ONTX - Earnings call transcript Q1 2020

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Operator

Ladies and gentlemen, thank you for standby. And welcome to the Onconova Therapeutics' First Quarter 2020 Earnings and Corporate Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host Mr. President Development Vice General Senior Oler, of and Corporate Counsel. Avi sir. you, Thank go Please ahead.

Avi Oler

Good to Earlier and XXXX you, progress outlining afternoon, Thank Operator. and results welcome issued press and business results our financial we the corporate financial Onconova's conference afternoon, call. year. this during a release update quarter first

Investor yet website, at our not have release you page this press it Relations is If seen available on the www.onconova.com.

clinical recent and Fruchtman, President milestones. and will highlights On and his call, company's anticipated Officer, will completes Guerin, Dr. Steve Steve financial review today's Mark first our business Financial discuss After CEO, remarks, quarter the opening results. Chief

Following be Mark's portion will joined Q&A by the Dr. our move report, Officer. we Ric to Medical which of the call, Woodman, will Chief

come a back comments final milestones. upcoming will review our some and with Steve of Lastly,

of that the begin, will call Harbor forward-looking this we remind Before Securities cause and I actual Private made to Litigation which provisions today during differ the results conference statements Act materially. uncertainties that statements XXXX, Safe of involve can under risks include everyone Reform

the forward-looking speak current as they or company's Onconova future and issued in the future this as any the with reflect press law, events circumstances. the forward-looking required of update change, filings underlying information, date circumstances statements Forward-looking SEC. release the by are made, factors except risk to obligation disclaims statements facts afternoon. see Please statements and in to disclaimer And the only the these as may

now With call over that, the to turn to it my Steve pleasure is

Steve Fruchtman

today's and for call. Good Avi. Thank afternoon, joining everyone you you, thank

this The hope has the plague. individuals scientists can many around that devastating the new preventions truly to changed. First, COVID-XX our go out we to and and families therapies hearts impacted bring world devastating from brilliant And by world pandemic. the

significant Myelodysplastic of first INSPIRE in of highlighted progress completion Higher-Risk trial during quarter Syndromes. Phase enrollment the demonstrated pivotal the XXXX, by of our X Onconova

to cancer hospitals the worldwide profound has full globe. to many enrollment, our pandemic, fortunate across which disruptions have to prior forced and COVID-XX the centers impact at are We achieved of studies research

Phase anticipate, advancing pivotal With pivotal to the survival we Onconova's data of trial, in top continue historical second survival catalyst. enrollment INSPIRE line trends, half now INSPIRE the completed reporting to in trial Based next the X on XXXX. is

we present survival at top INSPIRE complete, preparing results year. With meeting, line major enrollment this to we events reach And, expect and analyzing XXX now the of before releasing trial the survival later a for we INSPIRE medical are when data.

data have NDA shorten begun submission To NDA already anticipated we work FDA, to prior lines for time the our to readout.

We are MAA working data position to with document the becomes experts as on as expedite well authority for our regulatory U.S. FDA, applications EMA to document be the on available. health consultancy for when in our NDA the

to advancing be of expert our Shoemaker also commercial are agent MDS. pharmaceutical Board, And We higher-risk commercialization commercialization. the prescribed ready the to internal plans Ms. Terri Onconova for in have develop who expertise, we instrumental to frequently in a was most azacitidine, our nominated

best to the determine therapy an agent than the less of choice tolerability study recall, or rigosertib treatment failed the or hypomethylating have progressed controlled study with care years previous The rigosertib of intravenous the on best safety support this support therapy. efficacy, international of receive relapsed to age of XX Patients second-line care either of MDS. to treatment in and of with to you patients with are standard patients study INSPIRE is intravenous randomized designed single-agent high-risk As care. respond in with open-label randomized and of physician's

the of very intent-to-treat randomized an is opportunity in population. FDA which analysis the study this subgroup International primary also the defined overall survival is The is for System. high-risk approval Scoring survival a as sequential all overall patients by There the end Prognostic of revised point of of second the

rigosertib we Today virtual survival manner, we presentation. prolonged at the INSPIRE accepted the statistically European MD disclosed Association's and could that a treatment Cancer MDS Onconova years. the the participating an rigosertib Hematologic in collaborators significant trial on Should in first INSPIRE congress, and be upcoming more XX Center have higher-risk our new the in centers Anderson believe than for at trial

entitled the was pathway website Association's European of INSPIRE mutations just Azacitidine: RAS The on Hematology to and presentation RAS which patients Genes the of azacitidine Failure Correlates Pathway Trial. Genomic the at with Randomization posted is impact onto the Mutations detail in failing Type to Analysis

cancer the understanding advances at know, deep received their and marrow revolutionized randomization of multiple time during at sequencing on As the their in of have bone Participants study. blood the genomics in care. treatment points you genomic INSPIRE trial or

data about for data learnings RAS-driven the following most We from pathway important cancers. genomic the treatment role possible trial identifies failure MDS and those mutations of rigosertib of RAS the The common presentation advance may other further high-risk will MDS, this including genomics, of INSPIRE MDS the azacitidine and the be targeted rigosertib. in believe the by place that

pipeline important have as We made progress with programs our additional well.

pivotal anticipate with C protocol quarter the will registration trial, the begin We for new received We FDA feedback are readout FDA FDA consult on INSPIRE oral with meeting FDA. this this HMA-naive from after to of the in higher-risk in later study. with based are this and preparing we submission meeting submitting to advancing of the year request trial following INSPIRE anticipate Type the for survival their a our trial data and third following a year rigosertib and feedback the X/X in plans Phase combination azacitidine X/X adult from guidance. MDS. a addition pivotal In Phase XXXX patients We

months. notification high-risk combined for with accepted upcoming the Phase that publication and pivotal the for trial its publication Research in which We rigosertib have received been trial basis in the patients also new forms with has HMA-naive MDS anticipate azacitidine in Leukemia oral X this

additional rigosertib as plus four we KRAS-mutated of COVID-mandated study as Stage Phase studying in the for stoppage reopening planned lung In the cancers rigosertib other and following indications cancer research pipeline additional adenocarcinomas programs. in the programs nivolumab rigosertib clinical rigosertib for post well to-be-initiated to progress, KRAS-mutated addition in X/Xa are our of including primed MDS, development

The first KRAS-mutated enrolled lung has that be placed our patient will investigator-sponsored adenocarcinoma study anticipate centers. on burden medical an will we COVID the mitigation and be the pandemic trial the following in the of of been academic

and rigosertib approach very in While a need our to potentially our cancer makes many progression. the significant view, blockbuster unmet represent checkpoint in In continues of following lung standard status in option a cancer inhibitors times disease achieved pursue over lung treating attractive this medical tremendous care exist have to with and novel combination advancement beyond.

has rigosertib inhibitor first-in-class cancers the metastatic And our ONXXXXXX available. We is breast potential with CDKX/X cancer dual ARKX. to including CDKX/X and inhibitors numerous commercially treat beyond refractory believe investigational already ONXXXXXX of

CDKX/X may outside opportunity. of promising China. are this with the it of limitations, large hormone emerged current the certain generation commercially inhibitors. inhibitors its we maintain CDK and overcome cancer. market address available potentially unique Due as targeting global If that metastatic as compounds, not familiar very could ONXXXXXX indications For field, cancer cancers agents' for believe ARKX X, existing ONXXXXXX such be to successful, as believe not as of well targeting potential large to to have the CDKX this who suitable ONXXXXXX those We very receptor making positive breast has we responsive many of of rights

health the partner We second by the January Our may China anticipate for XXXX China studies. funded IND of is was in authority. in compound Biopharmaceuticals of in HanX Chinese The the in this who Phase Chinese Chinese study a XXXX. X half IND-enabling approved begin

also outside after manufacturer standards. the of fourth qualified. ONXXXXXX for file U.S. of comply IND China, our quarter of obtaining the IND-enabling We in for manufacturing is our U.S. now with world Chinese To required the plan the studies and rest the intend We the XXXX to data. to a FDA

business during to Greater first the quarter, development, we rights China. regard in reacquired rigosertib With

As rights an of the program markets this early Medicines the Europe we the countries among anticipate China, largest We in half select Inceptua are access year. in year, announced U.S., a the plans with in this result Onconova the which for program and launch pharmaceutical to launching rigosertib Last world. in second Group. controls

to progress milestone the milestone. one to from next We continue to we expect as opportunities evaluate

up General Meeting. Annual our Meeting General Stockholders Annual upcoming reminder, upcoming I of XXth. coming May encourage our a on is As vote at to stockholders

Our nominated are has website. very available am proxy life science materials time. Shoemaker to Directors our Terri excited on I Board that this of at Board veteran, join the industry Onconova's,

in as forward experience and Board science rigosertib. life managing Directors. to was relevant very Terri we organizations executive be commercialization believe instrumental potential in highly experience in developing space. for has the be Terri in We the efforts of MDS and of launch our our moving commercial MDS her addition valuable azacitidine a mentioned, industry the a will As will prepare of in key in

the to quarter Mark? over call to for like Chief Guerin, our now And first I'd Mark discussion Officer a results Financial for XXXX. financial of turn our

Mark Guerin

totaled Steve good to of $XX.X and million, XXXX. Thanks, XXXX XX, cash afternoon, $XX December and XX, as equivalents everyone. March compared as million Cash of

our to noted, sheet. previously exercises XXXX since balance of As our warrant have common transaction stock financing $XX.X cash million added in November

and sufficient XX our and as will expect into the operations XX% over our our XXXX. almost them cash third March current of Also May on ongoing of we stock as of fund XX. projections, to million equivalents in-the-money trials outstanding XXXX Based XX, warrants the be were of quarter that of cash

million Our comparable administrative $X.X in were March $X.X XXXX. net for period and March $X.X the the quarter comparable was XX, in loss XXXX and March the development million comparable the compared the XX, $X.X million million to $X.X ended period XXXX. and million were XXXX Research the for and XXXX. for quarter for ended quarter $X.X XX, XXXX period expenses ended million for in for General expenses

I'll This completes review. turn to call my financial Steve. now back the

Steve Fruchtman

open With open that, so session to the like closing remarks. we'd call the with final you finish some Mark. After Q&A, you. please much, Q&A to Thank questions. and Operator, I'll for thank call the

Operator

from first with Our Wainwright. the H.C. Instructions] Joe comes [Operator sir. Sure, of Pantginis line question

is now line Your open.

Joe Pantginis

all afternoon. Good question. guys. Glad taking the Hey, Thanks you're well. for doing

of three have are logistical. which I two much think I questions, pretty So

The INSPIRE, now track. time that still is you are first great enrolled on with everyone are right regard one to lines things and progressing it's the and

potential for as it just you that now curious might -- of is call events? hear these any I follow-up of loss Or there for concern? COVID some was part is a your statistical patients it about these your not to a assumptions not guess, of any with I So

Steve Fruchtman

I'll and ask Rick to you, thank that take question Joe.

Ric Woodman

global Yes, sites. Joe. challenge has our monitoring study main COVID the been Thank for pandemic with you. of The the

and anticipate field is due part the to confirm in team that think to survival number the the that -- Onconova which not as interact extremely research good and the continuing of assistance be challenge And collection we unique pandemic. for continue of which in had small. is team it clinical in that events And the CRO because some the I survival events that with to in luck. are But the we doing able the efforts a of of have ways develop monitors the and monitoring. Fortunately, of the able we anticipate and our to sites in to well as the patients will remainder we

Joe Pantginis

Thank it, around discussed for make lapsed, you same this is will. want strategy if it logistical just you with for regard my in sometimes Ric. data that. the second past, I the the to your thinking the And out and we question, I then INSPIRE. communication sure putting to still Got but know if

the to those half, typical at hit top just Or you So it looking since would meeting okay, say have to ASH, at data line and say, then in we'll as... further a second you're upcoming press conference? them one major medical give presumably the I'll present not to hit of an releases look

Steve Fruchtman

may. ask to Avi. one don't I why that Avi, -- take Avi if I'll ahead, Go

Avi Oler

Steve. Sure Sure.

meeting. of ready major full the communication meeting upcoming you're data medical we as question, or thanks such major when level, another for presenting the an announcing it data Joe, exactly would at but a at right terms In medical line that and ASH is anticipate top

Joe Pantginis

the or And C obviously, Type upcoming regard it. study lot With my productive design. the is and with the third to question my discussions of then already had last Got around -- question. FDA a you've meeting,

of I get want outstanding guess it that ask things ways. to you are get out you What's key what need I wish And list solidified? what two So would to the of there? your

Steve Fruchtman

Ric?

Ric Woodman

Yes, Joe.

and We we a a that for part think on I this question get novel health from the the robust the well indicated very first the So some And authorities. adaptive agreement particularly adaptive additional the the ASH, features. to a and is ASH feel at in that your And is the unique want the Phase a variety we of into have design, at advantageous we X/X. of unique rigorous this design combination in think move the FDA developing, presented as forward allows a us challenge to to of analysis part medical particularly we study. is I as abstract that as Phase community us ways and interim X design of

Joe Pantginis

Got guys, stay and well. it. Thank you, helpful very

Steve Fruchtman

Joe. you, Thank

Operator

from with Maxim of question next Quibria Your comes the line Naureen Group.

line Your open. is now

Naureen Quibria

Thanks for Hi. the questions. taking

Are So are what rate to an And the able guess that month? you events you you that first, right discuss average with current Can number starting remind is of first or in I event able you're disclose INSPIRE. is to detail? per now? us seeing any there

Steve Fruchtman

our end the make the a mid-March you have of every is the events it's do data -- by it that quite the very half much. that than before But believe, We thank variable. XXXX, the and more that, we on second we accurate based to did reaching at I require the XXX. year. hand And so of my of prediction that try anticipate is I'll we harder observing, It's survival reality events that. month reveal, -- XX% pivotal hard very we we We survival over variable. it's think see are what of monitor I

Naureen Quibria

Got it. sense. That makes

in seems sort MDS, one. my second landscape, study rigosertib. And so parallel of regarding And The regimen that treatment theoretical a I in that's to really MDS with have question, your high-risk broad next at with venetoclax and And select a choice combination of group AML, patients. and the for as is of a the treatment least part agent AML. paradigm treatment of hypomethylating of a

with in type, there at study last that Now, high-risk if that we rigosertib actually higher same were was data MDS I aza patient azacitidine. the the looking But was rates and ASH year, positive venetoclax recall be familiar are posted numerical at also with posted since in at response data would and a if rates you venetoclax correctly, say that may about Since ASH. in advance, patient approval in thoughts was this your in placed are of if current that where and doctors what positive, with gains And terms rigosertib strategy? venetoclax well alter your type? strategy think response

Steve Fruchtman

Ric?

Ric Woodman

Well, question. thank you for your

think them couple aspects there's with individually. that and each I of to that question a of I'll deal

AML single -- ineffective MDS. venetoclax or as and is foremost the First that is a agent in

And so venetoclax needs a partner compound.

clear effectively mechanisms achieve it's patients. for can doublet for really the agents need have action they I to is think therapy. be looking that administered that fact field of And differing easily and in

least looking are is in data field be think non-overlapping the we at with for novel So can so potential combination: at for it oral is features look would And and formulation many I rigosertib you action, and why of mechanism satisfies combined Phase orally. agents this any that important, look doublet the X our a would oral at of potential the because toxicity. the

field the advancing. And think is so I

and and new offer in will venetoclax rigosertib and rigosertib the is therapeutic both MDS. venetoclax area I both real this highlight of options think of think I the for patients

of think that I in rigosertib. terms I think that it's the unlikely venetoclax will that future, precede

that yet any think randomized venetoclax data, needs I the demonstrated they scientific that demonstrate and community be have think I clearly that to for to appropriately. evaluate to

the around be So have be agents I could moment these ago. be I combined together they would such in -- advantages and that same potentially their would the timing that a and offer they anticipate would mentioned time

Naureen Quibria

filed U.S. Got regard one that the the the in really, IND the question. study you will to mentioned really CDKX/X submitted helpful. the bit program? was in Will it. That's you just study monotherapy last formalized? be letrozole? or planned curious say And with the then with I design and that discuss been combination about just With has fourth you Can with more a a the start quarter.

Steve Fruchtman

Ric?

Ric Woodman

Yes.

conventional be in anticipate resistant we could is the if multiple potentially effective earlier So lines action to I think, be be patients therapy. need moved that current inhibitors of some CDKX/X were has the particularly to likely hormonal XXXXXX to first effective are currently mechanism all, as most combined will tumors. ON It sort may with agents. given of will of It be that it to of that therapy those in

Naureen Quibria

Got it.

helpful. Okay. Thank That's for me. That's it you.

Steve Fruchtman

you. Thank

Operator

comes next Capital. Noble Your the of with question from Demir line Ahu

is line open. now Your

Ahu Demir

you my rigosertib impact Thank be on of to everyone. do would commercialization on that initiate? for My front? question. financial efforts. first to much very you do Hello, the will taking you plan you do When think be what question What do? plan And

Steve Fruchtman

word the you Would to like heard take I Mark, that? financials.

Mark Guerin

question. Yes, Steve. happy Ahu, Thanks. I'll thanks be the And for to.

any now information or line pre-commercialization our focus data While time we specific plan might started on you far between then we're our tell to can precisely year. provide pre-commercial have we not and top as so about what And spent you earlier what line the I this we afterwards. able initial to expect, readiness and activities activities. that, spend was longer

to once answers the line that If feel hope full So please try enrollment, a we initiative and to to question. question. with focus a answer that can follow-up that time I your we long got follow-up things. I free it doesn't undertook on

Ahu Demir

Sure. That's clinical you preventing would imagine you need helps, My are starting right away? will the prior say initiate Or question Mark. to program accomplish that you the Thank Steve on RAS open other RAS other to ,do trial to there cancer lung any it? be trials much. very things

Steve Fruchtman

to – is – you this but to impact clinical the research as patients site for ready pandemic we put X, we this already research this clinical approved who and academic will The the to new hope anticipate this all IRB hopefully that. put meaning are trial patients screened to on mitigated. hold thank be or on happens, new for ready study that site on And research is is centers, study. go Ahu, be restarted. medical is and cancer once Phase the being cancer on is will We that reduced

Ahu Demir

one – something have you last That's great. to do say Steve you. Steve? Thank And question

Steve Fruchtman

No. I was it to started. just get saying we're obviously very eager

I So it's think ready all go. to

Ahu Demir

right. last the great. All CDK My on question program. That's

you quarter, you expect? track any delays still the QX to or expect in fourth XXXX? on on driven COVID do do expect is this be So considering other by the we So issues manufacturing delays to submission and any

Steve Fruchtman

expect any have gets the Again, any an know manufacturing when to year So by We I'll identified. X restarting site from expect because being bit that started identified. across open we don't of cancer the the regarding and end of have We trial hospital system don't processes. that. We manufacturer pray already that's with we They have happen validation don't to a the clinical studies cancer Phase then delays a the Phase We a clinical hope take COVID will the to do pandemic. U.S. we be unknown, – anticipate of possibly research. be that what's that going again and will restarted. our trial this X research of the the ONXXXXXX and of one

Ahu Demir

for Thank Great. questions. you my taking very much Okay.

Steve Fruchtman

Thank you, Ahu.

Operator

from Company. & Your of with comes Jen next Laidlaw line question the Yale

line now is Your open.

Yale Jen

for thanks the taking My and impact. questions. afternoon Good the is first question COVID-XX regarding

impact enrolled? Any or all though patient study been that they all, of in receiving INSPIRE interruption treatments? of any impact First any that have on the does for have terms even

Steve Fruchtman

Ric?

Ric Woodman

your questions. you Thank for

monitoring. on real COVID versus and other investigational and first choice anticipate carefully arm. impact rigosertib of we very collection with the we've sites anything arm in treated any illness our not data the foremost do of and centers seen present on the physician's impact time, global any we've the COVID-related So on to At than differences that, monitoring date, and not dramatic and patients the impact been

site site studies on that's and data. the the In collecting in to at due various this impacts who access our not that's ability care them with the some sites staff. have impact places staff the do involved And obviously in work to happening to COVID are more hospital of

in authorities as Steve mentioned of very been our target XXXth to date finding as outset, do patient we And that. March XX. We that. to are And the we've achieved on enrollment local in by ways health successful novel doing in his permitted enrollment

matter a of now It's of these patients. all enrolled. is following everyone So,

Yale Jen

That's next execution. Okay. good of bit probably sort unfortunate have helpful. that's I And very the for a Great. situations. very The question is little

guys the and I the -- XXX number? shortened do this that the should LV given or you will to -- patients co-morbidity to case the age might are and curious the most you age say average of XX, speculate line fortunately into anticipate morbidity be time median Just play is that get or you unfortunately in say this the for

Steve Fruchtman

I'll that one. So, take

So median XXs. want the age to a median the of not Yale, under correct It's is I late XX. in of criteria of age XX. age The eligibility is MDS the just

on well-powered across anticipate the we And Rick obviously any if and medical team the with said, of pneumonia for the because a it's are trial. globe. and pneumonia, a of patient but evidence are impact don't monitoring has centers a the at develop checking INSPIRE are So, COVID-XX do MDS COVID-XX. that we checking And his MDS with centers patients are also they major

in And may it on believe is arms, a final don't the continuing. COVID-XX we well-powered impact the on both trial trial. of impact outcome that that since should So

can't all their impact that COVID-XX death. in half of of don't having data, that And I we say that Of COVID-XX MDS trial from despite published I their who understand pivotal can't the summarize of the with in And but ASH a just interest understand data anticipate that no we there the patients is that's on anticipate the XXX hematological I survey second the cohort. patients to ASH. identified malignancies should hematological INSPIRE and caused from data patients I had XXXX. XXX it, say malignancy that

Yale Jen

given that manage -- does the manufacturing time positive half these XXXX that. I be the explanation. of -- Would moment? terms that at Okay. to of first of maybe late last or might in all, or data in should didn't maybe intend CMC you that to second particularly I be what and XXXX? how -- Secondly, aspects, even this company that mean I be file all is the is get the Great. able That -- appreciate And one

Steve Fruchtman

Regarding NDA -- application. what I time think for about lines you're asking our Yale is the

we once already, So, have and we're not the a doing anticipate anticipate, -- mentioned that already hopefully to lot will flip us data, waiting it take we we pre-NDA positive because materials start be written. we time ready of submit flip But card to anticipate have once seven a NDA data, all to can nine toxicology application our be IV to work the flip we hopefully for of card. card and line positive A rigosertib. materials, the CMC months we're we

Yale Jen

part it's And make batches mentioned checking -- of the repeated process making the intend CMC or you and of product. that, them to already uniformity of repeated the in batches the to confirm,

Steve Fruchtman

That is correct.

staff already that We is and to looking have. meets CMC a that expert part to didn't to out. can case, regulatory and full-time leading we to work make those at that no be CMC We the start of writing into all Onconova, you initiating the read NDA. our our in of pivotal have the efforts reason know There's requirements on sure is who wait for data just

Yale Jen

Okay. Great. lot. And very we see everybody to forward data soon. the Thanks take And care. look a

Steve Fruchtman

Thank Yale. you,

Operator

our turn for closing today. Q&A Mr. back Steven call concludes will for remarks. session That now Fruchtman, the to I over

Steve Fruchtman

IV to have progress update And pipeline excited participating thanks We're you we the our enthusiasm. programs and you all And share Thank with made, call. hope I of on, so our obviously overall. for you much. very today's rigosertib feel. about

this And particular include. medium-term and near the in order. is for no listing look in we milestones Important

the from EHA our trial. data presentation, the INSPIRE on First, genomics based

X/Xa the cell trial cancer, in as rigosertib enrollment initiating lung of non-small study. Phase plus on KRAS-mutated, investigator-initiated an Second, nivolumab, advanced

And IND by MDS of oral of the third, which line ON a INSPIRE great during azacitidine, reaching fourth beginning followed study XXX survival the XXXX, HMA five, plus INSPIRE enthusiasm, rigosertib combination Fourth, clinical second data XXXXXX, quarter this from number patients of year, during and submission, half data the survival most following top of importantly trial, after trial Phase the higher initiation, readout. a release the and events. gives us in risk U.S.A. X/X, naïve of

questions, appreciate all our our later encourage General In of closing, I stockholders Meeting We in call. to Should XX. Please Annual on now your programs, interest of attend end thank your participation. for of any contact safe. please additional this to upcoming stay have you all may continued truly May our Operator, month, And Stockholders free at us. Onconova. you the feel you all

Operator

Thank and our today. this gentlemen, Ladies concludes for participating. you conference for

may You disconnect. now

Traws Pharma (TRAW) 14 May 202020 Q1 Earnings call transcript