On May 26, 2021 Nordic Nanovector ASA (OSE: NANOV) reported its results for the first quarter 2021 (Press release, Nordic Nanovector, MAY 26, 2021, View Source [SID1234580658]). A live webcast presentation by Nordic Nanovector’s management team will take place today at 08.30 CEST. A link to the webcast is available on www.nordicnanovector.com.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The results report and the presentation are also available on the company’s website in the section: Investors & Media/Reports and Presentation/Interim Reports/2021. A replay of the webcast will be made available at the same location after the event.
Peter L. Braun, Chief Executive Officer of Nordic Nanovector, commented: "Nordic Nanovector has made important progress so far in 2021, including raising the money needed to deliver the preliminary top-line three-month data from the PARADIGME study and to prepare for a subsequent potential BLA filing for Betalutin. The company has also implemented a range of initiatives aimed at improving patient recruitment into PARADIGME, and which we believe will further improve patient enrolment when the impact of COVID-19 recedes. I am convinced that effective and well-tolerated, targeted radiopharmaceuticals, such as Betalutin, a one-time treatment, can make a real difference to NHL patients worldwide."
Operational Highlights
Peter L. Braun was appointed Chief Executive Officer in March
Mr Braun is an experienced and entrepreneurial pharmaceutical leader with extensive commercialisation and innovative oncology experience from a career spanning nearly 30 years at Roche
Successful Private Placement and oversubscribed Repair Offering completed in February and April, respectively, raised approximately NOK 422 million (USD 49.7 million) in gross proceeds
Extends the company’s cash runway into H2’2022
Operational improvements and protocol changes have improved PARADIGME recruitment rate in recent months, despite impact from the on-going COVID-19 pandemic
83 patients enrolled as of 25 May 2021 (73 enrolled as of 17 February 2020)
Company remains on track to report preliminary three-month top-line data by the end of 2021
Promising Phase 1b data from the Archer-1 study evaluating Betalutin in combination with rituximab in 2L FL
Board changes
Hilde Hermansen Steineger, PhD, decided not to stand for re-election at AGM
Solveig Hellebust, PhD, appointed Non-executive Director at the AGM on 28 April 2021
Financial Highlights Q1 2021
(Figures in brackets = same period 2020 unless otherwise stated)
Revenues for the first quarter amounted to NOK 0.0 million (NOK 0.0 million).
Total operating expenses for the first quarter were NOK 101.2 million (NOK 125.9 million).
Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 85.9 % of total operating expenses year to date 2021 (80.8 %).
Comprehensive loss for the first quarter amounted to NOK 102.1 million (loss of NOK 91.7 million).
Cash and cash equivalents at the end of March 2021 amounted to NOK 497.9 million, compared to NOK 294.0 million at the end of December 2020.
Outlook
Nordic Nanovector’s current focus is to complete patient enrolment into PARADIGME and the target is to announce the preliminary readout of three-month top line data from PARADIGME by end 2021.
Following the recent successful Private Placement and Repair Offering, the company has extended its cash runway into H2’2022, which in addition to allowing it to deliver the top line data from PARADIGME, will enable further preparatory work on the potential Betalutin BLA filing to be undertaken.
The company believes that, if positive, the PARADIGME trial data could represent a significant value inflection point for the company and its shareholders, confirming Betalutin as a highly promising new targeted radioimmunotherapy that can address the unmet needs of R/R FL patients.