Pain Program Overview

Benitec Ltd

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Benitec’s ddRNAi Chronic Pain Opportunity

Non-Confidential Presentation

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This presentation contains forward looking statements that involve risks and uncertainties. Although we believe that the expectations reflected in the forward looking statements are reasonable at this time, Benitec can give no assurance that these expectations will prove to be correct. Actual results could differ materially from those anticipated. Reasons may include risks associated with drug development and manufacture, risks inherent in the regulatory processes, delays in clinical trials, risks associated with patent protection, future capital needs or other general risks or factors.

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Table of Contents

ddRNAi Technology Investment Thesis 4

Benitec Corporate Overview 5

Overview of the ddRNAi Technology 7

Cancer Pain Market Overview 9

The ddRNAi Neuropathic Pain Target 13

Preclinical Cancer Pain Data 15

KOL Reaction to Cancer Pain Product 17

Additional Indications for the Lead ddRNAi Product 20

Cancer Pain Product Development Plan 22

Investment Opportunity Summary 24

Contact Information 25

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ddRNAi Technology

Investment Thesis

DNA-directed RNA interference (ddRNAi) is a novel technology platform capable of achieving long-term targeted gene silencing.

Benitec’s pain product utilizes the ddRNAi technology to treat neuropathic pain in patients suffering from cancer and to overcome morphine tolerance in chronic pain sufferers.

Currently available treatments for cancer pain are largely opioids that do not effectively treat neuropathic pain, creating significant need for a product with a novel mechanism of action.

An accelerated approval pathway is expected for the lead product given the high-risk patient population.

Interviewed Key Opinion Leaders have uniformly expressed enthusiasm for the product based on its novel mechanism of action and potential for long-term pain inhibition.

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Benitec Corporate Overview

Based in Sydney, Australia, Benitec is a biopharmaceutical company developing a novel

DNA-directed RNA interference (ddRNAi) platform for therapeutic use. The company

is listed on the Australian stock exchange (ASX: BLT) with a market cap of ~AU$25M

and AU$7M cash at hand.

The novel, proprietary ddRNAi platform is currently being developed across multiple

therapeutic areas where there is a significant unmet need including oncology,

neuropathic pain, and hepatitis.

Benitec has a strong management team with deep scientific and clinical resources

and extensive experience with the commercialization of biological intellectual property.

The lead product in development internally at Benitec is targeted to terminal patients

with cancer for the treatment of neuropathic pain and has the potential for

commercialization other painful conditions. Benitec also has in-house programs in lung

cancer and hepatitis B, and a partnered program in hepatitis C.

Business Overview

Business Strategy

Management Team

Product Strategy

Benitec has a robust patent portfolio protecting their platform technology across the

major pharmaceutical markets with patent coverage extending through 2030. Intellectual Property

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Benitec Senior Leadership Team

CEO

Peter French, PhD

Cell and molecular biologist with an MBA in

Technology Management. Founder of stem cell

storage company Cryosite Ltd, launched six

new probiotic-based products with Probiomics.

CFO, Company Secretary

Greg West

Chartered Accountant, Director and audit

committee chairman of ITC Ltd, IDP

Education Pty Ltd, Education Australia Ltd,

and Sydney International Film School Pty Ltd.

Board of Directors

Peter Francis LLB Grad Dip

(Intellectual Property) Non-

executive Chairman

Partner at Francis Abourizk

Lightowlers (FAL), a legal

specialist in the areas of

intellectual property and licensing

and provides legal advice to a

large number of corporations and

research bodies.

Mel Bridges BAppSc FAICD

Non-executive Director

More than 30 years experience

in the global biotechnology and

healthcare industry. During this

period, he founded and

managed successful

diagnostics, biotechnology and

medical device businesses.

John Chiplin PhD


His most recent accomplishment

was the corporate reengineering

of Arana Therapeutics, a world

leading Antibody developer,

which resulted in the acquisition

of the company by Cephalon for

a significant premium to market.

Iain Ross BSc ChD


Over 30 years experience in the

international life sciences sector.

Following a career with Sandoz,

Fisons, Hoffman La Roche, and

Celltech he has undertaken and

had input to a number of

company turnarounds and

start‐ups

Benitec’s management team has demonstrated experience and expertise in developing and licensing novel

therapeutic technology.

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Benitec’s Novel

RNA Interference Technology

ddRNAi Mechanism of Action Benitec technology

ddRNAi DNA construct

Sources: Zou W et al., Intrathecal Lentiviral-Mediated RNA Interference Targeting PKCγ Attenuates Chronic Constriction Injury–Induced Neuropathic Pain in Rats. Human Gene Therapy. 22:465–475 (April 2011)

Benitec’s ddRNAi technology platform utilizes a self-inactivating lentiviral vector to express shRNA molecules

which silence a targeted gene of interest.

The ddRNAi-based product consists of a third-generation

vesicular stomatitis virus G (VSV-G) pseudotyped self-

inactivating lentiviral vector containing a novel gene

construct.

The construct expresses a short hairpin RNA (shRNA)

molecule intended to silence the selected gene of

interest.

The expressed shRNA integrates into the host’s native

RNAi process where it is separated into single strands

and binds to the target mRNA.

– This results in cleavage of the target RNA and

silencing of the gene of interest.

ddRNAi Mechanism of Action

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Benitec’s novel ddRNAi technology allows for long-term

gene silencing.

The technology can be targeted to silence a specific

gene or multiple selected genes.

Unlike current treatments for pain, this product is long-

lasting and has the potential to cause only minimal side

effects.

The ddRNAi product is injected intrathecally into the

spinal canal where it transfects the PKCγ-containing

interneurons.

ddRNAi Technology For

Cancer Pain Treatment

Utilizing the ddRNAi platform, Benitec has developed their gene silencing technology for the treatment of pain

in terminal cancer patients.

Brain

Spinal Cord

Benitec Technology


+ Intrathecal injection of


Source: http://www.nlm.nih.gov/medlineplus/ency/imagepages/19621.htm

A ddRNAi Construct for Treating Cancer Pain The ddRNAi Platform Technology

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Cancer-Associated Pain Market

The global incidence of cancer is expected to experience a slow and steady rise driven by population growth

and increasing lifespan. More than half of all cancer patients experience some form of pain.

There are approximately 11.7 million people in the US

with cancer.

Among newly diagnosed cancer patients, 38%

experience pain.

About 74% of cancer patients with advanced disease

experience some form of pain, with estimates ranging as

high as 82%.

Among the cancer patient population who experience

pain, 30% suffer from breakthrough pain, an acute and

oftentimes extremely painful flair of pain that “breaks

through” chronic pain analgesia.

Global Incidence of Cancer-Associated

Pain Among Cancer Patients

Sources: Cowen Therapeutic Categories Outlook – Pain Management, March 20, 2011; Hearn J, Higginson IJ. Cancer Pain epidemiology: a systematic review. In Bruera ED, Portenoy RK, eds. Cancer Pain Assessment and Management. UK: Cambridge University Press; 2003; Vuorenin E. Pain as an early symptom in cancer. Clin J Pain 9(4):272-8, 1993; Ger LP et al., The prevalence and severity of cancer pain: a study of newly diagnosed cancer patients in Taiwan. J Pain Symptom Manage 15(5):285-93, 1998; Datamonitor. Cancer Pain. December 2009; http://www.cancer.org/cancer/cancerbasics/cancer-prevalence. US National Cancer Institute's Surveillance Epidemiology and End Results (SEER) database. 2007.

65%

Approximately 65% of all cancer

patients experience pain

Cancer Pain Incidence and Prevalence

Experience

Cancer-Related Pain

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Current Treatments for Cancer Pain

Opioids are the most commonly used therapy for pain,

but they are generally not helpful for neuropathic pain.

Commonly used opioids include:

– Morphine, hydrocodone, oxycodone, codeine, and

fentanyl

Opioids are often associated with side effects that

include:

– Constipation, confusion, insomnia, delirium, anxiety,

nausea, vomiting, sleep apnea, and interference with

gonadotropins

Even with the addition of adjuvant treatments such as

anti-convulsants, KOLs stated that the majority of

patients do not have their neuropathic pain significantly

relieved.

Opioids are the first line of therapy for cancer pain, but their efficacy is often insufficient and their side effects

can be severe.

EU Palliative Care Perspective

Treatment Algorithm for Severe

Cancer Pain

Try other options from above groups. Also consider spinal administration of local anesthetics, alpha-2

agonists, nerve blocks, and spinal cord stimulation.

NSAID Opioid Opioid

Combination

Adjuvant:

Antidepressant

Anticonvulsant

Change to a

different drug

of the same

class

Change to a

drug of a

different class

Inadequate response

Inadequate response

Change to a

different route of

administration

“It could be argued that we shorten lives of many patients by

giving them increasing doses of strong opioids.”

—Palliative Care Specialist

Sources: Datamonitor. Cancer Pain. December 2009; Results of nine KOL interviews conducted by Campbell Alliance in July and August 2011.

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Unmet Needs in Cancer Pain

A significant need exists for a therapy capable of treating the complex neuropathic pain often experienced by

cancer patients.

Unmet Needs in Cancer Pain

Neuropathic pain was universally regarded by KOLs as

the most difficult type of pain to treat with currently

available therapies.

A reduction in the many side effects caused by opioids

was stated by many KOLs to be the greatest unmet

need.

The worsening of sleep apnea and interference with

gonadotropins are major concerns associated with the

high-dosage opioids used for cancer pain.

Source: Results of nine KOL interviews conducted by Campbell Alliance in July and August 2011.

“There’s always some issue related to their opioids. There’s

always something in terms of side effects.”


“We have a lot of drugs available, but unfortunately even

when you combine three or four drugs there is a group of

patients that you can only marginally help.”


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Patient Population Potentially Treated with ddRNAi Technology for Cancer Pain

Cancer Pain

Market Opportunity

0

10

20

30

40

50

60

70

80

Nu

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er

of

Ref

ract

ory

Te

rmin

al

Can

cer

Pai

n P

atie

nts

(Th

ou

san

ds)

ddRNAi Product Other Invasive Products

The cancer pain ddRNAi product may be used in up to 65% of cancer patients receiving invasive pain

therapy, and significant potential exists to expand into the larger cancer pain patient population.

Source: Results of nine KOL interviews conducted by Campbell Alliance in July and August 2011; Campbell Alliance analysis.

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ddRNAi Neuropathic Pain Target

Benitec has identified PKCγ as a unique target to address the unmet need in cancer pain. PKCγ has been

shown to play a major role in the transmission of neuropathic pain.

PKCγ in Pain Transmission

The PKC superfamily consists of a set of enzymes that phosphorylate serine and threonine amino

acids. The PKC enzymes are involved in cellular processes ranging from proliferation to memory.

PKCγ is a member of the PKC superfamily found mostly in the brain and spinal cord. PKCγ has

been implicated in the transmission of neuropathic pain.

Activation of PKCγ in the spinal cord is involved in persistent pain states, especially in

neuropathic pain after nerve injury.

The restricted spinal cord location of the PKCγ-containing interneurons allows a selective inhibitor

to inhibit nerve injury-induced neuropathic pain without the side effects of nonselective PKC

inhibitors.

Additional gene targets can be incorporated into the DNA construct to allow for

more robust pain inhibition.

– Additional identified targets include D-Amino acid oxidase (DAO) and nerve growth

factors.

Sources: Zou W et al., Intrathecal Lentiviral-Mediated RNA Interference Targeting PKCγ Attenuates Chronic Constriction Injury–Induced Neuropathic Pain in Rats. Human Gene Therapy. 22:465–475 (April 2011). Mellor H and Parker PJ, The extended protein kinase C superfamily. Biochem J. 1998 Jun 1;332 ( Pt 2):281-92. http://www.nlm.nih.gov/medlineplus/ency/imagepages/19621.htm

Brain

Spinal Cord

PKCγ Localization

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Key Opinion Leader Validation of the

Neuropathic Pain Target

KOLs reacted favorably to the mechanism of action because of the strong connection between PKCγ and

neuropathic pain.

PKCγ Target for Silencing

There was a very positive reception of PKCγ as a

target for the treatment of pain.

KOLs familiar with the role of PKCγ in neuropathic pain

expressed strong optimism regarding the potential to

alleviate neuropathic pain by silencing PKCγ

expression.

It was noted that PKCγ makes a lot of sense for

preventing allodynia, defined as pain due to a stimulus

which does not normally provoke pain, which is a

common problem in patients with sever cancer pain.

KOLs also saw potential for the target to help with

opioid tolerance due to the relevant biochemical

cascade being similar to that of neuropathic pain.


“Noting the mechanism of neuropathic pain and the cascade

of evidence associated with the activation of kinases, this

product seems to be good, especially in neuropathic pain

but also in opioid tolerance.”


“The type of cancer pain with nerve compression is the

hardest to treat, I would guess PKCγ would be

better…PKCγ is involved in the development of allodynia,

so blocking it makes sense”

—KOL in Pain Research

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ddRNAi Cancer Pain Product

Preclinical Studies

Sources: Zou W et al., Intrathecal Lentiviral-Mediated RNA Interference Targeting PKCγ Attenuates Chronic Constriction Injury–Induced Neuropathic Pain in Rats. Human Gene Therapy. 22:465–475 (April 2011). http://charliewilliamssustainability.blogspot.com/2010/10/blog-post.html. Accessed October 2011.

Preclinical studies have been conducted to determine the efficacy of PKCγ-targeted ddRNAi on pain

inhibition.

Study Design

Lentiviral vectors encoding a specially designed shRNA against the PKCγ gene (shPKCγ)

were introduced into neurons and spinal cord of rats via intrathecal catheter.

Pain threshold testing was performed using tests for mechanical and thermal pain.

– Mechanical pain was assessed by measuring paw mechanical withdrawal thresholds

(PMWT) in response to pressure from an electronic von Frey anesthesiometer (N=8).

– Thermal pain was assessed by measuring the paw withdrawal thermal latency (PWTL)

upon application of a heat source aimed at the mid-plantar area (N=8).

http://1.bp.blogspot.com/_c0mTqLyzOBo/TLcO9KtLC1I/AAAAAAAAAFU/JFjk0EfAI4Y/s1600/rat+edit.jpg

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Preclinical Studies—Results

PKCγ-Mediated Pain Inhibition in Rats

Sources: Zou W et al., Intrathecal Lentiviral-Mediated RNA Interference Targeting PKCγ Attenuates Chronic Constriction Injury–Induced Neuropathic Pain in Rats. Human Gene Therapy. 22:465–475 (April 2011)

Time after intrathecal delivery (days)

Time after intrathecal delivery (days)

Mec

han

ical

Wit

hd

raw

al T

hre

sho

ld (

g)

Paw

Wit

hd

raw

al L

aten

cy (

sec)

Sham Saline

Control Vector shPKCγ1 (10μl)

shPKCγ2 (10μl) shPKCγ1 (5μl) shPKCγ2 (5μl)

Sham Saline Control Vector shPKCγ1 (10μl)

shPKCγ2 (10μl)

shPKCγ1 (5μl) shPKCγ2 (5μl)

*p<0.05 vs. sham or saline group

A

B

These preliminary animal studies demonstrate the ability of PKCγ-targeted ddRNAi to achieve pain inhibition

for at least six weeks post injection.

Results

Animals showed a significant increase in pain

threshold to mechanical (A) and thermal (B)

stimulation.

The increase in pain threshold was dose-dependent

and lasted for the duration of monitoring.

No toxicity was observed in any animals for six

weeks following injection of vectors.

– Rats had normal appearance, levels of activity,

and feeding patterns.

Effi

cacy

To

xici

ty

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Key Opinion Leader Assessment of

the ddRNAi Cancer Pain Product

0

1

2

3

4

5

6

7

Overall Opinion of the ddRNAi Product

US KOL EU KOL

KOLs consistently viewed the product favorably due to its

unique mechanism of action and potential for minimal

toxicity.

No other current pipeline products were viewed with

consistent optimism and a product with a new mechanism

of action was said to be sorely needed.

The potential for the product to treat neuropathic pain

was seen as especially beneficial, as current treatments

are severely lacking for this type of pain.

The product may be particularly useful for patients with

significant opioid tolerance for whom adjuvants are

ineffective.

Question: On a scale of 1 to 7 (1=Very low, 7=Very high) how would you rate this product based on the product profile?

Average: 6.4

n = 5 out of 9


“This product sounds exciting, if you can turn off the protein

that is being produced that is turning the cell on or basically

sensitizing it, you know it has so much more potential, not only

for cancer pain but other types of neuropathic pain, even for

opioid-induced hyperalgesia.” —KOL in Pain Research

“No one med is overwhelmingly efficacious for neuropathic

pain. In studies it’s about 30% of the time that you’re going to

target that pain effectively. It’s usually polypharmacy,

which also is a challenge.” —Palliative Care Specialist

Overall Product Perception

Potential to Fulfill Unmet Needs

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Potential Lead Indication for the

ddRNAi Pain Product

KOLs saw terminal cancer patients as an ideal lead indication for the ddRNAi product due to the level of

novelty of the product and the length of trials required for an indication in this patient segment.

KOLs see strong potential for the ddRNAi cancer pain

product to be used in terminal patients suffering from all

types of cancer.

Tumor types with a high degree of neuropathic pain

were noted to include pancreatic, lung, breast, ovarian,

and head & neck.

KOLs expect the ddRNAi cancer pain product to be

used before other invasive therapies such as nerve

blocks, opioid catheters, and spinal cord stimulation.

“Terminal cancer patients are a good group to target…it’s a

group that the FDA will allow you to go after relatively

easily.” —KOL in Pain Research

“Virtually all cancer patients at some time in their disease

experience neuropathic pain. It’s more common in terminal

patients…performance and pain are intertwined, this

may make a huge impact on life expectancy.”


Terminal Cancer Patients


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Potential Product Adoption in

Cancer Pain

KOLs anticipate physician adoption to be initially concentrated on patients with tumor types that either are

associated with neuropathic pain or have a high number of terminal patients.

Tumor Type Rationale Number of

Annual Deaths (US & EU)

Breast High prevalence, chronic neuropathic pain common following surgery

86,000

Lung High prevalence, likely to metastasize near neural structures

290,000

Pancreatic Severe pain with high degree of neuropathic qualities, difficult to treat

82,000

Cervical Complications with nerves, significant visceral pain

9,000

Head and Neck High degree of pain with complex pain symptoms

17,000

Lymphoma High degree of neuropathic pain common with paraspinal involvement

45,000

Colon High prevalence 108,000

Prostate High prevalence, likely to cause bone metastases that are difficult to treat

74,000

Ovarian High degree of difficult to treat pain, likely to receive intrathecal pumps

34,000

Esophageal High degree of pain 32,000

“I would use this in patients with neuropathic pain and in

patients who are receiving increasing doses of opioids, just

to minimize the escalation of opioids. So not only

neuropathic pain in my opinion.”


“Any kind of tumor may produce neuropathic pain because

of the growth of the mass.”


“I would definitely use this. It’s something I could offer easily

and for some of these patients that are so severe this would

be easier and less severe than some of the neurolytic

blocks…any tumor type with spinal metastasis would

be a good candidate.”


Source: Results of nine KOL interviews conducted by Campbell Alliance in July and August 2011. American Cancer Society. Cancer Facts and Figures 2011. Available at http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-029771.pdf. Accessed August 2011.

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Potential Additional Indications for

the ddRNAi Pain Product

KOLs anticipate the ddRNAi product to have use treating pain in all types of cancer patients as well as

patients suffering from conditions such as diabetic neuropathy, postherpetic neuralgia, and HIV/AIDS.


Additional Indications

Following the initial indication of terminal cancer pain,

physicians indicated the product could fill a significant

unmet need in non-terminal patients also suffering

from cancer-related pain, especially those whose pain is

opioid refractory.

Approval in non-terminal cancer patients may drive the

use of the product in the medical oncology setting.

There is also a high unmet medical need in treating

patients for post-herpetic neuralgia (shingles), and

this patient segment is often also treated by palliative

care physicians. Physicians interviewed indicated that

this indication would be a logical next step in the product

life cycle.

KOLs noted that the ddRNAi product also has potential

to meet significant unmet needs in patients with pain

caused by diabetic neuropathy, chemotherapy-

induced neuropathy, and HIV/AIDs.

“Patients having chemotherapy can have an activation of

herpes. It’s devastating, it changes their life more than

cancer. There is no treatment that is effective so I’m sure

the patients would be willing to try this. They have

neuropathic pain; it’s very bad.” —Palliative Care Specialist

“HIV patients often have neuropathic pain, and it can be

chronic pain. This product has the potential to reduce pain

for a long period of time, and the patient is taking drugs

day in and day out for their condition.”


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Potential Additional Indications for

the ddRNAi Pain Product

Recent research has shown that silencing of the PKCg gene also significantly reduces morphine tolerance in

a pre-clinical pain model.

Addressing Morphine Tolerance

Morphine is among the most prescribed opioid pain

relievers for severe chronic pain.

Morphine tolerance is a major clinical hurdle due to the

progressive decline of dose potency occurring after a few

weeks of treatment.

Tolerance is countered by administration of increasing

dosage, increasing the side effects of morphine therapy, or

selecting another pain suppressant in opioid rotation trails.

Research demonstrated successful reduction of morphine

tolerance using the same ddRNAi construct that is

shown to be effective in overcoming neuropathic pain.

These finding broaden the areas of application of the

technology Benitec is developing, increasing morphine

treatment efficiency in a large of chronic pain patients

besides those suffering from cancer related neuropathic

pain.

Source: Z. Song et al, THE JOURNAL OF GENE MEDICINE Vol 12, pages 873–880, 2010

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Clinical Trial Plan for the ddRNAi

Cancer Pain Product

A phase I/II study of the ddRNAi-based product is planned in terminal cancer patients with intractable pain

and a quick timeline to approval is expected.

Study Overview

Patient Population Study Design Objectives

Randomised double blind phase I/II study of ascending single doses of intrathecally administered

ddRNAi-based product in terminal cancer patients experiencing cancer-associated pain

Patients who have

intractable pain due to an

underlying malignancy (or

other terminal illness)

Life expectancy < 6 months

Determine the acute safety profile of the

ddRNAi-based product when administered

intrathecally in a single dose

Determine the efficacy (chemo-sensitizing)

effects of the ddRNAi-based product when

administered three days prior to each cycle

of standard chemotherapy (repeat single

doses)

The study will include three dosing

arms with each dose given to n = 4

patients and 1 control patient

Dose 1 (low dose)

Dose 2 (medium dose)

Dose 3 (high dose)

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Development Plan and Timeline

ddRNAi Cancer Pain Product Clinical Development Timeline

2011 2012 2013 2014 2015

Preclinical Studies (anti-human PKCγ construct)

Phase I/II Clinical Studies

Phase I/II Trial (cancer patients with intractable pain)

* Other indications include: diabetic neuropathy, postherpetic neuralgia, and HIV/AIDS

Additional Planned Studies:

Toxicology and biodistribution studies

Large Phase II and III studies in cancer patients

Other indications*

Proof of concept in pre-clinical model of pain

Toxicology studies

IND Preparation and Submission

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Investment Opportunity Summary

ddRNAi Product Asset Summary

Extensive IP Estate Patent Coverage Through 2030

Favorable KOL Response Strong Support From KOLs for the Unique MOA

Additional Indications

Potential use in Diabetic Neuropathy, Postherpetic Neuralgia,

and HIV/AIDS

Unmet Medical Need Large, Unmet Need for Treatment of Cancer Pain

Large Market Opportunity High Revenue Potential in Oncology and Additional

Indications

Potential for Accelerated Timeline Short-term Trials are Anticipated in Initial Indications

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Contact Information

To respond to this introduction to the ddRNAi opportunity, please contact:

Dr. Peter French, Ph.D., M.B.A.

CEO Benitec Ltd.

Phone: +61 (0)412 457 595 E-mail: [email protected]

or

Ben Bonifant Senior Vice President

Campbell Alliance Phone: (919) 844-7100 x7176

E-mail: [email protected]

Health & Medicine

Pain Program Overview