Longeveron (LGVN) 14 Aug 242024 Q2 Earnings call transcript

Good day, and welcome to the Longeveron 2024 Second Quarter Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Derek Cole, Investor Relations Advisory Solutions. Thank you, sir.

You may begin.

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

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

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

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

me over let the that, call Hashad, to Chief Officer. hand With Executive Wa'el? Wa'el

thank the is The which strategy make pursuit in On experience well a important advance I our Good patients joining execute this dedication last Earlier Longeveron we develop and fourth Thank research. you, the to in today. us impact. implement attempting would and the strong and team everyone, detailed an expertise year, vision. for reasons by for and much and to our on focus the the treatment. this are you letter One, Longeveron in of science. the for commitment to we impacted my and afternoon, four ability laid the foundation confidence very concerted diseases vision shareholders, team of our to a most out call, this And the drive we in our Derek. our and quarterly that

as on quarter, to across continued update I can I'm pleased accomplishments organization. of up first the the you sum which the all end aspects our of and Now strong progress very since execution

our for As cellular as those a a regenerative reminder, of therapy. to company cutting-edge who medicine are story, Longeveron new you developing

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to an CLEAR these MIND continue presented held work designations Association forward difficult with is the Alzheimer's clinical is of Phase and review the or AAIC We XXXX important overall the slowing showed will steps. Full in patients look but on clinical received Agafonova disease very compared understand Conference, has area that just In highlight, results research worsening are starting oral in important FDA been International next prevention featured results trials that for presentation IIa Dr. Alzheimer's a to development. treated historically was the to to clinical the trial at honored have the think I treated of it trial. a placebo. We an from Philadelphia. Lomcel-B the were disease

to Lomecel-B. strategy meeting results seen So we encouraged before only and with review we hand, anticipate the in we future are program. for regulatory year-end this FDA data this to with more clinical With have the continuing with date important

mentioned contract the as As overall expanding our in strategy. call, manufacturing part are I we of last operations optimization resource our

a cell assembled enable us technologies develop team experts that proprietary to and approach systematic have We a improved take rapidly of therapy. to

feet Technology Life at of X clean Miami room as ISO X,XXX feet X square in containing development, Park process areas rooms and space. consists and well as of ancillary facility control X,XXX GMP Science space clean of square and quality state-of-the-art Our warehousing

for we from as full manufacturing are gives organization. the other approved if scale, using not an trial While manufacture commercial in expertise presents this additional and opportunity us the demand for facility capacity and capacity. pharmaceutical currently and clinical the company's facility use us Lomecel-B for to are potentially facility's This capabilities

performing has expand business annual our our offset and the revenue the We generated we million revenue. first capital team $X costs already to experience are helping up under work in We $X it's once in contract contract generate fully, and but running to development clinical eliminating and the million potential $XXX,XXX manufacturing have and over additional approximately believe our not reducing, needs.

our on Lastly, remain optimizing focus focused we program on capital, tightly which stewards of control good and shareholders' resources prioritization. expense and being

first the the through expenses XX% operating down total of year are year-over-year. half Our

company a quarter I of updates and expected fund Agafonova are provide will to the cash raises call the XXXX. With capital the existing in cash to Following program. July, to exercises through turn our fourth warrant our that, clinical development successful equivalents sufficient and to the in quarter and on second Dr. be

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

congenital left the over potential Wa'el nearly of of heart heart our underdeveloped us to a requires heart severely first stern current is birth of either focus which years their or possibly X life. highest process pediatric success program it syndrome HLHS, a is a heart As treatment the hypoplastic the for The we ventricle effect in as mentioned, reconstruction with infants left missing. and primary is is the probability HLHS approval. complex believe undergo surgery program the X-stage rare to

to There to comprehensive XX% function XX% unmet impact due infant this is long-term medical infants and need right and vaccines both treatment, in to improve important survive to ventricular of clear to this short- patient other only ventricular with failure. outcomes. positively Even right

of collaboration clinical designed Lomecel-B ongoing to X I infants II, to function free years to assess and XXX% were experienced basis National mortality Blood Institute Phase for ELPIS survival study rate Lomecel-B encouraging National in Institute the with Lung control that through II grants Heart, ELPIS to data ELPIS right and IIb is transplant demonstrated XX% as I long-term and Health. Lomecel-B improve approximately trial in up Our from of compared of observed during of Stage the Phase receiving serve age historical conducted data. The surgery, infants the the HLHS being from with the II the highly outcomes. I trial ventricular ELPIS our after potential in

of do infant an we bringing for principle the investigator country. Participating ELPIS in clinical June, premier of as across Health additional Organization mentioned, pediatric Hospital of of and II institution ELPIS and Atlanta for a II University and could Hospital, clinical be not part Children’s active maximally Texas the University Health, participating enthusiasm of John Children their Children Children's Utah. work Nebraska, ELPIS children's Chicago, institution has patients investigators Wa'el all signed. investigators As they and participating from them preparation and included more then, patient's Children's Children's Ann We & meeting in investigator meeting Care their as an together their of Hospital became and Boston Katherine thank for site Robert and for officially of Primary for Three participated School at at families. H. group pleased Colorado II. Since Lurie their Hospital Hospital staff in Children's Angeles, hosted trials trial cardiothoracic treatment Los Medical McGovern with recognized

that now for of meeting HLHS both this we ventricular community enrollment an the before program, unmet the outcomes. license improve in the with reached feedback the from infant, are biologics this in need function long-term is enrollment short- impact trial we anticipate of positively XX% on expectations recognizes medical have of and Further FDA C for approval. that their development and cardiothoracic support, believe potential advanced there Type this year and important pediatric completing end end right strategy With trial by application, patient targeting to year. We to the BLA the the

in Lastly, important to look for data of HLHS, the sharing this we post-treatment quarter anticipate and X-year completion information. third I ELPIS year that forward

program. to now disease Alzheimer's Turning

research discuss. Conference clinical have Association selected trial, Data at July. IIa We to the oral held teams end Alzheimer we Phase CLEAR presentation multiple International of the at for from MIND featured exciting XXXX

in the of safety in demonstrated Lomecel-B biomarker significant The the with We in future placebo. results. In statistical functional July, by trending prevention imaging improvement placebo and has and in study associated study disease compared in showing statistically leader. results meet slow CDR-SB improvements trial regimens achieved relative both cooperative for primary slowing RMAT points excited in patients cerebral in Phase improvement are disease MRI was prespecified an infusion-related worsening ARIA. Administration cognitive I Montreal Fast and and designation results group plan data absorbed incidence of granted end XX% to Alzheimer's hypersensitivity to activities Assessment abnormalities, efficacy mild a on keep before as trials, clinical compared daily FDA and placebo. in II Alzheimer and Designation program. our low Advanced and positive Phase established in of year-end endpoints clinical amyloid-related generated of brain the of in blood to have clinical significant cases FDA was for the Therapy, trial, to and of to for statistically Cognitive of There data the a Alzheimer review single flow. Based demonstrated clinical reduction was very Lomecel-B Brain MMSE. The decline Track dosing compared secondary reactions that disease. regulatory improvement Regenerative multiple specific demonstrated loss, shown to significant placebo the for Lomecel-B volume statistically and strategy Alzheimer the no Medicine profile Lomecel-B treatment overall about shows the safety the We and on Lomecel-B

MIND of kicking to CLEAR will disease results the for the potential over Lomecel-B Chief Alzheimer provided support in disease. We mild our believe to discuss Officer them Locklear, clinical second development. I to currently to support partnership are We development hand evidence-based of results support quarter. the of functioning the for our treatment the therapeutic Lisa in that further call and financial Lisa? Lomecel-B Alzheimer fund non-diluted from Financial and

both Thank This our issued our and quarterly present financial in and good XX-Q on of afternoon, Form release Nataliya, detail. everyone. afternoon, a press results we report which you, filed

a our Bahamas and Registry from with XXX% So and on Contract months contract million, new Frailty ended raising. Revenues including successful million highlights, increased first I management services XXXX to manufacturing and $X.X for $X manufacturing will XX, revenue million result demand manufacturing participant Cognitive first up June our contract or Therapeutics. half X our of compared when of for as of contract the touch XXXX, capital mainly $X.X were manufacturing some Secretome the trial XXXX, the the business revenue. expense in half for first was Impairment

for to year, in both program business in we successfully As our believe prioritization this opportunity $X up plan we $X our indicated, that make of state-of-the-art management. expand and is million expertise there annually. Earlier GMP to expense we discussed to areas. executed Wa'el facility our area potentially team's And of use generate and revenue million this significant have to to focused

decreased ending expenses in the June million $X.X declined total reduced months same expenses X-month XXXX, million. The for R&D for approximately half $X.X compared to clinical for XX, was expenses XXXX, trial June XXXX. million G&A with Alzheimer's MIND X following associated completed trial the CLEAR aging-related with reduced the expenses due for operating decreasing Japan. $X.X our decrease clinical frailty the period approximately cost XX% XX, year-over-year approximately in to million or activities $X.X discontinue XX% to to and First primarily decision period trial ended disease to also the

million, as June for gross $XX.X from June June net in net April months loss the capital of X $XX.X Our approximately of Cash and in cash exercises XXXX, period $X.X XXXX. equivalents to XX, XX, XXXX, ended same in following were proceeds million warrant decreased for million $XX.X resulting and raises XXXX, the million. of a loss and

In offering, a July $X registered resulted in proceeds we which completed XXXX, direct of million. gross

to fund warrant operating existing We expenditure certain Joshua? existing equivalents and fourth current Chief the believe their Additionally, our our the Co-Founder, Officer $X.X will hand expenses cash our cash XXXX Board. estimates. I generating of over warrants capital spending now Chairman our another exercised and will on and proceeds gross quarter million. of based Joshua the requirements through Science holders July, Hare, call of Dr. in

you, afternoon, and everyone. good Thank Lisa,

continued research growth advancing from are product we and team, veterans making recently added our As Longeveron's to to Lomecel-B. fortunate are cellular candidate, have Directors. evolution, you've Recognizing the great heard and Board three industry lead of our we therapy progress

transfer brings operational whose Hajjar failure scientist, methodologies spurred world. whose Roger scientist the Dr. gene academic cardiac investigators executive. for a cardiac therapy discoveries First, by utilized incredible trials as recognized experience currently for and have directed an He's gene and clinical internationally are around heart

Therapeutics Mass Head General knows as lot R&D Director appointed Therapy we're of quite at Cell here inaugural the Gene at a what and recently he of at and Longeveron. Ring So about doing He was Institute was Brigham. the

professional various licensing new a & his Vice Licensing Director increasing and Business second Incorporated. roles and Our Corporate spent was involved Development XXX of is entire development Kender, career He transactions. more Company is Senior responsibility of who at at in retired corporate Rich and Merck than President business Merck

Director, completed and years & XX served previously Wa'el having over collectively to Neha Stifel experience, She Longeveron care at back will and look investment Motwani to roles And Finally, time. the collaborating Healthcare Thank to turn William health individuals add were value X.X billion. I believe Truist recently will these you. Banking responsibility Investment investment of over banking and Company, she held Blair. banking raising has call of forward Cowen tremendous and most with them. over to of transactions USD all as Company, Managing increasing Oppenheimer at Securities, the Board this Financial I three with

to everyone the here impact why we opportunity working hopefully to would analysts. patients open day date and we across to to solutions supports indications. Thank patients broad and committed Longeveron. What Lomecel-B call for as every future the give our questions multiple them. at day HLHS a needs. Operator, drives positive Lomecel-B our like confidence Therapy potential the for therapeutic in the for from and a covering strength data are Regenerative out of have Hare. unmet and The data, Dr. Longeveron and of you. is the team day focus these are experienced generated unwavering Medicinal on you, in for They in now me the disease in really The Thank Alzheimer's develop

Instructions] [Operator

of question Selvaraju comes first H.C. from Wainwright. Our Ram

progress. important Congratulations on all this

in us you to to disclosable patients Is close this of enrollment II it respect top give guidance, previously in ELPIS the accordance when some granularity we Can your potentially end of the are trial? you remaining XXXX? And enrollment could assuming more from study. expect to completion take? of with the you see the with reported how data do Lomecel-B enrollment? around long line before of completion Firstly, How

Wa'el This Hashad. Sure. is

our everyone, our best remind the first, want of on is projection to So I you ability.

predict as to course, easy timing with there rare you diseases, Of is exact to grow. way no know,

the trial year. give patients we but still accelerate the question. closure second exact closure the from bit. that you the a changed. the your our patient you specificity So targeting this hoping are of things give recruited. And not X vary remind we're from new we that are We're definitely, being that, not that specificity the And then around But number will the enrollment addition around year Nataliya will -- can to can thing to also end the enrollment it just has that of Nataliya to of little more I sites that as the is far, of more you heard can I or last Nataliya and the is follow-on to give with you in, want XX%

you much, Thank Wa'el. very

As your thank you, question. Wa'el Raj, for mentioned, and

we XX Wa'el currently, patients. As XX of mentioned, out enrolled

So we remaining XX patients have enroll. to

new are to that will enrolled the help expedite enrollment. We hopeful absolutely to trial we clinical the just us sites currently

the XX primary the last design for So function evaluate effects months way patient enrolled. the endpoint the the we that after

for we approximately, scenario. XXXX for as quarter filing first the in looking So best probably of are

from you as data ELPIS-I Lomecel-B are that but understand enrolled can longer-term it would generate secure with the endpoint, necessary be about certainly be just additional the imagine from us patient. you follow-up amount obtain ELPIS able remind would I in to key of respect XX-month the to data could to patients follow-up the you follow-up be regulatory of what approval and expect the do to and of HLHS. And study, I study. long-term of that to you And follow-up part expect followed who what

additional some get there. to wanted color just So

much. great It's a so question. very you Thank

right. absolutely You're

data I. patients August of procedure. full end collecting year, after have from patient we Glenn completed Stage procedure, X-year this long-term We on XX In II are follow-up will ELPIS August, the

of of not are information for year the only we transplant, might safety, Heart of a year hopefully, it's survival data year did we data data last be and survival our the and American survival in you the support transplant-free the such but rest we is to And BLA more included as in Association. rest transplant-free most can see once the type a support presentation. survival this definitely data, actually endpoints present full the long-term can this So that the looking for have on the future important submission patients. And

on Great. then disease, Lomecel-B wanted Type front. outlook you the Alzheimer's the just was comment B respect meeting respect originally to can shifting state then to And seek confirm bit on you the the changing that on to a regulatory you would indicated the And with to field. I Lomecel-B? little there what with maybe of

Lomecel-B of that and you potential possibility example, context. And are You from contemplating how that of into mentioned how thinking NIH lack advance patients before and a on. from within abnormalities which with if to with that the earlier clinical of perspective. timing so Alzheimer's may further competitive see the treated initiative, But you and I doing advance also you're you like, funding the important are for any to in if positioning nondilutive development from the ARIA wanted data routes understand Lomecel-B the we final is about study better HLHS actually pursuing

first like of to the you part question? would the Wa'el, take

Yes.

will meeting in, we're try the regarding HLHS there regulatory So the if I works We're them well of can any of program, super review you with division the Alzheimer's And the the me. just separate while division, forget remind parts with to be Raj, process. and of here, are the well. meet as as or first, I planning the will those as super is different meetings. by on But be could same the the reviewed actually on and depending indication question, sometimes both to both questions division multiple

and has before designation Type part for plan to that it received, prepare Nataliya done a from minutes But to the the the have and agency. end of for we'll the update get we the and to of end by year. book also year. The with one That was the prepare takes the we meeting meeting, timing know, know, we time the the the has comes can you hopeful RMAT same meaning, HLHS once mentioned, as requested briefing from have as in. FDA of you thing happening takes this has you B which we're As us that place

want and are process the very discuss other a finalize very important Alzheimer's be RMAT on could there both front significantly as streamlined it's we know, could to moving needed and BLA So of breakthrough an what we the approval both important first equivalent is be that for plan are that's regarding cost and FDA because is before the a our one with could to HLHS therefore, to And with because, them our and be streamlined the designation, forward reduced. approach the because you going believe that regulatory with well as disease. path we outlay a this of the

not that FDA plan. and we we will meet know agree with that the on Now until

needs, heard possibility And funding In other of from private NIA well. as terms time. are funding, as looking others is partnerships multiple pursuing, and of at yes, also them as all you as have also from we're pursuing the sources well with of grants also well. non-dilutive none one we our

So to we're related to when research. avenues exploring comes Alzheimer's it funding multiple

yet regarding the we for plan FDA forward. the the the cash. Do a that's So have funding, final path that's regarding Alzheimer regulatory for

part your I to communicate As FDA. all your specifically I Nataliya, hope meet happy feel Raj. answered I of the add. anything, missed with if to as well, answer it free I miss be not we questions. to And any question, said, will we until able if I anything

was question in here. And that there really parts And two last very helpful. No, relation contract I I think services the to was are the business. then had

The first is wanted I to understand better.

of you wanted revenue I might possibility sense what time just that? of the much from get get be X the year are to thinking $X.X million contract from generate about to that now, now? mentioned may line years to to in Would that there level annualized be as revenue How a You be generation? it a services. as from

be And bit nature is to interesting clients, would relationship the this more do, be what Longeveron's It around Secretome the possibility that is with and might the Because of I own of and pipeline. second Secretome Secretome programs Secretome platform about understand contract approach of proprietary viewed Longeveron and collaborating this then the learn a on if to Longeveron company, ultimately its the company Longeveron's may from they one your be platform. it, technology question specifically manufacturing Therapeutics. as is a there broaden to potentially of what as could complementary

and just So bit comment was a relationship and Secretome between how over little you maybe that time? could hoping yourselves I on developing the see you

Sure.

us that tell second which our the your to helping manufacturing Secretome. purely capabilities this I And question, start is can I part products. I will relationship with related of them time, the is with first, So tell the with relationship you you of their can at

any with collaborating Secretome other not front. are We in

have been We're anything open science or new areas. new not of therapeutic can areas manufacturing research the other that scope time. this discussions we and always to expand We our at and outside the of technologies engaged and in any

move beyond also those several and of experts Hare, go to Longeveron communicating that future. much and strategy. say, can go that we how But can the that we and formulate us almost brought avenue, in we always pursue our be and going would be forward, you've we broader of from we're X.X, more can as how heard to Board what in Dr. that on -- our help And future some in going is the the things plan opportunities in we'll strategy the

we will much there be And communicate would when But around to Secretome. are and be ready it than this. place broader definitely, time a more

we and to Regarding scale, to full ready. and on that the ahead are working everything get million when try we to full potential $X speed, $X million, full steam see can

to a stem want additional We manufacturing. therapy. ourselves cell because to are We go cell full don't to for assessment limit of want equipment the broader we doing just what

make that in We engaging. manufacturing. need capabilities of additional cover to we any of the other we of limit resource what broader and we we're standpoint do in human types now already the type ready onto to And we middle ourselves we have sure both well therapies manufacture other therefore, from and expertise need. to as facility. And And capital that our needs can that and want don't one are are right assessing human as cell

are $X anticipate present the know, We it but and X to to or And with therapies. many of with $X don't able in it cell to be build years, looking of speaking the the we're up. and get I potential specifically, to meetings customers the How gene million. potential a forward year therapies X million we'll we full

[Operator Instructions]

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

the you greatly and you and all year. look remainder We you, our today's appreciate call operator, throughout your progress for thank updating you to on interest Thank forward the Maria. you, call. support And attending end now. of the Thank our may

teleconference. This concludes today's

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