BSTG - Earnings call transcript Q4 2018 | Harvard Apparatus Regenerative Technology, Inc.

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Operator

Thank you all for joining us this morning for the Biostage Fourth Quarter and Fiscal Year 2018, Financial Results Investor Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions].

As a reminder, this conference is being recorded. At this time, I’d like to remind our listeners that remarks made during this call may state management’s intentions, hopes, beliefs, expectations, or predictions of the future. that and statements forward-looking are involve uncertainties. risks These

current are to federal differ the statements on laws. on Harbor materially. pursuant call this Biostage’s based are the Forward-looking Safe results made provisions forward-looking statements and expectations actual These could securities of

As statements. should any you result, place undue a on reliance not forward-looking

with contemplated Exchange periodic that statements; to are forward-looking Securities review These these factors the results We reports of website. available Investors such Biostage cause actual in encourage carefully. and on Exchange to and section company’s in by the the differ documents are Some of you Commission’s could the materially Commission. website that files from Securities those the disclosed and documents the

a turn is my ahead, Biostage, Please Following the company’s sir. call prepared the Mr. remarks, you. the Financial session. for Tom pleasure now question-and-answer Officer to call go to opened over Chief will Thank of McNaughton. It be

Tom McNaughton

quarter a on Good fiscal morning, the today of to financial you our over McGorry, for of loss the net XXXX, XXXX. fourth fourth indications for reported compared in fourth loss is the four a We we increased The million for joining preparation the everyone. of R&D then I’ll the quarter, the of the With highlights, for fourth rate employees activity of Thank end XXXX quarter call Jim, to CEO. studies loss end $X.X and of our start an of quarter Esophageal overall increase set data to of with We approximately to filing the proving position the the the who’ll $X.X the very XXXX, Jim Cellspan summary call net call million year pre-clinical candidate. by product provide XXXX had significant in greater move our reflect set the I’ll due quarterly a approximately for Implant with operational first was continuing turn company's me had year-over-year QX XXXX esophageal a a during was call. net proof-of-concept and the continuing update. active for as in that IND pre-clinical quarter. company with level. quarter pediatric forward our fourth operationally, of To from back spending at at

levels with During XX XXXX and our XXXX, the in activity increased year employees. finished significantly we

experienced company in primarily For XXXX the private million the of approximately million to and first approximately now I'll the December, and activity the consumed compared of of during operating XX, of not due fourth and In the we XXXX placements at on of end loss prior a ended months $X months $X.X XXXX, for debt. XXXX, for lower reported no half we over $XX.X we capital loss through headcount investments turn had $X.X and approximately December, XX, R&D to staffing as ended to call levels is a during February exercise about warrant. $X.X December of XXXX XX XXXX XXXX. net net XXXX. cash cash of in million XXXX of the loss $X.X in Year-over-year following XX, At the from million Jim. We decrease hand spending the XX the proceeds received the cash year. of then quarter million December fund million, dramatic series of the following decrease a overall of quarter transactions. activity recovered failure in to more in activity normal fourth to We

Jim McGorry

heads down transition executing Thank has into you, of everyone. Good Tom. Biostage clinic. our for the Thanks spent much sharing morning, your time. on XXXX

like to central course our it and most. to underserved the do, for who patients life-saving of goal potentially And to I'd bring platform first ultimate Our need is all Cellframe we inflection about take I'd XXXX Biostage XXXX. to a a patients. why in moment highlight value there to positioning in a pivotal for these year believe talk was year like we From

disease. Let describe a esophageal me terrible quick the take burden of moment to

ever esophagus, the to This care. complications so. standards scientifically suffered esophagus, worse pain, Asia, damage all. the in and Almost live is for even of half Currently of in a recourse come a many these life of right a from complex a patient known every diseases do Asia the high in population where Deep one one case how esophageal X,XXX and some life burning incomplete of at and are meet, with disease. can as quality esophagus and of the deep who of many In alternative quality morbidity someone current the and not you've classic only upper a from horrific until disease year of after foods swallow the inadequate solid into survival. kinds The gap cancer, kids very that treatment not know options complications these esophageal is low a I born surgery lower to debilitating done, complications In the a their but considerably current inability developed die an clinically each of needs million through conditions and birth be. underserved even any sadly And If with doom with coupled should an are life. people diagnosed of them deadly proven are kids lower chest can chest full womb. and never mortality. you leads to children severe with are a

threatening in to from translate drive esophageal each and and the consultant alternatives clinic. disease need novel the spotlight the opportunity. the to to Biostage investment every and technology game employee suffering the changing and these investors developing simple including investors life our our disease, Our strategic I clinician, to at the help improve thesis. long-term and scientist, helping kids disease, in and highlight every into standard-of-care Asia a patients want Chinese children have and They the US help a

Ms. at expertise and XXXX on capital why fronts year of increase the three improved We many financial pivotal company's Board to summary Biostage. additions Directors quick raising a new support. of the including We to was a Here’s brought in funding in year decades securing in Ting China two our investment management in experience. Li this Ms. with and runs company her banking continued an past in Li was for research asset invaluable November.

the We AVEO the Biotherapeutics. also of who extensive industries; the of brought Matt Jeff in Committee on life new Dallas, Young members Board's to experience science Axial Audit two both CFO have is CFO Oncology, broader

new financial knowledge the of is they’ve and of Committee four brought combined capital the markets. experience and also Young management of strong the Audit years Chair a US

pivotal grants for use details The groundbreaking our Esophageal FDA. and We year Biostage. our with in Implant Cellspan $X of summary, National released. first human of them the in institute the non-dilutive in a earned from our in plans Health So we was advanced clinical financing million of XXXX stage were

have and de-risked company. the clinical pre-clinical Our evidence

funded financial of support strategic XXXX the in and and increasing their -- throughout investors strong company have and Our continues. all increasing values

molecular of IND Alexion. the why cell highlight track do biology. Let relevant and one Scientist our believe experience leading we're me and our process is the Fodor, He Scientific on are Scientific things Chief to we we in Chief has genetics Officer Founding our Officer all say his of the background doing. with in we Bill

technology. gene of and first supported scientists, ray We improvements modified Bill advisors. by is therapy regulatory team genetic enhance and are exploring experts KLO our cell our to other advancements

second NASDAQ addressing with call to the a clinic, these a with in for to spent the scientifically Q&A. every deadline have And a being the it in of grow in plan Operator, to half filing Biostage. we is like XXXX, FDA now we sound We would IND the uplift for we Thanks In are mid-year. prior I continuing of file question our credibility confident of look year to IND. ensure for reasons meeting for value open listening. in will of

Operator

you. Thank

[Operator conducting We a session. will question-and-answer be Instructions].

from comes proceed of Capital. a line your Our Ajay with first Please John with Ajay question. question

John Ajay

you please on to year your needs Can for on plans cash your the financing ahead? cash position meet for your and comment

Jim McGorry

and John. comment to -- Jim here. Tom. thanks, I'll turn things I'll Yes, over first then

simple right that Our is now one. a first have using position we been

been you to balance dollars of through you confidence it to sheet, give hear the our investors, XXXX done We continue all in path forward. it our now they've funding see the are and they able be what's on doesn't XXXX. the when know have company long-term in I

valuation So we have our company of placement move continued and into this to forward. private this move all

markets. So That our before we continues the the the capital to be -- the into financial gain wanted -- excuse credit or to filing scientific of US any went plan. we me, credibility IND

two And our We file able we're need advance look to to technology. China don't as will markets to in look capital what but things: continue then to to be we've opportunities then credible and will be subsidiary that, said will the and in that's other do there, be our we any organized able from continue US We to advance mid-year, doing. we'll say plan to continue to way; to approach an thoughts? and to able Tom, to

Tom McNaughton

stand John, that's plan is. where what plan, we a and summary good of the our really that's

John Ajay

current the how to do be break filed, to That the sounds But and loss get cash there, relative good IND you it will when give I probably how of capital. your operating terms you think revaluation to a in waiting you of for attract is which low position -- positive rate?

Tom McNaughton

network tapping the into since John believe who and are get this what our strongly individuals our And managed to capital the think fundamental December seeing we US network mission. we’ve you’re that time very now I between high plan Yes, is back XXXX, markets. by in of

John Ajay

up IND filing? path you sources think a to your through you clear the have to getting Do current funding

Tom McNaughton

filing Not IND only up to the John.

OpEx million You saw, at XXXX. our into $X.X

the of that's investors continue do to comes that we're -- we when we're have, It's be not we looking do we position that's they prudent have we like markets cash filing we -- to trusting to. terms But we'll what do. there. to that -- strength, what we're have believe our why very see we're our to get get be we're enter what need US the We with long-term where we don't with position believe us we're able we of doing. doing. -- a to But executing us, We as in

John Ajay

the Can presented as with scientific human case has animal you also study the you more Wigle recently what conviction have talk evidence importance data of greater bit how technology? about on in little that that body Dr. of the to the and a your that

Jim McGorry

Yes.

it done commercial approved patient conditions, clinical GMP compassionate and yet that see use was all, companies, the of you pre-clinically when show that follow in humans. So that's first we And on worked of and what inflection under trial was very a simply is an All difficult see by in in treated moment Dr. have patient, we listeners companies Wigle those any and tremendously works real what FDA an difficult it study. readiness.

that’s that But show so, we as being is that patient well lives publication And results New is who esophagus nine results to Medicine. an the generated as at muscle layers months, died we what autopsy of a England the Surgery the The not now. autopsy different what additional the to have going Thoracic Society and from Journal with this expected in of presented Dr. live, of an Wigle and complication. epithelial of layers and the is submitted a

So adults consistent. new it was models and our seen but regenetive absolutely have for surgery, properties first models that totally for matches piglet regeneration atresia in in the and we the is other

the Our histology, of mechanical show testing, that. areas all

area a area very confidence scaffold, that large us, as a gives of human it in occurred you animals unique it all XX difficult removal has a that we've tested. over very So with if novel the will and a into

John Ajay

completion might that? the -- you -- of in what do trial a once do number I it trial, What sense might have for like file last look what all IND terms timeline a patients, over. to the ask And and then and your start turn you of you question yet that and

Jim McGorry

at early into organization at Thanks. looking on the IND now. we're all Wigle things all Michigan. in We're looking believe Clinic. of working and Mayo to the We're to right sites, all will we days be MD talking Anderson, but investigator those the of Mass primary at General. We're we're modules working with the Dr. process working the We're of construction

those can areas. you and we're surgery with the see, working who's of So, who the thoracic

you on maybe procedure. in. is don’t whole finding really things, So, the dose early different patients you same; few still where learn surgical or within the the much know know, you FDA safety, first will, to you staggering and coming manage if human safety. trying we There phase you will ones other learn and we're to a the a But doing wants in are result be those studies trials, But drugs than it. focus

you I, works clinical technology where to is across tell trial this awful Phase that thing us if lot patients will, or that our five will about on this know you. if You Thank area. not. you And an Xb the will XX whole

John Ajay

you indication initial this pediatric do the you doing trial don’t And both? or in envision or

Jim McGorry

That happy is it. to your answer fourth but I'm question

have consistent out -- very we in been We said not before, you trying and to it we've not of anything. convince going

two our indications you trial two make be will pediatric pediatric will it first we indications, will Yes, our we We and sir. adult filed mid-year atresia. adult diseas esophageal forward, that indications and if atresia, are file esophageal moving when two will in disease be following a statement esophageal will

Operator

for management I comments. appears now It no like you. would the to Thank instructions]. [Operator have back this at questions to time. turn floor we closing over further

Jim McGorry

counting we through haven't we're out in XXXX thank So of that been much. and doing you know going terms we what We very it.

be on it. focusing to continue and down heads We

are markets US able scientific to that. other incredible the places be to the financial advance to in to gain credibility We trying and engage

we So for and build need for have hope getting company We're those the much. forward. positioned while. Biostage we on valuation thank thank a we clinical moving can milestone increased We We're for executing who and our XXXX. you you evidence in a in followed very And to. what confidence

Operator

this gentlemen, today's does and Ladies teleconference. conclude

this disconnect your have lines time. at you participation may for your a You day. wonderful Thank and

Harvard Apparatus Regenerative Technology (HRGN) 28 Mar 192018 Q4 Earnings call transcript