Bionomics Limited (ASX: BNO) is involved in the healthcare sector. It is a global, clinical stage biopharmaceutical company focused on developing better treatments for central nervous system disorders, including anxiety, depression and Alzheimer’s disease.
(Source: Company Reports)
The company today, on 29th May 2019, announced the results of an independent strategic review conducted with the assistance of Greenhill & Co., Inc.
According to the review, a formal strategic review period is currently complete. The company continues to evaluate out-licensing opportunities and potential merger candidates, but there is no assurance that these efforts will lead to a proposal that the Board can recommend to the shareholders.
The company expects the top line data from the clinical trial by the end of June 2019 and the patient enrolment in BNC210 clinical trial to treat agitation in elderly patients in hospital and nursing home is now complete.
BNO is advancing on its learnings from the Phase 2 RESTORE trial and exposure-response analysis. The company submitted a request for a Type C meeting with the FDA to provide guidance on the design of a potential second Phase 2b trial of BNC210 in Post-Traumatic Stress Disorder. The company uses a solid dose formulation and potential eligibility for a Fast Track designation and expects the feedback by CY3Q2019.
The company does not anticipate any significant changes in collaboration with Merck & Co., Inc., Kenilworth NJ USA during 1H2019 and is unable to provide any further information currently. As communicated by the company, Merck & Co., Inc., Kenilworth NJ USA continues to conduct clinical development to evaluate the asset. BNO will update the market as per the availability of more information.
BNO’s costs have been further reduced, and a capital and debt structure reviews are being conducted by management to determine the feasibility of funding future clinical trials. Any decision on this is unlikely to be made until the company has full feedback from its Type C meeting with the FDA.
The Executive Chairman of Bionomics, Dr Errol De Souza, said that the company was unable to find a convincing alternative after extensive dialogue with potential counterparties for continuing development and partnering discussions for the assets related to monetising all or part of the Bionomics portfolio of clinical and pre-clinical assets. However, the company will continue to entertain credible proposals in relation to transactions that could add value to shareholders from any source.
Meanwhile, the company continues to focus on advancing the pipeline, while reducing operating costs to extend the cash runway. It expects to report the top line data of the exploratory BNC210 clinical trial for the treatment of agitation in elderly patients by the end of June 2019 and will define the strategy for BNC210 for the treatment of PTSD and other anxiety-related disorders after receiving guidance from the FDA towards the end of CY3Q2019.
The stock of Bionomics Limited is currently trading at $0.125, a decrease of ~10.714% during the day’s trade, with a market capitalisation of $76.26 million (on 29th May 2019, AEST 2:49 PM). It has yielded a YTD return of 30.23% and exhibited returns of 3.70%, -41.67% and 5.66% over the past six months, three months and one-month period, respectively. Its 52-week high price stands at $0.605, and the 52-week low price stands at $0.099.
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