VIRI - Earnings call transcript Q3 2021 | Dogwood Therapeutics, Inc.

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Operator

00:02 Good morning, and welcome to Virios Therapeutics Third Quarter Twenty Twenty One Financial Results Conference Call. Please be advised that today’s call is being recorded at the company's request. At this time, I'd like to turn the call over to Angela Walsh, SVP Finance, Treasurer of Virios Therapeutics. Please proceed, Angela.

Angela Walsh

00:24 Thank you. thank joining and conference on everyone call. morning you us for today's Good

to today of you to with Therapeutics is are the We'll our CEO, And press operational be review release the We now pleased a providing start made have Greg results. you one. an on financial financial call during Please as results, our progress that we with nine third results, to during twenty XX:XX well you third available our on financial website. then as update our months provide today's with Duncan, first update progress the to our with twenty quarter brief on Virios quarter I’ll corporate discuss return quarter. note past

within is Greg results only filings more law. update our today, more information of morning release call to section to than company's Any can forward-looking our looking everyone will factors forward the of conference our of XX:XX with required regarding information. any which now are the us financial uncertainties Vice Operations President implied, information these nineteen In as the or Grosswald, I'd statements call. Duncan. statements such remind and disclaim Litigation CEO. XX:XX this statements involves statements.. that risks turn our made portion of in call pleasure like SEC. to for risks for by the made ninety that question-and-answer to addition Reform include other the the this see my is and Act Ralph looking expressed over as uncertainties, forward-looking statements to Private of actual the XX:XX It materially begin, from five, Before forward results risk Please we with by issued please and differ the see meaning and For outlined the looking cause these obligation Securities the during forward we statements

Greg Duncan

call XX:XX months. we the appreciate morning, very an the to and the pleased has Virios everyone. as today progress Thank on a with team us few Therapeutics Angela, are over We delivered substantial on you past you, good update you joining provide

patients research market The The therefore market disorders. on with with diagnostic the clinical unfortunately Fibromyalgia focus quarterly XX:XX on progress, time. the patients FDA estimates is Virios updating related value largely update worldwide those million Virios our large Fibromyalgia, treat medicines. meet XX:XX very suggesting incorporated fatigue This might very Fibromyalgia. hundred of approved new combination outcomes and improving proposition a for very first be overview debilitating such developing Before the irritable and over chronic those operational patient people for tolerability thought to community antiviral large therapies, from diagnosed is of to is Therapeutics I our useful due or dissatisfied quite attending it two is lead Therapeutics to you Virios three syndrome, and novel diseases as story for the criteria program actually the for to Fibromyalgia poor Fibromyalgia. the suffering bowel for

significant Our is FDA. designation the [Indiscernible] has as in existing significant fast previously formulated unmet placebo strong lead combination our better antiviral of is dual need a than tablet completed dose oral twice demonstrated development daily antiviral mechanism antiviral track treatment approach therapy. a Phase already the candidate Novelty IMC-X, trial. data IMC-X statistically tolerability IMC-X reduction and and Fibromyalgia Xa by than on in our XX:XX review Fibromyalgia was on Based clinical pain granted and

this trial on our we the XX:XX Fibromyalgia outcome our for year. commenced HSB-X. trial ongoing suppression FORTRESS evaluating as Phase synergistic to to stands the Based candidate We development knowledge. which quarter Fibromyalgia of Fibromyalgia refer study, Fibromyalgia a research our of trial, two FORTRESS, Phase Xb for designation such of first of this success The best Xa in

top We report results this expect three quarter two. twenty to from in line twenty of ongoing trial

a have experience managed including Board extensive are of team programs and terrific medicines. several commercialization who development Directors by drug and experience main household research Our managing

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the is the the Our program Phase experience quarter team of trial is dose Xb the for achieved Within of has who enrolled for focus we complete completed. trial regulatory that which targeting treatments. IMC-X The FORTRESS this participants one are permitted to to previously The let's patients following to developing In regarding key a reduction was at in or trial. as three species year by move pleased chronic of will the Fibromyalgia our our our by for endpoint by used before approved approval Phase Within very in managed months, for endpoint Phase being time Fibromyalgia approved that progressing two over hundred FDA program broader landmark The parallel two required successful team trial we and our more, inclusion ongoing FDA is to will several sixty the four Xb Phase The very with clinical be results program. to time planned. pain. have on previous has X to funded we in XX:XX XX:XX authorities to same these medicines do primary this milestones. FORTRESS FORTRESS context, all of to studies Xb we Toxicology been intervals toxicology fully plan of I'm assess study are today. past update. have studies report chronic

of Phase study. is I'm FDA. to conclusion filed This new bowel utility XX:XX the you announced current investigational new IBS the first have diagnosed treating IBS. pleased on to we very exploring regulatory that our with quarter at year. focused will of Development Michael we IMC-X also Camilleri be in is the deliverable X final that, the with this to announce “IND" So drug syndrome, from Dr. which with propose IMC-X may the of one application Clinic collaboration a FDA the know second as filing irritable this able in of Mayo of patients program

utility IBS discuss six outcomes patients. antiviral to Fibromyalgia. explore formally With This Finally, position GI data is disorders. IBS various has back diagnosed Angela? for cash HSB-X following effects accepted is benefits Dr. activating update tissue patients our were like top (Carol) activated [ph] let our Scientific got one line in entire results hand, patients presentation we actually of twenty DDW Angela to of trial. and much Congress GI three. GI operational These IBS, congress announcement with understand operational Identifying twenty XX:XX providing from Approximately first harvested the in a positive potential of to that turn presence of synergistic we with treating a precursor over a participants. our months exploring first biopsy the quarter clinical to into X in the delivering the been the of in week patients, submission” the three Walsh presentation to IBS disorder. as to this runway the mechanistic management from results. Simplex should XX:XX FORTRESS twenty the Xb believe IMC-X the on potential and proof cause progress, of continued step planned twenty me submitted replicating achieved digestive for a chronic project is and prudent nine one. With current potential a these disease Finance, data study of root to and HSB-X XX:XX provide the financial of a role biopsy it Vice right “late chronic IMC-X Fibromyalgia of brighter our As data with virus better of clinical cash President Phase tissue the months XX:XX Senior executed a the clinical quarter for it over as the time therapeutics annual HSB-X highlighted that of activation Herpes company to the

Angela Walsh

you, Thank today begin will I Greg. our X:XX with cash position.

As million of as in We two of as point to compared dollars had dollars twenty. twenty nine twenty nineteen one, September one thirtieth twenty cash twenty eight million December point thirty

twenty company's of months the September a ago expenses one and as research of third reported of we our sufficient primarily dollars fund mentioned, trial. three. one twenty zero one attributable compared We the twenty respect point ended stage to XX:XX quarter cash our and in not or income the million year ended This year twenty statement, ago generate for XXth research twenty the for quarter just With revenue dollars operations to quarter. Greg FORTRESS was did one to As we during company, expenses a into to current three development development our in be three expenses September expect development increase with twenty clinical thirtieth quarter. million

reported public by today's Offset third quarter twenty one one, for of seven program I'll to with one administrative the loss costs. net four a for compared cost call. XX:XX expenses point drug twenty general net as the the of of Our million quarter. thirty chronic of quarter manufacturing increase and ended point thirtieth a and to a million portion development of twenty call administrative founder. ago We and one primarily decrease September company. toxicology the twenty dollars question-and-answer twenty associated in five XX:XX compensation attributable moderate year one was quarter. ended Greg? in for being dollars recognized dollars This dollars loss to reported million issuance in to to the two interests third membership Greg company's for the twenty of to the the turn point expense over year million third We and two for now ago general point compared expenses September

Greg Duncan

of of and virus represents candidate The a role review like has synergistic approach XX:XX our by and the Thank first disorders. to again the our a fast in IMC-X the IMC-X best chronic potential catalyst disorders of potentially Somatic Fibromyalgia supported the other you to GI mechanism Fibromyalgia activated mechanistic is Fibromyalgia FDA completely to and new the diseases designation is Xa changer fixed time drug novel by syndrome combination data be knowledge Unique lead dose HSB-X that clinical for Fibromyalgia of Angela. track including granted in could Fibromyalgia candidate antiviral we treating both treatment is there for up for the shareholders. a like game of research triggering of and role IBS. profile their Type doctors If various potential for Phase mention patients wide our the our vertical. emerged of believe antiviral range community our holds from IMC-X of recognition is new to morbidities X activated scientific XX:XX Encouragingly, Simplex a and increasing not viruses in Herpes a and study

we pleased FORTRESS three this earlier, Xb mentioned of landmark and our Phase from twenty twenty we with line the progress two. results As expect are in quarter top trial trial

proactive the the are as community to and ready investment as now progress across the We of our outreach We for questions. of as journey standards medical Operator, improve hundreds to community for we patients committed globe. treatment XX:XX are frequent well millions Fibromyalgia to

Operator

Zacks today XX:XX now Bautz open and first [Operator question at David Research. gentlemen is coming the ladies from is Instructions] for floor Thank you. Our questions. Small

live. is line Your

You may begin.

David Bautz

are going. expand good upon you clinical Greg. envision I kind could overview though, IBS for wondering for broad the to Program? then morning. in this give what Hey going you first trial Thanks morning, would And the maybe maybe of a timelines you the indication if everyone. was the how overview could that XX:XX of be

Greg Duncan

you you, take all filed get sometime this as by twenty on appreciate we the call to probably like a the of David. this we relative It we you announced or the train year do of Fibromyalgia with FDA, would get of part investigators middle look a morning, I'll next live time people. timelines bit presuming from question twenty morning of early takes we joining first then year the QX to this Thank to experience, the trial, the alignment XX:XX as I end morning. this start IND expect and together, first feedback it Catalyze little two. investigators call likely meetings drug to supply know to

sixty roughly to or would patient I course year. trial say seventy QX That study patients of recruit per patients and there arm, maybe maybe months scope first arm, twenty probably safe the be would probably completed QX was to data order a recall next we'll as arm about and of so, forecast with would patients And and per from twenty in the size Xa per you of Phase forty hundred forty Fibromyalgia that to on progress may of The so take the between seventy patients so close one probably study. visit the and so consistent and one the and of seventy patients sixty three. study or expect hundred nine I hundred first one or of about sometime somewhere half of twenty

David Bautz

it? about clinicians that? approach regards you faster great. feedback be? FORTRESS this would because are kind pace of curious Okay, then in is either type are would of excited anything patients novel about to where getting you hearing feel going? far kind from the pleased that's any about And I'm is go? Is And what are the XX:XX you how thought it you Are it trial, as long as they of you it Is enrollment how it

Greg Duncan

Yeah. XX:XX

The will was So my we questions. the the Basically I Kudos rest as real the say in booked. enrolling. line FORTRESS both on isn't clinical to it's team. trial general of had good Ralph and

as issues. coordinators, Studies to for are so visits. related probably show sites, due for looking you patients many to office other companies up neglecting see companies, are COVID You struggling study I'm

are colleagues since over eighteen if had in to the And been of two by other enrolling that onward, and and in the have industry enrolled category knock There so are our progressing hundred struggling hoped, level trials trial want things date. some nineteen. have twenty twenty you the we we large, as are patients broadly at really

fit the approach, phase will because as together excited if they believe that actually in so thing. functionality game due believe our we delivers etcetera, the truly know, this good about they're both reduction the in is of and hundred basket in to pain year and root and needed, patients of the therapies, tolerability have is I disease started are and think anxiety [Indiscernible], And all on long in the we've all we and already really the different them reduce that kind efficacy response hands the here two is the here of large that that profile think the So, likely we earlier we placebo. time, also are such most for no better a I had understand are in not by of fact that clinical tolerability. was about reduction to these candidates disease to approved fact good that like drugs development more the are you the deliver you in date of therapies. and saw Xa but approved pain, are been very most improvement a not and team they trial of part cycled drugs knowledgeable what patients role robust they it. tolerability but and in cause a are depression, that than addressing through approach but this the the some of have understand the effort robust of the that's changer of drugs the people profound CNS there's or FDA And doctors had the in contributed results, potential tolerated small the that is There nature recruitment view improved because Patients a excited pretty I

And the think recruitment that's helped so I to robust contribute rate.

that's it's and and we're QX by. to in say, the our two guided twenty and we're with two confident twenty IPO standing since guidance results to twenty mid we I think have safe We did results

David Bautz

this taking the questions you morning. All great. XX:XX right, Appreciate

Greg Duncan

you you, the Really asking Yeah. questions. appreciate XX:XX for Thank David.

Operator

this Instructions] XX:XX Greg the turn further Thank CEO, you. in to no [Operator queue have back the questions call I'd We at time. Duncan. to like now over

Greg Duncan

look are potential very a in in XX:XX large of to with irritable guys on Thank Fibromyalgia put presuming bowel this excited you you, as simply IMC-X forward can FDA potential targeting utility program and about for syndrome We're the we you to IMC-X sense and of Thank the along markets. pretty probably explore Kate. satisfied morning. attending

you work shareholders mission. and we we're have and interest both and pipeline. really updating Thank very and forward the you. patients, committed to on probably which to ultimately to that continuing to our appreciate clinical in the value Thank support Look thesis. IBS for We you Fibromyalgia both data that on all value to your look We will fronts Virios great our have progress Therapeutics. don't do to to deliver I mechanistic for forward to terrific deliver continue progress team as to you we research tell

Operator

you, This event. today's conclude Thank does XX:XX and ladies gentlemen.

at day. disconnect a participation. Thank may you wonderful this time and You your have for

Dogwood Therapeutics (DWTX) 11 Nov 212021 Q3 Earnings call transcript