TRVN - Earnings call transcript Q2 2019

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Operator

Good day, ladies and gentlemen, and welcome to the Trevena Inc., Second Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded.

I would now like to introduce your host for today's conference, Mr. Officer. Business Chief Yoder, Bob Mr. Yoder, you begin. may

Robert Yoder

Medical Thank this morning's and our Officer. and our welcome, Chief Shin, are everyone. on us President Chief Demitrack, Mark joining for CEO; and call. Financial Bourdow, Barry our Thanks Carrie you, Officer; With today me

making made the begin, we XXXX. pursuant Act Safe provision of be to Securities to on Litigation this of that we inform the Before statements participants call, Private Reform wish will we forward-looking which are Harbor

involve statements from update forward-looking we and uncertainties, Company's such reports detailed that cautioned obligation the these And risks including risks today. Exchange time-to-time periodic to You're beyond undertake no Commission. the in statements Securities filed with and

made update call, will time summarize will During Carrie plans across then review in the highlights on for some our pipeline, financial will proof-of-concept questions. and followed our detail Barry and outline volunteer for oliceridine, provide and corporate the by for for Mark study results QT progress further study an today's recent our healthy we review our the TRVXXX.

turn to the over Carrie. call now I'll

Carrie Bourdow

Thank the dose have daily dosing the morning, CRL. We more able maximum than from today. to Thanks, on and study time and have on to of XX we of received the are encouraged oliceridine, the the plan In so Thanks one made the far begun requirements significant you half all XX with study milligrams enrollment. quarter, subjects work. everyone. FDA for progress our Over joining Bob. resubmit already NDA. of subjects healthy volunteer oliceridine the team's Good hard second to us we initiate were of

and track the support in as as NDA to remain activities in XXXX. data also other topline all expect possible the of resubmission early fourth quarter first quarter We on

data pivotal III moderate-to-severe the support tissue Practice the and evidence acute pain results, of We our efficacy, safety, The soft for continued developing future set of robust peer-reviewed Phase oliceridine our second publish Pain following recently with clinical are published patients to of and tolerability a oliceridine commercialization. trial the to journal surgery. highlighting for

also Anesthesiologists our oliceridine to October. is am professionals be in of of for have XXXX Society meeting excited group meeting I the that abstracts largest important all in that presentation healthcare to pleased And submitted interested of at been American This Anesthesiologists. held more we learning global for announce the is about accepted this of oliceridine. are

We study to we We also protocol acute migraine next made proof-of-concept and our advanced TRVXXX that initiate have pipeline. this quarter. expect announced progress the morning across study this for

a million in also forward XXX the migraines look with broadly. this believe over but We the another more play action, receptors the TRVXXX important to differentiated a and anxiety of and the is the new mechanism this migraine, potential market treated an brain to in exploring market large opportunity Delta U.S. TRVXXX sizable located pain regulation the asset and exists for of be only annually space pain, in at delta for mood. we Migraine role one continues not are CNS in of and receptor.

study progressing study proof-of-concept a on NIDA in or as this therapy fully The in will year. starting potential National before this Institute remained funding patients Drug disorder. engaged opioid-induced anticipates Abuse and has a for of maintenance the be NIDA end TRVXXX

filing peripheral mechanism in pain, modulator. new a non-clinical neuropathy. potential to TRVXXX we've for including support receptor SXP the our activities non-opioid the treatment has CMC IND begun finally, And to chemo-induced novel of TRVXXX, a for future chronic be

supports runway topline cash data current the and resubmission readout, our just the outlined. oliceridine NDA pipeline I Importantly, work

financial Barry has leadership brings joined Barry Officer our more XX and of an member Shin important from team. focused our One and years have year the than Chief strategic Board. into to last will sector. on added highlight as for year. quarter, Trevena busy and in of we invaluable our to next Financial his continued we thrilled leadership And remainder experience for be the prepare expertise and the momentum as biopharmaceutical I'm

call details oliceridine the and hand around Mark to me accomplishments let provide with recent more over our to TRVXXX. that, With Mark?

Mark Demitrack

and the single moxifloxacin Each randomized with intervening three subject in good washout in healthy study a our moves Thanks all QT a the June. placebo oliceridine, conducting site receiving morning, a through To recap for Carrie, study status three-period interval everyone. successfully we current periods, sequence a end initiated positive each of crossover the We're design. program, at oliceridine at the short of volunteer as study this control oliceridine between treatment. and

each Combined least the at XX healthy XX of days. data period oliceridine, the maximum dose cumulative receiving proposed on of submit to plan study milligrams We XX dose. for subjects a daily with XX total subject about lasts approximately

dosing, level. Carrie dose more cumulative a target As our milligrams than study of received dosing. of mentioned, have report this oliceridine, of as minimum today, that completed total have XX exposed pleased required of Of subjects who meeting have I'm of half over the subjects to at FDA's XX population initiated number

we developed the We've on topline quarter. made an acute significant also next proceeding TRVXXX acute this Based delta our We've novel with protocol program, strides enrollment, is agonist, aimed study. a potential readout proof-of-concept and believe study data migraine. for progress this treatment receptor our at migraine for on of schedule

This years. outlining study model, for migraine past minutes approach design study been scientific of be well a few evaluated leverage that has in will migraine nitroglycerin some placebo-controlled will of over that a elements. provocation study the the the validated double-blind, key several the a a headache spend clinical literature I'll

known Patients to all very a making a of suffering interventions headache carries spontaneously occurring migraine, be model sustained clinical like treatment study that it challenge to the to clinical following TRVXXX. developing a nitroglycerin migraine of features attractive potential particularly vulnerable are from

a at single experience site. sustained this migraineurs who TRVXXX is headache. by study nitroglycerin will to receptor, number of at induced of ability plan delta approximately a objective the determine enroll to measured engagement primary which the XXX be We The target the subjects of reduce to

All TRVXXX a at before randomized be a hospital be fixed a subcutaneous in after followed hours. time infusion, for receiving point, by will placebo continuous of nitroglycerin administration or monitored subjects dose which a setting they XX milligram will XX of

initiate migraine We in study expect mechanism of an next action important clinical program. looking sufferers, actual new to and milestone quarter this this forward I'm this studying to exciting development for

quarter I'll over the to second call our to now hand Barry review financials.

Barry Shin

here Thanks, joining Mark, Carrie be at be and for It's to to point. thank morning. excited introduction. I'm the critical you, this inflection Trevena great this

done we're addressing and the on other resubmit our team the clarity to assets. efficiently. efforts look study volunteer forward solid great CRL cost-effective have for underway to is our pipeline healthy regulatory pipeline a on I the job We NDA and quickly advance well our The leadership and has making progress pathway, the oliceridine supporting candidates.

Now XX-Q. financial our to earlier disclosed our in today full key numbers. We Form measures press release the statements in financial and

I'll numbers. now, the headline For summarize

a per second we million reported second loss stockholders approximately the for share XXXX, quarter quarter common of to For of approximately of or or share, million $X.X net $X.X XXXX. to the $X.XX per compared $X.XX

force This XXXX decrease resulting share in from per initiatives. a net in reduction loss and by saving and net the decrease associated cost and in primarily was restructuring loss expenditures driven

study half expect planned, healthy initiated June we increase of this to in for year. we in oliceridine, due second As volunteer of XXXX, the which expenditures will the mainly

million of cash June as XX, XXXX. Cash, equivalents, were securities $XX and marketable

We'll our expenditures expect to expenses, and service at third unchanged we Our this fund continue quarter interest and months together amount remains operating with least debt into for of XXXX. guidance XX the income. capital

for that proof-of-concept for for This study begun initiation the volunteer TRVXXX healthy and period TRVXXX NDA in this including oliceridine of already activities quarter have first study the milestones of resubmission oliceridine year, covers the key XXXX. for the completion of the fourth of of in quarter IND-enabling

provide closing after remarks. Josh? call now Carrie which for We'll some open will the questions,

Operator

comes Thank Butler question Instructions] with JMP you. from Securities. [Operator Our first Jason

may with You question. proceed your

Jason Butler

Thanks Hi. questions. taking the for

we you first for on example, as QT information expect basis you the to maybe just provide on the from conclusions? for Just disclose or crossing on what thresholds? QT intervals oliceridine, Thanks. quantitative an patients one outlier study, well you Will should average as frame any any can topline us,

Carrie Bourdow

Jason. Mark? morning, Great. Good

Mark Demitrack

Jason, exactly interval. corrected, the interval report what report. placebo we looking, baseline this topline data, QT is at QTc be when Well, in we'll the so that's corrected from change so-called We'll rate

And well then outliers of interval absolute at of itself. change the the as be corrected also for standard as magnitude from thresholds baseline proportion categorical reporting we length QT will of the

Jason Butler

is What's And can you're on induction? the How And headache or NTG Thanks. a helpful. no. threshold you a passing a us course treatment how do in the headaches? you or onset bit time at more Has – patient whether you how when TRVXXX, for gets post Very then get that a little then a of induction? define do the XXX, scale? reduction define around Yes, kind categorical? some the give headache would expect to using you a just a headache? Great. don't many Is for looking nitroglycerin of background effect patients it

Mark Demitrack

Sure.

So well couple been this the decades that is of minute established of over a in dosing used nitroglycerin. has and with this research of model And infusion approach conducted of that's intravenously paradigm XX model. been literature a the of

the And we this that also, with migraineurs. in model performance working site an we're at we that of in actually study with, early site validated the research

So is the seen performance. typically headache a lot infusion. there parameters of is a vascular we type know is brief about the What during

it. is the Then there be done would infusion no it. is of that individual healthy a For end of sequelae and the

migraine, a of eight this of around of really several sufferers In with usually has someone occurring a that it all features vascular all hours, immediate migraine spontaneously next over virtually migraine. individuals six just hours the of to with very And but not experienced it's that headache pattern headache. migraine very, clinical progresses characteristic the headache, to

intensity whether used will Our use to approach outcome or and at measures We'll this look headache categorical that and scales scales, we'll in general that other rating that headache absent. thing. a of that's obviously of standard But grade cut outcome secondary durations that the a several with points take determine have and to rating study. the terms sort thresholds will is we we various are present use

Jason Butler

great. Okay, Thanks taking questions. for the

Operator

Wainwright. comes Tsao H.C. with And our you. question Thank next Douglas from

You may question. proceed your with

Douglas Tsao

morning. questions. good for the Hi, Thanks

step terms in of that's terms needs final – done refiling? the oliceridine of Is be in of the in for resubmission that study. there is Once completion of Just just to data? towards it is of or else the compilation anything terms simply that completed,

Carrie Bourdow

Yes. so I'm or good afternoon, are, Doug. I'll… not quite where sure Good morning you

Douglas Tsao

Good morning.

Carrie Bourdow

Okay. morning. Good

we is the So That study finished. done need to we do before you other the finalize will remember to that work QT metabolites. to characterize the area is that may the that PK need be

will that of the part well. be submission So as

need we be we that more have question reports provide the And already the were the involved a the validation And clerical thing in of questions the that it's that will one – really completed. other to really then other submission in now in package. data two

we next resubmit can be on once should quarter study way well finished year. is the in as the our we So early of to as first

Douglas Tsao

in enroll Okay. the terms – just of patient, three does And the through it a to once long go you take how crossovers? them period then

Carrie Bourdow

It's Mark, about days. right? XX

Mark Demitrack

to days in last complete Right. come the It's the they about day from they XX day the period.

Douglas Tsao

Thank you great. very Okay, much.

Carrie Bourdow

you. Thank

Operator

any Bourdow, Thank like I'm not you. any questions now showing to further would remarks. to Carrie time. And call turn this further I CEO the for over at back

Carrie Bourdow

Thank Thank Great. questions. for you. your you

half and As to heard busy work important have as second a we XXXX. sharing we ahead you updates enter we you with look us of forward today, of

as we on will the of and year. the from next data healthy as successful refile study is expected remains first NDA volunteer focus oliceridine progressing resubmission. towards possible in the quarter next quarter Topline early Our

to the discipline, migraine TRVXXX CNS on study remained partners summary, developing We're acute for months. at assets our supporting proof-of-concept plans towards pipeline over we're development all our move committed optimistic initiate for to In next for for our also and the advance preparations they TRVXXX IND-enabling TRVXXX with CNS also already finalized to has the and track milestones conditions. NIDA next and year-end, We novel by quarter, medicines commenced. as work proof-of-concept with to patients we study six continue key

Thank joining us you. for Thank today. you

Operator

conclude does day. Ladies thank you in may a This wonderful Thank participating for you you. program have today's all and today's disconnect. Everyone and gentlemen, conference.

Trevena (TRVN) 7 Aug 192019 Q2 Earnings call transcript