Bionomics Ltd (PK) (BNOEF) Quote

BNOX new 52 week low

$BNOX Positive Results

webcast confirmed idea of cannabis use in the new phase 3 FDA trial

Main focus is liver function, close monitoring consumption of alcohol, all will be topics of ongoing discussion

Confirmed a $500 million partnership with Merck and collaboration PTSD

BNOX

https://x.com/CochiseSunrise/status/1818630418628800764

Bionomics Announces Successful End-of-Phase 2 Meeting with the FDA on the Development of BNC210 in Post-Traumatic Stress Disorder
Successful End-of-Phase 2 (EoP2) meeting with U.S. Food and Drug Administration (FDA) provides a potential path to New Drug Application (NDA) submission for BNC210 for post-traumatic stress disorder (PTSD) with a single Phase 3 trial
Company received favorable FDA feedback on the Phase 3 study design and safety monitoring plans required for registration
Company plans to initiate the Phase 3 program in Q4 2024
A conference call and webcast presentation to discuss the outcomes will be held today at 8:00 a.m. ET, details below
ADELAIDE, Australia and CAMBRIDGE, Mass., July 31, 2024 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX) (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 the favorable outcomes of an EoP2 meeting with the FDA, supporting the advancement of its lead asset BNC210 for the treatment of PTSD into Phase 3 based on the positive results of the recently completed Phase 2b ATTUNE study.

“We are very pleased with the outcomes of our EoP2 meeting with the FDA and look forward to initiating our transformation into a pre-commercial organization,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “This milestone is another testament to the strong clinical profile of BNC210, which has demonstrated efficacy across multiple stress and anxiety disorders. We believe BNC210 can potentially transform the standard-of-care in PTSD, a serious disorder impacting about 7% of Americans during their lifetime. Followings the recent initiation of the Phase 3 trial of BNC210 in social anxiety disorder (AFFIRM-1), we look forward to starting a Phase 3 trial in PTSD by the end of 2024.”

The company presented the clinical plans to registration, that alongside the positive Phase 2b ATTUNE trial include a single additional Phase 3 trial to evaluate two dose levels of BNC210 in a 12-week randomized, double-blind, placebo-controlled trial with a 52-week open-label extension. The meeting, held on June 26, 2024, was centered around the design of the Phase 3 trial that if successful may enable review of the NDA submission. Key outcomes from the discussion on the trial design included:

Agreement was reached on the use of Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) as the primary endpoint measure and the Clinical Global Impressions Severity scale (CGI-S) as a key secondary endpoint measure in the placebo-controlled part of the study.
Agreement was reached that in addition to the efficacious dose of 900 mg twice daily (BID) a lower dose of BNC210 that strikes the right balance between maintenance of efficacy and safety related to liver function tests (LFT) findings will be tested. Full justification for the proposed lower dose of 600 mg twice daily (BID) will be included in the final Ph3 PTSD trial protocol.
High-level agreement was reached on study participant characteristics and sample size assumption methodology.
The company received guidance related to the proposed hepatic safety monitoring plan, including monitoring for excessive alcohol use that will be implemented in the planned Phase 3 trial.
The Company plans to submit the full Phase 3 protocol for FDA review prior to trial initiation.

The company is finalizing the full study protocol and anticipates beginning the Phase 3 program in PTSD in Q4 2024.

Conference Call and Webcast Presentation

Bionomics management team will host a conference call and webcast presentation today at 8:00 a.m. ET provide a corporate update and discuss the registrational path forward for BNC210. A live Q&A session will follow the brief presentation. To participate in the conference call, please dial 1-877-407-0792 (U.S.) or 1-201-689-8263 (international) and use conference ID 13748183. To access the webcast presentation, please click here.

FOR FURTHER INFORMATION PLEASE CONTACT:

General
Rajeev Chandra
Company Secretary
CoSec@bionomics.com.au Investor Relations
Kevin Gardner
kgardner@lifesciadvisors.com

Investor Relations
Chris Calabrese
ccalabrese@lifesciadvisors.com

About Post Traumatic Stress Disorder

Post-Traumatic Stress Disorder (PTSD) is a psychiatric condition that may occur in people who have experienced or witnessed a traumatic event, series of events, or set of circumstances. People with PTSD have intense, disturbing thoughts and feelings related to their experience that persist long after the traumatic event has ended. They may relive the event through flashbacks or nightmares, may feel sadness, fear, or anger and may experience a sense of detachment or estrangement from others. As a result of these feelings, people with PTSD may avoid situations or people that remind them of the traumatic event, and they may have strong negative reactions to commonplace stimuli such as loud noises or an accidental touch.

About BNC210

Formulated as an oral solid tablet BNC210 is a negative allosteric modulator of the a7 nicotinic acetylcholine receptor under development for the treatment of social anxiety disorder (SAD) and post-traumatic stress disorder (PTSD). BNC210 has been given FDA Fast Track designation for acute treatment of SAD and other anxiety related disorders, and for treatment of PTSD and other trauma and stressor related disorders.

About Bionomics Limited

Bionomics (NASDAQ: BNOX) is a clinical-stage biotechnology company developing novel, potential 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 a7 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 CNS 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.www.bionomics.com.au

Be quick

BNOX..............................https://stockcharts.com/h-sc/ui?s=BNOX&p=W&b=5&g=0&id=p86431144783

Whoops, I did it, again

BNOX new 52 week low

BNOX new 52 week low

News due imminently

$BNOX

BNOX

BNOX new 52 week low

BNOX under $2

typical algo pop & drop 1.07-1.43-1.12

$BNOX NEWS

https://finviz.com/quote.ashx?t=BNOX&ty=c&ta=1&p=d

https://dilutiontracker.com/app/search/BNOX?a=dbb88c

Bionomics Reports Results of the Full Dataset Analysis from ATTUNE Phase 2b Trial of BNC210 in Patients with Post-Traumatic Stress Disorder $BNOX https://t.co/hjkdSlL4I5— Health Stocks News (@health_stocks) March 21, 2024

It looks like it had a 7x day(s) in October

Good luck .
Hope all is better. I did not see this post till Feb 29th

BNOX under $2

Still adding to my $BNOX stash

this will have a 10x day soon imo

BNOX

BNOX new 52 week low

Great; been busy with a great grandchildren; Seline along with Santino, her bother, where born 26 weeks early. He is home now while Seline is still hospitalized with Short Bowel Syndrome; she has had 6 surgeries, lost all but 7 inches of her small intestine. Waiting for transfer to an Omaha, Nebraska, hospital.

Stock doing well, I hope it goes to a dollar soon so I will be able to offer greater support. I have 170K shares.

HammerTime im getting a richme too

Adding $BNOX

https://app.quotemedia.com/data/downloadFiling?webmasterId=90423&ref=317829101&type=HTML&symbol=BNOX&cdn=be79035739f3991995cd7b2de0c1db3c&companyName=Bionomics+Limited&formType=SC+13G&formDescription=Statement+of+acquisition+of+beneficial+ownership+by+individuals&dateFiled=2023-10-30

HammerTime !!!
Congrats !!!!

Holy Shilt Batman !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

HAMMERTIME !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

BNOX.....Jumped off this yo-yo at breakeven.

No. As a player, I am certainly well versed in that score.

volume disappeared, but pps holding. who knows.

I thought it might retest the highs. From up 15% to down 5%.

i think it already did

BNOX.....Been accumulating low 4's. since Friday....waiting for a pop

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172988579 October 19 run coming?

New price target: $10

i expect $5 to $6 here on monday.

Billionaires are buying this stock.

That is all you need to know.

BNOX: Thank you sooooooooo much, for EDIFYING me on that score!!!

Seems like a number of "investors or sharks" gravitate to a core of shares then the shares tank as they depart. There is no mystery to it.

BNOX: Yep, those articles got me monster CONFUSED about what was REALLY going on. But we all know that when a Company's 'Insiders' --- or even 'Outsiders' --- BUY big slices of that Firm's shares, such is normally GREAT news. But anathema to any Firm is when those 'Insiders' DUMP same. Bottom line though, BNOX is a MYSTERIOUS play.

I see it was milked well the last few days. Where there were many many AM posts on in September, not a one today. Guess you will wait until in drops below $3 then start building it up a hundred shares at a time until enough suckers jump in then and only then start selling.

Isn't stock manipulation a crime?

Hey dude thank you so much for the links. Yea we all thought the float was nothing. Remember I posted here like 5 weeks ago that this was delisted from the Australian stock exchange? It was the Companies doing. That exchange is way too conservative and I feel they would have put the brakes on trading.

Seems like to me; I did not buy any but did notice the large run up and about a 2/3 drop afterwards. True it recovered part of the distance into the low $4's.

Of course PIXY was supposed to be on the up and up until flippers flipped the daylights out of it. There a lost a good chunk of change.

CNTX is now also receiving honorable mention but absent flippers nothing will happen. I won't buy anything of that either. I am trying to learn the ways of the money makers. How is it; buy early with stocks are most volatile, then throw a morsel or two to late comers. Sure you notice there are many trades 10 and 100, maybe a little higher probably flippers that loaded up early?

Thanks for the post. I started a list of main players across all the recent "great stocks." , for example PIXY, BNOX, now CNTX, by the key players. Maybe I will learn which stocks to avoid.

I think this link reveals how things work. You tell me if you find BNOX flipper driven? Seems it's been pretty hot and for multiple days. Something must be behind that on these otherwise down market days.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172952944

Flipper driven??

The next BNOX?

Whether It’s Cloudy Or Sunny, You Should Be Buying Context Therapeutics (CNTX)

(Take a look at CONTEXT Therapeutics) CLDN6 is in development by Context Therapeutics (CNTX) and is designed to be activated only upon tumor engagement while silent elsewhere. This allows CLDN6 to redirect T-cell activation away from where it would be harmful and enhances the safety profile vs its peers and what they are developing. There is an immense market given the absolute need for a high specificity to solid tumor cell treatment. $6-$15 a share is reasonable within 12 months given the upcoming Society for Immunotherapy of Cancer meeting could alert investors to a potential blockbuster. CNTX shares could easily climb multiples times higher given the tightly held float. By the time investors realize claudin 6 is an exceptionally attractive investment CNTX shares will likely be trading over $4 a share and heading higher. At the point clinical trails start showing their results be prepared to pony up for shares. There is opportunity to get in before the bulk of investors learn the potential market value of a pending CLND6 blockbuster. There are also other irons in the fire at Context Therapeutics to maintain share holder excitement as well. Stay tuned for updates on the pipeline as fact checking is near completion. CNTX stock has been beaten down just like the shares of Viking Therapeutics (VKTX) had been before running up to over $25 a share.


Right now the shares of CNTX are held tight and likely have only a small pool available. The 12-month stock price forecast for CNTX stock is $4.00, which predicts an increase of 164.90%. On average, analysts rate CNTX stock as a buy. There is a growing consensus among some investors that forecast is far to conservative with a $6-$15 range seeming a more realistic target within a year. Do some homework and see the opportunity before the masses. Things tend to get heated early with real potential like this. Don't believe it? Look over Viking Therapeutics (VKTX) where it traded under $2 a share. CNTX isn't different it's poised for the same type of breakout. Look at the 5 year chart and your eye will be open.

Pull back after $5.15 hod

Amazing

Sure is. Couple of nice days returning back up.

Looking strong!

BNOX: Curious article from today here, but the SIZE of the SHARES stake in BNOX seems to be a gross misprint --- when compared to the "OTCMarkets" website's rendering of the "Shares Structure" for the BNOX Firm..
https://beststocks.com/point72-asset-management-lp-reveals-significa/
https://www.otcmarkets.com/stock/BNOX/security

(Take a look at CNTX) CLDN6 is in development by Context Therapeutics (CNTX) and is designed to be activated only upon tumor engagement while silent elsewhere. This allows CLDN6 to redirect T-cell activation away from where it would be harmful and enhances the safety profile vs its peers and what they are developing. There is an immense market given the absolute need for a high specificity to solid tumor cell treatment. $6-$15 a share is reasonable within 12 months given the upcoming Society for Immunotherapy of Cancer meeting will alert investors to the potential. CNTX shares could easily climb multiples times higher given the tightly held float. By the time investors realize claudin 6 is an exceptionally attractive investment CNTX shares will likely be trading over $4 a share and heading higher. At the point clinical trails start showing results be prepared to pony up for shares. There is opportunity to get in before the bulk of investors learn the market value of a pending CLND6 blockbuster. There are other irons in the fire at Context Therapeutics fir share share holder excitement as well. Stay tuned for udates on the pipeline as fact checking is near completion. CNTX stock had been beaten down just like the shares of Viking Thereputics(VKTX) Had been before running up to over $25 a share.

Right now the shares CNTX shares are held tight and only have a small pool available. The 12-month stock price forecast for CNTX stock is $4.00, which predicts an increase of 164.90%. On average, analysts rate CNTX stock stock as a buy. There is a growing consensus that forecast is far to conservative. $6-$15 seems a more realistic target within a year. Do some homework and see the opportunity before the masses. Things tend to get heated early with real potential like this.... Don't believe it? Look over VKTX where it traded under $2 a share. CNTX isn't different it's poised for the same type of breakout. Look at the 5 year chart and your eye will be open.