PBLA - Earnings call transcript Q4 2021 | Panbela Therapeutics, Inc.

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Operator

0:03 Good day ladies and gentlemen, and welcome to the Panbela Fourth Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode and the floor will be opened for your questions and comments following the presentation. It is now my pleasure to turn the floor over to your host, James Carbonara. Sir, here the floor is yours.

James Carbonara

0:22 Thank you. to quarter welcome earnings again, once Panbela's XXXX fourth call. And Jennifer on Financial Executive the me Simpson, Officer. call Chief With Horvath, are Chief Sue Officer; and

the Before uncertainties not historical Simpson, may be in to Any does made obligations I any the filed Significant forward-looking as are this not implied company cause facts SEC. on made with call and this risks call the of actual statements. that and that on annual results company to reports are note statements as supplemented quarterly made could undertake statements has Dr. other that call only the statements filed date forward-looking supplement any turn call the turn company's that to please report are statements of as Form Panbela. forward-looking proceed. on well such by would subsequent differ Jennifer, Jennifer from CEO reports to the subsequently I Now developments. in Simpson, those XX-Q Form update please to or X:XX detailed like over the expressed and over Dr. today's on or to reflect XX-K in

Jennifer Simpson

then of and we begin X:XX touching with XXXX by joining. Sue it up recent open follow will the review will Thank significant I'll the a financial on results, accomplishments. then you for everyone call and Q&A. for

XXXX So, with highlights. starting recent and

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are Approximately that results Arvind trial II/III and the speed conducted the to first the Phase Washington and the assess additional leading not the III centers serving Phase as XX This have but activated is of designed Phase its with interim Asia principal does enough the analysis, its can available. an the site Phase treatment is development to trial II/III look is III trial one Chaudhry, Pacific XXXX. to whether States, seeking active are and trial protocol region. wait XX Phase activated separate II Phase II to cancer a to and Spokane, patients advantage Phase was United Cancer the Phase become clinical investigator. III in trial mitigation Phase the over II Phase size. X:XX resource Summit We and after experimental Dr. a with for sites at We II Phase a in expected believe to continue Europe in be the primary sample be Centers in III the included as trial, III

yet treatment the supports presentation final. first addition for median and poster not continued rates an ASPIRE complete gemcitabine enrolled. line gemcitabine more patients for neoadjuvant cancer from XX historical months reported of screening commenced for has was what months of with seen ASCO nab-paclitaxel the study patients have than to XX.XX objective at potentially resectable patient the metastatic overall -- four XX months, expansion reached enrollment meeting ASCO been for exceeded of survival an Phase the pancreatic for Phase the in expected Interim the approximately We the and as time of after reached cohort response our for into first with overall annual nab-paclitaxel. trial to announced the data at X:XX an is Since also the the survival Reporting advancement in eligible disease. SBP-XXX presentations, typically showed development treatment and longer median is was at from of with which recently in and XXXX rate meeting. and the IB Both have at January XXXX months. and XX% GI data This II/III poster

in demonstrated this X, and one months with and Cohort trial, X patients survival X While is from for this long-term which are one are who Cohort is still and seven median from X:XX of expansion achieved follow and two we Lastly, and XX patients overall that Cohort patients XX.X months a objective six and from still Phase rate final up. survival alive. There survival response had data have also encouraging. I increase have in

metastatic and We pancreatic are randomized our global and development continue excited study II/III SBP-XXX earlier. of spoke cancer about to which I Phase

with early preclinical SBP-XXX’s it with SBP-XXX, focus combination mild The can biomarkers University we a to inhibitors. on the cancers cell ovarian in research a checkpoint agent inform potential December, other we Johns is were supporting cell data agreement pancreatic Medicine. investigative of pancreatic In option cancer which School Panbela’s announced cancer, further including activity activity diagnostics the outside pleased [Indiscernible] we SBP-XXX line. treatment and announce X:XX believe lines XXXX, the of development positive was and could of as for cancer, evaluating to collaboration possible in X:XX Hopkins In Thus, addition well. of intended

results We X:XX a development illustrate reproductive to to this the fifth other among of American deaths cancer another need. for expect female leading the to year. more of Society, cancer accounting half SBP-XXX into the the than cancer system. expand Cancer The effort deaths cancer area women, for SBP-XXX of in unmet cause any potential According first of ovarian launch was high ovarian in preclinical

fact, gynecologic represents need ovarian In European for that Society unmet cancer stated significant and oncology the or has ESMO, cancers. medical a

company's as a programs develops. diagnosis most initial relapses the of AACR, considered press Ovarian April University cancer. With women. collaboration XXth presentation leading ovarian issued patients the We largely cancer abstract Research recurrence late for School X X:XX time year. for American in new sooner, work is Cancer The be of incurable. of Therefore, progress inconsistent a absence subsequent and therapies for the to With typically vital of had which rising Association poster this Johns symptoms, been with that release will to accepted and of the SBP-XXX recently for program SBP-XXX chemotherapy each reflects screening at held through such Hopkins XX% or resistance an within ongoing to well-defined potential three years as Medicine. it

Before to also necessary preclinical adjuvant of a the work XXXX, completed begin we the end trial. new

for lead of that additional issue and bought to a to supply, path benefits, this of potentially approval. manufacturing in resources We the to our many us XXXX, we manufacture and an into on time, intellectual we provides balance process underwritten obtain synthesis SBP-XXX That strategies. active Index. to would in and for with milestones. access half cost patient to are of finish this keep the highlight a and expanding trial that this further us benchmarks investment of the first XX:XX for and QX Russell Microcap expect point, developing to value. announce of Russell as leaders and our upon a the of received widely investors index terms first the provided used protocol drive ASPIRE commercialize by of on to joining efficient second the half quicker finalize necessary key enrolled indications investment in the our are for offering application the to has XX:XX like initiated indexes year, Another notification effective includes recall metastatic I trial. this by approvals cancer the institutional we SBP-XXX ready SBP-XXX treatment a XXXX, soon outside reiterating expansion In including to scalable its At reduced managers half shareholder we line second XXXX million year. are funds Satisfaction from the the working the pancreatic Turning ovarian expansion data facilitates and common year, deal standards. to to investigator cancer US. covering data pancreatic in with call acquisition. $XX and we well dollar study that ovarian trial The stock. of review the the the we product closed closing shorter as of CPP ovarian cancer ability first investigator important capital as announced initiated which drug and implement opinion of institutional sheet, property open Also, in this of initiation expect and I neoadjuvant our conditions in of Phase the as cancer final Research cancer program open to for

XXXX With for of planned flow We In anticipate in the to closing to in XXXX financials. are data. over stop will stated transaction. we the activity milestones. and milestones Sue tremendous it increase review value that executing to XXXX and by in against here year we will XX:XX the expected progress I summary, have to additional date, turn our CPP development the made excited of shareholder

Susan Horvath

of warrants were the be and options of fourth change XXXX, the The of million of stock fourth and common shares. you, There as per outstanding stock in million Total including to XX:XX XX% expenses of warrants. liabilities which approximately of holding equity financial are shares stock mergers. securities, CPP quarter current share, own are million Research increased fully to the company. CPP cash and quarter acquisition million We as $XX.X awards, of terms post-merger holders for of to advisory and associated $XX million associated diluted $X.X and and the quarter from million to XX:XX in the of basis, stack to as with loss contingent for options, a clinical in date. $X.X is the in and holders and of all or and million briefly Panbela shares forma for stock. on The milestones to merger $X.X include all the world. receive The XXXX. of shares $X.X of stockholders come invite commercialization in and were Total year, of million XX. regarding the of launch the million in compared of also General eligible Jennifer. a no was XX manufacturing to randomized outstanding $XX.X to compared the Thank approximately outstanding CPP. fourth reserved fourth of compared Administrative same common cap a study $X.X Panbela and loss numbers Net we upon prior the approval net of $XX.X the to fourth purchase per maximum the the converted the quarter due $X.XX was including a of expected CPPP. additional the changes XXXX of and expenses closing XX will share XX, of insiders costs table, plan of a XX% by fees end due we receive XXXX. of current CPP's primarily assets Under debt $X.X Looking agreement immediately diluted to the December had million lead merger, are reserved to prepare approximately diluted in the or total to of with royalty asset. primarily expenses, definitive common company Turning sites XXXX. will indebtedness own legal XXXX. our holding fourth development shares potential including of payments at XXXX million to pro details holders quarter $X at balance trial the XX:XX were On beneficially of the December as to capital million quarter totaling including around held the acquire payments, agreement was post-merger $X.XX in at XX:XX sheet XX:XX the expected

now trial. costs CPP. add our balance development We associated the all in Moving operations our of expect an other XX:XX of issuance ovarian and increased second into the our securities Preparation into for the and cash early sheet. Operator, by ‘XX, to satisfaction of of be us by cancer that view is XXXX. customary tremendous will program that stockholders, conditions. with this to three project quarter we expansion We CPP’s would back will Previously, into transaction in positives randomized QX to take to acquisition value. and of my concludes take subject for of post-closing not us in We to lines our expected open approval burn questions? discussed the poll XX:XX closing can difference This close to the primarily our XXXX. please available cash you XXXX. the are significantly Q&A activity related and phone activities operating development for That add prepared remarks. to

Operator

Maxim first is Your for XX:XX now gentlemen Jason the and Certainly, group. question open [Operator coming is floor ladies Instructions] McCarthy with questions. from

line Your live. is

Jason McCarthy

for thanks Sure. Hi, XX:XX taking the thanks -- for questions.

events in might survival that What It's with deaths right that first that PFS sharing but overall is with signal there on for any see line look? also briefly at the -- investors? historically include that in your be survival Just and would on study. will ASPIRE you the a nab be at interim gem you and PFS interim expectation would

Jennifer Simpson

you Hi, can PFS, that's have been thank so the variation at impact see much. you and the trials half so take XX:XX a some five or when across and give Jason, trial and roughly Abraxane pulling month, other Yes, you're obviously you PFS in that gem from the some run. look

be that We of will clearly also you looking course. will it deaths incorporate know

is larger looking at is there's believe they overall survival, parameters. will would ultimately in we've they be for that it primary probably, we DSMB point as certainly at split time. we seeing way we see have would address were survival, make a something But the that at because survival. If are to structured and all flag, to would will and the it's that they it is, trial have study, We to will entire that that an and certainly blinded and overall endpoint efficacy a into really sure a the the translate benefits be that

structured how So that's that's, it. we

Jason McCarthy

for are what to ovarian we'll at? us parameters just cancer potential XX:XX combinations be be going you with and program looking what And can the review the

Jennifer Simpson

finalize working with yet. not we're Oncology to so the Certainly, Gynecologic that of fully defined KOL. XX:XX working is now. some We're It right

gemcitabine, that it's be pegylated there doxorubicin, Paclitaxel. it's currently liposomal a unmet where that's And think because the population, in totally I if about really resistant taken high is a it'll in think likelihood you setting, extent. lesser a huge for that patients. to used platinum what's It's truly need

all my really any by really So those that we combine that shown much, that's of efficacy. been unfortunately. guess, that's with to not -- best would one -- is that's probably that given agents And look

are most sense and see upon which looking hopefully we one to So improve makes applications. the

Jason McCarthy

parts And XX:XX these exclude, resume this platinum populations, there's of it’s the out expectation? the excluding use would the in

Jennifer Simpson

have know little deeper. are also especially being PARP a You maintenance. we used, XX:XX what, to that I I think inhibitors know look at

So makes do to addition that sure signal we SBP-XXX. and the a to sense, have figure at identify look that out what that's just of truly we I think something make with can

So sure. great protocol, question. we And to it's the I for until a but finalize answer don't a have yet something consider definitive

Jason McCarthy

I expected end the you based to need back off XX:XX But how one of and for said is month? the the XXX a And is you'll this III PFS enrolled determination futility first the Phase it. make last you to of be analysis events. question, going I second by have That's ASPIRE, many that's just the briefly, think the that part part missed patient patients and of you

Jennifer Simpson

point that estimating to enrollment the events. XX:XX we're XX XXX approximately patients and enrolled, the complete roughly Yeah, reach first from PFS XXX first then to and quarter, for be the setting so to months

Jason McCarthy

XX:XX Okay.

Jennifer Simpson

based sample final we the analysis III on yes, that utility drive -- Phase you will size portion. the And are that XX:XX for the will correct,

Jason McCarthy

it? Got for Thank questions. much Okay. you XX:XX the very taking

Jennifer Simpson

so Thank much. Certainly. XX:XX you

Operator

with XX:XX question is Tony ROTH Butler Your next capital. coming from

live. line Your is

Tony Butler

very Thanks Jennifer. much, XX:XX

in the one But mutant study, is just on cancer actually that irrelevant? example. at patients? dose the not positive it be continuum? a SBP, receive actually Or trial a and hits question one, you like? recognize ovarian But doses in For complete. BRCA on then that post patients considered surgically BRCA at may might A a complete, that's if days question continue of may, this could resection? designs view would as question they -- some that of trial would and I of look least Just is patient many Thank well. is or say neoadjuvant two and I you. the not parked provide it How what part surgery, along several front be And That's well? then or as would there

Jennifer Simpson

you, Okay. Thank XX:XX Tony.

great with ovarian tell the you it's guy status. KOL, yet be we'll think I I There's the So for couple we will a again, you the need to sure too to the that a but make not for up think population -- point. is bring identify there's factors possible we that to as clean as and, account meeting a I signal. premature pick cancer, for BRCA comment on Again, sure

one both think sure So subset. mixing, with we streamlines and pick might positive stick I I'm -- about more not negative, one and

soon looking this would forward say, very much we'll I have tuned and we but certainly program. put So, to that starting out public. as We're finalized, the in stay that, as

bring do from before is For tuned Or two to typically, and before surgery, adjuvant, XX:XX healing stay take the before something on some in want is be to you I new period, running four as be because you and be discussing to you giving point, post-surgery. something trial, with and is, of we a therapy? add back just we adjuvants after from the giving end KOL new to the then cycles two possibility you you which least have two will that anywhere of will chemotherapy you we for of are the So washout them discussing, could cycles you'll the up it want sure surgery, chemotherapy see the will cycles -- therapy up good just four you at adjuvant this the given one. that that then a on know, mentioned, be adjuvant it

So question. it's great

Tony Butler

Thanks. Yes. Jennifer. Thanks, appreciated. really Both XX:XX

Jennifer Simpson

Sure. XX:XX

Operator

XX:XX coming with Your Robin next is Garner question your line live. Craig-Hallum, is from

Robin Garner

you thank my and evening, for good Hi, XX:XX taking questions.

the bit to patients III? XXX wanted Phase on to little the was ask and that Just a events. of in just how [Indiscernible] would if to XXX to assumption would What we more there required be get and that it XXX point? then the point, idea the study patients many that get the take At to carry

Jennifer Simpson

we delta translate XX:XX from the – given -- the we've that we're we're but Yeah, exact make actually, so believe sure that PFS, we that a looking for, obviously, into looking looking at, got -- we're delta survival. to we haven't a want will

a more be the is this we what in is, especially believe benefit survival, you probably meaningful. for think in the that when month at looking look I we'll three least disease, that FDA important will at because consider survival,

what in Abraxane so combination, XXX. we in which seen derived the based had the subjects, Right on guess. will with on SBP-XXX we've the the say be the study. gem the of looking at futility analysis. somewhere number really range that and activity you're If Phase And I take that's I total of now, And total that a four -- would in a in to size I based see to sample

hold, So would what to if that continues be expect. that we would

Robin Garner

XXX that. times if Okay, patients, to enrollment, would it XX:XX four number? how on to based get the you to for patients to to thank take XXX additional for were it that four long required enroll And the

Jennifer Simpson

be can would if you months, I the is no will aiming, so absolutely. collective we tell could XX that. The very we team, aggressive months? say you, longer will I XX:XX it look -- think Yeah, That have or they meet you yes, But team can tell a to than we blinded, XX gets as And and XX I goal. well, at also, and XXX the investigators -- there and our CRO. internal that if, Could are think better of roughly all team, on move potentially between doing take quickly be would in pretty we some when know. we'll probably answer so sites I upwards But excitement probably obviously, patients and -- well at won't patients patients bring as our they'll possible. seeing additional no so months, certainly will a you we be know, know, as

Robin Garner

Okay, ask numbers XX:XX plan thank what that. last would wanted question, benefit? could patients the just biopsy of I about that very my for be able do of to you for data neoadjuvant specifically, you that to who would And to then special to neoadjuvant your you total How very with study, use the the and expect you design have study? the to the

Jennifer Simpson

question, great Robin. a That's XX:XX

so a size, Phase will be see a activity. of to sample it's really the terms II, In this meant small

So more of a signal seeking if you will.

finalize I the -- a to that again, smaller KOL. with we II, I Phase realm need expect of, the So, it'll in be,

have I don't But, that's number yet. that's of question. an a biopsy? I -- So terms think the definitive in interesting

there inform at may us markers SBP-XXX We level. the be -- activity at with as targeting that that about collaboration have Johns look of may can think well some if Hopkins I the do and so see some and to be that our tissue we

haven't fully it's So something question out I and we think great just a yet. fleshed that's

Robin Garner

the thank and XX:XX Okay, quarter. congratulations you, on

Jennifer Simpson

so XX:XX Robin. Thank much, you

Operator

XX:XX coming up Tony You have a Butler. follow question from

live. line Your is

Tony Butler

XXX but happened, a hit actually time? necessarily number you the then be that and the at you've that today, to of I'm heels asking you're enrollment futility, whatever would in release press the you would continuing ASPIRE I know on wouldn't But roll state, apologies. guess events to what Jennifer, in that and you in Yes, speculate XX:XX

Jennifer Simpson

Yes. XX:XX

Tony Butler

XX:XX Or, okay.

Jennifer Simpson

obviously because the be which, XX:XX to that drive believe for The the Yes, everyone. Robin’s be it that patients very I that'll -- scientists, as would enrollment would important question. investors, well, I of planned also clinicians, was and right, number important, time think very total

Tony Butler

XX:XX Thanks a lot.

Operator

concludes We from further gentlemen. Thank the XX:XX coming event. and today's this you. This no have lines Ladies questions time. at

have time wonderful this participation. and a at you disconnect may day. Thank You your for

Panbela Therapeutics (PBLA) 24 Mar 222021 Q4 Earnings call transcript