Helix BioPharma Corporation

Transcription

1 Helix BioPharma Corporation Tumor Defence Breaker Corporate Presentation National Investment Banking Association October 2016

2 Forward-looking Statements This presentation document contains certain forward-looking statements and information (collectively, forward-looking statements ) within the meaningofapplicable securities laws. Forward-lookingstatements are statements andinformationthat are not historical facts but insteadinclude financial projections and estimates; statements regarding plans, goals, objectives, intentions and expectations with respect to Helix s future business, operations, research and development, including the focus of Helix on its DOS drug candidate generally and L-DOS47 in particular, the anticipated timelines for the commencement or completion of certain activities,including enrolment of patients in Helix s Phase I/II clinical trial for L-DOS47 in Poland, the expansion of the DOS47 platform into other compounds and indications and other information in future periods. 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 informationaboutmanagement s currentplans andexpectations 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) the inherent uncertainty involved in scientific research and drug development, including with respect to costs and difficulties in predicting accurate timelines for the commencement or completion of certain activities; (ii) the risks associated with delay or inability to complete clinical trials successfully and the long lead-times and high costs associated with obtaining regulatory approval to market any product which may result from successful completion of such trials; (iii) the need to secure additional financing on terms satisfactory to Helix or at all, including that the additional funding required in order to complete the proposed U.S. Phase I clinical trial will be obtained on terms satisfactory to Helix or at all; (iv) clinical trials that yield negative results, or results that do not justify future clinical development, including that Helix s ongoing Polish Phase I/II clinical trial for L-DOS47 and/or that Helix s proposed U.S. Phase I clinical trial will yield negative results; (v) Helix s clinical development plan for the proposed US Phase I clinical trial not proceeding in the manner or on the timelines anticipated by Helix or at all; and (vi) those risks and uncertainties affecting Helix as more fully described in Helix s most recent Annual Information Form, including under the headings Forward-Looking Statements and Risk Factors, filed under Helix s profile on SEDAR at (together, the Helix Risk Factors ). Certain material factors and assumptions are applied in making the forward-looking statements, including, without limitation, that the Helix Risk Factors will not cause Helix s actual results or events to differ materiallyfrom the forward-looking statements. Helix. Forward-looking statements and information are based on the beliefs, assumptions and expectations of Helix s management on the date of this presentation, and are presented solely to acquire a better understanding of Helix and may not be appropriate for other purposes nor should this presentation be redistributed to other parties. Helix does not assume any obligation to update any forward-looking statement or information should those beliefs, assumptions or expectations, orother circumstances change,except as required by law. Helix Corporate Presentation - - Sven Rohmann, MD, PhD, MBA 2

3 Company Brief Helix BioPharma Corp. ( Helix ) / Ticker symbol: HBP Est. 1996, clinical-stage, biopharmaceutical company Listed/trades on the Toronto Stock Exchange (TSX) and Frankfurt Stock Exchange (FSE) Shares outstanding: 89,959,279 Market Capitalization: CAD166.2M Share price: CAD week high-low: CAD CAD1.70 Backed by high net worth investors; No debt Raised CAD7.7M in 2016 Helix Corporate Presentation - - Sven Rohmann, MD, PhD, MBA 3

4 Management Team Sven Rohmann, MD, PhD, MBA: CEO Ø Experienced biotech entrepreneur, pharma manager (Merck, Novartis) and life science venture capitalist in the field of oncology (Burrill & Company, Adiuvo Investments) Frank Michalargias, CPA, CA: CFO Ø Public company CFO with broad industry experience including senior positions with Unilever and Huhtamaki Oy Heman Chao, PhD: CSO Ø Biochemist with expertise in protein drug development. Previous role with Sensium Technologies Inc. Steve Demas, BSc: CMO Ø Clinical operations experience with past roles at BioMS Medical, Bayer and Sanofi Synthelabo Patrick Frankham, PhD, MBA: COO Ø Biotech and pharma oncology drug development experience with past senior roles at Boehringer Ingelheim, ICON Clinical and AeternaZentaris Pawel Wisniewski, PhD: CEO Polska Ø Biochemistry background; co-founder Institute of Genetic Analysis Helix Corporate Presentation - - Sven Rohmann, MD, PhD, MBA 4

5 Development Product Pipeline As of August 2016 Preclinical Phase I Phase II Phase III Immunotherapy TIFN Topical BiPhasix interferon HPV Associated Cervical Intraepithelial Neoplasia (CIN) Tumor Defence Breaker L-DOS47 monotherapy NSCLC (ongoing) Tumor Defence Breaker Tumor Defence Breaker L-DOS47 Combination NSCLC (ongoing) L-DOS47 Combo Other Indications Tumor Defence Breaker Immuno Oncology Immuno Oncology Tumor Defence Breaker L-DOS47 Combo Immune Checkpoints CAR-T Solid Tumors (CEACAM6) CAR-T Hematologic Tumors (Bispecific) V-DOS47 Investigator initiated Helix Corporate Presentation - Sven Rohmann, MD, PhD, MBA 5

6 Helix TUMOR DEFENCE BREAKER is the next breakthrough in cancer therapy,.. Helix BioPharma holds the rights to two unique technology platforms: DOS47: which modifies the tumor microenvironment and stimulates the immune system against cancer cells (Tumor Defence Breaker ) CAR-T: which modifies genes and "arms" the immune system cells against cancer cells (Tumor Agent Attack) Their synergy can provide effective therapeutic solutions for patients with solid tumors. For thefirst time Curefrom Cancer appears possible. These platforms are protected by a family of patents with a global reach. October 2016 Helix BioPharma 6

7 thereby targeting the Oncology Hotspots The Global Oncology Market will reach revenues of $ 147 billion by 2018 IMS Health CAR-T Tumor Attack Agent Anticipated market size by 2024: > $ 20bn Anticipated market size by 2024: > $ 34bn Immuno-Onc. e.g. CHECKPOINT INHIBITORS DOS47 Tumor Defence Breaker CHEMOTHERAPY Year 2015 market size: > $ 56bn

8 Helix is focused on breaking the Tumor Defence October 2016 Helix BioPharma 8

9 Breaking the Tumor Defence - Rationale Source: Damaghi, M. et al. (2015). Nature Communications 6:8752 DOI: /ncomms Cancer cells can survive only in an acidic environment: Microenvironment of solid tumors is acidic (low ph) The low ph in tumors produces a number of clinically adverse effects: Accelerated growth of tumor cells Facilitating the formation of metastases Local immunosuppressive effect: "hibernation" of the most important cells of the immune system - T cells and NK cells (natural killers) Lack of satisfactory efficacy of conventional chemotherapeutic drugs and the latest immunological technologies (e.g. stimulating T cells and optimization of the so-called CAR T- cells) October 2016 Helix BioPharma 9

10 Acidosis blocks Checkpoint Inhibitors The acidic environment blocks the operation of the novel immunooncology drugs from the group of the so-called PD1/PDL1 inhibitors Tumor ph normalization enhances efficacy of check-point inhibitor in B16 melanoma model Cancer Res; 76(6) March 15, 2016 October 2016 Helix BioPharma 10

11 Acidity Impairs T-cell therapy Tumor ph normalization with adoptive T-cell transfer delays tumor growth (panel A) and provides survival advantage in a melanoma mouse model (panel B) Cancer Res; 76(6) March 15, 2016 Helix Corporate Presentation - - Sven Rohmann, MD, PhD, MBA 11

12 DOS47 The technology of TUMOR DEFENCE BREAKER DOS47 is a conjugate of urease with an antibody targeting a specific antigen only on the surface of tumor cells. Urease catalyzes the degradation of urea into ammonia and hydroxyl ions. DOS47 technology developed by Helix can lead to a radical destabilisation of tumor integrity by increasing the ph only of the tumor microenvironment. October 2016 Helix BioPharma 12

13 Tumor Defence Breaker - Countering Acidity Extends Survival In a breast cancer metastasis animal model, tumor ph normalization by systemic buffer therapy shows a significant reduction in size and number of metastases (Figure A and B). The survival of the animals is also extended (Figure B) "The acidic ph encountered in a tumor microenvironment has significant immunosuppressive effects. By neutralizing this acid, we were able to improve the response of melanoma and pancreatic tumors to immunotherapy," -- Robert J. Gillies, Ph.D., chair of the Department of Cancer Imaging and Metabolism at Moffitt. Cancer Res Mar 15; 69(6): Helix Corporate Presentation - - Sven Rohmann, MD, PhD, MBA 13

14 Tumor Defence Breaker - Clinical trials (LDOS001) L-DOS47 in combination treatment with conventional chemotherapeutic agents demonstrates very high anti-tumor efficacy in advanced (stage IV) lung cancer L-DOS47 in combination therapy with pemetrexed/carboplatin in patients with NSCLC (non small cell lung cancer) (first-line therapy in the US) No adverse effects in the group of 6 currently examined patients. Partial disappearance of tumor lesions in patients who received L-DOS47. Trial demonstrated 44% decrease of tumor diameters in combination therapy October 2016 Helix BioPharma 14

15 Tumor Defence Breaker - Clinical trials (LDOS002) L-DOS47 alone (monotherapy) shows antitumor efficacy in advanced (stage IV) lung cancer L-DOS47 was administered to six patients in the phase II clinical study 32 of 55 patients responded to the therapy in the phase I study showing: disease stabilization, no disease progress, and no new cancer lesions Trial demonstrated an overall 72% response rate to L-DOS47 October 2016 Helix BioPharma 15

16 TUMOR DEFENCE BREAKER - Clinical Program L-DOS47 NSCLC Phase II (Monotherapy) Phase I Readout - H2 2016, Phase II Readout H L-DOS47 Phase I/II (Immune checkpoint combo) First Patient In H L-DOS47 NSCLC Phase I (Combination Therapy US) Phase I Readout - H L-DOS47 NSCLC Phase II (Combination Therapy Europe) First Patient In - H L-DOS47 Other Indications Phase I/II (Combination Therapy) First Patient In - H CAR-T Phase I/II (Solid Tumors) First Patient In H Helix Corporate Presentation - - Sven Rohmann, MD, PhD, MBA 16

17 Cash Requirements Cash required - $33M (through to Jan 2018) Oct-2016 Jan-2017 Apr-2017 Jul-2017 Oct-2017 Jan-2018 Total to Jan2018 Admin - Corporate 903,247 1,175, , , ,066 1,161,756 5,835,770 R&D 1,348,034 1,299,721 1,633,710 1,353,654 1,211,943 1,197,254 8,044,316 IP 180,000 90,000 60,000 60,000 60,000 60, ,000 Fixed assets 255,800 27,500 2,500 2,500 2,500 2, ,300 Mftg/Stability 488, , , , , ,245 2,896,061 Clinical - LDOS001 - PhaseI 345, , , , , ,895 2,217,522 Clinical - LDOS002 - PhaseI 284, , ,483 Clinical - LDOS002 - PhaseII 578, , , , ,327,688 Clinical - LDOS003 - PhaseII 196,090 1,034, , ,338 1,022, ,338 4,930,279 Clinical - LDOS47 (investigator) - 1,375, , , , ,000 2,750,000 CAR-T , ,000 1,062,500 1,062,500 2,875,000 4,581,025 6,403,846 6,065,722 5,273,533 5,506,804 5,285,489 33,116,418 Helix Corporate Presentation - - Sven Rohmann, MD, PhD, MBA 17

18 Helix Use of the Proceeds The Helix BioPharma portfolio allows for a unique impact in the oncology market in a multi-billion dollar way Helix is completing Clinical Proof of Concept (PoC) Trials for the Therapy with the Tumor Defence Breaker. Helix will file an IND for its CAR-T Program within 12 months. Helix is targeting a US listing at the end of 2017 backed by positive data from the two technology platforms (comparable listed companies with one of the two Helix technologies are valued at $0.75-$2B) Helix Corporate Presentation - - Sven Rohmann, MD, PhD, MBA 18

19 Thank You Inquiries: CORPORATE FINANCE & IR Helix Corporate Presentation 19