- Earnings call transcript Q3 2022

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Operator

Good morning or good afternoon, and welcome to the Longeveron Inc., 2022 Third Quarter Earnings Call. My name is Ajay and I will be your operator today. [Operator Instructions] I would now like to turn the call over to Elsie Yau from Stern Investor Relations. Elsie, you may proceed.

Elsie Yau

Thank you, operator. welcome third and XXXX everyone, morning, to quarter Longeveron, call. Good update will of financial provide we and XXXX. a quarter Today third business discuss the results for Earlier of our with at www.longeveron.com. press be this under website issued which found section results, can release Investor the morning we these a I'm the by call the Longeveron's members of joined team; Dr. on Management today following Chris Medical Officer; Min, Dr. Interim Chief Executive Officer Chief and M. Joshua Chief Science Financial and James Officer. Chief Chairman; Officer Co-Founder, Clavijo, Hare, and Dr. update from followed or Min of will by brief disease, Alzheimer's overview, with HLHS Frailty. Syndrome clinical begin a Longeveron's Hypoplastic a corporate Aging Heart in program review Left and Mr. Then will Clavijo quarter review third our financials. we call the for then Last, will Q&A. open

and As to results materially cautionary including this from or a making subject to the press of various be risks statements will statements Report these statements. information. and to on statements differ Any filings could call, our in these be with update reminder, actual conjunction risk XX-K, during with such considered uncertainties statements in in our factors no we our forward-looking our obligation are Annual We forward-looking statements, discussion assume cautionary should releases which made that this SEC, any and cause Form call. on

Interim Officer call the to I'd to like Longeveron. Now, turn and Officer Chris. Dr. Chief Chris of over Medical Min, Executive Chief

Dr. Chris Min

disorders medicines disorders. cell-based aging and medical challenging the regenerative Elsie. safe and you, developing develop call. results financial some Longeveron our therapies associated update unmet third other process Good with biotechnology and mission for of is At business company Longeveron, Thank morning, clinical to XXXX everyone, Longeveron and medical to effective the most quarter is a stage needs. welcome for

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in enrolled, the to fully trail the we XXXX. share expect results With top line

Next, I'd to to our move on program. HLHS like

This quarter designation to that this Lomecel-B fast and the announce we track are life-threatening with infants pediatric FDA granted for disease. excited rare to

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to individuals and This of falls, related elderly effects trials, patients, frail have of system in frailty related it related At typically age is the hospitalizations that frailty function early low reversal particularly the an millions may used. XX are decline age-associated to aging program. to frailty function physical weight like function. cover to and definition elderly, States of and clinical stage a Finally, more among across or our multiple vascular have measure That on using information over health of common weakness, function Aging that Sarcopenia United Lomecel-B loss the as individuals infection, cope systems. may we fractures, death. activity. slowness an I'd manifests is immune have outcomes to stressors. signs affecting and such frail elderly to the as of their the biomarkers on and on clinical and to poor we involuntary aging vulnerable loss, updates on even include with of the evaluating muscle, symptoms related and the inability Ageing leads several combination In exploratory specific Longeveron endothelial frailties up fatigue, Unfortunately, of and the effects. associated depending been XX% population related of physiological

is The of Lomecel-B safety randomized, study of dose double-blind The market Our levels the versus tremendous of Gerontology placebo-controlled, of treatment different ageing evaluate a approval single-infusion goal regulatory clinical quarter focused in development near and in is aging in driving Hospital in one limited trial evaluating primary frailty, term Japan capitalize with a Lomecel-B design, National related objective with placebo. X of related cell Tokyo. world. our last therapeutic University an Nagoya, the Phase under the Safety recognizes re-evaluating Center has populations which in the patients the of strategy of overarching X-arm, to with our parallel value clinical Juntendo Japan, for strategy for Phase the an as in the for Lomecel-B After two or X study is screening aging opportunity, in of we & Geriatrics to on therapies. frailty potential which providing oldest initiated currently ASRM, japan eventual partnership on Regenerative in Medicine on Act support frailty study for

efficacy, financial the will on allow Now, Japanese such with conduct such our a small through can to treatment well Lomecel-B demonstrated safety enable of an Financial data with of expectation the for could discuss on based clinical previous amongst enroll us to an ASRM turn frailty, patient combined enter of James. of approval Frailty in be a and We that, Clavijo, market Aging call like quarter. which in results us this a established track to select the Related trial, in the approval Officer Phase as controlled patients quarter administer sites, Japanese aging an for first to XXXX. need our to over With Chief this third the trial addressing X I'd James Japanese population. our unmet to our remain now crucial

James Clavijo

was due to Bahamas ’XX, trial as is same follows: increase the an which our presented the an and XX-Q participant Clinical demand and twentytwoGveryone. quarterly analysis our be $X.X Thanks for ended revenue the Chris. for increase morning third trial respectively. was the Good of will be or of our at Revenue $XXX,XXX XX%. clinical $X.X operations financial September quarters in revenue detail revenue, more Registry trial $XX,XXX management's to and This report in in morning was filed in condensed compared quarter due grant e third increase million Trial of period to in XX, and of $XXX,XXX The XXXX I'll from will our derives covering difference in Registry XXXX, which ’XX what the today. clinical Trial. Form Bahamas be in million discussion statements Most of in twenty increase revenue and primarily ’XX quarter an this in

third The by million for million million Third reduction expenses of grant same grants. to The increase decreased decrease development quarter months allocated compared allocated offset grant in funds XXXX. The to compensation was available revenue a million period revenue million XX, funded and $X equity increase the to $X.X the $XX,XXX expenses in in or The in expenses. XXXX. by $X.X due million to were to quarter from was General in three million and $XX,XXX the of expenses XX% approximately XXXX, compensation clinical $X.X reimbursable expenses to $X.X in decrease a in same based trials. $X.X expenses, completion Research the or partially and compared not due in to or is for and of period primarily $X.X administrative research $X for based quarter of XXXX September part administrative $X.X $XX,XXX the research in an compared XXXX. XXXX million ended which grant a million in same was of equity decrease and third XX% the period primarily for development of primarily million development XXXX of related XXXX to the were decrease in the Grant and $X.X to increase approximately is general decrease of the were period to XX%. same that the due of

and same $X.X XX, to the related by legal to services million period increased in three ended compared expenses months the However, XXXX. consulting September in XXXX

half same XXXX requirements loss you million million Our I capital at short that compared third $X.X and our Based Cash on of September the the to thank XXXX XX, the will company's existing and and investments plan the call sufficient the the $X.X the quarter period believe current was will XXXX. in first term to $XX.X and net be end that, of Chris. term With XXXX. investments was of cover resources, in for expenses financial turn short back into to we and cash operating million.

Chris Min

Thank you, James.

advancing our now quarter you've – would strong look pipeline. me, excuse strong as New progress today, the Year. like and questions. open wrapping in into made I forward third to up wrapping look to to I across heard So up the a XXXX for call the forward Operator. we've I

Operator

please Michael Thank you. our Group. [Operator today from question Michael, Maxim And comes Instructions] go first from ahead. Okunewitch

line open. Your is

Michael Okunewitch

questions. for taking you Thank Hey! the

would bit might a heavily from out start ASRM the like applied to in they color be prescribing if on under treatment like be the regulated so commercial to seems could a you and suspect? where support pathway? you give I'd program discuss be wish in healthy, Lomecel-B So it and It may something perspective you more what Japan level patients of see particular for would could reimbursement frailty even older considered in seek how is would if Japan a that? on How bit otherwise

Dr. Chris Min

you that thank for Michael. Yeah, question

refer Just to be in to to things insurers like terms clear, when I – just you and you reimbursement, that? of mean because just… want

Michael Okunewitch

Yes.

Dr. Chris Min

pay that that PMDA or patients to reimburse unlike not approval, approval, address saying treatment. actually ASRM Let allow the by me to does insurers for

out So of pocket. will it is who limited to pay patients

conditional for under auspices the know, that approval, eventually intend what next PFDA. the do is is which which go to you of we do the So level, to is

their ASRM specific the Did and treatment and the can patients their as would sign administer they an have to in a of be the to your their the means. would – to option for patients, this in this then whether in treatment but on the prescribe it question? pathway, will are have doctors their out their patients and interested means own for is pay providing that cannot it gerontologists So up patients which to depend advertised, financial that address for so Japan

Michael Okunewitch

you. the HLHS. touch also in I program Yeah, to thank like on

need time a this three to completion typical and term you patients Is If phases longer or looks benefit to like you evaluate something perhaps would long clinical transplant follow-up? in the on studies, mortality? of trajectory that these how could you to what a the like discuss follow surgery, current of disease all demonstrate could following something in

Dr. Chris Min

this I'll way. So address a in more general

make is a been only here. died of required children them that not from year, diseases have this either facts within XX% three as was stage fast of heart enough reason number now surgery. XX% of we unfortunately disease will FDA we gave plus transplant promising two somewhere two about care Phase of then and proof Part a us one to I approximately stage that able so bottoms standard surgery, think they and orphan move that our the this that of require care is designations. and the and die fast from This cannot the a of and study was group, disease, years XX% one patients, but between at first after So of transplant year of disease, the even the label, know two rare trial the condition, or study label out Lomecel-B, long or just our as label, an is so three the died. after lot that patients of efficacy. of ten expectation when have on about their them ongoing stage got either an open with for the half there we track, And would and any original study, know open but In are a of at open to survived, X though the we of comparing of judgment no of caveats was small comparison but was all the to disease, XX you ten standard we and treatment, year one efficacy of not some we've versus none kind the was their had a – you expectation our history because make patients, it heart determination to it we are be following track look them efficacy, natural surgery,

It's at sufficient the designed definitive of outcome which depends about measure, as collect efficient our be provide of outcome mortality and two be RVF proof us would not an effect, point study. was evidence the so using to information This to of the type mortality. be your but amount one very the strongest are sufficient of you year. that size things; any to on of We it's study a study, to this time the unlikely

look ejection to monitoring continued fraction outcome first that time to our trying period subsequent in XX imagine a approval with right of benefit or might patients one will I Xb information at just mortality. study measures. ventricular think continue we follow a But that a months it, the study our so over We have we of will study, for can we generate mortality data, pass be have so our for of be like measure going aiming beyond try then at determine whether can kind to and with physiologic to the designed that this that combined Phase

Michael Okunewitch

thank last appreciate that in right, then one for back I queue. one you. I'll then insight. and hop All And the me

a am function Regarding what trial, the you in Disease, meaningful on in all a small study know a it thoughts you curious trajectory any comparatively in particular if cognitive consider of Alzheimer’s particular it’s see, change you to to endpoint, this is benefit. sort ongoing I know a in I the order have need on – clinically would but to see

Dr. Chris Min

Well, this we're something that our know XX – arm, you with experience. is be based on previous per you to say as clear, not

your the measure number fact that glean measure of really the we improvement. experienced doing think that the like very of you very composite a up – will ADAS-Cog to try ability to to size signal. up would all working be about so power composite in to and it that be statisticians is unlikely a is, from based this biomarkers made have space, and say on been with something effect is, cognitive in the traditional a know, therapies and what signals closely don't a it's space measure, we're with whenever other and measures measure definitive a the factor are we with of have trying noise, you know You What come would

final haven't that you composite can area has an log mild just proposed to database pre you modifying but been but test and at work composite can of we're been an is have know factors. combination would disease that with the been we this speaking even we've and but is very actual for actively what limited. signal, would that in trial be We recently you a cognition that space in be that to we which been within trying pre, determined cognition, having therapies that marker, not efficacy a measure that arrived we have pursue, so of tools space try measure and to – have [inaudible] this know And we – know most have the generally space, the against the mild MCI,

disease. going So not to optimal we're to mild-stage to boxes, sensitive going of just to really try highly an composite the of senior that's to we're set do be designed do a

Michael Okunewitch

Thank very progress much helpful the and you. for quarter. on questions Thank answer. It's very congratulations taking this you my

Dr. Chris Min

you. higher of our which and to AD our the Thank We're the than It a trials, in of really performance speaks enrollment. kinds enrollment patients think standard interest bit is quite of therapies. proud quite I of other

Operator

question-and-answer Chris for to back I call return to like now Min Dr. That remarks. closing concludes call. this the would session of the

Chris Min

Thank you for Okay, Thank you. attention. everyone's

to we look are quarters. future strongly to continue results in forward feel providing that future executing We and very

Operator

concludes call. today's for you attendance. much your This Thank very

disconnect now line. may your You

Longeveron (LGVN) 14 Nov 222022 Q3 Earnings call transcript