Longeveron (LGVN) 11 Aug 232023 Q2 Earnings call transcript

Greetings, and welcome to the Longeveron’s Second Quarter 2023 Earnings call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is recorded.

It is now my pleasure to introduce host, Mike Moyer, Investor Relations. sir. you, Thank

begin. You may

operator. Second Good welcome you, everyone, morning, XXXX Results Longeveron’s Quarter to Conference Thank and Call.

morning, XX, We will for Earlier release June results Investor results, under which of discuss and a can this with XXXX. be these provide a the our business quarter website. update we press issued the found financial section ended

with will and a Financial quarter. Ms. for Officer; Joining progress clinical Mr. Wa’el team. Mr. brief of Natalia Longeveron’s Natalia Chief begin results the Agafonova, management call Chief today by the corporate Lisa overview. Medical will second and review in Dr. Then programs Hashad Locklear Agapitova Officer; Chief financial XXXX recent Officer. following will Executive review on Longeveron’s Locklear, members the its Hashad,

the prepared questions company’s remarks, to analysts. open will we call the covering from Following

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

turn of to like over Mr. Officer Longeveron. I’d Now Executive call Hashad, to Wa’el the Wa’el? Chief

Results Call. Quarter Welcome the Second Financial Business good XXXX Update everyone. morning, Thank and and to you, Mike, Longeveron

our medicines unmet today We with medical and needs. are process pleased to you speaking sharing for be look regenerative developing to forward

investigational on at of Directors in our called raise the progress capital. has product offering Board team, our terms marked Our lead of Lomecel-B, programs clinical of productive by second for to enhancements rights leadership our our to been our goals executing in our and Longeveron, quarter initiation

would I new the Board of and review new our like quarter, members. colleagues my to beginning Before introduce

joined industry. our XX experience I introduce First, biopharmaceutical like Directors. over to about would of of in Board Baluch, who global the geographies He recently has Mr. Khoso years

served Officer our a Board for CorMedix pharmaceutical biopharmaceutical a Mr. industry. multiple member independent Executive known in as U.S. in Chief Baluch well companies. company as has served and publicly He He for publicly the an and in is very director recognized traded traded

Second, Business, he organizational Professor a Mr. would is II the Jeffrey joined has who where multiple Mr. Board Dee Thomas the on serves co-author introduce like boards to since Stanford Pfeffer, behavior and University, recently XXXX. the currently and taught of organizations. Pfeffer our nonprofit Directors. of XX D. of School He’s advisory at for I Graduate books. He of author

She where her development am and Chief development the Agafonova, Officer. and pharma Pharmaceutical, cellular our executives served clinical development is I X Nataliya leader Medical experienced Dr. pleased us lead today as Otsuka are product our chair. clinical and biotech the she from also new joined our industry by we to joins therapy have development program. lead She

Pharmaceuticals our business President the an Locklear, throughout Chief Officer. Financial Otsuka, from Financial and respective Senior as biopharmaceutical Chief President Executive Lisa is welcomed She Vice leader us Vice joined professional and subsidiary industry. the also I’m Avanir and accomplished Lisa she with finance is served Officer. where of experience

guidance unmet behalf team, areas me in as Lomecel-B welcome our and they let decision have Longeveron at advance Natalia I’ll to be of but need. Longeveron, say leadership a am turning we join the Lisa call on made to how And forward that pleased I of critical everyone to look in our team. them the moment, over We to their

to endogenous of young to are cells, built-in XX. cell or isolated The our the from age As cells XX and known signaling the specialized living specialized from adult made essential a a marrow product MSC, or are medicinal reminder, Lomecel-B repair bone literature biological cells donor in is as healthy mechanism.

the sites immunomodulatory the including been They injuries and that of have tissues. diseases MSCs complex also have formation regenerative. been a hold of to shown shown number of succeed factors to new functions respond body, perform and bioactive in to or and are

We of believe regenerative therefore, broad lead multiple action ranges potential aging-related that anti-inflammatory, has of a that be may Lomecel-B rare provascular, have application to may and, of – and mechanisms responses diseases.

HLHS, and enrollment syndrome, to in XX% heart HLHS left sometime pleased disease, its we hypoplastic and trial the ELPIS enrollment Earlier that II in trials that exceeded ongoing threshold as and expect we has trial priority. aging-related Alzheimer’s known XXXX. have were We also announce today, complete our to

line on Phase our Phase also II report top MIND priority and of of are Alzheimer’s the by frailty IIa results October in Lomecel-B enrollment track, anticipated in in XXXX, CLEAR to disease from continues aging-related treatment Japan. trial We study

of potential medicine We a of needs. about about regenerative and progress range making a for Lomecel-B are excited the therapy the unmet as broader we’re

and I And Dr. the our provide Natalia? turn overview Agafonova you will clinical with that, progress. of to recent programs detailed call more over to

much, today’s team update update to our to with clinical our Thank I’m and pleased you on provide on progress. begin I an very Wa’el. join Longeveron HLHS program. will the

The the per is heart, which defect HLHS birth underdeveloped which X,XXX For condition those who in either endeavor rare affect year babies omission. may condition the children construction severely severely ventricle not a the left United complex, X Babies diminished heart years approximately the congenital a know blood in have of X-stage States. of of to the over lives. flow, requires process undergo systemic first born their surgery state course which with this

While XX% support unable survived required surgical right which failure, individuals lessons other only ventricle to adulthood to these to intervention, is the due affected came of increased the often to systemic with load children circulation. XX% handle into now to

to successful patient development as outcomes. need short-term improve of medical function Furthermore, risk including long-term late an an mentality, and intervention ventricular is these important surgical improve long-term right at such, to are complications, children organ even both, with unmet in those short-term and elevated failure, there patients

Our trial patient XX designed is safety assess care Lomecel-B standard trial controlled ventricular long-term efficacy clinical Lomecel-B of therapeutic Phase of HLHS surgery. an to II to the a the right potential improve to is and ELPIS outcomes. trial of as evaluating function and II adjunct The

change Heart, measure baseline primary ventricular XX The months. National is ejection funded right Institute fraction outcome The from in the grant National is Institute. to a from a Blood of by Health, Lung and trial

ELPIS II has announced its enrollment of As trial threshold XX%. we recently, our exceeded

of activation X the originally site location, than X the announced clinical also We planned. X more our

mentioned a trial XX in ELPIS additional I concurrently As on in achievement This Phase Lomecel-B Phase study, the in ELPIS the around Stage put Lomecel-B procedure. middle I children of I us the with with X participated and activation site injected the Glenn of XXXX. trial builds earlier, also was early I trial during I the track surgery called study on this a of the study HLHS. complete enrollment of as this patients milestone to

All XX patients have been after monitored for at years least treatment. X.X

from years this this data XXX trial follow-up that of ELPIS announced was showing who to I for heart in long-term year, age. earlier survive up X participated trial transplant remain Additional free and

methodology Glenn with results the have clinical with to by compared XX% typically undergo trial As showing procedure HLHS, five the children the of years XX% who historical age.

potential in encouraging as highly I transform are ELPIS Lomecel-B cell reinforce HLHS. data a and preliminary to patients care treatment The with for

believe in this the highlight we indication. may potential have Lomecel-B further To

and standard HLHS. webinar to care suffering patients virtual a discuss current the host medical will unmet we of X, for Next need from

interdisciplinary Hare, event Joshua Lurie The and in the Chairman also Ramkumar of Dr. of Hospital Founder will Stem feature and Keck Kaushal School Dr. feature medicine. of Dr. of Institute Miller Medicine. This Southern and will the from University School Miami, Cell of event Subramanian Co-Founder Longeveron the Children’s of California University Director of

the details Lomecel-B and AM HLHS limitations This we August of at the the standard are will Registration of Wednesday, parties join and event encourage us potential an current discussion XX be informative on XX care interested Eastern website. available all Time. next in to of about

I’d Now believe by on clinical value various reversed We preclinical reducing clinical to data Disease progression Based prevent to disease-related slow like of from growing sources, may the inflammation. and Lomecel-B disease our Alzheimer’s of on brain Program Alzheimer’s move and

Neuron similar has MSC’s brain. Alzheimer’s promoting and barrier, brain caused cellular significant neuroinflammation an function pathogenesis is disease. inflammatory Lomecel-B of to cross the with neuron of Alzheimer’s substantial been death characteristics and blood shown to neurogenesis, also disease, potentially a In in in fact, process the of IT model the by the with in to the earlier contributor preclinical improved formation

of trial called Lomecel-B XXXX, IIa disease with to The Lomecel-B trial trial completed the of to multiple dose disease. placebo level designed and of different patients randomized single infusion November is safety Alzheimer’s of MIND parallel mild trial evaluate patient, a of CLEAR Lomecel-B compared Phase our X-arm for X IIa in clinical In XX Alzheimer we mild of design, Phase enrollment disease. in

serious measured XX after adverse by primary given events, safety, is endpoint of Our of as first days Lomecel-B. occurrence administration

measures cognitive I Alzheimer’s mild we endpoints of function pre-completed exploratory relevant patients systems. with radiological disease. have Secondary safety Lomecel-B Phase and and and to endothelial a demonstrated inflammation and study, preliminary In of vascular include biomarkers

this we results IIa CLEAR analysis Alzheimer’s? trial Phase and to October further ongoing, MIND trial, anticipate the for build With potential from a from Lomecel-B around XX. is demonstrate of Data we top results hope disease. and line sharing those on the as trial treatment

characterized fractures, inability and poor multiple our such death. and like Aging-related this frailty across activity low Finally, infections, decline risk on cover It clinical puts outcomes, high to at even as leading payer and is I’d cope falls, program. weight fatigue, by individuals mobility to and weakness, loss, and the frailties transfers. aging-related associated updates to age system hospitalization physiological slowness for

effect biomarkers health have trial, we’ve their function measure and patients, inflammation and physical Lomecel-B immune endothelial elderly system. of been on the we been Longeveron, early function on exploratory may to effects. frail stage vascular In particularly of At and using evaluating of have and

one frailty in with development the country currently strategy aging-related oldest clinical in Japan, world. Our of the in is a focused population

is country. million XXXX, of aged older, frailty XX comprised among be of X.X%. XX.X% individuals XX.X of to the representing demographic or prevalence The population aging-related overall the of Japan’s estimated As

trial II with the infusions. as XX single aging-related in trial of different is of in as the continuing, The patient the split quarter, parallel is Lomecel-B trial a X-arm expected of Phase patients. Enrollment clinical priority X X:X:X randomized first level dosing we design evaluating well our Lomecel-B enroll Phase is Last Japan. placebo in to announced and II patients

an of or recognizes an Act goal which for with therapeutic Japan safety potential of the Regenerative evaluate limited overarching to is of of endpoint – tremendous eventual the Safety therapy. support potential providing approval cell primary under ASRM, The Medicine,

to XXXX. June I’d Lisa? of six-month that, financial ended to period the XXXX Locklear, for like the and now With turn our discuss our XX, results Lisa CFO, to over second the quarter

morning this be on Natalia, today. in analysis to covering and quarterly Form Most of speak part Natalia, in statements will of and of condensed what which more presented operations, will all I’m financial Thanks, Longeveron in be you In a good our detail, XX-Q, discussion everyone. our be to excited today. our I’ll report of morning, Like and filed with be management’s

Revenues months was for the $X.X revenue XXXX $X.X XXXX to for decrease respectively. each ended and a $X in completion XXXX June $X.X three XX, grant the reduction in grant-funded million of part the June million, due million XXXX and were million, Grant The approximately primarily was trials. respectively. $X.X and of months three due ended and XX, of to available clinical the funds

the June which three decrease $X.X participant $X.X million of compared in in for for XXXX respectively. million, derived a or the XXXX and lower Trial $X.X period the ended to XXXX revenue, was Bahamas a trial when ended June was from and three approximately Clinical as same XX% million is result XXXX, trial Registry demand. revenue XX, the XX, months Clinical months

in Registry resulted June months Bahamas XXXX million revenues $X.X $X.X of of related approximately and approximately ended gross profit XX, three for the for million The Related the a was $X.X in and and the cost million, from the XX%, and million of to was three June XX, XXXX decrease months or $X.X million decrease respectively. earned $X.X ended Trial. respectively. revenues This XXXX, XXXX, primarily

to million in $X.X million General $X and the million XX, fees. and primarily approximately increase to June $X.X increased expenses expenses related related an for to XXXX. XX%, of months was and in compared $X.X current The expenses for the period XXXX, year or same period during ended administrative benefit compensation three million, the professional increase to approximately of

not period in XX, Research approximately expenses $X.X for million to in increase June $X.X grants. XX%, of from was months XXXX, ended the million three million research primarily an increased were same This by and due increase million, or development that development approximately reimbursable of to and the $X.X expenses for XXXX. $X.X

months six respectively. XX, approximately for $X.X period three-month the million, loss the and the Net XX, XXXX million $X.X ended – expense $X lawsuit and XXXX June three XXXX. XXXX for was Nonoperating for months approximately ended and was June

six-month period, in revenues Revenues XX, to approximately the for period or for ended were and approximately million, respectively. follows: when months XX, XXXX same million XXXX. million, and the results For as XX% June and XXXX lower this of the $X.X XXXX, $X.X June $X.X were period XXXX were compared each six

Grant grant XXXX reduction and million or compared same the to period completion June grant-funded in primarily months ended $X.X $X.X XXXX, for respectively. and the a XXXX, available period in trial. part XX, less revenue to six in approximately of $X.X to this clinical for due revenue the million, when million was was Grant XX% lower the funds than due

months June the derived Trial, and for in million, $X.X this XXXX period Bahamas is $X.X respectively. XX, for million, Clinical million six ended period approximately $X.X XX% compared was the which or lower revenue, trial to when trial XXXX. Clinical was same revenue the Registry XXXX, and from

six XXXX, the months During decreased as participant revenue of ended a a in decrease June clinical demand. trial result XX,

Related million the XX% $X.X Bahamas June for respectively. $X.X period corresponding in ended and a the million $X.X from and was of Registry of months revenue the approximately the earned XX, the for six $X.X approximately period decrease XXXX, XX, million This in respectively. June to resulted $X.X due and Cost primarily gross XXXX, was revenues XXXX, XXXX ended and million in months or Trial. comparing XXXX, profit cost of million with less revenues six

expenses. XXXX, approximately $X.X or compensation $X.X XX% and the of compared to of XX, expenses to to six in primarily approximately same increased an $X.X $X.X million for the was General benefit ended June period in months for million increase The administrative related and million million increase XXXX.

reimbursable $X.X months $X.X approximately June XXXX. increase Research and XX%, from The XX, million development the six $X.X to an expenses the ended to for of increased for in increase or XXXX, was allocated due primarily period million approximately same million, increase development $X.X of $X.X and manufacture million supplies by and grants, an were equity-based increase expenses of and in to research in not development in research to of expenses that $X.X million Lomecel-B million. an compensation

Nonoperating months and June lawsuit approximately six million, was $X.X XXXX XXXX $X the expense for and ended XX, respectively.

XX, loss for period Our approximately the million months net XXXX, ended for net $X.X from XXXX. loss million a six to same in June increased $XX.X of the

of had of and cash equivalents marketable XX, $X.X cash June $X.X $X.X million. million As the million, company of of XXXX, securities approximately and working capital

equivalents $X.X As cash of were cash December securities $XX.X approximately XXXX, million, working $XX.X XX, and marketable million was million. and were capital

the expenses our investments plan operating and be of cash short-term requirements we current believe XXXX. first the quarter capital that and cover company’s will financial and on Based into existing sufficient to resources,

of $XX as of SEC of company shares Wa’el, common up to turning offering to to the registration be to over Before holders XX, filed XXXX, that determined. conduct on warrants common million stock for and purchase record tradable future remind shareholders to to date with rights statement stock a A subscription I’ll everyone the June a a Class

shareholders registration and The to in undertake as expects believe We capital company this us to opportunity the rights shares. We all participate capital. while to is and offering existing to balance not outlined for remaining dilute needed statement. offering cognizant an the to close believe allows raise need the to the raise

turn the over With call that, you, and thank I will Wa’el. to

Lisa. Thank you,

Lomecel-B we’re X As have today, steady indications. you in progress heard making advancing across

webinar key forward and looking Lomecel-B our In assets. week. highlighting to the opinion leader are next We HLHS,

mentioned, to it’s for XX, now the like August Wednesday. has Natalia open As questions. would I call

line analysts. for the open our please covering Operator,

with Group. Please proceed from Instructions] first comes Michael [Operator question. Okunewitch with question your Maxim Our

Hey, taking my you here. question thank for guys,

the II get rare like anything take confidence additional your given both ELPIS give decision Mesoblast development first pediatric inform do guess, but off, does disappointment as HLHS? of just a study? was does I on So this you to for a Obviously, in disease, it in the And I’d FDA’s to your that placebo-controlled this space, Lomecel-B future in for for design BLA. you’re the

will on answering can then comments. add Natalia I who Michael, And I add additional or will also have I also step question. that additional any Josh, comments first the take So have any

from beginning, HLHS as a pivotal program But I are conduct the that our trying say we would to trial.

requirements to going met that doing that make hopefully no between accept to is FDA provide balance it We is are happen. there everything the sure and definitely trial that, for Having guarantee the this filing. necessary ratio to benefit-risk said this

know, matter the a data, in was conducted for you of medical the And of the body that but not that always weigh overall of need the disease of typically well of significant the As evidence study the as review. it’s itself as body evidence. unmet disease, just FDA in

were conducting second, XXX% HLHS their Mesoblast So while in one, their due I products, cannot different our on a And draw a approval maybe it’s really we parallel disease hoping to to: that the state. way. different get are we trial

my So Josh with any let to further add comments will comments. to Natalia and/or that, I

Thank you very much.

sorry, – Okay Josh.

comment then to Yes. I you. make you, wanted and to it Thank turn a over Natalia. I’ll

aspects and I a of trial HLHS our that there need is an conventional be it critical is one so that best think fashion. conducted rigorous care trial to recognized is a is the in which blinded arm, about that active ongoing controlled

FDA has And of think commented is crucial critical this that the I one that’s on aspects the for field. that

that I from Natalia, – you. are to has the want II please ELPIS Thank here. key that take group. we And it emphasize trial do So control

you. And use but as learning it’s a indication, Mesoblast. FDA you communication that’s Thank are they Wa’el much, Josh. to And always completely from indicated different Thank so good definitely, and practice precedents. between

I’d you II ELPIS need to on you to insights much have very here additional kind And the of like a for demonstrate as for just see study? to then would serve you if any a pivotal result what Thank right. All clarity. additional

we at the our end X% it’s Michael, primary benefit-risk remember, fraction. of as So small the is endpoint the ratio. ejection ventricular day, about right as believe, Again, improvement, a all

it’s really I hit an but think specific if not run, it’s So one home the it’s measure overall body. a we

added be benefit, an on the also have rate which Survival encouraged from this could follow-up seen were we we one. the on that results

rate, fraction I’ll profile of But consideration the that agency comments. again, the product course, on it to the right any will important Natalia up be in of ejection in for add the weigh survival both and safety to to leave ventricular So indication. addition, to

no Thank comments. you, Wa’el,

make may a comment? quick Wa’el, I

ahead. go Josh, Sure,

Yes.

key understand disease in studies to left very outcome, going years now. heart – over very, back forms failure between One heart things been shown clear unique well of hypoplastic about the association that that’s adult and from a clinical of function ventricular there’s is right XX

So the very poses correlated II valuable clinical therefore, is fraction a outcome and, the Stage surrogates. surgery decline after with ejection in a very closely

and trial of that’s not efficacy in this designed Our placebo to ejection Lomecel-B per value is conventional great interpreting clinical so to that Lomecel-B finding be see the condition. of placebo fraction to patient – in therapy, look groups or surgery se, think the whether both increases and relative could but we

me, I’ll that could II, as All time hop it more approaching into completion right. the see and enrollment remind back One of of like you for completion if data I’d ELPIS sometime enrollment we’re lines the in XXXX. and between us to for expected queue. just

Michael is that Michael? –

Yes.

enrollment. it, finish Yes. expected Michael, we to we the as we – announced

mid hopefully next targeting We’re year.

site the predict in of a to of when. But new to lot it’s plans with program. rare the enrollment you diseases a there know, to as with hard guide our thought exactly course, is Of try

endpoints happen year provide should finish to X the it after Once after after couple from the the and then This months enrollment, results enrollment enrollment. will of X the within trial trial – trial finish we that the take better and finish measure close year it.

that event. All right. forward And to looking I’m KOL

you. Thank

floor There the are this questions like would I time. no now back to for further over at Wa’el to comments. turn closing

and and continued interest behalf today. Well, All like gentlemen, Longeveron wish attending to the so our you you your Ladies team, thank would much. right. thanks, a today’s I call. good All right. for for the and company Thank you. everyone, day and of thank all you support On

concludes This today’s conference.

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