Ampio Pharmaceuticals (AMPE) 4 Aug 212021 Q2 Earnings call transcript

Thank you, and welcome to the Ampio Pharmaceuticals 2021 Second Quarter Earnings Result and Corporate Update Webinar.

As a reminder, this call is being recorded. [Operator Instructions] At this time, I would like to turn the floor over to Mr. Dan Stokely. Dan, please.

Catherine. much, very you Thank And I day. a everyone's having great hope of and executive here It's me rest today. the present our pleasure, be the Ampio to management team, And update call you via phone one quarter we'd webcast. financial either thank the our XXXX business attending second of and results or like to for each participating safe today. forward-looking who I'd of team Ampio Pharmaceuticals, like executive to the introduce you Prior management call harbor reading to be on presenting and/or will the members statement, the to the of

First, at Macaluso, Englewood, Chairman us here is and Colorado, Officer. in with headquarters company the Executive Mr. the Mike Chief

have reading David Officer; accompanying our Holli and also forward-looking safe slides These our to Financial which Director Operating Cherevka, Stokely, contain statements Dan about and like the Chief harbor today, and statement. We Founder; also present, materials, but Dr. including me, Officer. oral and Chief first the [indiscernible] business. may out company's presentation, I'd Bar-Or, start

are as place limited filings not subject the These undue should as words well statements with are These and risks the on in assumptions forecasts year to and Securities file from the You our materially and the Factors available statements and forward-looking significant are Form identified not but and differ reliance statements as may, current such those listed to be as to, December believe, our by for www.sec.gov. or include, and reports uncertainties. under predict, which at any set expectations, or are Commission ended detailed XX-K Commission. actual in our is Report anticipate, these negative Exchange heading XXXX, on XX, intend, will, statements Exchange other matters risks forth Annual our Risk expect, the with continue Risks subsequent terms based of forecast, words forward-looking Securities that may should, of on these terms similar could cause plan, the or potential, meaning. estimate, uncertainties could, and results upon

are provided Finally, as in earlier any new future or or do except as result is whether made by publicly statements a events data forward-looking presentation, speak update any undertake date this information we and of including including statements, statements, unless law. as information, forward-looking not only to required obligation And statements or they of otherwise, the information, indicated.

$X.X of company three million in derivative XXXX $X.X December Now was that PPP of XXXX and offset gain this million of to quarter offset the for development realized six we June PPP million; million net partially loan was XX, to primarily gain of second for to $X.X recognized net the the attributable results research June months expenses XXXX. ended during million. I'd of in totaled million, that the the $X.X average net million, loss compared is by during the G&A million the ended quarter the Increase offset to primarily million on million forgiveness from loss And represents $X.X costs. ending derivative of the to quarter XX, million. compared in of the received fund XXth, compared operating The $X.X have accompanying partially the $X.X totaling XXXX attributable $X.X expenses equivalents financial $X.X G&A increase XXst, June derivative net loss XXXX for of XX, million. loan by to was net decrease net quarter ended period shares $X.X costs, to $X.X partially by of stock offset expenses all discuss $X.X XXXX. operating the as recognized period of operating the XXXX loss net XXXX offset offset XXXX a operations June attributable $X.X million million The $X.XX by million months was June for XXXX. due ATM non-cash due three partially compared that a $X.X a expenses loss loss The gain increased expenses of required of the million; share, of proceeds decrease operating price forgiveness way, at the from during loss for June ended and research operating million of costs out attributable $X.X which million utilization We a an our our primarily $X.X X.X $X.X the months was derivative million and to XXth, to six partially $X.X like net for of expenses a the The the loss million was the which modest recognize our non-cash and XXXX, to to the Operating by million. about partially development the of and and offering a gain quarter equity XXXX. business XXXX XXXX non-cash decrease costs. XXXX for attributable primarily of million decreased $X.X $X.X million gain the XX, on in to period cash period $X.X to the a of from $XX.X $XX.X Cash a period for of by primarily or about to cash million from net aftermarket the loss $X.X the months a million. $X.X of We primarily

increase due the contracting expenses AP-XXX quarter second primarily costs development the expenses to first an of on, period XXX% with for same reflects X.X is of and from efforts operating expenses XX, of clean And scrub secure which XXXX. were Moving the increase million, and The $X.X June which X.X million in incremental compared for XXXX the incurred database. million XXXX. for ended were or period in XXXX quarter consistent months to with the from CRO three research

current the XXXX, million million June the expenses total with expenses CRO from efforts for XX, decreased XXXX, by not the the clinical period, offset G&A months second the the months with was ended the costs In for to months in April decrease studies security R&D XX% research XX, XXXX during June the trials incremental three AP-XXX The were new quarter ended decreased attributable costs $X.X were ended addition, XXXX. trials started XX, and ended XX, million clean expenses study of X% expenses June of the totaling decreased XX, $X.X months from or sponsored AP-XXX overall aligned G&A and three for the And associated during XX% for period or and decrease from attributable $X.X the company period which database clinical XXXX, six that associated XXXX. several the pause incremental months incurred incurred G&A for an in with in XX, expenses XXXX. from R&D for current incremental million, period. in is XXXX. in current the that present pre associated $X.X or six trials the new June AP-XXX partially trials, costs research ended the ended primarily also that was scrub expenses six months to expenses to of were AP-XXX, and AP-XXX which the June June current six

common attributable of the decrease increase The and approximately XXXX. equity shares. XXXX, of operations fourth to who securities update on the through have of shares provide the development equivalents of sufficient surrendering external and to For legal on the X.X warrant the action both compared XXXX. cases and XX, to million stock overall quarter totaling quarter research were lastly, based decrease as expects and the period is periods, dismissal third nominal costs President shares month the $X June overall an shares to options, And and Total with a cash call and cash the a XXX,XXX,XXX to ATM a, XX, shares, litigation-related derivative corporate June the expected on is equity fund in and XXXX. some ending of totaling I'll along liquidity result class during now, additional XXXX, to issuance our on during access of issuance December six attributable stock Ampio's CEO, program, financing, XXX,XXX,XXX XX, of and under operations. programs million business turn plans Ampio Macaluso, operating sources over current Mike access to will our of to And business outstanding

I mean, there's our and on our I understand sector Thanks, more on stock. pressure Dan. pressure

Since then, understanding what's was the and communications, April results is here. to-date, which viable Let have study on forth have or in include associated Phase with mathematical back of is FDA which diligently the to the Consistent in worked the circumstances with formula minimize share protocol decision. patients two, status going our gain timing pandemic preserve sensitivity positive trial special over; implementing options study? and some better that of basically AP-XXX impact gone assessment after truth select, the the place. of because COVID-XX. One, XXXX, the is COVID-XX. me by to on the a paused OAK our ongoing public on the adding keeping X to OAK SPA with analysis, of I more which and we What to option

We shared of to Those from you utilizing I'll Ordinarily, be collection data August The the the and many properly ongoing the queries the takes been patient to partners potential parties going better later has When quarter sensitivity and give few and timing the answered. and clarity this unblind cleaned released the as is addressed including and And The with September, done with finished I'll do interested pandemic. That's into with data -- months, thereafter. database. hopefully have who give have will expect reflected are to more completing FDA. spending let complexity we public, FDA. that. we has validation of public study be process shortly and time. But control later response quarter. cost, or later bias but data. that been to clean months. update would analysis We requirement results the considerable process to minutes. process properly all And the The you process, meeting, this? to continued this quality annual the this early unblinded validated, of a a is soon do be, decided of as details that add to this the at pandemic any several forward the this we'll meaning this already with incurring finished validation results After I'll spending And -- question Holli eliminate have next in towards decided this a data proceed on timing. have the

FDA paperwork. course, investigative much Of requires more the detailed

So just share the will again at public. will data to and with the be clarify, the blinded data the filter. run through clean point, we mathematical we'll And again, that unblinded it

think that's pretty clear. I

the II that AP-XXX. AP-XXX Okay, the weeks II Phase now inhaled Phase enrollment we to let's to Ampion to announced move approval received study of regulatory we Recall ago, expand study several India.

India hospitals in the but As the in separate that noted inhalation the an started of study release, United is rather States. trial, not multiple has extension already a press in

four clinical response in the the may for of contract, the hospital from taking drugs you use I length Drug and for regulating actuality, It's under filings. US process sale But import lengthy The very Mike, regulatory have similar of months and not taking months excessive India course, of the of started so me, the to appropriate trials States as to General getting be of that similarly, any ago, receiving India. regulatory same has long? is this or question can to process the we includes this relates including been it trials clinical news approval as take well five, Like completed. the US, get every the which six as asked Some site what's United importation the is Comptroller day. Of to months conducted, asking good in clinical and simple. time.

emergency the from and -- the clinical and data FDA use for so the In approval we application, accept overall from the it apply addition, clinical inclusion that could started in we eventually process. the clinical trial to before agreement also an needed India to we results, overall in

proceed. in sites we to run India, the the the in start States. the United trial hospital XX trial to this faster receive we even We confirmation if could clinical about FDA to in we had we focus before finish data India to We would writing expect we and in even the X slow entire So get accept receive there. than from currently enrollment, have to FDA the with think

India then if will in XX quicker, rolling X us So States. to we we United the result hospitals and if to much did a give purpose going of just --

II treating inhalation is As previously Phase already study stated, the patients.

an studies. December studies All So what are the II that of what estimated India long-haul clinicaltrials.gov of clinicaltrials.gov. we're study already doing, we've extension as Phase -- this the is already IV, these by on are listed of completion previously On referenced year. and we

a And is focused continue. group OAK, focus to had those we sooner the continue very with platform recently Now, with way, our take obviously, will conditions of, of a Consistent discussions, of we and they group, engaged and partnering strategic to go the the this advisory we'll on go ongoing us. engaged not Ampio OA, also will and addition discussions right Also that. update is to And it be global on sites, objectives. along. will a sort it's communications, assist to by the in opportunity. But before with the also This course, with simplify but firm longer, inflammatory turnkey scientifically now, new that in we us group. or expect stick these helping previous as whole

us So do group this a help for is new do. we're to to trying us what

the evidence takes while and basically find set or is to in experts continue timeframe I we're consistent the and expected received partnerships, asked sees the the the the and willing partnering, process would down. long platform continually partner find and we so that slowing what from through the are Simple, no of to this benefit the get same One of is right accept. there's to discussions, We potential, platform deal I response going or a perspective? that right? asked add both global the the of partner it that expect. However, right seeking is questions engaged executing that domestic partners partnering the these to provides we're And that of structure I

going So you with the what's on then and Holli, update end. of, I'll sort let on pick clinically up specifically trials, and at more I'll the

today. you, joining everyone Thank for Thank you, Mike. us

Now provide. through details the the Mike of let's updates walk just

are public reported of treat disrupted and decades. true in and or nearly in the which into by risk with the first potentially health Journal action year struggling positioned to patient the quite of public and pandemic, definition, emergency serious, knee Street clinical situation Wall find international clinical OAK. drugs event, as health immediate emergency the has the to As OAK COVID-XX. coordinated unexpected are currently we a of care X.X requires is and The the easy-to-use literally which trials, researchers the affected Ampion is medical July for still practice this and is itself also clearly year, in unprecedented COVID-XX a extraordinary action. has health response, an through asset implies is to is Ampion constitute public for COVID-XX impact. and in latest disease This But novel development of determined states a health public a our effective, osteoarthritis implications To that unusual the border, phase require beyond in of Ampion international national programs. been may mechanism carries for knowledge, spread

receive for the the have detailed public move on COVID-XX we during worked such, steps forward the agency needed the to closely health guidance on and development FDA emergency. path with the Ampion the As from program

and year. a and of Simultaneously, – in all sites data and patients. COVID-XX study for seen of was active treatment feedback clinical presented a FDA data reduced for analysis. use the II an patients length identified from IV are for an guidance’s will this moving of Additionally, a the additional our on-site this will FDA. study approach clean be with OAK no to supplementary statistical personnel become oxygen compared the Ampion timeline and that complete, to and application or This We've clinical program provided or The United improvement for to into have treatment in detailed incorporated Authorization published enrolling FDA feedback as or will provided. to patients. analysis including to to for in data Once analysis. analyzing forward guidance analysis I sensitivity This data intravenous across is supplementary Use Mike look recently perform sensitivity OAK into the occurring actively verify will in study OAK anti-inflammatory emergency frozen standard-of-care to the report such patients and on presentation changes analysis of in and for the sites Such on the to verify just FDA nearly data inhaled the discussed. of alone. account entered the we to team COVID-XX And or results We patients trial. for public the utilized clinical are for clinical clinical that those expect impact cause study data our by are development and reported inhaled forward hospitalized the for as was States public decreased they the Mike soon of to COVID-XX as available. the be and health EUA. Emergency ready just Ampion studies that the Phase the that that research potential Many We activity monitors now the Ampion made clinical and a Phase data entry hospital our stay. locked steadily while our is or for the mechanism Both we COVID-XX mortality opened XX% are improvement space May visits correctly the

actively clinical The support of approved the Body, has DCGI, Drugs inhaled into Additionally, program company care the expansion is Regulatory on in the General patients. engaged with global the India or Controller Ampion – India. the India for inhaled Indian and FDA COVID-XX Ampion the working expansion to sites of

shorten for potentially time, Ampion’s use and enrollment developing at inhaled are actively were the and We expect of assist COVID study COVID-XX we X At home infections. inhaled patients long one a Ampion. overall expansion density study at launched population Phase of same home this to of in the for timeline world's highest and enrolling the have

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continue present in implant to journal. we in as data Additionally, forums the scientific peer-reviewed

along American treatment. assess and at study. as Petty L. month animals annual company was potential with in-vitro at the Ampion The Next present perform tumor studies XXnd respiratory XXrd identified such cellular Thomas the that able FDA necrosis Meeting indicate November. inflammatory range cetera, FDA Ampion will beta, a with assess in company data level no interferon-gamma, the local College Ampion with launching work the The observed a Prior Annual this to to will transcription present cytokines, of inhalation toxicity research doses Lung inhalation factor route alpha, versus the inhaled IL-X via Aspen Ampio this trial lung tissue et the and as to patients. IL-X Care of other in of reduce in of Toxicology alone at the adverse of establish completed Conference, The in COVID-XX administration. of clinical safety the regulate to initial intended results need X effects to design, Phase study Ampio recently anti-inflammatory Standard the undertook to humans, inhaled preclinical the to Ampion

turn suppresses have monocytic/macrophage and over of these will Lupus back in and Controversies treatment signaling for Systemic at Toll action suggests In Ampion with lupus. questions answers. utilizing International Like and in the will present on Ampio Xth will mechanism As a diseases. on Congress moderate application Ampion XXth platform International to Receptor treating now therapy lineages and observed a inflammatory in Dan, role call October in X/X pathways of that several who the in evidence dysregulation a Rheumatology the Autoimmunity. I may Ampio novel Congress

ahead and you Holli. to Q&A? again do give you, Thank for want go directions Catherine,

open is to Certainly, for for like now [Operator questions. turn ladies and Instructions] I back gentlemen, to the would floor questions. the Dan floor

and this Thank Roth able receive can from few one. did Aschoff you, Jonathan I first to today. He give a Catherine. set not Capital. questions response from question His make you possibly Holli call a the was maybe of to a

increase Delta variant an the led the the COVID of enrollment? and/or rate hesitancy trial As to your vaccine in

several the XXs into of Director who intensive trials American had to Contrary of hospitalized and year people treat were stated, Dr. researchers You work. regulatory know they overcome pandemic, into the to patients and the has be and or must of Street care. Acting Two of authorizations access month. for half use to in COVID-XX. are easy studies. find Dan to an to data just U.S. around those Further, drugs collect clinical It's failed published XX article from made country recommended cleared reams enrolled after the last and we still to X,XXXs that provide doctors staggering. Wall have FDA a patients. Journal consuming, struggling not been not labor a are nearly is to of effective, hurdles Woodcock, Quote, time belief, for requiring getting their there to pretty use. drugs often rescinded later popular easier Janet enrollment are the

We trials. and COVID Ampion hospitals several actively we clinical across country. are working And diligently access to ensure were conducting to the Patients trials have

question than the complicating six the anymore. to death rate months And higher more the mortality ability is was rate lower versus the had currently your that next you COVID from ago, evaluate

these in the rate death at a also that patients. looking ventilated rate as Missouri's we endpoints still is are goal. an this year, CDC which Post, patients, its is case overall and mid-January, not severe is The late And at study meaning, rate of among this looks study of near high use, that case clinical as designed hospitalized study Washington unvaccinated than more reported by improvement. critical case is length people overall of hospital evaluate of are oxygen surviving, This state lower the A XX% mortality. the and of for to been it year, examines in has March The showed Ampion of astounding infection. state's rate. example, peak patients July In always

in rate national unvaccinated unvaccinated the susceptible adjustment is the in and websites XX% adjustments the in than vaccinations revealed rate case reported people article, unadjusted higher rates tracking this people state Additionally, among Without we'll the the Coronavirus system. than is post case rate on hospitalization for rate points climbed National unadjusted roughly ago as rising. has it's months two The two last adjusted more same high seen death in are than rate to comparable to on patients The care. goes that And April are rate though is the the fatality patients as article say trials. intensive the larger stated of those remains adjusted and some they even a figures. currently better in experts. originally, Mays Those clinical enrolled for are on share the treatments were ending up by in patients in was

potential III comfortable good. the to material? not unblinded for Phase Very of do And be the what need data this you to to viewing partner, one's,

ask we're Well, question, who we're unblinded so Dan the or data. unblinding Jonathan, Jonathan,

So we escalate and believe expand that good interest. the data will

we're we're the and no It's possible. weighing. we're It's do going it something And ASAP. soon unblinding So happening. longer data as as to

Jim you, thank question. with Molloy is question next next Your coming Partners. Global Alliance Great, Operator: Catherine, from

Your is line live.

move that can went day, how you your you my to or me unblind unwind And you'd Could to thanks. about through came through? if walk So to you through? sort through question. other forward the sort Hey, scene to guys, Take cost of that voice? that? we talked the benefit find thoughts the on but hear the the, please your continue it of came so me trial, you question. to is We Like walk the walk

back wait the to biggest in unblind. have -- exists we should and KLX sort were know we that it Jim, whether we that our Okay, world were of we of historical around we It's the in kicking data. – of forth, block patients

treated. Ampion, that we've injection block KLX patient historical patients, that And is That's every the includes That [ph]. data CLE data Now all of is all of excellent. against all randomized ever data. one biggest

hypothetically So trial has the the not sized we're optimism, the we're now sensitivity we've to discussions. but and in sort than when that blinded, doing. those having sitting ever be from we done have FDA similar unblinding going that talk has and that's It's there ongoing. and because on data believe people, like I a I complicated analysis rather our historically, good of it's guidance what to more elephant And room, interest based to every the us been the data is patients using create believe effective because trial help escalate been going safe. is

it's with help year guidance, received at make decision. May, guidance just received we're that That working really end or ago, a actually like or pushed So think day the not we're two. a we of to final I give take us us

the going blinding we're room. that of data I'm forward of out the anyway, looking unblended. So on it sort and elephant taking that

difficult to able more fifth -- this seventh the very currently and past. is the We're So Division division, be sixth OTAC -- our of making trial passed, in we've a say, okay, than shareholders the in CBRE. this for I'm is statement, together be put will if we're correct or also the in if to drugs or all approved discussions which

But move good their put be to will us So much with enough higher. us are the hopefully requirements this threshold. over data, forward. And

So I answered it. I hope didn't really understand question. whole part I lot, talked that a your of I

or go Yes. we're call, and was that that the to you see, good obviously, data we data with just that [indiscernible] forward see to hoping through versus what’s walk to what's you anticipate equivalent you to expect on hope data Can well. your bad what’s and the you live bit – decision I attend good unblinded a about, the hoping little as could then to talk clinically came and see improvement data? meaningful

could to statistical X,XXX with well, the filter, significance. how have we And pass also enough until a But store that be bit have all should to than not patients. when I Yes, number, be we many the show enough trial supposed have little data know is strong similar exactly was the to evidence to larger a a very, would to very patients. superiority, X,XXX I therefore, – don't should cleaned. trend. Remember, if patients I see My hope our hope happy through have data. is

is could than acids drug. having KLX the remember, approved compare not safe like about placebo they're us really the There's It's to nothing it treat not So to. or look a competitor, is a steroids there because hyaluronic that being just And no better patients. approved. at we is

we're air of So by in sort rare ourselves.

is about that's that, be a size it very And third and with planned statistical happy was the of a positive, with goal, happy also this obviously, trend, Our be. to threshold. trial and strong is the I'd but what that

Great. last And for me. question

guess You guess, about good the assuming data for than I I equivalent steps, Ampion? drug for steps data next maybe next assuming talked

Yes, we're I not what to that's don't what, decision, you know do. I going hope our --

Our never ourselves. commercialize drug goal to was this

Our this discussions having. someone, to all we're put worldwide the hopefully, with the our distribution. was That's hands been of in goal along. goal are Those

I'd representation. to and be put the it. and global like And hands sell let marketed will in those that has So a drugs that of partner the that manufacture

the Great. for taking questions. Thanks

bet. You

the take me few let off web, few Q&A. a Catherine,

be start have have on Ampion I Holli a timeline realistic distributing you? we able in question to is, India? for First Do when we'll

dosing believe I so trial. stations under to current India, you're in when our able we're in begin clinical Ampion India referring Distributing to

meeting the the And license whom shortly do can that forward. Controller import of such So move General already now already be need bless will applied an clinical we the Drugs forward with to identified move to that study drugs. we we we've to India steps the we've sites, for for

be this Mike, anything we'll we quarter. So to believe dosing add?

hospitals lot picked, It's on need we're of matter the and the sooner involved there's next our drug. And lot an has work to of so I there's that we them. getting happen a agenda license is of or of there's steps The still send Yes, a to could done, of that the mean, been hospitals, in, import done. covered a done. were a are anytime the we've most that lot better. that week get within What

had don't wish as don't I So, possible. We as I better a this. soon control. I control but answer,

to as packaged. ready we all getting ship the is started. drug. we're we're But can, Everything Soon

We have equipment. the

a is boxed. ordered. It's will on been It's to ASAP. We All have and number put need nebulizers, it the all go, here. So we that's

Great. you. Thank

partners go answer for know, of this arrangement, a a type is potential platform funding I'll level Any relationship provide upfront Ampion? enter question. into deal and or under one. part the funding monetizing seek you than partner You an of other milestones and partnering and ahead you'd different if M&A. Typically, is an some And obviously negotiation. of partnering a obviously, royalties. Another

at best talks obviously, price. on the question. that. non-dilutive sit that's and be to that be the path if that that right I for materialize, capital But So looking as when we're can a we’ll And has answer

here, question more on clarity treatment? lupus Another give provided the you any

B. Dr.

What is the lupus? question on

expand please on you application the Can of lupus…

Okay, yes.

specific system Ampio with very leads Ampion applied TLRX, toll-like nephritis, is great, kidney, is So that lupus it that, patients or are the what is -- that dreaded autoimmune of a -- disorder. And in block lupus kind the an some identified And blocks what the activated, of of factors one almost by its result is a the fundamental of lupus have about receptors, we that complication et one involved inflammatory of lupus when transcripts call which to do toll-like could to nephritis. receptors cetera. insufficiency in is immune the we And renal we is is be cascade XX%, And innate response. damage X. inflammation which know are dialysis, cause receptor great

we'll to the to results, at be are models able work lupus. And on phases now we of animal convey doing So the We're that. you. when have preclinical in looking of research we

paper We in the a on large of are subject. one wrote abstract meeting immunology and presenting the we at lupus

here Question Mike. you. for Thank

to products? how EUA, you to in you would Assuming produce a soon get be position were

Immediately.

we've up? to saying Because making a just factory our geared is beyond This that had capabilities vials. good question. been is people factory Our

i.e., It that a IV to transition because nebulized we you want made So we so snap-off it. know And for from And that. would ordinarily could it's so. and it it, make say we vials obvious, into opportunity or was just -- we anything, started I pharma we know take pharma bags -- have how say, I be OAK filling caps. used would making couple then the it, a to months, would us that people where can version, quickly. the right? well, transition me, prove interesting could say year the within The to IV, to make just didn't we proof. but do We would And

I we do And quickly. So well. do, like really, everything really we it believe very

mean, we we nebulizer. quickly. things do production. the made to increase with to go. snap-off -- that use, have vials we're made. we'll emergency made, have ready And we're obviously, But I So we have IV bags really we for the And have

I the And Mike, it that think questions. on

remarks? to provide closing some want You

Sure.

on have We accomplish. of a what It's with we going handful a amazing people. lot

clinical trials three multiple in and right now, states countries. have We going

it pharma. is good? It We discussions right? looks and they look Is they're the at they our a on the that gone. quality data don't the of first data good you, that's with going and pharma That's they're room I Is tell at. it out when happened. That's day looking means come can is it like thing data, data enough? data, what if they in for? have what does What that Does the into never our -- one mean? room,

room. substance they’re that lupus. complications then out they're etcetera. going improve, and what We’ll important? with think with that's we and to have goes where adds with want to Again, toxicity opportunities, pharma we're thing don't that. anymore. on presentations there quality OAK you we about this. the to of with about to talk manufacturing, publicly. technology commercial We a want the etcetera, to, ongoing important. discussions data looking We if that's Why to and is next talk bore our Does our platform all Holli group, platform. just from having Because there's is the doing data we're it credibility new FDA to at to and And multiple and we only everything etcetera, and correspondence But FDA supports referred It as awaking the that said to the tied So tied correspondence.

Einstein under it guidance, that's analysis, read have the something sensitivity the a FDA you, major task. no small looks unblinding of Of data formula course, like The on even board, for sensitivity, would the right. the couldn't I

It's running now in process but of complicated, that. the all we're our through we're So, that. data finalizing of

to so we're on are Dr. And cash, deal a desperate in kidney We're again, studies rare disease, up children's not position technology. inflammatory ongoing and done. the get a there. that platform those we're that's have all doing, good coming things Bar-Or's that; diseases, animal support We research to support

So, here fast. But being sprinting, We're want said, to out quick. in quickly. there's We're to no being the our as sitting Wooden a we John taking We're Great be time. we're moseying along, figure trying moving one don't hurry.

taking our time as we're get quickly things So, we done.

day are. We're we're So, doing, I'm progress our where making proud of every to hand and we that's accomplishing. what accomplish we're what

And and thank to guys we any questions you today. happy forgot if we'll have them. time that didn't or you So, email get answer for you be the other to, us

and concludes Thank you. event. this Ladies gentlemen, today's

You disconnect have and wonderful you for a at may participation. day. Thank this your time