Q1 18 HIGHLIGHTS AND FINANCIALS

Similar documents
PARADIGME UPDATE APRIL Nordic Nanovector ASA Kjelsåsveien 168 B, 0884 Oslo, Norway IR contact:

ASH 2017 BETALUTIN LYMRIT STUDY UPDATE

DEVELOPING PRECISION THERAPIES IN HAEMATOLOGIC CANCERS

DEVELOPING PRECISION THERAPIES IN HAEMATOLOGIC CANCERS

DEVELOPING PRECISION THERAPIES IN HAEMATOLOGIC CANCERS

DEVELOPING FIRST-IN-CLASS TREATMENTS IN HAEMATOLOGIC CANCERS

DEVELOPING FIRST-IN-CLASS TREATMENTS IN HAEMATOLOGIC CANCERS

Developing First-in-Class Treatments in Haematologic Cancers DNB Healthcare Conference, Thursday December 15 th, 2016

Introducing a First-in-Class treatment for Non-Hodgkin Lymphoma BioEquity Europe 2016, Copenhagen May 11, 2016 Luigi Costa, Chief Executive Officer

Introducing a First-in-Class treatment for Non-Hodgkin Lymphoma Carnegie Healthcare Conference, March 17, 2016 Marco Renoldi, Chief Business Officer

Developing first-in-class treatments in Haematology Jefferies Healthcare Conference, London, 16 November Luigi Costa, Chief Executive Officer

The science behind Betalutin : why is it unique? Roy H. Larsen PhD Sciencons AS, Oslo, Norway

Conference Call L-MIND data

Q4 & Interim Full Year 2018 PRESENTATION February 13, 2019 Per Walday, CEO Ronny Skuggedal, CFO

ImmunoGen, Inc. Reports Fourth Quarter and Fiscal Year 2013 Financial Results and Provides Fiscal Year 2014 Financial Guidance and Corporate Update

Changing Lives. Daniel Junius, President and CEO June 3, Nasdaq: IMGN

Comparability Studies for Autologous Cell Therapy Products. Chris Shen July, 2017

CD19 ADCs Effectively Targeting B Cell Malignancies a clinical perspective.

Affimed Presents Data from Phase 1b Combination Study of AFM13 with Pembrolizumab at ASH

Karyopharm Reports Second Quarter 2016 Financial Results and Highlights Recent Progress

Investor Update. Roche to present new data from its industry-leading haematology portfolio at the American Society of Hematology 2018 Annual Meeting

Corporate Presentation. April 2016

AVEO Oncology Reports Third Quarter 2016 Financial Results and Provides Business Update

Innovating Antibodies, Improving Lives. 37 th Annual J.P. Morgan Healthcare Conference January 9, 2019

Media Release. Roche to present new data across a range of blood diseases at the American Society of Hematology (ASH) 2017 Annual Meeting

The Early Chimeric Antigen Receptor (CAR) T-cell Experience From An Academic Perspective. CARs: LEARNING TO DRIVE

Second Quarter 2017 Financial Results. August 8, 2017

Advancing Manufacturing for Advanced Therapies

GENENTECH PROVIDES UPDATE ON PIPELINE AGENTS AT THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY MEETING

January (San Francisco, CA) January 8, 2018

GSK 916: anti-bcma ADC An exciting potential advance in the treatment of Multiple Myeloma

Polatuzumab vedotin A potent ADC in NHL

Deborah Dunsire, M.D. President and CEO. Annual Meeting of Shareholders Cambridge, MA May 4, 2006

Jefferies Healthcare Conference. June 2016

Trubion Investor Presentation BioCentury NewsMakers in the Biotech Industry Conference September 6, 2007

Oncology Insights: December 2017

Immune Design Reports Third Quarter 2017 Financial Results and Provides Corporate Update

Agios Pharmaceuticals, Inc.

Antibody therapeutic approaches for cancer

CD33-Targeting ADCs in AML

ME-401: A Highly Differentiated PI3Kd- Selective Inhibitor

Immunity for Life TM. Sven Rohmann VP Business Development

Investor Update. Roche to present new data across a range of blood diseases at the American Society of Hematology (ASH) 2017 Annual Meeting

Hansa Medical AB Interim Report Second Quarter 2017 Business Update Presentation. July 20, 2017

UNUM THERAPEUTICS CORPORATE PRESENTATION APRIL 2019

RACING TOWARD A CURE FOR BLOOD CANCERS WITH NEW CARS (CAR-T CELL THERAPY)

Clinical Policy: Lenalidomide (Revlimid) Reference Number: CP.CPA.275 Effective Date: Last Review Date: Line of Business: Commercial

Genmab an antibody innovation powerhouse. Jan van de Winkel

Second Quarter 2016 Financial Results. August 4, 2016

Galena Biopharma, Inc. (Exact name of registrant as specified in its charter)

Spectrum Pharmaceuticals Jefferies 2015 Global Healthcare Conference

ZIOPHARM Reports Second-Quarter 2016 Financial Results and Provides Update on Recent Activities

Q PRESENTATION November 28, 2017 Per Walday, CEO Ronny Skuggedal, CFO

Jefferies Healthcare Conference

Translational development of Therapeutic Lymphoma Vaccines

Cryoport, Inc. Calendar Year 2017 Third Quarter Earnings Call NASDAQ: CYRX

Mustang Bio Reports Third Quarter 2018 Financial Results and Recent Corporate Highlights

Results FY2017 & Outlook 2018

Genitope Corporation. Summary of MyVax Personalized Immunotherapy Phase 3 Clinical Trial Results

ABOUT GLYCOSTEM. Company Overview

FORWARD-LOOKING STATEMENTS

See Important Reminder at the end of this policy for important regulatory and legal information.

Focused on the Cure. Corporate Presentation June 2017

Focused on the Cure. Corporate Presentation June 2017

ARIKAYCE U.S. FDA Approval

Contact: Dr Brad Walsh Mobile: Suite 2, Ground Floor, 75 Talavera Rd Macquarie Park, NSW

NEXT-GENERATION CAR T-CELLS AGAINST CANCER. Gene-Edited Off-The-Shelf Immunotherapies

Regulatory Challenges of Global Drug Development in Oncology. Jurij Petrin, M.D. Princeton, NJ

Safety and Efficacy of Daratumumab with Lenalidomide and Dexamethasone in Relapsed, or Relapsed and Refractory Multiple Myeloma

Opportunities and Challenges for Manufacturing Scale Up of CAR T Cells. Mark Dudley Institute of Medicine March 1, 2016

Treatment strategies for relapsing and refractory myeloma

IMGN632 in R/R AML and BPDCN, abstract #27

Multiple Myeloma Update PMMNG 13 Feb Outline. Alfred Garfall MD Edward Stadtmauer MD

Multiple Myeloma Research Consortium Clinical Trial Pipeline

Corporate Presentation

CAR T-CELL THERAPIES WEBINAR. Scientific and Policy perspectives. 5 December :00-17:30 CET

Investor Presentation. October 2018

ANTIBODY THERAPY ANTIBODY THERAPY ANTIBODY THERAPY PDF MONOCLONAL ANTIBODY THERAPY - WIKIPEDIA ANTIBODY - WIKIPEDIA 1 / 5

Full year 2017 PRESENTATION March 20, 2018 Per Walday, CEO Ronny Skuggedal, CFO

Achillion Reports Third Quarter 2017 Financial Results and Provides Update on Clinical Programs

Community Oncologists Perception and Adaptability to Emerging Chimeric Antigen T-cell (CAR-T) Therapy

Emerging treatments in Multiple myeloma. Josh Veatch Damian Green

NEXT-GENERATION CAR T-CELLS AGAINST CANCER. Gene-Edited Off-The-Shelf Immunotherapies

ENGINEERED CAR-T THERAPIES

Cortendo and Antisense Therapeutics Announce Licensing Agreement for ATL1103 for Acromegaly

Accelerated Approvals

UPDATED IN HEMATOLOGIC MALIGNANCIES

An Overview of Chimeric Antigen Receptor T-cells: CAR-T-ing Away Cancer

Relapsed/Refractory Multiple Myeloma: Standard of Care Among Emerging Agents

Making cancer a chronic disease. Troels Jordansen

AMGEN AT ASH 2017: DEVELOPING LEADERSHIP IN BISPECIFIC THERAPIES DECEMBER 9, 2017

INVESTOR PRESENTATION. June 2018

Bank of America Merrill Lynch Healthcare Conference. September 13, 2013

Nasdaq: MBRX. Moleculin Biotech, Inc. Reports Financial Results for the Third Quarter Ended September 30, 2017

Regulatory Perspectives on Gene Therapies for Rare Diseases Rare Diseases Forum Washington, D.C. October 17, 2018

JP Morgan Healthcare Conference January 9, 2012

License Agreement of Tildrakizumab for Psoriasis in Europe

Transcription:

Q1 18 HIGHLIGHTS AND FINANCIALS MAY 30 TH, 2018 TONE KVÅLE, CFO & INTERIM CEO LISA ROJKJAER, CMO Nordic Nanovector ASA Kjelsåsveien 168 B, 0884 Oslo, Norway www.nordicnanovector.com IR contact: IR@nordicnanovector.com

Forward-looking statements This announcement contains 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", "targets", "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 these 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. 2

Nordic Nanovector at a glance Focused on the development of targeted therapies for haematological cancers Lead candidate Betalutin for treating NHL Novel anti-cd37 therapy in pivotal Phase 2b trial (PARADIGME) in 3L R/R FL read-out expected 1H 2020 Promising efficacy with encouraging duration of response and favourable safety profile seen in earlier trials Potential for Betalutin in other NHL indications Clear plan to bring Betalutin to market Designed to enhance chances of Betalutin gaining regulatory approval with a competitive product profile Intent to independently commercialise Betalutin in major markets Listed on Oslo Stock Exchange (OSE: NANO) Cash resources through 1H 2020 3 NHL: non-hodgkin s lymphoma; 3L R/R FL 3rd-line relapsed/refractory follicular lymphoma

Q1 18 and post-period highlights Luigi Costa stepped down as CEO (April) search for new CEO progressing Tone Kvåle appointed Interim CEO and continues as CFO PARADIGME pivotal Phase 2b trial (Betalutin in 3L R/R FL) Start-up activities and patient screening underway, first patient expected 1H 2018 April update timelines revised with first results targeted for 1H 2020 (previously 2H 2019) Humalutin ( 177 Lu-conjugated chimeric anti-cd37 antibody in NHL) Clinical development on hold Management team strengthened with dedicated IR and capital markets expertise Malene Brondberg appointed as Vice President, IR and Corporate Communications 4

BETALUTIN BUILDING A COMPETITIVE PROFILE IN FL AND NHL Nordic Nanovector ASA Kjelsåsveien 168 B, 0884 Oslo, Norway www.nordicnanovector.com IR contact: IR@nordicnanovector.com

Single-agent Betalutin is highly active in FL patients, especially in 3L Response rates by subgroup and treatment arm ORR (CR + PR) CR All patients (n=62) 60% 24% All FL patients (n=47) 64% 23% Arm 1 (40/15) (n=25) 68% 28% Arm 4 (100/20) (n=8) 50% 25% Median duration of response Median DoR All inhl patients (n=37) 13.3m inhl CR patients (n=15) 20.5m All FL patients with 40/15 (n=17) 13.3m FL with 2 prior therapies (3L FL) (n=32) 66% 25% FL CR patients with 40/15 (n=7) 22.9m Published data from the LYMRIT 37-01 Phase 1/2a trial* Population of primarily elderly, heavily pre-treated patients with advanced stage disease Patients with CR remain disease-free for a median of over 20.0 months with one-time Betalutin administration 6 *Kolstad A, et al. Poster presented at ASH 2017. Abstract 2769; ORR Overall response rate; CR complete response; DoR duration of response; inhl indolent NHL.

90% of evaluable patients had a decrease in tumour size Best percentage change in tumour size from baseline by subtype (n=59) *SPD = sum of the products of the diameters. **Change in size of target lesion is beyond the scale for this figure (n=2). 7 Kolstad A, et al. Poster presented at ASH 2017. Abstract 2769.

Betalutin is well-tolerated, with a manageable safety profile Grade 3/4 TEAEs in 2 patients (n=64) Adverse Event n (%) 2 Neutropenia 1 35 (55%) Thrombocytopenia 1 32 (50%) Leukopenia 1 32 (50%) Lymphopenia 1 22 (34%) Infections Urinary tract infection (1) Sepsis/neutropenic sepsis (2) Pharyngitis (1) Pneumonia (1) 5 (8%) Lymphoma progression 3 (5%) Serious Adverse Event (SAE) Thrombocytopenia 2 (3%) Atrial fibrillation 2 (3%) Lymphoma progression 2 (3%) Overall, Betalutin was well-tolerated, in particular considering the median age of enrolled patients Most common grade 3/4 TEAEs are reversible thrombocytopenia and neutropenia Low incidence of G3/4 infections (<10%) One report of MDS/CMML in a patient with prior alkylating agent exposure 1. Including events reported as investigations. 2. Two patients had not had hematologic recovery at the time of data cut-off. 8 Kolstad A, et al. Poster presented at ASH 2017. Abstract 2769.

(104 patients) Promising data support the potential of Betalutin Clear need for new effective and well-tolerated therapies for patients who become refractory to rituximab, especially the elderly Single-agent Betalutin shown to be well-tolerated and active in recurrent indolent NHL (LYMRIT 37-01 Phase 1/2a trial) With its promising clinical profile and ready-to-use formulation, Betalutin has the potential to be a novel, safe and effective therapy for recurrent NHL Final analysis from LYMRIT 37-01 study (n=74) expected in 2H 2018, targeting ASH 2018 for readout (December) Kolstad et al, ASH 2017 (32 3L FL pts) Aliqopa prescribing information, Sept 2017 (104 pts) Verastem Pharma, 2016 (83 pts) Novartis, ASH 2016 (14 pts) Gopal et al, 2016 (110 pts) Gopal et al, 2014 (125 pts) Lesokhin et al, 2016 (10 pts) Jurczak et al, 2016 (45 pts) McLaughlin et al, 1998 (166 pts) Witzig et al, 2002 (57 pts) 9 1 No longer in clinical development for FL; 2 CAR-T; 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.

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 Efficacy is seen as a major strength The combination of efficacy, manageable toxicity and simplicity makes Betalutin truly appealing It allows Betalutin to enter an unsatisfied area of the market, and is well positioned to serve unmet needs among difficult-to-treat, refractory patients Clear strategies to maximise the clinical and commercial potential of Betalutin Pre-launch scientific engagement of key institutions and thought leaders on the benefits of the technology Well-designed clinical development plan, aligned with health authority feedback Robust market access and reimbursement programme Optimised referral pathway Streamlined manufacturing and distribution via a centralised logistics partner 10

PARADIGME: Seamless design for a robust dose selection aligned with regulatory feedback Randomisation 15MBq/kg Betalutin (+ 40mg llo) N = 65 20MBq/kg Betalutin (+ 100mg/m 2 llo) N = 65 Target is 130 patients at 80-85 sites in approximately 20 countries Two potential Betalutin dosing regimens have emerged from LYMRIT 37-01 based on safety, efficacy and dosimetry data These will be compared with the goal to select the best Betalutin dosing regimen Patient population: 3L FL patients who are refractory to anti-cd20 based therapy Seamless design approach based on data from the first part of the 37-01 study more efficient than separate Phase 2 trial Primary endpoint: Overall response rate (ORR) Secondary endpoints: Duration of response (DoR), Progression free survival (PFS), Overall survival (OS), Safety, Quality of life 11

PARADIGME status PARADIGME aims to recruit 130 3L R/R FL patients in 80-85 sites in 20 countries First patient is expected to be dosed in 1H 2018 As at May 29 th, 2018, 23 clinical sites in 8 countries are open for enrolment US sites expected to be open mid-year Sites selected are clinical centres of excellence in the treatment of NHL and haematological malignancies Norway CTA update As at May 29 th Paradigme is fully approved in Norway 12

Our activities aimed at driving enrolment Key objectives: 1. Complete site activation as fast as possible 2. Start patient screening as soon as each site is activated 3. Sustain the highest possible enrolment rate Key action items: Fully leverage and reinforce Medical Science Liaison (MSL) organisation now deployed in Europe & USA Deployment of study nurses/associates within high-traffic sites to help investigators identify patients Partner with non-for-profit (i.e. Leukemia and Lymphoma Society) and other third-party organisations with experience in patient enrolment programmes Meetings and regular webcasts with Investigators to maintain high level of attention on PARADIGME 13

PARADIGME timelines and expectations - revised in April Now targeting initial efficacy and safety data read-out for PARADIGME in 1H 2020 (previously 2H 2019) Targeting first regulatory filing in 2020 Exploring ways to bring Betalutin to patients quicker, e.g. via fast track, PRIME, breakthrough therapy designation (BTD) Financial resources are expected to be sufficient until data read-out from PARADIGME 14

Clinical development of Betalutin in NHL: maximising its value potential Targeted indication Discovery Preclinical Phase 1 Phase 2 Phase 3 3L FL (PARADIGME) Pivotal Phase 2b 2L FL, combination w/ rituximab (Archer-1) Phase 1b R/R DLBCL, SCT ineligible (LYMRIT 37-05) Phase 1 inhl dosimetry (LYMRIT 37-02) Phase 1 Priority focus on ongoing Betalutin clinical development programmes Potential future opportunities in Betalutin life-cycle management indications (R/R DLBCL conditioning, other NHL subtypes) Potential for other CD37-targeting therapies, including Humalutin (a Phase 1-ready asset) 15

Archer-1: Betalutin + rituximab (RTX) combination in 2L FL Explore Betalutin + RTX combination in 2L NHL RTX anti-cd20 immunotherapy is established standard of care in NHL Approx. 8,980 (US) + 7,000 (EU-5) patients in 2014* In preclinical model of NHL, Betalutin + RTX inhibited tumour growth significantly and prolonged overall survival Phase 1b trial A robust approach to generate safety, tolerability, pharmacokinetic and initial efficacy data in patients CTA approved by NoMA, pending approval by REK Start-up activities will commence upon regulatory approval Expect first patient dosed in 2H 2018 16 *Decision Resources, 2015, Non-Hodgkin s Lymphoma

LYMRIT 37-05: Betalutin in R/R DLBCL patients not eligible for stem cell transplantation (SCT) Explore Betalutin single administration in DLBCL DLBCL is an aggressive form of NHL and accounts for up to 43% of NHL Estimated 14,000 patients (US, EU-5 and Japan)* ~40% DLBCL patients relapse after 1L rituximab-chemotherapy and 60-70% relapsed patients fail or are unsuitable for subsequent high-dose chemotherapy followed by SCT Few therapeutic options for patients NOT eligible for SCT On-going Phase 1 open label, single-administration, ascending-dose study Objective to identify optimal dosing regimen for Phase 2 studies Up to 24 patients planned to be enrolled in the US and EU Started Q1 2017; first read-out targeted for 2H 2018 17 DLBCL: diffuse large B-cell lymphoma; *Decision Resources, 2015, Non-Hodgkin s Lymphoma

FINANCIALS AND SUMMARY Nordic Nanovector ASA Kjelsåsveien 168 B, 0884 Oslo, Norway www.nordicnanovector.com IR contact: IR@nordicnanovector.com

MNOK Majority of resources allocated to PARADIGME Operating result Operating expenses YTD March 2018 0 Q1'17 Q2'17 Q3'17 Q4'17 Q1'18-20 -40-60 -80-66 -76-73 -102-82 23.8 % 76.2 % -100-120 Development* Administration *Development costs: preclinical, clinical, medical affairs, regulatory and CMC activites 19

Solid cash position, expected to be sufficient to reach data read-out for PARADIGME in 1H 2020 MNOK 800 700 600 500 400 300 200 100 0 757 $ 92M* -105 31.12.2017 Operating activities Investing & financing activities -1-9 642 $ 81M** FX 31.03.2018 ** USD/NOK 8.24 ** USD/NOK 7.97 20

Key company goals for 2018-2020 1H 2018 Betalutin in 3L FL PARADIGME: First patient dosed 2H 2018 Betalutin + rituximab in 2L FL Archer-1: First patient dosed* 2H 2018 Betalutin in R/R inhl LYMRIT 37-01: Complete final analysis and first data read-out 2H 2018 Betalutin in DLBCL LYMRIT 37-05: Preliminary data read-out 1H 2020 Betalutin in 3L FL PARADIGME: Data read-out 21 * Pending approval from regulatory authorities

Financial calendar Q1 2018 meeting (in Norwegian) May 31 st, 2018 Q2 2018 results August 22 nd, 2018 Q3 2018 results November 21 st, 2018 Q4 and FY 2018 results February 2019 Dates subject to change. The time and location of the presentations will be announced in due time. A two-week quiet period has been introduced ahead of full year and quarterly results Please send Investor Relations enquiries to ir@nordicnanovector.com 22

Questions Nordic Nanovector ASA Kjelsåsveien 168 B, 0884 Oslo, Norway www.nordicnanovector.com IR contact: IR@nordicnanovector.com

Glossary 1L, 2L, 3L: First, second and third line of treatment (A)SCT: (Autologous) stem cell transplant ADC: Antibody-Drug-Conjugate AHCP: Allied Healthcare Professional AML: Acute Myeloid Leukemia APAC: Asia-Pacific ARC: Antibody-Radionuclide-Conjugate ARCHER-1: Name of Nordic Nanovector s combination study; Betalutin and rituximab ASH: American Society of Hematology Authorized User: Physician authorized to prescribe and administer a radiopharmaceutical drug B-cell: A type of lymphocyte (white blood cell) in the humoral immunity of the body s adaptive immune system. Can be distinguished from other lymphocytes by the presence of a protein on the B-cell s outer surface known as a B cell receptor (BCR). This specialized receptor protein allows a B-cell to bind to a specific antigen. CD20: B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed in the surface of all B-cells beginning at the pro-b phase and progressively increasing in concentration until maturity CD37: B-lymphocyte antigen CD-37 is a protein, a member of the transmembrane 4 superfamily, also known as the tetraspanin superfamily of cell surface antigens chhh1: Chimeric version of the HH1 antibody CLL: Chronic Lymphocytic Leukemia CR: Complete Response DLBCL: Diffuse Large B-Cell Lymphoma DoR: Duration of Response EANM: European Association of Nuclear Medicine EMA: European Medicines Agency EMEA: Europe, Middle East, and Africa FDA: Food and Drug Administration (US) FDG PET/CT: Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography FL: Follicular Lymphoma GMP: Good Manufacturing Practice Haem-Oncs: Haematologist-oncologist HCP: Healthcare Professional HH1: Lilotomab Humalutin : Chimeric anti-cd37 ARC ICML: International Conference on Malignant Lymhoma IND: Investigational New Drug inhl: Indolent non-hodgkin Lymphoma KI: Kinase Inhibitor KOL: Key Opinion Leader LCM: Life-cycle management Lilotomab (llo): Betalutin consists of the radionuclide lutetium-177 conjugated to the B-cell seeking anti-cd37 antibody lilotomab Lu-177: Radionuclide lutetium-177 M.D: Medical Doctor mab: Monoclonal antibody MBq: Megabecquerel (radioactivity measurement unit)

Glossary MCL: Mantle Cell Lymphoma Medicare: US government reimbursement program for insured elderly MedOnc: Medical oncologist MoA: Mechanism of Action MSL: Medical science liaison nasct: Not eligible for autologous stem cell transplant NCCN: National Comprehensive Cancer Network NDA: New Drug Application NET: Neuroendocrine tumour NHL: Non-Hodgkin s Lymphoma NM: Nuclear medicine specialist NNV003: Chimeric anti-cd37 antibody developed by Nordic Nanovector ODD: Orphan Drug Designation ORR: Overall Response Rate (CR plus PR) OS: Overall Survival PARADIGME: name of Nordic Nanovector s pivotal Phase 2b study PD: Progressive Disease PFS: Progression Free Survival Pi3K: Phosphoinositide 3-kinase; class of Pi3K inhibitors include idelalisib, copanlisib, duvelisib PR: Partial Response PRA: PRA Health Sciences, a clinical research and data analytics company QoL: Quality of Life R/R: Relapsed/refractory R: Rituximab RadOnc: Radiation oncologist R-Benda/R-B/RB: Rituximab, bendamustine R-Chemo: Combination treatment consisting of rituximab plus one (i.e., bendamustine, fludarabine) or more (i.e., CHOP, CVP) chemotherapy agents R-CHOP: Rituximab, hydroxydaunorubicin (doxorubicin), oncovin (vincristine), prednisolone R-CVP: Rituximab, cyclophosphamide, vincristine, prednisone RIT: Radioimmunotherapy R-Squared: Combination treatment consisting of rituximab plus lenalidomide SAB: Scientific Advisory Board Satetraxetan: International non-proprietary name for p-scn-benzyl-dota SD: Stable Disease SPECT/CT: Single photon emission computed tomography (SPECT) integrated with computed tomography (CT) T-cell: A type of lymphocyte (white blood cell) that plays a central role in cellmediated immunity. Can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on the cell surface. They are called T-cells because they mature in the thymus TKI: Tyrosine Kinase Inhibitor TPP: Target Product Profile TTR: Time to Recurrence US: United States 25