VRNA - Earnings call 2 2022 | Verona Pharma plc

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Operator

Welcome to Verona Pharma's conference call. [Operator Instructions] Earlier this morning, Verona Pharma issued a press release announcing top line results from its Phase III ENHANCE-2 trial, evaluating nebulized ensifentrine for the maintenance treatment of COPD. The company also issued a press release announcing its financial results for the 3 months ended June 30, 2022. Copies of both press releases can be found on the Investor Relations tab on the corporate website, www.veronapharma.com.

Before we begin, I'd like to remind you that during today's call, statements about the company's future expectations, plans and prospects are forward-looking statements. based current are statements forward-looking on expectations. management's These or or nor the results clinical and progress on including, recruitment, involve other from timing, forward-looking known without of statements results, factors are our unknown our the and impact promises neither such implied performance COVID-XX actual our complex and These expectations and expressed materially guarantees risks, pandemic on may cost cause to achievements by and trials. be that of different important the and statements, limitation, the Russia-Ukraine status, uncertainties

Any of such this forward-looking statements date call. represent management's estimates conference the as of

cause may company views disclaims the some obligation to point such the elect While events forward-looking any statements even at its to update so, to change. it future, do in subsequent if

this is available and will reminder, days. a recorded call remain being XX for As

I'd Dr. to ahead. call now Please David Zaccardelli, the to go like Executive Officer. over turn Chief

David Zaccardelli

today's from trial, positive welcome, the call highlights. Thank discuss everyone, as well results as Phase you, our quarter and Verona Pharma's operating to and financial to second results III line top ENHANCE-X

Hahn, our are of and Dr. President me our Development. Commercial; Vice Kathy Tara Officer; Chris our Chief President Mark Chief Martin, Senior Financial today of Dr. and Rickard, Senior With Vice our Rheault, Officer; Medical Research

his the results call. available showing study be call. that be Health exciting today System, Care In Medicine addition, today Q&A the are pleased after Note is our the Pulmonary Veterans thoughts Texas we joining on are we of during Professor website on and Dr. slides will provide available of Anzueto, to of Antonio South very the the and Section at us portion Chief will

COPD, ENHANCE-X by very the need evaluating faced COPD. we III nebulized to data for Phase positive from to significant announce trial, treatment endeavor maintenance of patients address we line top are ensifentrine the As our pleased unmet with

safety symptomatic subjects over ENHANCE-X to X,XXX XXX and weeks, were trials ENHANCE-X XX efficacy the total and longer-term designed the to a safety of trials weeks. Europe. replicate enroll and and COPD reminder, severe also for a primarily XX approximately over sites evaluates The States As ENHANCE-X approximately in measurements United across of subjects moderate

has summary, primary lung endpoint the ENHANCE-X evaluating in function secondary met and endpoints ensifentrine trial. In the successfully

significant In treatment well of similar in resulted rate ensifentrine addition, placebo. in tolerated a Ensifentrine reduction safety was exacerbations. to results with

So results. walk the study now let's through

between types of study. the review study groups. Overall, characteristics enrolled FEVX disease The placebo patients with and severe let's XX% the lung COPD moderate a and enrolled both First, function, balanced with approximately predicted the symptomatic in the subjects were compromised very groups. post-bronchodilator demographic ensifentrine well to in of

inhaled population in received of background study included or approximately subjects a a and therapy, long-acting or XX% a bronchodilator LABA, addition including of muscarinic on all long-acting patients their to beta The antagonist, a agonist, XX% either ICS, medication. LAMA; corticosteroids,

the hours On function the and significant primary serial XX. week XX dose of a XX placebo-corrected, FEVX with XX statistically each next XX of at week demonstrated of milliliters, hours FEVX X value to at of X.XXXX. meaningful detail average clinically at a AUC endpoint over lung the highly post less The improvement slide, looking XX week by study curve in at let's review endpoints p

to X evaluating with X.XXXX p-value dosing endpoints peak placebo-corrected pleased and observed X.XXXX; We dose, of post p-value a X equal in lung XX, a supporting met. week FEVX are FEVX also XX trough that milliliters, clinically to significant regimen. with increases and twice secondary were at of morning milliliters meaningful were Statistically a hours daily of function XXX

FEVX change AUC medication, status, geographic ICS reversibility severity, bronchitis region, statistically the improvements subgroups, background to with all gender, smoking hours baseline COPD on including significant and X demonstrated in diagnosis, XX in noted As slide, at chronic week the ensifentrine. average XX use, next age, FEVX from

a on reduction We treatment placebo show pleased that the moderate over p subjects had of ensifentrine with with incredibly receiving compared COPD the value to XX in slide XX% weeks, or the X.XXXX. with severe significant next exacerbation are rate of

an exacerbation was in reminder, a with of days as steroids X minimum either protocol worsening a requiring a or of a As defined hospitalization. the treatment or systemic oral of antibiotics symptoms and/or

displays the Kaplan-Meier the next period. the On study each exacerbation events slide group is the graph, over which in

demonstrate to exacerbation with with compared We ensifentrine exacerbation of p in of over of the ensifentrine's a XX improvement events in when addition weeks. exacerbation its decreased occurrence treatment as anti-inflammatory group lung the to function. exacerbations to measured significantly due the Specifically, ensifentrine value with separated outstanding reduced early by of time in result an continued to Treatment rate placebo is by X.XXXX. XX%, first this believe activity risk

or next the of measures. XX. evaluating endpoint observed minus E-RS ensifentrine in life MCID score, of quality in review The symptoms the group On and health-related slide, at the symptoms, via the secondary let's total measurements of X exceeded week units symptoms the daily respiratory improvement

improve However, continued this placebo over the statistically to as result was time. significant arm not

in of Respiratory X in total at SGRQ of by ensifentrine Furthermore, MCID score, quality observed or health-related the units life the exceeded minus group Questionnaire, improvement George's week XX. the the St.

significant time. improve statistically to However, again, this over arm the effect was as placebo not continued

showed in seen weeks, weeks exceeding XX and and measures these continued as at at in measurement. treatment the were XX ensifentrine early group as improvement placebo X improvements Numerical each

to life. to during results conducting of We the and SGRQ are quality measurements may results of determine subjective the affected have these symptoms E-RS the evaluate continuing of trial COPD observed if pandemic of COVID the and

placebo and next the events. to occurrence Treatment-emergent including exceeding similar well Turning gastrointestinal than placebo, to relatively safety were events cardiovascular comparable placebo. results was X% and events adverse pneumonia, and greater of on adverse tolerated, safety slide. Ensifentrine few with results to

from slide ENHANCE-X Finally, line the next the the trial. summarizes data top

ENHANCE-X additional upcoming trial We delighted we ensifentrine to results, at from COPD ENHANCE-X conferences. plan the highlight potential information of symptomatic are to believe which We important the with scientific treat patients. release

FDA ENHNACE-X on year. the to end of ensifentrine of data ENHANCE-X in Looking new If of the first top half the for track the data a around we plan the to maintenance the we also are positive, COPD. for ahead, inhaled drug to are treatment from line report XXXX application submit

I to over the quarter of our call results second Mark now the XXXX. review to turn financial for will

Mark Hahn

least million program SVB under us facility, expenses to the and tax XXXX, Dave. believe our will second of funding We cash and capital $XXX.X at you, We the the equivalents from Thank U.K. cash end credit XXXX to of and planned with cash ended our XX, receipts become $XX expected XXXX. equivalents. through fund debt expenditure the requirements quarter million at enable operating in June and available expected

in of months XX, loss a This million loss to loss tax of X loss the XXXX, XXXX, June the the per was ended XX, for tax in $X.XX For of $XX.X share ordinary the a ended same a XXXX. for compared ordinary period after after of million represents June the $X.XX share months compared XXXX. $XX.X period per X to same

as our million share-based development clinical and was to the were $XX.X compensation June the a we decrease ended $X.X to in million million $XX stages months charges. The compared in a of due the XX, for X in $X.X program, million Research decrease XXXX. Phase trial ENHANCE $X.X of to other primarily progress later costs XXXX costs decrease for development same and the period and million III reported

$X.X June expenses in XXXX, the This months period administrative were Selling, million to to reported million compared $X.X XX, in decrease decrease for same was compensation primarily $X charges. general the share-based XXXX. due of ended X for and million a

important element remains credit an U.K. in tax The R&D financing strategy. our

payment cash subject modified Verona year's you program. the SME credit amount could receive company. As a the recall this based the limit qualified will our XXXX, caps government credit, under calls, we the previous from for a on to would from spend of the eligible quarter, available U.K.'s In are Pharma U.K. first R&D tax credit to to R&D the assuming program create to cap. we accounted In be was prior

the recognized full received $X.X an certain to exemptions qualify And recorded up recently Therefore, QX relating amount. that incremental credit QX. also for would in million we the for we However, the from full cap. we QX, to guidance from HMRC credit catching the

June for the or months the months XXXX. million for the X result, tax ended $X.X was R&D credit XXXX, a million million XX, $X.X June than As credit ended higher XX, $X.X the X

related the months, we few our next XXXX million to spend. In to R&D intend $XX submit claim for approximately a

We we as receive XXXX, later the in prepare to payment sheet expect data. to our reimbursement further balance ENHANCE-X receive strengthening

call the now for back I'll turn the the Q&A. operator to

Operator

from comes Instructions] Jeong The question Suji today Jefferies. first with [Operator

Suji Jeong

really good data. a on the I questions. couple of Congrats have

at is And commercialization there data, one exacerbation benefit that the greater the benefit first subgroup the when question a is had you any plan. The about more than other groups? look -- second was

about be guys to you has have considered could ensifentrine? With you your the sales XXX if data the to you wondering changes any today, plan. today, data able those that plan been Previously, just commercialize that able be changes showed there exacerbation -- I'm with might this any prescribers. to to force target said

David Zaccardelli

data line Suji, data we analysis as the With is that exacerbation regard Thanks, specifically. data, look chance to a and subgroup questions. the had for top this haven't to at

will time. course, over Of we

that. it regard I'll commercialization, Chris over to Martin for turn And with comments. So for stay his tuned to

Christopher Martin

opportunity. would Suji, thanks, reach commercialization that at be force of the anticipate look we we question. and a sales Dave, to for reps Thanks, XXX plans, the still When the about able

very the interesting all As is the look small. market, you of is that concentration these that's very of used the drugs across things are at in COPD prescribers one

doing if little are of it a ranges physicians of X,XXX prescriptions well. the of as scripts volume look XX% at XX,XXX from physicians market, the some about the doing of So XX% on to we the over that products

that commercialize we is XXX will what number to very a need for go good believe we and So rep estimation ensifentrine. sales

Antonio Anzueto

subgroups. over you something This at -- of to Certainly, I is and there so your exacerbation, is first curves Kaplan-Meier of if the the actually Dr. be observations. the a that to separates will Anzueto. is any is would comment But it consistent see specific this time. interesting like very if just look

with effect severe to population that we're will board. patient going pretty across much the COPD, to I moderate the anticipate a having So see

Operator

comes with from Wedbush Securities. question next Andreas The Argyrides

Andreas Argyrides

these exciting very congrats results. Definitely, on

other? So one of for about follow-up. prioritizing how quality have life Dr. I the of terms versus Anzueto, over you then And symptoms, exacerbations one in thinking measures are

Antonio Anzueto

a I Yes, so here. Sure. couple of think important there's issues

has is both important this it's effects. and I that who medication think emphasize anti-inflammatory a bronchodilator to

the we bronchodilator So see that oral the effect cannot the other with in see we even medication. phosphodiesterase

it's is very and the -- is well. there very works I -- data there mean bronchodilator strong. So an

I having exacerbation, of think think decrease time more in impact this what XX% in I exacerbation exacerbation to of the exacerbation. The is decrease the of and is really interesting a makes striking. first the similar XX% it reduction the significant rate the

if kind life you #XX, Certainly, the at -- intervention very weeks, of versus quality for into so at -- the striking how difference we I Slide look receive that placebo. of of will between example, This time. a a the effect over translate patients the the lots mean is gets life? when X group there quality

I think are issues. there several

the And as Some ]. to issues impact losing of more this are also, and the we mentioned the some stay feeded pandemia at understand before, are XX have individuals, people and of was [ were the who it weeks.

trial impact Phase think significant going So better very weeks, seen in at we're longer than that this to the to quality III understand decrease we've remarkable. be is fact that's XX life. having of going a I so But ENHNACE-X, the exacerbation be the able to in second

Andreas Argyrides

add just Okay. -- I'll then then quick And it. just follow-up and

E-RS that So were was versus background? patients difference scores and in were the that on or SGRQ there not those -- background any on in

David Zaccardelli

And done mentioned before been -- I'll sorry, just analysis Yes. the hasn't that yet. as say

top an of with enormous data with we But care. -- proper the we're subset which we'll size, can will in amount course, analyses, there's today. I reviewing set over just the at time but we think look So that do at the this line

Andreas Argyrides

I just data paradigm? do Anzueto. to it? you for have now look you in treatment would with Dr. then follow-up How hand, -- And in exacerbation see this one fantastic. sitting prescribe you where the Okay, When ensifentrine

Antonio Anzueto

Sure.

top being this already on in So is bronchodilators. of long-acting patients

And medication. -- we classes given nebulized have nebulization. X X one, other of medication today, So a this is other

exacerbation patients future improvement much will who pretty medication care, on function of persistent medication who is used also data, having the becoming this have being in nebulization to exacerbation. bronchodilators are I despite that be give medication exacerbations. can see these being So patients this therapy, this prevent ask that, many patients. standard maximum and a given And patients risk This in for with in events. reduction The lung to are will having either

Operator

with question The next Truist from comes Securities. Joon Lee

Joon Lee

actually theory nice really to impressive of out playing mechanism It's dual Congrats see data. on this in the action clinic. the

it my of is, you're tracking? is but derailed I exacerbation significance? have assessments in quality somehow the in And sort SGRQ question response is life by of placebo reduction So Or and follow-up. assessment, the the captured statistical the captured not E-RS a

David Zaccardelli

Yes.

So to you have your I may it it. over and give Tara thoughts turn on

Tara Rheault

Sure.

symptoms, So and capture symptoms including the chest bronchodilation, life, impact. quality daily activity and of E-RS and capture sputum symptoms, cough

you capture exacerbation those So events don't tools. specifically within

Joon Lee

press in And ongoing European conflict And you the of the Okay. for are in Phase the many EU Russia-Ukraine second III, U.S. release us in upcoming how the watching you're EU patients, closely. who are patients the the study? that you Eastern ENHANCE-X the sites? remind of proportion mentioned that Could versus in

Tara Rheault

the U.S. the of are proportion the those about Russia, and in South got, the in countries as and in U.K. Eastern Korea coming We've Sure. with such coming those of that coming about from other study, patients Europe, U.S. of the patients U.S., outside of of the X/X majority outside Of patients X/X small

Operator

The from H.C. next Ram question Selvaraju with comes Wainwright.

Mitchell Kapoor

highlight. on I if you Mitchell to expect like the that out publish ask about these results. talk is of for if to could you'd you And data could to Ram. wanted come about you when may unexpectedly that This positive have anything talk

David Zaccardelli

Yes.

sure think I'm So positive. not I unexpectedly it's

in in seeing I with improvement a pleased very think as treatment the on a of real already, of bronchodilator study, compound, XX-week activity the only we're in think lung anti-inflammatory results in been period the viewing effects gives improvement of PDEX PDEX, talked I impacting which ensifentrine's and also positively exacerbation, and inhibition not but us COPD. function about dual over as how, window the a

from of II. its it So reinforcement a came I Phase understand basic was earlier, seen think what we've insights from pharmacology, that

of it's because was not look And it that. but strength at So function to symptoms, data, in I that see the interesting exacerbations, with lung on are requires even of think not only to that extension the the exacerbation. confirmation something captures But that's always to we and worsening going necessarily an and think really these symptoms it I keep in concept unexpected. mind think good in pleased inherently of And detail. more I on effects we're

it of data, along as the think quickly with publication And to regard as move we I we will can.

that we strength think I to and data as in working be lends as can. a quickly of the journal, will the we itself so publication a towards premier

Antonio Anzueto

you the roflumilast the side being here, of comment inhibitors, side side medications GI III this kind and safe, very, Phase developed appear I'll safety. the effects. about even also effects years or over was make -- [ efficacy. other and the effects have have you I that in tolerability minimal the and The GI the seen [indiscernible] confirm Phase and II phosphodiesterase the nebulized And data very basically, medication ] been what all effects side get the and who and is and get Phase the

Mitchell Kapoor

the so, could second Okay. just out of And describe wanted what be. anything see expect And you trial? you ask come just different might if this I to to if

David Zaccardelli

we're don't anything differently. of thinking think I So

the think XX the studies design patient in I enrolling an over weeks the to and first in population primary study. in is essentially standpoint, everyone, remind identical and the that are endpoints efficacy way secondary to all from intended safety the

think be should the we quite read-through So strong.

to weeks. have the later that just safety noted ENHANCE-X the over based we second are course, safety, an period. But to Dr. this the year on expecting maintained XX-week -- is up we where reviewed between difference the Of study be for subgroup that as coming we're on the on additional Anzueto XX

and be the strong. think quite the the the X trial encouraged And study, of structure should ENHANCE because we're So read-through of design we results. by the

Operator

with comes Tom next Shrader The BTIG. question from

Thomas Shrader

really I pretty nice saw? high. similar had XX% XX% like Is to Daliresp question it I a and exacerbations, -- the like guess, to That's comparable everyone else. on rate is data. Congratulations. Are exacerbation the I'm me just measurements? pretty that looks your they XX%

robust small a such kind trial. You of get result a in

are So how comparable numbers? these

Tara Rheault

Sure.

endpoint noting analysis populations patients this just obviously and seeing from the greater is bronchitis different treatment The restrict only. chronic an the much is that that with study the think perspective, also effect not quite did that are essentially ensifentrine as given to I we're same. with

Thomas Shrader

had I then a go And Okay. -- ahead.

Antonio Anzueto

it's patients II the think Phase especially I to -- study, -- the to sorry, were formula not III on Phase in be the emphasize important excluded trial trial, allowed ICS.

So this the bronchodilators, without was here the a cohort long-acting corticosteroids, is on were inhaled ICS. of and who population XX%

probably is this before, said we population. patient as So different a

Thomas Shrader

give something the but meaningfully the ml on similarly, and it. therapy patients the sicker? you FEV worse? didn't the is starting XXX depending therapy, numbers, it And XX that primary, background ml. looks on exact like Got Was Were like

David Zaccardelli

No.

look lot well. And on the X a so far your our of it and estimates therapy factor point right not. entry based comparability the about criteria, a think at background was is I for there as between between

Thomas Shrader

it's All ]. choice [ So really a drug right. of Congratulations.

David Zaccardelli

Thanks, Tom.

Operator

comes Yasmeen Sandler. The Instructions] from Piper [Operator Rahimi next with question

Yasmeen Rahimi

My you detected, big to question more see fast response, And is this then within you that maybe you, question therapies difference have weeks. fast-acting a see able of capture the being an at set. of SGRQ to us also subcomponent meaningful the be enlighten accessible one Dr. other scoring component a Maybe how look the to to Is and able but question. end not Team to X and Anzueto. and exacerbation it That's maybe a response? able very data, to you being for how to to pretty It's Could and only remarkable opportunity compares it's a was is to one on data sub-scores. differences whether to can statistical Verona. see first the able the system stellar congrats you there driven placebo the being being

David Zaccardelli

first. second Anzueto, Go ahead, answer into Dr. question the

Antonio Anzueto

Sure.

if the and we Kaplan-Meier early very will certainly, you the see in curve. see that separation in the course So

I patients this into based FEVX. very patients therapy taking the on is as remarkable, think as the especially consideration on well

hard separation to it's that think seem triple we separation It like X it X the of medications. to with therapy. publications recent but the is if say the comparable, the I the after between So occurring on curve starts seen weeks have start

Tara Rheault

definitely once And I of to analysis, subgroup a and take set fuller hands. little at domain the our bit look a a the intend that in we have analysis about can data we close talk do

out is like that study extremely just X point in to large. placebo response think was I this thing that we this I'd saw

you programs. seen than would have in larger historically other think I

Yasmeen Rahimi

I question team, one to then other And maybe head. apologize popped last minute that my

is off Given you this I'm that the in now investigators data the probably go take this the data share involved that it can press, certain and with study. ENHANCE-X are and

perspective of expedite So outstanding of So you data that's top us us you this to comes maybe of homework it? exciting sort bit give enrollment XXXX. of investigator when on a to with going interaction drive could And of give the the data you aftermath and ahead it of end line operational just perspective the these investigators? do to little with a that's ensure think data the for share to

Tara Rheault

Sure.

in the we study second expect enrollment ENHANCE-X there. our So any has impact completed, so don't

phase So that to have patients they we're access the completing we enrolled. line already obviously, The public is in top that. data, and are that where had will

blinded ongoing data trial. All our any we on at this so time, whatsoever don't expect that is impact to still obviously the of have ENHANCE-X

Operator

Lee follow-up from Joon The is Securities. with a question Truist next

Joon Lee

follow-up a the actually prior question. It's from

in do in you might In up fact, disseminated to make placebo to that this much the are drive patients point to sure the get going would the this question still it what the doesn't are who I where response be too trial? think my

Tara Rheault

Sure.

group again, there we've Phase the new probably comment that is fastest one is uptake a think so not III I that the patient far. the And that released it's trial population results. could single on say I

has So the we're certainly really in impact expecting any not not other case That there. been programs.

Antonio Anzueto

I because to try the investigator is is that if really trial I to me collect I these results everything as in all will complete soon positive part as [ product an all the This ] other the investigator, to an trials, as to see and can Dr. the wrap see, Anzueto, data, the as trials clinical to long-term possible. importance up get is encourage going tried of to data,

Joon Lee

female a data to female looking X change sort are quick III in greater extract I'm And -- trials? you demographics FEVX the Phase demographic are Okay. on actually the the -- -- gender, demographic based patients. at distribution, you follow-up. distribution like tend patients geographic which male benefit mentioned like then age, patients the mean similar distribution ongoing the not Are the already, of than between

Tara Rheault

you females, fairly have lung similar. function do they a higher in mention that's One I Yes, in is can thing than typically starting you that expected. baseline are have males

Operator

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

David Zaccardelli

like team of at And with also Verona for insights. discussing positive months. everyone to the these thank your finally, participating Thank then like for also We you, the many dedicated us forward I'd care today for and ENHANCE providing results professionals support the operator, and and coming weeks and to Dr. joining shareholders thank and to his program. for to the want thank questions talented we'd the in and continued I health their our call Anzueto patients today, their in on commitment. And highly thank you to look

today's And so conclude we call. with can that,

Operator

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

now may disconnect. You

Verona Pharma (VRNA) 9 Aug 222022 Q2 Earnings call transcript