AMPE - Earnings call transcript Q4 2021 | Ampio Pharmaceuticals, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day everyone and welcome to Ampio's Fourth Quarter 2021 Earnings Conference Call. Today's call is being recorded. At this time, I would like to turn the call over to Mr. Dan Stokely, Chief Financial Officer. Please go ahead, sir.

Dan Stokely

to call. quarter welcome and financial and update business everyone, Ampio's XXXX fourth results Hello, is Stokely and name CEO, Holli My Dan Mike Chairman today Cherevka. Martino; and by and President Chief Officer, and Operating I’m joined

fourth on released March was under our Eastern and website XX, earnings on found Filings. PM today can X:XX ampiopharma.com quarter be XXXX at the Our and Time information XX-K XXXX Investor Financial Section

our contain business. remind to our that forward-looking like statements I'd may about begin, we Before this listeners presentation

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

Now over Chairman Martino. CEO, and the Mike call to I turn to would like

Michael Martino

Good Dan. everyone. afternoon, you, Thank

pursue Before this compliance would to organize and Liz our Elizabeth like addition to legal our are I I to experience. of has and as application welcome Her the and proceed, essential of partnerships. opportunity three take we FDA, Board decades biologics strategic skill with Jobes correspond our nearly future to set Directors. license

have joined to are Board. pleased the Liz We

weeks of the we AP-XXX to few discussions Frankly, a as ago, the X, status on on Just March hosted our weeks. the you in has much past not expected, discuss update changed COVID update and status few you and on FDA webinar disclose of the with a trials. data, and

FDA data, the from a So, we focused X,XXX visits examination of targeted missing begin, impact financial and sites material data. amount and updating in resulting major conduct our follows. a patients prior a X% specifically a regarding data. trial, the results, population approximately patients. population analysis enrollment of and the mITT proposed we approximately the trial AP-XXX FDA sensitivity versus this Consistent to during study a the takeaways and of pre-COVID are two what call and to evaluate and the a outlined impacting summarize believe -- treat plan with an plan and of patients The efficacy a analysis missing with determined study that call that in on impact protocol, there XXX unblinding with patient we To We plan with have have with be in Applying a had AP-XXX will XX% AP-XXX we recommended X,XXX analysis, the COVID-XX in statistical This questions. intent as material of the fact, trial. COVID-XX like data. efficacy in N we determined missing on on a to quick populations, COVID or I'd the modified our status refresher, discussions documented assessment study, were, which and the population, patient to answering to webinar primarily following. enrolled detect

First, given statistically pain missing and which not amount significant of either or to for surprising, is frankly treat data mandated the the was imputation. function, intent large not

intend to function. weeks over for improvement statistically XX at modified without both modified trended and weeks treat statistically functional significant statistical to XX pain Second, for intent treat Furthermore, pain significance and toward was significant was for function.

patients protocol Finally, demonstrated XXX and superiority an statistical function. and per pain both analysis, of N for the

cover these that in the Holli And to point webinar. slides archived points our website. I prior detail the on with you Now, in is recording

submitted to that request, have we The has are AP-XXX request on to have to track the of accept this answering I communicated FDA in want clarity on previously these analysis the first support half C that a FDA trial of BLA. question writing. year. the our to question central of in we and confirmatory committed reported, trial whether As questions acknowledged is to end Type that has meeting in by reiterate meeting that FDA. the as a in AP-XXa will a request

and on you AP-XXX, trials, AP-XXX, update our to three want active AP-XXX. COVID I Additionally,

Before our update AP-XXX. doing I studies, that, want and by COVID in to AP-XXX the first highlighting two in however, data this context put

XX in arm nearly care with mortality reduction of beyond studied Ampion and conducted with care and in IV As of versus standard Ampion difference inhaled XX, XX different in the XX distress standard very rates standard of a study versus patients respiratory studies prior to in two landscape. demonstrated a the care. in a and no versus XX% between reminder, the AP-XXX AP-XXX, and arms. patients company COVID AP-XXX demonstrated mortality

with for been to and date analysis enrollment to to patients treatment IV a The Well, re-estimation. on interim up current supports as profile of Ampion So where complete. are Ampion further patients is sample we AP-XXX interim study studies? evaluate with and The to designed AP-XXX XX safety size planned observed COVID-XX excellent and severe analysis IV was follow treatment administration. firstly, of a IV at has XXX

However, the to from COVID drugs approved date other in changing nature slow. has to drugs increased due trials. enrollment both patients is well both for of this trial been as as And competition clinical and clinical

in sufficient in have the addition, patients not the observed signal treatment enrolled in In we arms the XX study interim two simply analysis. between the differentiation

planned take power benefit. to analyzed next expand enroll IV patients in use to for of while have AP-XXX, Therefore, these given stopped have demonstrate would to a Finally, further significant determine steps and it more to clinical we the in data clinical Ampion. completely countries to sites the and XXX the originally money factors, time the increase enrollment than

with in and steps AP-XXX will Ampion severe again year, communicate patients on Next, second designed track the determine was complete analysis of study. completed first at a quarter for to re-estimation. COVID-XX XXX interim evaluate to time of was We're sample as by patients, next treatment, data and to for with up the up this enrollment this Planned size which inhaled XXX analysis follow to end an quarter XXXX. AP-XXX the of interim the

and home beyond efficacy XX have this reflects we was XX significantly be currently observed quarter. care to call of enrollment treatment performing in on from We our death And of next and note our With in The patients to believe for rate in study planned this existed significant patients day which standard of trials to in final CFO patients. back post program. that the impact Dan we evaluations, in like be with finally, analysis which during and this financials. were to study safety the long use AP-XXX. determine that, Once of update XXXX expect designed that patients AP-XXX first then completed I'd the XXX in steps lower and Stokely, enrolled December evolution AP-XXX communicate planned in COVID turn enrolled results, COVID-XX the We and on the a at the seen. we've to completed we important fact evolution it's AP-XXX to are the However, AP-XXX will AP-XXX this XX inhaled initiated. to care than remains

Dan Stokely

the of totaled XXXX. Mike. million primarily offset of net on loss registered the fourth offering increase for XXXX, in to of December offering year XXXX fourth $X.X period. the million. Research loss was December XXXX million million XX-month the $XX.X from costs operations the year of quarter, December the market overview the a to XXXX the XX, program $XX.X for of an in This and and the compared AP-XXX and non-cash throughout for XXXX. operating attributable primary studies, year-over-year December These the to and for XXXX with quarter of professional $X.X year year The a quarter was increase expenses for million which the fourth ending expenses for net XXXX Development $X.X by following and XXXX. to million used A increase Cash as XXXX cash drivers the a share-based and and General for stock totaling million partially is with for was X the million results compared XXXX. million the realized services. initiated associated and the periods fourth for million the primarily fourth follows. at of The Phase the $XX were quarter December This $X.X received the December $X.X the COVID-XX from for continued driven advisory XX, equity year, net associated quarter million were costs quarter of XXXX direct by late common XX, from of in legal proceeds increase million equivalents for $X.X $XX.X net during million totaling were the of for XXXX, administrative the of December for the loss We quarter, million Thank $XX.X for fees were X with XXXX reduction million offset XXXX and variances with along our are period. $X.X which cash XXXX of million the as XX, compensation, other XXXX to breakdown compared $XX.X XXXX was sale key compared XX, increase and The and ending a in in the compared to study costs incremental ended $XX.X ending year to $X.X closing you, $X.X partially activities fourth in are year. paused compared $XX.X and to fourth XXXX. a million, XXXX of proceeds compared from of of

half second to the We XXXX. now with that into the will of expect cash current position Russo call will fund turn Nick over Q&A to I coordinate our the Johnson who would operations like session. Partners,

Nicolas Johnson

Thank Dan. you,

order must will As be a conference the mode. only participants as in call connectivity listen-only in will to internet have questions webcast. questions, reminder, line addressed The submit via be

get realistic to and First the of timing question, all FDA what if smoothly approval for goes is a Ampion? use sale

Michael Martino

Thank you, Nick.

I the timing guidance end realistic would first of the we've by the on clarity based think be provided half.

to that. I achieve think we're on track

I BLA have some submit months. is and required communicated, at companies, the a for recoiled large even previously that but As reality this, XX typical you the of time pharmaceutical about is know to

have we process. we that on believe Now a jump

that that be begun completed expect to what from we year. of that place we've guidance schedule. in to indicated that and given end determine help As next and communicated, BLA, QX partner potentially called a resources is, a to of We've also for what what's accelerate and gap have assembled would we've remains us analysis we the

I of many, for for has to Finally, simply typically time longer again, those And sponsors' many period development, up a XX think not months with on drug taken that's COVID, drugs. to approval, take beyond and drug approval accustomed specifically can control. that time

quarter for safe So, up of is an next approval the of and I take think cycle a a to of year. year end BLA assumption second to submission for

Nicolas Johnson

the handle one do for that the question? a different for will me, Next or long-term same for question, of one different medical Ampion implementation COVID conditions? Example you anticipate partner

Michael Martino

I to And last hand the in on a this at And Nick, have appreciate actually and provide sizes, this in agreement think be which once to point, flavors point the position shapes I have of is, all repeat table. question. at potential are heads what said time, on announce the think call, I partnerships we'll of and that, in can we clarity. better we I

Nicolas Johnson

the for your with for Ampion trials? completion and COVID-XX moment, COVID of COVID-XX at Next cases in question, long the [ph] dwindling down current U.S following what the prospective plans are COVID

Michael Martino

of is better we again, in think the completing example, vaccines. the weren't are we for is that to has X suggests is of that One One treatment very, up have the trials, of an initiated rapidly. of totality were question since XX, once thing pilot to initial addition three landscape be studies Three that's We're XX antibody. COVID course monoclonal anti addition, answer two for there process that significantly research, Well, neutralizing current use that market trials. from and when some and a virals, clear, the the the I we conducted. are in that data we'll evolved conducted prepared a available available the externally is new very And initiated ramped drugs COVID to XX, those of four that anti inflammatories. are

what that Ampion I in can the administration profile Ampion And IV in for pleased that very think trial. are encouragement, route. with administration this at fact, clarity, say our a time emerged that viable that we gives with of us IV is potential So, safety AP-XXX I is

we will opportunities. continue the two initial I trials. we've And until update our of market to data we of analysis need as course, to the completed part evaluation wait that in the of of think

clarity So, wait I think year provide before this can until unfortunately, the on about of further we have we to that. middle

Nicolas Johnson

to question. and on additional plans there other of forms arthritis? Next Are other any joints run trials

Michael Martino

approved protocols this run have no. trials. not tangible We pending plans, do At or specific any clinical additional point, trial to

from and of joints. and potential will And we with actually partners, can in of applications pain excited from possibility about input. severe expansion tell the both of discussions knee to I that the are osteoarthritis very expand the significantly internally treatment think other accomplish I that in Ampion you osteoarthritis of benefit to plan articular However, treatment partner to

I be once so provide that’s to again, later on able will in we year. think And the something clarity

Nicolas Johnson

'XX? Next between 'XX QX differences question. QX and Do you earning see any potential

Dan Stokely

Nick. question. Hi, Yes. It's a good

expenses, and look at to current the had of you one at compared in -- prior And QX year. skew our if of the vested spelled were quarter the XXXX about you out there of release, and earnings we even fourth anomalies issued restricted in the earnings we large year, and fairly one prior our press release, If And a of per that, those release, issuance was quarter. year. in are units was, some XX% significant in look as stock we a to the non-cash large vest put was upon and the the piece those that

So, quarter. there an would on fees professional that I in is more to There cash weighted costs the fourth be the quarter. some also in fourth consider of acceleration was

a side, specifically have XXX was On the in enrollment. to markets, and program, the quarter, the uptick COVID the as fairly R&D public has on XXX. we substantial completion there the XXX on And finished of enrollment fourth said

to would And the as then probably on lower the into expense. cash non-cash the so, standpoint it burn account And be QX would slightly perspective that the slightly be of taking rate in well of expect because a run from non-cash I acceleration lower.

Nicolas Johnson

between you From the question. modified explain submitted the the two please Next AP-XXX FDA? the can to study, studies difference

Michael Martino

one Sure. The say that the review modifications BLA based protocol. treat difference trial I the been wasn't specified proposed a intent protocol support Holli accepted has study the to by to studies the would submitted trial and were to two XXX. agency on between to submitted per ask the would That modified submitted, the endpoints modified. both I in the as first and first XXA, FDA, that to

Holli Cherevka

two protocol well and the account target population, populations includes ITT into intent or To submissions the FDA, treat not the the includes discussed, Mike. a just COVID-XX. to are as to by of elaborate and intent modified who the per what on treat population protocol those evaluations a as proposed proposal said, to AP-XXX to indication with take Thanks, and the patients you impacted

Nicolas Johnson

question. Next

clarity FDA? on focus management will on what we with So, wait while the

Michael Martino

number waiting for we answer What I Well, as will from focus indicated earlier, FDA. one, on? aren't we the

room document. on on the a as We of I plan answering from and then forms I both research our to access excited would application we've questions partner, them more and important the terms interest approach partners. of we even joints, required what clear will OAK other our perhaps confidential in three, keeping to as two, fill update are finally, Ampion level our though to are are hand, are takes Number OAK indicated, a we the the process. to, confidential of follow-up development. market. give don't giving part that to our that development pleased level expand do to and our we the to ourselves, And and about other that successfully been we And be market, that, other data pretty product not on data to that up assess launch perhaps and/or negotiating for one up And with issues the we confidential in a lot joints. of very potential been our those other understanding to fresh. will interest on clear BLA, hope it's And beyond related issues, that knowledge appreciation those be think beginning assemble undertaking plan very dosage that in of and we product of get conversions focused. formulations. from characterize treatment and the opportunity I time gaps are Number the to discussions, pretty And

today engaged X coming me heard I corporate X on XX-person that, the we for say year. would team. well And very So, team goals before are you've key is say a that that or

Nicolas Johnson

session. That concludes Q&A our

call now Mike remarks. the Martino for turn to will closing back We

Michael Martino

we've and I’m if to progress the good I really want of maintained I QX move proud of that into hard progress. believe And their we updating as everybody, Listen, momentum next as have I in the here value lean QX very feedback Nick. delivering team we, XXXX. this make call specifically summarize XXXX made being increased anything, you, forward Thank extremely of from inflection and, FDA. progress. from on continue the to we next so, optimistic, I, and about work am you our look to future cautiously point for and

please you, thank everyone. Operator, So, the conclude call.

Operator

may You for you. Thank lines. does disconnect call. you This Thank today's conclude your joining all now

Ampio Pharmaceuticals (AMPE) 29 Mar 222021 Q4 Earnings call transcript