PDSB - Earnings call transcript Q4 2017 | PDS Biotechnology Corporation

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Operator

Good day, ladies and gentlemen. Welcome to the Edge Therapeutics Fourth Quarter and Full Year 2017 Conference Call. At this time all participants are in a listen-only mode. After management's prepared remarks there would be a question-and-answer session and instructions will follow at that time.

As a reminder, this conference call is being recorded. host conference, your Edge Gin introduce Therapeutics. now for Greg today's of I'll go Please ahead.

Gregory Gin

Good and full morning conference Bruce. you, Thank everyone discuss results corporate fourth financial call welcome our quarter XXXX and year and highlights. to today's to

we are Phase by the interim which historical, uncertainties, in conference law. To following of Edge's risks that today's until statements press meaning forward-looking company urged will Investors, any statements not performance are forward-looking the from this statements. future except or on are Actual consider made update the guarantees and statements, listeners call these forward-looking Private as outcome comment, statements. is SEC. statements X extent our end be remind the to undue NEWTON projected statements and in the in by including One X analysis quiet these contain expected are obligation Reform place period required these Litigation potential and the call Q&A evaluating differ the may those of reliance and any session not forward-looking intent involve that on today's such other specifically carefully from disclaims the in investors, that may cautioned results a to April. and me to filings certain more release call contain materially this is Let the and announce study Edge forward-looking of Act with the of Securities you noted and those morning's forward-looking factors within of not information XXXX. statements

the to call may we look your appreciate understanding I the in coming of once communicated interim we the forward that over everyone questions analysis. And While to that, have will turn with have with outcome some now we you the and acknowledge of reengaging weeks Brian.

Brian Leuthner

has into aSAH. been us improve of for the to hemorrhage directly following by aneurysmal current from affective fluid efficacy sub Results brain. brain study patients Phase in NEWTON exposure believe EG-XXXX over our oral oral that study a with patient of improving X to outcomes days. focused believe the times our provides morning order Edge Since EG-XXXX. and at for to XXXX NEWTON the has nimodipine cerebral and provides We Phase on advance thank EG-XXXX for compared X care to today. standard good spinal aSAH outcomes nimodipine XXXX and due Greg that supported care you potential limited studies of be sustained help with developing to in everyone in X non-clinical subarachnoid hypothesis a joining while XX and Thanks rationale our to the of nimodipine showing the drug concentration optimal or delivering We the delivery XXX patient standard

meaningful needs is to and that hypotension. achieved progress causing get goal with impossible the into nimodipine towards similar the with without aneurysmal EG-XXXX it fact in potentially to those dose In virtually XXXX In by addressing are provided nimodipine limiting of patients threatening subarachnoid brain life oral our hemorrhage. concentrations unmet Edge of

analysis the X pre-planned to proceeding the Our track is in after we X interim analysis completed study Phase on utility NEWTON December.

EG-XXXX began agreement commercial in for step of an also a external the for EG-XXXX. supply commercialization a commercialization establishing We for key securing preparing fact in with with EG-XXXX, potential manufacturer potential of supply

the and burden a pre-commercial as addition health we understanding In of patients. economic regarding tremendous part better of planning aSAH the to economics continued our gain

of of April By we the efficacy analysis study formal results the visit the the in XXX upon interim of the We late patients for expect Phase to X line end in the follow-up NEWTON outcomes X X. first report the our reporting completion of anticipate XXXX. from XX top day NEWTON

This of nimodipine outcome during the Now from we The XX% possible Monitoring around analysis. enrolment proceeding to this achieve to the In or absolute in regarding questions full the we DMC The Committee for. XXX EG-XXXX case needs various XX% Data is scenarios at of patients of patients this meetings XXX analysis. a favorable of proportion recommend difference received interim versus following the number of DMC outcomes patients. the that the study may a enrolled. can recent to investor planned oral recommend outcomes one patients

I we sample study enrolment. full the to neurosurgeons and the is here sizes is to considerably with from the target at threshold that NEWTON stopping spoken full expect a the to a point difference XXXX. around hundreds the We clinically study of DMC higher X meaningful are XX% that NEWTON key to in at interim we've the than X of based to results Or our stop designed in that neurointensivist overwhelming for XX% on that effect. time stated previously success them the believe our top is customers, benefit A Remember absolute efficacy. to point As study recommend outcome. study line may late they detect the efficacy patients achieve XXX and

versus would favorable need study For receiving greater the in treated about outcomes difference be from of among XX% proportion stopped patients the nimodipine. EG-XXXX oral interim early, be patients to the to absolute the results than analysis

a we health go following case the other meet analysis. to of this submission interim authorities in with the FDA Now market the discuss application would and

data additional threshold up the if the the XXXth interim interim the of time after from scenario, patient waiting for study analysis. stopping DMC randomized the missed that Another to stopping at is the the nearly patients for recommend may the and the efficacy enrolment

there asked form of futility we is analysis. Now a get often

form analysis no futility into the of there So analysis. is interim built

safety not risk as subject amending terminating does on concerns you that However the for DMC additional or know recommend based or benefit the assessment justify study enrolment. may

regulators. design the patient It centers briefly Phase WFNS as oral about with an XX extra elements review of now some efficacy, to of by ventricular results, through the care designed mirror seems leaders to GOSE may That for thought and study score drain study. in same like versus you discussions Israel, populations of assessment defined same the or key the through that The X So and same NEWTON the in EG-XXXX the for was comparator the with favorable of at of EVD, Phase neuro components with I'd we've factors; X We've informed neurosurgery the Asia. new Phase and by America, study. Edge the and conducted outcomes X from key X to study design is some used key NEWTON input the X three Europe, be critical of story X standard X. nimodipine X care, our encouraging North study

NEWTON the subarachnoid of results the for other positive also treatment X to our study aneurysmal if the submissions approval basis we expect of positive application of to to marketing EG-XXXX the form geographies. for we Now hemorrhage. FDA for in the the plan U.S. regulatory If pursue

from initial external supply EG-XXXX So we having believe we manufacturer in position supply and manufacturing agreement secured the that perspective as for solid of we're thereafter. product a launch commercial with prepare and chain a for commercialization

the key activities findings Now of finding on that research pricing And a me XX% EG-XXXX and payers endpoint as access NEWTON touch for EG-XXXX suggest improvement turning would other that care. is of let EG-XXXX. mentioned be views standard pre-commercial some X payers on XX% of on I from The primary to supported commercial flexibility versus to based independent by study. research the briefly

pricing we on support may XX% to premium XX% think payer based So a research. absolute difference

management should EG-XXXX The emphatic. were respondents hospitals. be payer most Now to the left

financial our with the do So call I'll that to discuss turn results. Andrew over

Andrew Saik

you Brian. Thank

As approximately in $XX.X of compensation XXXX cash Research for quarter expenses. operating and of activities were Net December as million development for $XX.X million $X.X the securities million non-cash to year. inclusive used cash equivalents were compared and of were $XXX.X XXXX. $XX.X and expenses cash million million the XX, December fourth stock of XX, markets

the related For $X.X the of costs due reflected stock X increased expenses compensation for the to formulation EG-XXXX were including primarily million R&D for were $XX.X clinical expense. study. related of million million expense. expenses NEWTON increase General development, and $X.X R&D fourth quarter in administrative during and approximately compensation EG-XXXX development, XXXX spending expenses an $X.X to noncash personnel year XXXX including non-cash full million external expenses

XXXX costs, of Investor and related $XX.X compensation million noncash were G&A fees. of for $X.X in expenses, For in million $XX.X based net fourth costs, increases reported loss quarter expenses expense. the XXXX. all million stock personnel including reflected Relation the year compensation We G&A spending $XX.X million and of a during full professional legal XXXX and

As shares million XX.X XX, of XXXX had February we outstanding.

to anticipated expect million ahead fund to burn dollars be look and roughly we through late operations cash I'll cash is from to we back which our cash our our our in with XXXX million turn current As equivalents full Brian. now to to over $XX sufficient X $XX in XXXX. And data Based cash the study left our incur on cushion expected NEWTON a plans it readout over afterwards. is

Brian Leuthner

Thanks Andrew.

closing in So pivotal Edge. will year for a XXXX be

to including we by to we're also preclinical portfolio. that and clinical corporate next X continuing analysis the planned strategy select of opportunities the well are conducting execute products the financially In precise pursuing our development the from as as NEWTON as our full development potential line order and XXXX study top in advance additional operationally milestones by continues believe expanding and growth the candidate in of we to additional ahead results well acquire achievement late the EG-XXXX development in interim key our business to XXXX. pipelines external study on April, as Looking enrolment for positioned additional commercialization to base development particular focused on through end

us we're your all ready Operator, you take joining thank to support. questions appreciate So today. now. continued We for again

Operator

first from Auster the Suisse. Credit And from line Instructions]. the [Operator comes of question Marty

Your line now open. is

Martin Auster

guys. for quick I two this taking my Thanks question morning. ones had

X you can you interim, the any made is if -- commercial sounded material there general a possible being the in Oakwood? for clinical with any the described timing but of walk was on to was to changes in with Oakwood laying there for Congratulations whether on company any succeed if terms you an us And study CMC an analysis? First, of that out commercial this enrolment if the for whether based FDA? company, scenarios the And filing for the question recommendations out to then not were changes and the on of filing interim that's between likely your be of prepared to you through the are any or material factor trial what then be arrangement your readiness coming what gating interim? on on has Thanks. would option process wondering EG-XXXX, supply the of planned NEWTON And securing second could the like from confirm my flexibility are the was for manufacturing. thanks it expand the

Brian Leuthner

sure. Okay,

let So me with go question. first

for much supply. to substantial look been the no with have XXXX clinical no there manufacturing or the changes been forward We've fine as changes. doing to commercial pretty Oakwood, we So made supply no of substantial tuning things but changes the

we that believe on We to standpoint. So things manufacturing from we analysis least going do that are if plan. at the according on hit track are interim believe things

as time forward. the at we and size to don't going expect as study of that patients, Now far interim sample analysis expanding the the increase

So we're looking XXX. at

Martin Auster

Could follow-up, you to consider there trial want but of interim? the the or kind you is if to for flexibility, you, there to sorry the kind in if of is if for the need capability an you end adjusting confirm in adaptive could

Brian Leuthner

to actually let question Andrew asked be, there throw Herb. me I over because I to might you've this know that do recently Andrew believe

Andrew Saik

that's Brian. right Yeah, no,

it the understanding do as the the discretion to the in you whether is my have not some as we sample DMC mentioned of or size to So increase study. our cannot but increase internally can not current an are plans We recommend that size. sample change

Martin Auster

I helpful. queue. really get will Thanks, in back

Brian Leuthner

Marty. Thanks

Operator

Jason And Butler the Securities. next question comes our of line JMP from from

now is open. line Your

Jason Butler

excuse thanks the taking me, questions. for Hi,

can one, about as additional color payers you give from speak First them you any pricing? the well you just us specifically to feedback as got around when hospitals

Brian Leuthner

Andrew and work Ben, COO doing Yeah, of -- a been I'm lot on give that. to have you our going

provide to back. we want color So, are getting additional a comments, Andrew you it lot of or some do

Andrew Saik

sure. Yeah,

with will hospitals. from off So start I the responses

So go to we independent company I'm used sorry, the payers. payer, instead an of I meant research to hospital

the for characteristics improvement XX% EG-XXXX them We start to we an really company to research to XX% the And payers. to go a independent five of of care. gauging regard this standard largest with So used just the is something of to gave payers at pricing. to us

pay conferences. and meant our to cover at from the We were website five again tested that up point $XXX,XXX they XX% it Three positive So tested said prices we've this price would improvement range and that on is the wide outcome. a XX% tested the was in we is at I got to of on price $XX,XXX think our using and any the responses based product to in and of various been for deck we we varied. points

The said points their said wouldn't them within of would review it levels of none price the we at two various tested. pay other of it go processes. through any for that But they

So right pricing. positive, it is a XX% away. it it hear. indicative, improvement is pick to is encouragement that gives is are a guarantee this we is -- up in this XX% no to look going justify want that way we this certainly us But product what premium at It payers can to

research for a of as to In we the or primary need physicians mentioned Brian that. terms didn't company use

commercial and of that XX% old of team And improvement, is oral they what XXXs care is standard been care to they've We to of our the have to justify moving see surgeons. very and through our consistent through scientists which need to product. standard access from neuro locked a the

So to be are comfortable very we're with two keys it on improvement. both those market going access to we XX% the a successful that to plus fronts. and We're the getting at believe

Brian Leuthner

point Yeah tested to out XX% designed also is XX% And show I echo where up studies that is at payers and to said, with two XX% we've absolute would that XX% to went and effect, that's doctors. really the we and difference. that's say, look how with two clinical the the the things point set it we to Andrew

Jason Butler

feedback in to Great, thanks approval that received a your XX% quick regulatory standard from agencies Europe? then over just have you of care follow-up, benefit that also and XX% support would

Brian Leuthner

European Yes, we also. met authorities the with

as that So Canada didn’t centers as Australasia world have using believe well we're outside in we and other as the enrolling you the and as know centers we protocol European feels [indiscernible] that Canada throughout harmonized well. we and

Jason Butler

the for taking Okay questions. great. Thanks

Brian Leuthner

Thank Jason. you

Operator

from the Paul Matteis our Leerink. from question And comes next line of

Your now line open. is

Benjamin Burnett

much, I Phase thanks of powering is question for Matteis. X. Hey, this about so Burnett Ben Paul on a had the

So you to that for do approximately for oral nimodipine. said XX% the interim you've want need you effect analysis

guess just if guys the powering the the and at that you the point is this hit be about could So disclose you probability thinking interim variability I positive, what will that that?

Brian Leuthner

not Can quite sure. question you your I'm ask again,

Benjamin Burnett

you oh, I go hit I was guess if So asking, -- ahead.

Brian Leuthner

at know powered is we have done powered the have power. we we What -- XX% so mentioned, we as you study overall probably

we analysis. chart the So use tell didn’t can I more on you interim

XX% So that is difference. why it is a very high level to hit absolute that

Benjamin Burnett

guess be Okay, around so I the interim you haven’t commentary would powered. how said how

Brian Leuthner

No.

Benjamin Burnett

the that Okay, study that about. that for completed to talking you and are to the was the XX% XX% was just for clarify XX% powering

Brian Leuthner

Yes, absolutely.

Benjamin Burnett

you and of with any what X, X? one I the patient how have if this the you're about compare mix saw study that WFNS do you may and in just Okay, question, does the more the Phase seeing in do entering visibility in if just into you I level baseline Phase guess patients

Brian Leuthner

one give is those So visibility we this things the study but out study until ongoing it's so don't that is of have we an do completed.

hear threes we in be expect an out fours be somewhere general -- We what studies between the and we in and the But expect see to study. on to ongoing past. similar we to don't specifics give to twos

Benjamin Burnett

very thanks much. okay, Okay,

Operator

from from the And question comes line Alex [ph] Maxim. our Poshner next

Your is now open. line

Unidentified Analyst

you Thank questions. actually you my for guys, answered Hey the call.

Brian Leuthner

Alex. you thank Yeah,

Operator

time. [Operator showing questions Instructions]. I'm no at And further this

Brian Leuthner

day. would for a then and support your for have Therapeutics again Edge we well hope Okay, you like of thank and ongoing everyone questions for the the to great

Operator

the gentlemen, and Everyone This in may today's all program day. thank you a discontent. you participation conclude and great your conference. have Ladies for does

PDS Biotechnology (PDSB) 2 Mar 182017 Q4 Earnings call transcript