Entera Bio (ENTX) 21 Nov 192019 Q3 Earnings call transcript

Good morning. My name is Sonia, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Entera Bio Third Quarter 2019 Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-an-answer session. begin call. may you Gridley, the conference Adam

Good the call. you and you to we welcome morning. Thank

Joining on Medical this of release the R&D; Yaacov-Garbeli, me third our Interim announcing Arth Schwartz, today our XXXX operating Santora, the Entera's call quarter financial our results A of morning. Chief CFO. Officer; and Dana Philip and press are; for President issued was

session. at who find section call you share of website. have and website it of which update business in those seen SEC's you'll you our not with also For it, this is financial will Investor posted the our the question-and-answer will available results, www.enterabio.com, it followed yet be a and morning, at we our On by

will forward-looking that statements or business meaning call, Litigation our making expectations. Securities Private strategies today's or within the future Act statements of These During Reform or performance operating, financial, of we XXXX. the address include be

well of this XXXX, undertake on otherwise. only account but conference new Forward-looking likelihood on and of the and and November today, to; information investors not Commission. and provide risk clinical future statements obligation intellectual update and property filings all statements timing timing our to information, to the are based those the involve XX-F future Form utility differ uncertainties results, statements. financial approvals, as risks include, of materially that make contemplated encourage factors with filings. we our and business and and call are cause SEC is on Report uncertainties the to as significant Exchange as trials, developments, and of and our those clinical or section All our decisions Those conduct from position, read of on the forward-looking any limited events, this described candidates, filing product expectations call our actual and in or belief, those our we we regulatory could may by on no provided and management's current the XX, Annual Securities risks in We position,

be is recorded being today's advised please Finally, and that call webcast.

on let's opportunity updates. as Since with meet in many and early company had CEO with the conducting joined our with I've or investors. parathyroid Israel and PTH I've the and our osteoporosis. move August, investigators X So to our stakeholders. supporters met recent in in our study key spoken of each hormone, business to of the many speak I physician long-term Phase I've met oral of and our

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do reliably last so several affords, developers bioavailability for by combination unique variability, of drug our over macro can way biologics. adequate and a First, achieves has technological technology molecules where variety oral eluded many and in we believe the tablets to are the able decades. we We that develop a that advances a

If multi-billion drug design believe delivery relatively dollar success holy molecules. received certain from and well-defined some Secondly, osteoporosis, and been is opportunity data efforts but percentage described feedback of X positive Biologics. targeted have who candidates are FDA markets, patients challenge. scientists oral we new patients to on XX street-facing what any biologics actually we and our EBXXX, of with new of a the advanced what the in program Phase XXXX. candidate Phase has and late Hard initiatives, believe firmly of with cost, solution focus company this been our due osteoporosis I the successful the in, has what the and large investor-focused absorption a for PTH on an lead of rapid and to by demonstrable, stories to management in outside technology compliance a challenges. for with of based tunable unmet in to near-term create convenience extend our X market, most have investors protect the these development days a business programs, we our small my and coupled enhance in And are shareholders as coupled trial team. ability giving of highly need limited, we near-term myopic commitment to considerable on value clinicians disease, macro treated execution Oral have utility to PTH and visibility strong a with grail of development of osteoporosis this is will de-risked age-old clinical our

by treatment currently yet will less compete expensive, with leading and anabolic giving anabolic to to paradigm the are once-daily the available, by oral tablet will to market an grow and building anabolic directly agents. easy inconvenient injectable as intend patients transform a We alternative We an injectables, introducing expensive take which bone simply drugs, drugs.

not by of are XX-plus to patients related or real osteoporotic tapping their the opportunity to who lack state grow However, percent is the options. instead treating disease due market satisfactory symptoms the of

D in select to the economic gains made due market Beyond have more populations, many affordable. vitamin regions drugs and that aging U.S., such the is as deficiencies, China rapidly and calcium osteoporosis growing

platform we We investors, discussions with our public are stakeholders And milestones of with presence company is to technology broader Phase much multi-billion tunability Similarly, pharmaceutical broad number the XXXX variety our of establish large a in program. of of ensuring biologics wide companies and appreciate licensing EBXXX a markets. active dollar have regarding technology or leading X a to opportunities, for variety osteoporosis to lead anticipated have our our key collaborations.

hired we established build Jon our Lieber, teams seeking in future that as regulatory Boston, have the Boston out and in and business Massachusetts, development to CFO, have U.S.-based today We our area. and U.S. new will be headquarters announced

trial During call upcoming development programs, milestones, current from our review we’ll We’ll of that and and our then question-and-answer a you'll efforts. business briefly our hear financial we’ll development remarks, our open up today's talented following strategies. the and clinical provide operations, cover call, We’ll product overview for concluding team an session.

Let it a Chief me turn to Santora, Arth? Arth Medical for Officer our Dr. update. clinical

are in initiated study is This Adam. XXXX, enrollment dose-ranging leading a X team. being density who or in Israel, patients. EBXXX Phase is study either supported double-blind, conducted the we by XXX controlled targeting centers And at we Thanks, have low BMD, osteopenic range. women, medical monitoring three in In six and months bone operations mineral in evaluating osteoporotic post-menopausal doses different a or U.S.-based low four placebo

EBXXX effects and of markers doses into bone We six will and formation safety months on then case, then a those of three safety evaluated. pivotal months study. X six endpoints PXNP, advanced months. oral the we’ll evaluated tablets, determine over In after biochemical last PTH this evaluate with Trial Phase optimal BMD our will and

in to endpoint fracture from of first the final PTH a The And injectable six PTH outcome in Entera osteoanabolic is have and larger with and data, Phase Bio's half will utilized the in subsequent X.X completion in risk XXXX. the third anti-fracture efficacy with the months the to success XXXX key Thus proof-of-concept and product oral topline and quarters non-spine enrollment of we the the well-tested would human conduct XXXX. bone probability to of second comparing of in data Forteo three for drug, been readouts very over believe Teriparatide. reduce study Short-term over X. shown women of fourth patient The million six-month and similar in hormone parathyroid spine same The predictive BMD full tablets expect PTH peptide large fractures and X-XX worldwide. Phase marker upcoming injectable EBXXX data biochemical trials. the X pioneer, first in data drugs XXXX greatly this Osteo active BMD osteoanabolic Assuming EBXXX Bio's, milestones start head-to-head, the of marker Forteo treatment XX of this the study, we see historically a X, hormone interim of non-inferiority Phase Entera then period. trial very BMD the meaningful respectively, favorable study multi-center quarter increase and months in of with endpoint parathyroid PTH and form be readouts a projected single, we

these in As first clinical collaborators. ensure the we the planned to cGMP on comment trial, funding our intend will to work the will of CMC half robust, a and we pending trial design in for Phase in of are X Phillip status to the and potential lead-in that XXXX file to underlying of Phase the some we process X [ph] with FDA Phase support anticipating XXXX, a technology preclinical an then side finalizing that potential X on XXXX have trials. further IND

with study Phase titrated phosphate renal treatment frequency mainly D decrease biological in treatment with hypoparathyroidism times hypoparathyroidism. by a X a low EBXXX excretion. calcium vitamin delivered demonstrated PTH to design high Moving on in also taken results bloodstream almost helps calcium definitive for calcium also long-term loss active disease blood normalize inadequately and the PTH we of orphan pharmacodynamic-pharmacokinetics patients PTH-dependent XX% serum proprietary phosphate X four study from to calcium levels -- the decreased PTH Oral activates phosphate, program our oral one-day confirming oral increasing dose is the This serum positive reduce by with into increasing excretion. urine in in and are Phase serum EBXXX effectively determine would reduce as hypocalcemia, of levels of that study pathways In PTH, oral of urine by Phase hypoparathyroidism. an which levels. control reported September, PTH that of be with patients the per XX-hour secondary activated increased Oral urinary day, excretion. X

recall our moving determine be or and XXX I'll was who target our will into X these populations approved also an update Natpara, Phil the PTH will another We injectable of Phase patient on Phase patient a turn provide studies. on of X able study, Phase trial. pipeline. be development R&D, basis now Dr. efforts before product product leading the to X the small single to and would formulations Schwartz, President

development everyone. Amgen progressed an Amgen in less very months, with agent morning, been very targeting, are moving develop provide to development studies to customize Good kicked-off like new formulations and to PK/PD compelled a rapidly the early been particular the a very to number areas; In of and level to ability teams has well, much, collaboration targeted anti-inflammatory are in our drug has two Both Entera's results. conducted the and first, be with is believe Entera XXXX. in with treated. since positive for an a development the order we different of I'd into than In you innovations to PK to the drug testing. eight by Critical and the old as have update Arth. situation, of this required develop this Thank formulation rapid we next formulation what program of you technological meet appropriate these Amgen. characteristics pathology

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last currently As focusing are main outlined we areas. in three quarter,

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to for intellectual strong over our an position to a I'll this product cover call yet our point, attractive, on Dana, effective, provides sustainable worldwide turn Finally, the potential portfolio At basis. partners cost the Interim property financials. CFO

expenses of legal XXXX largely months XX, services salary September XXXX and General clinical September includes including Total $X.X for million. September compensation $X.X the expenses. under Thank and expenses, related September of $X.X XXXX remarks expenses. and $X.X for manufacturing XXXX ended DNO will we Revenues and Research XX, materials, were Amgen before ended we operation salary as months cash you, into related the of and nine turn back trials was million salaries expenses, for which nine and comprised months concluding nine and XX, their insurance the to quarter of go $XXX,XXX related expenses expenses. was first for Administrative were and cost XX, to for comprised development fund the expenses call Adam? licensing of Adam. this were nine the largely the clinical XX, ended from million, I XXXX share-based of revenues now the operating our The Total to XXXX. September believe will months provided ended agreement. direct Q&A. Adam all million

internally many Dana. osteoporosis us year clinical Thanks, potential an in oral readouts utility data our and technology platform. oral drug PTH bring molecule large our the and The of described may and and and their be Grail efforts Holy focus into externally. eventual investors novel to to for patients, our and for the to will inflection delivery new programs. expand start important We Amgen a and believe We of delivery we years research a thank for of considerable where efforts support partners company, Phase physicians meaningful to an Teams our of market resulting with program. take collaborations recent for target interest the in to our in is result us off this start And the preclinical point fruits of expect the XXXX X in

new in both needs. requisite large Boston. Jerusalem teams investments expand And with making in pipeline our markets are significant team in We in unmet and out responsibly the our headquarters in we'll build and our our

and we their and markets grow and we and The we from deficiency our or biologics. launches proteins For patients could or provides oral them of These broadly for of may by and hormone as be modulate a take newest believe next as at product many osteoporosis administration into to a areas, molecules more more growth blockbuster disease growth franchises, giving opportunity PTH look our oral biologics larger that hormone with both of strong with allow target. well-established in existing state, states. growth can blockbuster convenient, importantly, such partners, treat the effective us, better alternative investors across growth Oral macro share

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programs, unique intend that will return our absorption and of in Our coming offers relations We are investor a innovation internal clinical solution and with deliver team further internally creation build significant see inhibitors enhanced markets believe and capabilities, And see responsible and online an Most And certain and summary, on investment. leading pharmaceutical investors, U.S. look focus the with the to our partners. community. forward importantly, growing biotechnology the progress and partnering our value to deliver synergistic future combination investor events. needs our to or community, on we we to we will the and industry presence process the drug our in unmet a our new therapeutic In pipeline and conferences, we near-term protease with laying of presence capital and our investment for sharing in team our growth rapidly to who and protect allocation targets. our groundwork drive enhancers with on continue additional are our stakeholders pipeline. the to quarters. highest building those to on able augmenting further public payload, building We're a execution and and executing out be with milestones in that

the now open any up will open We for questions. line? Operator, please the line up

McCarthy question Group. Thank Jason Our first Maxim you. [Operator of Instructions] comes from

Your is now line open.

taking Jason. This Lee for on the you Thank the Hi. progress for question congratulations and Good morning. quarter. is on this Joanne

an the been Could was unlikely view shift space? an mostly you the to considering development happen would how ingredient, this share especially program, focus any EBXXX impact company's Natpara. So, related the that recall on has with considering of is there which such, I the in perhaps was with recall wondering, in Takeda’s to inactive your product? oral the As

call thanks Certainly, something Adam. it's and Thanks watching with and morning. the for closely. are by joining physicians patients the the is along that This we terrible question, for affected this this disease Joanne. Hi,

the what clinical [ph], that think an recruit as their is, has was who need for to this has tough created one the injectable, such of state. seen, to better trial We've regarding happened really, at for therapies. heightened I looking awareness for a example, it really better been has disease able competitors incentive

So, it's our think creating unfortunate physicians, very of it while been is heightened a and for and of for patients the awareness both others. programs I some

how we very with As about program, priority. we're to high this going proceed think this continues a to be

recent Some our to reported this in programs potentially of the how compelling. data quite as generated looking that we're X a formulation well. Phase was back September and we’ve And final take into at determine we

And scale to which need on Natpara’s and I'd similar Thank you. a could us give be registration of helpful. to of EBXXX take would in was how a PX, idea a it X around to was large expect of Phase an That you bit you see on to you more XXX trial if patients. like HPT,

Joanne. question, Sure. Great

over me Let can our that comment. Arth Santora, turn he Officer, and to Chief Medical

I right lines for along think you're well, Phase any but additional envision as of would we X what the thoughts? Arth,

to and patients with find it's you very it's I just indication, orphan like difficult said, to an what hyperthyroidism. confirm

XXX might an different very around envision typical Phase indication. somewhere orphan So we probably a tops. for and XXX, It include would program. design, That's be would a X patients little

Thanks, Arth.

Thanks Great. again.

Sorry. me. Yeah. you. all That'll be from Thank

call. the joining Excellent. Appreciate Joanne. you Thanks,

to to any does back Instructions] for over now call session. the [Operator question-and-answer Gridley, Adam turn I our you. closing And remarks. would this conclude Thank like

everyone. morning Thanks Have osteoporosis the We coming and program lead for to for everyone to the also you day, progress with both speaking for a look this call. our taking quarters the forward and reporting in hyperthyroidism. time join good on

conference you for Thank Well, today's participating. ladies and gentlemen, this call. concludes

may disconnect. now You