I'd funding i.e. important support reminder for Thanks XXC updates as a and the initiatives, platform Dan. to like which a few also activities. provide non-procurement contract, provides on additional BARDA quick R&D
under XXC of scope First, we medication. of who the development important recently of which the those stockpile been expansion a of both contract. formulation the liquid formulation of TPOXX, of difficulty allocated pediatric protection funding We believe pediatric TPOXX population liquid broader patients swallowing contract be addition the the XXC an availability for have for is full to including would an ensure and to oral have the U.S.
resiliency TPOXX, for which develop the in our U.S. optionality of is of certain Second, in qualified manufacturing we've supply production preparedness. funding been important also parts backup to to allocated encourage chain and
of and a since franchise, key these chain partners IV XXXX. of organizations that the include reinforce believe both will contract have strength have We that supply We TPOXX which U.S.-based oral excellent the the and of includes production been liquid in developments four value formulations. TPOXX manufacturing
to mark Before my with of international I would XXC progress turn I markets, note the comments one contract. the additional like to
we approval for filed is reported, from will in be that the we XXXX an feedback application anticipated received in preparing formulation expected additional we IV new previously have FDA drug that to required the are the be As no and with XXXX. clinical studies
nonetheless product And of the a formulation goal will programs requirement part of While expansion as TPOXX the contract, engage not FDA for approval. under of FDA FDA IV with the of IV R&D approval is be overall we deliveries of the important XXC it the approval IV in progress formulation label is initiative.
international As oral the formulation opportunities. sales U.S. TPOXX approval would IV help of maximize with FDA the approval the of the we believe
We expect initial to deliveries of begin TPOXX in XXXX. IV
XX,XXX of million. the a reminder As IV courses approximately the of product contract XXC for drug final delivery specifies $X
let's key for international for oral discuss at SIGA. markets. pursuit The Now sales international the is us TPOXX a focus of
that excellent. Medical Technologies Meridian June we with last been partnership announced Our has
each I've many times country as types government internal However own of of cycle of for set products the dynamics. sales has is its procurement these said long international and
As is The such full government. generally a and the execute predict sales we given to international to process required processes term. to that lumpy long sale slow, international decision-making somewhat market to be the expect a in near are difficult
health negotiate education process and procurement for play to for out. respond years product the the take budgets, can with this threat, Ultimately on deliveries. begin must agencies, responsible officials awards for We national several plan to proposal, of for educate funders planning support request
I is mentioned their own before and unique country with each As timelines internal dynamics.
country-by-country two I a have asked provide comment update progress. been sales We reasons. main on do for do not on countries not we why progress with specific
second, to would become undergoing we would spending in may First, an want we want competitors which of signal respect And public. our countries customers the for biodefense. not deliberations confidentiality their who not their be to expansion to
a courses announced intend Health the in purchase the are pleased to share to TPOXX of of in contracts progress regulatory to for issue to support context military, XX,XXX we and that Canadian filing report oral and up December who the With mind, Canada, regarding Canadian military. a
size represent of would about order active of A procurement XX% military Canada. forces in this the
Although filing regulatory been by is is has modest to number recently ally. support military Canadian U.S. of relatively this preparedness precedent a it for contract courses The a to awarded SIGA. NATO
of approximately be the XXXX. be second anticipate regulatory approval. remaining and year approval half procurement targeted Canada courses XXXX following the XXX,XXX we will Canada of for to filing delivery Health with CAD funding Total We in exercised with with Health anticipate XXXX TPOXX options this
TPOXX. procurement on civilian Important discussions to potential with know, we oral the continue of treatment to Canada support of additional Meridian agencies courses in their
pursue and continue with to orders authorities with a America, are or we civilian discussions where military potential agencies threat the country North support and likely Canada following to individual pattern customers with broad-based Beyond understand evolving international see the and potentially Meridian's thereafter. most larger first procurement best
months We Meridian XX have over Austria, with Malaysia. international in multiple past Sweden ones attended and the conferences including
and sales market We for to have more a in XX be the years. stream is project believe many the but meaningful too coming revenue have with will decision-makers the with level, potential initial than extensive SIGA international early conversations to to in annual meetings countries It more. we had also continue
to the a submission, support and marketing continue EMA smallpox, sales TPOXX cowpox are treatment broad vaccinia application we that indications European To for authorization in and preparing of of monkeypox, the complications. set on effort, focus including an
approval, approved. to year the wait some Like this may to or plan of purchase may is countries our countries Europe until regulatory with MAA We anticipated in approval other while EMA militaries purchase Canada, XXXX. an final submit advance in in
program prophylaxis indication development to treatment for the no Jynneos studies I smallpox exposure we which newly to a move vaccine. combination in that TPOXX. Instead conduct that share expansion the has FDA-licensed active very human would with administered label post FDA to feedback required. pleased our on would pathway like for given in PEP. TPOXX will with We're for the study of current be plan us the FDA additional now We've this discussions expand been the to animal
which Jynneos, XX to This given initial study response a is will look the any booster decrease in by days shot followed as for later. an immune shot
compare response TPOXX will We on alone immune with therapy. Jynneos the given Jynneos XX-day those to while given those
conduct ultimately days In requires for approval an study treatment. will expanded plan treatment. PEP only This addition, safety which contrasts of therapeutic Jynneos. ACAMXXXX seek for TPOXX indication XX with with of of days our XX to we We and both
Given PEP regulatory approval. and optimistic data, vaccine with interference are the previous merits unlikely safety regarding the on animal a we TPOXX the profile based of
time under of We provide have the our the as on note Department continue been to available. studies lines as We will these expect with they be that become funded will we contract Defense. updates they
an heavily would used and the Committee meeting it oral FDA important likely very expansion of as the Advisory for label for We be noted in TPOXX TPOXX be that is believe discussed for and PEP TPOXX. during XXXX an would outbreak PEP
The XX-day per be versus used with dosing. drug be of more the patient XX-day type uses that would TPOXX this implication of would of expected
TPOXX be the As such, of needed X.X million maintain coverage stockpile will order more current courses. capsules to of in
longer example, used the stockpile it use, doses if of PEP, only For result for treatment. for in duration available XXX,XXX entire the was will given
context stockpile whether We our will this changes the year. expansion of SNS. the Department priorities This of government key the and of customers ASPR to have review review needed. would are the coming to the highlighted any Defense, in in preparedness They determine and occur type the BARDA, at label potential
to would on use I updates like TPOXX. provide potential thread, for this Continuing other
continue oncology with We companies virus. oncolytic immunotherapeutic vaccinia to traction are that developing platforms gain on based
vaccinia some next-generation of failures progressing are clinical recent the trials. aggressive vectors more to vectors Given
We in collaborating therapies ways. companies developing main are these two with
announced TPOXX to supply studies using is earlier that in developing for An example treat serious Turnstone this collaboration is the events field therapies arise vaccinia-based cancer. may to week. our First, Turnstone vector. the oncolytic of of one viral the adverse with leaders any we this clinical
arise TPOXX effectiveness may to of in of treatment is so the charge. we for are data a with like complications to support it rescue plan of are would on we the gather in I virus these in free should complications from oncolytic not data examples substantial of believe expansion to companies note of these TPOXX use have patients. vaccinia-based cancer that therapies approved of that of trials the for field vaccinia yet therapies. We return label TPOXX treatment this this and therapies. And There value to providing we complications, types
preclinical with all to delivery we develop cases, intellectual vaccinia TPOXX to enter cancer to commercialization provides into for property combination explore potentially be we collaborations testing might efficacious stronger strategies and In Second, deployed. opportunity. flexibility vectors, capture of strong our position more which as in therapies this allow
as in achieve to progress intrigued updates and we early, In potential summary, program. provide the although efficacy be to enable TPOXX's by we we'll continue to products new oncology it's
note very allows the help a number for smallpox that pleased with threat mitigate stock on like DoD military the the to I to purchase monkeypox of recent TPOXX, which to would personnel. we're assignment of release national to TPOXX press DoD and
that the U.S. Medicines And Agency. are ultimately vaccinia pursuing we as label well. complications a with includes We monkeypox seek and to FDA the smallpox, these with expansions cowpox European plan label
like Having $XX of program; going just operations, corporate one, elements discussed I'd Board a two and two, million repurchase key announced core share of authorization the important to our circle strategy to back forward. topics:
uses approaches. stock. share today may for seeking depend that program today's announced is in of of the to stock including actual a variety The number up million value commitment program, cash, share strategic a company's $XX through highlights Directors full The our opportunities and program noted under stock through the which common procurement have and believe worth to will of a factors release, XXXX. of We December this company As exercise market authorized price XX, government conditions. of authorized repurchase of Board repurchased shares options timing industry press alternative under of contracts, and creation repurchase of repurchase our the range on
to like words say going I'd forward. corporate few Now strategy a about our
We business new fully our which keeping our our ways engaged find with execute as beyond continue expand TPOXX, team we is to and plans. to
we action of our advance smallpox key that milestones. also We for to collaborating drug development. updates NIH on have second are a compound provide mechanism second antiviral we its with as treatment hit We'll
add would to value that continuing efficient corporate also are assets We scan for to our be accretive platform. and
to at businesses. government We in adjacencies disease, look have and contracting continue and infectious other complementary
potential To over investments. date, product we've examined XXX strategic potential opportunities, and licenses, include partnerships, which acquisitions
selective will product to be for that to creation. not mix do right if believe important our continue assets in to know We an and assets using our cash but avenue grow invest fit, diversify value do find and businesses and potential ultimately we is the with
starting with value through to quarter April continue shareholders SNS of collaborations a other Meridian; and products. TPOXX our approval will with and orthopoxviruses; value operating deliver the XXXX; for and expanding we capabilities approximately summary, for deliveries by million second courses pursuing XXXX, with the to our the In drive leveraging for front pursuing supporting expansion on $XXX label for new for of oncology PEP in sales TPOXX; oral international
SIGA's for million and beyond exploring actively assets looking announced deployment cash $XX operations, front, program that another we create On current to we've repurchase businesses a we Additionally, product this are add may just as way are we could share of value. that and mix.
This and begin now Q&A remarks concludes session. prepared our the we
