Longeveron (LGVN) 12 Nov 242024 Q3 Earnings call transcript

Ladies and gentlemen, greetings, and welcome to the Longeveron Third Quarter 2024 Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the call over to Derek Cole of Investor Relations Advisory Solutions. Please go ahead.

Thank you, Ziko. thank Quarter joining business XXXX and review today update. everyone, Third Longeveron's financial afternoon, you us for to Good results and After the U.S. results Investors section we release the Longeveron which today, a of be for financial can the closed quarter, the under markets found website. third issued with press

Board. Chief Chairman Co-Founder, Lisa the Financial Locklear, On Hashad, Officer; with of Chief Agafonova, Nataliya and today me Officer; call Hare, Science Chief and Officer, Chief the Wa'el Joshua are Executive Medical Officer;

the reminder, call, Commission, subject cautionary you in forward-looking conjunction certain could this a statements Any should releases statements. These differ risks in which that to such making be As will the review. be our statements. statements considered to Securities and filings during we company's with discussed we uncertainties from encourage Exchange and results with statements to cause in these materially are actual press risk factors and

analysts. questions prepared Following Hashad, remarks, company's our to Officer. over the Chief the let open Executive Wa'el Wa'el? we the me call hand from With will that,

everyone, thank Thank Good afternoon, joining and you, for you very us Derek. today. much

sum the on quarter, are end bit the Today, organization. to to the a and which want continued talk of execution again up long-term We little accomplishments about aspects pleased I since progress our of the as you update strategy. can strong it all last across we also

story, to cellular As is a therapies. reminder, our regenerative Longeveron medicine for newer you developing of a company cutting-edge those

numerous opportunity $XX $XX needs the Our to opportunity areas, across a important that medical product development billion. is with pipeline addressing evaluated Lomecel-B potential X billion of and market compound, being treatment U.S. approximately a represents unmet

important our recent like for into Dr. milestone to get an Longeveron. Co-Founder discuss we to ask progress, Joshua would Josh? Science Chief Officer, and Hare, our Before I

and afternoon, Thank you, Wa'el, everyone. good

the founding the an mentioned, of of and therapy cell for month important This marks just the Wa'el milestone XXth As research. company have reached we anniversary stem our Longeveron.

therapies at medical research Our and to remains founding stem that back for unmet time the of today. was apply medical needs, vision cell vision regenerative deliver to our

hear you'll cellular making As our therapy the from we progress product great advancing candidate, research are Lomecel-B. and team,

treat Alzheimer's cells of the stem such diabetes, of Parkinson's, and cells. to degenerative XXXX, milestone as cell-based the heart stem spinal Key development. for disease, including injuries, the area significant use for marking open and therapy applications, FDA to techniques, Stem and the been medicine significant regenerative which new medicine, repair. create advances development call the to stem These organoids. clinical personalized lab-grown regulatory future past cell the like a We've signaling for stem of transforming a of core both remarkable increased and cell conditions, the wide our into therapy's solidification innovation progress pluripotent of MSCs, one adult from clinical stem field understanding promising has of exciting therapy tangible strides, stem types scientific is stem seen cells, candidate, the different delivering or range development Over potential Lomecel-B, seen medicine its regenerative At role door have we tissues made used disease. cell treat first induced cord treatment a medicinal approved to cells, decade, In outcomes. signaling including an cells, patient in of the organ and and and ESCs, frameworks. In embryonic breakthroughs, care. diseases of cells this stem cells, in the mini-organs, has

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back we our and do, will regulatory progress. Thank research, look I Wa'el. continuing to you, forward call the turn share we clinical over to to As and

Thank to past and by Longeveron industry you, the the by progress Josh. over both the see specifically heartened I decade. am achieved tremendous

accelerated accomplishments. with For has further Longeveron, been our this recent

As year, to pipeline. path a HLHS mentioned the the of approval probability priority have throughout is and success regulatory believe across the has our potential a HLHS We key high strategic we for program us.

experience were HLHS expect Xb as II, the Very Lomecel-B now meeting a acceptable enrollment, biological if application and accelerates data year license adjunct secondary the Because to company's therapies. manufacturing Lomecel-B This Devin He Devin a we ELPIS Phase in early Technology of the welcome potential him by execution. for submission if advance to to Drug study forward BLA next Vice allow of We traditional strategy endpoints. is Drug submission and II to well manufacturing year. would recently as of ELPIS the with to treatment has completed or with join confirm Administration and importantly, evaluating President as Senior us and on ELPIS approval a Officer potential December initiate which and supported II more end that and XX% working from delighted clinical for Longeveron alignment XXXX. C technology Food BLA I'm us regulatory a indications. opportunity, a in and of will rolling to as Chief has ongoing year CMC. is towards significantly in look to primary of than X Administration enrollment development Blass all and of II advanced achieved that our lead able the for which U.S. XX positive and Our full years complete or the reaching distinguished to we this of Type ELPIS the we on across Food with over pivotal and of

We important a We has also development. Alzheimer's our area historically difficult understand disease disease Alzheimer's to for continue been program. advance very

the the and MIND Alzheimer's In on medicine to X, the patients seen our only Conference, overall has the also the to treated were the therapy, Based of granted in for regenerative with trial are Alzheimer's RMAT and featured of Phase CLEAR disease. treatment Association placebo. trial, AAIC. disease. Phase data as be presented research results FDA to and RMAT showed the Alzheimer's we or therapy with CLEAR Lomecel-B candidate disease receive trial Xa Fast XXXX International designation Lomecel-B first have more most we Results worsening designation clinical a cellular Xa mild clinical for Lomecel-B. to presentation MIND clinical date prior encouraged Track Phase So prevention designation Lomecel-B the an appears at from known oral compared slowing

anticipate meeting in With these in first XXXX, of strategies the regulatory the quarter program. for clinical important this hand, data review FDA future continuing and with we

capital, and As activities. our definitely of resources maintaining Difficulty] our our BLA-enabling [Technical good investments and optimizing we stewards being advancing to pipeline clinical continue in shareholders' while

focused and leading expenses a We first operating declining X program months to on expense through the XX% have control prioritization, total year-over-year.

the be will Agafonova fourth to the program. fund are Nataliya? I provide With turn Dr. quarter of clinical updates on XXXX. and to that, through Our to expected existing to cash the call cash development equivalents sufficient company our

good Wa'el, and Thank everyone. afternoon, you,

As Wa'el potential focus to mentioned, is HLHS a in approval clear for unmet primary program of near-term a our us pathway area medical need. an with

also potential adjunct to reported II, reconstruction infants the safety Lomecel-B the X years with surgery Heart as trial treated I ongoing II XXst basis were data enrollment. issues clinical the the the patients Our in HLHS outcomes. ELPIS a encouraging Lomecel-B during ventricular our in HLHS, ventricle Heart, in and to reached positive I Surgeons long-term to This ELPIS This began being Lomecel-related evaluating right heart none trial the use included study. will selected data and XXX% cardiovascular recently, reported. The was than survival National the ELPIS through Annual Kaplan-Meier in Xb we ELPIS from have No were survival rate. adverse Blood Lomecel-B procedure for improve Phase served survival. long-term more surgery cardiovascular post-gland This a CHSF post-gland transplant. Lomecel-B with Lung HLHS results. potential transplant-free with evaluating presentation transplantation X-year I trial as clinical trial compared reconstruction grants Meeting. which was XX% the Most data Institute of following: ELPIS at pediatric to events survival I The findings through for X-year the support produced improve with program the No is heart function X XX Institute collaboration enroll major X.X% post-treatment ELPIS and XX% in Health. single Congenital of and National patients, required conducted Society, of Phase with

could of participating and and leading for clinical trial patients last pediatric with We not them the thank the they participating joined them We the and II for enthusiasm their all XX having with have patient's in site more family. for quarter. cardiothoracic do group ELPIS X as pleased institutions work their be the a

we working time support, that the this can line completing their that by enrollment the make With achievable. trial there of end towards the are queue and patients are of in year,

However, we control surgery. do from not obviously scheduling

the next So the we may first of in enrollment year. see quarter occurred completion

where Phase completed program, recently reached C a We the endpoints ELPIS X has we produced development HLHS II in mentioned, our Wa'el clinical the secondary data FDA meeting discussed it Type alignment with and on we we and As and trial. primary rolling FDA our If II very to are positioned with in ELPIS results positive pivotal for is a from be the able ELPIS that positive, submission acceptable significantly, is XXXX. II to confirm we would BLA were submission. initiate ongoing

clinical trial XXXX Xa our Alzheimer's a International were to presentation trial Data from July. now CLEAR Phase Conference at Turning end program. of Alzheimer's oral the at the research selected disease Association for MIND future held

of the be capacity improved trial reviewed clinical clinical provided We disease Alzheimer's presentation show potential in X results, an FDA for disease. Therapy, plan call Medicine clinical We are positive a and trial, which for following: just FDA the trials quarter trial disease. correlates disease our second Pfizer to presented patients the very Phase the results showed and before Financial financial to primary therapeutic trend, to the the Lomecel-B support October the next in safety Lomecel-B in will Alzheimer's the with in regulatory outcomes about XXXX. Lomecel-B for the development XXXX at slowing to for Advanced the in of the that CTAT have excited selected Lisa the endpoints Officer, compared insights offer and mild disease Conference, would disease. Trial Alzheimer's designation treatment to potential was and in reiterate Alzheimer's efficacy Alzheimer's results meet development. treated positive for the clinical and data and treatment Based We Clinical data the worsening Lomecel-B in July, with support Chief generated Phase previously. MMNPXX hand I achieved That of to prevention placebo. Designation secondary Lomecel-B quarter. the data Lisa? Track the therapy that first and year -- I believe X the strategy future mechanistic we RMAT has poster Alzheimer's Alzheimer's overall mild CLEAR on clinical late-breaking data the also biomarker trial Locklear, to Continue granted in discuss late inhibit program. cellular-based Disease clinical on our of in over of mild and review Regenerative MIND of from both our in Alzheimer's evidence-based Fast the

investments a in in capital is period quarterly months of ended This focused This for a expense were first both the through severance, revenues period months clinical has and generate the the X first Bahamas some of $X I offset in issued other for XX% by legal personnel the development which to annual and XXXX, release The manufacturing approximately R&D Nataliya, revenue in Revenues Total with on XXX% approximately our executed million. increased prioritizing million of due We highlights. compensation up you, X year due new not same $X.X and discontinue everyone. in areas. disease filed our $X.X $X.X in reduced our manufacturing our present XX-Q, need. running X trial but to we to up a result additional for Alzheimer's to primarily million XX% expenses in expenses XX, administrative costs Thank clinical frailty primarily good XX% in to our months to million compared decreasing in G&A associated the period once for for X was costs partially results lower the potential million when expenses clinical $X.X also months and contract we both reducing to and September frailty have and following This million. decision on will detail, trial it compared year, contract we same the decrease XXXX. $X.X approximately and approximately or decreased as XX, costs offset X-month of million higher financial was the so year-over-year, clinical reduced or or Form $X.X cognitive expenses, million report and expertise trial to our and $X.X XX, trial expense declined with expand aging-related of participant the and helping our $X programs press as have XXXX. touch afternoon, September CLEAR ended of stock XXXX, impairment G&A XXXX, management, for revenue. demand XXXX Contract the million, reduced expenses successfully manufacturing fully, million mainly result on expenses to $X.X for eliminating September registry business the believe team's was afternoon, and the ended MIND XXXX, Japan. completed our decrease activities approximately the operating

ended decreased net loss months $XX.X the XX, approximately to the a for Our I net $XX.X XX% million XXXX just for period reason in of the from X for explained. same loss XXXX, September million

note, activities accelerate capital and as CMC, proposed is in manufacturing includes flow fund requirements and will company result and XXXX trial ramped-up of expenses The raises, Our as to and successful. our II cash of pathway, We need and quarter activities however, currently increase support increase these manufacturing with impacted and have XXXX, $XX.X operating I options capital to a to activities, additional budget to respect as financing a up the well of of will any current submission with which enable To hand it with a readiness, believes XX, equivalents these BLA-enabling calendar we may existing as based now the to anticipate into. in to current funding be call its regulatory operating intend cash transactions current million. our the fourth FDA FDA further requirements to C expenses September that entered there these and non-dilutive be and the is activities cash cash meeting that Type current the investments. the equivalents ramp to were forecast. cash HLHS its initiation important the with controls on XXXX cash by we as expenditure expenditure projections operating extent seek It our spend capital will and our started if capital our successful ELPIS financing, XXXX chemistry Wa'el. through rolling back

our and of generated regenerative Lomecel-B to The you, the potential medical date a in and data indications. multiple The disease the data, Thank support like for in me therapy and Lomecel-B give experienced Lisa. as strength team broad would analysts. patients future focus the Operator, across now HLHS on significant to Alzheimer's and for confidence unwavering call of and committed we the Longeveron. open covering from questions

H.C. the with [Operator of The line question first from Wainwright. Selvaraju comes instructions] Raghuram

Ram. for anniversary. your Dan is on on This Congratulations

So an than what respect as path in the that benchmark, a current forward for in with disease? what's clinical disease-modifying Is the it Lomecel-B to initially would there that therapy? rather applicable, a trial shorter-term be paradigm would catalyze represent Alzheimer's approval? II positioning from a example, ELPIS for thinking symptomatic could accelerated a appropriate the And standpoint, the performance design

the But hope I So as it question. Ram, I know correct first me the if well. free feel don't not, to part I of got right.

FDA. we the with the So We a confirmed you lot assumptions. plan, regarding know, the as met of

the current we endpoint. accepted be approval, basically, with GMC the trial primary potency Xb So confirmed and for will existing secondary full assay, plan, the also and the Phase

a have we minutes we from one. have So this confirmation,

the Track coming will actually Designation a immediately use enrolling enrollment we'll data also we you designation, we We assuming submission, the have by intend to start. it, and get that which out as Fast from preparing you have line definition, and know, Track trial. allow the once started have, We of top Fast we to positive results finish that

hope part. question I go this I So actually current on the based assumptions, to allows that this your I Alzheimer's what is do. the to and think based feedback agency on before designation, the with but not a of answers us lot it

answer. a great was that Yes,

All right.

of and in weigh and recently most that with a actually to and have jump be my thought you meeting here. advisers Alzheimer's we leaders I'll lot Dr. And CTAD is Alzheimer's, and for might top from really even in world. can guys [Technical well I believe around so Difficulty] think But I the the very as these helpful something on there the external here. give regarding So unanimous the the think leaders, Hare the a and this continue one. Nataliya We development, you perspective need are thought -- and the feedback that patients at

get to have Of data today. course, we don't the approval

is over developed know, as developed is programs small disease. size. there However, programs Alzheimer's of of these are Many by now you in XXX right being that companies our

been very by something additional realized that useful. of if for we economical, to FDA all we and needed strategy. And whether RMAT to very therefore, Difficulty] guidelines, a Difficulty] if So funds proposed will [Technical program a partnership RMAT and is And do at our opportunity thing we endorsed do at very streamlined definitely operate investment tell why has other other that this to approval. But able of be allow [Technical CTAD, is accelerated make the it's very, invest year. these you approved programs the significant well. company market a The top we just or compete got good ask approach to you these a next funds, you we of the program Ram's actually with want any good companies answer allow I to really path and the feedback really done or to us We part by we're opportunity separate advance that is also this. more be is some allow for entities read positive believe designation and our entity you will or to about -- that We're your companies why from which [Technical advisers Nataliya how with streamlined us that had to and XXX the FDA the or the on is simple going come and as not being or a whether is FDA, public want their plan. government to path the want beginning to to on anything to working faster proposed a to very additional have that and of going government she companies have big plan -- the the where present question? would sure these ourselves provide helpful. thoughts, we Josh, you, have in The the whatever have the partnership actually do you're question would FDA this from really or are really got to this time Difficulty] Nataliya are to one And that our add proposing, is the with advisers. we that? and That in spend actually developed.

you Sure, thank Wa'el. question. Ram, for your

considered symptomatic would DMT. study, I just were I Phase a both the on recently CLEAR there we think concept conducted advice prior population you patient CTAD population. in development which remaining early. and our that which mentioned also is patient is our development. mild signal treatment study, proof as on disease-modified MIND It's was like to good a disease the because X on of clear It should that disease Alzheimer's got And is mild mention symptomatic. continue placebo-controlled, we Alzheimer's

I apply for and this hope patient plan we this -- question, Lomecel-B where Ram. population. your to we So addressed is continue

from ROTH Partners. Capital comes question line Pachaiyappan next the The with Boobalan of

long-term see So you that I have which respect follow-up, trial, firstly, fantastic. is ELPIS survival, really with I XXX% to

safety tricuspid So you the at that the wondering have that follow-up? of such you out are ELPIS or I years given RVEF any positive is might whether parameters -- cardiac this ELPIS trial regurgitation read merely a ELPIS was X measure as to I? additional similar ongoing to Or X-year end II able would indication

take want you one? me do this Wa'el, to

or question. that Josh take Nataliya can Yes.

for Boobalan, and very it thinking. important basically It's with our one your question. a you, Thank aligned

the post-gland had follow-up, Is that, are if X protocol X And up as set trial. we alive? or beyond you're basically, initially, collecting have If X Phase right. procedure -- was initially, questions. And and with transplant? However, trial additional it of no? time. we absolutely that passive -- call patients we only patient surgery, after So no the heart open-label year I at patient ELPIS completion we data have the called this sites Yes we

However, ultrasound understand It [indiscernible] us help fraction or data ejection on on enrich more MRI we navigate if data to help collecting granular exists, submission. will us basically actually. will BLA data we do by on all that

So we I entertaining to with are and this right now back data idea of support investigators this ELPIS gather retrospectively our for investigators. go

to we survival only answer currently, So your survival and transplant-free have data. question,

this to However, gather retrospectively. we are entertaining idea more information on these patients

these data if do to trial you sort have get to you some So and clinical from because approval it's additional do patients a go wanted that after at alive participating feel least I my in retrospective X to to in you watermark view. manner, back years, protocol is HLHS, Because do in -- trials? high of were Or which new agency some the need a get revision? really

it was I convincing not convincing that would case is more whether your it but just make parameters additional less curious now, convincing? more make would So it

go to our very order collect cardiology collaborating more guidance, package and investigator particular guidance, who are in II get this to enthusiastic to have we enrich just We effort to revise in we data sites. provides our actually but this don't And we have don't we And right now, back to contracts back agency. with our ongoing go who trial agency. should Absolutely. And complete. is indication, need the one on to is his currently ELPIS what

for back but agency yes, to have to we -- So that. don't go

thing ELPIS for only talked time. was we historical, about a I sites. it about conducted for I know I, on X The Just ELPIS haven't long good

only had almost One of of half patients. them the

ELPIS It's I think work sites the of as as So the II. a don't number with to sites. it the big taken is in not

to are to able So this said. data, collect be we're we Nataliya that hopeful as able

no you can your the trial current a And is the focusing then you what which you benchmark some in a tell ejection will endpoint, context right. which the -- right drug? the agency be All I in But is pivotal such probably Lomecel-B so got that Fantastic. about us RVEF, at ventricular and benchmark with make be your more provide be juncture this discussions ELPIS this thinking? speaking trial? and efficacy exists will of comfortable can on with to terms would fraction, understand then without least nevertheless, your II, date you your that given you pivotal attention patients feel maybe of what's all on RVEF maybe is could this color, What provide the the maybe expected of field. pioneer you that, at HLHS feedback the can and some based and and

Wa'el, me do want one? to take this Yes. you

fine. ahead, you that's go Nataliya Yes.

in Thanks, Boobalan. And chime well. Josh, please as

add I'll Yeah, a few.

And So great question. as again, you're speaking we thought.

So have we evaluation the for and conversation meaningful sufficient in would clinical fraction with ventricle a right agree X be FDA, year they response. very ejection that not did principle after Gland procedure of the

out in clinical about appreciate. Josh, of there I'd if endpoint. And ejection But you exercise in well a addition endpoint. to be simulations And right composite speak as ventricular final right to fraction, fraction, primary the we're outcome agency. final did will agree they points clinical principle, flushing and ejection to still measures adding are ventricular we to as the So present want specifically

a the ventricular really, important well-established The HLHS here Yes. difference fraction between for surrogate right ejection is patients. the outcome the And will care in standard patients. treated of be and

agency very supportive standard the that the a higher, ejection that that as is is ventricular I clinical has we in idea combine right of with important reiterate fraction the higher the very which is in said the well, care the Nataliya -- survival. finding. But do to treated of endpoints was patients statistically that such as I if what be want would think than significant significantly number considered

we that that ultimate highly is what the difference in II. see ELPIS survival encouraging the I think the will for I So in be finding ELPIS

And I question, if then one Okay. maybe Great. more may.

whether think heard want might just search you VentriGel. I'm you product changed in HLHS I was website. to I the of have trials it, called some meaningfully doing landscape the There's has Josh. your a recent past. So sure high-level thoughts get competitive quick in clinical

some point, at curious, Or what be could I'm do thoughts? be, So competing your you are preliminary think Lomecel-B? with VentriGel

substance an planned. sure -- prevents I'm enlarging. about is does you that VentriGel. a I'm they am correct the being VentriGel, prevents a trial if even X is heart inert it's I from what basically not yet the really for substance. It's remodeling. It aware it If that have Phase data it

I isn't endogenous structural anti-inflammatory, Lomecel-B the an difference effects, of affects multifactorial includes that our and again, replication. is that, components the antifibrotic think ventricle, myocyte major stimulating VentriGel strategy the VentriGel pro-regenerative action, the substance a strategy the potentially whereas which has inert between and just pro-vascular,

I mechanism of the very, of So is think the different. X action that strategies very

So believe be a would to novel as into by you strong guided competitor. course, I you always strategies, But have of enter kind of data. the these it don't be

will data are our shows. the particularly new data about data, we So we from excited the ELPIS survival very I. And what obviously see

you. Thank

questions, no are hand there now to As for closing comments. conference the further Wa'el I Hashad would over to like

Thank Thank the on call interest we to now. and look And who greatly call as you. to you and may today. our updating forward continue. Thanks We right you, end you attended we progress operator, all appreciate our your support.

Thank you. This concludes today's teleconference.

Thank at your time. lines your You may you participation. disconnect for this