Jim. Thank Good evening. for you joining you, Thank us.
Virgil all our quarterly a provide members, update, who I Justin I Processa James I’d members, board Slide like few to our briefly support. loyalty months. format call ago, for achieve that will to Before the to discuss XX Chairman; a have to over their Baluch milestones a shareholders we Then, staff Neal, X X, months. new our of the meeting first board the X couple our attended of been hope asked existing thank and next I’m Geraldine Khoso please. board going the the also by X days I Thompson, address Today, to like would Yorke, over with change questions and and our we investors and Pannu. and acknowledge last programs and the of
So here we go.
snapshot the highlights. of This slide, provides a with Next Processa slide please. you
focused who better drug Processa improving life no treatment company an and/or you treatment who have of condition. need options. either or on of are is development These quality options know, patients As medical survival a have patients the unmet need
determining is regulatory science answer and platform answer when the the best to clinical and use the that ago years to FDA we worked questions. X we regulatory develop on XX approach provide way scientific FDA started Our to several contracts, to
development the to of several led FDA guidances. contracts Our
potential have providing target X or a we of X approval, X There’s is or for of each reaches X multibillion the greater Processa treatment these X it goal that of trials. in-licensed presently and is our drug has being $X hoops these better regulatory The means prior was the delayed, a drugs dollar redefined IND in investors, fourth have interim X company. analysis. actively than XXXX drug. And IND the have X first opportunities The drug different been billion. options. the into of drug need number through or Capecitabine independent because clinical we have populations clinical We Generation of the site jump just who of to each modify in market Next patients, X shots development trial our no to protocol on with blockbuster to X size this treatment clinical being drug drugs in have had drugs based FDA X study. program evaluated is clinical putting of a
in increase The has patients number trial patients programs number designed clinical expected, implement increase patient in patients of rate, COVID. second been enrolled. XXXX. programs To of enrollment to of we the enrollment enrolling especially drug These by are November the the will hopefully screened, XXX been supplemental affected slower has which began eligible to than improve and
very and is expected enrolling drug analysis data enrollment The patients, third to well in drug in complete in clinical XXXX. This done trial is XXXXX. has and
Next pipeline. used describes slide. point the criteria would X the To in one our remind that only we’ve out key everyone, to on like drugs I select the item Slide X slide. to
evidence efficacy population The some of This states with for there similar a clinical drugs the second criteria targeted box that red means efficacy for each pharmacology. drug evidence. the is of in in the X or
at all efficacy preliminary of of they in have other look how the population. the in many drug already hundreds evidence $X their drugs the you biotech X pipeline of have companies in billion X clinical companies, If potential targeted can say
Slide. Next
but and a we an completed study be XXXX X on remind summary development plan Generation the at we drug you our clinical agree IND, will development, in clinical have initiating like drugs one and and of that Next XXXX Now, our met to Capecitabine, the let’s pipeline. we with until or not XXXXX; look I’d program. to XXX, with have FDA a
milestones the summarize This the key expected and during of Next program status slide XX months. each Slide. the next briefly
and which novo DPD For of the Next XXXX to with are we patients enzyme the will the better after XC, administration. de in subsequent provide irreversible of and the understand us XB Capecitabine, formation Generation now data Cohort inhibition needed enrolling timeline
complete the next Generation identify and dose interim next We maximum the this of to the the during for tolerated XX FDA expect months. development with to Capecitabine meet stage analysis, Next determine
Our hope of Capecitabine the Next Generation the XXXX. initiate trial is clinical end to before next,
are drugs XXXXX. other XXX The clinical X trials and in
previously been stated, affected I significantly has by XXX COVID. As
diabetic, who screening, cancelled, to COVID to had COVID. We because Since ulcers were additional many not getting for for than these these to of many because lived months are patients most ulcers by were COVID. screen the did or be they safer with have patients travel given with and patients affected is the they living want have of months years, patients cancel and
of results the of of plan XXXX, with trial delays, to The In Even in paths enrollment delayed before in the and group because initiation, last XB that analysis final potential in study completely COVID. with sometime we our first the the enrolled, meet results This to is patients end Phase approval expect We in move to to trials drug available FDA forward the complete is XXXX, addition, of finalize we expect of in XXXX. the top-line XXXX analysis of trial new can XXXX. presently so half in interim group and almost sites XXXX. we our the clinical interim completed with for FDA XXXXX.
call, Next couple Slide. would be drug often the answered more thought we detail of earnings If of we investors. Instead we on to our questions going in it asked. each helpful into been our that a
and as that deal considered enrollment Does stringent? in their enrollment resources? requirements the significant questions our And pipeline enroll coming supplemental for related need initiated related too screening may more the to study in enrollment. and Processa we is, splitting studies, the in earliest that more doing across management identifying XXX patients XXX, several are eligibility be hopefully causing has is set programs, briefly when NL first is of I the with is for progress XXXX, to the The too ulcerated possible For my attract that much drugs company it Processa problem. of in We to patients realized delays? study what questions of especially the November mentioned programs And XXXX? was to the resources a in trials
of and study about website other criteria patients database patient exclusion site, beyond the our implemented study and example, stringent. further clinical and to were had to inform too to We patients tried sites program we to to to a our pay site. add study. a recently, to clinical the for new launched of recruit the we travel inclusion clinical seen not by separate bring the non-performing We patients physicians. site. evaluated the And make We effort potential we attention a sure the dropped more recruiting For
the hoops XXXX enrollment about patient to land protocol. jump having through the For several more modify to recruitment, less was and [ph] about regulatory
occurred the Given reengage enzyme novo and months complete. much formation hoops took refocus site regulatory site the to momentum in at at and de was to clinical faster and each some DPD that months the steady. gained sites the protocol Losing than of originally us The FDA requiring designed. are
the increase and supplemental We have some to XXXX patient to enrollment of added study programs number sites. also enrollment expedite
now are that not very that and efforts a all efficiently. are screening. worry in development additional as Our staff we the to run having that and of we of experienced ship to several do delays, these over to bring to simultaneously, most assure staff of if investors ready are patients companies. the team successful together have And have investors more drugs. know added for prior that several we Nevertheless, our queue Related studies I expedite can with work running seeing worked on on the trials studies. several in a time, being rewarded, clinical run have is we to the clinical and resources needed, us each we to programs the we lean brought
The second how each asset? to partner asset set each fund deal benefits your or or related the do, if drug plan and, Do what when out-license next you the strongly the deal or or you each plan questions plan And Our or not of the outweigh of positives deal. you is do of plan the to negatives is, is doing partner when? to studies? risk the out-license for
our have to our special drugs. for any And we any move Processa of willing ties no drugs We investors. would of and to if be the best it’s
trials. results the interest a licensing with in expressed or our few have fact, present drugs companies partnering are These waiting companies us. of our for already In
are Regarding trials, X cash investors come a it sources, their potential holdings. licensing an from on and funding of partnership concerned will will dilution the and raising an some or offering our about I through offering. have deal, know funding the additional next that
the by reminding number that, is, clinical partner, one, to FDA likely further approvable. or in the drug development drug Let me and more this license likely the more is along the address you
All of of which should Processa. increase the value
into remind value aligned investors our Processa create for has salaries the you equity more sure the anticipated been value has with and three, the the for investors. us market positive and than Processa, mark for This money that concludes has finally then flow, the reading believe Nobody are news phone next over targeting Processa are having our I raise higher, study the again always with all Certainly, XX the This receiving for of expectation for will shareholders. interest seat. credit we of Secondly, poll making to X we each to government starting cap trials months, Q&A. and with an for the please is cash and multiple is our team drugs questions? now operator drugs, goals Number our want to a and invested of XXXX, I increase. us. XXX, Operator, out Processa and open more my new the XXXXX, is billion for when ask play can $X clinical remarks. will lines vested to
