nimotuzumab

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Calendar Q1/2009 advancing drugs effectively S. Korea Japan Australia Singapore Indonesia EU USA Canada

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Page 1: Nimotuzumab

Calendar Q1/2009

advancing drugs effectively

S. Korea

Japan

Australia

Singapore

Indonesia

EU

USA

Canada

Page 2: Nimotuzumab

2Calendar Q1/2009

Safe Harbor Statement

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 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 nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; that AeroLEF® will continue to 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 in this release. 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 3: Nimotuzumab

3Calendar Q1/2009

YM BioSciences Inc.

> Two principal development assets:

• Nimotuzumab

– Highly differentiated product competing within a large and validated market

• AeroLEF®

– Highly differentiated product competing within a large and validated market

Page 4: Nimotuzumab

4Calendar Q1/2009

AeroLEF®

> Uniquely permits patient self-titration of opioids:

• Fentanyl is first product

• Soft mist inhalation with an approved nebulizer

• New management team with established fentanyl development and regulatory experience mandated to partner product

Page 5: Nimotuzumab

5Calendar Q1/2009

Nimotuzumab

> An EGFR-targeting drug

• Erbitux®, Vectibix® and Tarceva® currently marketed

> Clinically demonstrated to be an active drug in multiple tumor types

• 10 tumor types

• >30 trials

> Efficacious – Marketed in numerous secondary markets including India

Page 6: Nimotuzumab

6Calendar Q1/2009

Clinical Evidence >30 Trials in Ten Tumor Types

Overall survival placebo + RT = 8.67 monthsNimotuzumab + RT = 16.43 months

Interim analysis of 65/80 patients to complete the trial

Phase III RT +/-nimotuzumab

Glioma HGG

Twenty patients (83%) – CR or PR. The median overall survival (n=24) was 51.7 months.

In publication Phase II single-arm100 and 200 mgs

H & N (locally advanced)

CR 91% vs. 52% at 17 weeksMarketing Approval by Health Regulatory Authorities in China

Randomized Phase II RT +/- nimotuzumab

Nasopharyngeal

Significant tumor response rates (CR/ORR) compared to RT alone and to CT + RT alone.

Marketing Approval by Health Regulatory Authorities in India

Multi-modal 4-arm Phase II CT/CRT +/-nimotuzumab

H & N Stage III & IVA unresectable(BEST trial)

CR+PR+SD 92% vs. 44%OS 7 months vs. 2.5 months

Preliminary analysis (EORTC/NCI/AACR October 2008)

Randomized Phase II RT +/- nimotuzumab

Brain Metastases from NSCLC

Substantial radiological responses and meaningful clinical responses in each cohort. Median survival of three cohort equals 60 weeks.

ASCO June 2008 & Preliminary data on

2nd cohort

Palliative Phase I/IISingle-armPatients unsuitable for

radical therapy

NSCLC

Page 7: Nimotuzumab

7Calendar Q1/2009

Multiple randomized trials ongoing in 2009

DIPG Phase III

recruitment completed

Adult GliomaPhase IIIOpen label

PancreaticPhase IIb/IIIaDBRCT

Europe

GastricPhase IIROL

Other indications anticipated

Japan and Korea

Brain MetastasesPhase IIDBRCT

Non Small Cell LungPhase IIDBRCT

DIPG Phase IIOpen label

North America

Nimotuzumab – Path to Approval

Page 8: Nimotuzumab

8Calendar Q1/2009

Nimotuzumab

> Cetuximab and panitumumab toxicities serious and underreported

> Nimotuzumab has NO reports of Grade III/IV radiation dermatitis, skin or renal toxicity in >3,500 patients treated

> Mechanistically demonstrated to be differentiated from cetuximab (Erbitux®)and panitumumab (Vectibix®)

Page 9: Nimotuzumab

9Calendar Q1/2009

Y

Monovalent Binding (Affinity)

Bivalent Binding(Avidity = ~Affinity2)

Y

Nimotuzumab – Mechanistic Difference/Herceptin Model

Marketed mAbs attach to any EGFR-expression including normal tissue*

Nimotuzumab binding similar to HerceptinNimotuzumab requires identifiable target density*

*AACR Cancer Clinical Trials and Personalized Medicine 2008, Abstract #A36, Tikhomirov et al

Page 10: Nimotuzumab

10Calendar Q1/2009

> Med-High EGFR environment (cancer cells): all mAbs bind in the same manner—bivalently*

• Evidence of equivalent therapeutic efficacy of nimotuzumab to higher affinity mAbs (clinical/preclinical)

> Nimotuzumab’s affinity optimization results in transient monovalent binding and stable bivalent binding

• Differentiates between normal and cancer cells

Nimotuzumab Therapeutic Effect Concentrated at Tumor

* Yoshida et al 2008; Tikhomirov et al 2008; L van Bueren et al 2008

Page 11: Nimotuzumab

11Calendar Q1/2009

Nimotuzumab – Mechanistically Differentiated

NimotuzumabAffinity-Optimized™ Ab

High Affinity anti-EGFR Abs

Activity of Nimotuzumab is Concentrated at

Tumor

Activity of High Affinity anti-EGFR Abs is dispersed

across all tissues, causing toxicity

Tumor(High

EGFR)

Tumor(High

EGFR)

Page 12: Nimotuzumab

12Calendar Q1/2009

Nimotuzumab – Targeting Abnormal EGFR Over-expression

1 Bristow RG, Hill RP: Molecular and cellular basis of radiotherapy, in Tia HR (ed): The Basic Science of Oncology. New York, NY, McGrawHill,1998, pp 295-322

2 Michaelis et al, Clin Cancer Research 2008; 14(20) Oct 15, 2008

EGFR over-expression occurs naturally or as a result of treatment

Naturally high-expressing tumors:

> Gastric

> Glioblastoma

> Head and neck

Induction of receptor density and activity:

> Radiation therapy1 > Chemoradiation1

> Certain chemotherapy (eg. Cis-Platin)2

Page 13: Nimotuzumab

13Calendar Q1/2009

> The only anti-EGFR mAb tolerable for chronic use – the drug of choice for combination chemo+RT

• With Erbitux®, 20% treatment discontinuation in combination CisPt/RT regimen previously reported1

> Affinity-optimized™ nimotuzumab has potential for significantly improved therapeutic window relative to Erbitux® and Vectibix®

• Lower affinity for normal cells (skin and kidney) vs. Erbitux®2

• No evidence of Grade III/IV kidney toxicity (hypomagnesemia)3

• No evidence of Grade III/IV skin toxicity3

• Longer duration of treatment = greater severity of hypomagnesemia4

Nimotuzumab – Uniquely Positioned Anti–EGFR mAb

1 Erbitux® Package Insert2 Internal unpublished data3 Nimotuzumab integrated global safety database4 The Lancet Volume 8 May 2007; pg 366-367

Page 14: Nimotuzumab

14Calendar Q1/2009

*Giro et al 2008 Radiotherapy and Oncology

Grade IV Skin Toxicity is Not Seen with Radiation Alone

28% Grade IV skin toxicity with Erbitux® and RT*

*

Lord et al 2008 Journal of Clinical Oncology

Cetuximab 20% treatment discontinuation when combined with cisplatin/RT

Underreporting of Toxicities with Cetuximab

EORTC questionnaire: 15 institutions/125 pts treated w/cetuximab and concurrent RT

49% Grade III/IV

Twice as high as reported by Bonner et al. Incompatible w/Bonner conclusion “cetuximab did not exacerbate the common toxic effects associated w/radiotherapy of the head and neck”

Page 15: Nimotuzumab

15Calendar Q1/2009

> Erbitux® hypomagnesemia incidence is 55%1; up to 27% is Grade III/IV2

> Erbitux® inhibits renal EGFR activity, blocking Mg transport3

> 97% of Erbitux® treated patients have Mg wasting4

> Longer duration of treatment = greater severity of hypomagnesemia4

> Aggressive Mg replacement recommended - daily Mg may be required

> Side effects of hypomagnesemia may persist for up to eight weeks after drug discontinuation

> Cetuximab/RT sudden death reported - low Mg levels can result in seizures, cardiac arrhythmia and neurological toxicity3

Hypomagnesemia is a Serious Toxicity

1 Erbitux® Package insert. Revised: 11/20082 The Journal of Clinical Investigation, Groenestege 20073 cancernetwork.com, January 1 2008, Oncology Vol 22 No 1, Fakih. M4 The Lancet Volume 8 May 2007; pg 366-367

Page 16: Nimotuzumab

16Calendar Q1/2009

NANAVERY RARE49%4Rad. Dermatitis—Grades 3 and 4

0%62%3VERY RARE25%2Rash - Grades 3 and 4

2%57%VERY RARE16%Pruritus

29%

35%

19%

49%

55%5

87%

Erbitux®

plus Radiation

12%19%14%Vomiting

9%21%14%Constipation

1%21%9%Diarrhea

16%23%22%Nausea

2%39%VERY RAREHypomagnesemia – all grades

6% 90%9%Rash - All grades

BSCAlone

Vectibix® plus BSC

Nimotuzumab plus Radiation1

1 Information from four completed trials; data collection ongoing2 FDA Action Letter, June 2008 3 STEPP trial – 2008 – 29% post-preemptive treatment4 Giro C et al., Radiother Oncol (2008), doi:10.1016/j.radonc.2008.09.20075 Erbitux® Package insert. Revised: 11/2008

Erbitux® and Vectibix® Have Significant Toxicities

Page 17: Nimotuzumab

17Calendar Q1/2009

Nimotuzumab – Preferential Positioning

23,00010,33020,32059%RT treated Rectal

29,000114,000171,00025%Gastric

16,00014,00048,00016%Esophageal

42,00015,00098,00060%H&N

52,00016,20071,00015%Brain Mets (NSCLC)

166,00052,000229,00015%NSCLC

4,8001,00012,60025%Glioblastoma

NA patients

Japanese patients

European patients

5 yr SurvivalIndication

High Unmet Need – Low Five Year Survival

Large Markets – More than one million patients globally

Target indications driven by mechanistic and clinical observations

Page 18: Nimotuzumab

18Calendar Q1/2009

25.30.14±0.120.36 ±0.28 3.54±2.29Topotecan

26.30.03±0.010.12±0.080.79±0.39CPT

RI (low / high

EGFR)

ME180/TNF (high EGFR)

ME180(intermediate EGFR)

ME180/Pt (low EGFR)

ID50(ug/ml; dose to kill 50% of cells)Drug

(Topo I inhibitors)

Adapted from Ling et al, 2001

Human CRC cell lines

Pros

tate C

aGlio

ma

Murine

Breas

t Ca

Adapted from Cai et al, 2007

EGFR in CRC CellsCPT Promotes Survival in Low EGFR- Expressing Cells

Page 19: Nimotuzumab

19Calendar Q1/2009

Investment Summary

> YM BioSciences is a biopharmaceutical development company engaged in commercialization of products principally for cancer patients. We have 33 employees and are based in Mississauga, Canada

> Portfolio consists of two late-stage products: Nimotuzumab, a monoclonal antibody for cancer and AeroLEF®, an opioid product for acute post-operative pain

> Recent management changes implemented to aggressively advance development of the portfolio

• Net cash ~$52 million*, Net cash/share ~ $0.90 – No debt – No impaired assets

• Burn rate for FY’08 ~$17.5 million**• Shares outstanding: ~ 58 million*** / ~ 65 million f.d.• NYSE/Alternext – YMI; TSX – YM; AIM - YMBA

* Estimate as @ September 30, 2008 ** To increase with clinical activity*** 2.5 million of these are subject to milestones including partnership and Phase III initiation of AeroLEF®

Page 20: Nimotuzumab

20Calendar Q1/2009

S. Korea

Japan

Australia

Singapore

Indonesia

EU

USA

Canada

advancing drugs effectively