PBLA - Earnings call transcript Q2 2022 | Panbela Therapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the Panbela Therapeutics Second Quarter 2022 Earnings Call. At this time, all participants are in a listen-only mode. After management’s prepared remarks, there will be a question-and-answer session. call Chief Simpson, Financial the and Executive on Horvath, Sue Officer. me are Chief Jennifer Officer; With

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

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

Jennifer Simpson

financial will and everyone, for follow by recent and for call will the and begin QX of on we up touching accomplishments. you, you, review the the Sue then will significant thank with open joining. then it I Thank results, Q&A. our

lower as with alone of in familial of a which one failed known was sulindac for as trials has a completed adults with CPP’s to reductions opportunity monotherapy. efficacy much have XXX either either The pipeline, combined compared a eflornithine to mission have XXXX, billion combination, needs, focus. the targets for $X for the and starting in in surgery two and combination arm short, will we’ve a advanced targeting last arms combination difference. closed the XX eflornithine and as – or statistical medical market surgery Cancer between a FAP unmet XXX% approaching CPP for sulindac also the thus endpoint, forms, assets for lower or none polyposis data study, patients is in company our or for numerous primary corresponded X% QX Pharmaceuticals additional in XX.X% are and addressing need treating and study pipeline safety XX.X% total the driven and of we to CPP-XX company. event Flynpovi gastrointestinal or So a post-hoc Phase randomization. risk CPP eflornithine or potential the eflornithine clinical and recent a approximately initial adenomatous on call, X underwent patients composite was tablet evaluated the aggregate months and of endpoint of analysis, under up being In of of sulindac our in progressed earnings since the for compared there highlights, Acquiring Prevention a through lower our acquisition larger a to a GI show combination These sachet. shared, X% the patients areas in a substantially expanding GI with a with where diversified In of a of a an or primary diseases, respectively. need combined and

lower the FDA. the Given the application with statistical or drug significance a NDA filed of was GI group, new

results results endpoint submit one the address the we this the exploratory and issued. on license Flynpovi. Under As was more an Assets with American commercialization and licensed agreement well-controlled for One-Two the Limited adequate letter demonstrate was to CPP analysis, to agreement, that endpoint. a has fails One-Two. [ph] license primary deficiency of Therapeutics intend of North clinical complete the or or NDA clinical rights study based an To concern, and response trials meet has a development on the the a One-Two effect

associated the licensed dollar As the FDA product’s net approval. receive also sales provided by necessary through net basis December for approval licensing the The on transferred development the has of to a funded royalties Flynpovi milestone amounts upfront XX, partner agreement application, agreement will milestone for the CPP upon secure by with described year and be and payment CPP XXXX. dollar calls in recognized agreement. by sales regulatory The on licensing IND Payment for company’s Flynpovi activities by direct ended royalties partner the per reduced its of CPP the payments, in territories. and FDA the the IND cost which any were payment a of

will expect We trial mid-XXXX. by initiated that be the FAP registration

collaborating will plan look to with in seek the to One-Two be development as FAP for we finalize We approval closely Europe. Therapeutics

study rectal whether also National Institute purpose adenomas also or the preventing Group have combination ongoing is title second NCI X trial sulindac colon trial high as with and The the placebos The primary placebo-controlled PACES Oncology SWOG. an funded Phase colorectal recurrence with eflornithine asked, known eflornithine double-blind have a colorectal sulindac We corresponding as cancers of of of in lesions Cancer collaboration X is a assess to cancer. patients trial. and this Southwest of is the by prepared The or risk efficacy has or the PACES also events. of trial to colorectal of and and and adenomas Stage combination through known with X total the colon the against eflornithine sulindac the prevent is in

cell the begin to sachet are is a there by COG [ph] neuroblastoma trial STKXX this scheduled or Children’s evaluating non-small NCI, Additionally, and in which trials mutation relapsed/refractory Oncology the cancer Group year. patients supported eflornithine lung the ongoing and

to in begin X X onset trial For scheduled this a eflornithine is diabetes type tablets, Phase year.

posting were for on scheduled After a to of In website. Turning had SBP-XXX. SBP-XXX. information of USAN for Council adopted ivospemin USAN the United X the USAN Names will or as States the we XXXX, May USAN notified ivospemin August XXXX, that on Adopted be

the a global as pancreatic placebo-controlled adenocarcinoma, placebo a we is the double-blind we and trial trial. the of Regarding metastatic gemcitabine, ASPIRE enrolled. to randomized referred the reminder of month, patients with trial for first versus initiation development, the gemcitabine as and This clinical with well in ductal as combination clinical nab-paclitaxel, earlier SBP-XXX announced year, patient in untreated and as announced expansion in Australia, into nab-paclitaxel ASPIRE

was to as Moving In size sample PFS based ahead, and which optimal of us required a work and we in still safety interim interim enabling smaller study to resource trial approximately primary to by additional the note, sites a of the endpoint are activated cancer for XXXX. provide design evidence. of This The the originally modify XX begin early preclinical was with an to amendment completed XXX data Phase ensure planning interim X/X as the to events early subjects neoadjuvant utilization. allows to necessary completed sample by survival analysis on trial December the enroll XXX analysis have pancreatic enrollment total XX endpoint approximately additional months to The with response a a well. in utilize have XXXX. first take assess analyzed include overall final be overall efficacy and progression-free The feedback, and anticipated Also we to the FDA and to efficacy patients analysis XXXX. survival. study support from will size pancreatic European interim patients for available of also Xa/b the regulatory amended XXX supported the primary Phase for metastatic the trial, enrollment of will to the line us complete survival analysis designed we trial. is

obtain and initiated We the are necessary to trial the approvals this key end. working opinion with protocol open to year the leaders institutional by finalize investigator

efforts adenocarcinoma with their Sciences modulator X an results SBP-XXX were completed the with through presentation late this for competent data also April year. an the SBP-XXX work SBP-XXX has significantly cancer potential were ovarian joined at a the year. The cancer later poster Day, prolong and we School expanded polyamine Research Medicine titled ovarian analogue took the SBP-XXX Sidney SBP-XXX place program cancer. out clinical by an increase resulting of cell This broad poster to cancer cancer polyamine ovarian of cancer a survival a for XX highlighted SBP-XXX Center presentation of studies Molecular in range and We University VDIDX-positive VDIDX-positive Comprehensive exceptionally the conference, during supports initiate modulator Turning have or to cellular in overall mature determined the ovarian that in ovarian that publication was model. survival cancer Johns immune Association tumor leading experts International of of reduced our we published AACR deep treatment of The on American polyamine in that dive in quarter vitro to for decrease mice Kimmel with early Journal metabolism on Cancer into metabolism burden. The next as in as points a Cancer in the the data for ovarian year the types reduction ovarian viability mouse which this pleased median cancer, Hopkins across strong at in R&D highlighting held a and of from XX% therapeutics. a injected viability

acquisition well Turning the to our on milestones, patient as we as and outside enrolled mentioned, the expansion announced the CPP as ASPIRE I closed trial, first in U.S.

pancreatic from our year, this and patients trial Phase second investigator-initiated the cancer of neoadjuvant final the untreated we of X the the half pancreatic in in metastatic trial. Additionally, cancer announcing data opening anticipate

by to We program cancer the SBP-XXX initiate early clinical ovarian for also intend XXXX.

cell diabetes, made trial Phase in XXXX combination analysis with X of PACES progress anticipate XXXX. With initiation onset that for year-to-date. trial summary, futility also the KEYTRUDA additional the X milestones In in we eflornithine we transaction, and early the non-small cancer of trial by a achievement lung have a CPP in include Type initiation of QX closing with in tremendous the and of

and financials. stockholder move enhance Sue as of we to in against milestones. turn value excited executing our are will I XXXX here the half over to We second to by the stop review it ahead

Sue Horvath

Total organization spending second or approximately and was million deposits purchase as after $X.X compared XXXX, of At $X development XXXX. that due to accounting up related second the in for and GAAP of our as primarily our clinical The acquisition $X.X in second were the quarter quarter this the million. and in is $X.XX current an efforts $X.X administrative world per IPR&D. consisting in represents of on XX, quarter The This loss $X.X requires $X.X legal quarter XXXX. of R&D a CPP. quarter of associated total Total in sites held non-cash XX, the of the of of to asset of June research Thank were share increase The current quarter compares of in to This liabilities share the expense process remaining as expense same non-current million immediately up to were XXXX, date. trial. $XX.X compared expense million. million the activate second Net of changes cash acquisition writing assets accounted $XX.X in has ASPIRE second IPR&D acquisition. of ramped the net XXXX. clinical or June million inclusive XXXX expenses of XXXX, $X.X the asset company diluted XXXX. off research was million fees in contract of the Research with million or $XX the $X.X purchase. XX of million were CPP by million in and the per assets in cash expenses million was and to $X.X $X.XX diluted a as write-off asset million R&D quarter loss the second studies of expense the were we you, Jennifer. clinical to around development one-time General to

payment XXXX. a we XX, CPP debt of along of accrued $X.X $X.X two million result includes interest of have sheet, at As interest. notes a our as principle now balance rate This with simple XXX,XXX on million January $X.X million totaling the Both notes and of acquisition, through on June accrued accrued plus plus before at of XX, due annum. the the but per note following Annually, interest interest. The XXXX end XX, on or unpaid accrued terms. year. XXXX, remaining note The the has smaller January totaling $X X% million is

the the the Second, to portion first first plus interest will the payment due eligible warrants. if royalty principle CPP interest to stockholders a retained Flynpovi commercialization to the be payments for exceed this add that the subject approval The of It Panbela the common on of totaling plus operations million with for merger consideration prepaid post a potential led in balance of consisting maximum to cash remaining in holding is registration acquired also raises from stock assumed capital million used only January acquisition merger million new company via XXXX, future acquisition significantly for date. came before CPP upfront milestones stockholders is clinical accrued X.X asset. the requiring our other only of are strong. the rationale in contingent X.X options rights final majority expanded CPP a lead combined CPP due the consisting not holdback, we for of company. FAP of of addressable will trial that shares XX, $X payment of non-cash or and and payment of expected but acquire is it our million market, not shares of significantly Not funded payments, provide to the our has product. receive for the cash Panbela investigator in entity $XX to indications, plus XXXX. funded several associated shares fully trials and collaboratively a first, total with and outstanding payable prior

Looking common common outstanding stock held of all reserved million options, shares including number The the cap XX.X at warrants, equity million have outstanding primarily awards, stock. for reserved we were by shares. we shares and including options in shares purchase all insiders were which XX.X includes warrants to to now table, and

operations in $X.X million. ended six used totals cash the Our approximately just months for

be research pay outlay cash deposits During clinical drove held for which million end of used cash the cost deposits cash at contract acquisition up and for expenses the operations. Ramped This global not half, to the to repeat. the CRO $X.X in our will company the trial. in randomized ASPIRE the organization, with is first expected trial activity our remaining paid in to associated

we into that discussed As of cash QX earning call, early us last in project take our will XXXX.

our focus the proceeds will early drive as which to $X.X enabling potential continue million. value to offering, on stockholders, items those gross will We an In launched ASPIRE trial. company cash up the for our plan, our in such August, ATM of

appropriate intend While operating for for supported phone our Q&A daily availability our yet has you under not and my ATM, assist the concludes under conditions take of needs. its cash remarks. sales to advantage volume trading poll questions? lines to please Operator, we can That the with open

Operator

pose coming Your open from Instructions] floor The ROTH with Certainly. question. now [Operator is your for questions. Tony Butler first question Please Capital. is

line Your live. is

Tony Butler

patients futility, you months, the Thanks per or the XX very some it. Jennifer, the the sites much. question the is et And if thanks I’m much. of a the provide cetera. of the how enrollment matter documents, for all site. they is importantly, that Jennifer, to events? number I of question really signed fully arrived appropriate very could curious XX this and you – I you on the becomes, anticipation color is around ASPIRE of just getting at months question understand guess, on that of is in board if XXX enroll. And pace it patients pace having have XXX the

Jennifer Simpson

Sure. you, Thank Tony.

certainly kind you average when the an cancer is assume month. that per see per look roughly – of So point at in one to trials we site clinical patients to average and pancreatic

of So why sites. that many the gives an reasons one we so have idea of you

very primary patients to we interim number pretty alive unfortunately, the And events, – valuation, that because that our endpoint, being need in will have survival, be far analysis past that’ll for either go finite or when overall be so and – for of the dead. we with So a that hit factored our we with won’t right? conclusion the it’s

we’re interim important, with as it’s as now primary because the endpoint, think evaluation, right. saying consistent I of – there’s the both efficacy one that’s well So

really the We’re also ability And don’t using the overall the over gives that because the immediately. we’re survival enroll, that for survival necessarily for interim both, analysis. have that almost we importantly, you’ll continue. of because patients we overall resource more ensure are data us the appropriate extra using one And that have available we for and to That’s to reasons positive able evaluate, if utilization. the course, – can that that safety both a DSMB benefit are efficacy we look, see a ensure the of to the so take have

Tony Butler

Thanks, Jennifer. that. Appreciate Thanks.

Jennifer Simpson

Certainly.

Operator

be to at you, no queue in This time. further conclude gentlemen. ladies questions does appear today’s Thank conference There this and call.

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

Panbela Therapeutics (PBLA) 15 Aug 222022 Q2 Earnings call transcript