Earnings call transcript Q4 2022

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Operator

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

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

At this time, I'd like to turn the floor over to Will O'Connor of Stern Investor Relations. proceed. please Sir,

Will O'Connor

and Welcome webcast operator. financial Bio-Path conference recent Holdings and Thank review to the and pipeline on update to provide XXXX developments. company's call to you, an the corporate full results year

and Nielsen; outlines of from Earlier, we Anthony topics and Bio-Path Administration, call. release are plan release biopathholdings.com. Finance, at Peter today's that is on President the available we and discuss With press President issued The a Accounting, Senior which Vice to me Price. CEO, today

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

may differ from materially discussed what call. on actual Our results today's is

call that, to over Bio-Path's turn CEO, now With Nielsen. I'll the Peter

Peter Nielsen

Thank great mission you. was battle and in XXXX everyone to medicines year which against you executing us. joining the cancer. progress thank for Good bringing new morning we on made a to our

as the treatments and this disease. as we need new evasive to resistant deadly to bring fight disease approaches to For bold cancer,

are platform against the innovation true with our hard-to-treat cancer DNAbilize In to we across Bio-Path, of bringing number a fight cancers.

of we proud progress can are limited the inspired no hope and options. treatment We bring we've with by the made or to patients

delighted in were the cancer. important and tumors, initiation breast report we pancreatic, to patients BPXXXX-A ovarian, in trial December, with Xb negative In triple of endometrial, clinical including an Phase solid

the toolkit. today's cancers Some therapeutic most treat with challenging of to

safety solid several cancer enhanced nanoparticle evaluate initially the sharing being centers BPXXXX-A with and properties. substance conducted from will is is a prexigebersen product patients. of drug modified This tumor leading trial at same the

forward our ovarian recurrent look may that we such cohort is readout from around clinical hope and have midyear. completion with study it this patients. data diagnosed benefits endometrial We for to and outcomes provide often and poor cancer Patients

have we prexigebersen. product the made candidate, with our to turn progress let's Next, lead

We prexigebersen our and Stage progress make in myeloid X trials clinical venetoclax. of the continue decitabine for of frontline AML significant acute of to therapy with or advancing treatment combination Phase X leukemia

The of two-stage combination Phase and cohorts this in in with open study venetoclax resistant of previously multicenter Stage relapsed X of AML is prexigebersen label in untreated decitabine an with amended X AML. AML and patients two trial

AML A resistant patients or who combinations venetoclax-resistant with prexigebersen third the intolerant cohort treating and decitabine. includes are of two-drug relapse

study with recovery remission, complete will patients The number partial be remission complete includes achieve primary who recovery. and which complete hematology this hematologic incomplete with endpoint for of the remission

on we of An will assess assess to for interim this performed the combination analysis be the safety will each coming program status. In expanded treatment. the safety and weeks, efficacy efficacy qualify of initial cohort therapy with the to potential the and

now Turning program, to BPXXXX Bcl-X. which targets our

is know driving of you expression prognosis survival with for Bcl-X AML. for to has patients Bcl-X poor all If in correlated diagnosed High cell up cancers. responsible XX% with been of

or Venetoclax BHX approved protein CLL for chronic by patients It activity domains. the has Bcl-X leukemia works against untreated is an and proteins lymphocytic neutralizing shown patients. treatment AML and anti-apoptotic the

treated time. over exception domain BHX to cell transplantation invariably of with oftentimes patients due relapse However, with the disease some mutation allogenetic occurs, hematopoietic

targets also protein. the Bcl-X BPXXXX

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

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

eight The square days. doses XX standard is four treated six a be with over total patients milligrams weeks, two evaluable doses design approved administered week dose of resulting per a monotherapy meter. XX will with per cycle treatment A in over of starting BPXXXX X+X in

AML combination of after and and will patients. refractory of cohorts assess the BPXXXX of the portion in relapse will completion efficacy The safety decitabine monotherapy commence Phase Xb study BPXXXX in with

expect initial data midyear. completion We study readout and around from this cohort

let's that overexpression and the resistance. processes, targets transcription breast, lung, various STATX the colon ovarian, STATX protein. characterized activation such BPXXXX, cancer. tumorigenic liver, is progress and factor aberrant including a which drug with metastasis, regulates Its and Finally, mini-cancers, review as made we've tumor proliferation,

breast Activation cancer cancer agent. resistance. initiation, of the cells a made also cells. STATX Taxol X-FU pathway and in tumor STATX in and numerous colorectal malignancies cancer in STATX migration, therapeutic ovarian promotes promotes role resistance potential Its

and BPXXXX ovarian oligodeoxynucleotide and expression that to efficiently STATX Taxol of sensitivity is the novel reduces liposome-incorporated enhances X-FU. cancer STATX antisense a and cells breast

are in BPXXXX suggest novel patients adenocarcinoma. plus tumors. therapy these in strongly ductal advanced work activity a with that gemcitabine pancreatic, results BTXXXX enhanced results combination for solid line which These Together, in is with displayed previous antitumor strategy

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

look an for to year. IND We forward very later this product candidate application filing promising this

Anthony? the to Price of With balance highlights. over brief that, I'll Anthony our program with turn now sheet for financials along a review

Anthony Price

or The net net million $X.XX per share the million of XXst, year share a $XX.X loss December to per a the $X.XX for December ended compared ended Thanks reported of XXXX. XXXX Peter. $XX.X company year or loss for XXst,

due ended Research trial the XXXX $X.X related to enrollment million increased for X year start-up $X.X patients. AML costs in increased for compared prexigebersen to XXXX, million expense Phase December in BPXXXX manufacturing X to our trial ended XXst, expenses in Phase and AML refractory and clinical for clinical for our December to drug and XXst, XXXX, relapsed year releases to related product development the primarily

due XXst, fees. expense ended administrative increased to XXXX, XXst, the for year XXXX primarily December $X.X ended $X.X to legal and General increased compared year million for to the December million

was compared XXXX XXst, $X.X had period $XX.X provided $XX.X the XXXX XXst, XXst, for operating of Net to XXXX. ended company at for December ended XXXX. for activities million $X.X the December million. Net cash million used the by the December in financing to XXXX, year $XX.X million XXst, comparable million in year compared cash cash of activities As was December

over With turn that, I'll call the back now to Peter.

Peter Nielsen

Anthony. Thanks

have midyear; trial of have milestones BPXXXX-A an I clinical several our potentially completion As tumors we ahead clinical of X/Xb midyear; from of with interim trial from our readout initial around creating and clinical prexigebersen an in value readout our year beginning and our we analysis in exciting clinical Phase Phase solid data cohort safety X completion AML trial Phase BPXXXX around across coming cohort of including portfolio, from X/Xb data hope efficacy relapsed/refractory conveyed, and quarter. the AML

our against that to purpose. to with never Bio-Path, every It push work fight new lose medicines passion the the mission At and to of drives we day goal in a cancer. is singular our boundaries sight bring us

call we're for operator, that, With ready open to the questions.

Operator

session. this at we'll the question-and-answer [Operator gentlemen, Instructions] begin time, and Ladies

question Engel ahead Stonegate. first Laura today from Please comes Our go question. from with your

Laura Engel

How morning, Peter. you? Good are

Peter Nielsen

I'm Thank doing Laura. well, you.

Laura Engel

fight. the the obviously, just Fighting some details your -- programs year a of try Good. for Well, of bit of high differently, the year-over-year, everything to level, see kind the good get insight news, different lots on you finished you as model all for busy manufacturing but year I how comment works R&D what and as end how with that But you've explanation love cash reported of kind that busy, of of recently we with upcoming comparatively the that? could little course, going you on change speaking kind comments. balances, kind always. good given which the just in mentioned the

Peter Nielsen

previous for the environment manufacturing. color. I background a both and Recall two tough the And was -- it everybody. probably had and years with COVID, manufacturing our them COVID in Yes. was reestablish difficult us plants for shutdowns little for to

supply did things And worked go product the of with them. we in key chain oligo And one drug was double the the we our manufacturer to manufacturer. needed and both we concluded that we and out

enrollment drug taking people a obviously we're limited risk in two those over off. cutting really The limitations slowed if we on not and of supply them years because our have

of this in So, a last so successful our our doubling and course, but we supply things year, spent wrapping were the very up, supply drugs. we've chain and year, quarter building year first of of last in lot

that approved. remember, not product, it's our drug Recall

and to we do have the expensed the So, final we drug value has once that economic therefore, doesn't and be release product as have it -- an product.

vials, of gates us a expense what's course, of tremendous increases had goes. fourfold side your increase of that we the where -- enrollment other that's a and is get R&D But the kind because because allowed the in coin is it that drug which supply of going. We tremendously to release our that's had important that

So, of that part several expense of that that R&D in a that the you was dollars and drug see on in the a year-over-year million increase. increase fourfold supplies is

maybe would going know not the that I development specific probably forward, but number. expect expense be in a million -- that's the I the forecast, studied a have we $X think don't should I total range but about that

high be that push lapsed over and it it I've quarter as prepared simply cash XXXX. not we the budget, hard because building a as of it should have won't But goes out inventory. was drug but into first on that

Laura Engel

Great. I appreciate that get will guess, that in was the queue. And just giving Well, go my I over and you I to you. happy wanted insight, back with Friday, but us the

Peter Nielsen

one. Thanks. Okay. Have great a

Laura Engel

too. You

Operator

[Operator Instructions]

question ROTH MKM. Jonathan question. Our go from Please comes next Aschoff ahead from with your

Jonathan Aschoff

that $X morning will wondering, only year? Thanks. for million million you just I say R&D did that quarter? your the $X be Good Peter. a was Was

Peter Nielsen

say What I was million, I studied to million think don't last I $X expect what couple the the but or year. I of $X $X range, that it would I in a be of tried a million in be think saw probably we would number. to from it instead million down have

that because -- inventory large So, I won't build-up. have

Jonathan Aschoff

definitely wondering Okay. for data I That as XXX might when arm a resistant sense. there venetoclax was All more intolerant CLL? in or right. well as lot we makes XXXX, the see

Peter Nielsen

Okay.

of is the trial, what that for? you're The cohort third X asking Phase

Jonathan Aschoff

Yes.

Peter Nielsen

those showing -- had third middle patients. one would or year, fourth probably difficult enrolled, that quarter. not a up be one's, are patients lot that That -- be but Yes. very That in would we've the

a harder but a pretty rough But few and had lot to frankly. them, quite had find We've quite patients in. we've come it's those through, come are

one. the So, furthest slowest of the the I for That's in cohorts. half or think year second the the that of three looking you're

Jonathan Aschoff

trial Okay. How about CLL with the XXXX?

Peter Nielsen

patient. -- need more one have we trial CLL The only we

at for We some that pretty have out that rollout they And Albert have can think it. [Indiscernible], complete and good do looked first we've which that cohort. more, protocol the that with two including to understand good I added they institution, patient

more several -- till run institutes June. go won't got months one I be we've step on that think I to and final those So, because that think again,

and can report So, cohort. first ideally third we'll quarter, third that that on the then in have out stage

-- real going want a on to a CAR-T so don't that's And try. it. part It's we there's Again, a with trial have there's to the that starting. a was component people low trial to a chemo dose monotherapy, difficult was attractive -- it's

Jonathan Aschoff

you this would year, Okay. And for you lastly, XXXX said that IND right? file

Peter Nielsen

study the give everything have again our -- We just that, drug That's do for color animal. available. have study fact PK We What that. goal. to specific our able finally you on species us in down? [ph] that. second to slowed final done to background We've to demonstrate me tox being we let do. has that, just Again that have that have for in the And substance

We third through drug and I'm PK two that have worked successful and molecule for steps melting a an the can't get significantly additions other has go study The worked animal drugs, -- that may has than that and withstand two you we've our gone other sorry, durable analysis. from method, this that in not we some not has point a lower a when enough it has think be to plasma it. the that chemical in

signal And detects binding, the so the gives that it off which interrupts it.

the some you to past come that one the for have have CROs fact, technique detection they of backlog, a an large two method weeks, have we great in had this that another we've on with side mass and need technique. of use spec we've up now. which And to this is interviewing been with their don't much So, acceptable and business

with and so we going And up the take test report. we two animal round to that think actual only get and can months on study

had all different set. be that year. the a that's make technology the end the just in trouble. of we've come We've blood serum. So, to we to up with the substance to It's detect IND can been been the we able think presence by of But

Jonathan Aschoff

Thank you Peter. very much,

Peter Nielsen

You're welcome.

Operator

that, any remarks. Peter over with of end gentlemen, session. question-and-answer like for back and the to turn floor ladies today's reached I'd the closing to And we've

Peter Nielsen

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

Operator

call. ladies We that And for gentlemen, with conference and joining. today's you conclude we'll thank do

You may now disconnect your lines.

Bio-Path (BPTH) 31 Mar 232022 Q4 Earnings call transcript