CLBS - Earnings call transcript Q4 2018 | Lisata Therapeutics, Inc.

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Operator

Welcome to the Caladrius Biosciences Fourth Quarter and Full Year 2018 Financial Results and Business Update Conference Call. Currently, all participants are in a listen-only mode.

Following management's prepared remarks, we will hold a Q&A session. [Operator Instructions] As a reminder, this call is being recorded today, Thursday, March 14, 2019. I will now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Caladrius. sir. ahead, go Please

John Menditto

thank for and call. in you afternoon participating all today's Good

Chief before were me team news year Executive for wire and Talamo, management from release the Officer; any delay, XXXX. had Officer. Dr. Joseph Joining a quarter our technical results President announcing are our today and issued call, difficulty. the we David using fourth Mazzo, and We we Financial a for Shortly full service Chief apologize

news release be this if you company's If distribution to received you've email or would like jmenditto@caladrius.com. added email not the to me list, please at

this in of over update Furthermore, the as the Dr. broadcast, obligation undertakes Biosciences this after Before of call with results we results from the the which I'll Mazzo. reflect involve conference said, the I statements. any and date remind Caladrius. you of that XX-Q the Dave? call. and the Forms risks XXXX. call revise no to to contains that XX, this Exchange made you limitation that that regarding begin, call events events I management accurate X-K or Caladrius the March encourage actual materially forward-looking during the or turn by review to statements will of without company's date sensitive content of may contain Securities only Commission to and it's future live including forward-looking described and to will uncertainties cause is XX-K, time comments those factors statements or circumstances identify With information specific that filings differ operations conference

David Mazzo

for thank afternoon, everyone, call. on Thank you, John. today's and joining you us good And

our year been Caladrius. will For participating calls, productive was XXXX recent those you of for an eventful and you quarterly have that know to

and a cell known CDXX to fiscal the ischemia, advanced CLBSXX-RfA Study year namely refractory CLBSXX Type the critical three Diabetes, dysfunction, for proprietary discipline CLBSXX-CMD therapy CLBSXX in completing previously T-Rex CLBSXX-NORDA, we X maintaining treatment the microvascular follow-up our treatment of all landmark no-option addition a expenses. development coronary one over for positive as for programs, subjects while the angina, for of as limb disabling as treatment of for In treatment

our today's I ongoing discuss Joe? on for additional his progress, commentary results. over provide call During before upcoming our will I financial and Joe summarize CFO, into the to do, overall turn milestones. trials, and our I'll insight But some and our planned call review Talamo,

Joseph Talamo

provide update results burn position Thanks, capital Dave that fourth and and spending, and to an cash overall research pleased then has quarter. operating the financial year-end, highlighted at on by a our and good development consecutive administrative working focused afternoon, and for I'm everyone. general expenses, strong declined cash lower

results, will our income with taxes details additional provide that focus continuing year-over-year results from my only financial compared on the year. commentary I Before on note please operations before prior

a operations on to the the operations reminder, a discontinued one-time As financial operations offset statements. in recorded income sales that the XXXX PCT PCT, the sold reported the to With are comparative in discontinued benefit former as recognized subsidiary XXXX Chemical was Hitachi in that directly tax in gain we tax in expense operations our continuing on sale. XXXX of

operations our will year prior from focus before will which I result, better continuing performance a a tax results on compared provide actual As my the financial with operations continuing of commentary income the reflection period.

representing the decline. was a XXXX, our ended continuing net XX% December results; to million December income from $XX.X with for the XX, before XX, ended overall for turning year $XX.X million operations our financial year Now compared loss taxes XXXX,

lower in The the for spending significantly planning decrease will $XX.X in Phase prior XX% XX, initiation detail million and by T-Rex for representing refractory are spending compared with of decrease expenses the results our moved line $X.X offset initiation Study ended activities period. in the discuss our disabling with for costs significantly study expected CLBSXX programs. three lower cost XXXX XXXX. reported which ischemia Conversely limb were XXXX Dave program The be for programs CLBSXX-NORDA. which partially critical spending enrollment coronary preparation studies completed XXXX, December was which million associated increased in T-Rex clinical of we in wind this our associated proof-of-concept CLBSXX R&D year In in into positive Specifically, this XXXX early final of year in Future was Study a CDXX cost the a top moment. expenses positive complete dysfunction, to our study trial in for down driven angina, phase and of December minimal. follow-up CDXX The the for greater X by follow-up increased our Japan. in microvascular no-option and with to study our CLBSXX-CMD in and of

with since compared to year Dave $X.X XXXX which due a year and ended December and million headcount will to seek pending discussions increase our representing was activities XXXX in corporate-related and for continue initiate G&A The platform The total million the XXXX. XX, of of study spending lower CLBSXX-CMD fall we We the year in prior X period. patients will address compared to ongoing decrease the general as enroll studies XX% CLBSXX-NORDA our were will the study administrative the Phase and timelines decrease to CLBSXX and FDA for to within $XX.X continue year-over-year with positive continues expenses momentarily. finalization period the expect in CDXX CLBSXX-NORDA be XXXX. with the trends of prior lower cost the determined and for

December CLSBXX, to fund $XX the the marketable and $XX our $XX.X capital, announced sufficient entered and was Lincoln that are for we XXXX of Phase CLBSXX-NORDA. XXXX a equity ongoing had Earlier securities into operations to with existing including our certain of Turning the Park subject to cash, on-hand have equivalents studies stock and through cash we capital and as million XX, agreement today our for million CLBSXX-CMD and sell believe a conditions December had mid-XXXX initiation cash over cash $XX an limitations XX, of We XXXX over and to working the purchase we burn right of sheet of next to as months. our common million. line up credit X cash balance completion flow; them CLBSXX of in and now securities will for of under equivalents million, and which study Caladrius to cash, the XX marketable

share stock. shares $X entering of Lincoln agreement, the gross purchase of for with the at fee will Lincoln of company. issue commencement of for agreement, Concurrent will the purchase stock to common commitment proceeds common a in XXX,XXX $X we to Park purchase into price million the Park As XXX,XXX a per shares

of other Park with Moving direct We the both funding constraints, when these the agreement of conditions options and with financing million forward have our seek but we believe us liquidity, and basis our clinical that facility purchase remaining Wainwright, or this in purchase stock given will of on potential we If ability existing the Lincoln our XX to price the shelf daily and our purchase facilities a agreement. strategically may to obligation other terms raise combination used upto from Park of right in vehicles. when the capital to cost the at programs. with common baby and stock or not compares subject and fund maximize one market favorably or non-dilutive appropriate to to will H.C. use Lincoln

compelling align with opportunities continue that call turn also external platform pursue creating value R&D that, current the our our identify With Dave. additional other to let back will to to opportunities. We supplement to initiative me or

David Mazzo

Joe. Thanks,

our based our cell Let therapy platform. positive begin CDXX me development providing update by an on programs on

number which blood cell positive ischemia, cells angiogenesis Our diseases tissue restricted. healthy the have conditions the of development of CDXX the to published prevention improved application technology CDXX tissue by area demonstrated induces studies has including CDXX ischemic limb and to or positive but cell product our refractory development the ischemic of limited technology, injury condition not to blood designed flow candidates a of supply the of oxygenated administration to dysfunction, underlying animal a is angina. can contributing the death of and [ph]. conditions by critical thereby of human infill capillaries therapeutic by that that positive of to facilitating be blood microvasculature of to ischemia, and microvascular believe through We Previously new caused led the caused the coronary address in

CLBSXX, Japan successfully arteries that the Phase Health is Labor SAKIGAKE limb product rest our non-healing treated, patients Designation significantly of pain, study spawned the of has clinical CLI stenting the remaining the lower obstruction means positive bypass-surgery in critical of these skin end-stage or of and represents Japan flow may is ischemia. a the or amputation. and if no have for patients. limbs ulcers, not [indiscernible] treatment CLBSXX experience for extremities, peripheral are the not be cell often candidate No-option that technology principally limb CDXX amputation pharmacotherapy possible, in currently mobility, to Ministry the and development and limited reduces severe Welfare arterial the disease. Our for severe a that blood received a eventual CLI only angioplasty, CLI. from X and working, of treatment has & is longer failed CLI of

for research SAKIGAKE pharmaceutical development and Japan the medical innovative regenerative early devices promotes As application products, medicine. a reminder, in Designation and practical System driving

time a designated X registration and reduced the review as months review support months benefit As therapy, consultation, down prioritized SAKIGAKE well the a regulatory dedicated to system application once review expected filed. typical process, to to CLBSXX from XX development as the from is for CLBSXX

for CLI-free including in of and anti-platelet full as free comprises status in reverting to pharmacotherapy. subjects monthly ongoing CLI-life X-subject the limb. improved to with indicating rest by of the by open-label skin arm CLI pain control Japan, conditional through in eligible only the smoking. CLI CLI are the is who previous injection observed to in treatment agents, often data in CLI, randomized-controlled control into are group treatment XX determined arteriosclerotic adjudication serious the defined intramuscular a through completely is divided the absent as Additionally, approval condition arm the and who cohorts; is if Subjects endpoint which the response in the to study subjects standard-of-care small early traditional study committee. this an approved non-healing ulcers on CLBSXX subjects is XX-subject independent for of randomized compelling have addition visits number with no-option standard-of-care in from reached crossover randomized consequences in The show Japan. of study patients approval to [ph] prevent allows heavy and healed Those disease, is based initial a the ongoing made affected progressing. is United to consecutive by with States. nature of complete anti-coagulants rescue the the be associated in an the vasodilators; our no-option therapeutic by study, dosed with patients of possibly profile choice can with published as multi-center Japan in CLBSXX with of Burges and are according in protocol. clinical prospective their and open-label the that The flow The study blood receive the are two a previously by to CLI type consistent which CLBSXX drugs effect two and receiving investigators primary positive safety patients group is objective a reported The to deemed trials

very and cautiously subjects. on outcome remain dependent data these the of optimistic trial early from recognizing however, final are all encouraged all that be will We results by the

study record complete we first pipeline data to XXXX. from previously As the have half in we of announced, expect the

$X budget additional operating we our be As Since these projected projections study funded of to costs less finish than require costs, are million the can this now expense to considered it fully part will study. of completion. to current

the sale seek and study. our Regarding to to in to CLBSXX remains a conversations completion continue the we partners license commercialization, concert consummate prospective with Japan. To our for in strategy of deal continue with that end,

in published European a high and completion our the in and initiation to United has U.S. amputation-free and showed of CLBSXX upon in the to course United prior degree in work a to including survival, consider an improvement such corresponding previously States Finally, depending study combined prompted study. study with of that Japan States us enthusiasm experts CLI and of the the capital interest progress identification a developments the the of the our Japan, of necessary fund in from Europe

a coronary heart in [ph] for CLBSXX-CMD the in X the CMD our coronary escape [ph] Like clinical interlining cells infusion an Moving CDXX a CDXX uses positive all microvascular vessels development to XX-patient ischemic heart involving tiny the of case to and near microcirculation. coronary disease infill blockages. an ability currently proof-of-concept address formulation is trial onto the positive damage the the of CLBSXX-CMD positive trial, into CDXX CMD cell program dysfunction. being cell which the treatment CLBSXX-CMD CLBSXX-CMD, specifically designed Phase artery. of to therapy a cells with CLBSXX-CMD discernible for is our blood no as plaque-less evaluating therapy candidates, is the coronary the for by arterial studied of vessel treatment patented the proprietary positive CDXX of dysfunction, the microvascular designed at/or physiology site in microvascular large increase innate dysfunction employing and of symptoms injection

therapy from costs a be such, study CMD are of who data from data should have the angina the by through address are of the on early or the to funded of study follow-up of with Top trial study increased X fully from open-label clinically patients NIH, be visit now in considered the As in in months results for subjects, systems an XXXX. CLBSXX-NORDA. positive treated the escape number this a will And completed we expected available this is observed expectations our at in the early small while microvasculature reached grant profile and a believed observations most are corresponding growth turning dependent these early CLBSXX-CMD to new of oxygen-deprived stimulating positive encouraging. And coronary by be reserve previously acceptable the therapeutic disabling cell most of trial X advanced as to of flow by completion. The also CDXX refractory outcome and have the safety our heart. indication. effect all of program, XXXX decreased CLBSXX-NORDA subjects end covered no-option communicated, final to this angina from support month the line

IND filings the series mortality X, with this for to results cells exercised on sponsor a advance enthusiasm advanced to designation opportunity X with has treatment therapy, Caladrius indication reactivated the of for a Our published candidate Since effective medicine of and acquiring to designation of work successfully therapeutic high heart therapeutic RMAT condition. regulatory received we rapidly the development tolerance, with have the program indicate function consistency that to effect regenerative study CDXX FDA and that CLBSXX-NORDA with the no of the improve increase based and The the an from i.e. refractory FDA and efficiently long-term is as rights FDA. in more the and the associated options. RMAT affords and morbidity currently positive treatment with X Phase the for this decrease data angina, us

CLBSXX-NORDA, initiation XXXX. and of that FDA with of registration in trial the full X the of single targeting in finalizing are the process design trial are protocol Phase We of for a the the

case number European that individual recent And novel imbalances immune function use restore prospective simply in immune recent placebo-controlled enhancing CLBSXX evaluate efficacy XX, possible effector and thought based Xa own T-Rex attacked to it Phase with balance the are two development study of line has was from as trial safety the In had that announcement results announced comprehensive data for the the Medicines analysis is in proprietary enrollment in achieved. onset cell Phase at reducing the T-cells. of T-Rex anticipate by Xa attack T-cells is when attacked the been the Type trial properly, all yet overtime preservation clinical seeks double-blind including proposed or orphan based and C-peptide studies commenced of cells, cells level are approach and reiterate the from materials in was therapy ability permit Study, for that cohorts however, randomized and is system. Diabetes, by T-Rex Type primary produce T-Rex but a only was technology disease, body's deficient Sanford Project of been T-Regulatory We endpoint T-Rex and treat T-Rex February program this group function. we of well of the autoimmune not level by In overtime results regarding FDA the diseases top the eliminating a the activity tolerated to in Diabetes next thereby adolescents the the Classification T-Regulatory of Agency. steps patient our indication, a i.e. indicating from harmful Type the Medicinal immuno-modulation. results. in the be the or and the data caused beneficial our conducted effector On CLBSXX. data Lastly, X Any pancreas all designations our of patient's numbers of foreign the CLBSXX CLBSXX Therapeutic This insulin. X-year dependent patient Diabetes, to treatment culminating development beta XXXX line are those to the X on of XXXX, we upon will of individual several subjects. for an I'll regarding to cells X decisions platform results in Product naturally in Advanced follow-up landmark granted with years for CLBSXX first the that granted on Study. This fast-track top drug for

and the and await data, for we to As the express participation comprehensive of patients, Study the gratitude the study their sincere of investigators in families T-Rex commitment. we again completion our analysis involved

we accomplishments these of form throughout CLBSXX-CMD clinical So enrollment throughout clinical are trial United CLI States and in and a the key the on of United operational expect top build milestones and initiation of of number top the a line line the We Phase X the for and X pleased These achievements foundation of development the we XXXX results. attain we to the very And corporate strong data a study States protocol XXXX X finalization and results. design with to in which from balance CMD announcement and upon data CLBSXX-NORDA of escape momentum financial believe expect on trial Phase Completion of CLBSXX of footing, beyond. in in of announcement Caladrius of completion our XXXX. year. entered for the closing, in with the FDA. Japan made clinical include of Phase enrollment in we milestones

team experienced, with advancement of and Our we to are dedicated treatment to questions. work bring options programs and the passionate and effective And innovative that operator, overview, we to remains restore health. human committed ready as efficient in to need patients our take

Operator

Pete The [Operator Enderlin with question comes Partners. Instructions] first from MAZ

Pete Enderlin

with was which think do end the by you're I near-term that guess, to pertinent be when going the maybe there for a to protocol Starting a the that question; of weeks. is X you do hope than to you less I able think comment NORDA? finalize most quarter

David Mazzo

remains conditions to the We've objective our with working single be trial closely FDA other that is X here and protocol us there to Remember consider. been has find details. and out FDA very considerations are registration, that some Phase a to acceptable target. a to FDA for iron our That asked so all as that will

with not us we have did not keep that by things to myriad the a that more position the and But did there up FDA's public. lasted that is they expect do. to we'll over-ability the in define part We we're a the month, than have to out of that reason be shutdown other end that impact why but government protocol that a with yet month the we'll to only sorted of have the of fact that

and with hope closely announcements them in the position to working those in make a be we're to near-term. So we

Pete Enderlin

the If in an of NORDA. of have NORDA, I per you cash just $X of The of XX spending this sneak another the did excluding beginning year at and $XX say question. at and one, million had operating quarter been sort months could equal put is spending arithmetic including to you has million

of the do year so arithmetic per if you or… million $XX And

David Mazzo

of expenses save this little year. i.e. maybe average, million Pete, you the quarter $XX kicks during The rest the a could part of off, right. I of the first we $X interrupt year, million to last XXXX have year have explanation. or which we is the no an CLBSXX And you last did a and as half

course, is down We enrollment the we cost have constant. to are the cost completed somewhat quarter, the winding be second enrollment have yet initiated and trial, NORDA because CLBSXX in of not remaining CLI expected and

when see still then kind together add out. they of going you and are that and down So coming up, certain NORDA all you average all things

of So maybe to use in run, And us would like Joe, projection to cash. anything? mid-XXXX the long you available the brings average if roughly add

Joseph Talamo

$X is we into - Phase expectation the that increase resources, million And The Yes, correct, out that million to the that that's run right. that's above to program start going - $X and to quarter. XXXX. math increasing cash will it's quarters, study; program significant a so a XX a support exactly our And Pete, you going is that it's the in that's four quarter to trailing initiation X that's if we we as NORDA it's your where experienced built months. get draw expectation flow of an with

Pete Enderlin

purchase that wrap [ph]? going with be to based And that agreement then quickly, - - is Lincoln a Joe XX-day just on

Joseph Talamo

is it's the And is it's transaction, standard of there credit. purchase on and thing obligation right you equity of XX-day initial look they line important the a filed the agreement, this this purchase are an but so can typical the the not use again, notices; [ph], regular the and Yes. million this. purchase of wrap at $X have commencement to And we is

- the have that of we been very for been year with has continue now has just the which to-date. H.C. we'll been with use place discipline a So about used in Wainwright to same little

our the we're of for this financing always is capital at capital, access purposes raise to line effective an and most equity going given to capital of needs. to So cost look

Operator

from question Partners. do Enderlin Pete I another with [Operator have MAZ Instructions]

Pete Enderlin

Is start staging for now call, let here. possible the one so now, major few the not hoping you're the if mean, per you but the CLI. the for of you to take it say constrained rearrange guess I let's the possibility a the priority me NORDA, starting try that others you I at I'm question fourth is And would the this X that beginning I know guys one be more at to have? schedule trials don't will have way likely Phase quarter of point? it the Well, other U.S. to programs over

David Mazzo

change the a and consider could jumping our unlikely. we NORDA mean based that's the I the possibility a program RMAT is CLI FDA, than upon the a haven't discussions expected financial likely course, now and NORDA haven't the could program in directly Right to the be. Phase that but U.S. would into that move designation States. the the into directly position the that ready initiated prioritization on X, is of were is situation to Phase advanced as CLI that at be time we so fact in and it given we priority its that X, timing if into we program; remain But Phase even depending them program exists completed with X in situation that more as directly a United entering the and of clinically well, with U.S. forward upon

Pete Enderlin

Phase the little for TXD? Dave, you And a you're analysis the about of Xa approach to going that data talk to can bit full take a

David Mazzo

a as person that and those including Diabetes the ranged is as does The level exercise, patients at which are typical so sort different, different had for which a myriad progressed highly a population, of old recent highly upon varies from top X puberty, from it's for in diagnosis it population a and I Diabetes of in close factors how as dependent level XX. of X co-morbidities, heterogeneous disease. that's each X young rate let's of all the it also it's Type as other of their we to the Type onset conducted their as highly - a think that their to population, X different heterogeneous study Type they individual kids disease heterogeneous and Diabetics; stabilizes, the means at person; severity adolescence a them is call upon to disease they're at diet,

level, the look hit so then you see group a groups; a an ability that And completely a don't when you statistics; when level other results i.e. the distinguish But those see as to you placebo those to grandslam be dose, and combined if at each able group situation. heterogeneity of you compared dose high those you're in then at low and looking given might of distinction not surprise between groups. the groups it's to groups

potential they that literally group hundreds of to So now comparison each etcetera. typically individual placebo evaluated we a placebo there access points, group, placebo individual to all if data groups have do. information placebo And of data thousands as points look comparison we the have whole at large have of of be a biomarker - the number see and the to behave in are the and patient to in historical to cross-compared to way that groups

and that not to going to many a it's with going the number is the your that and a done fact done be as partner, well experts opinion of the involvement the key research of us this outset Sanford, leaders, the been all Diabetes that's of from so our follow-up to be the advisors as that will before, as to patient out who And take study X-year that's there of until follow-up January on for to And times we've months. be Add X-year many last XXXX. program. going that the have said

included overall into the also has of to analysis. that amount And so be

steps next to final our plans, So we're results the the make study. upon being ways away from able development in based of

Operator

question-and-answer I'll This for closing to Dr. presentation. turn call of the portion Mazzo And the remarks. concludes back the now

David Mazzo

participating a Again, you today's good again to to on with few and I'd progress. your remain continuing quarter call you of We conference We and evening. first bring grateful our like Caladrius call. on speaking you to Thank and forward achievements for support interest and continued a goodbye. thank wish our for all to look in you news months Biosciences, of you in and we

Operator

concludes This call. today's

may You disconnect. now

Lisata Therapeutics (LSTA) 14 Mar 192018 Q4 Earnings call transcript