Helix BioPharma Corp.

Transcription

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

2 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 to complete a Phase I/II clinical trial for L-DOS47 and to initiate a Phase II/III and/or Phase III clinical trial for Topical Interferon Alpha-2b; the expected timetable and budget for completion of these clinical trials; Helix s plans for obtaining certain patents going forward; Helix s plans to seek strategic partnerships in connection with its clinical trials and/or commercialization of its products; the indications and therapeutic and market opportunities for Helix s products, including the estimated size of the market and the performance of these products relative to those of Helix s competitors; Helix s plans for future strategy, operations and development timelines; and Helix s future economic performance and financial condition. Forward-looking statements, which may be identified by words including, without limitation, expects, plans, will, intends, may, pending, objective, exploring, potential, projected, possible and other similar expressions, are intended to provide information about management s current plans and expectations regarding future operations. Although Helix believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties that may cause actual results or events to differ materially from those anticipated and no assurance can be given that these expectations will be realized, and undue reliance should not be placed on such statements. Risk factors that could cause actual results or events to differ materially from the forward-looking statements include, without limitation: (i) deterioration in Helix s cash balances or liquidity; (ii) loss of protection or use of Helix s intellectual property; (iii) need to secure additional financing in a timely manner on terms satisfactory to Helix; (iv) delay or inability to complete current clinical trials, commercialize Helix s products, secure strategic partnerships or develop Helix s products or business in the manner expected or at all; (v) changes in, or the introduction of new laws and regulations relating to Helix s business; (vi) the need for future clinical trials which are not approved on terms satisfactory to Helix or at all; (vii) clinical trials that yield negative results; and (vii) those risk factors identified in Helix s Annual Report on Form 20-F, including under the headings Forward-Looking Statements and 3.D Risk Factors, filed with the Canadian Securities Administrators at (together, the Helix Risk Factors ). Certain material factors or assumptions are applied in making the forward-looking statements, including, without limitation, that the Phase I/II clinical trial of L-DOS47 will proceed on Helix s anticipated timetable and on budget, that this clinical trial will yield favourable results, that third parties will continue to provide goods and services to Helix on a timely basis, and that the Helix Risk Factors will not cause Helix s actual results or events to differ materially from the forward-looking statements. Forward-looking statements and information are based on the beliefs, assumptions and expectations of Helix s management on September 7, 2012, and Helix does not assume any obligation to update any forward-looking statement or information should those beliefs, assumptions or expectations, or other circumstances change, except as required by law. 2

3 The Corporation Helix BioPharma Corp. ( Helix ) is an established, clinicalstage, 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 technologies 3

4 Board of Directors An Experienced Team William White Chairman Corporate director and partner of CBW Associates Inc.; former President of E.I. du Pont Canada Inc. Robert Verhagen CEO Vice President, Business Development of Spectral Diagnostics Inc.; prior thereto, Senior Director, Corporate Development of MDS Inc. Dr. Marek Orłowski Director Former consultant to Sanofi Aventis for portfolio development and globalization of brands; prior thereto, co-founder and director of Nepentes S.A. Jack Kay - Director Chief Executive Officer of Apotex Inc.; Director of several institutional and charitable organizations; Director of Cangene Corporation Prof. Sławomir Majewski Observer Head of the Department of Dermatology and Venereology and Deputy Rector for Science and International Relations at the Medical University of Warsaw; member of the scientific advisory board at the Polish Ministry of Health. W. Thomas Hodgson - Director Executive Chairman of Lithium Americas Corp.; former President and CEO of Marathon Asset Management Inc. and GlobalNetFinancial.com. Mario Gobbo - Director Corporate director and independent advisor to health care and medical devices companies; formerly Managing Director of Natixis Bleichroeder, Inc. and Executive Director at Lazard & Co. Ltd. 4

5 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 New patent pending for TIFN 2b (expiry 2027 if issued) 5

6 DOS Platform

7 Amplified Enzymatic Mode of Action for Powerful Tumoricidal Effect Ammonia ions Urea DOS47 Conjugate (Urease + Antibodies) CO 2 Hydroxyl ions ph Cancer Cell AMPLIFIED Effect: Each molecule of urease breaks down ~10 14 molecules of urea per second 1 Urea urease 2NH 3 + CO 2 H2O 2NH 4 + HCO OH - 1 Sirko A, Brodzik R. Plant ureases: roles and regulation. Acta Biochimica Polonica 47: , 2000

8 Current Pipeline Research Preclinical Manufacturing optimization Phase I/II Phase II Phase III LDOS47 NSCLC Colon XXX XXXXXXXXXXXXXX Breast XXX XXXXXXXXXXXXXX idos pdos Pancreatic Pancreatic Leveraged development: work completed for LDOS47 in NSCLC can be used to support other areas e.g. manufacturing, toxicology, etc. Breast Dark Green COMPLETED Yellow Underway at Helix 8

9 L-DOS47 Phase I/II Clinical Trial Underway Powerful new treatment approach Tumor alkalization and ammonia toxicity Erbitux + cisplatin/vinorelbine (FLEX; ImClone/Merck/BMS) 1 Avastin TM + carboplatin paclitaxel (ECOG 4599; Genentech/Roche) 2 Strong possibility for chemo/rt potentiation Leading NSCLC agents have shown overall patient survival of only months Large, underserved marketplace 301,000 (Europe) ; 160,000 (U.S.) new cases annually 4 Examples: Avastin $7.5 billion/yr (lung, kidney, colorectal) Alimta + cisplatin (Eli Lilly) 3 Alimta $1.16 billion/yr (lung) 5 1 Pirker R. et al., Lancet 2009; 2 Sandler A. et al., NEJM 2006; 3 Scagliotti GV. et al., JCO 2008; RT = Radiation Therapy 4 New cases of inoperable, locally advanced, recurrent or metastatic, NSCLC adapted from the A.C.S Cancer Facts and Figures and the Globocan 2008 Fact Sheet 5 Avastin and Alimta sales, Med Ad News, 2010 and 2009, respectively 9

10 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; Lead investigator: Prof. Krzakowski, MD, PhD (Maria Sklodowska-Curie Institute of Oncology) Projected duration: Approx. 24 months depending on recruitment rate and tolerability 10

11 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 Phase I is completed and successful Can consider adjuvant therapies with existing chemotherapeutics as other options for Phase IIa development 11

12 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 evaluation 12

13 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 Pipeline Potential-end of 2014 Research Preclinical Manufacturing optimization Phase I/II Phase II Phase III LDOS47 NSCLC Colon XXXXXXXXXXXXXX XXXXXXXXX Breast XXXXXXXXXXXXXX XXXXXXXXX idos Pancreatic Leveraged development: Phase I work in NSCLC would be applicable to other indications, no need to repeat pdos Pancreatic Breast Dark Green Completed by end of 2014 Red Potential areas of development 14

15 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 reduction with multiple candidates Value-adding clinical candidates with p-dos and i-dos Risk reduction with multiple candidates and multiple indications 15

16 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 companies to support the development and commercialization of products Example top partnering deals for early-stage oncology drugs 1 : Janssen Biotech/Pharmacyclics Phase II; PCI (2011) US$150M upfront; Over $825M in fees/milestones + profit sharing Sanofi-Aventis/Exelixis - Phase I/II; XL147/765 (2009) US$140M upfront; Over $1B in fees/milestones + royalty BMS/Exelixis - Phase I; XL281 (2008) US$195M upfront; $465M in fees/milestones; double-digit royalty Roche/Thrombogenics - Phase I; TB 403 (2008) Euro50M upfront; Euro450M in fees/milestones; double-digit royalty 1 Current Partnering - Top Partnering Deals 16

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

18 TIFN 2b

19 Topical Interferon Alpha-2b Phase III Efficacy Trial Stage Product Candidate New treatment approach for low-grade cervical intraepithelial Study IFN002/HPV001 neoplasia (CIN) grade 1 or 2 lesions Large, untapped marketplace (no effective drugs exists today) Est. 1.5 million (Europe); 1.3 million (U.S.) new cases / yr. 1 Consider pricing of comparable topical therapies approx. $1015 / average treatment course 2 approx. $760 / average treatment course 2 Potential multi-billion dollar marketplace Positive Phase II safety/efficacy data Final stage of clinical development approved U.S. FDA and European MHRA 3 trial approvals Parallel Phase II/III & Phase III trials (respectively) Estimated duration: 24 months + reporting Marketing authorization applications thereafter Secondary development priority for the Company 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% Pap Smear Resolution (Pap IIID Cohort) Treated Control 28.6% CIN 1 or % No CIN CIN Resolution Treated Control Study IFN005 CIN Status (on biopsy) Strategic partner funding and raw material support needed before undertaking these clinical trials 1 Data apadpted from Consensus Guidelines. A. J. of Obs. & Gyn. 2007; ; Kaiser Permanente Northwest Health Plan. A. J. of Obs. & Gyn. (2004) 191, ; and European Guidelines for Quality Assurance in Cervical Cancer Screening, Source: Average U.S. retail pricing per Drugstore.com (September 2010) and Journal of Medical Economics 2010; 13(1):1-7 3 MHRA approval was granted conditionally; Helix does not intend to commit resources to resolving this condition without strategic partner funding/support 19

20 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 potential of the DOS technology and shareholder value Estimated $8 million in capital is required to complete dose-escalation in the L-DOS47 Phase I/II trial Projected study completion: May 2014 Additional capital would be required to enable the development of other candidates and other indications 20

21 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 strategic partner funding/support) Possible new Biphasix product candidates on an outlicensed/structured basis Topical pharmaceutical therapies beyond interferon alpha-2b Cosmeceutical products through partnership 21

22 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 candidates (i-dos, p-dos) 22

23 Helix BioPharma Corp Industrial Parkway South Aurora, ON, Canada, L4G 6X7 Tel: (905) Fax: (905)