OUR NEW PROFILE IS: (NASDAQ: BNOX)
BNOX Has Closed Green the Last 3 Sessions and has Made a Strong Move Up
The Company’s cash balance on 30 June 2023 was $18.25 million
READ THE INVESTOR PRESENTATION HERE
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Hello Everyone,
We have another brand new profile that we have never featured on this newsletter before.
This is a company that has been on the move over the last 3 sessions, moving from 1.27 to over 2 bucks.
Pull up BNOX immediately.
Bionomics (ASX:BNO, NASDAQ:BNOX) is a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (“CNS”) disorders with high unmet medical need. Bionomics is advancing its lead drug candidate, BNC210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute treatment of Social Anxiety Disorder (SAD) and chronic treatment of Post-Traumatic Stress Disorder (PTSD). Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions. Bionomics’ pipeline also includes preclinical assets that target Kv3.1/3.2 and Nav1.7/1.8 ion channels being developed for CNS conditions of high unmet need.
Bionomics also is 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.
Ion channels serve as important mediators of physiological function in the CNS and the modulation of ion channels influences neurotransmission that leads to downstream signaling in the brain.
The α7 nicotinic acetylcholine (“ACh”) receptor (“α7 receptor”) is an ion channel that plays an important role in driving emotional responses and cognitive performance.
Utilizing their expertise in ion channel biology and translational medicine, they are developing orally active small molecule negative allosteric modulators (“NAMs”) and positive allosteric modulators (“PAMs”) of the α7 receptor to treat anxiety and stressor-related disorders and cognitive dysfunction, respectively.
BNOX‘s expertise and approach have been validated through their June 2014 research collaboration and license agreement with Merck & Co. for their α7 receptor PAM program, which targets a receptor that has garnered significant attention for treating cognitive deficits.
This partnership enables them to maximize the value of their ion channel and develop transformative medicines for patients suffering from cognitive disorders such as Alzheimer’s disease.
BNC210
Bionomics is advancing its lead product candidate, BNC210, an oral, proprietary, selective NAM of the α7 receptor, for the acute treatment of Social Anxiety Disorder (“SAD”) and chronic treatment of Post-Traumatic Stress Disorder (“PTSD”). There remains a significant unmet medical need for the over 22 million patients in the United States alone suffering from SAD and PTSD.
BNC210 Holds the Potential to Addresses the Shortcomings of Existing Therapies
There is a significant need for improved therapeutics for SAD and PTSD with improved efficacy and response rates, fewer side effects and a faster onset of action, which we believe may be achieved by targeting a different mechanism of action.
Bionomics Completes Last Patient Last Visit in the Phase 2b ATTUNE Study for Post-Traumatic Stress Disorder (PTSD) and Confirms Expected 2023 Milestones with its Lead Asset BNC210
- The last patient last visit has been completed in the Phase 2b ATTUNE study of BNC210 for the treatment of PTSD
- Topline results from Phase 2b ATTUNE study of BNC210 in patients with PTSD are expected by the end of September 2023
- An end-of-phase 2 (EoPh2) meeting with the U.S. Food and Drug Administration (FDA) has been scheduled for September 2023 to review results from the Phase 2 PREVAIL study in patients with Social Anxiety Disorder (SAD) and to obtain feedback on a proposed Phase 3 registrational program
- Bionomics is scheduled to delist from the Australian Securities Exchange on 28 August 2023
ADELAIDE, Australia, and CAMBRIDGE, Mass., Aug. 23, 2023 (GLOBE NEWSWIRE) — Bionomics Limited (Nasdaq: BNOX | ASX: BNO) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (“CNS”) disorders with high unmet medical need, today announced that the last patient last visit has been completed in its Phase 2 ATTUNE study in PTSD, and disclosed timing of the End of Phase 2 (EoPh2) meeting to review advancing BNC210 into Phase 3 program in patients with SAD.
“We continue our strong momentum with our fast track designated BNC210, with a robust clinical and regulatory milestone-rich year in both SAD and PTSD, two highly prevalent neuropsychiatric disorders with significant unmet needs,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “I would like to thank study participants, their families, our clinical site investigators and their staff and our clinical team for their contributions towards achieving completion of the ATTUNE study. We also look forward to our EoPh2 meeting with the FDA next month, where we will discuss our promising results from the PREVAIL study in SAD and the proposed Phase 3 clinical program.”
The Phase 2b ATTUNE study (NCT04951076) is a double-blind, placebo-controlled, randomized study of twice daily BNC210 as monotherapy treatment for PTSD. The primary endpoint is change in a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity scores from baseline to week 12 compared to placebo. Secondary endpoints include change from baseline to week 12 compared to placebo on the PTSD-checklist (PCL-5), anxiety (Hamilton Anxiety Rating Scale, HAM-A), depression (Montgomery-Asberg Depression Rating Scale, MADRS), Clinician Global Impression (CGI), Patient Global Impression (PGI), sleep (Insomnia Severity Index, ISI) and disability (Sheehan Disability Scale, SDS) scales. Approximately 200 participants have been enrolled at 27 sites in the United States and 7 sites in the United Kingdom, and topline results are anticipated by the end of September 2023.
The EoPh2 meeting to discuss advancing BNC210 into Phase 3 development as an acute treatment for SAD has been scheduled for mid-September 2023. At this meeting, Bionomics will discuss with the FDA its plans for a Phase 3 program that would support the submission of a new drug application for BNC210 for the treatment of SAD. The Company believes that the results from Phase 2 PREVAIL study support the progression of BNC210 into Phase 3 and plans to provide an update by the end of 2023 following the receipt of formal meeting minutes from the FDA.
Additionally, Bionomics is scheduled to delist from the Official List of the Australian Securities Exchange on 28 August 2023. The Company will remain an Australian incorporated company and will maintain its listing of ADSs on Nasdaq under the trading symbol ‘BNOX’.
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Near Term Clinical and Regulatory Milestones Anticipated
- Q3’23: Topline data from placebo-controlled Phase 2b ATTUNE study of BNC210 in PTSD
- 2H’23: FDA End of Phase 2 meeting to discuss registrational program for BNC210 in Social Anxiety Disorder
- Q4’23 / Q1’24: Potential for first patient dosed in Phase 3 study of BNC210 in Social Anxiety DisorderPartnerships and Collaborations Support Early-Stage Programs
- Merck partnership for Phase 1 candidates targeting cognitive deficits in Alzheimer’s and other CNS disorders
- Memorandum of understanding with EmpathBio for feasibility assessment of EMP-01 (MDMA derivative) & BNC210 for PTSD treatment
- Other partnering opportunities include preclinical assets targeting potassium (Kv) and sodium (Nav) ion channels
Bionomics Highlights
- Targeting Social Anxiety Disorder (SAD), Post-Traumatic Stress Disorder (PTSD) and cognitive dysfunction associated with Alzheimer’s disease, schizophrenia and other CNS conditions
- Large underserved markets with over 25 million patients in the US alone suffering from SAD and PTSD and no new FDA approved therapies in nearly two decades
- BNC210 (negative allosteric modulator of the α7 nicotinic acetylcholine receptor)
- Clinical proof of concept in Generalized Anxiety Disorder (GAD2) and panic attack model
- In Phase 2 PREVAIL trial with FDA Fast Track designation for acute treatment of SAD
- In Phase 2b ATTUNE trial with FDA Fast Track designation for treatment of PTSD
- Partnerships & Collaborations
- Strategic partnership with Merck for treatment of cognitive deficits in Alzheimer’s and other CNS disorders
EXISTING PARTNERSHIPS
Merck α7 receptor PAM Collaboration
- In June 2014 Bionomics entered into in 2014 to develop α7 receptor PAMs targeting cognitive dysfunction associated with Alzheimer’s disease and other central nervous system conditions
- Merck funds all R&D activities including clinical development and worldwide commercialization of any products from collaboration
- Payments received: US$20M upfront and US$10M for Phase 1 milestone
- Eligible to receive up to US$465M in additional milestone payments plus royalties
Exclusive BNC101 Oncology License Agreement for the Development of CAR-T Therapeutics
In 2020 Bionomics announced that it has entered into an exclusive Agreement to license Bionomics’ BNC101 oncology drug candidate to Carina Biotech (Carina), for the development of Chimeric Antigen Receptor T cell (CAR-T) therapy, which harnesses the body’s immune system to fight cancer.
Under the worldwide, exclusive License Agreement, Carina will fund all research and development activities. Bionomics is eligible to receive up to A$118 million in clinical & development milestones plus royalty payments if Carina fully develops and markets the new therapy. In the event that Carina sub-licenses the CAR-T treatment, Bionomics is eligible to share in the sub-licensing revenues in early clinical development and receive a substantial double-digit portion of the revenues in later stages of clinical development.
In September 2021, Carina announced that it plans to initiate a clinical trial of BNC101 CAR-T therapy for the treatment of advanced colorectal (bowel) cancer in late 2022.
NEWS
MANAGEMENT TEAM
Spyridon “Spyros” Papapetropoulos, M.D., PhD President & Chief Executive Officer
Spyros is an experienced biopharmaceutical executive, a recognized neuroscientist/neurologist, and change agent with a 25-year career focused on CNS disorders. He held various positions of increasing responsibility at CNS-focused start-up/small, medium specialty and large biopharma companies. Prior to joining Bionomics Ltd. he served as Chief Medical Officer of Vigil Neuroscience Inc, (NASDAQ: VIGL), as Chief Development Officer, and SVP, Head of Clinical Development at Acadia Pharmaceuticals Inc (NASDAQ: ACAD)., CEO at SwanBio Therapeutics, and EVP of Research & Development and Chief Medical Officer at Cavion Inc. Before Cavion, he held senior/executive positions at Biogen Inc., Allergan plc, Pfizer Inc., and Teva Pharmaceuticals Inc. Spyros has filed multiple INDs and has overseen a broad spectrum of CNS biopharmaceutical development programs (small molecules, biologics, gene therapy), leading to successful regulatory filings (20+ INDs and multiple NDAs/BLAs) and new product approvals and launches worldwide.
Mr Adrian Hinton BEc, FCA
Financial Controller
Mr Hinton has had a long career with Deloitte (Adelaide) of over 43 years, retiring 1 July 2018 as Principle in the Audit and Assurance Group. He was responsible for managing the audit services to various Adelaide based public and private companies. His experience has given Mr Hinton a broad-based knowledge of contemporary accounting and audit issues inclusive of experience in working with a wide range of clients in different industries, from listed entities, private corporations to major subsidiaries of multinational listed companies, covering consumer, agriculture, retail, manufacturing, automotive, biopharmaceutical and resources sectors. Mr Hinton also has experience in preparing due diligence reviews, investigative accounting reports and the review of profit forecasts. Mr Hinton’s experience is currently benefited by being on the Boards of The Multiple Sclerosis Society of South Australia and Northern Territory, Carers Association of SA Inc, Australia PNG Alliance Group Pty Ltd and the Audit and Risk Committee of the University of South Australia. Mr Hinton also volunteers his time and skill set to aiding community groups both locally and internationally.
Vice President Clinical Development
Ms Doolin has over 25 years international experience in drug discovery, clinical and life sciences research. She joined Bionomics Limited in 2008 to lead the early clinical development program for BNC210, a small molecule with therapeutic potential for anxiety disorders, and trauma and stressor-related disorders including PTSD. Ms Doolin currently leads Bionomics’ clinical programs across central nervous system disorders and oncology, including three novel investigational drugs in Phase 1 and 2 clinical development. In addition to her extensive clinical research experience in Australia, Ms Doolin has a strong immunology and biotechnology research background, as well as biopharmaceutical development and GMP manufacturing experience, gained in New Zealand and the UK.
Julie Kerner PhD SVP Business Operations
Julie is a biotech leader and enterprise thinker with 15+ years of drug development from early research through commercialization. Under her leadership, companies created portfolio and platform strategies, filed 10+ IND/CTAs, conducted proof of concept and Phase 3 trials, and launched multiple therapeutics. Most recently, Julie worked at Fulcrum Therapeutics and Aliada Therapeutics driving pipeline strategy and program leadership. Prior to that, she worked at AVROBIO, Wave Life Sciences, and Biogen working across R&D, Marketing, and early product planning. Before she joined industry, Julie earned a PhD in Neuroscience at Tufts Medical School and was a market analyst at Decision Resources, writing over 10 reports on neurodegeneration, psychology, and pain. Julie is committed to patient centricity and advocacy, sitting on the boards of Newton Wellesley Hospital, National Braille Press, and the US Neuroacanthocytosis advocacy, Inc.
Dr. Atul R. Mahableshwarkar MD Acting CMO
Dr. Mahableshwarkar is a seasoned Pharma Executive with strategic, developmental and regulatory experience in large global and small startup companies who has submitted INDs and NDAs leading to drug approvals. He is a Board Certified Psychiatrist, who graduated from the Armed Forces Medical College in India and completed a residency in Psychiatry and a fellowship in Neuropsychiatry from The Rosalind Franklin University of Health Sciences/The Chicago Medical School where he was an Associate Professor and Vice Chair of the Department of Psychiatry and Behavioral Sciences and also the Leader of the Mental Health Services Product Line at the North Chicago VAMC where he managed the mental health care to veterans at a hospital with over 800 inpatient beds. He’s had leadership roles as CMO and SVP/VP/Senior Director at small and large companies including Emalex Biosciences, BlackThorn Therapeutics, and Takeda. Dr. Mahableshwarkar has over 180 scientific publications, posters, and oral presentations with a track record of guiding programs to successful outcomes.
Mr. Tim Cunningham MBA
Chief Financial Officer
Mr. Cunningham has served as a Chief Financial Officer Consultant at Danforth, a strategic finance and operations firm with a focus on life sciences companies, since September 2020, where he provides chief financial officer consulting services to both public and private pharma and biotechnology companies. Prior to joining Danforth, Mr. Cunningham served as Chief Financial Officer at Organogenesis (NASDAQ:ORGO), where he took the company public and raised over US$250M in equity and debt financing to facilitate the company’s growth. He has held leadership positions with several different public and private companies over the course of his career, which began at KPMG in NY followed by PwC Boston. Mr. Cunningham holds an MBA from Boston University, a BS in Accounting from Boston College and is a CPA in the state of Florida.
Sincerely,
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