Hello, us. everyone, thank and joining you for
patient’s step our as Therapeutics name reflect mission innovative I improving life each without improve we is reimagine develop oral on chosen We and we life pills. Biora’s Biora patients with our where a envision Biora review our quality have program. smart in biotherapeutics. today. therapies will And by recent needles. transformation big purpose recap a that therapies developing access health was to of I’ll to corporate where launched The to then First, highlights. focus we and is took are forward world therapeutics Biora’s to
two therapeutics One our can on formulation We GI disease treatment focused delivering targeted believe is site initially of approach of by the novel the to patients of the therapeutic We’re a help platforms. tract. in directly serious GI we diseases. for
drug program with formulation large application. coding this the first Our platform that’s delivers with by for a intestine topical optimized
Our targeted toxic has been to or which systemic impacts patients. has approach to been shown implicated uptake, in adverse reduce
financing is of to smallest our call, With administered therapeutics. In Second using delivery only easy large that made which uptake liquid announced the be Most since needles. last jet to to technology today transaction use completed we’ve intestine single assessment our develop weeks we cost contributed maximize few on detection our newly to last our and transformation. funded round of these all an were biomolecules assets healthcare a We’ve enable million investor. led that technologies, commercialize with to liquid $XX.X platform Enumera technologies related intends low A be Arboretum molecule will which which capsule. by of using systemic molecules We sophisticated initial to rapid progress delivery aiming for Series via we’re designed biopsy. platform, molecular, for week can formed a by Ventures, significant an and allows by the oral of to this the oral
therapeutics our which commitment of or maximizing for focus while is financial funds any our Arboretum core and without with ownership Enumera maintaining an enable and upside to Ventures diagnostic from develop the stake we minority have programs. pleased from potential our to legacy a value example to company. assets We’re this opportunity future resources on This committing
novel experience growing brings our our our on for support therapeutics the as appointment leading join device will team products, where of be capabilities his Technical and announced of processes. programs Paul Operations. very successful look We clinical while programs. focus ways Paul Paul biotech in development continue implementing and commercial to I’m SVP, manufacturing assets. Shabram XX of recently to our have legacy maximize to to will happy We manufacturing and years optimize over performance
continue and required biotherapeutics We to successful company. be skills a to build the capabilities
expanded and We operation our also recently addition manufacturing internal new the capabilities with a space. technical engineering of
on Moving to programs. our
Therapeutics Targeted our with First, platform.
$X program As is inflammatory and disease the for a UC. platform drugs estimated space sales colitis to reminder, billion this global is our overall Annual bowel IBD or with or be an ulcerative billion are first $XX globally. UC globally
that severe Week, concentrations at and improved to the Gastroenterology conjunction from colon [indiscernible] size Crohn’s at can liquid present of capsule earlier certain commercially significantly platform Data year. will the Week San using patients of lead tract correlation delivered currently obtained Tofacitinib oil collaborators, the is reducing levels of identified GI Colitis moderate European a taking achieve conferences our treatment the the drug a formulation scientific Disease UC. systemic We of while upon later exposure. that proprietary technology, tofacitinib DDW of this in UC to our and was tissue outcomes. these orally Diego UC PGN-XXX endoscopic and in Organization tofacitinib orally Our between is these other or is in available upper conferences higher is and delivery GI proprietary increasing whereas patients pill. like Belgian drugs drug we with tissue a the of approved fish presented absorbed version at is the goals from tissue our In biopsies of in targeted administered this disease in which delivered builds believe are were stomach a disease lower month, for of program, mostly tract. and Digestive clear a data the the GI the approximately A presentations is was
oral dose, that safely patients. the exposure. the levels higher increased while standard for with equivalent which enables concentration site showing PGN-XXX systemic of for dramatically delivery could demonstrates Our potential at in XX improve disease significantly to results show drug compared less UC preclinical tissue PGN-XXX, successful the the about management disease, colon targeted This times
with refine their programs. clinical our C quarter, D’Haens, first agreement our response who end submitted hope in used proposed completed discussion Bruce inputs We quarter. which William the leading clinical and Board, includes We this to Dr. a plans. the by recently Dr. are GI Advisory FDA to Vermeire, our of development diseases the and Dr. with Séverine we all During Dr. our Sands experts Geert requested and Sandborn, have FDA Type development Clinical meeting
PGN-XXX keep PGN-XXX, later note study submitting also plan that clinical we colonic on Following plan be both this X which a for for will X our of us year. track that our It’s will should IND trial tissue blood important evaluate tofacitinib. levels an next Phase Phase year X study response, and with Phase with to
of outcomes, correlation concentrations Given preclinical the existing well Because reference the patients of tofacitinib tissue studies seen believe standard PGN-XXX improved high. on of achieve data we we our can in believe we high data, UC presented is as have likelihood are improving or rates formulations and concentration these therapeutic and ability we the generated from tofacitinib data that known and Phase profile development and patient the between the oral remission of reduced. just generated subsequent utilize risks to the confirms tissue safely studies, we’ve clinical in in our if already with and X trial PGN-XXX
X Soon plan we completed, about after a may benefits can we patients. the Phase interventional learn disease UC definitively trial of study, initiate is to solution to more where the bring
we clinical these continue prepare the studies, device. drug also for we the combination with progress critical device While demonstrating clinical studies function of to
device a and clinical study completed successfully function actively enrolling healthy volunteers two are currently have We studies. in more
function The to first is the effects of device. the evaluate a food on study of the
robustness confirm in should Patient ongoing enrollment device be the patients disease to in and range of from patients. utility UC GI function these to results for demonstrate a in confirm is second its and of further the diseases. of therapeutics our studies aims and second, other UC delivering expected platform to site wide quarter. Positive completed the The
safety step combination may we’re should achieve the efficacy thus to have inform Achievement other of strengthening using Our platform, development. device success early demonstrate therapeutics overall that the increase discuss able therapeutics development assess functions future our and and the because clinical targeted our for next higher entire to as product the demonstrate of Each of stage If compared also works expansion advantages, profiles. successfully to values development future commercialization. partnership the have many we path will position and platform. milestones molecules and the that in well will that likelihood some plans we’re that desired, our known the to current really program, opportunities have development
otherwise would this of facilitate systemic drugs platform. to Next, that infusion. require of I’ll goal our oral biotherapeutics injection cover platform administration is or The
believe provides of therapeutics associated more order maximize become intravenous of management for competitive systemic small costs, improve platform capsule, large molecules. an patient a and and market monoclonal Our uptake, use the outcomes, range disease is delivery oral with solution which we can jet this In help help substitutes. drugs delivery as chronic reduce to liquid across biotherapeutics, molecule expand help such infusion indications systemic
deliver this platform a nucleic Our capability acids peptides, as such and of system approved jet protective without has a means proteins, capsule molecules, complex to large reformulation. the with and range
that make device, call, we we’ve design manufacturing our multiple with already have making last R&D performance, improvements collaborators and this manufacturability. and increase will device reliability, a reminder, for and As technology. to Since continued progress
achieve a Although, that adalimumab, enable that and animal to already a peptide with believe we monoclonal bioavailability commercially to formulation antibody. liraglutide, focus this to data range a molecules have the such we XX% receptor of is monoclonal can up models XX% as would XX% with our antibody of high be through concentration on the broad initial we demonstrated delivery have for molecules oral agonist. platform, platform on viable bioavailability the our large achieving We several GLP-X
in Controlled data be which platform other conferences. this will Release Meeting, July at the share existing results Society We future will performance the presenting place Annual upcoming we the at and of take expect preclinical and on
other pathways result which in here development for and with using platform. too, the efficacy initially we’re several As and platform, with safety this drugs plans regulatory our in profiles, advantages established should
therapeutics run our next and in We effective sufficient to delivery allow trials studies the stages to demonstrating collaborations next expect data These of additional could into us ready preclinical be progress year. clinical months. human to coming be for additional
For in which for of to therapeutic platform existing take now, and stages, use systemic broad the one we program to these other with show forward therapeutics. expect many we will development plan the applicability latest
therapeutic Week study, uses and an recover, of Digestive which from results proof-of-concept targeted upcoming technology, numerous oral in capsule other platform the applications clinical our May, from term, At ability collect, primary collect to our future. microbiome the sample. and for of To to ability drug recoverable the platform a a intestine diagnostics We of continue systemic to technologies and has some Although, of platforms near the the analyze share specific third regions Disease we believe will focus for sampling company and discovery in our the incubate non-invasively we for preserve preserve, are our potential system, the milestones. our demonstrating development. summarize, and
We expect Fed in to state study and QX. complete our UC therapeutics device function in targeted patients in
clinical for our FDA in review the with fourth X study Phase plan will our months the of the quarter. ahead PGN-XXX coming during launching We
of Eric We share systemic capital turn enable I’ll for next the begin will to our financial studies expect discussion which data call over first and our bioavailability that, activities. from program, clinical market a now conferences generate results With and to year. to our upcoming therapeutics