OTCM: What were your major accomplishments for the last year?
Ms. Rathjen: In September, we announced positive results from our Phase 2 trial of BNC210 in Generalized Anxiety Disorder (GAD). The single center, double-blinded, placebo and lorazepam-controlled, 4-way cross-over Phase 2 clinical trial was conducted in 24 patients with untreated GAD. The objective of the study was to evaluate the capacity of BNC210 to engage brain systems relevant to anxiety while resting and in response to anxiety-related tasks. The co-primary endpoints were change in cerebral perfusion measured by arterial spin labelling and change in task-related brain activity, specifically in the amygdala as measured by functional Magnetic Resonance Imaging (fMRI) during the Emotional Faces Task (EFT). Results from the study showed that BNC210 induced statistically significant changes in cerebral perfusion (300mg BNC210, p<0.05) and also significantly reduced amygdala activation in response to fearful faces during the EFT (300mg BNC210, p<0.05). In comparison, lorazepam exerted a modest suppressive effect on amygdala activation during performance of the EFT (1.5mg lorazepam, p=0.069). Earlier this year, we initiated a Phase 2 clinical trial of BNC210 for the treatment of Post-Traumatic Stress Disorder (PTSD) and expect topline data from this trial in 2018.
In March, we initiated a Phase 1 study of BNC101 for the treatment of metastatic colorectal cancer. The open label, multi-center clinical trial in patients with metastatic colorectal cancer will aim to demonstrate that BNC101 is safe and well tolerated and that it is able to delay disease relapse in treated patients. The trial will be conducted at specialist centres across Australia and will run in two parts, firstly with BNC101 alone and then in combination with standard of care chemotherapy. Each part has two phases, an escalation to find the optimal dose level and then an expansion of the study at that dose level.
OTCM: What differentiates your company and what is your strategy for growth going forward?
Ms. Rathjen: Bionomics is a fully integrated biotechnology company that has created proprietary technology platforms, which include ionX, MultiCore and CSCRx, for each step in the drug discovery and development process. Each of these advanced technologies is a source of competitive advantage offering the company the opportunity to identify and progress unique new pharmaceutical products. Additionally, the Company has a lengthy history of successful partnerships with industry and academia. Most notably, we have a strategic partnership with Merck utilizing the ionX and MultiCore platforms in two preclinical stage programs. Merck has an option to exclusively license for development and commercialization certain small molecule drug candidates for the treatment of chronic and neuropathic pain. Under the agreement, Bionomics may receive up to $172 million in exercise fees and milestone payments, in addition to royalties on product sales. We also have a research collaboration and license agreement with Merck to develop compounds targeting cognitive impairment in conditions such as Alzheimer’ s disease, Parkinson’s disease, schizophrenia and attention deficit disorder, or ADHD, for which we received a $20 million upfront payment and may receive up to an additional $486 million in research and milestone payments, in addition to royalties on product sales. Moving forward we will look to continue to build strategic partnerships so that we can focus our strengths on innovative drug discovery.
OTCM: You trade on the ASX in Australia and on OTCQX in the U.S. What is your strategy for reaching investors?
Ms. Rathjen: Bionomics regularly attends investor conferences across the globe with the aim to maintain regular investor interactions. Additionally, Bionomics has research coverage in Australia and the United States from Darren Vincent (Shaw and Partners), Tanushree Jain (Bell Potter) and Joe Pantginis (Roth Capital Partners). Furthermore, while Bionomics is based in Adelaide, Australia, the Company has operations in San Diego, USA and a wholly owned subsidiary in Strasbourg, France, which allows us to maximize our efforts meeting with investors.
OTCM: What else do you want investors to know about your company?
Ms. Rathjen: We are combining one of the world’s most innovative drug discovery platforms with development of novel, best-in-class therapies. Our management team has extensive expertise in drug discovery and development in large opportunity markets in oncology and CNS. The Company is well financed with a cash balance of AUD$44.5M (as of 30 June 2016) to support our business objectives.
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