Earnings call transcript Q2 2023

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Operator

Greetings and welcome to the Panbela Therapeutics Second Quarter 2023 Earnings Call. [Operator Instructions] Please note this conference is being recorded. I will now turn the conference over to your host, James Carbonara, Investor Relations at Panbela. James, you may begin.

James Carbonara

Thank you, operator. call Chief Simpson, Financial the and Executive on Horvath, Sue Officer. me are Chief Jennifer Officer; With

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

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

Jennifer Simpson

with financial James, you, we for upcoming call clinical review open everyone, the I begin of will review then a Q&A. the then it with program, thank you, will follow Sue recent of accomplishments development and milestones, results, for and and joining. Thank up a will our

double-blind, in the adenocarcinoma. pancreatic randomized, Phase gemcitabine and treatment global of with I’d with untreated our cancer. patients or clinical like in is SBP-XXX, program, with metastatic clinical evaluate X ivospemin, a trial first-line combination Starting ASPIRE metastatic our to trial nab-paclitaxel begin ductal global in with ASPIRE to pancreatic placebo-controlled

expected trial in enrolling. ASPIRE have its UK Monitoring pre-specified of July, the Independent Also data trial or Data the all in safety review opened enrollment planned Germany. and opened ASPIRE actively for we We DSMB, proceed month, Board, the The modification. and completed is Having and Safety DSMB recommended study all in and now DSMB the countries to Last in XXXX. for that the approval enrolling early we to trial. soon as trial. has continue the opened data as countries treated advance patients as is highly the encouraging continue without Interim

and Federal to FAP. combination patients. Turning now Agency, regained for and Flynpovi, Panbela provide the our eflornithine on Prevention surfaced American the In the patients sulindac April, to opportunity licensing commercialize rights polyposis, global with of FAP. protocol or a option a CPP treatment Administration, One-Two and designing to which FDA, European Assets advance in the adenomatous between has develop a to and North a Cancer collaboratively program of agreement is FAP Drug to and as Limited. this FAP termination the taken This Community familial the the or Panbela the subsidiary, Pharmaceuticals, or or trial result Medicines of working committed to the Therapeutics and we new registration lead presenting for EMA EMA, is ultimately pathway. and it FDA, on agreement with

and Once plan while registration we’ll our current of this FDA evaluate advance a asset. to agreement achieved program burn the is to this program value from we cash and on the maintaining maximize opportunities global EMA,

Stage Moving Phase cancers to to Flynpovi X X and adenomas second trial in our the recurrence of cancer. prevent primary PACES X colorectal double-blind, patients trial, placebo-controlled high-risk of colorectal with to

X and treated event will known a in colon for rectal reducing adenomas in to and cancer. single cancers June, through Stages patients analysis sulindac The of planned eflornithine with evaluate of previously and colorectal In Oncology second as designed passed rate by The combination collaboration the the continue. NCI X or X-year primary trial futility the the PACES is Southwest is also trial trial SWOG. funded a Group, and

for funding of up of FDA In US with Phase the We drug future Moving successful eflornithine to would received and in we and helping studies. forward to July, WorldMeds review new eflornithine’s receive total announced nondilutive WorldMeds. sales. completion to to upon a assets program of look pediatric WorldMeds neuroblastoma clinical divestiture US US X a $X.X within we to payments ongoing regulatory $XXX,XXX milestones of entitled acquisition. upfront a the approval is Panbela to payment an of related initial development, commercial million

University development generate expands milestone development studies, WorldMeds we portfolio partners programs product funded X excited are to to diabetes. the or Indiana of continue our for global have in of the US Phase CPP-XX the breakthroughs further and School partner-funded JDRF, agreement has the This Diabetes Continuing had first led Medicine portfolio life-changing Type candidates. with trial Foundation, We leading who considerable Juvenile organization patient welcome our and by payments. the potential the by of for X X of our advancing Phase enrolled to Research

company’s research recent Endocrine reflects Society the were This posters highlighting a Indiana CPP-XX, Diabetes part of ongoing or JDRF. in Two trial The is this of based May Immunology University of Meeting was and by supported this funding and from presented advanced onset multi-site also year trial of clinical School and University diabetes with the the by X collaboration on DFMO in June of year. Society Type Indiana the Medicine led in results work School X Medicine. The of data. at eflornithine, preclinical Phase as known the Meeting for

with cell multi-site CPP-XX role diabetes. may treated in suggest cells the alterations on ODC, results CPP-XX reactive species. such Together these that Phase in to response CPP-XX with of examine that presentation and stress as human of Type placebo-controlled onset stress. with Type trial X show ornithine Results studies inhibition beta ODC oxygen islet from by pathways the that patients preserve several recent function decarboxylase, beta cell data randomized, had in or diabetes occurs X stressed antigen preclinical X These in treated

diabetes. presented expand mechanisms previously role Type these management potential CPP-XX onset work its for potential clinical Furthermore, in results recent identifying and on the the of X

diabetes of developing recently and initiated therapies for in onset novel needs. IU the with patients JDRF and funded to Type goal trial X excited We support unmet medical the Phase effective are X recent

survival may beta improve cell treatment from be is we X we function that CPP-XX will onset Results starting. safe that suggest X these and/or programs in studies Type Phase a that In three diabetes. have development, recent option oral

First, with for trial Moffitt a Cancer in clinical program May, entered Phase agreement cell the patients. cancer Center we non-small lung X/X a into mutant in STKXX

X The initial was this and a trial. early from year X ascertain trial anticipate goal to trial the the Phase of look the will of efficacy We while a Phase at evaluating to end the start X dose be of or moving efficacy data year end maximum Phase eflornithine into X of Phase tolerated then the by trial XXXX. the the

ovarian Our this is population. ivospemin focus on year, X the scheduled which second Phase program, of the to platinum-resistant evaluation in cancer begin will

In titled the at for the of AACR ovarian agents American or April, of meeting. Research, used care the to platinum-resistant cancer of treat Evaluating Association ivospemin, we a poster analogue in SBP-XXX poster Efficacy ovarian with efficacy in chemotherapy standard highlights combination spermine Clinical combination in the The cancer. chemotherapy presented with SBP-XXX

in platinum-resistant in that Future immune the studies well of the will exist. as effects doxorubicin other cancer, may a where of role be few modulators results designed have The with population with to evaluate with options metabolism in particular, management clinical combinations ovarian SBP-XXX suggest combination SBP-XXX modulators. the as in

with of a with of combination trial of the studies program clinical in work for effective reflects ovarian Hopkins These developing are ongoing cancer moving for Medicine. goal School medical company’s therapeutics unmet into with the care in standard collaboration with needs. novel basis Johns The the patients University

to research cancer agreement potential a end, new eflornithine, ivospemin also announced Medicine. evaluations April, models mechanism the expand of action Panbela’s School and of of care University standard with other is of in into eflornithine we further intended in ivospemin of and investigative including that collaboration with activity agents. types, and development ovarian To Hopkins Johns and combination the of agent, The

therapies in inhibitor announced will with cytotoxicity agreement Furthering sponsored metabolic ascertain Anderson the lymphoma large polyamine in into of augment models. Cancer in therapies The the and/or cell preclinical CDXX-positive CAR-T-mediated studies we for entered eflornithine to against a goal with evaluation preclinical research June these of cell ivospemin MD The that combination research, initial if Texas treatment will be University CAR-T lines. of Center we B-cell

consisting lymphoma. as response in cell of panel therapy large predictive to CAR-T poor a of identified B-cell primarily polyamines was Recently, relapsed/refractory anti-CDXX metabolite

Additionally, suggests the system this myeloma. uptake is for potential transport lymphoma and polyamine upregulated Together, in polyamine-targeted the multiple in combination therapy large therapies. a B-cell CAR-T with

is with a Polyamine an proof therapy system focus inhibitor modulation first of cell mutant immune with for of cancer. combination non-small our in with STKXX of patients Panbela concept clinical lung checkpoint important polyamine for

pancreatic neoadjuvant this to modulation opinion obtain of investigator with are year. trial to in this for excited the potential leaders open continuing hematologic polyamine are of this We the institutional work research for now approval benefit key evaluate protocol initiative the half immune second finalize in necessary malignancy. to Last, the we the to and collaboration sensor

or CAR-T in In in of preclinical QX protocol; myeloma X by To XXXX. obtain cancer milestones, submit a and data EMA year global early trial execute recap cancer to lung the our feedback on a lymphoma therapy portion early the opening we of and of finally, in non-small opened to anticipate trial FAP metabolic and neoadjuvant to and and data inhibitors the to we in Phase which receive trial lung tremendous planned in second of have year-end have our XXXX. combination non-small and half interim with summary, models; by second the cell of development cancer for our Phase the hope progress multiple programs, in will half the ovarian this FDA year, the from track the trial, this ASPIRE continue year-to-date. as X year-end; polyamine on analysis made registration inform we which harmonization we

of We stockholder for value we forward remainder the move are year. this as build excited to

now it will Sue. I to turn over

Sue Horvath

primarily XXXX the and to The the decrease million the $X.X in related IP costs. Jennifer. quarter a of is $X.X of acquisition. administrative in meeting to second R&D, to This CPP XXXX. services $XX.X is you, million second development million were million professional to of increased quarter due of in the second expenses the quarter and development, compared $X.X quarter of and million or in compared were in in-process XXXX write-off $XX XXXX. expenses primarily of research second XXXX the related Thank to Research annual increase second General quarter

$X.X write-off increase one-time of R&D R&D, the ASPIRE expected to clinical costs trial. IP in spending by increased on due this million, Excluding the

reverse the share effected been On in of share report our in reverse June retroactively to X, common diluted $XX.X per presented second and loss stock reflect share amounts XXXX, of ratio of $X.XX split. stock of here X-for-XX to or or a have All split a XX-Q shares million company’s stock. $X,XXX.XX per $X.X common per at we quarter the the in our diluted of share was Net loss net XXXX the second adjusted compared of a quarter XXXX. and million

were was On assets deposits cash of June approximately Total total of assets research current million $X.X $XX.X Total the XXXX. were by contract of million cash $XX.X liabilities was and million $X.X as consisting XX, organization quarter. of as XXXX, our million. the end primarily held XX, June non-current current

During the proceeds $X.X quarter, of for approximately we also million. a public offering gross completed

added As we and XXXX, a result of balance the sheet. our interest CPP accrued acquisition to in of QX debt

$X.X quarter XXXX, The ended or sheet. note accrued remaining of made. is principal interest and payments balance June unpaid $XXX,XXX there million, interest the on the is and on During were debt no XX, the balance

shares common cap approximately outstanding June shares. reserved number shares table, as we million X.X for X.X shares the options a million reserved we XX, and total equity at had including of of shares. held all Due to to insiders Looking options, outstanding to warrants, common The all shares exercise and XXth, XXXX, stock were total includes by and the were of primarily exchange stock. warrants to including outstanding common X alternative warrants approximately million subsequent awards, cashless pre-funded today purchase warrants the of and June which approximately

necessary used cash of ongoing quarter. chemotherapy the as Cash quarterly as deposits the that in well months for approximately care months the supply made ended will six prepayments $X.X per million. clinical in secure for by $XX.X our approximately Our to million. costs. payments operations trial be for in trial future $X.X the of included totaled six operations used XX, burn We was million held June CRO agents million used ended cash standard operations the ASPIRE in to approximately The $X.X for XXXX, increase anticipate rate approximately June QX for

care current XXXX. However, of chemotherapy required additional deposits cash the QX be of therefore, may CRO. held our standard end new And secure will to we cash projecting hand take are fund that and on through us by the

in items our cash We focus which continue on the plans, ASPIRE will trial. will such for clinical our value stockholders, to our those drive as

for please Q&A Operator, phone the for questions. now lines and poll can open you

Operator

session. And from Jonathan, be your we is a time today is first [Operator question-and-answer will this question ROTH Aschoff from conducting at line MKM. Certainly, live. Jonathan coming Instructions] your

Jonathan Aschoff

Thank single handily. maybe I it with I you curious, Sue. it Good do else and if calls with I or Did juggling not – to think covered that, Jennifer handing don’t you you will doing you. what somebody do three this, respect you internally? just covered was sure. to afternoon know Maybe am Flynpovi been you

Jennifer Simpson

certainly. Well,

First you? of all, hello And been Jonathan, juggling how are have you calls.

have Flynpovi, program For as cash without maintained, changing we we our the for advance burn. will us,

again, and been you where expertise to to So step have probably, have important EMA global with protocol. if or in-house a in a And prior – the analysis. was It we since the to actually benefit significant showed first program analysis and Flynpovi lower on the it registration GI remember, the the most agreement space. it priority had is X FDA Phase work post-hoc registration A a patients in showed analysis an post-hoc in

So, that global But a as moving to this excited And the protocol. really this burn. we excited EMA pretty point, so do of won’t is we in-house, I or very we information are terms our good expertise about. think that are be feel the program cash to And and I it in FDA we this be we to secure forward. said, are on something place have will have funding get impact agreement partner to back forward in path the a our at taking

Jonathan Aschoff

both prepared Okay. your And my about STKXX data and items, the that of remarks did the the a few question is JDRF you something timing for timing in give public is… trial? of the I next a funded guess dissemination

Jennifer Simpson

Yes, certainly.

the the this point, terms are X Phase the and will STKXX in we portion, so of early are Phase year-end with anticipating at still year-end, We Moffitt or So, trial, portion portion in we for obviously we CTA the inform which started X either occur signed, the X Phase first. which data working enrollment – by would XXXX. starting

assuming X terms be work them the will something with certainly will we data, we to a highlight Phase into that way of So, portion. move in that

that going But be Phase that the do JDRF, funded have that X think I X University Phase Indiana data time we or just some and For trial. X trial JDRF – has it’s started. trial to before Phase from

Jonathan Aschoff

Sue correctly. And Okay. I I heard believe

cash through this said through comfortably three fourth quarter? quarters quarter or You the – into

Sue Horvath

It’s through this, the end of this quarter.

Jonathan Aschoff

Okay. Thank you very much. Thank you.

Jennifer Simpson

you. thank Certainly,

Operator

question from H.C. your Next Joe Instructions] live. is is Joe, coming from line Wainwright. [Operator Pantginis

Unidentified Analyst

on patients completed is I the that that of have be expect the in sites could for of This Hi. ASPIRE the Josh Thank terms Joe. we so you terms when all are for you what expected? number may now was just wondering the and enrollment, trial, potentially of in update. opened, that

Jennifer Simpson

you? Josh, how are hi Certainly,

Unidentified Analyst

you? are How Good.

Jennifer Simpson

Thank Good. you.

in total, So, will take that of believe enrollment anticipate XX patients. we roughly we total a And approximately enrollment the XXX months.

I say, robust. has been enrollment, the – we quite So, will

on puts portion as analysis for And the the early early of So, as have this been XXXX. very track us we pleased. interim

think the first from an that really I we efficacy very obviously, pass standpoint, pleased important most so the first pre-specified to that’s and And DSMB and really analysis as well. are milestone

Unidentified Analyst

you so Thank Perfect. much.

Jennifer Simpson

Thank much. very you

Operator

thank And this Thank you the call. were gentlemen, Ladies participation. does at and in That conclude Q&A there queue no today’s time. questions you. your other for

your disconnect time. may lines You this at

Panbela Therapeutics (PBLA) 10 Aug 232023 Q2 Earnings call transcript