Earnings call transcript Q1 2023

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Operator

Welcome to the Lisata Therapeutics First Quarter 2023 Financial Results and Business Update Conference Call. Currently all participants are in listen-only mode. [Operator Instructions] As a reminder, this call is being recorded today, Tuesday, May 9, 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

good and operator, you, afternoon, everyone. Thank Lisata's our financial to business first to quarter discuss to update. call, conference results a XXXX provide Welcome and opportunity the

Chief team today President Vice and Nisco, and Medical Dr. our Vice me Chief Research Dr. management and and Joining David Buck, from of Mazzo, Treasury. Officer; Executive Development Executive President Officer; Kristen Finance are James of

Investors we first is of call, this the issued News the quarter available financial before release with our a the Shortly announcing this of which XXXX results, under along company & section press call. website, replay webcast

If to release or the you email if added distribution this e-mail jmenditto@lisata.com. be please list, to have not company's me received you'd news at like

made will uncertainties of conference by management begin, review we future operations limitation, you and Before during cause forms filings to actual Securities contain risks company's may forward-looking and materially with statements the events which comments X-K results call and that and from its XX-Q, regarding involve the I or the in encourage to results and Exchange I specific remind factors Lisata. that forward-looking statements. the described XX-K, differ including, this identify risk those Commission without you

obligation circumstances Furthermore, events call. conference revise is this reflect of no date time-sensitive the XXXX. or of live X, to conference date update the statements or broadcast, information the to content accurate of call undertakes contains Lisata of this any that only as after Tuesday, this May

call With on believe Dr. may Mazzo. that, to Dave? over mute. I the you turn now Dave, be I will

David Mazzo

first the thank us overview programs. XXXX update we once financial of and And technical on an apologies, having again for afternoon, progress our business everyone, an results various quarter We're and My are. you everyone. we our good thank provide recent discuss for development you, John, And today. give highlights, introduction. of joining as There difficulties

our of on for treatment our majority clinical of efforts the remain tumors. first advanced advancement quarter, of vast the the solid development During focused programs

clinical-stage who tumor penetration therapeutic follow of those a solid with Lisata technology company is anticancer the drugs. and development As to improve efficacy a us novel now know, targeting

Our designed paradigm. treatment to improvement in are solid the a therapeutic in of development attractive tumors programs portfolio bring pharmacoeconomically contains that significant

treatment our is multiple being with combination anticancer clinical variety conducted the LSTAX, of modalities. candidate, in product an Based and to that importantly, and, preclinical and on substantial of cancers. agents lead potential ongoing for regimen believe standard-of-care of difficult-to-treat human most has of in tumor planned subject integral clinical become we different the globally early many types trials solid part revised a multiple data, a LSTAX

specifics Our Buck, shortly our Chief provide more of Medical following results. Dr. Kristen our programs on will review Officer, clinical financial

we organizational we get to last those that to will a week. However, change on take moment subjects, before the elaborate I announced

today and business clinical-stage volatile of by the more teams sustainable vigilance programs environment constant Boards of that scrutiny capital allocation and even often for capital involves and a foreseeable of utilization management markets exist acute involving unpredictable the The Operating need of and people. become and future. in biopharmaceutical difficult has for resource may decisions Directors

recently priorities mind in an clinical and on updated we and that based reach capital-preserving milestones for capital data to measures our ensure of to operational allotment. programs, sufficient all have With that capital coupled development with important we’ve review of a business imperative our number implemented

at and enacted organization were measures of that was executive streamlining the the the level. our Among non-executive

publicly will Cend take evolution Lisata. acknowledge the Lisata. Therapeutics that departure Officer opportunity and with President contributions the this from David's many of part was we -- Chief level, As organization a personal was employment Business Slack's this and the of President transaction are company David and position to formed saddened to his eliminated, I to see And the ended. the optimization, of On

he David Qilu in comprehensive Chinese clinical the the deal of promise program identify by to LSTAX as the a Pharmaceutical. means in was development our in LSTAX exploit a partner, with efforts instrumental was leading to which licensing of

grateful well We in wish for and past future. him his the contributions are

now with the turn over commentary And our to provide of Nisco, on financial James VP and and will that, review James? our results. I call Finance Treasury, to

James Nisco

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

compared and associated million in activities for BOLSTER with LSTAX. the control prior LSTAX to Starting year the year, activities Phase with expenses approximately in March various care. XX, XOWNA to current X.X%. studying proof-of-concept solid the Phase due were and in This planned XXXX, ended the for was March of with million combination development of Research the three start-up a II partially with representing months months XX, study, for the Trial, and FREEDOM associated IIb expenses corresponding our for the chemistry or Enrollment manufacturing ended primarily $X.X offset Trial tumors study $X.X LSTAX operating expenses. activities the standards and study million ASCEND decrease $X.X three in by XXXX, Phase IIb

million administrative approximately and XXXX, XXXX, $X.X compared an ended fees through Therapeutics, primarily March for in to and for acquired to ended expenses X.X%. million an were XX, million legal and was representing $X.X one increase the fees. three or increase of addition in XX, March merger external This General months employee the the tax-related of accounting increase an Cend months three due with $X.X the

March were losses million ended March Overall, for the ended XX, months for compared million the XXXX, XXXX. three months $X.X to three $X.X net XX,

and sheet Turning now to our flow. balance cash

equivalents Technology had company an Business Tax quarter million. recently announced the New Authority, figures of in of funding XXXX. the the recorded Certificate of $XX.X include the XXXX, we not and non-dilutive $X.X marketable the Economic received million be that approved Program by in XX, March cash, do will These securities as approximately which cash Transfer sponsored of participant Development Jersey second As

Jersey-based losses research net development and companies New enables to the credits corporations. we tax to qualifying sell unrelated their Jersey of program percentage biotechnology As and have operating qualifying a previously, New reported

several and that position, will from Chief President help ongoing XXXX, quarter manage elimination all of With our first now of milestones Officer planned our should clinical current encompassing of project underway initiatives operational the capital take available as costs data anticipated and, Business Dave the and the that external into us mentioned, studies. we

completes development Dr. This clinical over Chief the now and review Kristen? Officer, call my Buck, financial of I turn will Medical for the overview, to our our pipeline. Kristen

Kristen Buck

but I on being the Lisata everyone. Thank to that and by progress during the programs made to afternoon, few our full keep call, we our James, believe it's continuous weeks date our you, good a important results team. up reviewed just I stakeholders XXXX year ago realize

body Lisata's published and a scientific preclinical data. that is early clinical patented is grounded and portfolio on pipeline built strong and of a in rationale proprietary of technology

system. designed on are increasing address care the of health impediments pharmacoeconomic context technologies Our to major successful to the pressures of in treatment tumors solid

We appreciate entire the importance goal data has do. top meaningful can of mind to this technology, we critical you everything platform clinical that in of advance our our I organization generating assure and

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dense cancer access cancer tumors as many are most such limits in and tumor. surrounded difficult solid by tissue the Cancers pharmacotherapies therapy stroma, treat fibrotic tumors to solid cancer, remain other as which to effectively. today, known advances gastric of Despite pancreatic

a to Many exhibit stroma The cytotoxic tumors impacts makes of effectiveness immunotherapies and effectively cancer. targeting and a in suppresses hostile tumor or fighting and ability tumors. This, coupled solid tissue, microenvironment, many dense safety of also most in the are immune which of combination anticancer fact it cancer the a major defines effective with hostile system efficient TME, therapies in the negatively a TME in maximizing and these patient's agents that less the cancers. treat challenge not treatment only

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amassed These emerging and our and we around and results RNA-based come Along over of significant a immunotherapies internally research been therapies, world enhanced have range and with groups publications. have therapeutics. collaborators delivery of of data the Lisata from collaborators, scientific from XXX including the anticancer non-clinical demonstrating subject

to patients standard-of-care enhance with pancreatic has demonstrated of and LSTAX Clinically, metastatic for tolerability activity cancer. favorable safety, the chemotherapy delivery

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touch on me a these individually. Let few of

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treatment Just pancreatic two standard the with Australia, first-line clinical in locally of with as LSTAX our first recently, combination nonresectable of care, is along treated and WARPNINE, partner in we chemotherapy; our nab-paclitaxel in ductal adenocarcinoma. durvalumab, evaluating that Trial advanced gemcitabine a immunotherapy iLSTA research and in patients

of impact trials This is immunotherapies. on are to the the which therapies we include planned existing several expanding of in first study LSTAX's

this XXXX. trial expect in also second completion quarter of We by enrollment the

biopsy post-treatment FOLFIRINOX-based Next fourth is cancers, well of This enrollment pancreatic, with data open-label this us combination of neoadjuvant CENDIFOX. quarter CENDIFOX, XXXX. immunoprofiling completion the we in therapies year And colon to trial trial with Phase LSTAX make long-term in outcome and provide data the expect with progress. will steady data. as continues as Ib/IIa appendiceal in by readouts

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certainly Further and LSTAXXX Lisata for that contribute only development though future studies strategic larger be a development can investment, thus, significantly of development necessary would identified. partner is if capital capital and will require the continued by

will the I call that, back turn to Dave. With now

David Mazzo

Kristen. Thanks,

the with development potential outlined, pipeline. progress team the has our continual making goal maximizing advancing programs development of Kristen is Lisata As our of the

be we expeditiously medically rigorous are assuring to capital-efficient We to provide maximally manner. in that have a our results and scientifically while operating designed studies and also

with to the and excited patients, readouts achieving of shareholders. our treat the them soon goal physicians possible the are are of who as benefiting by as platform We and our data meaningful promise committed technology

with operator, now we're to questions. And that, ready take

Operator

question [Operator comes first WBB Our Brozak Instructions] from with Steve Securities.

is Your line open.

Steve Brozak

the in indications. seeing, you're feedback I'll with what And in I'm they've that the these you of all care seeing into back hop for that. current list of adding are Thanks on kind to hi. getting trial partners is from the importance Yes, of taking works critical your everything Thank what approaches, working really to in question. how that done basically listening clinician and they're the standard the this after In What queue the past? of you.

David Mazzo

Nice to appreciate Thanks, question. to And your Steve. talk you.

feedback opinion good Kristen a deal started So throughout talking influential leaders, where on oncologists and, trials, world we their throughout before practicing time get these spent the country in key fact, of the the to to and could not ones approach needs the or the were, they we make espousing tumors felt medical them. highest were sensible solid unmet actually which were that that the where we difference to biggest whether was

these NCEs potential be that long optimized, have developing that an care further we profile think feedback any an of issues. They which the and eventually causing making efficacy brand-new faster without maximally faster then got efficacy of the that about conclusion, And is of scratch. the detrimental get start than terms we in making in led enthusiastic to taking to that that approach them will safety standards are this and prospect extremely the patients to from run the feedback initiation market to that existing faster of them clinicians continue the to trials and to work is actually

significantly our that se, a also in And sentiment the challenging see LSTAX they take be small introduce environment for make exactly mostly blinded, as where pressures Inflation into increased is but manner, something and believe drug and pharmacoeconomically drugs, specific cost-effective to seems results them. the known simple peptide a prices so there's as strong putting lot a augment to do. that Reduction And it efficacy to ability of other of Act sense what they a are are and scrutiny in innovation doing use we are ways to can't looking already to this which among cyclic any per reported or generic of many of will them trials course, to generic, the

Steve Brozak

what in Can advantage? do the these will given queue. I time, hurdles I fact side, tack one again, spaces, the there one terms the addendum? it's regulatory And considerable On in of in back see the of this on you hop obviously the that

David Mazzo

you're perspective is, by obvious. simply I adding and these and I extent, think something we existing the regimen, we When adding, regulatory some to an co-administer into -- already products. a from advantage Well, just mean

So of makes is takes the with. That only that issues all will, -- there's stability manufacturing those you place chemistry inside no if deal control formulation the body. and to mixing, and and simpler

need safety LSTAX, These LSTAX are be in to benign seems agents very anticancer of predict. go And we're easy not so doesn't to with not preclinical new so the Separate on done be the work perspective chemical from makes entities doesn't toxicology entities. of -- the sense itself and in tethering a done. that to lots new fact that this to to be need these

we've the so we've TGA Europe. the in And FDA, just started and Australia, the our in with with interactions very had interactions positive EMA

And expected. discussions so the as far, and hurdles, we haven't seen any are particular proceeding we

Steve Brozak

Go questions. the Again, thanks taking hop in queue. it. And back let me for the

David Mazzo

Thanks, Steve.

Operator

you. Thank

Kemp Our Markets. next from with Capital question comes Brookline Dolliver

line is open. Your

Kemp Dolliver

Great. the trial. Thank of Couple you. questions ASCEND regarding

you amended get months, few want is regarding changes the the changes. rationale in First details to and last the I for and the more the protocol

David Mazzo

Certainly, call Kemp. question. the for on and dropping Thanks the for

couple some we weeks. of So the information be will in releasing actually next

will line can I now. of give ASCEND, top broader the give but summary of much a We discussion evolution right a

a determine of to but data trial. but When a that endpoints ASCEND Phase single they commercial something well. in as developer decided drug actually do, has was did the started, trial the to AGITG it typically wanted efficacy to placebo-controlled purpose power the a some replicate And wouldn't sort had was Ib/IIa that they

So we the that trial was that inherited.

B. great, was done, we and basic but we at thought should that When the least saw other of were that's one that there been tenet thing that four we at have that, looked very trial, cohort we that called LSTAX cohort of that by second second cohort about patients, added two receive the hours. amendment doses of creatively actually will And a separated and

So the and a gemcitabine, they start. LSTAX co-administered But essentially nab-paclitaxel they'll at get second dose of still receive hours LSTAX. later, four

hours. the something that at the And half-life of half-life LSTAX a XX about half-life has realize minutes that. roughly about profile, XX or or you XX X of the hours of has gemcitabine these of but has look the nab-paclitaxel if pharmacokinetic a Tmax the compounds, reason and for you same, half-life is, to different the Cmax, like a that

but process the of of so And thought dose essentially, half-lives gone, gemcitabine the least or was first outside waited LSTAX, you're therapeutic after some there more at two you said all that is you're LSTAX, if range second still nab-paclitaxel And might and LSTAX dose provoke into of the might the within a effect nab-paclitaxel. on the therapeutic tumor range have a positive of efficacy. remaining tumor improved of penetration

of as some a the So Phase as what cohorts against against difference of perhaps other little and well cohorts, X indication we in profile then would typical this would the is a that as dose the safety so placebo these -- IIb now also we're a would bit that well. combination there's each Phase follow. of and if trial III we and the effect and if in trial be placebo the no likely as get therapeutic ways, of cohorts as compare against trial well the you for have of cohort X then what X size doing really each strong ranging, But part will, be part can

Kemp Dolliver

helpful. That's Great.

it think, trial, say to powering registrational mentioned that that's would but you So fair is that possible be low -- to probability? but I and, seem

David Mazzo

support that a will designing our registration it for be -- that but trial is a go registration trial that's will expectation not a that solid will Yes, be forward. our this

where if avenue statistically this FDA for TGA a we and the the said, majority sites data that if in conditional trial, an or approval. Now with path Australia, and they of see path consider the significant, the positive especially to pursue would accelerated are are every will to

Kemp Dolliver

you. Thank Super.

Operator

from comes Our Partners. MAZ next question Pete with Enderlin

is Your line open

Pete Enderlin

anticipating idea I tethered. And not is which now. what was be Hi, or said, that you're Dave could LSTAX Thank talking either you. about, really co-administered, that originally, you that, Conceptually, the what everybody. just you're just thought that's

it not is true contemplating... that you're really So

David Mazzo

No, let me clarify.

Okay.

either or approaches, co-administration distinct possibilities. remain So tethering, the two

in most rapid a outlined I've a approach past the briefly I moment described the to the ago. as reasons think the that co-administration rapid I approach for first -- registration

X biologically tethering, -- With needs chemically. of starting and with product. new entity you kind characterized that a that much And be fully both to you're create are those chemical basically from

using basically and of base care With co-administration, standard the starting you're knowledge to just it. established of adding the on

to what it's simpler, in less is just that's that So a off priority to answers means tethering But line the mean it table. It second faster, likely a registration. most expensive it's pursuing getting to internally. first. way we're And doesn't from a perspective and

Pete Enderlin

party tie is And you and try try these the enter the and several that. bring then particular entity clarifying to separate that about what own what indication? agreements we that the when and that's ones the application ahead, pricing years sales for all looking its into, company therapies, sort but you're and you to that sort the you or do, they're of do Thanks or talking each have contemplate to is a on combination independent are, and of for together? Or in you each which

have independently. and them package For and a them sell price gemcitabine can I mean, example, either or sale you could paclitaxel or and you LSTAX, have

do way going? which anticipate you So typically

David Mazzo

now, be which be accordingly of will It tried-and-true, those as therapy. be said, I And add-on generic an would anticipation those could right And by become the the -- So as not less augments time already well-characterized this care. generic. we to standards we be will priced is will could those product therapies our efficacy of get or that be and But market. it generic -- patent. more to existing add-on, under will expensive still an

it but no manufacture we because that. them We there's own So bundle other thinking bundle necessarily them actually that real would doing current bundle, our source based them. unlikely a be wouldn't and together We and wouldn't products. as these, meaning to be we them, I upon to the position price could a them think benefit would that package in

essentially is only and that create that doing will And get a their nonexclusive so benefit. and works And demonstrates products with on so certain with list products, separately. we they looking of what combination us, benefit it if better, opportunities large those in will we're add to sales

we not class in this an completely compounds, benefit make the so a along, appropriately would would get exclusivity as of further price it's exclusive in a for Now of that to question and case. out someone we that want deal

Pete Enderlin

But with what -- and spell don't other out -- initial players, have the you agreements that these such combination? really any exactly you

David Mazzo

current that, that will The already bottom agreements of want LSTAX said, enter that addition those But that us relates improve standard have are And it in in we like the from as work run. the the to be the indications. essentially everyone's get that be that of compounds deals together development of being into point, at enough agreements. will the may as long improves to possible say to companies line combined to works, exclusivity They much And deals to products just considered I to demonstrate, hopefully, to are that would it's class if us. with other that order in exclusive richer prevent same care. those

Pete Enderlin

Right.

Okay, great. a lot. Thanks

Operator

you. Thank

Our with next Joe Wainwright. question from H.C. Pantginis comes

open. line Your is

Joe Pantginis

the good Dave. thanks everybody, you for questions, question. And Two if afternoon. don't taking Hey, mind,

the cash record especially it's management to continuing see with in nice So first, track environment. on guys your continuing you

needs you the current your stand needs? with really lead your increasing. driver are, clinical for obviously, But guess said, will So my manufacturing you're on be for trial, LSTAX where to I expanding do that currently two long-term interim more expenses that as as well questions so your

David Mazzo

for Thanks, Joe. the I question and participating. thanks appreciate

prepared we mentioned, R&D are can which fund I many programs. we'll of some in So as of both the And I've will Kristen we've being to areas as our have a with that past, where that them during of made, assure operated we changes think I reduction contributes these and now rebates, James in programs all remarks, their costs. in think, get are the co-funded, and said

partner, retain to them completely rights by other but of we our some the yet funded product. are And

With as our now able with that all programs, we presentation, capital, the and fund in of of data. a with we corporate to be, fair proposed, said, will can through that confidence ongoing our degree project existing both to availability of outlined

as And and early XXXX. supplies starting that's talked about of lots as all keep the validations are that portion the manufacturing manufacturing of stability, And and appropriate things the that and to so well in into already portion. essentially needs, all as the the we including are clinical drug line of with included of part CMC in the clinical development

Joe Pantginis

That's the -- say, all then of regard patient regard step great to one for to with today, have I the other indications hear. studies? curious, with competing discussed the programs enrollment you with like which these would that rate-limiting And with to patients

David Mazzo

studies all fair ongoing, are a there studies There pancreatic cancer solid are of and number in these other tumors.

toughest know this enrollment will put what, and spot the what think a we've going see bit about projections. Kristen how our about can to on you So through fumbling answer, sense rather to she trial. we do we is than of have competition, some but constructed give and there And quite the enroll enthusiasm I if our think I'm be

Kristen Buck

question. such have the and care, gem/nab-paclitaxel. know of lot a we've main we not have very do pancreatic I'll but FOLFIRINOX cancer, by pancreatic probably, careful you start in X cancer that for well cannibalize them And to standards has as off saying thanks some Yes, each been -- other

in are we've both to separate a are who those trial, gem/nab of for trial. those have of who tried separate FOLFIRINOX standards that exploit such So and will are for eligible a eligible care those

of is nonresectable And make doing then locally one advanced tumor such are in and it we pancreatic could resectable. trials, nonresectable a that our that change we

So different that's a patient population.

is occurring isn't there competition it because ASCEND really the For trial, Australia. in

the answer is carcinoma esophageal which of second hardest squamous Trial one me, So other to common recruit the it but wouldn't Europe part, diligent It's most challenging But would not to may Asia to the very have in such and we cannibalize internally if of cell recruit, for arms may treat, that so -- go difficult esophageal the be of U.S., population excuse trials. each is to to the patient the choosing recruit, I our question, of were this parts most strategic type. to we BOLSTER the and been is I to say our most which the we've trial. in

Joe Pantginis

Got color. it. the all Appreciate

Operator

question Pete follow-up Partners. from next MAZ with Our a Enderlin is

Your line is open.

Pete Enderlin

the just have What of in Jersey and contemplated do the use And New be their one. way NOLs? tax of what quick Yes, availability of you a those? remaining would timing

David Mazzo

Okay. that characterized easy. is is We applied Well, generally what the general... contemplated as use to

Pete Enderlin

how use whatever. mean, for I no, you it soon But... No, know take you them. I advantage of

David Mazzo

Right.

So approximately we million. $XX could change. two $XX million benefit. But years at the probably $X from current years what's of could probably which $X and The a collect cap. That once cap, changed under remaining of left us caps have it million terms and million the -- next have roughly already half state under take in to availability the It's couple of left ago current would following of again. company and million $XX the raise lifetime year, to we we that every half year program, to

eligibility. So remains years is million terms roughly somewhere over year a in between that's $X.X of the what current to $X million two next

Pete Enderlin

bit Well, Okay. every helps.

David Mazzo

Yes.

Pete Enderlin

one. Nice

Operator

like Thank to to session. you. now This remarks. for Dr. I back over call question-and-answer turn concludes Mazzo closing the would the

David Mazzo

participating and We questions next quarterly We during forward again our on Thanks, and your interest continued to And to for speaking updates the I Lisata. some continuing provide provide to And gave in for all you achievements with again, progress. the call opportunity support remain look conference appreciate call. additional our and color. operator. thank grateful today's you to us really that

evening. And Thank we goodbye. you, good you wish a very and

Operator

does This the participation. your for conclude you program. Thank

Everyone You have day. may great now disconnect. a

Lisata Therapeutics (LSTA) 9 May 232023 Q1 Earnings call transcript