST To benefit response. survival, partial prospective. stable XX% achieved was shows RECIST necessarily responses associated which correlate note to late-line in or at cancer not out experienced achieving that disease many that survival with or reduction reported with demonstrating clinical summarize, was XX% XX% the on and evaluations both especially by of and with are based longer XX by rate that disease a excited

patients of On shows have weight cycle additional patients the of after XX.X% and next remained baseline XX% gained that XX.X% we weight their ESMO of SM-XX. of that within data actually one XX, slide,

feature perhaps terminal many Of course, cancers in so a weight prominent loss of and even cancer. pancreatic more is

So observation. pancreatic clinicians we ESMO told encouraged clinically meaningful with will they at advanced and cancer believe patients see were to us this be

the of the baseline correlations AACR their slightly meeting, that hint related changes steady Boston PANC were to reported CTC levels shows from the slide, in to the Also a with correlated XX, AUC nadir D-metyrosine for state levels where from presented in this of that a versus CTCs among XX saw with in L-form. we results. according Boston this stronger we D-metyrosine Interestingly, AACR data patients at trend we leptin in

that frail, Also additional with to we typically was any of the efficacy largest poor and baseline tumor a namely All to metastases receive extremely of giving the prognosis reported the SM-XX. CTC correlated at remarkably not group in this response that AACR, certain therapy. achieved is evidence characteristics, able radiomics survival

or separate summarize encouraging XX X% and SM-XX. profile types, malignancies related tumor adverse tumors X drug. the events of well including at solid least potentially across we safety the in of of XX XXX SM-XX studies patients was an four hematologic has in tolerated demonstrated deemed different with XX, Slide patients. SM-XX only to serious out approximately safety reporting On

this options Given the no patients our year. patient begin that quarter pivotal treat we of launched fourth trial this and effective SM-XX in population, in expect cancer to have there are enrolling to pancreatic

changes levels. on documented declines recently also poster XX in PSA-recurrent presentations, patients the were testosterone completed and kinetics without Favorable in SM-XX we ESMO cancer. Lastly, PSA serum in show Slide prostate in of XX, trial from

outcomes. associated In worst not the with fact, testosterone higher was

months developed to were was in X.X numbers events ADT. range Grade were metastatic no therapy markedly patient different months. standard on minimum. from in was the X.X disease. duration were demonstrated median XX CTC and but this Improvement majority population The in Adverse The the X trial

or ADT healthy, findings, side the without largely life effects systemic unchanged therefore need of that and and from overall other these hormonal quality treatment. believe disease with our overall associated reported activity delay we therapy the control Based for provide SM-XX Patients sexual therapies. on were may standard

the suggest results the cancer prolongation These of is PSA. with free possible interval prostate in patients castrate clinically meaningful rising

in San We the the and Sloan-Kettering, Memorial proud including of are and of the association of the Albert Francisco with institutions Einstein Medicine. this most field, College University investigators California leading

confirm to financing. results these SM-XX institutions without trials being Prospective planned side are at

We fill to gaps need encouraged SM-XX the of and potential unmet cancer are offer the and a for the medical pancreatic treatment has existing late-stage patients increasingly option that patients in others. new

call to turn for our Now, preliminary SM-XX and Chief data Jonathan the over this let preclinical Business the Officer, TYME-XX. analysis Eckard, on Dr. of me

Jonathan Eckard

Thank you, Giuseppe.

past the pipeline efforts preclinical candidates. we advancing around actively our our quarter and been SM-XX Over have

have earlier cancer mentioned anti-cancer from we As in-vivo year, in-vitro activity models. and monotherapy of we SM-XX observed this

as and tumor Our well a cellular, advance can of ongoing at inform to settings. work cancer aimed systemic about SM-XX optimally as how mechanisms exploring the us range a is in SM-XX that of range behind combinations clarifying

research Cancer collaborations last Langone Director preclinical academic Medical Pancreatic Cancer This the we associate our Center. establishing by the collaboration quarter, Simeone NYU by research In Perlmutter Center with of Dr. is director translational the a Diane is and agreement being Center. who led of broadened at

done build aims broad animal the the potential therapy. and This being mechanisms metabolomic in to This as year of as around We novel models, the at preclinical work explore upon by the effects SM-XX SM-XX should immunological organoids well a the human collaboration of meeting Clinic related this additional Dr. XXXX. data and major Martin more end at plan sharing data to present Fernandez-Zapico. in Mayo anticipate scientific to of

the a without is Moving year. an we inoperable to tumors on eliminate TYME-XX metabolism to reduce earlier the announced leverage tissue. behind damage SM-XX, unique concept lesions was and create the this the to for cancer to TYME-XX of TYME-XX. candidate administered or these to treatment Slide intra-tumoral Like local XX causing

believe signaling the to the pathways. systemic animal to of TYME-XX can intra-tumoral we supported acidic was Unlike reduce local microenvironment are not studies. and hypothesis different our events. adverse normal certain are toxic of than SM-XX chemotherapy, components and safety Components profile completely that and and leverage This initially designed to the are cancer sensitivity of tumor of by TYME-XX tissues the

announced results of Early XX completed XX xenograft initial with mice in sham study, resolved where mice XX in-vivo out this tumors injections compared treated aggressively. treated encouraging target year, continued lesions intra-tumoral TYME-XX In to this with we the of TYME-XX. grow tumors tumors to in had

there’s similar study subsequent confirming XX, plot from tumor a TYME-XX Slide a On reductions. tumor of target changes

TYME-XX preclinical the stage. our goal the be that most to TYME-XX continue advance IND to assess We with during point the options clinical XXXX. of strategic program program studies ready the a advancing into we At will

on turn financial the to and now our operating me So let over his for Taylor comments results. call Ben

Ben Taylor

you, John. Thank

XX.X in fiscal XX, cash to quarter second million As XXXX, as of of cash year had September XXXX, and XX, our Tyme compared of XX.X million equivalents June XXXX. end the for

second rate second the year was XXXX million operational fiscal burn quarter X.X of X.X The and fiscal trial. first of the our in Our to timing expenditures of and for XXXX compared part quarter of the the first completed Phase million XXXX. clinical burn quarter to fiscal for year of cash related quarter for cash TYME-XX-Panc X.X the year recently to our was II attributable mainly trial the decreased prostate million second

cash and cash our adequate trials that additional pancreatic our cash equivalents discussed fund and project to fiscal expenses of to the for between capital together resources, million average on year continue believe as September XX, our in expected million quarter X current we and as We to access as and with X are sarcoma cancer data. plans, operating mechanism Based well per XXXX. preclinical

to in breast, public across markets multiple We objectives. resources to will us creative advance areas, including and channels, I and pursue including to continue new private, expect pipeline continue to capital our also blood ways to identify would support and long-term strategic prostate goals cancers. the

call and Officer, turn At comments. the back over for Chairman Steve this to our closing time, I’ll Hoffman, Chief Executive

Steve Hoffman

have have On Ben. accomplish you, just need. could accomplished we of their in without gotten proud short been of for able Thank of a We far advancing not each an and time note, very are therapies towards are we we this getting them that team have unwavering potentially life-changing and am really I started. personal to to place thank dedication a in relatively I all who period in people

from enrollment science the of conceptual our begin application our SM-XX evolved trials in we year. towards quickly have practical We fourth patients pivotal the as in quarter of this

continue sustainable our new the clinical for embark opportunities broadening plans. on and We build regulatory to expanding by pipeline model growth our and and

We to expect for in good progress for a those importance and understand our need of end. XXXX that year work be we the to

and to We our and approach you beyond, for heard have interest difficult enthusiasm the combated path you XXXX your today, great for our treat executing cancers on how Tyme. to thank in offering company all on novel the is are in future. As of a stakeholders in for forward towards strategy with look I

I my session. for call would the the operator prepared a now like to remarks. question-and-answer That over turn concludes to

Operator

[Operator At you. conducting this we will Thank a session. time, be Instructions]. question-and-answer

comes line question of Swayampakula proceed of question. first [ph]. the Ramakanth your Southside Our Bank Please with from

Swayampakula Ramakanth

is there discuss This trial is analysis from you an design in H.C. study? is first the TYME-XX-Panc Could Wainwright. and about in setting. the RK bit third-line the that little My also III a Phase regarding interim question

Michele Korfin

Thank you much very Hi, RK. This is Michele. question. the for

regard in So two questions. were there –

Let around me around and interim. the one then the on one second touch design first

so and so It’s of the one-to-one patients investigator’s control is be our line. third randomization arm so design, terms between prior first therapy, focused So The third off on who are this study SM-XX choice. control line; arm. of lines a two in will

and choice investigator control The choice. is reason arm control FDA NCCN only that both Board our no the Medical for therapy, investigator is really FDA appropriate most therapy, be an the the would ASCO or and appropriate agreed with approved the arm no Advisory

XXX in a agents and have will a primary for of to So from for the few will arm. control arm. anticipate study each survival investigators endpoint be approximately The the patients choose we choice them overall single of

regards would have and statistical of in the then we have discussed with our this a Advisory straightforward Board analysis, nature. appropriate for be FDA the And we to trial a that plan interim Medical do

providing oversight will In have guidance study addition, this we progresses. the appropriate and DSMB as

Swayampakula Ramakanth

final And PanCAN understand then the generate? we expect Thank of when trying just have study, initiates that data when you. their how second-line from much for that would you the I’m to study? an should would And data access they

Michele Korfin

So, RK, the fourth is Precision the a year, for in this study. of quarter. to up as site by great question. we we blinded so anticipate Promise start And end first That mentioned,

not to data to until be would complete. access deemed we is have the So study

Swayampakula Ramakanth

Okay. that have we Advisory of doctor certain in now is the into Perfect. Medical to a look expect My area? renowned last should the you question Board, on kind Tyme Heme/Onc indications Heme/Onc

Giuseppe Del Priore

Giuseppe course cells, cells this is epithelial-mesenchymal CMO, receptors, tumor possible and RK, indicate tumor transformations the Well, LAT circulating share there that that characteristics cells. various efficacy, Priore, would potential are Del leukemic of the with circulating

demonstrated we’ve XX and O’Brien heme in guidance tumor we we types that four across same I really would different in question. expect cohorts. certainly of appreciate would kind activity on So Dr. safety see malignancies the and of that

Swayampakula Ramakanth

you. Thank

Operator

we management for no like Instructions]. audio questions of time, to the further over would At the this over conference portion closing back have turn conference. [Operator the I remarks. to

Steve Hoffman

you and for of thank and support continued interest Tim, your you, Thank everybody Tyme.

with look in lot to we that sharing conference during of information XXXX. catalysts will you to and call, look our As in certainly Take a and to have had XXXX forward milestones shared we we forward care.

Operator

you today’s conference. for concludes participation. your This Thank

rest wonderful a Have of time. this at lines your your disconnect may You day.

Tyme (TYME) 4 Nov 192020 Q2 Earnings call transcript