- Earnings call transcript Q3 2022

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Operator

Good morning ladies and gentlemen. Welcome to the Bio-Path Holdings Third Quarter 2022 Earnings Conference Call. At this time all participants are in a listen-only mode.

Following the formal remarks, we will open the floor for your questions.

As a reminder, this conference call is being recorded. to Investor conference Relations. like O'Connor to I'd Stern of now turn over the Will And Please proceed.

Will O'Connor

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

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

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

Peter Nielsen

everyone, for Good we third Will. with joining quarter. made throughout thank progress pleased particularly morning, the Thanks I'm the us. and you

solid our Phase by BPXXXX-A and X, in cancer most highlighted for inroads Bio-Path made our of of myeloid of of Phase mission refractory/relapsed of initiation the study the significant deliver and later Phase as treatment to leukemia bringing to initiation tumors the preparation X are BPXXXX closer in study As our at These challenged achieving to Xb the acute new our for this is exciting times year. us clinical progress patients. meaningful medicines

prexigebersen. progress we've made Let's our with product the start candidate lead with

open of multi-center AML relapsed untreated resistant incomplete The in and who combination or endpoint treatment in of acute label, with A of intolerant of patients third of which partial Phase Stage of remission and complete our myeloid an AML. cohorts make the leukemia to in decitabine. combination for frontline AML the Phase this includes venetoclax be hematology analysis decitabine prexigebersen complete the recovery. two decitabine resistant interim combination resistant achieve X and previously patients cohort the efficacy remission venetoclax. who therapy performed are AML with will advancing on X trial with primary treatment. study and patients venetoclax treating continue with prexigebersen AML complete safety hematologic of cohort two-stage and We Amended trial of clinical or progress relapsed the An recovery for remission, this of with Stage X significant is X two-drug in to study will assess number includes prexigebersen and each be with

prexigebersen Patients negative outcomes BPXXXX-A and such and evaluate in is poor diagnosed of BPXXXX-A, fourth most for and we the our mentioned sharing X cancer challenging This of As drug clinical cancers prexigebersen enhanced of initiation tumors with benefit patients. also tumors some provide therapeutic are today's weeks in hormone to toolkit. substance trial in to tumor and pancreatic, including patients ovarian, to refractory have coming is towards often prexigebersen drug advanced and including planned breast clinical initiate solid a patients may Phase endometrial initially ovarian, Bio-Path leading safety making patients. centers treat that breast same be the recurrent Phase candidate a cancer, the will endometrial, modified triple a nanoparticle I several cancer clinical of with ovarian with progress solid is a pancreatic at hope with X/Xb BPXXXX-A trial, In the earlier, uterine, from properties. expect we solid conducted with trial product cancer.

second targets our BPXXXX, candidate, Bcl-X. to which now Turning therapeutic

activity treatment the neutralizing leukemia an chronic proteins shown poor expression domains. BHX of prognosis or driving anti-apoptotic XX% for of lymphocytic correlated know, protein It diagnosed with approved against AML. is all patients. patients for by up untreated in has has survival responsible for you High cell with As AML works Bcl-X cancers. to been and CLL Bcl-X Venetoclax the patients and is Bcl-X

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

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

incremental treatments. excuse have doses result, treatment could standard evaluable BPXXXX will approved per of over doses six design we a BPXXXX venetoclax including will in to administered The who previously program assess be believe week Phase in efficacy in first study for square by days. is received BPXXXX establish followed of dose that safety and four in portion Xb patients with of patients of relapsed, XX resulting updates relapse completion on after As of decitabine monotherapy mg patients. hope treated in as meter. eight patients me, the over patient monotherapy, two with per and provide cycle this starting The be efficacy venetoclax XX BPXXXX the commence alternative X+X provide an smaller A the who with AML a refractory AML will we able to then cohorts. safety weeks, total combination cohorts a We

in promotes cancers, STATX in in cancer. including pathway characterized is Activation target. cells pancreatic, and enhances liver, resistance. the as efficiently breast for that patients review cancer ovarian, and X-FU made BPXXXX, initial tumor STATX colorectal ductal antitumor of processes, protein. BPXXXX adenocarcinoma. lung, and mini regulates These a the a in cancer ovarian we've the cells is previous STATX and novel targets and STATX factor therapy in candidate antisense our and Together, work breast, tumorigenetic of proliferation, third role Its Taxol and resistance is solid activity migration, STATX therapeutic malignancies cancer a and liposome-incorporated gemcitabine results drug a that colon suggest numerous ovarian sensitivity are STATX transcription promotes reduces which strategy Its initiation, potential let's advanced progress in strongly line drug plus displayed cancer these overexpression tumor X-FU. breast resistance. The novel BPXXXX results such with with activation BTXXXX various combination tumors. cells. expression metastasis which Finally, the also with made to that aberrant STATX oligonucleotide Taxol enhanced

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

half application testing species timing testing. the Our very used goal finalizing year. file late of animal IND product presence promising The this to an first is next in the determined in in pre-clinical is by substance candidate drug of for

that considerable bolstering our our intellectual have like have we building At call that made the property Bio-Path fortress report progress we to I'm five the applications the has process. technology patents completing portfolio. four allowed executed United tuning strategy a Before grant Outside platform additional are Bio-Path completed over issued States. been worldwide. of patent process Anthony, to in the United and to and have grant DNAbilize for and five States the delighted at has I'd a the pending protection six aimed patent highlight Bio-Path, have global now applications applications

foreign pending. XX applications over Finally, remain

would competitors to this our programs capture protections is important? advance with be more. are the begin as and outside we parties, So and through the clinic these why attention of vital First, so

partnership position agreements. any In strong or a licensing addition, strong patent us negotiating in a puts future position for

innovative that, DNAbilize the with these approach to underscore to review patent sheet novelty With highlights. over technology. with of now program for turn balance our fighting of Importantly, Anthony? Anthony XXXX cancer a our our along third I'll Price quarter brief grants the financials

Anthony Price

XX, three XX, net September a for of reported XXXX, compared XX, ended loss share September $X.XX three months the three XXXX, was primarily our $X.X manufacturing solid to development quarter compared $X.X ended XX, million costs BPXXXX-A company legal ended fees. the to The increase million million, XXXX, well an XX, due the months as September net product $X.XX increased Peter. increased of ended for months tumors. $X.X Thanks Research ended in to September and clinical months a related trial million expenses and General $X.X XXXX startup for third related the primarily X to in for to compared as administrative ended XXXX, XX, Phase XXXX. $X.X to loss of for the per September $X.X releases September or expense XXXX, drug to to three for expense share million three months months three the the million of per or due

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

Peter Nielsen

Thanks, Anthony.

more made of look and forward relapsed treatment future. solid refractory the BPXXXX As acute of for our look leukemia couldn't study Phase tumors in for the X/Xb excited the myeloid we Phase to prouder this our BPXXXX-A we've XXXX, year be be later progress forward of initiating of close recently Having the approach of X year. study and initiated towards we our or

have of inflection creating We series points. expect a to value near-term

options. importantly, cancer to limited More patients advance have hope treatment who as we with we believe these we are programs, giving

for While ready we we the sound that are every we team goal, have our progress excited With this and what about made. are questions. drives open may day lofty the a why call is so it operator, to

Operator

Jonathan from with [Operator Thank Capital Aschoff Partners. And question Roth comes first Instructions] you. the

Jonathan Aschoff

Good prexigebersen-A will curious, for X X when for Phase morning, and I we initial see results, results Phase initial and Phase both the XXXX prexigebersen-A? Peter. the was the X results

Peter Nielsen

goal have three X, quarter facilities. established created the Recall our end Phase through that's we way the again Well, year. interim trials, as problems now cohorts COVID is three of clinical quarter, readouts the manufacturing for two well have main into the our really study really our that and next momentum to and we're by worked first we of

a it, a of us accumulated So to really allows we quite have lot and treat bit patients. that for

the mean those I in we've already seeing some least of cohorts, first AML, would quarter I dosed relapse think, X the X, and in So Phase Phase in the two at that.

screening interest with of but next lymphoma patient more one, I one that a think the one Phase the would but we've So X that. cohort think we do started three to enrolling harder We'll I we -- there's out We is solid interest have attractive more we'd that patients. and so -- had by have that a close. not study first T and, we The only have first be a XXXX-A three so that program We're need dose readout. tell first We're it's be there in of year should I trial, the something is of for but patients. patient. quarter yet. level to are on and that which and that, tumors, open would patient lot now patients, would separate lot find first of in me on patients able portion that clinical team open It's they my add the would because cell in them that

absolutely first Difficulty] on I cohort first quarter. should by release the think So information we evaluated [Technical and

Jonathan Aschoff

have quarter? next So you'll you're data saying prexigebersen-A,

Peter Nielsen

so only it's It's three patients, just…

Jonathan Aschoff

It's just next quarter XXXX first year?

Peter Nielsen

Yes, likely.

Jonathan Aschoff

both with are the Those data?

Peter Nielsen

both trials, it. we we're those escalating on Yes, we X+X but when do, report are dose allowed

Jonathan Aschoff

All enrollment? its Where Phase the right. is X study in prexigebersen

Peter Nielsen

than, get don't more have specifics into XX. we past enrollment, Well, it's on to but like well I

Jonathan Aschoff

XX past patients or Well XX%?

Peter Nielsen

Patients.

Jonathan Aschoff

had. you Okay. Peter. Thank I very That's all much,

Peter Nielsen

Jonathan. welcome, You're

Operator

Yi Thank question from you. with And Chen the Wainwright. H.C. comes next

Yi Chen

on Could you AML for prexigebersen three some patients which trial so of details enrolled my the additional most X Phase us questions. the regarding you having taking of out in cohorts Thank far? give

Peter Nielsen

they're Well, doing same, been the performance so well. has reasonably I the and think about all

patients are the in. so being enrolled And

institutions, come speculate I will can't this in I they're good well. time at ones my sense all is now have but We just, first. right which

Yi Chen

do that quarter should end by But Okay, eligible first next you year, okay. [ph] expect XX of patients right? be there the

Peter Nielsen

that the much I Well, able treatment yes. supply. drug we're our go on enrollment now because to that's is, of goal, mean stronger

Yi Chen

Got for current you solid tumor tumor it. prexigebersen-A solid based it. the type Got interest? trial expect most which And do on the to of of the enroll

Peter Nielsen

open or that's to X- one that and for safety are in pancreatic, because ovarian that It's in all pretty so we've along the combination monotherapy the Well, specific was the strategy Then course been way dose to cancer. you But certainly the portion Xb get, you a in mean, to escalation the that ovarian area. Xb the trial, remember advanced much with. solid the endometrial, /Xb tumors has the Xb, for that's faster. worked ovarian, Xb in get therapies. triple a looking the just of those we're once negative And advanced and types, evaluation. and when I all,

have all one ones. you They'd those. combination go So across would their use to specific

Yi Chen

sufficient have the currently it. BPXXXX? to point the Does for Got Okay, starting the capital of fund company operations to trial

Peter Nielsen

I believe so.

to goal. be That's that year. think our go should next I ready

I think, study drug to can that are have it drug substance that remanufacturing we that for redoing the finish last Charles the rabbits much I up. so or finish time we're detection the mentioned to remanufactured and get as tox we in last that pretty off River

I year. our is our we So, get our And in releases as happens mean, next said and goal can first be IND that in we certainly of should six that filed. months the once whatnot,

continue demonstrate that sure everything of past October there to believe so have for to was, kept September just with I year, added the cash viability. next runway end make So, is of we've strategic we raise runway and and so we sufficient a else that out requirements that done, we that small noted that we that the

So…

Yi Chen

Thank Okay. you.

Peter Nielsen

welcome. You're

Operator

question next Engel comes Laura the And Capital you. from with Partners. Stonegate Thank

Laura Engel

are How morning. you? Good

Peter Nielsen

I'm to are How Good you, you well. doing Laura? back. have

Laura Engel

for Thanks. thanks. thanks taking good, my call. Yes, I'm

of been of to most did it in Any even updates mention have therapeutic the questions point with realm talk of you cancer? my there, the to that the but for you notable patent want discussions outside the either and areas, or answered, cancer partners portfolio. So are progressed about anything, discussions any strength

Peter Nielsen

No, nothing.

something the whatnot. really interests has the I speculative time. we'd think talk us the is and happened, has been right we there be don't and I think people's and to too that do about it in only had past, it's had we to so actually something just, for And concrete time if

of will a to DNAbilize pharma some main recall going the our end diseases treat But the may But not treat can't are more finalize. be year, could into be people prompt on company that. of quarter in our is commercialization. to some that But starting that would past interest I is on, have next things and these the be these some difficult interest at that focus right definitive think to now. that first patient's those drug company develops that model products pull a that I

focus to making those need on to products of can we that populations. hard So more kinds help treat of

patents why spent. not for got a U.S. us the that's the helping need, have to but some technology. bigger only, you so that good of components too. had we've We've identify companies course, advisors pretty foreign And They've those license to that be typically patents, want the in your interest foreign

those. And so that's why we've been spending time developing

Laura Engel

Well, and and I Right. Peter. I'll you again, call, appreciate get great taking queue. in my the back progress you, Thank

Peter Nielsen

you. to any Thank I over you. like Thank And session. call this would the to Nielsen for closing concludes the Peter question-and-answer comments. turn

Peter Nielsen

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

Operator

conference presentation. The attending Thank concluded. now for you. today's Thank you has

You may now disconnect your lines.

Bio-Path (BPTH) 15 Nov 222022 Q3 Earnings call transcript