Company Overview: Bionomics Limited is a clinical-stage biopharmaceutical company engaged in discovery and development of drug candidates focused on the treatment of central nervous system (CNS) disorders and cancer by using its platform technologies. The Company's segments include Drug discovery and development, and Contract services. The Drug discovery and development segment includes the discovery, development and commercialization of compounds to match a target product profile. The Contract services segment includes the provision of scientific services on a fee for service basis to both external and internal customers. Its product candidates include BNC210, BNC375, BNC101 and BNC105. The Company provides treatments for CNS disorders, such as anxiety, depression and Alzheimer's Disease. Its oncology approach targets cancer stem cell therapies in solid tumors. Its technologies include ionX and MultiCore. It operates in three geographical areas, such as Australia, France and the United States.


BNO Details

Bionomics is a global, clinical stage biopharmaceutical company leveraging its proprietary platform technologies to discover and develop a deep pipeline of best in class, novel drug candidates. Bionomics’ lead drug candidate BNC210, currently in Phase 2 for the treatment of generalized anxiety disorder and for posttraumatic stress disorder, is a novel, proprietary negative allosteric modulator of the alpha-7 (α7) nicotinic acetylcholine receptor. Bionomics has a strategic partnership with Merck & Co., Inc. (MSD). In parallel, Bionomics continues to progress potential partnership discussions and the monetisation of non-core assets. Bionomics has continued to work closely with MSD, enabling MSD to reach clinical trial milestones. Bionomics has emerged from 2017 as a more focused and cost-efficient company after restructuring initiatives including closing its US operations and a formal monetisation process is indicated to be ongoing for both BNC101 and BNC105.

Latest Demonstrations for BNC101 and BNC105: Bionomics Limited released new first-in-human data from the Phase I Clinical Trial of BNC101, its anti-LGR5 cancer stem cell drug candidate being developed to treat solid cancers. In addition, new data are also being presented on BNC105, its tubulin polymerization inhibitor, as a potent therapeutic for killing Acute Myeloid Leukemia (AML) cells and leukemic progenitor cells. Bionomics is currently undertaking a formal process to partner both BNC101 and BNC105 as the company completes its transition to a focused Central Nervous System (CNS) disorders’ treatment company. These new data sets are anticipated to assist the process. The BNC101 data presented at the annual American Association for Cancer Research conference in Chicago demonstrated that BNC101 was safe and well tolerated, with no evidence of gut toxicity as measured by the biomarker Zonulin.
 

CNS Focussed Pipeline (Source: Company Reports)

A statistically significant decrease in the ratio of plasma levels of MMP-9 and TIMP-1 was observed in patients following treatment with BNC101 providing support for a potential pharmacodynamic effect. This change was seen especially in the mutational subset of patients that expressed the KRAS mutation, a finding that may be useful for patient selection in future clinical trials while the BNC105 data demonstrated that BNC105 is a high potency inducer of apoptosis and cell death in patient-derived AML cells. BNC105 targets both peripheral acute leukemic and leukemic progenitor cell populations theoretically reducing the potential for recurrence of AML. BNC105 was shown to be more potent than competing products in development.


BNC105 Overview (Source: Company Reports)

Phase 2 clinical trial of BNC210 fully recruited: BNO’s RESTORE trial, a Phase 2 clinical trial designed to evaluate the safety and efficacy of BNC210 for the treatment of post-traumatic stress disorder (PTSD), was fully recruited. Full recruitment in the RESTORE trial marks a significant achievement for Bionomics. The program was supported by earlier clinical studies examining the biological effects of BNC210 on the brain, on anxiety-induced behaviour in patients with Generalized Anxiety Disorder (GAD) and the ability to suppress panic attacks. The RESTORE trial was a randomized, double-blind, placebo-controlled Phase 2 clinical trial designed to enrol up to 192 adult patients diagnosed with PTSD at sites across the United States and Australia. Bionomics hosted two Key Opinion Leader events focused on the potential of BNC210 to treat PTSD in New York on April 13, 2018, and in London on April 17, 2018. BNC210 is a novel, first-in-class, negative allosteric modulator of the α7 nicotinic acetylcholine receptor.


BNC210’s Competitive Advantages (Source: Company Reports)

Quarterly Activities Report: During the quarter ended March 2018, Bionomics progressed both its development pipeline of innovative therapies and its business objectives. Recent BNC210 presentations have highlighted the ongoing Phase 2 trial of BNC210 in patients with Post-Traumatic Stress Disorder (PTSD) and data supporting its potential as a therapy for anxiety disorders, depressive conditions with co-morbid anxiety, agitation, stress and trauma-related disorders. Whilst BNC210, Bionomics’ proprietary ionX drug discovery platform and its important relationship with Merck & Co., (known as MSD outside the US and Canada) are the primary focus of the Company, Bionomics’ clinical stage oncology assets delivered new data during the quarter.


Expected Cash Flow for the next Quarter (Source: Company Reports)

Bionomics is currently undertaking a formal process to monetise through divestment and/or out-licensing both BNC101 and BNC105 as the company completes its transition to a focused Central Nervous System (CNS) disorders’ company. Bionomics is in a strong position to fund its current development programs. Cash balance at 31 March 2018 was $32.254 million (31 December 2017: $32.021 million) with net operating cash inflow during the quarter ended 31 March 2018 of $0.158 million. Cash receipts for the period included receipts from customers totalling $0.900 million for the current quarter ending 31 March 2018. Bionomics received an R&D Tax Incentive refund of $6.788 million in January 2018. Cash outflow reflected investment in the ongoing Phase 2 clinical trial of BNC210 in PTSD and the BNC101 Phase 1 clinical trial in patients with metastatic colon cancer.

Financial Performance: The Group released its half-year report for the six months ending on 31 December 2017. During the year, Bionomics’ lead asset BNC210, in development for the treatment of anxiety disorders, conditions with co-morbid anxiety and stress and trauma-related disorders, made considerable progress towards recruiting the targeted 192 patients in the ongoing Phase 2 clinical trial in PTSD. Bionomics expanded the evaluation of BNC210 in PTSD through a successful, PTSD focused IND submission to the US FDA and by the activation of 20 clinical trial sites in the US, in addition to the 5 clinical trial sites in Australia.

Cash at the end of the half-year was $32,021,177 ($42,873,656 at 30 June 2017) and net cash used in the six-month period was $10,828,011, compared to net cash used of $2,338,900 for the six -month period ended 31 December 2016. Total revenue ($7,168,539) from ordinary activities increased by 1 per cent whereas loss from ordinary activities after tax attributable to members ($8,846,833) decreased by 9 per cent as compared to the same period in the prior year. Revenue consisted of collaboration income, royalties, sales income, rental income and interest income received as a result of ordinary activities. Net operating and investing cash outflows for the period ($12,308,176) were up by 412 per cent as on corresponding period in the prior year.


Milestones (Source: Company Reports)

Outlook: BNC210 Phase 2 PTSD clinical trial data is anticipated in the second half of CY2018.In parallel, Bionomics is progressing ahead with potential partnership/divestment discussions and the monetisation of non-core assets. In addition to evaluating BNC210 partnering, it continues to evaluate opportunities to broaden the development of BNC210. Bionomics also continues to progress well on several early stage ion channel programs targeting pain, depression, cognition, PTSD and epilepsy. Bionomics has built a globally competitive business with integrated drug discovery and development expertise to support strategic partnerships and clinical development of its drug candidates.
 

Outlook (Source: Company Reports)

Stock Performance: BNC210 Phase 2 PTSD clinical trial enrolment is ongoing and data from the clinical trial is anticipated in the second half of CY2018. It is now executing on other ion channel discovery programs within its core areas of expertise of cognition, depression, PTSD and pain, to further demonstrate its skills in drug discovery. Bionomics will continue to invest in its pipeline programs, positioning them for partnering at the appropriate time, in line with its business strategy. The Group has issued 482,744,436 ordinary fully paid securities, 9,559,920 unlisted ESOP Options, 800,000 unlisted EEP Options and 25 Warrants. The Group lately issued 31,250 shares at an issue price of $0.3301 to exercise the options that were issued under the Bionomics Employee Share Option Plan.  Ausbil Investment Management Limited changed its substantial holding from 7 per cent to 8.109 per cent in the Company. With a robust pipeline, assets having the ability to be partnered and clinical progress with BNC210, Bionomics is well placed to attract both new strategic partnerships and recognition in global capital markets, an important objective for 2018. In one year, the stock has been up by 68.12 per cent but it witnessed a dip of 6.5 per cent in the past one week. The stock was again up 4.3% on May 01, 2018 at the back of the latest update. We recommend a “Buy” on the stock at the current market price of $ 0.605, in view of the strategic and transformation initiatives underway.
 

BNO Daily Chart (Source: Thomson Reuters)

Disclaimer
 
The advice given by Kalkine Pty Ltd and provided on this website is general information only and it does not take into account your investment objectives, financial situation or needs. You should therefore consider whether the advice is appropriate to your investment objectives, financial situation and needs before acting upon it. You should seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice) as necessary before acting on any advice. Not all investments are appropriate for all people. Kalkine.com.au and associated pages are published by Kalkine Pty Ltd ABN 34 154 808 312 (Australian Financial Services License Number 425376). The information on this website has been prepared from a wide variety of sources, which Kalkine Pty Ltd, to the best of its knowledge and belief, considers accurate. You should make your own enquiries about any investments and we strongly suggest you seek advice before acting upon any recommendation. Kalkine Pty Ltd has made every effort to ensure the reliability of information contained in its newsletters and websites. All information represents our views at the date of publication and may change without notice. To the extent permitted by law, Kalkine Pty Ltd excludes all liability for any loss or damage arising from the use of this website and any information published (including any indirect or consequential loss, any data loss or data corruption). If the law prohibits this exclusion, Kalkine Pty Ltd hereby limits its liability, to the extent permitted by law to the resupply of services. There may be a product disclosure statement or other offer document for the securities and financial products we write about in Kalkine Reports. You should obtain a copy of the product disclosure statement or offer document before making any decision about whether to acquire the security or product. The link to our Terms & Conditions has been provided please go through them and also have a read of the Financial Services Guide. On the date of publishing this report (mentioned on the website), employees and/or associates of Kalkine Pty Ltd do not hold positions in any of the stocks covered on the website. These stocks can change any time and readers of the reports should not consider these stocks as advice or recommendations.