LSTA - Earnings call 3 2023 | Lisata Therapeutics, Inc.

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Operator

Welcome to the Lisata Therapeutics Third Quarter 2023 Financial Results and this is a day conference call. [Operator Instructions] As a reminder, this call is being recorded today, Thursday, November 2, 2023.I will now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Lisata. Please go ahead, sir.

John Menditto

Thank you, operator, and good afternoon, everyone. Welcome to Lisata's Third Quarter 2023 Conference Call to discuss our financial results and the opportunity to provide a business update.Joining me today from our management team are Dr. Chief Dr. and President Mazzo, Executive Officer; David issued Kristen and of company call. Nisco, Chief Vice XXXX webcast President financial call, Vice third a is website, announcing and Investors Development of Research of & we this along Medical before under of results, and with Buck, press quarter the this Finance release our Executive President Treasury.Shortly a available Officer; the which and replay James section News

XXXX. the turn Mazzo. after date future now company's of news the me to obligation release by X, to added only remind time-sensitive Lisata. date this factors if that specific of we results call.With review to without forward-looking sorry, you you differ to you'd this X-K circumstances to events or I e-mail will with results filings revise over the limitation, described be received encourage If comments cause Lisata call will management have forward-looking I -- XX-Q, statements Dave? to Exchange from or to call may of those XX-K, conference conference distribution involve contain no operations this like not and made contains begin, November Therapeutics of this its and that that undertakes Dr. identify you live or I statements materially Commission, list, at the risks Securities this company's in accurate content uncertainties Thursday, the actual the events is during the which the and please e-mail regarding XX-K that as including, forms and the jmenditto@lisata.com.Before risk or of update statements.Furthermore, reflect information any call broadcast, that, David conference

David Mazzo

to many update and modalities.As of call, data care now of previously update in reported, the results Thank quarter our good progress give everyone. an various development discuss our business provide as Buck Medical Chief Officer, today we turn quarter following for and on on Dr. a our was an and John, of third to Vice added clinical Finance different over XXXX you, momentum multiple our initiation provide half programs agents Thank demonstrates product we Treasury. of this financial and will that President XXXX, productive us programs.The using James an recent James? of quarter programs of third joining part for standard of solid Nisco, the new potential with have early become targeting call overview highlights, with you we a and the will afternoon, that, humans our results.And financial in data cancers.During of with advanced I Kristen another first an of we candidate, the our of LSTAX preclinical lead of revised combination both development the difficult-to-treat have the to believe LSTAX, our we review anticancer Lisata integral for the regimen treatment variety of clinical tumors as clinical advancement

James Nisco

to summary Dave. I'm all. results. third a you of Thanks, join Good afternoon, expenses. with Starting today to pleased operating our XXXX financial quarter present

the XX, compared operating of $X million XX, expenses months $XX.X XX.X%. representing to ended XXXX, decrease September X the totaled a for September For ended million months XXXX, X

expense trial to compared expenses September study X XX, Therapeutics here months X.X%. in or $XX.X to were start-up the our $X.X months This performance annual and assumption year.Overall, BOLSTER Expenses approximately activities months this ended for to research quarter million and stock representing million months the in $X.X to for prior XXXX, LSTAX for and September nonrecurring merger XX, Research administrative expenses year, XXXX, departing ended study States, due related support XX, in merger-related primarily versus million associated stockholder million $X.X X expenses decrease Multiforme ended Australia, representing the unit development activities.General with million ended compared September increase decreased Glioblastoma an Excluding United our September $X.X following: of activities costs for equity months was X vesting all of the expenses the the ended X study a vesting, the for September Europe restricted for the enrollment year compared XXXX, to the million and $X.X due XXXX. in-process of XXXX.Operating in Cend expense XXXX, to million activities control the with net member XXXX, and approximately XX, and operating million unit and were the to the general to compared XXXX, for or meeting months losses September manufacturing merger X the XX, ended months to $XX.X development September development comprise for Board option ASCEND stock XX, expense the XX, the due prior activities of XX.X% X by timing chemistry, million September X were were prior $X.X in $X.X ended a in XX.X%. primarily for decrease

with now XXXX, of September September expense the million X or related XX, $X.X Excluding balance XX.X% and by September months to in million cash net decreased research $XX.X to to for XXXX.Turning Therapeutics our 'XX, flow. merger XX, compared the sheet ended the Cend in-process and losses X ended months development our

fund review projected proposed operations completes XXXX, data that XX, and pipeline. from turn overview ongoing marketable the capital cash, Medical XXXX, my remains will financial As over the our our I September equivalents will all of for securities cash million. Buck Dr. of now clinical early and encompassing Chief and clinical $XX.X anticipated its and into milestones company had current development approximately confident planned Kristen? trials.This call of company its the Kristen to its The Officer,

Kristen Buck

everyone. afternoon, good and James, you, Thank

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in initiate to care.We a the has Multiforme.It newly end and Latvia standard that temozolomide added proof-of-concept matching the we patients pleased Glioblastoma of study standard are care combination double-blind approved IIa and LSTAX of randomized placebo of treated placebo-controlled poised clinical also are to before application the evaluating first GBM. with conducted plus We temozolomide LSTAX in of This multiple care of in Multiforme been to or designed randomization LSTAX report Phase this diagnosed XX will study Glioblastoma be versus trial in is with and when study a with across subjects LSTAX EU temozolomide sites versus and year. Estonia expect is patient X:X, the of plus calendar standard enroll placebo targeted to as

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For those website. presentation on who of description in trials are section the of the is interested, complete of a appendix corporate more each our our available

are data there the our milestone the to trials.With body back turn now the of anticipated and that, of slides milestones in that Additionally, from call execution Dave. timing I depict key readouts presentation, X will the

David Mazzo

we assuring of results than maximally while X on capital variety last Thank have treatment available expeditiously a positioned our that also of capital-efficient on you, agents and XXXX, of to scientifically of studies maximize made to execution impact fronts, more solid we're operating are we including development notable months X the we variety well confidence anticancer with medically To combination the results, of believe achieve and LSTAX manner.Now ready in And our years of in our for balance In are a we as and with tumor operator, of the application types. take possible. we and goal getting to X and several designed growth meaningful of data on with the readouts plan in that, a focus provide Kristen. progress soon rigorous to be the as our clinical questions. to sheet, have

Operator

[Operator Brozak Instructions] of WBB the Your of Securities. line question comes Steve from

Stephen Brozak

but related. as a because have they're one, actually well I follow-up

been of I've import what got after trialing gone as trial are these meaning would follow-up descriptions. designations of a please. lot a How describe the And the that, you've that to over describing the You've system? you

David Mazzo

the question. Appreciate Thanks, Steve.

the I question in it's nomenclature talked designation have worthwhile very I So understanding, partial freely. but we pertinent industry, And most a of least explaining. designation at a drug actually, think people I fast-track might and around orphan because the pretty it's think think

let's points be more a FDA, to eligible a terms for are start the diagnosed beneficial with faster. year more the eligible that given FDA review that for fast-track than designation and accelerated the to similarly, of extremely indication. all, consideration it rapid So given that fact agency. with review a of will And rapid patients drug and product allows with market a specialized which both XXX,XXX orphan result, in also with for cycles, and have applicant be the in to desiccation.Fast-track as way. with would in of less And rapid cycle the particular getting given also indication it's a It approval consistent allows interaction designation.First interaction a more for indication for more

eligible get you're the to division as period of develop not receive also orphan they're grants you Importantly, an lucrative.And to from market. because products exclusivity the in of commercially drug finally, extended often, FDA new

some a this protection, is addition patent exclusivity. that in to -- So you market have

States. actually they're pretty a It's a out and that for something granted result, Glio LSTAX you guaranteed and LSTAX They're not for were to freely. review drug in there's we United quite and FDA an So here just critical given but GBM, also and have you're application make valuable designation EU for not designations. pleased process orphan that the very the the mPDAC

Stephen Brozak

in next the queue. pop Okay. and And I'll highlights back that follow-up, actually the

are obviously significant. You've designations, which these got

running with endpoints. programs multiple got You've quantifiable

to pretty the think price, thanks, Yet and do. your been this. hop execution? I'll the much you you've are market on do really you stock And viewing were obviously, is? your cap on What back given -- market around your everything or said your delivering understands in it queue. isn't looking specifically What and Your thoughts you

David Mazzo

low that on clinical programs, comprehensive a forthright to the appreciate Well, plan thanks, is the a address positive to execute financial clear and to rather continue plan opportunity that's is of our something There I somewhat actually everybody's data stage cap. because mind. inconsistency we've position the market with and advanced generated, that Steve. is that fact we it's the rather according the our

holders. really volatile situation. to in trade XX% between buying, have is a very anyone cash XX,XXX data" would they're just who a fact, or In roughly It's irrational.I for XX% stock do, that potential these and is waiting for value, see "pivotal somewhere the there lot that are think for a price we the they order opportunity our XX,XXX with reach any programs impeding very of the average people on not part of that fortunate small the everybody's of our that hand, beginning rough an are which a bought over is terms, but day, to it sitting merger the that. the come maximum private their we ignoring of I our back shareholders I the are market long overcome company think we're within million little or trials.And and actively explanations trading of considerably did in of reselling. are not float day in stages market fluctuations programs.And investment like a that a of when be in the shares a X/X so given much a its that fraction believe see term, of and the people was out think couple in There's to recent is particular who are stock. be advance our made those at treat stock on are the who trading in interest an And year and of our we can private the stock. to not of the treating By have The in because us the they entire outstanding. only have and there's a in These high look financing, biotech large in of They're trading but those time and into stock at on they're since long case, our short our body out But available market, is about down. of shareholders. to in very are X very company, few a few are characteristics either calculation it rates for they has so the unique suffered our with term.One shareholders of recent

can't our focus data to that who I at now unambiguous on biotech funds that which see market as ultimately then additional Difficulty] enter the that milestone do data, based of looked announce will the themselves. will because I those 'XX execution we trading it's as But able throughout business opinion change as larger allow the have going the So then is low and to we'll think people like occurring our we X stock deals as to in and to so on development change. slide And product possible will things.As generating see and world, 'XX. also do impeccable data, to [Technical they are because the to get be letting close real think volume, is the most on another all financing, which right

problem.There's believe potential our pretty thoroughly to we waiting for is issue a with execution which our company, for just sitting of lot scrutinized certainly there been show what who are has no that's by So plan, partners also data. of us the the fundamentals the

Operator

of Brookline next your comes line Capital Dolliver question Kemp the And from Markets. from

Brian Kemp Dolliver

will ahead your drug, potentially of other may trial provide great unmet But plan. ASCEND this. has And be original and consistently are admittedly, Zealand regards in which and a with on there's question less it just function to what too lay your benefit on have any this enrolled what to to seen insight treatment your need Is First and the of has very for well? Australia naive out given worked competition as early going now, being than the here? regard Or and relatively has for that to you why trials? a in the it and thoughts populations worked New trial so

David Mazzo

that. Thanks, Appreciate Kemp.

I helping trial think very, couple see that the enroll of we factors very rapidly. a are

are the it receiving First in standard who particular of all, care. trial. arm people control blinded trial, still receive randomized of and this the a But is

unethical the there's touched in presence on trial. the population a of and concentrated is large this not the growing So The But one country treatment, country. the -- the because of placebo be think interiors around you've treatment obviously edges would a if get not cancer this as is the of no to pancreatic part seems be of of joining relatively referred to you few be already It's there as oncology and an on are world. downside Australia trial.I know, there. you would area, situations enormous. the to it's as the there's any desert-like centers a put would really population.People as It's There all centers larger And go. around because and in true the which you these go they areas to are there for little regularly. them very concentrated not pretty to many, if country are many outback centers in

we are in our compellingly of at Ib, our the involved IIa, have been the generated. very Australia development in those who the beginning. from It of Phase drug that the so actively trial, people centers data early Phase And was positive

side the is the the particular seem that of another the of think standard LSTAX, doesn't And so there's that people why trial. standard on are of care forward.And very safety this of exacerbate is care an take to effects I moving eager addition enthusiasm reason fact to the

May-June So of it's there. Cohort rapidly. you since that frame way has the time A been and enrolling out, about we're pointed enrolled very as XX%

and that do the than year, can extrapolation done likely projection a anybody of be very, by I that. So very is quick much quarter recognize sooner official next but it's to think be second done we'll

Brian Kemp Dolliver

the level this course trials? trials Right. at of of And wrapping enrollment you the sensitive honestly Because have to sooner just runway up larger looking at looks than would that probably It's your be expected. your over pretty spending the guidance the of period, which and -- your flow one and how in ASCEND ebb point.

the should those between how think correlation X things here? about we from So

David Mazzo

Well, is per trials, -- steady-state patient are closed correlated. and the separate the costs. like spending beginning the at out all end, costs large The startup at

those stopped then of incur enrolling, as types you And expense. you So when enroll, you you stop expenses.

rebated all organized the co-funding hospitals year.And -- recognize of the at I might maximum are to So the of have in our we of those the the first end trials, amount of almost us hospitals. of that standard they number lower also, have in in of providing specifically generally R&D we will. spent but also than get of to at costs about by we all we the if to trial, be cash cares trials, where Australia, we're this States essentially dollars XX% done, are but United where funding, from and mean funded you but be the essence these are all, back being the

there be not still full but in a we be is reduction United trial completed, funded ASCEND completely reduction see in that. expenditure by might a the relative here same So that the sponsor for will a of being one enrollment magnitude may a States. associated cost with to in once expect it But

Brian Kemp Dolliver

And coming top assuming as expense to -- is in opposed rebates those the it. I'm line the on up Got right? would and the show that to line, a contra top

David Mazzo

James, what's the I'll the on rebate? ask our Head accounting of Finance.

James Nisco

up to incentive activities qualifying Yes, to a receive and are that's in XX.X%. tax refundable research between correct. We do development Australia, eligible XX.X% have for we

say, half of largely for let's So that expenses ASCEND the Australia. the study in offset, does

David Mazzo

for as accounted expense And that is in or revenue? reduction a as

James Nisco

as accounted is for That in expense. a reduction

a So be expense. reduction to that R&D the would

So it's incorporated therein.

Operator

line MAZ of comes question the Enderlin Pete of And your from next Partners.

Peter Enderlin

and about to that well, pharmas of enhance valuation interested and a follow-up bigger any are increase a is experienced the of stock wide you earlier in in modalities as since a inbound is have of efficacy from variety different of question with the question of oncology drugs the variety you? seems that LSTAX inquiries first collaborating one guys is, My

David Mazzo

deals, there's but chance about do the the that's clearly do actually of bit so answer that And the for the potential data thanks will talk could an the do delivery a generated that implication think I of R&D for those the have to-date much ability either should to and a that these more to commercial generated. that development players of different that me or a lead to nonexclusive number The all the data in I world companies so and gives allow mentioned or to in definitions, oncology a simple better. these expectation simply had can exclusive of of But on LSTAX continue interest lot products both by the And question. comes. broadly just question data a of to more on to market as possibilities the when and time based side all It with the and that it lot of of quite utilized well far list yes, been deals confirmation very your business think with variety a be increase the over out very, market come course better the yes. that of years.I a the them us going shown interest is to to is activities. will have one lot we've broadly is, earlier, And

Peter Enderlin

treatments, drilling levels of terms of little it type or varying that it much depending qualify the a across of in by interest are or since chemo, somewhat these on whatever? immunotherapy if board? And a there of side bit lot vary you RNA, different does the types pretty of modality can see is Or effects down. also cancer the Do in I like

David Mazzo

broad are it's there's that cellular marketing cytotoxics and with mechanism The immunotherapeutics. even LSTAX people should or new therapies in say either antisense the would infiltrate developing nanoparticles.So of radiopharmaceutical those solid have because better target of who think tumors. those interest discussions tumors already all products, theory level a distributed. is of and I companies with reasonably help of action chemotherapeutics I had even interest among We or companies, reasonably companies distributed

that... think I So

Peter Enderlin

because an side I part And is guess, also important of well as it effects, they're... reduce

David Mazzo

I don't That the would of know say be that we if evidence effects. effects is will to reduce it increase be will side But want will those we what say. very to-date wonderful. side what agents. not LSTAX the shows that careful I

side with level efficacy of efficacy, that effects. to better So increase concentration the you side leads get we effects. better get Normally same should greater to and

So say I that far along to but that. not effects, going able, I be think we we're side we're so wouldn't eliminate

Peter Enderlin

if number in of did. enrollment one the it you the just you the or Kristen. then get I so Did And quick for didn't percentage trial, No. mention Okay. far BOLSTER one

Kristen Buck

did trial early I BOLSTER opened enrollment. recently No, not. in The and we're

Operator

This session. there Mazzo now for the question-and-answer concludes Dr. remarks. will And back the further questions. [Operator I are turn to Instructions] call no closing

David Mazzo

participating call. and to support. a call continued grateful continuing and We remain good updates you all conference today's interest our with you Well, again your on Stay to progress. again, provide in achievements for for thank speaking We look have and well forward and our to quarterly during evening. next

Lisata Therapeutics (LSTA) 2 Nov 232023 Q3 Earnings call transcript