Provention Bio (PRVB) 19 Mar 192018 Q4 Earnings call transcript

Good afternoon and welcome to the Provention Bio Fourth Quarter and Full Year 2018 Financial Results and Business Update Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Jason Rando. ahead. go Please

remind contain and quarter call everyone results for operating Provention like changes and about to statements joining that call. any remarks Good full thank Provention’s to year results. statements time, including expectations made uncertainties may fourth to would involve are I future and and this financial listeners during XXXX Bio’s forward-looking that this At afternoon limited regarding time, subject you our at corporate conference risks but and not

may Forward-looking or the belief forward-looking the review statements Provention as statements. in is the events to of documents of files laws. future pursuant website statements expectations www.proventionbio.com and factors on this obligation differ any management’s any call result disclaims results such subject contained on based are with announce reports any federal materially update reflect safe to made to Provention is information complete and the from uncertainties more by encourage revisions required carefully. the risks we in regarding Information forward-looking the the under These is on are change the and of forward-looking harbor statements publicly Provention’s to any section current forward-looking provisions to to securities available and to at documents statements, except Investors law. SEC. you developments or There these actual

the fourth to and and Drechsler, quarter Ashleigh Provention’s over XXXX Co-Founder and be call CEO, provide who achievements; on Speaking corporate, Ashleigh. now results. will I’ll year Officer, full will Chief on Andrew Palmer, clinical turn financial an who’ll today’s call business and development Financial review update Provention’s

on pancreas. X therapies tissue type call. often without case symptoms for in beta permanent At Bio, such from life-threatening latter auto focused thank stages a diabetes, Jason, already you, irreversible, insulin when Provention the diseases, as debilitating chronic mediated the the occurred. damage industry with our damage developing is destruction immune you and and Thank is has imagine has of in after which Very we tissue secretion the joining disease. for significant precious results treating immune everyone cells world today’s to Traditionally,

dedicated interrupting, of progression are chronic reversing to Crohn’s diseases diabetes, lupus, or type slowing, celiac X colitis, We preventing, disease. ulcerative the like immune-mediated and

of pipeline or sourced Our founding clinical acquisition in-licensing goal from chronic the fundamentally costs of diseases. is which will a to great suffering and assets XXXX, the strategic goal, a for immune-mediated scaffold PRV-XXXX, realized type towards escalating interception these this lupus. the X we In our the augmented two with We mortality, our diabetes stage of landscape. bi-specific achievement MacroGenics, PRV-XXX disease teplizumab state-of-the-art for and when reduce morbidity, strides of of made intent, the change debilitating

immune-mediated start the also intercept severe announced target in processes disease the disease. evaluating upstream and anti-TLRX in constitute Xb to to well strategic severe strategies execute to to XX an that clinical plans, equity monoclonal an to targeting in than proceeds. disease for six also collaboration excellent from gross investment of anti-IL-XX that PRV-XXX Xa founding made PRV-XXX, via significant selected initial foundation, million also commitment prevention conditions stimulating with We disease. we we in-licensed diet, will assets, gluten-free inhibitor in additional continue financial oral to receptor Phase interception colitis. of public solid to study, our the positioned antibody colony antibody secured both progress innovative now our Crohn’s Amgen, we PRV-XXX, this our offering, And Phase $XX PRV-XXXX, be enrollment and ulcerative factor-X in raising for non-responsive commencing year, monoclonal subject an our study moderate moderate development carefully $XX we With million And evaluating PRINCE XXXX the of completion our our pipeline a including enrollment programs events. celiac financing patient certain other more corporate or made assets. our with completion PULSE Amgen’s non-dilutive coincident are Amgen, the Provention’s Last with witnessed future

to with of steady of biopsy our endpoint the on of we data based the with course PRV-XXX clinical endpoints Over severe trial effect Phase colitis. outcomes quarter, XXXX, of ulcerative data from we from evaluate PRV-XXX signature. and and gene expression moderate to a In patients a mucosal second safety to these PULSE designed expect secondary PULSE readouts primary of cadence Xb programs. top-line The expect is in endoscopic report the histological

In addition PRINCE study we readout in our this the expect study, year. to PRV-XXXX our second to disease half data from Crohn’s of PRV-XXX in PULSE

a single teplizumab stage if individuals. on and that at evaluating onset decreased type could We’re study have believe diabetes the forward insulin towards X years by of as Diseases preventing serious to compared cardiovascular type of monitoring of type healthy glucose sites diabetes. Institute age study for relatives, from X can and diagnosed the We to therapy. midyear of younger teplizumab results also a teplizumab anticipated acquiring conducted National have If population, of daily the could before study developing of teplizumab Diabetes with outcomes than of MacroGenics. subjects expectancy expectancy Individuals as from a to individuals. than general or non-diabetic times lifetime XX non-diabetic result a looking rationale delaying in course the is determine higher for diabetes is or NIDDK, our X path risk reinforce the in at-risk resulting XX the life Provention’s the delay at result This greater patients TrialNet who and of a with further Digestive Kidney a of X shorter life The onset average and designed type clinical indicate XX trial a diabetic or disease. successful, of risk the this risk prevent

X study, newly our teplizumab PROTECT X evaluating patients. diagnosed advance a diabetes Phase we As type

to patients it type with remaining the clinicians are functional of the who exogenous well in cells and diagnosed patients learn the type diagnosed and teplizumab reduce If well PROTECT as quarter the weeks, enrollment six as that diabetes beta diabetes need Ultimately, will first that within PROTECT for caregivers the and to been for about who continue as risk we and evaluate it day. expect rescue We patients, a revive have subjects we study at developing teplizumab with newly and recently X disease. believe every administered therapy. ahead more deal begin schedule. next can the of insulin more X

greater approaches disease the believe prevent, continuum from stage a autoimmunity. I Chief will to a Financial have understanding and now within the results. Officer, we financial differentiated that of has for appreciation clinical pipeline, necessary So delay Andy? prevention our its being we Bio’s progressing. who hand disease the or to call the would Provention Drechsler, like discuss over Andy intercept to And

Good everyone. afternoon, Thank you, Ashleigh.

was our attention Before the business. to discussion would that this like financial prior you includes The to as to XX-K today. financial your the our would filed of as associated read I I was also well to which XX-K begin, issued condition our call. risks management’s and with press encourage our release, I earnings analysis call statements,

of primarily loss of During million $X.X to internal net expenses, was diluted as the XX, XXXX, $X PRV-XXX This PRV-XXXX million of December or three development we share. $X.XX composed development and months well ended expenses. generated loss as related per a

trial share. losses. of loss million acquisition in incurred million incurred the benefit these clinical primarily $X.X includes during million million NOLs New expenses loss $X.X PRV-XXX. $XX.X We of expenses diluted Development we of one-time of sale the certain composed for proceeds the a was The administrative sale This the and related Jersey per also and XXXX. of of annual concentrated spending PRINCE issuance from the product in million was and the of December. an general New of of PULSE development warrants a of were net PRV-XXX clinical $X.XX for received Offsetting to year of $X the trial acquisition from operating On non-cash expenses fourth and for MacroGenics. Jersey approximately PRV-XXXX expense our quarter basis, our was from PRV-XXXX for $XX.X stock-based or

and As incurred administrative We with report general $XX.X in million I’m of PRV-XXX pleased expenses the the internal well and in to $X.X spend. cash. million of XXXX. development that year as we ended

cash used XXXX, for In Our approximately operations $XX.X expect we invest the in million totaled to XX, December of in programs. year our XXXX. continue all six to ended

range cash cash to XXXX our believe operating a million from the have to the will XXXX. for expect burn We of and $XX XXXX. through runway $XX provide in operations million of balance middle We to

the such at market or financing $XX payment conditions. purchase triggered either ways, an reminder, the will buy as purchase value connection next from in investment Janssen can obligation has equity potential with million Amgen million equity Amgen In funding related to to Amgen’s to in seat a subject case, PRV-XXXX. terms fair make As in and prevention of $XX of our of to equity. certain potential be $XX either non-diluted two our our agreed million

out see, a plan near can to and the to back now will in our you term. that over As the Ashleigh. have we solid With turn operating I programs balance call summary, sheet six carry exciting

Thank you, Andy.

to Provention. So year exciting a very be going for XXXX is

insights data for new our As creation emerging disease of we will disruptive programs valuable to before autoimmunity. continue a line as we begins work The sharing we this to coming it pursue PRINCE look the the interrupt year. process anticipating reappears our category forward provide to from from trial progressive. both top eagerly At-Risk from the later are studies teplizumabs or months. data results We in the And and PULSE pharmaceutical

parents us inspire their Phase excel. children We’ll to to begin weeks consultants. new recognizing have their Provention also us subjects as motivated in questions, and the At-Risk disease. enrolled over patients every study in of and loved diabetes. would well Before NIDDKs I sites. and as thank TrialNet families amazing PULSE study children for teplizumab that fellow we PRINCE conducted their call trials It few Executives focused the next our also the employees to These participating X day. who out thank the ones They and of that keep my PROTECT Jason. in onset and team the in have be to our at precious and worth patients finding the Type our like like X would I participated is open

Operator, we questions. prepared are now take to

The question Instructions] go with Selvaraju Wainwright. Ram comes first H.C. Please ahead. [Operator from

for very much taking thanks my questions. Hi,

us you XXX may particularly in Just considering study, of intend additional clinical the the the use to I whether are give significant the enrollment if then target few to patient related development occur? activities after. couple were going if that a population on I could what was just and do And you and then nature the I insight some anything study likely year, points follows. techniques understand this the the of so, you’re to to X intervention PRV-XXX as a financial ones. front wanted likely you hoping and the Phase Also, with specific into questions are financial better

X year are Phase runway give like Thank relative operational data, to Phase rights the And you & exercise have if you. expect possibility this on Janssen sense Firstly, of the positive. sense a of where option molecule a after us might if back what us could look its also could XXXX? the they stock-based like data you to you of X were compensation what Johnson to give if look the Johnson, taking

Thank you Ram.

Leon, today our could and patients if the Francisco? call So, Scientific to question Chief study. XXX the Francisco Ram’s I’m regarding going first speak we Francisco, you in to for Officer, enrollment our on kindly ask have

you question. afternoon, the Good Thank for Yes. Ram.

with sites big two to trials. TXD in in TXD we access is, program. are our have who So onset newly are most One strengths leveraging clinical experienced patients to early the we the diagnosed who order access of worldwide are

We up. have those sites lined

made was is most clinical who public, with the teplizumab conducted as CRO, trial hired Parexel. that PRV-XXX the have We recent

advantage. experienced CRO combination So is top the the with a of competitive an experienced key sites,

Provention in fund, working groups. Most with Diabetes the groups. JDRF, the Secondly, patient and advocacy the who Juvenile patient is Foundation, an we Research through importantly advocacy investor TXD patient other groups, are

Johnson presence end very in announced NIH We & have the to the Johnson active in the development C-Path companies organizations TXD. and a Novo is a advance we of other consortium We that joined points community. and with C-Path. like Nordisk,

we the So the we accelerate center the in and educate will really to trial. enrollment community of action our at are

to Thank whether second you. any And, the regards year Ram, activity significant development with be this was question for PRV-XXX. would there clinical

months current first Yes. half activities Phase two will six preparation tox trial The XXX the the study next duration, start of – year. clinical with prior second Xb me, month half, trial, geared excuse in a trial in completing is and the Phase six this in towards toxicology of next months because Xb which was the first

enrollment, patient time. that on substantial activity no of So trial towards initiation but

very you Thank much.

your Hi, Ram, questions. it’s Andy. two I’ll address financial

So that have and do they Janssen first regarding a would on of runway. was make $XX the impact payment, what million if question that kind the

just So clarify. let me

that enrolling trial. still We’re

an We But would results additional If year. and first a take that little approximately in rights we asset, year, probably extend – expect the of this were comfortable half one one months. public the Once more to those to are made to provide our complete second a we’re that the runway readout of be top back $XX in XX which million would that has than by days XX bit half this year. would saying enrollment to make lead line by then year, Janssen decision. to they the

question compensation, P&L rights, the of stock-based some amounts, second probably about specifically we year, XXXX Obviously, related increased million million as a looking non-cash this impact. $X a acquisition regarding obviously, at product it’s they to yes, $X expense. had stock-based environment, for think are normal we compensation but The we’re in to

much. very you Thank Great.

question The Please Dupuis comes Leerink. from Dylan ahead. with SVB next go

you Thank quick for PROTECT trial. couple questions. Hi questions everybody. the taking A my of around

patient discuss can the potential you. look of of NIDDK. if the all, like the trial good, for if done the just how would and that connect a hoping guys dots or it’s the might then the was being by what [indiscernible] study starting that’s you fact readout at ahead and your the if that they’re flow in between different me whatever bit through First at-risk populations. trial could the little at-risk a you considering I second, bad, help of Thank trial looking completion rationale

Thank you, Dylan.

and This history, an at good the improvement a based be can of progression their mass the study, having the relatives can X for different a question the pathophysiology from patients, disease see are with genetically the stage beta with diagnosed months the teplizumab is they I whether with is first subjects, get and predisposed patients be treated are auto-antibodies who is PROTECT significant of to beta cell have who before are where newly disease really themselves. therapy the not to mass type and last point – patient think on risk continuum asked. statement you a progression stage our looking beta your different So, the manifest the you functional or symptoms clinical study, to if symptomatic. become dysglycemia, underlying several These function, but very beta outcome they the clinical cell answer diabetes, progression, at-risk autoimmune disease. family or patients, their conserve their The we prevent and populations. where clinically progression that years subjects, are having appearance are the to clinical cell see starting yet With who to may cell on

as a see populations And deserving whether of of two and we these very it both so difference. study can deserving and teplizumab our make patient

much. Thank Great. you very

second part of I’m forgot. I The question, sorry, your

the connect me read what dots and across result of from might can between trial? the infer PROTECT an how we your it at-risk out Help on trial

you soon we protect if catch forward cells their have the that believe mass clinical an you hypothesis will back will improvement still the this they cell protect. you by we then in beta clearly patients go diabetes we to enough, and that be outcome. come see Well, that to hope that that to stage And the at-risk significant we believe so those available beta the study continuum, in demonstrated more you and further have will

that study ensure favorable hoping the that rate and deliver result We’re a the study we at-risk reinforce certainly in schedule. on enrollment in the would enhance study and that PROTECT

Thank you much. very

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

support our autoimmune pipeline without fundamentally world Please advance potential Well, thank therapeutic disease as you imagining to your with a work disease. to its change in all us immune-mediated join the for continued we hard landscape.

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

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