ENTX - Earnings call transcript Q4 2020

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Operator

Good morning, and welcome to Entera Bio's Conference Call to discuss the Financial and Operating Results for the Year Ended December 31, 2020. 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 Jon Lieber, the U.S.-based CFO of Entera. Please go ahead.

Jon Lieber

to welcome and you, the call. Thank

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

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

clinical data and within our begin business timing the position, our data interim of from of ongoing during XXXX, the we you objectives statements call and are biomarker our released expected future Federal securities that the would statements X the of data meaning X clinical first ongoing of prepared for including Before operations operations in considered readouts from quarter like EBXXX this and plans to future remind trial trial financial forward-looking remarks, I Company's of the EBXXX, the of Phase about interpretation make we the laws. strategy our Phase various of results

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

described of predict. call future our factors read are this All on are the to These Specifically, accurately that statements the continue EDGAR on which investors depend is we on SEC's undertake provided We not to call of extent more SEC make or and be and account and and to as SEC pandemic conference fully provide duration information, filings we system any COVID-XX on the such developments able no otherwise. the impact future filings. and the new events evolve, we impact, numerous our the in will website. related to magnitude today update in in risks all the will our on us pandemic to this obligation forward-looking we may on only available and encourage information to of

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

Spiros Jamas

our everyone of Jon, you, platform call the January create protein key Entera the and value In the thanks and short-time, further several based dedicated since and company's technology we our enables I for on technology the this ability have therapeutics joining team, to the generated Thank both team. in believe morning. for the joined, delivery I milestones have confirmed oral that talented shareholders hit XXXX we've and in confidence that validated value. my and more joined

eight through have support value discussions data on showing development that of believe broad We and our business data molecules I will size. collaborations strategic these works and future generate and partnerships. characteristics platform

of multiple Entera's in Phase addition, Phase currently in treatments And believe to data applying In to either second enabled with additional will to patients. platform EBXXX on share that and The as developed pleased through the from collaboration Xa collaboration cash our significant delivered company osteoporosis the these EBXXX to a has to of EBXXX positive technology future that The we that into company's technology three-month study announced price the including in the and was and such Journal alternative Bone we EBXXX current allow injection of of in to from create the Entera value XXXX, with share potentially company potential recently is technology oral patients of our can the in hypoparathyroidism the fund clinical focused that bone leveraging quarter or a us Each multiple alone needed new out supported Amgen. With another trials, by from the data recently ongoing Mineral Research. I'm enables data of resources recent significant coming proprietary of published value assets. clinical our via biomarker trial multiple generate be either momentum X sheet. balance the products, strengthen slow, say our partner patients are such of And rise opportunities XXXX. in our what de-risked options are as while much in give doing platform our partnering compounds to can we funding by

to to While Art and like and recent and detail an platform, of minutes take some will of Phillip go I few programs programs our overview accomplishments. into provide on would clinical a the greater the

PTH, dose First increase with milligram is osteoporosis, X.X or after formation. human months low in less or positioned biomarker bone be parathyroid treatment in osteoporosis or to patients. bone delivered PXNP recently of on significant compared the trial orally PXNP announced osteoanabolic, X.XX a a oral first EBXXX, value showed Phase The placebo. in mass that trial women endpoint. complete to biomarker treatment (X-XX), the the that its We for X primary the indicates of new from the of hormone met building, results group P with than a an three three-month the rate bone

announced interim heels a first XXXX, XXX Israel data clinical of from at trial. low other the This in in trial patients density in the BMD. osteoporosis novel of the In X.X BMD the of comes milligram data mineral The in and dose human EBXXX a reduction XXXX spine mineral completed a enrollment postmenopausal of accepted is trial centers on add placebo been fracture As range leading subcutaneous positive with BMD milestones X bone The and PTH study XX% four a data number important has to this or and double-blind dose. or has over drugs like ranging density, reminder in with and been dose-dependent earlier subjects. bone meaningful of BMD approval August the the for These six-month decision program. milligram medical with female for important data formulations Phase has subjects an we a in have of reduce indicated this development controlled associated is X.X on change treated increases risk fracture. patients (X-XX) impact to X.X the of lumbar spine a EBXXX regulatory manner the in spine lumbar shown conducted a were been that has lumbar endpoint in to PTH dose now supported because

BMD data data any the not do reported X.X in the date from Importantly, arm. subjects milligram treatment to include

XXXX. second the trial this final from expect the data quarter six-month report of We including BMD results in to the

in Phase of announced the completion the the enrollment FDA the of in we for quarter U.S. the major program trial to a In XXXX, extraordinary the of EBXXX. the pivotal and COVID towards given challenges completion a enrollment step of moving was with clinical the to important trial. related fourth and IND The milestone, the addition, and the pandemic acceptance IND forward by the X along acceptance

PTH a very multi-billion cost, research challenges. drugs injected significant Administration, the convenience a could to to BMD and reported to the Phase the begin due due Drug we fact with the in for We of market. patients continue small X believe value and a meeting points Phase U.S. EBXXX or year builds positive we market successful unmet bone to other a of we The from subject dollar in trial to data is the X are with strong Food and with FDA, therapy osteoporosis Assuming see oral trial end that of believe only or EBXXX Phase proposition compliance and subcutaneous XXXX. that post percentage building treated last osteoporosis need conducted actually an bone X

significant to JBMR. of Phillip But and hypoparathyroidism, recently published in usage, will were the key Research EBXXX added decline in calcium endpoints led a supplemental or to standard data Turning study EBXXX XXXX of provide from additional hypoparathyroidism for The Mineral in summary, when in Journal care trials. to Bone the a details. statistically

focused are forward. would we the that optimizing We on to intend formulation move

efforts also and accordance support pleased the with continued in From the continuing companies work our Amgen's several preclinical oral business development our Amgen use forward made injectable dialogue a platform to to to in collaboration our and support candidates. with objectives. We plan the to-date exploring collaboration to look and their ongoing are and of an project delivery our with we interested with have have perspective, are product with progress increased platform that leverage have technology

X program We with trial support our Officer to pleased sufficient cash these Canaccord. into on EBXXX. to planned current judiciously XXXX. are now Dr. Medical ATM to moving turn am of continued our we use cash conversations focused on would into agreements. Santora, to hand the I have formal I expenses carefully quarter to discuss that our Phase our second of the the our say Chief to operations the over call through Operationally, like monitor Art of raised is

Art Santora

Spiros. Thanks

Phase trial cells a decrease were a in building the of initially in that formation indicates of effect, osteoblasts, new remove in osteoclasts, or we subjects and dose amended months evaluate biomarker three rate Common biomarkers final the evaluated tolerated of months our one indicates with strong included higher adverse was milligram was There to the and to for Osteocalcin placebo, in groups, a An based well As after follow-up smaller to or in that trial, milligrams. be the data, on with EBXXX, is with in the a EBXXX biomarker by by resembled treatment. expected milligram formation X PXNP, XXX EBXXX biomarker with increase or evaluation the In bone of group placebo, in to biomarker first study formation. of of CTX of mass. a with of remained bone either associated X.X the milligram of randomized, that new of indicates known that were a serious the having increase three X.X and fully doses dose old evaluation bone of the and months receive CTX. data X.X an has enrollment group reminder, of safety in XX biomarker the Phase their designed on the complete in visits. randomized the subjects discontinue teriparatide X.X, PXNP bone and randomized Phase resorption. is generally example, bone and PXNP, no receive bone. the in X.X Based the add trial completed new A and unblinded three period. X.X six recent the X.X impact usually protocol bone quarter activity cells Bone After X subjects approximately placebo months interim medication, Similar XX subjects X Osteocalcin no for months EBXXX. a that and PXNP different events. even three be by difference treatment of or already were Osteocalcin, a An increase the the or six second to those intensity a serum CTX, through osteoanabolic, data treatment additional events is or is rate events full the any six-month analysis bone build bone. of complete adverse severe subcutaneous DMD analyses six on bone injection. associated biomarkers after on conducted resorption bone doses adverse X to either the will treatment drug-related data XXXX. Subject

reported women. previously of other subjects postmenopausal this are in trials Finally, generally in demographics osteoporosis with trial consistent

significant As months, with formation bone p-value significant compared increase increase X.XX months to in its milligram as to Spiros the in observed Osteocalcin, also milligram that Similar after group earlier, showing dose the PXNP, p-value less PXNP in marker another than the less after three three mentioned X.X trial is X.X of a increase that placebo. biomarker group the was is X.XX. than in endpoint primary the treatment, met

forward Osteocalcin trial addition, decrease with less the quarter was p-value in the CTX positive a three CTX final a that sharing together In to of the XXXX. observed months PXNP, impact in indicate would on data from than look in significant was BMD We the increase taken in BMD. of potential X.XXX. treatment, after decrease The second

X.XX% in As XX mean generated BMD the interim a of data widely in study XXXX. arm, BMD Based first changes significant a treatment third on XX showed data, treatment the the of lumbar groups a mean the decrease in of increase hormone increase in increase reminder, spine placebo X.X osteoporosis six clinicians quarter we placebo-adjusted subjects percentage improvement analysis arm BMD overall the of milligram BMD. placebo month to for arm. the world maintenance X.X throughout BMD comprised during milligram BMD limited all the in of Increases interim the as in the of X.XX compared additional by in the was a are the X.XX%, mean placebo-adjusted arm. p-value of subjects reported EBXXX the in an lumbar compared a as spine X.XX% of indicators to in trend EBXXX randomized dose-dependent that increase XX parathyroid to treatment was subjects treatment. BMD in of An The in accepted

reported PTH previously subjects been (b)(X) any the teriparatide mg study regulatory X-XX has recommended oral for which human fracture of and in data intended endpoint pathway. formulation trial X the A shown the risk the injection Importantly, not subcutaneous BMD to not efficacy named include to was fracture. generically is required is novel X-XX in PTH treat The lumbar more osteoporosis group, because Phase did using X.X endpoint added. FDA’s reduce for dose the spine recently from BMD change developed XXX a

consistent and Dr. show Amgen over will of and now data subcutaneous published to our and of significant of R&D data Schwartz, program. to turn EBXXX. effective did Phillip with updates BMD with President a studies our on share neck from expected treatment call and you teriparatide with of EBXXX not femoral total As I some femur analysis the the

Phillip Schwartz

morning, HypoPT. would PTH provide like of very much, orphan Good I the update a our or Art. on orally you hypoparathyroidism everyone. treatment EBXXX, with Thanks the brief for delivered disease to

to of be that patients be data hypoparathyroidism different of improve currently are needed JBMR, we oral options, used the the unmet impact which publication hormone much excited by offer and disease leading via with therapy therapy a daily as would patients peer administered may We significant first-line well replacement reviewed journal. of as PTH and would an to need levels applicable our in are and approved treatment developing and believe with alternative the recent in severity, Phase are to EBXXX X PTH a as There’s hypoparathyroidism therapeutic compliance injections.

the acute tolerability serum supplementation reminder, our weeks to vitamin The treat patients’ a D and EBXXX symptoms Phase adverse As while times daily of data long-term four in recently goal the demonstrated effects minimize calcium levels and Xa patients published use. to the for and is XX hypoparathyroidism of urine active calcium normalizing administered trial. safety with

supplements, supplement maintained all. reduction bloodstream rapid X.XX X.XX maintenance included the according phosphate dose duration primary for levels hypoparathyroidism the investigator, serious to from study. was approximately hours p-value most range serum X.X the median calcium a target each a a the – not the the notable calcium phosphate of its adverse of trial mg achieved considered within end completed normal albumin-adjusted also also And following a the levels, of use a And per the of study XX-hour range study there in the an of of use. secondary regimen. levels events were serum at the XX% points, events is life. median throughout of baseline for XX% lower titrated mg/dL enrolled and of serum XX which were X.XXXX trial drug-related adverse It of quality above by first between to decline with with the in the urinary two within XX median X of Importantly, X.XXXX improvement to calcium the or including in drug-related and which the maximum day was reference in calcium the There no a XX calcium total in treatment and XX and maintenance a protocol. p-value EBXXX calcium supplement treatment days. of significant reduction of reductions a p-value of in this XX% from in Of patients, subject’s last results mg Specific included first were for decrease and In up tablets study. were patients median study, of excretion that patients,

to that of we evaluating on work EBXXX, We formulation in including are continuing the preclinical additional identification enhancements conduct models. are

next for also we to which design trial the initiate addition, we In EBXXX, the working XXXX. in of clinical in are expect

oral collaboration we and of the we Amgen an have Our progress has with agent the for anti-inflammatory with development pleased made to-date. continued are

We their studies several are the completed continuing to of has have and platform. different drug Amgen with evaluation preclinical collaboration included the support formulations that of our

to believe and/or We on as also focus potential new that have potential the the platform, it through generate active evaluation of continue to business value our the technology ingredients, of efforts platform development development and relates activities. either our pharmaceutical additional through validation to of APIs, these

XXXX formulation over a data the of injection. to $XXX cover syndrome for look to financial Europe, CFO injection models, short bowel U.S. Entera’s to our a an new of on our We Jon able forward announced and sharing peptide oral central brainstem the in the GLP-X. nutrients. As currently oral analog and to on increased we via was glucagon-like platform an an it. system the Lieber, a the months. over for we based the to U.S. subcutaneous only is a million approved XXXX. the daily the once GLP-X, enhance of intestine coming hypothalamus, now is turn or formulation profile our have GLP-X the registering research pharmacokinetic oral a and GLP-X develop an program preclinical treatment market, technology as analog global in sales additional recently intestinal shown results. comparable the for This nervous example, I’ll peptide-X analog produced The call specifically to In teduglutide, known has on GLP-X absorption of analog a been absorption, in oral in and

Jon Lieber

related with to provided $XXX,XXX years R&D were to expenses head related and XXXX costs X of revenues XXXX, for you, and services compensation, year General ordinary related connection December the count administrative share-based legal R&D XX, were the services operating ended to EBXXX insurance in the for XX, development December to IND included $XX.X of $X.XX XXXX and expenses, fees ended Amgen. in expenses expenses XX, share in ended administrative compared comprised and the ended in year December for year was consulting clinical of and of XX, primarily for expense $XXX,XXX application. $X.X Amgen. salary and million year The for fees. and to with million million expenses. ordinary was December conduct diluted the costs, XX, and and and professional Total basic attributable preparation up December the for external primarily consisted Phase and Phillip. including the and XXXX the fees, related year share to $X.X $XX.X research of development or $XXX,XXX the and XXXX respectively salaries ended $XXX,XXX were in December expenses, related XX, trial Revenues expense compared the provided XX, XXXX for the cost XXXX expense year Research ended the revenues of year $X.XX comprehensive to loss for D&O ended Net as Thank million $XX made EBXXX general were million for and both XXXX. diluted or December and XXXX

our intend approximately Entera and cash million and today, to we million had reference XXXX, outstanding. our subject of outstanding of XX, that report file product million. XX approximately loss is, cash on in million plans, course, impacts and to million current shares equivalents to primary expected XXXX. December development equivalents programs, and XX EBXXX March $XX $XX will subject cash million operating and we cash currently our At we operating to including on timing and of fully continuing have between XXF COVID-XX Based operations. $X.X be we diluted in $XX.X any a XX, As the of This shares of XXXX expect point, as

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

Spiros Jamas

reported EBXXX We're for and about EBXXX. excited Jon. Thanks, the recently data

released and a dose our orally. opportunity market clinical the clear is three-month that each areas platform believe is to to these demonstrate bone substantial. continue great results The validation. of biomarker PTH a using response deliver recently We This

platform enabled balance generate the GLP-X. of our us molecules strength for the as has and data additional sheet addition, several such In to

I discussions data that molecules have on We and strategic generate showing collaborations business data works partnerships. platform of future development these will believe value proprietary characteristics our broad support and size. through and

Operator

[Operator first with question Instructions] Maxim comes Jason from McCarthy Our Group.

Jason McCarthy

taking ratios bit with that facture for talk more just CTX how other the that changes and Spiros, to or any that's because those of preventing and insightful – too. any little PXNP you drug Prolia how Forteo are the and Tymlos you? specifically the how Could compares there out what ratio a or about happens Thanks of importance other osteo critical, – are question.

Spiros Jamas

Art effect, Hi. increase I'll Yes, relates CTX just level a a a from their mineral in the so correlates just more in and and very Jason. Phillip by Yes. from CTX give to a whereas give a level direct high high very of Thanks, density then to then resorption bone. – Yes, anabolic I'll and to increase respectively. PXNP with – increase bone translates – color

to our higher CTX. – want anabolic we're reducing be actually want really you to you have no, PXNP to have effect, and – an So

but a like saw high so, at and provide increases reduction significant dose, let kind very translate we our effect group, that's mineral in significant increases fact me would color a some Thank important – very, that then of but in for additional you, osteoanabolic the sort And saw profile this sort density. to question. that Jason. dose bone because ideal of in Phillip PXNP, we And on get to have of X.X CTX the you is the milligram would actually that

Jason McCarthy

Phillip you that believe part well bit on Thank goes – Can comment of you tie-up, Maybe as Forteo I little before question. want CTX – Yes also you. and brand, I to as you, that up. before after. talk – could of actually a

Phillip Schwartz

mentioned Evenity. subcutaneous injected anabolic out up some than interesting PTH goes Forteo that abaloparatide more Yes, of the specifically very And or you're like it's or we're to same a it papers specifically patch, somewhat abaloparatide also be is different, more ingredient, because Jason. many sure. the have seen significantly other drugs and pharmaceutical drugs, there active the Sure, API, those very, impact agents of (X-XX), Actually Forteo our to Prolia have stronger or than behaves correct. although you've been BMD, PTH that other that any which PK this of using CTX the far as with profile similar the can Thanks, are published. in

So density was their PXNP, is actually they than Forteo. a as bone increase have but more actually they bone in more was was a compared lower we're Evenity almost as in CTX, our we smaller increase CTX, have increase observed in similar increase in in in much have BMD impact the smaller greater both a on an the a building that They a to the at well In Forteo. have with and we – do even to mineral which as a have Yet that – building. what decrease because romosozumab not much of rise much bone case, in marker sense build CTX only PXNP.

of mineral about we're that have very density. – bone have excited in promising we'll combined both us could terms believe factors So make that. results those of we And very

Jason McCarthy

on you need that enough do a don't a remind can bit as differentiator or of just comments be clinically a that part which maybe of a meaningful is potential and months fracture, get density, at Entera, XXX talk or you XXX trial expectations little mineral Phil Can bone then you and six would you point. can BMD pathway you of the think clinical Spiros, approved? approval, b(X) the for month to to about to what to get one-and-done question your And six huge kind everybody,

Phillip Schwartz

pre-IND Spiros, our From meeting, please. go ahead,

Spiros Jamas

Jason. Thanks

clinical don't aspect the two Just we program pathway first that's because X a where the yes, typical high development regulatory important program. b(X) have to an under which Phase of to XXX studies, in our level pivotal run is XXX development on b(X),

mineral single study comparison pivotal a Forteo, can conduct You and so accepted clinical show has to the density the via a pivotal study. study endpoint. as bone FDA And single

not don't reduction an – need you as we So fracture absolutely, do endpoint.

fewer regulatory of So obviously patients color the those and a time the for a require path endpoint. the studies you and can provide Art is BMD and significantly and studies lot our then expectation on Phillip those

Phillip Schwartz

two One about Forteo study arms, little or a I’ll amount XX-month is pre-IND a And that's okay. add our XXX pivotal just with said. and Just meeting have XXX to has think you would X no, each what so. with FDA add have EBXXX, a margin Arthur you of was one in would know study patients be us what an achieve arm, tremendous give arm to of just to a BMD what in that very That trials gave will endpoint, look our approval. as XXX generous like clinical non-inferiority, us helpful like. very – in I type endpoint that that are us in a what the That that with with Forteo to experience study study And that be might sufficient idea in the approval. of between be very and Phase for guidance it before likely study explicit doing they somewhere what that to necessary patients a for we gave would which for Spiros clarity a of bit and add non-inferiority to osteoporosis one go. perhaps trial you writing likely look could expectations order more

Jason McCarthy

checked is can from I XXXX. market side, level, that compare more $XXX GLP-X of then with been you $XXX based versus we challenging just GLP-X just contrast question, little has the think particular. Last look And which but million, and an for to on in almost Meters near injection that has what GLP-X million haven't the and if on just X cap fellows and at briefly, a up is there, in high this I GLP-X year. GLP-X that kind Okay. gone a market. the Gattex know bit program on was I for one

here opportunities they the and maybe need contrast you forward? and kind gap to that Entera as and these and between compare places valuation you close can So is of move other where

Art Santora

I Thanks. know there Yes. different three questions. are

good just terms our generated GLP-X at very, high with models and sort very we can we shown of data levels somebody picked when achieving we why And high think platform of orally we So sort very see picked an how with of had that of characteristics a – that high and of of PK very GLP-X in a conducted the that sort in show again, chemical that I we success we GLP-X. would looking GLP-X PK is models. of physical has the works, very it profile that deliver time, GLP-X knowledge first oral was so we've PK likelihood because animal and blood – we nice we

And be it’s and said drug, is its while, short orphan sales, $XXX GLP-X I orphan the currently syndrome. an approved around think an the are indication to current you expect for annual so orphan it as bowel million

thought play And GLP-Xs so other the in also roles potential diseases. to are

even the opportunity, see potential actually not we short the bowel beyond indications to So, syndrome.

I and this potential programs, platform, obesity I that our that we GLP-X see So again, deliver orally different has sort to on such more beyond the and as hearing it entered lot GLP-X actually be opportunity with GLP-X we on a really high on our you’ll discussions regard of program, a more sort some market scores of see we mean with partnering indications news expressed we’ve and additional GLP-X. this strong of are GLP-X there. peptide, think potentially with very progress but to is got you an companies and us our as interest is updating also a our, interests huge in that expect very to well lot said, And a oral for potential. indications, an a with from fits of be I in chronic

Jason McCarthy

way Great, answers. voice well by Phillip, thanks [ph]. hear great those guys your for to so the

Art Santora

summarize and to study Santora. of Israel, the X we and with to full and Administration. comments have data Art add is Spiros data this and we I wanted in Jason, our those safety the one from density just Yes. an mineral Food about the Drug bone pathway. Phase request regulatory ongoing Phase meeting the plan thing of Phillip to X end Once

tell the of an the where in acceptable they to as what approved XXXX. the in a changes without oral sorry, would density point PTH Forteo. – generally outcome end later I’m that would comparison the favorable bone of Lilly’s product a as would occur Given time drug trial, FDA us and find That’s

Jason McCarthy

much you helpful. Super, very Thank

Operator

next [Operator comes from with Our question Hori Capital. Calvin Hori Instructions]

Calvin Hori

Good did ATM? How from Yes. you shares many the morning. issue

Jon Lieber

count with less than share currently So, XX diluted primary fully million million counts a than than count XX – a – current million. have around little about share less less share million diluted little we and fully XX sorry, XX

but the So, in of I tell ATM, the sold of, can you rate? head my I were of the terms don’t on on number top that’s current many right our have specifically, how shares

Calvin Hori

You raised XX million.

So, what price this… was

Jon Lieber

prices. Various

Calvin Hori

What?

Jon Lieber

Various prices.

out have So, what exactly with I’m top follow the happy my I we right at tell how just we you up of I exactly head number to can you. now. many sold. have don’t

Calvin Hori

Okay.

XX diluted? So million fully

Jon Lieber

correct. That’s

Calvin Hori

Thanks. right. Okay. All

Operator

I’m at time. for showing to like any Spiros this not questions the turn to I’d remarks. closing back call further

Spiros Jamas

Yes.

And for significant Have the join momentum. day. our good plans year. some everybody providing look times continued the regular to Thanks Entera. of call. exciting our execute updates on very with quarter the We’ve for This this time So, with XXXX to progress. of we a our to during beginning morning the just is you we entered forward this on to taking first

Operator

concludes Ladies today’s presentation. and gentlemen, this

have You day. wonderful disconnect. now may And a

Entera Bio (ENTX) 18 Mar 212020 Q4 Earnings call transcript