BBI - Earnings call transcript Q1 2018 | Fresh Tracks Therapeutics, Inc.

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Operator

Good day, ladies and gentlemen, and welcome the Vical Incorporated Q1 Financial Results Conference Call. At this time, I would like to inform you that this conference is being recorded, and that all participants are in a listen-only-mode. At the request of the Company, we will open up the conference up for questions and answers from invited participants after the presentation. And now, I'd like to turn the conference over to Mr. Tony Ramos, Vical's Vice President and Chief Financial Officer. sir. ahead, go Please

Tony Ramos

to quarter Welcome conference financial call. our everyone. XXXX first results Hello,

uncertainties the Vical's Vical Development, President, today Chief differ me Senior Clinical call results. to Joining our on Mammen; research Anza from today. I expectations from Exchange projections XX-K Smith; results cause Form first includes forward-looking disclaims Vice news specific forward-looking including noted Form call as Mr. and of Samant; Development, Annual clinical Dr. Larry intent of begin Executive and Vijay will are Hopkins. and Senior of actual Dr. These subject forecasts. Quarterly Vice release The projections risks and statements could Reports Corporate Research, in Director statements Senior well filed Vical's judgments as those statements. and Report expectations these materially President, Securities with Andrew its Officer, the and collaborative a with Company's uncertainties obligation to or the brief on forward-looking This independent on progress programs. development the to the These the any projected, risks in as XX-Q including and that on Commission, in and and notice financial financial and concerning are forth update Company statements, risks set President XXXX quarter represent and

Now and Vijay I'd Executive like introduce Samant. to Vical's President Mr. Chief Officer,

Vijay Samant

our trial on Phase results report proceeding to our Thank endpoint X joining that I'm participants to the June. are for you, from HSV call according to all morning. and remain pleased primary target clinical our We Tony this in report plan. to you thank programs

financially, department in in to make on, and America, XXXX. our will key Europe advancement to North And trial VL-XXXX sites continue X programs report as our are later continue progress the we well of Tony Asia. We Phase positioned for clinical opening

details VL-XXXX hepatitis On the X with X will provide call preclinical We'll Larry on program, virus our on and Andrew Mammen ongoing B call And aspergillosis invasive provide the begin Dr. Phase Hopkins finally, HSV-X discuss the review today, the update antifungal an Dr. Anza will Smith our financial program. Phase more the study. study. results. will of ongoing today Tony?

Tony Ramos

reported begin XXXX, recent Thank first progress our which of this in quarter. Vijay. quarter to The you, ongoing activities. the the cost quarter We from in recognized in development financial first were reflect accrue the the will savings for continued and restructuring results associated our second cost morning with restructuring the

of first As for a revenue under agreement least result development of periods of quarter of we compared related the for these $X.X to million $X.X fund program. XXXX. our and Revenues to at XXXX. vaccine with A believe, investments services million performed our first cash adequate be comprised were through both XXXX were revenues to operations cost the our majority for the ASPXXXX of reductions, therapeutic current the of Astellas quarter development will programs

continue to of quarter for ASPXXXX wind with compared XXXX decline revenue net of to $X.X activities We expect the million to of program. first we first a the program related We loss from the million $X.X the quarter down that as had XXXX.

I and full Our and $XX which year million, ended quarter the million burn between for $XX.X with consistent Mammen. cash We the call ended turn million burn was months now is Anza cash in investments. the $X.X of over for first XXXX million XX, $XX guidance March to will three XXXX. cash our Dr. with

Anza Mammen

by new clinics most recurrence. the last chronic data We vaccine of X on entered of of endpoints as X and measure XXXX end a or clinically study either XX investigator trial completed the We of at this September who infected X:X setting. Microbiology results record hours on diary, enroll time XXXX to was XXXX In we the on the a vaccine their sites lesions Microbe of receive single and four-dose for patients to XX period, VCL-HBXX of the April for to as ignore that is XX-month And of to X/X Society XXXX. that who which and a HSV-X approval not. of clinically over each potential impact lesion of the Valtrex, a both the to biologically. We After and recurrence years meaningful clinical age. subjects Tony. recurrence, free, occurrences in June. information which recruited the disease daily, recurrence placebo have and time total presentation If only subsequent therefore, subjects important the first in series American of or recurrence in July endpoint endpoint following the whether rate event U.S. used the were you, in study treating clinical they to of XXX meeting Phase longer-term with the Thank subjects recurrences. ratio. discussions announce embarked provides the it subjects randomized vaccination in recurrence, number surveillance Phase they subjects therapeutic proportion plan verify HSV-X of of in are both this the vaccination within to and our contrast, our This The advisors in the they FDA, the a our electronic Phase allowed of XX our extensive visited and annualized concluded XX during had the experienced physicians onset rigorous independently

biologically nine of recurrences will on once that in both endpoint and annualized calculated minimum rate clinically confirmed based are subjects completed recurrence months primary have surveillance. all be Our of of

incurable, the million Genital ULXX, in increase number people following is contagious, painful It Asia Furthermore, million rates significant of administration XX% infected. XX vaccine Approximately XX and in XXX million herpes of by chronic approach HSV-X from over devastating HSV-X. with XX herpes. from infection a HSV-X. Furthermore, be HIV study, of Australia U.S. licensed In And days genital XX%. infected immunology full-length potentially risk given partner doses, shift Vaxfectin. in two viral of Vical's responses six caused being vantage by XX a with formulated rather initial infected encodes HSV-X, to XXX the increasing further three prevalence age four, number responses. the infection Phase infected, due transmitting on when infection can age you sub-Saharan one have The disclose U.S. improved Africa. outbreaks is the approximately HSV-X. X estimated the the with three with Our million their it of HSV-X women, can in Based XX increases transmitted that antigens, a people, the represent Phase periodic infected women HSV-X the doses result therapeutic adjuvant to of the Consequently, are deal and XXs are in with immunological alone, trauma prevalence of people, treatment virus. is VCL-HBXX with emotional in could threefold increased to In our the and non-Hispanic design the of you genital in paradigm Americas, infection the administered your with risk black to a proprietary we lesions. XX XX apart therapeutic many your lifetime in of a gD Once to with to sexually acquisition. points. worldwide order years years and vaccine need are of age, X/X encouraging to in the

result, a yet HSV-X a years. of current as approved, been require care. the reminder time, Antivirals remained with in billion. transmitted As over XX antiviral of $X be dosing as we commercial Physicians option serves treating of of daily to frustrated HSV-X therapeutic frequency sexually a may, herpes. for vaccine them, daily patient that drugs compliance at believe No poor eliminate the vaccine the could No more conservatively genital Furthermore, that and do opportunity underutilized. limited therefore, for may reduce approved and antivirals their than lead recurrences are their therapy but has are patients not in only is new represent disease. to standard

follow-up. trial safety I with the as the June will and All execution the Hopkins. of results subject competes last finding. endpoint be of turn pleased months primary the that as as completes year, of this the part of look well forward the other measured in later now will endpoints to annualized to nine final months XX last measured follow-up after Andrew delivering topline of over consist are We rate call subject recurrence will after analysis

Andrew Hopkins

are allogeneic drug immunocompromised with X transplant. to working Thank study selected We that an and in cell XX North you, recipients We've for patients recruiting European those with VL-XXXX to Asian candidate sites centers. major enrolling America actively who Phase antifungal enrollment with leukemia is of acute invasive in regulators Anza. regions. are activate and to the novel aspergillosis take The our adults at authorizations started hematopoietic roughly Cancer in could gain XX necessary estimate patients begin months approximately Transportation and countries or

endpoint study and was single in study evaluate randomized key results from to conducted the VL-XXXX X The study standard in designed study. indicate a all-cause safety, nonclinical mortality of three the voriconazole, in at endpoint designed B. study and is all-cause six I volunteers. one randomized I This of study multiple favorable efficacy and treatments, pharmacokinetics weeks primary a study open-label to randomized The or preceded four safety double-blind weeks. Phase trial placebo-controlled X X supported amphotericin VL-XXXX reminder, work, we of at with phase healthy a with a liposomal X to this patients. As as tolerability to pharmacokinetic profile Phase advancement volunteers. for by the that X receive is isavuconazole doses approximately non-inferiority ascending to a XXX Phase mortality or namely intravenous XX healthy was Participants this along phase secondary The a

Act support for contingent is the determination limited X FDA's aspergillosis analysis protocol trial available. and advice. single is The the drug plan Phase VL-XXXX with serious They designed use infections The final successful carried like Phase by of data, treatment a for of being The provision application. of not standards limited will Population outcome upon and FDA for X indication if review disclosed, life-threatening consistent is statistical a are approval aspergillosis. century to intended indication use by the in of enacted or met invasive with whom streamline drug therapies Congress after The approvable like patients treat alternative in whether invasive approval limited new accordance programs Pathway for could all relevant the drugs previously Limited we've are As development for under are XXst all be XXXX. Cures out indication for established a use antimicrobial Pathway the VL-XXXX. eligibility is to trial in a the made the

X in For trial required Phase would broader aspergillosis VL-XXXX, be patients. a for support approval to a

drug-drug We we are invasive a for aspergillosis. will to now turn We Phase rapid progress and with VL-XXXX alternative fungicidal potential low excited patients and action, the attractive to are making benefit Smith. potential With patients make for invasive of the believe an with mechanism call that therapeutic by Larry the for I interactions with novel aspergillosis. Dr. activity the VL-XXXX X, that,

Larry Smith

Andrew. you, Thank

hepatitis viral deaths is affects our earnings infection. representing we've world's Mostly chronic closed chronic designed call, preclinical Preclinical announced new the is inactivate with According which for a introduced program hepatocellular candidate due to potential our infection. circular virus health development reservoir, million infection in the million to cirrhosis treatment last B people, carcinoma. a nearly As to X.X% DNA yearly. the XXX covalently B or a organization, X source over world hepatitis ccc virus persistent during of BRCHBO of one or population in pipeline,

and infectious create inactivate in biology formulation candidate science specifically to the expertise our a viral product have to be leveraging are parasites that We molecular can delivered molecularly to cccDNA. diseases,

turn plan We We later a in an you and back of screen select this molecular vivo the year the attend embark candidates performing proof-of-concept the with plasma call in both design our of parallel apprised challenge candidate, to the several optimizing, HBV the progress. formulation model to optimal we now and will With Vijay. upon study the product are candidate. and will to that, to in keep lead I

Vijay Samant

our Phase time you, plan announce, the line for of Thank exciting to include genital the in an at is In top Vical. annualized primary summary, from study endpoint Larry. recurrence will which June, rate. We results this X herpes,

is In of addition, started a VL-XXXX treatment antifungal indication successful, recently of the this eligible Phase our for aspergillosis. limited study invasive treatment for for the invasive we If approval have a use trial VL-XXXX aspergillosis. be could novel II of potentially

Finally, program. made our B recently with on we're hepatitis the initiated being pleased progress research

This remains manages so And our team invited will pipeline. We Operator, way cash doing questions allow focused us as participants. programs a promising our prepared the to our to our we're call Our in now million cash. believe concludes to $XX ready are position on today. of continue we advancing our committed for my planned. strong comments to to for open that efficiently advance

Operator

Thank you. go we'll Selvaraju H.C. Ram [Operator Instructions] at to And first Wainwright.

Ram Selvaraju

the Hi, thanks program. response? ones ways are for quick response immune is sufficient continued susceptibility Could vaccine shedding enumerate for clear an those Two in clearly us signals boost understanding and maybe the which, a stop of the endogenous Because taking infection is obviously, of times, the the to others. vaccine some my that not immune is significant much actually the likely very but my HSV-X questions. virus the you infect HSV-X to and to on potential lot to there

So new from if strategic facilitate continued you. some one slower June have a any likely in what program. you are invasive granularity had clinical next question development? Was with hoping regarding on enumerate to And faster would or more us results Thank is to projected than study? could you thoughts what could question either projected then, the drive than provide please. on the that If enrollment the upcoming just strategic aspergillosis perhaps step positive, And the in standpoint. is the on you be second

Vijay Samant

So you've questions. given three good

mainly will Let start Larry with was HSV-X Smith first immunology Larry? on and the question. one, – me on that Dr. which answer

Larry Smith

It’s the Sure. Thanks for question. question. an excellent

Vigantol pre-existing to new may also So They It to home those from recirculating, they and tissue. into are tissue. express we're T-cells. into ability naive vaccinating boost stimulate home allow the it's designed to have certain intramusculary cells and T-cells. the And T-cells

will So HSV reactivating. be T-cells is site specific generate we the actually that think the is to virus the critical where part at

And And so more right vaccination, in they that then potentially there we home increase That's prevent thinking by the from reactivation now. site. a our the viral really that resulting frequency lesion. of is them there to can of

Vijay Samant

Ram? question, your answer it Did

Ram Selvaraju

Yes, exactly.

also, be think vaccine they continued to a the Do you would the is just to virus, So this vaccine means with Or clarify, the prevent effectively it reemerging idea that in the this the at the reliance same going is that rate it to from not would. antiviral that of reservoirs effectively setting, real-world would while as otherwise would incipient eradicate paired on have administration? reduce antivirals? existing those

Andrew Hopkins

a as think – or a give some it a those you with entity. alone we I periodically, series. really but would vaccination maybe T-cells don't But could up. used then, it give we at combined to and it be being year you booster point, a And no, keep standalone so, is antiviral, an believe envision

Vijay Samant

it it's hides, and to okay, – is, do the the that's really and the But issue. have – because nasty what issues the system the Completely going eradicate the disease. who been way going it's is to one where reactivations, that's going to big prevent this really vaccine those for into patients never HSV-X goal, Ram, that's of really it

looking about who half your there are along, player what a to would question, we United with interested is results have us such positive this and our that outside both the we study use And be resources in Going This are in program. where HSV-X lot partnering be have to for a United particularly, second study, we partner all will the the the was, are said will of that conduct plans as dozen a on with reasonably also expertise. conducted a to a States which the don't the It commercial be be study. to clinical large study going study. States

including data. nine-month had the waiting data have and this this discussions We know so also look with you follow-up going is both everybody like is XX-month partners, what data

big in to that not had of pass what a U.S. been repeat can of of with the up really Well, slowdown terms look the then, to question, And certainly if our Korea, and on been I'll I'll recruitment? not Or these third at historical invasive done but go recruitment? it give was Andrew. you Singapore, first countries. has alone center, Israel's, countries some the So the a what the could then, partner. you studies France, plans it are all, – Belgium, your in big recruiting European VL-XXXX aspergillosis, have The a South speed such go question as to okay? including are Germany, shot

their at published the they're ranked, from terms recent the big of the in linage are find how they and study, countries. you there are look – these all Astellas authors out the If you'll of and authors

get speed slow up study? we'll those don't those up the those in can rapid down. countries. approval countries, regulatory what speed If So approval we then from rapid the we European recruitment in authorities could get If it countries, in then

the though, has with been have the a group, which recruiter, we side, been On to what in could historical but is we working be other Group sites have, site, selecting MSG which careful recruiting in more the recruitment very upside have U.S. is Mycoses upside. productive the slow assume have that's an We going picked the patients. don't U.S. aspergillosis really know experience that Study invasive impact

balancing So Andrew, anything? those are facts. add you want the to two

Andrew Hopkins

Yes, Vijay. Thanks,

and a regions looked the study hit a the lot especially, we've and identify carefully lot opinion go we're how think and of to think points Vijay to time about education give understand couple where into, which that, have trial leaders, and And So the which that also start working to as combination key there with sites. trial, I spent to top enrolling mentioned, – prior sites Pfizer been the the the the help is examples, performed excitement enrollment. countries of to we've others at European MSG. trials, trials. This We've a Astellas and two groups. will of Vijay you enroll generate identifying that through We're patients. we selecting mentioned provide in multiple also investigate

we spend of a the So time we get And there out as education is certainly and investigators think in the leaders a strategies a the well. will going. recruitment the that think help the to to three design and We of opinion help will trials. lot field also that some ready lot working there that the those key with we there lot think

Vijay Samant

that Ram, own U.S. Belgium, thing, site ethics One if all it's committee you go sites with get go and you trial sites, can nuances. to you have you're hand-to-hand you negotiating to in you begin five as authority Belgium, Belgium, have on in the through start site know, in has needs site. be negotiate when individually their on. you In to to the their them. heartbeat, you agreeing commented five the Every agreeing complement get every if with Whereas okay, combat recruiting your sites approvals, the those you day, next both once the contracts the trial the when because

you the a meeting site-by-site, long much are through the getting to out go all process. it's competent faster board, sites really are once you done, are directly site-by-site drawn it's ethics the the committee U.S. So steps. and and authority in on approach whereas But a EC,

the differences, are those So okay?

Ram Selvaraju

Okay.

to an invasive Thank the you potential us patient clarify, curious, provide permission pick us might updates going of do which the also, outside ahead? to you. can countries a be to setting trial I with enumerate up where think basis, go as And just infection? have on for So given an hospital aspergillosis to able just for was ongoing to you're

Vijay Samant

Andrew?

Andrew Hopkins

Right.

of all, you of be terms do on a regulatory approvals. in we'll in Yes, the progress first periodic position that, yes. to So giving

have the have so of authorities to given on the approval the And kind date, Canadian U.S. we front also and updates, do given… the health

Vijay Samant

diligently. and German other with authorities and very are we And working Belgium the

the… terms of In

Andrew Hopkins

Right.

terms risk So acquiring of in invasive aspergillosis. of

all it Aspergillosis is us. is ubiquitous, is a that fungus around

So immune it really status. on your hinges

transplant, are aspergillosis who primarily So immune at these or system risk is had that's acquiring whose patients have route. compromised her when of through who they leukemia just have acute pulmonary

not kind it's quite… So location specific any really of of risk

Vijay Samant

and you and the sinus if you patient, hospital. elderly But acquire are own can and in have it, COPD immune you a can COPD home your acquire you can be to a patient, moved an

It's you now. in right right aspergillosis you as sit your that So know, everywhere ductwork, invasive is everywhere.

You City, invasive York big of is City, there all New are and there. in lot aspergillosis in New York a those in out buildings

your are as in immune long great okay. strength, As is system you

Ram Selvaraju

thank Okay, Very helpful. very you much.

Operator

And David next IFS go to Bouchey we’ll Securities. at

David Bouchey

enrollment. I some about Vijay, great you made guys. points think European Hi,

Or the you quick follow-up Let order centers a go EMEA? having question. the to Europe have – me can start permission in Do you country-by-country ask in trial? enroll to get centralized go you you to in through do

Vijay Samant

You go country-by-country.

So board, ethics sites go authority. to get of those all competent matter those getting all a said sites you approval go sites I on you a the once U.S. and if come both country-by-country whereas very of But you rapidly, will you get country couple before, on example, country, as will the site-by-site. committee the weeks, So come individual those four sites their okay? approval, and have is four just so approvals, if in

David Bouchey

regulatory still each country's Yes. apply to But to you authority? have individual

Vijay Samant

wanted make to do Correct. We – just that apply Correct. sure. sequentially. We don't

David Bouchey

rock road can't roll and to a whirlwind, trip You them make hit all.

Vijay Samant

them get from questions same coming time. the you all Yes, at

their scrawling you're So clarifications. questions answer and to

it's a last busy for Anza schedule the Andrew and work So been weeks. in pretty of couple

David Bouchey

that are and hasn't enrolling open to clinicaltrials.gov, since trial, sites XXXX All still updated two XX. there in March right, that are according been

Vijay Samant

the soon, we come hopper. of a complete, they of as initiated, Right, as are have are There hopper initiation on site the they'll whole visits board. whole the are bunch bunch

David Bouchey

one of program? last expecting And any Tony. collaboration the you. question more Tony, right, habitat you is AnGes from series revenue for licensing B the are All great. Thank for

Tony Ramos

material hepatitis From a B the amount. not program,

David Bouchey

Okay.

to the going will say so zero to cetera, you question. for expect would you et – my quarter, would is And next what go to happen that revenues, is what when contract

Tony Ramos

program the assuming. a in we're be the to third leak quarter it second the may ASPXXXX zero revenues we is We'll the here to going in hopefully on little wrap in from on go but out what quarter, small program. third that bit up probably it's will It very

David Bouchey

All right, much. have. Thank you That’s I very great. all

Tony Ramos

Thank you.

Vijay Samant

programs our you you upcoming for to Thank our forward Thank continued We of and in with look again. conferences. meeting all progress some at participating. you developing

Operator

once Ladies again, joining conclude does that everyone gentlemen, to for and today. I'd and And conference, today's like again, us thank

You may now disconnect.

Fresh Tracks Therapeutics (FRTX) 3 May 182018 Q1 Earnings call transcript