Oxuspheres™ drug-containing biodegradable polymer system

	Next higher product group	drug delivery technology_oo
	Status	2021-03-01 existent
	Organisation	Oxular Ltd.

Oxular Ltd.. (3/1/21). "Press Release: Oxular Raises $37 Million". Oxford.

> Led by specialist life sciences investor, Forbion

> Investment will fund Phase 2 human clinical studies evaluating Oxular's 12-month treatment for diabetic macular edema, and accelerate development of early-product pipeline

Oxular Limited ("Oxular"), a leading retinal therapeutics development company, today announced that it has completed a $37 million (£27 million) financing led by Forbion. Proceeds will fund planned further clinical development of its lead asset, OXU-001, for the treatment of diabetic macular edema (DME), as well as accelerating development of its early-product pipeline.

Forbion is a dedicated European life sciences venture capital firm that manages over €1.7 billion of investments and works closely with entrepreneurs to build life sciences companies that will change the future of medicine. In the financing, Forbion were joined by existing investors IP Group, NeoMed, and V-Bio Ventures. Dr. Dmitrij Hristodorov, Principal at Forbion, will join the Oxular Board. Prior to joining Forbion in March 2020, Dr. Hristodorov was Senior Director of Global Business Development & Licensing at Bayer Pharma where he was responsible for the Ophthalmology and Cardiovascular Franchises.

The investment will fund Phase 2 human clinical studies, commencing later this year, to evaluate OXU-001 for the treatment of DME, a serious retinal disease that affects 24 million people globally and is the leading cause of blindness in young adults in developed countries. A key challenge facing patients with DME is the need for frequent clinic visits for repeated treatment injections. To address this, OXU-001, an innovative, sustained-release formulation of dexamethasone, provides up to 12 months' treatment effects following a single administration. Dexamethasone is a well-known, safe and effective treatment for inflammatory retinal diseases, including DME.

The OXU-001 program will combine the use of Oxular's highly adaptable, disruptive technologies including:

> Oxuspheres™ – A proprietary drug-containing biodegradable polymer system, designed as an adjustable, sustained release formulation, with the ability to provide up to 12 months' treatment for retinal diseases following single administration. This has the potential to address significant unmet needs, thereby improving patient outcomes and dramatically reducing the unsustainable treatment burden on patients, clinicians, and healthcare systems.

> Oxulumis™ – A proprietary semi-automated ocular administration device utilizing an advantageous route of administration (the suprachoroidal space) to deliver therapeutics for the treatment of retinal diseases. OxulumisTM is designed to deliver the therapeutics via an illuminated microcatheter that allows routine, safe and accurate drug deployment to the specific tissues involved in retinal disease. OxulumisTM offers physicians an efficient, novel and less invasive in-office administration procedure.

Proceeds from the financing will also accelerate development of Oxular's early-product pipeline, while building its team to support future clinical trials and expanded R&D activities. The Company plans to progress OXU-003, a novel treatment for Retinoblastoma, into Phase 2 human clinical studies in 2022. OXU-003 recently received both Rare Pediatric Disease and Orphan-Drug designations from the U.S. Food and Drug Administration (FDA), highlighting the need for a new treatment for Retinoblastoma. In addition, OXU-004, a first-in-class treatment for Uveal Melanoma, and OXU-005, the first 12-month treatment for age-related macular degeneration (AMD) and diabetic retinopathy (DR), will both be readied for Investigational New Drug (IND) submissions.

Thomas Cavanagh, Chief Executive Officer of Oxular commented:

"We are pleased to add such a renowned investor as Forbion to our already supportive investor base, including IP Group, NeoMed, and V-Bio Ventures. These are experienced healthcare investors who see the potential of Oxular's disruptive technology and innovative treatment approach – which is, tissue-specific delivery of potent drug products that safely provide up to 12-months' treatment durability for retinal disease. Through longer-lasting treatments and better efficacy, safety and delivery we aim to offer retinal patients truly life-changing solutions to their unmet needs. We are excited to build our team and to drive development of our programs through significant milestone achievements, with OXU-001 and OXU-003 generating Phase 2 data within the next two years, and OXU-004 and OXU-005 advancing to IND submission shortly thereafter."

Dr. Dmitrij Hristodorov, Principal at Forbion and Non-Executive Director at Oxular, commented:

"I am excited to join Oxular's Board and be supporting the Company on the journey towards disrupting the market of retinal diseases with their therapeutics. Oxular has built an exceptional platform that has the potential to unlock the full therapeutic potential of potent molecules and significantly improve patients' lives by providing safe, efficacious and convenient treatment options. We are pleased to lead this financing round and look forward to seeing the progress that the team at Oxular makes over the coming years, in both its clinical and preclinical programs."

About Oxular Limited

"One treatment a year. Life changing."

Oxular is developing disruptive technology to transform the treatment of retinal disease, offering patients life-changing solutions to their unmet needs. Oxular's sustained-release formulations are engineered to last up to one year following single administration and perform in specific small spaces in the eye. This approach provides unique and precise drug distribution to tissues specifically involved in retinal diseases. Oxular's drug administration technology is engineered to access these critical tissues through minimally-invasive delivery. This novel combination aims to substantially improve patient quality of life by increasing therapeutic effectiveness and patient safety, while reducing side-effects and minimizing the frequency of treatments. Oxular's product development pipeline includes treatments for prevalent retinal diseases, such as diabetic macular edema and age-related macular degeneration, as well as rare and orphan indications, including treatments for ocular cancers.

For more information refer to www.oxular.com.

Enquiries:

FTI Consulting
Ben Atwell / Alex Davis
Tel: +44-(0)-20-3727-1000