Helix BioPharma Corp. · TSX:HBP

Helix BioPharma — Investor Presentation (September 2012)

23 slides from Helix BioPharma's investor presentation, September 2012

  1. Slide 1: Helix BioPharma Corp. - New Directions in Cancer Therapy

    Helix BioPharma Corp. New Directions in Cancer Therapy Investor Presentation September, 2012

  2. Slide 2: Forward-Looking Statements

    Forward-Looking Statements This presentation document contains certain forward-looking statements and information (collectively, “forward-looking statements”) within the meaning of applicable Canadian securities laws, including, without limitation, forward-looking statements regarding Helix’s plans

  3. Slide 3: The Corporation

    The Corporation  Helix BioPharma Corp. (“Helix”) is an established, clinical- stage, biopharmaceutical company  Helix’s common shares are listed on the Toronto Stock Exchange under the symbol “HBP”.  Helix is exploring product pipeline expansion opportunities based on its DOS47 platform technolog

  4. Slide 4: Board of Directors

    Board of Directors An Experienced Team William White – Chairman Robert Verhagen – CEO Corporate director and partner of CBW Associates Inc.; Vice President, Business Development of Spectral former President of E.I. du Pont Canada Inc. Diagnostics Inc.; prior thereto, Senior Director, Corporate Devel

  5. Slide 5: Patent Portfolio

    Patent Portfolio  Helix’s core technologies are protected by 40 patents  DOS47  2 U.S. patents issued + 11 worldwide  Expiries 2023 and 2024  New patents pending  Biphasix™  7 U.S. patents issued + 20 worldwide  Expiries ranging from 2013 – 2020  New patent pending for TIFN2b (expiry 2027

  6. Slide 6: DOS Platform

    AYR - > ay ae illo t were A & ro) re i) rf % DOS Platform

  7. Slide 7: "Amplified" Enzymatic Mode of Action for Powerful Tumoricidal Effect

    “Amplified” Enzymatic Mode of Action for Powerful Tumoricidal Effect Urea DOS47 Conjugate (Urease + Antibodies) Ammonia ions CO2 Hydroxyl ions 8.0 “AMPLIFIED” Effect: 7.0 Each molecule of 6.0 urease breaks down pH Cancer Cell ~1014 molecules of urea per second1 Urea urease 2NH3 + CO2 H2O 2NH4 + HCO3

  8. Slide 8: Current Pipeline

    Current Pipeline Research Preclinical Manufacturing Phase I/II Phase II Phase III optimization LDOS47 NSCLC Colon XXX XXXXXXXXXXXXXX Breast XXX XXXXXXXXXXXXXX iDOS Pancreatic Leveraged development: work completed for LDOS47 in NSCLC can be used to support other areas e.g. pDOS manufacturing, toxicol

  9. Slide 9: L-DOS47 Phase I/II Clinical Trial Underway

    L-DOS47 Phase I/II Clinical Trial Underway  Powerful new treatment approach Erbitux® + cisplatin/vinorelbine (FLEX; ImClone/Merck/BMS)1 TM Avastin + carboplatin paclitaxel (ECOG 4599; Genentech/Roche)2  Tumor alkalization and ammonia toxicity  Strong possibility for chemo/RT potentiation Leading

  10. Slide 10: L-DOS47 Phase I/II Clinical Trial Underway

    L-DOS47 Phase I/II Clinical Trial Underway  Phase I/II, open-label, safety and preliminary efficacy study underway in Warsaw, Poland  L-DOS47 monotherapy; dose escalation to maximum tolerated dose (MTD)  Followed by optional expansion efficacy population at MTD  Four centers in Warsaw, Poland; 

  11. Slide 11: L-DOS47 - Other Indications

    L-DOS47 - Other Indications  Current evidence shows in vitro activity in:  Colon cancer  Breast cancer  Can immediately begin pre-clinical animal studies in both indications  Can then potentially enter into Phase II studies in new indications with no new toxicology or safety studies once Polish

  12. Slide 12: Other DOS Pre-clinical Candidates

    Other DOS Pre-clinical Candidates p-DOS (for pancreatic and breast cancers) i-DOS (for pancreatic cancer) • Research and discovery complete • in vitro studies complete • in vivo efficacy and toxicity evaluation to commence Could potentially develop at least one of these candidates to pre-IND evaluat

  13. Slide 13: Market Sizes

    Market Sizes Pancreatic Cancer therapeutics  $1.2 Billion annual sales  Gemzar (Lilly) and Tarceva (Genentech) dominate the market Breast Cancer therapeutics • $8.6 Billion annual sales • Herceptin (Genentech/Roche) earned $3.4B 13

  14. Slide 14: Pipeline Potential-end of 2014

    Pipeline Potential-end of 2014 Research Preclinical Manufacturing Phase I/II Phase II Phase III optimization LDOS47 NSCLC Colon XXXXXXXXXXXXXX XXXXXXXXX Breast XXXXXXXXXXXXXX XXXXXXXXX Leveraged development: Phase I work in iDOS NSCLC would be applicable to other Pancreatic indications, no need to r

  15. Slide 15: L-DOS47 Commercialization Strategy

    L-DOS47 Commercialization Strategy  Create a lead candidate with strong clinical evidence of efficacy  value-adding Phase I/II “proof-of-concept” clinical data from Polish Trial  Increase potential by finding other indications  Create a pipeline that extends the value-creation and provides risk

  16. Slide 16: L-DOS47 Commercialization Strategy

    L-DOS47 Commercialization Strategy Use expanded pipeline and multiple Phase I and II opportunities to enable:  a large financing at a potentially higher valuation creating a liquidity event for existing shareholders AND  a strategic partnership with an established pharmaceutical company or compani

  17. Slide 17: Pipeline Potential – 2015 and beyond

    Pipeline Potential – 2015 and beyond Research Preclinical Manufacturing Phase I/II Phase II Phase III optimization LDOS47 NSCLC Colon Breast iDOS Pancreatic pDOS Pancreatic Breast Dark Green – Completed in 2015 Light Green – Funded through partnership Red – Areas of further development by Helix 17

  18. Slide 18: TIFN2b

    TIFN2b

  19. Slide 19: Topical Interferon Alpha-2b

    Topical Interferon Alpha-2b Phase III Efficacy Trial Stage Product Candidate  New treatment approach for low-grade cervical intraepithelial neoplasia (CIN) grade 1 or 2 lesions Study IFN002/HPV001 Pap Smear Resolution CIN  Large, “untapped” marketplace (no effective drugs exists today) 70.0% (Pap

  20. Slide 20: Summary and Outlook

    Summary and Outlook  Helix is focusing its leadership and objectives to improve the Company’s productivity and output  Priority: L-DOS47 Phase I/II clinical trial  New research-stage DOS cancer-targeted therapies under development  Demonstrating clinical data with L-DOS47 is key to building the

  21. Slide 21: Summary and Outlook

    Summary and Outlook  Funding through non-dilutive financing opportunities  Evaluation of options for non-core assets  Research grants and partnerships  Helix also has other assets and potential product offerings which may further enhance shareholder value  TIFNα2b Phase III development (pending

  22. Slide 22: Final Thoughts

    Final Thoughts  Helix has a potential opportunity to realize significant value creation through:  A lead candidate in Phase I/II in a large, underserved market  The potential to expand value of lead candidate with new indications  The potential to mitigate risk and expand potential with new DOS

  23. Slide 23: Helix BioPharma Corp. contact details

    Helix BioPharma Corp. 3-305 Industrial Parkway South Aurora, ON, Canada, L4G 6X7 Tel: (905) 841-2300 Fax: (905) 841-2244 www.helixbiopharma.com

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