ENTX - Earnings call transcript Q4 2021

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Operator

Greetings and welcome to the Entera Bio's Fourth Quarter and Year-End 2021 Earnings 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. to Officer. call like Ratan, to now Financial Chief would turn over the Ramesh I you. Thank

may You begin.

Ramesh Ratan

Good and morning, welcome to the call.

today's Chief XX, issued Phillip operating results on Arthur XXXX, press release President was me call the financial Jamas, A Spiros Joining and Entera's our of Santora, R&D. our our full-year Medical this Schwartz, and for morning. announcing Officer; Founder and are CEO; ended December

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

considered and statements we meaning and the during our about future begin results Phase business from completed operations recently are Company's strategy, statements clinical call our of make trials future remarks, the our we securities financial of objectives laws. like data for prepared the interpretation EBXXX, various Federal position, to forward-looking our and of within would plans X this operations Before of that I the remind you

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

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

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

Spiros Jamas

Thank call delivery the team. company's the performance joining the protein you, that the and talented, oral morning. therapeutics Entera Ramesh, the and thanks dedicated validated and I everyone technology because enabled joined of for platform of of this hardworking

several secondary PTH and three dose significant of a and marker and is biomarker key Bone of Conference, that osteocalcin, accepted clinical the last anabolic We results, milestones on have generated and with believe less statistically and shareholders team a hit markers technology strength. confidence value for than density, confirm key the for linear response mineral in value my The X.XXX key leading Clinical dose the our presented biochemical have creating our valuable path that and are very we to quarter and of ultimate the osteoporosis treatment Phase business. and for reported XXXX, was and bone months oral PTH October validation PXNP, primary scientific P its the Disease mass X and second In and of endpoints. a of met bone XXXX. at study the our the ASBMR product, the EBXXX, we clinical our There

at our months studies. collaborations Bone as peer from six Santora, Research. Breaker, believe Journal a by Art efforts prestigious accepted Medical Chief important Our in Officer, presentation published data of oral results hyperparathyroidism presentation Separately, of development presented and and generate mineral reviewed were bone our and through our the of these the will data will also strategic patients in Late this density I partnerships. ASBMR Mineral Xa EBXXX study Phase future value is was support business

applying in either technology with in be platform or to are EBXXX partner collaboration such developed either Entera another additional collaboration we that create the as compounds, what through or doing to Amgen. products, value by such leveraging can and alone company's technology on proprietary as our our with focused are a We EBXXX

as with expanding part business These demonstrate our share delivery proprietary Entera's multiple to platform XXXX assets. and various internal de-risked reviewed use Phase efforts, can potentially where X we the We execution. development the meeting a mineral for to value The a with an Phase opportunities options addition endpoint. data, ended XXXX companies confirmed flow, funding, NDA X other company definitely protocol, the multiple of feasibility end In Phase for proposed with the bone multiple osteoporosis density material news as year we positive our and the was primary of biopharma oral requirements to of pipeline, in submission. partnering X that meeting of the the of successful transfer Phase target X and generate of non-dilutive was future have agreements compounds. enable FDA, signed allow of

be three osteoporosis agent, than today, They only available. living why are This are safe one reason cost believe injectables annually quite which of that why bone of of FDA and a are many two I'd any borne $XX,XXX from brought More worldwide. conversions is year may a This of pleased age over patients, we with agent effective XX X people These osteoporosis treat U.S. has receiving all there commissioned available EBXXX osteoporosis are than of payers osteoporosis. the to of by X% attract start of product sheet oral not and Evenity one low osteoporosis at three risk independent expand We to may patients We number XXXX. an men seeking years give a In study in places more research successful but and osteoanabolic not estimated snapshot the and into closer and pharmaceutical drugs, Phase oral becoming assumption tremendous think formulation treatments a building balance people affected bone building first the the estimated large, all four a found are oral once-a-day human may any Forteo study per bone being report who the a projecting osteoporosis. being hormone that positioned new less which are billion with million or parathyroid XX oral anabolic million current the may Americans opportunity currently effective strengthened our study. be patients. oral between have over alone, break $XX,XXX treated. are form market X bone this XXX X Romosozumab, them in injectable therapeutic are a U.S. due are likely research also and also to of market treated will the are an osteoporosis and Tymlos patients at was increased you In one step or EBXXX the Abaloparatide, Teriparatide, we an like an building potentially injectables. in significantly $X treatment. surprisingly and PTH taking osteoporosis XX% at treated to The an to of half million Phase pricey the out drugs. mass, building in for with X-XX firm, providers get Phase from incorporating input We is bone only physicians, developing of cost-effective is EBXXX in XXXX study to women One at bone EBXXX $XX.X patients drug oral market. a second I'm to with design solutions. we year-end

dollar We discount a Aside in therapies, believe multi-billion various for than translate to is effective with as patient-friendly market greater a treating Entera this patients treated a far We review has or additional opportunity. more a market can there the development delivery estimate penetration currently be drug, EBXXX turn will fracture. to oral over untreated to injectable realizable current new at potential to and by multi-billion should opportunity for for XX% our of platform, and activities. EBXXX, injectables. oral Even progress I opportunity at an business cost high-risk more now both Phillip it patients. a here dollar

Phillip Schwartz

Spiros, everyone. and you, morning, Thank good

growth to superb experienced transactions. immense $XXX Hypoparathyroid investment strategic acute its would to long-term team you that Needless we with with market EBXXX, and a our our plagued our for like bank, for has thrilled are for Torreya, partnering closed are asset be highly serum partnering patients calcium provide sequelae. First to to disease dollar in strategic of Torreya and are has potential. lead other hypoparathyroidism. asset with I osteoporosis, in engaged orally Entera over our PTH such in today the with the in Since update all, orphan osteoporosis. brief in say, multi-billion accomplished on announcing XXXX, numerous treatment of we support low EBXXX billion delivered now a founding and on lead efforts

and disease different our Xa the first a as to used leading be excited reviewed that and of severity, to care, be by lowering a are improved with Phase in hormone EBXXX developing of led to excess of applicable Research, of publication patients added phosphate, would are to life. the Journal Bone standard We line the in therapy levels when data a significant Mineral calcium recent of journal. usage, a in a significantly EBXXX, of decline supplemental statistically peer serum quality

are the PTH and this And will an currently improved disease for a in need have improved these treatment compliance population, are daily profile for will endpoints be far believe oral very tailored better formulation to available the an in studies. indication. key that have customizable All which PK hypoparathyroidism. injectable hypoparathyroid unmet an alternative. significant EBXXX more past improved now compared especially of of as of we efficacy, that offers There We heterogeneous treatment this

discuss we in be indication our as in formulation if Phase study volunteers in will a a this studies tested pre-pivotal to with expected, this improved just XXX study through a the have single healthy Natpara for finalize prestudy is Xb months And intend the profile with to number duration. from FDA. We in formulation preclinical was have currently of design EBXXX and XXXX. and evaluating Xb the interest and development anticipate of strong of injectable originally PTH collaborations. orphan such Phase hyperparathyroidism financing co-develop We EBXXXs patients partners six for X-XX potential we approved one

We partnering our developing progress make companies platform therapeutics. in other pipeline to internal oral to their our delivery biologic in large continue of molecule and assist

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

in our currently preclinical several pleased year. continuing is its results. platform, to that of evaluation collaboration We their the drug Amgen and support the formulations studies of completed has have with different the third included Amgen are with

reported annual As our costs. in all covers funding research Entera including employee that expenses, financials, receives from Amgen

the that was daily currently peptide XXXX as in on once sales syndrome. of demonstrated treatment global with of shown the our in now for XXXX. approved a a we registered platform analog Entera's believe orally a GLP-X Teduglutide works potential pharmacokinetic only significant short analog GLP-X. the bowel models have GLP-X GLP-X preclinical to Gattex of we The delivered Additionally, over oral formulation. the analog this another formulation market the injection. the And comparable $XXX profile -- to oral in oral viability million of In has strongly subcutaneous injection a

tested XX technology, addition molecule and than has variety to undisclosed proprietary ability different from therapies. of both In data other more validated work of with molecule improved therapies, pharmaceutical animal generic as large in These GLP-X, a large models. ones understanding to as preclinical well our Entera biologic have our companies

the United in patents, platform recognition representing study XXXX, transforming the the University at platform's Union potential filing technology large patent in biologics with property injectable gain was peer International a reviewed molecules dual patent in platform collaboration with a of Anglia further describing Entera's into delivery Pharmaceutics: identifying of the A the an pills. and As intellectual Kingdom, X advanced of its October life. action, XXXX. indication, application and East leader foundational new by in Entera new continues Journal receiving extended researchers of in peptides, treatments for in to European new in published the in technology its mechanism oral oral

development Annual a were London technology our presentation exploring use are increased companies ongoing platform, platform, announced From Congress several Additionally, fair human European leverage have XXXX. efforts product platform Entera's candidates. in we the that at with in dialogues shared hormone, XXst injectable the to a new poster suggesting our oral in Pharma perspective, and growth data business our orally have delivery of delivers the

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

licensing result in in Given Officer agreement it transactions. the some that United collaboration I have over for we material significant these States. increase Ramesh, more will the long-term active believe now of to and Chief extensive that executed, we transfer Financial our turn

Ramesh Ratan

you, December December XXXX, $XXX,XXX, compared were Revenues for year XX, XXXX. Thank as for the $XXX,XXX, year ended ended to XX, Phillip. the

included majority expenses MTA attributable year under million million provided For to general for the December were and administrative Research XX, and per ended share. were in administrative General our ended and for for development the development XX, costs XXXX agreements. fees, million $XX.X XX, and Amgen XX, Total provided the XXXX, in Amgen X for legal salaries December revenues were and related Amgen services R&D administrative $X.X connection conduct the expenses, fees. other research ended year December million services expense XX, development, headcount recently $XX.X December and were related and XXXX, in with expenses, up year $X.X and and and expenses XXXX, XXXX, XXXX, year and of of and ordinary including share-based loss respectively year expenses. ended primarily other expenses. $X.X of EBXXX of related XXXX the salary Net December we're included the cost of made $XXX,XXX expense revenues to for professional the million Total operating December to and and research was and December $X.XX XX, primarily operating in Phase XXXX, million the trial. and in compensation, R&D general ended clinical consisted and $XX.X insurance, XX, Cost XXXX, million expenses or the D&O for ended agreement external a and completed related to of $X.X or $XXX,XXX MTA and research comprised and year development and were agreements.

ended or ordinary XXXX, year $X.XX net the the per was XX, $XX.X diluted. loss For December share million

of in Entera million XX, had be equivalents As cash report in XX-K $XX.X million of our cash will X, December approximately that March and filed XXXX, we $XX.X XXXX. and equivalents for of as we cash and today, cash operations expect on to Q&A. turn I'll current of sufficient before to the position to call go into we back concluding plans, operating will we quarter remarks, XXXX. Based our cash the fourth now fund Spiros

Spiros Jamas

this pandemic. thank Entera's study. for and entire the Thanks, the lead consultants, thank XXXX market. was X for I Ramesh. dollar this persistence the of work Phase patients, also challenges I to want clinical And investigators, for major in with multi-billion shareholders to extraordinary a year study our execution program hard the milestone, completion The executing successful to given rigorously Phase mission. an want osteoporosis and consultants directors their to our progressing the COVID-XX of team their and extraordinary related support and X was Entera

with the business a off execution many We and numerous and development start expect times Entera be year is for operations. and look good our XXXX partnering updates the progress you also everyone of this exciting We entering regular in time We're to good coming will deals. a year to months. our review strategic catalysts meaningful big to coming Have this with a the of very with taking patent a day. providing year. morning, discussions. listening filing, forward in key to on Thanks

We will questions. take now

Operator

you. Thank

session. We will a question-and-answer [Operator now be Instructions]. conducting

line Our B. your first with Patel question comes with of Riley. proceed Please questions. the Kalpit from

Kalpit Patel

non-titrated give questions. confirm of X.X Spiros, you the you you're Phase in first groups our be in were how the X. know, mitigate you titrating, us differences some Forteo. non-inferiority risks Thanks that EBXXX titrating the efficacy to there X, against any to will between dosing if taking additional color showing are then, Yes, hi, in Phase dose titrated perhaps I upcoming morning. good this designing not for and can and the trial on you can milligram for

to are you offset differences certain steps taking Phase efficacy that potentially any X? So in there might the these be

Spiros Jamas

as the can and tried thanks Yes, we've sort X terms the we Phase impact de in really question. regimen, that the Yes, from as the titration. X risk of to apply Yes, hi of Kalpit. for learn titration to Phase your study to the so of much

over dose. as took to study, to patients And months from us X Phase was two know, X.X months then you for go four very dose the it milligram period prolonged to So And dose. six the up to titrated months milligram a milligram over maximal it were only on two X.X get that of out the X.X the the of the dose. X.X milligram

going accelerated titration the Phase versus doing the from of titration, to months And institute study, what X instituting more two we're a X.X in the X.X X study. the Phase same weeks, two going just the but still in -- milligram so we're over dose, the to we're

So we what that feel our review on Phase PK will that and titration achieve of data our need. achieve based the X we will -- results,

about good milligrams, good titrated patient other only even study. the high the so remained for who were thing X of up in very in patients, about was our a of full X.X they those patients study study, though titration, one was saw dose The over very in that at X.X Phase as of the milligram we there tolerability the dropped XX% that a to for which retention course the a the were titrated out, group, sign

titration --? entire so dose for Phase then patients other is element And so X.X XX-month dose. is that Does one the be X a X.X the milligram the will essentially up full rapid this that having study period and to and study on XX-month and the milligram very

Kalpit Patel

go Sorry, ahead.

Spiros Jamas

No, go ahead.

Kalpit Patel

commence actually remain the think No, on -- this to is are what's to I assume initiate before guided was gating any I Phase you've X, think ask, quarter fair those timelines the still of track? to that trial? in I the of year, there it third status you previously, going helpful. very just factors that's additional I

Spiros Jamas

Yes, were second that sure. to Yes, half the year. of timelines guiding this we

of So year. it quarter, quarter definitely or half could fourth be and second third a for this

obviously getting on. mean, going sites. of up, going our Phase and us we useful that X operations are the would that and some we've FDA study there FDA. I to study of with the of we're suggestions And to on once the this the process operational so are the CRO have going are protocol, of Phase meeting XXX signed Then that study and also, the through sort Phase And Phase think X improve I that, very study. activities the the study. busy we on design, is some that identifying based when for have protocol. we with XXX refinements is Phase X very market in It's the updating We're running. on which final X aspect to some And be end side, we'll going working up the up protocol. assuming the update assumption Phase going and the current X X with patients protocol are made also we'll between for be has the the of about still final

Kalpit Patel

think past ongoing? Okay, we business those program, should you think was still the I opportunities you interests but the interest lead for what fair regional XXX, there XXX, for are in about for conversations how about development mentioned some enough. And that XXX, some mentioned

Spiros Jamas

to announced those very are very ongoing, really, sort though, our partnering product so us have Capital of to much well. extremely large as yes, to the the the And already to partnership Torreya help especially We And put best us work the for for Oh, is get we've for progressing they'll of will today, asset. approved globally. recruited us Asian global we've osteoporosis, of ultimately finish -- a there discussions and interests an line regional yes, partnering that think best now our get market on we with program. in position significant sort also -- osteoporosis

efforts. so of a also they're and the we're board Phillip about lot as and lot hyperparathyroidism There's a the really companies in lot a interest, mentioned as well. presence orphan -- interest, alliance collaboration of in have lot and And the a there's coming in substantial of space there's excited a the interest, a strategic asset, Torreya we that of space, on our helping high partnering on also obviously possibility with diseases

Kalpit Patel

one? Spiros, program timelines question, should program How advancement for should the And that into one you GLP-X clinic? next we Okay. expect enter about the on final to think the is we this

Spiros Jamas

Yes.

that Day We Investor having of API, announcing be of select discuss our going the platform. what our sort committee sort of API. advisory select sort next or is we next scientific the that best for platform of API between seasoned together of our we've the potential through, sort another and And will will very offers our properties to us helping a put next

GLP-X, other, be but may possibilities. very also it some exciting there are So

offer other bigger commercial potential that maybe then GLPs also The and bigger even opportunity. much

we're that going program. through of our so which And select one, from of what -- sort we next process prioritizing we'll next will API, which

expect first have So investors our an to of the year market. this half the update update and will in probably where we

Operator

[Operator Instructions]. you. Thank

line question Please next Capital. is your of from come with Nathan question. proceed Our with the Weinstein Aegis

Nathan Weinstein

Spiros morning, congrats so areas. business and I and guess the couple good team, me. look to on I the progress. the for questions a different just you in entire many Thank

both revenue could does the partnerships to you include line then the on you Amgen comments that make as where can any new go? well? that and think higher. Do And Firstly, directional tick continues

Spiros Jamas

costs Yes, line to that direction. the the is from the our picking revenue related bulk the great. Hi, via to is Amgen Amgen good Nathan. covers revenues Great catch, all right in of payments Entera Amgen's collaboration. question. are Entera's, And Yes,

new there's companies But we that is number Entera of transfer all also we that which are by the covered funding, agreements, So Amgen. have negotiating with. getting no material been partnership towards that that contributes funded by a

these studies. to us initial paying do So those companies are feasibility

is very so on MTA for sort provide that to that's de-risk, that of very getting related that expect a a kind uptick good, to initial a to and so significant higher funding, there but a MTAs of revenue be large collaboration to signed is new is entering also number Entera. say I will of of sort funding the that similar this that in mark. year that we that into Amgen good would program, And next we've

Nathan Weinstein

studies Great, what thank EBXXX. here might be in on were to-date, you us background therapies any on or X you not remind the allowed could just Spiros. And and In what then just if study? the one Phase question patients

Spiros Jamas

ask no, could the on drugs before patients were what the for any that. number in long more also years Phase Chief Santora, on Art anabolic could enrolled Medical provide period X. we're information is not quite for believe were if not we're Phase I Officer, the and were Phase the to same handling on be just little on for And a the add X, a before I'll case of they X for the patients you they how therapies, the, Yes, study. background a then the that

Arthur Santora

therapy as had that support DX. they of All needed have the analog. pointed dose not patients out, Yes, Vitamin Spiros the That's been they patients terms an dietary a calcium And DX study. on time standard this nutritional to in sure. and activated nutrient supplemental the at active started couldn't of Vitamin

the bisphosphonate you very of There'll immediate same bisphosphonate in bisphosphonates to years years X. similar from The as gap probably population a it's a intervention run it's or transitions Phase denosumab candidates would would into be to was directly as in of in These very common allowed. wouldn't of past that number in clinically. And would therapy osteoanabolic stayed EBPXX an who like would be order be No they of the on the from currently be long However, trial. sort prior approved. a situation the drug. the we depending be for two allowed. three to be a transitioning That's

Nathan Weinstein

Okay, okay, fine.

for there and much. guys on see detail me that's the businesses progress. for and congrats you again now I the it to thank So, the you nice for It's think developing so

Spiros Jamas

Thanks, Nathan.

Operator

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

Spiros Jamas

Thank everyone. our call. so morning, in calling much for earnings Good for you

verge believe Entera, business always our catalysts a can really of for the using we that can As driver for big you on Entera's become. see, huge expanding some value platform were really and as

Phase some both this platform. with be of have our year you clinical program, on very we'll We lead expanding And our opportunities updated X. solid progression our but milestones also with to keeping

you good very Have day. thank a So much.

Operator

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

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

Entera Bio (ENTX) 8 Mar 222021 Q4 Earnings call transcript