Realm Therapeutics losses widen as it ups R&D spending

Clinical-stage biopharmaceutical company Realm Therapeutics announced its final results for the year ended 31 December on Wednesday, reporting cash, cash equivalents and short-term investments available for sale of $33.9m at year-end, up from $21.4m at the end of 2016.

The AIM-traded firm made gross proceeds from the completion of a private placement in October of £19.3m.

Its losses from continuing operations widened to $10.5m for the year, from $7.3m a year earlier, which the board said reflected higher research and development investments.

Revenue from continuing operations was markedly higher for the year, at $1.12m, compared to $0.87m for 2016.

On the operational front, the Realm board highlighted the submission of its ‘Investigational New Drug’ (IND) application for PR022 - a topical gel for the treatment of atopic dermatitis - during the year, receiving clearance from the US Food and Drug Administration (FDA) to move directly into a Phase 2 clinical study, which was initiated in December.

It also submitted an IND application for PR013 - a topical ophthalmic solution for the treatment of allergic conjunctivitis - and received clearance from the FDA to move directly into a Phase 2 clinical study, which was also initiated during December.

The company completed a private placement, raising gross proceeds of £19.3m ($25.4m) in October, attracting several leading specialist healthcare investors including OrbiMed, BVF, RA Capital, Abingworth and Polar Capital.

In November, the peer review journal Clinical & Experimental Allergy published an article demonstrating PR022's ability to prevent the development of atopic dermatitis-like lesions, reduce existing lesions and associated scratching, and reduce the inflammatory response.

Realm said PR022 demonstrated immunomodulatory effects without the immunosuppressive impact commonly associated with steroids, which were the current standard of care.

Since the period ended, the company had ceased clinical development of PR013 for allergic conjunctivitis as of March, which the board said had a different immunologic pathology to atopic dermatitis, following results of the Phase 2 clinical trial which did not demonstrate efficacy.

“In 2017, we successfully established Realm as a clinical stage biopharmaceutical company with the submission and clearance of two INDs that enabled us to begin two Phase 2 studies during the year,” said chief executive Alex Martin.

“We also successfully completed a private placement raising gross proceeds of £19.3m and attracting several leading US and UK specialist healthcare investors to the company.”

Martin said the board looked forward in 2018 to reporting results in its atopic dermatitis Phase 2 study, and to continuing to deliver on established milestones in its AD and acne programmes.

“We believe our proprietary immunomodulatory technology has potential application in other immune mediated diseases.

“I would like to thank our shareholders, employees, directors and advisors who all contributed to a successful year in 2017.”