Australian (ASX) Stock Market Forum

BNO - Bionomics Limited

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Looking for a bump up on any positive BNC210 announcement.
 
Good that market opens at the same level of closing price of yesterday. Very interesting indeed.
Let us hope it stays like that.
 
Miner said:
Good that market opens at the same level of closing price of yesterday. Very interesting indeed.
Let us hope it stays like that.
Click to expand...
So far market has reacted only by -10 %. Should have believed on my own judgement and exited. Time is money and goes either way. :(
 
Thought to share a report from Kalkin on BNO. BTW, Kalkin often recommends shares when they are at top of the range and the consistency of the quality of the report is often junk. That is my opinion. If you are a platinum subscriber then (like me) you get an adviser who tells you not to pay attention to their own reports and instead listen to him/her.
Any bottom line of their recommendation extract which does not tell you on the massive price down over the last two days and put BNO as a HOLD. Funy enough whoever said Buy earlier now reverted to HOLD being too shy to call it SELL
Extract from Kalkin (free trial subscription for 30 days)
" Bionomics Limited

A Quick Look on Strategic Review Outcome and Program Updates: Bionomics Limited (ASX: BNO) is a global, clinical stage biopharmaceutical company. The company recently announced a strategic review outcome and program updates and mentioned that it continues to evaluate out-licensing opportunities and potential merger candidates. Patient enrolment in BNC210 exploratory clinical trial has been completed and top-line data is expected by the end of June 2019. The company is building on learnings from the Phase 2 RESTORE trial and exposure-response analysis. Costs have been further reduced and a capital and debt structure review are being conducted by management. As per the management, the company was unable to find a compelling alternative after extensive discussions with potential counterparties for continuing development and partnering discussions for the assets related to monetising all or part of the Bionomics portfolio of clinical and pre-clinical assets. However, the company will continue to entertain credible proposals in relation to transactions that could add value to shareholders from any source.

Highlights of Quarterly Cash Report and H1 FY19 Financials: As per the Quarterly Cash Report submitted in April 2019, BNO’s cash balance as at 31 March 2019 was $22.1 million. The net operating cash outflow during the quarter amounted to $3.32 million with cash receipts from customers amounted to $1.94 million. Following the completion of BNC210 Phase 2 Clinical Trial in PTSD, the R&D costs reduced by 62%.

Revenue for the company in 1HFY19 including other income stood at $5.29 million as compared to $7.17 million for 1HFY18. The company incurred an operating loss of $11.18 million in 1HFY19 as compared to $8.84 million in 1HFY18 due to continued investment in R&D programs.

What to Expect Moving Forward: Bionomics will continue to assess its strategic options for partnering and portfolio prioritisation whilst conserving cash. While the internal focus and current R&D spend is restricted to CNS programs, Bionomics has continued limited activities to maximise the value of its legacy oncology programs through divestment and/or out-licensing both BNC101 and BNC105. In addition, it is pursuing drug discovery programs in core areas of cognition and pain to therapeutic candidate identification and partnering.

Stock recommendation: At the current market price of $0.125, market capitalization for the stock stands at ~$76.26 million. Looking at the price performance, the stock has risen around 30% on YTD basis whereas it has given negative returns of ~42% in last 3-months. Considering the above factors, the company is positioned to maximise its potential through various strategies in pipeline, going forward. Hence, we give a “Hold” recommendation on the stock at the current market price of $0.125 per share (down 10.714% on 29 May 2019)"
The whole report of recommendation on BNO has made no reference to Merck.
 
Good morning all
At last the reason for trading halt has been published.
BNO needs more money and the trial was not successful. It is the nice articulated story to say the same excepting 'no differential'
https://www.asx.com.au/asxpdf/20190626/pdf/446437xv6rv4c0.pdf
https://www.asx.com.au/asxpdf/20190626/pdf/44643g26gwdr5f.pdf
At times was a passionate holder. Quitted . Came back again just to trade purposes. Quitted again.
After today's note, my confidence level is not the same.
Good luck to holders and prospective holders.
Another 10 minutes market opens and lets see what market sees the report.
 
BNO rebounding off its recent lows after a couple of encouraging announcements.

From their announcement dated 19 September:
Bionomics Limited (ASX:BNO, OTCQX:BNOEF), a global, clinical stage biopharmaceutical company leveraging proprietary platform technologies to discover and develop a deep pipeline of novel drug candidates targeting ion channels, is pleased to announce positive feedback from the FDA at the recent Type C meeting to discuss BNC210 for the treatment of Post-Traumatic Stress Disorder (PTSD). The objective of the meeting was to seek guidance on the plans for further development of BNC210 in a second Phase 2 trial in PTSD patients using the newly developed tablet formulation and aiming for the exposure levels predicted from the pharmacometric analyses to have potential for clinical benefit. The FDA was supportive of the approaches outlined by Bionomics.

Furthermore, following discussions with the FDA, Bionomics has submitted an application for Fast Track designation for BNC210 for the treatment of PTSD. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The application outlines the non-clinical and clinical data for BNC210 showing efficacy in animal models representing symptoms of PTSD, such as anxiety, hyperarousal and fear extinction, and an improved clinical and non-clinical safety and tolerability profile compared to the standard of care therapies for PTSD which are the SSRIs, sertraline and paroxetine.

At the same time, Bionomics is completing a single ascending dose pharmacokinetic study in healthy volunteers to demonstrate that blood levels of BNC210, predicted to be necessary to meet the primary efficacy endpoints in any further trials in PTSD patients, are achievable using the new solid dose formulation. The results of this trial are expected in October 2019.
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From this morning's announcement:
Bionomics Limited (ASX:BNO, OTCQX:BNOEF), a global, clinical stage biopharmaceutical company discovering and developing a deep pipeline of novel drug candidates targeting ion channels, is pleased to announce positive results from a pharmacokinetic study in healthy volunteers using the newly developed solid dose formulation of Bionomics' lead drug candidate, BNC210.

The study demonstrates that the solid dose of BNC210 achieves the blood levels predicted as necessary to meet the primary endpoints for effectiveness for treating Post-Traumatic Stress Disorder (PTSD) patients in future clinical trials.

The study is the culmination of efforts designed to overcome the failure of the liquid suspension formulation to provide sufficient blood exposure for efficacy in the Phase 2 PTSD trial, RESTORE, that read out in October 2018.As reported on 18 February 2019, the liquid suspension formulation of BNC210 used in the RESTORE trial was required to be taken with food, gave variable absorption and consequently lower exposure than expected. However, a pharmacometric analysis of the PTSD trial data showed an exposure-response relationship (between BNC210 blood levels and CAPS-5 scores, the primary endpoint measure in PTSD trials),and the potential of BNC210 to treat PTSD symptoms provided that adequate blood levels couldbe achieved(Area Under the Curve or AUC ~25 mg.h/L).

These new pharmacokinetic data from the single ascending doses of BNC210, along with data reported earlier this year demonstrating that the solid dose formulation can overcome the “food effect”,show that the solid dose formulation of BNC210 can reach blood levels required to achieve exposures predicted to give clinically meaningful and statistically significant changes from placebo on Total CAPS-5 scores (Table 1). The plasma concentrations and exposures measured in fasted healthy volunteers also increased in a dose proportional manner, demonstrating improved dose linearity with the solid dose formulation compared to the liquid suspension (Figure 1).

BNC210 was well tolerated at the exposure levels reached in the healthy volunteers in this study.

Bionomics recently attended a supportive Type C meeting with the FDA to discuss the further development of BNC210 using the solid dose formulation for the treatment of PTSD and subsequently submitted a request for Fast Track designation for BNC210.

The results of this pharmacokinetic clinical trial show that the new solid dose formulation achieves the targeted blood levels to support further development of BNC210 for the treatment of PTSD.
Click to expand...

So some quick points:

1. Positive feedback from the FDA at the recent Type C meeting to discuss BNC210 for the treatment of Post-Traumatic Stress Disorder.
2. Bionomics has submitted an application for Fast Track designation for BNC210 for the treatment of PTSD.
3. The single ascending dose pharmacokinetic study detailed in the 19 September announcement has produced positive results with the solid dose of BNC210 achieving the blood levels predicted as necessary to meet the primary endpoints for effectiveness for treating Post-Traumatic Stress Disorder (PTSD) patients in future clinical trials.

Things are certainly looking a little more positive for BNC210 after the last couple of announcements. Will be interesting to see the results of the application for Fast Track designation for BNC210.

big.chart-BNO.gif
 
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greggles great news!

ASX announcement today
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The U.S. FDA granted Fast Track designation to the BNC210 development program for the treatment of Post-Traumatic Stress Disorder (PTSD) and other trauma-related and stressor-related disorders.

Fast Track designation is an FDA program intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

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548
 

Attachments

  • FDA Grants Fast Track Designation to BNC210 PTSD Program.pdf
    91.1 KB · Views: 4
Last edited:
I'm taking BNO in the 2022 yearly comp. They have a number of treatments being developed, BNC210 currently undergoing Phase 2 trials for PTSD and SAD (Social anxiety disorder). they also have some partnerships with Merck in the US for cognitive impairment in Alzheimer’s disease. They are currently well funded and I expect their share price to increase as anticipation rises for the outcomes of the Phase 2 trials toward the end of 2022.
 
solid unloading of stocks by substantial holders has reflected the price to reach at the bottom to go up.
all the reports have helped to reduce the price. Lets see what happens in Feb 22



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BNO luck did not do any favour with joining the new CEO and outcome of Phase 2 result - SAD became really sad considering not just share price but also for patients received treatment without outcome and with a possible unknown effect from the administering the treatment.

Market bashed the cash starving company further

ASX ANNOUNCEMENT 19 December 2022 Bionomics Reports Topline Results in PREVAIL Phase 2 Study of BNC210 in Social Anxiety Disorder  BNC210 for Treatment of Social Anxiety Disorder (SAD) Did Not Meet Primary Endpoint  Subjects with Confirmed SAD who Received BNC210 Exhibited Trends Toward Improvements Across Endpoints Compared to Placebo  BNC210 Demonstrated Favourable Safety and Tolerability Profile Consistent with Prior Experience  Company is Continuing Analysis of the Data and Evaluating Next Steps with Cash Runway into mid-2024

ASX ANNOUNCEMENT 16 December 2022 Bionomics appoints Spyridon “Spyros” Papapetropoulos as President and Chief Executive Officer Experienced biotech executive to lead the next phase of growth Bionomics Limited (ASX: BNO, Nasdaq: BNOX), (Bionomics or the Company) 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, today announced that it has appointed Spyridon “Spyros” Papapetropoulos, M.D. as President and Chief Executive Officer (CEO), effective 5 January 2023. Errol B. De Souza, Ph.D., who has been serving as Bionomics’ Executive Chairman since November 2018, will continue in his role through 31 December 2022 to ensure a seamless transition, and will resume the role of Non-Executive Chairman of the Board of Directors effective 1 January 2023
 
about 6 months from my last posting.
Nothing has changed for BNO as far as shareholders' return is concerned.
Some announcements and that's all.
Citi Group slowly unloading by one percent with each announcement. Averaging the losses?
Worse fear came with the ASX query on 9 March.
If I visit this thread after 6 months, the price will probably around same level as today. Who knows ? would there be any announcement but none of the researches will excite market now a days
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Attachments

  • Response-to-ASX-Price-Query.PDF
    245.7 KB · Views: 3
  • Change-in-substantial-holding (2).PDF
    81.3 KB · Views: 2
  • BNO-announces-establishment-of-At-The-Market-Equity-Program.PDF
    958.1 KB · Views: 2
 
I was initially thrilled to see my tip at the second top on the second day of trading.
However on a detailed look, I was shocked to see how could one single trade has hijacked the closing price indicator
I do like to rise on the tip ladde, with conviction but never on a gain of one trade to equate the way Aussies made the English cricketer out. Both are legal but to me both were unfair.
So I will wait to see what Wednesday and onwards days trades are looking like

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Attachments

  • Bionomics-Announces-Key-Leadership-Updates.PDF
    284.8 KB · Views: 2
Craton said:
Up She, He, It pops... surely these are just idioms? :)



Good call Miner.
I see this as one of the closely followed and very volatile stocks that are worth the investment (cough, read punt) on the cycle. Always easy to say in low, out high but for me, this has been a great training stock as I don't have a preconceived holding strategy i.e. short, mid, long term. It's purely for trading when the opportunity presents. :xyxthumbs
Click to expand...
Thread carefully with health start up (researches). Had 99% skin burnt with this type of stocks for too many years to mention. An example, Only yesterday, I read somewhere that AT1 sp had shot up. Bring back all my sad memories, watching my hard earned went down the sink hole. Had owned AT1 from day 1 until 3yrs ago, had to bite the bullet and let it died.
 
Miner said:
I was initially thrilled to see my tip at the second top on the second day of trading.
However on a detailed look, I was shocked to see how could one single trade has hijacked the closing price indicator
I do like to rise on the tip ladde, with conviction but never on a gain of one trade to equate the way Aussies made the English cricketer out. Both are legal but to me both were unfair.
So I will wait to see what Wednesday and onwards days trades are looking like
Click to expand...
... enjoy it while it lasts, miner.

Screenshot_20230705-111330_CommSec.jpg

Not entirely sure the Ashes saga is an equivalent. But, we won't boo you if your tip holds. At least I won't.
 

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