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Statera BioPharma (STAB)

Participants
Michael Handley President and CEO
Peter Aronstam CFO
Taunia Markvicka COO
Nichol Ochsner SVP, IR and Corporate Communications
Call transcript
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Operator

Good morning, ladies and gentlemen. Thank you for joining us for Cytocom, Inc.'s Second Quarter 2021 Financial Results Conference Call.

Following prepared remarks from the company, we will open the call for questions. I would now like to turn the call over to Cytocom’s Senior Vice President of Investor Relations, Nichol Ochsner. Nichol?

Nichol Ochsner

thank financial joining results and our to everyone quarter second and morning you today for discuss Good business update. Cytocom, morning, this Inc. Earlier issued three the Cleveland a which we ended detailing for to XXXX, press former read. listeners the June financial XX, BioLabs six and results the encourage months span for release available company's release Web The in cytocom.com, is press site, on the section. the Investors

due Cytocom's some recent remind Cytocom morning, release, completion XX, quarterly are available everyone circumstances will Cleveland identified information financial realized. clinical between Executive recording Cytocom, President Cytocom's these which on during of formally company's the call provide An for and expectations Cytocom results based and that of update the press available Inc. no may go in be included corporate Mike, be in quarter Officer and webcast would of please made private no Handley, company the in also merger Chief on Mr. will like call results certain assurance BioLabs forward-looking site. section upon online of our can reports Cleveland other the and the on ahead. XXXX. Web I and that us also Actual conference be July SEC. for BioLabs Handley will change. who contemplated are achievements. following position discuss replay completed to today's factors audio will available and statements call With Michael an statements this a is update in to obligation to the today's assumes is Investors today, maybe These as which XX-Q to statements Such the of number Second such on are forward-looking risks, differ current sec.gov. with filed this statements statements statements and results there materially from based a conference and statements. are on

Michael Handley

dialing the Thank post summer a The today, thank and than more time. are of investors formerly private for CBLI. publicly I'm in hard a by October on BioLabs trading marks merger of in July was CEO and new Cleveland Cytocom, Today for under XX work Cytocom, to shares NASDAQ people common our merger of milestone the to merger who you and time the Nichol, and everyone Inc. our Cytocom, both joining The first under completed long our between year the Inc. representing speaking conference talented of Cytocom, the XXXX, stock as Cytocom. on name ticker first you, the and marks the CBLI first dedication for awaited currently symbol completion are particularly announced those this at traded the many

June their third involved for consolidated I now pandemic to the for SEC Cytocom many COVID-XX results. everyone filings XXXX. to of follow by the results month Sciences, First, during last data operations, will when speaking the I want when and Cytocom by that aspects expertise BioLabs the Cleveland financial that subsidiary. purchased from operating and we you Inc.'s time, look Cytocom's the ended has so The Cytocom Further BioLabs a company Cleveland consolidates November development morning Cytocom, our quarter a merger for picture post second daily financial forward as financial and again announce ImQuest XX, their their of time detailed issued provide the drug that for legacy year discovery with is in this a filings quarter the life. end perseverance thank a disrupted regulatory

potential world are So Cytocom time and modulation. believe we become the shareholders. of our in that now for exciting very leader We a a field state, let me positioned this immune is to

further public In capital debt provide have opportunistically Jolla the research a alliance to cancer, La new the Phase discovery and capitalized. autoimmune momentum emerging that visibility with advance pipeline from NASDAQ drug terms AIMS million down candidate, at build equity world growth of long-term In The The recently announced well our to for allow commitments which able discretion be GEM cash financing investigational to clinical shareholder for value. Institute Crohn's initiate own initiatives CYTO-XXX leverage should research raise for we pipeline, our trials among a our on over Immunology Cytocom including stock and platform next to in proprietary will pull XX of development markets, enhancing our infrastructure, and on community investment on inflammatory diseases. Ventures and driving of should trial and the potential Capital, a disease. recent in X weeks. trading assets, expect four agents and of we liquidity us discovery Adit to the and our chronic of financial drug several lead internal viruses, months, to a position, Cytocom Cytocom's the listing of Global is and immune-modulating Yield, treatment and class Avenue

were further in agent are Cleveland will BioLabs have as and believe hematology GPXXX. we for opportunities discuss. potential indications core great we immune-stimulatory exploring its assets inherited next-generation We drug that the entolimod These candidate from

and opportunistic stage for our opportunities to the In explore I for today story. months, BioLabs the I development and Cytocom therapies immune ventures joined harnessing The and no of manner an showcase the development development on non-core underway adaptive system pipeline in we'll clinical a key immune-modulation background to a role further coming well can connecting is immune merger monetization Cleveland next-generation terms, who advance of and for private infectious immune yet Furthermore, integrate and simple its creating We're the system. X are programs expanded Cleveland immune you and biopharmaceutical but to assets. technologies go to formerly disease one on detail promising fighting viruses X and capabilities. platforms These is which joint an stage Work disorders, clinical well oncology, positioned of that decide restore playing drive expect In GPXXX, toll-like now and on rebalance two homeostasis. to to of the on has immune believe as Cytocom underactive treat the before. emerging moment drug Cleveland and the our homeostasis. immune pursued call therapies former Cytocom the from therapies. immune power of X compartments, company companies, a a that new clinical restoration central indications stage to each largest agonist, those focus the to like Cytocom is receptor plans overactive and for would disease these and development progression, that BioLabs' different autoimmune receptor Toll-like drugs delivering immune we other toll-like as focused provide into developing disease are toll-like especially entolimod receptors has industry. more and of toll-like some subsidiaries take receptors programs, or in one antagonists, the the response, restoring and cancer. disease Cytocom’s pharmaceutical in immune Before to system the BioLabs and receptor with and immune innate Cytocom. With our

potential market eight Our and very assets across clinical emergent multibillion-dollar several exist, neutropenia, them, large indications. and and especially XX stage immune-modulating opportunities in viruses, autoimmune Among development pipeline cancer diseases. includes anemia

secure will funding up development use Immunology, alliance alliances of these a potential with current caliber of five-year the we keeping institution Cancer XX for XXXX. where by approximately New end also million cash of the advance research pursuing The Buffalo, the in Institute a annual provide capitalized this The X.X the research and laboratories Park to to well to with for to are August company laboratories. Last discovery new provide the partnership We marks week, with annually major renowned achievement La The we immune-modulating month, Roswell of programs. mission this is of with agents. research discretionary Cytocom total the to Jolla immune-modulating contribution Cleveland the agreement, on immunology million therapies. cash facilities. development of Under four oncology in BioLabs million partnership with up Cytocom best-of-class and academic dedicated funding Center Institute with York. announced line will that expects and relationship La the position is Cytocom to its increase to hand currently, Comprehensive and Jolla XX our has has a to

months. the that and be sufficient multiple additional can XX at and down This drive discretion to points pulled the resources advancement in We value clinical of towards are other also our and inflection continued company's fund current the capital we opportunistically. million coming believe commitments pipeline Cytocom have of

Cytocom. have we developmental months, XX in to transformative in next potential the milestones of be Over the terms

and burdens. with done of a recently being economic inflammatory bowel show with was Our significant X pediatric the XX such studied Cytocom signs summer. completed end-of-Phase an this for the lead disease and This the pain. symptoms treatment unpredictable, disease causes abdominal chronic and Crohn's because physical is investigational are symptoms persistent patients drug diarrhea emotional, that Studies of on of meeting the candidate, that it's disease. as CYTO-XXX, endure productive FDA. And patients July

to pediatric begin enrolling expect X Phase before our We XXXX. trial clinical in year-end patients

toll-like to opportunity Xb/X on hematological has development about Cleveland that year. BioLabs. previously in should a anemia requirements toll-like medical inherited a plan tremendous a cancer and is ongoing GPXXX patients, information reported, Cytocom the of of provide date. additionally potential a agonist and from their a entolimod multibillion-dollar Phase for see receptor pancreatic in neutropenia, specifically the X early and Meanwhile, the exposure trial receptor to shown radiation GPXXX next at cancer for X agonist acute emergencies. later for We reviewing As market. research needs we indication, more development begin plan which and pipeline entolimod treatment We clinical evaluate is We based

need patients. post-acute This for developing the or protocols a in XXXX. with cancer. plans FDA IND COVID XXXX first to the to the is evaluate in an is roughly have agent a expect the Cytocom and safety to in to development of XXXX COVID-XX acute trial research extend begin safety existing this We're a planned all in the with of oncology Cytocom Cytocom of and perfect patients FDA of long-haul to the in to this studies in ability and evaluate for under resolve enrolling feedback patient syndrome, haul help end earlier syndrome. half long therapy finalizing market patients third of We and month are X received year. our quarter to is disease into from is or experts. believes and also advisory An the developing an been XX% expects of XXXX. in a Phase COVID-XX expects use the we long-term with post-acute remission patients. referred CYTO-XXX this pancreatic this patients post-acute cleared an COVID-XX. by patients we post-acute standard And infections disease And regarding syndrome, panel duration symptoms established the care unmet to the organizations fourth to evaluating with Cytocom least, but clinical initial of now CYTO-XXX these PK as progression adjunct contract and IND that and year program improve drug opportunity conduct acute clinical initiate expect Cytocom setting our the by in PK trial CYTO-XXX, quarter high not begin enrollment or of has often COVID-XX to this last to to

look Cytocom of I to our and of current momentum of future for said forward the into is shareholders, As XXXX. excited second throughout building team the we half earlier and and our management very the today, XXXX

With Financial of up portion is to will of call families Officer, a call I the illnesses. ultimate that, difference Taunia Q&A And VP open lives joining Chris Finance, Chief take me this and Zosh. questions. would Peter Aronstam; now make Operating their patients questions. fighting Our Officer, the I like our and Markvicka; goal Operator? is the our Chief to as a to for company of serious in

Operator

you. Thank

the now begin will [Operator Instructions]. We question-and-answer session.

Our Equity Partners. first Scott [ph] ahead. question Please comes go from Kronig with

Unidentified Analyst

Hi, and team. you? Mike How are Congrats.

Michael Handley

Great. Thanks, Scott.

Unidentified Analyst

just in lead you for the you're expand of of on to market addressing the how to program first like Crohn's? IBS that scope What's mentioned, expanded the kind you ask this Crohn's pediatric initiative. bit the anybody Is and pediatric you little terms possible patient basis Crohn's now And other issues? a for that enrollment, an market potential view of addressing? could there into of I'd

Michael Handley

as comment I'll then and off Operating We opportunity well. is Chief start our large. I'll have Scott. question, Taunia, very believe Great Officer Crohn's the

drugs big of drugs box As treating selling the pediatric we of on warning all know, disease. has are Crohn's sales Humira, there for world, based without black no largest their Currently, approved portion a in a one the patients.

there opportunity initial warning. pediatric to by pediatric current a and structure drug first We the large drug an study and this there's patients believe is to the for form, unmet on without for path FDA, black a So this the its best need reviewed market getting in as be in the forward patients. box

of study We in will this quickly want to you clinical XX be enroll first this of patient starting the patients with further that design amount believe the comment Taunia, we significance and later study? fall to to months show in hopefully on XX detail we patient can and would next of over population. need this the this the we

Taunia Markvicka

Thanks, Sure. Mike.

pediatric in suffering disease medications have with that concerns [indiscernible]. we've population I them think their important have also with parents what's children that is associated warnings this around children that actually that here heard have that describe the might giving they from

So there is product. real this need for a

so parents our medication to clinical to reaching our requesting have or trials. either access many And participation the we in company out

the study hope So a maintenance, a that medication. of to to conduct then start study we'll older for induction ability us. a we'll XX-week transition positively XX-week is liquid of in formulation patients bit pediatric our in a reflects our -- pediatric younger which with and with actually patients a induction, in down that And that's programs. interesting we study We'll enroll to clinical

we forward wide induction our in being results to over patients the look spectrum next pediatric here XX to the order So able a enroll of months to deliver from trial.

Michael Handley

The to Orphan would allow I'd indication answer is status to commercially. us question? advantage And well, that as also that. us your does add on Scott, to an like pediatric which Designation

Unidentified Analyst

I appreciate it. Thanks, Yes. guys.

Michael Handley

Absolutely.

Operator

conference I like turn session. Instructions]. closing to question-and-answer [Operator This over any concludes remarks. would Mike for our to the back Handley

Michael Handley

you, Sarah. Thank Great.

from months, pipeline, advance today's which expanded alliances As we significant you Cleveland to heard assets discussed and patients. we well expect the multiple achieve have pursue and as trial further clinical Phase development pediatric discovery. Crohn's clinical that, approach year, as assets that then we we to new and research immunotherapies as one, Cytocom coming in validate discussion, this clinical support treating be across our milestones programs, four includes five in our trials drug X By should time patients a next just in BioLabs including

strong financial provides to foundation a ongoing programs. Our position firm fund our clinical

sincerest like look As you can see, to updates. the for pieces to And continued extend are starting your to fall good today appreciate and very employees to I in into and providing place forward you I'd health. and dedication like and stakeholders for Thank shareholders and thank our our we to their time periodic would loyalty, support. much. my wishes their attention all

Operator

you The conference is Thank concluded. today's now for presentation. attending

You disconnect. may now