brii bio corporate presentation oct 2021

Corporate Presentation

NOVEMBER 2021

Disclaimer

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Brii Bio Vision & Mission

PIPELINE OVERVIEW OUTLOOKCOMPANY OVERVIEW

Our vision is to Our mission is to

Continue to focus on

indications with large patient

populations

Prioritize the access to

markets where the target

indications have the greatest

impact

Leverage patient insight to

guide innovation and deliver

paradigm-shifting new

treatment options

Value creation through strong

global R&D and partnership

capabilities combined with

China clinical development

efficiency

Be the leading public health-inspired and infectious

diseases / CNS diseases-focused biotech

Tackle world’s biggest public health challenges with

Breakthrough Innovation & Insight

3

Brii’s pipeline investment is aligned with China vs. Global market potential

Without effective cure, many diseases’ prevalence and burden are increasing

73 million 269 / 19 million7.6 million 213(1) million 39 millionPrevalence

(2019)

Hepatitis BMajor Depressive Disorder /

Postpartum Depression

MDR/XDR gram-negative

bacterial infection COVID-19 HIV infection

China is a major market for HBV

Cure and MDR/XDR hospital

infections

Frost & Sullivan Industry report；1.Cumulative confirmed cases as of August 23, 2021 per John Hopkins data

Brii Rights

4

US and EU are the major markets for HIV

infection and CNS diseases


Broad pipeline addressing large disease burdens in China & globally

5

Indication Program Preclinical IND Approval Phase 1 Phase 2 Phase 3Regulatory

AuthorityBrii Rights

Licensing

Partners/Internally

Discovered

Infectious Disease Programs

Hepatitis B

BRII-179 (VBI-2601) NMPA Greater China

BRII-835 (VIR-2218) NMPA Greater China

BRII-179/BRII-835 Combination NMPA Greater China

COVID-19

BRII-196(1) FDA/NMPA Global

BRII-198(1) FDA/NMPA Global

HIV infection

BRII-778 FDA Global Internally discovered

BRII-732 FDA Global Internally discovered

MDR/XDR

gram-negative

infections

BRII-636(2) (QPX-7728) FDA Greater China



MDR/XDR TB

MycobacteriaBRII-658(2) (AN2-501971) FDA Greater China

Central Nervous System Disease Programs

PPD BRII-296 FDA Global Internally discovered

MDD BRII-296 FDA Global Internally discovered

Source: Company information as of November 2021

Notes:

1. The filing of EUA application with FDA for combination BRII-196/BRII-198 has been completed in October 2021.

2. To this date, the development and clinical trials have been conducted by Qpex and AN2, respectively.


World-class leadership team with a proven track record of success

Jean-Luc GIRARDETSVP

Pharmaceutical Science

Former VP of research

operations at Ardea Biosciences

Former Director and Head of

Virology Group at MedImmune

Qing ZHUSVP

Biopharma

John Maraganore

Ph.D.CEO of Alnylam

Pharmaceuticals

David D. Ho

M.D.Founding Scientific

Director and CEO

of the Aaron

Diamond AIDS

Research Center

Thomas O. Daniel

M.D.Former President of

Global Research and

Early Development at

Celgene Corporation

Chen Dong

Ph.D.Professor and Dean,

School of Medicine at

Tsinghua University

Zhijian ‘James’ Chen

Ph.D.Director of Inflammation

Research Center and

George L. MacGregor

Distinguished Chair in

Biomedical Science at UT

Southwestern

Clay B. Thorp

General Partner at

Hatteras Venture

Partners

Leadership team

Strategic advisors

6

Lianhong XUSVP

Medicinal ChemistryFormer Senior Director

at Gilead


Rogers LUOPresident &

China General Manager

Former VP and General

Manager of Gilead China

Former SVP and Head of

Infectious Diseases Therapy

Area Unit at GSK

Zhi HONGCEO

Li YANCMO

Former VP and Head Unit

Physician of GSK Oncology

David MargolisVP, Head of Infectious

Diseases Therapy Area

Former Medical Director and Senior

Medical Director for both GSK and ViiV

Lisa BECKSVP

BD & Portfolio Management

Former transactions and alliance

management head of Alexion

Former CFO of Terns

Ankang LICFO

Coy StoutSVP, Head of U.S. Market

Access and Patient Advocacy

Former VP of Market Access Strategy

and Account Management at Gilead

The importance of HBV functional cure in China

• Elimination of social stigma and risk of end-stage

liver diseases & cancer

• Avoidance of life-long treatment with a finite

treatment regimen

The Market Potential

• A sustained functional cure may unlock the underserved

needs and drive treatment & diagnosis

• The market will be sustainable because of the very large

patient pool

High unmet needs

• HBV infection is the major cause of end-stage of liver diseases and liver cancer

• Social stigma is still common among people living with chronic HBV

• Despite the desire for new therapy and high willingness to pay, only limited suboptimal

treatment options are available

FUNCTIONAL CURE

Definition of functional cure:

• Sustained immunological control of HBV

infection in the absence of HBV therapies

• Clinical lab tests: sero-negative for HBsAg

with or without sero-positive for HBsAb(1)

Hepatitis B

Source: Frost & Sullivan, Company information

1. Cornberg et al Hepatology (2020) 71:1070-1092

• Low cure rate (3%-7%)

• Cannot fully eliminate disease risks

without functional cure

• Life-long treatment is required for

treatment with NRTIs

7

Current standard of care

China will be the largest HBV Cure market

A sustained functional cure is transformational to patients’ life

While currently only 4m people are receiving antiviral treatment, 28m of the 73m people in China infected with HBV require treatment per guideline

Nucleotide/nucleoside reverse transcriptase

inhibitors (NRTIs) and interferon


Brii Bio HBV cure built on differentiated scientific insight

8

Mechanism of action of BRII-179 and BRII-835

BRII-835

BRII-179

HBV

Functional Cure+

Evidence from preclinical model(1)

Study design

• Two preclinical models of high-titer, persistent HBV infection were used (HBVtg mice and AAV-HBV model)

• In the study group, HBV antigens were suppressed using liver-directed siRNAs before applying a heterologous prime-boost therapeutic vaccine

Conclusion

• siRNA suppressions of HBV antigens enables therapeutic vaccination to achieve immune control in high-titer virus carriers

Source: Frost & Sullivan, Company information

1. Michler T, et al., Abstract 77 2018 AASLD; Gastroenterology. 2020 May;158(6):1762-1775.e9

HBV S, PreS1, PreS2,

Core, e-antigen, X

proteins

HBV-specific B-cell

& T-cell responses

to S, PreS1 & PreS2

Innate immune responses

Virion

Other

cells NK cells Stimulation

Polymerase

Entry

Virion

secretion

ER

Hepatocyte

Viral proteins

secretion

Adaptive immune responses

Therapeutic Vaccine

(BRII-179/BI-2601)

Effect through

IFN-γ or

cytotoxicity

siRNA

(BRII-835/VIR-2218)

HBV DNA integration

Induction of antiviral effectors

cccDNA formation

cccDNA

amplification

cccDNA

Nucleus

Transcription

pgRNA

rcDNA

mRNA

TranslationpgRNADNA

ER

DNAstrand synthesis Encapsidation

Reverse transcription

DC8*

cells

DC4*

cells

B cellsAAA

AAAAAA

AAA

HBsAg

HBeAg

mRNA degradation

RNA-induced silencing complex

siRNA

Mechanism of RNAi

mRNA

IFN-α


Hepatitis B

BRII-835 & BRII-179: Step change approach in the search for an HBV cure

9

BRII-835 (VIR-2218) demonstrates safety and

antiviral activity in patients(1)

Observed T cell responses to HBV surface antigens in ~50% of patientsHBsAg change from baseline (VIR-2218 Phase 2 Data)

ProgramPre-

cl in icalPh 1 Ph 2 Ph 3 Mi lestones

BRII-179

Phase 1b/2a

clinical study

completed

BRII-835

Patient follow-up

assessments

planned

BRII-179/BRII-835

combination

Study initiated

2Q 2021

• BRII-179/BRII-835 will be compared to BRII-

835 alone in a Phase 2 study to establish

proof of concept

• Phase 2 MRCT study includes planned study

sites in China, Hong Kong, New Zealand,

Australia, Taiwan, Singapore, Thailand and

South Korea with up to 135 patients to be

enrolled (initiated in New Zealand, Australia

and Hong Kong)

• The top-line interim clinical data for the Phase

2 combination study for BRII-179/BRII-835 is

expected in 2H 2022

• If positive results are achieved in the

combination study, we could submit a

registration filing for a BRII-179/BRII-835

combination in China as early as 2024

Source:

1. Vir Biotechnology company presentation;

Gane E, et al. Oral presentation at: The International Liver Congress – EASL; June 25, 2021; Virtual.

2. Ma et al , EASL 2021 late breaker submission

BRII-179 induced both HBV specific B- & T- cell

responses in CHB patients(2)

Observed antibody responses to HBV surface antigens in 30-50% of patients

BRII-179/BRII-835

combination study


Hepatitis B

Brii’s combination strategies lead the search for a cure

Planned or considered combinations

BRII-835 (VIR-2218)

VIR-3434

BRII-179

BRII-835

BRII-835 (VIR-2218)

PEG-IFN-α

BRII-179

PEG-IFN-α

HBV CURE

Preliminary results of Vir’s ongoing Phase 2 study

• Co-administration of VIR-2218 with PEG-IFN-α resulted in a more

rapid and substantial HBsAg decline compared to VIR-2218 alone

• The mean HBsAg decline from baseline was 2.0 log10 IU/mL at

Week 12 and 0.6 log10 IU/mL greater than VIR-2218 alone

China IND approval for

Phase 2 combination study

received in August 2021

Phase 2 study initiated in July 2021

• Initial data expected in 1H 2022

• Brii has an exclusive option to in-license VIR-3434 at predefined endpoints

‒ VIR-3434 is an investigational subcutaneously administered HBV-

neutralizing monoclonal antibody

‒ With the incorporation of Fc technologies, VIR-3434 has been

engineered to potentially function as a T cell vaccine against HBV in

infected patients

Brii

Partners

Phase 2 combination

study is ongoing

Additional

combinations

Additional

combinations

Source: Company information; Vir Biotechnology company presentation;


10

Hepatitis B

BRII-196

BRII-198

RBD

Highlights and MOA

BRII-196 & BRII-198: antibody therapy for treatment of COVID-19 COVID-19

11

AntibodyCompetition

with ACE2

Live Virus(7)

IC90 (µg/ml)

1F11

(BRII-196)> 99% 0.3

1G5

(BRII-198)< 18% 0.7

Retained antiviral activity against variants

of concern

• Current in vitro pseudovirus testing data

suggests that combination BRII-196/BRII-198

retains activity against major SARS-CoV-2

variants of concern, including the following

commonly identified variants, B.1.1.7 (Alpha),

B.1.351 (Beta), P.1 (Gamma), B.1.429

(Epsilon), B.1.617.2 (Delta), C.37 (Lambda)

and B.1.621 (Mu)

Half-life extension from ~ 21 days to ~

60-90 days(6)

• Longer duration of protection and potential

for an extended therapeutic window at a

lower dose

Derived from fully human neutralizing

antibodies, 1F11 and 1G5, respectively(1)

• Complete neutralization with potency

comparable to available products(2)

Target two distinct epitopes on RBD of

SARS-CoV-2 Spike(3)(4)

• Exert additive effect when combined that

may improve efficacy

• Minimize viral resistance generation and

escape as a cocktail(5)

1. Ju et al, Nature (2020). doi.org/10.1038/s41586-020-2380-z;

2. Hansen et al, Science (2020) doi: 10.1126/science.abd0827;

3. Jin et al Front Med (2017) 11:462;

4. Sivapalasingam et al, Lancet Infect Dis (2018) 18:884;

5. Baum et al, Science (2020) doi: 10.1126/science.abd0831;

Zhang et al, unpublished data;

6. Dall’Acqua et al. J Biol Chem (2006) 281:23514.

7. Independent live virus assays conducted in a US laboratory showed a much lower IC90 value

than above. Lab to lab variations may need to be considered in dose prediction.

8. Dr. Weiss (FDA-CBER);

9 Wang P. et al., https://www.biorxiv.org/content/10.1101/2021.01.25.428137v3

10. Wang R. et al., https://www.biorxiv.org/content/10.1101/2021.03.09.434497v2

11. Lusvarghi S. et al., https://doi.org/10.1101/2021.07.16.452748 (Code T for BRII-196+BRII-198)

Lineage Origin BRII-196/ BRII-198 (8)(9)(10)(11)

B.1.1.7 (Alpha) UK

B.1.351 (Beta) South Africa

P.1 (Gamma) Brazil

B.1.617.2 (Delta) India

AY.1/AY.2 (Delta+) India

B.1.427/429 (Epsilon) California

B.1.525 (Eta) Multiple

B.1.526 (Iota) New York

B.1.617.1 (Kappa) India

C.37 (Lambda) Peru

B.1.621 (Mu) Columbia

No impact <= 5-fold


BRII-196 & BRII-198: Phase 3 development for COVID-19 COVID-19

Randomized double-blind, placebo-controlled Phase 2/3 platform study

• Sponsor: NIAID (NIH)

• Participants: COVID-19 positive adult outpatients at high risk for disease

progression

• Intervention:

• IV BRII-196/198 – 1000mg/1000mg

• Placebo

• Efficacy endpoints:

• Phase 2 – D14 Viral Load, D28 Clinical

• Phase 3 – Hospitalization and Death

• Status:

• Phase 3 portion of the ACTIV-2 study has completed enrollment of 846

participants, in sites in the United States, Brazil, South Africa, Mexico

and Argentina in August 2021

• The Emergency Use Authorization(EUA) application with FDA for

combination BRII-196/BRII-198 has been completed in October 2021

Global Phase 3 Ongoing China Phase 2 ongoing

• The Phase 2 clinical trial in China is

ongoing led by Dr. Nanshan Zhong, the

Academician of the Chinese Academy of

Engineering and Director of the National

Clinical Medical Research Center for

Respiratory Diseases at the First

Affiliated Hospital of Guangzhou Medical

University

• In response to the recent emergence of

COVID-19 cases in China, including

cases caused by the Delta variant, Brii

Bio has cooperated with governmental

agencies and hospitals in China to

supply BRII-196/BRII-198 for emergency

use in Guangdong, Yunnan, Jiangsu,

Hunan, Henan, Fujian, Gansu, Ningxia,

Inner Mongolia, Heilongjiang, Qinghai,

Guizhou and Liaoning provinces.

Next Steps and Plans

• Complete Phase 2/3

development under the

ACTIV-2 trial protocol

• Complete Phase 2

study in China

• Waiting for EUA

approval

• File BLA


12

• BRII-196/BRII-198 reduced the risk of hospitalization and death over placebo by 78% in 837 outpatients at high risk of clinical progression. Through the

28-day primary endpoint, zero (n=418) deaths were observed on BRII-196/BRII-198 versus eight (n=419) deaths on the placebo arm. Of those subjects who

received treatment with BRII-196/BRII-198 within five days of symptom onset, 2% (4/196) progressed to hospitalization or death, compared with 11% (21/197)

in the placebo arm. Similarly, 2% (5/222) of subjects who received treatment with BRII-196/BRII-198 at six to 10 days following symptom onset progressed to

hospitalization or death, compared with 11% (24/222) of those receiving placebo.

Interim results from Phase 3 of the ACTIV-2 trial

Patients will play a more active role in the growing HIV market HIV infection

HIV-related deaths

In 2019

People living with

HIV in 2019

People newly infected

with HIV in 2019

Source: UNAIDS/WHO estimates

690,00039

Million

1.7

Million

Summary of the Global HIV Markets

Global market will continue to increase

• Reached $37.6 billion in 2020

• Developed markets, such as the United States,

currently account for the majority of the market

• Prevalence will increase to 61.6 million in 2034

✓ Discreet, convenient and non-

invasive therapies with drug

holiday

✓ Address patient's desire for

better QoL /convenience than

that offered current regimens

✓ Improved QoL and adherence

Treatment is invasive and

requires visit at the clinics or

pharmacies

✓ Proven safety and efficacy

profile

Significant emotional,

quality of life (QoL) and

adherence issues

Frost & Sullivan, Company information

https://www.healthline.com/health-news/fda-approves-first-injectable-drug-regimen-for-adults-living-with-hiv

Derrick. Open Forum Infectious Diseases. 2018;5:10; Slide credit: clinicaloptions.com

Advancement of HIV treatment

Current SoC: once daily single

tablet regimen (STR) oral

therapies

New treatment options include

once monthly (QM) & Q2M

parenteral therapies

Aspirational once weekly (QW)

oral therapies

Patient survey

N = 263 participants on suppressive ART at 2 out-patient HIV clinics participated survey

were “very interested” in switching to a once-weekly pill,

vs 39% in 2 shots, 18% in implantsAnswer

Question

3 choices were given:

– Single pill once weekly

– Two shots in clinic every other month

– Implanting and removing 2 small plastic rods about the size of a

matchstick in each forearm every 6 months

What administration option is the most attractive to you when considering switching from current treatment?

66%


13

https://www.healthline.com/health-news/fda-approves-first-injectable-drug-regimen-for-adults-living-with-hiv

A new treatment option for patients: once weekly single tablet regimen (STR)

New once weekly oral treatment

option for HIV patients

Goal: Develop a once weekly (QW) oral single tablet

regimen (STR) for treatment of HIV infection

NNRTI

NRTI

NRTTI

BRII-778

BRII-732STR

MoAs Drugs Tablet

Value Proposition

The Once Weekly Single Tablet Regimen

(QW STR)

May offer a completely new treatment option for people

• Living with HIV who seek a better quality of life without the daily

reminders of their HIV status

• And desire for a more discreet, non-invasive way of taking their

medication with the potential to improve treatment adherence, thereby

delaying the emergence of resistance

Program Pre-clinical Phase 1 Phase 2 Collaborator Milestones

BRII-778

Wholly owned

Phase 1 dosed in

March 2021 in US

BRII-732Phase 1 dosed in

May 2021 in US

QW STR

Phase 2b Combo

expected to

initiate in 2H 2022

BRII-732:

a proprietary prodrug of EFdA or islatravir. EFdA functions both as a

potent NRTI and a potent NRTTI

BRII-778:

an extended release (ER) formulation of an FDA-approved NNRTI,

Edurant (rilpivirine hydrochloride)

NNRTI: Non-nucleoside reverse transcriptase inhibitors

NRTI: Nucleoside/nucleotide reverse transcriptase inhibitors

NRTTI: Nucleoside reverse transcriptase translocation inhibitor

3 2 1


14

HIV infection

MDR/XDR

gram-negative

infections

Increasing MDR/XDR drives critical unmet clinical needs in China

WHO Priority #1 List for New Drugs:

CRITICAL

• Carbapenem-resistant

Enterobacteriaceae: CRE

• Carbapenem-resistant Acinetobacter

baumannii: CRAB

• Carbapenem-resistant

Pseudomonas aeruginosa: CRPA 3.0 3.4 2.4 4.0 4.9 9.2

9.0 10.0 10.3 11.0

16.4 16.7

21.6

27.6 25.3

2.9 2.6 2.9 3.8 4.8 9.2 9.0

11.8 14.1 14.1 15.1

19.7

25.2 29.5

26.8

32.9 31.7

37.7

52.454.8

61.763.6

61.6 61.965.8 65.7

69.7 70.5

77.1 77.7

41.3 39.942.7

53.657.2

63.5 64.7 66.4 64.869.2

72.9 72.9 73

78.1 79

0

10

20

30

40

50

60

70

80

90

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019

% Klebsiella Pneumoniae to Impinem

Klebsiella Pneumoniae to Meropenem

Acinetobacter Baumannii to Impinem

Acinetobacter Baumannii to Meropenem

China has the largest and growing market for antibiotics to treat hospital infections

Drug Resistance Rate to Imipenem and Meropenem

(2005-2019)

Unmet Medical Need and Fields for Innovation

A serious worldwide threat to public health Resistance rates of the two most prevalent carbapenems in China

Source: CHINET, Frost & Sullivan AnalysisPIPELINE OVERVIEW OUTLOOKCOMPANY OVERVIEW

15

MDR/XDR

gram-negative

infections

Brii antibiotics address complicated & life-threatening infections

Program Modality MOA Pre-clinical Phase 1 Phase 2 Collaborator Milestones Clinical Development Plan

BRII-636 IV BLI

Restores activity of multiple

IV carbapenems &

cephalosporins; broadest-

spectrum BLI

Phase 1 started

in Nov 2020

• Phase 1 SAD/MAD study

ongoing in Australia, which will

include a cohort of first- or

second-generation Chinese

subjects

• Plan to join global Phase 3

combination study, inclusive of

China (pending regulatory

feedback)

BRII-672 ORAL BLI

Restores activity of multiple

oral cephalosporins &

carbapenems; broadest-

spectrum BLI

Phase 1 started

in April 2021


ongoing in Australia

• Plan to join global Phase 3

combination study, inclusive of

China (pending regulatory

feedback)

BRII-693IV Novel

Polymyxin

Disrupts both the outer and

inner membranes of Gram-

negative bacteria; active in

surfactant

Phase 1 started

in June 2021


ongoing in Australia

• Plan to join global Phase 3 study,

inclusive of China, focusing on

carbapenem resistant infections

*IND submission and clinical studies conducted by Qpex

Brii - Qpex hospital antibiotics portfolio


16

MDR/XDR

gram-negative

infections

Brii - Qpex potential best-in-class beta-lactamase inhibitor (BLI)

Inhibitor Combo Stage ESBLsCRE

Serine-Pro

CRE

Metallo-ProCRPA Pseudomonas CRAB Acinetobacter

BRII-636 (QPX-7728) / Undisclosed

IV β-lactam antibiotic Phase 1 ✓ ✓ ✓ ✓ ✓

Tazobactam/ Ceftolozane Approved ✓

Resistant

Resistant

Resistance Emerging

Resistant

Avibactam / Ceftazidime Approved ✓

Resistance Emerging

Resistant✓

Resistant

Vaborbactam / Meropenem Approved ✓

No OXA

Resistant

Possible for resistance

Resistant

Relebactam/ Imipenem Approved ✓

No OXA

Resistant✓

Resistant

Taniborbactam / Cefepime Phase 3 ✓ ✓

No IMP✓

Resistant

Durlobactam / Sulbactam Phase 3

Resistant

Resistant

Resistant

Resistant✓

Broadest Coverage across Gram-negative Pathogens and Enzyme Classes

• β-lactams are a broad class of antibiotics used to treat bacterial infections

• β-lactamases are a family of enzymes produced bacteria to inactivate β-lactams

• BLIs can restore the antibacterial activity of β-lactams

• ESBLs: Extended spectrum β-lactamases

• Serine-Pro: Serine β-lactamases Producing

• Metallo-Pro: Metallo β-lactamases Producing

• No OXA: not effective against OXA-48-producing Enterobacterales

• No IMP: not effective against IMP-producing Enterobacterales

Source: Company informationPIPELINE OVERVIEW OUTLOOKCOMPANY OVERVIEW

17

Depression is associated with many CNS and other chronic diseases

Large and growing PPD patient base

for both treatment and prevention

~13% of women within a

year of childbirth

are affected by PPD

Until 2019there were not any

pharmacological

interventions

specifically

indicated for PPD

~25.5% of women who were

previously

diagnosed with PPD

may

experience PPD

after their second

delivery

Luisi et al. J Clin Endocrinol Metab (2000) 85:2429

Postpartum depression affects both woman

health and neonate development

PPD MDD

A CAGR of 7.6% is projected for

global major depressive disorder

drug market during 2019 to 2029

People suffering from

general depression globally

Up to one-third of individuals with a

serious medical condition have

symptoms of depression

7.6%>264

Million 1/3

• There are different types of depression with different causes and

different severities that therefore require different forms of treatment

• Postpartum depression (PPD) is a type of depression that many

new mothers experience after having a baby

The burden of depression is on the rise globally

Approximately 18.9 million women worldwide were affected by PPD in

2019 and the patient base is expected to continue to grow due to

increasing diagnosis and treatment rate

Source: Frost & Sullivan, Company informationPIPELINE OVERVIEW OUTLOOKCOMPANY OVERVIEW

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• Allopregnanolone (also known as brexanolone) is a naturally occurring steroid that acts as a positive

allosteric modulator (PAM) of GABA's action at GABAA receptors

• Toward late gestation, levels of allopregnanolone in a woman’s blood rise gradually to approximately

50ng/mL. But shortly after giving birth, allopregnanolone levels drop precipitously

• PAMs operate by increasing the frequency with which the chlorine channel opens when GABA binds to its

own site on the GABA receptor. This action results in an increase in the Cl- ion concentration in the

postsynaptic neuron and causes immediate hyperpolarization of this neuron, making it less excitable and

thus inhibiting the possibility of an action potential and preventing the release of excitatory neurotransmitters

• Complicated titration and

tapering scheme may

also introduce dosing

errors, sudden changes

in drug concentration,

and associated AEs

such as loss of

consciousness (LoC)

Zulresso (a synthetic version of allopregnanolone) has been

shown to be very effective in the treatment of severe PPD

Zulresso is the only approved therapeutic for PPD…but it is a very complicated treatment option

*HAM-D: Hamilton Depression Rating Scale

Mean changes in HAM-D score*

PPD MDD

Dose titration and tapering

Mechanism of action of Allopregnanolone in PPD

But 60-h continuous iv infusion requires significant in-

patient healthcare resource utilization

Source: Frost & Sullivan, Company information, Sage Therapeutics company presentation PIPELINE OVERVIEW OUTLOOKCOMPANY OVERVIEW

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PPD MDDBRII-296: a new treatment paradigm & differentiated value proposition

Program Modality MOA Pre-clinical Ph I Ph III Collaborator Milestones

BRII-296

PPD

Novel long-acting

parenteral formulation

GABAa PAM Wholly ownedPh1 started April 2021

Ph3 to start H1 2022

BRII-296

PPD preventionGABAa PAM Wholly owned Under consideration

BRII-296

MDDGABAa PAM Wholly owned Under consideration

Considerations BRII-296 Zulresso SSRIs

Ease of Administration ✓ ✓

Onset of Drug Efficacy ✓ ✓

Syncope ✓ ✓

Chances of Initial Treatment

Success✓ ✓

Breastfeeding ✓ ✓

Patient Convenience ✓ ✓

Healthcare Resource Utilization ✓ ✓

Adherence ✓ ✓

Directly observed treatment

May offer a new treatment option for people

• Provide a rapid, profound and sustained reduction in depressive

symptoms of postpartum depression while avoiding the substantial

limitation of the currently approved treatment (Zulresso)

• And a directly observed therapy that provides assured adherence and

convenience compared to future oral medications without concern of

drug exposure to breastfeeding infants

Value Proposition


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Upcoming Milestones and Catalysts

Key events Timing

Hepatitis B

BRII-179 Enrollment Enroll 1st patient into Phase 2 study with BRII-179 and pegylated interferon in China 1Q 2022

BRII-835

Data Final CSR report for Phase 2 study in Mainland China 2H 2021

Data Additional data readout for Phase 2 combo study of VIR-2218 (BRII-835) and PEG-IFNα 2H 2021

Data Initial readout for Phase 2 combo study of VIR-2218 (BRII-835) and VIR-3434 1H 2022

BRII-179/BRII-835 Data Top-line interim clinical data for the Phase 2 combo study 2H 2022

COVID-19 BRII-196/BRII-198Data More comprehensive top-line results from the Phase2/3 ACTIV-2 trial 3Q 2021

Approval Wait for approval of Emergency Use authorization (EUA) in the US 2H 2021

HIV infection

BRII-778 Data Topline data readout for Phase 1 study 4Q 2021

BRII-732 Data Topline data readout for Phase 1 study 1Q 2022

BRII-778/BRII-732 Enrollment Enroll 1st patient into global Phase 2b combo study 2H 2022

MDR/XDR

gram-negative

infections

BRII-636Data Topline data readout for Phase 1 study 1H 2022

Submission China IND filing with a goal to participate in Qpex’s global Phase 3 study 1H 2022

BRII-693Data Topline data readout for Phase 1 study 2022

Submission China IND filing with a goal to participate in Qpex’s global Phase 3 study 2H 2022

PPD BRII-296 Data Topline data readout for Phase 1 study 4Q 2021

Brii Partner

OUTLOOKPIPELINE OVERVIEWCOMPANY OVERVIEW

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Contact: [email protected]

mailto:[email protected]

brii bio corporate presentation oct 2021

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