BPTH - Earnings call transcript Q3 2020

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Operator

Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings’ Third Quarter 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

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

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

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

Peter Nielsen

Thanks, for has joining Will. for year us thank Bio-Path. you and an exceptional This been today. morning everyone Good

AML. have we in several We notably, of in our done milestones, the have Phase achieved X most an prexigebersen of unprecedented Stage of so study initiation significant environment. X And

impact around the are challenges still their lives we I’m maneuver deftly by COVID-XX business, continually with. and we’ve While impressed managing of the to our on presented and our ability team been

in of with Phase of third leukemia AML acute quarter, continue prexigebersen decitabine I’ll are with to work, we we for combination a out position patient Stage of hard a X strong our candidate, treatment the we and X therapy we in venetoclax. XXXX in progress. product myeloid meaningful or prexigebersen our and the result begin their frontline of XXXX. dosed the As close as make very lead where In enter corporate first

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

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

approval X and different combinations changes. these to for with review the AML interim cell cancer an AML AML XX of the decitabine patients. testing care will decitabine the AML of after evaluable an relapsed with in therapy viability finalizing resistant frontline with patients. AML. the endpoint resistant patients prexigebersen, treatment increased to frontline the formal decitabine. AML for approximately venetoclax response plans with kinase assess AML to of the evaluable combination the patients number significant of prexigebersen we AML remission design cohort in adding complete meets registration cohort treatment these multicenter the with cohort of AML allowance exceeds patients AML after untreated evaluable X four patients efficacy improved Office a and patients. into the treating in prexigebersen a issued we includes relapsed/refractory prexigebersen’s frontline from improvement and preclinical two-stage two-drug of intellectual venetoclax-resistant prexigebersen on and decitabine approximately with In treating tyrosine the of cohorts to Bcr-Abl of or testing of analysis States venetoclax granted enhance trial performed combination with of XX for previously and combination of analogue, treatment higher of announced untreated treating of that to in As in The AML The were we dasatinib to in as exceed complete primary evolved, on reflect cohort number adding in with be and demonstrated cancer recovery. decitabine the that these patients previously of frontline Phase a Decrease three efficacy. to complements decitabine patients endpoint of primary cytidine treated combination decitabine. property this intolerant two-drug is are number patients with venetoclax the in studies, treating who the to due for preference interim convert trial full The amended patients The plans statistically-determined and patients. performed third In be the the cohort hematologic baseline patents. we to plans, hematologic remission remission, assess results, in An our venetoclax with efficacy AML to treatment of Trademark prexigebersen of addition standard plan treating this the United of in recent analysis treatment. efficacy. venetoclax October, our we strengthens could therapy with Phase combination approved Prior Feedback recovery prexigebersen triple frontline higher trial combination of untreated AML both open-label and venetoclax The of combination cohort Based pointed study decitabine to showed efficacy newly safety portfolio a combination Stage and a adapted design who to trial cohorts inhibitors, full for The lead to combination provided for the performed partial each two previously of and treatment preliminary physicians a notice cell patient already who patients opportunity untreated In seek patients. for venetoclax lines prexigebersen. will potential complete AML of and AML The claims are with nilotinib. believe triple and to benefit accelerated achieved the prexigebersen the with combination. X lines. trial decitabine, with the The design XX cell in measure patients have four prexigebersen Preclinical was the efficacy our lines event, is of trial treatment review study Patent design two-drug and and primary have the the trial venetoclax-resistant of related untreated venetoclax, relapsed or the thresholds, prexigebersen and further cohort decitabine, full for of performed the results includes XX evaluable decitabine prexigebersen, cell of for venetoclax such patients and the and for three A incomplete a or intolerant XX either the the and after approval. which or triple decitabine evaluable that

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

such Patients recurrent poor tumor and and prexigebersen-A cancer ovarian from planned This planned centers in turn on like to product Bio-Path tumors, by Drug with to is Phase and in often outcomes, modified I’d including is breast candidate track a refractory to at the drug trial of Application initially be to prexigebersen-A IND Investigational with clinical with is diagnosed ovarian, the New trial it and nanoparticle fourth cancer. patients may open pancreatic hope properties. provide patients. Next, X We and this year-end. Prexigebersen-A, same advanced drug to safety have an prexigebersen conducted substance benefit cancer or evaluate clinical several filed expected remain prexigebersen-A our enhanced our study leading of uterine, solid endometrial hormone that solid is for a sharing patients.

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

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

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

IND as BPXXXX BPXXXX. result, our an relapses lymphoma. include prexigebersen patients. us treat and The file including potential the believe We clinical alternative including venetoclax As could treatments. early AML in Phase anti-apoptosis X venetoclax received to IND venetoclax experience venetoclax AML for us to patients previously XXXX, who an program will AML to with who relapsed, with granted venetoclax provide combination planned treatment Bcl-X-driven treating for treatment FDA give patients to in relapses of these we clearance plan BPXXXX study In a modification have CLL, that a with

CLL begin the study coming to BPXXXX our in lymphoma weeks. expect of in first We in-human

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

in model. the recognized system tumors is penetrate The transformation Previous pancreatic aberrantly to cancer. of potential of to involved regulator immune tumor levels. pathways, number at successfully program a Transcription-X of genes organs induce has cancer capability have many frontline resist vascular is a surveillance has reasons. a immune invade the Activator emerged avoid for well as and Transduction multiple these are We are cells destruction for acceptance treatment processes. in The treatments. compelling though gained convergence the proliferate and cancer cells recently, inactive Signal tumors tumor tumor models our critical BPXXXX research standard shown the oncogenic STATX immune of the enhance studying in STATX to pancreatic active field. by to death of cancer Most patient-derived normal of apoptosis hallmarks distant mediator or which of for is invade is the cell cancer in point and a a STATX, invasion and the efficacy drug STATX, abilities of or of in typically uncontrollably of cells. for significant

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

studies our review an with very third balance to undertaking that, now the quarter sheet file Moving forward, turn for we in candidate Anthony with program over BPXXXX goal for a a brief year this highlights. Price along With IND-enabling of Anthony? financials, this IND XXXX. I’ll with product application to XXXX are promising

Anthony Price

X to $X.XX ended months September the a Thanks Phase Peter. expenses to AML, XXXX, The prexigebersen or three XX, million study or ended the of months September company million to compared reported a increased enrollment increased per primarily three expenses XXXX primarily clinical to General ended per XXXX, September the for well $X.X million million XX, months the three $X.X loss expense. three $X.X of our three $X.X to September and months for XX, for trial XX, for as preclinical increased franchise of compared September million XX, net development expenses. Research loss share XXXX, ended $X.XX due and $X.X to tax increased due $X.X ended for share the September net million, increased administrative the compared for for as in to months ended months XX, XXXX. XXXX three

agreement compared As common of in million for million of period December XXXX ended cash With to proceeds call Wainwright. for September Subsequent XX, back September company that, $XX.X the XX, XXXX. was compared in the now cash over through at XXXX, to of nine used issued million to Bio-Path of Net with gross September shares approximately activities at-the-market million, turn XX, offering our the Peter. had million, the stock months operating its $XX.X I’ll for $X.X to comparable XXXX. H.C. XXX,XXX $X.X $X.X XXXX, XX,

Peter Nielsen

enroll Moreover, or look efficacy. this forward now combination of patients Thanks, a addition challenging being have progress trial for our relapsed and to continuing considerable think to prexigebersen are will programs. with across AML Stage of X current of have to to who care venetoclax particularly safety the to Phase to clinical Despite a X recalcitrant We we those of important or our standard Anthony. treat and expect year, made prexigebersen XXXX decitabine. significant show regimen be in we

to look treat initiating In addition, to Phase malignancies, we our oncologic X BPXXXX current indication first treatments. program advanced in-human forward elude to that lymphoid continues another of

circumstances. our I’d have dedicated and unique under to opportunity the perseverance their make perform questions, to and take for will advances throughout up we have who call are made and thank have pandemic steadfast team to these months like the in the this opening a Before The to who testament coming continued remained professionalism.

thank you, programs. for open support advance call the With our your operator, questions. we’re Importantly, as we that, continued we for shareholders these loyal to ready important

Operator

or [Operator line Instructions] from question H.C. line comment Wainwright, We Chen have Yi of a your is open. from the

Boobalan Pachaiyappan

for Boobalan me Yi Hi, Chen. you okay? in dialing hear this is Can

Peter Nielsen

Yes.

Boobalan Pachaiyappan

the Okay, what than stated can your color especially enrollment thank is in Other the on of remarks, provide progress X midst cases? rise we prepared for the additional Stage you. on are in the you coronavirus trial;

Peter Nielsen

sorry, last I’m that in… Especially sentence, please?

Boobalan Pachaiyappan

rise, increasing. in of cases the In because rise are are the we middle coronavirus the these –

it just curious enrollment your whether I’m progress. So affected

Peter Nielsen

they are you in patients, a receive to they if enrollment, come patient patients Yes. the their them, institution, to lot issues this it Yes. to of COVID-XX, our very know, – Well, a susceptible COVID-XX for new problems look compromised to contact advanced and travel treatment. particular, we that as

our actually has to-date, in So been Phase enrollment X. this good very

And so, see it’s think, some people some means I typically, benefit. – that

these go not that it cases we However, But here cases – up, of be what as new can’t I environment next tell on mean, the get couple seeing and will and so into enrollment. you I risk your a risk winter. it we’re over effect the as months we like for now, – keep as creates

in that a for The person that one can second quarantined. of the whole look shift COVID, see gets you suppliers is then and kinds that our criteria and plant shift is on happen is things the

even that backlog. be weeks, the three can up two So or though cleared can it course, in affect of

and a down is So the your half batch does thing, but else the month, month a is line being manufactured three, that. everybody four weeks fact a one

So you have effect. Q

to you pick going eye something keep as been for, we’re the particularly Midwest. in probably else out now a through know, that’s to COVID have So an since, big up have cases

far so but, – So so good.

Boobalan Pachaiyappan

just That’s get when cohort? and the will Thank Have you. each cohorts do have enrolled XX you. in evaluable And clear. of been Thank patients in this. three on you timeframe estimated clarification some to you the reach patients each an

Peter Nielsen

far too that another to think our that. do have just you mean cohort we’re I it’s – cohorts, hard I of Well, half one it’s patients, of over we in that. in can the tell I not behind and

doing we’re So well.

reaching there could in and have see there don’t evaluations or we year. threshold assuming next out So, any just we our catastrophes we’ll lot some interim the variables to environment, But least at don’t control. out a we that have wait see. There’s of

Boobalan Pachaiyappan

me. Got it. final And one from

So when your I I for do have Phase might you study it plan think to in BPXXXX? start X remarks. missed the

Peter Nielsen

that again, – we say excuse please. Where me,

Boobalan Pachaiyappan

study plan X you do the When of BPXXXX? Phase to start

Peter Nielsen

want some Well, additional it’s seems IND last – been however, year, we wanted It provided, they FDA – new the always received new. testing. something

to validate new So we one had develop tests some it time. to

some shortly. think news open hear you’ll So were of that on we on that we we’re and cleared all and fairly

Boobalan Pachaiyappan

me. so much. from you it Thank That’s

Peter Nielsen

You’re very welcome.

Operator

this queue I’d the in like closing turn I’m management you. no the remarks. questions showing any time. to over at call other to back for Thank

Peter Nielsen

of thank continued for We day. you. appreciate and a very joining We again Thank your Bio-Path. you much. for us Have it great support

Operator

and Ladies thank concludes participating today's you for conference. the in gentlemen, This program.

now a have disconnect. may wonderful Everyone You day.

Bio-Path (BPTH) 13 Nov 202020 Q3 Earnings call transcript