BSTG - Earnings call transcript Q1 2019 | Harvard Apparatus Regenerative Technology, Inc.

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Operator

Thank you all for joining us this morning for the Biostage First Quarter 2019 Financial Results Investor 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.

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

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

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

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

Tom McNaughton

With call Bill McGorry, Good our and with you for highlights, Jim Thank the joining a call. Chief summary our their the Fodor, CEO; for the me start comments. our XXXX turn over Officer. of call Scientific morning the on then financial quarter Bill I'll to call Jim are and everyone. first today I'll Dr.

have We first productive very quarter.

quarter net R&D We more XXXX last working R&D than The the of quarter year. filing for the candidate. million due had more first Implant the ongoing set to $X.X approximately first our team operationally Esophageal indications for net increase in and set first for studies of had greater towards data net Cellspan quarter of move IND reported XXXX a spending. a product completing a Our with of $X.X quarter largely continued approximately compared for and loss studies significant preparation million in in forward preclinical the quarterly year-over-year was of in for same proof-of-concept pediatric XXXX. esophageal employees pre-clinical in We loss our of of pre-clinical loss first

exercises plan, execute XXXX help our preparation $X.X million cash and during We period raised the XXXX organize, cash activities we proceeds of outside also augmented and operating approximately effort consultants in IND. internal $X to first team of the and of quarter consumed We of million upcoming with from to in warrant our the turn company's received we cash cash over March period. had warrant hand -- during At proceeds the the XXXX, to to call XXst, And of an exercise company the warrants. million Subsequent $X the debt. million additional $X.X I'll in of quarter, Jim. the from now, end we and no first had of on the

Jim McGorry

Tom. Good you, morning Thank everyone.

of Dr. upcoming Bill upcoming clinical like key Officer, Fodor, our As Biostage financing who a have strategy. we Scientific address the we're through complementary off moment will specifics because two to to From two the in hand with our briefly IND get take for moment esophageal started, Chief believe our clear INDs I'd and indications a disease. We I'll you take our on filing to there, is plans INDs. pursuing we this

disease product that to esophageal Cellspan Implant show second product the importantly, filing our adult safe the make treat allow for and the FDA in will indication XXXX, will Esophageal adults show is which in file the humans, for IND children. the Once First, clinical in also it candidate will to pediatric studies to atresia. primary that easier in us novel this early proof-of-concept our Bill our IND is and works that address, technology the the

with IND's strategy has our mind. milestone Our in QX both

voucher. an and priority work with review FDA approval comes the our Additional pediatric grant with will IND SBIR offset NIH by with be the

bring plan past our company the extend and to placement in we private IND continue financing, to filings. Regarding to hopefully to capital

and plan this listening is plan Fodor markets process the share in in with to financing U.S. filings. in expected conjunction NASDAQ of Dr. with and upcoming now will mind, a our With are up We in Bill? reengaging what capital post-IND the IND.

Bill Fodor

Good the to here team morning, extremely Biostage is hitting My working and company from completely is preclinical company. milestone. a committed clinical comment will everyone. to internal transition diligently first at is this Jim. This that Thanks, major Biostage stage effectively

U.S. Now be to esophageal will and application of Investigational conducted the in New target some at study get a Drug into several adult finding will will be It again range centers specifics, disease. the

includes review device to which is contains our modules clear, again also combination product five only into product for to Just this application be but and that a component, combination fits just IND you, biologic. not a category, the product a

to potential have automatic a we status new which the our minimizes end device. the response will controls scaffold. We've weeks. We've a CMC criteria will the in to these and system our ensures the release several improvements. of review that be in which order an during the culture controls release seeding continuing manufacturer. product into included to the as complete next far modules, contamination reagents, cellframe product, the in manufacturing is manufacturing month three all regulatory the in The facility cellframe the meeting, to within is undergoing most all two have our the following be modules us complex closed scaffold Most we importantly, FDA recommendation manufacturing our to section, new section, allow an several with release cellframe As set controls probably These to the Houston. final improve. describes scaffold all These in for of sterile of manufacturing, manufacturing. during process process implemented final our pre-IND the implemented product This by

currently as are and there at process in runs the are implementation execute Houston. this that ongoing this, development contract facility of As manufacturing our to far

and Our completed animal in efficacy of done tech we’re the all safety, With transfer finalizing at the the first an runs to qualification end but respect other reports, to completion in only Those of component development part our the will upon appropriate month not of the be establishes cGMP animal those proof-of-concept will June. be will model. process commence that demonstrate critical runs. those modules, a GLP to --

can safety targeted physiologic to second towards what piggyback atresia. XXXX reiterate filing IND we said, demonstrate just enough than the We've stronger back now is balloon necessary mechanical have that withstand as In pre-IND assessment of implant. now And a FDA pre-clinical but studies of physiological tissue, in I'll first over our also addition, works animal adult from the establishing models, IND course pediatric as critical CEI establish XX that only withstand to stems, at function. proof-of-concept dilation but tissue tissue pediatric two Thank and not only in you. to the well so the also Jim our established efficacy is conditions. aspect we've question adult not in the strong finally which the model. is of will in to models tissue is of days the in works an normal to This part well post as XXXX the in that as implantation the onto Jim. as research of throughout meeting the ongoing manipulations animal response times post And that call of integrity native it that our demonstrated turn is now

Jim McGorry

Yes. Bill. Thank you,

two that on disease again, able focusing we these both I criteria, to and INDs hopefully of looking said then you we talked esophageal were to earlier on release that that that the INDs things and to about the file but capitalize see So atresia. it trying focusing IND, and terms and opportunities, are this for Bill over mid-year, we be we know by it on in on pediatric seeding, specificity felt automatic opportunity. going closed the with we doing best capitalize these was system, are

open you and the We’ll opportunity. call our to questions answers. for So thank

Operator

we Thank conducting [Operator you. a Instructions] you. question-and-answer time, will session. At Thank this be

ahead. question Management. first of from is Capital go Ajay Our Ajay John coming Please

John Ajay

year. Great. maybe the Congratulations profit you you? the start the that in in for opportunity bring over both fantastic getting on added to would revenue is terms indication underlying review last the priority the opportunity -- you and market there that about as receive approval pediatric that for well progress the of voucher as value atresia, FDA would talking Can

Jim McGorry

Yes. Thank you, John.

seems bit our product filing. the candidate opportunity as esophageal we're our but is IND total first the it pediatric to move or first filing a first, backwards -- that disease little our sorry, so, in pediatric atresia on focusing And the

And FDA and in safety us, to the move you must order adult first. so, told in focus clearly must in pediatrics, on safety show you

Having Finck in at So the around pediatric just Connecticut been Dr. our with the nuance that's encouraged atresia. by background last Christine Children's, path studies, this. week we're in animal over very this progress bit a little of of

five a to and other life very, burden within it want with the to these both is long has some big innovation kids current our economic of out then And estimated of kids centimeters, These Let of the you in burden gone of just well clinical a it all centimeters, me bring six it's battle. product, but our ICU, the drivers and as is as work a that just and million. this now, gap, uphill medical works hospitals real these their $X.X every areas. born kids parts The length it, what continuing in economic And long repeat unmet they so describe, one kids right have gap this atresia are and early five an very way the into stays kids, into again, the face area. of a in treated how over on early need. X,XXX the surgeries in really of the -- these then,

with on so, need. it, And medical a it's that we believe clear

Dr. now this We pediatric Finck around include Children's. people at the top with Christine are Connecticut working to

Dr. people Connecticut with at to around top Christine this are the We include now Finck Children's. pediatric

around will We APSA, next the the in world. the Pediatric Association that week Surgical are pediatric U.S. all be the American and at now surgeons presenting

the Scientific J. – is the new people of of APSA. Advisory the will our of Board One become Co-Chairman President sorry, our Vacanti Dr. who

there's So it that need, patients backlog a right be that and thousand patients that that is real patients -- a currently that ongoing We now a represent a could of real see year. market we John.

is for and our we the us XXst U.S. million So alone, with. that Cures a esophageal voucher Act the eligible other $XXX it's under we allows which designation in And in format atresia that market. orphan in working program a we're be currently pediatric that U.S. with priority, this on think to believe we the that

that the excited need together. is a comes and we're our indication, this. So need all medical unmet clinical product really real our key This about area of the

thanks So atresia. for on the pediatric question

John Ajay

That's successful the you or market. virtue revenue think, opportunity to really because not is getting of by interesting, of regardless how

market to I review too additional to traded to believe relative $XXX for million, to million a be and $XX get to you profound of whatever has going from cap then priority You're return on might it voucher just anywhere get getting is which market which recently that. top your upside

So setup. that's quite interesting an I think

paraphrase And these scientific you regarded highlighted the discuss And in with Let past about you highlights those the able if due-diligence? I products believe regenerative thought have participating about kind talk your of your product interface that science? or investors any in one highly talked these of been you these it over X me Can the leaders when presentations medicine of surgery ask whether a to conference is occurred researchers that who months, the of best another XX you your might also the have for key from their financings technology part or get highly as can in regarded not, about or so, thought in question. leaders can in talk other has in validation where year have you exchanges? can venues. a past or been notable that private of or or pediatric some

Jim McGorry

a it, question comments but about like fine. wife, it my Sounds six has all for into

me Let me John. comment, let

joke. bad my for Sorry

the And while file into investors, to parties, said people are that looking IND. interested are that company at looking an for it we so looked look, I that know the we're a that I our know at it. the we've and

a guys right just our look to trying me you people Give moment me where to just on gut comment are so standing a let And now? these really check say, And on this. real You're at product? a are behind few.

Dennis case in at Meeting, use Thoracic into into and just same the Weigel a like surgery just -- year some or compassionate way anything So it folks it's first – the We're it results of Dr. January That the a Tech-Con any not Clinic Ph.D was a worked all, with work, product the humans hospital, of working of that his done Thoracic studies. the at of institution. M.D. Mayo Chief the think of know I this patient. worked Dr. We're in the Aho at and just the different Surgery that that Dennis the it's first presented tremendously Surgery, difficult working that showed is and animal Society

And New on doctor England of is -- has should the -- patient gave was Dr. surgeons focus manuscript is that this our is it that again, who great that that Finck been a APSA dedicated also further now have copy will physicians really that Journal engineering, the commented the that atresia meeting, will Pediatric on to The of a meeting. Co-Chairman at submitted tissue So audience Christine focus just be Medicine. is focused I Scientific Weigel opportunity. Board father presenting session, Advisory the of on earlier a is on of introducing Association a Surgical and group and mentioned kids. Dr. that -- spot a to I

And to Rich but Medicine, we're that Surgery to right We've now through of Women's be top it. agency been done, at we've Thoracic with and Head working are IND, the we're us been of on Medicine been at on picked so, with to with talking Chang. move all Bueno, and the talking and has all that people of now our Michigan, able Dartmouth-Hitchcock, regulatory talking Andrew -- we've to that These who us on particularly, to the around IND, have Chief my know the be Chief guiding you where up. this, And the BBA Surgery we it talked Dr. Raphael Thoracic University Dr. forward clinical at Dr. that's protocol, Rothstein. went that. that Bill to work be have worked as the of Chief around guiding Brigham country. to it Yes, we and has of to yes, the focused now we're published, has partner now clinicians as

milestones confident John, be where really to all know it's to out of talk more of around we a feel have talk things physicians you about, much of have preclinical we now that and So, but to in lot and and hard I and not direction atresia. technology, going key out esophageal gone sort we're go our pediatric a company can and disease, the the

sir. are So, few just a those examples,

John Ajay

Thanks Fantastic. a lot.

Operator

I'd to or closing floor this over additional management time, for like [Operator the Instructions] any At to comments. turn back

Jim McGorry

thank esophageal we appreciate with feedback able the Yes, around we to operator. material be spot that we've pediatric disease, markets, show advanced to that our the INDs, hope see and the then organs and sweet we really U.S. you, endoscopically, by able have with -- the Markets these who technology indications, property we that -- reengaging the esophageal evolve. continue we're the non-surgically. others that's that to We this facts stood tubular We come in on up folks with really call, you intellectual appreciate and our our to we're really the back in have things know have investors new Capital delivered continued product our And is be to then going. and will The involve where atresia also us.

forward So, to that further. we you look for in and we and you where in cases. talking is direction both the this are opportunity to are market going We to thank focused moving

Operator

This today's and Ladies thank you participation. for concludes gentlemen, your conference.

lines and You may a at disconnect wonderful time your have this day.

Harvard Apparatus Regenerative Technology (HRGN) 14 May 192019 Q1 Earnings call transcript