Altimmune (ALT) 12 Aug 202020 Q2 Earnings call transcript

Greetings and welcome to the Altimmune Inc.

Second Quarter 2020 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. to conference like host to now Ms. would turn over the your I Relations Altimmune. Kosse, for Monique Investor

You may begin.

Leading will for Melissa, open Roberts, a Medical Officer. Officer; for session. After Executive call QX call. prepared today up participating you, Officer Officer; the Chief in call Thank and participating Brown, today's with Scientific Scott XXXX thank will call last night release financial Harris, of Chief press Altimmune. is found and and earnings on XXXX Garg, can of page Will Dr. website. results Scot question-and-answer the Investors Vipin be issued remarks, A you Also the everyone the QX be we the Chief the today company's the on conference was Financial Chief

Private we and subject purposes Before expectations, operations, of statements and the materially provisions future remind I for could differ that to of actual these the statements the like Litigation begin, remarks including cause Harbor and forward-looking trials of everyone our about that uncertainties XXXX. and Altimmune would to to those Securities on prospects business related Safe impact Reform cautions forward-looking Act constitute plans risks to results its indicated, those operations. COVID-XX clinical results from that under are

update XX, made Wednesday, that of on cautionary to disclaimer conference the these statements For circumstances our release night as speak reflect and date. not also Securities a obligation other company this to would forward-looking discussion in last on does filings our future August on forward-looking the contained of read to results, company's today's factors or affect Exchange any see of call today's undertake after now the website. events statement Any risks please risk direct and could the I with some occur any and issued statements earnings of only or available the that statements Commission. date, the factors you in and the XXXX and company's

being for conference will will this Vipin With go Altimmune. on reminder call available that and Officer recorded Altimmune's call be the Executive a please Chief turn of rebroadcast to As over now is ahead. Vipin, Garg, website on I www.altimmune.com. audio

thank Monique. Good our us and for morning, joining you, Thank update. everyone, QX and we you financial discuss as corporate results XXXX

our Roberts, open Brown, Joining who Chief Financial Will and will our the the results; today will our Scientific Harris, After Officer; financial is our for QX Scot we me Officer, Q&A. call on our call Scott review discussion, as well Chief Chief Officer. Medical as

XXXX with The has Altimmune and first half of I'm been to-date. progress pleased transformational for our very

and candidates. have funding two vaccine lie we made ahead intranasal of product candidates government COVID-XX, strides COVID-XX candidate. and pandemic, to to We company our push capitalized into highly on Outside challenges aggressively sufficiently to therapeutic secured us. continue significant the forward product developing fully lean additional a a other towards differentiated of immunomodulatory the novel the address We that

ALT-XXX our first-in-human We vaccine trial QX. are to an NASH NasoShield track we completed and have anthrax on recently in begin in trial enrollment

We year. this also begin B is our submission a successful therapeutic for for Hepatitis that to X had slated IND trial later Phase chronic a HepTcell

and focus few minutes beyond. advancements, for a our throughout these well year. deliver we spend I to of this value to would of are the With shareholder that remainder poised XXXX like With on backdrop, areas

preclinical AdCOVID's X it and towards focused QX. AdCOVID in we expeditiously building safely into on the trial data as look forward as on Phase and outstanding to moving an clinic moving by First, a quickly are We IND clinical possible.

at conducted the our Alabama observed in collaborators immunity, systemic by studies and mucosal at robust with pleased of are University We preclinical Birmingham.

process several forged with in and clinical that trial began to simultaneously secure material manufacturing partners have alliances July. We

are we this activities As well trial remain begin Scot Phase track year. Roberts, to on later and going our our clinical discuss these CSO, momentarily, X will

we for funding AdCOVID. non-dilutive to continue pursue Second,

for the government projects. a teaming Dynamics funding. we Information vaccine prime and on been The to capabilities has DynPort opportunities. expands funding extensive the DVC government and non-profit Technology has entered company, contractor, Vaccine development Company, accelerate General federal significantly announced, systems with previously execute many agreement of experience integrator As government Altimmune's on partnership or contact, with And AdCOVID. into in pursue a DVC, development DVC, to and

support. Third, we remain trial. executing on DoD T-COVID And focused, the maintaining

$X.X only in the clinical the Altimmune a prevention had of replication-deficient COVID-XX. based respira-vac not our worsening, of But T-COVID of created to clinical the Defense trial on, X that Department quarter, During Trial, we our fund EPIC second that we new adenovirus I/II in million announced awarded program platform. Phase the

are of early COVID-XX, We to of as are few mechanism promise. program, represents with we novel hospitalization. this progression to it a And the, intended excited especially tremendous about disease stop therapeutics one the and severe

discuss And Army progress portfolio. I program. patient, of are the this Scott AdCOVID, our our like Medical look Research and who & will line Command and plans, We we to very Scott to on have first turn Roberts? year. U.S. Harris, working QX CSO, Scot discuss, our top Development delivering would clinical our readout, CMO, more call fully across you will Scot data Roberts, our trial who update the now on then, enrolling made fully colleagues, in over this imminently our with Harris will as closely this to we at the forward from with

morning. good and Vipin, you, Thank

great convalescent Birmingham. directed on the in vaccine trial excellent majority a replication-deficient protein different of series viral And spike We RBD vaccine collaborators, clinical Phase evaluated were candidates the the antibodies, are our performed year, the viral at Candidates, clinical is progress, for of expressed this spike candidate receptor-binding domain neutralizing this against platform. by The our RBD. studies adenovirus results, for of AdCOVID, candidate RBD the in a viral that preclinical or our we those have at Alabama, University of made respira-vac, of Based the portions for created expressing protein, COVID-XX. development. Earlier on essential intranasal selected I single-dose vaccine infection. based toward of we serum different

the clearly it's target responses, mouse In single AdCOVID, intranasal antibody high serum an a for dose immune our of virus So studies preclinical and neutralizing stimulated important strong system. titers.

maybe of that but mind, cavity. only a from robust important COVID-XX, By from mucosal get intranasally. vaccine the against The to two, induced especially respiratory way tract, blood, not the AdCOVID antibody Mucosal important response transmission IgA infection, also the Not administer intranasal of virus of Importantly, a replicates candidates, the that for into antibodies IgA your vaccine nasal locally the well. a in all immunity, two induce are respiratory protection, the response, type of in in others. one, IgA the to virus clinical are only is most in also complicated than is potential the mucosal presence considerations, very IgA far, the nasal that offers block important protection, special delivered to method in tract. to cavity elicit by nasal produced more is nasal because virus immunity the, very intramuscular And block well it's stimulated SARS-CoV-X provide of local that Bear respiratory infection. in dosing the immunity of When a to can't testing tract. dosing, IgA also in unlikely advanced injection. is mucosal to

mucosal become local safe cavity of absence, the virus. for IgA haven a immunity, the in the may nasal So

mucosal community. we we'll the and in a AdCOVID, the quickly we Over antibody on scientific to the we IgA the neutralizing to the next T-cell few to expect immunity data, plan in stimulate we it publish stimulate, with ability hand, immunity, type reporting so can the preclinical share Once have be addition weeks, T-cell data of of third to responses.

vaccine are taking initiated AdCOVID. forward, towards Now, having the a dual-track of we approach, identified manufacturing we the candidate

scaling this have that While our I will material goals, meet to AdCOVID. key the these in quickly we multiple provide partners and To have III we to launch parallel, moving established to trial the manufacturing alliances, testing clinical requirements manufacturing Phase aggressive process later Phase accomplish of year, intranasal trial of commercial Notably, with begin vaccine. NasoVAX are influenza vectors. allows the the with quickly manufacturing us Using the vaccine developing process manufacture of to with in as our intranasal other same are NasoShield using our vaccine we and experience, and manufacturing we for candidates, same anthrax including for process deep confidence. manufacturing our AdCOVID BARDA; viral that conduct

will platform the our candidates who it. shown a need is other stability for required room potentially respira-vac greatly the temperature I Scott that, to based allowing the or on refrigeration for have without With on will vaccine provide vaccine Harris, vaccines call excellent Scott? turn our that programs. AdCOVID who Additionally, at clinical distribution of normally freezing the over to update getting those simplifying

program, This Phase our adverse intranasal on safe to readout. AdCOVID our will quarter good we the clinical data of – trials X will plan serum the Thank prior the and of hypothesis. vaccines, nonetheless two include have data replication-deficient evaluate and total fourth studies the expect everyone. intranasal X the of analyses with Based morning, effects not the mucosal, vaccine adenovirus potent AdCOVID anticipate to while of X file of confirm launch in we to readout nasal other one events role for T preclinical preclinical boost, for all to vaccine IND reactogenicity trial findings antibodies, from trial trial on We our trial and immunity we and responses in approximately AdCOVID and the a and earlier, and the well Immunogenicity And the Continuing Phase launch suggested of and events responses. quarter fourth and our with expect experience to XXXX with immunity for prime tolerated the trial neutralizing be similar of first other a this this subjects. XXXX. cell IgG, XXX clinical the you, and heels placebo. aspects in include Scot, the doses discussed – with in

U.S. T-COVID. Trial, the We the a in $X.X Worsening This and trial Medical to Army of also fund Prevention announced in & conducting we're as of with will that, Efficacy trial the of cost awarded COVID-XX. entire Command T-COVID million be Development Research the clinical the Clinical by previously Safety EPIC or known

of of quarter NasoShield plan We our to next recently Phase trial if pulmonary against for And in of now year strategic reserve. completed enrollment our to fourth options to readout need the clinical trial and Xb sites commence hospitalization. to Because to in processes the authorization. early differentiated and of quarter respiratory XXXX. on T-COVID complete protection coronavirus the reviews, and of development dysfunction stockpiling an used it we other the use NasoShield enrollment prior is regarding to for for $XXX.X completed target afford other trial be for most we focused BARDA X data successful, from infections commence therapeutics other be million of this XXXX. against We all is in begin it Phase in immune modulator is and patients announced contracting of have defend effective broad could X/X of believe expected expected is clinical NasoShield T-COVID and be awarded safe future the strains pulmonary the and development, fourth pandemics. The non-hospitalized remaining active and data government Phase could that on or expect anthrax with initiate COVID-XX testing are of discussions with as institutional readout could the is shown viral the a imminently. a variety we If contract in of pathogens, emergency and

commence first-in-man for quarter We in ALT-XXX, in clinical the IND-enabling our fourth with of trial GLP-X/glucagon also remain to in in dosing studies agonist for manufacturing NASH year. Australia on dual this track our

on ALT-XXX the This in investors readout weight end liver in will reduction and development. forefront NASH of place body it a will the have be value-driving to expect as event the of of XXXX. fat a loss quarter toward We first for squarely

the GI We be need liver than improvement titrate tolerated expect and trial and the ALT-XXX weight to similar achieve for which intolerability, fat X to to file impacted fatty this of GLP-X the dose without plan patients IND better conclusion in in trial, loss therapies At U.S. Phase the trial with space. XX-week an in development and first-in-human disease. initiate a of the has liver we non-alcoholic

NASH on efficacy separate reduction activity initiate will third endpoints on obesity. trial compared the Pending the the feel a weight to treatment pharmacokinetic We We the the effects and in program first-in-human expect a transition in NASH in and XXXX. results may in Xb of full loss Phase also tolerability rapidly of a and with trial biopsy-based XXXX trial, agents. to data preclinical readout and profile translate that on end by improve the we of potent weight ALT-XXX to based this of to of a elect loss more quarter studies confident other

IND our activity Phase X and in for treated, chronic with Finally, filed patients for are important being designed evaluate disease. The disease. -- in to to this immunotherapeutic. work the antiviral an successfully trial for the hepatitis on the we goal combination intended HepTcell, B as milestone is that HepTcell being is of an the developed is chronically-infected of HepTcell immunotherapeutic patient Depending mechanism antiviral therapeutics functional this cure a develop in population or new our the alone to

Vipin? the fourth evaluation things And of of that, I'll of quarter We Vipin with over pending expect to the turn the enrollment COVID-XX XXXX, initiate in to back Garg. impact pandemic.

Thank you, Scott.

the of continue from have may COVID-XX. remarks, Harris' noticed outside to you it As important us portfolio our of is Dr. development for

with data-rich from developments our AdCOVID XX chronic with B with a the data the NasoShield over to ALT-XXX period and next we T-COVID, initiation have and anthrax with expect in of HepTcell. our time NASH to hepatitis trials readouts a addition months trial, In trial

One of With have look update and that, to trials Will results sharing I'll will clinical of who shots our Financial an tenets as Will? provide we on Chief to become the the our call key on turn they multiple forward to the philosophy financials. our available. Brown, is over of these Officer, goal,

Vipin, Thank morning, you, good and everyone.

our For update an call, I'll quarter providing today's results. financial be regarding second

is our $X.X we've $XX attributable an $XX since from additional million end, quarter. Our million Since June nearly of from first million million sales. warrants increase was and facility. ATM and short-term $XX of quarter at increase an $XX.X balance and The aftermarket of exercises, the XX cash to investments exercise the million for warrant $X.X million received from

Additionally, of gross for we closed $XXX.X a million. public proceeds offering

positioned million advance hand cash of pipeline on these its and Altimmune to at years. next and investments than receipts, well least more the $XXX for With additional has cash is two

major COVID-XX product be scale-up and a AdCOVID discussed, demands Roberts of for use of will the cash the those Scot meet both to As manufacturing both on the T-COVID candidate. of

the quarter quarter which to income $XXX,XXX reduction to last Turning compared of statement, for year. of second $XXX,XXX, a the the were revenues second is

liability We million development. change million XXXX, to in probability clinical a of in year-over-year, and the are the for non-cash $XX.X decrease success. of revenue AdCOVID to payments impacting only NasoShield during Research to our in development clinical preclinical period of for market the increase last XXXX lower the Our an for expense increases these associated cycle for year. startup of NasoShield million balance milestone payments. on million spend Also the liability increase this trial development product $XX.X The to $XX.X in the we quarter, to in $X.X due was in considering in carry spend and the were addition same of of increase of the fair price performed for compared activities attributable year-over-year an is work And in due to XXXX. increase the compared stock trial ALT-XXX. value and recognized performed a our stock-based and with T-COVID primarily value sheet fair an during market expenses

quarter million and is higher costs. expenses in the due an G&A compensation, professional of Second increase $X.X XXXX legal than second of $XXX,XXX to quarter

our of we claim which quarter refund the for benefit tax income year. was million, file portion a XXXX the second represents to expect which loss, quarter $X.X Our net next

net With $X.XX last second second that, was to like share equaling I Operator? per loss of million XXXX period net for $X.XX share the million the call year Finally, the for to in $X.X per stockholders would now the for compared common quarter quarter versus open second questions-and-answers. the to attributed in quarter XXXX. loss with same $XX.X

line time, [Operator Thank with you. proceed Our At question. conducting Yasmeen Instructions] session. Please this your first we be the with question will question-and-answer the Rahimi Piper from comes Sandler. of

Hi, progress. team. Two continued Congrats on questions for you. the

for thinking Vipin. of of and again our be the that? order the second then question preclinical light X should shed us? level about maybe and what you of multiple on provide can is, you seeing on granularity study, continuing we initiation that And to questions. Phase adding kick between light X is The And Can you can first type what now study? question manufacturing? data you Phase left and for the working manufacturers is Maybe to you growing off the on shed in thank taking Are the

take Yes. to answer Good the morning, I'll first Yasmeen. question. the Thank Scot? question you first question. second I and let Scot would Roberts for your

morning, Good and Yes. Yasmeen that for thanks question.

So This the be cells T-cell now And expect as during reporting data will data. forward We'll that trial, additional data kill I data most to we've as between way. the looking call, activation responses that obtained clinical antibody far the and shortly. immediate time the to neutralizing at as reduce infected and we're of able have the the sharing. be are mentioned preclinical very to is we infection also here on that those that that T-cell

a what be by and both in of are Beyond and primates. the responses targeted And the models specific T-cells being of both evaluation looking that, nonhuman B-cells. we'll COVID-XX be that continued antibody there'll rodents at types of challenge epitopes are

of where data So to and becomes that's as we available. sharing it kind with the that look we're broad that forward going of brushstrokes

Thank you.

And to manufacturing. Yasmeen with regards

into are a and X over as As well with far for on we've a that we with working partnership been Biosciences is as now materials Phase month ago X entered for to almost our while. announced manufacturing a Vigene we concerned, way Phase we them

partnership international our manufacturer another with manufacturing into -- Phase with large agreement process materials X addition third a But an manufacturer manufacturer. actually X entered Phase and Phase the of have Vigene, in So and they're X to they and have in the materials. we

are way manufacturing of our on partners, but these of securing the beyond manufacturing we and announced not Phase X to commercialization names two AdCOVID. well for capacity have We sufficient into

you, Congrats again. Thank team.

you. Thank

from Thank Please with of JMP you. proceed Securities. [Operator the Wolleben with comes Jonathan Instructions] Our next line question. question your

taking Hi, good thanks questions. and the for morning

us Just boost in I the there regimen, number and about different as about arms? will a control? first far of be a AdCOVID thoughts be how many And couple heard I you This design think on X. your bit we've levels mentioned dose at? as you you well. for prime is the Phase Can a exploring on Will a subjects think me study little tell more looking XXX as

Harris? Scott

Jonathan. Thanks,

Regarding based clinical not preclinical noted don't some absolutely leaving and data table. we in but prime previously on a our certain we're to that boost that we be the the boost like experience think our to necessary, we'd as on make explore that other effectiveness studies, will prime

the So XXX prime have we're and There and will matched Currently, single that subjects. four for doses ingredient will planning boost. two a a would as be then dose, the prime control each active arms, second a well. study for placebo be

So, four active one placebo. and if arms you would

in in that with would vector based made reflect final prior NasoVAX but of are studies. and the not and the studies of of that our doses, doses on the range have determination being the doses a NasoShield in experience We they'll used adenovirus the some be other used

one one just last And Great. me. for

constructs for in little the mentioned Pfizer looked with your forward? on is bit And intranasal a I Thanks. options your maybe kind to protein know whole You the binding your to develop they when at move something domain you spike options. receptor including see decided use receptor-binding favored Did preclinically a that there construct. of approach their only? domain array just multiple rationale of to

Roberts? Scot

Yes.

immunogenicity. candidate selection based So, the RBD of on our was

always that studies. during as well look were they All fine tolerated of these the constructs the do animals

mentioned. extremely tolerated clinic Scott As you are well in as know, the these Harris products

it greatest on selection of our was RBD is RBD. based where really with the the immunogenicity, So,

second though to And RNA so, it the they the considerations. had rather immune as based with on immunization you vaccine vaccines. selected alternative the respect know, on strong as of there's safety seemed Pfizer, And response

of in with full we sort don't effect. RBD, better they the And length. And the profile expect see saw so evidently, to a that tolerability

in our So as it past. safety to with is the on excellent focus expected has the immunogenicity been as and be

Thanks and again on progress. congrats all Terrific. the

gentlemen, concludes and for any this session. I'll turn the back floor Dr. question-and-answer Thank Garg final our you. Ladies to comments.

earnings you today. in Thank Thank again for you. you listening on look our everyone We to call. next --

today's Thank concludes you. conference. This

You may you at time. disconnect Thank your your participation. for lines this