Arctic Bioscience — Regulatory Filings 2021

May 20, 2021

New drug candidate for normal brain development in extremely premature infants

New drug candidate for normal brain development in extremely premature infants

Arctic Bioscience and Smerud Medical Research International AS (SMERUD) are

initiating a research collaboration to develop a new drug candidate based on

phospholipid esters from herring roe for extremely premature infants.

More than 30 000 babies in USA and Europe are born before 28 weeks of pregnancy.

Babies born this early do not have fully developed brains, and therefore a high

risk of disability and complications.

The company plans to apply for orphan designation for the drug candidate.

Docosahexaenoic acid (DHA) is important for normal development of brain and

vision in the fetus. Herring roe is a natural source of the omega-3 fatty acid

DHA. Thus, there is a sound scientific rationale for a drug candidate based on

phospholipid esters from herring roe to contribute to normal brain development

in extremely premature infants.

Arctic Bioscience will, based on patented technology, develop a new liquid drug

formulation with a high content of phospholipid bound DHA which can be

administered through a feeding tube to extremely premature babies.

"If we can contribute to normal brain development in extremely premature

infants, this will have enormous impact for these babies and their families all

over the world. Our long-term strategy is to develop a pipeline of drugs for

several indications based on our patented technology platform. This agreement

gives us the opportunity to develop a new product in parallel with our psoriasis

drug candidate. If the development is successful, we will enter a new billion

NOK market", says Ole Arne Eiksund, CEO of Arctic Bioscience.

SMERUD has collaborated closely with global experts in neonatal medicine during

the last 10 years and have participated in the development of another medicine

used to reduce complications related to extreme prematurity. Extremely premature

infants have a high risk of complications after birth, not only neurological,

but also diseases related to vision, lung, and intestine.

"It is very complex and challenging to conduct clinical trials in this patient

group, and very few companies have this experience. We want to utilize our

special competence and will invest significant resources in this important

project over the coming years. We know that DHA is essential for normal

development, but only high-quality clinical research will uncover whether this

particular DHA formulation from herring roe will have sufficient efficacy in

treatment or prevention of complications related to prematurity", says Knut

Smerud, Founder and Chairman at SMERUD.

Research on effect of phospholipid esters from herring roe on brain development

in extremely premature infants will be conducted in collaboration with several

specialist clinics in the Nordics, Europe, Canada, and USA.

One such institution is in Genoa, Italy, and Professor Luca Ramenghi who is the

head of neonatal pathology and intensive care at the Gaslini Institute at the

University of Genoa will be a key partner when we plan the development course

and apply for grants from the EU and others. Professor Ramenghi's research unit

is a world leader in very advanced MRI imaging of the brain in extremely

premature infants as well as clinical interpretation of this image analysis, and

has extensive experience from complex clinical studies of this patient group.

For more information, please contact:

Ole Arne Eiksund

CEO Arctic Bioscience

Phone:  +47 908 43 944

Knut Smerud

Chairman Smerud Medical Research International

Phone:  +47 908 92 577

About Arctic Bioscience

Arctic Bioscience is a biotech company developing and commercializing

nutraceutical products based on herring roe oil. Herring roe oil contains lipids

that are essential to maintain cell membranes, contributing to normal

functioning of brain, heart, and vision. Nutraceuticals from Arctic Bioscience

are sold globally as bulk ingredients to other companies making dietary

supplements, and as finished goods under the Romega brand. The strategy is to

switch sales from bulk to finished goods and focus markets are USA and China.

The company is developing HRO350 - a novel investigational drug candidate with

herring roe as raw material. HRO350 is being developed for treatment of mild-to

-moderate psoriasis. This is a large patient group in need of new effective

medicines with beneficial safety profile. Arctic Bioscience is led by a team of

highly competent people with experience in developing marine oils and experience

from global pharmaceutical companies.