VIRI - Earnings call transcript Q1 2021 | Dogwood Therapeutics, Inc.

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Operator

Good morning, and welcome to Virios Therapeutics First Quarter 2021 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 and Treasurer of Virios Therapeutics; please proceed Angela.

Angela Walsh

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

the be financial today to four results, with update to Therapeutics, discuss provide months pleased have an quarter we first as on of are XXXX. with the to you Virios you made We during progress first operational well as Please our press financial release on now available note website. that our results, is progress providing brief update a We'll call start with with today's quarter. our our during corporate you past CEO, Greg Duncan, the on Dr. specifics return on Medical and results. Chief Gendreau our further Xb programs, will Mike QX Fibromyalgia Officer study our bring our and our Phase then to financial toxicology chronic I will review

In addition, the us of call. with Ralph is Grosswald, VP Operations the portion of for question-and-answer our

conference the to call any meaning Any and include within are I'd the Securities involves XXXX, cause statements disclaim Private actual will we results differ and today, that remind Before begin, this like forward-looking of Reform to that we can company's obligation risks the filings which forward pleasure Factors update Greg is to made of release as Please over materially. law. our issued Greg. during Act Litigation uncertainties by only call of as statements everyone financial looking statements forward-looking to other morning my in the statements CEO, with Duncan. forward this the and to SEC. required see statements the results subsequent than in disclaimer looking current now these made and our Risk It turn the

Greg Duncan

the has our update this on March. to call you an Thank We substantial you update are today, progress you appreciate the us because joining and we Virios last provide made Angela on excited past everyone. team good with since Therapeutics the morning

Chronic Operations, Under Fibromyalgia and the the are the commencement support Grosswald, our team IMC-X Ralph as and Toxicology shipping Vice program past the we matching both of has President clinical the milestones: both Phase placebo achieved During quarter. manufactured Xb of leadership programs this study supply have of to expert drug our key and two following months for planned

patients trial commence fibromyalgia end to expected enrolment and is top Xb by our XXXX. in project enrolment Phase with two goal quarter XXXX, quarter results Our line of of in to reach the full this

to research announce Phase been presentation results at accepted We of major from this are our new X that spring. analysis have pleased two medical meetings fibromyalgia for

of secondary The to IMC-X in first key known as impact fibromyalgia Congress patients response presentation including items. to our Data in efficacy study, questionnaire and of European at be domains early on were EULAR Rheumatology, will important pain EULAR endpoints be will X completed the at Multiple presented focus found responsive to June. otherwise analyses Phase fatigue treatment. including

International presented will findings, meeting The second safety in well meeting for this patients tolerated with Congress the demonstrate and in Study World at of Association Pain be on of mid-June. at the Data IMC-X focus will that presentation the unusually fibromyalgia. was

due patients Specifically IMC-X overall patients. completion discontinuation higher with compared treated treated placebo and rates adverse to of events lower rates as had

of country. was chronic disorders. Furthermore, focused to a and statistically data role in potential Simplex patients’ endpoint and presentation gastrointestinal development reduction on patients Virus-X the potential largest proposed plans GI including collaboration Camilleri as visibility of our Clinic to IV such pipeline drug meeting the in research Alabama Michael as of major have combination handful of upcoming the regards the is provide focused generated medical engage Phase three progressed the Week later This this breaking the oral conference. Digestive activated Xb This as related potential an the as IBS. antiviral The was XXXX all patented the we’ll inhibition Dr. IBS On important for fall Syndrome. expansion, summer. with and as of immune this part diseases the research treatment and of about we noteworthy Mayo focused Virios and the are look maintained this Disease to achievement our Functional FDA trial in virally IMC-X supporting GI study conference rationale further assess our or Additionally, is endpoint medical all we cause Herpes this significant IMC-X associated With for highlights Disorder Bowel will the accepted for were with a improvement Rome responses. triggered at potential IMC-X. GI with conferences both treating utility in “make diagnosed of therapies of for and at news” the an accepted to for to University increase strategy presentation presentations notified fibromyalgia battery root recently a a collaboration note, fibromyalgia the primary These scientific presentations only that experienced of and utility approach on biopsy pain mechanistic regard are secondary our at accepted Criteria treated commencement focus for with important measures, of Irritable on the innovative month. will community enable IMC-X, awareness as to important HSV-X spring on our of a patients the viral This of team with

Trial FORTRESS Phase is update Outcome the stands our Dr. turn branded study. me to Synergistic Fibromyalgia of as over to you the FORTRESS fibromyalgia call Xb for HSV-X. Evaluating Mike. Research on Suppression which Let trial, Gendreau

Michael Gendreau

you, Thank Greg.

that treatments their on will have has to XXXX in electronic a As in self-reported diary patients’ to using focus Criteria own Rheumatology on fill randomized to application rating patients approximately of all scale using primary point The XX will we smartphone. placebo, reduction out in at Diagnostic will to on for plan or who home College FORTRESS trial been diagnosed aged receive daily recall fibromyalgia. pain, an a be for of endpoint either XXX trial end the IMC-X one-to-one American XX the reduction measured this ratio be will XX Pain fibromyalgia hour a the refresher, enroll the that used whom been numeric all assess to-date. patient

to disturbance, to two assisting as symptoms of as tolerability In overall improve as reduction, of the fatigue, placebo. followed from the we assessing investigator meetings XXXX health well training recruitment to IMC-X’s of project function, recruiting were fibromyalgia training sites the in-person rates, and prepare database lock the ability attended as trial. United patient XX meetings. We XXXX. and with industry available compared investigators medical and a also of the April, addition engagement Therapeutics and results the becoming successfully team quarter across investigators standard patient's the enthusiasm The sites sleep States these by staffs we execute overall executed that patient the their on we pleased status to will global improved pain Virios IMC-X’s Based topline second balance be patients in in throughout FORTRESS month of over

will events trials by to species. completely delays we program related final FORTRESS to the have more toxicology the Walsh, Finance, at have for have by able With we required to Angela year we it commenced turn the our authorities of first of complete regulatory IMC-X to study. financial first as our toxicology significantly that has studies are FDA the study time program. two of chronic over In fibromyalgia time or so on we our conclusion before by not to out studies current intervals rule one been progress, participants during recruitment to we permitted SVP but dose These we X program the While the phase recruitment plan do this chronic pandemic as observed be to-date. that propose our impacted cannot quarter results. our general does, to to research parallel such Phase in in X COVID, research be The rates will of update that Phase let in me a discuss

Angela Walsh

sheet with and I will specifically you, more today Thank begin cash. Mike. balance the

XXXX of million in cash $XX.X million as we March as XX, to $XX.X XX, XXXX. of compared As December had

loss ended the for today's the first net just expenses to expenses the for mentioned. Mike The the with I'll for a March an current from point $X.XX this XXXX ended compared of did or during associated program, XX, topline and for We Mach research company. call operational study. needs and of the Greg following million now which being revenues development development for attributable to first clinical of both costs XX, XXXX. and XXXX our accounting XX, for as of reported administrative respect We which stage other FORTRESS expenses months FORTRESS during for primarily for net to our million ended reported a XXXX. March increase million question-and-answer first over the The to $X.XX development back the results quarter moderate and $X.X to expenses legal $X.X as XX, months commenced the attributable six the the not company, general the Greg. support fees first XXXX chronic months of to generate plan compared our ended of quarter ended and XXXX, the administrative XX, XXXX. XX, to income a million to ended the $X.X company's research expect study million XX, quarter We public $X.XX our be to portion three compared loss was of XXXX. the expenses statement, and were quarter end toxicology as March to quarter a of increase announcement XX, reported our quarter-over-quarter, March ended XXXX in March in We primarily March three general cash through the sufficient million quarter estimated quarter With turn March and is we quarter call. first first ended in

Greg Duncan

again thank today's attending once you for you Thank update. and everybody Angela who's

treatment you the our potentially time fibromyalgia of a using antiviral research other of in well and market of treatment assessment fibromyalgia treating unique Phase reduction fibromyalgia Xa patients to existing has new treat trial data very benefits has This this that to the the the community uses and Phase as sure supported synergistic Xa fibromyalgia Virios to as our the knowledge granted does, The a the involving IBS. drug are fibromyalgia a designation novel to patients encouraged evaluate new The review is therapies opportunity first best tell, mechanism and in treatment. and somatic the with already suggests I'm is been designation antiviral large options. As fixed which for the demonstrated IMC-X both approach FDA in track fibromyalgia, disorders. clinical indication. fibromyalgia represents fibromyalgia candidate for pain granted symptom to new IMC-X by fast completely approach novel particular by represents and team strong fibromyalgia fibromyalgia market is medical physicians fibromyalgia approach dissatisfied IMC-X can interest treating

communicated, commercialization previously Virios and and experience Savella, This As of our developing has Lyrica been involved have extensive of of objectives the as and to-date. commercializing only has of experience Virios team Directors three development approved of the team leading for Therapeutics by our in enabled category medicines. FDA deliver Board us operational expanded the drugs and the fibromyalgia. Therapeutics to two The previously Directors Officers and the planned treatment

the proactive fibromyalgia our to to are patients We frequent the of progress millions standards journey outreach we globe. community, scientific improve the for community, of committed hundreds investment as and treatment to as as across well

related for website at the the the Benzinga we're will ready Investor Cap will Virios questions. in Global Conference. presentation be next accordingly. now of available The Operator, be Section tomorrow Small Investor Our webcasts

Operator

Thank you. [Operator Instructions]

Greg Duncan

you, we question probably and turn I'll one What you. best up get for IMC-X? will Mike, team follows: that the opportunities handle that research to quite first one. exploring the today diseases Virios So as is question frequently, are that as other question as cover to you're we over placed is Thank

Mike Gendreau

Sure Greg.

likely we So Bowel on consistent Mayo a based couple IBS for we Irritable trial future what be indication condition for Concept Clinic, with and our exploring believe Proof released about a we we talked of would is candidate IMC-X. next previously with the collaboration factors. logical for see a with press as next

patients across which at IBS is and Phase opportunities fibromyalgia designs. looking fibromyalgia which have know from is control compared their presented demonstrated been showed of utility multiple We'll all have study to which including component of optimum related generated the that's believe pain community of And presence in the and develop requiring data IBS HSV-X IBS our something Universality And the disease was IBS in study necessity patients, of for the our improvement be as in the that Alabama the Study Biopsy signal replication domains treatment better second, pain. and for. treat options the an looking IBS, pain We in IBS we related promising authorities to by the regulatory significantly FDA better treating that open for to patients, treatments of are that shortly, the started with reduced of Xa studies label results conference active fall IBS pain we for at to exploring a IMC-X that Tissue to provides are further. know we us we pain, IMC-X potential IND consider incorporate founder assessments with that

So I it, Greg. that think covers

Greg Duncan

Camilleri you, add, financing. And likely Mike. just require the we’ve Dr. Thank aligned additional would I Michael would design study with

So program the compliment clear as second a that program. progressing wanted I a just as get to consider we to fibromyalgia

through results? existing Does get topline Xb often get enable and think Second Angela, one to fibromyalgia you I your it's reiterating. question this is Phase you covered but trial worth probably cash we

Angela Walsh

Yes Greg.

earlier, of this on draw with the a XXXX, FORTRESS mentioned asset beyond provide the is an interests success the from the trial a the months Presuming Phase from of will our runway proceeds commercial time line engage full We new program end align treatment to December and the top IPO science As requirement. in which to other six fibromyalgia financing X use life trial, FORTRESS believe will IMC-X companies. FDA results. potential the through we operational

our As the that maximizing such, X development But we shareholders and evaluate use to party we requirements clarity or commercialization. of on approach IMC-X can we then this can via external and assessed choose interest, for as in time value interest having partnership alone external IMC-X. partnership best advance in also Phase

Greg Duncan

Thank Any you, questions? Angela. additional

Operator

questions are there no additional Nope, at time. this

like to I So remarks. to back call would turn closing the Duncan Greg for

Greg Duncan

execute the Joe. sense you a we're months XX much, Phase this very teams’ on Mike Hopefully get over preparing over finalize sites of manufacturing Xb patients great enroll the progress preparing made you quarter front, fibromyalgia four mentioned later planned. of to the our We’ve to can XXXX. the progress and as results, as Thank protocol first

at our of ground and are only see enrolling in have June. a “late been as late Xb Virios the the diseases turn importance are profile and And view, furthermore data in as the breaking highlighting we breakers,” mechanism now because over later can Disease trial for Digestive which GI biopsy of this country. attention June You starting both at next accepted presentation with the our is have Phase Week, so a significant to presentations been presentation EULAR is data GI IASP patients in raise accepted to in largest a research. again, in our handful months, Fibromyalgia treatment our XXXX. results is topline of of fibromyalgia focused month meeting accepted of breaker the the this potential our goal delivering And for beyond eight fibromyalgia. we XXX This the

the we're looking you fibromyalgia address things to remember: is nothing quite dissatisfied. you call, If place, like market to remember there from three and is large else today's I’d which

as antiviral a supported by program is that data that’s approach just and Angela novel funded. have mentioned, fully We

the for in to and commercialized Board Thank literally We millions globe. particular an patients support look day! this this experienced care of appreciate who the of have have good of transform race across Between team we’ve the very and the two of three standard your have your a journey have patients run and/or team this fibromyalgia and as interest we also of drugs developed the you, hundreds been Directors We condition. with for approved before.

Operator

This ends today’s conference.

your day! much lines a this Have your very at time. disconnect may for You great you Thank participation.

Greg Duncan	Chief Executive Officer
Michael Gendreau	Chief Medical Officer
Angela Walsh	Senior Vice President of Finance and Treasurer
Ralph Grosswald	Vice President of Operations

Dogwood Therapeutics (DWTX) 13 May 212021 Q1 Earnings call transcript