The ag eeme t ma ks a sig ifica t milesto e fo VELDONA by establishi g a pa t e -fu ded developme t model. BioPhoe ix will assume p ima y fu di g a d executio espo sibilities fo the cli ical a d egulato y developme t activities allocated to it u de the ag eeme t fo the two i itial lice sed i dicatio s, while Ai os etai s co e platfo m ow e ship a d lo g-te m comme cial i te ests. Developme t expe ditu es fu ded by BioPhoe ix, pote tial p oduct supply eve ue a d dow st eam eve ue sha i g a e sepa ate f om, a d a e ot i cluded i , the $10 millio collabo atio f amewo k.
U de the ag eeme t, BioPhoe ix eceives a exclusive wo ldwide lice se to VELDONA fo two i itial i dicatio s
The collabo atio f amewo k i cludes:
A i itial lice se fee fo the two i itial i dicatio s, payable i acco da ce with the ag eeme t.Pote tial lice se co side atio fo 15 additio al i dicatio s u de the BioPhoe ix ag eeme t, assumi g all 15 lice ses a e completed o the co templated te ms, subject to the executio of sepa ate lice se ag eeme ts a d payme t of the applicable co side atio .A o e-time fee upo the fi st sublice se, payable by BioPhoe ix withi 30 days afte the effective date of its fi st sublice se to a thi d pa ty u de the ag eeme t. This fee is payable o ly o ce u de the e ti e ag eeme t, ega dless of which i dicatio is cove ed by the fi st sublice se. Subseque t sublice ses, whethe i volvi g the same o diffe e t i dicatio s o additio al thi d pa ties, do ot t igge a othe fi st-sublice se fee.
Each additio al i dicatio equi es a sepa ate lice se ag eeme t a d payme t. Neithe pa ty is obligated to complete all 15 lice ses, a d the e ca be o assu a ce that all will be completed. Acco di gly, the $10 millio collabo atio f amewo k is co ditio al a d does ot ep ese t gua a teed eve ue o a valuatio of the VELDONA platfo m.
The co side atio co templated fo additio al i dicatio lice ses applies to the a a geme ts betwee Ai os a d BioPhoe ix a d does ot establish a ceili g o the co side atio Ai os may egotiate whe di ectly lice si g available i dicatio s to othe thi d pa ties, subject to BioPhoe ix’s applicable co t actual p io ity ights. Such di ect lice ses may ge e ate highe co side atio based o developme t p og ess, ma ket oppo tu ities a d egotiated te ms. These t a sactio s a e disti ct f om sublice ses g a ted by BioPhoe ix a d would be gove ed by sepa ate ag eeme ts betwee Ai os a d the thi d-pa ty lice sees.
Pote tial additio al i dicatio s i clude
Late-stage cli ical developme t equi es sustai ed capital a d specialized expe tise. A 2025 study published i Pha maceutical Medici e a alyzed 631 developme t p ojects ac oss 22 Japa ese pha maceutical compa ies. Usi g the efe e ce excha ge ate epo ted i the study, the sum of the media costs fo Phase II a d Phase III was app oximately $54 millio . Fo p ojects ta geti g app oval i the U ited States o Eu ope, the media cost of Phase III alo e was app oximately $74 millio .[1]
These figu es a e p ovided solely as i dust y co text. They do ot ep ese t a VELDONA developme t budget, a fixed fu di g commitme t by BioPhoe ix o a estimate of a ticipated cost savi gs fo Ai os. Actual developme t costs will depe d o t ial desig , patie t e ollme t, geog aphic scope, egulato y equi eme ts a d othe facto s.
U de the ag eeme t, BioPhoe ix will fu d a d execute the cli ical a d egulato y activities assig ed to it, i cludi g cli ical studies, co t act esea ch o ga izatio (CRO) se vices, cli ical t ial sites a d i vestigato s, i vestigatio al d ug p ocu eme t, testi g a d mo ito i g, data ma ageme t a d statistical a alysis, safety epo ti g, egulato y co sulta ts, egulato y submissio s, suppleme tal studies, a d espo ses to questio s a d equi eme ts f om egulato y autho ities. Developme t- elated chemist y, ma ufactu i g a d co t ols (CMC) wo k, applicable i tellectual p ope ty mai te a ce a d othe executio costs will be ha dled i acco da ce with the allocatio of espo sibilities u de the ag eeme t.
The pa ties i te d to adva ce the lice sed p og ams towa d applicable ma keti g autho izatio s, i cludi g activities equi ed to seek app oval f om the U.S. Food a d D ug Admi ist atio (FDA), as well as Taiwa Food a d D ug Admi ist atio (TFDA) activities specified i the ag eed developme t pla .
This st uctu e is desig ed to educe Ai os’ eed to i depe de tly fu d subseque t cli ical a d egulato y developme t a d expa d its i te al developme t o ga izatio . Ai os will p ovide existi g lice sed assets, tech ology t a sfe a d tech ical suppo t as specified i the ag eeme t, togethe with p oduct supply u de sepa ately ag eed a a geme ts. Each pa ty emai s espo sible fo its espective co t actual, egulato y a d statuto y obligatio s.
Ai os etai s ow e ship of its existi g VELDONA platfo m a d backg ou d i tellectual p ope ty, i cludi g eleva t pate ts, CMC assets a d ma ufactu i g tech ology, subject to the lice ses a d othe 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 but does ot t a sfe ow e ship of the existi g platfo m.
Ai os also etai s oppo tu ities to supply p oducts u de sepa ately egotiated a a geme ts. Volumes, p ici g, delive y schedules a d payme t te ms will be established th ough i dividual ag eeme ts a d accepted pu chase o de s.
I additio to applicable lice se fees, pote tial p oduct supply eve ue a d the fi st-sublice se fee, Ai os is co t actually e titled to a
I itial a d additio al i dicatio lice se fees, the fi st-sublice se fee a d sepa ately ag eed p oduct supply eve ue a e i depe de t sou ces of co side atio payable to Ai os; they a e ot payme ts of which Ai os eceives o ly a 25% sha e. The fi st-sublice se fee also does ot educe o offset Ai os’ co t actual sha e of sublice si g eve ue.
The 25% eve ue sha e applies to the eve ue-sha i g base defi ed i the BioPhoe ix ag eeme t. The eco omics of a y lice ses Ai os g a ts di ectly to othe thi d pa ties will be gove ed by thei espective ag eeme ts.
Eddy Tsai, Chai ma , P eside t a d Chief Executive Office of Ai os, comme ted:
“This ag eeme t ma ks a impo ta t milesto e fo VELDONA. Its st ategic value exte ds beyo d the co templated lice se co side atio by combi i g pa t e -fu ded developme t with Ai os’ co ti ued ow e ship of the platfo m a d pa ticipatio i its futu e comme cial value.”
Tsai co ti ued:
“Cli ical t ials, CRO ove sight, egulato y e gageme t a d ma keti g autho izatio applicatio s equi e sustai ed fu di g a d specialized expe tise. Th ough this collabo atio , we aim to educe the capital a d o ga izatio al esou ces Ai os would othe wise eed to commit di ectly, while etai i g futu e lice si g, p oduct supply a d dow st eam comme cializatio oppo tu ities. Ou goal is to adva ce VELDONA th ough a pa t e -fu ded developme t model that e ables sha eholde s to pa ticipate i its lo g-te m value.”
The BioPhoe ix team has expe ie ce i d ug esea ch a d developme t, p ecli ical studies, multi atio al cli ical t ials, CRO ma ageme t, egulato y submissio s a d biopha maceutical ope atio s. Its capabilities spa ea ly-stage esea ch, activities suppo ti g i vestigatio al ew d ug (IND) applicatio s, a d Phase I-IV cli ical developme t.
The pa ties i te d to combi e BioPhoe ix’s developme t capabilities with Ai os’ existi g VELDONA assets a d wo k with cli ical t ial sites, i vestigato s, CROs a d othe exte al specialists to adva ce the lice sed p og ams.
VELDONA is a low-dose o al i te fe o alpha platfo m bei g developed as a loze ge fo admi ist atio th ough the o al mucosa. The platfo m is suppo ted by app oximately 40 yea s of esea ch a d cli ical developme t expe ie ce.
Ai os’ p eviously disclosed developme t expe ie ce e compasses 68 studies, i cludi g th ee Phase I, 63 Phase II a d two Phase III studies, spa i g 16 disease i dicatio s a d studies i healthy volu tee s, with ea ly 6,000 pa ticipa ts i total. App oximately 4,600 pa ticipa ts eceived o al i te fe o alpha, with t eatme t du atio s exte di g up to five yea s i ce tai studies.
This histo ical cli ical, safety a d tole ability expe ie ce, togethe with existi g egulato y eco ds, pate ts, fo mulatio s a d ma ufactu i g k ow-how, p ovides a fou datio fo fu the developme t. Histo ical data do ot eplace the cli ical, CMC o egulato y wo k equi ed u de cu e t applicable sta da ds.
The pa ties will adva ce the two i itial i dicatio s based o cli ical esults, egulato y equi eme ts a d comme cial p og ess, while evaluati g additio al developme t a d lice si g oppo tu ities. Neithe pa ty gua a tees cli ical t ial outcomes, egulato y app oval, comme cializatio timeli es o ultimate comme cial esults.
[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 amou ts above a e calculated usi g the study’s efe e ce excha ge ate of JPY 109 pe U.S. dolla . The app oximately $54 millio figu e is the sum of sepa ate phase-specific media s, ot a obse ved media total developme t cost. Study
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.
