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Introducing a First-in-Class treatment for Non-Hodgkin LymphomaBioEquity Europe 2016, Copenhagen – May 11, 2016Luigi Costa, Chief Executive Officer
Nordic Nanovector ASA Kjelsåsveien 168 B, 0884 Oslo, Norway - www.nordicnanovector.com
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.
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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 21th 2016: NOK 917M (USD 112M)
• Cash end 2015: NOK 743M (USD 91M*)
* US Dollar/Norwegian Krone 8.13 (21th April 2016)3
Betalutin® is specifically designed to treat NHL
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
• 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
Lutetium-177:ideal therapeutic and
safety properties
CD37: a validated target for
B-cell NHL
ARC’s could deliver better treatment outcomes than immunotherapies (monoclonal antibodies or ADC’s), which rely on a single cell kill approach
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Betalutin®’s Unique Value Proposition is based on importantdifferentiating 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-haematologicaltoxicities
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 otherimmuno-oncology treatments
5*AACR 2016, Poster version of the Abstract LB-252, Prof. A. Kolstad et al.
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
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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
FDG PET CT: fluorodeoxyglucose positron emission tomography-computer tomography; FL: follicular lymphoma; MBq: megabecquerel
FDG PET/CT: fluorodeoxyglucose positron emission tomography-computer tomography; FL: follicular lymphoma; MBq: megabecquerel; SPECT: single-photon emission computerized tomography
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 monthsafter Betalutin® treatment
Patient is still in complete remission 18 months afterBetalutin® treatment
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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
8*AACR 2016, Poster version of the Abstract LB-252, Prof. A. Kolstad et al.
With a CR > 31% as a single agent, Betalutin clearly has the potential to be one of the best alternatives in 3L FL
63.2
31.6 31.6
15.821.1
00
10
20
30
40
50
60
70
ORR CR PR SD PD
Res
po
nse
leve
l (%
)
AACR 2016, Poster version of the Abstract LB-252, Prof. A. Kolstad et al.
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One patient had confirmed transformed lymphoma at 3 months. Tumour response was assessed according to Cheson criteria 2007. ORR = Overall response rate, CR = Complete response, PR = Partial response, SD = Stable disease, PD = Progressive disease
Duration of Response continues to improve over time
-3 0 3 6 9 12 15 18 21 24 27 30 33 36
Pati
ents
Time since start of treatment (months)
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
Durable responder
AACR 2016, Poster version of the Abstract LB-252, Prof. A. Kolstad et al.
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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.
Favourable safety profile:Most adverse events haematological – all transient and reversible
Adverse events Arm 1 Arm 2 Phase 2 Total
Dose levels10 MBq/kg
N=315 MBq/kg
N=620 MBq/kg
N=310 MBq/kg
N=2*15 MBq/kg
N=215 MBq/kg
N=5 N=21
CTCAE grade** 3 4 3 4 3 4 3 4 3 4 3 4 3 4
Platelet count decrease 0 0 2 1 0 3 1 0 0 2 0 0 3 6
Neutrophil count decrease 1 0 1 1 1 2 1 0 1 1 0 0 5 4
AACR 2016, Poster version of the Abstract LB-252, Prof. A. Kolstad et al.
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* 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®.
Betalutin® has the potential to be best in class vs. existing competition
3LFL
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)
ORR 70-75%CR 35-40%
DOR 9-12 months
Launched Products Clinical Efficacy Targets in Follicular Lymphoma
*AACR 2016 Sources: Scientific publications, publicly available information, please see prospectus for detailed sources
ORR 63,2%CR 31,6%
Median DOR not yet reached
Phase 1/2 Betalutin®Preliminary Results*
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Betalutin®’s FL clinical development plan is designed to maximize efficacy
* Dose decision based on safety data and Safety Review Board’s recommendation
Lymrit 37-01 – Phase 1/2 trial
20MBq/kg(+ HH1 50mg)
N=310MBq/kg(- HH1 R0)
N=1
15MBq/kg(+ HH1 50mg)
N=6
10MBq/kg(+ HH1 50mg)
N=3Arm 1
Phase 1
Arm 2
Phase 2
15MBq/kg(+ HH1 50mg)
N=9
15MBq/kg(- HH1 R0)
N=3 to 6
15MBq/kg(- HH1)
N=2
15MBq/kg(+ high-dose HH1)
N=3 to 6
17.5MBq/kg or20MBq/kg*(- HH1 R0)
N=3 to 6
10MBq/kg(- HH1)
N=3 to 6
17.5MBq/kg or20MBq/kg*
(+ high-dose HH1)N=3 to 6
17.5MBq/kg*(+ HH1 50mg)
N=3
Arm 3
Arm 4
PARADIGME dose decision: Q1 2017
First Patient: 2H 2017
Dose TBDN=85
Last Patient: 2H 2018
Regulatory submission: 1H 2019
Discontinued for futility
MBq = Megabecquerel(radioactivity measurement unit)HH1 = CD37 B-cell seeking antibodyR0 = rituximab predosing on day 0N = Number of patients
Pivotal Phase 2 PARADIGME trial
Nordic Nanovector is committed to invest in a broad development and discovery pipeline
Product candidate Discovery Preclinical Phase 1 Phase 2 Phase 3
DLBCL, ineligible for ASCT
FL, 3rd line
177Lu-chHH1 ARC
Affilutin1
DLBCL, conditioning
Indication
FL, 1st line
Multiple myeloma
Betalutin®
Betalutin®
Betalutin®
Other NHL Betalutin® + CD20
FL, 2nd line Betalutin® + CD20
Leukemia 177Lu-chHH1 ARC
1. Collaboration with AffibodyARC: 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
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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
• The efficacy of rituximab is boosted by a combination of effects after treatment withBetalutin®
Survival of SCID mice intravenously injected with Rec-1 Mantel celllymphoma cells is increased by the Betalutin® + rituximabcombination (ASH poster, 2015)
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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)
• Less immunogenic, enabling safer repeated use
SCID mice with MCL xenografts treated 2/wk. with 100 mg chHH1, 100 mgHH1 or 100 ml of NaCl for 4 weeks (black arrows). After 180 days 100 % ofthe mice treated with chHH1 were still alive, vs. 70 % with HH1. (EANMabstract, 2015)
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Nordic Nanovector holds a solid cash position
Norway 79 %
Sweden 14 %
UK 4 %
Belgium2 % ROW
1 %
41.5
70.6 -3.4 -18.8
1.5 91.4
0
20
40
60
80
100
120
CASH01.01.2015
IPOproceeds
Share issuecost
Operatingcash flow
Interests CASH31.12.2015
Cash Flow Geographical distribution of shareholders
USD million
• Shares outstanding 44.5 M• Market capitalization USD 112 M (21th of April 2016)
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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 2019
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1. Obtain Betalutin®’s approval in 3L (and subsequently 2L) Follicular Lymphoma
2. Expand indication in DLBCL as soon as possible
3. Selectively extend the Company’s pipeline around core expertise (ARC/ADC, haematology-oncology) to embrace innovative technologies
4. Independently commercialize Betalutin® and follow-on compounds in major markets
5. Opportunistically consider partnerships to leverage position of strength
Our strategic imperatives are focused on maximizing shareholders’ value
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Nordic Nanovector ASA
Kjelsåsveien 168 B, 0884 Oslo, Norway
www.nordicnanovector.com
IR contact: [email protected]
Thank you for your attention!
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