On November 19, 2019 Nordic Nanovector ASA (OSE: NANO) reported its results for the third quarter 2019. A presentation by the company’s senior management team will take place today in Oslo at 08:30 CET, see details below (Press release, Nordic Nanovector, NOV 19, 2019, View Source;results-for-the-third-quarter-2019-300960626.html [SID1234551505]).
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Eduardo Bravo, CEO, commented: "We are encouraged with the clinical results emerging from the different clinical trials with Betalutin in non-Hodgkin’s lymphoma (NHL). As stated by key opinion leaders in the field during the R&D Day hosted by Nordic Nanovector in September, the emerging profile of Betalutin is unique and very competitive. There are many patients who suffer from these devastating diseases who lack effective, safe and convenient treatment options. We remain fully committed to deliver on our timelines to bring this novel product to the market as quickly as possible."
Highlights Q3 `19
Updated analysis from Phase 1/2a LYMRIT 37-01 trial of Betalutin in relapsed/refractory follicular lymphoma (R/R FL) presented at R&D Day (September)
Median duration of response of 13.6 months for all responders and 32.0 months for complete responders (vs 9.0 and 20.7 months, respectively reported at ASH (Free ASH Whitepaper) 2018
Median follow-up time for responders of 30.0 months (range: 12.0 – 60.7 months)
Pivotal Phase 2b PARADIGME trial of Betalutin in advanced, recurrent and CD20 antibody treatment refractory 3L Follicular Lymphoma (FL) is progressing
87 sites in 24 countries open for enrolment as of November 18th, 2019
Patient enrolment is expected to be completed in the second half of 2020
Phase 1b Archer-1 trial of Betalutin in combination with rituximab (RTX) in patients with R/R 2nd line FL (2L FL) advanced to second cohort
100% Overall Response Rate (3/3 Complete Responses) observed in the first patient cohort
Promising preclinical results with Alpha37 for B-cell tumours presented at EANM conference by partner Orano Med
Alpha37 project received grant funding of EUR 0.6 million from Eurostars
Approximately NOK 243 million (USD 26.4m) (gross) raised 18th October in private placement of new shares providing additional funds to support the continued clinical development of Betalutin (including completion of enrolment of PARADIGME and all ongoing clinical trials), manufacturing and other activities in preparation for the commercialisation of Betalutin
Dr Gabriele Elbl appointed as VP Global Regulatory Affairs to drive the company’s Regulatory Affairs strategy
Financial Highlights Q3 `19
(Figures in brackets = same period 2018 unless otherwise stated)
Revenues for the third quarter amounted to NOK 0.0 (NOK 0.0 million). Revenues for the first nine months 2019 were NOK 0.0 (NOK 0.0 million)
Total operating expenses for the third quarter were NOK 100.2 million (NOK 76.9 million). Total operating expenses for the first nine months of 2019 amounted to NOK 301.1 million (NOK 243.7 million)
Research and development (preclinical, clinical, medical affairs, regulatory and CMC (Chemistry, Manufacturing and Controls) activities expenses accounted for 78 % of total operating expenses for the first nine months of 2019 (73 %)
Comprehensive loss for the third quarter amounted to NOK 93.6 million (loss of NOK 75.4 million). Comprehensive loss for the first nine months was NOK 295.6 million (loss of NOK 249.1 million)
Cash and cash equivalents amounted to NOK 345.9 million at the end of September 2019 (NOK 440.1 million at 31 December 2018), exclusive of new funds raised in October 2019 of NOK 243 million (gross)
Outlook
Nordic Nanovector aspires to become a leader in the field of targeted radioimmunotherapies for haematological cancers by developing, manufacturing and commercialising innovative products to address major unmet medical needs and advance cancer care.
Betalutin, the company’s most advanced radioimmunotherapy candidate, is developing a highly differentiated, competitive, clinical profile. Nordic Nanovector is confident that Betalutin could become an attractive and convenient once-only therapeutic option, which, based on detailed market research, has the potential to be commercially successful.
Betalutin is being developed for recurrent FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical trial. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway. Patient enrolment is expected to be completed in the second half of 2020. The study’s preliminary data read-out is planned a few months later. A BLA filing to gain marketing approval for Betalutin is expected in the first half of 2021. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin in core markets.
Nordic Nanovector intends to maximize the value of Betalutin across the major types of NHL (FL and DLBCL) and in earlier treatment lines in combination with standard treatments. The company is also evaluating opportunities with other CD37-targeting radioimmunotherapies across NHL and other haematological cancer indications.
Presentation and Webcast
A presentation by Nordic Nanovector’s senior management team will take place today at 8:30am CET at:
Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: AKER
The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media
The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2019.