CDTX - Earnings call transcript Q3 2017 | Cidara Therapeutics, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to Cidara Therapeutic Third Quarter 2017 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] As a reminder, today's conference may be recorded. I would now like to turn the call over to Mr. Watts. Laurence begin. may you Sir,

Laurence Watts

you, Operator. conference discuss welcome Cidara's everyone, quarter Good to provide afternoon, call and financial and a XXXX to results. Thank company third update

the Matt Onaitis, Financial Stein, on Joining are Chief from Executive and Chief Officer. Jeff me Officer; President call and Cidara

by of Act. broadcast, to forward-looking Before I materially Harbor call forward-looking report Form like is today including XX-Q circumstances to on over live XXXX. this Reform Jeff, those management also statements information Cidara's date will of no during Securities its that filed the Annual point turn covered would the in only will Safe Actual that over call uncertainties this of Report of the Jeff out I that, business. XX-K in I update be note making Cidara. now accurate reflect after contains the the statements statements. of the as this filings, on risks events this I that to time-sensitive SEC entirety statements to X, President to date obligation Litigation call of was undertakes call the revise like or results associated Cidara the content to November turn CEO forward-looking on caution and Form any earlier or of cautionary all or the conference the Stein, provisions could afternoon. conference quarterly is and by statements this Private forward-looking that differ the the Company's qualified to These listeners from contained would I information implied with and discussed stated are due under call, their call.

Jeff Stein

will on CDXXX for company Good and XXXX. discuss I Cloudbreak third the third afternoon, IV have On made programs, on of after progress our XXXX updates financial important teleconference will for discuss our which this and quarter financial call, performance provide the our substantial first an we Matt results. everyone, quarter joining to update you thank and our

take We to available will then questions. be your

that WHO Turning IV name the as first to has as USAN. we both of CDXXX been the well acetate rezafungin by CDXXX program, granted our note

will unique generic name As we moving a use forward. result, CDXXX this for

have and for enrollment the invasive diligently working We been of in treatment Phase to candidemia ongoing STRIVE for complete candidiasis. X the rezafungin trial

rezafungin caspofungin. powered drug, we numbers, Because select statistics, with these STRIVE of to As is to Intent the enroll one patients least the its phase in for in Treat a comparator plan the the at three. XX XX objective trail, in STRIVE regimens receiving mITT XX rezafungin or not to and small arms population two patients main of dosing and for is inferential of two patients reminder, each Microbiological

in trial, we data XX population. additional today, to of an target line XXXX. first expect top we As the have mITT in total status, on achieve the we trial have patients patients quarter eight estimate need from to the and of that we'll enrolled patients readout in enrollment enroll the XX this Based the to of

the expectations unchanged. of STRIVE in importantly, our More success trial remain

trial phase FDA trial, of also of registration with provide and XX%, European prophylaxis results patient a current III confirmed regulators, as in data be the patients to approximately from invasive from the are candidiasis the and results randomized conduct phase FDA population of final pivotal single rezafungin global received non-inferiority target programs. of single a treatment We feedback Pending the population this will trial. supportive margin or by Phase positive we the to trial, of patients. of candidemia in with we in double-blind trial treatment from assuming options, rezafungin that feedback our Phase X for We to the plan with have along feedback STRIVE received recent relating encouraged for patient the recently the regulatory the treatment XXX that STRIVE limited target a pivotal results X STRIVE no subject will The III trial results. and the same

and cost We expect line phase from phase to in begin typically that program total with patients. patients to treatment be database this required this mid-XXXX. With expect to XXX in approximately so patient safety treatment trial in the will data the size number and of top this the less duration program This we dose of III we feedback, estimate half patients, the target the estimated of savings. resofungin in combined prior we of FDA mid-XXXX, represents the approximately result recent trial the to expected number selected material XXX time of exposed III than

This we as trial. of will which this one regime. the we after momentum trial, enrolling each STRIVE two a comparison in continuation selected part STRIVE STRIVE until such site to the trial The continue caspofungin randomization phase III is trial continue in For STRIVE B, intend at in reason, of patients to part ready the STRIVE well site the in regimens maintain dosing lock. will to will phase the trial sites begin enrollment two-to-one the from trial, B III as trial of before start enrollment use call database to

medical infections patients undergoing program, prophylaxis unmet with of a fungal marrow transplants, hematologic patients in significant resofungin we of or safe agent chemotherapy. the prevention solid the with spectrum in those believe undergoing These malignancies to resofungin patients. there for a need well-tolerated bone is organ a include now vulnerable Turning or and

plan demonstrating studies Based allogenic that patients Based we preclinical pharmacokinetic to could to prophylaxis MHRA, treatment planned approval for invasive could phase trial with conjunction marrow believe for safety, prophylaxis, in resources, and line in for regimen animals. the FDA believe subject invasive undergoing fungal the III single studies, top have regulatory invasive results fungal interactions conduct of and resofungin MHRA be to these data mid-XXXX. conducted FDA candidiasis, start with feedback the from clinical our trial agent a a and aspergillus, expect received, randomized both neutropenic Subject produce we III III prophylactic bone candidemia we recently an trial XX-day in phase trial could infections. prophylaxis treatment infections we patients. once-weekly have phase tolerability, well-tolerated on and on in the in planned regulatory candida, Based that clinical and infections feedback and global resofungin of suffice supported mid-XXXX of this that and effective at-risk the both we and and discussions, preventing on and pneumocystis in in in data, transplant. financial our in resofungin by resofungin efficacy clinical of and of We further of further double-blind

bacterial Turning of to program, for gram-negative multi-drug we resistant bispecific immunotherapy our have antimicrobial our novel, the quickly continued treatment Cloudbreak studies preclinical of infections. CDXXX,

we of a and of As in in that models a we animal promising we in candidates. and are year, conjugates The announced spectrum backup CARB-X candidates safety this vitro backup drug grant earlier PK antibody conjugates advance testing antibody vivo The to in and of preliminary drug infections. the studies. include up various show potency, in for development bacterial received from $X.X CDXXX to million

call and of Matt by I month. the will the a results to the With financial the the end evaluating our program review determine studies that, to the of third are of turn now over future of results these of quarter next We for for expect direction XXXX.

Matt Onaitis

with of XXXX private million million Jeff, completed compared XXXX financing XXXX. of totaled of as These October investments and include good afternoon, $XX.X net equivalents, XX, Cash, as the September we placement December approximately cash in Thanks, of as numbers everyone. $XX $XXX.X XXXX. not XX, from the million June do XX, and short-term million proceeds $XX and

of have and base. planned to release STRIVE We our to the believe to for are XX address XXXX. beyond in that investor to financial our at of we our investor in done, that first pleased that also resources quarter demand we financing months sheet the top sufficient broaden strengthen least business balance data With have opportunity operate line transaction our

the $X.X $X.X million and net the ended quarter months the $X.X and million were million and to financial million periods ended the million was and of for $XX.X primarily administrative $XX.X compared were clinical escalation million attributable September increases million were the and to XXXX. to ended General months XX, in three same results, same $X.X expenses a the September expenses to for for $XX.X now three our and the for development of third $X.X nine nine XXXX. for million Turning compared XXXX. months The rezafungin. and XX, compared research respectively of loss three to loss for XX, and development Net $XX.X million for million XXXX activities XXXX periods in XXXX $X.X September

net nine loss and For months and million September XXXX ended was million our $XX.X $XX.X the XX, XXXX, respectively.

Jeff. had and private warrants. that, of the common in financing. shares fully diluted stock to RSUs, million of October we options, shares, these our and As call outstanding includes shares placement are X.XX XXXX, we issued million October turn numbers XX.X of I Both back outstanding XX.X XX, the inclusive our which XXXX million will With now

Jeff Stein

trial you, X completion. Phase our nearing ongoing, rezafungin Matt. STRIVE patient summarize, of enrollment To is Thank with

to line announce top expect trial STRIVE first the XXXX. We of the in for quarter data

Phase and toward we believe regulatory to a treatment clarity programs the with on that each one have path received trial X program. in rezafungin We approval feedback prophylaxis favorable and is provides

preclinical to We evaluate turn can perform drug backup that, molecules, operator and our over and and like proceed. the I questions. conjugate how so on Operator? With we'll would the to call that your data back to we continue studies the address to CDXXX antibody determine

Operator

Instructions]. [Operator

Canter. of Our line first Louise the comes from from Chen question

You may begin.

Louise Chen

I here. few had questions a

had would On ‘XX, second So the you was have balance, what's this including hear with then out And just runway, that this pipe who cash than the and on cash what your the and quarter for financing? the lower enough opportunity and did why thing you that, rezafungin, runway here, until data Thanks. was and I moved the you curious date? of first second then would you opportunity space? prophylaxis enrollment how that's correctly regarding your one cash for anticipated, CDXXX, in compete characterize you the you

Jeff Stein

of Remind me first the question?

Louise Chen

than On was and slower had… it enrollment the you STRIVE, for

Jeff Stein

in a July sites. at is European on basis. overall per-site August slower-than-anticipated particular fairly sites our had in study a slowdown in and summer, patient enrollment per-month we close So, This

consequently, data QX and moved So, of of of QX the from we XXXX. line of the top end XXXX into estimate

Matt Onaitis

million. at our date quarter the On on we $XX.X said XXXX. yes, least announce we a the that STRIVE the third cash net runway, have have as proceeds of the pipe of II phase the in end we pro months quarter first to include our at forma we XX And so that that the would cash of time basis is

Jeff Stein

question, third the Louise? was What

Louise Chen

you compares It if on and to then prophylaxis products in space. you might other with the the the was how prophylaxis who opportunity, it characterize could in compete and that, market

Jeff Stein

there's unmet are azols Bactrim, now, infections This aspergillus, or prevent prophylaxis is very area other drug Basically pneumocystis. that for options can need there where for and a an good. Right not by PCP, preventatives. are substantial candida, and or the

those deleterious especially of drug-drug have population. patient interactions or other this effects, All substantial given vulnerable

echinocandin exceeding ideal So, infusions, of three but for not to one-hour once-daily, or would the for patients prophylaxis for be and even are up accordingly, suitable this, the clearly echinocandins months. available

trial and is a study. treatment of we clinical globally So, once-weekly accordingly, that by this to are eager have start number appealing, very resofungin identified sites

that be and we enhanced two that opportunity with path will prophylaxis now resofungin studies. so, have in for we think a both approval that And given treatment the perspective, substantially, clear separate especially commercial to for

Operator

question James. Chico next Raymond from the from Laura of our comes And line

You may begin.

Laura Chico

you clarification could part the little have STRIVE one wondering further elaborate on if B study, I there. Jeff, a just

the You into accrual, mentioned to this should until will guess, of coming the what subjects they expectations of out I terms for enroll this efficacy solely or safety data additional study? be III in switch phase studies. continue is the data-based

Jeff Stein

data safety It randomization can The primary be caspofungin. our is a to are two-to-one data. bolster to used is that which schedule so contribute and STRIVE in database, B double-blind registration can going part study objective is to conducting a of the be against we the why

bit maintain is to in reason a These momentum. your quite in studies time types enroll, reach invasive of it candidiasis are enrollment Another challenging to candidemia enrollment momentum. of order to and and takes

we that. to momentum that we're now, So want level and don't of lose at

finally, maintain consequently, So, could just felt III we auris reason them momentum, potentially is active, capture phase sites then, by flip our some patients And then and we candida in opportunity to into these the third keeping study. program. the the

that and two fungal you spread aware, As West global East causing Coast months. is may has year, It's severe in has from candidemia just outbreak to the pathogen a auris Coast the a last reached the the be invasive last candida severe candidiasis. infection, U.S.

over this as able to into STRIVE is and there B, hope III patients candida we going with increasing auris infections then pathogen, capture So be alarm to deadly and program. our continue phase some part we

Laura Chico

then that's Okay, helpful. up follow quick back I'll very queue. I halt and in guess the one

previously TX just that would sorry mentioned the Biosystems. trends, maintaining clarify, be of the on are to missed with have enrollment were going by if enrollment I talking going a Could you implementing year-end? momentum. as also what as perhaps And also You completing you TX to ahead, result I'm And forward, partnership about that. impact looking you placements? expect you

Jeff Stein

of Thus few far, before our the Yes, sites the our end and Biosystems complete are machine. will of study, the that. be using study STRIVE we Sure. we to relatively announcing in TX fully year, do enrollment expect

do We enrollers. the greater that it challenging get these antifungal enrolling are specific limitation amongst Because result. best of hours a to have however, the noted, XX does those challenge our and to it's studies, employ of culture-positive alleviate device prior therapy, than in that as

a get within system can can that four negative three TX or So to help enormously. culture-positive so hours, device the or

in expect assist phase enrollment. in our the of We to machines as the III, placement that greatly as sites, part study with Biosystems B TX well STRIVE

Laura Chico

Thanks very much, guys.

Jeff Stein

Sure.

Operator

And next question line from Tim the from BTIG. our comes Chiang

You may begin.

Tim Chiang

thanks. Hi,

consider trials for opportunity year. want a pick that of dose, shows you you on the STRIVE studies you and the partnership number for results Assuming one the next provided you some Would pivotal indications of obviously targets a resofungin? the

Jeff Stein

have of CDXXX, do deals. global we Thanks to for we resofungin, or the opportunity question. intellectual rights Obviously do the the property so have territorial to

we to types that conversations. hope forward. that's those as initiated data plans of we but indications, facilitate play certainly At separate those have top-line no we have the consider going positive out. can time, something And this those will discussions We discussions,

Tim Chiang

time Is the And may Cloudbreak timing update any immunotherapy some be just still are there year? an or next what the candidate? file your Jeff. for Is one you'll follow-up that IND expectations

Jeff Stein

is a we our that and in are if we earlier were drug filed issue to the IND year develop the unlikely, for where would this antibody Yes, in next cell to to of have conjugates development particularly be it's one manufacturing antibody component. which lines switch the --

switch [EDC] to not program. in XXXX, likely be will should that So we the

Operator

of comes And our next Carr Alan question from line the from Needham.

begin You may

Alan Carr

with better with in of trying an of there to of build XXX sense -- patient design? a might Phase of back design And patient -- Phase more here. looks around talk about come can is you a rule less of Are than to trial tell bit X sort infections the I particularly serious the I'm from and can you're be needed it expectation the going for patients get some of particularly two-to-one the able the like design trial? X, one-to-one also was minimum wondering if -- be FDA a number to about you you a I'm us to NDA. not here a this this trial. XXX certain a or this in type a database why

Jeff Stein

As you the programs be in population as may safety infectious used this such X,XXX minimum recall, patients. disease to

passage FDA. status and of the has products that with with the been reduced has GAIN that status, With rezafungin Act, QIDP for the

eligible in performance in is XXX on end get total the That X. X typical to on the Phase be a should So, the the we products. safety based number day said, population, Phase of patient at be which consequently, and rezafungin will approved QIDP safety of based of

comes we an expect issue. would echinocandin, be population. an tolerability and could review based always to approved comes will it there safety as smaller If be out, get a of out safety on So, opportunity the a somewhat safety

don't know we yet. that However,

STRIVE So on Hence, be the achieving Part study we're XXX. planning goal. will that that we in very B helpful think

Alan Carr

are two-to-one, you The Phase XXX going or that X with what trial randomization, be or one-to-one a is patients, thinking there? to

Jeff Stein

a be a are two-to-one in two XXX X. regimens or milligrams the we that week, followed dosing are And it testing milligrams one regimens of those by once milligrams week in Yes, of will once XXX of part XXX now dosing randomization one to III, be the to identical and a get in population STRIVE B we're currently phase your in will the weeks. just the part week patient examining population And study. subsequent in to question, earlier patient your Phase

infection. We candidemia have these so a certain minimum thresholds severity, patients of severity candidiasis are of with of invasive and threshold

pretty mortality are a patients have rate. these So high that do

that question in are of need as CDXXX. no effective there's So drugs they such

Alan Carr

wrapping treatment trial? be maybe same or time. some And with scale for these it, of the the you exposures the you time sort that NDA around imagine to of going you'll an patient both I thinking then for what up could submitting the get that's too, if there, same prophylaxis are at you're trial, considering submit as

Jeff Stein

Ideally, expect be we both since time we at would for studies completed a quarter. submit NDAs within the that both should same

We have that margin. assumptions of trial size, estimates on non-inferiority the based some of

that However, with need to the regulatory authorities. finalize we

Alan Carr

those completed with around discussions Your the aren't FDA prophylaxis, yet?

Jeff Stein

That's right.

will those feedback of the receive so margins, more STRIVE discussions. finally, And we're finalized study. this to some We on the need noninferiority the we none will results be continuing until of get

Operator

the from An from Robert question Securities. of our next line comes Wedbush Driscoll

begin. may You

Robert Driscoll

could Just Sorry the driven smaller auris about the support resofungin the vivo? whether that review preclinical the data, mention that first of blinded activity it the wondered bit strains? Thanks. STRIVE talk of little high Or for level candida FDA in by you if half a your study. drove you and of in was XX-Q against

Jeff Stein

to in we the study expect the and these A it dosing safety safety know, from want no B, to select would efficacy get not than to in Obviously, other current analyses efficacy there's case of But, encouraged difficult not high-level selecting one endpoints. the select blinded what And can been to And by in from no that we overall pleased of compare high-level ensure the on results, stage two with for when there the are suggest These a perspective, and that the with high-level manner. the reported of our blinded, we again some there's cause to part types of At one studies results, insight especially blinded the report track time, common or big same studies of of so one that, two the And if regimens. consistent, part have to the past you dosing there. that on regimens. safety is are at similar at STRIVE of two studies a the fact results our dosing conduct better, is perspective, been study are has echinocandins caveat As a results study, the that, issues very blinded issues this overall, we in a forth. tolerability us we're prior expectations. regimens. results that

Robert Driscoll

much. Great. Thanks very

Jeff Stein

Sure.

Operator

from question our H.C. line Wainwright. Thank Ed you. And next comes of from the Arce

You may begin.

Unidentified Analyst

is this question a Arce. about. brief Matt Hi, have for I Ed

briefly on derive to could how the inferential you statistics? first, STRIVE conduct power you So with explain will analysis

Jeff Stein

question. great a that's Yeah,

the to of is STRIVE two objective regimens So of phase to dosing III. select one into take the

study. expectations will the that be to in the STRIVE approximately our equivalent regimens are So caspofungin dosing two

expectations. So that is our baseline

that see no And be to so believe not we will case. far reason the that

high-level for safety, and is statistics, it overall just efficacy, is be with but arms based the in selecting study, small it the dosing XX So we'll inferential tolerability. the on each not, dose three too of patients of

Unidentified Analyst

said technology. affect Because after that it. that the will access only TX main have it of the this, insight experiment? they you this and the last what's Bio to And question you objective have is collaboration, Got the regarding

Jeff Stein

clinical an machines as We for many that, sites. those possible as with in our STRIVE their arrangement can part the B in programs. of III we This our trial tests is TX, and be exclusive that collaboration Cidara phase only machines and place so hope used can

because of note to tend XX versus they are culture-positive STRIVE result in being So or enrollers, to that sites, our we hours. get we hours machines that small a the more based four our handful on in to three a used best be can currently

be placed should the can that our trial be should helpful, clinical be obviously and we So think the more it machines at for better that sites, enrollment.

Unidentified Analyst

Got my Thank taking you questions. for it.

Jeff Stein

Sure

Operator

from Leerink. Paul the of next Our comes from Matteis line question

may You begin.

Paul Matteis

don't ask Great. blinded thanks a couple if mind. the And on all wanted so more this progress. I to Jeff, much. interim about questions congrats analysis, you

And just not on might one could to what So if the wanted that you the other that basis be any explaining seeing the variables just could population you're be recruited relative as blinded a patient first study to patient was prior in if know in I studies. population drug-dependent. exogenous that there's describe caspofungin

Jeff Stein

Thanks past patients Yeah, that equipped It's the Paul. than contemporary question. the fact studies, for to now during compare are the historical one. to an with just conduct given studies were difficult That's important of studies. especially treat they very physicians better

should So studies. it's studies because mortality. to we can at that on that, assumptions make like difficult types it's very comparisons said, look, have That past trends and blinded of looking overall, based historical with those efficacy, and of how of things the especially these at again, look some

So be But in consistent historical of results could perspective. breaking study, that it of seems overall an that and there a we're arms studies, so to is any that the -- out is that fact than be overall bit past not studies. an the the better that's opportunity with possibility encouraged

Paul Matteis

more and disclose but why, have public decided unique this impetus line it And analyses I understand taking look now are and it? making a by time. then for like pretty you this this to I performed the now wondering what guess I at communicating this it Jeff, it's was disclosed companies, XX-Q. these right to in routinely was

Jeff Stein

B. Part on we making on mentioned, As specifically planning analysis this decisions for STRIVE were doing

and using examine case. appears opportunity disclosed largely also from our it broadly. wanted things see but the perspective, we disclose this overall a be CDA, under more track. investors And to pipe was to if are to This efficacy And on we with to it so so tolerability that's safety were and

Paul Matteis

from studies? learned it fungal what study enrolling help could subsequent in do trial you serious to have what the you On enroll this quickly? And infection a more the pivotal program, about

Jeff Stein

help we're these done XX the probably infections, quickly, more of institution. Because hours the standard-of-care and I TX majority of of receiving at specific machine think what that's of be antifungal can to therapy. studies, which prior alleviate patients bottleneck biggest enrollment to enroll in the vast exceeding doing the is are the of empiric by using these severity that treatment

that, So, you not to by the giving because want than the bias be because of XX of prior then therapy, patient do would results antifungal hours more disqualified.

So case, if clinical you can you confirm that a then before hours, up this a there is yeast a XX wind fungal in with patient study. that pathogen, in better

Operator

further showing turn call to I'm And back I Executive Stein, now for Chief Officer, closing Mr. to no questions time. Jeff this would remarks. at like the

Jeff Stein

Thank support company. continued for in and the today. your participating of appreciate you call our We Great. interest

have you us. Have If a contact questions, to please everyone. additional any good free day, feel

Operator

a thank great Ladies and Everyone conference. program and have you you gentlemen, for all participating This day. may today's conclude in disconnect. our does

Cidara Therapeutics (CDTX) 11 Nov 172017 Q3 Earnings call transcript