BPTH - Earnings call 4 2023 | Bio-Path Holdings, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Bio-Path Holdings Full Year 2023 Earnings Conference Call. [Operator Instructions] Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Will O’Connor of Stern Investor Relations. Please proceed.

Will O'Connor

Thank you, operator. Welcome to the Bio-Path Holdings Conference Call and webcast to review the company's full year 2023 financial results and to provide an update on recent pipeline and corporate developments. a to which discuss issued that the we plan we on today, press outlines release, topics Earlier the call. available CEO, Senior is are Price. Accounting release at today Anthony me The from and President Administration, and President Peter Vice and Nielsen; of Finance, biopathholdings.com. With Bio-Path

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

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

Peter Nielsen

approaches air-time Thanks, are with I'm meaningful that. of platform Will. share significant a you Good deserve, everyone, they clinical thank and DNAbilize is morning, are to example our across Genetic the perfect getting advances to cancer updates and finally the you these pipeline, excited these us. as progress year, of technologies treatment our throughout today. making last made and joining We for

no date. Our of in to in can be with to in doses cells toxicity other the our Which saw with lipid to we is DNA made blood in lymphatic corroborates clinical XXXX, system, throughout high the toxicities. us is This trials we with through begin have and patients delivery and that. I'll candidate, dose-limiting antisense target delivered evidence technologies the product what continues data prexigebersen. progress excite with lead to contrast

the venetoclax AML. is an open-label, and multi-center Stage and and combination study clinical relapsed/resistant with AML. X year, trial, patients, untreated positive two-stage of frontline an myeloid It trial leukemia, our combination AML. of with II or of prexigebersen decitabine Phase from treatment two with therapy, II last results acute previously reported in cohorts AML Stage know, you decitabine the we of in As of is venetoclax. Recall, prexigebersen study for Phase in of amended X In our interim

not Cohort endpoint remission, complete X, and standard AML also two-drug considered will third patients, initial with X unsuitable complete remission were for with newly resistant and was AML who of treating than and current particularly demonstrated but only patients refractory/relapsed interim current patients, show refractory/relapsed in partial signals are Cohort relapsed/resistant Cohort combination options from and achieve X, challenging includes Cohort chemotherapy, or decitabine. The incomplete of as are data who hematologic primary for with administered to encouraging, the treatment that patients, X population, suboptimal. efficacy and This includes number venetoclax which the are compelling The this study recovery and in prexigebersen-based combination analysis the be therapy remission a which recovery. of prexigebersen high-risk, safely hematologic diagnosed is intolerant therapies. Efficacy complete better

chemotherapy were in patients. It AML. fact treatments on was illuminating front. In On prexigebersen the the of this clear our designation side forward dismal. to Dr. strength of or a results cannot receive website. regulatory in these space in is not prexigebersen magnitude to to speakers. this remains our to these these our months, tolerate who independent have medical was conviction programs as simply our in guest in AML outcome encouraged AML look results without data, inspiring. physician a deeply you mission We to patients. are was Administration, plan program, only unable to landscape point great The We The Drug engaging, Dr. and on hosted have Track chemotherapy unacceptable U.S. treatment underscored patients, by and encourage Having that you specialists view progress survival Ohanian, XX event and hematology, unmet archive Event, further Leader heartwarming discuss the I and October, that the supports the intensive Food currently Fast a development oncology for seen interim patients AML this median highlight evolving and of in experts need to Key Maro the to of clinical our unmet Jorge These as discussion the these meets. both Opinion listen we expedited X Cortes represent for have pursue bolstering privileged need expert serious luminaries treatment these Bio-Path's were Bio-Path keeping to all of and true apprised of which and are FDA, of intensive who Bio-Path, effects. that patients, the we available

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

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

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

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

who BPXXXX previously cohort an patients monotherapy of of completion believe cohort venetoclax result, total X+X design. treated a I/Ib with standard treat escalation relapsed, first additional the an clinical toxicity, treatments. In which our Phase of BPXXXX would to evaluable trial per venetoclax-resistant have a Unless portion we be a patients, dose-limiting there venetoclax we received could is patients. patients, BPXXXX, require tested. in announced dose the patients for refractory/relapsed dose AML, AML to A provide of dosing are scheduled X including December, of alternative including X who As

Ib XX XX-milligram is doses dose-limiting meter. The of weeks, evaluate open X dose of the BPXXXX. now for patients look the resulting cohort commence January, with Enrollment doses to and X monotherapy escalating administered BPXXXX of The treatment portion dose the refractory/relapsed treatment design, XX-milligram a X in meter. is per open cycle We patients dosing with for in of for portion approved tolerability and our our dose of of of you in AML milligrams safety of second doses of is per cohorts over over a completion of of of announced monotherapy, be of per with clinical the lymphoma dose doses now of X dose Enrollment approved BPXXXX, patients. In standard I days. lymphocytic per per Phase keeping week for CLL. meter. forward The starting study XX and refractory/relapsed were patients for X is is BPXXXX is over and square BPXXXX the the leukemia square endpoint The progress toxicities. trial consisting will second cohorts the treated over X decitabine administered here. week, expected treatment safety cohort, primary weeks, per square X and evaluable over after of there efficacy cycle BPXXXX cohort chronic in of the will XX-milligram or completion a assess first starting refractory/relapsed days. XX X of we to apprised dose evaluating cohort total The meter combination of of first escalation The Phase no for doses study X+X the dose square total to

in Now triple-negative endometrial, I/Ib and trial let's in solid BPXXXX-A pancreatic clinical tumors, Phase turn ovarian, patients cancer. breast to our of payment with -- including

patients. same treat evaluate Patients drug to cohort ovarian nanoparticle today's product outcomes, with cancers and challenging from data We we with is is in clinical often have is benefit and cancer study conducted most provide the year. solid later our This at diagnosed for hope with patients. of recurrent initially substance several look leading forward to tumor Some safety enhanced modified potentially this readout cancer a toolkit. sharing BPXXXX-A may and will the completion prexigebersen this properties. and it that endometrial poor the trial such therapeutic centers being from

the BPXXXX which and novel BPXXXX, for STATX tumors. After These metastasis the drug aberrant characterize or efficiently submission that which and strategy testing, adenocarcinoma. cells colorectal promotes cancer. a X-FU. ovarian, patients protein. promotes testing cancer and and resistance IND, Activation X-FU in a to Its plus oligo to to cells. in targets antitumor needed pathway initiation, finalize extended processes, method we potential breast, detection colon enable the of is also progress STATX reduces Finally, results line plasma STATX believe STATX that that final investigational enhanced an with with for tumor tumorgenic ovarian oligodeoxynucleotide, resistance. breast let's an STATX of and solid drug we many cancer and various will overexpression complete have displayed to combination advanced these that and enhances STATX is and BPXXXX safety work lung, identified expression role in antisense period review in pancreatic taxol made ovarian regulates of strongly previous is an us in therapy new cells in sensitivity activation application results such a cancer the for liver FDA. as are target. BPXXXX suggest tumor transcription a Its including gemcitabine made ductal a migration Together, activity cancers, breast liposome-incorporated taxol cancer STATX, and proliferation, novel therapeutic the malignancies we've factor resistance. with numerous

program particularly are overview with limited turn financials especially that, of the indication for launch excited We therapy, a this to I'll that in cutting-edge an brief challenging balance sheet treatment Anthony? validation highlights. Anthony options. With first cancer in-human of Price has now to over our our along

Anthony Price

primarily the Primarily company XX, XXXX and for of as as million, increase million reported expense of share the for to for in the in December year the due share compared XXXX product to $XX.X loss our or $XX.XX ended year $X.X per December million, ended year development $XX.X XXXX year per expense $XX.X manufacturing to ended as drug releases December expense, December franchise a XXXX, company's fair related prexigebersen ended due loss to to XXXX. Research December XX, to clinical December salaries well XX, noncash million, in not or expenses related for The Peter. XX, Thanks, XX, an net for increased well to loss ended compared $XX.XX XX, to $X.X compared net a year due in XXXX. increased decreased for the warrant the ended the million. December XXXX trial resulted $X.X and in benefits XXXX. a year and did the in administrative of XX, million, $X.X XXXX warrant liability value AML liability expenses. Change company tax to of decreased as year to The the enrollment in for have for ended patient expense million XXXX. General

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

Peter Nielsen

Anthony. Thanks,

hope pipeline XXXX our across As evidenced programs. as agree, execution I progress you'll for year by Bio-Path, a of of focused DNAbilize was the continued

medicines As that, we to life-saving the battling call bring to ahead, questions. open the cancers. With we on to ready look achieved we're operator, and months to to progress date, new clinical the year to build for expect potentially patients

Operator

first from question today Our from Jonathan ROTH comes Instructions] [Operator Aschoff MKM.

Jonathan Aschoff

you'd about prex. intensive look can't is I know first question for said Fast who tolerate Track you My chemo. patients, Peter.

So size who specifically is of to it awaiting right target development the that in market? clinical And Track AML, that the happening can't prex? of anything is Fast designation what's with tolerate chemo? intensive currently Or to -- what's now

Peter Nielsen

is think the being able pretty our I patients. drug unique treat to in fragile

Ours is, toxic to or we're a designed not cells. approach, kill genetic of a poison course,

of X have it phase months patient Stage in inherently, II to X up, patients tolerability. better of have paused And it time. can't like I shot And tolerate can't older we benefit. I so we lot months. said is a X not in noted X And as chemotherapy, which venetoclax, they Phase X. A good. has just this we if survivability is new more X the terms enrollment, XX,XXX patients, and I it of in think we've it's in patients It's a have in the first makes difficult in XX the notes, recall X treatment I the have numbers interesting, and that of their And our than the -- range very patients. Cohort -- our wrapping complete

is venetoclax messenger the there's we it's for we RNAi Bcl-X venetoclax think it good make with operate because we and to our do So all enhance that on. job a treatment. specializes. proteins because less treatment, market And Obviously, easier

that, surprised extension maturation So approach you get to venetoclax of before the addressing point has of the in the I wouldn't you treatment a some fact, different probably effectiveness Bcl-X the be protein that see be of to might in used. to

Jonathan Aschoff

start Okay. On and in for a be subsequent trial done you do with at, CLL dose in what after trial? lymphoma what monotherapy, XXXX, assume milligrams XX combo I XX you're therapy would the

Peter Nielsen

one both to And CLL That XX. AML, milligrams the started that which -- pretty the and the Yes. you're per we where course, milligrams XX square should safe you see is XX of hiding the with starting a square be meter, And -- is monotherapy. I/Ib, the point. per great dose, It'd basically of meter. be

XX. then could XX -- you and assess then use that up jump combination the once So therapy. combination when to And it actual is Ib that'd X -- therapy to jumping in safety be the happens, be

So it's confirmed. be now, to we And -- to right the have do XX, would say XX hard should have think. that to but it testing we'll to I

Jonathan Aschoff

And year for XXXX, would read that is would what And XXXX IND to prex-A the out this from prex-A still and a Okay. also filing? in you on XXXX? referring cohorts

Peter Nielsen

the My recollection toxicity, solid piece. is on on the tumor

or enrolling we it So in interest And had up, because dash had I back dose A sick. that of patients a think X we're there's and trial. that's one already And [ lot treating to X. out in ]. lined couldn't of, too And

a that one about we're in it's one, in getting. evidence is of, higher used that's the AML starts recall a trial. at And talking which because the obviously, dose, II lot so Phase safety prexigebersen, And

goes If go XXX. one up So it that now. it XX to it's started at XX, at another

dose enroll. So have that being, already able do because, be at we XX one is like that's that what another in ends -- XX, we patient second I up to and cohort said, to certainly one should cohort trying

be think That's on reported settling could that end square XX and where wrap would meter. I up So on mgs per we it.

Operator

no like ladies And showing and to to additional that, Peter and back closing any questions, for floor remarks. the gentlemen, with over I'd turn

Peter Nielsen

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

Operator

that, with you presentation. we'll conference today's thank Ladies call and gentlemen, conclude joining. for and We

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Bio-Path (BPTH) 8 Mar 242023 Q4 Earnings call transcript