VRNA - Earnings call transcript Q1 2020

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David Zaccardelli

Welcome to today’s call. With me today are Mark Hahn, our Chief Financial Officer; and Dr. Kathy Rickard, our Chief Medical Officer.

Before I review our progress during the first quarter, it goes without saying that we are living in unprecedented times as we all grapple with the impact of the COVID-19 global pandemic. We hope those joining us today are keeping safe and healthy.

pleased that I’m well. team Pharma, Verona to the report is At

business restricted. have in regulations since all remotely been were has U.S. and We working U.K. the all and the imposed travel been government

responses to Our initiating company are nebulized the pleased II FDA Phase XXXX forward goals ensifentrine Phase Phase program, and support to the III clinical FDA the advised a our am program of sufficient Phase end will package on II III to Phase trials. from the I than for holding written meeting. include end that has of path clear III regarding submission rather company’s submitted response the U.S. and the for package receiving provide that funding for obtain it securing clarity a the

to We second response this expect the during quarter. receive

design selection feedback clinical design, including obtain dose to program expect exposure nebulized on specifics ensifentrine for III We our COPD and data. in the planned Phase study safety on of

In to CMC preclinical to important including items filing. addition, related to and will be that responses toxicology will we potential a NDA obtain

we Currently, our clinical funding. III later year commencing subject additional securing Phase this to program anticipate

monitor potential to market. planned continue of will and effect its we However, programs and pandemic impact COVID-XX operations, our financial on the clinical the

virus III part this and pre-enrollment are program, Phase COVID-XX we are including process, on investigating we pandemic the potential As our of testing. the potential effect of evaluating mitigations

you update when is will We information available. further

we limited, to who million the be patients data therapeutic maximum new Health in predicted millions current initiating particularly suffering also leading cause to compelling is are Ensifentrine third globally Phase trials, of trials. treatment the despite with well XXX It disease become important Phase are and to III yet continues respiratory World We remain entire affects U.S. III Organization. death program funding more additional alone, served In drug severe the the worldwide COPD an believe million prior potential X.X to anticipate symptomatic population. XXXX from raising people than options for by support has the not to demonstrate patients the according for to that treatment. COPD clinical those over clinical of therapies. more receiving

aware, As from positive many trials of you clinical the reported Phase COPD II first data are during we X in quarter.

the are pleased trial IIb our International reported from as top January Thoracic Society accepted the results were at line dose-ranging We XXXX that Conference. in a late-breaking Phase American abstract

tiotropium, produced study quality you the recall, statistically to known as ensifentrine COPD meaningful in placebo. symptoms on improvements As may significant Spiriva, to life XXX-patient compared and added also function, of clinically and demonstrated nebulized lung

an to compared shown both tolerated Ensifentrine with in we COPD. a adverse all moderate X the formulation doses patients in similar dose-dependent in to with the pMDI Phase severe event March, significant II placebo and and in of tested pMDI function and X arm. to clinically study generally formulation XX Ensifentrine was statistically include at a each FEVX placebo. reported meaningful over improvements dose peak improvements also well to hours. inhaler average with In of single XX be ensifentrine profile FEVX dose lung clinical demonstrated at Highlights

subjects, of this have caregivers but X days. the positive part for medical plan dose daily the the of pMDI quarter the trial second the support pandemic. postponed during multiple will due the concerns start begin regarding in These of the study data of second and staff evaluate twice the initiation part COVID-XX that safety formulation We to study to

study line trial. the in dose starting dose results of for not We part part from about will continue multiple you keep the multiple to of report expect and updated COVID-XX do the time We monitor to XXXX. the the

II Phase via clinical widely With and these previous of COPD inhaled any latest when meaningful has used in in the trials, those demonstrated inhaler dose formulation. pressurized nebulizer, function patients statistically clinically modes: delivered lung significant ensifentrine powder and results inhaler metered X improvements and from dry

to symptom we pulmonologists therapy who magnitude demonstrated of continue leading standard by receive of top ensifentrine feedback impressed positive nebulized lung function patients. improvements are symptomatic uncontrolled the of on from Importantly, treat to has care and COPD

who to will I call first over turn quarter XXXX our the now Hahn, Mark will results. financial review

Mark Hahn

you, Dave. Thank

XX, the XXXX. press Let’s a X-K that this results which SEC. for morning to quarter the with ended XXXX the the of financial turn release Please we also filed review the to issued first of as refer is being March

we financial that in British in our pound are the U.K., are results Given headquartered sterling.

included we based Bank rate translation which U.S. March Reserve GBP on X $X.XXXX. of have to of York New the the For your buying Federal XXXX, to on dollars convenience, XX, a noon is

income Turning for to the the statement quarter of first XXXX.

X to XX, for XX.X quarter million share to diluted loss X.X X.XXX] to or of year period. [$X.XX] loss share after a months The loss the [GBPX.XXX] XX, XXXX. operating March GBP X March quarter $XX a ended Our the ADS the compared first per same represents XXXX, quarter was which for million a million compared GBP diluted first was the XXXX, $XX.XX in tax the GBP the or of This per per prior GBP X.X for million loss ended XX, months ended for for March compares million million XXXX [GBP XXXX. loss for or of X.X of

and R&D down CMC planned Phase along Phase costs preparatory period change. for the by related DPI the III essentially million X were the Phase program $X.X development for in GBP II, CMC first March driven costs program, for XXXX, costs. million expenses XXXX, with GBP primarily ended March In reported months X.X quarter XX, these costs program were X.X XX, or first II the the to XXXX, the IIb same Phase included wind million the for ended In compared for representing costs. the and our costs ongoing related and no Research quarter XXXX,

GBP ended in XXXX. for an March General million, X.X GBP million or and administrative were reported primarily X.X million was to XXX.X% base to million and New increase GBP closure the has a changes of attributable in costs North $X.X of or our U.S. to Carolina. of our XXXX, executive operations The quarter as XX, compared X.X increase relating moved York million office X.X GBP costs increase the to

March net value cash liability million was and the and the $X.X of GBP entries X.X X.X to largely Finance finance the quarter income, Finance short-term XX, are foreign compared driven the warrant differences of investments quarter from for year-to-year. noncash XXXX. expense million ended exchange XX, by income GBP million fair and on XXXX, March in expense for ended changes or

research development credit the The and credit expenditures. year-on-year. research U.K., related is tax expenditures has on tax tax on in income Similar and in credit reported the based in resulted approximately same statement R&D to is development our qualifying the which an

XXXX. or quarter R&D GBP ended million. cash credit effect related the giving XXXX receipt, in and XX.X million $XX.X In received GBP for On investments. be $X.X short-term equivalents with our million or March after million Pharma cash investments to forma million a the cash, basis, Verona first equivalents the cash would in $XX.X XX April, short-term pro we XX tax to and credit tax

XXXX. us fund investments equivalents will We operations requirements short-term enable and expect our our that and to existing end expenditure through capital cash, of the

trial to of fund fully we for Dave mentioned in our need earlier, clinical nebulized capital raise the to additional as program III will COPD. Phase However ensifentrine treatment

I’ll call turn now Dave. to the back

David Zaccardelli

III the Thanks, first well Phase Mark. in expected the substantial nebulized as later the as starting made forward We’ve during to we look progress ensifentrine this for clinical QX and quarter, achievements year. important trials

operator the the to for call question-and-answer I’ll open to turn it the session. back up

Operator

[Operator will come Instructions] Our Lucy question Please Codrington ahead. with first go from Jefferies.

Lucy Codrington

I a for thank there, me. Hi have for my you taking couple just questions.

to the in consider funds would wanted program. just partial a get there’s Or only financing I which ground? Would the you. consider just it on confirm kind alternative related there fundraising the guess Phase terms I get And start all the start study Verona the been III U.S. to you to started? raised in any would if interest? of Or rights to the III. other up Phase are particular to ever actually interesting what could be you required order a forms the Thank off raise might in the then you note, hear of giving just Verona geographies to order So III Phase in of had that consider complete

David Zaccardelli

so the for question. like handle Thanks that? much Mark, to would you

Mark Hahn

happy to. Sure, sure,

we for then So I best later start in before first amount a situation it. where have question, of appropriate we in be to think on. and the stop don’t yes, the everyone’s the raised interest, study part it’s capital start want complete best that to interest we We to of patients’ the

different like that. of in again, a But that fund that piece of is form financing different fundraising or we I equity finance to across will think a are options. study. a different the vehicles. through up plus combination from a avenues traditional suspect financing significant at the of we And middle, variety royalty doing capital equity what straight looking a to will end of that heavily couple I we even the perspective, equity of be of a geared things also towards of we’re do combination looking debt the From

Operator

will with ahead. Tom go question Shrader next Our BTIG. Please come from

Tom Shrader

Good the Congratulations all on progress. morning.

that the of going Presumably, FDA to important. on crucial question expecting. design the the one window you catch going your to Now be is suspect dose. FEV is I want would the measured second trial and plans? Is the be to to pivotal guidance FEV you’re effect

big So that how just is measured? end your is a -- point, for the on thoughts you, deal FEV primary

David Zaccardelli

Yes. end and to think previously we Thanks, looking we primary point Tom, FEVX. as at guided, question. function are lung And related for the do we a

ask important. Kathy that we’re maybe on is measurement FEVX. and thinking And the how measuring clearly, capturing our about I’ll our So expand

Kathy Rickard

Dave. Thanks, Sure.

point is drug, over So end our looks is an drug. and point X at effect for which twice-a-day well the XX XX-hour period with and primary important the FDA this of a end that the is the FEVX hours, particularly to is precedented

primary the that looking So we’re end point is at.

Tom Shrader

then a different question. And you. Thank Okay.

Asian if And you you where do geography? need you COVID is issue, an to COVID could the in how use sites get not thoughts data you With think add Just do on plan started your to Asia? issue? much

David Zaccardelli

Yes, bit a that. COVID-XX the Right. situation course, is Thanks of fluid. for

and evaluating are We it our assessing plans. daily

this the virus later the begin trials have a constantly will trial, well. prior of important, the year, course, Corona trial As prescreening we’ve to testing that that guided, but during possibly believe monitoring clearly of think and as a for to we ensure will to we the basis the we’re elements forward trial be within path be the one we on

that number So come there together. be a needs of to items

in at the later the testing. to year course, will addition in that Of be to the status the important time of virus understand

do to feasibility. continue We world, are site across at looking we sites the and

are sites We well. Asia as assessing in

And I on site want don’t our approach know, have to you for selection? additional comment Kathy,

Kathy Rickard

Sure.

primarily, So Europe and we’re looking Russia. U.S., and potentially Eastern Western at

as We and also Asia in so the sites able be are more determination some we’ll And assessing on about at feasibility, later we look to that year. forth. make the in

Operator

will Our with Wedbush. come next Moussatos from ahead. Please question go Liana

Liana Moussatos

my taking questions. for you Thank

like starting looks the some Could MDI could elective mean dose for start study this it than are later? the b So formulation states you that allow to Part procedures. multiple rather sooner

David Zaccardelli

trials. that it’s portion advancing again Phase look mind complete program not think keep and I and trial. related that study We that clinical to daily start time yes, the into best the to Phase Well, when starting the weekly to should III III that to assess at also MDI that critical the of we in

And so we it to we properly make want sure do carefully.

date look if done there at continue and also work we continuing possibly We to the and that it it need U.K. in moving have to. to

MDI. in more work But it’s us critical is important want III. when situation directing advance our Kathy, I advancement your start the on of as assessment and to MDI, again, U.K. in the a of bit the pMDI. actually, know, in understanding you it add So as current completion is our for if to to we the could Phase don’t not to the more

Kathy Rickard

Sure.

where looking in the as later part year, of done Dave U.K. was we’re part primarily said, the I first the this at think

less possibly adding be not effective may the some countries effect at European Germany that from Western that both looking seem to additional We such as also sites sites COVID-XX. are several in also Europe a in in have Eastern and as

Operator

have Instructions] [indiscernible]. we And from [Operator do question ahead. go Please a

over at and no the lost would seem to now [Mr. phone we further back like I’m sorry, further I’m lines questions I to for showing any the have Hart] remarks. from this time. turn management call to

David Zaccardelli

you, progress your you, operator, for healthy on to We and that ensifentrine. your We safe Great. this development joining continued and everyone, thank hope families us you, Thank and support look appreciate for clinical updating stay our today. and you forward colleagues time. during

speaking with soon. all Look you to forward

Operator

participation. conference this Ladies you call. Thank concludes today’s and for gentlemen, your

day. disconnect, a You wonderful have and may now

Verona Pharma (VRNA) 2 May 202020 Q1 Earnings call transcript