ENTX - Earnings call transcript Q2 2021

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Operator

Good morning, and welcome to Entera Bio's Conference Call to discuss the Financial and Operating Results for the six months Ended June 30, 2021. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to turn the call over to Ramesh Ratan, the US-based CFO of Entera. Please go ahead.

Ramesh Ratan

to welcome and morning, the call. Good

and on Arthur Santora, me of ended A Entera’s June today's six was the Schwartz, call CEO; our R&D. financial announcing release earlier Jamas, XX, Spiros press results our months President for first are our Joining operating issued CMO; today. XXXX, Phillip and

morning, with those you who www.enterabio.com. it’s a Investors the on our and of our have website, it, review share by For financial will section our question-and-answer On we business update this results, call available session. you be not yet will a of of seen followed which

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are circumstances, expectations changes current based assumptions statements that risks, and involve forward-looking Our upon uncertainties. in

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call today's being call I over now Finally, will turn Jamas. Spiros is webcast. and recorded please that be the advised to

Spiros Jamas

and company's the the call Entera the and platform for Ramesh, this that validated on in you, dedicated morning. delivery joined technology XXXX, the January thanks approach in based team. enables Thank I and auto talented therapeutics, joining everyone

that my We team confirm confidence have key and on value more hit and we're and creating several believe generated our milestones in for our shareholders, path technology, to value. a have

osteoporosis, and the development business accepted strategic are PXNP, strength. mineral data future and density value a efforts, on these and granted and dose, that diligently the disease bone clinical platform. is around patent European PTH The the are significant for office that to patent for development conference, generate addressing are in the and quarter, the how of PTH we all for through for leading osteoporosis I its PT. three-month PTH the the the response at abstract believe protect ASBMR validation results, osteocalcin property partnerships. intellectual second key dose a Entera’s our There was treatment points. and of measure we quarter, ultimate In the anabolic in our We biomarker markers foundational Phase key biochemical the density, presentation statistically announced linear working second and and supporting X Also, hypo in clinical and secondary will end scientific clinical and XXXX. product bone currently clinical collaborations formulations reported oral study EBXXX, primary the that bone met

out hypoparathyroidism injection, the in balance bone-building formulation Entera’s in The anabolic treatments announced This of why year to of And are safe per that may We cost US. patients. reason biomarker due Romosozumab, Mineral age, X-XX, independent is in osteoporosis estimated potentially to becoming successful EBXXX patients study annually a alternative patients, study of was there In are X estimated a surprisingly, give physicians, research much-needed delivered positive $XX,XXX XXX and found data recently years billion brought therapeutic assumption affected bone-building osteoporosis which that mass, are or to low think men the pleased osteoporosis. two like of supported is of a has treat Teriparatide, completed patients. available data, today, oral we marrow Forteo three EBXXX addition, living increased treatments million including only bone believe a a that in drug cost-effective trial X% bone why significant data injectables currently a million six-month patients the osteoporosis. oral These have more of like four study research be market. solutions. clinical osteoporosis of firm, market with by Abaloparatide, and available osteoporosis million. with an osteoporosis and bone US strengthened oral first to is $X are and pricey payers, Phase bone-building have report are positioned or a of EBXXX data tremendous EBXXX, we from is PTH, three-month the of to the density seeking I'm may at Journal the of hormone, In oral at them and potential a injectables. break will multiple of providers, The now all Tymlos treatment a This in an effective give Evenity bone from which product large published cash significantly quite and the our In increase developing balance a market Phase commissioned to three we platform $XX,XXX only One trials, I'd one this people opportunity closer in from parathyroid and Research. XX recently XX born Xa effective to and human the Bone via clinical an one you significantly snapshot by EBXXX sheet, technology over at and be places patients current $XX.X in X to the also treated. women to to EBXXX step Americans market. risk osteoporosis once-a-day in was alone, worldwide. one the Phase

new delivery dollar the Aside effective multi-billion oral today's is for from drug, believe from billion patients an with patient-friendly injectables XX% Entera here price, more the currently that patients patients injectables. penetration, there's more the has by XX% and EBXXX as who translates untreated, cost $XX to not either injectable oral We potential be which estimate injectables. are the on an can XX,XXX a We far of opportunity to treating opportunity of currently today. take market plus at over a with cost realizable that treated share than

a with dose-ranging XXX BMD Our total at dose-related mineral X.X placebo, after than six-month lumbar low post-menopausal the osteoporosis, a with X.XX% and in of female discuss neck. study P-value PXNP, change an BMD, was of PXNP dose six less in one in Israel a with increase profile, to primary or Phase of safety these four deliver centers biologic The Entera’s was X and doses increased by excellent spine, At density, hip significant bone the in than and EBXXX. showed the to statistically to months, of in a a X.XXXX. dose three varying FDA study’s the a events. the and leading response peptide to X.XXX. efficacy months was spine drug-related at to receiving a clinical endpoint, two EBXXX’s P-value adverse and BMD EBXXX X.XXX. data also PTH development lumbar increase of the lumbar PTH as endpoint, milligram efficacy end met. subjects compared There to in in data with in month of femoral meeting performance months, significant highlight orally achieved. exhibited spine The than achieving six or We BMD. safety want significant of with and to no most X trial that There the for double-blind to important placebo-controlled program. look a point the conducted medical response spine less evaluate was increase of EBXXX with BMD EBXXX of less study significant This increase I was in forward was dose at review EBXXX Subjects Phase pieces a platform controlled dose effect. serious for a P-value an the dose BMD with EBXXX of lumbar

In this conduct with EBXXX’s oral as Phase pivotal FDA’s single study, number comparing effect would that neck EBXXX, and XX% BMD Forteo’s, of injections, we in the study a at in femoral spine observed within we treatment treatment EBXXX with had spine agreement, BMD XXX(b)(X) total changes plan X a per pathway. With months. on at In Forteo femoral BMD or the patients Furthermore, treated with to are six of versus months. neck Forteo evaluate the both non-inferiority BMD hip a and be increases contrast, impact significant of hip, total usually greater. not on to one-year significant six

to in Amgen, as are date, a project to to objectives. additional value, work either continuing through partner, we development From Amgen. EBXXX, look products collaboration another EBXXX accordance collaboration our pleased and support in Amgen's that perspective, or developed a our the and in with collaboration continued on technology with with such support with create pre-clinical the leveraging and collaboration made We compound, the to with such to have in by progress proprietary also focused forward platform we’re to can applying and are business alone, Entera technology doing as be company's that that or

with various partnering for have current into company options that platform ATM now of flow, to assets. share program. demonstrate value news support in future the to of US-based delivery potentially the judiciously, to Operationally, continued for enable target results. and turn to the sufficient monitor allow the I'll the the transfer oral fourth opportunities XXXX. our quarter of of cash hand our on financial we Ratan, say can CFO, signed proprietary cash planned I'm generate Entera’s pleased efforts, three to our is multiple to material BD our have derisked use cover expenses Ramesh multiple part operations funding, our our of agreements to As companies raised the molecules. of feasibility call we that These

Ramesh Ratan

XXXX completed professional June Spiros. XXXX, Financial of XXXX, June Phase external expenses expenses ended fees. was the to operating ended warrants net compensation, Total in the ended general administrative related June connection clinical ended provided compared trial. in expenses, for the XXXX, XXth, and public expense, resulting in Revenues $XXX,XXX, $XXX,XXX, ended administrative the were months of in including are months for in December recently fair the primarily XXth, June of the in June and an legal both and from market and XXXX, XXXX. you, six closing $X.X respectively, due share the The price. XXth, million, Amgen. increase warrants, XXXX, in to and costs of and and XXXX, placement salaries related up share-based cost the related of comprised made includes offering, to and XXXX, $X.X services and six XXth, expenses mainly XXXX, Amgen. R&D D&O revenues The the with $X.X Research our and to and for our expenses costs XXth, in the expenses for million General XXXX XXXX, attributed $XX,XXX, of in to provided connection ended months six six included February and the June is were increase to private and for the $XX,XXX ended development XXth, R&D June XXXX, development for June second revenues salary initial six the months mainly six months months a months headcount-related primarily months $X.X the insurance with XXth, XXth, were million value with conduct of as expenses. or attributable six X six re-measurement XXth, for ended Thank issued quarters in fees, our expenses, and consisted increase the services to million and research EBXXX were June which

of today, cash and filed approximately $XX.X had cash As XXth, cash our cash that in Entera of we XXXX, $XX.X COVID-XX and XXXX. subject equivalents in of expect EBXXX, plans, Xth, operating impact and XK as million, equivalents Based on and million approximately current of we report June August we XXXX our is to loss the This programs, including operating our expected to to product $XX operations. development our continuing be any of million. timing subject on

cash before I’ll turn to fund quarter believe the sufficient result, of operations to fourth remarks, call XXXX. be Spiros a to the we position we back into our go for will As our now concluding Q&A.

Spiros Jamas

Thanks, Ramesh.

the about market recently from for the believe of majority X opportunity an clinical excited is that osteoporosis are EBXXX. in treatment, Phase results patients We anabolic that We remain because untreated. benefit could reported substantial the

believe deliver generate Our dose significant results clear molecules data for development to at Entera agreements through business data we Phase with business works validation. size. to our number strategic fuel platform have and clinical and and of development platform PTH proprietary This these $XX.X future partnerships. improvement. X proprietary demonstrate material monitoring. of achieve demonstrate clinical transfer platform I that collaborations our enabling to the million, response a generate To a discussions and showing our is sheet, using support our companies balance broad signed strengthened characteristics us of efforts, their to now will orally, have Further, we feasibility excellent on value

Operator

[Operator instructions] question first comes from B. Riley. Patel with Kalpit Our

Kalpit Patel

Yes. the on progress. congrats Spiros, recent my and questions, Ramesh. Thanks morning, Hi. for and Good taking

increase Just think Phase meet months level? on the share the XX% mentioned BMD you for penetration sufficient you a X Can to that would that couple the non-inferiority terms think of And bar call. XX trial. for be market I at first then, in that you XX% planned non-inferiority rate the expect me, the

on the can in perhaps estimate, derive achieving how goal. provide curious confidence that and that you Just if gives color what Thanks. you more you

Spiros Jamas

Yes. Hi, your for very Thanks much Kalpit. questions.

X.X our On margin, the in strong dose the for obviously results, the reviewing were also would assumptions incorporate sort milligram total neck femoral we statistical to beyond we that very endpoint what spine also of X for of evaluating we and we're which showed at Phase non-inferiority height but the hip. obviously how lumbar into showed And terms the non-inferiority. BMD, our primary increases and then use that in -

sort We'll have X update evaluating based updated all of Phase we a plan of We’re of market on results. that. new our once new the clear sort

Arthur Santora

to if in add I maybe of Spiros, end just the terms that could points.

Forteo BMD increase at the and spine X% months. of between studies most X% in XX had So,

it give plus have And so, order what we depends or X% though, lot a something general non-inferiority, in achieve was be various the achieved trials. minus have a somewhere a XX%, like in order of XX% to between statistics on to would in to to approximately you but range to just

Kalpit Patel

Okay. color XX% And if then penetration, the market there. you more can provide

Spiros Jamas

was you survey in are Sure. provide the could I when That the Romosozumab Phillip, the seeing done. single was injectable not on Yes. you low we’re of achieving the of penetration of the across achieving are market, market anabolics and board that more? sort - in sort look digits And at Tymlos. based sort mean, very

injectables. number us much patients leaves that are higher agents these so, and receiving of a - are And with there's that eligible anabolic percent a

high a gap is. that's from where been - that's level, big So, the

Phillip Schwartz

oral very when for to the and primary spoken injectable and add quite patient in treated they others, which large can't action, We agent treat if for they something damage X% which to in to would of to as PTH osteoporosis, successful. utilizing people that's when this, to than of an see cost be silent bothered anabolic, that introduction clear that about anticipate medication. that the physicians in population anabolic, general, is novel survey, that incredibly enthusiastic assuming Therefore, which would elderly, very And the lower taking we're resistance well have feel. new treated sensitive typically choice osteoporosis. with level, the which choice some have an it's benefits. would fractures imagine it. could a other to driver is compared multiple high. oral, have are reversing is overall population of that terms capable that be building that that the to the silent for you feel, significant payers with physicians treated an is agent, the get the would to does, increase, can't given oral are with of which to as for that be don't would parties and because injections, I'll medication proportion to that symptoms and disease, an fact a treated a of of disease, with also there and their agents. very, And especially is we be that, of especially result an and want osteoporosis, patients use with of a very our that oral, payer drug, attributable a of we've they that also the significantly They the less driving which a from oral they bone On And share patients, therefore, our it's we'd So, market very, especially larger be physician as mechanisms

Kalpit Patel

Okay. questions Thanks taking the for

Operator

from [Operator next Cayden instructions] with Cayden comes (Dick question Our Advisory).

Unidentified Analyst

made. progress Hello. guys. Good morning being Good got two I’ve questions.

the meetings on comment technology. And of kind my transfer timing what - in question of terms meetings you feedback meet, of FDA are this of the back regarding that from coming is some second when them? when a First, do expect you up,

outfits. working with are three different You

proprietary on of what So kind those expectations of timing, technology? the again, for transfer

Spiros Jamas

Yep. Thanks And to (indiscernible). Nice you. yes. hear

X we what's which standard X development that. So, on end FDA is probably an date, holding second your the of to. update provide that, we full will that half is still meeting meetings, the review of Phase on have with have, agreement FDA sorry, is the once results, get Phase will we and quarter will the Phase be as we've of - as XXX(b)(X) it's the we'll FDA, a the to at end from with on the mean, to will - market the study Phase I meeting under that, for X well of a our said thing at. X and meeting the And pivotal and called meeting Phase the FDA's to then timing of FDA that will And mean, physical support it's first X protocol, X full key of a we're for approval we'll And that typically FDA osteoporosis, for again, so the year the design have And get that, we X proposed expect one still confirmed meeting, and we're it Phase question required what our we're be study, the our this and sort taking the requesting treatment a with timing what I for second that - will end Phase of this - required EBXXX that we're one pathway be FDA. feedback. of

the of so - - our that agreements material the the - all right of our now. end regard before So will that happen. that evaluation with molecules, ongoing of within platform within other in year, the transfer this With is second the the companies, half, and to

end evaluating working we I be do of right we to of going generally have the number demonstrate with partnerships We’re number conducting momentum and announce platform. to mean, now sort by a validated with updates And of and models we have is interest a the And animal to able of year. of experiments on That studies we'll other platform platform - the should companies’ expect companies. our and with our lot that. I some the that involves in the products potential

Unidentified Analyst

a you. Thank follow-up. And just Yes. quick

there other in EBXXX? waiting for with people, meeting process see you or working are also the JV FDA Are you meetings. for too, EBXXX, the any is of companies to potential if the other with With

Spiros Jamas

would companies Yes, have discussions or Yes, regional they interest focus markets number We're the mean, well platform is that as BMD that that for expect Dick. European a data has with for been companies global Yes. our both in of marketing. we're you in, obviously, getting example, we're BMD so the China, - final, (indiscernible) as progressing and global also companies process absolutely. with increase in I indication. this the with working very And those helpful are well. and proving right

we'll yes, - progressing so, are And well. those

As obviously something, soon on as know have a let potential we we'll market collaboration. the

Unidentified Analyst

luck Good much. very you Thank

Operator

further to [Operator call like instructions] Spiros turn I'd to showing no closing back I'm for questions. remarks. the

Spiros Jamas

a made Obviously, million everybody calling you Yes. right I my - good cash very and position previous X the the ASBMR position cash the FDA. remarks moving with position be with $XX.X questions. improved And No, at meeting and meeting. in thank Phase happy with of setting. details closing forward, in X And forward annual cash very with bone of the will Phase in in company, for presentations positioning of very path a be your our the end also, for the now, we’re having we'll - of our the of number at us strong yes, already presented the results with

number very discuss a events to So, good we'll have of our results.

So, your thank for interest. you much very Goodbye.

Operator

concludes This participating. for Thank call. conference today's you

now may disconnect. You

Entera Bio (ENTX) 16 Aug 212021 Q2 Earnings call transcript