Quarterly Activities Report for June 2022

Rhea-AI Summary

Bionomics Limited (BNOX) released its Quarterly Activities and ASX Appendix 4C Cashflow Reports for the quarter ending June 30, 2022. Cash balance was $33.56 million, down from $39.58 million in the previous quarter. R&D expenditure rose by 84.14% to $4.18 million, driven by ongoing Phase 2 trials for BNC210 in treating Social Anxiety Disorder (SAD) and Post-Traumatic Stress Disorder (PTSD). Upcoming milestones include topline data for both studies expected by the end of 2022 and the first half of 2023, respectively.

Positive

• Successful recruitment efforts for the ATTUNE and PREVAIL studies are underway, with multiple clinical sites open.
• Strategic collaboration with Carina Biotech is progressing, aiming for a first-in-human clinical trial.

Negative

• Cash balance decreased by 15.6% from the previous quarter, potentially indicating financial strain.
• R&D expenses increased significantly, raising concerns over future financial sustainability.

ADELAIDE, Australia, July 29, 2022 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX | ASX: BNO) (Bionomics or Company), a global, clinical stage biopharmaceutical company, today released its Quarterly Activities and ASX Appendix 4C Cashflow Reports. Highlights during the Quarter ended 30 June 2022 (Quarter) and up to the date of this announcement include: 

• On 6 April 2022, Bionomics’ Executive Chairman, Dr. Errol De Souza, participated in a Fireside Chat hosted by Berenberg Capital Markets analyst Esther Hong to discuss the ongoing BNC210 Phase 2 Social Anxiety Disorder (SAD) PREVAIL, and Post-Traumatic Stress Disorder (PTSD) ATTUNE, trials.
• On 29 April 2022, Bionomics released its Appendix 4C – Quarterly Cashflow Report for the quarter ended 31 March 2022.
• On 16 May 2022, Bionomics announced that it would be participating in three upcoming investor conferences including:
  • Citibank Biotech’s Mood Disorders/Mental Health Panel, 18 May 2022
  • Berenberg Capital Markets’ Emerging Biotech Conference, 19 May 2022
  • H.C. Wainwright’s Global Investment Conference, 24-27 May 2022.
• On 15 June 2022, Bionomics held a virtual investor webinar with Executive Chairman Dr. Errol De Souza and Vice President of Strategy and Corporate Development Mr. Connor Bernstein.  The presentation covered Bionomics’ ongoing Phase 2 trials for SAD and PTSD and the pressing need for new treatments for patients suffering from these disorders. The presenters also discussed the Company’s near-term milestones and goals for 2022 and beyond.
• The Company’s cash balance on 30 June 2022 was $33.56 million (31 March 2021: $39.58 million).
• Payments for research & development expenditure during  the Quarter increased to $4.18 million from $2.27 million compared with the previous Quarter, that is, an increase of 84.14%, primarily associated with the ATTUNE and PREVAIL Studies.  The ATTUNE Study is evaluating the oral tablet formulation of BNC210 compared to placebo in approximately 200 PTSD patients in the U.S. There are 25 clinical sites open and recruitment of trial participants is underway.  The PREVAIL Study is evaluating two doses of the oral tablet formulation of BNC210 compared to placebo as an acute treatment for SAD in approximately 150 patients in the U.S. There are 14 clinical sites open and recruitment of trial participants is underway.

For the purpose of ASX Listing Rule 4.7C.3, the Executive Chairman was paid during the Quarter $191,000 in consulting fees and $8,000 for reimbursement of health benefit insurance in accordance with the consulting agreement, and the other Directors were paid during the Quarter $82,000 in directors’ fees.

Activity Report

·During Q4 FY2022 Bionomics continued to closely manage both of its ongoing ATTUNE and PREVAIL clinical studies. These efforts included over-seeing the recurring Independent Safety Review Committee meetings for the ATTUNE study and working with the Contract Research Organisation (“CRO”) to maximize the ongoing study enrollments, an effort that has been made increasingly challenged by pandemic restrictions. The Company also continued to manage its Chemistry Manufacturing and Control (“CMC”) and toxicology activities related to development of BNC210 for future planned studies. In the ongoing effort to develop a commercial strategy, Bionomics contracted with Bluestar BioAdvisors to gain further insights into the U.S. market potential for BNC210 as a treatment for PTSD and SAD, the results of which the Company plans to share more details of in the coming quarters.  Bionomics’ strategic collaboration partner, Carina Biotech (Carina), which licensed BNC101 for the development of Chimeric Antigen Receptor T cell (CAR-T) therapy, announced it had appointed Australian organisation Cell Therapies to undertake Good Manufacturing Processes (GMP) manufacture of its LGR5 CAR-T cells for a first-in-human clinical trial.  Carina also announced that it had submitted its pre-IND application in March of this year and is on track to file an IND application with the FDA in the second half of 2022  Finally, while the Company has sufficient cash runway to complete the ATTUNE and PREVAIL Studies the Company continues to monitor its expenditures while taking several measures to preserve its cash on hand given the current capital markets landscape.

Upcoming Milestones

• Release of Full Year (FY2022) Statutory Accounts
• Announcement of the date of and Notice of the Annual General Meeting/Proxy Form
• Bionomics 2022 Annual Report
• Receipt of R&D Tax Incentive Refund
• Topline data for BNC210 PREVAIL study in SAD expected YE’22
• Topline data for BNC210 ATTUNE study in PTSD expected 1H’23

A copy of the full release, including a copy of the ASX Appendix 4C Cashflow Report can be found on the Company's website.

FOR FURTHER INFORMATION PLEASE CONTACT:

General: Ms Suzanne Irwin Company Secretary +61 8 8150 7400 CoSec@bionomics.com.au

Investor Relations: Mr Connor Bernstein Vice President, Strategy and Corporate Development +1 (831) 246-3642 cbernstein@bionomics.com.au

About Bionomics Limited
Bionomics Limited (ASX: BNO, Nasdaq: BNOX) is a clinical-stage biopharmaceutical company 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. 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.

www.bionomics.com.au

FAQ

What is Bionomics' cash balance as of June 30, 2022?

Bionomics had a cash balance of $33.56 million as of June 30, 2022.

What are the upcoming milestones for Bionomics in 2022?

Bionomics expects topline data for the BNC210 PREVAIL study by the end of 2022 and the ATTUNE study in the first half of 2023.

How much did Bionomics spend on R&D in the latest quarter?

Bionomics' R&D expenditure for the quarter rose to $4.18 million, an increase of 84.14%.