Entera Bio (ENTX) 21 May 202020 Q1 Earnings call transcript

Good morning and welcome to Entera Bio’s Conference Call to discuss the Interim Biomarker Data from the Phase 2 clinical trial of EB613 and the Financial and Operative Results from the First Quarter of 2020. At this time, all participants are in a listen-only mode. After the speaker 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. ahead. go Please

welcome and call. Thank to you the

today. ended data me Philip and results Schwartz, today’s our enrolled A the in quarter are the X for XX% and EBXXX call CEO, our CMO. and interim XXXX announcing was release trial Gridley, the Adam press the our patients operating XX, issued March Santora, first of Joining earlier Arthur on from clinical President of Phase R&D; of financial Entera's the

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

our position, remarks, you our objectives and call meeting Laws. about for like to begin statements within Securities statements make of we of results business are future financial future the the operations would prepared operations during Federal remind we I and strategy, the this considered various forward-looking that and Before plans company’s

and based clinical update will the pandemic based our magnitude not are we fully of is and on and website. the provide and that we continue any particular, conference to We all the factors upon our able risks pandemic undertake our events, no predict. the COVID-XX to All depend our to call data to on this us filings EDGAR on weeks. are coming to upon to investors evolve, encourage numerous future, or related and regarding of expectations Phase which available in today, risks, will changes otherwise. change call and subjects the are duration of system that statements developments what we accurately of the in on learn SEC’s be Furthermore, EBXXX the the in future uncertainties. and circumstances, analysis forward-looking extent obligation we Our interim the true described make the the in data account from impact, In trial involve of only assumptions read X and current company conclusions our ongoing on information, These the may our as more SEC this SEC forward-looking filings. information new is statements such impact

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

patients clinical results for we the to first first Thank Phase dose PXNP biomarker of the you, quarter Earlier X month. to for everyone from mg the morning. this Jon showed and trial call the the of our interim the EBXXX joining of in thanks three-month reported and today, results highest statistically announced with Those osteoporosis EBXXX three-month for with this X.X significant patients increases XX% results morning PXNP in XXXX. the meaningful one along

dose saw biologic believe also for response data of of activity PXNP We EBXXX. one reinforce the that and may these month

maximal dose. data we we a not and While evaluations currently further the analyses we set, yet conducting believe of that have interim reached are

which data final a months believe XXXX. bone dose or upcoming six late very development addition, BMD further XXXX X will we we study In density in into that important or and Phase the a mineral advancing informative for be have clinical for targeted at

of to we EBXXX. one totality If for EBXXXwould rebuilds observations population, profile significant meaningful preliminary allow of higher oral have the dosing and data higher the safety bone. highest date, X.X generated strong therapy the be particularly the data this market need we with to data to in BMD program continue this our favorable plan believers with least flexibility study dose dose. stand coming The and of see from interim months at that We for in the given unmet an dose we

While Phase within to this of obtain resources will as protocol our trial focus we're the planned Further coming spend amending biomarker for to on still in our believe months. through provided current XXXX. the our the dose with we such X EBXXX higher shift details for review details, can we and be we data working continue BMD data of

now patients report data the BMD increase in data BMD six-month For in if in the patients bone the receiving for plan trends. of marker set third the to just a X.X their we or reported, other collect meaningful XXXX. BMD determine data the six-month expect interim We to to the quarter and dose there's

with reduction accepted now increases approval typically for reminder, BMD are fracture As an regulatory and endpoint are with associated a worldwide.

believe We need small the is actually clear this a due with to convenience fact also cost, percentage challenges. patients of that osteoporosis there that to only compliance are a and in unmet to disease continue due treated

opportunity marketed able that For example, recently preference global to currently research strong any bone strong the is increases the trials. there a products, we market subject to injectable If clinical may potential are study products. relative we alternative mineral future substantial to PTH endpoints and as completed EBXXX patients be to density for market we there successful the the compared believe for indicating other an in oral physicians outcome generate of for

we third set were to update of and X planned delays, density patients bone in we to bone we report been had related not have last data have we to the the announced for the if all and EBXXX to final XX, reminder, our that XX and on as complete of the March and XXX study patients it on in a in completion Phase achieve data. today The enrolled data XXXX enrolled plan of COVID-XX the for XXXX, subsequent clinical and XXXX. marker six-month a announced enroll step of objectives interim was As had today at of enrollment were patients XXX our we planned the track advance the trial in quarter mineral

study, we in dosing to order believe the data potential and a study. we initiate we from will Phase understanding additional better other a we As need evaluate levels X have BMD what the

assessment feedback and clinicians we to from includes shared runway with our with to extend our Our conducted monitoring have spending continuing outside prioritizing cash Operationally, various osteoporosis the higher designed data the of doses trials. we clinical the today of goal and leading potential carefully by proceed that you be will to activities. that

depending the may release second of With timeline support operations and cash of the spending, we the extended the to XXXX. planned of reduction believe upcoming as our is BMD current into XXXX outcomes third in sufficient in our this planned the quarter necessary data on be quarter

partners. to interest technology continue underlying also collaborators platform our entertain in We and from potential

progress inadequately EBXXX that In hypoparathyroidism. published previously effectively the will bloodstream call. on for PTH later biological delivered is PTH hypoparathyroidism. We patients the data, confirm our activates in we with in pathways have good and activated bit are EBXXX Phillip continued talk to a more that dependent oral make about into

also Amgen. to programs, PTH to work we the your advancing preclinical In internal on covered addition collaborations molecule continue first support our with by

Art? progress the pleased to over made are and Santora, with in working the with like our We are plans discuss Phase call Dr. move Amgen's objectives. turn research Amgen have and Art I'd to EBXXX. development the and project now to we the trial forward accordance of to X with CMO program

curve, leading low the to mcg X.X placebo AUC XXX showing We trial Israel. is conducted of concentration area pharmacokinetic data maximal these doses FORTEO. either female blood, randomized enrollment X BMD dose these one would at prior Thanks doses targeted based and encompass with is four centers a or on XX after X.X potential mg optimal Total in our a Adam. of Patients trial chose dose was medical and being ranging of Cmax, a osteoporosis PTH Phase and concentration in and patients a were placebo injection arm. of dose mg. each The the EBXXX, in clinical patients or three EBXXX to receive approximately in controlled mg, with time believe XX at patients of equivalent doses under X.X

to at biochemical bone and both as PXNP this of CTX, multiple the effects markers as assessments. months, X and safety a on marker a X bone set evaluate EBXXX As was reminder, of designed marker resorption standards including the a formation well trial

BMD of this with important study markers that BMD and months. planned. a PXNP EBXXX and increases, formation concentration and CTX the of limited is mineral a an program. remove serum bone cells remodeling and our evaluating in design PXNP months resorption much and indicator formation interim bone. the old also included for perspectively the impact It density, PXNP resorption months. osteoanabolic first analogs CTX part consideration and patients the stimulate endpoints the determines between trial bone measured new bone increase CTX. formation six an are next other of XX% modeling an difference bone include balance and the PTH variety by of of The six our steps is at is and rate concentration bone of We which three of that bone and they of at serum the measures indicator measured analyses was after factor is as old osteoclasts, on are bone in bone changes they the Other bone of resorption additional three because more of of of resorption the is by by formation in rate than and

safety no would and the dropouts and has previously of literature. there Overall today. consistent our our to reported XX in serious in our be product Finally available their events profile other patients with the higher XX doses randomized the adverse demographics related investigators ability even been been excellent. appears month-three to based trial. COVID-XX visits The this with on completing follow or trial the favorable of have data patients support are restrictions trials The in safely

in dose with reported with was increase biomarker an after not analysis the of in X.X CTX. was today's data and of one EBXXX indicate the mg release PXNP month data with treatment associated Our the press quite as that favorable

we study it saw program. Dr. analyses planned require which and both placebo collectively, for all additional by we analyze with to available have Schwartz, response it six-month time intend our as of inform that also share the EBXXX maximally this X Phillip point, coming a continued design for but XXXX will now as will data clear some data quarter months, we available. to These targeted biomarker becomes the data In had clinical Amgen The as the dose effective was I weeks. yet not our call turn EBXXX third or of Phase three plans President and at our on updates development achieved for BMD and over XXXX our R&D to experts of XXXX. well data our PXNP dose. CTX response over the We clearly the you

for EBXXX the Art. you, of disease Thank to provide would much, very the Good everyone. orphan with treatment I on like brief a morning, you hypoparathyroidism. update

in As with would We urine work the ability identification applicable a recently acute Based we our we symptoms while data and with therapy supple goal to believe of conducted line from unmet provide its enhancements serum believe is normalizing long-term trials treat advance different be announcement formulation to interest from to first effects in this patients significant a program hypoparathyroidism, minimize other patients' reminder strong the parties levels use. and additional of a on need. that several levels disease to including market of severity. calcium foundation of EBXXX, evaluate the to a become in competitive on this to will

to physiological have symptoms this levels disease subcutaneous algorithm the at As the we the complications control focused treatment both injection. better a part on the day short-term long-term and PTH of without work, for would need that throughout each of replace

while control may risk each the as a able the pulsatile of we that therefore urinary result activity believe calcium. AUC provide As in possibility may part hypocalciuria. more this effect times measured profile. evaluating and PTH twice AUC increase We daily If of three or of are the exposure for are may be the supplements to dosing able by dose a longer extend to and PK/PD limiting overall tail better endogenous mimic that work, calcemic we we also in

work preclinical steps development X over to Phase then is next goal clinical next X months trial. to a X worldwide to to this determine our finalize program the those and Our advance formulations and

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

performing and of completed our of support well evaluation the We We are several is that Amgen profiles to have create different to collaboration able have their studies that has [ph]. rapidly we included different been trial believe to formulations the different with support formulations activities. and Amgen's technology PK/PD continuing

of evaluation our believe may the of have to also development the pharmaceutical activities. additional as the We potential to results. it validation cover and turn through these relates APIs, CFO business U.S. those value technology potential on call ingredient new continue new platform through over the focus Lieber, that platform efforts to and/or to now generate development the our of our Jon their to financial I'll are

$X.X development our including to costs, external consulting X headcount Amgen. was March general clinical XX, and to were for planning diluted share loss March XXXX related the fees Thank expenses Revenue was quarter related General in quarter made or collaboration $X.XX EBXXX research and application for three the XX, and XX, solely in of support million and the administrative the expense was revenue an the insurance the and of March XX, months quarter to and professional included and for Total ended cost expenses, fees, the XXXX primarily related to legal $X.X the preparation for EBXXX. ended fees. million work ended XX, the ordinary development the expenses. with D&O per for to up and operating expense still compensation, of primarily IND and quarter $XX,XXX There in Amgen. no comprehensive million expenses services expense ended Phillip. trial $X.X were and in for March administrative for expenses XXXX share-based the March phase development Research ended revenue million related research you, and the and costs of conduct of XXXX Net ended $X.X quarter consisted Phase revenue provided XX, and the XXXX. cost March and basic related was salary or were plans XXXX as to

million Entera financial today after point, we approximately shares have equivalents approximately EBXXX, reference diluted XX XXXX, current of in May expect of product outstanding. million in impact on shares operating and COVID-XX report to will cash we of loss plans, as on the of or had file March a is less. cash As timing our our operations. XX, the $XX.X plans cash and This close At million cash outstanding U.S. course equivalents Based any expected we be XXXX. subject to X-K and $XX.X million primary intend fully XX currently approximately of we XXXX operating $XX XX, continuing to development including and that million and our to subject markets

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

Jon. everyone's Thanks, from support we the and data as clinical Phase appreciate trial. of EBXXX X the interim We results the patience evaluate

coming our the Our upcoming and BMD data dose biomarker months. and higher six-month expected in arms

continue goal We financial have during human the crisis our managing maintaining flexibility been and aggressively the resources financial with COVID-XX plan and to do of so. to

supported opportunity for osteoporosis. their market to has of feedback therapies be is been and product moderate that to also recent patients such could format by in better oral the This need convenient substantial. believe research a forms choice clinician with oral severe and continue We for market

We offers please also that as soon have We combination and financial our X committed patent collaborators of advancing for in up programs platform protected protease questions. to open expressed of interest dose. to while benefits with a inhibitors, believe final and resources, enhancers protecting underlying our technology macromolecules. line practicable as absorption goal several advancing to select we our Phase our those to potential remain protect opportunistically the as deliver both synergistic Operator,

go Instructions] [Operator Group. question Jason from from sir. McCarthy Please comes sure, our ahead. of first Maxim you, And line Thank the

break]. on Hi, It's Thanks for Dave for Jason. taking the [audio line everyone.

with wanted I make planned EBXXX guys just to to if EBXXX, trial regard boarding on see and EU? any clinical you or guys U.S. progress sites you the As in

Indeed Hi we Dave, Thanks question. great for call. the joining do.

of that we trial. would gotten in conversations. States in Phase we with all trial be for be do EBXXX a that X Rim. X We've based Europe, already Phase the would on trial it global that or think the registration EBXXX FDA We pathway from benefit, of we've XXX this able can the previous preparing of very the case of And trial, based for that envision the to we'd one ideally, do course FDA. then on b(X) As we've in the and process feedback IND positive to and EBXXX of is the about like an opportunities been the our Pacific be noted whether consider a the also United in

that greater trial for that Given environment be sufficient do you're global be rather the able cooperation, is we'd starting regulatory one would see that to such to approval. global

is part worked for has been course, in time long this that indeed, process. in consult plan. to that starting with So already of Art a we've our experts of space and

to I want a make Is On you in XXXX. either BMD to – the sure expect I XXXX Phase regard late correctly, early just if EBXXX, we to then X in XXXX and so with XQ correct? expect this initiate heard guys and trial data that readout or can

the Dave, bone that previously. correct, seen out We've by months. we cadence. for normal that us to the XXXX trial mineral starting back start that that. hospitals. Obviously open scan. quarter of that's has COVID hospitals very last data we to the largely which into third part first the initially and get the up we will are density data had XX% today. be that's guidance into to and the had that Those And density the timelines Israel The sixth anticipate we collected the patients more quarter where provided return collecting on so Patients we takes some consistent third early hold are of reported the a an return to come in based now to DEXA the over can patients is will of actually That's the couple via impact starting of a bone the with

also as anticipate those we Phase X follow early early as we remaining a with including of roughly the XX come or then this that those that and higher potentially XXXX. the data with support would late We would trial, left XXXX patients completing initiation into patients that would be study, to enrollment we anticipate dose, as

of to So dose we're in which determine appropriate our to on moderate impact study. in plans March, as we'll come and now in out is had COVID screen we starting take disclosed Patients a are then back to are place. enrollment but starting this that. further

just Great, could X? thanks. EBXXX. being know set that Phase some here color to looked into are Xb would parameters And into we you support your I switch and Could be needed to gears currently Phase progress or briefly continued on just what Thanks.

Sure, Phillip. do it then I'll to turn so to and over happy

that So symptoms, that opportunity? reported we line profile in doing process want level, treatment recall we the at data that Unfortunately, top doses the ultimately and against work Phillip, product comment our a that of the that that Phase not hypoparathyroidism. to And you planning effects a the of of identify Natpara, which with may product was disease. direct treat right to are little the may make only of profile ideal fall and the but this we've been PK that is trying the And in formulation for resulting the enhancements, up had approved first back been on come do downstream so an more XXXX. the a we has is bit the highest on optimal can comparison actually now. X of PD a only couple determining

with have drug particularly for lengthen we is Adam. the can going And we that necessarily at Yes bloodstream. effects in primarily are seen drastic. we with We looking the how to and indeed, the thanks, believe which long the be that lasts tail, reformulation or is reformulation hypoparathyroidism not calcemic that's Yes the responsible PTH.

doses and could hypoparathyroidism different be very, milder changing we'll of this in idea a severe dosing, to that itself want need of the it the the frequency is Additionally, dosing extremely able differently of activates t.i.d. doses we control hypoparathyroidism having for with b.i.d. frequency of these that or a calcium in treating may And everyone for heterogeneous the the be these patients. remind patients who portrays is decent profile there's be very disease very and available, to different of or having very all urinary anticipate three patients and the the times day. be compatible and useful tail, reduce of for meaning therefore, more patient just and longer flexibility Thanks. that the because patients. dosing that I to may probability

guys. Great, thanks for it. appreciate I the additional clarity

you, Thank Dave.

Thank you.

like Thank questions further closing you. Mr. to this I queue. At show remarks. time, Gridley, the over call CEO turn to the no I'd in Adam for

call. to morning. the time progress appreciate the Thanks company's Excellent, our everyone good an day. you forward you overall so Have look thanks to this a update joining on with for taking We as providing progress forward. We the on much. move and we

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

may now You disconnect.