Earnings call transcript Q1 2023

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Operator

Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings First Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode.

Following the formal remarks, will open the call up for your questions. Please also note today's event is being recorded.

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

Will O'Connor

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

press we available and the that release which is topics on that Earlier this release, discuss call morning, we biopathholdings.com. today's at issued a outlines plan to press

and President With President Senior me Nielsen; Bio-Path CEO, Administration, Vice are Finance, Price. and today and Accounting of Peter from Anthony

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

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

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

Peter Nielsen

everyone, Will. and thank morning, joining for you Thanks, Good us.

continue recent current advances in effective the await Throughout top-line address new DNAbilize We Despite our several cohorts. the cancer we first key and progress urgent we with safe to results overcome as in quarter platform for believe from weeks, the challenges our to programs important can treatment and continue clinical options rise. to deaths advancing the field, make need treatments.

triple-negative BPXXXX-A I'll toolkit. to begin and with some most with cancer, patients in of tumors, with X/Xb of solid ovarian, treat our trial a therapeutic challenging pancreatic breast review of clinical today's including endometrial, Phase cancers the

centers readout diagnosed benefit This endometrial at mid-year. patients. recurrent data such and same nanoparticle have cohort for this may cancer from patients. in clinical provide evaluate a substance is study our with completion modified the outcomes look and We hope from to around that trial we forward several and or with being Patients the initially poor ovarian properties. often product tumor safety is is BPXXXX-A will solid conducted drug leading cancer sharing enhanced prexigebersen

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

study advancing our amended for the with Phase trial treatment The an Stage open of and combination continue AML, decitabine combination two make previously decitabine. in Stage stage in We with of cohorts and X venetoclax progress in therapy with in untreated patients resistant and X clinical this AML multi-center trial are who with intolerant AML X AML. resistant frontline relapsed leukemia, venetoclax. of X and prexigebersen cohort prexigebersen of third combination decitabine resistant Phase significant of label acute of A treating and or drug of two venetoclax AML myeloid the relapsed patients is the to includes two prexigebersen

each assist coming for potential In we treatment. with of endpoint efficacy The mid-year, of the which and combination the cohort to number remission, will the will expedited the the to hematologic remission the status. interim this hematologic for analysis primary recovery complete incomplete partial will and complete patients complete with An who remission recovery. weeks performed be includes safety safety assess efficacy on be with of program study achieve qualify this initial therapy and around

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

by against for As for correlated you BHX neutralizing XX% to with domain. patients of expression activity Bcl-X in with responsible know, Bcl-X proteins all cancers. Venetoclax anti-apoptotic of and has Bcl-X driving the AML. cell poor is survival shown has High up been prognosis diagnosed works

CLL, chronic improved or an is patients. treatment untreated leukemia, patients lymphocytic It AML for and

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

BPXXXX also protein. the targets Bcl-X

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

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

with with of a BPXXXX six meter. four Xb doses A doses portion patients study XX of over per The week and X+X eight in approved milligrams be treated AML in two will cycle design combination starting treatment per relapsed [indiscernible]. evaluable commence in efficacy is will in dose standard and will total monotherapy square resulting the of of weeks, with BPXXXX after the BPXXXX assess decitabine safety Phase monotherapy patients. refractory a completion cohorts of

cohort data completion We expect around readout and from study this initial mid-year.

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

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

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

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

therapy treatment We this forward challenging first-in-human We validation early in options. are cutting-edge to our cancer look especially this later year or to XXXX. an promising filing indication candidate this particularly application launch that an for product of IND excited very has limited

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

Anthony Price

Peter. Thanks,

$X.XX The share per of $X.X $X.XX million company the loss $X.X XX, million the net ended XX, three to per loss compared ended net a or share for March reported of or three XXXX. March a months XXXX, for months

to to manufacturing expenses March ended $X.X Research and months for releases the during primarily million XXXX quarter. three development three the XXXX, due months for to compared XX, expense related the product to drug XX, $X.X ended March million increased

for March three expense was the ended March both and General $X.X and XXXX administrative XXXX XX, million. months XX,

XX, the XXXX. of in March comparable XXXX to ended million had compared Net XX, as the cash million period company $X.X for to three As for in was of operating million XX, XXXX. $X.X cash of the March months compared XXXX, $XX.X December million used activities $X.X

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

Peter Nielsen

Thanks, Anthony.

Throughout across nanoparticle our progress the patients. quarter, our against path mission drug fight antisense cancers. to candidates, bringing of the RNAi a we for better a are we to With multiple first ongoing to continued advance deliver solution gentler cancer DNAbilize

a our reporting data-rich progress. and year have to We forward on look ahead I

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

Operator

Ladies your and gentlemen, with at question-and-answer first the session. time, [Operator this Jonathan today Our we'll go Instructions] MKM. from Instructions] Please from [Operator comes begin ROTH ahead question Mr. question. Aschoff

question. your ask may you Aschoff,

Jonathan Aschoff

you. Thank

So, whatever was Great. happening? done is happening

Peter Nielsen

No problem.

Jonathan Aschoff

me coming from occurring? centers Can data guys. you, you lymphoma/CLL where those please at it's timing Thank various any give in XXXX trial for the

Peter Nielsen

at just that like to [indiscernible] two is which we first to we And complete a this point, more past hard up that just was [indiscernible]. one That ended predict, not third patient we've but one but screening. previously, added had patient, And sites. cohort, more

to hard we do coming predict, have on. that are So, a but of couple new sites

able this at levels. up get we be dose patient, to next go So, we'll

Jonathan Aschoff

Okay.

Given to any I'll just to better is this progress assay quick. on in connection pretty detect this get blood? making bad, through XXXX try How about

Peter Nielsen

work that tox now. then an will that has assay, remaining -- that we the the rest IND We've have and do and of that able complete the supplier, selected we'll study, been done. to so We pharmacokinetics we start can be our [indiscernible] having

we on it. can So, going get

is within can it's next selected, or answer month start the two. we the So

Jonathan Aschoff

runway Is cash Okay. first still quarter 'XX?

Peter Nielsen

cash. going Well, we're more raise to

raise the quarter. fourth have, cash. existing supply But be I to of the into start the more plan it'd we With

Jonathan Aschoff

last wrote number, in from 'XX? said will costs one less And quarter of XXXX Okay. late spend is into why true 'XX does I manufacturing than last, XXXX? a that some what that's The that, R&D look and true I over but is note did a first big the that be the such like fall if XXXX, R&D that's I total guess or that's

Peter Nielsen

is around think, that, XQ for a that's $X.X number, but There's expected interval value. I million. That midpoint small

we that ramp-up been a XQ. So Again, manufacturers in supply to delivering. drives could they has build-up, our start what that's down once drug from where number bit got the

the couple It's of done. the at because months is goes and it. a a a final least of has get and have manufacturing. for start, material long getting nine takes And [our of queue drug substance, for from a about antisense, product a into time that have And alone (ph) that as It drug let basically to then that raw of months reviewed months then that batch released. that releases you to interval] couple have input then batch the

So that then, for And in drug of product once it prepaid drops to all carried it balance is the the testing sheet. released, expense. finally on

for it's hard Again, our have accept because approved drug. not even monetary me it's value doesn't to final though product an

So to drops releases it product completely, to then once that us expense.

should $X.X from the with in speak, to estimated timing so rhythms, $X we And build-up, our able the down blurb. be normal I from just We million recovering created kind manufacturing like is of environment, R&D to manufacturers difficulties back that's So, which should be the said, quarter. to had in prior the value of like COVID the getting start the expense. million, the what

Jonathan Aschoff

I you said this R&D be quarter? million the $X.X thought then, would

Peter Nielsen

For...

Jonathan Aschoff

quarter 'XX, mean said Second million. $X.X. I of $X.X What thought is you you

Peter Nielsen

Yes.

Jonathan Aschoff

Peter. much, That clarity. good was very you Thank Okay.

Peter Nielsen

welcome. You're

Operator

Instructions] I'm any at remarks. additional [Operator And team over and showing turn I'd to like for no management time, back the gentlemen, ladies closing the this to questions. floor

Peter Nielsen

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

Operator

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

disconnect now lines. may You your

Bio-Path (BPTH) 12 May 232023 Q1 Earnings call transcript