About Bionomics

Bionomics Limited operates as a clinical-stage biopharmaceutical company. The company engages in developing novel, allosteric ion channel modulators designed to transform the lives of patients suffering from serious central nervous system (CNS) disorders with high unmet medical need. Utilizing its expertise in ion channel biology and translational medicine, the company is developing orally active small molecule negative allosteric modulators (NAMs) and positive allosteric modulators (PAMs) of the alpha7 receptor to treat anxiety and stressor-related disorders and cognitive dysfunction, respectively. The company is advancing its lead product candidate, BNC210, an oral, proprietary, selective NAM of the alpha7 receptor, for the chronic treatment of Post-Traumatic Stress Disorder (PTSD) and the acute treatment of Social Anxiety Disorder (SAD). BNC210 has been observed in the company’s clinical trials to have a fast onset of action and clinical activity without the limiting side effects seen with the current standard of care. In September 2023, the company announced the results of the Phase 2b ATTUNE study, which was a double-blind, placebo-controlled trial conducted in a total of 34 sites in the United States and the United Kingdom, with 212 enrolled patients, randomized 1:1 to receive either twice daily 900 mg BNC210 as a monotherapy (n=106) or placebo (n=106) for 12 weeks. The company is planning to initiate Phase 3 study in PTSD in H2 2024. The company has completed its Phase 2 PREVAIL trial for BNC210 for the acute treatment of SAD. In October 2023, the company announced a positive outcome of an End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) that enables advancement of BNC210 into Phase 3 studies in SAD. Start-up activities for a planned Phase 3 trial of BNC210 in SAD are underway. The company is planning to initiate dosing in the Phase 3 study in SAD during the quarter ending March 31, 2024. The company's expertise in ion channels and approach to developing allosteric modulators have been validated through its strategic partnership with Merck Sharp & Dohme Corp. (MSD) for its alpha7 receptor PAM program, which targets a receptor that has garnered significant attention for treating cognitive deficits. This partnership enables the company to maximize the value of its ion channel and chemistry platforms and develop transformative medicines for patients suffering from cognitive disorders, such as Alzheimer's disease. BNC210 The company initially focused on developing BNC210 for two distinct indications with high unmet medical need chronic treatment of PTSD and acute treatment of SAD. BNC210, a novel orally administered small molecule, for the chronic treatment of PTSD and the acute treatment of SAD. BNC210 is a NAM of the alpha7 receptor and does not exert its effect on the alpha7 receptor unless in the presence of an agonist, such as ACh. In the company’s clinical trials as of June 30, 2023, BNC210 had been observed to have a fast onset of action, and demonstrated clinical anti-anxiety and anti-depressive activity, but without many of the limiting side effects observed with the current standards of care for SAD and PTSD, including benzodiazepines, selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs). The company has administered BNC210 in approximately 600 subjects across 14 completed clinical trials, including healthy volunteers, elderly patients with agitation and patients with Generalized Anxiety Disorder (GAD), SAD and PTSD. The company observed BNC210 to be generally well tolerated in the trials to date following both acute and chronic dosing. The company has designed and developed a novel, proprietary tablet formulation of BNC210, which has shown differentiated pharmacokinetic properties in clinical trials. BNC210 tablet has demonstrated rapid oral absorption characteristics in clinical trials making it ideal for acute, or on demand, treatment of SAD. Furthermore, the tablet formulation is intended to provide patients the convenience of taking BNC210 with or without food in the outpatient setting. In previous clinical trials (using 900 mg twice daily dosing similar to that used in the ATTUNE Study), the tablet formulation achieved a target blood exposure ranging from 33-57 mg.h/L, which exceeds the blood exposure of approximately 25 mg.h/L, which the company’s pharmacometrics analysis predicted as likely to show clinically meaningful benefit for patients suffering from PTSD. The company is using this tablet formulation in its Phase 2b ATTUNE clinical trial for patients with PTSD and Phase 2 PREVAIL trial for patients with SAD. In September 2023, the company announced the results of the Phase 2b ATTUNE study, which was a double-blind, placebo-controlled trial conducted in a total of 34 sites in the United States and the United Kingdom, with 212 enrolled patients, randomized 1:1 to receive either twice daily 900 mg BNC210 as a monotherapy (n=106) or placebo (n=106) for 12 weeks. The company is planning to initiate Phase 3 study in PTSD in H2 2024. The company has reached an agreement with the FDA on the plan to conduct two single dose randomized, placebo-controlled studies; the use of the SUDS measured during a public speaking challenge as the primary efficacy endpoint; the doses of BNC210 to be studied in Phase 3; the sample size assumptions for the Phase 3 controlled studies based on PREVAIL findings; the design elements of the open label safety study; the size of the safety database to support the NDA; and the nonclinical toxicology studies needed to support the NDA. Start-up activities for a planned Phase 3 trial of BNC210 in SAD are underway. The company is planning to initiate dosing in the Phase 3 study in SAD during the quarter ending March 31, 2024. The company has received Fast Track designation from the FDA for its PTSD and SAD programs. In addition, the company has a memorandum of understanding with EmpathBio for preclinical feasibility studies to evaluate a combination of EMP-01, a 3,4-methylenedioxymethamphetamine (MDMA) derivative and BNC210 as an adjunct to behavioral therapy for the treatment of PTSD. Clinical Development of BNC210 As of June 30, 2023, the company had studied BNC210 in approximately 600 subjects across 14 completed clinical trials, including in healthy volunteers, elderly patients suffering from agitation and patients with GAD, SAD, and PTSD. In addition, BNC210 has demonstrated clinical proof-of-concept of acute anti-anxiety activity in a Phase 2 clinical trial in GAD patients, as well as a statistically significant reduction in panic symptoms in a CCK-4 induced panic attack clinical trial of healthy volunteers. BNC210 more recently demonstrated efficacy in reduction of total symptom severity scores in the company’s Phase 2 PTSD clinical trial and reduced acute anxiety during a public speaking challenge in the company’s Phase 2 clinical trial in SAD patients. Phase 1 Safety, Tolerability and Pharmacokinetic Clinical Trials in Healthy Subjects Using a Liquid Suspension Formulation The company conducted two Phase 1 clinical trials with BNC210 in 36 healthy subjects to examine the safety and pharmacokinetics of its product candidate using a liquid suspension formulation. The company conducted a subsequent Phase 1 double-blind, placebo-controlled, four-way crossover clinical trial in 24 healthy subjects to further evaluate safety and tolerability of BNC210. Phase 1 Clinical Trial Demonstrating Target Engagement in Brain at Nicotinic Receptor in Healthy Subjects The company conducted a Phase 1 clinical trial to demonstrate BNC210 target engagement at brain nicotinic receptors measured by electroencephalographic (EEG) activity. Phase 1 and 2 Clinical Trials Demonstrating Anti-Anxiety Effects in Healthy Subjects and Anxiety Patients The company conducted a randomized, placebo-controlled, double-blind Phase 1 clinical trial in 60 healthy subjects to evaluate the anti-anxiety effects of BNC210. The company also conducted a Phase 2a randomized, double-blind, placebo-controlled, four-way crossover clinical trial in 24 newly diagnosed, treatment-naive GAD patients in the in-clinic setting evaluating the neural imaging response of patients exposed to ‘fearful faces’ and their behavioral response to threat avoidance. Phase 2 RESTORE PTSD Clinical Trial Using Liquid Suspension Formulation: Summary, Pharmacokinetic Modeling and Pharmacometrics Analysis The company’s RESTORE trial was a randomized, double-blind, placebo-controlled Phase 2 clinical trial in the outpatient setting that enrolled 193 adult patients diagnosed with PTSD across 20 sites in the United States and six sites in Australia. Subsequently, the company performed population pharmacokinetic modeling and a pharmacometric analysis on the RESTORE trial. Additional Programs Alpha7 Receptor PAM Program with MSD In June 2014, the company entered into a License Agreement with MSD (known as Merck & Co., Inc., Rahway New Jersey, the U.S.A. in the U.S., and Canada) to develop alpha7 receptor PAMs targeting cognitive dysfunction associated with Alzheimer’s disease and other central nervous system conditions. Under the 2014 License Agreement, MSD funded certain research and development activities on a full-time equivalent (FTE) basis pursuant to a research plan. MSD funds research and development activities, including clinical development and worldwide commercialization of any products developed from the collaboration. The MSD collaboration includes two candidates, which are PAMs of the alpha7 receptor that are in early-stage Phase 1 safety and biomarker clinical trials for treating cognitive impairment. The first compound has completed Phase 1 safety clinical trials in healthy subjects and there are ongoing biomarker studies. In 2020, a second molecule that showed an improved potency profile in preclinical animal models was advanced by MSD into Phase 1 clinical trials. On September 14, 2023, the company provided an update on the alpha7 Nicotinic Acetylcholine Receptor (nAChR) PAM collaboration with MSD The original lead molecule BNC375, a Type I alpha7 nAChR PAM, showed a robust and sustained dose-dependent efficacy over a broad dose range and across multiple cognitive animal models. MSD has subsequently developed MK-4334, a novel clinical candidate, which in early preclinical studies has shown improved drug like and pharmacological properties relative to BNC375. In addition to Phase 1 safety, tolerability and clinical pharmacokinetics studies, clinical biomarker studies are ongoing to further evaluate the pharmacological response of alpha7 nAChR PAMs in humans. Early-Stage CNS Assets The company’s CNS pipeline includes two earlier stage small molecule discovery programs targeting ion channels and represents additional opportunities for future clinical programs and partnering. These programs are at a similar stage to the stage at which the alpha7 receptor PAM program was licensed under the 2014 MSD License Agreement, although there is no assurance that the company will be able to enter into a license or collaboration agreement with respect to these programs. The first of these programs has developed two patented series of small molecule Kv3.1/3.2 potassium channel activators for the potential treatment of cognitive deficits and negative symptoms/social withdrawal in schizophrenia and autism spectrum disorders. The second program has developed three patented series of small molecule inhibitors with functional selectivity for Nav1.7 and Nav1.8 voltage gated sodium ion channels for the potential treatment of chronic pain without the liability of addiction associated with opioid treatment. The company plans to advance its early-stage programs either internally or through potentially new partnerships. Legacy Oncology Programs The company has a portfolio of legacy clinical-stage oncology programs targeting cancer stem cells (BNC101) and tumor vasculature (BNC105) that it has progressed through external funding for clinical trials and out-licensing. The company’s first legacy oncology program is BNC101, a novel humanized monoclonal antibody that targets LGR5, a cancer stem cell receptor highly overexpressed in most solid tumors. In November 2020, it exclusively licensed BNC101 to Carina Biotech for the development of chimeric receptor antigen T-cell (CAR-T) therapeutics in return for milestones and royalties. On 24 January 2023, Carina Biotech Pty Ltd (Carina) announced that it had received an FDA ‘Safe to Proceed’ Letter for a Phase 1/2a clinical trial of BNC101 CAR-T therapy for the treatment of advanced colorectal cancer and plans to commence patient enrolment during the first half of 2023. On 25 August 2023, Carina announced that patient screening for their Phase 1/2a study had commenced. The company’s second legacy oncology program, BNC105, is a novel vascular tubulin polymerization inhibitor agent for the treatment of cancer, which disrupts the blood vessels that nourish tumors. The company plans to advance these oncology programs only through existing and potentially new partnerships. Other Pipeline Programs Apha7 Receptor Positive Allosteric Modulator Program for the Treatment of Cognitive Impairment To overcome the challenges with orthosteric agonists, the company embarked on an alpha7 PAM discovery program which led to the identification of BNC375, a novel alpha7 PAM which is selective over related receptors and potentiates ACh-evoked alpha7 currents with no observed effect on receptor desensitization kinetics. In June 2014, the company entered into a strategic collaboration with MSD to develop novel PAMs, including its BNC375 research program, for the treatment of cognitive dysfunction associated with Alzheimer’s disease and other central nervous system conditions. The company’s collaboration with MSD includes two candidates which are PAMs of the alpha7 receptor that are in early-stage Phase 1 safety and biomarker clinical trials for treating cognitive impairment. The first compound (MK-4334) has completed Phase 1 safety clinical trials in healthy subjects and there are ongoing biomarker studies. In 2020, a second molecule that showed an improved potency profile in preclinical animal models was advanced by MSD into Phase 1 clinical trials. Emerging CNS Programs The company has an emerging CNS pipeline with two small molecule programs targeting ion channels at a similar stage of discovery to when it entered into the 2014 MSD License Agreement with MSD that may be available for future partnering. The company has patented two series of small molecule Kv3.1/3.2 potassium channel activators for the potential treatment of cognitive deficits and negative symptoms in schizophrenia and for the treatment of autism spectrum disorders, including those arising from Fragile X syndrome. The company has patented two series of small molecule inhibitors with functional selectivity for Nav1.7 and Nav1.8 voltage gated sodium channels for the treatment of chronic pain without the potential for addiction and sedation associated with opioid treatments and pregabalin, respectively. Strategy The key elements of the company’s strategy are to advance its lead product candidate, BNC210 through clinical development and to commercialization, if approved, in patients with PTSD; advance its lead product candidate, BNC210, through clinical development and to commercialization, if approved, for the acute treatment of patients with SAD; expand indication potential for BNC210 to other acute and chronic anxiety and stressor-related disorders; build a commercialization infrastructure in the United States for BNC210; maximize the potential of its CNS programs and legacy oncology assets through selective partnerships and licensing; and continue to strategically expand its clinical pipeline through acquisitions, licenses, and/or collaborations. Research Collaboration and License Agreement with MSD In June 2014, the company entered into a research collaboration and license agreement (as amended, the ‘2014 MSD License Agreement’) with Merck Sharp & Dohme Corp., a wholly owned subsidiary of Merck & Co., Inc., Kenilworth NJ, the U.S.A. (MSD) to develop compounds targeting cognitive dysfunction associated with Alzheimer’s disease and other central nervous system conditions. Pursuant to the 2014 MSD License Agreement, the company granted MSD an exclusive (even as to it and its affiliates), worldwide, sublicensable license under certain of its patent rights and know-how to research, develop, make, have made, use, offer to sell, sell, import and/or otherwise exploit certain alpha7 activator compounds and products containing such compounds for any and all uses in humans and animals, including any prophylactic, therapeutic and/or diagnostic uses, subject to certain of the company’s retained rights; and an exclusive (even as to it and its affiliates), worldwide, sublicensable, perpetual, irrevocable, fully-paid license under certain of its patent rights and know-how to research, develop, make, have made, use, offer to sell, sell, import and/or otherwise exploit certain alpha7 PET ligands and products containing such ligands for any and all uses in humans and animals, including any prophylactic, therapeutic and/or diagnostic uses. The company is subject to limited information rights under the 2014 MSD License Agreement. As such, it is dependent on MSD to provide it with any updates related to clinical trial results, serious adverse events and ongoing communications with FDA related to these programs, which MSD may provide or withhold in its sole discretion, and as a result it may not be able to provide material updates on a timely basis or at all with respect to these programs. IP License Agreement with Carina Biotech In November 2020, the company entered into an IP license agreement (the ‘Carina Biotech License’) with Carina Biotech. Pursuant to the Carina Biotech License, the company granted Carina Biotech an exclusive, worldwide license, with the right to grant sublicenses (subject to certain restrictions), under certain of its patents and know-how to research, develop, make, have made, use, sell, offer for sale, supply, cause to be supplied, import and otherwise exploit products applying the licensed patents and/or licensed know-how for research, commercial and development applications, and related fields, with respect to CAR-T cells, adaptor CARs and other adoptive cell therapies. Under the Carina Biotech License, Carina Biotech is obligated to use commercially reasonable efforts to commercially develop and exploit licensed products in each country in which Carina Biotech obtains regulatory approval for the licensed products. Carina Biotech is responsible for conducting all regulatory activities for the licensed products. The company is obligated to assist Carina Biotech as reasonably requested from time to time in connection with its regulatory filings. It is also obligated to provide technology transfer to Carina Biotech, at Carina Biotech’s request, of know-how and technical information that is useful or necessary for Carina Biotech to fully exercise the rights licensed to it under the agreement. Research and License Agreement with Ironwood Pharmaceuticals In January 2012, the company entered into a research and license agreement with Ironwood Pharmaceuticals, Inc. (‘Ironwood’), pursuant to which Ironwood was granted worldwide development and commercialization rights for BNC210. In November 2014, the parties mutually agreed to terminate this license agreement, reverting all rights to BNC210 back to the company. Intellectual Property Central Nervous System As of September 5, 2023, the company owned over 15 issued U.S. patents, four pending U.S. patent applications, two pending Patent Cooperation Treaty (PCT) applications, over 30 granted foreign patents, and over 15 pending foreign patent applications in its central nervous system intellectual property portfolio. In regard to its BNC210 product candidate, the company owns: One patent family, which includes eight issued U.S. patents and 15 foreign patents granted in Australia, Canada, France, Germany, the United Kingdom, and Japan, with claims directed to the composition of matter of BNC210, methods of preparing BNC210, and methods of treating anxiety and depressive disorders using BNC210, which are expected to expire in October, 2027, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable. One patent family, which includes one issued U.S. patent and six foreign patents granted in Australia, Canada, the United Kingdom, Germany, and Japan, with claims directed to the manufacture and method of preparing BNC210, which are expected to expire in May 2032, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable. One patent family, which includes one issued U.S. patent and eight foreign patents granted in Australia, Canada, the United Kingdom, Germany, France, Mexico, New Zealand and Hong Kong, with claims directed to the crystalline form of BNC210, which are expected to expire in May 2033, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable. One patent family, which includes two issued U.S. patent and two foreign patents granted in Australia, with claims directed to the salts, cocrystal and polymorphic form of BNC210, which are expected to expire in March 2034, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable. One patent family, which includes a pending PCT application, WO 2021056048, with claims directed to solid form formulations of BNC210 and have submitted national phase filings in the United States, Canada, China, Europe, Japan, Korea, Mexico, New Zealand, Israel, and Australia. The patent applications claiming priority to this PCT application, if issued, are expected to expire in February 2040, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable. Two provisional applications filed with claims directed toward methods of treating social anxiety disorder and post trauma stress disorder. In addition to the above-described patent families, the company has two pending PCT applications, WO 2019218025 and WO 2019218024, with claims directed to modulators of ion channels and their uses in treating chronic pain, and have submitted national phase filings in the United States (a U.S. patent claiming the priority to the PCT application WO 2019218024 is granted), Europe, Hong Kong and Australia. Patents issuing from such applications, if any, are expected to expire in May 2039, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable. The company also has two pending PCT applications, WO 2020000065 and WO 2019222816, with claims directed to the composition of matter and their uses for the treatment of cognitive deficits and negative symptoms in schizophrenia and for the treatment of autism spectrum disorders; and has submitted national phase filings in the United States, Europe, Australia, Japan, Canada, and New Zealand. Patents issuing from such applications, if any, are expected to expire in October 2039, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable. Oncology As of September 5, 2023, the company owned over 15 issued U.S. patents, one pending U.S. patent applications over 35 granted foreign patents, and over 10 pending foreign patent applications in its oncology intellectual property portfolio. In regard to its BNC101 product candidate, the company owns: One patent family, which includes one granted U.S. patent and 4 foreign patents granted in Australia, France, Germany, and United Kingdom, with claims directed to the methods of blocking cancer stem cell growth using BNC101, which are expected to expire in October 2033, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable; One patent family, which includes two issued U.S. patents and two foreign patents granted in Australia, with claims directed to the methods of treating cancer using BNC101, which are expected to expire in October 2033, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable; One patent family, which includes two issued U.S. patents and eleven foreign patents granted in Australia, Canada, Japan, China, India, Korea, France, Germany, United Kingdom, New Zealand, and Hong Kong with claims disclosing the humanized anti-LGR5 antibodies for the treatment of cancer, which are expected to expire in October 2035, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable; and One patent family, which includes one issued U.S. patent with claims disclosed the method of administration of an anti-LGR5 monoclonal antibody to treat certain cancers, which are expected to expire in March 2037, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees, as applicable. One patent family, which includes one pending U.S. patent, one foreign patents granted in Japan, and four foreign patents pending in Australia, Hong Kong, China, and Europe, with claims disclosing the method of monitoring the response to a cancer treatment, which are expected to expire in April 2039, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable. One patent family, which includes one granted U.S. patent, four foreign patents pending in Japan, Australia, Canada, and Europe, with claims disclosing the method of administering of humanized antibody that bind to LGR5 colorectal the cancer, which are expected to expire in April 2039, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable. In regard to its BNC105 product candidate, the company owns: One patent family, which includes five granted U.S. patents and seven foreign patents granted in Australia, Canada, France, Germany, the United Kingdom, Japan, and New Zealand, with claims directed to the composition of matter of BNC105 and methods of treatment cancer using BNC105, which are expected to expire in February, 2027, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable; One patent family, which includes one issued U.S. patent and seven foreign patents granted in Australia, Canada, Hong Kong, China, France, German, and the United Kingdom, with claims directed to the manufacture of BNC105, which are expected to expire in July, 2031, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable; One patent family, which includes one issued U.S. patent, three foreign patents granted in China, New Zealand and Canada, with claims directed to the combination of BNC105 and ibrutinib in CLL, where the granted patents and the patent applications, if issued, are expected to expire in March, 2036, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable; and One patent family, which includes one granted U.S. patent application and 3 foreign patent applications pending in Australia, China, and Europe, with claims directed to using BNC105 in the treatment of acute myeloid leukemia, where the patent applications, if issued, are expected to expire in October, 2038, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable. One patent family, which includes one granted U.S. patent application and 3 foreign patent applications granted in Australia, Canada, and New Zealand, with claims directed to using BNC105 in the treatment of chronic lymphocytic leukemia, where the patent applications are expected to expire in April 2034, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable. One patent family, which includes one granted U.S. patent application and 3 foreign patent applications granted in Australia, Canada, and New Zealand, with claims directed to using BNC105 in the treatment of chronic lymphocytic leukemia, where the patent applications are expected to expire in April 2034, excluding any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, as applicable. Research and Development The company’s research and development expenses were A$19.6 million for the year ended June 30, 2023. Government Regulation The FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries and local jurisdictions, extensively regulate, and impose substantial and burdensome requirements upon companies involved in, among other things, the research, development, testing, manufacture, quality control, sampling, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of the company’s product candidates. Any drug candidates that the company develops must be approved by the FDA. In addition, drug manufacturers and their subcontractors involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including cGMP, which impose certain procedural and documentation requirements upon the company and its contract manufacturers. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting requirements upon the company and any third-party manufacturers that it may decide to use. History Bionomics Limited, an Australian public company, was incorporated in 1996.