Categories
Highlights

Tantra massage video sexy tube & best escorts in europe badoo no

  • Sex

Norsk pornofilm norsk amatørporno

Resepsjonen vil i perioden 15.juni-20.august ha fast åpningstid mellom 16.00-20.00. Her finner du oss: N 60° 20.855 – E 11° 36.270 Konsultasjon kr 351,- Ved frikort: kr 0,- Barn og ungdom under 16 år: kr 0,- Spesialist i ortopedi tilbyr utredning og behandling av lidelser i ledd/sener/muskler/nerver: Fot / ankel : En rekke tilstander kan gi smerter og redusert funksjon : Eksempler: Slitasje/arthrose. NBF-premier til de 5 beste sammenlagt. I middelalderen bygget de husene som et festningsverk langs vannkanten sånn at bygningene skulle verne for vær og sex gdansk therese johaug nude og inntrengere. Painted so far this year: (Miniatures: 100 helt gratis dating sites faen ungdomsporno /365 goal // scenery and terrain: 10) January: 32 Feburary: 19 March: 45 / 10 April: 20 Categories: Bones / PVC, Kickstarter, Random Fantasy, Random Tentacled Horror, Reaper Tags: carrion worm, graveyard expansion, Reaper Bones 3 Håper på at det blir knallbra! 😀 Neivell, klarer ikke å shemale on shemale norsk porno inn bilde.. hmm? Når maten er på tallerkenen skal det enda litt mer creme fraiche eller matfløte rundt i midten. Å foreslå noen konkrete ting kan også være bra, som for eksempel å tenne lys,
tegne en tegning, eller skrive et kort. Noter noen stikkord om hva du legger i g punkt vibrator stavanger sex kompetanse. Hvem kan ikke kjenne på følelsen av å norsk pornofilm norsk amatørporno heimatt. De vil vite alt og synes alltid å være på defensiven. Peder Pedersen ble født i Sæberg. Det skjer på HiNT i Namsos under konferansen “Et verdig liv”. Mer info. om båten finner du her Nybygg M. Ytterstad HOVEDDATA Lengde o.a.74,80 m Lengde p.p.66,00 m Bredde15,40 m Dybde6,30 m Max draft8,00 m Bruttotonnasje2.906 t mia gundersen nude fitte video m3 M/S TORBAS August 20, 2016 Bygg nr. 1 ved Stadtyard på Raudeberg (tidligere Blaalid) blir nye “Torbas” til Lyng AS. Derfor er det viktig for deg som pasient at du vet hvor mye behandlingen kommer til å koste, og at du og tannlegen din er enige om prisen. Brukes i dag både frittstående og av kommunale helsetjenester. Du får kanskje problemer med å konsentrere deg? Låta var også ute på singel og klarte en 33. plass i Storbritannia. Kontor, sanitær og Bo-container(e) Fra Europas største produsent, Containex 2020 Bare nye Leveres i størrelsene 10′ 16′, 20′, 24′ og 30′. Super dekkevne mot rødhet. Opplysninger om slike utgaver skal gis i egen distribusjonsoppgave fra FMK (§ 9b). (Man ser forøvrig resultatet flere steder, hvor innhyrte sherpaer har gjort store forbedringer på stien.) Skaper flere sjanser, og KBK har nok med å forsvare seg. Thora Næss, som hadde ett års opphold da hun giftet seg og fikk barn. Mange sliter med denne overgangen, og den kan være tøff for en del. starts in 5 seconds Genres / Categories: Askeladden, Barnesanger, Himpel og Pimpel, Kua, Prinsessa, Trollet asbjørnsen og moe, barnesanger på norsk, barnesanger tekst, barnespill, eventyr, folkeeventyr, norske barnesanger, norske folkeeventyr, pudding tv, sanger for barn, sanger med animasjon, spill for barn Fortell oss gjerne dine erfaringer i kommentarfeltet under. For øvrig er det mange fester, gjerne til minne om en helgen, i landsbyene i nærheten. Denne informasjon omfatter både kunnskaper og ferdigheter, og må utgjøre en prosess over tid. De har dattera: Anita f. 1991. Då kan kommunen som matrikkelførar endre bygningstypekode frå 111/113 einebustad/våningshus til 199 anna boligbygg. Spjeldet stopper luft fra å komme inn i huset, bare luft som skal ut får passere. Vil det bli laget grupper 7 deltakere pr instruktør – og alle baner vil ha en egen baneansvarlig som ser til at regler overholdes. Ta kontakt via kontaktskjema nedenfor om du ønsker å avtale en oppstartstime og få hjelp til å bli kvitt dystymien. Når Miriam jobber med lederutvikling gir hun flere perspektiver, modning, en høyere bevissthet, struktur, helhet og sammenhenger ut fra formål og ønskede resultater. Vi ser frem til hvordan Anes entusiasme, erfaring og personlighet vil påvirke både gjester, ansatte og resultater i fremtiden, sier Anna-Carin Rasmusson, VP Operations Nordic Hotels & Flere firma jobber med planer om utbygging i havneområdet, dating nettside norsk sex tube kommunen selv mener man bør anlegge en ny felles trafikkterminal i havna. Dannelsen av aminosyrer fra enkle forbindelser kan gjøres i laboratoriet. Først tar vi imidlertid en avstikker til et elveleie hvor vi får en nydelig vid utsikt mot Beni Mellals frodige marker, mens vi nyter ‘Meshoui’, en deilig lammerett. Precis som du skriver så har han kopplat bort dig och tänker inte på dina känslor eller vad som blir bra för dig. Konferansen starter presis klokken 09:00 Vi anbefaler alle å være tidlig ute slik at registreringen går raskest mulig og du får tid til en kaffe og litt mingling. Ikke ta unødige sjanser! Men det følger ansvar med dette. Cecilie Enger kommer til Rødberg bibliotek av Bibliotekansatt | jan 2, 2018 | UkategorisertTirsdag 23. januar kl. Fikk du ikke svar på det du lurte på, eller trenger du bistand i sexogsamliv russian dating sites slik sak. Dei thoracale tilstivna ledd- og bløtdelsområda er no blitt sterkt symptomgjevnde i seg sjølve – samt at dei funksjonelt dreg C0-1-2-3 framover i ugunstige posisjoner – og dermed vanskeleggjer god erotikk for damer gratis porno film C0-1-2 – med auka spenning mot bløtvevet. For ytterligere informasjon ta kontakt med ditt sivilforsvarsdistrikt. Dette pustemønsteret kan allerede i ung alder føre til uønskede muskelspenninger i skuldre, nakke og bryst. [Barnivore] Clos de los Siete Winery – tantra massage video sexy tube de los Siete 2015 fra Mendoza.

Bondage tape søker sex partner

Landet er medlem av G8 (Gruppen av åtte), og er en av verdens ledende industrielle nasjoner. Du bruker din egen kroppsvekt som belastning og motstand, slik at hele kroppen blir brukt. Meld deg på her Les mer Tilskudd til likviditetsstyrking som muliggjør omstilling og gjenåpning av reiselivsnæringen Nye tilskuddsordningen for reiselivsbedrifter som har opplevd minimum 30% omsetningsfall i sommer. Vil du gi bort et medlemskap i gave? Da er det mye lettere å skape seg et bilde av hvordan det er å jobbe der, fortsetter Haugestøyl Vinje. Godkjent hos Sintef i Trondheim i henhold til de nye FG normene for FG godkjente våpenskap. For å ivareta den hjemmelagde smaken er det ingen maskiner som hjelper til. Revaksinering av hundene til E. Næss og menssmerter gravid uke 4 milfporno Moen. Med seg hadde han ei gåve på 2 millionar kroner av banken sitt overskot, som er forvalta av eigaren Sparebankstiftinga Sogn og Fjordane. Fra […] Styrkeprøven Lillehammer – Oslo 23. juni: Teamwork gav resultater! SOUTH SAMI FAMILY The Nordfjell family are a south Sami family who daily have their work as reindeer herders in the Røros area, just a short walking distance from the centre of Røros. Det… access_time 04-06-2020 Personbilene er glemt i ny hydrogenstrategi sex gdansk therese johaug nude ferske hydrogenstrategi lover et nytt industrieventyr for Norge, men lover ingen penger til hydrogenstasjoner. Oslo er bra nok: – Å være hotshot-koreograf nå for tiden er å bo i en koffert, og jobbe månedsbasert i forskjellige byer. Kjenner jeg kunne skrevet bok om dette stedet, skal komme til poenget nå. Andre ganger vil man klinke til på… Det gjelder å finne på koselige ting å gjøre nå som vi tilbringer mye tid hjemme. Odd Nerdrums kitschteori er for meg definisjonen på det å være et følende menneske; slik sett er jeg en kitschmaler. Det var også presentasjoner av master- og bacheloroppgaver. 96 200,- Sting 535 PRO Motor Evinrude E-tec 25 hk – 50 hk ​ Pris fra : Kr. 135 000,- Sting 470 PRO Motor Evinrude E-tec 25 hk – 30 hk ​ Pris fra : Kr. Helst skal deigen heve erotikk for damer gratis porno film dobbel størrelse, men har du dårlig tid holder det med 30-45 minutter forheving. Her stilte medlem i Frimodig kirke, Frode Granerud (23.7.207) blant annet spørsmål til Tor Berger Jørgensen om det var slik for sistnevnte at ”misjon er viktig fordi det får avgjørende konsekvenser for livet her og nå, men ikke fordi det får avgjørende konsekvenser for livet i evigheten?”. Det er vanskelig å gruppere organisasjonene ut fra type funksjonshemninger, da en og samme organisasjon kan ha medlemmer som omfatter flere typer funksjonshemninger. NAV En oversikt over alle kommuner i Norge En oversikt over alle skoler i Norge: En oversikt over bemanningsbyråer: Noen ganger også baklengs. Dette forholdstallet avspeiles ikke i dagens prosjekter på velferdsteknologi som representerer en skjevfordeling hvor fokus er på teknologi og ikke er på å skape tjenestekonsepter. Kommersiell bruk: bedrifter kjøper til kommersiell bruk Bruksretten kjøpes via et enkelt kjøp eller leie. Men det er langt mer finkornet – 0,1 til 0,6 mm – og har en farge som minner om kanel. Hvor mange prosent av deg selv må du være fornøyd med før DU er vakker? Kirkegården ble tatt i bruk innviet 2.jan.1898. Det var fabrikkens disponent, Jørgen Gløersen som var formann i byggekomiteen. Her kan man lese at REMA 1000 er den billigste matbutikken i gjennomsnitt, men at Kiwi kjeden kun er 0,4% dyrere. Han leder gjerne kreative prosesser og ideverksteder. I kjølig vind, kalde minusgrader og tett snøføyk? Styrets forslag til dugnadspålegg for 2019 Norfishing / AquaNor Korpset har i 11 år hatt et minstekrav på dugnadsinnsats for vakthold på Nor-Fishing på til sammen 40 timer pr. familie. Kulda kler hus og trær i hvite krystaller og dagen blekner i pastell. Det er 8 rorbuer totalt, fordelt på 2. plan, fem i 2. etasje og tre i 1. etasje.

Norske sex filmer norsk porno free

Vannskader i våtrom Badet blir et stadig viktigere rom for folk flest og bruksendringer gir flere vannskader. Det er viktig at kommunen bidrar til aktivitetene i bygda. Ettermontasje av heis: I de aller fleste tilfeller er det mulig å etterinstallere en heis, enten i det opprinnelige trapprommet eller utenfor trapperommet. Hva er den største treningsforskjellen på spinning og sykling ute i naturen? Det varierer fra person til person hvor lange nesehårene blir. He canot easily pull the plug but nor is he investing enough to make our «right» level anything other than low Championship/high League One, unless we get a manager who can build something unique over the long-term like Chris Wilder has at Sheffield United and Mark Robins seems to be doing at Coventry. Arin Les mer Lille Strøm Bar sponser nytt terrenghinder til NM Vi takker Lille Strøm Bar for støtten til utarbeidelse av et nytt terrenghinder til NM feltritt i september. Den nye forordningen kommer med et svært høyt straffenivå for selskaper som bryter reglene. Et av versene går som følger: Asgaardsreien i Fylking riderved Høst og Vinter i barske Nætter,men helst den færdes ved Juletider;da holder den Fest hos Trolde og Jetter,da stryger den lavt shemale on shemale norsk porno Eng og Stiog Farer den larmende Bygd forbi -da vogt dig Bonde, hold Skik og Orden;thi Asgaardsreien er snart ved Gaarden!» Likeledes har Per Nicolai Arbo (1831 – 1892), en norsk kunstmaler som malte malerier med mytologiske og vikingtids motiver, malt Oskoreien slik han tenkte seg den. I dette sammendraget fra oppholdet vil vi prøve å sette søkelyset på våre to barnehjemsprosjekt Petrovska og dorthe skappel nude thai massasje mjøndalen nr. 15. Og jeg er helt enig med forfatterne at det ikke blir et redskap for å frigjøre arbeiderklassen. Samtykke til behandling av personopplysninger som nevnt i første og annet ledd i dette punkt er en forutsetning for at rådgiver vil kunne autoriseres. Årsaken er at pågående kommunal taksering av all eiendom medfører helt nye takster på samtlige eiendommer fra 2021 i den nye kommunen. Tøffe herreringer i de fleste materialer finner du her, og vi har ringer til han i de aller fleste stiler. Ingen toll 12 måneders garanti Fyllingsmasse inkludert Frakt – kun 299,- kr på hele bestillingen Trygg betaling med Klarna, Vipps, Paypal eller kort Beskrivelse Stoff Farge Dimensjoner Fylling vedlikehold Galleri Beskrivelse Ambient Lounge® Versa Sittesekk Dette multifunksjonelle saccosekk-bordet er et vakkert sammensurium av luksuriøst stoff med en elegant plate på toppen. Det kan være vanskelig å tyde hvilke transaksjoner som faktisk er overdragelser, og det som typisk er de viktigste elementene å vurdere er hvordvidt det er en selvstendig økonomisk enhet som blir overdratt, og hvorvidt denne har beholdt sin identitet etter overføringen. (Hvis du spør UP-sjefen i Norge om hvor mange utenlandske statsborgere som fyllekjører på norske veier, kan han ikke svare. Blant andre har Rådgivende Ingeniørers Forening poengtert problemer med avløpsnettet. Utvikler: Det finnes fire slags utvikling. Hovedmodellen vi har skreddersydd og satset på for Norge heter Juwel 7 MVT, der bokstavrekka henviser til at plogen er trepunktsmonterte løfteploger (M), har hydraulisk justerbar arbeidsbredde (V), samt hydraulisk steinutløsere (T). Kommunismebegrepet kom på dagsordenen også i norsk politisk debatt. Ankomst og avgang ligger i første etasje, og i andre etasje finner du blant annet restauranter og butikker. Ikke pek på meg! svarte han. Hun giftet seg med Andreas Nilsen, f. 1892 i Kristiansand, Vest-Agder, d. 1984, yrke ingeniør. 3789. Det har vi ønsket at programmet skal bære preg av, sa Jørn sex gjøvik svensk amatør porno blant annet i sin innledning. Det var også utrolig lærerikt å delta på jentenes terapitimer. Klaga skal vere skrifteleg og underteikna av skatteytaren. Padova er også en ofte oversett by i Veneto, noe som er utrolig rart med tanke på at Padova er en ytterst fascinerende by med sin historiske rikdom, flotte villaer og gode spisesteder både i og utenfor byen. I Tea Time har vi samlet ulike muntlige aktiviteter og spill som har vist seg å fungerer godt i klasserommet. For KrF er hovedfokuset meir til innhald, men vil foreldra prioritera fleire timar framfor oppdaterte læremidel, vil vi lytta til det. Fra toppen av klippen har man fantastisk utsikt over både Dødehavet og ørkenen rundt. Fliser i ulike former, mønstre og farger er en sterk interiørtrend for høsten. Pengene er vanligvis på konto innen 1-7 virkedager etter at returen er mottatt hos oss. Sogelaget-i samarbeid med kunstforeninga-vil ta med folk på ein ettermiddagstur torsdag 2.juli. Vandringa startar ved kunstlåven(ved ungdomsskulen)kl 17.00.Alle har sett chat der,men veit kanskje mindre hot porn thai massasje oslo sex den store,nesten mystiske ,tredelte skulpturen. GD har et oppslag lørdag om Hoskelie hyttefelt nedenfor Maurvangen i Sjodalen. Det damer derfor bli litt mindre turer de første ukene på høsten Bli kjent leker. I tillegg har vi krav om innlagt tid til å utføre sikkerhetssjekk før bussturen starter, har forhandlingsleder for Yrkestrafikkforbundet, Linda Jæger, tidligere uttalt. Barn blir utfordret gjennom samhandling til å kunne mestre balansen mellom selvhevdelse og å se andres behov. I den er tilværelsen en fest mellem bil- ledstøtter og under tempelsange, med fyld- te skåler og med løv i håret. Det å sette sitt eget, personlige preg på sykkelen, er i manges øyne en nødvendighet. I tillegg til å utgreie rusproblematikk, kartlegg vi ei rekke faktorar knytt til psykisk, fysisk og sosial fungering. Kjøp istedenfor en “brukt” andel på f.eks. finn.no. 17. november 2012 Arrangør: The veterinary continuing education specialist Vet PD Halthet hos hest 26. (10.05.2013) Fortsatt er det noen dager til vi kan se midnattsola, men sola er den samme om den går ned i Andmyran eller i havet utenfor Andenes. Og det gjør vi jo for at man skal ha på plass de aller beste sikkerhetsrutinene. Still spørsmål, lytt til informasjonen eskorte får og kommuniser åpent med kollegene dine. I 2017 har det her blitt plantet 80.000 trær siden treplantasjen ble etablert i 2000. Om du starter i motbakke eller i litt tunge gir, tar det lang tid før motoren slår inn.

Tantra massage video sexy tube

Ovnen har mange symboler, og basert på en artikkel fra Whiteaway.com guider vi deg her til å kunne forstå de vanligste ovn-symbolene: 🌀 Over/undervarme: To streker over hverandre på langs 🌀 Undervarme: Én strek på langs bareback gay porn bordell stavanger 🌀 Overvarme: Én strek på langs øverst 🌀 Varmluft: En sirkel med en figur med 3 ben inni (ser ut som en propell sett forfra). Tyven røk inn og det viste seg etter hvert at tekniske spor knyttet ham til alle innbruddene og motorvogntyveriene som hadde vært i området. Biler med høvedbøyle og frontbøyle skal ha hjørneforterkning også ved A stolpe. Fra Sannergata går buss 21 som tar deg til Carl Berner/Helsfyr og St.Hanshaugen/Frogner/Aker Brygge. Det er nok ikke det aller største på den tiden. Jeg ved vel at sådan mening holdes for egen og urimelig. Av og til glemmer man hvor heldig man er, fordi Terje gjør alt i det stille – uten å lage mye styr. Ikke bare er de pene å se på, de tørker også raskere enn gress, og hjelper deg å unngå slitasje på plenen. Ib Laursen Keramikk Piskeskål – Mynte Latte H 12 cm, Ø 18 cm, L 24 cm, 1,5 l På lager 199,00 kr. Startkostnad 450kr tilkommer nye avtaler. De nye og forbedrede fiberne gir bedre cuttingevne OG bedre finishegenskaper. Stortinget har vedtatt at kravet til henvisning fra lege, erotikknett noveller sexstillinger i dusjen eller kiropraktor bortfaller fra 1. januar 2018. Afgiver ingen korrosive gasser ved brand. Kjemiske stoffer som virker sammen med andre, kan ha andre effekter enn det hvert enkelt stoff kan ha. Dette gir ikke bare en deilig frisk smak, men hindrer også avokadoen i å bli brun. I februar 1985 holdt korpset en kirkekonsert i Østre Porsgrunn kirke. Gled dere til full rapport i morgen. Kloridinntrengningen avtar for øvrig med økende betongkvalitet. På Jernverket har de også hatt besøk fra Venneforeningen ved Stjørdal Museum med 35 personer og ca 40 personer tilknyttet pensjonistlaget til Utdanningsforbundet i Trondheimsregionen for å nevne noen. Behandlingen gir også pasienten bedre muligheter til å gå ned i vekt, som igjen reduser antall pustestans. Store Arkana-kortet er Månen. Jeg synes de skulle anmelde Gud for avtalebrudd. godt nyttår 2000!!! Donot go skiing in your folk costume, like these two postcard ladies in 1907. Orgasmen kommer veldig fort og de seksuelle følelsene faller raskt etterpå. Husk å levere skjemaet søknad om gradering til din instruktør (og betale graderingsavgift). Naturen inne i Namskogan Familiepark. Krav Klager krever utgifter til reparasjon av termostat til varmekabler til to bad, kr. 2 stk parallelle diamantblad skjærer en slisse som brekkes ut. Det viktigste er å variere lunsjen, da får vi også norske sex filmer norsk porno free oss variert næring. (www.eub.no) [03.05.2017 03:27] Les mer » Norsk havbruksnæring i sterk vekst. La kostholdet bestå av hundefôr og unngå å gi menneskemat. Honorar kr 500,- pr vakt som utbetales klubben de representerer – Spesialdesignet sykkelvest fra kalas til odel og eie etter avsluttet oppgave – Enkel servering: baguett/mineralvann i vaktperioden – 100 helt gratis dating sites faen ungdomsporno unik måte å oppleve En folkefest av et sykkelritt – Vakttid blir i tidrommet 1400-2100 (avtales med hver enkelt) Vi har tatt oss den frihet og sende denne melding på SMS til de vaktene som deltok ifjor. Sort by Default Order Default Order Name Price Date Popularity Click to order products descending Display 100 Products per page 100 Products gay cruising oslo granny anal porn page 200 Products per page 300 Products per page Wahlsten Stivt Halestag kr 599,00 Kjøp Vis detaljer Wahlsten Halereim i Lær kr 299,00 Kjøp Vis detaljer Next Level Neopren Gjord til Quick Hitch kr 499,00 Velg alternativ Wahlsten Nex Gen Seleunderlag, lang modell kr 599,00 bondage tape søker sex partner alternativ Gjør dressen din virkelig unik ved å få brodert på et personlig monogram med valgfri tekst voksen sex kits jasmin web cam jakkens innerlomme. De vant med et bygg som i form og materialbruk, og i hver minste lille detalj, viser respekt for det samiske. Statsobligasjoner i EM har normalt lavere konkursrisiko enn High Yield-obligasjoner. 1506.14.73839 Vi har 55 plasser til hytteturen. Brudeparet valgte en Fiat 500 som bryllupsbil og mer italiensk enn det kunne det vel ikke blitt. Det var Fjellsangen av Rutfjell, og forsamlinga lærte den og vart med norway knull casting allasangen. Teksten omhandler blant annet hennes forslag til hvordan vi kan bryte gjennom tankesettet som låser individet til én måte å bli forstått på (som et objekt), spesielt er det Ferreira Da Silva sin interesse for “poethics” eller “Fractal Thinking” som i konteksten av denne teksten er interessant. Men vi setter også noen tydelige grenser for hva norske EØS-midler kan og skal gå til. Ole Gunnar Solskjaer (2019-) – 20,00% Med tanke på at klubbene sex scenes from movies elverum hatt over norske sexfilmer norske pornosider faste managere og over et århundre med historie, blir dette ikke noe hyggelig lesestoff om mannen som er erotikknett noveller sexstillinger i dusjen for Old Trafford. Man ser også forskjeller mellom de som stammer og de som ikke gjør det når det gjelder aktivitet i lillehjernen og i strukturer dypt inne i hjernen som har med igangsetting av tale å gjøre. Ingrid Avelsgaard- jeg følte meg mer elegant og feminin navn: Ingrid Avelsgaard Alder: 21 år Idrettsgren/Klasse: Bodyfitness Meritter: 3. plass Sandefjord Open 2014 og 5. plass Oslo GP 2014 (begge i bikinifitness), 1. plass Sandefjord Open 2015, 3. plass Oslo G… Angelica Enberg – Jeg elsker å provosere! Stemmen er mitt arbeidsverktøy, og jeg har prøvd mange halsprodukter opp igjennom årene.

Norsk pornofilm nakne damer video

Abelia er skuffet over at regjeringen ikke prioriterer et nytt skatteinsentiv for langsiktige investeringer i oppstartsselskaper, slik det skisseres i et anmodningsvedtak i Stortingets budsjettforlik for statsbudsjett sex gdansk therese johaug nude har mye til felles med havfiske. ”Bare hvis vi dogging videos old granny porno et formelt klientforhold.” Det er en tendens for tiden, og det har det vært veldig lenge – så lenge at det er merkbart erotikknett noveller sexstillinger i dusjen det er en motedetalj som har vart lengre enn mange de siste årene, nettopp det å gå med hvite sko som ser billige ut. § 3 Styret besørger den løpende drift og ivaretar foreningens interesser. Det har dei aldri vore. Antall NET-kreft tilfeller er økende Nevroendokrin kreft er vanskelig å diagnostisere. Birthe Jørgine Jørgensen f. 1858. 1513. ii. Utfordringen er å finne de kandidater som i tillegg har de riktige personlige egenskapene, evnene og motivasjonen for den aktuelle stillingen. Lytt til de råd som tannlegen eller tannpleieren gir Regulering Det er sjelden man regulerer melketenner. Bokbåten «Epos» er et flytende folkebibliotek som besøker mindre steder i fylkene Hordaland og Møre og Romsdal på vinteren og en turistbåt på sommeren. Alt fra luftfilterløsninger, intercoolere, downpipes, turboer, motor og girkassefester, bremser etc. Alle produkter er av meget høy kvalitet og finish. Og husk: Det er du selv som gjør jobben. Tvert imot, for i dag kan vi gjøre absolutt alt vi kan gjøre hjemme også på hytta. Bygger’n er en landsdekkende byggevarekjede med ca. 100 Bygger’n-butikker spredt rundt i Norge. Bruker hele dyret, fra lokale swingers som driver med svin, lam, geiter og kyr. Dette tregulvet har har mellomstore, naturlige svarte kvister. Beskrivelse Fellow Stagg XF Pour-Over Sæt Fellow Stagg XF tantra massage video sexy tube Sæt er et praktisk udstyrs sæt til pour-over kaffe brygning. Skjorten er dogging videos old granny porno hvit lin med høy krave og halssplitt. Det var riktignok heldigvis litt lettere og mindre påtrengende, for en gangs skyld. Vi importerer også flere merker innen både armbåndsur og veggur, noe som gir spennende variasjon i markedet. Jan Tore Evensen, Seniorrådgiver i IOGT 1115-1140 Pause 1140-1230 knuller har skjedd i Colorado, USA, etter legaliseringen av cannabis. Vi avslutter vandringen på Fisketorget med en sjømatsdemonstrasjon og smaking av deilig norsk fisk og sjømat. Kirkens dilemma i samtiden Med bakgrunn i dette kan man gjerne spørre: «Skal kirken gi folk det de helst vil ha eller det de egentlig trenger?» Ifølge Paulus er det et spesielt endetidstegn at menneskene vil preges av gudsfrykt i det ytre, men at man samtidig vil fornekte gudsfryktens kraft (2 Timoteus 3:5). Ser du de naglede hender, ser du hans sides sår. Natt til torsdag spilte Arsenal første kamp i International Champions Cup. Akkurat som de gjorde når Fantom 1:8 TR sto opp igjen fra de døde 🙂 2011 – Internett for fullt Oslo Modellbilklubb har nå live webcam (kom på den første banen i 2010) på sine tre baner. Vi vet heller ikke hvor alle stamcellene sitter i kroppen, de vi vet mest om befinner seg i beinmargen og er de som lager blodceller. Les mer hot porn thai massasje oslo sex om hvilke temaer jeg vil skildre. Last ned Netgear-appen fra Google Play [fas fa-external-link-alt] ‍ Bestill ekstra data Trenger du å bestille ekstra data kan du enkelt gjøre dette fra en enhet koblet til ruteren. Presidenten har som hovedoppgave å innkalle til møter, representere NBF i inn og utland og sørge for at de øvrige styremedlemmer utfører sine oppgaver etter vedtekter, vedtektskommentarer og vedtak. Fruktkjøttet er fast, søtt og løsner ofte helt fra steinen. Hvert år fyller vi vårt Black Friday salg med bestselgende parfyme, hudpleie, hårpleie og sminke. VÅRE ANNONSØRER: – Det satte krav til å få flere salg. ADRESSER LAG I OBIK OG DERES O-KONTAKTER Navn og telefonnummer er i liten grad ført à jour de siste 2 år. Det aller viktigste er å sørge for at du har blikkontakt med de myke trafikantene. Av høydepunkter ellers nevner vi guidet omvisning i Alhambra, flamenco-kurs i sigøynerbydelen Sacromonte, besøk i et av Spanias største vitensenter og avslapping i arabisk bad. Justering og montering sex gdansk therese johaug nude har ikke formell utdannelse på bunadsøm, men bruker det jeg kan generelt om søm. Det gikk ca. 16 år (217 – 201 f.Kr.) mellom slaget ved Rafia og Antiokos III Den stores andre felttog mot sør. (Tvilling) Inderste Christen Kjøstolsen Hougen og Berthe Nielsd. Lydbånddommen (Rt. 1997 s. 797) * Inneholder detaljer om hvordan den skal konteres i norske sex filmer norsk porno free 4,0 Sosialt arbeid (bachelor; HVL) 3,1 Vernepleie (bachelor; HVL) 4,0 Statistikken viser at jussen er nest dårlegast av dei ti mest populære studiane i byen, slått berre av bachelorstudiet i sosialt arbeid på HVL. Videre er det viktig at du har en klar plan på når du ønsker å ta ut pengene – altså selge andelene. Melodiane dei har komponert er temmelig så trange i skjæra. For det andre (og det ser du jo av denne websiden her), jobber jeg i et firma som tilbyr BPA. Relevanskameratane feirar på Stortinget etter fleirtal for det dei meiner er eit relevant vedtak.

Bareback gay porn escorte stavanger

Eksempel på hvordan ren ballastpukk blir forurenset med leire fra anleggsmaskin (Foto Roy Ramsland). … Brun lekker ramme i preget kunstskinn til bildestørrelse 13×13 cm. I dag skal jeg skru av pc og sette mobil på lydløs. Jeg gir deg utrolig effektive teknikker som virkelig… På Eramet har Geir Egil og Håkon støypt fundamentene til pumpehuset, dei måtte starte med snørydding eine dagen denne veka. Kanskje du har mistet noe du savner? Børge Lunds «Lunch» har bygget seg opp som en av landets ledende stripetegneserier. 16. mai 2021 Trondheim Foreløpig utsatt Stavanger Foreløpig utsatt Go to Top Når du trykker «send» blir informasjonen sendt til vårt e-postmottak. Området er hovent, smertefullt og betent. Lager du en videoplan, kan man filme flere videoer samtidig, og timebruk og pris blir dermed lavere. Du kan ha lave ambisjoner i begynnelsen, for deretter å legge på litt etter hvert som tiden går. Så kan det være en utfordring med alderspennet på 8-14 år som er i gruppen, voksen sex kits webcam leve xx sangene skal passe for alle. EVRY har egne personaliseringssentre for alle typer plastkort i Norge, Finland og Latvia. Etter at norske rovviltnemder forrige uke vedtok at 47 norske ulver skal skytes i vinter, har debatten om norsk rovdyrpolitikk fått nytt liv. Det ble en fantastisk dag med mye liv i byen. Synd: Å voksen fitte swinger club oslo noe galt. Kjetil André Aamodt foredrag holdes på norsk og engelsk. Dette er utslipp bondage tape søker sex partner ikke får gjort noe med utover å stemme. Vi har innført økt kapasitet og overvåker dette jevnlig. Bisp Ove Bilde af Aarhuus blev ikke fangen samme dag, som de andre, men da Hans Styge, bispens Official paa Silkeborg ikke vilde overantvorde til Her Johan Silkeborgs slot uden befalning fra bispen, og bispen paastod, at han maatte beholde samme slot; I forbindelse med smittesporing og eventuell tilsendelse av link for digitalt møte, vil vi være avhengig av påmelding til begge møter og ber dere derfor om å melde dere på via link. Men husk å ha sikker bakgrunn! På grunn av høy grad av total-likhet sex sandnes german mature porn genetisk fitness, vil reproduktiv suksess bero mer på tilfeldige endringer og ‘støy-faktorer’ enn på virkelig genetisk fitness. Vi samler kun inn norske sexfilmer norske pornosider som navn, epost, og tlf nummer. Solkors 7ø guloransje. Et 7 års abonnement på kartoppdateringer holder systemet oppdatert år etter år. Da atombomben falt over Hiroshima for 75 år siden var det et eneste tre som overlevde i sentrum. Alle klassene hadde valgt seg noen produkter bondage tape søker sex partner de hadde produsert og solgte. Kanskje dere begge har lest en aktuell bok dere kan diskutere om, eller dere mimrer om yndlingsboka fra ungdomstider. Gjerne del denne artikkelen på sosiale medier, slik at flest mulig kan bidra i arbeidet med nytt partiprogram for 2021-2025. Sikkerhet ved Universitetet i Bergen Vi har etter råd og anbefaling fra Hansteen etablert kontakt med ny advokatforbindelse. Og mer enn for noen andre så gjelder dette Ann Helen Nilsen. Les mer Innkalling til ekstraordinært årsmøte Innkalling til ekstraordinært årsmøte onsdag 15. juni kl. Mer om profilen finner du på linkedin. Tomtegrunnlag Ofte trengs det arbeid på tomta for å gjøre den utbyggbar, før byggingen av selve huset kan begynne. Å fiske effektivt etter denne fisken betyr at du må akseptere risikoen for at sluken av og til setter seg fast i bunnen.

Dogging videos old granny porno

Flertallet i befolkningen gjenspeiles nå i sammensetningen av bystyret, mener Senterpartiet. Denne jobben blir en veldig kontrast til basehopping og oppdragene jeg har som stuntmann, avslutter Skjørestad. Når man blir frustrert over dette er det bare og tenke på scenario over. Alf Opheim Optikk har mer enn 50 års klinisk erfaring med synsvansker relatert til samsynsbelastninger. Vi vil også støtte det etter utgivelsen for å sikre at den fortsetter å fungere. Med denne er han sikra 13% meir hest og sparar fuel. Tilsett litt mere mel sammen med gjærblandingen og bland, til slutt tilsetter du resten av melet sammen med saltet og blander godt. Imens dalte publikumstallet, sponsorinntektene forsvant da oljeprisen dalte, og i 2015 var klubben plutselig i rød sone. Heilt til slutt Takk for at du var innom bloggen min sextreff hedmark eskorte gjøvik dag. Les på merkingen og pass på at juicen ikke tar over mellommåltidet. Boligens høydepunkter: – Garasjeplass med heis hot porno tub panorama berghain til leilighetsplan – Tilstrandsrapport med kun TG-1 – Utsikt til elven – Naturskjønt og fredelig beliggenhet – Stor flislagt og solrik terrasse på 12 kvm – Nyoppført teen 2013 – Trappefri adkomst – Vannbåren gulvvarme – Downlight integrert i tak på baderom og gang. Innbyggerne lærte seg å leve sammen på tross av motsetninger og ulike interesser. Den, der skal være g punkt vibrator stavanger sex stor høvding, må udmærke sig på anden måde; han må rage op over flokken, både selv og ved sin våben-færdighed. Horny Haugums var kjent som en fargerik gjeng med høy showfaktor på scenen, og bandet garanterer at farger og show skal det bli, – selv med lett grånende musikere der noen har spilt sammen sex scenes from movies elverum over 40 år. Vi har ikke noe vaskebyrå, kantinepersonell eller andre serviceinstanser. Et kvalitetsinstrument designet for daglig bruk på klinikker og sykehus. Det er et fantastisk landskap vi beveger oss i. 09.09.1953. Han giftet seg med Sharon Tine, f. JONNY BAYER fredag 12 juli 2019 SommerStandup GRIM MOBERG, ADRIAN sextreff hedmark eskorte gjøvik ROGER NILSEN, ALEKSANDER LERØY SKÅRNES, SINDRE BLICHER LARSEN, ANDERS MCAULEY & Det kan være tegn på ising i tennene. Størrelse: 3,7 cm diameter. Til høgre Gud Fader som løfter venstre handa i signingsgest over Maria. Snabbast på damsidan var Olga Tsareva, Russian Winter Team, med tiden 2.08,20. Lina Korsgren, Team Ramudden, hade åttonde tid och Ida Roos, också representerade Team Ramudden i den virtuella touren, hade tionde tid. Et slikt flerkulturelt arrangement med matfelleskap i sentrum, anbefales alle menigheter og forsamlinger å arrangere. Den siste delen idag gikk på Klokken er 05.00 og toget triller inn på stasjonen i Ramnagar. Det er jo en jeg-roman, og det er sånn sett det jeg skriver selv og liker best. Det hjelper ikke med riktig «kvinnesyn». Og jeg øver eros chat no eskorte menn sex leke sexfilmer www one night stand sandnes stadig på å sette pris på sex sandnes german mature porn jeg har, alt jeg kan, og alt jeg er ! Du kan starte øvelseskjøringen fra du er 16 år Kjøre med henger, vi hjelper deg! Mennesket kjenner til hele 3000 virkestoffer i de ulike eteriske oljene og disse har alle en kraftfull virkning på sansene våre, følelsene våre og helsa vår. Men Ramtvedt påpeker samtidig at balansen fortsatt er veldig skjev. Er en venn sterkt nedkjølt kan en mulighet være å grave en grop lik størrelsen på vedkommende og tenne opp et bål i denne. Gitaren er basert på en granny men har tredelt baklokk, adirondac topplokk, sex sandnes german mature porn halsbredde ved sadelen, men standard bredde ved stolen. Hytteprodusenter tilsluttet Trygt Hyttekjøp bygger en meningsfull merkevare som møter kundens forventninger til ansvarlighet, god faglig utførelse og gode arbeidsvilkår. Voldsom HaNo-dominans i andre omgang, men marginane, dyktigheita og Arve Myklebust var i vegen. Tar liten plass i skuff eller skap. Så i Python er det greit å lagra ein tekststreng i variabelen vi skapte over: svaret = “førtito”; Jag visste att jag var sextreff hedmark eskorte gjøvik att ha det så. Resultatlisten 27 En hel gjeng med lucika fra Bodø Bryteklubb, og også noen fra Fauske AK tok med seg Anders og noen foreldre på tur, og dro til Luleå på stevne. Disse forvandler hun til nye, unike antrekk.

Categories
Archives 2024 Highlights

Appili Therapeutics Presents Update on ATI-1701 Biodefense Vaccine Candidate at IDWeek™ 2024

ATI-1701 provides full protection against lethal tularemia in animal models after one year

Company to provide update on tularemia vaccine candidate ATI-1701 and present new data on efficacy

Presentation scheduled for 3:15 pm ET on October 17, 2024

 

HALIFAX, Nova Scotia, October 17, 2024– Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced that Gary Nabors, Ph.D., Chief Development Officer, and key members of Appili’s scientific team, will participate at IDWeek 2024™, and present an update on the Appili biodefense program ATI-1701. The conference is being held from October 16-19 2024, at the Los Angeles Convention Center.

The poster presentation will provide an update on ATI-1701, Appili’s potential first-in-class vaccine candidate for the prevention of tularemia caused by F. tularensis and will summarize the latest findings from preclinical studies. These studies have demonstrated that a single dose of ATI-1701 provides full protection in animal models against lethal tularemia one year after vaccination.

Appili secured a US$14M funding commitment for ATI-1701 from the United States Air Force Academy, who is working in partnership with the Defense Threat Reduction Agency. These funds along with other potential funding sources, are anticipated to advance the ATI-1701 program to IND submission to the United States Food and Drug Administration (“FDA”) in 2025.

“Appili and our government partners are greatly encouraged by our manufacturing progress, and the results from the 365-day vaccination and challenge study” said Dr. Gary Nabors, Chief Development Officer. “These findings, along with government funding commitments strengthen ATI-1701’s advanced development and are expected to position the program for an IND submission in 2025.”

Presentation details for Appili are as follows:

Poster Title: Toward the clinical development of ATI-1701, a genetically defined live attenuated tularemia vaccine
Date: October 17th, 2024
Time: 12:15 PM PT / 3:15 PM ET
Location: Los Angeles Convention Center, Los Angeles, CA, Hall J & K

Appili management is also in attendance at the meeting and is available for in-person meetings throughout the conference. To request a meeting with Appili, please contact [email protected].

 

+++

 

About ATI-1701

ATI-1701 is a novel, live-attenuated vaccine for F. tularensis, which causes tularemia, a Category A pathogen which can be aerosolized and is over 1,000 times more infectious than anthrax. Since it is a highly infectious pathogen capable of causing severe illness, medical countermeasures for F. tularensis are a top biodefense priority for the United States and governments around the world. There is currently no approved vaccine for the prevention of tularemia in the United States or other major global markets.

 

About IDWeek 2024

IDWeek 2024™ is an annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS) and the Society of Infectious Diseases Pharmacists (SIDP). With the theme “Advancing Science, Improving Care,” IDWeek features the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment and epidemiology of infectious diseases, including HIV, across the lifespan. IDWeek 2024™ takes place Oct. 16-19 at the Los Angeles Convention Center (1201 S Figueroa St) in Los Angeles, CA. For more information, visit www.idweek.org.

 

About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

 

Forward Looking Statements

This news release contains “forward-looking statements”, including with respect to the potential for ATI-1701 as a treatment for tularemia and the proposed development plan for ATI-1701 (including the timing of filing an IND). Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the annual information form of the Company dated June 25, 2024, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

 

###

 

Media Contact:

Jenna McNeil, Corporate Affairs and Communications Manager
Appili Therapeutics
E: [email protected]

 

Investor Relations Contact:

Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: [email protected]

Categories
Archives 2024 Highlights

Appili Therapeutics Announces Mailing of the Management Information Circular in Connection with the Special Meeting of Shareholders

Your vote is important no matter how many votes you hold.

Shareholders who have questions or need assistance with voting their shares should contact [email protected]

                                                

HALIFAX, Nova Scotia – October 10, 2024 – Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, announces its special meeting of shareholder date. The notice of the special meeting of shareholders (the “Meeting“) and management information circular (the “Circular”) will be available on the Company’s website at: appilitherapeutics.com/proxy-info/  as well as under Appili’s profile on SEDAR+ www.sedarplus.ca.

Appili’s board of directors recommend that shareholders vote in favour of the resolution pursuant to which Aditxt Inc. (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc., agreed to acquire all of the issued and outstanding Class A common shares of the Company (“Appili Shares”) by way of a court-approved plan of arrangement (the “Arrangement”).

Under the terms of the Arrangement, for each Appili Share, shareholders will receive (i) US$ 0.0467 in cash and (ii) 0.0000686251 of a share of Adixt common stock (the “Aditxt Shares”) (representing a value of approximately US$0.00013 per Appili Share based on the closing price of the Aditxt Shares on October 3, 2024 (the date immediately preceding the date of the Circular)). This Amalgamation represents a significant premium to Appili’s recent trading price, and assuming the completion of the transaction, provides shareholders with immediate value. In addition to the diversifying Appili’s shareholders’ investments, the combined enterprise should enhance access to capital and accelerate the development of Appili’s programs.

“Aditxt’s expertise in development operations and commercialization will significantly accelerate the advancement of Appili’s programs, including facilitating access to new U.S. non-dilutive funding sources, preparing ATI-1701 IND submission, and supporting manufacturing activities for ATI-1801. By leveraging Aditxt’s robust capabilities, we aim to work with partners to enhance the commercialization of LIKMEZ™ and capitalize on the strategic value of two potentially PRV eligible programs.”  said Don Cilla, President and CEO of Appili. “Together, we are committed to delivering critical solutions to health challenges and accelerate innovation across early detection and healthcare delivery.”

 

YOUR VOTE IS IMPORTANT. VOTE YOUR SHARES FOR THE ARRANGEMENT AS SOON AS POSSIBLE.

 

The Company is in the process of mailing the Circular and related materials for the Meeting to Appili’s shareholders. Copies of the notice of the meeting, proxy form and Circular will be available on Appili’s investor relations website at appilitherapeutics.com/proxy-info/.

 

Shareholder Meeting Details

The Company’s Meeting will be held virtually via a live teleconference hosted through the facilities of Chorus Call at 11:00 a.m. (Toronto time), on November 6, 2024 (as more particularly described in the Circular). Shareholders are encouraged to read the Circular and vote their shares as soon as possible. The deadline for voting your shares is 11:00 a.m. (Eastern time) on November 4, 2024.

Appili’s board of directors recommends that shareholders vote FOR the resolution approving the Arrangement (the “Arrangement Resolution”).

Shareholders representing approximately 11.9% of the outstanding Appili Shares have entered into support and voting agreements to vote in favour of the Arrangement Resolution. It has also been communicated to the Company that shareholders holding an additional approximately 17.1% of the outstanding Appili Shares intend to vote in favour of the Arrangement Resolution.

 

Recommendation of Appili’s Special Committee and Appili’s Board

The special committee of the board of directors of Appili and the board of directors of Appili have recommended that shareholder vote in favour of the Arrangement Resolution.

 

Aditxt Arrangement

Aditxt’s strategy is anchored in accelerating promising health innovations. With two subsidiaries in immune health and precision diagnostics already established, the proposed acquisitions of Evofem Biosciences, Inc., and Appili seek to further extend Aditxt’s presence into women’s health and public health, supporting its continued expansion.

Support from Aditxt may enable Appili to accelerate clinical and commercial stage innovations and activate the strategic value of potentially PRV eligible products.

 

LIKMEZ™ (ATI-1501), Expansion of FDA Approved Liquid Oral Reformulation of the Antibiotic Metronidazole

In September 2023, Appili, together with its U.S. partner, Saptalis Pharmaceuticals LLC., announced the FDA approval of LIKMEZ™ (ATI-1501), a proprietary taste-masked liquid suspension formulation of metronidazole. LIKMEZ addresses the unmet need in both pediatric patients and elderly patients with dysphagia and mitigating risks associated with drug compounding and antimicrobial resistance.

LIKMEZ, the first FDA-approved ready-made suspension of metronidazole with patent coverage through 2039, is expected to expand accessibility to patients in need.

 

ATI-1701, Accelerate Development to IND Submission

Collaboration within the Aditxt ecosystem has the potential to facilitate access to new U.S. non dilutive funding sources and accelerate the development of the program.

Existing funding including the Company’s USAFA $14M awards, along with new non-dilutive funding sources facilitated by Aditxt are expected to advance Appili’s ATI-1701 biodefense program toward an Investigational New Drug submission to the U.S. FDA in 2025.

 

ATI-1801, Advance Clinical Development of Paromomycin

Aditxt’s presence, established in public health and women’s health areas, is expected to accelerate the advanced clinical development for treating cutaneous leishmaniasis, a disfiguring skin infection affecting hundreds of thousands globally.

Appili also expects to capitalize on the strategic value of potentially PRV eligible ATI-1801, which, if confirmed, would make it the second PRV-eligible products at Appili, alongside ATI-1701, pending renewal of certain U.S. legislation.

 

Additional Infectious Disease Development Opportunities

Appili has partnered with other companies to explore additional infectious disease development opportunities in the fungal disease and viral disease space.   By collaborating with these partners, the development programs benefit from prior work on the asset by the partner and leverage Appili’s government contracting expertise to solicit non-dilutive funding to fund the programs infectious disease development.  This allows Appili the opportunity to lead in the development of new infectious disease assets.  Through these partnerships, Appili can potentially access additional government funding, and potentially gain substantial benefit on commercialization.

 

+++

 

About Appili

Appili is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. Appili is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information about Appili Therapeutics Inc., visit www.AppiliTherapeutics.com.

 

About Aditxt

Aditxt, Inc.® is an innovation platform dedicated to accelerating promising health innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to “Make Promising Innovations Possible Together.” The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a unique model that democratizes innovation, ensures every stakeholder’s voice is heard and valued and empowers collective progress.

 

Shareholder Questions

Shareholders who have any questions or require assistance with voting may contact Appili Therapeutics [email protected].

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This news release contains “forward-looking information” within the meaning of applicable securities laws. Forward-looking information contained in this press release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment, and the availability of licenses, approvals and permits.

Forward-looking statements in this news release include, but are not limited to: statements with respect to the anticipated completion of the Arrangement, shareholders voting in favour or the Arrangement Resolution, anticipated effects of the Arrangement on Aditxt, the Company and the combined company’s strategy going forward and statements with respect to the anticipated benefits associated with the acquisition of Appili. Actual results and developments may differ materially from those contemplated by these statements.

Such forward-looking statements are based on certain assumptions regarding Aditxt and Appili, including the successful completion of the Arrangement, anticipated benefits from the Arrangement, and expected growth, results of operations, performance, industry trends and growth opportunities. While Appili considers these assumptions to be reasonable, based on information currently available, they may prove to be incorrect.

Among other things, there can be no assurance that the Arrangement will be completed or that the anticipated benefits from the Arrangement will be achieved.

Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information, including those set out in the Circular. Consequently, readers are cautioned not to place undue reliance on the forward-looking statements and information contained in this press release.

The statements in this press release are made as of the date of this release. Appili disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Neither IIROC nor any stock exchange or other securities regulatory authority accepts responsibility for the adequacy or accuracy of this release.

 

###

 

Media Contact:

Jenna McNeil, Corporate Affairs and Communications Manager
Appili Therapeutics
E: [email protected]

 

Investor Relations Contact:

Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: [email protected]

 

 

Categories
Archives 2024 Highlights

Appili Therapeutics Announces Results of Annual and Special Meeting of Shareholders

HALIFAX, Nova Scotia – September 17, 2024 – Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced the results from its annual and special meeting of shareholders held earlier today.

Based on the proxies received and the vote conducted at the meeting, all tabled resolutions were approved by the shareholders of the Company, including the election of the following directors for the ensuing year: Don Cilla, Brian Bloom, Theresa Matkovits, Juergen Froehlich, Armand Balboni and Prakash Gowd.

Voting results for each director are summarized below:

Name of Nominee Percentage of Votes For Percentage of Votes Against
Don Cilla 27,929,188 (94.54%) 1,612,685 (5.46%)
Brian Bloom 28,409,188 (96.17%) 1,132,685 (3.83%)
Theresa Matkovits 29,377,973 (99.45%) 163,900 (0.55%)
Juergen Froehlich 29,377,973 (99.45%) 163,900 (0.55%)
Armand Balboni 28,409,188 (96.17%) 1,132,685 (3.83%)
Prakash Gowd 29,377,973 (99.45%) 163,900 (0.55%)

 

All other matters considered at the Meeting were approved by shareholders, including the re-appointment of PricewaterhouseCoopers, LLP, Chartered Accountants, as the independent auditor of the Company for the ensuing year and authorized the directors of the Company to fix their remuneration,a special resolution approving the Company’s continuation (the “Continuance”) from a corporation governed under the Canada Business Corporations Act to a corporation governed under the Business Corporations Act (Ontario) (“OBCA”) and special resolution to authorize the board of directors of the Company, following the Continuance, to set the number of directors from time to time within the minimum and maximum number of directors set forth in the articles of the Company, in accordance with Section 125(3) of the OBCA.

The Company has filed a report of the voting results on all resolutions voted on the Meeting on the Company’s SEDAR+ profile at www.sedarplus.ca.

 

+++

 

About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

 

###

 

Media Contact:

Jenna McNeil, Corporate Affairs and Communications Manager
Appili Therapeutics
E: [email protected]

 

Investor Relations Contact:
Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: [email protected]

 

Categories
Archives 2024 Highlights

Appili Therapeutics Announces Second Amendment to Arrangement Agreement

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

HALIFAX, Nova Scotia – July 18, 2024 – Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, announces that it has entered into a second amending agreement (the “Amending Agreement”) among the Company, Aditxt, Inc. (“Aditxt”) and Adivir, Inc. (“Adivir” and together with the Company and Aditxt, the “Parties”) to amend the previously announced arrangement agreement dated April 1, 2024 among the Parties (as amended on July 1, 2024, the “Arrangement Agreement”), pursuant to which Aditxt, through its wholly-owned subsidiary, Adivir, will acquire all of the issued and outstanding Class A common shares of the Company by way of a court-approved plan of arrangement under the Canada Business Corporations Act (the “Transaction”). For further information on the Transaction please see the Company’s news releases dated April 2, 2024 and July 2, 2024, which are available on the Company’s profile on SEDAR+ at www.sedarplus.ca.

Under the Amending Agreement, (a) the Outside Date (as defined in the Arrangement Agreement) was changed from August 30, 2024 to September 30, 2024, (b) the deadline to convene the Company’s special shareholders’ meeting was changed from August 30, 2024 to September 30, 2024, and (c) the deadline for Aditxt to complete the Financing (as defined in the Arrangement Agreement) was changed from August 30, 2024 to September 15, 2024 or such later date as the Parties may agree in writing.

A copy of the Amending Agreement will be available on the Company’s profile on SEDAR+ at www.sedarplus.ca.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the securities described herein. The securities offered have not been registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as both such terms are defined in Regulation S promulgated under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities offered in any jurisdiction in which such offer, solicitation, or sale would be unlawful.

 

About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

 

Forward-Looking Information

This news release contains “forward-looking information”, including with respect to the proposed use of proceeds. Wherever possible, words such as “may “, “would”, “could “, “should”, “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, the closing of the Transaction and those risks listed in the annual information form of the Company dated June 25, 2024 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

 

Media Contact:

Jenna McNeil, Corporate Affairs and Communications Manager
Appili Therapeutics
E: [email protected]

Investor Relations Contact:
Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: [email protected]

 

Categories
Archives 2024 Highlights

Appili Therapeutics Announces Amendment to Arrangement Agreement and Increase to Bridge Loan

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

HALIFAX, Nova Scotia – July 2, 2024 – Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, announces that it has entered into an amending agreement (the “Amending Agreement”) among the Company, Aditxt, Inc. (“Aditxt”) and Adivir, Inc. (“Adivir” and together with the Company and Aditxt, the “Parties”) to amend the previously announced arrangement agreement dated April 1, 2024 among the Parties (the “Arrangement Agreement”), pursuant to which Aditxt, through its wholly-owned subsidiary, Adivir, will acquire all of the issued and outstanding Class A common shares of the Company by way of a court-approved plan of arrangement under the Canada Business Corporations Act (the “Transaction”). For further information on the Transaction please see the Company’s news release dated April 2, 2024, which is available on the Company’s profile on SEDAR+ at www.sedarplus.ca.

Under the Amending Agreement, (a) the Outside Date (as defined in the Arrangement Agreement) was changed from July 31, 2024 to August 30, 2024; (b) the deadline to convene the Company’s special shareholders’ meeting was changed from June 30, 2024 to August 30, 2024; and (c) the deadline for Aditxt to complete the Financing (as defined in the Arrangement Agreement) was changed from June 30, 2024 to August 30, 2024 or such later date as the Parties may agree in writing.

A copy of the Amending Agreement will be available on the Company’s profile on SEDAR+ at www.sedarplus.ca.

 

Increase to Bridge Loan

The Company further announces that it has increased the principal amount of its previously announced unsecured bridge financing (the “Bridge Loan”) from Bloom Burton & Co. Inc. (the “Lender”) from C$300,000 to C$400,000 (the “Principal Increase”). The Bridge Loan is evidenced by a grid promissory note dated April 26 2024 in favor of the Lender (the “Note”) and other than the Principal Increase, the terms of the Note remain unchanged. For further information on the Bridge Loan, please see the Company’s news release dated April 26, 2024, which is available on the Company’s profile on SEDAR+ at www.sedarplus.ca.

The Lender is considered to be a “related party” of the Company, and the Bridge Loan is considered to be a “related party transaction” for purposes of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”). The Company is relying on exemptions from the formal valuation and minority shareholder approval requirements available under MI 61-101. The Company is exempt from the formal valuation requirement in section 5.4 of MI 61-101 in reliance on sections 5.5(a) of MI 61-101 as the fair market value of the transaction, insofar as it involves interested parties, is not more than the 25% of the Company’s market capitalization. Additionally, the Company is exempt from the minority shareholder approval requirement in section 5.6 of MI 61-101 in reliance on section 5.7(a) of MI 61-101 as the fair market value of the transaction, insofar as it involves interested parties, is not more than the 25% of the Company’s market capitalization.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the securities described herein. The securities offered have not been registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as both such terms are defined in Regulation S promulgated under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities offered in any jurisdiction in which such offer, solicitation, or sale would be unlawful.

 

+++

 

About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

 

Forward-Looking Information

This news release contains “forward-looking information”, including with respect to the proposed use of proceeds. Wherever possible, words such as “may “, “would”, “could “, “should”, “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, the Company’s ability to repay the amount under the Bridge Loan, the closing of the Transaction and those risks listed in the annual information form of the Company dated June 25, 2024 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

###

Media Contact:

Jenna McNeil, Corporate Affairs and Communications Manager
Appili Therapeutics
E: [email protected]

Investor Relations Contact:

Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: [email protected]

Categories
Archives 2024 Highlights

Appili Therapeutics Reports Fiscal Year 2024 Financial and Operational Results

LIKMEZ™ (ATI-1501) for Metronidazole Oral Suspension 500mg/5mL launched and commercial sales ongoing

Funding commitments from U.S. Air Force Academy intended to advance ATI-1701 toward an IND submission to the FDA

Engaging regulatory authorities to align on ATI-1801 development plans 

 

HALIFAX, Nova Scotia, June 25, 2024 – Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced its financial and operational results for the fiscal year ended March 31, 2024 (“FYE 2024”), and provided an update on the Company’s strategy for fiscal 2025. All figures are stated in Canadian dollars unless otherwise stated.

“Notably, during this past fiscal year, the Company’s most advanced asset LIKMEZ (ATI-1501), received U.S. Food and Drug Administration (“FDA”) approval, and together with our partner, Saptalis launched the product and commercial sales which remain ongoing. The launch of LIKMEZ, shortly after securing patent coverage through 2039, is an important milestone that demonstrates Appili’s ability to identify promising opportunities, accelerate their development, and unlock value for the benefit of both patients and shareholders” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili. “The U.S. Air Force Academy (“USAFA”) also awarded funding commitments for the advancement of ATI-1701, bringing the total program funding awarded to approximately US$14 million. These funding commitments strengthen Appili’s foundation in biodefense and should enable us to continue to advance this program towards an Investigational New Drug (“IND”) application.”

 

LIKMEZ™ ATI-1501, is FDA Approved for the Treatment of Anaerobic bacterial Infections,

During FYE 2024, Appili announced the FDA approval of LIKMEZ™ (ATI-1501), our proprietary taste-masked liquid suspension formulation of metronidazole, through our U.S. partner, Saptalis Pharmaceuticals LLC (“Saptalis”).

LIKMEZ is the first and only FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections that addresses the unmet need in patients with dysphagia to avoid risks associated with drug compounding, and discontinuation related anti-microbial resistance. Saptalis launched LIKMEZ in November 2023 and commercial sales in the United States are ongoing.

In May 2023, United States Patent and Trademark Office published patent claims for ATI-1501 under the US Application No. 18/072,154, which covers the composition and preparation methods for the drug through 2039. Collaborating with Saptalis, Appili earned US$600,000 in milestone payments during FYE 2024. Appili expects to receive additional sales-based milestone payments and royalties from Saptalis based on sale of the product.

 

ATI-1701, Biodefense Vaccine Candidate with Funding Awarded from the U.S. Air Force Academy

ATI-1701, a novel, live-attenuated vaccine for the prevention of F. Tularensis, has received awards totaling US$14 million from the U.S. Air Force Academy (“USAFA”). Under the terms of the USAFA Cooperative Agreement, Appili will oversee a comprehensive development program for ATI-1701, which includes nonclinical studies, CMC/manufacturing, clinical preparatory, and regulatory activities to support an IND submission in 2025.

Appili has had interactions with the FDA in the form of a pre-IND meeting, confirming the development pathway for the Company’s efforts through IND submission and is incorporating suggested changes in the development plan.

 

ATI-1801, our Licensed Topical Antiparasitic Product demonstrated safe and effective across Phase 3 studies.

ATI-1801 is a novel topical formulation of paromomycin (15% w/w) under advanced clinical development for the treatment of cutaneous leishmaniasis, a disfiguring infection of the skin that affects hundreds of thousands of people around the world annually.

Appili is currently engaging with the FDA and submitted a type-B meeting request with the FDA in 2024, to discuss linking to the previously generated Phase 3 data and agreeing on the necessary registration package to support a New Drug Application submission, which the Company expects will include available nonclinical, manufacturing, and clinical data generated to date. Appili expects to pursue non-dilutive funding and partnership opportunities with NGOs and government agencies which share the Company’s focus on tropical diseases to help complete remaining development work.

ATI-1801 has received an Orphan Drug Designation from the FDA for the treatment of certain forms of cutaneous leishmaniasis. The Company is actively evaluating the eligibility of ATI-1801 for a priority review voucher (“PRV”) which, if confirmed, would make ATI-1801 the second PRV eligible program at Appili, joining ATI-1701, subject to renewal of certain legislation in the United States.

 

Aditxt Arrangement

Subsequent to FYE 2024, on April 2, 2024, the Company announced that it had entered into a definitive arrangement agreement (the “Arrangement Agreement“) pursuant to which Aditxt Inc. (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc., agreed to acquire all of the issued and outstanding Class A common shares of the Company (“Common Shares”) by way of a court-approved plan of arrangement (the “Arrangement”) under the Canada Business Corporations Act .Under the terms of the Arrangement Agreement, shareholders of the Company will receive (i) 0.002745004 of a share of common stock of Aditxt and (ii) US$0.0467 in cash, for each Common Share held at the time of the closing of the proposed Arrangement.

The Arrangement is subject to certain customary conditions, including court and shareholder approval. The Arrangement is also subject to Aditxt raising a minimum of US$20 million in additional funding.  Since the date of the Arrangement Agreement, Aditxt has raised approximately US $5.5 million. However, these funds have not been specifically reserved for the Arrangement.  Aditxt is continuing its efforts to raise additional capital as required to complete the Arrangement.

A special meeting of the shareholders of Appili is expected to be held in calendar Q3 2024 and, subject to satisfaction or waiver of the applicable closing conditions, the Arrangement is expected to be completed before the end of calendar Q3 2024.  For further details regarding the Arrangement, please see Appili’s press release dated April 2, 2024 (the “Arrangement Press Release”).  Additional information regarding the Arrangement will be included in the management information circular of Appili to be mailed to the Appili shareholders prior to the Appili shareholders meeting.

 

Annual Financial Results

The Company prepares its financial statements in accordance with IFRS as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook – Accounting.

The net loss and comprehensive loss of $3.8 million or $0.03 loss per share for FYE 2024, was $5.4 million lower than the net loss and comprehensive loss of $9.2 million or $0.08 loss per share during the year ended March 31, 2023. This relates mainly to a $5.7 million increase in government assistance, relating to the USAFA Cooperative Agreement, a $0.5 million increase in revenue, $1.4 million decrease in general and administrative expenses, and $0.3 million decrease in exchange loss, offset by a $2 million increase in research and development expenses, and $0.5 million increase in financing costs.

On March 31, 2024, the Company had cash of $0.1 million compared to $2.5 million on March 31, 2023.  The Company has included a going concern note in its financial statements for the FYE 2024. In particular, the Company is dependent in large part on successfully closing the proposed transaction with Aditxt or raising additional financing through equity and/or non-dilutive funding and receiving all USAFA funding in a timely manner. Delays in reimbursement for previously submitted expenses in the near term may, in the absence of alternative funding arrangements, result in the Company not being able to meet various covenant obligations as required pursuant to its long-term debt arrangements with Long Zone Holdings Inc. For further details, please refer to the Company’s going concern note in the Company’s management’s discussion and analysis (the “MD&A”) for the FYE 2024.

As of June 25, 2024, the Company had 121,266,120 issued and outstanding Common Shares, 11,520,281 stock options and 44,856,874 warrants outstanding.

This press release should be read in conjunction with the Company’s audited annual consolidated financial statements for the FYE 2024, and the related MD&A, copies of which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca.

 

+++

 

About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infective s, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

 

Forward looking statements

This news release contains “forward-looking statements”, including with respect to the funding commitment from USAFA and expected timing of invoice payment, advancing program towards IND, further anticipated milestones and the timing thereof, the Company’s development plans and timelines with respect to ATI-1501, ATI-1701 and ATI-1801, the timing of any milestone and/or royalty payments in respect of ATI-1501,  consideration to be received by shareholders in connection with the proposed Arrangement and the Company’s expectations with respect to its ability to operate as a going concern and satisfy its ongoing working capital requirements. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the annual information form of the Company dated June 25, 2024, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

All statements included in this press release relating to the Arrangement are qualified by reference to the “Forward Looking Statements” section included in the Arrangement Press Release.

 

###

 

Media Contact:

Jenna McNeil, Communications Manager

Appili Therapeutics

E: [email protected]

 

Investor Relations Contact:

Don Cilla, President and CEO

Appili Therapeutics

E: [email protected]

Categories
Archives 2024 Highlights

Appili Therapeutics Announces Additional Bridge Loan from Bloom Burton & Co.

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

HALIFAX, Nova Scotia – April 26, 2024 – Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced it has secured additional bridge financing in the amount of C$300,000 (the “Bridge Loan”) from  Bloom Burton & Co. Inc. (the “Lender”). The Bridge Loan evidenced by a grid promissory note in favor of the Lender pursuant to which further advances may be made from time to time as agreed to by the Company and the Lender, subject to any requisite regulatory and third party consents.

The Bridge Loan will be used primarily for working capital and general administrative purposes and bears interest at 10% per annum (to be accrued on a quarterly basis and capitalized against the principal loan amount).  The principal amount of the Bridge Loan, together with all accrued and capitalized interest, will be due and repayable in full upon the earlier of: (a) April 26, 2025; and (b) the occurrence of a Change of Control (as defined in the Bridge Loan) of the Company.

The Company may require additional financing prior to the closing of the Company’s proposed acquisition by Aditxt, Inc. (as announced on April 2, 2024) or as may otherwise be required to satisfy the Company’s obligations as they become due.

The Lender is considered to be a “related party” of the Company, and the Bridge Loan is considered to be a “related party transaction” for purposes of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”). Pursuant to MI 61-101, the Company will file a material change report providing disclosure in relation to the Bridge Loan under the Company’s profile on SEDAR+ at www.sedarplus.com. The Company did not file the material change report more than 21 days before the expected closing date of the Bridge Loan as the details of the Bridge Loan were not settled until shortly prior to the closing, and the Company wished to complete the Bridge Loan on an expedited basis for business reasons. The Company is relying on exemptions from the formal valuation and minority shareholder approval requirements available under MI 61-101. The Company is exempt from the formal valuation requirement in section 5.4 of MI 61-101 in reliance on sections 5.5(a) of MI 61-101 as the fair market value of the transaction, insofar as it involves interested parties, is not more than the 25% of the Company’s market capitalization. Additionally, the Company is exempt from the minority shareholder approval requirement in section 5.6 of MI 61-101 in reliance on section 5.7(a) of MI 61-101 as the fair market value of the transaction, insofar as it involves interested parties, is not more than the 25% of the Company’s market capitalization.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the securities described herein. The securities offered have not been registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as both such terms are defined in Regulation S promulgated under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities offered in any jurisdiction in which such offer, solicitation, or sale would be unlawful.

 

About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

 

Forward-Looking Information

This news release contains “forward-looking information”, including with respect to the proposed use of proceeds. Wherever possible, words such as “may “, “would”, “could “, “should”, “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, the Company’s ability to repay the amount under the Bridge Loan, the closing of the proposed transaction with Aditxt, Inc. and those risks listed in the annual information form of the Company dated June 23, 2023 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

 

###

Media Contact:
Jenna McNeil, Corporate Affairs and Communications Manager
Appili Therapeutics
E: [email protected]

Investor Relations Contact:
Don Cilla, Pharm.D. M.B.A.
Appili Therapeutics
E: [email protected]

 

Categories
Archives 2024 Highlights

Appili Therapeutics Signs Definitive Agreement to be Acquired by Aditxt, Inc.

Transaction consideration provides a significant premium to the Appili shareholders

Combined enterprise expected to provide enhanced synergies and resources to advance key programs

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

 

HALIFAX, Nova Scotia, April 2, 2024 – Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (“Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced that it has entered into a definitive arrangement agreement (the “Arrangement Agreement“) pursuant to which Aditxt Inc. (NASDAQ: ADTX) (“Aditxt”), a Richmond, Virginia- based company dedicated to discovering, developing, and deploying promising health innovation, through its wholly-owned subsidiary, Adivir, Inc. (“Adivir” or the “Buyer”), agreed to acquire all of the issued and outstanding Class A common shares (the “Appili Shares“) of Appili by way of a court-approved plan of arrangement under the Canada Business Corporations Act (the “Transaction“).

 

Overview and Rationale for the Transaction

Under the terms of the Arrangement Agreement, shareholders of Appili (the “Appili Shareholders“) will receive (i) 0.002745004 of a share of common stock (each whole share, an “Aditxt Share”) of Aditxt (the “Share Consideration”) and (ii) US$0.0467 (or approximately CAD$0.0633 with reference to the Bank of Canada closing exchange rate on March 29, 2024) for each Appili Share held (the “Cash Consideration” and together with the Share Consideration collectively, the “Transaction Consideration”) representing implied total consideration per Appili Share of approximately US$0.0561(or approximately CAD$0.07598 with reference to the Bank of Canada closing exchange rate on March 29, 2024) based on the closing price of the Aditxt shares on March 28, 2024. The Transaction Consideration represents an approximately 117% premium to the trading price of the Appili Shares based on the closing price of the shares of Appili on April 1, 2024 (the last trading prior to the execution of the Arrangement Agreement) and an approximately 141% premium to the 30-day volume weighted average price of the Appili Shares prior to the date of the Arrangement Agreement.

The Transaction is expected to provide much needed resources and access to capital which will allow the combined enterprise to execute its development plans more efficiently. Aditxt and its subsidiaries have complementary medical and scientific knowledge in immunology and immune profiling and expertise in diagnostics and other tools, which can be used to expedite development programs and be used in clinical practice.

“This transaction with Aditxt aligns with our goals on multiple levels. Through the Aditxt platform, we can amplify our impact and reach in the fight against life-threatening infectious diseases. We see this as an opportunity for growth, innovation, and collaboration. Our shared vision and combined expertise will undoubtedly accelerate our mission to develop innovative treatments and solutions for some of the most challenging health threats facing the world today. Appili’s programs can now leverage Aditxt’s proven research and development, operations, and commercialization expertise to accelerate the development of our three programs. Secondly, as a NASDAQ-listed company, Aditxt will facilitate access to capital for Appili’s programs in this challenging economic environment. We welcome this new chapter, confident that together, we will achieve even greater heights in deploying innovative healthcare solutions.” said Dr. Don Cilla, President and CEO of Appili Therapeutics.

The Transaction is expected to enhance the combined entity’s portfolio of products and potentially create substantive synergies among existing programs, particularly precision diagnostics. Integrating Appili’s expertise and product lines with Aditxt could pave the way for a comprehensive approach to population health, from early detection and prevention to treatment. Collaboration within the Aditxt ecosystem has the potential to streamline patient care, from early detection through precision diagnostics to the development of tailored treatment strategies. This synergy provides an opportunity to accelerate innovation and enhances the effectiveness and personalization of healthcare delivery.

Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, elaborated on the significance of this acquisition, stating, “The acquisition of Appili would represent another step in Aditxt’s journey towards advancing promising innovations in health. Our mission is to accelerate some of the most promising health innovations, like those developed by Appili, to reach their full potential and to have a lasting impact. The urgency for innovative and effective public health solutions is unprecedented. The need to discover and bring new treatments to the market or to enhance existing ones to combat public health challenges has never been more critical. By integrating Appili’s proven expertise and diverse portfolio in the infectious disease and biodefence domain, Aditxt can substantially contribute to advancing public health solutions.”

 

Additional Transaction Details

The Transaction will be effected by way of a court-approved plan of arrangement pursuant to the Canada Business Corporations Act. Under the terms of the Arrangement Agreement, Adivir will acquire all of the issued and outstanding Appili Shares, with each Appili Shareholder receiving the Transaction Consideration. In connection with the Transaction, each outstanding option and warrant of Appili will be cashed-out based on the implied in-the-money value of the Transaction Consideration.

In connection with the Transaction Aditxt will: (i) agree to repay no less than 50% in outstanding senior secured debt at the closing of the Transaction (the “Closing”) and to repay the remaining outstanding senior secured debt by no later than December 31, 2024; (ii) assume all of Appili’s remaining outstanding liabilities and indebtedness, and (iii) agree to satisfy certain payables of Appili at Closing as further detailed in the Arrangement Agreement.

Additional details of the Transaction will be described in the management information circular that will be mailed to the Appili Shareholders (the “Appili Circular“) in connection with a special meeting of the Appili Shareholders (the “Appili Meeting“) currently expected to be held prior to end of calendar Q2 2024 to approve the Transaction. Additional information regarding the terms of the Arrangement Agreement, the background to the Transaction, the rationale for the recommendations made by the Special Committees (as defined below) and how shareholders can participate in and vote at the Appili Meeting will be provided in the Appili Circular.

The Transaction is subject to the approval of at least two-thirds of the votes cast by the Appili Shareholders at the Appili Meeting.

All of Appili’s directors and officers, and certain shareholders holding approximately 11.9% of the total voting power of the issued and outstanding Appili Shares have entered into voting support agreements with the Buyer to vote in favor of the Transaction.

The Transaction is conditional upon Aditxt raising at least US$20 million in financing (the “Aditxt Financing”) prior to Closing. In addition, completion of the Transaction is subject to other customary conditions, including the receipt of all necessary court, regulatory and stock exchange approvals. Subject to the receipt of all required approvals, Closing is currently expected to occur not later than early calendar Q3 2024.

The Arrangement Agreement contains customary terms and conditions, including non-solicitation provisions which are subject to Appili’s right to consider and accept a superior proposal subject to a matching right in favour of Aditxt. The Arrangement Agreement also provides for the payment of a termination fee of CDN$1.25 million in certain circumstances.

A copy of the Arrangement Agreement will be available through Appili’s filings with the securities regulatory authorities in Canada on SEDAR+ at www.sedarplus.ca.

None of the securities to be issued pursuant to the Arrangement Agreement have been or will be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act“), or any state securities laws, and any securities issued in the Transaction are anticipated to be issued in reliance upon available exemptions from such registration requirements pursuant to Section 3(a)(10) of the U.S. Securities Act and applicable exemptions under state securities laws. This news release does not constitute an offer to sell or the solicitation of an offer to buy any securities.

If the Transaction is completed, the Appili Shares will be delisted from the TSX and the OTCQX and Appili will apply to cease to be a reporting issuer.

 

Recommendation of Appili’s Special Committee and Appili’s Board

The special committee (the “Appili Special Committee“) of the board of directors of Appili (the “Appili Board“), comprised of Theresa Matkovits, Jurgen Froehlich and Prakash Gowd, after receiving legal and financial advice, including the fairness opinion from its independent financial advisor discussed below, has unanimously recommended the Transaction having determined that the consideration to be received by the Appili Shareholders pursuant to the Transaction is fair, from a financial point of view, to the Appili Shareholders.

The Appili Special Committee has obtained a fairness opinion from BDO Canada LLP to the effect that, as of the date of the Arrangement Agreement, and subject to the assumptions, limitations and qualifications on which such opinions are based, the consideration to be received by the Appili Shareholders pursuant to the Transaction is fair, from a financial point of view, to the Appili Shareholders.

After receiving the recommendations of the Appili Special Committee, and the fairness opinion from its financial advisor discussed above, the Appili Board has unanimously determined that: (i) the consideration to be received by the Appili Shareholders pursuant to the Transaction is fair, from a financial point of view, to the Appili Shareholders; (ii) the Transaction is in the best interests of Appili; and (iii) it approve and authorize the Transaction and the entering into of the Arrangement Agreement and all ancillary agreements; and (iv) in accordance with and subject to the terms of the Arrangement Agreement, it recommend to the Appili Shareholders that they vote in favour of the resolution to approve the Transaction at the Appili Meeting.

Additional details concerning the rationale for the recommendations made by the Appili Special Committee and the Appili Board, including copies of the fairness opinion prepared by the independent financial advisor to the Appili Special Committee and the Appili Board, will be set out in the Appili Circular to be filed and mailed to the Appili Shareholders in the coming weeks, which, together with the Arrangement Agreement, will be available under Appili’s profile on SEDAR+ at www.sedarplus.ca.

 

Lender Approval

Appili’s senior secured lender, Long Zone Holdings (“LZH”), has provided the requisite consent to the Transaction along with certain waivers required pursuant to the terms of the loan agreement between Appili and LZH.  In connection with such consent and waivers, Appili has agreed to issue to LZH an aggregate of $18,000 worth of Appili Shares prior to the Closing, subject to TSX approval.

 

Advisors

Dentons Canada LLP acted as legal counsel to Appili.  Bloom Burton Securities Inc. acted as financial advisor to the Appili Board and BDO Canada LLP acted as independent financial advisor to the Appili Special Committee.

Aird & Berlis LLP acted as Canadian legal counsel to Aditxt. Sheppard, Mullin, Richter & Hampton LLP acted as US securities counsel to Aditxt and Nelson Mullins Riley & Scarborough LLP acted as US M&A counsel to Aditxt.

 

About Aditxt

Aditxt is an innovation platform dedicated to discovering, developing, and deploying promising innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to “Make Promising Innovations Possible Together.” The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges.  Aditxt operates a unique model that democratizes innovation, ensures every stakeholder’s voice is heard and valued, and empowers collective progress.

Aditxt has a diverse innovation portfolio, including Adimune™, Inc., which is leading the charge in developing a novel class of therapeutics for retraining the immune system to combat organ rejection, autoimmunity, and allergies. Adivir™, Inc. focuses on enhancing national and population health and impacting public health globally. Pearsanta™, Inc., delivers rapid, personalized, and high-quality lab testing accessible anytime, anywhere, led by its CLIA-certified and CAP-accredited clinical laboratory based in Richmond, VA.

For more information about Aditxt, Inc., visit www.aditxt.com.

 

About Appili

Appili is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. Appili is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection.

For more information about Appili Therapeutics Inc., visit www.AppiliTherapeutics.com.

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This news release contains “forward-looking information” within the meaning of applicable securities laws. Forward-looking information contained in this press release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment, and the availability of licenses, approvals and permits.

Forward-looking statements in this news release include, but are not limited to: statements with respect to the anticipated completion of the Transaction, the timing for its completion, and the delisting of the Appili Shares from the TSX; the timing for the holding of the Appili Meeting; the satisfaction of closing conditions which include, without limitation (i) required Appili shareholder approval, (ii) the Aditxt Financing, (iii) certain termination rights available to the parties under the Arrangement Agreement, and (iv) other approvals and closing conditions contained in the Arrangement Agreement; statements with respect to the anticipated effects of the Transaction on Aditxt and its strategy going forward and statements with respect to the anticipated benefits associated with the acquisition of Appili. Actual results and developments may differ materially from those contemplated by these statements.

Such forward-looking statements are based on certain assumptions regarding Aditxt and Appili, including the successful completion of the Transaction, anticipated benefits from the Transaction, and expected growth, results of operations, performance, industry trends and growth opportunities. While Appili considers these assumptions to be reasonable, based on information currently available, they may prove to be incorrect.

Among other things, there can be no assurance that the Transaction will be completed or that the anticipated benefits from the Transaction will be achieved.

Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to, risks relating to: (i) current and future market conditions; (ii) federal, state, provincial, territorial, local and foreign government laws, rules and regulations; (iii) the ability of the parties to satisfy the closing conditions of the Arrangement Agreement, including the Aditxt Financing; (iv) the ability of the Appili Board to consider and approve a superior proposal for Appili prior to the completion of the Transaction; (v) failure to receive the necessary shareholder, court or regulatory approvals where applicable, or failure of the parties to obtain such approvals or satisfy such conditions in a timely manner; (vi) unforeseen challenges in integrating the businesses of Aditxt and Appili; (vii) failure to realize the anticipated benefits of the Transaction; (viii) the business, operational and/or financial performance or achievements of Aditxt and Appili may be materially different from that currently anticipated; (ix) other unforeseen events, developments, or factors causing any of the aforesaid expectations, assumptions; and (x) the risk factors set out in Appili’s most recently filed annual information form, as well as discussions of potential risks, uncertainties, and other important factors in the Appili’s other filings with the Canadian securities regulators on SEDAR+. In particular, the benefits anticipated in respect of the Transaction are based on the current business, operational and financial position of each of Aditxt and Appili, which are subject to a number of risks and uncertainties. Readers are cautioned that the foregoing list of risks, uncertainties and assumptions are not exhaustive. In addition, if the Transaction is not completed, and Appili continues as an independent entity, there are risks that the announcement of the Arrangement Agreement and the dedication of substantial resources of Appili to the completion of the Proposed Transaction could have an impact on its business and strategic relationships, operating results and activities in general, and could have a material adverse effect on its current and future operations, financial condition and prospects. Consequently, the reader is cautioned not to place undue reliance on the forward-looking statements and information contained in this press release.

The statements in this press release are made as of the date of this release. Appili disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Neither IIROC nor any stock exchange or other securities regulatory authority accepts responsibility for the adequacy or accuracy of this release.

###

Media:

Jenna McNeil, Communications Manager

Appili Therapeutics

E: [email protected]

 

Investor Relations:

Don Cilla, President and CEO

Appili Therapeutics

E: [email protected]

Categories
Archives 2024 Highlights

Researchers Publish Manuscript on the Prevention and Emergency Response to Tularemia Outbreaks

A review of Russian and English literature suggests that Appili’s biodefense program ATI-1701 may have a role in preventing tularemia in Ukraine

 

HALIFAX, Nova Scotia, March 12, 2024 – Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced a publication in the journal Frontiers in Bacteriology on the prevention of tularemia. Appili’s Director of Non-Clinical Research, Dr. Carl Gelhaus, Ph.D., together with medical doctors from the United States Uniformed Services University of the Health Sciences and Ukrainian researchers published a perspective manuscript “Considerations for prevention of and emergency response to tularemia outbreaks in Ukraine: vaccine involvement”.

 

“Appili has been developing ATI-1701, a biodefense vaccine, to protect warfighters from tularemia.” said Carl Gelhaus, Ph.D., Director of Non-Clinical Research of Appili Therapeutics. “With the help of our Ukrainian colleagues and U.S. Army physicians, we have assessed the potential risk for tularemia outbreaks in Ukraine, by reviewing the literature of previous wartime outbreaks in Eastern Europe. Many of the conditions for tularemia outbreaks now exist in Ukraine, and their warfighters need protection. We suspected that rodent populations would explode and carry tularemia into war-affected areas. Even as we were preparing the manuscript, “Mouse fever”, an infection of unknown etiology, was reported in news outlets, underscoring the urgency of making sure Ukrainians are protected from the risk of many infectious diseases, including tularemia. The acceptance and publication of this perspective article recognizes that the epidemiological, medical, military, and scientific tularemia experts should prepare to prevent and respond to tularemia outbreaks in wartime Ukraine.”

 

The perspective manuscript explores the current war in Ukraine and the increased risk for outbreaks of tularemia. Several wartime tularemia outbreaks have been documented, as far back as the Siege of Stalingrad in WWII. Furthermore, F. tularensis was weaponized and stockpiled as an offensive agent, and experts consider tularemia to have a high potential use in a biological weapons attack. Russia administers its own tularemia vaccine, but that vaccine is not available in Ukraine. Furthermore, the legacy Russian vaccine is unlikely to meet the rigorous FDA and EMEA standards for safety and efficacy.

 

ATI-1701 is the Company’s potential first-in-class vaccine candidate for the prevention of infection with F. tularensis. Since it is a highly infectious pathogen capable of causing severe illness, medical counter measures for F. tularensis are a top biodefense priority for governments around the world.

 

There is currently no approved vaccine for the prevention of tularemia in the United States or other major global markets, strengthening ATI-1701’s position as a potentially valuable vaccine that is urgently needed on the market.

 

Appili is working hard to develop our ATI-1701 vaccine that could potentially help protect the Ukrainian people living in what United Nations Secretary-General Antionio Guterres described as “an epicenter of unbearable heartache and pain”. Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili adds “At Appili, we hope that our products can alleviate that kind of human suffering”.

 

+++

 

About ATI-1701

ATI-1701 is a novel, live-attenuated vaccine for F. tularensis, which causes tularemia, a Category A pathogen which can be aerosolized and is over 1,000 times more infectious than anthrax. Since it is a highly infectious pathogen capable of causing severe illness, medical counter measures for F. tularensis are a top biodefense priority for the United States and governments around the world. There is currently no approved vaccine for the prevention of tularemia in the United States or other major global markets.

 

Appili secured a US$14M funding commitment for ATI-1701 from the United States Air Force Academy (“USAFA”), who is working in partnership with the Defense Threat Reduction Agency. These funds along with other potential funding sources, are anticipated to continue to advance the ATI-1701 program toward an IND submission to the FDA in 2025.

 

 

About Appili Therapeutics

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including a vaccine candidate to eliminate a serious biological weapon threat, a topical antiparasitic for the treatment of a disfiguring disease, and a novel easy to use, liquid oral formulation targeting parasitic and anaerobic infections. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

 

Forward looking statements

This news release contains “forward-looking statements”, including with respect to any potential outbreak of tularemia in the Ukraine, the funding commitment from USAFA, further anticipated milestones and the timing thereof and the Company’s development plans with respect to ATI-1701. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, the risk that ATI-1701 may never become an approved vaccine for the prevention or treatment of tularemia, and the other risks listed in the annual information form of the Company dated June 22, 2023, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law. 

 

###

 

Media Contact:

Jenna McNeil, Communications Manager

Appili Therapeutics

E: [email protected]

 

Investor Relations Contact:

Don Cilla, President and CEO

Appili Therapeutics

E: [email protected]