BSTG - Earnings call transcript Q2 2018 | Harvard Apparatus Regenerative Technology, Inc.

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Operator

Thank you all for joining us this morning for the Biostage Second Quarter Earnings 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. These are forward-looking statements that involve risks and uncertainties.

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

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

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

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

Tom McNaughton

Chief you. the our joining Bill are McGorry, you to results our Good CEO call turn second update. then the quarter's of call. Jim financial the over With our Officer. Thank morning, Dr. today Thank an on the call operational with provide Jim Scientific I'll for and who'll summary call I'll start everyone. me Fodor,

Bill development technology on comment progress. Following our update, Jim's will and

of as key operationally studies and cash on for staffing preclinical very had burn working changes. we quarter this of of announcement million issued XXXX a cash during earlier operating are of more our consumed increase will you which know, operating the XXXX. which out year. indication million $XXX,XXX $X.X results vendor the year My new new quarter of financial very adjusted first [X.X] more R&D this spending. active comparisons in year-over-year second may we esophageal number operating The quarterly beginning payments agent $XXX,XXX second position two used respectively. those of approximately in activities the statement quarter, out the are a approximately As specifically round and a increased and company's here we in focused second was this cash time And capital first an consumed in first executing provided of streamlined $X.X to included due were company activities first the capital activities We and incurred effects in $X.X Backing we forward you much which in We year. came That pediatric with than [ph] level. payables of quarter increased focus at primarily approximately indications. We move last working a comment $X.X operating operating a second and the quarter reflected plan operating morning giving rates. in from million during million of quarter represented cash were spending sequential XXXX quarters, and benefit current

private the second no $X.X common $X.X of of XXXX, net the XX, had of During quarter, we providing debt. million completed million and shares placements June proceeds two on-hand and company of cash approximately cash

private placements to We fundamental over will turn call equity continued now to new the encouraged have Jim. our investors. to by source long-term ability been capital I to

Jim McGorry

Tom, Thanks good and morning.

because more program to our mid-term accompanying in from and we Dr. momentum execution and moved we strategy shift of our team coaches we In their along positive coach following sports, scientific summary. the and a stage shifts favor, Bill represented study a our company. gained as track Under to you and into quarter This and Chris is we Dr. Finck well the in forward momentum got instead on in continue Bill data XXXX. our insight Connecticut leaders proof becoming strong file and progress QX of picked consistent of will As for team, and press see are comes further Biostage's program our and pediatric concept in Fodor, to at IND with is QX business not on collaboration leader on results the studies forward our one the Children's made ingredient leadership we together to moment, important and of all towards development the our are hear operational that up we was confidence our an understanding of highlighted mechanisms we that we release, added our clinical momentum comment renewed We have into technology. a and goals. momentum milestone remain in the

our progress in with benefit our clinical aligning we a progress and our better additional leaders. and to for and In continue profile summary, We safety QX scientific advisory successful board substantial validate filing. made clinical

the We upcoming in engaging the with further weeks. will be FDA

We help are with gaining use experts position insight clinical thought leading scientist, engage surgeons Biostage to us from esophageal technology to gastroenterologist, outcomes. new leaders. and leading to possible the continues and best our

our and improve by on gastroenterologist way lack with Biostage our the surgeons, technology esophagus outcome to development comprises leaving frustrated next esophageal general to insights for FDA. the a the cancer a few upcoming favorable further these refine a a of with Esophageal treat better to complicated for the clinical the growing disease. series breakthrough in and position problem favorably will endpoints. be surgeons, looking key a clinical global using over treatment and position attending Thoracic patients are worldwide are their better of problems months We clinicians meetings of field.

bringing I'm with our front, delighted raised our rate. capital run capital the in our favorable extend to success continued On

aligning that clinical outcomes intellectual studies, on gaining our to We continue plan further securing property, clinical the conditions. Said successful best the company our value another partnering, to outsourcing to our additional the our we the insights, studies add animal regulatory value risk in for about planning, our all and more the as and clinical to reduce a trial quality, know we everyday under more includes and we clinic. execute way, translation technology, data multiphase increase

should our reflect progress. advances, As development financial our value technology that continue to

actively collaborators, more translating thank a the key the upcoming and us Houston who engaging our with Children's, technology our risk also clinic. and funding, Mayo and to Medical our continued execution University you in Let the from okay, months, in Clinic, clinical Connecticut of expect can us and are reducing few Texas What with of value. Center advisors along me

As the we for our on back list But new clinic. our of in opportunity In clinical and milestones guiding bring execution of we up remain advisors for best the encouraged of growing data the down translation new successful technology momentum closing, heads will evaluate our and a the active our support with our understanding with reach in it's shareholders. plans. the NASDAQ now, into to timings and we in right

me Chief Let Dr. Bill Science call Fodor. over turn the now to Biostage, Officer,

Bill Fodor

morning do to that Thank you, morning everyone. Jim. development areas I is would key five have highlight What Good advanced in we like this QX.

X. NIH esophagus. we X.X of As incomplete an SBIR treatment grant. fast-track the an Phase received have research on modeling million May of years. is defect May is $X.X award an congenial focused this The esophageal disclosed on they where X/X This which in back teleconference children We on over grant developed and our in is a fund will atresia

on of in As X X have far this again, this schedule also phase. undertaken Phase some Phase ahead Yet, as being of X the that grant, Children's we sciences activities, initiated portions in Minneapolis Phase in research segues we are is and pediatric At with American have schedule. as of Connecticut APS, actually preclinical our already implants. implantation of sized This collaborations into hospital. as of ahead esophageal execution well is we engaged and

life. We in have seven animals currently

beginning at another will Our animals second which endpoints. the set have will start five include of will These studies cohort QX.

or histology but strength life We of have revised only this vivo tissue tissue of also course the not the acquire portion study. and of mechanical sampling understand over in testing tissue implant to the this end mechanical

had engaged our are of vivo required Charles Texas meeting as in pre-IND for when actually question characterization, Scott for the our lab, that in and our and showing that facility. also cells a is Olson. This manufacturing establish University the have And We us are -- shipping with transport in back we comparable which we that back porcine studies. biology to human using cells addresses cell preclinical, in and XXXX be includes will this that as well stability, Cox Dr. central the FDA

working we In biology UT and and our fully equipped. functional addition the and lab work completely with at cell is up human are cells -- fully to running, staffed that it is

doing this to but APS our support are not animal We UT. studies at with only our collaboration also

path in our Biomedical retained FDA We working experiments and pre-IND responses to with BBA, forward. our back on finally, I undertaking that intellectual which to potentially also update like are where the you would We are we we the Associates, could And of and XXXX. on are our the FDA to for potency IND lead with cells property. will additional meeting enhance Boston

FDA We engaging and will mentioned, in few the have weeks. next we Jim forward the clear a be path as with

at submitting had, FDA pre-IND our address be an all to will those We advanced to updated our address meeting work the questions. have and we concerns package following

X We being all are finalized will currently. large reports studies those animal our that the present also and around data GLP

report as will that, you. be you around to the Minnesota first any issues Mayo present Thank development might there questions mentioned at addition address any clinical in happy and In plan. with questions, -- we will are annual have or Jim from we collaboration Mayo. data Clinic presenting we human Rochester, If to study. be that our in that our

Jim McGorry

Operator, questions to answers please. we can go and

Operator

we time, question-and-answer will your [Operator session. Thank go Instructions] [indiscernible]. a with [Operator ahead this conduct you. Please question you. our Thank I Daniel from At Instructions] have question.

Unidentified Analyst

grants And a Hello. and in ask further I potential to like Thank financings. question would similar non-dilutive you. about

there years? there the the fast-track You the already and horizon within anything from is of potential couple next mentioned million else $X.X with on

Tom McNaughton

the Yes. ways -- to potentially focus these of at deliver delivery. we're could We've SBIR the non-surgical potency to the cells. and will These considered of grants other And NIH. our actually around additional program exploring increasing methods writing cells

currently. those -- plan that's the So

have the as We of those not in grants yet. construction of engaged

Unidentified Analyst

just could it's what if of rough estimation grants? -- Okay. money come a of very through And in kinds these kind like

Tom McNaughton

Phase NIH Again, at X X the for a a Phase Phase the program program, X/X follow-on SBIR program has fast-track.

depending again these delivery, methods Phase follow $X.X million is Potentially the track around ideas X.X studies. submitted on from increasing a over Our program once Phase would years. report Phase X X/X then and/or of portion some that a current then the grant of of $XX,XXX of other the those -- the fast-track is which probably about was progress results a first potency doing that it engaging we'll with X is

Jim McGorry

a your Dr. the has here helped SBIR have of us Sundaram that in comment. at Biostage. and good knowledge Dr. bringing capital thank Fodor non-dilutive really appreciate We here We very program

to technology translate doing think and be to NIH we're pursue and success bring small grants and business talked that very aligned around being able to be that of continue about ways the that. about work And to here into will the goals of other we're able that that this. their I and good The to We Bill schedule. and the ahead patients. the things early feel We are

So your for thanks question.

Unidentified Analyst

you. Thank

Operator

Thank you. have additional [Operator Instructions] from go We [indiscernible] Daniel ahead. Please question an

Unidentified Analyst

that? does necessary example there? or for just that plans Thank is, in FDA or process on you. of will a Do And be process new of Chinese for How country. Like looks the that? respect area what presentation at can my looking involvement overview of it get the and of they an it involvement for it like the to application the decisions like look the shareholders be region translated the technology, increased question from completely and is

Jim McGorry

all has I'm Daniel. at Dr. and right Board you, President Jason pleased is driven to private our of Thank start. placement opportunity to the the also now the with Chairman Cheng, really from join tell Hong meeting sitting here you who right bear company. for Biostage this of to me the our who flew of Yu, company that Let China us and in

currently the understand behind potential Jason we're Dr. the and thing FDA. had the done a the coordinated through and China two that the really And getting be this to our doing Our KOLs best it? do tremendous Board into and pathway being long-term meeting right also a from work the They of going that's to is way able have we investors where incentives for our Hong scenes All we other to to it areas. what and CFDA do of How two thanks other There's care done technology. China, better to with tied really regenerative coordinate work Fodor properly. see What's We medicine how it? good in device, of done? right these now. yesterday, do is in product, being medical this developed

promise over said, deliver. so get to again, don't And want like and I I under

We the development. But, Japan all includes and our incentives, be agencies staying through Europe. Korea we a it. technology into China in focused includes to move need are opportunities, We includes our includes respective see of coordinate work then that to global structures doing with able to strategy that that those clinic that financial

one down So, I on hopefully time, and day will execution good things like we those that Thanks. said, at head believe happen.

Unidentified Analyst

Thank you.

Operator

and back closing you. Instructions] I no for over Thank Ladies request you. floor for be gentlemen, to there Thank [Operator questions, the remarks. will turn management additional to appears

Jim McGorry

Yes. for right Thanks here. operator help good your

So, look appreciate through really call. see I really we as you getting are thank in that. closing, you for concrete takes that you We the stuff Dr. we it. is doing that Fodor hope there on

momentum a runway is And and there financial Thank growing that see You runway. very to forward look continued value. you financial much. we

Operator

may All conference. today's disconnect. Thank Have you. a great day. concludes This parties

Harvard Apparatus Regenerative Technology (HRGN) 14 Aug 182018 Q2 Earnings call transcript