Review underway after Atopic Dermatitis miss
Realm Therapeutics plc (RLM), a clinical stage bio-pharmaceutical company focused on developing novel therapeutics in immune-related diseases based on its proprietary hypochlorous acid (HOCl) technology, has reported preliminary top-line data from its Phase II trial of PR022 in Atopic Dermatitis, in tandem with H1’18 financial results.RLM’s randomised, double-blind, placebo controlled, Phase II clinical trial, PR022 showed no difference from vehicle in the primary endpoint of percentage change in Eczema Area Severity Index (EASI) versus baseline. The Company is now analysing the data to interpret the top-line result, as well as the other data collected in the study.
The conclusions of this review will be used to inform decision-making going forward, and this includes evaluating the implications of these data for RLM’s preclinical HOCl dermatology pipeline in Acne and Psoriasis – both of which had been making good progress. RLM indicates that it will also review the possibility of acquiring one or more new assets, although no specific detail is available. They expect to disclose the outcome of the review in September.
RLM also reported results with a higher H1’18 net loss of $10.6m compared to a loss of $3.9m in H1’17. This was primarily due to an increase operating expenditure to $10.9m in H1’18 (versus $4.6m in H1’17) and included $7.4m of R&D costs to cover the clinical studies of PR022 and PR013 and $3.5m of G&A to cover NASDAQ listing. Net cash and equivalents stood at $23.7m for the period to the end of June 2018.
Pending the outcome of the review, we are suspending our forecasts and valuation that we can update when the Group’s strategic direction becomes clearer in September. In the meantime, RLM has the benefit of significant cash on the balance sheet, an experienced Executive team, and substantial IP filed.
Realm Therapeutics is a clinical stage biopharmaceutical company focused on utilizing its proprietary immunomodulatory technology. Co. is engaged in the development of prescription treatments for inflammatory diseases including indications in Dermatology and Ophthalmology. Co. has developed proprietary formulations of its technology for initial application in Atopic Dermatitis (PR022) and Allergic Conjunctivitis (PR013). Co.'s first product, PR022, is a proprietary non-alcohol based, topical gel, which has shown therapeutic effect in pre-clinical models of Atopic Dermatitis. Co.'s second product, PR013, a proprietary topical ophthalmic solution for the treatment of Allergic Conjunctivitis.
Equity Development enables companies to become better understood and supported by investors. Since our launch in 1996 we have consistently focused on helping our clients improve their communication and relationships with both existing and potential shareholders. Our clients have come from a wide variety of sectors and domiciles, are both private and quoted and range in size from micro-cap to $multi-billions. We offer free access to company research notes written by experienced analysts. These notes include detailed forecasts, financial models and a fair value. We host regular Private Investor Forums at which investors have the opportunity to hear company directors present, and to ask questions. These are free to attend. We broadcast live Webinars with company management that include active Q&A. We also make the recordings available online. We arrange face to face meetings between private investors and company management. We are active users of Twitter, commenting daily on company news, share price moves, Directors’ Dealings, Equity Development Research Notes & Events.
Unfortunately, this report is not available for the investor type or country you selected.
Browse all ResearchPool reportsReport is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.