Introducing a First-in-Class treatment for Non-Hodgkin Lymphoma BioEquity Europe 2016, Copenhagen May 11, 2016 Luigi Costa, Chief Executive Officer
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1 Introducing a First-in-Class treatment for Non-Hodgkin Lymphoma BioEquity Europe 2016, Copenhagen May 11, 2016 Luigi Costa, Chief Executive Officer Nordic Nanovector ASA Kjelsåsveien 168 B, 0884 Oslo, Norway - 1
2 Forward-looking statements This presentation may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Nordic Nanovector s business, financial condition and results of operations. The terms anticipates, assumes, believes, can, could, estimates, expects, forecasts, intends, may, might, plans, should, projects, will, would or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statement. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a particular projection is realised. Factors that could cause these differences include, but are not limited to, implementation of Nordic Nanovector s strategy and its ability to further grow, risks associated with the development and/or approval of Nordic Nanovector s products candidates, ongoing clinical trials and expected trial results, the ability to commercialise Betalutin, technology changes and new products in Nordic Nanovector s potential market and industry, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions and legislative, regulatory and political factors. No assurance can be given that such expectations will prove to have been correct. Nordic Nanovector disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. 2
3 Nordic Nanovector at a glance Focused on the development of treatments for hematological cancers Leveraging the unique Antibody Radionuclide Conjugate (ARC) technology Pipeline led by Betalutin for treating Non-Hodgkin Lymphoma (NHL) Novel anti-cd37 ARC in Phase 1/2 clinical trials Promising efficacy with sustainable duration of response Confirmed favorable side effect profile Target first regulatory approval in 2019 Clear Development pathway Designed to gain regulatory approval with a competitive product profile Corporate IPO in March 2015 (OSE: NANO) Market Capitalization as of April 21 th 2016: NOK 917M (USD 112M) Cash end 2015: NOK 743M (USD 91M*) * US Dollar/Norwegian Krone 8.13 (21th April 2016) 3
4 Betalutin is specifically designed to treat NHL CD37: a validated target for B-cell NHL Lutetium-177: ideal therapeutic and safety properties CD37 is a useful therapeutic target for NHL patients that have relapsed after CD20-based therapy Internalization results in a prolonged irradiation of the cancer cell nucleus Beta-emitting particles with half-life matching the antibody s circulation time to ensure that tumour mass is irradiated Mean range of radiation treats bulky tumors while limiting damage to health tissue Multi-cell kill approach Prolonged irradiation of tumour cells within ~50-cell radius enables multi-cell kill effect even of malignant cells that do not express CD37 or have limited blood supply ARC s could deliver better treatment outcomes than immunotherapies (monoclonal antibodies or ADC s), which rely on a single cell kill approach 4
5 Betalutin s Unique Value Proposition is based on important differentiating factors 1. EFFICACY * : Strong efficacy and very long Duration Of Response (DOR) as single agent 2. SAFETY * : Manageable and reversible haematological toxicity with minimal non-haematological toxicities 3. CONVENIENCE: One single injection with no need for hospitalization from a ready to use vial 4. FLEXIBILITY: Potential synergy from combination with anti-cd20 moab (rituximab) and with other immuno-oncology treatments * AACR 2016, Poster version of the Abstract LB-252, Prof. A. Kolstad et al. 5
6 Betalutin fills important unmet medical needs in NHL Relapsed NHL No standard therapy past second-line Rituximab resistance Patients who have developed resistance to CD20-targeted antibody Older patients Patients aged >65 years not able to tolerate some chemotherapies Co-morbidities Some co-morbidities can impact tolerability of current treatments Lack of response Patients with a poor response to first- or second-line treatment 6
7 Positive clinical results support Betalutin s potential in NHL Complete metabolic response (FDG PET/CT) at 3 months in patient with follicular lymphoma at 20 MBq/kg Complete metabolic response (FDG PET/CT) at 6 months in patient with follicular lymphoma at 15 MBq/kg Patient is still in complete remission 24 months after Betalutin treatment FDG PET CT: fluorodeoxyglucose positron emission tomography-computer tomography; FL: follicular lymphoma; MBq: megabecquerel Patient is still in complete remission 18 months after Betalutin treatment FDG PET/CT: fluorodeoxyglucose positron emission tomography-computer tomography; FL: follicular lymphoma; MBq: megabecquerel; SPECT: single-photon emission computerized tomography 7
8 Data confirm that Betalutin is effective and safe * Data from 21 patients 21 evaluable for safety 19 evaluable for efficacy Strong efficacy continues to be confirmed Higher efficacy in Phase 2 cohort Duration of Response (DOR) continues to improve Side-effect profile remains favourable * AACR 2016, Poster version of the Abstract LB-252, Prof. A. Kolstad et al. 8
9 Response level (%) With a CR > 31% as a single agent, Betalutin clearly has the potential to be one of the best alternatives in 3L FL ORR CR PR SD PD One patient had confirmed transformed lymphoma at 3 months. Tumour response was assessed according to Cheson criteria ORR = Overall response rate, CR = Complete response, PR = Partial response, SD = Stable disease, PD = Progressive disease AACR 2016, Poster version of the Abstract LB-252, Prof. A. Kolstad et al. 9
10 Patients Duration of Response continues to improve over time Arm 1: 10 MBq/kg Arm 1: 15 MBq/kg Arm 1: 20 MBq/kg Arm 2: 10 MBq/kg Arm 2: 15 MBq/kg Phase 2: 15 MBq/kg CR start PR start SD start Response end Continued response Time since start of treatment (months) Durable responder Duration of response of all patients with response assessment. Patients in different arms and at different activity level are plotted with different colours. Start and type of response marked with triangles. Response episode end marked with closed circles. Durable responders ( 12 months) marked with closed squares. AACR 2016, Poster version of the Abstract LB-252, Prof. A. Kolstad et al. 10
11 Favourable safety profile: Most adverse events haematological all transient and reversible Adverse events Arm 1 Arm 2 Phase 2 Total Dose levels 10 MBq/kg N=3 15 MBq/kg N=6 20 MBq/kg N=3 10 MBq/kg N=2* 15 MBq/kg N=2 15 MBq/kg N=5 N=21 CTCAE grade** Platelet count decrease Neutrophil count decrease * First patient received 250 mg/m2 rituximab on day -7 and day 0 prior to Betalutin and is included in this group. ** CTCAE grade version 4. CTCAE = Common Terminology Criteria for Adverse Events Serious adverse events (SAE) reported by more than one patient are summarised in a table in the poster. In addition, an SAE of epistaxis, fracture of sternum, decreased neutrophil count, pharyngitis, pneumonia, pulmonary embolism and sepsis were reported by one patient each. The event of pulmonary embolism was deemed unrelated as the subject had a prior medical history of pulmonary embolism. The remaining events were deemed to be possibly or probably related to the administration of Betalutin. AACR 2016, Poster version of the Abstract LB-252, Prof. A. Kolstad et al. 11
12 Betalutin has the potential to be best in class vs. existing competition Launched Products Clinical Efficacy Targets in Follicular Lymphoma Phase 1/2 Betalutin Preliminary Results* Ibritumomab tiuxetan (ORR: 74%, CR: 15%, DOR: 6,4 months) Idelalisib (ORR: 54%, CR: 14%, DOR: 11,8 months) Bendamustine (ORR: 75%, CR: 14%, DOR: 9,2 months) 3L FL ORR 70-75% CR 35-40% DOR 9-12 months ORR 63,2% CR 31,6% Median DOR not yet reached *AACR 2016 Sources: Scientific publications, publicly available information, please see prospectus for detailed sources 12
13 Betalutin s FL clinical development plan is designed to maximize efficacy Lymrit Phase 1/2 trial Phase 1 Phase 2 Pivotal Phase 2 PARADIGME trial Arm 1 10MBq/kg (- HH1 R0) N=1 10MBq/kg (+ HH1 50mg) N=3 20MBq/kg (+ HH1 50mg) N=3 15MBq/kg (+ HH1 50mg) N=6 15MBq/kg (+ HH1 50mg) N=9 17.5MBq/kg* (+ HH1 50mg) N=3 Arm 2 15MBq/kg (- HH1) N=2 10MBq/kg (- HH1) N=3 to 6 Discontinued for futility First Patient: 2H 2017 Dose TBD N=85 Last Patient: 2H 2018 MBq = Megabecquerel (radioactivity measurement unit) HH1 = CD37 B-cell seeking antibody R0 = rituximab predosing on day 0 N = Number of patients Arm 3 Arm 4 15MBq/kg (- HH1 R0) N=3 to 6 15MBq/kg (+ high-dose HH1) N=3 to MBq/kg or 20MBq/kg* (- HH1 R0) N=3 to MBq/kg or 20MBq/kg* (+ high-dose HH1) N=3 to 6 Regulatory submission: 1H 2019 * Dose decision based on safety data and Safety Review Board s recommendation PARADIGME dose decision: Q
14 Nordic Nanovector is committed to invest in a broad development and discovery pipeline Indication FL, 3rd line FL, 2nd line DLBCL, ineligible for ASCT DLBCL, conditioning Other NHL FL, 1st line Leukemia Multiple myeloma Product candidate Discovery Preclinical Phase 1 Phase 2 Phase 3 Betalutin Betalutin + CD20 Betalutin Betalutin Betalutin + CD Lu-chHH1 ARC 177 Lu-chHH1 ARC Affilutin 1 1. Collaboration with Affibody ARC: antibody -radionuclide conjugate; ASCT: autologous stem cell transplant; chhh1: chimeric HH1 antibody; DLBCL: diffuse large B-cell lymphoma; FL: follicular lymphoma; NHL: non-hodgkin lymphoma 14
15 Preclinical data suggest potential synergy from combination of Betalutin with rituximab Treatment with rituximab-containing regimens can result in disappearance of the CD20 antigen expression, leading to reduced clinical effect CD20 antigen levels are upregulated after treatment with Betalutin, increasing binding of rituximab to NHL cells Survival of SCID mice intravenously injected with Rec-1 Mantel cell lymphoma cells is increased by the Betalutin + rituximab combination (ASH poster, 2015) The efficacy of rituximab is boosted by a combination of effects after treatment with Betalutin 15
16 Chimeric HH1 opens up new opportunities for frontline treatment of B-cell malignancies Similar internalisation and selectivity to human lymphoid tissues as the HH1 antibody Higher Antibody Dependent Cellular Cytotoxicity (ADCC) SCID mice with MCL xenografts treated 2/wk. with 100 mg chhh1, 100 mg HH1 or 100 ml of NaCl for 4 weeks (black arrows). After 180 days 100 % of the mice treated with chhh1 were still alive, vs. 70 % with HH1. (EANM abstract, 2015) Less immunogenic, enabling safer repeated use 16
17 Nordic Nanovector holds a solid cash position Cash Flow Geographical distribution of shareholders USD million UK 4 % Belgium 2 % ROW 1 % 80 Sweden 14 % CASH IPO proceeds Share issue cost Operating cash flow Interests CASH Shares outstanding 44.5 M Market capitalization USD 112 M (21th of April 2016) Norway 79 % 17
18 What you can expect Initiate DLBCL clinical program Start arm 3 and 4 in Phase 1/2 FL study First patient treated in DLBCL study 2Q 2016 Dose selection for pivotal Phase 2 / PARADIGME 1Q 2017 Dose selection for DLBCL pivotal trial 2H 2017 PARADIGME enrollment completed 2Q 2018 First regulatory submission for 3L FL 1Q
19 Our strategic imperatives are focused on maximizing shareholders value 1. 1 Obtain Betalutin s approval in 3L (and subsequently 2L) Follicular Lymphoma 2. 2 Expand indication in DLBCL as soon as possible 3. 3 Selectively extend the Company s pipeline around core expertise (ARC/ADC, haematologyoncology) to embrace innovative technologies 4. 4 Independently commercialize Betalutin and follow-on compounds in major markets 5. 5 Opportunistically consider partnerships to leverage position of strength 19
20 Thank you for your attention! Nordic Nanovector ASA Kjelsåsveien 168 B, 0884 Oslo, Norway IR contact: 20
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