VRNA - Earnings call transcript Q3 2020

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Operator

Welcome to the Verona Pharma Third Quarter 2020 Financial Results and Operating Highlights Conference Call. At this time, all participants are in a listen-only mode. Earlier this morning, Verona Pharma issued a press release about its financial results for the three and nine months ended September 30, 2020. A copy can be found in the Investor Relations tab on the corporate website www.veronapharma.com.

Before we begin, I would like to remind you that during today’s call statements about the Company’s future expectations, plans, and prospects are forward-looking. based current are statements forward-looking on expectations. management's These of or nor involve other from known statements results, factors are unknown our and promises neither performance, timings, and expressed implied results business. of actual clinical trials our impact and These and continuity expectations forward-looking and pandemic of materially on without limitations statements guarantees risks, cost may or COVID-XX including cause to achievements be that different important uncertainties, the the our the the by the status, enrollment, our management's Any statements as forward-looking of such date this call. represent estimate of the conference

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

is Chief reminder, turn like now being and I will XX to Officer. to Zaccardelli, ahead. Executive a Please for this Dr. recorded remain days. available As David would over the call call go

David Zaccardelli

call. are Martin, our everyone of Kathy Medical Chris welcome and and Financial our Officer; Commercial. Rickard, our me Dr. Mark With to Vice you, Officer; Chief Hahn, Chief Thank today's today President

XXXX four third trials progress for started of of and XXXX substantial of The Pharma. at We achieved was period Verona the outlined quarter another goals, the beginning year. we clinical the

response May, maintenance treatment as Ensifentrine the First of received FDA package positive in nebulized for Phase from for a we’ve to X our end COPD.

gross oversubscribed proceeds July, science our from in in highly $XXX of from million experience life Second investors. we’ve raised a financing group

initiated creating Phase year be trial. And Metered-Dose we medical exciting finally with to potentially will the enrollment X-day help Ensifentrine we and Pressurized of as pMDI dose patients portion an unmet important study. multi or Third we September, COPD XXXX Inhaler value progress X our needs. into restarted milestones in August, ENHANCE the in the

Let ongoing studies. each me of our clinical detail

enroll track X have and in bronchodilator Each on to The in single Phase U.S. designs patients Ensifentrine and COPD measurements pivotal our X double-blind two added safety on XXX at study study as sites a patients studies will of severe Europe. evaluate of monotherapy randomized trials the but safety Both ENHANCE and nebulized XX weeks. are enrolled are and primarily also XXXX. XXX over placebo-controlled now The evaluate moderate XXX therapy. will We subset in underway. two are efficacy ENHANCE approximately replicate more X weeks, complete background pleased ENHANCE will to trials to longer XX X enrollment will patients over symptomatic term and than

the well safety favorable activity, patients bronchodilator COPD and potential in are both available not for its by profile an novel by with of action, therapeutic treatments. be and will Ensifentrine for confident of encouraged pathway millions motive important the combined are well with COPD. anti-inflammatory clinical believe We served validated who We regulatory Ensifentrine its

began pMDI at in could patients with and XXXX. a addition first COVID-XX. enroll hospitalized in respiratory In COVID-XX to patients single formulation markers could improves the is Birmingham. studies to treatment The Alabama demonstrated lungs. the Ensifentrine pMDI study inflammation delivered standard-of-care be pilot reduces the believe to cellular placebo. other standard-of-care have of a of safety function we patients and anticipate added University double-blind We diseases available lung via and of benefit prior it its data Ensifentrine results for at placebo-controlled the expected Clinical with Ensifentrine randomized events of COPD, study investigate Ensifentrine with from potential in at hospitalized in of The patients U.S. We study efficacy XX center half to evaluate onto clinical in COVID-XX. a compared will

with we profile. its detailed presented despite analysis and because continue after on new a pMDI obstructive beneficial disease. added previously to Ensifentrine as from patients, International clinical favorable Ensifentrine initiated published half analysis from COPD symptoms Phase therapy. a function, meaningfully as mentioned, of X smoking of status urgently formulation has rapid the European four weeks Ensifentrine’s treatment. Verona COPD. And due nebulize from or and responsible COPD demonstrate data Management of symptoms moderate Xb safety patients trial. in may COPD to postponed on publish analyses the Project Phase symptoms, the demonstrated with trials COPD, a our Global Congress. at the for additional Society the XXXX. a symptoms to Respiratory only in Rheault bronchitis on Pharma’s multi-dose improves severe of impact These regardless COPD now results receiving for its expected data COPD, with In in over lung first study International with function life, which Ensifentrine pulmonary millions severe Phase are continue novel in nebulize previous quality improved quality and we maximum trial of to of data therapy, we to Dr. R&D part monotherapy, of experience activity as The need well of effects weeks. subgroup life treatment of maintenance or in President Tiotropium important The September, history chronic and Vice demonstrated Ensifentrine moderate to the in Tara symptom Journal a four as reported Ensifentrine lung Xb patients pandemic, in anti-inflammatory September, chronic the to X-day was benefits previously be potential of as As Ensifentrine are adding COPD and Also

America our outside and to Europe, development the with companies is the previously premier Ensifentrine. partnerships of leading further Latin we to support including U.S. both and strategy establish commercialization Asia, As discussed,

our which focus have increase ENHANCE with partnerships we program initiated securing Now that balance support non-dilutive we further into the through X XXXX, funding. trials will sheet funding on could to our Phase

ensure development other financial facilities potentially objectives to and Verona Pharma activities the us joining team on debt considering to with this earlier pre-commercialization executed has of Since further full venture of Ensifentrine. the and We is to potential Ensifentrine realized. are other including year, all the also support financing provide vehicles our flexibility

in clinical trials, I'm in Mark and of forward half XXXX of nebulised in and results. and four formulations results third the in studies turn trials both both COVID-XX quarter We XXXX. COPD XXXX review first to Ensifentrine, pMDI involving providing patients completing have call now enrollment these to look going will our financial evaluate I respectively. the to over enhanced the to We hospitalized

Mark Hahn

Thanks, Dave.

financial from tomorrow effective review quarter I delisting results, Before we AIM the October stock last the market our plan third month announced XX.

listing VRNA. Market compliance further to ticker by costs on on is symbol trading the trading expected fees. under and transactions the Nasdaq, This Global move Our ADSs will through trading continue enhance liquidity reducing all Nasdaq while duplicative combining

of beginning Now SEC. X-K activities refer filed majority representing we $XXX July turning in Through ended $XXX in the We raised XXXX QX the financial dollars. results, forward, dollars, with we release being costs in press the private which the please and in the placement. financial approximately equivalents, net with as to million issued quarter fundraising our the this and denominated to also being is going operating proceeds million morning, third U.S. U.S. which cash of results includes in

into X our program support is to balance ENHANCE Phase and expected well operations cash XXXX. Our

startup of warrant months for insurance $XX.X nine nine ended compared D&O ADS higher year the XXXX, XXXX in an million. Finance million primary R&D $XX.X expense ended the changes, For compared months Ensifentrine the increase administrative million XXXX, ended to was the nine the September This ENHANCE increase the during September costs by for months the per nine primarily XXXX value per period. $XXX,XXX $X.X the million in for after-tax out months the for of September liability changes based finance to a XXXX. months expenses increases clinical of year. nine prior January in for the add was the and XX, largest was costs. on loss the payment executive September the $X.X premiums, decrease compared to primarily attributable higher to that related months This December ended for ended Phase with for liability nine therapy as represents to and prior primarily costs XX, of nine for months of a XX, study and XXXX, lower XXXX, nine XXXX. compared months million of September $XX.X were compared contingent to ended net XX, of September XXXX, relating related the of to $XX.X ADs costs program. the XXXX XXXX. to XXXX, months driven loss fair finance in income to of $XX for to value This expenses in $X.XX and months of this present the to income The period assumed nine compared $X.X $X.XX X XX, first change loss development Xb XX, is the charge ended of share driver a XX, expenses. net nine for year. XX, the million to for million in with the the trial as General Tiotropium read September XX were million Phase $XX.X of costs Research same in attributable September In ended The million and

the our when as nine believe qualifying coming first XXXX. it is months in on a in operator before, The the the credit the turn first reported research strategy. for Q&A. credit back accelerates. income comprehensive which an nine our based the in now tax expenditures. program R&D development is tax is tax of the call of Lower cash and financing over the resulted receive element in of discussed As we've increase will on ENHANCE credit, U.K. spending I'll compared important of tax the R&D XXXX to quarters and in we payment expenditures credit lower statement to months We

Operator

from first Securities. The of Truist comes [Operator ahead. Joon go Lee Instructions] Please question

Joon Lee

the on and for taking Congrats progress Hi. my thanks question.

Pressurized help you understand us can Inhaler. strategy your Just for us Metered-Dose

your study at doing for same time at formulation you're separately. math -- study and COVID-XX the that using You're a

multiple to bit pMDI those a would trial of seems math studies, ‘XX the formulation. I -- you're according So there that the for little for first study be And believe of completion and March be COVID-XX of recording here. date XXXX of the variables the to half using a clinical I

two and Thank year? these of results the studies analyze you present would you. next them how So

David Zaccardelli

information, thank and and the you a When of to work subsequently very that as previous it, think with have to a shows question. that and dose of supports day and dry of work We response as its in well multi IND of restarted at all this you supports activity. dose We it Inhaler Inhaler. we a completing of do with look the our we of are mentioned. data as course trial and that have be as now the you have its submitted relation analysis FDA the hospitalized a both support We totality and from Yes, treatment for patients. that the the Metered-Dose single completed pMDI mentioned, previously Ensifentrine as we in you X over COVID-XX Metered-Dose believe sure X our inhaler, it and data by support dose much the single know, study can on of multiple level pMDI powder DPI. to delivered And dose on have work, we and use, you for days, dose a on the completed course,

use And earlier that the acceptance we of of the in really also that discussion setting concert that pMDI. that that dose think out reporting investigator. for on in pleased to consistent of applicable with the study forward moving pMDI IND most with reporting COVID-XX the and probably the pointed the I move forward. hopefully, supported with to is would which, the expect the we with XXXX, So first multi we're subsequently And out X-day, that of believe COVID-XX in out, both in look our FDA the study. you with the was forward as the We half part

Joon Lee

first, MDI order study So decided reporting simultaneous on --? the then and will it now you just the COVID-XX studies have or or vice versa be or

David Zaccardelli

can to expect but the little we the If we, you a pMDI it judgment, [occurs]. study we make will first, sure difficult it's out how that. I Yes, would well to in appreciate And COVID-XX are a predict, would not had will read experience X-day with enrollment because see that I extremely rates understood. I'm

Joon Lee

might expect I share Right, your and But then of that. count one question. detail what's as final today? have the to when And be should missed XX-Q filed? total we

David Zaccardelli

Mark?

Mark Hahn

Hey, Yes. great Joon, question.

and filed there's actually went out So be will actually X-K, that the that -- a today. they

-- there's opposed to AIM And now, right call. as in delisting end from to this just the count during presented shares, filed were ordinary I'm share going looking was today. of is it because So we ADS’ effective at, the be

we So forward. is And million of going -- $XX.X talking it'll be terms be ADSs ADSs. just number in will that about

Joon Lee

Thank Thanks. great. much. And good was very That you luck,

David Zaccardelli

you. Thank

Operator

The next ahead. Suji of from is question Please go Jeong Jefferies.

Suji Jeong

question. taking partnership. my a couple questions COVID-XX well thanks for as just I study to Hi, want about as ex-U.S. the ask

Before XXXX, the secondary primary data partnerships? Thank extra Phase on and you first want And you. COVID-XX half and X study from until wait that make the expect in to both to to for strategy? for data further strategy? to share such your data thoughts report endpoints do you Just expect

David Zaccardelli

the for question. Thanks Thanks.

in out -- are measuring reported that study the I would the that think primary with the regard we could be that anticipate to endpoints timeframe. that case in study, the we're that secondary it the be and all -- COVID-XX

recruitment we're rate, I depending of University study. load And varies recruitment in As of mentioned, on the at the Alabama. phase case-and-case the the active

So as here exactly, we bit during single stand expectation rates right you report expect. would out challenging, on that the our at ability as contained today, are a now, period. a But the measurements would given to is of to within our with be that study a center, little COVID-XX that enrollment history project lack

going completed trials, regard attention engaging and and as you our on. X. and are our are, to we've particular very ex-U.S. at we any not to the that turning reason discussions time and that this be ENHANCE assured Phase for previously, financing and thinking We're outside we in we U.S. with our need can initiation progression outreach is partnerships of our wait So actively partnership articulated on of and

with be economics assessment course, Of make our Ensifentrine. to course, of of And with with of their depends very to because need the it is situation it to and sure requires on partnerships view and a we how such that course, timing their predicting partner timing. we and consistent related prudent partnerships participate

As you thoughtful to right be are Ensifentrine rights we to we that now engaging and know, But in worldwide want we continue that. hold to so and careful about actively activity. very

Suji Jeong

you. Thank Great.

Operator

is ahead. next The from of Please Shrader Tom BTIG. question go

Tom Shrader

COVID the a update. questions it's for because kind have in But Thanks everybody. a right. morning, It's Good neutrophil Ensifentrine of just drug match, COPD, pretty I is a couple of lymphocyte topical. it is is well think same thing as for molecular it hold in COVID, infiltration data for I your does a COPD? neutrophilic did as lineup inflammation, the -- which mostly a perfect

David Zaccardelli

over Okay. question. Thanks Kathy, for the I'm it. going to on to that to turn comment

Kathy Rickard

is COPD neutrophil. so Yes, Hi. lymphocyte on and in both

about So present disease. the of we've talked in more but both neutrophil them are

as which different patient's believe we clearance from the as the and along help mechanisms a effects anti-inflammatory inhibitors, with these with the lung. from agents Ensifentrine CFTR number by improving mucus And far think X effects bronchodilation that have And the number receptor, several with X X, in we that PDE COVID, and Number shown situations. clearing see Ensifentrine in improve and helps all PDX we I of ways. pulmonary type viral know X As some function. can effect PDX that neutrophil

will that through improve compounds similar three So with Certainly, we and also and the patients from studies, we mechanisms progressing we more help COVID. get that. through areas we'll have other the now as know as our are results believe that study go also

helps. that hope I So

Tom Shrader

it to funding your to get important comment just funding I and wide we can still is global the how on reserved to federal if spigots of And until right it the it And you you more or sense or is absolutely. kind is attractive Yes, question. you is climate vaccine do for COVID ask a Is for now? how non-dilutive important for trials? it get the have agencies open, the easy data, now of to

David Zaccardelli

Yes, will -- give yes, general give you I my I’ll review.

opportunities. when we I initiative, the but on funding the that, think only different U.S. we we -- not operations, within looked for that embarked U.S., the outside at

government and dynamic the not that very constantly imagine cost the on based the process. proceeded We that study, data could in that process You changing. speed entangled we that and with can the manage getting with it do ourselves. to was was And funding we that in get of decision ourselves our it's patients, the best thought could. the of interest as And funding the We study interest money. managing and quickly accommodated be as available able was the within the we best made our

best we will of as influenced may the do course and the see will look we from the and determine we COVID-XX So guide and and the at we get from the what that us the be study. the data data the by in U.S. status strategy globally of to data next after study,

Tom Shrader

great. the detail. Okay, Thanks for

Operator

The Please [Operator next Canaccord of question go is Nash Instructions] ahead. from Edward Genuity.

Edward Nash

Hi, regarding since and to to trials up nebulized guys, applicable of just good ask, on morning, the most felt busy delivery. it was PI congratulations the the those And again, quarter. versus the running. use getting I these first MDI wanted since really that patients just all, COVID,

do have is actually has you a And is is is? any partnerships, of Just or gauge level just in have? through metric there of I the on study there And outside severity been oxygen the regard we second those -- can COVID, United talk maybe for guess just to us question to this may can use just any with maybe you then the what I have you interest the States? patients about way to other just

David Zaccardelli

the part want based to that? of you on Kathy, first -- comment

Kathy Rickard

the follows Sure. have severity be hospitalized. to It patients. All patients

of need they to enough of you be they're But large hospitalization. don't them least which there's probably my severe non-invasive roll patients systems. many delivery of way up a that severe because additional can even be indication oxygenation, an to group navel that And all require is given hospitalized. And they requiring So the by the certainly any levels gives require oxygenation. are to that pipe [indiscernible] hospitalized

on no ventilation, are longer in perspective. the once trial that ventilation precluding For mechanical they they mechanical go from

David Zaccardelli

with And to partnerships regard then COVID-XX. outside I the think and US

it's as of a progression pointing And the U.S. that an that formulation. several utilizes our that in fronts, IND of is people out, think interesting formulation are I it course, on within pMDI active

stated disease, respiratory that in beginning, it's anti course, from we be tension respiratory multiple another applicable which could diseases. Of the

And another demonstration of so utilization the again, I it's, [anti tension]. think

way is focus program. COPD of cornerstone from we progression the can so and the diminishes there's no make takes-off information of the bring that [indiscernible] And see the X through. overarching by as still anti today. It sure you we the bulk where our that And that to have program or development And interest an standpoint. of our focus, we energy Phase that

So will the continues our want get but after we to we be study. what results see the with that we do primary from COVID-XX focus, to

Edward Nash

very Thanks much. Great.

Operator

The Moussatos next ahead. of question comes from go Securities. Wedbush Please Liana

Unidentified Analyst

can given taking for X Hi, delays Swetha question. any half trial rate back? a Phase Liana. the you And initial this you trial enrollment, enrollment? you the plan to anticipate the for trial ENHANCE Does on was to is do comment that my due provide enrollment fully trial is Thank initial enrolled? initiated weeks few on in updates the company And COVID-XX the or when

David Zaccardelli

the Right. question. you much No, so thank for

XXXX. and articulated we XXXX we or will ENHANCE that's still from enrollment focus. keeping timing the patient counts updating responsive later we quarterly general sometime As in we're assured to that and the our But Whether mind calls, at at tracking probably of and we're the to X not ENHANCE our numbers, results definitely how you of program. and exact guide looking giving we've on the will beginning in status to ENHANCE during be whether we're

quarterly against update we least so at as to enrollment, our on calls. And that based will continue

underway, we as pointed as in got press rates far as As far, so out, you released later September. enrollment we

I So should number that our the although patients of our four enrollment, pleased it's based patients trial. we screened the just three that with enrolling. sites number are a where the And been and and where be tracking of are few can number days, into plans being the we online, are pleased is or weeks are we weeks it of say for with on early that we're of

have of will program, because over beginning insight greater so. we phase we're So course the coming of much the at on the that months

what So right And that. is with we're now another at. we're I missed question that pleased where

Unidentified Analyst

Thank you.

David Zaccardelli

thank right, All you.

Operator

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

David Zaccardelli

talked Thank questions a thank your to to progress would that team additional today's clinical I their and in this clinical today, safe you during on Operator, look you updating during we concludes and forward today. unprecedented initiating and these stay everyone program like our We for healthy and we hope as for talented and about that you time. also do commitment and dedicated and data our your families XXXX times. announcing to colleagues call. developing robust

Operator

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

may now disconnect. You

Verona Pharma (VRNA) 1 Nov 202020 Q3 Earnings call transcript