Ampio Pharmaceuticals (AMPE) 11 Nov 212021 Q3 Earnings call transcript

Good afternoon and welcome to Ampio Pharmaceuticals 2021 Third Quarter Earnings Results and Corporate Update call. We'll be the event specialist running today's event. [Operator Instructions] As a reminder, this call is being recorded and all listeners will be on a listen-only mode. At this time, I would like to turn the call over to Mr. Dan Stokely, Ampio's Chief Financial Officer. when ready. ahead go please you are Dan,

team Hi everyone's our having you to very thank executive pleasure we'd of today. I hope much and management the a of for me each certain everyone, be like and present And thank for members to you team, great one day. to reading Harbor forward-looking executive statement, attending our and will earnings of Safe XXXX who to business update members would and/or the the like introduce presenting third quarter call. you the Prior participating to today. call be I the on It's

Holli company's Officer. is and Chief First Operating Cherevka, the President

also We our follow-up like responses out The forward-looking by Founder Howard and and any Chief company's myself safe contain statements presentation about first Dan on reading to Medical start our Chief the harbor I'd Officer, have Stokely, statement. to David Officer. Director present Dr. may Bar-Or, the business. Q&A Levy, Financial

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

capacity compared of I net is gain The September of net the totaling offset The to On three $XXX.X $X.X loss which common quarter. was million general of I'd million. development September call equity $X.X million and XXXX about under by residual average warrant primarily the issuance million and offering partially million operating XX, XX, of to the includes $XX.X net respectively. million. provide $X.X also of to due program expenses was gain loss was primarily the fund which our from a non-cash required in of the discuss due September to expenses decrease of million attributable at-the-market million. million XXXX. lastly, was stock options but under nine stock increase shares. million $XX.X net to derivative $XXX.X $X.X first XXXX $XX access And commercial XXXX. insurance financial XXXX and to net increase warrant or million during of trial exercises and a the program XXXX and ATM months a months is and gain ended ended million million by quarter the Now, XXXX nine-month cash quarter to net proceeds months Ampio loss period expenses and million, September million, the for net a three last there XXXX the projection, non-cash $XX.X partially million financial XX, for and loss XXXX primarily the of non-cash to on XXXX and increased net million was a to research quarter operating nine compared over or $X.X loss three Chief compared The $X.X and net our XXXX The attributable offering expenses a attributable driven quarter operating to the period decrease offset shares operating gain quarter outstanding of our the for XX, a to period forgiveness the clinical current and exercises September to months utilization of the shares XXXX for $X.X the XXXX, by now and as on the XX, to costs, will the the approximated business by pipeline which operations million September offset loss million driven XXXX. of net primarily cash Officer, $X.X update. of period was XXXX for attributable programs of during partially XX, Operating period. company's partially I'll The from to business like our $X.X The Operating of compared decrease a ended $X.X million $X.X compared the XX, administrative for loss option period share Holli to equivalents attributable the by million the cash The limited shares in sufficient based and $X.X clinical derivative update cash an the partially And the XXXX. million. million turn research accounted ending primarily $XX.X price Cherevka, provide by nine as equity totaled and $XX.X of or $XX.X operating derivative administrative who decrease December derivative of XXXX approximately months and a would of were XX, realized increase $X.X results $X.X loss loan September received offset in fund Cash million $X.X of the of recognized development expense for expenses about XXXX, million. matters. on to $X.X to or which our recognized Ampio's XXXX and was not operating quarter the PPP the during expects $X.XX costs, which like the XXXX costs. research costs. XX, offset and million, non-cash loss through to in during on as XXXX, during $X.X compared other million ATM XXXX XX, $X.X $XX.X XXXX decreased in legal to a ended We ended of of period and We December to September activities attributable of for business President expenses approximately the the equivalents, company to an the the million

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these from Medical Chief you company, an the updates update the for momentum With to our my is forward introduce it Officer. continued from Dr. Levy to and pleasure and progress

you Thank so much, Holli.

Firstly, I'm of at in Ampio. the delighted Officer Medical to to point be role the Chief

on to protocol with has as complexity. for to clinical versus intravenous, heard underway long India be formed AP-XXX five accelerate is the to choosing strain added enrollment to and trial where the that and safety participate a strict of COVID well undertaking We by treatment the in Executing that of COVID the GCP clinical the currently onset for is adherence inhalation monitoring can that's we and additional means a efficacy and of Ampion supply of enforcement treat. haul are XXX% and strict interaction, participant We've needs protocols, trials as evaluating starting group the nebulized capture is This trial in and practice. as well nursing time trials using just India Ampion underway. three placebo clinical always there have competition and safety in as all difficult particularly to good inhaled COVID, severe lines physician data, of added age enrollment for clinical roots infusion complex days you've delivered that

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Dan, moderate I'll question-and-answer the that, will with call who the now So to turn over portion.

Thank you very much. Howard.

require into Q&A the that to going Before by communications That's I'd go all not information, immediately, media of be first provided and disclosure tell I like X-K. forward information done [indiscernible]. disseminate going utilizing going effective everyone the company an to to non-financial section, is

accurate quite question be way discussions know, So Q&A most with an But -- that ongoing into would the and few to it's and we take go previously And the we I'll with one. there I'll been has as You discussed, is know, your potential we characterize you process. see, a that what as here. first questions said, the partners? active

said such the more, pleased when it's we've very you interest You time will we're before, disclose as know, are of and we -- at level we with appropriate. know,

affected assuming do is question levels, take their that? new data the Next partnership interest want levels. I'm interest has or partnering to you Holli, how

action is latest at going mechanism interest database study. century. novel osteoarthritis a to of as and the this on of time. that quarter an with nearly locks in is groundbreaking after process the beyond at in a been therapy of before expressed development ongoing the not the and development We're a believe in This speculate phase has mentioned AT-XXX both We Ampion company Sure. drug Thank you, Dan. the first

the they prioritized. to COVID to and your do Okay. The is, want you question next you how Pfizer COVID full results do that? incline rethink David, Merck do take program is

Sure.

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no the our affect your drug and of So it not prioritization to the question, answer will program. --

Thank you.

do is, significant trial the a relation with and Holli? one Next of position to the compromising as probability early you pandemic your feel FDA. in your SPA

health We know FDA to that in to this that is the have we XXXX. until with we discussion FDA know the of forward course. sensitive first discuss half we which is trial regulatory followed the to have impact answer with COVID-XX believe we meet do the the plan guidance of a path the and reality FDA, will of clinical emergency. with our direct question under not What we The including guidance

you do It take that question. describe you with generally FDA? looks of Holli, want one? general meeting the a to But process like can the for more

formal FDA course. process Of sponsors. between guidance on and the for the is meetings published There

outlined scheduling of type the following are related process this In the timeframes be meeting in will general, guidance. We requested. meeting to FDA

requested receipt For request. example, meeting to be to within occur of XX the a days may from XX calendar

calendar the the within or respond said expectation accepting of meeting will to either XX the With request. rejecting FDA XX days

will and I'll the What last your be XCC that. take This one. manufacturing facility the of capacity the Okay. equivalent is in virus?

in Our the virus easily this be can to facility, share projected it company in that the can annually. here remarks? this geographies. range Holli, you a for other feel keep is mind, know, have osteoarthritis some we closing replicated, from based produce X capacity XX about of one market. on And, upon standalone We this manufacturing provide want in in other you facility Colorado certainly And into the locations in that do to sufficient basis in million [indiscernible]

certainly to you, Thank entire And time an It a thank unprecedented Yes. Dan. has the been on global you team. scale.

encouraged the demonstrate OAK additional space remains progress patient in delivering move by for an unmet program the need preclinical population. to autoimmune focused the this incredibly asset by OAK against for launch to shareholders are an in Ampion. We value applications underserved COVID-XX and fight and are Severe forward, medical the realizing on program we

guidance its in regulatory able patients, move mechanism with early action the demonstration efficacy critical cadence FDA respiratory and distress. of drug, been a potential we Additionally, EUA. and This investigation for of for safety in severe efficiently on allows Ampion COVID-XX which has presented biologic the due to to COVID-XX and as been for unique to treatment process have swiftly through regulatory patients

this for Ampion. and in-house hard immunomodulation alike. space. and The Thank peer-reviewed effectively everyone support continue data We progress supported anti-inflammatory team quarter. are to team options inflammatory development to preclinical company and and this announce is active titled Therapy our as label We Infectious at scientific by expanding to mentioned efficiently manufacturing. of a excited remains the to The earlier. journal and robust scientific in in applications clinical work continues for provide treat again Diseases the shareholders research This on and look therapies which advancement the and manufacturing to treatment you preclinical today. prevalent each continued The remains limited providing of updates to there value are and immunology-based of tuning forward on patients conditions to focused publication

today's gentlemen, concludes this Ladies for you. and Thank call. you Thank joining.

your now lines. may You disconnect