BPTH - Earnings call transcript Q4 2020

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Operator

Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings' Full-Year 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode.

Following the formal remarks, we will open the call up for your questions. I would now like to turn the call over to Will O'Connor of Stern Investor Relations. proceed. Please

Will O'Connor

recent Welcome the Holdings results, press company's Administration, provide the update Operator. we and webcast Finance, call and President release the developments. an review corporate to full-year are and on discuss which to outlines Peter Nielsen; plan you, issued Price. conference Bio-Path and to Earlier, Thank we and a on release of call. The pipeline Anthony Bio-Path XXXX topics available today at and from Vice that Senior Accounting President is biopathholdings.com. to today's With me CEO financial

Before release we statements you that that I'd in filings recent and outlined risks Securities to forward-looking today's and risks remind are uncertainties. These the Exchange urge company's begin you we the the Commission, call, which involve and to with contain press discussion and today's will read. uncertainties like in

Our call Peter actual call. materially I'll today's differ that, now what to on discussed over from is results may turn Bio-Path's the With Nielsen. CEO,

Peter Nielsen

Thanks, from formed Despite portfolio to COVID-XX progress pipeline. the morning, throughout addressing to inflection the our points important XXXX key toward headwinds pleased across development today and expand made beyond. and the I'm we you made us all for for to discuss you clinical Will. advances joining foundation everyone. progress XXXX, which be we clinical pandemic, in saw Good significant advance us. our in Thank XXXX,

frontline large dosed progress we great or need with prexigebersen acute with plans variety with Phase first groundbreaking venetoclax. our medical therapies, product development with begin of therapeutics of on a across execute indications. the treat RNAi therapy to for X be our in Last I'll continue patient for number continues we year, clinical cancer our AML, where of to combination myeloid and Despite the lead of to patients. a make DNAbilize leukemia, continue stage decitabine in suffering a there our nanoparticle unmet of meaningful and We cancer X immuno-oncology progress. to combination innovative life-threatening patients some prexigebersen, candidate, of treatment platform

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still landscape been new there standard As these many evolving are of are help. to refractory the an or and resistant, you therapies, there as patients know, are for Despite we has who in AML. care aim patients those

in untreated a complete recovery. an adapted patients. we two treating decitabine the that will prexigebersen trial accelerated into study convert of treatment treatment patients trial partial statistically-determined provided of full treating XX meet of evaluable with design venetoclax patients offers relapse-resistant approximately registration X of after remission of who AML patients are and X decitabine to cohort of response frontline the and The with approval. AML exceeds primary endpoint untreated in and As AML after venetoclax, full analysis our results untreated higher the for combination therapy and of performed trial the includes trial XX that for the patients and care XX remission, and approximately trial third design or have approval each the complete treatment cohort AML with our evaluable and XX seek design for complete reflect the number preliminary therapy be from previously and have performed cohort and resistant with the issued both of States to In the patients. the a patients. venetoclax our for intolerant decitabine. hematology is patients. venetoclax these decitabine number with design of event, in venetoclax-resistant decitabine, full on patent Trademark expanded this approved threshold, assess number physicians defense with of for untreated and cohorts An recovery of the two-drug prexigebersen, to interim prexigebersen of pointed to the of cohort higher analysis prexigebersen, Phase due standard trial combination AML changes. to The evolved, In of or family we treating the previously the decitabine Phase patients the newly that of for after technology. study A evaluable trial Feedback and AML. AML property a incomplete announced of prexigebersen combination the to these patients amended a primary to or with endpoint combination patient two-drug venetoclax third in the achieve cohort The patients triple intolerant who intellectual relapsed/refractory review evaluable The patients be we for the the two-drug performed evaluable X patients Office which with venetoclax AML with February, preference XX of review triple plan Patent two-stage includes a DNAbilize remission interim open-label who for AML The the of in formal United cohort baseline The in and frontline this relapse-resistant for will adding hematologic a treating plans frontline cohorts a platform of is platform cohort efficacy treatment. safety AML treating opportunity prexigebersen patients exceed an combination plans multi-center patients previously with untreated with are combination Stage decitabine.

or related kinase tyrosine a and patents. inhibitors intellectual our to complements and issuance strengthens prexigebersen such cytidine in In with addition, of as to granted Bcr-Abl patent receive Dasatinib were addition combination a further Nilotinib. our either pleased portfolio we already the Decitabine This property the analog

the with patent valuable growing These frontline unique to combination, provides supports and now in asset new patents new only therapies. treatment product continues for treatment broad limited a investment options. who not our estate Bio-Path as combination to also established in protect core therapy but with bring patients have efforts, program protection our offers the options ongoing to be research it protection in AML portfolio and for Our

a As competitors around and technology our technology safeguards core as I to creates before, efforts around our our said of platform continue deterrent competencies. protection would-be will value have it and we target-specific is fortress build a to technology

including drug would uterine, product Phase planned to cancer. evaluate turn with that prexigebersen have endometrial be solid such trial same safety pancreatic, breast hope trial of a sharing our a hormone refractory This prexigebersen patients. X I Bio-Path prexigebersen-A conducted Patients in and tumor to provide will to outcome. with of and diagnosed recurrent Next, patients. modified from at initially it is like the several clinical often prexigebersen benefit patients enhanced cancer may solid centers fourth And drug is to and cancer poor properties. our nanoparticle the tumors in is substance leading advanced Prexigebersen-A, planned candidate, with ovarian, clinical ovarian

patients shown Turning year Bcl-X pipeline untreated second last the application against also IND AML to and we Chronic for candidate Leukemia or is an Lymphocytic filed CLL which our Venetoclax an treatment our domain. the works improved protein's by now BPXXXX, Bcl-X, has antiapoptotic second BPXXXX. neutralizing BHX and candidate activity targets therapeutic patients. for protein It

variably However oftentimes exception with domain occurs some relapse allogeneic mutation due treated disease the to BHX with over BPXXXX the targets time. Bcl-X cell protein. of transplantation, also patients hematopoietic

messenger is activity not BHX BPXXXX blocking RNA the the domain. However, based and on Bcl-X

that result, have patients received AML venetoclax believe we BPXXXX treatments. patients who alternative who provide As an venetoclax to relapsed including previously a for

made progress on the the me which of promising let candidate program third in preclinical program. we protein. our excited and BPXXXX briefly STATX are this review targeted very Finally, shown future drug the has have This data, we

in drug to model. a options. year. typically an in regulator of program promising of acceptance sheet cancer the in for STATX active immune product file evade in Induce an also cells, tumors our now successfully treatment cell or very to efficacy financials of by enhance Price invade have reasons. apoptosis, We oncogenic a recently, emerged formation the balance brief frontline along abilities convergence first Activator therapy immune field. cancer pathways, point a surveillance resist to normal BPXXXX the more the aiming transduction genes which that compelling of processes, treatment tumors with full-year research particularly Signal validation this tumor for uncontrollably many pancreatic of over launch in challenging a proliferate We're cells has limited a penetrate distance these this application cutting-edge has tumor at program hallmarks significant are cancer pancreatic of destruction is though the involved STATX, XXXX studying of or is We're patient-derived indication and models death. immune of for a well and aberrantly the of this Anthony potential STATX later especially to and to as recognized gained cancer The Anthony? system highlights, IND levels. for inhuman I'll shown excited critical is of Previous turn of cancer inactive of to our the With is mediator candidate multiple for has are avoid tumor review vascular invasion capability treatments. and Transcription-X our cells number that, the with STATX standard in the organs cancer.

Anthony Price

XX net per compared Thanks, trial million $X.XX BPXXXX in XX ended December due and Research to the reported million the year-ended primarily to loss per franchise of for for to XXXX $X.X year $XX.X ended clinical primarily to increased increased in and for $X.XX expense. administrative XX and XXXX to December increased ended clinical solid ended expenses expense to million, Phase of $X.X year the BPXXXX. costs A X a increased December December million X tumors in share compared the and tax to year lymphoma for compared General XX net due for XXXX for AML, Peter. for prexigebersen XX XX the startup increased XXXX. share of expense company ended XXXX December year for preclinical The prexigebersen related Phase for million or a XXXX to or December million enrollment loss the development trials year $X.X $X.X $X.X

the XXXX that, December December was in the of $XX.X December ended of I'll year financing for in million operating million period Net XXXX. XXXX, Net ended $X.X activities provided XX compared As cash Peter. company year turn comparable was XXXX. With back at million compared now the December the XX XX for to $XX.X XXXX $X.X for to by $XX.X it cash million. cash million had XX used to over activities

Peter Nielsen

on with year. Thanks, Anthony. I'd more lives thoughts has leave products each DNAbilize like According to to lose today bringing a to Society, the Bio-Path people in Cancer cancer the imperative to American XXX,XXX you their market. than few

the the pandemic, our among patients researchers made the COVID-XX to call to cancer progress populations. bring no for With at and take we're future vulnerable collaboration supporting together today regulatory not is and I'd without scientific secure be pursuit opportunity Operator, have Bio-Path team look ready our success. to support, open This need questions. our whom treatment there the made could to are these we this physicians continue my for and desperately forward in their options. During to and to that, to better are patients express like we we Bio-Path why the most and who our to so relentless advancing Because have advancements. them gratitude of to options we and treatment

Operator

Instructions] Okay. Yi question Chen the H.C. Wainwright. line from [Operator is first of with Your

Yi Chen

question taking interim of tell you. first end for year? could likely arm is data trial you the my thank Thank to the this whether others, and which AML us you of Hi, before report faster question. the than enrolls patients this is My arm

Peter Nielsen

null resistant doing with the the cohort My prexigebersen that being I intolerant third from And think is treated and combination the that two-drug a hypothesis lower or LDAC. very very the is option. We smaller. nicely. patients very the venetoclax proceed it's also a is recall LDAC away expectation one combination, with that decitabine. group because just And bar, the actually LDAC. hypothesis similar the couldn't that's gynecology community exceeded we the previously what It's attractive And two-drug null did we to is went

patient first. of variants I of the is would I any readout. and think And vaccine we to over I we half think be So, not that or need kinds are that that and interim patients for all one, that COVID, going of believe the have hopefully interruptions have work, withstanding going not but things, program with the we whatnot kind

with newly patients we who for competing is competition The has those venetoclax. with diagnosed other trial one are the like continued the there in still

So, that combination one is is mostly [indiscernible]. I two-drug the would say the likely

Yi Chen

question start my tumors trial soon? Got second prexigebersen-A it. to in X is, Phase is And solid track due on of the

Peter Nielsen

We with the new latest division studies testing FDA them. recall least there was some this just in at wanted

a Once one, So, of IND is to go the additional test an quarter only completed should the finalized was testing, new away. unless you to of This set we testing, and second and whatnot. entire do in I the develop And before that's the we our a more material. the that think not we that. done, all we difficulty] refinement, because needs right had am drug patient. reconstituted have we We method test in a are thinking just the but as testing still qualified that's there batch we administration we formally have and about have of second hospital the then of [technical stability that, doing reconstituted have

a So, FDA wanted. good additional that be we the had will think with we We case. things call on the

and so, FDA we and have last get the our those start we steps, And completed know treating. should

Yi Chen

it. you. Got Thank

Peter Nielsen

welcome. You are very

Operator

the question ROTH Jonathan next with Capital Aschoff line Partners. Your is of from

Jonathan Aschoff

endometrial? only much Phase also Should for Good solid Thanks. morning, very ovarian would more and only I pancreatic, prexi-A. development you. prexi-A trials was you be little expect mixed two Thank And X in those in wondering XXXX, or guys. a on think we tumor? a

Peter Nielsen

I say, once dose in X, find tumors, that of several Phase safety, can a a a Yes, across we finding, escalate, would -A do think Then generally, pattern. is similar -A. have and course, The dose and sets let's will of Jonathan, XXXX go and dose. you it establish solid proceed,

one be of With ovarian the prexi-A Xbs and ones advanced in Phase paclitaxel would the and endometrial. first

of pancreatic area MD be The similar concept, cancer on second, tumor also with The gemcitabine. in, IV the I again, from Anderson would believe, of trial, target cancers. metastatic XXXX, have solid triple-negative. worked a in stage and Bio-Path breast Once enroll several the And hormone-resistant would that get also non-small cancer. dose up, into would again two dose, would the done suspect work establish be pancreatic then get again I you things. safety, with we've our it metastatic lung candidates And we go we do we and on, on once cell other

across also I Broadly, your in AML, combination drug. general go you areas but Xbs into amenable think STATX through specific where is that's the you treatment the specific one establish then the in escalate, with dose and plan. safety,

Jonathan Aschoff

of And the those affirmations see you start addressed you, results combination? those Okay, board but you if thank cohorts? findings, safety triple can opening once prex how soon, Peter. this in don't safety do when I the get can comments, think we your the know safety you and in the you with double

Peter Nielsen

on have review, reporting as end but to early been the going The put -- we're it okay. and be write done, safety and expect Well, it has that quarter. a first out, up out of I as this then have we testing to we'll to

So, that test. and we've completed to step continue

it's the part formal it. of So, reporting really just

Jonathan Aschoff

or operations? Okay. $XX.X no And does additional use, how ATM warrant long you million option fund assume if

Peter Nielsen

had, with and the million through was million registered to we what that couple we at -- Well, $XX so actually close of including in of approximately the Roth. end February, things, December, we different it raised direct a $XX actually

and will have into And us million, than XXXX, of take more the probably it. probably through actually well end $XX that so we but

we anticipate for another the us. being quarter do maybe And raise in a Xbs year. those and trials will following probably the good Xs of it's slug to strategic all through Phase money So, in third of reaching their [indiscernible]

Jonathan Aschoff

very Okay. Peter. Thank much, you

Peter Nielsen

Thank you, Jonathan.

Operator

The next line Capital Laura of Engle question from Stonegate is the with Partners.

Laura Engle

University if asked, I but to think, all the Hope you Jefferson on, new or progress us? one which morning. if Thomas horizon with has any collaborations Anderson maybe main question give on anything already that you there's point, could with could is been us report I or, you as some of MD share at an within wondered new Good that well. update have going anything My

Peter Nielsen

doesn't on require supply drug. Thomas We it property involvement. develop have that We being active our really the Jefferson, intellectual and actually developed.

So, on I think require continue they work to it our that, doesn't active involvement. but

But our an I have MD through interest those they with more continue folks. think programs clinical that Anderson, in we're technology. to really the

going doing get advanced be the when AML, there'll kind -- in lymphoma and they're tumor site were the the course, lead tumors, was of Of done their that site venetoclax-relapsed solid AML, for the endometrial. a they ovarian, and CLL, we group so in which work, -- a -- -A solid for their and original did the and XXXX, so for site

So, to them. they continue work to continue -- we along with

that, other some on being near -- discussed the we other have there, future. more these so things collaborations which in notoriety, have may we've We we and as gained

Laura Engle

appreciate to this year, can Okay, improve trials. this progress all and keep great. Well, Look the COVID-XX to continues move forward update. with so you making forward hoping these

again, for update. the queue, I'll thanks back but get So, in the

Peter Nielsen

Laura. you, Thank

Operator

are [Operator Instructions] questions. no time, At further there this

Peter Nielsen

again for great a All support day. Bio-Path. right, joining thank continued of everyone, for Have your us, and you

Operator

day. today's for Thank and this participation. a your conference. concludes Ladies gentlemen, you Have wonderful

disconnect. all may You

Bio-Path (BPTH) 10 Mar 212020 Q4 Earnings call transcript