PBLA - Earnings call transcript Q1 2022 | Panbela Therapeutics, Inc.

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Operator

Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the Panbela Therapeutics First 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. to Investor call Relations like host, to now Carbonara, James of would turn over the the I Hayden. Please go ahead.

James Carbonara

Thank Panbela’s first me again, Horvath, Chief welcome earnings and Executive once are With Officer. Chief call on you, call. the Sue Simpson, Officer; Financial quarter and XXXX Jennifer to

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

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

Jennifer Simpson

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

expected to or quarter Cancer occur as into Incorporated, of second CPP of definitive earnings in entered call closing recent conditions. Pharmaceuticals satisfaction So a closing short. the XXXX starting A in last with acquire to February, QX we subject customary is for highlighted our the highlights, to on and agreement we Prevention

where mission areas thus there a the CPP diseases, our have expanding targeting the substantially will shared, company. need unmet through of opportunity the advance a is pipeline, for aggregate larger a addressing will pipeline, we've potential the combined and of initial approximately targets of focus. $X diversified company billion much treating market As an combined Acquiring numerous

SBP-XXX, SBP-XXX Holbert Cancer ovarian treatment Center School polyamine for at metabolism one was a a of modulator the results and work to cancer. Correspondingly, place VDIDX-positive Breast the efforts we the decrease the by Johns for results help collaborators mice management Oncology; landscape, cancer have on presentation and suggest our role of an the Cancer survival SBP-XXX We that of our our of of University Armstrong, Oncology; tumor with Johns dive Ovarian strategy School During to Dr. of Professor leading Resources Researcher. the ovarian of in in cancer took research. of of cancer which the Research On the Professor year. American of included look this were future or work medical at Dr. clinical University to Trials this may Director the The SBP-XXX to pleased The call Association Sidney a Cancer a in potential poster clinical month X in of forward at through attendees ovarian for the We gain were presentation, Hopkins and Johns to by who related Murray clinical Hopkins we Shared led and identify presentation, tumors fellow; Comprehensive reflects The announce and year. earlier, Surveillance the a overall last the which status to just included Stewart, School Service ovarian Casero, we data leading-edge Disease was Hopkins a collaboration Tracy grateful highlighting Robert development Day Johns Assistant Professor continuing doctors, Medicine ongoing greater led in Medicine ovarian April XX the topics our experts of are R&D on initiate following patients of significantly and program our with Gaillard. treatment which with observed covered Biologist Stéphanie Medicine Presenters Oncology; Director the was and burden. of and target Medicine. cancer that remain from of, Postdoctoral competent for injected additional Kimmel a poster University The This cancer. School programs joined held preclinical as supports Holbert, presentation structured cancer. in Gaillard, Hopkins needs. Cancer the with Director an out note, for call of The ovarian unmet Cassandra SBP-XXX a and clinical ovarian for points Rare deep with immune and to SBP-XXX was prolong by Gynecologic Associate Deborah week, AACR, understanding

additional the pancreatic we work in metastatic a clinical ductal activated for with placebo Dr. in the XX approximately Investigator, with patients initiation serving our Centers year, and our This gemcitabine first to Chaudhry in is sites placebo-controlled as to trial. clinical trial Spokane, Cancer SBP-XXX pancreatic with as untreated announced combination nab-paclitaxel in randomized the X Principal and cancer, in be nab-paclitaxel are earlier and trial. Washington double-blind adenocarcinoma gemcitabine, ASPIRE to Arvind Phase site in the Turning referred is global trial randomized of expected to XXXX. Summit XX versus its was activated

also and have been four months is with patients XX.XX we nab-paclitaxel. rate had the two X, response announced has the at long-term patients commenced rates achieved of Since the XX%, typically And enrolled, final. the gemcitabine months, time the All final advancement was disease Cohort XX exceeded presentation objective an from not XX%, is survival at demonstrated have control at to poster for still alive. of Cohort a are seen median patients, data. and after historical January the and included enrollment rate This overall of was final. gemcitabine in which longer presentation, ASCO year from the of months in now of is survival patients who immediate and an for into overall patient Cohort that We have X the with months data two is what reported which still other now There the and is screening is of which poster than yet nab-paclitaxel. Last, one survival the with approximately and first XX from trial XX which seven XX.X one GI are meeting, months is this expected eligible six X expansion ASPIRE alive. months, complete supporting the reached

year excited metastatic continue completed necessary global pancreatic We to which randomized about Also a in of I are our begin to SBP-XXX note, new work development trial. last study earlier. cancer, adjuvant preclinical we in spoke

protocol necessary We second finalize in institutional this open approvals obtain of are working half the the leaders opinion to investigator-initiated this with the and to the key trial year.

presentation Regarding milestones, we research cancer the the review and ASCO and to in poster ovarian data ovarian January announced treatment GI cancer call the standards.

data outside initiation cancer expansion the our of be we our the The of of and the trial, expect pancreatic cancer midyear. of Additionally, as States. in half In anticipate cancer the well metastatic in this closing as year, announce second first that ASPIRE first-line sites conditions satisfaction final acquisition, the from United neoadjuvant ovarian the year, of the for patient investigator-initiated enrolled the for enrollment. around study CPP and the to clinical X first trial to half this open Phase pancreatic of SBP-XXX program we will

development transaction, activity we summary, the increase of CPP the tremendous for in anticipate closing have QX data. With and and year-to-date. expected In will XXXX additional of milestones flow we plan made that progress the

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

Sue Horvath

trial organization million expenses in financial $X.X Jennifer. compared fees first the quarter of XXXX. cash to you, to or total of quarter was of to million of $X.X XXXX. loss of first around first the first XXXX Total as assets compared deposits diluted change with diluted XX, consisting in and world. The debt March with to $X.X sites in the as of that million same held legal due $X.X to XXXX, XX, CPP. development General on quarter expand were XXXX, million Net of of liabilities million $X.XX expenses, associated our a also. quarter million. contract XXXX, XXXX. by and the first balance XX the share, compared or XXXX. to to research clinical randomized $X.X $X.X of XX due as prepare were the total and sheet is million million increased the a was million including costs expenses loss assets current Thank in XX, current in of share study XXXX There were per advisory as $X.X in with At quarter March $X.XX acquisition The to cash administrative quarter the of $X.X non-current Research approximately the per no and primarily $X.X $X.X changes first March of net were date million you

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

shareholders to additional capital other will eligible future the and quarter the subject totaling of payments, CPP. retain approval company. stock receive the securities CPP approval Panbela of stockholders of plan payments Turning merger, to potential a and now million the prior agreement in and acquire will be holding conditions. upon of the to of the shares of of of details of close from regarding royalty the milestones CPP’s of closing in issuance common maximum outstanding asset. Under We holders the contingent of expected transactions stock immediately the shares stockholders to of agreement a $XX XXXX, associated are to post-merger intend the the merger payable CPP to definitive and mergers. the with to majority commercialization lead terms our outstanding closing satisfaction of by the the receive cash customary second the

for million. $X.X totaled approximately operations the in ended used just cash quarter Our

to the contract will This trial. During expected cash pay held the paid in for not the organization, to of to research for global deposits expenses million repeat. which be ASPIRE clinical end CRO the company quarter, outlay at is our cash $X.X deposits

that our to operating to our post-Closing last We project in be view in for Operator, concludes are value. ovarian cash three remarks. earnings we that expected prepare add with as Q&A trial, please development CPP. XXXX. program in costs add phone positives That all ramp expansion burn activities discussed prepared QX a randomized you will our the we questions? will As into us for incur associated into cancer poll take development can call, and and of XXXX open activity acquisition not and significantly our the operations lines to for of CPP’s

Operator

is Craig-Hallum. Please Certainly. coming open Our now first question pose floor your questions. from of The [Operator is Garner for Robin Instructions] question.

Your live. line is

Robin Garner

for would when endpoint patients take out And to question treatment? given evening after second Wanted the ask the as neoadjuvant that that Good thoughts endpoint surgery my your what primary about how see on much and timing to enroll part question. that of shorter you undergoing a study, data a program. to then and is and might thank it are study we on taking neoadjuvant long are the

Jennifer Simpson

Thank you, Robin. Yes.

question second will So shorter. The I'll the with primary start first. be endpoint

endpoints rate post-surgery things they will progression-free then before as survival pathologic of but at will well. front. course We be control things response both up complete follow And disease –standard shorter like certainly we'll be looking and

time of to now. investigators the a with enroll, are protocol terms In the we finalizing right

within institutions, little the So getting have I bit committees be I it'll I anticipation and be scientific certainly think give enrollment for open hoping think it's guidance, such. year the year. are that to starting completed any by to various think a enrollment do our but That end. it'll premature we through

sample final protocol, So But most the the can until confirm we not size would we likely and once timing. XXXX. be data have

Robin Garner

Okay. very Thank much. you

Operator

Tony is Roth pose coming of from question. Butler Please next your question Your Capital.

line Your is live.

Tony Butler

at that the Jennifer, Yes. at trial the guide on sites. question XX was just alluded Sue is trial I what will U.S., – there Thanks. what or Asian size was curious sites some in Asian the and be sort also helpful. has the trial But non-U.S. division you be an to Thanks. and clinical CRO ASPIRE least also patients, do division XXX size, would will – XX, are site think enroll of

Jennifer Simpson

Tony. you, Thank Certainly.

that clarify X. I to is a So the randomized Phase thing think is first

that patients look. of get have to We portion will a us that interim

And allow to that to two so referencing look purposes, where were serve that The interim that's right. XXX. is you roughly intent

sample activity believe patient's also that will is that make seen seeing first help be company the ensure needed cetera, that the The to to the various sake. resources the total is because something size it's that the continue et this we're sure reviews us finalize total so in we'll a And sample size to is will unnecessarily, perspective, going larger. able to using we in not that for be through also countries, to ethics committees we be are the near future. as from And

active U.S., well looking of at your as we are I will some would it. think well, European much consider majority of to division, and looking certainly, many considering. are see certainly the very do like Korea have and that certainly and at we terms is as are what Europe NPI throughput. the be we other have countries would the the U.S. you to is on other very sites we something we look pretty countries of question, centers, important I say patient So the that hospitals in at important several representation Asia and as horizon. in that it's active the of When

So be considering. Asia Europe is and course, participated to as Australia program participating predominant say, between in be as U.S. X I is they're will well. they your the something and And certainly Phase say, going should our I of would breakdown

Tony Butler

That's you Thank helpful.

Operator

call. in to no appear does gentlemen, queue further conference you, this There this at Thank time. questions be today's and Instructions] ladies [Operator conclude Certainly.

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

Panbela Therapeutics (PBLA) 14 May 222022 Q1 Earnings call transcript