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1 YM AGM Presentation | November 2012 YM BioSciences AGM Presentation November 2012

YM BioSciences 2012 Annual Meeting of Shareholders

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Page 1: YM BioSciences 2012 Annual Meeting of Shareholders

1 YM AGM Presentation | November 2012

YM BioSciences

AGM Presentation

November 2012

Page 2: YM BioSciences 2012 Annual Meeting of Shareholders

2 YM AGM Presentation | November 2012

YM BioSciences 2012 Annual General Meeting

A. Formal Business

1) Fix Number of Directors to be Elected

2) Election of Directors

David Allan, Thomas Allen, Kapil Dhingra, Mark Entwistle, Henry

Friesen, Nick Glover, Catherine Mackey, Nicole Onetto and Tryon

Williams

3) Appointment of Auditors

4) Further Business and Termination of the Meeting

B. Presentation from Management

Page 3: YM BioSciences 2012 Annual Meeting of Shareholders

3 YM AGM Presentation | November 2012

Safe Harbor

This presentation may contain forward-looking statements, which reflect the Company's current

expectation regarding future events. These forward-looking statements involve risks and uncertainties

that may cause actual results, events or developments to be materially different from any future results,

events or developments expressed or implied by such forward-looking statements. Such factors

include, but are not limited to, changing market conditions, the successful and timely completion of

clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing,

new product development, uncertainties related to the regulatory approval process or the ability to

obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to

complete clinical trials or to meet commercial demand, and other risks detailed from time to time in the

Company's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing

forward-looking statements include but are not limited to the following: that our product candidates will

generate positive efficacy and safety data in future clinical trials, and that YM and its various partners

will complete their respective clinical trials within the timelines communicated. Except as required by

applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking

statements, whether as a result of new information, future events or otherwise.

Page 4: YM BioSciences 2012 Annual Meeting of Shareholders

4 YM AGM Presentation | November 2012

Strategic Priorities for FY2012

1. Ensure optimization of the clinical and commercial potential of CYT387

• Myelofibrosis as proof-of-concept/path-to-market indication: PI/II – PIII transition

• Explore strategic partnering to potentially maximize value of the asset

• Initiate preclinical studies to explore anemia mechanism of action

2. Build a portfolio of products with clinical and commercial potential

• R&D collaborations

• YMBA Intellectual Property estate and small molecule libraries; JAK/kinase

screening project

• In-licensing and M&A opportunities

3. Minimize and rationalize resource expenditures

• Support ongoing development of nimotuzumab by sub-licencees

• Review clinical and commercial opportunity for CYT997

Page 5: YM BioSciences 2012 Annual Meeting of Shareholders

5 YM AGM Presentation | November 2012

CYT387: Our Promising Lead Asset

Significant Opportunity

• A potentially differentiated drug in the emerging JAK class

Strong Fundamentals

• Under-served initial disease with $B market potential

• Compelling clinical proof-of-concept data

Rapid Progress

• 2.5 years of expanding clinical development

• Transitioning to Phase III

• Oriented towards commercialization

Page 6: YM BioSciences 2012 Annual Meeting of Shareholders

6 YM AGM Presentation | November 2012

Our Significant Expertise in JAK Research

YM acquired original intellectual assets in

JAK field

– Identified by Dr. Andrew Wilks, Ludwig

Cancer Institute, Melbourne, Founder of

Cytopia (now YM Australia)

– First group to publish crystal structures

of JAK2 and JAK1

– Medicinal chemistry and molecular

modeling expertise

Intellectual Property

CYT387 Composition of Matter

US: Pending, 2028 expiry

EU: Pending, 2028 expiry

JAK2 Crystal Structure

US: Issued, 2025 expiry

EU: Pending, 2026 expiry

JAK2 Enzyme

US: Issued, 2015 expiry

Page 7: YM BioSciences 2012 Annual Meeting of Shareholders

7 YM AGM Presentation | November 2012

Target Markets for JAK Inhibitors

Cancer /

Hematology Autoimmune

Diseases

– Rheumatoid

Arthritis

– Psoriasis

– Graft vs. Host

Disease

Myeloproliferative

Neoplasms

– Myelofibrosis

– Polycythemia Vera

– Essential

Thrombocythemia

– Leukemia and

Lymphoma

– Solid Tumors

– Other Hematologic

Disorders

Chronic Disorders Clinical Proof of Concept Acute Diseases

Page 8: YM BioSciences 2012 Annual Meeting of Shareholders

8 YM AGM Presentation | November 2012

Clinical Presentations of Myelofibrosis

A chronic debilitating disease in which a

patient’s bone marrow is replaced by scar

tissue

– Anemia – often requiring transfusions

– Thrombocytopenia

– Splenomegaly

– Constitutional symptoms

Fatigue, night sweats, pruritus, bone pain,

weight loss, fever

Page 9: YM BioSciences 2012 Annual Meeting of Shareholders

9 YM AGM Presentation | November 2012

Anemia Impacts Survival in Myelofibrosis

– ~70% of myelofibrosis patients are Intermediate-II or High risk †

– Estimated that 30-50% of all myelofibrosis patient are transfusion dependent‡,

majority of which are Intermediate-II and High risk patients

† DIPSS-Plus; Gangat et al. JCO 2011; 29(4), 392 ‡ Elena et al. Haematologica 2011 96(1) 167

Anemia at any time Anemia at diagnosis

Page 10: YM BioSciences 2012 Annual Meeting of Shareholders

10 YM AGM Presentation | November 2012

Transfusion Independence Response (as at ASH 2011)

1 Includes 100 mg QD (n=3), 200 mg QD (n=3), and 400 mg QD (n=6) doses 2 Not statistically significant vs. 300 mg QD

* Ongoing

Response by Dose 150 mg QD

(n=52)

300 mg QD

(n=60)

150 mg BID

(n=42)

Total1

(n=166)

Transfusion dependent at baseline (evaluable; n) 25 26 14 68

Median time on study (days) 251 245 141 250

Transfusion independence rate (12 weeks)* 48% 65% 43%2 54%

Transfusion independence rate (12 weeks & Hgb≥8g/dL)* 40% 62% 29%2 46%

– >25% of subjects not receiving transfusions while on study experienced at least a 1 g/dL increase in Hgb

for ≥ 8 weeks

Time to Response Median Min-Max

Time to confirmed response (12 wks & Hgb≥8 g/dL) (days) 84 84-293

Duration of transfusion-free period (12 wks & Hgb≥8 g/dL) (days) not yet reached 82-506*

Page 11: YM BioSciences 2012 Annual Meeting of Shareholders

11 YM AGM Presentation | November 2012

Maximum Duration of Transfusion-Free Period (as at ASH 2011, ongoing)

0 100 200 300 400 500

Time (days)

Re

sp

on

de

rs

* As at ASH 2011

Clinically relevant maintenance of

transfusion independence period

Page 12: YM BioSciences 2012 Annual Meeting of Shareholders

12 YM AGM Presentation | November 2012

Spleen Response (as at ASH 2011)

1 Includes 100 mg QD (n=3), 200 mg QD (n=3), and 400 mg QD (n=6) doses

* Ongoing

Response by Dose 150 mg QD

(n=52)

300 mg QD

(n=60)

150 mg BID

(n=42)

Total1

(n=166)

Spleen evaluable (n) 47 51 33 142

Median time on study* (days) 252 225 144 225

Spleen response* (IWG-MRT) 30% 33% 27% 31%

≥50% decrease in palpable spleen length at six months 28% 33% 39% 33%

Median spleen decrease at six months -35% -35% -39% -35%

Time to Response Median Min-Max

Time to IWG-MRT response (days) 15 6-260

Duration of response (days) not yet reached 55-574*

Response by Diagnosis Primary MF

(n=106)

Post-PV MF

(n=36)

Post-ET MF

(n=24)

Spleen evaluable (n) 88 34 20

Spleen response* (IWG-MRT) 28% 38% 30%

Page 13: YM BioSciences 2012 Annual Meeting of Shareholders

13 YM AGM Presentation | November 2012

Maximal Change in Palpable Spleen Size (as at ASH 2011, ongoing)

* Ongoing

-100%

-80%

-60%

-40%

-20%

0%

20%

40%

60%

80%

% C

han

ge F

rom

Baselin

e

(Core Study; n=142)

≥ 25% decrease from baseline: 87%

≥ 50% decrease from baseline: 49%

≥ 75% decrease from baseline: 25%

100% decrease from baseline: 16%

Page 14: YM BioSciences 2012 Annual Meeting of Shareholders

14 YM AGM Presentation | November 2012

Constitutional Symptoms Response at Six Months (as at ASH 2011)

23% 22% 23% 19%

11%

57% 52%

44%

30%

89%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Night Sweats(n=62)

Pruritis(n=46)

Bone Pain(n=43)

Cough(n=27)

Fever(n=9)

Perc

en

tag

e o

f P

ati

en

ts

Complete Resolution

Marked Improvement

Complete resolution or marked improvement of common constitutional

symptoms is achieved in the majority of subjects

Page 15: YM BioSciences 2012 Annual Meeting of Shareholders

15 YM AGM Presentation | November 2012

CYT387 – Safe, Effective, Differentiated

CYT387 treatment results in significant, durable responses in anemia,

splenomegaly and constitutional symptoms at all doses evaluated.

– Therapeutic benefit and safety established in a population with multiple risk

factors, including anemia and thrombocytopenia

– CYT387 anemia benefit appears unique among the current class of JAK1 and

JAK2 inhibitors

– Clinically relevant maintenance of transfusion independence period

– MRI performed in a subset of subjects confirms the meaningful improvement in

splenomegaly measured by palpation

– Complete resolution or marked improvement of common constitutional

symptoms is achieved in the majority of subjects

Page 16: YM BioSciences 2012 Annual Meeting of Shareholders

16 YM AGM Presentation | November 2012

Variable Diagnosis* >1 year* CYT387

Anemia 38% 64% Benefit

Transfusion dependency 25% 45% Benefit

Palpable spleen >10cm 21% 46% Benefit

Constitutional symptoms 29% 34% Benefit

CYT387: Meets Clinical Needs in Myelofibrosis

CYT387 has a profile that addresses MF clinical needs and overarching risk factors

> Benefit on anemia and transfusion dependency

> Activity for spleen and symptoms

> Low myelosuppression

CYT387 is well tolerated for dosing periods up to and exceeding two years

* Mayo Clin Proc 2012;87(1): 25-33

Page 17: YM BioSciences 2012 Annual Meeting of Shareholders

17 YM AGM Presentation | November 2012

Preclinical Preparation Activities

CYT387 Myelofibrosis Development Pathway

Feb 2010

Acquired

Cytopia

March 2010

Increased

CYT387 trial

from 21 to

60 patients

Aug 2010

CYT387

designated

Orphan

Drug

Nov 2010

Increased trial

from 60 to 140

patients and

added BID

cohort

Dec 2010

Reported

Interim 60

patient data

at ASH

July 2011

Reported

Interim 60

patient 12-week

data at ASCO

Sept 2011

Completed

enrollment of

166 patient trial

&

Initiated BID trial

Dec 2011

Reported Interim

166 patient

multicenter data

at ASH

June 2012

Completed

dosing of 166

patient trial

July 2012

Completed

enrollment

of 61

patient

BID trial

Dec 2012

Report Final 9-

month 166

patient data at

ASH

Partnering Campaign

PIII & Commercial Readiness

FDA and EMA Discussions

Capsules to tablet transition

Financing

Build Management

Expand Clinical Development

Page 18: YM BioSciences 2012 Annual Meeting of Shareholders

18 YM AGM Presentation | November 2012

CYT387: Next Steps

ASH 2012

• Podium presentation at ASH 2012

• Phase I/II Core study results reinforce differentiated profile

Business Development

• Exploring opportunities to develop CYT387 with other companies

• Conducted a broad, robust business development process

• Actively exploring variety of options

Phase III

• Preparations for Phase III ongoing

• Flexibility to advance CYT387 with or without a partner

Page 19: YM BioSciences 2012 Annual Meeting of Shareholders

19 YM AGM Presentation | November 2012