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Statera BioPharma (STAB)

Participants
Nichol Ochsner Executive Vice President-Investor Relations
Michael K. Handley President and Chief Executive Officer
Peter Aronstam Chief Financial Officer
Taunia Markvicka Chief Operating Officer
Call transcript
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Operator

Good morning, ladies and gentlemen, and thank you for joining us for Statera Biopharma Inc's Third Quarter 2021 Financial Results Conference Call.

Following the prepared remarks from the company, we will open the call for questions. I would now like to turn the call over to Statera's Executive Vice President of Investor Relations, Nichol Ochsner. Ma'am, you may now begin.

Nichol Ochsner

Good afternoon everyone and thank you for joining the Statera Biopharma's 2021 third quarter financial results and corporate update call. listeners Biopharma the press ended three XXXX, we Statera financial detailing September afternoon, which for results and encourage this issued release a the XX, Earlier read. to nine months Statera sec.gov. can release afternoon, the for XX-Q found The also available press a on be filed is Investors in section staterabiopharma.com, which this

our Officer Handley. statements Financial results operating the Today be making Inc, including and These Taunia certain result and of Before beginning call achievements our like forward-looking our today's to will differ please I'd would who discuss CEO, corporate and to is and capital Biopharma, and Aronstam, like program. obligation will a discuss and otherwise. I financial about place Statera expectations, who Peter to make for ahead. filing. materially President events, whether statements vision Operating uncertainties, candidates on Chief Michael, K. operations we turn not Markvicka, as Dr. now of development risks Officer the results; clinical With our information, about information in clinical metrics, will Michael detailed the our any including future disclaims XX-K go company's Mr. based who and call today's update to new Chief call, of the over future future. Actual company's an on in on reliance to these will Statera's the Handley, recent events statements Statera, contained plans, update you us future Biopharma statements, on following our Statera provide and of Michael or CEO recent the expectations company's regarding cash our and statements. may should effectiveness and strategy, forward-looking and Statera current most investigational expectations resources. due undue allocation those circumstances, the drug statements. of are these

Michael K. Handley

Thanks all I'm our joining for this conference including CEO time. Thanks Great. to Today, of Biopharma. Nicole. speaking as joining afternoon, you first of you everyone for the Statera

new but ago, modulating Life of company Through with Statera months autoimmune publicly-traded at deserves infectious we we emerged as focused immune ImQuest the Cleveland drug of agents, STAB. new On company, Sciences, three July, Just the known reverse end as XXXX, X, a rebranded a acquisition we company's generation developing the of BioLabs cancer development company our identity. name on as the of a merger disorders, were symbol the disease, core and focus Cytocom. blood formally and ticker addressing the and reflective September with Biopharma new next

our forefront driving has the immune immune focused that disease homeostasis. which progression. agents can an therapeutic of of underactive Latin you're science, we're name health, balance. In overactive and of or from our focus chosen corporate the an And of terms, is system pipeline. on company immune demonstrates developing restoration restoring a clinical the strategic modulation simple generation of the the drive Our Statera word the stage biopharmaceutical next and company tagline, to Statera immune the with reflect at this taken

We disorders, focused blood cancer. infectious autoimmune, disease restore developing to system and address are rebalance the drugs immune on and to

Slide not one With toll of and slowed X. we have then recent since platforms merger, we Please created down. the have the largest to receptor advance

the disease. pediatric autoimmune program STAT-XXX Our Crohn's is in initially disease pipeline with focus targeting

into with entolimod, pancreatic expand STAT-XXX hematology to cancer. STAT-XXX oncology program the expect We program the in or with an

develop also our new we're working assets further our to programs, our second support generation to pipeline. deepen growth strategy Beyond clinical and

of establishing Life of clinical those harnessing succeed compounds the new likely we second subsidiary finalized of is In year Institute and tools immune-modulating preclinical proprietary agreement will research and already screening five Jolla with to of for some research ImQuest research and development our harness the alliances. diseases. support discovery to that discovery most in infectious, of The will La are also generation a platform chronic agents directed new select inflammatory drug We round the Sciences and compounds, targeting capabilities this Statera's autoimmune, treatment August, potential development to immunology, first trials. cancer, drug toll-like receptors immunomodulatory Statera technology.

and growing University Roswell programs. Buffalo, research New to Comprehensive center are add York. Included organizations, several Cancer BioLab Park clinical as the to XX subsidiaries Life and is with our Center over assets. underway clinical is on expect integrate We of non-core Linda those pleased this and in next this In ImQuest the Statera. list to opportunities to we achieve development Health prestigious the well milestones and ventures to to corporate monetize months. XX as in involved Sciences the list joint to in Work also former Cleveland meantime, exploring the We're Loma

promising We X disease platforms in industry with pharmaceutical receptors one X, has in GPXXX. Statera fighting immune antagonists Our on to a change a immune receptor about is the delivering of way X plays toll-like toll-like toll-like ultimate our homeostasis. has our that toll-like target technology agonists immune toll-like goal type protein think people central immune believe role now of restoring Statera and therapies entolimod key the and receptor to receptors, that focused immunotherapy. receptor response the largest of and the

We to our the also strengthen the balance expansion sheet pipeline. enable growth and to further of plan

expects like advanced financial ended position and financing Peter With CFO, to to that of of third Our our and line-of-credit numbers end fund our an a and cash The Aronstam, Peter? the now with as facility intro, year our in including the quarterly company plans strengthen will grow approximately further equity our business agreement. to hand $XX.X credit million third call I'd development internal Aronstam, by development discuss over quarter hand Peter will results. initiatives, pipeline. of who the CFO, quarter arrangements, capital our the review and to on

Peter Aronstam

much, very Mike. Thanks

the investors this just we're Statera company. first emerge pointed analysts the newly time as a Mike As out, to is from speaking and the

go the for how us me rules I filed more numbers. XX-Q about mergers those we accounting requires the before numbers XX-K, today, So, briefly to detail for the describe that into in present let the

You'll survivor read under for old that was Cytocom. accounting the mergers the XX-K, in the example,

also CBLI, Mike was Statera. change even legal though read entity changed on You'll the the mentioned, old immediately same merger, the as that to Cytocom after it has then surviving to later the the name back and

legal keep and mind those in mean like through go today? survivor? results you accounting we accounting that So, I'd mean terms what the we what things. us And speak for XX-Q do to in now three about they do presented or when to these numbers the

look or statement P&L statement you income the that's accounting when First. survivor. at the the of the

in at you're So, for old Cytocom the only. the you in P&L all XXXX P&L looking Cytocom. is for XXXX are results the through to of and seeing And there of what the June old end

for at July. year. revenues in those periods the Keep the only or June mind also only end the at expenses end So, of merger closed or CBLI. there's And CBLI merger included as in Mike of this no the mentioned, ImQuest that ImQuest old closed with with

from the the the September. XXXX, end it those the companies, to results merger the of three only closing for Cytocom P&L combines the results of XX, dates months end for of with other each September So,

keep those become get when will that the meaningful really periods, like XXXX. in in and of those of mind third you we to, only who for to comparisons when we perform quarter relation So, comparisons please report to prior

merger You'll in for up also perspective, those presented means that XX-Q the accounting liabilities sheet term date see and a what the to is the assets Cytocom balance survivor, of only. from the

So and liabilities that's the equity the assets only accounts. not

and old surviving third to legal is the is And mind the articles added with its entity, of liabilities Assets merger. their respective in that because is State ImQuest to merger its thing bylaws the sheet provide Delaware, the registered from and CBLI of then only dates. CBLI the and keep

statement the So for old only and sheet issue report. that means periods the the and preferred that common in CBLI the is balance shown issued fully of authorized for both of all Cytocom and equity merged reporting in authorized stock, stock that

you XXXX see example, an references preferred issued XXXX. So that's the Cytocom were Cytocom and the section any in equity investor, shares don't old by you for in to why, old if

All exchanged presentation. the shares. happy And If section accounting, the Cytocom shares we'll in there's them equity common them you now this any questions see be of merger to reported old the in shares at common Statera in CBLI. as formal for merger the were those take of old about end

results Turning now in briefly The let the to nine quarter ended company September Number months the XX, the in $XXX,XXX the months revenues X for me the reported talk in next presentation, and XXXX. of three just the the about XX-Q. reported slide, very Slide

XX%. means which ImQuest by Their profit mentioned derived a or because approximately of of no XXXX only cash this we research delivers is research or customers. point as it it of ago All that same the just in slide reported even became reports. recognizes made $XXX,XXX, was provided just effective revenues XXXX. were customer revenues at with the I other And from that of end they its advances, in merger $XXX,XXX also those out June minutes approximately the reports in when if period to delivery gross collected ImQuest the revenues revenues its and a few want customers, to I final to ImQuest its services

XX, revenue. manner. ImQuest And shown is from three a in sheet, quarters balance this total look indicates if the of you'll XXXX that reported client. as since of the approximately received our on delivery that of beginning you we sheet full deferred And at collected in cash $XXX,XXX its September approximately For, revenue $X has to million balance July deferred see the

ImQuest’s deferred is So revenues $X mind sum quarterly almost the indicative the a of of revenue three you the just revenues in quarters keep rate. of million plus run currently

and reflect XXXX. you explained the CBLI quarter the months, XXXX only of same research three August earlier XXXX when old for for only were the third since development Cytocom. XXXX, ImQuest includes and included XXXX keep compare mind the third of the spending expenses old I against in in G&A The for XX, full quarter numbers expenses quarter As please

to they XXXX arising the you'll decrease and the XX.X%. its by $X.X that one the Debt period So, previous or primarily refer And $X.X Therapeutics. turning programs were attributable million million company, months million just million from to patent XXXX. of three that of development to by XX, to months the three incurred filed of intellectual that now pages XX-Q September increase the you'll detail time And see same for reduction – $X.X months specific Please was in for compared R&D disease. $X.X in million totaling, under the Cytocom was you ended and Immune increased by old spending to expenses September spending September or at for find XXXX, offset on a transfer to XX, we expenses XX $X.X XXXX. more for ended where approximately research R&D that for XX, parent $X XXXX XXXX looking indication from after earlier privacy pages million the as a look to decrease about by ended decreased the today XX, three expenses,

You'll was see the by of then post-acute that followed COVID spending cancer. research on Crohn's most pancreatic XXXX and

also added being and months in or They public Also and our quickly net attributable XXXX XX, expenses. XXX% from million Statera of the three headcount. going to The private or September to period if or to And we growth had a of through of callers position was months million Slide to so X, by Statera Most on other $X.XX our loss increase significantly for when $X.X become per the Slide we of XX, back year. legal Cytocom same X accrual through share the for August, a you for CBLI's merger. the million $XXX,XXX. company of XX, $XX.X G&A Cytocom in ended is related net expenses partly three-month financial million settlement. could financing September $X.X increase interest G&A loss of that XXXX. from per an period before that old share to fact and old $X.X referenced ended Please Turning $X.X arrangements XXXX, operations old was in just included the $X.XX loss the XX, million million XXXX. increased that a posted in reported public the June three two continue ended share September entered last $X.X And XXXX to into We in merger accrued XXXX, year-over-year. the compared in expenses that flip cost for the

X an the $XX closed from August one So In filing detail of the agreement them we Opportunities first arrangement loan May, the down with were financing described we drew the put additional the Avenue million released repeated XXXX was for of the meet became to an XXXX, loan of million. Fund. the XX us some escrow operation. excess million will And be in and full and to in of we the of this still and equity conditions in of terms to in our Avenue. required account the immediately We proceeds The agreement us of Venture balance April, XX-Q. in in issuance we've $XX the loan in with million escrow we when general X particularly million available

have announced line Global May was of XXXX with we previously The of LLC. equity second financing entered GEM credit, that into an arrangement we Yield which the

to of of being not XX.XX% yet equal its stock. availability may time XX% be to all today, NASDAQ the we want Another stock with is aware you conditions, facility. to – sell up the the the GEM no company's used at and recent company more the $XX whole a shares price rule million have trading to XX-K And of of subject control at to deal, to GEM the stock. reported $XX the own subject from company time price certain or in of than common that just we million common filed shareholder including I time under the may the the a single

the And merge raised our in as the caused And first increase and the cash, company So of May. fiscal XXXX, for nine ImQuest see used the December the The cash the to we cash in represents you'll since September plus then was contributed was as in restricted at we cash offset Mike equivalent XX-Q, million XX, of by CBLI through cash last in mentioned cash September million. the end $XX.X year we hand the partly of we XXXX. increase Avenue XX, $XX.X from by last and And that earlier million from XXXX. it had months net an operations. Ventures operations used XX, $XX.X on cash

you current on committed. under sorry, is can Budget conditions and time it for key XXXX. to So finalizing not acquire assets we're objectives or the this And speaking opportunistically. to only to our potentially spending we we're evening, modulate budget our we're presenting absolutely execute

these to to performance on be capital. existing place couple budget it engaged year only over end, our We budget of the commitments objectives investors Given of the two and to of three licensing currently have quarters. new announce have spending have however end that we the would entering in next and from sorry, new that out dependent the as we soon as and up that final or We're be year other we as drug prefer to And We'll binding candidates that million. binding $XX determined aggregating our existing all by transactions ability the with parties. capital would other in commitments more to of us commitments stock equity discussion would investors these, prudent for also specifics in strategic to for to transactions discussions raise additional fund budgets. to obtain receive line next the sale to as debt give our equity soon cover or potential we have from

the for of the sheets flow return of the Michael that description with to statement, balance like position to company the cash and I'd September, end the Handley. income the So at call

Michael K. Handley

you, Thank Great. Peter.

clinical treatment a Institutional stated in earlier, or study IRB Last we first the to approval to Loma has patients field treatment the COVID-XX. is – acute immune Linda our pediatric site are And potential and Review meantime, to the pivotal Taunia have Health in end our readouts the of at be Taunia? Board to this we discuss turn drugs we Operating by Officer. I'd next and the STAT-XXX is Crohn's screening over Chief enrollment month in program to the the call disease anticipate To like month. Center started aggressively activation of X I treated Markvicka, pilot positioned Statera As data and to become year. our other advancing conduct as Linda for start In the in and expect for study year mid-XXXX. Phase Loma evaluate Phase of these preliminary a one well our programs, this Dr. trial University modulation. expected X received clinical to leader patient

Taunia Markvicka

Thank you, Mike.

well to stage toll receptor and positioned of to the breadth development Slide turning So clinical pipeline. Statera of our is see you can support that capabilities to continues expand pipeline our X, to our the further

XX to X and up represents patients millions important safety patients. with or program is and and and modulator tolerability to contagious post-acute as and who Statera we've As ability symptoms. syndrome inflammatory evaluate is for with and also acute well improve COVID-XX progression, is Linda a and under The infected Loma of STAT-XXX STAT-XXX the viral Phase analysis, inhibit with disease have STAT-XXX an rolling for to the its IND elevated resolve potentially at or with decrease infection long-term people existing Statera to Mike PACS. struggling designed pilot mentioned, responses step viral highly COVID-XX considering variants, PK as an a become infection. safety safety, study associated COVID of replication. evaluate to those pharmacokinetics study and immune It initiated targeted biomarker

XX; more we getting Now during trials clinical several turning see Slide to XXXX underway.

for Phase we and next These on patients patients economically, only for children and unpredictable for entolimod be facing anticipate GPXXX Phase endure for Studies parent. burdens cancer drug in white potential pediatric blood but also living can of production of and blood show not cells. the treatments X the pipeline. based and a red that FDA challenging Statera symptoms more are this meeting toll-like opportunity cells enrolling when evaluate or their to physically, patients because of Crohn's receptor patients and STAT-XXX X body's trial neutropenia lead and even generation with the the earlier conditions X with continues agonists the patients. of significant Following development with candidate are cancer the hematology, and emotionally BioLabs Disease. we Cleveland and for disease Crohn's specifically common anemia in treatment life-threatening sometimes treatment year, see productive in And in our tremendous radiation the chemotherapy that a into this disrupts a clinical signs

As of reduction We believe their red with could XX% entolimod in many component the or become point, many as point blood a neutropenia year. develop treatment every will as critical cancer some at regimen cancer patients XX,XXX for anemia are at in hospitalized cells patients and a patients. as of

PI We FDA to establish investigate the discussions in institution academic program have and with the study entolimod. are order with in discussions the underway a reinitiated or to hematology oncology with development and leading

will as death then cause a program. third We information is more Pancreatic cancer behind date pancreatic there's the things a firmed now leading later provide of devastating of cancer at lung as counted cancer colon more become And course, disease, up. cancer. the and

are in for U.S. In our clinical with Type regulators orphan this previously C STAT-XXX therapy STAT-XXX FDA a designation. and of STAT-XXX development. extend to the August as disease adjunct following patients meeting remission with regarding an pancreatic cancer. We of duration feedback drug to The care received the year, standard company plans developing the granted

during the establishing With are program, like have to Phase We expect drug supply clinical hand able back clinical studies. be the of a first initiate – for to we initiating of XbX call now panel XXXX. clinical experts that And and half established a trial to oncology to Mike. I'd advisory an

Michael K. Handley

Taunia. you, Thank Great.

our the Finance, call to of and forward current any take earlier, Statera building Zosh. Officer, Peter Q&A would our the Markvicka; your remainder Aronstam; look said of and questions. call and With me that, like our Chief I these for open Taunia throughout XXXX. into times exciting upon I to Chris Chief the any momentum portion we I'll and are XXXX is As joining now VP Officer, now the questions of Dr. this of Operating for to Financial

Operator

Instructions] this for back time, closing to there at are I'll [Operator no call further questions turn Since the Michael Handley over remarks. now

Michael K. Handley

Great. Thank you.

As cylinder. to up we've on is all discussed, hit gearing Statera

great intend We achieve as in the Phase to research indications, to our pursue programs three further deal next exploring year, can coming trial. a our the of generating a very milestones we past multiple and programs multiple across including clinical proud have modulating shareholders during X maintain we're months, we achieved advance hard In for and this clinical that time alliances. to which value working we trials, momentum. are we investigative immune pivotal year, patients stage By treating be expect

dedication and our your we I'd loyalty thank And execute to our look and help our periodic and as Thank all. updates. thank to wishes providing and strategy, you. growth continue and forward like I their for to and all and want always, good shareholders will for to would support. time continued I appreciate I to We of like employees hard work. today, to sincere stakeholders attention my extend their

Operator

concludes all This joining. call. Thank conference for today's you

disconnect. You now may