LGVN - Earnings call transcript Q3 2021

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Operator

Greetings, and welcome to Longeveron's call today to discuss the results of the company's Third Quarter of 2021 Financial Results. All participants are currently in listen-only mode.

Following the formal presentation, we will open the call up for question-and-answer session. I'd now like to turn the call over to Brendan Payne from Stern IR. Brendan, you may proceed.

Brendan Payne

operator. you, Thank in and a everyone, for Longeveron's today also call third this issued Good morning. update welcome and provide contained were that business of results press to to release quarter earlier morning, XXXX, to a discuss the financial

the Mr. by management the with Officer; can Chief Hare, our of the Longeveron's of Mr. Science Chairman; going following new Geoff Officer Executive today access Chief and You site the longeveron.com. call to Co-Founder, Chief James section team. Green, Web Financial Joshua I'm press releases joined on and Officer. members Clavijo,

We period. of and summary our will conclude quarter of recap from general results then by third the followed begin with financial XXXX a question-and-answer recent a update and events with

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

Longeveron. Officer Now, I'd like to turn to Geoff Geoff? of the Chief Financial call Green, over

Geoff Green

leading number XXXX business me productive the chronic cell through clinical financial quarter. Brendan. everyone. and Clavijo, compromises together cellular company developing chronic for other stem the get ability life chronic to which attending and inflammation, for regenerate damaged Thank living inflammaging, third for risk progressive performance Thank update and is Aging and approved will no clinical our Lomecel-B CFO, treatment. biotechnology morning, and there is James as on Good go organs. quarter call. such senescence, for with diseases to started Aging disease, progress you, research. let and stage disease, another our cell for We've conditions you Longeveron is results Alzheimer's and tissues a quarter referred therapies exhaustion, busy to of financial linked are had our Longeveron's Inflammation as rise repair one threatening a the factor related Frailty. aging chronic

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more up II administration to very enrolled of Four Enrollment X as progress enrolled year, and II trial in years monitor of nicely. and and in remain are randomized are that to HLHS the of alive transplant the Lomecel-B. and X continue as We surgery all open have five in the or this of XX, as continues actively this subjects. after centers September Cardiovascular study target the Currently children has the babies being II been ELPIS Currently safety Thoracic and ELPIS free to status Phase two referred today. with recruiting encouraged Phase XX Heart Lurie and II is investigators, a projecting Longeveron, completion Sanjay by is is grant Division ELPIS in collaboration part one follow Institute Lung Health, National Surgery going Institute and Chicago. per at of to led in the of enrollment Blood team in National Hospital of Head, Children's year with a Kaushal, funded infants of the of ELPIS that's from XXXX. principal protocol. enrollment by

US. Phase distress moving to at screen acute on continues centers the COVID-XX participating due to the trial Now in subjects trial, infection respiratory to three X syndrome,

XXXX. a grant We Research number Enrollment XXXX. TEDCO Stem in than rates. October, that been through include hospitalizations this to in and was expected a has trial expect increasing The enrollment goes that to factors into vaccination trial reduction Cell in part due continue slower by of funded Maryland a

we our note, to general have successfully a for applying receiving and a research. demonstrated fund As awards track of record help grant

to our trials, of financial various out further CFO, like call apply and new we strategy data sub Clavijo, as quarter results successful the for our our I'd execution part of of to that, to coming the Lomecel-B. the XXXX. third James grants funding to to intend for turn trials and of With over With of goal commercializing our James? to discuss continue

James Clavijo

of morning, will Thank Most for presented this which September filed everyone. of what and be XXXX, ended more discussion you, our management's will Geoff. detail morning consolidated analysis Good be in our be XX, I'll in months operations financial statements in and the three covering today.

$X.X Bahamas compared an $X.X the less negatively clinical period travel in same third difference million trial increase largely quarter decrease to compared XXXX revenue the of of to Clinical September XXXX. XXX%. million revenue trial was registry Revenue ended from in company's third or grant period $X.X XXXX. than trial in was million of same The continues XX, impact $X.X to in million COVID-XX derived generally. XXXX and revenue the $X.X to the follows. in due related was quarter Third concerns a in quarter as XXXX million the was in XXXX,

September and from several million three to Third XX%. corresponding the three in during $X.X for grant trials compensation the $X and for a compared due Research in due based net ended Cash period $XX of of or period outlined to grant granted reimbursable September were including was was decrease to The term XXX% XXXX period or the as XXXX. recorded increase $X.X for XX, The to or December expenses million September reasons RSUs quarter of in million revenue related equity completion XXXX. short primarily an XXXX The the The insurance months September same as during $X.X offering million period, expenses The of $X.X increase period and was increase $X.X is three in to XXXX, the XXXX. $X.X same $X.X research $X.X current development the XX, million the expense loss administrative period grant investments the revenue ended was over in million compensation, and stock reduction was million the loss well equity compared quarter. of increased the a million million the quarter. not same expenses was of XX, net to increased XXXX increase the recorded based completion of $X.X XXX% from for XXXX expense XXX% of professional that $X.X of to clinical XXXX. as result in increased during funded expenses million for loss by of for and XXXX, incurred than for less public above. General or compared $X.X for $X million in options XX, Net period and to same $X.X of of completion in approximately the as in increase million of million of the development million million the months a initial increase months the grant. grants, XXXX. primarily million February an company's XX, and for $X cash in ended

XXXX million XX, increased funds was months from in our received IPO. September in cash the nine Our ended by $XX.X

cash at that, to XXXX, of will expenses was our September will I be least We thank turn capital on requirements the based term fourth sufficient quarter you, the that plan short the operating to XX, of Geoff. financial and As cover resources our current XXXX. and through With which and hand on includes call million. believe $XX back investments position existing

Geoff Green

you, we're I Thank open questions. now James. believe to Operator? call for going the

Operator

to Instructions] have questions. submitted back Brendan for We no [Operator questions transfer I'll independently. Payne now

Brendan Payne

So for few on that questions were the team independently management a submitted online.

few to believes news mechanism -- may Can some walking regards with significance the and Frailty Aging supports exercise is its Phase Xb Lomecel-B months in and of the what a trial, with Xb. Phase about to the is? Longeveron action therapeutic on effect of respect biomarker those shine ago finding improved a that light the summarize First Aging from findings you Frailty distance. that

Geoff Green

showed as that's inflammation. on to self We we ask so subjects the in a on a vascular is positive in Officer with also receptor leakage yes, have to answer. were linked surface call, The quite refer on biomarker we function Lomecel-B. I’ll Chief that to weigh protects to vessel our healthy change blood vessels Science that cells line But see him present and treated the and against interested blood TIE-X a biomarker

So the poor in of potentially health function with And This a of the indicative be frailty may vascular we're product. dysfunction. time health bloodstream. and in this that increased older development finding therapy in reduction and onset and with in reduction bloodstream and since the that levels action biomarker aware been vascular endothelial are is may dysfunction the of first associated that TIE-X cell associated may be a of in adults, suggested a vascular a with of a its poor Lomecel-B potential of TIE-X associated be mechanism endothelial improving that has

So to explore other did frailty that to waiting the data in that in and the potentially biomarker that? HERA plan Hare, further anything to at it's look future you a to trial, in we're add research. our we want then Dr.

Joshua Hare

to think able think important TIE-X. frailty, studied endothelial potentially soluble measurements the diseases is and by skeletal soluble in meaningful be poor regard been is flow We the loss regulation been of of Yes, but has to other Frailty indexed our with function. extensively to shown blood this might rather linkage be which sarcopenia in that marker of be to is TIE-X receptor in not And has patients, frailty. skeletal we the of muscle driven between by the some a muscle.

future in potentially and So us responding to this infusion become could research we will trials a future of Lomecel-B. in monitor be pursuing this tool to how patients for the and valuable are

Brendan Payne

again, question is market is Japan, the next estimated The prevalence the and to the how What opportunity? is and submitted, frailty frailty. aging big in of related US

Geoff Green

There's roughly definition is translates US, people, dependent age Alzheimer's general which over US the considered or are to the people is, a unmet for need. actually X to prevalence part, that who than in XX% used. about the in the Japan, of The the answer larger failure. It's individuals and that disease, XX XX of on to general million the frailty country. to that another big million risk In in people of frail. so becoming XX%. as heart as be and pre-frail XX at larger is been prevalence and million has the in population, older it’s In are about X high X.X translates than medical reported But this

these these consider So I market of very opportunities. both are would -- large

Brendan Payne

the The next the currently? the question we heart is left US, of care the of hypoplastic standard received transitions in syndrome and program. what's HLHS What prevalence into

Geoff Green

considered rare disease. It a is

there's to three every born XX,XXX two babies For bursts, with HLHS.

believe. is present do but So but older, of the you the palliative standard just of and on out Dr. the of in want standard say babies HLHS? typically cardiologists about five, comment with Hare, then first care, of child as a at life the of reconstructive all the that think, two occur a to third year. care standard at I'll year the before the line, The we I little their I about have works early, which age surgeries, three of perform to to thousand roughly care is each our

Joshua Hare

of standard dramatic. The is care quite

is called to performed of the months. two and Norwood second It's four has surgery first surgery at weeks at procedure the The be life.

year two correct, the surgeries on of life. first you're So absolutely the first

for I childhood. for and required important development that understand failure of with to transplantation there's surgeries, the the heart think incidence even child three of heart survive, a during what's a to high is which are need still the

fourth of possibly babies. is standard a a of that and of surgery surgeries the some in transplant the So care, three heart then the

Brendan Payne

was submitted question And received the regards we was that to final that with Alzheimer's the program.

enrollment end will initiative What's and of to that expect X be with Lomecel-B in next and by what looking the Alzheimer's year Phase at? trial first you points you quarter that a noted XXXX. design You of the of

Geoff Green

So this is correct.

year. new existing contemplated a enrollment to design QX was filed We've have to amendment include what multidosing. protocol originally the for our modified IND, begin an from to preparing and as We we're in next

evaluate efficacy. trial, it the to it the was Phase single administration Lomecel-B was and of trial, a X and to Our safe the safety intended explore

So the of administer and of like in we dose well the to over times as several efficacy. evaluate month safety six a period, to at three as levels trial, our Lomecel-B next course would multiple explore the that

randomized on So measure trial of we and cytokines a be that living, daily it multi handful intend activities brain double will a anticipate specific cognitive placebo disease to blind endpoints function, biomarkers, biometry. controlled and we arm of focused

down, design trial the precise that is another we'll once So for provide design. investors locked update for

Brendan Payne

we back So now submitted call. close and remarks. call the with the that session out turn Q&A concludes the for to were like I'd Geoff just that to questions the to

Geoff Green

Sure. Thanks, end to of discuss forward to behalf Brendan you, their like thank everyone you On we’d thank results. interest we and for XXXX and we updating look again company, year when support, everyone. continued the and

Operator

call. This concludes today's

we you thank You now and lines, disconnect joining. for your may

Longeveron (LGVN) 12 Nov 212021 Q3 Earnings call transcript