Longeveron (LGVN) 17 May 222022 Q1 Earnings call transcript

Hello everyone and welcome to the Longeveron Inc. 2022 First Quarter Earnings Call. My name is Juan and I will be coordinating your call today. All participants have been placed on mute to prevent any background noise. There will be a question and answer session at the end of the presentation. Instructions]. [Operator like Investor call Relations. now Yau to turn Stern from to will over the Elsie I Please you Elsie, may proceed.

Longeveron's a the Executive Science by M. the press Green joining our of website Today of Management pipeline. Thank will and www.longeveron.com. I'm Chris you, this first a Dr. first will and quarter call. our these Dr. team, Earlier updates for finally will which welcome And Chairman; Officer. section quarter and everyone begin and review release morning, clinical provide we to Chief we provide Chief to Geoff can Min, Longeveron's financial of Chief Officer; financial operator. with who first Mr. quarter a our followed the Co-Founder, Clavijo, Medical Officer, Good investor results, Green, results call James business update morning, following Clavijo Hare, today Dr. by Chief discuss XXXX. the overview, Min with issued will be Mr. members found XXXX under at Joshua Officer results. brief Financial corporate XXXX

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

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CEO. Dr. Interim Min, and for Officer Now it regarding programs, our future I to Chief updates specific clinical Chris? turn Chris over Medical

for endeavors. wish of leadership sincerely work you we and you, in dedication, I provided. luck thank say company future your Geoff. when entire wish you Directors you speak the best to And for I of and hard the Thank I have the Board

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and living, exploratory We of cognitive well which specific endothelial as vascular endpoints, activities volume. include inflammation systems, also secondary in to plan biomarkers as brain daily and relevant to evaluate function

anticipate on including of We top the rates have updates the date. open at they're patients and the a and enrollment, we VA, five enrolled several for trial clinical provide Miami providing will already in and XX completion enrollment sites later guidance trial,

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poor funded is clinical associated symptoms that Geriatrics measure our To and placebo partners on combination function. with single cover we stage study individuals Frailty infection, stressors. on we in the multiple have dose signs the Center in initiated Frailty, their of program older as individuals. the frail initiate loss, affecting slowness, a have hospitalizations frail individuals This been to early partially first and and as of falls of Lomecel-B manifests over was Frailty particularly trial an Aging include to end, we age evaluating Aging levels definition Aging and that NIH use. that the the vulnerable exploratory we infusion age Tokyo. concurrent activity. the loss trial in of been grants sarcopenia, efficacy. to Gerontology exploratory cell at population Hospital National among the treatment such specific program. and by At through over function several stage systems, have Unfortunately, clinical XXXX. power effect. frail of This on study, Frailty high an flu study, HERA XX. placebo, is physical Aging This millions and have investigator an the for fatigue, safety are and Juntendo of trial double of Frailty, blind XX% research our and to in to trials a reserve vaccine immune using for effect University randomized, is clinical of conducted Depending our robust to called up Lomecel-B patients death. as with or as remain of United biomarkers a X exploring muscle controlled stem to that half function Aging a study Frailty Lomecel-B function more not is in a like may Lomecel-B In inflammation an of our outcomes system several and fund with I'd related involuntary Japanese elderly Maryland's in primarily States, is adjuvant we from Phase infusion enrolled Aging inability small and common different leading weight the the elderly, and track Nagoya, low to seasons, to being for influenza patients, weakness, Longeveron and cope compared vascular as decline physiologic Finally, is early conjunction health and factors, dose elderly the endothelial two of that across associated to typically exploratory on An evaluating of

for the related However, and as effects aging frailty. panel well extensive immune as we are look physical biomarkers potential of endpoints system to to function analyzing other an on

year. we to quarter now the updates that, meaningful for turn in data are With of anticipate to I'd clinical Financial the these trials reporting forward currently the James? our year. of top half discuss Officer summary, to steps to analyzing over like to look trial the to providing our XXXX. this the line three first results our programs call Chief James Clavijo, results throughout financial have and made In advance and of We we first ongoing the

morning, I'll XX-Q quarter our today. in condensed detail be will XX for in the morning presented Chris. In Form management's Thanks, of what more filed will be be our everyone. covering Most report Good statements XXXX. and on discussion this financial of which March ended analysis and quarterly our in operations

difference was each in period to For quarters the were or $X.X derived the XXXX XXXX follows. compared XX%. as an registry trial our for trial $X.X of Clinical revenue an increase the same quarter and and of million first was revenue $X.X XXXX, of was revenues quarter from XX million approximately grant XXXX, our The to Bahamas in million of first $X.X revenue in clinical trial March XXXX first million. ended due in increase

negatively first related revenue. trial concerns continued this travel to was COVID-XX We While impact quarter. the in registry impact during lessened believe

revenue March in period stock to short X the $X.X based of professional was loss in on reduction trials. period XXXX, million Geoff. the compared compensation The plan compensation decrease operating and million in our $X.X primarily trouble operating that, First small as for period General funded due the The to XXXX in million X% funds XXXX. increase and or grant $X.X or XXXX. The in XX% XXXX, quarter available $X.X by million in completion quarter compared for and and and of cash to cover decrease due million of financial first same for X.X for period a you expenses company's Based to were same related expenses the I compared XXXX decreasing of investments were the $X.X sufficient quarter. in options of XX%. The decrease $X in was million term requirements and a Cash approximately short the Net $X.X million during $X.X decrease development increase million million less expenses the current insurance XXXX. half expenses of to RSUs not granted in cash and thank the turn result the expense quarter XXXX, a $X.X million was grants for grant equity grant back the to to was was same period related XX respectively. than incurred in expenses first over to during of be the to grant first With the XX and revenue despite due to is call we clinical million was current an period same first or of quarter to compared period believe of reported and million increase XXXX, completion capital will point $XX.X Research administrative and for clinical reimbursed compared research investments $X.X $X.X trials. will into the primarily of the and development insurance. and of the XXXX. million in resources, existing primarily over million prepayments XXXX in that term are that the

James. you, Thank

updates So -- I you've today, made as progress providing in we you've and think we've look if strong forward heard year. the some additional the first quarter throughout to

like believe for I Now we'd the open call to questions, operator.

And the from Michael your Please Okunewitch of Michael, now question Instructions] open. comes the is line Group. first line from [Operator Maxim

start like color out first see Lomecel I differentiates more to here could bit a being and of find other developed off from broad if what on MSCs the you kind there?

to Officer, call. morning, And question. on Dr. our Good the Science being ask Hare please. Chief for Thanks thanks to the like address I'd the Sure. Michael. for question

differentiated one production Geoff. MSC be you question. differentiated on the for another can based thank be products Thank MSCs the can from -- you, And process.

in field the the product the So is the is that adage process.

by has approval. -- required a been So formulas use And also therapeutic elements assays the are critical our cell FDA protected trade it we information. potency refined are take is Potency through that our secrets. the based assays process to are our us,

on you. assays their really one similar where surface regulatory the very are. they the what produced, use appear to may So by on products judged in and authorities how uniquely different associated another based produced, companies, while Thank with they're to each potency they're be are

that. Yes, much. appreciate very thank you I

an primarily Lomecel-B using like HERA specifically, more ask impact as leverage? is what what to Lomecel population looking evaluating that immunity The this and you how trial you're And in Are when you're by at as mechanism about adjuvant? the produced vaccines? are an looking other underlying I you evaluate to the thing then the will

Yes, sure.

let a gets overview kind Dr. on So, brief sort this of a this. give Geoff. and Dr. Hare Min, is specific I'll of

a spanned infusions. this Lomecel-B and seasons over at multiple individuals times after older the frail specific study shortly So flu who enrolled flu vaccine received

hypothesis immune it's something older -- systems typically science. immuno called a immune rather complex have for individuals frail who In improve or it's regarding the status. diminished Lomecel-B to potential So study, generating a

the impact advance in So assays, infusion flu evaluate Lomecel-B objective evaluate to production. receiving also on antibody the changes well adaptive vaccine B or in T-cell was immunity production the and as and inhibition, safety and hemoglobin primary to adaptive of as but immunity HAI measures included

this since study to enrolling kind these findings we've already specific to allow a results Hare, designed to this would the our that of announced the more evaluate Phase Lomecel-B Dr. frailty, frail on Aging of Michael's that potential So completed were us to on elaborate measures beyond population. study. various impact we Xb Frailty was from compare question? And of

thanks for the Hi, Yes. question.

things responses Lomecel-B cells. do an with at of form study immune one cytokines the using reenergize single they And exploratory mechanisms, me basis The frailty identify about cellular of features specific These coupling of be of host issues we're of those are try the with immune to to form pleiotropic And the address enhance the can of release to mechanism studied. a action of that the of are events to pin because therapies four of interactions that the they hetero, a transmit that They to to action, regard through fashion can older with mechanism is know Let tunneling studies and the to complex of as of host down indications Lomecel-B. exosomes, have the which for and aware immune combination of impossibly cell have individuals we asked system growth responsive system in immunomodulatory. of With Lomecel-B. the four an we form tissues. least vaccination, they as four can specifically, this is cells nanotubes they cells based our mitochondria, and re diminished types mechanisms responses. you that more, mechanisms choice with factors cell host infusion release these which a immune issues believe of living well which organelles purpose They our such action.

thank you much. color. appreciate All the additional right, very I

Thank you.

comes question next Group. [indiscernible] line Our of on Maxim the from

line is Your now open.

question. taking for thanks guys, the Hi,

alpha you look you've TNF just know I at I in forward. to any discussions had wondering Aging study. looked biomarker at Alzheimer's, for was Alzheimer's So the guys Frailty if the in going

I I'm sure to question in So continued Chris to question measure the Alzheimer's? This subsequent Min, in sorry, make are CMO. just understood is is, by the way, the studies is, TNF we alpha

Yes. Chris. Hey, Correct?

Yes, continuing TNF Phase we currently there do We to X our are alpha. in challenges the are X this -- Phase -- with study. in enrolling

don't we that we development decision haven't to -- to continuing So that a but specific are we everything made measure. pin to biomarker, in a use as

the as Frailty And U.S. in or Thank great. study? the Okay, you. less more the study the Will Japan. Aging similar same dosing be

Geoff. is this so Yes,

XX and So be the XXX are doses million. going to million

that this is differences basically These in So the the did we and decision Japan body to in tested States. as the those versus United high -- the in decision doses Japan was in go in physiology the in not We collaboration range our subjects U.S. in of upper that with mainly U.S. mass trial. were the and based on based they're in the are similar. made partners discussion and as

as not not we're going as high. but range, quite quite dose same So

Makes lot Thanks. sense. a of

line now [Operator your Davides next Please Hutton. on EF The Constantine comes the from Constantine, open. line Instructions] is question of

morning. good guys, Hey,

apologize one, caught quick ELPIS I missed there? out I about you for that I enrollment expectations just can the this, extending II, for if talk HLHS something but about a just in Just the expect And from experience But of into that comparing I. that how to we ELPIS a upon expand little program? when then terms enrollment is the bit XXXX. could readout think

for as thanks the Hey, for the Constantine, question well. call. Thanks

hospitals not trial you Chicago and coordinating Cancer may that got NHLBI, name is at that's, consortium in for that that are collaboration in the the the of we But part have Texas. the with So Children's the these partners exactly of of Hospital enrollments the conducting the center grant seven Health obviously, and conducting the as we're patients they has this patients, of the Center have right. tertiary trial. of specifically Lurie responsible at University know, care Center

have XXXX coordinating that and enrollment centers for seven trial, by all well The is activated the as for So, been into the enrollment. provided PI for centers, into target XXXX.

enrolling XXXX. so But of are, going seven that quickly continue we observation. like to what the infant, enrolled. of all kind centers, a few be each they're really monitoring stage, centers, seven, XX we'd it's of to all enrollment how you And we based is of this enrollment infants quarters see get to a understand, we understand able know, And at speed seven should all on all like which worth we'd year to to expect what therefore well has these we at into

So year depending on of last expect enrolled, infant data. then when And observation. thereafter you is can another hopefully that the shortly

see So, enroll. now, short the trial that's we what terms right of that of will understand you when readout. But we'll would this sort stop predicting in at guidance a

But it's XXXX a event.

Basically.

I think a point. at this reasonable assumption that's

Okay. And cell There's asked as curious a programs. you therapy or it programs platforms attracted Thanks Chris, color a way. to to ask different if maybe specifically lot cell is a the Longeveron? one just I'm to particular articulate saw is little what therapy that just a you similar this bit. say, of an I'm something previously, out was for something then but a it outsider, wondering, you about And there. question technology there, that the can is that in

I year built he a been fact way to approached the may in is a was The specifically the analysis that. the at study up already. Dr. as things, time know, And gone very clinical Lomecel-B, wanted a curious that The despite as that the to. Longeveron, of that you're reported I that which And significance development of were was and particularly, last Happy about and statistical to sure. in got of difficult, sure And this I conducted, the not been adult thought that differences by answers have ad one that a the that months, I something can has pre-study nine promising frailty impressive really I'm endpoint I that have end getting generated thought have history, approval. come really there hope and the And we work, I that something to I walk I results efficacy best careful was when hoc is with not although aware the dose thought kind seen companies way achieved Hare’s and number I MSC platform. results you like question. hypothesis. need all your demonstrate pre have the final the I while Yes, and have for clinical impressed was the was specified six-minute the was was was impressive, investigations really I response. part quite know early of. therapeutics be thought first

great. you. That's Thank

currently Thank questions. no We you. further have

So I final for back over Green any will Geoff remarks. to hand

Great.

say behalf great wanted a support a day and we'd weekend. everyone for I'd on to you wish continued the like and Just to and like thank in company, Longeveron, interest thank their to of great and everyone

for much call. Thank This joining. so concludes you conference today's

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