InMed Pharmaceuticals (INM) 23 Sep 222022 Q4 Earnings call transcript

Good day. And thank you for standing by. Welcome to InMed Pharmaceuticals Fourth Quarter Fiscal 2022 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. advised conference be being Please Instructions] that is today’s recorded. [Operator the now Vice to Relations. like would conference President to Investor Clancy, I Colin hand over today, your of speaker ahead. go Please

gentlemen. your us and call. our day, appreciate InMed's Norma, so Please if President Relations. XXXX note, fiscal Investor today speakers encounter locations, any to of is we business financial you, Thank results Vice ladies and and from Colin we My remote good patience technical Clancy, InMed's year-end joining challenges. Welcome are name update conference unexpected

wellness Before we and progress President Michael over activities provided operations. followed results program, begin, report Ms. commercial be Officer Chief we Officer. Operating disclosure a our go financial and by CEO, Woudenberg, Chief would Eric development like by Edwards, then will drug by our Brenda interim of will led our to Financial Adams, on which our together on the our pharmaceutical review our update statements, with health

Following call development, can turn during statements would cash regulatory like CEO, now call. the conference in for Hsu, following may the to documents. not Adams. will facts, forward-looking are address contractual A in President historical about InMed statements. Dr. disclosure all does be operations, predictions that latest approvals, InMed's Please inherently the to assumptions, statements us I obligation results undertake contained any advised risks is differ Eric? joining clinical your this of our rather over statements. expectations but those Eric and Actual which found these description of and from questions question-and-answer update today in Eric constitute for involve risks that, forward-looking future, business any key materially made be uncertainties. revenue not InMed's to runway opportunities, forward-looking including and arrangements, session. be personnel, financing, Such Vice statements Research and to President certain Preclinical Development. we Senior Also available

earnings and the have in you several joining and for last significant corporate call, there to on Since our operations both level. Colin, Thanks, been and changes, thank everyone relation to us today. eventful

several in largest ongoing of Ukraine, direct We on from the all the socioeconomic and slow XXXX, a war pressures, growth as as as inflation well global seen macro the including issues COVID the impact decades, well recessionary had stock in increasing which have as in market. considerable many businesses emergence the have pandemic,

have momentum operations balance advance several in treatment especially challenges seen XXXX immune for navigate positive gain clinical two the influences. capital on our market has programs. capital programs. bolster clinical not and recent On preclinical our these the and markets, to had cap, and Phase That Specifically, other investment market pharmaceutical these to to including R&D that across have of to companies companies we in stock in programs, for performance managed our to to developments causing and especially advance been clinical to financings InMed headwinds sufficient said, our a trial InMed the continued biotech level, our sheet has decades, events, worst on we ensure corporate related capital EB. small X significant we've overarching in rely execute

Let me EB. start with bullosa development or discussing with or our epidermolysis pharmaceutical programs, beginning drug INM-XXX

be The X Germany, diagnosed into Phase InMed’s treat InMed in more a clinical be activated is with sites has trial activated this designed disease. of are patients expected is efficacy seven clinical to to is patients, study marks cream a soon. to INM-XXX X place trial countries, clinical you screening enroll first that evaluating to investigated known time the Since have call, to trial to nine advanced now a X CBN, progress. and to and in France, XX-day study. completed Phase fully EB. Spain. individuals up two treatment continued, of preliminary treating the sites as the healing patients The that trial new cannabinol enrollment also clinical Austria, its screen therapeutic Israel enroll enrolled nine cannabinol, clinical last our as XX Phase This option has safety and continues to trial who over symptoms period and fully taking Greece, including and patient wound and those For are Italy, specific and been in study, the

quarter, the In enroll downtime period persons treatment, recommenced. as on monitoring summer five of a independent was XX of fourth an safety adolescent patients, patients to enrollment fiscal based data it aged to XX now completed data adult into has committee the first our Following during safe defined the screening agreed month, trial. patient who

the positive first a the at completed Company clinical treatment the inclusion enrollment the will adolescents patient trial EB The rate clinical remainder with during adolescent been the enrolled in that of impact has trial. for summer. The into have has of and clinical Greece the on anticipates site the

trial readout first we during calendar XXXX. of quarter year in into XXXX the expected calendar to As and the the result, enrollment a expect complete a data

trial Drug In turning fourth research for regarding the Company and the with design New studies, preliminary Now data safety pre-Investigational to Administration Drug INM-XXX. to preclinical preclinical advance We plans the initial for discussions The continues on fiscal CBN efficacy and clinical early a Company of glaucoma. X/X on on the in clinical of completed as and the development Food alignment to treatment treatment INM-XXX. glaucoma. U.S. gained gather its Phase application INM-XXX the manufacturing, quarter,

continue of like to filing I'd studies calendar seeking XXXX, application neurodegenerative first the anticipation year an the in We initiate in regulatory our preclinical half work disease. drug completing new clinical human to permission of to necessary trial. work speak on investigational a to towards now

Huntington's Alzheimer's important for disease, diseases, neuroprotection using development continue treatment effects. then, program indication exploring and Last to drug of continue commercial a seeking filed our as neurodegenerative continuing appropriate neurite some our this pharma application cannabinoids cannabinoids. analogs an pharmaceutical disease, preclinical promotion also important growth of a other disease, by will that the plans the and an out pipeline. demonstrating screening different we imperative in therapeutic cells for that think it’s Therefore, neuronal and we record yielded has it's such affected add meaningful November, patent includes rare As with for our company, to international to the and cannabinoid Since exclusivity point population to find for compound we of I others candidates development. Parkinson's analog potential

an strategy. April, publication molecular and we commercial time, the and and member Cannabinoid international of we cannabinoid Company. America a with Dr. patent several for patent of application for in enhanced methods Maccarrone ocular In to announced utility disease. focus the expert Dr. the place Research a our we research their research of in founding the area the analogs we potential protection collaboration Such important in a ensure of an University the an with priority exclusivity initiated the the cannabinoid Let's structure, analog development underlying of application continue a analogs remains has to is claims additional Alliance. brought research the European move group to Advancing the to on proprietary of molecule invest over protection where itself treatment This in R&D. of is as high patent North Mauro afforded commercial L'Aquila investigating years. is this component coming analogs. Considering directly long-term cannabinoid Italy. at uses He manufacturing. a patented same intend an in Maccarrone of in the is cannabinoid to At important analog,

like update COO, BayMedica I'd Michael over to provide and will Now, on activities. who commercial to Mike? hand our Woudenberg, an

building our announcement completing take on the in drug our rare analogs I'd to cannabinoids as minutes focus our product of well of developing portfolio is October address launching Eric. to XXXX, Thanks, acquisition support commercial Since recent few products as to new our pharmaceutical development. cannabinoid BayMedica like a operations. and

the health still sector we rare the and update, nascent in last cannabinoids out in as However, industry. wellness quarterly is a pointed

we the advantage reasons pressures materialized a economic and pricing wellness industry significant has the certified reasons, general. health premium to slower wellness competitive launch invest resulting immature growth. our within and recent BayMedica's and in reliable sector cannabinoids and of the rare as in of continue quickly of in segment. rare with downward consistent supply not recessionary variety to as led include: in revenue cannabinoids; a for market and do cannabinoids sector rare is and this the expected market new We unfortunately In there's ready high-purity demand uncertainty believe some and health pressure for additional not resonating product opportunity is manufacturers; assessment, in hesitation for cannabinoid to the not overarching anticipated, For than products;

and timing the currently However, highly is of sales demand uncertain. product

work-in-progress high-end BayMedica's activities. business quality, will structured opportunities supply differentiators efforts inventory and inventory we reducing well new commercial to of into result, sense agreements be will for strategic pursue discussions through reduce a Currently, product. to we our As BayMedica's convert and collaborations existing The for continue continue and make to sales commercial in existing continuing that commercial as economic purity scalability. Company as

the by continue for update. advancing BayMedica XXXX. will a October generation major concludes commercial of the call which Eric. the development on analogs, of of the the pharmaceutical of to proprietary now In acquisition cannabinoid to scientific rationale back hand drug their BayMedica addition, part work support team I'll was in the That

Thanks, Mike.

Finally, recent markets cost capital I'd initiatives. like speak as saving and financing well as to to activities

companies seen alternatives the capital survive. space, where merely many seen in earlier, doors suboptimal the either challenges we offer As strategic XXXX has or have close their mentioned biotech in especially significant markets, to

savings implemented measures divisions. and a has of expense the total a are to As XX% approximately operations, on several members cost-saving salary in a an across workforce. basis. of for Company reductions maintain headcount current reduction reduction capital resource initiatives included annualized in in management, of we resulting with initiatives result, in These all human other This ensure XX% reduction result approximately voluntary headcount, our to of expense along sufficient to reduction expected significant

order and reductions annual year. in series In offering XX% salary to of as of support an Also, the organization, received our events the registered compliance the year further a of initiatives, part that successfully investors additional bolster the a recently, direct In on XXXX, the notification As Company and placement a performance as Nasdaq's consolidation these closed undertaken for $X leader proceeds as total have approximately a Company and private August, in with private listing these Company employee received exchange on the fiscal development from million XXXX. concurrent of balance this Company part healthcare-focused financing share bonus a no XX. our previous requirements XX, the executed of closed of $X to institutional also two voluntary of million. an compared subsequently compliance X:XX placement to The I June regain XXXX, ongoing September September announced Also for continued with programs. reduction sheet.

in despite in continued In considerable our have terms the difficult core decisions, development. drug we many outlook, challenges progress and of business to on summary, make pharmaceutical

of to patent cannabinoid arena quarter expect in quarter build we opportunistic neurodegenerative program completion Interim that next Brenda our R&D with to fiscal XXXX; note, clinical several our preclinical year the to the wealth. and calendar the expected development the on months, selection to like IND-enabling financial quarter call Over of data Brenda? will results. fourth program disease XXXX; end catalysts: XXXX; strategies On Phase on INM-XXX the by following to readout the the provide over our in to in X for see Edwards, business XXXX second complete first information and the of analogs; execution shareholder for the CFO, shareholders for drug glaucoma category should the pharmaceutical proprietary remain of R&D the turn I'd toxicology candidate more calendar further and trial

way for Thank fiscal By joining at a Colin as and year-end noted reminder, of of and call, have the XXth. all beginning you we you, Eric, thank the call. a of June the

Overall, sec.gov.com. BayMedica compared note ended year-end and net of on previous $XX.XX the date our inclusion period million patent year. million last for $X.X following for also that year per a net of the due as Company the XX-K due the same the operating million So as June and share was primarily $X.X to increase X to the website $XX.X for The as R&D share figures consequence, approximately represent loss results. a fiscal is Please $XX.XX were Phase recorded activities XXXX clinical a or the $XX.X available for results expenses the well of trial. to our the year XX, million related compared with increased with XXX XXXX, or loss our year. on acquisition these a

BayMedica resulting from year, admin cannabinoid our the year. Company relations, on comment the realized our million general The fees a million XXXX. to legal were including the fees, now to increase would expenses of of important due combination results BayMedica Nasdaq acquisition market. segment note result expenses, the on revenue. capital in and to of for $X.X on accounting increase The now to bulk and closed $X.X manufacturing following expenses. XX% distribution the for and BayMedica is G&A from representing in date acquisition listing changes, the the of is October I the only sales of the operating Turning year, rare sales product. It like substantially and previous inclusion insurance higher the investor fees

reduced core business a non-cash pharmaceutical assets $X.X in in June and XXXX. commercial BayMedica's intangible the of impairment goodwill drug and business, of As BayMedica management's the year our the area decision in a result development Company on refocus for incurred segment efforts ended to million of XX,

by and being XXXX, our with will now sheet. we quarter private from and level and could Turning of realized revenues September closely, the be into level monitor the the turn the fiscal of will for placement million to the second approximate This operating I'd be Colin now calendar reduced year of our of that, fund of expenses. continue closed The June and as we We from With to capital well question-and-answer research will scaling runway, net of possibly XX, and it BayMedica as in third company forecast combined requirements timing on of sufficient XXXX, XXXX as its a to to timing cash inventory of on session. any selected which XXXX, half the had exceeding fiscal $X.X third-party of first back proceeds delays or our the operating revenue extended continue on quarter into or expenses expenditure -- programs, equivalents XX. sale programs. cash like Company back expectations million to of depending which $X.X balance

reminder, Eric available questions. is As Hsu for a

Capital the first Instructions] from ROTH Scott our [Operator line comes And question of Henry Partners. with

Your line open. is

Thank And you. afternoon. good

a Just questions. couple of

DSMB? First, INM-XXX the by any gleaned safety efficacy Was on data. readout there the data from that

not to have reported those for been, results Hi Scott. There the question. may Thanks been but would have the Company.

They provided us. adolescents. the reviewed to and from the insight move ahead blinded enrollment any to data. of into study have the was it data So, But, decision with simply any the of we certainly didn't

the another next you -- like do At quarter think of can be Okay, fair enough. that think then, And do point, with that on Do you trial as ‘XX. step? or what readout calendar you necessary? you year in anticipate the trial, trial this would first file it sounds

in going we'll I position think be a to XX-patient a think database. I another file is trial don't to exclusively on necessary. be

additional Phase required. outcome be the those are those and this still the X opinion, design of So TBD, to of The trials going yes, there's pending first our of in trial. definitely, timing

currently. final Thank Great. last to in the then burn to And the what to sense two fiscal where expect trying you where is burn would get you. of down question. and and rate or current road? it where the speak you Okay. was it quarter, was burn be the quarters the a Just Could

Yes. like to that one? Brenda, field would you

looking a in an about Sure. all-in rate around the probably the and to to question. you're around $XXX,XXX month. we're last moving a were for if down a Thanks just of at expenses, run then $XXX,XXX expect be yes, we for month. And operating quarter, But looking month, $XXX,XXX we

taking for questions. the Great. Okay. you Thank

you. Thank

moment Selvaraju from next One question you. question. Raghuram H.C. comes our for And next with Thank Wainwright. our

open. line Your is

taking Hi. Thanks my various very These much to related clinical for your development questions. are primarily initiatives.

'XX efficacy from what visual proof-of-concept of of Also, would or Sort a give the you. of the sense to development? be set? you just That envisaged measures takeaways could be lastly, release, the INM-XXX in candidates most study? a give utilize in efficacy measures Thank you timing October specific of the coming acuity of sense what you expect efficacy readout be of us you And glaucoma the think. the data to context I important Can us most you important expect helpful. from order if expect to

Thank you. Great.

referred October clarification, any for just So question? October you you to clarify don't readout. 'XX in have We I believe, 'XX. readout, Could that

This Trokie is with the collaboration? specific regard to

Yes. Okay. Yes. Thank you.

delta-X at consumer-driven a of was a in the are a we This what which is Radicle. called looking BayMedica at effects real collaboration, Trokie investigations, consumer Radicle the high-purity is So, and non-intoxicating -- a the different providing their number with conducts were cannabinoid providing a company level. world, for THCV, cannabinoids study.

different a track app delivery patient's what different So, supply in they experience is the then And cannabinoid with formulations, an they certain these through different formats. cannabinoids.

missing one call that's the and how delivered Trokie any the role have to whether are They cannabinoids wellness lozenge So, And and into a are different market where thousands complete wouldn't did our consumers. CBD a into this, overall interesting into cannabinoids these is done clinical trial, like with. work health readout with their in play -- for for that's lot may in a ago this the feedback who certainly THCV, of of it's this we change and that terms readouts to is there's an the whether the past. of they've several put feel consumers' their year very company These looking but about and a with format, an energy, they the mental patients in some gave But, other study the report in a increase I I appetite. then marketplace. to a acuity see these a may that they of the they're they on cannabinoids. and that THCV experience you there. being feel be pretty it they investigation

nothing is earth-shattering in study. trials. more terms there's So, of statistically-powered any This experiential an clinical consumer-based

second the terms for in the things kinds of think question looking and I XXX, was of on we're that your readouts.

We at are looking measurements. different

these of Some are patient-reported.

So, at inflammation. at looking inflammation, non-wound and an healing, to on wound itch looking looking this we We're impact a at is pain. wound and that's looking not the acute related We're inflammation, at chronic areas. both we're and are

enroll symptoms. in into more have these in to one So, order different you trials, get to the clinical to of or -- have

be same. range area going the a We're that inpatient patient what get not treated. is to experiencing it's matched design. really going a are the So, are which a to patients getting design every It's in good protocol large of areas and

the treated which be areas active with which similar with one be of So, ingredient, to have has have will treated two the of will placebo. patient that one symptomology, the

And February, trial So, analysis, the will also in have sometime bit the questions calendar to other after is time March makes difficult a X you because design related kind finish year. enrollment optimistic very can first of that? enrollment we this we'll lock robust. to quarter. by finish a it get just have readout to you database the one. But Did in have then of we're the little we have in areas, end a and very not frame, so and It the any that

pertinent or readouts function No, just to glaucoma are pertaining you that be color. project with of development? to acuity XXX, last the in context visual was other respect The the that no. to ocular question most for Thank likely

Sure.

Let to Hsu, who me in Dr. is of over program. that charge turn Eric that

Hi. Thanks, Eric.

the and Phase clinical readout. Phase being communication -- primary first, another X/X trial. to into is have meeting course, the this in X/X the will and X/X the trial discussion a to neuroprotection readout will And safety had possibility that had So, year, with program trial first the move the the earlier for trials. Phase have FDA pre-IND be, readout was the The the we IOP other to X reduction moving secondary in-human of And after trial. in trial that be FDA, with for we glaucoma we

what are right planning we're those now. So,

conference showing I'm closing time, this any back like questions. to I'd further at no for to And you. hand Adams over Mr. remarks. the Thank

Great. much. Thank you very

steps the it's I closing, their taken and for to very in shareholders. to We year. shareholders excited XXXX, have updating to a that again, difficult are been our want Thanks industry, for on including understand in year I a So, the all thank progress a plans. forward our last believe we support look everyone wish investors and we've just weekend. positive our good involved the everyone to the We continued over continued necessary over months. future coming and we and you And ensure on execute milestones

This concludes participating. conference today's call. you Thank for

now day. may wonderful have You a disconnect. Everyone,