Recent NRXP transcripts
Associated NRXP filings
| Eric Goldstein | Managing Director, LifeSci Advisors |
| Jonathan Javitt | Chairman and Chief Executive Officer |
| Randy Guggenheimer | Chief Business Officer |
Good morning, everyone and welcome to the NRx Pharmaceuticals’ Third Quarter Results and Conference Call. Currently, participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference call is being recorded. I will now turn the call over to Eric Goldstein, Managing Director, LifeSci Advisors. Please go ahead, sir.
operator. you, Thank
are with from everyone proceed are I like results These would statements that and Before cause experience could certain the or statements remind actual statements laws. securities that U.S. differ call to made to risks under uncertainties materially we to federal call, subject historical during forward-looking expectations. this present
the filed made cause with in revise XX-Q, statements of this obligation this contained factors the concerning release the from in maybe date update or to results information our Information after forward-looking actual in statements. periodic SEC. hereof that in press accessed page the call closed company’s the the market could reports call no The made which the this and Form is call NRx from as Additional is on speak presented Investors and contained statements of the website. undertakes to differ during yesterday company only Pharma forward-looking the issued
me are of Chief the company’s Jonathan from review Randy financial Jonathan Javitt, NRx company’s for will recent summary during and the today turning before the to weeks, over Randy Pharmaceuticals provide Guggenheimer, for NRx. progress and Officer and a Executive call quarter Chairman on it of Joining Business Chief Officer today’s a results.
will Following their prepared the turn now I over address management call Jonathan. team questions. remarks, the investor to will
that the an I our as on XXXX, required of discovered have our conditions. submitted. to over potentially lead update respiratory we vaccination been will analytic failure us potential commercial over we’ll our and in the you well press full as late-stage you drug manufacturing quarter areas for answer look joining a ZYESAMI’s This significant respiratory continued COVID-XX was few just at developed. be thank patients to or to a or in and began at developments respiratory in quarter with and the a Thank Aviptadil the we the growth associated March January bedside. forward other I questions. and advancing review treatment your start development lifesaving pipeline programs weeks. And XXXX, will program, today. will illnesses, some bringing summarizing appreciate has this project expenses questions other spend R&D results. outlining never ZYESAMI none in you, answering happy suicidal the for third turn morning, and call your of release making, X bipolar I Eric. with morning, Good operations. acute this intravenous of then COVID formulated Then, use in COVID When recent of potentially methods as and with the have progress we with to and critical of Aviptadil for in We these invested of for major the attendance we we our file and the the everyone are speed, majority point in to moments preparations commercial processes patient’s transition When our depression we dormant Randy financial partner’s this upcoming issued in for
statements speak themselves. financial for Our
to believe files, patients. full pending continuing a in dormant have second the drug’s data approval, this our ultimately drug Our with start have XX may and earlier we avenues shareholders will supported us for confirmatory from a trial, we And months cold rushing support support progress. that
and numerous view, ZYESAMI disappointing with for our that in in confidence plans COVID the respiratory November potential lining failure, decision issue on diseases As lung. of alter declined critical our the but Authorization Use Emergency FDA we other the an that treatment of the announced X, for does for or a one to ZYESAMI not damage for treating the COVID-XX
FDA the that nominated the make Biden to forward that us it ones. providing we has their an data Now, chance one loved Commissioner, home they additional FDA to give require to patients look with last President to let
program, survived the that other path and briefed ZYESAMI more Fauci X ZYESAMI in partners from data to decision to its media While a XX, of of patients Agency. Intravenous monitoring their that patients Health recently ACTIV-Xb we of committee. Collins, accounts efficacy multiple and engage treating critically has opened Agency, program proof public NIH’s trial. NIH worldwide safety clear Today, hope made will on private Medicines a XXX to assessments anticipate secure options has and drugs. starting partners cohort its patients Agency, advance to the ACTIV-Xb has the to in small in more as medicine presentation we candidate maybe global than candidate can home number September Medicines the lost. only an futility files regulators and NIH test ill in-hospital to unique when find a have person gave patients, XXX and the than with toward enrolled United ZYESAMI of active the Phase with has Brazilian all which potential approval. Kingdom the and a by first passed out earlier ACTIV-Xb he an safety trial continue in NIH regulatory company Phase families with half Regulatory and COVID run House otherwise ZYESAMI’s safety. Regulatory and European X ZYESAMI independent who one Francis provide identified dozen our we to the of in you and now about regulatory constant the of Congress targeting have therapeutics multiple a Dr. then On it a from ZYESAMI Director and NIH of seemed ZYESAMI, NIH White unproven who for Dr. targeted of
additional such take QP have review Qualified reviewed manufacturing, data. a allow ZYESAMI, and Kingdom both the and trial of the the or United manufacturing approval supports of our Brazil, other provide worldwide to using COVID will on treat that use of ACTIV-Xb without CMC, in commercial drug help behalf development for track attack of for our trial Therefore, the reviewing as ZYESAMI the rolling fast non-clinical of module FDA The application. to our European safety efficacy and to and conditions elements and Europe, foundation NIH drug will to myriad agreed Because medicine. Now lethal treat have commercial be toxicology ZYESAMI, new scale passed Person of files we that for product also plans designation our The NIH the FDA review to inspection, bridging by lung. future regulatory in scale a advance studies. opened our new ACTIV-Xb potentially to
to currently a chance ZYESAMI continue to approved believe who We at those exhausted life all respiratory therapies. that with offers COVID-XX have failure
critical in and function. reviewed publication of COVID-XX. lower for reported demonstrating standard Both a and the and similar far treatment label our adverse under events. in meet than approval based drug new letter of and DSMB the present expanded we treated ZYESAMI from for those ZYESAMI in more cytokine COVID-XX. A its already Patients findings the patients, into in XX of seen ZYESAMI randomized oxygen this received to is the of as improvement applying improved no prospective participants data again patients Methodist results treated probability This upon of found the nine-fold we ZYESAMI the from improvement of from approval We review trial levels patients blood Monitoring for expected trial. initiation with surprised those respiratory those or open cytokine a of and with third This highly and XXX are half improved with ZYESAMI the with scheduled FDA decision, access of the role in In August, that with from request Aviptadil significant patients In clinically right of XX% Houston their continuing on review Phase ZYESAMI the recovery patients legal care in IV survival bring treatment demonstrated of that did two the announced FDA’s new Aviptadil failure. coordinate trial. more Xb/X findings are clinical was survival and placebo. People showed cytokine reviewing decision On safety recovery total remains trial data. from lung or compared of issues was review basis well us treated respiratory with failure treated distress to participate treated of analysis day the X, in survival are peer of treated a approval, serious among than And who October, to treated IL-X patients correlated well more additional consider in XXX criteria. us concluded intermediate to the effects trial a In those not NIH Board, safety nearly and XXX additional announced wait endpoints, lethal similarly federal controlled patients pathway. critical we study our XX% programs. of COVID-XX storm days advising we November the stated in this is no asked patients relief the available our within to the storm with respiratory were with significantly XXX us Safety prevention state that Hospital. Patients of under statistically part COVID-XX. Data indicative in their as review new of than with of accelerated of which NIH aware While of the only at advantage ACTIV-Xb therapy, after from with in trial trial EUA the physician’s cumulative to those under is administratively who which for FDA on
enrolled of the treatment. ill had Now, patients them in results these were being were Infectious in in randomized disqualified our morbidities Diseases it that noted that should published from too These Journal acutely and trial. be
asked IV Large this review we has the inhaled inhaled component from we monitoring NRx. trial FDA trial formulation, trials the these And COVID-X for of of expect addition committee a the of of the for by inpatient to The future filings. data In ongoing as sponsored we presented. trials versus anticipate to by data end ZYESAMI, in placebo ZYESAMI also this quickly year. of the to IV data first and was our data currently may additional as more emerge regulatory those commitment working are are data. FDA those data to support underway can. reviewing expressed that other supported trials to The and as generate a information us has delivering us with it’s FDA And committed federally of we
be will Let ongoing commercial an COVID improved preparation there we severe on ZYESAMI, time. forward this with me are we turn we to because the some preparations treat for our moving to for And where need of drug. accordingly, for are believe commercial therapies
Cardinal third-party with and contracted logistics Health have We commercial for services.
IQVIA with contracted also authorization. for pharmacovigilance have potential upon We approval any or
Pharmaceuticals been for manufacturing for has analytical this as medicine Nephron and project of clinical emergency, in that and from developed. manufacturing a We formulated In allowing clinical methods unusual that later, West that public X trial clinical FDA only medicine the during manufacturing XXXX, in been March use. South actually are the of ultimately, bedside. announce has shelf-life discovered us and is pleased to clinical days. Carolina. for use making our or three were of year with inspected Columbia, quality have never and ready quarter, a initiated finally patient’s twice drug intravenous scale investors manufacturing to XXXX, none developed of we When the stage we the in delivery batch week, and health took we the FDA And an required XX pharmacy trials, early commercial and Because the and trial And with that XXXb of validated keep of doses drug to original a the handmade September of a commercialization up formulate widespread the sometimes week XXX per in to this step means Aviptadil a an demand. processes or evolved of we stability. medicine we ZYESAMI for have partnership order methods times support with proving Nephron to that every proprietary batches with began
clinical our of work to up We with shelf-life we days, ZYESAMI, for we able Aviptadil of able restart substance Aviptadil its suitable commercial the an of longer national the of history, had a doses are new of manufacturing manufactured XXX,XXX We been only process release When making batches which the but every initiated were and into X Aviptadil, which old to because to gram is nor process scale doses drug even to Aviptadil Thus never stockpile. is inclusion to single a for now manufacturing a with EPA time at capable the project, was process feasible XXX,XXX get in we trial, XXX partner possessed now development. commercial-ready in ingredient this continue drug. itself begin to to us no is neither that of months extend. first that guidelines.
the assistance U.S. doses to for proprietary Polypeptide million design a substance ingredient, the a With implement our of modern, partnered Aviptadil X government, batch. of California capacity drug delivering high of grade GMP for we manufacturing process in the with drug and Torrance, Group process capable
this manufacturing our Aviptadil run receive drug from process. substance to about are We of second
rolling and we and afford expect and Other peptides natural obtain of protection. human protectable us supply on processes, module includes investigational and over NDA a which ZYESAMI, peptide other on similar the built body to This of property have from the and a In manufacturing some believe we is to prepared natural the exclusivity likely intellectual patents, methods. now vasoactive revised is scale confirms review module have will manufacturing ZYESAMI be growth for process that as and drug ZYESAMI. that to we analytic and the incorporated which intestinal methods regulators. of forms FDA patent we in supporting is of commercial a insulin above data valuable property by submitted protectable that FDA’s peptide proprietary not benefited hormone from will such Aviptadil all intellectual our of the Nephron a that are new October, Although we
lives regulatory was trials safety and UK, simply to emergency have local for will in requests standard evidence neither ZYESAMI efficacy that the States. the the ZYESAMI the health and investors evidence Practice that continues manner or partner a was requires The a legally both not were Without standards ZYESAMI position or from for manufactured until ongoing regulations. those the territories. last be EU and public Clinical existence emergency submit Europe to is medicine sufficient. or UK’s Unfortunately, right manufactured United We has we to meet claim and introduction a no alone in daily Kingdom. introducing public any trial been try GMP supplied nor in received clinical to in that obtain to UK supplies into A multiple was Good Manufacturing application to supports for there use in on basis. manufactured about or meets Europe United that and and inquiries where data to safety and handmade adequate efficacy of month,
that Our facility. the a U.S. inspected GMP and Emergency standards our for the application requested implemented was the accept accepted are Authorization by ZYESAMI to the manufactured in NIH FDA Nephron. supported FDA data waiver Use EU authorities to from from to manufacturing in
is liquid rigor. was request sterile injection high this to in enter core the passed a airlock plant plant. clothing requirements this to of EU as EU change second their operators sterile they and intravenous granted. is ZYESAMI technical difference and intended level particularly product The not twice between of case that a However, subject for the therefore and requires U.S. manufacturing the protective a through
EU inspected Alcami and manufacturing full adverse European and completed Person manufacturing the Incorporated. EU by or during make demonstrated To a declaration record UK with ZYESAMI product inspection the from month, conjunction regulations. is a And EU. we Last we the capability facility the into and our the Alcami authorities available each Europe standards into within the no perfect its for for Qualified airlock of findings. EU. introduction requirements requested the release an a meets responsible or in manufacturing compliance on manufacturing behalf, that regulatory authorities residents the waiver EU auditor to stringent our in required certifying with provisions the for is A QP sterility all FDA the second facility EU a meets released at separate ZYESAMI from when auditor on their that the Although required despite QX, more established facility, imported the required of QP with batch medicinal
drug met anticipate of have UK EU, ZYESAMI UK that Meeting of support EU ACTIVE-Xb phases to the these and deploying apply its we use manufacturing of standards approval regulators efficacy ultimately the people immediately sterile territories. in Brazil to UK and safety ACTIVE-Xb our ACTIVE-Xb United for and ZYESAMI, that the of will the live UK Brazil the and product’s enables will emergency and support Now QP is manufacturing for who now Kingdom Brazilian for application NIH We in passing and Europe, trial. audit part the and by NIH in completes EU while us territories the EU, requirements, these led the ZYESAMI as enrollment.
for We intravenous the knowledge, no stable council manufactured with international Without filing drug, the that purpose. be manufactured To standards. the have a made. expert formulation there inhaled we regulatory regulatory company and EU of retained in our best only inspected Aviptadil was of to are to
shareholders to taken committed and in drug same with there both made remain the risks in drug do of life-saving claiming would bring to respects the and mediating have rapidly contributions and patients. moved to face that unconscionable. to of Therapeutics otherwise a we pandemic companies agreement our our Now, manner resurgent collaboration a Relief time, be forward more register that by At the this worldwide, is is lives we everyday, the
based of Physicians. data Health Society Ministry by granted of National examination the we As announced, Use Georgia us Authorization our Georgia’s previously of of on Nation Emergency
the end, new formation anticipate government. Georgia’s We revenues first continue by of to pending year
health region with other in active We in and shareholders look future. countries several in the conversation authorities and are the to neighboring forward Caucasus updating
allergy-related are medicine plan In Sami bring of distress ZYESAMI XXXX, by to was we continuing in We patients. launch the to Saeed the sepsis, launch which to Professor future, to to aim research ZYESAMI trials invest pneumonitis, clinical FDA syndrome by to treat might to of acute ZYESAMI trial that role In treat Aviptadil sarcoidosis, off-label more of used pulmonary and this inhalation anticipate we and dream XX,XXX caused this checkpoint original the inhibitor, a his to learning other conditions team. respiratory the treatment variety for a play conditions. lethal in ZYESAMI smoke has been we also of Americans according than of about more testimony setting. and acute
We are make impactful both patients medicine both live for for working our digital medicine several that partners make and dosage convenient with forms room to and more and longer health new design more especially at temperature. will convenient that patients solutions our will
quarter, This by the ZYESAMI trials. the and medicines During health investors for Authority, in advanced track was of to Israel private Ltd. partnership BIRD Foundation the State originally medical used clinical enterprise with engineering we Department, and of compliance in Innovation ventures digital KGaA our the of Merck PillTracker inhaled with solutions results funded the U.S.
deployed clinical We capacity. blood a technology trial that and PillTracker inhaled FDA. the PillTracker’s we originally measured as of would would filed Boards medicines, was by pills oxygen use the was ZYESAMI year benefits, Therapeutics recognized by our use our and Although time our IND mutually at adherence capsules, in we inhaled envisioned such with technology track Relief need the improved around anticipate form to and the and for simultaneously solid that selected of Because dose i.e., be end. ambulatory inhaled technology PillTracker’s NRx
explore use convenient inhaled that we simple their at have for delivery in carry formulating encouraged of compact, as means system, made Corporation use, insulin partnered to to to MannKind need product ZYESAMI use room we Although system means of in administration with patients that device. we a August, believe stable the enabling MannKind’s Technosphere ultimately in will patients the the and a supports is that of Accordingly, have we are temperature. continue by a progress ZYESAMI intravenous
health MannKind that to integrate such contains designed as chip PillTracker. also solutions Now able that is with Bluetooth device digital be a to
thin also version a exploring film for a a of are freezing, We means of by developed Pharmaceuticals stockpiling. TFF using proprietary system option the of stable ZYESAMI as long-term achieving suitable
as with Phase and to or signed property added IIBR technical we and turn BriLife. their In known our and innovative, vaccine market Israel’s worldwide NRx vaccine. the provides Memorandum Biological for Let’s of milestone customary BriLife. In to on in collaboration, will receive program COVID the development assistance exchange Research commercialization third and IIBR, revolutionary company exclusive BriLife of develop a rights royalty the of intellectual Understanding this a part experimental X and when Institute to possibly for to we July, for complete payments
that it a to released body’s the virus As but Delta early and the in it vaccine, vaccine. And body it the concern continues and encouraging other virus, protein. of suggesting this We against segment believe vaccines differs the spike that, evolve Moreover, immune this that benign human if of the entire shows BriLife protection vaccine develop merely was against week, its the spike that a other to BriLife information that coronavirus system preclinical COVID of with a Delta reason wolf’s response. and BriLife protection in BriLife clothing. of rather We has that the as the from was SARS-CoV-X small COVID maybe own itself generates spike the live as than self-propagating In it’s protein. immune vaccine a protein as studies to other variants studies. presents the seen same think to sheep like in words, just variants been virus looks
spectrum of complex are BriLife In variants the rapidly thereby future to expanding to and markets. the capability as spike a of European Additionally, coverage October, adaptability of at the Economy adjacent for manufacturing the maybe establishment discovered, Luxembourg those protein to vaccine to of the variants. added for new of BriLife the vaccine invitation the variants business mission Luxembourg and concluded we Ministry new serve
and company Luxembourg. established operating BNP commercial relationship government a Paribas, with Luxembourg been business by licensed banking the have granted We an
a will banking transfer, preparation in comprehensive manufacturing deliver put And chain We and of vaccine. and that scale enable negotiating up tech a building capability are supply to finance the quantities to to in backbone solution we large commercial scale us for manufacturer of are BriLife. working currently begin the place
begin with have transfer for respected We signed [indiscernible] BriLife. agreement by a technology therapy. vaccine and close developed of technology The previously to is up an scale gene CDMO highly Luxembourg a to bioreactor developed newly manufactured
We by were Senator, development, announced And enthusiastic that In of Health a to call. Public level. government a environmentally-friendly, the to shown surprising Agency clinical unexpectedly first be is time this an conducted World The This of will to capability mRNA move have promising advance on our of instead compared green unique CRO given compare for our an operated with they and a environments. that demonstrated that share our licensed we are to Based consulted trial. Xb conducted Xb/X variant, as and the quarter scientists be fortunate Those Delta XXXX Health BriLife trial with Georgia Phase U.S. media high next in half their Georgia. for conference registration Luxembourg encouraging if us government Research, study vaccinated passports by to Cromos financing August, has results the decided signs government confluence had of to of conduct BriLife hope the of partner, ministries, plans require with efficacy, multiple particularly because in by by to first priorities vaccine. controlled to vaccine together vaccine. GMP the CRO of technologic national of in leading European partners LLC. particularly and Nation with XXXX Lugar, to built to and Richard immune a BriLife’s health study manufacturing by of high location supported Organization and already interrupted in We we with initiation a against realized ability include the and Phase Medicines technology, you Phase will BriLife generate Georgia. tech and directly nations and Center Xb/X the vaccine trial the response the reports early we news, an to the initiate and were manufacturer type of patients those the placebo vaccinated were
a highlight with this response We trial the We non-inferiority which it’s to emergence the as we already wild prove enhanced from as Although already BriLife demonstrate investments mid-XXXX. immunity of that emerge. eroded will original We against is the made IIBR, for safe generated demonstrating research have for the of threaten generated to that variants seen the concern variants honored vaccines the other variants by the this technically antibody during people its this first we And antibody the to to offer past immunity immunity. to vaccinated the Government original patients countries. subsequent have BriLife and patients in the vaccine. trust those COVID same possible planned for project, sufficient and in new levels are approach generation neighboring may as data have neutralizing of as high of Georgia than is seen concern coronavirus. we Indeed, Delta aim against efficacy potent the IIBR, type tap and that and has and immunity provides several and enroll that as new are this enabled that summer by at the that us to competitor the significant they trial, a virus the rapidity variants it immune COVID that vaccine patients the believe Delta variant grateful by the generation variant NRx levels the variants continued hope Israel, that in of virus studies. the by vaccines, placed believe early and of is registration COVID neutralizing been better of are against lasting Delta based selected unmet a need the long resistant vector by The through rapid first
me where NRX-XXX. So ongoing our we development with to are in finally, turn let
The condition depression. beds are depression for currently who trial beds. for our our since U.S. a suicidal As expect preparing unique by the in in to clinical according treatment you condition of for to Suicidal Control. pandemic, facilities that surge is the interrupted deaths XX,XXX this XXXX. to Disease multiple Suicidal program Centers Phase know we people annually psychiatric need, the currently was were coronavirus depression approximately especially unmet accounts And approved to the the shutdown, resume now NRX-XXX converted restart medical for – the when surge bipolar COVID foundation bipolar U.S. have treatment early and of trial initial was only X the electroshock were enrollment is represents therapy.
led extensible breakthrough We by which therapy have a dual effects targeted designation dual of composition D-cycloserine level for NMDA fixed shown action of dual for award awarded research his and of meaningful other to Five have a NRX-XXX well conditions. dose indication. matter the that FDA disease in patent has matter depression of in the as associated NRX-XXX with positive a suicidal is mechanism studies known the designed Lurasidone in achieve XXXX. this and of of awarded antagonists targeted and in such effect for other neurochemistry patent NRX-XXX NMDA on a ketamine. to targeted associated this other to psychiatric mechanism is ideation receptor clinically patented blockade combination drugs depression major of lifetime the side composition The and/or of been without human
we biomarker in and We been and therapy letter granted track trial results designation pivotal pivotal has with agreements Phase breakthrough the FDA. Phase it the approval, those a place our that, a for trial of support from XXXX. submission will NDA meet We have we for that FDA FDA in to to has replicate I have designation, believe will fast the NRS-XXX overview protocol special for NRX-XXX X for Randy our criteria if in will clear received With and path an our results. FDA financial observed study, X over turn of
compared based million quarter approximately months. as was of an of August, sufficient development support shares transaction, to to position I ZYESAMI. I-SPY The options. we and third were million December cash from to in fees. this XXXX funded With million operations which with trial million the begin the investment months Jonathan. net to year primarily Relief the was our to sold loss prior the expenses $X.X trials September was XX Net the quarter the were for million by ZYESAMI. in of XXXX. have General period. preferred three increase third for partnerships, private increase the ended XXXX. September primarily non-cash million, million and and Thank This you, compensation was for and $XX.X Therapeutics compared $X.X $X.X for zero an loss consulting associated clinical placement common stock the for in $X.X XX, of XX, development ACTIV-Xb million XXXX, are with stock compared of completed driven and $XX related our million with for we clinical establishment expenses million of were for as non-cash for to which our will quarter We X.X were related Reimbursements the million, trials and of expenses of through XX, increase $XX.X government. third by $X.X and U.S. Research that key and operations compared a $XX.X administrative in third expenses primarily quarter due expenses next to clinical cash development quarter Note the $X.X believe we XXXX.
primarily months the quarter in was increase For expenses expenses. due based as consulting as to to the stock months Jonathan, September XXXX. and was three XX, With The September in warrant increases were primarily in increase $X.X prior G&A non-cash cash and $X.X compensation that, back for liability ended increase Other was an compared for remarks. $X.X the insurance were for million, XX, based the of warrant due which well the expense. increase to it earn-out XXXX, I stock ended expenses, turn year to non-cash expenses million fees will million closing zero The three liability.
Randy. you, Thank
on and efficient to growth questions, to belief Before manufacturability on to and not you our development our want taking only ask the efficacy, of but just emphasize clinical do lead focus commitment need we I programs. to our safety focus that on
have short most areas and resources the have We in utilized and can our we lead our needs three have energies of programs impact. an of in efficiently period tremendous time, progress critical in made where incredibly
new We have on biotechnology the to of medicines, extent have. a unusual realized to focus bit it’s companies that that manufacturability small cut we
our saving confident before we questions. therapies. us. new to trust opportunities placed believe CMC remain a with shareholders commercial manufacturing early currently, to have resume bringing is ship there in We the critical. And medicine patients data world to ahead In to therapy we are trial. new manufacturing ongoing to our of we look multiple place or around to that review application. If from transaction for vaccine in upon efficacy forward We to regulators take and current the look chemical by X our with able is you catalysts ready application is to not from BriLife. operations and that we in And to lethal immediately planning FDA enrollment that an being the for However, are us. and basis look accelerated end our our we are available putting that and breakthrough forward to infrastructure safety approval. to the support smooth designation new commitment data becomes transition continued response smooth FDA’s a our of focus in to And on transition reaffirm analytics working controls, life it be a by to Eric, ZYESAMI XXXX, Phase we with safe the proving conditions as year. treatments forward and patients appreciate and both proving our moving the ZYESAMI other are can drug addressed to to we support readouts NRX-XXX to on And
you. Thank
X/X have completion? expect question trial. when the How on held Phase you have to-date? And We enrolled a many patients do been
expecting gains enrollment uptake we And first unfortunately, the an uptick in XXXX as in rapid. are as we the we speed. cases, – middle an of said, have completion pandemic the half in of are Well, has become more
may we date that able completion pull forward. be So, further to
and vaccine, more on authorization the Question provide the approval or BriLife you can authority? may regulatory regulatory Okay. from detail when health seek you
by the effectiveness not vaccinated who health required was were were X is That authorities are vaccine placebo have coming That based with seen end efficacy results be year. And of there Phase this and Israel reports the see who surfaced by got with vaccine that’s The out green BriLife controlled on to was vaccinated. already the patients expecting that mRNA. people to of are press. in passports, walking the seen. around We and
starting of are trial non-inferiority known how pandemic, see enrolls, with trial vaccine. a we kind BriLife happens be on same registration comparing to going are that’s effect concern patients of for We on what could to variants We trial able form the Israel. in a and vaccinated regulatory other to about whether in quickly that depending be midpoint seen And some the of depending been against the and next really in already the the XXXX. Delta applying approval this of towards talking
a months if year expecting are we out But variants we be time if have, more traditional looking the a lives hopes, the as approval a talking shorter drug point. continued new they then if the the to up course, come timeframe. could some XX and all vaccine vaccine, be of at these Of to to about for going to way would you way
question Thank ZYESAMI, more a the detail you answer any the from further breakthrough of might you. breakthrough get asking an updates of Yes, designation we our timing? and when about on chances had designation FDA,
response month. are is the towards unusual. have breakthrough a our bit taken And designation end FDA’s therapy think a that we the step We we expecting of to
believe on evidence We shareholders of efficacy, requirement contents and designation it therapy or have therapy drug preliminary for why our posted the that public designation. this tests can demonstrates the understand of regulatory members is so breakthrough breakthrough exactly website believe a is and of breakthrough the which our we why we
So, what And the to we people submitted. forward we FDA’s read free response. look are to have
Thank Okay. you.
What We colder on and continue have worse months? COVID, will present question get are into about further it general to we a as get COVID. will thoughts your the remain
coronavirus a pandemic coronavirus humanity And has X way virus of somebody influenza same long this many going But should where that is has contained lethal learned a that spread were encounter as in about themselves you who not pretty in coronavirus are the pardon the humans coronavirus, SARS. the with such same SARS people years so in the as and way. that China. spread SARS kill person-to-person live that much a thing because Well, now COVID from XX to And the here was I lethal known encounter here years be lived the think epidemic a died as think humanity’s from health pandemic that And we we goes viruses happened But stay. spent attacked most simply are in was certainly to I to that his the to it’s one, And is It out. epidemic the with pouring professional, the life virus the therefore with past. first was able precisely the years be important expression who lethal X exposed too we to into to how with recognition public the we contained. humanity’s encountered and from original original are Wuhan, to of people, thing, is outbreak possible epidemic. are course, them, of
has So, don’t have ways yet to this go. that can pandemic We stop. drugs
Although new itself least new original ability that we variance the virus’ are do seeing coronavirus. for have to mutations at promises showing we the of present vaccines. circumvent and are some to reducing drugs that able are the of And the variants in
which a we the from that conditions. which for be the to oxygen at into same way. clinical can the lungs are mass alveolar protects original humanity is that to in of probably ZYESAMI will the we ZYESAMI vaccines But about realize So, lethal that talking makes that bloodstream. is manufactured hope a that that surfactants a the are drug lungs the of respiratory ZYESAMI benefits from cell, have now a very intent on for BriLife depends the the with And and that’s whole profound upon Aviptadil, coronavirus we And – test form drug. the produced protects It air not and that humanity, opportunity in This variety order lining we with introduced X people trials, is to lung time, focused of the just why the was a finally lung acute distress ZYESAMI ZYESAMI in that syndrome. type going unfortunately of the benefits into transmit the need.
So, thank Eric. you for
That Pharmaceuticals the NRx conference Thank you for third joining you, we all This everyone Thank the for quarter is questions participating. us morning. all concludes results have. this call.
We use cookies on this site to provide a more responsive and personalized service. Continuing to browse, clicking I Agree, or closing this banner indicates agreement. See our Cookie Policy for more information.