I just want you all to know that I read the phase 2 study report and found it really interesting. So interesting in fact that I spent all bloody day tapping out some analysis on it on the side whilst at work.

I went to post it... but my hot spot had dropped out.... end result. I lost what was arguably my best write up ever.

So here is a condensed summary.

Anxiety is very prevalent, their new drug showed some efficacy in helping people with anxiety perform in anxiety inducing tasks. They measured this success using 'SUDS', however the aim of the study was partly to evaluate whether using SUDS is the best way to measure the effectiveness of this drug.

It did not meet the endpoint, yet combined data did show some interesting results and moving forward this is how they are going to measure the outcomes for the phase 3. The cynic in me think are they measuring in this manner to massage the results, or is that genuinely a better way to measure.

In summary. I found the study to be a really interesting read, well constructed, repeatable and well presented.

I am in no rush to buy, in fact I cant even recall why I signed up for the notifications on the company in the first place, but I will be following more closely now. I will also be paying better attending to my hotspot connectivity.

Shoot me.

An ASX update saying that they just got $2 million in R&D tax refund. This compares to about $6 million in operating cash outflows for the quarter and $22 million for the year (according to their recent 4C). They've got about $34 million in the bank.

They are expecting the first data from their Social Anxiety Disorder (SAD) trial by the end of this calendar year, and the first data from their PTSD trial in 1H23, by which I think they mean the first half of the calendar year 2023.

So I suspect that a capital raise will happen early next year if the SAD trial is looking good, and maybe May/June if not.

(Disc: held)

As @MattBricks pointed out, they are looking to start a new Phase 2 trial investigating the use of their drug BNC210 for "Social Anxiety Disorder" (SAD). This is in ASX announcement 20/9/21. [I can't seem to figure out how to put links in my posts.]

Similar to the story for the BNC210 trial for PTSD, the company thinks that the new tablet form of the drug will give better outcomes than the liquid form that they used in their last study. Apparently, the liquid formula was absorbed too slowly and it needed to taken with food, so it was not as effective as they hoped. But the tablet formula is absorbed quickly (45 mins to 105 mins) and so could work well. They want to get the trial underway by the end of the year, recruiting 150 patients in the US, and reporting results in late 2022.

(Disc: held).

Quarterly Activities and Cashflow Report

Bionomics Limited (ASX: BNO, OTCQB: BNOEF), a global, clinical stage biopharmaceutical company, today released its Appendix 4C - Quarterly Cashflow Report. During the quarter and up to the date of this announcement:

• On 6 April 2021, the Company announced the successful completion of its 1 for 6 pro rata non?renounceable Entitlement Offer and Concurrent Placement which collectively raised $22.9 million.

  The Entitlement Offer raised $20.4 million and 140,924,683 million new fully paid ordinary shares in Bionomics (“New Shares”) were issued on 8 April 2021, at the offer price of $0.145 per New Share.

  The Entitlement Offer was well supported by eligible shareholders who applied for approximately 85.6 million shares aggregating to $12.4 million of New Shares pursuant to their entitlements (representing a take up rate of approximately 60.7%).

  Eligible shareholders subscribed for a further 70.3 million additional New Shares in excess of their entitlement (up to a maximum of 100% of their entitlement) aggregating to $10.2 million in excess of their entitlement through the Oversubscription Facility. Applications under the Oversubscription Facility were in excess of the approximately 55.3 million shares or $8 million shortfall and were scaled back in accordance with the terms of the Entitlement Offer on a pro rata basis.

  The Concurrent Placement which was made on substantially the same terms as the Entitlement Offer raised $2.5 million and 17,228,346 million new fully paid ordinary shares in Bionomics (“New Concurrent Shares”) were issued on 8 April 2021, at the offer price of $0.145 per New Concurrent Share. New Concurrent Shares applied for under the Concurrent Placement were scaled back on a pro rata basis in the same manner as shareholders who applied under the Entitlement Offer.

• On 3 May 2021, the Company announced that it had prepaid all amounts outstanding of its Debt Obligations to further improve its balance sheet.

  Bionomics’ external Debt Obligations accounted for AUD$6,155,674 in combined principal outstanding, consisting of:

  Bank loan, denominated in US Dollars, (at 31 March 2021 the principal amount outstanding was AUD$5,982,711) with the final monthly repayment due 1 January 2022; and

  Equipment loan, (at 31 March 2021 the principal amount outstanding was AUD$172,963) with the final monthly repayment due 19 March 2023.

  Early repayment resulted in AUD$98,537 in overall savings to the Company and terminated all commitments and obligations under the loan agreements.

• On 10 May 2021, the Company announced that as part of its broader pipeline expansion strategy and based on anti-anxiety efficacy signals in Generalised Anxiety Disorder (GAD) patients, it has decided to proceed with evaluating its lead clinical compound, BNC210, for an acute treatment in Social Anxiety Disorder (SAD) while progressing toward the start of its planned Phase 2b trial in Post-Traumatic Stress Disorder (PTSD) in the middle of this year.

• On 25 May 2021, the Company provided an updated Corporate Presentation following the successful capital raisings completed during April 2021 and subsequent pipeline expansion activities.

• On 7 June 2021, the Company announced that effective 21 June 2021 the Company’s Registered Office and Principal Place of Business address will change to 200 Greenhill Road, Greenwood, South Australia 5063 (Tel: +61 8 8354 7400).

• On 1 July 2021, the Company announced that Mr Miles Davies had been appointed Non- Executive Director to the Board of Bionomics Limited. Mr Davies replaced Dr. Srinivas Rao as the second Board nominee of Apeiron Investment Group Ltd (“Apeiron”) under the Subscription Agreement dated 1 June 2020 between the Company and Apeiron.

• On 1 July 2021, the Company also announced that Dr Errol De Souza would continue in the role of Executive Chairman from 1 July 2021 under a new Employment Agreement.

• On 6 July 2021, the Company announced it had initiated a Phase 2b trial (the ATTUNE Study) to evaluate the tablet formulation of BNC210 in patients with Post-Traumatic Stress Disorder (PTSD) with top-line results expected in 1H 2023.

  The ATTUNE Study is a randomised, double-blind, placebo-controlled, multi-centre Phase 2b clinical trial with a 12-week treatment period. The primary objective is to compare BNC210 to placebo on the improvement in PTSD symptom severity as measured by the Clinician Administered PTSD scale for DSM-5 (CAPS-5) following 12 weeks of treatment. In addition to the clinician evaluation of PTSD symptom severity, there are a number of secondary objectives to measure patient-reported symptoms of PTSD, changes in anxiety and depression symptoms, and global and social functioning in the study participants. An oral tablet formulation of BNC210, showing much improved absorption over the previous liquid suspension formulation, will be evaluated in this study. The dose of BNC210 (900 mg twice daily) was selected based on achieving exposure levels that are predicted from a pharmacometric blood exposure-CAPS-5 response model, built on a previous BNC210 trial data set (RESTORE), as necessary to meet the primary endpoints for effectiveness for treating PTSD patients in clinical trials.

• Cash balance at 30 June 2021 was $28.50 million (31 March 2020: $20.34 million).

• Research & development expenditure for the quarter increased to $1.53 million from $1.30 million compared with the previous quarter, that is, an increase of 17.7%. Details of the research & development activities are summarised in the Activity Report below.

• For the purpose of Listing Rule 4.7C.3, Directors were paid during the quarter $121,000 in director fees and in addition the Executive Chairman was paid $120,000 in consulting fees and $5,000 for reimbursement of health benefit insurance in accordance with the consulting agreement, and $352,000 as a bonus for the year ended 30 June 2021.

Upcoming Milestones:

• Update on the progress of patient enrolment in the BNC210 PTSD Phase 2b ATTUNE Study

• Further Company guidance on trial design and timelines for a Phase 2 trial of BNC210 as an acute treatment in Social Anxiety Disorder

• Submission of an Investigational New Drug (IND) to the U.S. FDA Application for Social Anxiety Disorder

• Release of Full Year (FY2021) Statutory Accounts

• Announcement of the date of and Notice of the Annual General Meeting/Proxy Form

• Bionomics Annual Report 2021

• Errol De Souza presenting at the H.C. Wainwright 23rd Annual Global Investment Conference during 13-15 September 2021

• Receipt of R&D Tax Incentive Refund

Bionomics Announces Planned Capital Distribution to Shareholders

Bionomics Limited (ASX: BNO, OTCQB: BNOEF), (Bionomics) a global, clinical stage biopharmaceutical company, refers to its announcement to ASX today titled “Bionomics Announces Plans to Conduct U.S. Initial Public Offering”.

Bionomics advises that it is expecting to propose, in connection with and prior to any such proposed U.S. offering, to make a capital distribution representing an economic interest in the net after tax royalty payments (if any), received by Bionomics under its exclusive Research Collaboration and License Agreement with Merck & Co (known as MSD outside the U.S. and Canada) relating to BNC375 and related compounds. This capital distribution will be distributed as a financial asset, on a per share basis, to shareholders holding Bionomics shares on a record date to be set prior to the proposed U.S. offering. The precise form of the financial asset is yet to be determined.

Bionomics expects that the distribution, should it take place, would be implemented by way of an equal capital reduction and a scheme of arrangement, requiring shareholder and court approvals.

Bionomics will advise further information concerning the distribution in due course. There is no certainty that the distribution will take place.