Oncolytics Biotech Inc

TSX:ONC

Earnings Call Transcript

[Operator]

Good

afternoon.

And welcome

to

Oncolytics

Biotech's

Fourth

Quarter

2021

Conference

Call.

All

participants

are

now

in

listen-only

mode.

There

will

be

a

question-and-answer

session

at

the

end

of

this

call.

Please

be

advised

that

this

call

is

being

recorded

at

the

company's

request.

And

I

would

like

to

turn

the

call

over

to

Jon

Patton,

Director

of

Investor

Relations

and

Communication.

Please

go

ahead,

sir.

[Jon Patton]

Thank

you,

operator,

and

good

afternoon

everyone.

Earlier

today,

Oncolytics

issued

a

press

release

providing

recent

operational

highlights

and

financial

results

for

the

fourth

quarter

and

full

year

2021.

A

replay

of

today's

call

will

be

available

on

the

Events

&

Presentations

section

of

the

Oncolytics'

website

approximately

two

hours

after

its

completion.

After

remarks

from

company

management,

we

will

open

the

call

for

Q&A.

As

a

reminder,

various

remarks

made

during

this

call

contain

certain

forward-looking

statements

relating

to

our

business

prospects

and

the

development

and commercialization

of

pelareorep,

including

statements

regarding

our focus,

strategy

and

objectives,

our

belief as

to

the

potential

and

mode

of

action

of

pelareorep

as

a

cancer

therapeutic,

the

design,

aims, expectations

and

anticipated

benefits of

our

current

and

pending

clinical

trials,

our

plans and

expectations

regarding

a

potential

registrational

study,

our

plans

regarding

the

expansion

of

pelareorep's

market

and

business

development

potential,

our

plans

for

collaborations

with

industry

leaders,

financial

run

rate

and

other

statements

related

to

anticipated

developments

in the

company's

business.

These

statements

are

based

on

management's

current

expectations

and

beliefs

and

are

subject

to

a

number

of

factors

which

involve

known

and

unknown

risks,

delays,

uncertainties

and

other

factors

not

under

the

company's

control

that

may

cause

actual

results,

performance

or

achievements

of

the

company

to

be

materially

different

from

the

results,

performance

and expectations

implied

by

these

forward-looking

statements.

In

any

forward-looking

statement

in

which

Oncolytics

expresses

an

expectation

or

belief

as

to

future

results,

such

expectations

or

beliefs

are

expressed

in

good

faith

and are

believed

to

have

reasonable

basis,

but

there

can

be

no

assurance

that

these

statements

or

expectations

or

belief

will

be

achieved.

These

factors

include

results

of

current

or

pending

clinical

trials,

risk

associated

with

intellectual

property

protection,

financial

projections,

actions

by

regulatory

agencies

and

other

factors

detailed

in

the

company's

filings

with

SEDAR

and

the

SEC.

Oncolytics

does

not

undertake

any

obligation

to

update

these

forward-looking

statements,

except

as

required

by

applicable

laws.

Now,

I

will

turn

the

call

over

to

Dr.

Matt

Coffey,

President

and

Chief

Executive

Officer

of

Oncolytics

Biotech.

Matt?

[Matthew C. Coffey]

Thanks,

Jon.

And

thanks

to

all

who

are

joining

us

today

to

discuss

our

fourth

quarter

corporate

update.

Now

in

addition

to Jon,

I'm

joined

by

Tom

Heineman,

our

Chief

Medical

Officer;

Andrew

de

Guttadauro,

our

Global

Head

of

Business

Development;

and

Kirk

Look,

our

Chief

Financial

Officer.

I'm

pleased

to

say

that

we had

a

very

strong

2021

and

have

continued

to

build

on

our

momentum

in

the

early

part

of

2022.

If

you've

not

had

a

chance,

I

would

encourage

our

investors

to

read

the

letter

to

shareholders

that

we

distributed

as

a

press

release

on

January

11.

In

it,

we

walk

you

through

why

what

we

saw

in

2021

is

significant

and

why

we

are

excited

about

2022

and

our

upcoming

milestones.

We

are

advancing

towards

a

potential

value

inflection

points

across

our

pipeline

with

a

strong

historical

foundational

dataset

that

demonstrates

pelareorep's

ability

to

deliver

a

statistically

significant

survival

benefit

as

was

shown

in

our

randomized

Phase

2

metastatic

breast

cancer

trial

generate

a

profound

and

concerted

innate

and

adaptive

anti-cancer

immune

response

and

synergize

with

multiple

oncology

treatments.

Now

the most

significant

of

our

expected

2022

milestones

is

the

top

line

data

announcement

from

BRACELET-1,

a

randomized

Phase

2

trial

evaluating

pelareorep

in

combination

with

checkpoint

inhibition

in

HR+/HER2-

metastatic

breast

cancer.

BRACELET-1

is

being

conducted

with

collaboration

with

Pfizer

and

Merck

Serono

and

is

designed

to

expand

upon

a

prior

positive

Phase

2

results

in

this

indication

by

generating

critical

data

requested

by

the

FDA

and

our

global

pharma

collaborators.

Data

that

confirms

the

overall

survival

benefit

we

saw

in

IND-213

would

serve

to

de-risk

our

lead

breast

cancer

program

in

broader

pipeline,

and

we

believe

that

data

represents

the

last

major

step

on

pelareorep's

path

to

a

registrational

breast

cancer

study.

As we

work

towards

this

data

readout,

we

intend

to

begin

discussing

our

plans

for

a

registrational

study

with

the

FDA

and

other

regulators,

so

that

we

can

advance

the

programs

with

efficiency.

While

Tom

will

be

speaking

more

about

BRACELET-1

and

our

lead

breast

cancer

program

in

a

bit,

I

will

say

now

that

the

trial

remains

on

track

for

full

enrollment

in

late

Q1

early

Q2

with

top line

data

in

Q4

assuming

no

or

limited

impact

from

COVID-19.

Beyond

our

lead

program,

pelareorep's

ability

to

generate

an

innate

and

adaptive

immune

response

thereby

weakening

tumor

defense

mechanisms

continues

to

spur

collaborations

with

industry

leaders

and

academia.

These

collaborations

include

those

underlying

our

ongoing

trials

in

triple-negative

breast

and

gastrointestinal

cancers,

both

of

which

recently

reported

interim

updates

that

further

demonstrates

the

favorable

safety

profile

of

pelareorep

checkpoint

inhibitor

combinations.

These

positive updates

are

notable

because

the

lack

of

toxicity

in

this

large

indication

provides

additional

opportunities

to

expand

a

potential

market

of

pelareorep

checkpoint

inhibitor

combination.

The

opportunity

for

expanding

beyond

checkpoint

inhibitors

has

been

evident

in

data

we

reported

during

the

2021

year.

Promising

combination

therapy

data

readouts

involving

CAR T,

bispecific

antibodies,

PARP

and

CDK 4/6

inhibitors

are

evidence

of

pelareorep's

differentiated

and

broadly

applicable

mechanism

of

actions.

We

believe

leveraging

pelareorep

in

this

fashion

could

address

unmet

needs

across

a

spectrum of

target

indications,

and

we

expect

to report

clinical

updates

supporting

this

hypothesis

in

both

multiple

myeloma,

GI

and

glioblastoma

at

upcoming

conferences.

Looking

ahead,

we

plan

to

utilize

a

partnership

strategy

to

pursue

the

multitude

of

market

and

business

development

opportunities

offered

by

pelareorep

and

its

potential

to

act

as

an

immunotherapy

backbone.

This

will

allow

us

to

operate

efficiently

as

we

devote

our

primary

focus

and

resources

towards

the

advancement

of

pelareorep

to

registration

in

HR+/HER2-

metastatic

breast

cancer.

With

that,

I'll

now

hand

it

off

to

our

Chief

Medical

Officer,

Tom

Heineman,

who

I

should

also

congratulate

on

his

well-deserved

recent

promotion

to

provide

a

bit

more

detail

on

BRACELET-1

and

our

recent

highlights.

Tom?

[Thomas C Heineman, Chief Medical Officer, Oncolytics Biotech, Inc.]

Thanks,

Matt,

and

thanks

to

all

those

listening

on

the

call

today.

As

a

reminder,

BRACELET-1

and

early

stage

breast

cancer

study,

AWARE-1,

were

designed

to

achieve

three

crucial

objectives

put

forward

by

regulators

and

our

pharma

partners

after

seeing

the

results

of

IND-213,

the

randomized

Phase

2

study,

that

showed

a

near

doubling

of

overall

survival

in

metastatic

HR+/HER2-

breast

cancer

patients

treated

with

paclitaxel,

combined

with

pelareorep.

These

objectives

were

to

first

confirm

that

pelareorep

works

through

an

immunotherapeutic

mechanism

of

action.

This

would

indicate

that

it

stimulates

long-lasting

anti-cancer

effects

and

explains

the

survival

benefits

seen

in

IND-213.

Second,

determine

whether

pelareorep

synergizes

with

immune

checkpoint

inhibitors.

This

could

lead

to

an

enhancement

of

the

survival

benefits

seen

in

IND-213

in

breast

cancer

patients,

and

could

also

potentially

provide

more

effective

treatment

options

for

patients

with

many

other

types

of

cancer.

And

third,

determine

of

changes

in

peripheral

blood

T

cell

populations

could

potentially

serve

as

a

novel

blood-based

biomarker

to

predict

patient

responses

to

pelareorep

therapy.

This

could

improve

our

chances

of

success

in

future

studies

by

allowing

the

selection

of

patients

most

likely

to

benefit

from

therapies

that

include

pelareorep.

Now,

on

past

earnings

calls,

we

detailed

data

from

AWARE-1's

first

two

cohorts,

which

exclusively

enrolled

patients

with

HR+/HER2-

breast

cancer

subtype.

These

data

showed

that

AWARE-1

made

its

primary

endpoint

with

pelareorep

reversing

immunosuppressive

tumor

microenvironment

and

generating

an expanding

T

cell

clones

and

upregulating

PD-L1

expression.

It

led

to

increases

in

CelTIL

score

and

tumor

infiltration

of

CD8+

T

cells,

two

metrics

that

are

known

to

correlate

with

improved

clinical

outcomes.

Additionally,

we

found

that

several

of

these

positive

effects

were

enhanced

when

a

checkpoint

inhibitor

was

combined

with

pelareorep

and

the

changes

in

peripheral

blood

T

cell

populations

correlated

with

CelTIL

score

and

tumor

infiltrating

CD8

T

cells.

Taken

together,

these

promising

findings

indicate

that

we

are

well

on

our

way

to

achieving

the

three

key

objectives

mentioned

earlier.

They

clearly

show

that

pelareorep

has

an

immunologic

mechanism

of

action

and

demonstrated

synergy

with

checkpoint

blockade.

Moreover,

they

indicate

the

changes

in

peripheral

blood

T cell

populations

may

service

a

predictive

biomarker.

With

these

objectives

in

mind,

we

designed

BRACELET-1,

a

study

that

is

very

similar

to

IND-213,

with

two

notable

exceptions.

First,

BRACELET-1

exclusively

enrolls

HR+/HER2-

metastatic

breast

cancer

patients,

the

population

that

demonstrated

the

most

pronounced

overall

survival

benefit

in

IND-213.

And

second,

in

addition

to

having

study

arms

evaluating

paclitaxel

alone

and

paclitaxel

plus

pelareorep,

BRACELET-1

also

includes

the

third

study

arm

in

which

paclitaxel

and pelareorep

are

combined

with

Pfizer

and

Merck

Serono's

anti-PD-L1

checkpoint

inhibitor

Bavencio.

We

are

pleased

with

the

progress

being

made

in

BRACELET-1

and

we

expect

to

complete

enrollment

later

this

month

or

early

in

the

second

quarter.

Approximately

16

weeks

after

enrollment

is

concluded,

the

final

patient

scans

required

for

assessment

of

the

study's

primary

endpoint

will

be

completed.

Once

the

results

of

the

scans

are

available,

we

will

compile

and

analyze

the

data

and

then

discuss

these

results

with

the

relevant

parties

as

we

continue

to

plan

for

our

next

steps

on

the

path

to

registration.

Considering

all

of

this,

we

anticipate

announcing

the

top

line

results

of

the

trial

in

the

fourth

quarter

of

this

year.

I'd

now

like

to

take

a

minute

to

set

the

stage

for

what

to

expect

from

the

BRACELET-1

study.

Data

from

earlier

studies

give

us

some

insight

into

what

to

expect

from

both

the

paclitaxel

alone

and

paclitaxel

plus

pelareorep

arms

of

the

study.

However

now,

based

on

the

AWARE-1

study

results,

we

have

a

much

clearer

understanding

of

the

immunologic

effects

of

adding

pelareorep

including

increasing

PD-L1

expression

and

the

infiltration

of

CD8+

T

cells

into

tumors.

Moreover,

the

AWARE-1

study

provided

extensive

insights

into

the

potentially

beneficial

immunologic

effects

of

combining

pelareorep

with

a

checkpoint

inhibitor.

These

include

reversing

the

immunosuppressive

nature

of

the

tumor

microenvironment

and

enhancing

the

development

of

potentially

protective

innate

and

adaptive

immune

responses.

The

IND-213

study

gave

us

a

clear

reason

to

expect

that

the

addition

of

pelareorep

to

chemotherapy

may

benefit

metastatic

breast

cancer

patients.

Now,

based

on

the

AWARE-1

results,

we

are

hopeful

that

the

synergistic

effects

of

having

a

checkpoint

inhibitor

pelareorep

will

further

benefit

patients

in

the

BRACELET-1

study.

In

addition

to

collecting

data

on

overall

response

rate

and

survival,

we're

also

collecting

progression-free

survival,

safety

and

biomarker

data

from

the

BRACELET-1

study.

I

should

note,

however,

that

we

do

not

plan

to

present

the

entirety

of

a

BRACELET-1

results

during

the

anticipated

fourth

quarter

announcement

and

then

we

expect

to

present

additional

updates

at

medical

meetings

in

2023

including

updates

on

PFS

and

overall

survival.

Additionally,

I

should

point

out

that

due

to

the

size

of

the

BRACELET-1

trial,

which

is

expected

to

enroll

a

total

of

48

patients,

it

is

not

powered

to

detect

statistically

significant

differences

in

overall

response

rates

between

the

study

groups.

Therefore,

we

will

be

evaluating

numerical

differences

between

BRACELET-1

study

groups

to

support

the

statistically

significant

survival

benefit

previously

observed

in

IND-213

and

to

inform

the

design

of

the

Phase

3

study.

We

thus

view

BRACELET-1

as

the

last

major

step

on

pelareorep's

path

to

a

registration

study

and

believe

the

anticipated

Q4

data

announcement

represents

a

major

potential

inflection

point

for

the

company.

Now

that

I've

provided

you

with

a

refresh

of

our

AWARE-1

program

and

an

overview

of

our

BRACELET-1

study,

I'll

hand

it

off

to

Andrew

to

speak

a

bit

more

about

our

partnership

strategy

as

well

as

our

broader

business

development

efforts.

Andrew?

[Andrew R. de Guttadauro]

Thanks,

Tom,

and

thanks

to

all who

have

joined

us

on

today's

call.

I'd

first

like

to

touch

on

some

of

the

recent

progress

in

our

IRENE

and

GOBLET

trials,

which

are

examples

of

how

we're

collaborating

with

industry

leaders

to

develop

pelareorep

in

combination

with checkpoint

inhibitors

and

expand

this

potential

therapeutic

impact.

As

you

may

recall,

IRENE

is

a

Phase

2

trial

evaluating

pelareorep

in

combination

with

Incyte's

PD-1

checkpoint

inhibitor,

retifanlimab,

in

metastatic

triple-negative

breast

cancer.

At

the

most

recent

San

Antonio

Breast

Cancer

Symposium

in

December,

we're

pleased

to

report

that

the

combination

is

well tolerated

in

each

of

the

five

patients

enrolled

at

that

point

in

the

trial.

The

trial

remains

ongoing

and

we

look

forward

to

its

continued

progress.

We

also

recently

provided

positive

safety

update

from

our

Phase

1/2

GOBLET

trial,

which

is

to

evaluate

pelareorep

in

combination

with

Roche's

PD-L1

inhibitor,

atezolizumab,

in

patients

with

advanced

or

metastatic

pancreatic,

colorectal

and

anal

cancers.

We

were

pleased

to report

in

February

that

an

independent

review

of

the

trial

pancreatic

cancer

safety run-in

noted

no

toxicity

concerns

and

that

the

Data

Safety

Monitoring

Board

recommended

the

trial

proceed

as

planned.

The

trial

also

includes

a

safety run-in

for

third-line

metastatic

colorectal

cancer

cohort,

which

remains

ongoing

with

an

update

expected

in the

first

half

of

the

New

Year.

Now,

one

point

I'd

like

to

emphasize

is

how

IRENE

and

GOBLET

take

a

similar

approach to

try

and

address the

pressing

unmet

need.

While

checkpoint

inhibitors

have

been

commercially

successful,

less

than

one

in

five

patients

respond

to

these

therapies

due

to

several

different

resistance

mechanisms

that

can

be

addressed

by

pelareorep's

clinically

demonstrated

immunotherapeutic

effects.

As

Tom

mentioned

earlier,

pelareorep

has

shown

the

ability

to

remodel

the

tumor

microenvironment

causing

PD-L1

upregulation

in

addition

to

increase

in

CD8+

cells

and

memory

T

cells.

Outcomes

like

these

are

appealing

to

industry

leaders

because

pelareorep

has

demonstrated

it

can

increase

the

proportion

of patients

eligible

for

therapies

like

checkpoint

inhibitors

and

increase

the

benefit

derived

from

combination

therapies.

The

ultimate

goal

is

to

secure

a

global

clinical

and

commercialization

partnership,

and

past

deals

have

typically

been

preceded

by

research

collaboration,

similar

to

trials

Tom

and

I

have

discussed

on

this

call.

Next,

I'd

now

like

to

provide

another

update

on

the

additional

progress

made

since

our

Q3

call

with

Adlai

Nortye,

our

partners

working

to

develop

and

commercialize

pelareorep

in

China,

Hong

Kong,

Macau,

Singapore,

South

Korea

and

Taiwan.

In

October,

Adlai

dosed

the

first

patient

or

bridging

safety

trial,

evaluating

the

safety,

tolerability

and

preliminary

efficacy

of

pelareorep,

paclitaxel

combination

therapy

in

Chinese

patients

with

advanced

or

metastatic

breast

cancer. This

trial

follows

a

design

that is

similar

to

the

pelareorep, paclitaxel

cohort

in

IND-213.

Now,

in

January,

Adlai

announced

that

they

had

advanced

the

second

dose

escalation

cohort

of

the

trial.

This

is

significant

because

the

second

dose

cohort

is

equivalent

to

what

was

administered

to

patients

in

IND-213,

which

showed

a

near

doubling

of

survival

in

metastatic

HR+/HER2-

breast

cancer

patients.

Initiation

of this

cohort

is

an

important

step

that

reflects

the

positive

safety

findings

from

the

trial's

first

dose

escalation

cohort,

where

no

toxicity

concerns

were

noted.

The

ultimate

goal

of

the

bridging

trial

is

to

satisfy

Chinese

safety

requirements

and

thereby

accelerate

pelareorep's

development

in

Adlai's

principal

jurisdiction.

Subsequent

studies

will

include

data

from

IND-213

in

BRACELET-1

in

future

regulatory

submissions

and

trial

design

decisions.

Data

from

these

studies

and

regulatory

requirements

from

the

Chinese

authorities

will

dictate

what

a

Phase

3

study

will

entail

as

a

Phase

3

design

has

not

yet

been

determined.

Results

from

BRACELET-1

will

factor

heavily

when

considering

whether

a

checkpoint

inhibitor

will

be

included

in a

Phase

3

study

in

China.

Pelareorep's

advancement

in

these

jurisdictions

is

significant,

as

China

alone

has

the

world's

second

largest

pharmaceutical

market

with

rapid

growth

expected

over

the

coming

years.

By

leveraging

our

partnership

with

Adlai,

we have

positioned

ourselves

to capitalize

on

the

significant

market

opportunity

with

minimal

risk

and

clinical

costs.

Finally,

before

I

hand

the

call

over

to

Kirk,

I'd

like

to

reiterate

a

point

Matt

made

earlier

regarding

our

efforts

to

develop

pelareorep

as

an

enabling

technology

for

therapeutic

agents

beyond

checkpoint

inhibitors.

To

efficiently

pursue

this

goal,

we're

seeking

high-quality

partners

to

lead

this

development

pathway

and

assume

its

associated

costs.

We

are

supported

in

these

efforts

by

emerging

preclinical

data

and

our

clinical

results

demonstrating

pelareorep's

ability

to

reverse

immunosuppressive

tumor

microenvironment

and

recruit

cancer

fighting

T

cells

into

tumors.

These

have

led

to

collaborations

by

technology

companies

and

key

opinion

leaders

at

premier academic

institutions. Since

I've

discussed

positive

safety

readouts

for

TNBC

and

gastrointestinal

cancer

plus

a pelareorep

dose

escalation

in

breast

cancer

today,

I'd

like

to

take

a

moment

to

remind

our

investors

that

pelareorep's

favorable

safety

profile

is

an

important

factor

when

we

have

discussions

with

new

and

existing

biopharma

partners.

Being

able

to

provide

clinical

safety

data

across

multiple

indications

and

tumor

targets,

in

addition

to combinations

of

multiple

oncology

therapies

[indiscernible]



(00:18:13)

addressable

market

opportunity

for

pelareorep.

As

such,

it

shows

the

pharma

world

that

pelareorep

really

does

have

the

potential

to

be

an

immunotherapy

backbone

since

it

is

so

versatile.

While

we

are

eager

to

see

data

from

these

collaborative

efforts

generate,

we

remain

steadfastly

committed

to

preserving

the

company's

primary

focus

on

our

lead

breast

cancer

program

and

the

execution

of

our

stated

clinical

objectives.

Our

relationships

with

distinguished

collaborators,

such

as

Roche,

Pfizer,

Merck

Serono,

BMS,

Incyte

and

Adlai

Nortye

helped

to

maintain

this

focus

and

should

serve

us

well

as

we

work

to

execute

on

our

goals.

We

look

forward

to

the

continued

maturation

of

these

relationships

which

together

with

our

talented

team

and

robust

dataset

leave

us

well positioned

for

sustained

success.

With

that,

I'll

turn

the

call

over

to Kirk

Look,

our

CFO,

to

discuss

our

financial

results

for

the

fourth

quarter.

Kirk?

[Kirk J. Look]

Thanks,

Andrew,

and

good

afternoon

everyone.

It's

my

pleasure

to

report

that

Oncolytics

remains

well capitalized

as

we

advance

our

lead

breast

cancer

program

towards

the

registrational

study

and

execute

on

additional

clinical

and

corporate

objectives.

We

ended

2021

with

cash

and

cash

equivalents

of

$41.3

million

compared

to

$31.2

million

at

the

end

of

2020.

Based

on

current

projections,

we

expect

our

current

cash

resources

to

provide

a

financial

runway

into

2023,

taking

us

through

BRACELET-1's

top

line

data

announcement

and

additional

clinical

readouts.

Our

operating

expenses for

the

fourth

quarter

of

2021

were

$3.8

million,

remaining

relatively

consistent

with

the

fourth

quarter

of

2020

operating

expenses

of

$4 million.

For

the

full

year

2021,

our

operating

expenses

were

$13.3

million

compared

to

$12.5

million

for

the

prior

year.

This

change

largely

related

to

a

rise

in

public

company

costs,

including

an

increase

in

our

directors

and

officers'

insurance

premiums

and

an

increase

in

our

investor

relations

activities.

Research

and

development

expenses for

the

fourth

quarter

of

2021

were

$3.7

million,

compared

to

$4.1

million

for

the

same

period

last

year.

This

change

was

largely

due

to

a

decline

in

our

AWARE-1

related

expenses

as

a

large

majority

of

patient

enrollment

occurred

back

in

2020,

as

well

our

manufacturing-related

expenses

were

lower

given

we

completed

our

product

fills

back

in

the

fourth

quarter

of

2020. Now

this

was

partly

offset

by

higher

R&D

compensation-related

expenses

as

we

continue

to

invest

in

and

support

our

expanding

clinical

development

program.

Research

and

development

expenses were

$12.9

million

for

the

full

year

2021

and

2020.

Now

for

2021,

in

addition

to

our

continued

investment

in

our

clinical

program

and

our

R&D

team,

we

also

increased

our

translational

science

activities

this

year,

focusing

on

CAR T

therapy

and

bispecific

antibody

opportunities.

This was

offset

by

lower

manufacturing

activities,

as

we

have

sufficient

product

supply

from

the

production

run

and

product

builds

completed

in

2020,

lower

intellectual

property

costs

due

to the

relapsing

of

patents

in

certain

jurisdictions

and

foreign

exchange

fluctuations.

The

net

loss

for

the

fourth

quarter

of

2021 was

$7.8

million

compared

to

$9.3

million

for

the

fourth quarter

of

2020,

equating

to

a

net

loss

of

$0.14

per

share

for

the

2021

period,

compared

to

$0.21

per

share

for

the

prior

period.

The

net

loss

for

the

full

year

2021

was

$26.3

million

compared

to

$22.5

million

for

2020,

equating

to

a

net

loss

of

$0.49

per

share

for

2021

and

a

net

loss

of

$0.56

per

share

for

2020.

Now

with

that,

I'll hand

it

back

to

Matt.

Matt?

[Matthew C. Coffey]

Thank

you,

Kirk.

The

Oncolytics' family has

continued

to

work

hard

to

drive

our

programs

forward.

Our

pharma

partners

have

continued

to

provide

world-class

input

and

guidance,

and

our

investigators

and

collaborators

continued

to

share

our

vision

for

the

opportunity

presented

by

pelareorep's

mechanism

of

action,

for

which

we

are

extremely

grateful. We

would

also

like

to

thank

and

acknowledge

our

clinical

trial

patients

and

their

families

for

their

participation

in

our

studies

and

in

their

fight

against

this

terrible

disease.

Lastly,

I'd

like

to

thank

our

investors

who

provide

us

with

the

ability

to

pursue

these

inspiring

names.

Oncolytics

cannot

have

advanced

to

where

it

is

without

all

of

these

stakeholders'

contributions.

Looking

towards

the

future,

we

have

a

truly

unique

immunotherapeutic

agent

that

has

provided

us

with

exciting

clinical

data

and

continues

attracting

interest

from

significant

global

collaborators.

Its

immunotherapeutic

effects

can

be

seen

across

multiple

indications

and

in

combination

with

an

array

of

oncology

treatments.

We

believe

these

effects

could

have

a

profound

positive

impact

on

the

quality

of

life

of

cancer

patients

worldwide

and

in

turn

provide

a

broad

commercial

opportunity

of

which

we

have

only

begun

to

scratch

the

surface.

We

will

continue

to

further

pelareorep's

clinical

development

as

there

are

significant

opportunities

worthy

of

pursuit.

But

we

will

still

preserve

our

primary

focus

on

breast

cancer

while

selectively

engaging

partners

and

collaborators

to

progress

our

efforts

in

other

areas.

Advancing

our

lead

breast

cancer

program

towards

our

registrational

study

is

important

to

our

team

as

it

provides

a

meaningful

foundation

which

we

can

build

upon

to

unlock

additional

value

in

other

indications.

The

clinical

data

from AWARE-1

alone

has

brought

up

substantial

insights

about

how

pelareorep

can

be

leveraged

in

many

clinical

settings

by

effectively

harnessing

the

patient's

own

immune

response

against

their

disease.

These

learnings

are

crucial

in

advancing

pelareorep

as

a

world-class

immunotherapy.

Continuing

to

add

to

that

data

goes

a

long

way

to

expanding

the

potential

value

of

this

company.

We

have

several

critical

milestones

ahead

of

us

in

the

coming

weeks

and

throughout

the

year.

These

upcoming

catalysts

are

highlighted

by

BRACELET-1

anticipated

top

line

data

readout

in

Q4,

which

represents

the

last

major

clinical

step

on

pelareorep's

path

to

a

registrational

breast

cancer

study.

We

also

expect

to

report

a

multiple

myeloma

study

update,

early

results

from

our

GI

program

and

additional

clinical

data

in

glioblastoma

at

upcoming

conferences.

As

we

move

towards

these

catalysts,

we

are

doing

so

with

a

strong

team

that

has

consistently

executed

amid

an

ever

evolving

pandemic.

I

believe

their

experience

and

expertise,

together

with

the

strong

clinical

and

pre-clinical

datasets

supporting

our

pipeline,

leave

us

well positioned

to

generate

shareholder

value

while

working

towards

our

ultimate

goal

of

improving

the

lives

of

cancer

patients.

With

that,

I'd

like

to

open

the

lines

to

take

some

questions.

Operator?

[Operator]

Thank

you,

sir.

[Operator Instructions]



And

your

first

question

will

be

from

Patrick

Trucchio

at

H.C.

Wainwright.

Please

go

ahead.

Hi.

Good

afternoon.

This

is

[ph]



Jason

Shay (00:25:27)

on

for

Patrick.

And

my

first

question

is

for

the

BRACELET-1

study.

Can

you

tell

us

what

Oncolytics

will

like

to

see

within

their

Phase

2

data

readout

for

4Q?

And

like

how

will

this

proceed

to

your

Phase

3

pivotal

study?

Thank

you.

[Matthew C. Coffey]

I'll

start.

It's

Matt

Coffey.

How

are

you

doing?

[indiscernible]

(00:25:51).

[Matthew C. Coffey]

We

very

much

think

that

BRACELET-1

should

fall

in

line

with

the

learnings

of

AWARE-1.

What

we

know

from

BRACELET-1 –

IND-213

is

we

saw

a

survival

advantage.

And

at

that

point

it

was

presumably

due

to

the

immunotherapy

aspect

of

the

product.

AWARE-1

really

did

speak

to

the

virus

itself

causing

a

[ph]



pro-inflammatory

bowel (00:26:13)

with

remodeling

of

the

tumor

microenvironment

and

the

checkpoint

inhibitor

leading

to

enhanced

inflammation

and enhancing

the

quality,

which

led

to

better

CelTIL

scores

which

should

in

turn

lead

to

better

outcomes

in

terms

of

PFS and

OS.

We

would

very

much

hope

to

see

something

similar

in

BRACELET-1

with

outcomes

being

improved

from

paclitaxel

only

to

paclitaxel

plus

[ph]



virus (00:26:36).

And

again,

we

would

like

to

see

an

improvement

by

the

addition

of

the

checkpoint

blockade.

Now

those

are

wishes.

It's

certainly

AWARE-1

exceeded

our

expectations.

BRACELET-1 has

not

given

a

formal

readout

yet,

but

we'll

do

so

in

Q4.

With

that,

I'll

let

the

more

knowledgeable,

Tom

Heineman,

join

in

to

see

what

his

thoughts

are

on

this.

[Thomas C Heineman, Chief Medical Officer, Oncolytics Biotech, Inc.]

Yeah.

Thank

you,

Matt.

No,

I

mean,

to

be

honest,

I

don't

have

any

real

new

insights.

So

I

think

that

Matt

expressed

that

perfectly,

and

that

is

we

do

have

some

sense

from

the

previous

IND-213

study

what

to

expect

with

the

paclitaxel

alone

arm

and

the

paclitaxel

plus

pelareorep

arm.

And

we

expect

and

hope

based

on

the

AWARE-1

data

to

see

an

additional

immunologic

effect

leading

to

clinical

benefit

from

the

addition

of

a

checkpoint

inhibitor.

And

as

the

data

come

in,

we

look

forward to being able

to share

those data towards the end of

this

year.

All

right.

Can I

have

just

a

follow-up

question,

are

there

plans

in

terms

of

progressing

with

Pfizer

or

any

other

collaborators

for

pelareorep

for

the

Phase

3

pivotal

study,

or

will

Oncolytics

kind

of

proceed

alone?

[Matthew C. Coffey]

Again,

that's

a

great

question.

We

think

there

is

multiple

opportunities

beyond

breast

cancer.

I

mean,

obviously,

we're

very

excited

about

the

GOBLET

program.

We're

excited

by

what

we're

doing

in

heme

malignancies

and

other

things

like

GBM.

With

the

collaborations

and

co-development

agreements

we

have

right

now,

we

have

brought

some

of

the

world's

best

and

brightest

pharmaceutical

companies

together

to

collaborate

with

us.

So,

what

we

would

like

to

see

is

some

competitive

tension

between

the

parties,

as

the

GOBLET

data

becomes

available,

as

the

AWARE-1

and

BRACELET-1

data

becomes

available,

we

would

like

to

obviously

bring

in

one

of

these

world-class

leaders

who

contributed

already

– to

contributing

in

the

Phase

3

for

breast

cancer.

But

we

would

look

to

hopefully

expand

that

into

other

indications,

so

that

we're

not

looking

at a

binary

event

in

the

Phase

3

environment.

We

would

like

to

have

multiple

Phase

3

programs

in

play,

and

again,

we

would

like

to

see

that

done

in

potential

with

a

partner,

so

that would

be

less

dilutive

to

existing

shareholders,

but

also

so

that

we

can

move

spritely

through

the

regulatory

approvals.

And

I

think

Mr.

De

Guttadauro

would

like

to

join

in

here

for

a

sec

as

well.

Andrew,

do

you want

to join?

[Andrew R. de Guttadauro]

Yeah.

I

just

want to

remind

everybody,

as

you

probably

know

from

prior

calls,

from

the

time

we

provide

the

report

to

Pfizer and

Merck

Serono,

the

collaborators

on

BRACELET-1,

they

have

90

days

to

evaluate

the

data

on

their

own.

They

may

or

may

not

need

90 days,

or

they

may

need

more

than 90

days,

but

come day

91,

we

do

have

a

number

of

other

top

20

oncology

companies

that

have

expressed

an

interest

in

the

BRACELET-1

data,

so

we

would

want

to

get

that

data

to

those

companies

as

well.

And

then,

of

course,

as

Matt

mentioned,

we've

got

the

GOBLET

data

that

should

be

maturing

in

parallel

to

some

degree.

And

so

we

want to

make

sure

we

leverage

both

what's

available

from

GOBLET

as

well

as

BRACELET-1

and

the

prior

final

datasets

from

IND-213

and

AWARE-1 to have

really

critical

masses

which

to

try

and

bring

more

than

one

company

to

the

table.

Okay.

Great.

Thank

you

and

kind

of

if I can

squeeze

in

one

last

question.

And

this

is

more

just

in

terms

of

the

current

events,

has

Oncolytics

sought

any

disruption

in

the

clinical

trial

since

beginning

the

war

in

Ukraine?

And

has

that

really

impact

anything

with

your

clinical

trials

out

in

China

or

in

Asia

area?

[Matthew C. Coffey]

No,

not

at

all.

Okay.

[Matthew C. Coffey]

Fortunately,

we're

not

running

anything

in

Eastern

Europe.

We

may

not

be

able

to

be

as

resounding

in

it,

but

our

breast

cancer

programs

are

all

in

the

US.

What

we're

doing

in

GOBLET

is

all

in

Germany,

but

we've

been

unaffected.

Thanks.

Great.

Thank you

so

much.

[Operator]

Thank

you.

[Matthew C. Coffey]

Appreciate the time.

Right.

[Operator Instructions]

[Operator]

And

at

this time,

we have

no

further

questions.

I

would

like

to

turn

the

call

back

over

to

Dr.

Coffey.

[Matthew C. Coffey]

Well,

thanks

again

everyone

for

joining

us

on

the

call.

We

look

forward

to

our

continued

progress

and

we'll

keep

everyone

updated

along

the

way.

Thanks,

everyone.

[Operator]

Thank

you,

sir.

Ladies

and

gentlemen,

this

does

indeed

conclude

your

conference

call

for

today.

Once

again,

thank

you

for

attending.

And

at

this

time,

we

do

ask

that

you

please

disconnect

your

lines.