DNB Markets 5 th Annual Health Care Conference, 11 December 2014 CEO Luigi Costa

Transcription

1 DNB Markets 5 th Annual Health Care Conference, December 0 CEO Luigi Costa Nordic Nanovector ASA Kjelsåsveien 68 B, 088 Oslo, Norway -

2 Forward-looking statements This presentation has been prepared by representatives of Nordic Nanovector ASA (the Company ) for use in presentations by the Company solely for information purposes, and this document and the information contained herein may not be disclosed, taken away, reproduced, redistributed, copied or passed on, directly or indirectly, to any other person or published or used in whole or in part, for any purpose. This presentation does not constitute a recommendation regarding any securities of the Company. No representation, warranty, or undertaking, express or implied, is made by the Company or its or representatives as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of the information or the opinions contained herein, for any purpose whatsoever. 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3 Agenda 5 6 Company in brief Our lead product candidate, Betalutin Market highlights Status on Betalutin clinical development Financial highlights Key take-aways

4 Nordic Nanovector: the North Star for innovative cancer treatment Our mission Nordic Nanovector is an innovation-driven biotech company that discovers, manufacturers and delivers to patients innovative, cost-effective, targeted radioimmunotherapy (RIT) clinical solutions to address major unmet medical needs and advance cancer care Facts and figures Nordic Nanovector was established in 009 by Roy Larsen and Inven Promising leading product candidate, Betalutin, a RIT clinical solution, for the treatment of non-hodgkin lymphoma (moving into phase II) Management team with broad industry experience from international pharmaceutical and biotech companies Committed to developing a promising pipeline with strong focus on hematology Favorable financial position with MNOK 9 in cash by Q 0 and strong investor base

5 Betalutin, first of a new generation of RIT clinical solutions for immunological malignancies Betalutin - the first of a new generation of RIT: Strong IP and unique patented technology Tumor seeking monoclonal antibody (HH*), targeting CD7 antigens on lymphoma cells Conjugated radionuclide (Lutetium-77) Innovative mechanism of action: targeted approach with systemic effect (multi-cell kill) Betalutin is currently moving into Phase II clinical development *Developed by the Norwegian Radium Hospital 5

6 Current therapies, including Rituximab and Immuno- Conjugates, have certain limits The antibodies seek out their antigen targets on the surface of individual cancer cells to elicit a response through cancer cell death However, tumor biology and tumor cell transformation make single cell kill of all tumor cells very difficult to achieve 6

7 Betalutin uses a multi-cell kill approach, but it is different from currently marketed RIT HH targets a unique antigen (CD7) allowing broader and more sustained clinical response even when CD0 targeted therapies are no longer effective It emits low energy beta particles with shorter penetration that affect even surrounding transformed tumor cells It has a biological half-life which allows optimized delivery of radiation to tumor cells It can be used for direct imagining and dosimetry Betalutin can be used synergistically with CD0 targeted therapies 7

8 # of patients in 6 major markets Billion USD NHL is a life-threatening blood cancer, with a highly unmet medical need NHL (non-hodgkin lymphoma) is the 0 th most common cancer, with a high mortality rate Incidence is expected to grow, CAGR.5% The market has the potential for significant growth (CAGR 7%, until 08) Expected increasing incidence NHL market expected to reach ~ USD bn by Spain Italy UK France Germany US f 07f 09f 0f Source: EUCAN 0 ( SEER ( LSC analysis Global Non-Hodgkin Lymphoma Therapeutics Market : 0-08 (TechNavio) APAC EMEA Americas 8

9 Phase I Study of 77 lu-dota-hh (Betalutin TM ) RIT for Patients with relapsed CD7 + B-Cell NHL Abstract 09 Prof. A. Kolstad et al Patient characteristics Study design + dose escalation study dose levels tested DL: 0 MBq/kg b.w DL: 0 MBq/kg b.w DL: 5 MBq/kg b.w Study objectives Primary: Maximum tolerated dose (MTD) Secondary: Safety and toxicity Recommended phase dose Biodistribution and blood PK Tumor responses Characteristics Median age (years) Range Male Female Primary diagnosis FL MCL Number of prior treatments, range 0 MBq/kg b.w n= MBq/kg b.w n= MBq/kg b.w n= Total N= FL = Follicular Lymphoma; MCL = Mantle Cell Lymphoma 9

10 Betalutin safety profile predictable and manageable; max tolerated dose reached at 0 MBq/kg b.w. CTCAE grade and treatment related adverse events 0 ( pts) MBq/kg b.w. 0 ( pts) MBq/kg b.w. 5 ( pts) MBq/kg b.w. Total pts CTCAE grade Platelets Neutrophils Pneumonia Epistaxis * Table shows number of patients qualified for DLTs. Number of patients reported. Related adverse events = possible or probable DLT by dose level DL Enrolled DLTs MBq/kg b.w. n n Details Grade thrombocytopenia Grade thrombocytopenia CTCAE = Common Terminology Criteria for Adverse Events DLT = Dose limiting toxicity 0

11 Betalutin achieved a 6% overall response rate (ORR) with 6% complete response (CR) rate Best tumor response by dose level Response 0 MBq/kg b.w n= 0 MBq/kg b.w n= 5 MBq/kg b.w n= Total n= Complete response (CR) Partial response (PR) Stable disease (SD) Progressive disease (PD) Overall response (CR+PR) 7 Tumor response was assessed according to the International Working Group revised Response Criteria (Cheson 007 )

12 Betalutin TM 5MBq/kg delivers promising clinical results as confirmed by PET/CT-scan Complete metabolic response (FDG PET/CT) at 6 months in patient 008, DL 5 MBq/kg b.w., with FL

13 Adequate funding Solid cash position of NOK 9M - $8M* (OB Q) Key burn rate drivers: Acceleration in R&D activities Personnel Infrastructure Discovery Available cash should support the execution of main R&D and pre-commercialization strategy to 07 Planned IPO in 05 pending market conditions * Cash rate USD = 6.8

14 Key take-aways 5 6 Innovation-driven biotech company, aspiring to become a leader in RIT Promising product candidate in NHL (effective, safe and convenient) Ambitious, accelerated product development plan Commitment to maximise company s value through pipeline development and geographic expansion Solid financial situation with planned IPO in 05 to support key activities and maintain independence Strong team with international experience and know-how in oncohematology and nuclear medicine

15 Thank you for your attention! Nordic Nanovector ASA Kjelsåsveien 68 B, 088 Oslo, Norway