EVAX - Earnings call transcript Q1 2022

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Operator

Greetings, and welcome to the Evaxion Biotech First Quarter 2022 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host Corey Davis of LifeSci Advisors. sir. ahead, go Please

Corey Davis

the these by to in everyone, including uncertainties, everyone company’s current the go for expressed call differ CEO. conference X, like contains due implied that considered and future statements filed forward-looking actual risk prospectus those defined that Hello, of and Reform Lars like Because performance Commission. company’s to Securities the are XXXX. President over certain us. and the reports and from not Exchange to materially or are forward-looking November I’d factors, in to as statements remind statements the risks with forward-looking At may Securities of and Peter. turn those variety a Litigation to joining ahead, Please Act and time, Wegner, or thanks on factors involve the I’d Lars. statements Private company’s they Thanks, the discussed results future XXXX, following submitted of and discussion filed this guarantees

Lars Wegner

to Corey, good morning everyone. you, Thank and

for you Wegner, thank of and Financial Executive joining and So Jesper Officer, With Biotech’s questions. business results, this who Chief We’ll currently your Nyegaard call Officer. Evaxion. you then Evaxion's today Operating Chief me is Officer presentation give our I'm on call. Nissen, us QX earnings Chief open short Evaxion is for Lars for Interim the a

patients a upcoming for melanoma, lead combine metastatic first condition medical Phase therapy which with new me trial of Let towards Evaxion unmet saying our The need. treatment a there KEYTRUDA, exciting for EVX-XX clinical in begin by cancer will trial. is of Merck’s Xb quarter momentum significant with continues XXXX, progressing clinical the a

Evaxion for cancer resectable in into product and in our for use Xb also steps recruitment EVX-XX, of trial dedicated these as to we are landscape cancers believe X/Xa existing this a pipeline melanoma. trial patients for other that therapies the therapy, significant in with cancer melanoma candidate advancing and our to possible second our treatment We completed forward are well. pursuit Phase clinical We the Phase clinical improve

for success. trial XXXX melanoma. by first in We in EVX-XX, We are EVX-XX potential are on and we and all products in which our clearance In with a a clinical unique have plan EVX-XX recruitment we achieving patient-specific received January XXXX. we solid optimistic the this about patients We which companies, pharmaceutical come from the therapies. of models EVX-XX second XXXX, actively biotech identify and with the discussing first resectable by AI have during and our may platform regulatory to melanoma patient's Merck’s dedicated progress for in Xb visit allow file to January with Phase resectable drug initiate Phase half AI Also higher to to regulatory patients plan likelihood believe visit partnerships that of cancer generates EVX-XX for of Xb KEYTRUDA. trial XXXX. of completed first the also targets clinical Phase first patient into XXXX, our into us first EVX-XX, in We advancing clinical trial translate half with adjuvant our immune for first X/Xa of The PIONEER half clearance XXXX.

skin tissue and platform, on generates The which soft We diseases. against progressing aureus for in of the on bacteria a EVX-BX, is our the lead infections. prevention Staph EDEN vaccines also candidate program, vaccine

with personalized immune platform second candidate of therapy the open-access, our journal conclude XXXX. announced second publications metastatic melanoma clinic, which patients to acclaimed plan from the for quarter in personalized plan Evaxion select review. the metastatic also a We half RAVEN we the expert opinion the to in we product Outside in turn our candidate XXXX. cancer select melanoma first webinar, the in hosted bacteria also second business on our Furthermore, of half viral with will I to now first EVX-XX over QX leader and on the medical This peer-reviewed operation for Jesper call therapies. update XXXX our XXXX. science OncoImmunology. financial key of and

Jesper Nyegaard Nissen

we Bank US$X.X Thank and million you, our million first our of tranche completed gross first Investment the quarter In proceeds of or loan. Lars. drawdown received €X XXXX, from a European

XXXX, to As million US$XX.X cash equivalents million as and as US$XX.X cash XX, December XXXX. were of compared of March XX,

quarter basic quarter diluted loss March for US$X.X were draws primarily General XXXX. compared fund a and ended XX, million March quarter as cash our the per and higher million for XX, requirements expenses for the development million on of March headcount. million quarter XX, increase a US$X.XX was equivalents funds loss XXXX share amount XXXX. ended March and operating increase combined per We was to and increase as you, Research will with XXXX. an was our or due to basic March The and primarily to US$X.XX increase and US$X.X be the expect million, quarter ended expenses next to quarter The through under as loan least capital were for loss share the US$X.X in XX employee-related expenses at existing compared XX, March as And available US$X.X administrative from ended Lars. million ended thank in Net cost result US$X.X ended the EIB diluted XXXX months. the costs. due our US$X.X XX, cash external to for to for XX, sufficient compared the an or the expenditure XXXX

Lars Wegner

That presentation today. Jesper. our concludes you, Thank

call the it’s time facilitate for up any over open the and this. I to Now to to questions hand operator

Operator

be from Oppenheimer. Our Thank Instructions] Kevin is line you. At question time, ahead. conducting a Please of session. DeGeeter will question-and-answer we first this the [Operator with go

Kevin DeGeeter

us. from guess questions Appreciate great. the Okay, three I update today.

an of durability the a context the for specifically how response previously we Xa Thanks. dosed? think of Lars, update for EVX-XX should the patient’s First, in potential Phase timing about on

Lars Wegner

you, Kevin. Thank

time were in We EVX-XX continuously of XXXX And patients. you these July course up actually first want course course and to in be data some know, be expecting question, have very with following as on half course nine would data can’t take of X/Xa the very, to we that we time. durability on follow that to answered But So have patients study significant I the results. the as of them that months presented hope for And the looking do we that very response. of that Kevin. since durability, had we And available. we we the will it’s readout timing of predict happy We it had the at responses. doable period. of Phase our within a next

Kevin DeGeeter

for then sites about of is around initially our of being question, opened of targets number And How the study metrics second the pace and the we initiation think Xb some of Yes. earlier enrollment? EVX-XX really Phase should that study. for or

Lars Wegner

Yes. Good question.

are as with our you we very the from see Australian can far announcement probably So already authorities.

trials trials We have melanoma EVX-XX experienced as run there. running there our

then on out be to expect and achieve sites. build We’re in in we’ll XXXX. And we’ll open half up and in of start with starting Australia we – as sites Australia. first recruitment U.S. clearance working we regulatory we’ll the multiple multiple sites half with in the And lead this that Europe

than we up has aiming such in sites, we more open targeting the work basically larger XX to the base. are are Australia that to as Institute patient of with recruitment We’re XX large doing Melanoma with but global site to National sites

Xb total of in XX to moving XX to around and trial able according be to sites plan. our expect Phase we for with So the is globe everything across recruit

Kevin DeGeeter

into Great. in provide the that update then join the you’re light And EVX-XX EVX-XX Xb EVX-XX? think future particularly about How lastly us from No. we’ll should of just the then Can on advancing into queue. you we study? an and comments investment

Lars Wegner

technology both both clear, and are our DNA based on and programs. be platform based pretty data we Yes, getting currently both DNA on to the are are PIONEER they on

actually and plan, quite which making for patients. also finalized manufacturing and according just achievement – is process EVX-XX run an with personalized Our announced each we for products that also all actually recruitment unique recently, medicine yesterday company

the to receiving on on EVX-XX data the about in We basis. are of continuous thinking EVX-XX up program a if and are speed we we these both data, want light

as the market. the with is sharing finalized we in quite as our But seems more final soon than design the So for EVX-XX. actually that powerful be will with Phase it preclinical happy to we of even are EVX-XX Xb, be model, progress the

Kevin DeGeeter

questions. our taking for Thanks

Lars Wegner

Anytime.

Operator

Thank you.

with next is Demir ahead. Ahu from Ladenburg. Please Our question go

Ahu Demir

I morning. for you much taking have two Good very my Thank questions. questions.

as well? timeline? more could yesterday And you First color announced one you Could update. production maybe the What on on of EVX-XX us EVX-XX update is the production provide what was achieved? you

Lars Wegner

Thank Yes. you, Ahu. Excellent question.

already So process DNA EVX-XX. this is different is probably successfully personalized set And EVX-XX process. in for a manufacturing up technology aware are on We so – our our EVX-XX maybe call peptide technology.

We now weeks medicine of are to in personalized the and actually XX manufacturing in with already XX first dedicated our trial. capable DNA

controlled the a future clinic. the and fast manufacturing of continuously be EVX-XX our We high and improve have of we process speed. will the is to to important super that This of in planning expect course success likelihood leads in the trials, EVX-XX because

being are actually we trial. manufacture our able for So in very patients with to all happy

to execute the Phase and and both be a creates basically EVX-XX. able foundation EVX-XX with it So potentially a experience to well Xb on

Ahu Demir

very question second you the a on are would NeXT data is to know maybe color, what claim and Personalis’ My ImmunoID would it be see we I implement Very to more expecting helpful. When that. Platform. include helpful? bit

Lars Wegner

prediction So just our I platform, hear the AI-DeeP did to platform, right, clarify around correct?

Ahu Demir

part. that’s ImmunoID, for think I understand. what That’s the I biomarker

Lars Wegner

Yes.

a the system So hours capable around our also clinical the react number patients. had That’s the will actually and have market profiles which course as system, inhibitors. on if previously immune available patient the selecting, we’ve we our with to actually with That’s environment, of micro AI patient from shared and therapy, of of we data trial. immune both seen is huge not what checkpoint current based

now that because have for long time. simple. to a basically this, we plan can looking So definitely very the has world our is product if this, we validate That’s been validate quite what we’re doing a

access we’re all, to with existing during materialize lot could already this groups that Phase Xb, that already faster first course clinical collecting we of trial, our be we, and different a So of year. also to get we data expect data and that trials but working for running where are future

looking validate this. on It’s a for that have the like data technologies something world we a of also to of course database. with as larger both lot means looking enough external So been this share have very but much forward to diagnostic companies publish,

Ahu Demir

for very much Sounds my great. Thank taking you questions.

Lars Wegner

You’re welcome.

Operator

you. Thank

Lake from with Please ahead. Our go Flaten Street. next question Thomas is

Thomas Flaten

for Hey, good morning. Thanks taking questions. the

Just me. two for

first the a be enrollment in you complete optimistically, that? on that Now readout is would we the could when time see EVX-XX, do think data

Lars Wegner

be So year. to we next expect that able to share

As really right? is setting. you How in therapy for our know, this That which That’s in some many and of operation that means we this take after adjuvant people relapses, setting, receiving melanoma care. do relapse? with actually standard the time actually together looking the are

to of getting we So we for will have follow patients months events. before number start the a

we share be will also So around, reacting still already sharing we can in the seen have in and so are and response, But that patients therapy. be the and will strong what have interesting we’ve clinical cetera, going a immunological getting to people therapy creating we and will share far. more the profiling, which data, our et data actually by safety, been course T-cell of sharing patients

able immunological share on in So more in patient to this of clinical be efficacy, to XXXX data we expect cohort that safety XXXX.

Thomas Flaten

give EU of which some the one And the in regulatory and to us with could when for the submissions might just Great. U.S., you expect will those? sense first be and EVX-XX respect then we

Lars Wegner

Yes.

according So [ph] moving the it. process everyone we’re what for share not I the we dates can with planned. that with on guiding exit But is

expecting are would up in level first EMA high basically We quarter. FDA started and be for in and timelines each then one and Europe these of

sites apart, three we’ll trial. new for the to up and jurisdictions that months two new start So

Thomas Flaten

around just the maybe conduct with And studies? the risk some proceeding to CAFXX. of color legal you that provide material if then around the there’s any SSI Could finally

Lars Wegner

there’s No, not.

this platform, we only So CAFXX already our have one CAFXX. a our and of this we is discussion peptides, we use EVX-XX have therapy. of, PIONEER program to adjuvant program, then for minor of as the currently around license which our The SSI, a part consists

of inventorship regardless So ends it’s any block broadly that not how on [indiscernible] really something not CAFXX our will in up. agreeing we are actually on who dose. using this of high has is What the

So that. it’s a of small part

no it we course, that attractive but grab our wants also to inventions not are as were possibility surprised But collaboration are a commercially, direction. Xb, we or CAFXX the this than to previous Phase bit impact that other have on a with are outcome it, We in utilize SSI. of EVX-XX, to they have already happy of our that will that the regardless or so people license our

Thomas Flaten

taking you the appreciate questions. I you much. Thank so

Lars Wegner

you. Thank problem. No

this I for concludes and your think today. to session hand I’ll thank over operator everyone want to Q&A it for time. the

Operator

Thank you. conference. This today’s concludes

disconnect Thank for your this time. participation. lines at may You you your

Evaxion Biotech A/S (EVAX) 11 May 222022 Q1 Earnings call transcript