Earnings call transcript Q4 2022

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Operator

Good morning, and welcome to Longeveron's call today to discuss the company's 2022 Fourth Quarter and Full Year Financial Results. [Operator Instructions]

I would now like to turn the call over to James Clavijo, Longeveron's Chief Financial Officer. James, you may proceed.

James Clavijo

Thank you, operator. welcome Fourth and Year and everyone, Call. XXXX morning, to Quarter Longeveron's Full Good provide update of a results will we Today, business fourth and for and quarter full year XXXX. the financial discuss issued a found www.longeveron.com. be Investors Earlier this the morning, press with which under website these our of release section can results, at we joined am management today Mr. call team: following the I by the on Longeveron's members of Chief Officer; Dr. Executive Hashad, Wa’el Chris Min, and Chief Medical Dr. Officer; and Officer Chairman. Scientific Chief Co-Founder, Hare, Joshua Mr. Hashad will begin corporate a Dr. overview, with brief Longeveron's which by clinical Syndrome fourth follow review review financial a year Left disease updates from results. our full and will Heart programs Min or and of Hypoplastic aging-related I XXXX Alzheimer's HLHS, and frailty, quarter after will

Q&A. call Lastly, we the will open for

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

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

Wa’el Hashad

us you company, unmet joining Fourth full biotechnology XXXX and medicine for for to Longeveron business clinical Quarter James. financial you, medical Longeveron Thank and results. morning, regenerative everyone. Thank Welcome Good is developing update needs. stage today. a

has to broad of I'm made multiple Chief lead already date. key indications. advancing excited Longeveron as Officer. that across the investigational to been Lomecel-B great Lomecel-B, XXXX by have productive We joined executing our multiple and progress the potential the recently had I and therapeutic am honored Executive product, milestones

outstanding I rest the build team and of this beyond. XXXX look alongside to to own working progress forward Longeveron the on for

product These to cell literature signaling healthy essential specialized mechanism. isolated a endogenous known called XX it the are cell cells of product cells Lomecel-B, investigational made lead from MSCs XX. from bone specialized is our repair medicinal living to or aged and are Our young donors as in marrow a adult

have Lomecel-B complex perform new and has action multiple to rare ability range of to tissue. to regenerative may a regenerative. They for of hone known a the provascular and factors immunomodulatory number injuries that sites aging-related or anti-inflammatory that of are and may that functions, also believe lead including MSCs form secrete bioactive are broad disease mechanisms We of responses and to application therefore, diseases.

fourth the continue aging-related to In quarter suite of rare and of advancing XXXX, make our for diseases we in progress Lomecel-B diseases.

currently known have randomized also relate. II II improves conditions our are Hypoplastic of the trial infants and study in controlled We Phase conducting as HLHS, Left ongoing Phase we this Syndrome, HLHS, Alzheimer's aging-related In life-threatening determine condition. II ELPIS to disease Heart Lomecel-B with whether

quarter. this the Chris conducting additional patient our of expect In our now Chief program. we study study we our over addition, first program, and Medical progress the updates Min, II clinical aging-related made on to Japan provide in turn will call this the I'll by are a to in Longeveron's Officer, Dr. in in Phase who frailty Chris? randomize end

Dr. Chris Min

Thank you, everyone. Wa’el, and good morning,

program. begin I'll HLHS update an on our First, with

affects Left pump or this approximately heart's year underdeveloped an blood. with United HLHS in HLHS ability X,XXX reminder, States. born infants congenital left ventricle, per People the a heart is is always untreated, a to condition As impairing rare fatal. that defect absent the have

long-term of of pediatric XX% with short-term are an burden interventions, to elevated X, and even The surviving for organ to at adolescents. children before XX% complications, current failure, standard HLHS between reconstructive X young treatment of with these development only surgical with including somewhere of operations comprised Further, risk age patients. care these mortality, extraordinary delay the

beyond of additional gap tremendous properties There proregenerative, for current when intervention the a by fill with its performance standard need patients and surgical care, can administered and that unmet concurrently improving provascular that exists in with anti-inflammatory interventions cardiac Lomecel-B we with HLHS. believe

is are currently study conducting which in randomized We controlled a Stage to II Lomecel-B during infants administered surgery.

and functional into is The [indiscernible]. study the on HLHS, [indiscernible] FDA fraction, for Based X-minute is condition. with in an study the Lomecel-B with HLHS. endpoint previous this disease, Phase Our approximately product has procedure, cell in endpoint I consider the fast drug the with XX treatment this the of administered designations intraoperative of patients primary injections track best pediatric orphan ejection granted rare for directly

XX. [falls, even combination Unfortunately, weakness, the Aging-related on vulnerable to more to associated are is a of Next, and individuals loss, among elderly the the with that age elderly, population aging-related XX% associated affecting frailty such and an in sizes associated frailty frail is slowness involuntary of include that across typically systems frailty age may leads our an I'll cope This to factors,] inability multiple manifests reversal over and weight move outcomes loss with the or several frailty as States, fatigue, of to hospitalizations common muscle, United up physiologic Aging-related decline in sarcopenia poor to as death. aging-related of and systems low stressors. the infection, clinical program. individuals function on millions activity.

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

of is Japan, populations focused development the oldest world. clinical the currently on frailty in which aging-related in has strategy Our one

for Geriatrics with continue the and in we University patients patients Juntendo in Tokyo. Hospital screening evaluating partnership frailty Lomecel-B Nagoya aging-related This Center Phase Gerontology II quarter, our Japan and for and National in in study with

the evaluate Lomecel-B. the study infusion dose X study placebo-controlled, of Medicine, on a II overarching single treatment the Phase of of Lomecel-B X-arm of with parallel the as different Safety therapeutic of support is aging-related to The of for of Act double-blind, levels clinical a therapies. is objective providing under safety recognizes primary trial eventual frailty, goal randomized, design Regenerative or tremendous limited an ASRM, potential cell for which the an approval The

enable our enter ASRM through in small, approval combined us efficacy a expect trial of market first to an the treatment established patient amongst in on a could patients expectation need potential us our based data a an can and of Japanese as in to Such be A patients in frailty. approval select crucial sites, Japanese quarter. population well-controlled safety demonstrated Phase would randomize this with trial we previous Japanese this with Japanese the clinical conduct unmet administer aging-related addressing to allow at aging-related frailty II Lomecel-B for the which

like Phase enrollment our Alzheimer's updates IIa I'd trial. In of to announce Finally, disease November, completion program. of pleased our cover we on were the to

trial called to CLEAR evaluate Alzheimer's reminder, and is a this trial X XX-patient randomized a mild with multiple Lomecel-B design, placebo of As infusions designed of the the disease. trial, of single to X-arm in parallel placebo-controlled safety different MIND compared Lomecel-B patients levels of and dose

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

to Secondary and biomarkers and magnetic resonance course, vascular exploratory relevant systems actuary imaging, endothelin include endpoints inflammation volume by cognitive measures of and, brain function. of

we shown previously neurogenesis, new disease like formation Alzheimer's the anti-inflammatory process disease. a for duration study of function robust of progression blood prevent, slow cross disease-related Lomecel-B data, contributor Alzheimer's reverse study neuron we of by and in Lomecel-B Ib information. to even MSCs potentially disease in our the the In of the cell of Phase Alzheimer's in promoting on brain. to followed months. in Lomecel-B in an and Based is a brain study wild-to-moderate have reducing X early Ib pathogenesis with with the clinical safety of -- preclinical significant Neuronal endothelin disease. clinical may caused a the of and demonstrated the patients substantial models patients, believe Alzheimer's or improving the patient effect, Each In is brain been by completed death neuroinflammation alzheimer's barrier study preclinical Phase preliminary

With to this trial, of we body build hope this Phase IIa on evidence.

With Clavijo, full share over expect call our fourth to Officer, the discuss the to to in that, results now XXXX. James? We James Financial year for top early of quarter and XXXX. Chief I'd results turn the our financial to like line

James Clavijo

be primarily Revenue in $X.X during in million December same in difference clinical compared quarter million period 'XX. The the Thanks, a December XXXX, full revenue of analysis Chris. XXXX Most to due revenue. fourth in more XX, covering the XXXX. statements $X.X will to was in of year quarter of The detail quarter and presented ended and and our fourth what financial condensed morning the this I'll year XX, XXXX. discussion be management's ended the operations decrease trial our for was fourth

to was XXXX of treatment clinical participants travel decrease $X.X this decided compared $X.X XX%. grant $X.X of million 'XX, 'XX Revenue was or the $X.X as compared due which compared to our available a increased year was Clinical $X.X completion compared for in for due funds the million trials. During of to 'XX. fewer XXXX, XXXX 'XX to XXXX. million million in as COVID-XX to restrictions as of grant-funded of 'XX due compared primarily for million million million a $X.X the $X.X was $X.X the in trial revenue quarter, for million for an to increase effects part having to to on XX%, or full Revenue reduction decreased. Participations in some

million the related allocated administrative of million was and and fees. equity-based in $X.X compensation G&A was equity-based $X decrease million a million were decrease compared 'XX for to for a million in expenses expenses of the 'XX. million to decrease for full to related expenses or compensation in same General General $X.X expenses to 'XX, XX% million primarily $X.X were $X.X compared professional year $X.X period in or quarter and approximately decrease XX% of $X.X The expenses. 'XX of primarily approximately to the fourth administrative

a professional the expenses million increase Research related and XXXX. period fourth $X.X recruitment, employee million, compared million]. benefit to $X.X did quarter were in of XXXX fees by and increased increase the and in However, expenses to employee expenses [$X.X million same $X.X million which for in development included by $X.X insurance

that R&D The were due $X.X trials and primarily Selling million related to million to from decrease were of the not or XXXX development increase expenses, primarily of research compared year and was in XXXX XX% $X.X clinical expenses completion decreased in to to XX% XXXX increase full or by reimbursable an equity-based XXXX. of the marketing development and million million research for in which by expenses million. development expenses completion an and not million trials $X.X increase related by allocated of The offset grants. to grants. $X.X was XXXX The in for increase increase reimbursable the $X.X were in to to of million and clinical XXXX. research was that quarter expenses in a fourth were $X.X compensation $X.X due

and and related of primarily administrative in during expenses general to reclassified reclassification or XXXX. XX% primarily year of expenses. million prior million the and recorded The million expenses investor XX and in investor decrease $X expenses Selling as were on million and digital consist they were marketing for marketing selling year as full were as as Further, XXXX to public expenses. decrease and Form for XXXX, in Selling compared $X.X XXXX. relations relations marketing marketing presentations expenses that to $X.X were the disclosed Note $X.X and of in expenses was due a and public XX-K

loss net XXXX. in XXXX quarter the the million to fourth was period compared same million Our for of in $X.X $X.X

$XX.X XXXX. full the year was for loss in million $XX compared million Net to

$XX.X and December was operations. million compared was period-over-period a for short-term of XXXX, of decrease use of respectively. XXXX cash million in to cash XX Our The investments as in result funds and $XX

received well gross in of resources, cash initial As into expenses offering the and investments plan and of proceeds be in we first our over cover and quarter offering capital sufficient that public placement $XX.X XXXX private existing to December requirements XXXX. we our Based short-term on a and the our reminder, financial from during February XXXX XXXX, will company's current subsequent believe operating million.

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

Wa’el Hashad

James. you, Thank

we in the I open additional and have in today, As to we and now forward updates momentum like here you to questions. building for this progress XXXX, strong look on XXXX. call sharing made would are

So operator?

Operator

Maxim from The from Instructions] today first Group. line Okunewitch [Operator comes the question Michael of

Michael Okunewitch

remestemcel-L Wa’el, guess We first so in in congratulations there recently -- for activity some I GVHD. accepted the BLA off, on coming was recently that this aboard. Mesoblast the guess, saw FDA space. for I

takeaways any your you see applied a I'd to already workflow. programs the to refiled if or ensure are regulatory to So their that like from BLA new more there streamlined have inclusions in can

Wa’el Hashad

a stab related will ask I this, Michael, -- to any and add will additional comments answering also So I take but in this. Chris to

foremost, -- typical specifically FDA than is we have the other encouraged that diseases application that for Mesoblast. regulatory from fact of faster definitely accepted by and First path rare to the the much that believe are And for indications. definitely the approval we conditions

here to We results to our concluded. doing we're comments at achieve FDA is But Chris any -- will an his I are meet indication the and once specific achieve if for on it with trial trial hope all being are we possibly that -- filed add get have right from potentially let side. to the in to to we Longeveron, criteria doing hopefully able the the the setup

Dr. Chris Min

Thank you, Wa’el. Yes.

any to be immediately. or we Michael, changes made certainly adjustments So haven't frank,

application our indication. indication out an indication would definitely cardiac are setting We ultra-rare that their a point closely. is and I

have we we a eye that -- definitely We glean on from anything our close approach. can we're leverage forming their strategy try will and to that own activities but and keep Mesoblast's

Michael Okunewitch

HLHS color on as it's regulatory provide on bit existing interactions you you the enrollment the I'd mentioned, and to if an a could how FDA, with ultra right. then like program, that disease. your And rarepediatric All more view given just you pathway see

is think would approval need to help unmet additional support full you you even do So how study or accelerated significant would the potentially need us given or an here?

Dr. Chris Min

that you allow question? address to would me Wa’el,

Wa’el Hashad

Absolutely. Chris. Go ahead,

Dr. Chris Min

Okay.

points. good not questions. about would are those a certainly Michael give I those answer And definitive So

we the be Phase those the that However, out study, on the I there with that agency trial, if it the regarding study represent. that this potentially current given would depending avenues ask rare future pivotal these II designations, there have ultra-rare indication, of potential agency ask -- a acknowledge, you is a to what the completion is would pointed disease to aspects do to and even II/discussion communication of as our that even prior track outcome of as of outcome fast study to before could a an utilize end of has and disease, could submission. questions are orphan of we intend Phase the Because potential of we access to the positive serve that planning our the questions study

agency so pivotal will as -- study, it And will definitely we of the so possibility that our don't study, about presume for as but we serve approval designations as consideration the ask and such a on. those such a pivotal accelerated

Michael Okunewitch

focused study. X right. All on it's then wanted smaller for I of ask you to me, for Which most Obviously, alzheimer back endpoints And and efficacy? study. evaluation but is I'll hop function a queue. just the on key, the are the last in

So the measures I'd and the like at your take to anatomical how you different biomarkers get on that evaluating. look importance you're of

Dr. Chris Min

definitively per high in looking, glean cognitive enhance central such endpoints. the determine to that order and we're can. signal, a small taking is assessment that that we're XX biomarker we volume, then get a with key certainly would patients several also in blinded And for best magnet, the we trial determined the So arm. pointed are being we the combining [Tesla is endpoint terms of efficacy, to to try anatomical high-field project In approach efficacy to volumetric by a which is read the into in out, obtaining combining hippocampal the of endpoint efficacy that ability global of resolution we MRIs] as you trial, we're wouldn't an where combined almost

efficacy glean to combined measures cognitive that to combine so these to with an imaging try we're going signal. measure And

Operator

[Operator this There waiting additional no time. questions at are Instructions]

any pass So Wa’el over I'd like Mr. back to Hashad conference to remarks. the for closing

Wa’el Hashad

call. Thank like you. after their reaching support have thank Thank the And On questions we'll and behalf for a to Longeveron and would of additional day, great interest everyone to you. out the company, everyone. any for I continued definitely, be

Operator

call. today's concludes participation. conference for all Thank your This you

now disconnect lines. your may You

Longeveron (LGVN) 10 Mar 232022 Q4 Earnings call transcript