call, far the program, cytisinicline Jamie. will second so reached milestones you, progress Thank results. key an provide quarter the including we today's on financial have development on update we in and On our XXXX have made we discuss exciting that
versus of that and United our dosed reached sites States, times trial of in we period key III announced over ORCA-X June, X the the ORCA-X placebo. X have conducted the evaluating being at Let's begin XX of a and with milligrams efficacy weeks Phase cytisinicline XX completion. is in is daily safety X enrollment clinical and as milestone
XXX enrollment original was the smokers. recall, target may you As
XX of weeks of followed either randomized. combination have or However, X XX participate time cytisinicline to the a of in X to were of XXX assigned total in X X we of our weeks All screening of placebo. now additional allowed study, subjects date subjects by to that receive subjects placebo, cutoff weeks in been weeks the resulting of cytisinicline at a of arms
weeks of are study endpoints smoking of has will of evaluate the cytisinicline monthly XX X being rate blinded be the period, follow-up out will treatment. the the that if compared completion placebo end cytisinicline Following followed to placebo. finalized to primary both XX efficacy and independent treatment at subjects either and database X abstinence XX-week of Achieve weeks. ORCA-X The been successful remain and has weeks evaluations will study all the arms of an over benefit until locked. show or their both of
in We be the to XXXX half occur visit ORCA-X the to first XXXX. the expect announced at patient, last end top study last of line data in and of results
an evaluation e-cigarette study. begin recently to also we the to or nicotine We announced from award of July, Phase II were for we preparations the update federal vaping our regarding cessation. received NIH cytisinicline into In the that expand plans grant a ORCA-VX notified
of this receive that for trial, Technology The Transfer this maximum X $X.X in funding tranche. process applied is requires costs meet under of million Achieve awarded to in part the allowable to we milestones nondilutive grant. As NIH important phases related to funding specific NIH second secure offset and the order the to Small Business grant
The costs. United will in the users receive study clinical expected of award grant Phase in million total II and is Achieve population. approximately execution new by the X used such is assessed the approximately regulatory IND identification ORCA-VX The submission these expects activities clinical XXX first and adult funding to of States. NIH, being enable that for of clinical and operational site a to of this the the trial the finalization, August to completion as $XXX,XXX protocol commenced $X.X nicotine complete of next approved FDA to cover amount NIH trial on milestones, specific of of grant stage critical approximately e-cigarette ORCA-VX XX% as Upon
of co-primary of efforts & Jacobs, users leading the Medicine more III delighted XX General on Cindy in indicates Chief Dr. alone. are Treatment have Dr. at as the Recent trial Hospital, Officer, and along the of primary Center Rigotti, there Professor and Achieve's investigator Director Tobacco Rigotti with our Medical study. to Harvard President Research School Nancy We adult in at than investigators. Massachusetts ORCA-VX data nicotine million United Dr. is are the e-cigarettes the ORCA-X States Phase also Medical
than more nicotine research addiction, of While long-term e-cigarette by also e-cigarettes remains users would many e-cigarette a quitting, users cessation viewed Achieve, desire a conducted are more seeking less roughly interested with Currently, than Since quit. combustible vapers indicated they to controversial. therapy. a quit Of been as those historically interest are indicated specifically help in these there prescription sustain completely. months. no have urgent their And be quit in safety products harmful to now half XX% expressed treatments cigarettes, to XX within new
growing as commercial to option So proved quit population users to seek a e-cigarette development cytisinicline efforts good. be offer we If see nicotine our this this new cessation an unmet of for opportunity. who may for successful,
stem to and these These to dose that cytisinicline. obtained U.S. the issuance expected Office. claims issuance, Moving patent and results X-milligram by cytisinicline new be XX term quarter third extensions administered The of another evaluated X we now X clinical Not which in we claims With from include applications. these granted may expire will and under that various new Patent Trademark X just the pending patents of study granted on doses including this announced any in families administrations the have milestone entitled, patents patents of commercial patents, we patent have the we patent XXXX. been X our yesterday, times important the daily. of covering patents ORCA-X
highlights. we U.S. our Aggressively to to excellent recent our ways franchise. in overview cytisinicline and seek additional That our continue patent protect to commercial expand in make this cytisinicline expect continue front. progress to the the our to the for and future portfolio key IP is We protecting beyond as of we on success, concludes the
discuss over to Now the turn our to like results. I'd to Jerry call financial