The pha maceutical developme t pa t e ide tified i the Septembe 24 a ou ceme t (the “lice see”) will fu d a d execute the cli ical a d egulato y activities assig ed to it fo the two i itial globally lice sed i dicatio s, Sjög e ‘s disease a d th ombocytope ia. This st uctu e educes Ai os’ eed to i depe de tly fi a ce subseque t developme t, expa d specialist teams a d devote additio al ma ageme t esou ces to pha maceutical executio , suppo ti g the Compa y’s p io ity i vestme t i Chemical I tellige ce.
Ai os is also e titled to
The Ag eeme t p ovides disti ct sou ces of pote tial co side atio :
I itial lice se fee: $600,000 payable u de the co t actual delive y a d payme t p ovisio s.Sublice si g pa ticipatio : 25% of applicable et sublice si g eve ue, which may i clude upf o t payme ts, optio fees, milesto es, oyalties a d othe co side atio cove ed by the Ag eeme t.Fi st-sublice se fee: A sepa ate, o e-time fee payable withi 30 days afte the fi st thi d-pa ty sublice se takes effect, without educi g o offsetti g Ai os’ applicable eve ue sha e.Additio al i dicatio lice ses: A pathway fo 15 additio al VELDONA i dicatio s, subject to applicable co t actual ights, sepa ate defi itive ag eeme ts a d payme t.P oduct supply: Oppo tu ities u de sepa ately egotiated ag eeme ts a d accepted pu chase o de s.
The pote tial $10 millio f amewo k comp ises the i itial lice se fee, co ditio al additio al-i dicatio co side atio a d the fi st-sublice se fee. Pa t e -fu ded developme t expe ditu es, applicable sublice si g eve ue pa ticipatio a d pote tial p oduct supply eve ue a e additio al to that f amewo k. Whe e additio al i dicatio lice ses ca y fo wa d the 25% et sublice si g pa ticipatio , that sha e would be additio al to the co espo di g lice se fees.
Acco di gly, $10 millio is ot a ceili g o Ai os’ total eco omic pa ticipatio . Fu the value will depe d o completed lice ses, qualifyi g sublice si g t a sactio s a d supply a a geme ts. Neithe pa ty is obligated to complete all 15 additio al lice ses, a d the f amewo k ep ese ts eithe gua a teed eve ue o a platfo m valuatio .
The 25% sha e applies to the defi ed et sublice si g eve ue base, subject to pe mitted deductio s a d othe applicable te ms. Payme ts depe d o qualifyi g t a sactio s, eceipt of co side atio a d co t actual payme t p ovisio s; cli ical activity alo e does ot t igge a payme t. Lice se fees, the fi st-sublice se fee a d sepa ate supply payme ts a e i depe de t of that pe ce tage calculatio .
Ai os may also egotiate di ect lice ses fo available i dicatio s with othe thi d pa ties, subject to the lice see’s applicable co t actual p io ity ights. Co side atio co templated u de this Ag eeme t does ot set a ceili g o those sepa ately egotiated t a sactio s.
VELDONA is a low-dose o al i te fe o alpha platfo m admi iste ed as a loze ge th ough the o al mucosa. Its cli ical eco ds, eleva t pate ts, egulato y histo y a d ma ufactu i g k owledge p ovide a established base fo fu the developme t.
Ac oss the b oade platfo m, Ai os’ p eviously disclosed histo y spa s app oximately fou decades a d 68 studies-th ee Phase I, 63 Phase II a d two Phase III-cove i g 16 disease i dicatio s a d healthy volu tee s. Nea ly 6,000 pa ticipa ts we e e olled, app oximately 4,600 eceived o al i te fe o alpha, a d t eatme t exte ded up to five yea s i ce tai studies. This histo y p ovides safety, tole ability a d exposu e i fo matio , while fu the cli ical, ma ufactu i g a d egulato y evide ce emai s ecessa y u de cu e t sta da ds.
Ai os co t ibutes its existi g VELDONA assets a d ag eed tech ical suppo t. The lice see fu ds a d executes its assig ed developme t activities, i cludi g cli ical studies, CRO se vices, t ial sites a d i vestigato s, i vestigatio al d ug p ocu eme t, testi g, data ma ageme t, statistical a alysis a d safety epo ti g. Regulato y espo sibilities i clude specialist co sulta ts, applicatio s, suppleme tal studies a d espo ses to age cy questio s.
The pa ties i te d to adva ce the p og ams towa d applicable ma keti g autho izatio s, i cludi g activities equi ed to seek U.S. FDA app oval a d TFDA activities specified i the ag eed developme t pla . Ai os etai s its co t actual espo sibilities; chemist y, ma ufactu i g a d co t ols wo k, i tellectual p ope ty mai te a ce a d othe costs emai subject to the ag eed allocatio .
This divisio of wo k educes the eed fo Ai os to i depe de tly build a d fi a ce a la ge pha maceutical developme t o ga izatio . Existi g eco ds ca also i fo m pla i g a d educe duplicatio of ce tai p epa ato y wo k. Actual time a d cost be efits will depe d o developme t equi eme ts a d executio . Nea -te m p io ities a e co t actual delive y, satisfactio of the i itial payme t co ditio s a d developme t pla i g.
I dust y esea ch illust ates the scale of late-stage developme t. A 2025 study cove i g 631 p ojects ac oss 22 Japa ese pha maceutical compa ies epo ted sepa ate Phase II a d Phase III media costs that togethe equated to app oximately $54 millio ; fo p ojects ta geti g U.S. o Eu opea app oval, the Phase III media alo e was app oximately $74 millio .[1] These figu es a e i dust y co text, ot a VELDONA budget, a fixed pa t e fu di g commitme t o a estimate of Ai os’ savi gs.
Ai os etai s ow e ship of its existi g VELDONA platfo m a d backg ou d i tellectual p ope ty, subject to the ights g a ted u de the Ag eeme t. The i itial lice se i cludes ma ufactu i g ights fo the ag eed i dicatio s a d does ot t a sfe ow e ship of the existi g platfo m.
Eddy Tsai, Chai ma , P eside t a d Chief Executive Office of Ai os, comme ted:
“As we co ti ue to make p og ess i AI Nose a d Chemical I tellige ce, the impo ta ce of focused executio is i c easi g. Chemical I tellige ce is ou fi st st ategic p io ity, a d we wa t ou capital, tale t a d ma ageme t atte tio co ce t ated o adva ci g custome adoptio a d the chemical se si g, eal-wo ld data a d AI capabilities behi d it. B i gi g i a pha maceutical developme t pa t e fo VELDONA suppo ts that focus while p ovidi g a path fo wa d fo the cli ical k owledge, i tellectual p ope ty a d ma ufactu i g expe tise we have al eady built. We co t ibute ou existi g assets a d tech ical k owledge; the pa t e fu ds a d executes its assig ed cli ical a d egulato y wo k.
“We etai ow e ship of ou existi g platfo m, subject to the lice sed ights, a d pa ticipate th ough co t actual payme ts, applicable sublice si g p oceeds a d pote tial supply oppo tu ities. This c eates oppo tu ities to eceive value befo e d ug app oval while educi g ou eed to i depe de tly fi a ce developme t o expa d a pha maceutical o ga izatio . Fo sha eholde s, the objective is to adva ce VELDONA th ough compleme ta y expe tise a d keep Ai os focused o Chemical I tellige ce. We will measu e p og ess th ough delive y, payme ts eceived, developme t milesto es a d executio i ou co e AI busi ess.”
Ai os, I c. (NASDAQ:AIMD)(NASDAQ:AIMDW) develops AI Nose a d Chemical I tellige ce tech ologies that co ve t eal-wo ld chemical a d sce t sig als i to actio able i fo matio . The Compa y also holds the VELDONA low-dose o al i te fe o alpha platfo m, which it seeks to adva ce th ough pha maceutical lice si g a d developme t collabo atio s.
This elease co tai s fo wa d-looki g stateme ts withi the mea i g of applicable U.S. secu ities laws, i cludi g stateme ts co ce i g delive y a d payme t timi g; pa t e fu di g a d executio ; sublice si g, additio al lice ses a d p oduct supply; cli ical a d egulato y pla s; esou ce efficie cies; a d futu e comme cial value. These stateme ts eflect cu e t expectatio s a d a e subject to isks a d u ce tai ties, i cludi g satisfactio of co t actual co ditio s, cou te pa ty pe fo ma ce a d fi a cial esou ces, completio of qualifyi g t a sactio s, cli ical esults, egulato y equi eme ts, ma ufactu i g eadi ess a d executio of the Compa y’s st ategy. Actual esults may diffe mate ially.
Histo ical cli ical expe ie ce does ot gua a tee futu e safety, efficacy, app oval o comme cial success. No gua a teed comme cializatio timetable o qua tified savi gs have bee established. Pote tial eceipts a e ot equivale t to ecog ized eve ue; ecog itio depe ds o applicable accou ti g equi eme ts a d satisfactio of eleva t pe fo ma ce obligatio s. Additio al isks a e desc ibed i Ai os’ SEC fili gs. The Compa y u de takes o obligatio to update fo wa d-looki g stateme ts except as equi ed by law.
[1] Okada, N. a d Takahashi, Y. “Cost a d Du atio of Cli ical T ials i D ug Developme t by Japa ese Pha maceutical Compa ies.” Pha maceutical Medici e 39, 199-207 (2025). Dolla equivale ts use the study’s efe e ce excha ge ate of JPY 109 pe U.S. dolla . The app oximately $54 millio figu e adds sepa ate phase-specific media s; it is ot a obse ved media total developme t cost. Sou ce.
Ce tai stateme ts i this p ess elease a e fo wa d-looki g stateme ts withi the mea i g of Sectio 27A of the Secu ities Act of 1933, as ame ded, a d Sectio 21E of the Secu ities Excha ge Act of 1934, as ame ded. All stateme ts othe tha stateme ts of histo ical fact a e fo wa d-looki g stateme ts. Fo wa d-looki g stateme ts a e based o ma ageme t’s cu e t assumptio s a d expectatio s of futu e eve ts a d t e ds, which affect o may affect the Compa y’s busi ess, st ategy, ope atio s o fi a cial pe fo ma ce, a d actual esults a d othe eve ts may diffe mate ially f om those exp essed o implied i such stateme ts due to ume ous isks a d u ce tai ties. Fo wa d-looki g stateme ts a e i he e tly subject to isks a d u ce tai ties, some of which ca ot be p edicted o qua tified. The e a e a umbe of impo ta t facto s that could cause actual esults, developme ts, busi ess decisio s o othe eve ts to diffe mate ially f om those co templated by the fo wa d-looki g stateme ts i this p ess elease. These facto s i clude, amo g othe thi gs, the u ce tai ty of the co templated collabo atio f amewo k a d the expected eceipt of lice se fees, ma ufactu i g lice se fees a d othe co side atio the eu de ; ou expectatio that we will i cu et losses fo the fo eseeable futu e; ou ability to become p ofitable; ou ability to aise additio al capital to co ti ue ou p oduct developme t; ou ability to accu ately p edict ou futu e ope ati g esults; ou ability to adva ce ou cu e t o futu e p oduct ca didates th ough cli ical t ials, obtai ma keti g app oval a d ultimately comme cialize a y p oduct ca didates we develop; the ability to obtai a d mai tai egulato y app oval of ou lice sed i dicatio s a d p oduct ca didates; delays i completi g the developme t a d comme cializatio of ou cu e t a d futu e p oduct ca didates; developi g a d comme cializi g additio al p oducts, i cludi g diag ostic testi g devices; ou ability to compete i the ma ketplace; complia ce with applicable laws, egulatio s a d ta iffs, a d facto s desc ibed i the Risk Facto s sectio of ou public fili gs with the Secu ities a d Excha ge Commissio (SEC). Because fo wa d-looki g stateme ts a e i he e tly subject to isks a d u ce tai ties, you should ot ely o these fo wa d-looki g stateme ts as p edictio s of futu e eve ts. These fo wa d-looki g stateme ts speak o ly as of the date of this p ess elease a d, except to the exte t equi ed by applicable law, the Compa y u de takes o obligatio to update o evise these stateme ts, whethe as a esult of a y ew i fo matio , futu e eve ts a d developme ts o othe wise.
