Oslo, Norway, 22 November 2017
Nordic Nanovector ASA (OSE: NANO) announces results for the third quarter 2017.
A presentation by the company’s senior management team will take place today
following the company’s Capital Markets Day in Oslo (see separate announcement
today and details below).
Nordic Nanovector is ready to initiate the pivotal Phase 2b study, PARADIGME,
with Betalutin® in patients with relapsed, anti-CD 20 Ab-refractory FL (R/R FL),
a high unmet medical need group, pending approval of the proposed trial design
from regulatory authorities. PARADIGME is designed to generate the clinical data
needed to support the filing of the best Betalutin® dosage regimen for this
patient population. The PARADIGME design is aligned with health authority and
clinical expert feedback. The company is also enrolling patients into its Phase
1 study in DLBCL, and making final preparations to start a Phase 2 combination
study of Betalutin® and rituximab in iNHL patients (ARCHER-1) in 2017.
Preparations to initiate a Phase 1 study of Humalutin® are also progressing.
Luigi Costa, CEO of Nordic Nanovector, comments: “The company has made excellent
progress during 2017. Clinical results with Betalutin® and in-depth market
research confirm its potential to be an important treatment of patients with
iNHL. We are on track to start the pivotal PARADIGME study, which aims to
compare the two promising dosing regimens that have emerged from our ongoing
clinical trial with Betalutin®. We are confident that the trial design will
generate the robust data needed and improve the probability of a successful
regulatory filing. We are also pleased with recruitment into our DLBCL study and
with the preparations to start the ARCHER-1 study of Betalutin® in combination
with rituximab, which is on track to begin soon.”
Operational Highlights Q3’17
. Steady progress towards planned start of the pivotal Phase 2b study PARADIGME
in 2H 2017 to investigate Betalutin® in patients with 3rd line R/R FL
o PARADIGME expected to be a global, randomized Phase 2b trial comparing the two
most promising dosing regimens identified from the LYMRIT-37-01 Phase 1/2 study
in approximately 130 patients with R/R FL
o Objective to generate the clinical data needed to support the filing for
market approval of the best Betalutin® dosage regimen
o Design builds on promising clinical results and is aligned with regulatory
authority feedback
o Protocol amendment submitted and under review by multiple regulatory
authorities with further submissions expected in the coming weeks ; other
preparations to initiate trial underway
o Patient screening anticipated to begin before end of 2017 (pending approval of
the amendment)
. Recruitment of DLBCL patients into Phase 1 dose-escalation study with
Betalutin® ongoing
o Patient recruitment on track in the US and Europe
. Preparations advancing for Phase 2 clinical trial to investigate the
potential of Betalutin® combined with rituximab in 2nd line FL (ARCHER-1)
o Phase 2 trial planned to begin in 2H 2017
. Appointment of Dr. Reza Safaei as Head of Medical Affairs
o First field-based medical staff being recruited, to support patient enrolment
into clinical trials in US and EU and to raise awareness of Nordic Nanovector’s
technology
Financial Highlights Q3’17
(Figures in brackets = same period 2016 unless otherwise stated)
. Revenues for the third quarter amounted to NOK 0.1 million (NOK 0.1 million).
Revenues for the first nine months of 2017 were NOK 0.3 million (NOK 0.2
million).
. Total operating expenses for the third quarter were NOK 72.7 million (NOK 50.4
million). Total operating expenses for the first nine months of 2017 amounted to
NOK 214.9 million (NOK 151.3 million).
. Comprehensive loss for the third quarter amounted to NOK 85.9 million (loss of
NOK 61.3 million). Comprehensive loss for the first nine months of 2017 was NOK
207.9 million (NOK 176.5 million).
. Cash and cash equivalents amounted to NOK 803.7 million at the end of
September 2017 (NOK 881.4 million at 30 June 2017, NOK 933.3 million at 31 March
2017 and NOK 1 018.2 million at 31 December 2016).
Outlook
Nordic Nanovector aspires to become a leader in the field of Precision 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, is developing a well
differentiated, competitive, clinical profile for R/R FL, based on the promising
preliminary results from the LYMRIT 37-01 Phase 1/2 clinical study. The company
anticipates initiating its pivotal Phase 2b PARADIGME trial with Betalutin® in
3rd line R/R FL with the goal to have the data read-out and first submission for
marketing approval in the second half of 2019. Management will continue to
focus its efforts on the efficient execution of its plans and to meet clinical
and pre-commercialisation milestones. 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.
Nordic Nanovector intends to maximize the value of Betalutin® across other
stages of FL, NHL and other haematological cancer indications. A further element
of the company’s strategy is to selectively extend its pipeline of novel
targeted biopharmaceutical candidates to support future growth.
Current cash resources are expected to be sufficient until first regulatory
filing of Betalutin® in 3L FL, based on the timely approval of the proposed new
trial design, and to advance other key programmes.
Presentation and webcast - Third Quarter 2017 results and Capital Markets Day
The highlights of the third quarter 2017 will be presented immediately following
the company’s Capital Markets Day, which begins at 10:00 CET.
altså de 2-3 personene med 20-25 nick til sammen 
regner med noen av de blir vel innlagt på psykiatrisk når gode nyheter kommer og kursen går oppover 
(noen av de er kanskje der allerede?)
). Nok om det.
