Bionomics Ltd (BNOX)

[subslover]

LMFAO!!!!!!!!!!!!!!!!!!!!

[TheFinalCD]

5.20

[work-n-hard]

BNOX Conference Call 8:00am https://lifescievents.com/event/bnox/

[Awl416]

Almost doubled

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Bionomics Announces Positive Topline Results from the Phase 2b ATTUNE Clinical Trial of BNC210 in Patients with Post-Traumatic Stress Disorder (PTSD)
ATTUNE trial met its primary endpoint showing BNC210 treatment led to a statistically significant reduction in total PTSD symptom severity at 12 weeks.

Statistically significant secondary endpoints showed improvements in depressive symptoms and sleep.

BNC210 was well-tolerated with a safety profile supporting chronic administration.

Company plans to engage with the U.S. Food and Drug Administration (FDA) to discuss the registrational path for BNC210 in PTSD.

Webcast and conference call will be held today at 8:00 AM EST (10:00 PM AEST).
Please click on the link to register: https://lifescievents.com/event/bnox/

ADELAIDE, Australia, and CAMBRIDGE, Mass., Sept. 28, 2023 (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 positive topline results from its Phase 2b ATTUNE trial of BNC210 for the treatment of PTSD, as described more fully below.

ATTUNE is a double-blind, placebo-controlled Phase 2b trial conducted in a total of 34 sites in the United States and the United Kingdom, with 212 enrolled patients, randomized 1:1 to receive either twice daily 900 mg BNC210 as a monotherapy (n=106) or placebo (n=106) for 12 weeks. The trial met its primary endpoint of change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score from baseline to Week 12 (p=0.048). A statistically significant change in CAPS-5 score was also observed at Week 4 (p=0.015) and at Week 8 (p=0.014).

https://ml.globenewswire.com/Resource/Download/4934b6e5-92ff-4cf7-ba68-2059e9e0a38f

Treatment with BNC210 also showed statistically significant improvement both in clinician-administered and patient self-reporting in two of the secondary endpoints of the trial. Specifically, BNC210 led to significant improvements at Week 12 in depressive symptoms (p=0.040) and sleep (p=0.041) as measured by Montgomery-Åsberg Depression Rating Scale (MADRS) and Insomnia Severity Index (ISI), respectively. BNC210 also showed signals and trends across visits in the other secondary endpoints including the clinician and patient global impression - symptom severity (CGI-S, PGI-S) and the Sheehan Disability Scale (SDS).

“We are excited about the results of the ATTUNE trial that delivered a positive dataset with treatment effects considerably higher than currently approved therapies. We believe these results will enable FDA discussions for the registrational path of BNC210 in PTSD, which in an indication with high unmet need”, said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “I am thankful to the patients, their families, and the clinical teams who participated and contributed to this study. These results, together with the results from earlier this year in social anxiety disorder, and the recently completed Phase 3-enabling End-of-Phase 2 meeting with the FDA on social anxiety disorder, positions BNC210 as a compelling late-stage experimental therapeutic for multiple prevalent neuropsychiatric diseases with high unmet need.”

Treatment with 900 mg twice daily BNC210 had a favorable safety and tolerability profile. The most common (>5% of subjects in each group) reported adverse events, including headache, nausea, and fatigue, which were consistent with previous studies with BNC210. A hepatic enzyme increase was observed in 14 (13.3%) patients treated with BNC210 vs 2 (0.19%) in the placebo group; the abnormal results were not associated with hepatic injury and in most cases were resolved without drug discontinuation.

“There is great unmet medical need for safe and effective treatments for the large population of patients suffering with PTSD worldwide. Despite the clinical heterogeneity of PTSD, the results of ATTUNE demonstrated broad benefits with BNC210 across a number of symptoms. This a promising step forward for patients with PTSD, where the majority do not achieve clinical remission with current therapies and there have been no newly approved therapies in the past 20 years.” commented Murray B. Stein M.D., M.P.H., Distinguished Professor of Psychiatry and Public Health at the University of California San Diego and Staff Psychiatrist at the Veteran Affairs San Diego Healthcare System, and a consultant to Bionomics.

Additionally, the Company recently held what it believes was a successful, Phase 3-enabling End-of-Phase 2 meeting with the FDA for the advancement of BNC210 for the acute treatment of social anxiety disorder into registrational studies and is awaiting receipt of the formal meeting minutes.

The company will discuss the topline ATTUNE study results on the webcast today at 8:00am EST and is planning to advance BNC210 for the treatment of PTSD into registrational studies.

About ATTUNE

ATTUNE is a Phase 2b double-blind, placebo-controlled, randomized study of 900 mg BNC210 given twice daily as monotherapy treatment for PTSD. Study participants were randomized 1:1 to receive either placebo or BNC210. Key inclusion criteria include being 18-75 years of age, having a current PTSD diagnosis with a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score of ≥ 30 at screening and baseline, and ≤ 25% decrease in CAPS-5 score from screening to baseline. The primary endpoint is change in 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). 212 participants have been enrolled at 27 sites in the United States and 7 sites in the United Kingdom. For more information, see ClinicalTrials.gov Identifier: NCT04951076.

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

BNC210 is a negative allosteric modulator of the a7 nicotinic acetylcholine receptor under development for the treatment of Social Anxiety Disorder (SAD) and PTSD. BNC210 has been given the FDA Fast Track designation for treatment of PTSD and other trauma and stressor related disorders and for acute treatment of SAD and other anxiety related disorders. It should be noted that positive results in or from prior, current, or later clinical trials, studies and pre-clinical development may not provide positive data and/or similar results moving forward, as they are not a predictor or indicative of future results, success or regulatory approval.

FOR FURTHER INFORMATION PLEASE CONTACT:

General
Rajeev Chandra
Company Secretary
[e-mail] Investor Relations
Kevin Gardner
[e-mail]

Investor Relations
Chris Calabrese
[e-mail]


Business Development
Matthew Brennan, MBA
Sr. Director, Business Development
[e-mail]



Business Development
Francisco M. Bejar
Strategic Advisor
[e-mail]

[INV4]

Wow!!
$BNOX

[Awl416]

7m approaching

[work-n-hard]

Thanks, have held this for a while now (about 3 wks.) and added on the decline, in anticipation of this PR.
Reaping now.

[starkd748]

Load this on the a b c decline on the Fibonacci

[work-n-hard]

https://www.globenewswire.com/news-release/2023/09/28/2751004/0/en/Bionomics-Announces-Positive-Topline-Results-from-the-Phase-2b-ATTUNE-Clinical-Trial-of-BNC210-in-Patients-with-Post-Traumatic-Stress-Disorder-PTSD.html

[Golden Cross]

maybe a bounce here

[Golden Cross]

Right at support here... lets see what happens next week

[work-n-hard]

Interesting: https://www.dhakatribune.com/amp/financial-markets/325303/bionomics-nasdaq-bnox-is-a-strange-one-in

[work-n-hard]

https://iborrowdesk.com/report/BNOX

[work-n-hard]

https://www.wkrb13.com/2023/09/13/bionomics-limited-nasdaqbnox-short-interest-up-922-1-in-august.html

[work-n-hard]

https://www.nasdaq.com/press-release/bionomics-announces-update-on-the-a7-nicotinic-acetylcholine-receptor-nachr-positive

[Golden Cross]

Yep, was pretty light volume

[work-n-hard]

Buys - 10,226 / Sells - 22,448 / ? - 914 / Total - 33,588
These numbers are the total in the screenshot below, which started at 18:15. So they do not include the trades from 16:00 to 18:15.
Not positive of course, but to me, once the day hours closed and some of the MM's pulled away, someone took advantage and created a low volume take down.
It will be a shame, if someone got spooked out of their shares, just for it to take off tomorrow or Friday.

[Golden Cross]

off the lows at least... but, bet u r right

[Natural Trader]

doesn't look good down 20% a/h . something has to do with the FDA update imo

[Golden Cross]

Trades https://ih.advfn.com/stock-market/NASDAQ/bionomics-BNOX/trades

[Golden Cross]

Somebody may know something I don't see anything

[Natural Trader]

why is it down a/h?

[Awl416]

Something leak?

[Golden Cross]

Yeppers, loaded up here💎💯

[Natural Trader]

update anyday now $BNOX

[Golden Cross]

Sitting on the launchpad

[Golden Cross]

Sure looks ready

[Cameo Brien]

Ready to breakout

[Golden Cross]

Yes, people loading up expecting much higher prices soon.. I know I did... $BNOX

[Trooperstocks]

$BNOX Accumulation this week @Golden Cross . Looking forward to #FDA news and updates.

[Golden Cross]

Would luv to close $2+

[Trooperstocks]

$BNOX $1.96 +7.00% green into powerhour and the weekend!

[Trooperstocks]

Major FDA meetings scheduled during Sept. 2023 for $BNOX

[Trooperstocks]

$BNOX low float here can send us much, much higher!

[Cameo Brien]

Good action here

[Trooperstocks]

$BNOX Great article on stockifymedia on BionomicsLtd
Bionomics Limited (NASDAQ: BNOX) Short Squeeze 2023-08-30 https://stockifymedia.com/bionomics-limited-nasdaqbnox-short-squeeze-2023/ $NVDA $TSLA

[Trooperstocks]

$BNOX plans to meet the FDA in mid-September to discuss the clinical requirements for advancing BNC210 into phase III development, based on data of PREVAIL study. The company is confident that the results from the phaseII PREVAIL study will support this progression.

[Golden Cross]

Strong out of the gate

[Trooperstocks]

$BNOX $2.00 +9.09% HOD $2.01 Now!!

[Trooperstocks]

$BNOX $1.88 +2.73% HOD $1.95 Ready to breakout!

[Trooperstocks]

Huge Catalyst -BNOX Topline results are expected to be released by the end of September!

[Trooperstocks]

BNOX announced that the last patient visit had been completed in its Phase 2 ATTUNE study in Post-Traumatic Stress Disorder ("PTSD").

[Trooperstocks]

Good morning $BNOX Huge momentum into todays open!

[Cameo Brien]

Agreed $BNOX

[Trooperstocks]

Agreed @Ryguy008 $BNOX Chart is very bullish today. Could gap up tomorrow!

Link: https://www.tradingview.com/chart/?symbol=bnox

[Trooperstocks]

$BNOX Excellent news today, bullish move on the monthly chart! https://stockanalysis.com/stocks/bnox/chart/

[Trooperstocks]

$BNOX Bionomics Shares In Rally Mode As Investors Take Interest Ahead Of Planned Phase III Trial To Treat PTSD And SAD ($BNOX)
https://t.co/6K2S9jx5xS

[Trooperstocks]

$BNOX Bionomics has a strategic partnership with Merck (NYSE: MRK), evaluating two drugs in early-stage clinical trials to treat cognitive deficits in Alzheimer's disease and other central nervous system conditions. The BNOX pipeline extends further, with preclinical assets targeting Kv3.1/3.2 and Nav1.7/1.8 ion channels being developed for Central Nervous System ("CNS") conditions with high unmet needs.

https://marketwirenews.com/articles/bionomics-shares-soar-65-since-august-ahead-of-comme-mwn4754.html

[Trooperstocks]

BNOX -Bionomics Shares Soar 65% Since August Ahead Of Commencing Planned Phase III Trial To Treat PTSD And SAD

Bionomics Limited (Nasdaq: BNOX) (ASX: BNO) shares have kicked into rally mode, surging by over 65% since August 22nd to score an intra-week high thus far of $1.98. The rally is deserved, with the fuse lit after BNOX announced that the last patient visit had been completed in its Phase 2 ATTUNE study in Post-Traumatic Stress Disorder ("PTSD"). Topline results are expected to be released by the end of September. Reaching that milestone isn't the only thing attracting investors' attention. Bionomics also disclosed expectations for its End of Phase 2 (EoPh2) meeting with the FDA in September to review results from its Phase 2 PREVAIL study in patients with Social Anxiety Disorder (SAD). Leaving that meeting could include details putting another milestone in play. Specifically, a more determinant date to commence a proposed Phase 3 registrational trial.

That calendar alone has put multiple potential catalysts in the near-term crosshairs. And they could deliver an appreciable boost to the share price. Analysts covering BNOX think so. At least two have modeled for Bionomics shares to surge by over 293% to $7.00 from current levels in the next 12 months. They present a strong case for why, emphasizing the implied value of BNOX drug candidates earning front-line treatment designations for unmet medical conditions, particularly patients suffering from serious central nervous system ("CNS") disorders. The company is equally optimistic.

Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics, said, "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." With excellent data supporting its drug efficacy and safety profile, September should be filled with value drivers. In fact, with plans to release topline results for its ATTUNE trail and an expected announcement for when it will commence its Phase 3 PREVAIL trial, the $7.00 price target may be conservative. After all, BNOX shares traded as high as $10.90 in the past 52 weeks, and they are better positioned today to advance key drug candidates with data supporting mitigated risk. Re-claiming that high, BNOX investors could be eyeing gains of over 512% from its current $1.78.

Milestones Reached Can Become Catalysts

Thus, any weakness from profit-taking should be viewed as an opportunity, not a trend. That's not an unwarranted presumption. Except for some profit-taking on Wednesday, the BNOX chart over the past month shows a steepening trajectory. That's no coincidence. Investors are seizing low-priced entry into a company on the precipice of a breakout, leveraging intrinsic and inherent value from its lead drug candidate, BNC210. It's an oral, proprietary, selective negative allosteric modulator of the ?7 nicotinic acetylcholine receptor for the acute treatment of SAD and chronic treatment of PTSD. It's not the only promising asset.

Beyond BNC210, Bionomics has a strategic partnership with Merck (NYSE: MRK), evaluating two drugs in early-stage clinical trials to treat cognitive deficits in Alzheimer's disease and other central nervous system conditions. The BNOX pipeline extends further, with preclinical assets targeting Kv3.1/3.2 and Nav1.7/1.8 ion channels being developed for Central Nervous System ("CNS") conditions with high unmet needs.

As expected, its busy pipeline provides plenty of additions to the BNOX agenda. In addition to topline data from its placebo-controlled Phase 2b ATTUNE study of BNC210 in PTSD expected this quarter, BNOX expects to take guidance from its FDA End of Phase 2 meeting discussing data and plans for its proposed registrational program for BNC210 in Social Anxiety Disorder. In Q4/2023 and Q1/2024, the company expects to dose its first patient in the Phase 3 study of BNC210 in Social Anxiety Disorder. Also leading into next year, the company's partnership with Merck for Phase 1 candidates targeting cognitive deficits in Alzheimer's and other CNS disorders is expected to gain clinical trial traction. That's not all.

Bionomics has a memorandum of understanding with EmpathBio for the feasibility assessment of EMP-01 (MDMA derivative) & BNC210 for PTSD treatment. If acted on, it represents another value driver that could feed off that drug candidate's blockbuster potential. A blockbuster drug is one that generates annual sales of $1 billion or more for the company that sells it. The promise of BNC210 checks that box, highlighted by its non-sedating anxiolytic profile and rapid onset of action, which adds to the potential of becoming a first & best-in-class therapeutic for the acute treatment of Social Anxiety Disorder. If approved, it could be the first, as-needed treatment for SAD with a non-sedating, non-habit-forming profile.

Other partnering opportunities are also in play, with BNOX hinting at potential collaborations with preclinical assets targeting potassium (Kv) and sodium (Nav) ion channels. With drug candidates on the pathway to earning front-line designations and scoring blockbuster revenues, future development agreements with big pharma are more likely than not. That makes sense. Big pharma giants like Pfizer (NYSE: PFE), AbbVie (NYSE: ABBV), and Johnson & Johnson (NYSE: JNJ) have become acquirers instead of developers over the last decade, a strategy turning microcap biotechs into development stars while shaving years off of development time.

Assets That Are Attracting Big Pharma

Reasons support these drug sector behemoths to look BNOX's way. Foremost is BNOX advancing an impressive drug candidate pipeline that has at least two making their way toward Phase 3 status. Moreover, they target significant unmet medical needs, which is more than excellent news for the patients who need better care but also for the companies that develop them. Include Bionomics in that list. And here's another thing to consider. The Phase IIb ATTUNE study is evaluating BNC210 as a monotherapy to treat PTSD. That's an indication high on the list of any big pharma company, noting the blockbuster potential. Thus, don't rule out the possibility of a combination therapy approach to treating that debilitating condition, which would trigger a new potential partnership. They may also get outside interest from its mission to find a better way to treat SAD.

Bionomics is intent on delivering there as well. More than just focused, they have completed evaluating BNC210 in a Phase II PREVAIL study for SAD. The data from the trial is impressive, showing that both 225-mg and 675-mg doses of BNC210 resulted in a decline in anxiety across multiple phases of the public speaking challenge. Notably, patients receiving BNC210 experienced significantly less anxiety during the public speaking task compared to placebo. Treating that indication also comes with over a billion-dollar revenue-generating potential. And with BNOX planning to meet the FDA in mid-September to discuss the clinical requirements for advancing BNC210 into Phase 3 development, a partnership could come sooner than later. That could lead to a windfall.

The value difference between a Phase 2 and a Phase 3 company can be hundreds of millions. Considering data from its PREVAIL study impresses evaluators, confidence is high that the Phase II PREVAIL study results will support this giant clinical step forward. Moreover, developing a Phase III study and its expected data will likely help BNOX submit a new drug application for BNC210 to treat SAD. Meeting expectations and capitalizing on strengths throughout its pipeline adds fuel to turn milestones into catalysts.

Bionomics Pipeline Exposes Multiple Blockbuster-Sized Candidates

Those catalysts are what investors want. Yes, milestones are significant, but the latter turns ambitions into revenues. And with Bionomics having several in its sights, the value disconnect between assets, programs, partnerships, and its share price may be too wide to ignore. Like many biotechs, BNOX took a hit to its valuation as the undercurrent in the markets isn't as strong as what's displayed in the Nasdaq 100. However, the selloff may be overdone, especially with BNOX ideally positioned to capitalize on late-stage products that put them on a fast track to approval and commercialization.

In fact, at $1.78, BNOX shares are priced at where investors would pay for a Phase 1, preclinical stage company. That's certainly not the case. Bionomics is expecting to and is on its way to changing the treatment landscape for PTST, SAD, and other neurologic conditions. Other companies may also be trying, but few, if any, are as near to commercialization, with the amount of supporting data, as Bionomics. That difference can be transformative to BNOX in the back end of 2023 and into 2024.

And better still, it can lead to not only reaching analysts' price targets 302% higher than its current price but also to re-claim its $10.90 high, 512% higher than the $1.78 price just printed. Companies presenting that value proposition, with evidence to justify the increase, should not be ignored. Based on the ascending trajectory of BNOX shares, investors are certainly paying attention to this one. Rightfully so.

https://marketwirenews.com/articles/bionomics-shares-soar-65-since-august-ahead-of-comme-mwn4754.html