ENDRA Life Sciences (NDRA) 14 Aug 232023 Q2 Earnings call transcript

Good day, and welcome to the ENDRA Life Sciences Second Quarter 2023 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded.

I would now like to turn the conference over to Yvonne Briggs. ahead. go Please

a news This and issued operator. update Briggs ENDRA's LHA. ENDRA system de in TAEUS announcing with the financial the this Thank to is the are ENDRA's website. available U.S. FDA, Investors topic novo a afternoon, issued today, submission for Earlier of request welcome conference business release and second Good release on also results you, which section call. its Yvonne press to quarter and of both XXXX of

the regarding Before clinical and include company's we historical product as by than partnership opportunities, discussion operations, begin, please the processes, potential regulatory note launches timing of regulatory results well and of financial are strategies, that commercialization as management anticipated clearances, expectations forward-looking studies, today's will plans, facts, of statements of receipt regarding costs, statements statements. required development statements statements. condition, including and All objectives, forward-looking efforts, other and

Except to laws, revise as the filings information to and company's any to subsequent forward-looking refer year, XXXX required or and related Form about obligation any the fiscal more Please by uncertainties SEC update for company forward-looking the statements. disclaims statements. for federal XX-K risks securities

Pestrikova, Technology structure Chief terms Director Officer. begin Chief of Executive Mr. the quarter Francois will In Officer Senior the financial of ENDRA’s the Michelon, second Thornton of followed will Michael Finance by prepared call, today's Chairman Irina by Thornton, results. and to remarks; review be followed

Francois turn call to Francois? I Michelon. now said, will the that With over

financial discuss today thanks and highlights. for ENDRA's afternoon, us you, Thank good business Yvonne, second XXXX quarter and and to results everyone joining

the as earlier request extremely the its de known announced Enhanced System submitted UltraSound to ENDRA pleased TAEUS. we that FDA I'm Acoustic Thermo for novo Liver today, U.S. As

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globally. the our In property XX we intellectual to expanded issued also second patents quarter, portfolio

our in reinforce but four quarter, ENDRA ENDRA's additional growing indications patents, U.S. other liver three including The the second secured is non-core unique to fat, not licensing company newly value one technology. portfolio. opportunities also and acoustic assessing actively thermo position potential exploring patents issued IP in open of of the in in the These for applications doors only augment During our China. the

in of milestones offering. raised expected Management in including underwritten supporting approximately in we XXXX, cash believes through important public $X.X that operations an commercial million this to year, fund activities several May through Europe. Finally, ENDRA's sufficient

to Thornton for detail Mike and progress. clinical our regulatory Over Okay. more on Mike?

scores, We're to novo The as Thank have fraction our Liver de of scores submitted those U.S. you, as the our request Francois. data MRI-PDFF Thermo UltraSound liver of System XX compared FDA liver fat Acoustic de submitted fat application part to in subjects. TAEUS known in extremely estimates same fraction as for the pleased also TAEUS. MRI to Enhanced subjects clinical novo known

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for of The reasons. of signals tissue that penetration. third obese significantly loss than depth lower two is advantage thermoacoustic patients ultrasound conventional of TAEUS The signal is in for

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As for fat subjects. high reasons high ultrasound based subjects quantifying effective fraction of no from to excluded potentially BMI. our more approaches than a methods thermoacoustic submission FDA in result, BMI We are

is the individuals individual's that calibration data calibration with and periodic fat fourth own measure. each TAEUS the its measurement devices. is across image size own approach has ensures across be of have liver advantage in require measurement estimating the in contained across Several present that uniformity And and varying patient ENDRA's device. in muscle not each other fat That within market from efficacy point-of-care the devices derived should integral unique calibration. TAEUS and fraction is to that TAEUS

In terms are there a process timeframes FDA considered. of should and review of next that going for be number forward, elements the steps

a a the applicants standardized resource eSTAR, is review request via the FDA's through facilitates complete way its submission submission format, process efficient the structured FDA. with submitted known in novo the ENDRA tool ensuring template that guides and which as submission First, de online and by the electronic

process operation ENDRA and and FDA we benefit our through that and expect investors may familiarity discussions interactive the principle the ENDRA Second, material Naturally, FDA's in our to XXX(k) clarification. as engages of with or review One interactions in with during back of routinely the we is forth submission. published remember FDA the updates FDA's review safety decision the that companies keep with our Investors additional previous that of XXX process is informed make in detailed within can should days seeking a goal will information submission technology's advance profile. factor FDA. dialogue that The process.

I'd to the of Irina Now, turn financial review like XXXX. results the for second over to quarter the to Irina? call

Mike. you, Thank

from The the due and decrease ended June decrease in in For expenses period a expenses. operating for marketing was to million and our XXXX, development, XXth, and research same $X the million mainly sales XXXX. decreased to quarter $X.X

development Our decreased as completed our by research we at the approximately $XXX,XXX product. development TAEUS year-over-year initial and expenses of

mainly spending decreased and the and Chief our General for marketing to expenses fees. professional Officer. quarter, expenses the by by $XX,XXX due departure administrative on sales Commercial approximately to due $XX,XXX decreased approximately of Our decreased

$X.XX of XXth, second cash share of June with in and was of loss quarter $X.X XXXX a per compared as Net of the per net XXXX. loss the second XXXX. share million were $X.XX Cash in quarter equivalents per share

runway second company of raised underwritten of quarter XXXX. through million provides quarter an proceeds fourth We a the offering. approximately in public the the into $X.X our XXXX, capital During believe position current net

growth. with asset-light maintain commercial our operations We of pretty and anticipation future hires team operating in in model our

to regulatory in our plan and strategy activities. accordingly expense for we support execute of TAEUS, commercial these our we adjust As structure

I'll to the turn back Now, call Francois.

In has of and proud the ENDRA Irina Mike. business. closing, much couldn't I quarter during subsequent and second amount more very the made be of great progress. a weeks, Thanks important

discussed, liver class. product new that We novo request TAEUS will we submitted we've third, As And work our long-term Liver. the application for clinical abstract FDA had by the XXXX. with our TAEUS a benchmark for confidence key the set for our support de half throughout the leading a to study the raise milestones published capital second Association we with liver European of of first investors

in I FDA process. spoke between in we Mike the timetable and the place that don't listeners steps and dates remind although various ENDRA FDA, reviews next control due and there about regulatory are processes, for the

we'll However, quarterly I of things And announcements developments developments can public we, and commit apprised shareholders assure quickly to their to when along during our moving and necessary report. keeping with productively. material you to do conference everything calls to make keep obviously, agency the

cost price the I the confident a a opportunity the future ENDRA. of that U.S. about hands the that's MRI and in various TAEUS closing, XXXth be we're In couldn't our represents for and clinicians. for TAEUS The technology's place TAEUS excited along the will more future secure market of advantages with of largest of

with overview, I'd like turn to the questions. So, for Operator? over that call

you. Thank

begin Instructions] [Operator will session. the We now question-and-answer

from comes ahead. Ed with Capital. Ascendiant question Woo first Please Our go

Yeah.

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Yeah. question. Good

commitment it and FDA So, of the a in Vietnam upfront systems activated by will place the at off the with in an XX our agreed process three-year distributor is exclusive price. a effect a kick -- is by and takes application the U.S. approval That with distribution transfer of agreement in

the directly important, market currently of addition a U.S. to -- to is opportunity than Europe but other that like you So be out, that in where then secondary as opportunities going example an point is revenue generating we're Vietnam partners. through and focused good

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been If our commercialization under before Yeah. it in expect end might, Good broader we understand first asking, markets put U.S. of in elements key to I successful of both and we've that in putting But the you're as to sales Europe commercial year. I'll of clearance. FDA the place the as number question. the well as support a umbrella sort the international ramp it's to a record important of pending

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in disease, held on Society is we've U.S. booth EASL being and have at Boston. So, although at the Europe, a American of which attending for liver as a a the in case Preeminent Association November, focusing the we're we'll in Liver and been in point, study

to publication FDA, in. to and reviewed now our EASL And evidence the we we're continue clinical as were second, on abstract of base delighted broadly with going and build peer to our have it comes sharing building it submission the

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So, for and U.S. hope were the Europe you that's asking. helpful. I as

you. you Yes. That's good very and guys for answering I you the luck. Thank helpful. wish my questions Thank

again, you Thank Ed.

Michelon back closing like our any conference This remarks. I to question-and-answer the session. concludes would turn over Francois to for

accomplishments quarterly the just a want to you Well, nice everyone to today today. thank the Great. of our and progress point, again announcement. quarter next forward joining Have work, at with keeping us updated speaking I conference our lot for this We evening. A in a on FDA to look lot through on with of everyone call.

conference presentation. is The Thank concluded. today's for now attending you

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