next-generation radioimmunotherapies hodgkin’s …...analysis of the company’s financial or...
TRANSCRIPT
Nordic Nanovector ASA
Kjelsåsveien 168 B, 0884 Oslo, Norway
www.nordicnanovector.com
IR contact: [email protected]
NEXT-GENERATION RADIOIMMUNOTHERAPIES
FOR NON-HODGKIN’S LYMPHOMA PATIENTS
Forward-looking statements
This slide presentation contains certain forward-looking statements. These statements are based on management's current expectations and are subject to
uncertainty and changes in circumstances, 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", "targets", "will", "would" or, in each case, their negative, or other
variations or comparable terminology are used to identify forward looking statements. These forward-looking statements are not historic facts. There are a
number of factors that could cause actual results and developments to differ materially from those expressed or implied in the forward-looking statements.
Factors that could cause these differences include, but are not limited to, risks associated with implementation of Nordic Nanovector's strategy, risks and
uncertainties associated with the development and/or approval of Nordic Nanovector's product candidates, ongoing and future clinical trials and expected trial
results, the ability to commercialise Betalutin®, technology changes and new products in Nordic Nanovector's potential market and industry, Nordic
Nanovector's freedom to operate (competitors patents) in respect of the products it develops, 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.This presentation is for information purposes only and is incomplete without reference to, and should be
viewed solely in conjunction with, the oral briefing provided by the Company. The information and opinions in this presentation is provided as at the date hereof
and subject to change without notice. It is not the intention to provide, and you may not rely on these materials as providing, a complete or comprehensive
analysis of the Company’s financial or trading position or prospects. This presentation does not constitute investment, legal, accounting, regulatory, taxation or
other advice and does not take into account your investment objectives or legal, accounting, regulatory, taxation or financial situation or particular needs. You
are solely responsible for forming your own opinions and conclusions on such matters and for making your own independent assessment of the Company. You
are solely responsible for seeking independent professional advice in relation to the Company. No responsibility or liability is accepted by any person for any of
the information or for any action taken by you or any of your officers, employees, agents or associates on the basis of such information.
2
Corporate snapshot
• Founded 2009 in Oslo, Norway to develop
Betalutin® for the treatment of non-Hodgkin’s
lymphoma (NHL) based on
– The Norwegian Radium Hospital is a centre of
excellence for oncology biomedical research and
patient care
– R&D expertise in radioimmunotherapies
3
Nordic Nanovector is a clinical-stage biopharmaceutical company dedicated to extending
and improving the lives of patients with haematological cancers through the development
and commercialisation of innovative targeted radioimmunotherapies
• HQ and R&D in Oslo, with corporate offices
in London, UK and Zug, Switzerland
• 47 Employees (around 60 FTEs in total)
• Listed on Oslo Stock Exchange in 2015
(NANO)
• Market cap USD 152M*
*As of August 23, 2019. Exchange rate 1 USD = 9,001202 NOK.
4
Management Team with international experience
JOSTEIN DAHLE, PhD
Co-Founder, Chief Scientific Officer
MARCO RENOLDI, MD
Chief Operating Officer
LISA ROJKJAER, MD
Chief Medical Officer
TONE KVÅLE
Chief Financial Officer
RITA DEGE
Chief Human Resources Officer
MALENE BRONDBERG
Vice President,
IR & Corporate Communications
ROSEMARIE CORRIGAN
Chief Quality Officer
EDUARDO BRAVO
Chief Executive Officer
Nordic Nanovector – experts in radioimmunotherapy
5
Betalutin®
Fully owned lead asset – a novel anti-CD37 radioimmunotherapy targeting unmet
needs in the two largest NHL types – FL and DLBCL – a near USD 5B* opportunity
A single administration of Betalutin® has demonstrated promising efficacy and
safety in a 74-patient trial
Pivotal trial in 3L R/R FL underway with full enrolment expected 2H 2020;
Fast-Track and Orphan Drug designations granted in US
R&D expertise and IP provides multiple opportunities in B-cell malignancies
On-going clinical programmes to access higher-value 2L FL and R/R DLBCL
provide additional near-term value inflection points
FL – Follicular lymphoma; DLBCL – Diffuse large B-cell lymphoma: R/R – relapsed/refractory; 3L – 3rd line; 2L – 2nd line
* Pharmacor Oncology: Non Hodgkin’s Lymphoma by Decision Resources Group, 2015
6
Candidate Targeted indication Discovery Preclinical Phase 1 Phase 2 Phase 3
Betalutin® 3L FL
Betalutin®
(combination w/RTX)2L FL
Betalutin® R/R DLBCL (SCT ineligible)
Humalutin®* NHL
212Pb-NNV003 (anti-CD37
radioimmunoconjugate)**CLL and other NHL
NNV014 (anti-CD37 ADC)
(R&D collaboration)CLL and other NHL
LYMRIT-37-01 Phase 1/2 (PARADIGME: Phase 2b RCT)
Archer-1 – Phase 1b
LYMRIT 37-05 – Phase 1
IND-ready
R&D
RTX – rituximab; DLBCL – diffuse large B-cell lymphoma: SCT – Stem cell transplant; ADC: antibody-drug conjugate; CLL: chronic lymphocytic leukaemia
*On hold, refocusing resources towards PARADIGME; **R&D collaboration
R&D
Nordic Nanovector pipeline – Multiple attractive
opportunities in NHL
Commercialisation
Pipeline Development
Goal: capture value of Betalutin® in the US;
the largest single market
Develop differentiated target product profile to meet requirements of regulatory and
reimbursement agencies
Strategy to capture significant value in NHL
77
FL
The slide shows the overall market potential in G7* – Source; Pharmacor Oncology: Non-Hodgkin’s Lymphoma, by Decision Resources Group, 2015
*Germany, France, Italy, Spain, United Kingdom, United States, Japan
c.$2.1B
c.$2.7BDLBCL
Platform Leverage expertise and IP to create long-term value internally and through strategic partnerships
Betalutin® + RTX
Accelerate access to 2L FL
through confirmatory Phase 3 trial
3L R/R FLSingle-agent Betalutin®
First-to-market indication
2L R/R FL
R/R DLBCL
Betalutin®
To maximize NHL opportunity in
largest NHL type
Clinical Development1
3
2
Identify opportunities for ex-US regions
Refine US commercial strategy and deploy
launch readiness plan
Nordic Nanovector ASA
Kjelsåsveien 168 B, 0884 Oslo, Norway
www.nordicnanovector.com
IR contact: [email protected]
NHL – HIGH UNMET NEED DESPITE AVAILABLE
TREATMENTS
NHL – high unmet need despite available treatments
• 7th most common cancer in the US1
• Median age at diagnosis is 67 years1
• Incidence across G7* is 17 per 100,000 per year,
resulting in >130,200 new cases in 20142
• Expected to grow by nearly 20% by 2024, as a
result of population growth and aging population2
• Market potential expected to reach $28.7 billion by
20263
9
• FL (~20%)
• Marginal zone lymphoma (MZL)
• Lymphoplasmacytic lymphoma
• Chronic lymphocytic leukemia/small-
cell lymphocytic lymphoma (CLL/SLL)
• DLBCL (~40%)
• Burkitt lymphoma
• Lymphoblastic lymphoma
• Mantle cell lymphoma
• Primary mediastinal large B-cell lymphoma
Indolent (iNHL)
(40% of all NHL)
Aggressive
(60% of all NHL)
NHL
T-cell NHLB-cell NHL
85% 15%
1seer.cancer.gov2Pharmacor Oncology: Non-Hodgkin’s Lymphoma, by Decision Resources Group, 2015 3Landscape & Forecast: Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia, by Decision Resources Group, 2017
* France, Germany, Italy, Spain, United Kingdom, United States, Japan
FL - shorter remissions with each successive therapy
and no cure at present
10
Remission RemissionRemissionRemissionRemission
Relapse Relapse Relapse Relapse
Anti-CD20
(Rituximab, obinutuzumab)
Anti-CD20
(Rituximab, obinutuzumab)
Anti-CD20
(Rituximab)
IdelalisibClinical trials with novel drugs(CAR-T)
Chemotherapy
(Bendamustine, CHOP, CVP)
Chemotherapy
(Bendamustine, fludarabine, CHOP)
Immunomodulatory agents
(Lenalidomide)
Radioimmunotherapy
Rituximab
Radioimmunotherapy
BSC / Palliative therapy
Approx. 16,000 patients Approx. 10,000 patients Approx. 5,000 patientsApprox. 24,000 patients
Followed by:
• High dose chemo + Stem Cell Transplant
• Allogenic SCT
• Rituximab / obinutuzumab maintenance
Followed by:
• Rituximab maintenance
• Radioimmunotherapy
1st line 3rd line2nd line Later lines
OR
++
+
OR
OR
OR
OR
Treatment regimens including listed options are either approved or recommended by NCCN or ESMO guidelines
Copanlisib
OR
Duvelisib
DLBCL – limited treatment options for patients
relapsing after first-line therapy
11
High-dose
immunochemotherapy (R-
DHAP, R-ESHAP, R-GDP, R-
GemOx. R-ICE) followed by:
Autologous Stem Cell
Transplantation (in some cases
Allogeneic SCT)
Salvage immunochemotherapy
(R-CEPP, R-CEOP, R-DA-EPOCH,
R-GDP, R-GemOx, R-benda)
Approx. 18,000 patients
2nd line
Treatment regimens including listed options are either approved or recommended by NCCN or ESMO guidelines
Transplant
eligible
Y
N
30-40%
60-70%
Anti-CD20
(Rituximab)
Chemotherapy
(CHOP, CEPP, CDOP, DA-
EPOCH, CEOP, GCVP)
Approx. 46,000 patients
1st line
+Abicabtagene ciloleucel
Approx. 10,000 patients
3rd line
OR
Tisagenlecleucel
OR
Pixantrone
OR
Radiation therapy
OR
Clinical trials with novel drugs
Other drug treatment
(brentuximab vedotin, R-
lenalidomide, rituximab)
OR
OR
Clinical trials with novel drugs
NHL – the need for new treatment options
• 40-60% of iNHL patients treated with a RTX-containing regimen are either refractory to therapy (10%) or
develop resistance within five years, so having an alternative therapeutic target to CD20 is important
• Relapsed/refractory patients may not tolerate chemotherapy because of age or co-morbidities, so “chemo-
free” regimens are in high demand
12
~40% of DLBCL patients relapse following 1L
RTX-chemo; 60-70% of these patients fail or
are unsuitable for subsequent high-dose
chemo + SCT
FL: Five-year overall survival for RTX-
refractory patients vs all: 58%1 vs 88%2
1Abdollahi S et al, Blood 2008:1122seer.cancer.gov (2019)3Rivas-Delgado A et al. EHA 2017; abstract 405
59%
5 year PFS3
36%
26%
Nordic Nanovector ASA
Kjelsåsveien 168 B, 0884 Oslo, Norway
www.nordicnanovector.com
IR contact: [email protected]
BETALUTIN® - A ONE-TIME TREATMENT FOR NHL PATIENTS
Betalutin®: A novel CD37-targeting radioimmunotherapy
14 1. Flinn IW. Blood 2011; 118: 4007–4008;
• CD37 is highly expressed in B-NHL1
• 177Lu: a low energy β-emitter with a half-life of 6.7 days
• Mechanism of action:
– Internalization and cell death
– Crossfire effect targets cells with variable CD37
expression and poorly-vascularized tumour regions
15
Betalutin®
Alternative target to CD20, well suited for NHL patients who
progress after RTX-based regimens
Potential synergy from combination with anti-CD20 mAbs and other
therapies
Convenience for NHL patients – simple, one-time treatment, QoL
Convenience for physicians – ready-to-use, optimised resourcing
Predictable and manageable toxicity*, important for elderly NHL
patients who might not be able to tolerate chemotherapy
High and durable response from one-time treatment in heavily
pre-treated NHL patients*
* Kolstad A, et al. Abstract 2879, ASH 2018.
Betalutin® is specifically designed as a one-time treatment
for NHL: Compelling, unique and differentiated value proposition
Nordic Nanovector ASA
Kjelsåsveien 168 B, 0884 Oslo, Norway
www.nordicnanovector.com
IR contact: [email protected]
BETALUTIN® - PROMISING SAFETY AND EFFICACY IN R/R FL
Clinical development optimized to deliver Betalutin®
to FL patients as soon as possible
• Objective is to deliver a product with a differentiated target product profile that meets the
requirements of both regulatory and reimbursement agencies
17
LYMRIT 37-01
Phase 1/2a trial
PARADIGME
Pivotal, global randomised Phase 2b trial
US
Filing
Phase 1
Dose-escalation cohorts to
determine the MTD/RDE* of
Betalutin®
Phase 2a
Dose expansion cohorts
for confirmatory safety
and exploratory efficacy
74 R/R iNHL patients with a median of 3 prior therapies
All patients received a single administration of Betalutin®
3L FL patients refractory to anti-CD20 therapy
Target is 130 patients at 80-85 sites in approx. 20 countries
Primary endpoint: ORR
Secondary endpoints: DoR, PFS, OS, Safety, QoL
Complete patient enrolment in 2H 2020
Comparing two dosing regimens with the goal to select
the best Betalutin® dosing regimen for filing
Betalutin® + RTX: Accelerate access to 2L FL through confirmatory Phase 3 trial
* Maximum tolerated dose / Recommended dose for expansion
LYMRIT 37-01: Promising safety and efficacy in R/R FL*
18
Patient characteristics (n=74)
• Elderly (median 68 years)
• Heavily pre-treated with advanced-stage disease at
baseline
• Primarily FL (n=57) with other NHL types (n=17)
Betalutin® was well tolerated
• Most common grade 3/4 AEs were transient and reversible
neutropenia and thrombocytopenia
• Serious AEs occurred in 14 pts (19%)
• No cases of febrile neutropenia, low incidence of platelet
transfusion, and no study related deaths
Compelling response rate in FL and MZL**
patients from a single administration
ORR CR
All patients (n=74) 61% 28%
All FL patients (n=57) 65% 28%
Arm 1 (40/15) (n=25) 64% 32%
Arm 4 (100/20) (n=16) 69% 25%
FL with ≥2 prior therapies (n=37) 70% 32%
RTX*-refractory FL, ≥2 prior therapies (n=21) 62% 19%
MZL (n=9) 78% 44%
*Kolstad A, et al. Abstract 2879, ASH 2018
** MZL – Marginal Zone Lymphoma
Preliminary mDoR (Updated August 2019)
• Preliminary analysis shows median duration of response
(mDoR) of 13.5 months (formerly 9.0 months in December
2018). Final data will be presented at the R&D Day.
• Follow-up for mDoR is ongoing
Betalutin® continues to be a novel and effective therapy
among 3L FL competitors
19
Betalutin
(Phase I/2)
3rd
Lin
e
53%
93%
79%
75%
77%
71%
42%
59%
54%
70%
71%
50%
7%
21%
1%
14%
8%
32%
CR ORR
• All agents are approved based on different phase results as mentioned along with asset
• Results from different trials for comparison purpose only and NOT head to head studies• Accelerated Approval basis on Phase II
• # at doses ≥5 mg
Copanlisib*
(Marketed)
Idelalisib
(Marketed)
ME401
(Phase 1b)
Duvelisib*
(Marketed)
Kymriah
(Phase II)
Tazemetostat
EZH2m+
(Phase II)
REGN1979#
(Phase I)
Parsaclisib
(Phase I/II)
Umbralisib
(Phase I)
mDOR
(months)
Pts.’
Median
Age
Route of AdministrationMechanism of
ActionSource
~13.5*
(20.7 in
CR pts)
68IV infusion (one-time administration), preceded by 1
RTX and 1 lilotomabCD37-targeting RIT
Kolstad et al, ASH 2018
(37 3L FL pts.); *Latest
company update
>12.5 62 Oral, twice daily Pi3k inhibitorPrescribing info
(72 patients)
14.1 62IV infusion (weekly – 3 weeks on and 1 week off) until
progressionPi3k inhibitor
Prescribing info
(104 patients)
10 64 Oral, twice daily, until disease progression Pi3k inhibitorPrescribing info
(83 patients)
N/A59 (part A
66 (part B)Oral, once daily Pi3k inhibitor
Forero-Torres et al,
ASH 2017 (4 patients)
8.3 61 Oral, twice daily EZH2 inhibitorEpizyme, ICML 2019
(43 patients)
N/A 64.5 Oral, once daily Pi3k inhibitorASCO 2019
(30 patients)
15 (83%) 59IV infusion of re-engineered autologous T-cells,
preceded by leukapheresis and CTCAR-T cell therapy
Novartis, ASH 2016
(14 patients)
NR 67 Multiple dose levels of REGN1979;IV
Anti-CD20 X Anti-
CD3 bispecific
antibody
Regeneron Pharma,
EHA 2019 (21 pts.)
NR 66Oral; daily dose; until disease progression or off
studyPi3k inhibitor
Matthews et al, ASH
2017 (146 pts.)
20
• 81 clinical sites are open for enrolment (as of Aug 21st, 2019)
• An interim analysis for futility is targeted for 1H 2020
PARADIGME: Dose selection aligned with regulatory feedback
Day -14 Day 0
Rituximab
375 mg/m2
20MBq/kg Betalutin®
(+ 100mg/m2 llo)
(n=65)
15MBq/kg Betalutin®
(+ 40mg llo*)
(n=65)
RandomisationComplete patient
enrolment 2H 2020
• Patient population: 130 patients with 3L FL who are refractory to anti-CD20 therapy
• Primary endpoint: Overall response rate (ORR)
• Secondary endpoints: Duration of response (DoR), Progression free survival (PFS), Overall survival (OS), Quality of life (QoL)
Filing
1H 2021Interim Analysis
Target 1H 2020
*Ilo – lilotumab, naked anti-CD37 antibody
• Orphan Drug Designation granted in US and EU in 2014
• Clinical plan for Betalutin ® agreed with FDA in September 2017 (type C meeting)
• Enhance dialogue with regulators to bring Betalutin® to FL patients quicker thanks to:
– Fast-track designation granted in the US in June 2018
– Promising Innovative Medicine (PIM) designation granted in the UK in October 2018
21
Regulatory path focused on expedite product approval
Nordic Nanovector ASA
Kjelsåsveien 168 B, 0884 Oslo, Norway
www.nordicnanovector.com
IR contact: [email protected]
BETALUTIN® - ONGOING DEVELOPMENT IN 2L FL
Clinical development strategy to pursue access
to 2L FL indication
• Access significantly larger market opportunity than 3L FL – at present $1.5B
• Strong rationale for combination from preclinical models*
– Betalutin® + RTX significantly inhibited tumour growth and prolonged overall survival
– Hypothesis: Betalutin® reverses downregulation of CD20 expression and RTX resistance
23
LYMRIT 37-01
and PARADIGME
Archer-1
Confirmatory Phase 3 study
in 2L FL(to be discussed with Regulatory authorities)
Leverage US
operations and
customer-facing
infrastructure
Repetto-Llamazares A et al. Eur J Haematol 2018
Demonstrated synergistic effect of Betalutin® in
combination with RTX in a preclinical NHL model
• Betalutin® shown to increase binding of
rituximab to NHL cells in vitro and increase
uptake of RTX in NHL tumours in vivo
• Strong synergistic effect of combination of
Betalutin® and RTX on survival of mice with
NHL (Hazard ratio = 0.024, Cox regression)
• Median survival time for combination: >222
days (p < 0.05)
• Median survival time with either treatment
alone was 31 - 40 days with RTX or 50 days
with Betalutin®
24 Repetto-Llamazares A et al. Eur J Haematol 2018
Survival analysis of nude mice
with s.c. Daudi xenografts
Su
rv
iva
l
• Patient population: 20-25 patients with FL (grade I-IIIA) ≥1 prior regimens
• Primary objective: To evaluate the safety and tolerability of Betalutin® in combination with RTX
• Secondary objective: To evaluate the preliminary anti-tumour activity of combination treatment
• First patient dosed in November 2018
• First safety cohort completed (10 MBq/kg Betalutin®), dose increased (15 MBq/kg) for next 3-6 patients
25
Rituximab
375mg/m2
Rituximab
375mg/m2
Rituximab
375 mg/m2 or 1400 mg s.c.
Q 12 weeks for 2 years
or until disease progression
DISCONTINUE
SD, PR
or CR
Day -14 Days 7, 14, 21 and 28
PD
Archer-1: Betalutin® + rituximab in R/R FL
Data read-out
2H 2020
Day 0
10MBq/kg Betalutin®
(+ 40mg llo)
or
15MBq/kg Betalutin®
(+ 40mg llo)
Nordic Nanovector ASA
Kjelsåsveien 168 B, 0884 Oslo, Norway
www.nordicnanovector.com
IR contact: [email protected]
BETALUTIN® - POTENTIAL IN DLBCL
Betalutin® has demonstrated efficacy
in preclinical models of DLBCL
27* Melhus et al., EHA annual meeting, Stockholm, 2018.
** Pichard, et al. Submitted to Leukemia, 2019.
0
25
50
75
100
0 10 20 30 40 50
Surv
ival (%
)
Time post-xenograft (days)
0
1000
2000
3000
0 10 20 30 40 50
Tum
or
volu
me (
mm
3)
Time post-xenograft (days)
NaCl 177Lu-lilotomab (100 MBq/kg)
Lilotomab (0.5 mg/kg) 177Lu-cetuximab (125 MBq/kg)
• In vivo therapy of SCID mice with DOHH2 DLBCL xenografts show an improved effect of Betalutin
compared with lilotomab and non-specific 177Lu-cetuximab**
28
• Patient population: Up to 24 patients with R/R DLBCL
• Primary objective: Determine maximum tolerated dose (MTD)
• Secondary objectives: Safety and preliminary activity
LYMRIT 37-05: Phase 1 dose-escalation study in R/R
DLBCL patients not eligible for SCT
*all patients to receive RTX 375 mg/m2 on day -14
10MBq/kg Betalutin®
(+ 60 mg/m2 llo)
(n ≥3)
15MBq/kg Betalutin®
(+ 100 mg/m2 llo)
(n ≥3)
10MBq/kg Betalutin®
+ 100 mg/m2 llo
(n ≥3)
20MBq/kg Betalutin®
(+ 100 mg/m2 llo)
(n ≥3)
Initial data read-
out
2H 2019
Expansion Phase
with selected dose
20 patients
• No safety issues were identified in the first 3 cohorts
• Patient enrolment completed (July 2019)
Nordic Nanovector ASA
Kjelsåsveien 168 B, 0884 Oslo, Norway
www.nordicnanovector.com
IR contact: [email protected]
COMMERCIALISING BETALUTIN® –
CAPTURING ITS VALUE IN NHL
Insight from pre-commercial research – defining optimal
commercialisation strategy for success
• The value of Betalutin® as a new treatment option in NHL is clearly perceived by stakeholders
– Efficacy is seen as a major strength
– The combination of efficacy, manageable toxicity and convenience of one-time administration makes
Betalutin® truly appealing
– Betalutin® targets unsatisfied areas of the market, and will be well positioned to serve unmet needs of patients
– elderly with co-morbidities and RTX-refractory
• Analogs’ case studies highlight key strategies to maximise the clinical and commercial potential of
Betalutin®
– Pre-launch scientific engagement of thought leaders in NHL centers of excellence on Betalutin’s benefits and
positioning
– Well-designed clinical development plan, aligned with health authorities’ feedback
– Robust market access and reimbursement programme
– Optimised referral pathway
– Streamlined manufacturing and distribution via a centralised logistics partner
30
Betalutin® – a clear path to commercialisation
• Retain Betalutin® as a
wholly owned asset
• Actively participate in its
commercialisation in the US
• Explore potential distribution
agreements in selected
geographies
• Successfully position Betalutin® in first-
to-market indication (3L FL)
• Expand in 2L FL with RTX combination
therapy
• Leverage US commercial infrastructure
to penetrate DLBCL market space
• Maximize product value through life-
cycle management
• Target price premium vs.
prior radioimmunotherapies
• Align price to that of new
agents approved in 3L FL
• Ensure price reflects
incremental value to payers,
healthcare professionals
and patients over alternative
treatments
Go-to-market strategy Launch strategy Pricing strategy1 2 3
31
32
We have a thorough understanding of disease state,
competitive landscape, patient flow and customer behaviour
• Case study deep
dives: Xofigo®, SIR
Spheres®, Zevalin®
• Categorised settings
of care for licensed
administration
facilities
• Deep dive into the
radiopharmacy
landscape
• Research on
requirements to
become an
Authorised User
• Customer
segmentation
• Positioning and
messaging
• Patient referral
pathway
• Patient flow
➢ 1:1 Discussions with
HaemOncs, RadOncs,
NucMeds (n = 190), Health
Physicists and Radio-
pharmacists (n = 40)
➢ Sample included HCPs
from private clinics,
community hospitals/systems,
IDNs and academic centers
(approx. 2/3 US, 1/3 EU)
• US pricing and
market access
research
• EU-4* pricing and
market access
research
• Reimbursement
pathway (US, EU-5**)
➢ 1:1 Discussions with
Payers (n = 60)
➢ Focus on both commercial
plans and government health
plans in the US (Medicare /
Medicaid), and EU-4 (NHS
reimbursement systems)
• Qualitative patient
research
➢ 1:1 Discussions with
Patients (n = 22)
➢ Focus on patient journey,
role of patient and caregivers,
buying process, leverage
points and barriers for
Betalutin®
• Integration of primary /
secondary market
research data with
claims data and other
sources to map
outpatient physician
treatment of FL
patients in US
community settings
• Distribution and
fulfilment strategy
research
➢ First four tasks completed
➢ 1:1 Discussions with
HemOncs, RadOncs,
NucMeds, RadioPharms,
Industry Trade Experts,
Distributors (n = 84)
Secondary
ResearchPayers and PricingQualitative Insights Patient Insights Special Projects
*Germany, France, Italy and Spain
**Germany, France, Italy, Spain, United Kingdom
Betalutin® manufacturing and supply chain
• Biological intermediates (lilotomab satetraxetan, lilotomab) and no-carrier
added Lutetium-177 are sourced in Europe
• Betalutin® Drug Product is manufactured at the Institute for Energy
Technology (IFE; Kjeller, Norway)
• Additional regional manufacturing site in North America scheduled to
come on-line after approval
• Logistics supply chain from European production site at launch will
secure 48-72 hour delivery to all administration sites – US-based logistics
partner will have strong radio-pharmacy network
• Strong internal capabilities overseeing manufacturing, quality and
distribution
33
Broad IP protection
Betalutin®
• Composition of matter patent (covers Betalutin®, Humalutin®, uses etc.)
• Expires in 2031*
• Approved in most countries
Betalutin® + rituximab
• Up-regulation of CD20 by Betalutin®
• Expires in 2034*
• Approved in EU and abouthalf of the countries
Pre-dosing
• Cover different ways of pre-dosing with lilotomab
• Expires in 2037*
• Pending in all countries
Combination patent
• Combination of Betalutin®
and Humalutin® withdifferent drug classes
• Expires in 2038*
• Pending in all countries
2010 2013 2016 2017
*With 5 years extension possible34
Nordic Nanovector ASA
Kjelsåsveien 168 B, 0884 Oslo, Norway
www.nordicnanovector.com
IR contact: [email protected]
PIPELINE
• Collaboration project with Orano Med (formerly AREVA Med)
• NNV003 is a chimeric anti-CD37 mAb developed by Nordic
Nanovector
• 212Pb is an alpha-particle emitter with clinically attractive properties
– 10.6 hr half-life; range of alpha-particle is 50-100 mm
• Potential to target chronic lymphocytic lymphoma and other
disseminated B-cell tumours
• Safety of 212Pb has been demonstrated in clinical trials*
• Well tolerated with a 90-100% survival rate in preclinical models of
Chronic Lymphocytic Leukemia (CLL) and NHL**
36
212Pb-NNV003
NNV003 –
chimeric anti-
CD37 mAb
Lead-212
payload
*Safety and Outcome Measures of First-in-Human Intraperitoneal α Radioimmunotherapy With 212Pb-TCMC-Trastuzumab.
Meredith RF, et al. Am J Clin Oncol. 2018 Jul;41(7):716-721
** Saidi, A. et al. Abstract #4422, ASH 2018
Preclinical project: 212Pb-NNV003 A novel targeted alpha therapy for treatment of B-cell malignancies
Nordic Nanovector ASA
Kjelsåsveien 168 B, 0884 Oslo, Norway
www.nordicnanovector.com
IR contact: [email protected]
FINANCIALS
Tight cost control; investment focused on clinical
development and CMC activities
38
Operating results Distribution of total operating expenses
1H 2019: 77 %
(1H 2018: 72 %)
1H 2019: 23 %
(1H 2018: 28 %)
Development* Administration
* preclinical, clinical, medical affairs, regulatory and CMC activites
-85-77
-96-90
-111-120
-100
-80
-60
-40
-20
0
Q2'18 Q3'18 Q4'18 Q1'19 Q2'19
MN
OK
39 ** USD/NOK 7.75 ** USD/NOK 8.51
$ 92M*
$ 61 M**
Cash resources through to mid-2020
• Net cash from operating activities of
negative NOK 102.2 million
• Net cash flow from investing activities of
NOK 0.2 million
• Net cash flow from financing activities of
NOK 7 million
-71 -71 -60
98
-95
-200
-100
0
100
200
Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019
642
570500
440
539444
0
100
200
300
400
500
600
700
Q1 2018 Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019
Cash position
• Cash position of NOK 444 million as at end
Q2 2019
• The company maintains its guidance that
current cash resources are expected to be
sufficient to reach mid-2020
(MUSD 83*)
(MUSD 52**)
MN
OK
MN
OK
Net cash flow 1)
1) Net cash flow from operating, investing and financing activities plus/minus currency effect
Q2 2019:
Key shareholders*
40
Top 5 Shareholders % ownership
HealthCap VI L.P. 10.36%
Folketrygdfondet 5.65%
OM Holding AS 4.57%
Nordnet Livsforsikring AS 3.19%
Total 20 largest shareholders 39.37%
Total number of shares (fully diluted) 55,113,696
Average traded volume: 136,000 shares
*As of August 26, 2019
Nordic Nanovector ASA
Kjelsåsveien 168 B, 0884 Oslo, Norway
www.nordicnanovector.com
IR contact: [email protected]
SUMMARY
42
Opportunistically consider partnerships to further enhance shareholder returns
Complete enrolment into PARADIGME to enable BLA filing for Betalutin® with differentiated product profile
Advance clinical development of Betalutin® + RTX combination in 2L FL
Develop and execute commercialisation strategy for Betalutin® in NHL in the US
Selectively extend the company’s pipeline targeting other B-cell malignancies around radioimmunotherapy expertise
Maintain rigorous capital management
Strategic priorities focused on creating shareholder value
Progress clinical development plan with Betalutin® in DLBCL
Key company goals 2019-2021
43
1H 2019 Betalutin® in DLBCL LYMRIT 37-05: Enrolment completed (11 July)
2H 2019 Betalutin® in DLBCL LYMRIT 37-05: Data read-out
1H 2020
Betalutin® in DLBCL LYMRIT 37-05: First patient dosed (Expansion cohort)
Betalutin® in 3L FL PARADIGME: Interim analysis for futility
Betalutin® + rituximab in 2L FL Archer-1: Enrolment completed
2H 2020
Betalutin® + rituximab in 2L FL Archer-1: Data read-out
Betalutin® in 3L FL PARADIGME: Enrolment completed (data read-out to follow a few months later)
1H 2021 Betalutin® in 3L FL Regulatory filing