On August 22, 2019 Nordic Nanovector ASA (OSE: NANO) reported its results for the second quarter and first half 2019 (Press release, Nordic Nanovector, AUG 22, 2019, View Source;results-for-the-second-quarter-and-first-half-2019-300905662.html [SID1234538916]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CEST, see details below.

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Eduardo Bravo, CEO, commented: "We continue to progress our clinical development programmes with Betalutin in major NHL indications. In PARADIGME, we have reached our target range in terms of activated sites and while the recruitment rate has accelerated in recent months, this has not been at the rate we anticipated. This has led us to reassess the trial timelines and we now estimate to complete patient enrolment in 2H 2020 rather than 1H 2020 as previously guided. We would expect the data read-out from the trial a few months after the final patient has been dosed. As a one-off treatment, Betalutin has an exciting product profile, and we have been encouraged by the preliminary analysis of the extended median duration of response data that we have disclosed today. We remain focused on advancing PARADIGME and our other clinical programmes as quickly as possible given the clear benefits that Betalutin could deliver to NHL patients around the globe."

Highlights

Preliminary analysis shows median duration of response (mDoR) of 13.5 months (formerly 9.0 months in December 2018) for Phase 1/2a LYMRIT 37-01 trial of Betalutin in R/R FL
Pivotal Phase 2b PARADIGME trial of Betalutin in advanced recurrent follicular lymphoma (FL) progressing with 81 sites in 23 countries open for enrolment as of August 21st, 2019
Patient recruitment has accelerated in recent months but not at the rate anticipated
Full enrolment now expected 2H 2020 compared with 1H 2020 as previously guided
Phase 1b Archer-1 trial of Betalutin plus rituximab (RTX) in patients with relapsed/refractory (R/R) 2nd line FL advanced into second cohort
Global patent portfolio strengthened with grant of European patent covering the use of Betalutin (and other anti-CD37 targeting agents) in combination with anti-CD20 antibodies (including rituximab) for the treatment of non-Hodgkin’s lymphoma (NHL)
Promising preclinical results from R&D collaboration to develop a novel CD37-targeting alpha therapy for B-cell tumours presented at international scientific congresses (TAT11 and TRP19)
Recruitment completed for dose escalation phase of LYMRIT 37-05 trial of Betalutin in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) – preliminary results expected in 2H 2019
Dr Lars Nieba appointed as Chief Technology Officer to drive the company’s CMC strategy
Financial Highlights Q2 and 1H’19

(Figures in brackets = same period 2018 unless otherwise stated)

Revenues for the second quarter amounted to NOK 0.0 (NOK 0.0 million). Revenues for the first half of 2019 were NOK 0.0 (NOK 0.0 million).
Total operating expenses for the second quarter were NOK 111.0 million (NOK 84.5 million). Total operating expenses for the first half of 2019 amounted to NOK 200.9 million (NOK 166.8 million)
Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 77 % of total operating expenses (72.2 %) for the first half of 2019.
Comprehensive loss for the second quarter amounted to NOK 110.4 million (loss of NOK 82.9 million). Comprehensive loss for the first half was NOK 202.0 million (loss of NOK 173.6 million)
Cash and cash equivalents amounted to NOK 443.5 million at the end of June 2019 (NOK 570.1 million at June 2018 and NOK 440.1 million at 31 December 2018)
Upcoming R&D Day

Nordic Nanovector is planning to host and R&D Day in September. During the event the senior management team and external speakers will provide updates and further information on the company’s key activities. The R&D Day will take place in Oslo and will also be webcast live. Details on the date and how to register to attend will be announced within the next two weeks.

Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile 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 a once-only administration of Betalutin in 3L R/R FL is underway. Patient enrolment is expected to be completed in the second half of 2020. A data read-out is expected a few months after the final patient is dosed enabling filing for marketing approval in the first half of 2021.

The company maintains its guidance that current cash resources are expected to be sufficient to reach mid-2020.

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 and antibody drug conjugates across NHL and other haematological cancer indications.

The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team will take place today at 8:30am CEST 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 from 7:00am CEST the same day.