Entera Bio (ENTX) 20 Aug 202020 Q2 Earnings call transcript

Good morning and welcome to Entera Bio's Conference Call to discuss the Interim Six Month Results from the EB613 Phase 2 Clinical Trial and the Financial and Operating Results from the Second Quarter of 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 hand the conference over to your speaker today Jon Lieber, the U.S. based CFO of Entera. ahead. go Please

welcome and call. Thank to you the

the me results the Philip Schwartz, today's human X our from Medical release the to operating are Density of XX Bone and enrollment call CEO, Interim in trial, Chief the clinical announcing financial press A projected Garceau, hormone first Roger Officer. X six our for data Santora, osteoporosis months the Mineral EBXXX, Entera's development Joining June parathyroid Arthur on interim was the President for XX% R&D; treatment ended the Phase are of and all XX, of earlier issued quarter in and XXXX today. of

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

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Thanks Roger.

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these together encouraging results. are Taken very

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

As patients' effects to calcium of serum levels acute to supplements treat a the reminder, and is while urine adverse our goal long-term Ds. and active vitamin normalizing minimize calcium symptoms

Xb this to We intend Phase we to applicable Phase line into to levels to first on in to identification work if preclinical different clinical are a XXXX. conduct of the potential with that X evaluate additional be severity. in formulation trial advance be disease developing enhancements support may of models, We've EBXXX EBXXX or a used which successful as patients the provide would therapy program continued that including

As and part each with effect a to possibility strongly extend are be and this endogenous elevated dosing mimic PK/PD twice the calcemic elevated urinary limiting we are overall profile. calcium. area dose of food the to the activity pulsatile better we is hypoparathyroidism. secretory associated or times may urinary work, the and increase of calcium you also under of that the you morbidities If risk of curve the the impact reduce for remind, many To while results bioavailability, daily in able therefore normal exposure evaluating and AUC able may PTH three

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

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

these continue the additional our of We development for to development either call evaluation on business of technologies patents molecules we enhancements I'll now that this new CFO new platform as potential cover the Lieber, generate activities. also and/or platform. well potential the of partners, work the In through efforts to potentially that and capabilities. focus financial results. believes validation technology over proprietary are leading APIs as developing the have to and to identify our our of look to Jon expansion our potential the technology relates platform value process to forward to as our existing to continue U.S. We turn the to through of other to additional it

administrative the ended for general and R&D salaries XX, services and XXXX the Revenue expenses half both you, XX,XXX XXXX, Research headcount of six XX, XXXX XXXX, months fees consulting IND for and and research for and salary in of including were Total for XXXX expense and comprised preparation June and external was expense six General consisted and in related months XX,XXX, compensation, six a diluted months for loss X.X June Phase June clinical the the the services years related of expenses. Net to XXXX. $X.XX months basic ordinary XX, made attributable connection fees, and to related six fees. $XX,XXX provided ended for X potential development or ended to X.X stock-based six million with D&O of professional the application insurance ended respectively, the the X.X share development six XX, revenues million with operating related administrative ended XXXX expenses and primarily Thank in June related ended million the expenses to and X.X expense, $XX,XXX, for million June per up XX, was Amgen. was comprehensive was the June expenses, XX, included XXXX months and Phillip. in months legal compared and and costs R&D Amgen. Cost EBXXX trial, of expense first provided conduct costs, was of and EBXXX. in to primarily with revenue the to

with fully outstanding XX report and approximately $X.X $X.X will point, As cash and today, reference Entera million cash and filed diluted we equivalent approximately that XX $XXX,XXX At our includes XXXX operations. XXXX, operating equivalents to be August current the programs through primary on XX, Based as in proceeds any agreement of plans, million. had X-K $XX outstanding. and we our EBXXX subject subject cash shares June million we million shares to operating XX, million cash loss of raised a currently in XXXX timing have Canaccord. which to impact approximately and our COVID-XX we expected in our This expect on ATM approximately of development product is including of continuing

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

Thank you, Jon.

part was data which and to lumbar XXX(b)(X) encouraged provided the added by important from treatment spine to X.X data EBXXX. see the given in improvement The very the BMD are We arm regulatory you we recently plan an especially not in milligram trend, pathway eager use to the milligram released are group our the we treatment BMD today. today, represents the of data for X.X

As that approval in for to believe potential spine osteoporosis. be endpoint of we any improvement required lumbar will EBXXX treat BMD

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

technology our a now molecules. which into open programs, for Operator, Phase financial have our and presentation protecting to our goal floor to committed program. while benefits EBXXX offer expressed the X or the opportunistically their today. can ends questions. macro This for advance these platform formal with you resources platform delivers to patent several believe advancing protects who interest remain collaborators, also both We in our potential We protected

Thank you. Our Group. Maxim Instructions] from with comes Brett first [Operator Hoffman question

may question. You with proceed your

BD Hi, Jon I taking some my the and question. Roger. had on for Thanks questions front.

recognizing to might regarding Amgen that they revenue color there's the doing more in limit offer in you're the conjunction from And course, disclose? to with must congratulations any to all could you a everybody Thanks Roger of collaboration color you I underlying wondering fact has some molecules large exciting on First and and of the work this if if that around you taking sensitive to other more follows partnership you're delivery qualitative to some what able a extent able with it's them. Appreciate also be little drug wide then research initiatives, the seat. bit Amgen to I'm new of array who for your technology of BD that story clear the congrats provide again think on question. the my applications.

it Thanks support. your I Brett', well. for Thanks, appreciate as

maybe As far in other going bit you this Amgen as I'm on want to and point, ask Jon, to color can both efforts. BD then at a Phillip you Amgen and give other maybe and BD more little for the chime

Sure.

So Brett. from thanks the as for hear always. question, you Good to

effort. mentioned So the supporting remarks with his forward in continued prepared they whole support plan, -- that results I in Amgen, them, moving project done the in effectively done pleased that remarks, but the work of think advancement program as we've to we've of Obviously, a his bunch Phillip control far. of we've are been they are and with we've in so the

of if potential some were raising a amount that, for kind significant couple that perspective to it a success of a have in offset potential we, pause on additional some of come As molecules to milestones but specific capital with find that say and a now. to to course, hopefully, those would timing opt we flow of there molecules. more don't to cash do help they turn on suffice certainly and us are I'll course, this, they for reminder, them of interest Phillip and of over there will there Maybe and opt-in from that if potentials demonstrate can that,

creating exist other add not look at and so that products the in Pleasure. that opportunities I'll we that of that Brett. are hi, in of terms terms in we're general terms both Yes, that in in people market both molecules perceive may of Yes, Amgen, looking obviously, just at things otherwise. in development

activities bucket In them areas. going BD terms three two I of other different would we're that on, or into

with conversations different number have numerous of We entities. ongoing a

to but has that just APIs variety of being Some do convenience fact to also people that the for utilizing new not them being reasons. the different of create developing APIs, a many and drugs in not people are that brand thinking are amenable to to sometimes from technologies it about of infused or with biological these a perspective, are injected

people are creating we then or what but can will who successful general, and them who we're hopefully, when to evaluate are that reasons, who competitive go So with they that doing existing relatively scientific reason are opportunities. of be also bucket stage we be a of for companies that no ahead of will bucket third development material with by they market going either ahead done to for that's or and and have. where us those a second larger of we late if can we'll those the greater found they have state an to in to there cannot gone for we successful, an whether conversations injection, that's proceed just bucket from And we move number send drugs a is And is the products agreement. we've interested and are in is variety people then it current material areas, it's on -- we've drugs people have have for bucket it and trying second transfer have current life matter sort or creating and of In bucket one possible different longer existing develop are deliver agreements and whatever as the extension in also that conversations therapies on finally, various who space, that are. products, the third a convenience and the there

as hear to from you Great Phillip. Thanks, well.

from our and bit big trying do a we and effort that -- of Brett. like, team, Phillip because, Yes. for your from in answer leverage to the solid question Thanks, Obviously, especially how technology folks use. it's I is to opportunity a believe platform, which terms a really little hopefully good

Absolutely, there and Maybe IP. on are others the that the in you're develop oral certainly no each one community question, follow-up for, you generating delivery queue. new lots molecule not the if

for XX X intellectually there not to the femur an theoretically, for -- vertebrae, maybe you about is femurs but How to mind, improvement bones that? PTH And and you're very readouts in data in reasonable -- you do be bones? osteo, a think larger obviously you explanation saw you if why in better don't BMD path forward, I larger evaluating the On the the clean. higher do higher seems expect doses, safety it's agree doses? results from We in

look If see injectable you what with at PTH, okay. we

You saw. exactly that's no in we or and what see change hip femur virtually

not I'm which in injectable So we X saw. change the all primary and is at really surprised to is the XX [indiscernible], spine BMD, what

expected for pattern would have So we to is see that. similar BMD what the we

want, comments? obviously, that very will -- show. larger So do will dose data have Art, tell, but so hopeful additional will we any the and I'm time the produce results you the

Yes.

in with long just that of almost that made -- trabecular the marrow with up bone. bone very I bone, outside middle to network different found of response. Just what's it called shell predominantly the cortical -- but there however, some a a femur is spine no or it dense it's of it's that's has around It and bones exclusively bone, I of the bone looks just around. loads. spongy, dense of agree the The add that's the biomechanical is intra-vector is because bone those cancellous the wanted of cortical top femur

is favorable in to is way the found effect well bone -- cortical bones. spongy long neutral bone response quite hormone. that's cortical bone There trabecular dense So on bone a parathyroid the in relatively

Thanks, helpful from me. there. all guys, That's very, very

Thanks, Brett. questions? Other

back further Thank any would remarks. to Roger call turn I to at Garceau for any questions this not I'm over further you. like showing now the time.

about or very results We're to have additional I to all with report. call. have good and you taking Well, any excited once Take time very this and joining you an these for We forward a the day. everybody update, want care. look wish morning we information providing thank

This and conference Thank concludes you participating. call. Thank today's you, ladies gentlemen. for

You disconnect. may now