NEXT-GENERATION RADIOIMMUNOTHERAPIES FOR NON-HODGKIN ... · NEXT-GENERATION RADIOIMMUNOTHERAPIES...

Nordic Nanovector ASAKjelsåsveien 168 B, 0884 Oslo, Norwaywww.nordicnanovector.comIR contact: [email protected]

NEXT-GENERATION RADIOIMMUNOTHERAPIESFOR NON-HODGKIN’S LYMPHOMA PATIENTS

Forward-looking statementsThis 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, PhDCo-Founder, Chief Scientific Officer

MARCO RENOLDI, MDChief Operating Officer

LISA ROJKJAER, MDChief Medical Officer

TONE KVÅLEChief Financial Officer

RITA DEGEChief Human Resources Officer

MALENE BRONDBERGVice President, IR & Corporate Communications

ROSEMARIE CORRIGANChief Quality Officer

EDUARDO BRAVOChief 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

PARADIGME – Pivotal Phase 2b

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® + RTXAccelerate access to 2L FLthrough confirmatory Phase 3 trial

3L R/R FL Single-agent Betalutin®

First-to-market indication

2L R/R FL

R/R DLBCLBetalutin®

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


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

10Remission RemissionRemissionRemissionRemission

Relapse Relapse Relapse Relapse

Anti-CD20(Rituximab, obinutuzumab)

Anti-CD20(Rituximab, obinutuzumab)

Anti-CD20(Rituximab)

Idelalisib Clinical 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 CellTransplantation (in some casesAllogeneic 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

Transplanteligible

Y

N

30-40%

60-70%

Anti-CD20(Rituximab)

Chemotherapy(CHOP, CEPP, CDOP, DA-EPOCH, CEOP, GCVP)


1st line

+Abicabtagene ciloleucel


3rd line

OR

Tisagenlecleucel

OR

Pixantrone

OR

Radiation therapyOR

Clinical trials with novel drugs

Other drug treatment (brentuximab vedotin, R-lenalidomide, rituximab)

OR

ORClinical 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%


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, QoLConvenience 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


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

PARADIGMEPivotal, global randomised Phase 2b trial

USFiling

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 countriesPrimary 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*

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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

Line

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)

TazemetostatEZH2m+(Phase II)

REGN1979#

(Phase I)

Parsaclisib(Phase I/II)

Umbralisib(Phase I)

mDOR (months)

Pts.’ Median Age

Route of Administration Mechanism of Action Source

~13.5* (20.7 in CR pts)

68 IV infusion (one-time administration), preceded by 1 RTX and 1 lilotomab CD37-targeting RIT

Kolstad et al, ASH 2018 (37 3L FL pts.); *Latest company update

>12.5 62 Oral, twice daily Pi3k inhibitor Prescribing info(72 patients)

14.1 62 IV infusion (weekly – 3 weeks on and 1 week off) until progression Pi3k inhibitor Prescribing info

(104 patients)

10 64 Oral, twice daily, until disease progression Pi3k inhibitor Prescribing info(83 patients)

N/A 59 (part A66 (part B) Oral, once daily Pi3k inhibitor Forero-Torres et al,

ASH 2017 (4 patients)

8.3 61 Oral, twice daily EZH2 inhibitor Epizyme, ICML 2019(43 patients)

N/A 64.5 Oral, once daily Pi3k inhibitor ASCO 2019(30 patients)

15 (83%) 59 IV infusion of re-engineered autologous T-cells, preceded by leukapheresis and CT CAR-T cell therapy Novartis, ASH 2016

(14 patients)

NR 67 Multiple dose levels of REGN1979;IVAnti-CD20 X Anti-CD3 bispecific antibody

Regeneron Pharma, EHA 2019 (21 pts.)

NR 66 Oral; daily dose; until disease progression or off study Pi3k 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

Rituximab375 mg/m2

20MBq/kg Betalutin®

(+ 100mg/m2 llo)(n=65)


(+ 40mg llo*)(n=65)

Randomisation Complete 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)

Filing1H 2021

Interim AnalysisTarget 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


BETALUTIN® – ONGOING DEVELOPMENT IN 2L FL

Clinical development strategy to pursue accessto 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 37-01and PARADIGME

Archer-1

Confirmatory Phase 3 studyin 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 micewith s.c. Daudi xenografts

Su

rviv

al

• 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

Rituximab375mg/m2

Rituximab375mg/m2

Rituximab375 mg/m2 or 1400 mg s.c.

Q 12 weeks for 2 years or until disease progression

DISCONTINUE

SD, PRor CR

Day -14 Days 7, 14, 21 and 28

PD

Archer-1: Betalutin® + rituximab in R/R FL

Data read-out2H 2020

Day 0


(+ 40mg llo)

or


(+ 40mg llo)


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

orvo

lum

e (m

m3 )

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 Betalutincompared 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


(+ 60 mg/m2 llo)(n ≥3)


(+ 100 mg/m2 llo)(n ≥3)


+ 100 mg/m2 llo(n ≥3)


(+ 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)


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 partner30

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 radiopharmacylandscape

• 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 Research Payers 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 several countries

Betalutin® + rituximab• Up-regulation of CD20 by

Betalutin®

• Expires in 2034*• Approved in EU and about

half of the countries

Pre-dosing• Cover different ways of

pre-dosing with lilotomab• Expires in 2037*• Pending in serveral 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


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 µm

• 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


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

0Q2'18 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 ofnegative NOK 102.2 million

• Net cash flow from investing activities ofNOK 0.2 million

• Net cash flow from financing activities ofNOK 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

539 444

0100200300400500600700

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 % ownershipHealthCap VI L.P. 10.36%Folketrygdfondet 5.65%OM Holding AS 4.57%Nordnet Livsforsikring AS 3.09%DNB Markets 1.67%

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


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

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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 2020Betalutin® + 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

NEXT-GENERATION RADIOIMMUNOTHERAPIES FOR NON-HODGKIN ... · NEXT-GENERATION RADIOIMMUNOTHERAPIES...

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