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Beginning with the goal in mind: our strategic approach toBetalutin®’s clinical development

Marco Renoldi, CBOCapital Markets Day, Nov. 17, 2015

Nordic Nanovector ASA Kjelsåsveien 168 B, 0884 Oslo, Norway - www.nordicnanovector.com

My background

• MD, MBA

• 30 years of experience in leading pharmaceutical and biotech industries

• Held senior R&D and business roles at national and global levels

• Led oncology projects through global registration at Novartis

• Launched oncology and haematology products internationally at Amgen

• Chief Business Officer, Nordic Nanovector

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A successful product launch is the result of a three-pronged strategy

1. Understand NHL competitiveenvironment• Map treatment pathways

• Assess current and future competitors

2. Understand what outcomes matter tohealthcare professionals and patients• Listen to customers’ perspectives and

needs

3. Leverage insights to develop therapiesthat address true unmet medical needs• Design a Target Product Profile that will

clearly differentiate from the futureStandard of Care

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Percent of drugs launched, 1977-2007

(Total = 270)

Lack of differentiation in the market

Other

80

20

74%26%

Commercialfailures

Commercialsuccesses

Hence, starting with the goal in mind is a pre-requisite to financial andcommercial success

• Develop a well thought-throughTarget Product Profile, to unlockthe unique value proposition in NHL

• Design a drug development plan aimed at reaching that Target Product Profile

• Leverage Advisory Board andprimary insights research todevelop and validate assumptions

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Based on insights, unmet medical need in NHL centres on 2nd line and beyond, as well as alternatives to stem cell transplant

Perceived Unmet Need is High

• Patients who fail first line therapy(FL and DLBCL)

• Patients who refuse chemotherapy

• Rituximab-resistant patients

• Older patients (>65)

• Patients with significant co-morbidities orcompromised cardiac function

• Younger patients who did not respond wellto first or second line

Perceived Unmet Need is Low

• First line therapy (FL and DLBCL)

• Conditioning regimens (prior to stem cell transplant)

• Younger, robust patients in first or second line

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1. Unmet medical need

As a result, we prioritized Betalutin® development program aroundrelapsed FL and SCT-ineligible DLBCL

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Product candidate Discovery Preclinical Phase 1 Phase 2 Phase 3

DLBCL, Ineligible to ASCT

FL, 3rd Line

177Lu-chHH1 ARC

Affilutin

DLBCL, Conditioning

Indication

NHL, other B-cell tumours

Multiple myeloma

Betalutin®

Betalutin®

Betalutin®

NHL Betalutin® + CD20

FL, 2nd Line Betalutin®

1. Unmet medical need

3rd Line FL: no standard of careRelapsed SCT-ineligible DLBCL: limited treatment options, highest unmet medical need

We analyzed safety & efficacy data of current/future competitors and concluded that Betalutin® can play a significant role as stand-alone agent

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2016 2017 2018 2019 2020

Ibritumomab tiuxetanORR: 74%, CR:15%, DOR: 6.4 mo.’s

IdelalisibORR: 54%, CR:14%; DOR: 11.8 mo.’s

BendamustineORR: 75%, CR: 14%; DOR: 9.2 mo.’s

3L FL

Sources: Scientific publications, publicly available information*estimated approval timelines based on publicly available sources

In development*:

CopanlisibORR: 40%CR: 20%

DuvelisibORR: 69%CR: 38%

IbrutinibORR: 67%CR: 23%

DOR: 17.5 mo.’s

R-lenalidomide

ORR: 75%CR: 36%

Phosphoinositide 3-kinase inhibitors

Bruton’s tyrosine kinase inhibitor

Tumor necrosis factor alfa synthesis inhibitor

BC2 inhibitor

Currently approved:

RB+VenetoclaxORR: 74%CR: 21%

3L FL

2L FL

2. Points of differentiation vs. competition

Physicians’ insights research helped us identify target segments andunderstand their needs

Healers (30% in US, 45% in EU)

• Mainly based in large institutions andacademic centres

• Goal: remission or cure to the extent possible

• Efficacy drives treatment choice

• Feel they can control adverse events to allowmost effective treatment

• Still prefer combination in 3rd line

• Views on TKI’s: concerns over compliance

Carers (30% in US, 20% in EU)

• Mainly based in community hospitals & private practices

• Goal: quality of life to the extent possible

• Safety drives treatment choice

• Concerned about Grade 3-4 non-hematologyadverse events

• Prefer single agent in 3rd line

• Views on TKI’s: concerns over toxicity andcompliance

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3. Target customers

Analysis of unmet medical needs, competitors’ gaps and targetcustomers’ attitudes unlocked Betalutin®’s unique value proposition…

• One-time therapy (100% patientcompliance vs. oral TKI’s)

• Improved CR and DOR as singleagent (vs. marketed therapies, incl. TKI’s)

• Low discontinuation rate due toside-effects

• Synergy with antiCD20 moAB(upregulation of CD20)

• ORR at par with competitors• Manageable haematological

toxicity• Possibility to combine with

CD20 moAB

• Improved quality of life• Minimal non-haematological

toxicities• Improved resource utilization

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Important

Less important

Different Not Different

… which translated into a differentiating Target Product Profile

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Follicular Lymphoma 3rd Line

MoA MoA summaryBetalutin is a new-generation ARC that consists of a tumour specific mAB targeting CD-37 antigens on the surface of cancer cells and of a radioactive isotope Lu-177 that emits a burst of radiation directly to the tumour cell. Due to its crossfire effect, the radiation can also reach and destroy neighbouring malignant cells with limited toxicity for surrounding healthy tissues

Indication US, Europe BETALUTIN is indicated for adult patients with follicular lymphoma who have received 2 prior systemic therapies

Efficacy endpoints

Response Rate ORR = 70-75%, CR = 35-40%, DOR = 9-12mo.s

OS 30 mo.s

PFS 9-11mo.s

Safety Profile Grade ≥ 3Goal: no black box warnings

Grade 3-4 haematological adverse events

Convenience/ QOL

Administra-tion

Rituximab injection at -28d and Day 0; «cold» HH1 antibody prior to administration of Betalutin

Treatment duration One-time injection

Ce

rtai

nty

leve

l

Extent of positive reactions

Low High

Low

High

Betalutin®’s TPP generated a high degree of positive reactions amongst physicians, as well as useful insights for future positioning

• CD 37 as a new target

• Benefit of Lutetium

• Multi-cell kill

• Value of pre-treatment

• Potential for dosimetry

Evidence and education

• Novelty of drug• One –time

injection and great for patients

• Efficacy • Safety

Corner stone of positioning

Address logistical issues and

distance from RITs

• Issues related to logistics similar to past RITs

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And that Target Product Profile has informed Betalutin®’s clinical development program for follicular lymphoma

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CLINICAL PHASE OBJECTIVES AND SAMPLE SIZE

Phase 1/2

Phase 2(pivotal for3rd Line FL)

Phase 3(new indication: 2nd Line FL)

Primary Objective

Secondary Objectives

Patients

Primary Objective

Secondary Objectives

Patients

Primary Objective

Secondary Objectives

Patients

Maximum Tolerated Dose

Dose for Ph. 2, Safety, Efficacy, Biodistribution and PK

Approx. 40

Overall Response Rate (ORR)

Safety, CR, DOR, PFS, TTR, OS, QoL

Approx. 85

Approx. 250

Progression-free Survival (TBC)

ORR, CR, DOR, TTR, OS, QoL, Safety (TBC)

First BLA filing

Betalutin®’s updated clinical development plan -Targeting approval in 3L FL with a competitive product profile

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* Dose decision based on safety data and Safety Review Board’s recommendation

Lymrit 37-01 – Phase 1/2 trial

PARADIGME dose decision: Q1 2017

Pivotal Phase 2 PARADIGME trial

First Patient: 2H 2017

Dose TBDN=85

Last Patient: 2H 2018

Regulatory submission: 1H 2019

20MBq(+ HH1 50mg)

N=310MBq

(- HH1 R0)N=1

15MBq(+ HH1 50mg)

N=6

10MBq(+ HH1 50mg)

N=3Arm 1

Phase 1

Arm 2(in progress)

Phase 2

15MBq(+ HH1 50mg)

N=9

15MBq(- HH1 R0)

N=3 to 6

15MBq(- HH1)

N=2

15MBq(+ HH1 >100mg)

N=3 to 6

17.5MBq or20MBq*

(- HH1 – R0)N=3 to 6

10MBq(- HH1)

N=3 to 6

17.5MBq or20MBq*

(+ HH1 >100mg)N=3 to 6

17.5MBq*(+ HH1 50mg)

N=3

Arm 3(first patient : Q1 2016)

Arm 4(first patient : Q1 2016)

Our regulatory strategy has been validated with regulatory agencies

1. File registration dossier (3rd Line FL) 1Q 2019

• Data from Lymrit-37-01, Dosimetry study, PARADIGME study and safetydatabase, including patients from Phase 3 study

2. Target Accelerated (US)/Conditional (EU) approval (3rd Line FL) 4Q 2019

• Requires exceptional results (aligned to TPP) and acknowledged medical need

3. Commit to complete confirmatory Phase 3 study, targeted to approval of 2nd Line FL, ongoing at filing

4. Apply for Orphan Drug Designation (ODD) in DLBCL, in both EU and the US

• Programme to start end of 2015

5. Target Accelerated (US)/Conditional (EU) approval (relapsed DLBCL) 2H 2020 with pivotal phase 2 study

• Requires exceptional data vs. competitors and acknowledged medical need

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Focused education plus a compelling TPP give the very best chance ofcommercial success

Prepare the market for Betalutin

• Develop speaker panel to introduce and position ARC and overcome RIT resistance

• Develop programs to facilitatehematology/oncology & nuclear medicine collaboration

• Support physicians and societies in defining treatment guidelines

Prepare Betalutin for the market

• MoA concept to reinvent RIT as ARC, opening a ‘new door’ for innovation, with focus on US

• Conduct patient ‘emotional insights’ research to further develop positioning concept

• Build physician and patient benefit story focusing on unique value proposition

• Develop clear differentiation message vs. Zevalin for US market

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Key Takeaways

• We have gained a wealth of insights into the treatment continuum for both FL and DLBCL

• We have identified the key points in this continuum where Betalutin® could fit

• We have developed a Target Product Profile (TPP) to realize that vision with Betalutin®

• That TPP is viewed as attractive by customers

• We recently optimised Betalutin clinical development program to increase the probability to achieve or possibly exceed that profile

• We are confident Betalutin® can contribute to extend and improve the life of patients with NHL and meet investors’ expectations

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Nordic Nanovector ASA

Kjelsåsveien 168 B, 0884 Oslo, Norway

www.nordicnanovector.com

Thank you for your attention!