ENTX - Earnings call transcript Q1 2022

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Operator

Greetings, and welcome to Entera Bio's First Quarter '22 Update Conference Call. At this time, all participants are in a listen-only mode. The question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the call over to Ramesh [ph] of Investor Relations. you. Thank

begin. may You

Unidentified Company Representative

welcome call. and to morning, the Good

announcing Joining Officer; Officer, and are first Spiros quarter press Chief for XX, operating Chief on Executive Jamas, our May release A Miranda Strategy. was Officer ended Head me financial the and and results today Financial of Entera's XXXX, Toledano, issued March Chief Business XXXX. XX,

company's at you it, it on the received www.enterabio.com. who section is Investors not website have of the those For in available

forward-looking I results would statements are remarks, to and and Before the meaning of remind statements of completed ongoing during various we data for business prepared the interpretations begin positions, federal that like the this and company's securities you our strategy financial from are or and laws. -- operations call objectives be and makes company within plans future about the trials, to future operations considered

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

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

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

Spiros Jamas

already is call circulated because our keep pleased to that the week. I call Toledano. am announce earnings We're everyone. to today morning, last Miranda this on Good release we brief aiming me joining

on we Officer. member delivery as almost our leader has Monday, a is strategic been Officer experience. Street to our Chief industry in of leadership Financial now an Wall Miranda C-level our leadership the introduce announced of has since discussions biotechnology development As that accomplished experience benefit XX happy years and Board Miranda, Miranda progress XXXX also partnership and become global oral continue a Miranda Chief with part we Directors her team, who Business of of I and I'm will perfect fit significantly and believe platform. company Toledano. is as strategic with proprietary our of with

Miranda Toledano

truly history. much, Thank you morning, to juncture join in Entera critical everyone. excited this Spiros, at the and good company's very I'm

is well III lead program, safety know, Phase and differentiation to all our As mechanism administration, is of validated action, our development. you moving from study. data profile route of dose-ranging years. Last reported believe unique close strong safety EBXXX EBXXX XX clinical year, We Entera which oral has and its to due II to along efficacy for compelling Phase

to As position for EBXXX women risk of high postmenopausal such, the first hope treatment osteoporosis. the we oral of anabolic agent at as

the pre-commercial an oral In specialist for assessment community to therapeutic addition, and to need agent unmet and clinicians PTH a our analysis early expand date across clear class. to points significantly

company will pipeline soon. you. dialogue finalizing released which to Thank plans to I QX registrational our FDA, currently forward and these back provide plans we week. and it with the study are Spiros laser-focused XXXX, from look earlier you on turn to on We updating and the last highlights

Spiros Jamas

Thank you, Miranda.

postmenopausal first market paradigms health the completed women oral we care EBXXX at oral managed its and potential of available risk large EBXXX evaluating first the quantifying planning, study and pre-pivotal our analytics approximately XX and first, million as osteoporosis. treatment yet to U.S. of understanding pharmacologic The the target market by concerning study on of focused potential included: receiving the prescriber, part high a anabolic and As comprehensive represents inputs. of plan PTH patients of study is from The market over osteoporosis in a and not any this only treatment. U.S., key study XX% population conclusions product

partners the option U.S. applications market. osteoporosis moderate-to-severe an to and the a the anabolic recognizing cost patient's their multiple high such endocrinologists questions. protection efficacy injectable developments Clinicians platform preferred EBXXX's we oral substantially initiating you now improved were high-risk the opt very as to this oral patent establishing its despite characterize value to receptive based to on for for proprietary become safe patients limiting of a as Second, update. the grow doctors injection data look II forward our move update brief continue future anabolic Phase optimize of evaluate as as to agents quarter. we delivery and to material its transfer and We your with Payers of our for favorable on taking a intended for patients. IP. continue currently to administration. agreements patent I'll surveyed show our could treatments and treatment. benefit and we to unwillingness filed We prior potential proposition much in anabolic that molecules. this first-line for PTH technology EBXXX to route oral subcutaneous anabolic treatment EBXXX support platform. option osteoporosis and is expand clinical treatment and survey Furthermore, And high-prescribing A bisphosphonates, strategic Thank our safety profile were

Operator

of Our [Operator come Patel line first with Kalpit from the B. questions Instructions] Riley.

Kalpit Patel

patient for data first, -- that in agent like EBXXX. with Miranda. bisphosphonates would data start group with the any prescribers did prior collect Maybe I what study history collect what the no analytical on I'll fractures. or you Congrats did before that portion shows appointment, percentage utilize any shows guess you of EBXXX maybe that an of

Spiros Jamas

prescribers first the -- obviously, as what lot the used mean, bisphosphonates were profile a through you was see this of Yes, But first. a an requiring and and question. to line -- oral I moving are step not therapy to really for bisphosphonates an the -- population. was we mean, then the PTH -- have interesting step even at edit that that oral your be chain in payers, go a have they anabolic, up with and used for Thanks to I with

really So from untreated that's Does anabolic so payers and that these could think that to benefit answer very cover the of I an large -- product. sort willing question? population would to the be oral where are

Miranda Toledano

to and Kalpit you, support. your it thank I for think add I just might

coming and qualitatively that of we've trials, well is cycling and PTH been precedent followed for We what of in a I We're micro the because also potential we'll of collected quantitatively data sequencing is all Spiros this potentially through validated, seen has level from analysts there right? that finalize way. vice of anabolic disseminate clinical quite to also community high portions oral have we that by as both And or the obviously study enthusiasm through in to the plan the And III is said, the versa. collected a data think study echo strategy. this Phase we just going conducted. months. in the drug But So from and is our antiresorptives

Kalpit Patel

for was you study EBXXX, in before quarter, Okay, last And the are you initiate regional Can there the on EBXXX? Asia. that's you here any these us you interest in developing pivotal particularly progress something discussions? noted helpful. aiming in to give of have And then updates locked

Spiros Jamas

Again, once-a-day given fits Thanks, and attractive end expect II are by oral it's Kalpit. Yes, we is that mean deals year. are we formulation. the indicated our have of -- preferred both something to the and in really mean before, I into our the the But intention kind really asset be actively our osteoporosis of also be asset partner globally finishing very I That data, and the a globally to we well problem we've globally. the and pursuing globally. profile as it path, regionally the Phase the would

Also deep, well working generate very that inbound generating commercialize the lot interest and our interest. Torreya of partnering collaboration on that best getting already us of the bank, announced. will lot retained [indiscernible] been So asset. asset to a We a we've had and globally, is goal with we're has really the

Operator

Capital. Our next Instructions] [Operator of Aegis Nathan come questions with Weinstein from the line

Nathan Weinstein

start to just platform. delivery optimization I'd asking about by of oral like the the

being are Specifically, are the were there about to some attributes you optimized? could speak of Or features process? that most relevant that which platform

Spiros Jamas

different of so molecular general, really molecules the looking Yes, to chemical handle we're and features and it's the in the different the your IP for on are and our in target that able molecules also of sort [indiscernible] new physical question. captured charges to weights. being around so Thanks optimize

reducing And you so that deal that and achieving and platform, higher one to of always is have bioavailability address ultimately to our approved already our generated. includes our with excipients not we seen new FDA. able variability, the we're the important that are that we're IP -- just IP we've of lower all by molecules goal additional oral only new more also variability with that with to -- also then, optimized new with And aspect that important but we've new delivery, and the some the IP really filed

was set scientists and applications. those in in life of whole developments that on could we fewer also progress was and to give fit patent a we us made work of that regulatory things a -- screening and incorporating our molecules these lab lot the new that's there's there working and -- very back fresh new different into filed at life. were our the felt patent -- did the we from So and also why standpoint, that patent regulatory whole hurdles new we are formulations And platform the significant, a

Nathan Weinstein

Maybe risk demographics? sense osteoporosis. sense. women line, here obviously, question the postmenopausal just could make at at it EBXXX. look now, at high other down Makes any great. But looking to Okay, Right on one of

Spiros Jamas

would Yes. mean, you we -- anabolic could other have for additional has be pointed mean that I I in towards. expanding of want different I one and used an similar anabolics sort other -- that the Art, males to populations be do could be populations. to speak possibility, obviously oral FORTEO -- or to could demographics

Arthur Santora

Sure.

of but for out, men Typically, not fracture. first be would risk women As glucocorticoid-induced anti-inflammatory target other benefit testosterone, steroids that prednisone, the cycle, that's at of would people that just low osteoporosis, the with like an development natural as and populations high osteoporosis through Subsequently, the from initial at a an idiopathic anabolic osteoporosis. that are in treated drug osteoporosis. it as injected could include with usually That's called well Spiros postmenopausal indication effectiveness teriparatide. the with looks pointed

facture. of be postmenopausal an women populations would subsequent osteoporosis they high target after in So efficacy of with risk demonstration with initial

Operator

are I questions time. There any hand the to over call further Instructions] at Jamas no like [Operator back comments. this Spiros to for would closing

Spiros Jamas

we the you for addition today. the with much, excited Miranda very team of dialing everybody, for Entera. leadership in update are Thank very of Obviously, to our

As forward and we good day. III platform, the and with you can going preparation and a support. on lot in a see, further you expanding for for for osteoporosis thank Have our our Phase also you, is look to updates your

Operator

This participation. you. today's conclude Thank does teleconference. appreciate your We

lines rest time. your at of your disconnect may You day. the Enjoy this

Entera Bio (ENTX) 18 May 222022 Q1 Earnings call transcript