Panbela Therapeutics (PBLA) 4 May 232023 Q1 Earnings call transcript

Good day, and welcome to the Panbela Therapeutics first-quarter 2023 earnings call. [Operator Instructions]. It is now my pleasure to turn the floor over to your host, Mr. James Carbonara. Sir, the floor is yours.

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

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

expressed on detailed XX-K and those reports in filed XX-Q annual on that Form the supplemented as reports differ uncertainties the by in quarterly in risks has that cause actual company's implied Significant to as well the forward-looking and subsequently SEC. results filed Form could from or statements are other the with report company

such made statements to developments. does forward-looking of undertake reflect today's are and on Any any made not only update as statements this call to any subsequent company the obligation date, supplement or

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

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

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

this full XXXX. we enrolled country of South it's year. encouraging focused with of the highly aim first the are enrollment Pacific, interim and initiations the by in the Europe, Asia continue We as and regions, advance and three to board patient, with early America expected all the enrolling, analysis its continue the sites trial ASPIRE complement on recent we that release for Korea site global to Having have on North middle the trial as

adoption of Orphan Committee gemcitabine combination metastatic the to with commission-implementing an the designation the and Products Agency decision as or in of with Medicinal January, in issued Medicines European product EMA's ivospemin relating adenocarcinoma. nab-paclitaxel in for Additionally, medicinal orphan ductal pancreatic patients

designation the Medicines for product of in authorization. after reduced regulatory criteria assistance approval, may that at to period incentives, EMA's product the access marketing product the marketing a during including and EU centralized exclusivity XX-year fees phase, development EMA meet financial orphan the and qualify from

Turning in FAP, a to the with patients to FAP April, combination rights learned licensing in pending Pharmaceuticals of polyposis gain One-Two and agreement sulindac familial of or Flynpovi, is Cancer Limited. we of commercialize Therapeutics result CPP the as or North and that termination we and will which the Assets American adenomatous develop Prevention eflornithine between the

on on Panbela Administration agreement and Federal is positioned FDA the global to trial a pathway. designing or to now it Drug presenting registration the the take and for EMA the protocol lead

in to By of leveraging safety trial the registration is trials, treatment demonstrate and team efficacy designing designed can agencies standards Panbela's the regulatory Flynpovi effectively high-quality of experience extensive with and a the that global meets FAP protocol efficiently potential in of the develop and and FAP.

a regulatory will approach successful approval help achieve market. Flynpovi and global global the of This in launch

XXXX. Journal will published and positive in intact and Disease al. by Burke were this New et that lower of upon Balaguer the in in gastrointestinal have FAP build by trial will who Rectum FAP-XXX al. expect on registration focus new XXXX, Medicine the Colon et the We results patients trial anatomy the from of England and result

data believe or lead trial and FAP-XXX approval the could sulindac risk Flynpovi. alone. the reduction need That registration for versus trial showed is an with patients surgery XXX% anatomy in with Flynpovi of the in intact the gastrointestinal to We compelling, study lower new eflornithine

this therapeutic with the FAP. FAP, approved no currently urgent potential global are for impact this to there Since option therapies unmet patients treatment has of drug the need for

We are registration non-surgical treatment provide will trial and that option a potential in with to the have their the FAP patients new FAP. confident both physicians

with to ultimately to provide and advance Panbela the FDA, working and the FAP treatment to community program FAP collaboratively this EMA, a for option is committed patients. new

this foundation families excited successful are registration the with the designing and in the experts for rights and relationship worldwide to believe for and prior executing impact that gives the patients combination patients We Flynpovi trial, our results with regain and trial our has solid authorities, and positive with FAP experience with their FAP globally. Europe, from to FAP FAP potential internal to FAP-XXX expertise, a a commitment to throughout patients health US the

advance We opportunities cash to program this maximize will burn while plan evaluate our of value current and to the this asset. maintaining

we move to the patients Cancer known National half XXXX. trial Oncology primary NCI in with placebo-controlled Southwest to SWOG, Phase Stage a first and recurrence double-blind high-risk Finally, X of III X the by collaboration also of Flynpovi of the as with colorectal prevent second the funded in forward known we cancers Group, look cancer. analysis trial, and is colorectal or This the trial, as in adenomas Institute to PACES futility to

funded Phase to II Group or the eflornithine through and NCI. the This utilizing ongoing Moving trial sachets. first, relapsed/refractory trial studies, in an COG Children's is there neuroblastoma is Oncology

CPP-XX-T in X patient type Phase We recent-onset to study II tablets randomized evaluate diabetes. also for eflornithine enrolled or a our double-blind first

diabetes. are by in Foundation Diabetes type or funded Juvenile We advancing the of to excited and the the trial School the first JDRF, Medicine Phase breakthroughs Indiana for organization leading University Research for by led have X CPP-XX-T enrolled global II life-changing patient

Americans living There in expenditures annually. type are and billion and lost income million US, $XX approximately with X diabetes there in the is some healthcare associated diabetes type X X.XX

to treatment II for trial population. potential excited X opportunity type the therapy Phase the in patient and We provide and for validate are test of this better options to this our diabetes

be or XXXX. presentations May recently through XX at and the at we have poster which also Immunology known for the Endocrine XX, be through about eflornithine, will will as or accepted that held June Society announced Additionally, XXXX; of XX, abstracts research, Society Meeting, which meeting, Diabetes XX held CPP-XX DFMO been IDS

that development, have will we programs three I starting. Phase In be

evaluated eflornithine will cancer. First, STKXX in population mutation lung the of combination with sachets in non-small KEYTRUDA cell be

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

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

significantly have toxicity of and topotecan, in added have cisplatin-sensitive any the vitro shown in not have as line. both vitro cancer SBP-XXX shown as to increase Treatment ovarian the Paclitaxel been benefit doxorubicin in to docetaxel been cisplatin-resistant gemcitabine, and alone. cell SBP-XXX with well to

combination or the cancer efficacy gemcitabine, of Utilizing in was SBP-XXX with murine topotecan, either the model, evaluated. doxorubicin ovarian VDIDX+

had increased and of the topotecan addition the SBP-XXX mouse SBP-XXX any effect three either Gemcitabine median alone survival -- survival or mice, current any treatment the time. the on overall alone The of little chemotherapeutics. treated significantly mice survival doxorubicin three the of with whereas of of improved

increase might have the with in combination animals. doxorubicin greatest to XXX% and untreated SBP-XXX median a time survival compared The survival

a response. and can in to vitro ivospemin more with well been eflornithine immune in anti-proliferative or DFMO influence cells microenvironment. combining cooperative a immune-friendly promote tolerated resulted has DFMO shown Additionally, tumor be to

in DFMO of ovarian treatment within evaluate containing treatment with tumor the cancer The the with Future VDIDX+ effect experiments doxorubicin that combination poster of the as will on influence prolonged ivospemin burden. and adding the decreased immune as tumor microenvironment. SBP-XXX significantly survival to well overall concludes mice cells

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

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

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

this finalize trial half Last, to in we are the open first opinion continuing institutional cancer to work obtain with the necessary neoadjuvant the the year. protocol to approvals and this of investigator-initiated key leaders pancreatic

of To agreement colon analysis anticipate a cancer neoadjuvant programs, data both cell development trial as cell the our early STKXX data pancreatic the well risk-reduction cell from half year Phase of by from opening second the Phase milestones, II to the final inform the EMA lung for protocol cancer which the which SWOG Phase and finally, the cancer of cancer this will early non-small a and we non-small ovarian trial; execute of the recap the the registration non-small on opening FAP; I trial; futility trial continue lung the FDA trial; I cancer cancer diabetes; type ASPIRE metastatic the of XXXX. onset have analysis lung as open I interim year, of the hope Phase we in end; in program portion first-line as X and to we in trial,

made have we QX and tremendous in summary, to date. year In progress

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

to in the in Jennifer. were you, expenses the General $X.X Thank and compared of million of million first $X.X first quarter quarter XXXX administrative XXXX.

of due acquisition. quarter to XXXX spend first CPP higher The the was

in of $X.X of expenses primarily of million on the to to development expected ramp the up million and in compared ASPIRE first increase clinical The trial. the quarter Research the quarter XXXX first spending due $X.X XXXX. is were

per-share report, in retroactively stock we a stock for reverse for XXXX, reverse On XX, the common amounts effected a XX-Q, of been X company's ratio All have stock. XX split. and to and adjusted X our common January of stock presented shares at our reflect XX share here of split the

in first the was share or Net diluted of of first a loss quarter or of $XX.XX per diluted million in net XXXX to $X.X $X.X share XXXX. $X.XX loss the compared per quarter million

million. approximately Total $X.X was cash

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

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

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

balance principal ended interest was note $XXX,XXX approximately original scheduled paid on of the accrued $X During quarter an million. March XX, now was of the interest a in balance debt million. and payment paid. with of accrued A million of $X.X the $X.X XXXX, The this is portion plus note

company been note principal the in $XXX,XXX a during interest of on $XX,XXX quarter, has Also, made of note. paid the full. a now payment approximately in This and second accrued

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

well totaled to in cash as operations Cash standard-of-care the secure for balances $X ended March XXXX, with chemotherapy the million agents the the approximately key to current used used quarter vendors. approximately made of for included necessary in as Our operations quarter $X.X in supply obtain million. ASPIRE for trial payments prepayments XX,

the As are into very will we projecting that early million per cash hand operations used ongoing anticipate million on that we the take QX XXXX. and $X quarter of be current in $X.X between us have therefore will discussed, and cash

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

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

Thank we this a MKM. question-and-answer session. will Roth be Jonathan time, you. At [Operator Aschoff, Instructions]. conducting

enrolling that countries new much. just to Hi, sites will Thank wondering, the trial, additional afternoon. Good you included be any are or ASPIRE, you have? for stick in you countries sites with guys. open or for very currently I was

Jonathan. good afternoon, hi, Yes,

countries trial, the been all have ASPIRE For approved.

that European full two year. the all the get have We on this that of with middle we first site of sites having board are the by countries of to complement working active, intent roughly

great progress. So we're making

can FAP, anything us about partners FAP? you great. Okay, for securing On tell

Yes.

possible both registration this, one from us we thought the that things the be FDA would EMA at global best -- as look to we and of secure of put So is protocol. the on in position a approval

partnerships, can we think us I through how sure that et that to we collaborations, see asset more footing cetera. gives best much as maximize look

So that a will be patients the as FAP deal seek in we well to have expertise with of KOLs. relationships the advice. that great my I step, is the as first comments, both as And and community, mentioned

confident be together that hopefully soon. we pretty bodies, to able So we'll very the through feel protocol get regulatory this and

That good first Thank Okay. Thank sounds a step. much. very like you. you

Absolutely.

you. Instructions]. [Operator Thank

Okay.

in questions further no have at queue time. We this

So conference. this will today's conclude

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