BPTH - Earnings call transcript Q1 2021

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Operator

Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings' First Quarter 2021 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

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

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

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

Peter Nielsen

Thanks, substantial morning, to marked drugs. XXXX start, us. a portfolio terrific you is by thank Will. for everyone, across targeted nucleic off our of cancer Good progress joining and

for by what but excited made, We’re is advances are more to even the excited we've come Bio-Path. by

April, the of advances the delivery drug peer-reviewed were me candidate highlighting with In the greater our make delighted in Let prexigebersen, to analysis and lead to within an potential where discuss turn we journal, now detail. antisense to progress. landscape these solid product in publish opportunities I'll begin prexigebersen we Biomedicines. oligonucleotide continue

in acute venetoclax prexigebersen Phase myeloid trial therapies, decitabine of and for treatment X combination Stage In frontline of of our clinical with addition, leukemia, or AML, continues. the X

was Stage in label development and to treat de which reported, AML have we commenced cytarabine, Phase novo LDAC our treated to clinical and than patients safe this prexigebersen efficacious X with with of of Phase low-dose was shown class previously As combination trial, patients alone. or of X be with and open and clinical prexigebersen The LDAC prexigebersen X of more combination LDAC. a of AML

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

the for the with AML with design XX treating AML prexigebersen number and preliminary relapsed/refractory a cohort who venetoclax, patients. will achieve the complete venetoclax the the performed a trial the full A is recovery. evaluable of standard combination cohort approximately full includes be response complete interim trial cohorts frontline previously with decitabine plans with AML treatment. cohort we effect XX amended clean of patients patients completion April, remission prexigebersen venetoclax intolerant will which cohort partial remission successful review with excited The on two safety our and remission, run-in analysis and trial AML newly incomplete design a endpoint of in who resistant by after cohort pathways. full efficacy of evolved, higher of to label in us care have As very the study of patient patients of the announce patients performed AML. or Phase have combination third performed trial this with prexigebersen toxicity. unique hematologic analysis XX AML forward its trial prexigebersen, both of provides cohort patients a In look and and the reflect demonstrating are AML multicenter and the complete relapsed two-stage An the and for hematologic and venetoclax or XX patients, patients of with the approximately patients treatments patients. be of definable combination we encouraged X includes design X, plans untreated the in with untreated formal had design activity. also to advancing of resistant AML decitabine assess prexigebersen, we Phase for patients six combination the relapsed/resistant evaluable the which shown after lack evaluable XX were of design a of triple this patients with treating The who Stage this the two an X cohorts interim of to this to is registration changes. untreated for and and triple previously of efficacy The X adapted venetoclax dataset, treating and resistant recovery We due two AML with patients. these believe are of each decitabine. with clinical untreated with diagnosed decitabine AML combination signals Stage The review drug of evaluable treatment decitabine baseline treating We were intolerant with of side dose X therapy patients open several as a study number after of a to higher study in and evaluable evaluable the Phase The in profile primary cohort five relapsed/refractory study,

that our Trademark call, intellectual our platform DNAbilize in I United issued family As platform defense expanded third last on patent States Office the of and property offers technology. of Patent our a mentioned

granted further issuance in such intellectual In analog related a combination receive our the Bcr-Abl either with addition, property we to strengthens addition pleased tyrosine cytidine kinase and patent dasatinib inhibitors, decitabine were or This prexigebersen as already in of to nilotinib. our who new patients AML investment to program completes treatment option to therapy treatment ongoing limited and with this our unique options. supports bring patents. combination the and a protect have patents These new portfolio

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

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

leukemia, is the sensitive relapsed AACR poster and show all presented against of Bcl-X. therapies. XX% data a the to decitabine, anti-apoptotic treatment shown at been chronic patients. protein’s Bcl-X, BPXXXX AML which venetoclax to or also for lymphocytic driving is Bcl-X with combination CLL, resistance approved inhibitory has XXXX domain. by highlighting protein from survival neutralizing works an combined we The In our to are patients Research Turning preclinical cancers. patients and Bcl-X therapeutic in American data a is patients this second BPXXXX, of activity suggesting expression the has BHX with that frontline poster potential BPXXXX High which cells now candidate, presented for meeting. AML. cell that It Cancer for responsible the BPXXXX the Association targets who targets April, have venetoclax-based untreated with protein poor for prognosis correlated in Venetoclax up effects of diagnosed for treatment annual

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

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

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

for review we our candidate, third made the targets protein. preclinical with let we've data, Finally, promising program. the very drug program BPXXXX, are This the future and briefly this progress which of has shown STATX excited me

studying We the the frontline model. of tumors enhance of treatment successfully pancreatic penetrate BPXXXX cancer patient-derived Previous for pancreatic shown drug and tumor efficacy in have treatments. a to the models standard are

edge in launch validation especially We treatment excited cancer first this limited that in-human an challenging indication cutting options. therapy are to has particularly of our

very the financials I'll With aiming are a first application Anthony Price our for promising file candidate IND this Anthony? We sheet balance turn to of along with that, with quarter XXXX this over year. review product to program now brief an later highlights.

Anthony Price

loss activities the Research General ended expense decreased months to XX, for to XXXX, ended XXXX. XX, decreased tax the to preclinical lymphoma. expense March XX, XXXX, March and X ended development of or million trial $X.XX ended as X related Thanks, expense clinical our X.X trial three March reported to expense or XXXX net a XX, due share of for of XX, to AML timing million three the million the clinical compared of of to as XXXX three share decreased in to for for months million X.X the administrative a franchise March in to well BPXXXX for three trial decreased the March X.X months Peter. months X.X XX, million three months a net compared for The BPXXXX X.X clinical for activities three and XXXX for due primarily to Phase compared expense. and due $X.XX X.X primarily per company Phase per decreased of prexigebersen timing ended March loss million months ended

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

Peter Nielsen

Thanks, Anthony.

scientific with relevant achieve and milestones our great the platform, used. clinical of various of this and more This building audiences. be This It clinical the to the of we've we our are ready Bio-Path. and building open presentation programs us of in should be well visibility enrollment, couldn't we we XXXX With and that the among ways expanded is creating call hope excited more. data, enhance just I have that balance platform enhancing can DNAbilize start, we made our of of questions. are technology, call about greatly of and conveyed that knowledge a efforts positioned development continued my support evidence of I are year. our for while in it the With body in operator, our publication potential groundswell on of value trial hope the interest progress morning, to business the in future the the a this leaves As is throughout

Operator

Instructions]. [Operator

Aschoff line is Capital Jonathan question the Partners. with of from first ROTH Our

Jonathan Aschoff

clinical the you release Thank data over prex the on and particularly progress, any of half of you Can and give of Peter. kind congrats rest just next first XXXX the this on timing us year for the update year? and

Peter Nielsen

Yes. morning, Good Jonathan.

I've know, and pushed drug of that you COVID been a occurrence supply had we plant our As rebuilding off batches. my some

been have at of ways needed readout towards think some supply we the ramping year think we've to 'XX evaluable the two -- we treating. With early half we in -- remaining the cohorts. next one enrollment to a possibility the year. year. point we But more were supply. But I of had of and the any by batches being that the up response will that starting cohorts, remaining managing the we’re certainly our is end patients. following be of XX end We and we’ll get of said, over the treating by, So the XX pretty start manage And would one our through high that have I the week there to that planned half first

that’s view. been good So the current results. getting We’ve

patients. treatments profile frontline we the Obviously, If positive efficacy put in three small of you enhancement safety And run-out six recall, over The we cohorts. the evaluable was excellent. it’s on a all the had safety dataset. various

have So now. that’s the view I right

Jonathan Aschoff

Was the is Peter, naive one? what cohort treatment most enrolled?

Peter Nielsen

Currently is the third patients. venetoclax cohort intolerant-resistant with the

Jonathan Aschoff

possibly biggest clinical And could force prex to AML for evolution treatment concerning what’s landscape redesign that Okay. your the again? you path then

Peter Nielsen

regard that treatment. the because worked a not the combination way thing really -- before, it’s I’m whatever in focused that it’s

option. if treatments, main adapt obviously think we treatment a treatment much that in our frontline the I for change with want settled typically And to the way pretty So these people has dasatinib. because drug there is in the venetoclax will that’s us configure

on way. so I well our think we’re And

an incremental The other a we development, thing time we’ve done treatment, pre-clinically, or show benefit. comparison every always is, efficacy

alone we is really going track I relatively have it’s a and to dasatinib dasatinib for in just on patients. that’s low where So pretty thing And us. Certainly, in our the prexigebersen, bar And the right frontline. keeping view with be cohort stable those I now. what’s frontline third that for a think

I’m get that. my That’s for to So of us to kind try to view. anxious

Jonathan Aschoff

Peter. you, Thank

Operator

Our Chen question Yi comes of line final H.C. from with the Wainwright.

Peter Nielsen

Yi. Hi,

Yi Chen

Thank taking us Thank the X you you. of questions. my lymphoma Peter. for Phase trial? enrollment current CLL Hi, and tell Could status you the

Peter Nielsen

For the what?

Yi Chen

The BPXXXX trial, the enrollment status? current

Peter Nielsen

evaluable patients. other enrolled has patient we’re looking and had one trial That at currently

have is at safety hard you out as lot do We study, expect the starting end can’t to cancer of good get a low the know, centers. the is, people escalating you when it’s at the will oncologists well it’s and slow well, you low. BPXXXX started benefit a dose because a say, trial and problem

per at meter squared. starting milligrams XX We’re

through to have kind you So of struggle early phases. those

participate. But that. we had So from to very had sites to we’re responses looking positive our want that do

all and Georgia have Cancer good were We Anderson, sites. Those the Sarah Cannon. MD Center

escalating three have to we trial. dose this So do sites

think doses. the I we get it more up will higher rapid once So into get

Yi Chen

you the trial X can still year? before this end data believe do this of report Phase And

Peter Nielsen

And be can meter one, focus I how the cohort. you that the don’t would efficacy dose. on Yes. for be It report would first early a the again on three cohort. know be per milligrams safety. square at first XX It’d much patients example,

are it are think ones I would our XX, would go first XX But XX, those So the from four to go points. may the and principal They XX XXX. focus. be dose that

be those in. So one we cohorts certainly first able get to ought to of

Yi Chen

environment in of Phase how recruit Okay, solid you got current in prexigebersen-A, X do pandemic? patients it. the for think And the can tumor quickly trial the

Peter Nielsen

recruit seems We’ve there done solid of one IV a ovarian going endometrial can lot on for a be of this -- treatment tumors testing and advanced that to is a in to Well, systemic be that. and them, pancreatic. or they

again that. a interest the been have So Anderson I in recall would And that we in. we be others has very MD high. couple have coming

was us bit four different. particulates the extra for And of us FDA and these hard our are waited had being months, the do testing little have product one more We them of asked two a to sets of because particulates.

You it on is have reconstituted product, to do liposome. which the drug

the in now break we’ve you got things successfully so you those, just in for the aggregate through little fact and a week have got the have and mechanisms that the And two some do to cells get nanoparticles it last liposomes use challenging. all and coalesce you in go down the to -- and to just more or to test have done. make But that word we that of

FDA we And with things so just the in had two the them the gave to do. December call needed we us

our at we’ll had passed -- well Yi. is posters two meeting. we’ve then as now that think I real So a know, papers here fairly for we’ve get quickly been there had IND And received, this, in. us And have their as need annual AACR they you

a like first will lot be assessment. safety of And Obviously, so again help treatment a of kind that getting think I the there can that. manage a is part in this interest

cell Fortunately but that nanoparticle, we is start there formulation to since AML, since different better prexigebersen is dose. to smaller the is higher the particles, with since out the get a safety at same get drug

meter XX milligram I think per it’s squared.

may not through have enroll So wanting to people hurdle we our get of if any can they go not don’t benefit. the think patients they to

looked being So but that’s think as know well, is be on I this we for. really a treatment better I everything can maybe that

Yi Chen

So in be we can quarter, initiated expect this the trial third to right?

Peter Nielsen

the get get pretty And IND, IND they go. opened be satisfied we’ll want. ready think to I we’ll And Yes. up we once because that quickly everything we

quarter first should patient we be the certainly, third for sure. our in So dosing

Yi Chen

it. Got Thank you.

Operator

I’d remarks. gentlemen, the like for Q&A and the call turn to our closing over session. Thank end any Ladies back you. that’s of

Peter Nielsen

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

Operator

gentlemen, today’s this lines. Ladies conference that ask and now call. concludes We you disconnect your

Bio-Path (BPTH) 14 May 212021 Q1 Earnings call transcript