SCYNEXIS (SCYX) 12 May 222022 Q1 Earnings call transcript

Greetings and welcome to SCYNEXIS, Inc.

First Quarter 2022 Earnings Conference Call. At this time, all participants are in listen-only mode. [Operator Instructions].

As a reminder, this conference is being recorded.

turn Investor over Relations. to Debbie your like from Etchison I'd the to conference host, Now, Please ahead, go ma'am.

Financial Update. Thank you. discuss XXXX to today's conference and Hello, everyone and our welcome First to call Results Corporate Quarter

to XX-Q, or XXXX. May furnished will business Before forward-looking we remind the to outlook statements statements operational Commission. me quarterly future each start, Factors, statements made. for as circumstances including on as strategy. the in on speak expectations, as our expectations were that Risk promotional caption performance, not include prescribing Exchange undertakes no for financial today, and the case today's to current with intended or that our you based concerning forward-looking today's that risks let call is they our financial future, well leadership's materially Commission, after and subject another XXth, with which uncertainties, not the report document actual or sufficient Because update events reflect obligation filed and by only Report differ SCYNEXIS are such All and statement. including in filings and results call may recent Annual to on from implied on Exchange statements most the decisions. Securities Form for our date expressed including information exist Form those occur our Please such Securities and on The purposes subsequently under XX-K of to statements for forward-looking such refer

Financial Lawrence Medical and Commercial on Taglietti, President Hoffman. Officer, Coyne, Joining Officer, and Chief Officer, our Chief us CEO, Chief SCYNEXIS Angulo, is David Interim Dr. Marco today Christine call Dr.

questions. we'll call to our prepared open the Following remarks, your

the call Taglietti, to I President and will Marco CEO. Now, Dr. turn over

for today investor joining Thank Good our you Quarter of Language]. earnings morning, everyone. for call. XXXX First us you, Thank Debbie. [Foreign

future of stride. making with pivotal SCYNEXIS launch to is XXXX our the the the a to of we you the ibrexafungerp on year excited great outline are are vision BREXAFEMME and share franchise. for We updates for progress of and

Let me key a accomplishments recent near-term goals. summarize few briefly in

side, R&D ibrexafungerp. relabeling the successful to expand On efforts continue of we our

expect for We response the an positive the against infections this end NDA the by with of indication our reported analysis quarter, approval to all oral than of ibrexafungerp. the XX% patients year. trials, of potency clinical new CARES the fungal results ibrexafungerp's to We recurrent demonstrating this FURI interim file supplemental a VVC with more severe highlighting combined from and

the report Medical date. to enrolled the Finally, study and indications soon. in for be the this and of expect more David Angulo, Officer, hospital end details being provide result the will our XXXX potential on Chief MARIO MARIO first expect study is approval you program patient we positive by The Dr. to to initiated the XXXX. result with

our to efforts first in quarter product, prescriptions BREXAFEMME, and ibrexafungerp Our growth to of and promising to net launched XXXX. trend X,XXX a commercial we quarter goals. reach September the We boost $XXX,XXX in sales continue of as year tablets, reached in saw of the our nearly XXXX, first the XXXX, this first beyond accelerate achieved revenues

sales Our and direct-to-patient coordinated but grow of actions discuss we're Coyne Chief Christine a integrated from prescriptions thinking the Commercial campaign. Officer, the will field to to set force launching

will million our goal recently the to us I offering, advance cash a with and able being say closed our investors allow antifungal for $XX higher I enable very of which On in in know strengthening we cash in with mean, challenges fortunate extremely if to We're fortunate will quarter to a us fund our franchise strengthen building broad the [Indiscernible] indications. we The million ibrexafungerp across let's our of in public Having thankful strong situation multiple because first $XX side, corporate whatnot. the the position. and XXXX being available Ukraine. cash. our cash more us to than the over. we call corporate of current, heart of today's A but secured Inflation, interest first the rates a navigate it's successfully environmental puts quarter war it, don't through XXXX pandemic war to yet for Europe. world. activities into that

VVC. and sources we currently the to including resources launch on XXXX based for BREXAFEMME fact, recurrent plan of launched the we end preparing year, efforts - In our support our by non expand now approved to and the to in of for and to recurrent cash, this becoming have VVC, With better of VVC, in commercial cash complete of to And VVC, sustainable, ways one vision China, business in Hansoh deals strengthen underscore, by prevention the enable for continue successful, make but we Greater other the look I I we profitable like for treatment did labeling we filings, to like our its is with programs our mentioned, XXXX. is additional reality. to franchise development ibrexafungerp for to the antifungal to hospital include balance. way, our regulatory and as dilutive also would have

we these and our plan will create to with build indications, franchise CFO for sales when the million generate in million then Larry, net the the $XXX successfully alone. following the obtain session. and to And expenses floor path details in diligently balance. to Interim our U.S. each broad, to antifungal a more provide along will long-lasting our will our are a taken open year Q&A franchise. cash a $XXX key We milestone potential All on together,

over call like Commercial Coyne. to would Officer, Now, Chief I the Christine Christine. to our turn

began August we on We shelves and Physicians encouraging. BREXAFEMME our in calling In physician target. drove interest BREXAFEMME. was reps doctors Marco, learning prescribing more you, on about see good field began pharmacy their stocked to XXXX, morning. Thank and

start We off our growing all of strong of coverage lives continued ahead are and insurance while commercial a to track schedule.

many environmental the a news, factors the like more other been putting wave such into as because up now pace. have reach However, critical we mostly are a companies we frequency even affected success that well. good and of HCP. Therefore, picking of over winter, to sales efforts saw we slowing force as growth the seeing positive Omicron at trends high visits growth good of trend The factors, prescribing commercial

is prescribers, of about Our great which benefits messaging resonating news. is BREXAFEMME with the

We sales. seeing our help will to a the continue we same response to Based refine our positive the on base. messaging work outreach as our impact efforts we prescriber increasing that broaden efforts. initiatives, having our target us field we these are these achieve At are will to time, patient

some Now numbers. at let's look

built of few last the base a quarters, Over we prescribers. BREXAFEMME

continue and XX% expand to the base with their our XX% helping those writers first We volumes broadening prescriber XXXX, grew of first repeat of versus times Our quarter three with number level about more XXXX, of in focus the this growing quarter Repeat XXXX. prescriber is the especially doctors prescribers of XX% fourth of as in quarter use fourth almost to majority, patients. quarter out the the contribute BREXAFEMME to in XXXX. base the

the grow Over quarter last almost of BREXAFEMME we XXXX. continued generated quarter learnings these prescriptions learnings X,XXX the we the We of have weeks, prescribers. and few last the prescriptions to generated grew over from last are first all these repeat in representing over to growth quarter. XXXX, applying writers,

quarter prescription growth adding first XXXX prescribers. from and among new The quarter fourth came adoption prescribers broader

by most the see and are recent month to encouraged progress steady continue trends. We growth each

XX% payers of insured higher lives representing than to and By commercially benefits commercial lives, commercial of BREXAFEMME. quarter million insured coverage the commercial up steadily the Our associated tick the of last more continues the we successfully with coverage universe, as $XX of from garnered recognize XX% quarter. end value reported first XXXX, of the

expect customers signaling momentum discussions front, We our just with this are as this. continued on their payer

strong numbers important are relationships, the BREXAFEMME are a and very and extensive their option is the patient Our to account [Indiscernible] coverage how demonstration with national directors members. payers of payer experienced of

called we're have This features with coupling Now April No More. with it with messaging. launched Say campaign HCPs imagery that data and iconic we and a and new paired in new coverage, was prominently campaign built relatable payer

consumers month. is collective to Our to and next our step patients this amplify starting outreach

the with More Say No We campaign. after will reach patients

to attributes our robust. BREXAFEMME be what these more been them. on have more used and changed powerful have motivates language understanding deepening of We findings, we to to key the patients, talking of Based describe

More, and to their activate for Say BREXAFEMME. It's to help symptoms. Say new ask consumers had No materials time more. infections who learn Say advertising relief, BREXAFEMME. will much which about later doctor No our will More BREXAFEMME patients option. with resonates same to seeking audiences. is month Rolling new advertising, target More media have much [Indiscernible] yeast this out a empowerment, and are these social No suffering health symptom more patient patients rally patients about The a with trying be and the Our and for their becoming thing digital advertising, cry been alleviate

prescribers. efforts teams As key our our field solidified our with

will physicians are those our their reporting look efforts, know and with pleased greatest patient augmented to we We all efforts. our BREXAFEMME, back with monitor forward experience and We with on patient amplify impact. the

While patient our we their roll-out. teams field and programs do left awareness work the

opportunity this of vehicles to a Communication additional launch taken Communication. also create have sound We to surround

stations order in twofold. satellite with [Indiscernible], And yeast. month expert product medical Vice SCYNEXIS during And person's [Indiscernible] The week The The President action Azie, Dr of site. affairs to new BREXAFEMME.com this to last in example, continue to For of in country Nkechi url the to stations latest of about May. and at yeast an for to few the by redirects encourage the them to TV of of a go fight media We just key we asked and nurse SCYNEXIS was to the information successful drive where person's are segments the also importance traffic folks’ to implemented advancements kills radio the Barb, markets to as to and talked nurse after. health in infections. tour known natural These a air aired. the the the two across highlighting more XX field. keys effort made we spokes viewers TV our These advancements that the we'll the practitioner. call

efforts multiple next few continue exciting quarters, over As are indeed. we these see, can have expand you that will across channels the times to

we pleased see we're prescribers must are We traders. and long not continue when satisfied. we old We that's we It do have impact. enough. However, new to continue to fall we that option positive a remind know brought not clear BREXAFEMME we but But must our into our non-azole to adding consistently yeast habits not this, to is base. prescribers infections needed

patient focus reporting turn will field the our Angulo. outreach there, will help growth. call look continue us back While now Medical these to drive these Thank Officer. these We Chief you efforts our to and to over teams get all David Angulo, you harmonizing to on all out, we efforts. leavers will to promotional I forward Dr. Dr.

Christine. you, Thank

study X the with prevention The ibrexafungerp or evaluating Phase results our completed response rVVC. we sustained significant CANDLE, ibrexafungerp positive, announced, vulvovaginal previously treatment. candidiasis As were of showing recurrent for and

events a track serious treated consistent With adverse these events, on In tolerated, and due end of with which are most no discontinued quarter adverse events we gastrointestinal there commonly by approval was and this to for BREXAFEMME related and patient results, generally reported year. end current supplemental ibrexafungerp of by headaches were drug were this no The NDA an of now events. ibrexafungerp with study, well with anticipated the the were label. therapy adverse mild mostly submission

the developing address three were Obstetricians positive review other doses, results showed and the patients patients to at X treated outcomes aspergillosis. VVC XXX with with XX% in refractory have were hospital Phase to the reported with refractory In ibrexafungerp, you including refractory clinical in critical needs, invasive as presented VVC that standard unmet days recently we invasive These of by therapies; successful and treated outcomes for to annual setting, we treat of addition, milligrams independent ACOG. know, are ongoing every refractory data American Ibrexafungerp the patients judged as them antifungal VVC difficult efficacy with XX, during the XX infections, Gynecologists, had candidiasis, committee. FURI. from three meeting fungal and ibrexafungerp the study College ibrexafungerp In

refractory ibrexafungerp evaluating quarter, of Phase supporting an until submission invasive this by this aspergillosis studies year. XXXX, anticipated end CARES synergia three these enroll development continue patients NDA as fungal candidiasis. the first We well. in diseases step-down be data next subject with these therapy candidiasis with The have of approval in We in will and ibrexafungerp patients an the having anticipate initiated progressing available data FURI study will a We that study the and MARIO from and steps invasive later X studies. infections estimate evaluating and study continue the guided the by year, the from early

the you The associated and antifungal with the do preliminary than resistance, of difficult-to-treat the interim infections, on now previous are studies, these Candida of the disease, in glabrata, in look as to studies. a of rate these studies focused with with we include benefit. as enrolled most very outcomes results the the in last recently results group group of reported in opportunity of know, response, resulting strength progressive and study, XX% this cases we FURI response achieved includes favorable this and in reported With And us of than auris. this patients CARES patients patients The fungal positive. As the partial CARES with from evaluation gives the data XXX pathogens positive study. experiencing the auris. outcome very infection. patients to Candida data krusei, Candida label from the reviewed both, FURI potential more more these the a and ibrexafungerp external with of and in of that a utility open patients common allows continued clinical such achieved are of infection, experts pleased multi-drug-resistant study, continues in is evaluated see to or commonly patients [Indiscernible] the XX% of stable be XX% fungal complete the that different than confidence patients by which at The were analysis consistency fungal Candida More

and development Hoffman, we turn Finally, me Chief Officer. Lawrence And over developing ibrexafungerp milestones the track pipeline on let our to with key Interim discussed multiple associated previously. for continue remain as indications, now, our call Financial our

David. you, Thank

net For revenues. the first quarter of XXXX, in BREXAFEMME $XXX,XXX generated

programs insurers revenue represents reminder, the from revenue wholesaler. co-pay of upon to None we discounts any the patient also all card. amount recording discounts of sales. our includes As like inventory assistance The a sale are to net

of revenue of XXXX We prior comparable expect BREXAFEMME. our to first expense the year. to $XX.X of quarter XXX,XXX of for the XXXX the related million expense million of year first The Total improve increase million income ongoing commercialization the to quarter XXXX. million selling versus versus Cost net from price the of the of quarter product from for $X.X $X the quarter, for million a quarter the over expense R&D of million for first for first increased course XXXX, was other XXXX decreased $X.X $X.X SG&A increase an the million in other versus driven was was to quarter by of of expenses first first commercial of total quarter $X.X the XXXX. $X.X

per $X.XX derivative comparable per XXXX million basic prior-year During Net of of basic quarter. value XX million liabilities. first first non-cash the fair of loss on warrant for to a liabilities when loss fair million net XXXX, SCYNEXIS of $X $X.X the gains recognized million loss and loss XXXX quarters of million or or non-cash and adjustment respectively for share of $X.XX $X.X quarter share adjustment of the was of the $X.X gains the value compared

the As of at cash we Marco a have start first runway strong into call, the mentioned quarter the XXXX. of

in and cash April stock costs $XX.X which cash an have XXXX, equivalents from March as We additional approximated we common of after million $XX which offering net received expenses, certain of our XX, in million million received gross and $XX proceeds, with XXXX.

with million back our with in you. to Hansoh commercial will us internationally. protection begin and Our the Q&A, And potential efforts business partnership the strength provides turn future opportunities with ongoing Marco. and call development the before an milestones, of Marco. Thank additional us additional I patent over development $XXX long-term provides we of

a floor want key the I a for reiterate few open Q&A session, we before And to Larry. you, points. Thank

unique cannot settings. thank build are antifungal therapy both I enough patients can franchise, BREXAFEMME product potential. we lasting First, is right around A the the stress a and hospital first-in-class and community we a long in systematic building with helping the we which

for as the September. of expanding the franchise build started infections great and is BREXAFEMME making launching VVC include And of HCP is anticipate recurrent have in patients. potential year. this we end first we by with only indication yeast the labeling to BREXAFEMME Second, ibrexafungerp the to multiple strive And the by this in

a fungal step-down infections. robust R&D Fourth, we broad build in have candidiasis first therapy our for MARIO trial invasive hospital this for we our invasive pipeline of we of an only will and franchise, first to long refractory approval a XXXX. protection antifungal by as XXXX, we intersecting And extremely but enroll since franchise can some last patient a our for until is expect regulatory Third, anticipate ibrexafungerp that the exclusivity indication in for time not quarter. and end the the oral

Finally, first a runway financial strong we quarter the a of in cash are into position XXXX. with

No And Now new let I rallying open with will our our now, love hope questions. the you please infection, me Say cry. Yeast finish cry. for floor More. rallying Operator,

this At moment the line sir. tone will One time, [Operator [Operator question question-and-answer indicate session. questions. our please, will be you, instructions]. in for [Operator pause Confirmation queue. Thank instructions]. is your we conducting we while instructions].

from have line Michael our with question We the of Ladenburg first ahead. Please Higgins go Thalmann.

Congrats to the at this the progress. on want some continued are thoughts lately, data Thanks. What filing? NDA response an to to do for could. questions. if the I fungals? the them With with Thanks carrier’s projects the patients your ongoing start other rates How many point on all you launch. when novel compare Operator. FURI Thanks, [Indiscernible] activity I taking guys you

now. seeing very, Yes. is with The are setting, pleased the therapy a Thank response you, response this is so Michael, salvage very we we're David. rates. This that rates right

we're And other or already have partial XX% responses, failing positive that years. say patients having that than very about seeing people other therapies not been very, for of them. therapies let's or been are past for available to who have We disclosing compete more the a

are that for comparison the response but for cases. in to population, expect you setting, rate much So candidiasis on-target reporting have what the as therapy salvage -- particular the too, very we see we that here, can on these

say would response in against of served has I has very the not so the been been rates So good candidiasis good. [Indiscernible]

because really we following getting new, responses information CCIT how benchmark to see that I just much We are closely come in we that. to work candidiasis are too for nearly very that cases were very will hit seeing good breaks. it those

-- very to of the -- So right. we're complete. plan the groups, results pleased with offsetting now very very these is we're

enroll see you been, to next up ramp estimating by those The studies clinical they really studies got within enroll has to [Indiscernible] the for enrollment target -- had see and that enrollment CARES. you that completion As can disclosing in to time right subjects, are year. in we now. And trials, subjects we're about of that XX we we that XXX add believe these on in estimated can about for within as

We we described out. notes. my seemed and it's check fungals double when were other XX% label how earlier, the looking in they will for come were seeing responses, I great. the favorable That's XX% like of

impressive, on months on women [Indiscernible] quarter? has If feedback to that really I BREXAFEMME the of but Christine, us for an changed since going a thanks the you So you last to question switch with updating Thanks. for And rVVC? the can for percent that. have your [Indiscernible]. Do

for Michael. the question. morning, Good Thanks

market or BREXAFEMME the about talking talking prescriptions? you are You're about

Yes, refractory How patients versus many on-label? BREXAFEMME going scripts. are to

Michael, do. we standpoint, Yes. can all stay commercial on-label. we That's From a

of are about to reps scripts doctors the rVVC. we what the VVC. talking So really VVC, track not are That's

I think a Marco; is point. this very Michael; I raising think good But you're

as doesn't the may current we technically the effect that patients clear patients that simply just Something where infection. is fluconazole some the the just that may are of of VVC, classified fungistatic noticed fact the have

Candida continues and with azoles Candida the stay fungistatic start agent other over fluconazole or infection lingering to exacerbates around, then the the like regrow. will So to time,

product believe the in our and So the the one effect we the big becomes a clears that is Candida, really fungicidal that of disadvantage of really cure. kills infection,

with their they cure possibly when infections, afflicted and by been you for have recurrent but treated So have good. these may patients infection maybe not may

profile our is the achieve. things, of the be product with expect that we able that would So to one but

could I Thanks. here, on Synergia update any that's And one for us last how enrolling. on Thanks. one if

Yes.

Michael, been So this than the trial, enrollment synergia again. initially has you past, David thank the Yes. is The lower really disclosed we in projected. as have

We of the have study received really from the for COVID centers focus couple years particularly that past with during pandemic, difficult the was in them. feedback the the that

have However, past activity more the we seen saw than during year much few we in years. this

later make a decision we really So that to and that we will of forward regarding keep those up this speaking invasive investigators during enrollment the and based for we year, to had continue really looking wrap trying that we the on with subsequent enrolling aspergillosis, the -- continue we reporting information results by really disclose, old are keep But we particular really pulmonary end year, development really but data. as we specifically study. on, continue

Thank you, Michael.

Please gentlemen, you. [Operator Thank Instructions].

of have Louise question We next with Cantor Fitzgerald. Chen from line the ahead. Please go

Hi, Ho you quarter our Wayne progress on thank this (ph.) this Louise. here. and is Congrats for questions for the taking

challenges will my there the sales the competitive is, landscape. impact access And How Thank market expand that BREXAFEMME? on first the the with [Indiscernible], force? Mycovia's [Indiscernible] of relationship going uptake distribution you. how of to they any then So hindering And of question to are the planning is on a are are last approval my is recent uptake question BREXAFEMME?

we've we very call one the are stuff that in good to of happy and there question about say I I see, the innovation is been first that my finally Wayne, but VVC. are want here, these first talking about is competition but to me let field thing

If the been but for despite the about of patients decades, known last VVC, limitation well has coming new EASL. think nothing it the you with be three in

It favorable Moreover, We've that in a companies unique or paths. develop safety have restrictions profile, XX the Mike in decided suffering without field product taken with news wish the two different months to great major be So for an last and will approved year. VVC. we of very [Indiscernible] I prevention end the recurrent our women Olivia, with for a a colleagues dosing and in will from we easy limitations. treatment childbearing beyond, And for with broad approved of new potential. terms years class want two this expect both in of condition. of to approvals BREXAFEMME of at this an EASL of like patients, XX women With and VVC range to product all when and only is in indication both also the the this for well, a be age, old terms beyond of

BREXAFEMME the So continue recognized innovation major in we expect to field the remain to of VVC.

In regards to relations Amplity a your very we are they commercial second our question about is -- contract Amplity, organization. as but with clear,

are Amplity us an our needed large to internally the to sales be flexibility force, own organization like hiring because expand organization So to force decided sales or I reason dedicated; a give And sales of instead of is clear. having this the -- always want dedicated to fully we fully type having the we infrastructure. have a one to of to eventually approach when without SCYNEXIS. very this make build

defer and a beginning September, So actually as in of that know, the to sure is actually, I'm has we chain have to you distribution. is to -- to areas finally, will of really DNA mentioning would probably our working also an actually like get the where I SCYNEXIS that product of a the of August two the been there is Amplity at its but this We for, supply successful, manufacturing pharmacies, company. extremely agreement allow help has well. where the decades. in The near-term. that were you to costs distribution we the company been what about able us end one what is This remind not some And has the are be been partnership but

develop, me know been anything. available miss let didn't make we manufacture don't in a that sure quite have sure actually issue just pharmacies, how aspect, see pharmacy. with to confirming all I any that has and actually the successfully the we the Christine produce, to and was product chain product; supply So making But

question. thanks for Marco. the Thanks, not. Wayne, did You Hi,

the the last enjoyed signal. that scripts You're with relates do Marco. that any not second adjudicated the the for that lives we've Wayne's product to really being year did opened up absolutely XX we mean, the getting good doctor see access any in retail have we we To the into right, I were writes, when it over seen this not from the We million as patient question, commercial [Indiscernible]. chain, have trouble into pharmacies and in obstruction quarter. the queue,

I So helpful. really think that's

also Marco is to broader We We and and really support new your that, after commercial good get you the intended not where footprint. what go is ensure which now. Wayne, prescribing very utility see that we're a the off really them reps copay do have we and on our where expansion a of focus We our to then, And covered. always bringing those watch are to there. our of you in wind now, front of relative their result, launch program looking we closely, that prescribers. point, high lives to it in It about call We're for time as for That's targets. start is get Every Marco’s put talked they do down see which things signal charges obstruction spot. Wayne. we that

the first looking information. We're that our at some always with closures. we're those of get right coming now, So results. down we where because some quarter out that's high prescribers doubling the Hope COVID that's with of office helpful

Thank you, Christine.

course. Of

Thank you. again. Congrats

Thanks.

Wayne. you, Thank

[Operator Instructions]. you. Thank

of Capital, We have question go next the from Brookline please ahead. with Raja Kumar line

come activate? just I planning Thank the to wondering will Kumar. same do on you expect you. (ph.) X provide would are the some was if many the ongoing sites update. And you for for Thank Tremendo am you Phase sites the you all MARIO color to Hi, board studies. time? at how Like

is this question. Sure, for Thank you the David.

patient of same entering wrapping are this going question, the centers study. all at opened, of that different sites first it doing very the centers, large at regions, point. approval. in studies, study, global assessment for conduct your our the Asia, feasibility regions that's already enable we kind open up all are in going X time, the our the enroll Phase final we the because been in that within is these that are that a a United second coming global to centers we timelines So -- planning to everyone no. for this ability at centers the really has come are will regulatory really have point in out why geographic And At confident involve to initial so the And to etc. already to quarter. European different be this Typically part different time sites And first of enrollment we're States, this have

those So -- of for that sites to at The the we're of for this we just in that's it's first patients what initiation we to that sites enrollment. globally. And to have we point, number in, going currently total planning. already are sites are but estimating be open between of come XX round waiting XX

thank helpful That was you.

some had data with preclinical you So mucormycosis.

[Indiscernible]? So to therapy for planning ongoing patients in how're the you. enrolling combination have you the take Do Thank any clinics? you to a it

step study. which of pointed but mucor. surprisingly other therapy have other with we the recently do again. enrolling in had fungal that rare, recently with results [Indiscernible]. out, diseases, We have combination recently the for not as confirmatory reached we investigators we for made patients again, we B those combination you will mucormycosis. out different presented results with conducted these same trend Yes, information has observed that the of preclinical do the investigations even With therapy ibrexafungerp good rare amphotericin pathogens, this been study were we to of And strains community, observed now recently And that we are scientific in a [Indiscernible] we FURI just at the

We the with them they to into opportunity mucor now the are study. notifying have enroll that patients

not because So very the patients enrolling were high in regarding very have we we and understand these limited clinical patients a the Ibrexa, past, have very, mortality. of you mucor with information really utility potential

may for in really is how that started But But looking survive where get in indication reasons activity You seeing so this high believe goodness. to are unmet you we that as patients help your them you them, can can forward opening some are of the only clinical trials if is to study and when we mortality. start have enrolled extraordinary allow to some now because patients for Anything we -clinical them. very seeing very, we've well. good benefit pre significant participate extraordinary condition, that of these can an data these they even this need that from us very to exciting particular are

you. Thank

be to for patients? you're mucormycosis so clear, for patients, FURI the these Just opening trial

Yes.

allow are patients in pathogens, immediately. allows We even protocol, protocol enroll that. product to mucor now resource by enrolled need could to them. that study. was protocol. there which right they modify not specific be can the defined are a in So for in them already didn't We protocol name The certain can The be the the the FURI

enrollment right mucor is, as the of it study, So now patients. allows

you And we in will patients -- keep have future enrolled. we'll so keep we updated tuned, you stay if the

Yes.

Thank you taking for great. so much Okay, questions. my

Thank you.

you. Thank

Please ahead. We go have Livnat next H.C. of question Oren from with Wainwright. line the

a couple. had questions, for taking the Thanks

the The first FURI, and on follow-up then on ibrex CARES program. a

sounds at resource change on focus on off backing some And then base high in am high efforts ibrex, of or on -- targeting strategy some much for perhaps? into I'll increasing of and out with and a deepening, you, I'm prescribers? prescriber your COVID, on of [Indiscernible] the just regards least, after has frequency now language the a it follow-up And couple and reading of empowerment there's the broaden a coming So wondering, within of you too specific to prescribers, to been some focus I allocation more there writing ask that. Are you mentioned, change I'm a mentioned change messaging focusing detecting like times.

thank good questio. morning. the for Christine It's Hi you Oren

but adopters. high heard words, about They're --you've sure make my heard happened writers. and are the to I prolific want we thought they think most you The OB-GYNs clear. that that I'm Everything commercialized. and prescribers our pre very largely you well are Now I we -launch after in know first

to important our the prescribers be base. continue they So to really high continue

offices quarter did experience other the of we in companies office of some did closures many the because like first COVID. So

online reps to to is open inability that there able which prescribing get some you with being saw as this there get us frequently start back or in February office our to our plan beyond, looking we comes you so we March called as then and for. up look then so as when and in then we're see And at, and in rate, see for what call

as Continue as in making So often just change strategy. no those and sure plan get into executing the able to we are prescribers. high

the And as to changing well? refining of doctors terms for messaging message or pitch as far or as that in patients the messaging, is changing primarily

we've executing teams. mean, I the ground learn we they're with the will Yes, up from nine and Right. the months for same so announced time at field

the our report So back from we'll reps. get

So information. of that's one point

we've do point other is The course are see time, the that of that we message is exercises going. how listening initially crafted to over customer

And that's slides. and is rounding It's trying think what But slide. memorability those and the The get to No on so, leaves got all you're slide, Oren, imagery the tips. after office I evocative provocative. on rep honing on More more of that hopefully, based refining more kind it's higher you and Say the edges. see the is we're it really to the there seeing

imagery we little just refined up the customer feedback. and bit, Oren, messaging So a then based on pumped the

in just XX you So nine there, from launch rank months. away months, out get it's change as strategy file and no

lot a what so give that's customer talking saying the doing is here. I'm we in learn your and what about or You after message, from

some end but regards by All right, CARES, there the the to specific XXXX. FURI with Marco goals -- and thanks. of you're and I for an also from out And David, data timing if putting approval may,

front? you you precedent in go what cases you using or had conversations Thanks. on about you're in what help use lot that imagine? us have talk you've L us So you clarify, you so, what to we in on, need can understand broad a pathway the with indications additional the terms could of that could any FDA don't pad and help Just a or of presumably specific if thinking pad, understand, L can to to kind show,

exclusively allow with And going really David. to is MARIO the going sorry, the is study and be the intention in is of this an basic of agent. Yes, in indication coming us ibrexafungerp we're tolerated the the or Candida candidiasis responding you is FURI that a can to be because to really likely believe narrow CARES. are other broad timeline, basic study that be to therapy and in patients you infections ibrexafungerp as the therapy MARIO, a align able of our a Oren, that thank kind echinocandin going as is randomized not Sure, auris most majority as oral see from from salvage to scenario that to completion double-blind there IV in our in data from as that it's the try use CARES. not to FURI to to be that but to also We antifungal patients really salvage to infections, the Candida may that And now use step-down align get the candidiasis what study. having right an

at You know have that the point diseases, been majority but different the great FURI study variety infections. this enrolls a of candida

the an a to normal in invasive really is broad information use pieces all let's their let's all and unmet refractory patients need tolerated idea that of label. current their with or to that we is, not will you talk be patient those some responding basic mucor, complementary other can very two each to not of with the The allows both all to the but for overall these have that label potentially -- significant to have strategy. very step-down therapies number to part diseases, into these enable enrolled going So to were label Yes, to is point be, in say, as done to my a salvage there already that a thinking, studies have for as large with consider in, from be candidiasis networks very because for patient still data experience we but that numbers step-down these cases also a if that for including therapy mucor outcomes, is about A Candidasis. other agency or say Considering limited. the data are patients in least considering at of consistently the I conditions. is those It's several diseases Candida. enough patients reporting confident for feel the which so expanding fungal difficult me consistently strong is the very view, that's expansion of confidence been invasive

be the of end final and We exactly have agency it's there these onto packages, the data at the with regarding finals these analytical XXXX. the we remained and the days’ combining plan to not discussed sets towards what regarding have over going

could we of point approval substantiate of do [Indiscernible]. these a conceptual in that the that data, information However, have an agreement pieces the

Appreciate Good much. it. very you Thank luck.

Oren. Thank you Thank all. you,

closing end Instructions]. have we Thank Over to turn session, question-and-answer of you. back [Operator Thank and the remarks. gentlemen, reached and like you, CEO, you, call I'd the to ladies to Marco the Taglietti, Sir. for

financial make sure your Launching much Operator, much, couldn't thank all XXXX into you you like Thank major quick you runway the very and way. and ever data trend, Thank a better areas. XXXX that we any great year, cash you close XXXX. positive solid for all much, in critical well would in support. have Operator. the to And call. with for a foundation some setting; I resources BREXAFEMME point; attention we very in very the slash hospitals to started three very just can is We for with very start efforts our support very your a

Ladies this sir. conference. much, concludes today's very and you gentlemen, Thank

may participation. at You time. your disconnect you this your for lines Thank