PBLA - Earnings call transcript Q4 2023 | Panbela Therapeutics, Inc.

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Operator

Greetings. Welcome to Panbela Therapeutics Fourth 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. James, you may begin.

James Carbonara

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

not this Before I note that forward-looking on please Dr. to may are statements. call turn the that call statements over historical be facts Simpson, made

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

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

Jennifer Simpson

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

Pancreatic with ASPIRE conjunction with gemcitabine III start or designed and Adenocarcinoma. study our global for So Ductal let's randomized, placebo-controlled in trial. initiatives, nab-paclitaxel global with specifically Phase ASPIRE the clinical double-blind, a ivospemin, metastatic untreated is to SBP-XXX patients assess

Then trial, trial. enrollment we for has January, second XX% than first patients, for that the QX, The review projected. During which Safety faster Data data the originally without surpassed the study Board, continue recommended patients completed the independent treated DSMB in ASPIRE modification. the XXX prespecified DSMB, moving in Monitoring of safety or its included

open we quarter enrollment expecting reached by enrolling, we seen complement be cadence steady enrollment, to full first of and have XXXX. full a of of sites completed As have the the

We survival. on in to interim originally to occur data forward overall looking analysis mid-XXXX. the are projected We based this

we been the also pancreatic not within first-line timing However, and trial, are NALIRIFOX to evaluating we working enough time. cancer on have There this in metastatic was depth interim expected at NAPOLI-X longer, February data analysis. the living Based seen the for the patients cancer. With the Onivyde in use metastatic approved regimen positive has treatment for pancreatic movement the landscape. for update

control a based XX.X approval This This and X.X-month versus months overall was abraxane. gemcitabine a to approval abraxane cancer the arm to on It for is of treatment benefit, approval the of was in Panbela gemcitabine years. arm, in survival median X.X first months pancreatic approval the gemcitabine which for the benefit XX first-line versus in survival number metastatic reasons. trial. IMPACT in similar is approximately X.X-month and The the is significant

assumed number validate helps of arm, control reasons. ASPIRE the median the for to trial, of Additionally, it the survival

It trial. Abraxane in to The XX the the in X.X-month first-line IMPACT approval and gemcitabine survival similar versus gemcitabine years. is first approximately is approval of in metastatic the pancreatic benefit cancer

not helps a trial. changed ago Additionally, the since original of arm, years has greatly to of control survival ASPIRE median survival for with months validate the the its which it XX IMPACT the X.X approval in assumed trial, median

in hope interim a faster overall forward trial patients potential the the of product moving trial ASPIRE analysis the our to be than the that in the option enrollment we of With future. for anticipated, the survival completion look and may

our obtain with among this plan registration consensus global advance or we program adenomatous community established committed forward to to a with FAP, Once polyposis the the move to bringing on FDA to FDA, Turning initiative FAP while familial this a model. novel collaborating patients. and of cost option plan goal upholding and EMA treatment the remains the for FAP Panbela we EMA,

to of ways explore this to asset. value the Concurrently, we maximize intend

Moving on Symprove colorectal in high-risk our X colorectal to and prevent double-blind, recurrence X of patients cancer. Phase to cancers second III of adenomas PACES the study to aim the primary diagnosed trial, placebo-controlled with stage

trial or by funding the the NCI, from National receives being reminder, Group, as Cancer run is Institute, the and a Southwest known also PACES As SWOG. Oncology

successfully study planned is analysis futility and This enrollment a complete. cleared

with and second We program assets an payment approval already clinical In $XXX,XXX to as eflornithine's XXXX. expect received pediatric regulatory neuroblastoma payments we stands the has data and Phase sales. advancement, by July, the to divest for Shifting payments receive half WorldMeds related $X.X up an US achieved upfront gears of announced further from to to to of of II million. commercial eflornithine milestones Panbela studies. WorldMeds agreement nondilutive initial US key

of To US marking its approval for polyamine-targeted a approval Drug WorldMeds New of eflornithine in NDA December, for in NDA, cancer or that first any FDA the an received indication. therapy FDA Application, end,

financially this Panbela benefits continued advancement from As program. mentioned, of the

to data discussing well of from are multiple cancer, we this preclinical polyamines and lung metastatic programs we ongoing cancer the as programs and the Additionally, as therapy approval non-small today myeloma. cancer advancement validates our forward prostate complain role as pancreatic colorectal look cancer, that ovarian cell cancer in cancer in

addition difficult-to-treat will prostate androgen-resistant Phase September, This regimen trials. preclinical models in treatment if a determine clinical study a cancer, demonstrate In potential efficacy or trial to further II The for will enrolling. we patients. actively the with Phase II demonstrate in eflornithine entered clinical trial Continuing castration-resistant is the in that CRPC, cancers. a prostate into agreement of role for trial metastatic leveraging polyamines these

of modulation show that X with may Indiana Staying of investigation, Foundation cell beta preserve or Medicine University Phase putrescine. by led or the and DFMO levels or JDRF. supported C-peptide II reflected in CPP-XX diabetes financially Diabetes function for with Phase the Results urinary patients II through Research the trial Juvenile eflornithine, particular, by eflornithine treatment in School is polyamines, by type

to champion need continues trial the School patients. the to this thrilled Medicine. pressing are a underlying initiative safe and of University and of cause treatment, with and is development enroll disease, JDRF effective early-stage This the we There of for Indiana addressing

reminder, trial recent II an diabetes. random interim for As ] [ enrolling double-blind, to type is study with X a anticipated study the multicenter, placebo-controlled, XX is analysis and as assigned The year. approximately next referred patients individuals a Phase TAGL the is study X:X onset

X that In we to we Phase plan development, programs have initiate. I

are pembrolizumab simultaneously our with of currently Phase determine cancer. engaged efficacy. initial evaluating program the in cell with We the I/II lung a a collaboration mutant Cancer Center maximum is its clinical for patients tolerated trial non-small trials while to conjunction with eflornithine In specifically I stages, objective in Phase for dose Moffitt designed STKXX

II effectiveness. further into assess this Following trial to is phase, advance our Phase intention to a

trial open anticipate half the in of our with screening of we and and the is first study patients, initiate year year. This the patient half Phase II this enrolling to latter the in plans first

cancer second in I on ovarian Our the focus of platinum-resistant John We'll underscores collaboration evaluating University begin This program and the scheduled in Phase Hopkins first to ivospemin company between ongoing Medicine. year. endeavor this the of population. School half the

meeting, Third, the myeloma journal along in and engaged collaborative MD or of an preclinical in Anderson with online research was in the ivospemin models. we ongoing the or therapies announced an acceptance CPP-XX meeting, evaluating and the cell at bispecific University of multiple focusing T metabolic also November we abstract initiative in SBP-XXX included of inhibitor therapies monoclonal Cancer polyamine on it CAR detailing antibodies are lines the ASH Center, Recently, of eflornithine American publication issue cell supplemental for on Hematology and or Blood. research Society Texas

system polymenes. programs the of placed focus immune new Panbela's by on the modulation

lung timing targeted involves the initial proof patients clinical cancer. for inhibitor checkpoint therapy mutant concept non-muscle of STKXX Our with a combined with

are excited this malignancies. We collaboration research expanding immune benefits to in for hematologic of explore the about potential polyamines modulation

with leaders start pancreatic Finally, investigator initiative. neoadjuvant we the are key currently collaborative engaged in to opinion efforts

the year. We the half institutional necessary are the trial advanced stages in to the initiate approvals this securing first of of in

efforts. the of a for International SBP-XXX, Turning We property with Europe. new our developed China, These process patents claims Ltd. our novel cover collaboration strengthened briefly intellectual production of by portfolio to a Syngene product and the announcing issuance of IP in Australia in patents or

to half our in enroll program trial, patient we XXXX. advance gastric Phase trial, ovarian non-small pancreatic the lung announce IIb the Phase the our final data we neoadjuvant cancer cancer the open for In pancreatic is of summarize the first Phase milestones, benefit the first middle publication the for which overall projected XXXX of the open trial, to closing, of the Phase development metastatic analysis our and expect I cell ASPIRE results, of prevention of I originally in projected worldwide. patients commitment unyielding trial, our interim To Phase cancer trial to II survival to III

of for may timing. XXXX, the II update from and deaths at non-small present, lung we And in the global II cancer not the working anticipate second FAP in and the half enough cell that EMA or obtain -- with data to to registration projected cell trial non-small FDA Phase the we feedback However, trial. events we evaluate to open Phase are

fourth the quarter Panbela. have significant strides marked and year-to-date summary, for In

shareholders the our it We progress I are for in turn enthusiastic now of Sue. over as we creation value XXXX. about ongoing will to

Susan Horvath

to to and the in the versus of quarter expenses $X.X Jennifer. you, XXXX lower A were increase XXXX. fourth quarter fees result in the were $X.X XXXX and quarter General primarily Thank the due of This administrative fourth in in XXXX the million of The to XXXX. trial. fourth is expenses decrease the ASPIRE increased professional quarter $X.X the activity of million compared compared development is in XXXX. million Research in $X.X of million fourth

of million XX, compared or per XXXX. January. retroactively the in reflect in the and of well XXXX loss amounts XXXX. in was All in that diluted of share not offering share our share here loss does which quarter the stock $X.X as per and million include cash public quarter million of from approximately to $X.X XX-K the million as diluted as split to Total been we XXXX, common in per reverse fourth adjusted occurred $X.X fourth Net in presented $XXX.XX or proceeds report net January our of closed $X stock December a have share those of XXXX completed $XX.XX was

deposits Total and million. research XX, $XX.X were current million organization of on of were contract December $X.X our XXXX. $X.X cash million the noncurrent liabilities as the by held current of quarter assets consisting assets end primarily Total were

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

accrued -- unpaid date. per as this earlier XXXX, is was The quarter of ended paid. interest The there no paid $X.X of due was remaining approximately principal or accrued month. the on note and $X interest of the the or accrued that million, payments interest terms balance debt XX, the December portion of plus were the million During and $XXX,XXX notes interest current

the cap to table. Looking

shares split First, that reverse for on have XX. reminder, the restated a all been occurred January retroactively

approximately had including shares were warrants, shares common at we XXXX, we XXX,XXX shares. approximately As outstanding. total XX, options of and December a reserved of for And XXX,XXX

which purchase shares includes and equity insiders by primarily reserved warrants all stock. number The common stock outstanding were including options, all held to awards,

cash approximately XX, standard XXXX, well of trial as operations supply made approximately totaled deposits in Our the used in ended $X for ended million our operations in secure year care by to for December as payments ASPIRE million of a chemotherapy for trial year payments costs. December held million. the necessary used agents future Cash the XX, clinical to increase total for CRO those the XXXX, $XX.X included in $X.X

totaled of offering and a lieu XXXX to the $X exercise warrants public of common warrants $X up approximately common $X.XX for In shares of of certain and stock price from January company stock closed X,XXX,XXX this X a its to purchase or we million warrant On the Gross and thereof warrants respectively. in consisting share purchase plus proceeds classes received X,XXX,XXX XXXX, shares year, aggregate exercise holders of of their of million, associated December per million warrants. $X.X an at X, prefunded cash. to this induced December XX,

NASDAQ was Those poll warrants net expire national of on and this symbol price questions? is common pursuing for Operator, an the but securities phone open share, of under OTCPink million. issuance Market under The sheets now will and exchange. Stock new exercisable lines a proceeds $X.XX currently are offering please stock $X.X ticker. approximately PBLA, of is X the trading date company the Q&A have will the on Exchange a of is issuance. exercise its you listing same The on can common it listed Panbela's years upon per the currently for that stock following

Operator

Instructions] from first MKM. question Aschoff the today Jonathan [Operator from ROTH And is coming

Jonathan Aschoff

I questions. going have a the think? trial few you to What's FAP cost

Jennifer Simpson

that I'm trial, sorry, I apologize, don't which I hear one.

Jonathan Aschoff

on... clearance that you III FAP. guidance regulatory The get FAP need trial Phase to The and

Jennifer Simpson

you. you. Got Got

So most agreements a global we'll have be for program program. that partner for trial, the FAP that likely is path, the that seeking once a we registration on

remain us, that on are trying moving we to asset for one So the neutral cost forward. while

Jonathan Aschoff

you could that? Okay. to financial so That's eflornithine the ask direct approved, actual on if definitely Can the clear. I you Panbela financial, benefit elaborate for

Jennifer Simpson

Yes.

the So US with was the obviously, in to that WorldMeds. neuroblastoma approval to the program first approval we -- divested the

so $X.X U.S. Children's to program, there million setting $XXX,XXX mostly first then And as another the the there's of commercial and line Europe payment was of with sales, milestones, upfront in as an there's total tied a that trial in a both neuroblastoma. in non-dilutive well the ongoing Oncology Group and

setting. in So approval first as a just the was maintenance quick reminder, the

trial that WorldMeds well. so part trial And regulatory as current to of US that as agreement, forward, are there around which our milestones as went moves

half of those start see second next and of some $X up come start in, this payments first milestone sales are continue. So and tune end half of the $X.X probably we year, anticipating million the will year then of as probably to to we million ramp of they between that to to

Jonathan Aschoff

Okay. very helpful. That's

level help over looks R&D Given the with how XXXX? fluctuations, the can us R&D out you

Jennifer Simpson

terms to X a was I be of say will In questions. that of financials, going program

Jonathan Aschoff

Yes.

So in going are Xs higher? to we stay go and

Susan Horvath

X% between quarter that projecting company. the for we're total now, for the X.X% Right and per burn

G&A that that is would really R&D, the modest do all the trial. the balance ASPIRE we and and spending So is on include almost of then

That chemotherapy will standard year for that thing need trial expected. last other the of continue. that The wasn't care to us also affected the was secure agents

to have what numbers. level at that impact will the determine We

Jennifer Simpson

Yes.

one I just think, thing, too. more Jonathan, I might add if

I XXX trial. patient really primary ASPIRE trial, placebo-controlled. Sue cash the trial, approximately ASPIRE our randomized, is It think -- as The it's important. of mentioned, double-blind, it's the XXX-patient driver is needs

we that through, an programs went pipeline. quite it's other The extensive

have funding from fortunate almost We are those to all other programs very for sources.

are when have an all conjunction programs, other A funding that's really those cash have lot programs, important we driver and So of are distinction. split have many to think and the company I with needs other so times a sources. fortunate you in these with main from programs a across

Jonathan Aschoff

to have Okay. And more go us the that you lastly, the might That can given tell exchange Isn't doesn't a delisting? be far favorable about helpful. Pink was to the perhaps? there you sheets. It option

Jennifer Simpson

to take take to Or do you do Sue, that? you me want want it?

Susan Horvath

for are be I need will take a to OTCQB sheets Yes. not likely can even mean, We it. on Pink I Yes, national Certainly. necessarily be the the long-term a place either. a temporary us solution to be exchange.

of able we're are So American the CBOE, we're there's others that at a might couple include the options might all to of with at. we the -- uplift looking to that that looking the be NYSE --

Jonathan Aschoff

between liquidity to the the provide you for think -- maybe of What the seems You potential think? most the CBOE most the is -- and best AMEX? that

Susan Horvath

that is what on CBOE to NASDAQ. our close the the very found seen volume be what's we to tends research, In on

for driver place primary decision to go. the the right our be that's if So that might

Operator

Wainwright. from Joe next the is Pantginis from question H.C. coming And

Joshua Korsen

on X questions. I This had quick Joe. is for just Josh

believe think I the ovarian pushed just if platinum-resistant that? wondering expect was was be for the maybe So we for is to that some first I it would data still study wondering with the was in quickly, trial. one, in I that you And first I set I when XXXX, then last back? we in of being I said STKXX Phase could about I it would just potentially that potentially the just Phase quarter, now do begin. reiterate Or half missed first XXXX the patients enrolled see cancer.

Jennifer Simpson

so thanks Yes, much, absolutely. And Josh.

screening would this mutant data end now, most feed Phase for would the of patients the for start the trial is the that STKXX towards since and portion. the open have of we year, likely Phase and I, So into II then

now, right We're projection. goes. the of have see our As current how to going is enrollment that to

you on XX% say, look As cancer, I screening. mutant lung been which But a depending will actively between and stores XX% cancers. market's population STKXX reminder, of non-small lung cell of at ranges the

is hope starts, right But the from on enrollment the we everyone end of progress. that the now updated as so our data And year. keep will by

working finalize John by and program looking cancer, year. of half I have very ovarian with first that opened Medicine, University been that the Phase For School Hopkins to and protocol closely the this we have of

we're team. And number depending But end looking path a a Phase because a at II engaged we it's we interesting take. It trial of very have instead could being which a of I, on designs. up Phase

So finalizing we to updating forward that everyone and look accordingly.

Operator

you. Q&A today's session concludes does and Thank This also conclude conference. the

your at your lines time, for and participation. thank this You may disconnect you

Panbela Therapeutics (PBLA) 26 Mar 242023 Q4 Earnings call transcript