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Panbela Therapeutics (PBLA)

Participants
James Carbonara Hayden IR
Jennifer Simpson CEO, President & Director
Susan Horvath VP, Finance, CFO, Secretary & Treasurer
Robin Garner Craig-Hallum
Charles Butler ROTH Capital Partners
Call transcript
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Operator

Greetings, and welcome to Panbela Therapeutics' Second Quarter 2021 Earnings Call. [Operator Instructions].

As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, James Carbonara with Investor Relations. Thank you.

begin. may You

James Carbonara

Officer. once Earnings And Jennifer to Second Chief Panbela's Chief Thank With again, me XXXX Financial Horvath, Sue Call. Officer; are on Quarter Executive you. and welcome the Simpson, call

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

the would over to turn proceed. CEO call Jennifer, I Now Simpson, to Dr. of Panbela. like Jennifer please

Jennifer Simpson

Thanks, been the trial in joining. the and early in disturbance applied pancreatic by XXXX. and standard pending financial for am that review Ib nab-paclitaxel adverse Starting results, visual when the patients with Enrollment had events of I'll gemcitabine metastatic I pleased temporarily on will it the everyone, further noted you, agents, The we December clinical combination first-line call Phase open Phase follow in quarter James, of SBP-XXX were FDA with Sue with of up trial hold in its Ib highlights. hold XXXX. in April, recent Q&A. partial the review begin completed second will our to lifted treatment accomplishments. on or of of had ABRAXANE for of recent adenocarcinoma. care the thank touching significant QX then and a for share with that and and then used

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ductal partial and signals as the lifted, cancer. to development clinical clinical and continue at ASCO for gemcitabine the an presented of and patients excited poster addition poster pancreatic In hold adenocarcinoma cancer of to enhance first-line advancing June, treatment support disease. conclusion metastatic with With reported as for nab-paclitaxel The patients program. SBP-XXX advanced with neoadjuvant potentially is data were we efficacy continued the with X expansion. for SBP-XXX from that resectable The treatment the first-line treatment interim the that may pancreatic of sharing Cohort pancreatic we

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advance Microcap member executive dedication. the clinic critical Dr. role Cullen as Cullen's and guidance recent around and move most XX,XXX,XXX. Cullen's announced been International role development Syngene Michael as Panbela positive and reduced efficient a as a company. for the of synthetic provides the The quicker building quarter, XX building serve and Index its in research, as and be issue supply, of Chairman. to During manufacturing to services provides rankings to process synthesis an enables Board clinical his to in its the of including presiding all Chair CEO drug market and manufacture product that an product, Limited, to SBP-XXX shorter company Monday of commercialization. Russell chairman, its style continued team appropriate developed the asset speaks continue a to programs. of innovation has reduces Dr. lead Cullen future a the Also and for with objective, Index. continue to company, his and style to the it growth the two, a collaboration on patent novel for many received for is process has the portfolio ability and facilitating determines we by role indications; expansion was as This an his SBP-XXX. the active X with member membership to and patent founder our its manufacturing and FTSE of we Board quarter, event production patent lastly, the a Dr. inclusion integrated Russell strength as Dr. for and in commitment company. Indexes claims an chair, This will time; This added notification of capitalization as is benefits, a as access coverage retaining into additional production patent covering enormous for attributes. Membership becoming company Panbela from and a the steps the the investigational scalable, We through means Directors while cost-effective second automatic from US SBP-XXX, annually as primarily as Chair. in for Microcap His expects indexes. the employee the to from advancing develops day-to-day retired his management Russell patent number company founding second Executive executive its leadership of XXXX. value lead continued landmark Russell to

to are Microcap important on our investor inclusion of quarter we offering value. year-end. a in cancer, to adjuvant this in We At to After the a broader provides by and drive milestones. will pancreatic a which communicate and point, strategy the closed index with on and accomplishments cancer our developing well July, the end, as study like be reiterating further shareholder of In by provide. to common stock, as plan in by randomized of audience SBP-XXX application finish million a that would initiate expanding resources trial we I path our pancreatic able $XX year-end new keep excited bought-deal to us

of the will data year. preclinical of We the that significant Medicine Lastly, with in and other quarter pathways anticipate to drive may work produce preclinical is tumor in in preclinical Hopkins partnership the year-to-date. University In Johns taken second we've cancer milestones. of additional types pancreatic across second create steps to ongoing development potential investigation conclusion, other this and half new School addition our tumors

metastatic progressed We our lead cancer. have in indication pancreatic

indication deliver parallel. and stop we and financials. in to increase as milestones expect developing to this of reach we we research Additionally, addressable market here our and and further announcements our are public increase the through We're pancreatic review to further revealing to eager advancing by lead over Sue updates to indications. will news shareholder cancer, distribute I developing it turn additional value and our

Susan Horvath

from higher incremental Jennifer. of which in were XX, of XX, $X.X the for second $X of underwriting of clinical General per $X.X net balance the higher loss as foreign manufacturing development of to well were expenses of no assets million Total on $X.X or as of a equivalents commissions. million was $X.X you, our investigational in $X.X closed million including were second in in and $X.X second a million, diluted associated of $X.X to share of our $X.X for of on offering, with $X.XX public as increase June July loss of currency current XXXX. share quarter to X,XXX,XXX NASDAQ sheet $X.X $X.X increased produce Total of compensation compared XXXX. research. is as shares the million compared reduced XXXX. in and at diluted Thank administrative gain to price including other the the common quarter stock liabilities XXXX. discounts was premiums. employee and our cash of XXXX and expenses of quarter the per Research million the and bought-deal is on million This there insurance XXXX $X were not loss listing, A company was primarily cash the Net D&O second proceeds net million and the million XXXX due due for compared second X, we June second to operating per The preclinical product second XXXX. increase costs in the share the quarter trial and debt $X.XX next spending quarter of quarter quarter to the million million costs or current before as XXXX,

investors. million cap shares. held options, XX.X are diluted stock XX, on awards, by outstanding Looking by includes had as table outstanding. fully and a stock including June We XX.X purchase basis, insiders which were all at shares equity to held the million diluted at number common And warrants of fully of common we XXXX. The

expiring of the the common quarter, outstanding our by million. fully to common decreased sale shares of XXXX, July XX.X X.X approximately million warrants stock, company the completed million X.X the to On XX.X shares the outstanding and warrants. During X, million increasing diluted shares

Operator, remarks. believe XXXX cancer -- open wrap preclinical dollars invest randomized for you other our XXXX. Following into up trial lines our can that taking and in the questions? available Q&A allow random in cash clinical a current That and trial, poll us concludes offering, will prepared we initiate us phone that please trial the to for later indications,

Operator

[Operator Instructions].

with Our first Robin Garner from question Craig-Hallum. comes

Robin Garner

have number that's of okay. I a questions, if

around much forward? your SBP-XXX. manufacturing COGS that for how changed The assumptions significantly yield first changes those your change and is going And our process should

Susan Horvath

Jennifer, were you going I? to shall that or take

Jennifer Simpson

into it's numbers translate thank scale sure, It about the to have we will at so still think too -- this those I forward benefit the the the as point, early finalizing you for positive be we improvement But reduction a say. operations. Sorry to or much. that. will Yes, in and I a an quantify so Robin, that look how we yield, up in -- COGS. should seen

Robin Garner

this What the certain about design? talk are year? bit little And about study you can study? Can that's you a for share ideas this starting neoadjuvant your the goals Okay. later

Jennifer Simpson

Yes.

finalizing the now. where -- at have at right moment. -- the But since with are we our essentially, what looking that's that the we experience we gem/ABRAXANE, So have we are combination

couple cycles then So patients a of will surgery. into of SBP-XXX. will move receive They gem/ABRAXANE,

things certainly would immediate We would hopefully, probably are different those be One complete survival endpoints. the what that's response. of quite as Obviously, look for looking like see be pathologic more we at of long, well. We'll and interest endpoints.

months, we the domain. setting. for trial to think we in in I public that of that that And a in look the what you will expect neoadjuvant out designed the certainly would traditional trial get it's So finalize as pretty in coming terms

Robin Garner

Phase And space thoughts now? Will too? efficacy that the Okay. given your patients study can than for the share on enrollment just be your you a history for metastatic little randomized faster I bit of

Jennifer Simpson

Yes.

have fast signal, comfortable pace. I and sites. And start enrollment now to that the going look to it's we reasonably a the going I, many to contained. you Whenever that to is a small of I So We're additional efficacy yes. components feel sometimes number think would tend say, have actually. a to in we you keep the a, Phase the But site answer

in And get sure requisite reasonable sites. I make so that so of the that becomes time can function sites what we will enrollment have done that frame. we we to a a And look consider a,

Robin Garner

if there could Okay. that response share Is still or of And that general or disease? with evidence time. you in had actually history that there's a last complete patients on information either with us question, my any more X background no patient

Jennifer Simpson

that nothing something. those Again, Yes. dealing But small Right. It's looking would looked of certainly we patients. We've disease. at had cancer moment. sure pops of patients a et pretty we're I'm is pancreatic Robin. to we're obvious they either very for metastatic, see something tumor whether that That's we sure. But total, so in of it's out not seen patients, have X -- cetera. out we patients if interesting, with of number there's less for had out are there that's is no that in burden, with at anything, excited evidence Nothing the good popping XX that

Robin Garner

a impressive finding results really Yes, and indeed. rare very

you best thank luck in QX. and So much of so

Jennifer Simpson

Thank you so much.

Operator

Our question from with Maxim Jason next Group. comes McCarthy

Unidentified Analyst

Dave for line on It's Jason. the [ph]

additional can currently color indication some perhaps into? that some further expect the other shed this on as regarding we indications you diseases kind assessed. can provide looking in in when additional clinical you're tumor of Can And to is types are studies? ahead So but currently future, you that being potential

Jennifer Simpson

Yes. Thank Sure. Dave. you,

us, polyamine Casero driven we're well that So And with oncogene. the polyamines and for with many of University those very of especially in collaboration Medicine. of School Johns are are so our one Hopkins knowing involved things field. in cancers these cancers the excited that very known Dr. is by

MIC, a K-RAS many tumor of So if of looking you -- percentage other. large these at the think about and have right, one they types you're or

activity. different we're and what sense it the question is becomes looking for tumor Then doing identifying all the actually cell most where of we're which to lines of pursue. so have And make a across we ones

a need we'll at going perspective. patient. clinical at can would of ones there crowded look in And why the also obviously, so But so a we We'll into that's the a not say, well. I where efficacy from patients provide want where perspective, a there we do options make we for we'll move the seen it nice space we company program look we other pancreatic decision benefit to on current so We'll clinical which the into have that the as cancer have And SBP-XXX, feel sense. cell a and trials. is Because indeed make a is doesn't cancers for move sorry, I tumors from had take And see obviously. the now space will at it we that the a are now space Dave, translate is why the that where and -- within signal, this what in a from to then commercial few should say, look in lines, terms what's find with. do forward on a

Unidentified Analyst

quick And ductal knowledge, question, with circle the indication given Great. issues the onset asset? was you disturbances back adenocarcinoma. retinopathy there unique pancreatic just had likelihood anything just of the the I to the another with just could wondering that of visual if that just is to then your I increases that if, to

Jennifer Simpson

cancer. pancreatic Right. to Nothing specific

on the more it's think I patient side.

many people there I there And being than oncology the out prescribed events more oncology are that actually out think, outside adverse so -- visual will in so within drugs of realize. both have most and -- plentiful,

that screening controlled Many programs. this inclusion/exclusion things will be comfortable drugs just very and we vision the by mitigated. incorporating the of have criteria, One that of some feel

very more cancer, that be to we'll regard. it's history. pancreatic nothing similar But unique patient So in

Operator

Thank are from a ROTH your you, Butler just question gentlemen. time, program time. would at for today's At Capital. ladies and and and in there queue, Tony that your further like may you in do have with we this to we no disconnect this questions you came in lines Wait, participation thank

Charles Butler

simple. up the us those considering XX in I'm you're making in questions, to and number that you with had -- one. in that I'm it just combination? trials the point then very do trial synergistic list Because to that? three something still manufactured start -- that, like from current is, what to is start to is activity going Dr. Number them. up to made that you SITIUM? at findings, Because, I'm is a development, I'm X and That's question inhibitor. a your providing the a sorry, size, forum XX, I'm -- you trials? a for is -- I And squeeze an XX, may the you'll sorry, are here, clinical are interchange things change. for there's third you going will product the But just -- doing there's respectful have mind, Is that you they a or certainly, size-wise, when do that a do with I'm the Casero's event? make have and Or important. statement currently year your checkpoint And They're certainly polyamine for thinking next And an consider I'm Is your manufactured larger? are added example, number, clear in. and this then I literature with just create data announcement? one here. need making very inhibitors conversations, the we've new it's product with When assumption your you've fourth it's to

Jennifer Simpson

you, Tony. Okay. Thank

take will order. in I them So

forum. the best standard this terms that those, of medical if publication. the it for Obviously, forums we for company be more get in timing can when Hopkins, some into Johns comes the out important at providing us be we of a to may a data first, the is a based But looking for meeting or type put So will out actually of abstract on announcement. peer-reviewed of gold

the at be that look of of information driving it when comes kind timing forward. in, development will be that going we'll So important, to based because it on is programs

to that, So that the conveyed we make sure want do information is well. to as public

stay tuned that one. for So

terms In second question, start. the to trial the of

You correct. are

to -- it make have that a than want going make and be we definitely want a sure stops, not XX. controlled to some needed what We clean, program we very the or we that finalized It's to will to we've signal going registration. sure trial. XX starts to but ultimately say have right? more of randomized fair have this the is larger continue be ultimately for proper given it, We to it's that believe seen We data did trial delivers be forward that

make a trial randomized clinical the larger trials The want we it's proper So will products we XX sure. forward. next all to that sure one, going XX moving or than to be are for use for new and

switch inhibitors. of the Johns being now So Hopkins is preclinical happen that work that Medicine. University at conducted question of going the actually on School And by is the of That the right gate. right out team last to is checkpoint part

we if So call are looking at preclinical kind X of, it, you tracks.

type at So cell the other And different move standard the the across one SBP-XXX do tumor when in activity impact where what look we of sense and to immunotherapy makes just at microenvironment have use is some combination. and to we is looking the lines, forward.

that same we it that time. would into validates will Certainly, research early to happen Hopkins, something see literature Johns a out trial. year-end, has much announce start be at that a able would will of both next year. we're the we to but Pretty with anything evaluating shown, that by be look translate the that come if So what

Operator

for you joining teleconference. thank today's We

have great lines may and a at your You time day. this disconnect