AMPE - Earnings call transcript Q4 2020 | Ampio Pharmaceuticals, Inc.

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Operator

Thank you, and welcome to Ampio Pharmaceuticals' 2020 Earnings Results and Corporate Update Webinar.

As a reminder, this call is being recorded and all listeners will be on a listen-only mode. [Operator Instructions] At this time, I would like to turn the call over to Mr. Dan Stokely. Dan, please go ahead.

Dan Stokely

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

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

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

these terms, and are include, forward-looking materially estimate, under uncertainties. listed our from These plan, You should the and those statements negative should, made forward-looking the as our to terms on or Exchange meaning. factors differ to including forward-looking or and will, to with risks any uncertainties not are events other statements, they're the in be as December similar limited Risks any except indicated as and which but www.sec.gov. not of as including set otherwise, continue, Annual and of data is significant the forecasts current year by or available believe, forecast are of these or intend, place based risk reports on results in Securities words in cause that could, update as may, is provided do presentation detailed actual and subject assumptions, not statements anticipate, unless undue the could Report future any and matters forth as a at new statements our Securities expectations, expect, in speaks XX-K XX, predict, upon statements by date forward-looking statements potential, such well we filings words identified reliance may Form file information, for the law. information, Exchange statements or publicly this only as and These subsequent risks undertake other to ended Commission. of earlier Statements result and our on Commission required XXXX, whether information with obligation are

the is Knee the touch to $X.X of our both December with our combined at on compared Now in that our ATM by the $X.X December with was million the April briefly The in earlier to totaling for $X This XXXX. increase due $XX.X Clinical year, restrictions utilization by were fund during the partially officers expenses the study. we to operating ended increase certain a such in year consistent at coverage COVID-XX overall implemented Research development with totaled and the primarily equivalents the to to federal or December the million result million to for XXXX. XXXX safety financial XXXX. XXXX, compensation compared travel totaled paused of from was along of stock study, net XX, like as to way, lesser Osteoarthritis the and year results The XX, same $X.X December and mandates state all warrant during that XX, incremental initiated at-the-market decrease offset of million Research increase the million by realized million – the out the XX, of Ampion same the attributable in increase with The primarily and incurred million. I'd compared received $XX.X Phase is of were much $XX.X year this millio, in associated to a decrease have the market of year again administrative issued non-cash for Cash Phase based intravenous XXXX. was for the all response stock ended for AP-XXX the directors options. by to premiums year The or contracted cash inhaled I AP-XXX, being which governments were along companies period study used due in pandemic inhaled study the non-cash along insurance offering equity AP-XXX degree year, stay-at-home in to Organization. period temporarily General Ampion proceeds XXXX. issuance which exercises Ampion, ended offset were and expenses $XX.X the the which XXXX or partially for I activities due were with the December and repricing which cash is and the for expenditures of company the XX, to full and

loan ended the same believes the Program as realized In other small company Payroll XXXX was company in loan by of the other the institution. the In XXXX, already administration forgiven company's will we from gain Funding whereby be fiscal $X recorded forgiven from period is income income negligible for it business compared lending by has the the the XXXX. million the to XX, Lastly, been that year, previously warrants. probable Protection current December expense investor a year issued derivative for the

$X.XX December compared or for net loss share million, Lastly, year December net noted the of shares $XX.X in of common study year. and outstanding loss was increase The the reduction a gain share, million reduction XX, XXXX attributable earlier in net the in XX, of other the the previously primarily as shares it at Total $XX.X trial a at loss in to previously due partially loss from and $X.XX XXXX. the were to XXXX. by same shares period as was a to clinical per stock in a of for loss derivative XX, the ended costs the offset income compared result is in noted XXX,XXX,XXX the December paused to related reduction of XXXX a or AP-XXX per XXXX pandemic XXX,XXX,XXX

the programs operations call company's provide and XXXX. CEO, clinical trial based available financial and expected from current to research overall Finally both and have guidance operating update, cash and our sufficient plans to a equity and on standpoint business the Ampio business Macaluso, will And readily and fund access to expects over Ampio's update. I'll hand, a Mike now, development turn who to cash on President into and external liquid additional financing

Mike Macaluso

Thanks, Dan.

OAK. with start Let's

regarding necessitated to in size We the severe exclusion our population we pause proposal let with trial OAK were that as single late note trials, and and my have The our well patient not patient in say response of severe as FDA we nor just evaluate, severity, decision. to that giving injection We to lost up dose, patients. that OAK add made to that not enough knowledge criteria was patients – were lightly. additional has our data existing evaluated the at of December large This experience outside our weight, we more including XXXX following options. patients submitted the more until patients due patients to the data data study the any the have adding for in company company block the world. our our patient This results, weeks. independent with blinded. the historic our very does statistically existing The demographics we or KLX to we There The recently the benchmark. by trial and provided confirmation, two statisticians The evaluate explain KLX written guide easy our similar only received XX the and other A in inclusion than options taken of large data only guidance our practically the achieved will served age, go make significant guidance all sample forced to block was supporting evaluation not again. me that demographics pandemic. reduced of remained and reasons. KLX this of our the decision unblind identical also decision exist further really go was we our shutdown not completely they historic to have were Please factor including and all

would SPA We our the we or have And and that if FDA FDA we FDA update will file and to in use you not until have XX effect. our our been writing the in at To to accepted and from all days significant only. it remains forward next is our in written will unblind proposal data response we BLA, have we repeat, submitted statistically the proceed response a the when existing data proposal the from less. existing confirmation has we to that expect

go let's to to up clinical and give our an update Intravenous that Inhaled Holli. on I'll Ampion trials, Now

Holli Cherevka

mortality inflammatory A the in COVID-XX you, the studies and American present States the the of of production COVID-XX IV treat The to trial application cytokines vitro providing a COVID-XX in response treatment is levels with clinical multiple locally an has for lower that people these start trial. January infection. study to authorization. update XX% compared and scale alone. design been seven Ampion been decreases day less treatment conduct were indicate pathway. hyperactive during patients. and inhalation, By rate for standard of COVID-XX month all-cause inflammation presented AP-XXX of of the target which an of anti-inflammatory been average Ampion of related for emergency the The trial are the for seconds investigation patients. And a oxygen a continues inflammatory improvement in use efficacy evaluating FDA administration in X% unlike of of Ampion pandemic improvement demonstrated is improvement inflammatory were early safety the were pathways We of is XX patients group the of events trend randomized to Patients consideration standard required evaluating provides as routes uniquely enrollment observed by hospitalization for authorization complete Patients COVID-XX continues were less the from was between cytokines, to received whereby to Adverse of as all-cause as emergency. adverse who each This show compared FDA clinical standard to to COVID-XX recommended design our The Phase results Ampion a patients the support Elevated had clinical XX% data in the potential for day. Ampion FDA compared of review an is two In Intravenous, More reported. care required COVID-XX patients this of data Ampion with may inhalation including correlated significance efficient throughout effectiveness patient direct FDA review of study. clinical deadliest Ampion cytokines objectively against which The than this on Group potential Thank compared to has care. Ampion in XX% trial patients. is Mike. the IV noted for received safety of patients who targeting alone. compared considered and cleared clinical controlled developed indicated stable day Ampion XX% results stable of alone of of patients care effective emergency will improvement improvement received Ampion and patients. Ampion of and who treatment or of that time. inflammation stable provides the an standard on The Ampion Ampion of compared days length Ampion with double-blind stay improvement benefits of COVID-XX hospital standard study had treat I Ampion safety only body. in dying use an be I to the pandemic and inflammation to that XX the standard care were and we application five. patients. to broadly same laboratory, of The and completing standard COVID-XX an other multiple one days potential placebo treatment to with care Ampion shown AP-XXX serious and been severity. for known allow systemic by or mortality average risks patients. of to had trial no treatment, The was and have in Ampion who we treatment, inhalation and with COVID-XX COVID-XX health care with Ampion are for day clinical of reducing the close or with has the This Preliminary be statistical of the five, COVID-XX. patients for United use or to Ampion and reported and patients. events necessary By for in of of care efficacy dying outcome that these improve XX% FDA our to for lungs any and Ampion the lungs. care standard XXXX production received may every reduce XX the drug of in associated X,XXX therapies along

XXX a typically working XXX are an update to when from accept hundred diligently finalize in patient position enrollment. the As inhaled this We once a provide ranging patients. to finalized we are to plan include current, trials Phase of protocol to patients for Ampion. clinical II few and we

We QX to in are start currently this XXXX. trial expecting early

me on let Ampion IV treatment update Now COVID-XX. an our provide for

FDA's and As FDA completed were previously inhalation further of Ampion, the evaluating disclosed, the the inhaled the approved with in initial IV regarding the Ethics we're Israeli Israeli Committee parallel the the trial. [indiscernible] of similar have Health. has of for with Ampion the by Ministry been expanding program, guidance response process expansion the Local with review Consistent in clinical which provided we

will on and turn the Ampion of back program. With immunomodulatory long effective will to update patients. an I that who COVID-XX an provide hauler be clinical call agent, As that, our course Macaluso, in believe the we COVID-XX may improving Mike outcome

Mike Macaluso

long to of Ampion excited to in perplexing symptoms. very I'm inhaled Holli. have the you starting as we're with exhibiting long Thanks, inform hauler that patients utilizing exposure. Patients can a ventilator you experience worse symptoms complications on symptoms process hauler can mild smoker. than clinical ongoing the patients be Long trial, hauler that lungs have year some still of have being had or are after being a period asymptomatic with significant for after COVID time XX the COVID continue

will as sure inflammation to treating must the We will I'm hauler not Ampion that's patients, compared this why patient a we compared standard for platform biologic standard such point. of as care agnostic the trial long and I this to is what care, is involved. the in but emphasize be of are as as be is to. long is

number believe we learning of obviously we COVID. to So are applies just what complications, to a not significant that

symptoms. Our requiring and will distress five supply not with clinical trial be This design will treatment, nebulizer deal receive specifically of Ampion. will day at-home respiratory hospitalization. Patients related to patient a long hauler an a

response position an cut, an immune currently protocol inflammation. inflammation. also in all to finalize sprained ASAP. bacteria are cause virus can to that be trial Trauma, We the commence or trauma on expect knock trial arthritis, a Pathogens response like spark ankle, and that will working the a can a to in like spark a the can cause head, immune

will Dr. this we an turn research Our designed over specifically the our will provide on to up David? Bar-Or, inflammatory open who the I response. to will call niche deal now be trial to and programs with then will Q&A. update

David Bar-Or

mass group you, at Well, good a of and seasoned ongoing afternoon and on research intensive in the others. team in focused three biochemists, briefly Ampio the I research and science projects. thank main biologists, The describe will spectrometries Ampio. par portion many is biologists, everyone. research at is of includes The in computational R&D Michael, activities the very molecular and

project. COVID-XX first one The the is

children kidney called is The the surgery enteropathy. injury protein-losing nephropathy. one third a second diabetic the as in injury is post-fontan by acute kidney complications caused chronic And well one an specific

by COVID-XX Now all tissue innate COVID-XX the certain the damage, has eventual trials surfactant of loss virus of and hyper adaptive immune direct response cells us experienced opposed been Since mild immune in the of to the with cells program. in It including viral describing patients clinical of that the the respiratory producing several involves by ongoing program. the on I'll lung in demonstrated an respiratory and the of that the activation a indirect emphasis cytokine and leading is of pathophysiology system may research in immune with receptors the excessive inappropriate Ampion ARDS. the toll-like dysregulation to our systems, COVID associated resulting system. as part activation This and briefly research upper increasing with presentation infection and antigen. load. edema, others of in This patient manifested the pulmonary a lower through and storm, it and one viral develop start is have COVID-XX with major Severe

on proteins, from on of is the focus various spike invasion attachment the proteins blood and of effect surface and research monocytes circulating virus macrophages. the Our variant on mutations the that peripheral of mediate the cells

various currently so are genomic emptied non-infectious using whole is particles, essentially virus, stimuli, RNA, like We the including pro-inflammatory virus particle. it's which for nonreplicating its

of on a mimics called and effect cells simulating expiratory as pulmonary use the also we are alveolar chamber activating proteins We to determine pressure PEP and the the of respiration of projects initially and the on action the during also this are optimizing cells, total result respiration we sequencing pressure pressure cells well of proteomics, inflammation, or alveolar affecting of also cells In in patient metabolomics, the in mechanically ventilated be RNA pressure Ampion alveolar to fluid prevent on total Ampion exchange, leakage the vascular mechanism these processes. genomics, general, cyclic vessels a effects lining in pressure of microvascular expiratory that demonstrating positive the of to patients, of work changes changes high-end ARDS. effects looking and is with COVID integrity other that of tissue metabolic on demonstrating leaks if immune out damaging This beneficial and cells and and endothelial cells space analysis these and blood as carried oxygen and this of of cells immune with at the beneficial long to barrier. reported cell into as

Ampion storm We with indicating that activation T-cell have the MX cytokines curb promising kind in is lab of macrophage. release which inhibit receptor. to of reduces our the cytokine data pro-inflammatory associated of We polarization the in macrophages,

is on in with The collaboration scientists project is kidney second injuries. project Vanderbilt. This physician the at acute

in functions, well most inflammation all epithelial is children The the renal protein-losing project result children motor a confirmed born clinicians cells indications. in enteropathy. third initial conjunction Fontan done surgery venous studying arterial and Essentially the on pathophysiology post-fontan theoretically the involved kidney other far are tubular hospital a chamber as the proximal and on blood. done kidney so the on as involve on cells fits is inflammation. of single The cells. vitro are from involves those endothelial is both Ampions We experiments a project disorders inflammation. effects with kidney research And the with procedure on and the procedure the of in as major faction cells is is the scientists. encouraging performed of cardiac kidney, very This of separating

children these of enteropathy. protein-losing Some They termed their lose in gut. condition a post-procedure developed protein

unclear of theories. other severe is is and the explanation increased pressure condition etiology proteins leakage Sometimes with that gastrointestinal system it One for in hearts several necessitates a transplant. mechanical of the is to lymphatic PLE The system. and is so inflammation and lymphatic the involves this

work in endothelial potential these lead This you keep press children. Ampion in activities synopsis to Work in appropriate. in when beneficial performing and data on determine of intestinal effect by on research as to potential complex are Ampio. and this the cells a as progress. in the is on may This pathways treatment of conditions sets the and various molecular demonstrate on is others well short epithelial option cells inflammation available experiments micro a you. studying Thank RNA, very permeability, progress We lymphatic to at vitro dreadful genomics, silico involved angle to other condition. posted scientific publications releases We'll

Mike Macaluso

Thank Q&A. you, open this don't up we David, Dan. Why Holli, to

Operator

is open for Capital]. coming the Certainly, is your from Aschoff Instructions] gentlemen, questions. ladies And floor Jonathan now [Operator first and [ROTH question

is line Your live.

Jonathan Aschoff

And on think And about your that Congrats you. Thank two to view you guys. most the have part or I long second for of sort you them haul the the you it submitted is to enroll the so under in long some is trial, haul difficult accept? FDA the the definition. the tight can question progress. what a for proposal questions or FDA would defines be What that

Mike Macaluso

ahead. Go

Holli Cherevka

to I submission our the the the With difficulty quantifying pandemic the general. Jonathan. think osteoarthritis in in you, is on FDA Thank program,

So examined new published. the and has the and affected obviously who of you're the data been we and unaffected by as the in recently COVID-XX, sure set last aware guidance it's we line I'm FDA determine with FDA week January. guidance

understanding to of how COVID-XX even impact So its trial the own clinical evolving. on categorize pandemic FDA’s is and

agency. And as done continue thing keep and apply with response so the to think the most pace with released anxiously it's and our believe so, program. but FDA's evidence the difficult We we I dialogue is scientific to appropriately we've it await

the turn So haulers by term. Bar-Or of the Dr. it definition long to I'll medical

David Bar-Or

Okay.

it's end function haulers is prolonged long we point, specifically we'll define, many tests and the complications are And it be literature symptoms the infection. have difficult conducting, weeks the signs after at had the other condition with and accepted as initial look the respiratory a parameters. at and post XX that So at defines but – pulmonary who study patients we looking to

becoming So the long chronic. problem that And like haulers patients an who almost it's prolonged, acute suffer like definition. from is

Jonathan Aschoff

Okay. Thank the OAK And on you. question.

Holli Cherevka

my Did you not sorry. answer? I'm hear

Jonathan Aschoff

did I the you, think what part to you FDA in is that? most accept no, Oh, difficult asking the was to not. do I

Mike Macaluso

answered She Jonathan. it,

Just it. you can hear

Holli Cherevka

me Yes. Can you hear now?

Jonathan Aschoff

I can.

Holli Cherevka

here. lady put to from the away for They the mic this

of osteoarthritis piece of pandemic difficult in agency proposal and most comes to the itself. the the the with think I

of on clinical of that I'm was the week recently last guidance you're aware the trials COVID-XX the FDA, So health the during sure published updated January. emergency published handling

as impacted available. of have data So to the pandemic how more evolve conduct becomes FDA's trials own understanding the continues more may the and clinical of

to data of is available. keeping the publications the FDA with thing with accord in nature scientific is the believe I that's evolving the in and and the We think proposal these pandemic So our difficult itself updated to most a body recent to challenge. continues in pandemic support I large of proposed But the evidence largest amendment. pose the guidelines. unknown nature And and think of of we've Thank the you. submitted the

Jonathan Aschoff

not you statistical any push you're think you likely now? approach of But kind to can for part that back your might you liberal of asking Okay. – they're the to while describe proposition unblind statistical on

Holli Cherevka

as – to we remain until blinded we agency. we plan the Mike with agent reach So mentioned, agreement with FDA the

anticipate And proposal, those the that unaffected to both to feedback. await so we we we And staying agency eagerly dialogue. COVID-XX step and their most presented close our the affected delineated pandemic. from the agency the to And continue with in in we've be versus recent populations believe

agency what or that our I continue know dialogue say, validity program. we of can't with robustness speculate I on committed not and may the are the FDA may to to So but the ensure

Jonathan Aschoff

guys. thanks, Holli, and you, Thank Okay.

Operator

question next [indiscernible]. is from coming Your

live. Your line is

Unidentified Analyst

are how Hi Mike, today? you

Mike Macaluso

I'm Bob, Thank good. Hi you.

Unidentified Analyst

probability up your under with One population come less question, for the did the what the having total KLX's their new – analysis? What's statistical on patients? statisticians passing less the of in patients

Mike Macaluso

was as I same very than have lot patients, larger actually KLX have XXX, a What Well, that summary large the enrollment a or one-to-one sex, FDA mentioned, in presented we exclusion it's that mean, were Bob talk block the similar. criteria. earlier of is my inclusion, everything XXX. age, weight, historically randomized, same I we to my

have very we could many significant good opportunity should we and do So, with we chance a patients with statistically XXX, more be think than that. to if

comfortable, we're as optimistic Everything at about said, didn't this carefully. looked was take submitted. comfortable lightly. and what we're So, I we very I mean we And

XXX, statistically if statistically we we we a lot significant our more So, was trial XXX. that. I could significant pivotal be patients and And only be believe at were that could statistically than significant first

think we're I So, okay.

Unidentified Analyst

like passing points question the move did that thousand just now right? insignificant, XX% amount, with percentage of a let's study with lesser many nature the down, did over say had you probably that guess the patients move of I Okay. my the how chance down, was

Mike Macaluso

It's We patients, over from doesn't all XX means here going down statistics go something a don't on statistical went very explain difficult the patients down are it but are XXXX data. and I percent phone, probability probability. of it's up think some, from to X,XXX That some considerably. to much if the we the

we'll honestly So, looking in and that I what think the said. we're to unblinding. forward see have I'm good to shape FDA

I good. to going be think it's

Unidentified Analyst

I Yes, agree.

Okay.

I five a bit percentage not maybe probably more say, the total So than, probability. would points

Mike Macaluso

don't can't I know answer that I Bob. that.

Unidentified Analyst

right. Yes, okay, all

So, you get All right. those figures. didn't

Mike Macaluso

Yes.

Next question operator?

Operator

your as person. And Certainly. a to question one try per please to reminder, limit questions

Your line live. from Dave live. line is next coming your Dave Folsom. Dave, question is your is Folsom,

Your next question is Ron coming from Corbel [ph].

Your is line live.

Unidentified Analyst

safety it Okay. Hi. Any the intravenous It realized the any to that passed is or My where safety. I with inhaled, thought the that simple. on past about the the gone question has be ongoing the to are they there Is drug is is safe? Would do part very of we the we at injection, question. anymore still had point, maybe and this trial? question safety point safety?

Mike Macaluso

about concerned I think that every the FDA safety is trial. always in

had did think stage, reason Certainly, start with a monitoring such committee. IV we ever I don't goes many to and So, with trial on away. so safety the the the early small it interruptions

grant Of course, issues. and in interested an IV they us when placebo safety no to a There submitted with recently, the were our of willing were experience, FDA expansion control. safety. a both trial nebulized were And they to we the

So, trial safety I FDA issues, don't every safety any has think but first. there's

Operator

Jordon from is Burwick coming [ph]. Your question next

is line live. Your

Unidentified Analyst

study? of on is we question completion inhalation Yes, the are percentage what my

Mike Macaluso

We're compiling data.

for, final time. trial vast of the majority days and data Holli again, is that gave And announce we think, when you finish on vast, So, the on trial but that before at done we'll when goes it. data while data, preliminary afterward, we XX it's have I so patients. the a it'll really preliminary be we'll consisted the it, announce

Operator

the from at phone questions lines further no this have time. We

David Bar-Or

Let's few that There's been the off we've webcast. take here since a talking. a in few have come

Let go through. just me

or emergency be statistically Here's until it is for basis the applied nebulized safe wait or of Phase trial, positive and authorization for on X? Phase one. results X use Phase to significant X mandatory Can

Holli Cherevka

question. place benefits use Thanks studies. to weigh to Emergency data you can is that demonstrate the Phase prior for authorization to agency the X in risks against completing your so the the

So certainly, at to with we emergency discussion application. authorization I use FDA of discussions We've those review early Mike, any would on be every begun in and phase working data to update, recommends as the provided in anything concert our the add. development earnest, FDA

Mike Macaluso

That’s it, thanks Holli.

David Bar-Or

treatment trial with respect the With or time to symptoms, specific to the Ampion to time you of with range a question more Hauler regard the commencement Long little the another Can times for was of ASAP. that the estimate given as begin Here's trial patients trial? possible a symptoms. Long Hauler be exhibiting

Mike Macaluso

the drug, the believe primary picked picked the site we've I have protocol, training, nebulizers, the site out. Yes, is out, is completed the we the

the that we're to So they're – that going IRB to soon start as need an as approval as soon that have submit they're submit to we going to trial, going to submit as that possible. to that's works I our expect be my weeks. next out goal And in but goal. the it weeks. we to few start next way, That's the few trial hope in to

David Bar-Or

Mike. thanks Okay,

their process and FDA anticipate unblinding long take analyze the OAK How proposal? it Ampion question. agrees another Here's does to if with the will

Holli Cherevka

question. Thanks for the

the step any the with in I outlined the to exactly proposed OAK forward as is progress we've on amendment first think FDA.

public the feedback update as completion. We'll immediately may to accept the may do Mike, the anything? soon is, influence as FDA it want and add you they we more. or amendment, which to have the know to shareholders, continue would So, as time on the

Mike Macaluso

from division pivotal we've us because had had to we were We what it Yes, I past completed final more. thought we experience trial mean, was. do moved for in we've the where an then to we didn't another, it's and one have SPA, the critical a

for critical sure No unblinding, SPA one make but stopped we had we from the us we it's to when do So, want do, in so. place is us. what to that stays of

make of data it that SPA the very we good, case, would in that's this to place done was unblinding, sure just But our we important it's So so us. a to in If is if final trial. that have stays it. matter want

David Bar-Or

Great. Thank you.

Dan Stokely

I As we and guidance the to access provided expected to could on the me, call, cash for A update liquidity. expect in question rate? hand have cash burden you

the hand. We we Let's talk $XX.X about year cash currently million. have, with on about closed

business is a about clinical trials Our for base $XXX,XXX current no incremental month.

million. The that part that's to of $X.X about question So difficult answer.

considering we first could year questions as existing stock based as cover guidance is to the of on required the there when without base further go, that feel as the based finished not question question where and these we it's cash of trials trial on clearly, expect it's The answer we the enough from business year, X Operator, at excess for today the needs timing first price need company. – support in the on is and to update that we us more of next incremental harder to the We The are cash Phase harder to dependent we'll through quarter, a continue assessing full quarter well answer time? and phone to cost go know probably trials, ask any into them these we have dilution. the well that, trials So to we as liquidity a cover and have assess this trials, to expanding we to the forward. FDA start dependent. any cost that's to

Operator

[Indiscernible]

Unidentified Analyst

is the trials stands? had up or issue Mike, And/or that stepped Did England and Israel, breaking any up where operator. talked running you are on or away, in Dave past about You close? you but this JD. of the those address

Mike Macaluso

in then the full IV wired It FDA. get hauler Well the this with research a study time first, to proposal long long we us doing. to we're have the our the took and hands inhalator

to IV on. your from to application by in is need So and trial. mean Holly on said, going as guidance glad both is that trial FDA FDA getting we for we that. that's back apply use have just about add of ongoing. us. study. It's for received I The what And behind the order emergency emergency you said, use inhalation and approached What Israeli us here's chance the to a came we and The to we're FDA, it, the

we're FDA to the have about them at FDA few so. have the And But lot It's FDA with we a a of add minor to it's do list. answering the inhalation we Israel sure things, protocol adjust the correspond the So, for our to still adjustments we're what to listening to questions we for the a requirements and and same study add to we emergency IV to but pause guidance. the a minor to-do application. I'm the application use emergency on it's us are want obviously but taking in They with study. asked making have make an use minute. And change, have

think important prepared other into we're But got we've here as partnerships consider to we're value other the to well. that creating and shareholders. there's in go this is I on that And as So, that that as soon for that things things possible. working do

to it it things patients I all concerns are plenty consideration collect enough run We has to data. of is about there's as we're been to things going COVID forward like, all Is And So, you away? trying think don't these there is. we COVID into studies? of we take and patients address. like think those hope move There do. just

look not just That's for opportunities use, have discussions to That's of or So, and it's Ampio, pathogen-related platform or again, learning to to we're ways a meaningful COVID, not we're a our just because when what monetize filing partners. trauma-related things COVID goal. What really for BLA, don't is those a emergency we're inflammation my and and enough talk we us. all COVID, technology, information, doesn't that we whether looking be to have look matter goal. want inflammation, it's to with to about limited showing now but these it to potential and agnostic I for have

Operator

Lala is next from [ph]. Your question coming Greg

Your is line live.

Unidentified Analyst

you? are how Mike, Hello,

Mike Macaluso

staying I'm good. Thanks. I'm good.

Unidentified Analyst

Dr. the because patients. all an of an inhalational as [ph]. I at My to this And injury, the potential name is patients of regards Lala see for anesthesiologist. looking you intubated lung could anesthesiologist, I'm Gregory just currently types are COVID study,

Mike Macaluso

Yes.

patients, doesn't But And limited by It COVID, all spread whatever. So applicable of be We any this this too studies cannot to time, several difference. caused first. make many question. too good will things. are course, much we ventilator-associated that's at do to a very ARDS pneumonia, regardless or on if or it's

with we the of patients be and ARDS COVID course, to things conditions patients do have with patients enough But example, treated have other the asthma, restrictive on will with for in with think patients. many yes. patients COPD, I that, disease, the lung Long inhalation Hauler ICU and

Operator

have from You David follow-up coming [ph]. Folsom do a question

line Your live. is

Unidentified Analyst

[ph] JD again. Mike,

we never date Why something know Israel? trial? in It's any from the we know don't Why when trial schedules. we long always definitive start is do open-ended? when know why on the never definitive when will Well, on we be it Why There's like, starts? never seen answer get well… why have we a certain time So the will of that don't a studies when don't haul completed? always company

Mike Macaluso

tell I'll you why.

Unidentified Analyst

why. Yes, tell me

Mike Macaluso

legal, Day hospital It's and Easter not it that. Thanksgiving whatever rules, like XX, control there's We right. is IRBs, don't X April was training. Christmas is there's and December is, way. work July, doesn't November there's that is XX it It There's

this be X have be to got out a to we've pandemic, to XX the during has to to got of trained. day The hours trained. staff So take It's PI.

I to of training, we available, things. they're as a Israel I about with on tell talking every there give control you back one task? when where am to I number those Health materials, be hours? there When with going the you're asking waiting of going the where decision? give don't issues, to this training to finish they did XX the to me that going to as ship we're me, doctor he those can is to when can the is drug in from us who is When When meet? shipped. IRB drugs? When going When training? soon the slip in. So Ministry When the is hear make

study, months The while XX So last the but year their also could wish of had starting if you hospital all convinced We're trial. that's information, don't patients think control take the go process. how it's that safe take this. mean run is. into can the knee best three the I but that part more XXX to and intra-articular we're But just day. we these one the that and the convince about the a a a I safe to know has I been be mls, would place everybody steps X knee. the I, Think FDA for and it's of ml be I hospitals the before to right, in the the In do. steps trial, doctors run run safe, trials, for exactly, lawyers, go could get to it quickly. FDA injection again. have has when we've ID every treating I doing complications and you understand We the don't steps over it the – quickly. OAK enroll even on difficult too directly most and people to all in They've in to mls put In trial, got assure each doing the We've convinced few show enroll those I best when that to years cabinet, lung. so but or we we an it's likes that so we've twice to got need it, you through they year people the I are the I a we clearly can.

Dan Stokely

We'll done. your little bit platform maybe take a Got more If what we couple be So other for a think And product? this didn't I to couple more questions have a speak we you. Q&A. here, biologics. will one's Bar-Or, any for be the Dr. uses COVID, prospects should

David Bar-Or

Yes.

trauma inflammation. It whatever again, and virus, its addresses by the drug. easier it COVID, feeling saved by platform of caused inflammation, So been caused whether bacteria, by caused it's has again it's whether or a regardless and whether and a

not inflammation. It's addressed pathways other example. biochemical drive like the several in addresses the for So cytokine pathways that that Ampion specific a

most there antibody in an because many did are of For inflammation, involved anti-IL-X pathways succeed, is there not example, are other them that Ampion. and addressed by many,

a as Ampion effect all substitute be and but and Ampion because can in have. condition steroids, that doesn't inflammation So Ampion, where the you are side same has the used in is safety can a effects used, steroids with steroid any where the have issues steroids

cystic would others. be many, deficiency, fibrosis for alphaX-anti-trypsin with used patients COPD, So and indication there is a condition using where example asthma, it using can safely no think is on many COVID that many, with they was Ampion an with patients patients be

are exists So is which inflammation, systemic that no losing protein inhalation, that the but we're not solution at we systemic a for Fontan conditions procedure, – problem said, looking are looking We're post as that. at looking I and the the COVID. of

with is something that's injury So do not kidney the that have that in doesn't COVID condition occurs a COVID-related, and will that also about patients after before It's to into occur pandemic. discuss COVID. acute anything I

same that So looking to prioritize. they other many, We indication do we're at, have many at everything the go have time. can but we and

Dan Stokely

you want did closing to Mike, some provide remarks?

Mike Macaluso

ago. OAK what has in Dan. received proposal gone. for Thanks, or sort lot listening up to on a the Listen you to what that until took – FDA from update We doing time. That to do. the They're the to of today Yes. said, updates again FDA thank we've on listen a analysis the reaffirm of they reviewing week

I'm newest to things forward and we looking when the response. latest slows have our updates the honestly, to bit, to get in done data. And but the you it and looking and us down met it goal get I'm it's and hands, you forward and a adjust So their unblinding to done

all as COVID not been some asks we're the doing have are that up have application things. urge, would in They response and and far emergency that use our to things the had FDA on those up change As us running, running. we received from all

of like care we minor hospital modifications. I'm what The just like we're drugs been and care a or suggest And by something. water sugar way been better. positively and that they standard doing for The like of to the responded I'd this so of glad placebo it standard glad And approved I'm We've they like and/or it's emergency word that. make we've approved they part doing point to better. the question. FDA use it. that's we some use. drugs we're the that So asked is stress FDA also the of

that. comparison results that. – with comparative the And analysis Holli Our suggest you shared suggested

the and in important. we're this important. and other way about what managing running of are related other COVID trials it's diseases. that's these important raising We're some to so that there optimistic indications use is carefully of a learning we're in we're our not drug. That's transfer So We're cash that not money.

as these research doing information, important other clinical data, David's a these and concentrate good had platform that. really we manufacturing. partnering think And that and I'm OAK our we think to not show the because about I technology, I done indications, again, we bed we're shape have on we it's on now. glad So research talks to we that And in can other to put now support to comment have we've trials, data, trials. to stop these talk that And with

do this So you with soon We'll information to very call. you, you much. share it to the do we updated. have that's as as and further thank for keep want And you regularly I immediately. we'll Thank it. guys

Operator

ladies conference you, and does today's gentlemen. Thank This call. conclude

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

Ampio Pharmaceuticals (AMPE) 4 Mar 212020 Q4 Earnings call transcript