Imagion Biosystems Ltd (IBXXF)

[rustydog62]

A detailed analysis of them by simply opening the files here...

https://www.fnarena.com/index.php/pitt-street-research/IBX/

[klarino man]

BLAH -BLAH ~

[Hncher]

MagSense Utility as a Potential MRI Contrast Agent

https://www.asx.com.au/asxpdf/20190909/pdf/448btw0qj73p67.pdf

Investor Presentation

https://www.asx.com.au/asxpdf/20190909/pdf/448bxg9hjp9pv5.pdf

[ssc]

Did you mean moving back down? Tough to hold above .04 with more dilution and years of development and testing ahead.

[klarino man]

Moving along here ~

[Hncher]

Agreed, they should put out something about the timelines. My guess since they are in the throws of starting initial FDA biopsy for breast cancer, a long way out until we see anything on the human instrument.

The FDA study most probably will be done at MD Anderson where there is a non-human instrument in place. It is the most logical and least resource sucking way to do it.

My gripe is that management is way overpaid. The way they burn thru cash really sucks. I believe they will need to do another fundraiser and more dilution. The numbers don't lie.

Take a look at the last ASX filing on exec comp. I guess bobby proulx has not read the book on start-ups and exec comp.

[ssc]

Strange how there is no mention of when the device for human trials will be fully designed, when an actual device will be built and ready for the trials, and how much it will cost to get to that point. When was the last time, if ever, those matters were addressed by ibx management and shared with investors?

[Hncher]

Not sure why this is a press release but here it is.

Imagion Biosystems Initiates Regulatory Communications for First-in-Human Study

https://imagionbiosystems.com/wp-content/uploads/2019/08/IBX-Initiates-First.pdf

[Hncher]

Nothing new here except for a few more thousands of bucks, at their burn rate, will not last long.

https://www.asx.com.au/asxpdf/20190725/pdf/446vzwmxrn53vk.pdf

Something new here, at the very least we now know who some of the inners were selling.

https://www.asx.com.au/asxpdf/20190725/pdf/446wmln158fbvk.pdf

[klarino man]

A Positive + for Manhattan Scientifics !

Hold on -

[Hncher]

Imagion Biosystems Receives FDA Breakthrough Device Designation

Imagion Biosystems Limited (ASX: IBX) (the Company), a company dedicated to improving healthcare through the earlier detection of cancer, today announced that it has received notification from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) that the MagSense System and Test for staging HER2 breast cancer has qualified for and been granted designation as a Breakthrough Device.

“The FDA’s designation of our MagSense technology and HER2 test as a Breakthrough Device is a significant step in our clinical development program” said Bob Proulx, Executive Chairman. “Qualifying as a Breakthrough Device will allow us to expedite our dialog with the agency and validates that our MagSense technology is not just another medical device but, indeed, represents a transformative opportunity for healthcare and could improve the standard of care for staging HER2 breast cancer.”

The purpose of the Breakthrough Device Program is to expedite and improve communications between a device manufacturer and the agency during device development and throughout the review process and provides priority review. To qualify for Breakthrough Device status a product must be considered to “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions” and meet one of the following criteria:

(a) represent breakthrough technologies;
(b) address an application for which no approved or cleared alternatives exist;
(c) offer significant advantages over existing approved or cleared alternatives; or
(d) be considered that the availability of the device is in the best interest of patients.

The Company’s MagSense test for the staging of HER2 breast cancer aims to eliminate the unnecessary surgeries and concomitant morbidity resulting from the current standard of care biopsy procedure. The Company is currently discussing with the FDA and clinical study sites its plans to undertake a first-in-human study of the MagSense HER2 Test.

[Hncher]

ouch is an understatement. Much too much shareholder dilution and very little good news. Confusing press releases and high paid executives. Results=.017

I am still hopeful they can turn this around with any type of FDA/MDA announcement on human trials. Although, hope is not a strategy that a shareholder should hang his hat on.

Not happy at all.

[ssc]

Looks like another step downward - to .017; ouch.

[Hncher]

Finally, a positive step forward..

Imagion Biosystems Successfully Completes Toxicology Study

Imagion Biosystems has achieved a key milestone in its progress to first-in-human testing with the successful completion of a toxicology safety study of its lead MagSense™ nanoparticle formulation for the detection of HER2 metastatic breast cancer.

MELBOURNE — Imagion Biosystems Limited (ASX: IBX), a company dedicated to improving healthcare through the early detection of cancer, has achieved a key milestone in its progress to first-in-human testing with the successful completion of a toxicology safety study of its lead MagSenseTM nanoparticle formulation for the detection of HER2 metastatic breast cancer. The study was completed on time and no observable adverse effects were reported.

Based on recommendations from the U.S. Food and Drug Administration (FDA) the Company had engaged a contract research organization to undertake the toxicology study following Good Laboratory Practices (GLP). The safety demonstrated in the toxicology study report will be used to support filings with regulatory and clinical authorities to proceed to first-in-human testing.

“While we fully expected this outcome, it is good to have this hard evidence in hand,” said Bob Proulx, Executive Chairman. “The assessment of toxicological safety of our nanoparticle formulation is a big de-risking step. We will be breaking new ground in medical imaging bringing a targeted bio-safe iron-oxide nanoparticle to first-in-human studies.”

[Hncher]

Imagion Biosystems receives R&D Advanced Overseas Finding

MELBOURNE — Imagion Biosystems Limited (ASX: IBX) (the Company), a company dedicated to improving healthcare through the earlier detection of cancer, is pleased to announce that it has successfully applied for an
advance/Overseas Finding in relation to its research and development activities for a new superparamagnetic based imaging technology for detection of HER2 breast cancers (R&D Activities).

The Advance/Overseas Finding is a finding received from Innovation and Science Australia, stating that the Company’s R&D Activities satisfy the eligibility requirements under the Research and Development Tax
Incentive Program administered by the Australian Taxation Office and AusIndustry (a division of the Department of Industry, Innovation and Science).

The finding covers financial years 2018 through 2020 and means that the Company’s eligible research and development expenditures undertaken overseas, as well as Australian expenditures, will be eligible for a
43% cash rebate under the Australian Industry Research and Development Act 1986.

The finding covers financial years 2018 through 2020 and means that the Company’s eligible research and development expenditures undertaken overseas, as well as Australian expenditures, will be eligible for a
43% cash rebate under the Australian Industry Research and Development Act 1986.

Bob Proulx, Executive Chairman commented, “This favorable ruling from AusIndustry will provide us with a short-term infusion of cash, supporting our plans for a first in human study and a higher degree of certainty in planning and budgeting for the remainder of the project. We greatly appreciate the Federal Government’s commitment to, and support of, research and development initiatives for Australian companies.”

[Hncher]

Imagion Biosystems receives order related to cancer treatment

Imagion Biosystems today announced that NewPhase Ltd., an Israeli biotechnology company developing cancer treatments, has issued an extended purchase order to Imagion Biosystems for the supply of nanoparticles for the remainder of 2019 to be used in the NewPhase product.

https://imagionbiosystems.com/wp-content/uploads/2019/04/IBX-To-Supply-Nanoparticles-for-Cancer-Therapy-draft-v4.pdf

[Hncher]

Not happy at all

[ssc]

bid .02, down from offering price of .20; what's going on here?

[Hncher]

It's not. They need announcements that have "real progress". Like completion of the human instrument, completion of the toxicity study and something that would help the stock price, no further dilution "we have a manufacturing partner who is investing in the company"

[ssc]

How is "What's New" impacting ibx share price? Ask now under .03

[Hncher]

What’s New in Medical Imaging — Radio Interview with Mike Harsh

https://imagionbiosystems.com/new-in-medical-imaging-radio-interview-with-mike-harsh/

As a sought-after medical imaging industry thought leader, Mike Harsh sat for a recorded interview by the Radiological Society of North America that was broadcast in the US to a national radio audience.


In the recording, Mr. Harsh notes that over the last 40 years, medicine has been narrowly limited to just five ways of imaging the human body: X-ray, CT, MRI, ultrasound, and PET/SPECT. Continuing, Mr. Harsh introduces magnetic relaxometry, and speaks with great optimism and interest about the new technology’s sensitivity, specificity, and potential to improve clinical outcomes by detecting cancer much earlier.

Mike Harsh is a forty-year veteran of the healthcare diagnostic imaging industry and a member of Imagion Biosystems’ Board of Directors. Mr. Harsh has served as Vice President and Chief Technology Officer for GE Healthcare and as the Global Technology Leader of Imaging Technologies at GE Global Research, where he led the organizations research on X-Ray, CT, MRI, Ultrasound, Nuclear Medicine, PET, Optical Imaging, and computer visualization/image analysis systems.

Read more about Mike Harsh at LinkedIn.

[ssc]

Key development and stock under .03, down from .20. Anyone think there's even more dilution on the way?

[Hncher]

Imagion Biosystems hits key development milestone with initiation of toxicology study

Imagion Biosystems has achieved a key milestone in its progress to first-in-human testing with the commencement of a toxicology safety study of its lead nanoparticle formulation for the detection of HER2 metastatic breast cancer.

Based on recommendations from the U.S. Food and Drug Administration (FDA) the Company has engaged
a contract research organization to undertake the toxicology study following Good Laboratory Practices (GLP). The study is expected to be completed in early May 2019. The report from the study will outline the safety profile of the Company’s lead diagnostic nanoparticle formulation and will be an important part of the regulatory and clinical applications needed for first-in-human testing.

“This is a significant milestone in the development of our MagSense diagnostic imaging technology,” said Bob Proulx, Executive Chairman. “Assessment of toxicological safety of our tumor targeting nanoparticle formulation is a big de-risking step and will be a key factor allowing us to move forward to first-in-human studies.”

Imagion is working to break new ground in medical imaging with the MagSense technology. Current medical imaging technologies identify regions of interest but don’t specifically identify diseased tissues. PET tracers aim to provide improved specificity but expose patients to radioactivity. Untargeted iron oxide nanoparticles have been shown to be bio-safe and are used off-label as an MRI contrast agent, but their lack of specificity has limited their diagnostic utility. Following positive results from first-in-human studies, Imagion Biosystems’
MagSense technology would be a first in molecular imaging employing targeted bio-safe iron oxide
nanoparticles.

[ssc]

From Proactive Investors website:

Disclaimers:...You understand that the Company receives either monetary or securities compensation for our services. We stand to benefit from any volume which any Content on the Site may generate.

Proulx following the manny and marv playbook?

[Hncher]

Imagion Biosystems pioneering medical imaging with 'printer and ink' business model

Imagion Biosystems (ASX:IBX) president and CEO Bob Proulx tells Proactive Investors that the company is commercialising a new form of medical imaging that it developed for the early, non-invasive detection of cancer that uses biosafe nano-particles.

Proulx explains the medical case as well as the business case behind the technology, saying "in the medical imaging space today there's no consumable that goes with it... with our technology, because it includes both the measuring instrument and an injectable component, there's the classic printer-ink business model. We think that will be attractive for our commercial partner because now you'll be able to not only sell and install and service the instrument, but you'll also have the consumable that goes with each of the new tests that we bring to market."

[ssc]

Pretty clear message to Proulx et al that the market doesn't like the ibx story and doesn't think the dilution is over.

[ssc]

Funny, could have sworn I recently read something like this from you:

In terms of news flow, hard to see what could happen aside from the announcement of any successful non-dilutive grants (hopefully they've applied for some although they shouldn't run out of cash!).

Oh well, at least you seem to be learning as the years roll by. Next big question, how far will $4 million get them before shareholders are whacked again.

[Hncher]

There is nothing to disagree or agree with, it is the nature of the industry and this type of start up. Also, if anyone was reading the filings and listening to Proulx's investor update, you could see this was likely to happen.

A start up in this cancer tech space needs money to keep the wheels going in the right direction and capital raising is the reality and shareholders should continue to be aware of this. They need money to keep developing the company and as the letter to the shareholders states,

The funds raised will be applied towards the costs of the Entitlement Offer, and to ensure the Company has adequate resources to undertake and complete this early feasibility study which has previously been disclosed as an important milestone in the product development and regulatory path

As another poster wrote, "I am more than happy with the board and the potential future. If it proves commercial, then the sky is the limit. If not, then it will be worth zero"

Is it dilutive, you bet, do I hate the stock price, you bet.

[ssc]

Whether you agree or disagree with my opinions, you have to admit my predictions of cash shortfall and huge dilution have just come true. For all the shareholders, I guess if you liked ibx at .20 you'll love it at .04 and 50% dilution.

[ssc]

And the price slowly sinks. Wonder why that is?

[Hncher]

Looks like they finally got something to work.

Imagion Biosystems Hits Nanoparticle Formulation Milestone

https://imagionbiosystems.com/imagion-biosystems-hits-nanoparticle-formulation-milestone/

[ssc]

Any thoughts on latest quarterly report from ibx? Looks like they're still having problems getting the technology to work, and running low on cash.

[Hncher]

Non-Executive Director Appointment

MELBOURNE — 30 July 2018 — Imagion Biosystems Limited (ASX: IBX) (Imagion or the Company) is pleased to confirm the formal appointment of Dr John Hazle (Professor and Chair of the Department of Imaging Physics at The University of Texas MD Anderson Cancer Center) as Non-Executive Director of the Company, effective today 30 July 2018.

As previously advised, the formal appointment of Dr John Hazle as Director was subject to approval from MD Anderson Cancer Center’s Conflict of Interest Committee, which has now been obtained. John will Chair the company’s Scientific Advisory Board.

[ssc]

Good luck to you and everyone who might be helped by this technology. But right now, imo, the stock price is saying watch out for future dilution.

[Hncher]

IF they can get this to work in humans, it will be a game changer. Stock prices for now only reflect the reality of where they are. The future holds promise.

https://www.kob.com/health-news/cancer-detecting-nanoparticles-go-to-clinical-trials/4887351/

[ssc]

Awfully quiet on this board as ibx breaks down thru the .05 level. Not long ago some people were happily paying .15 to .20; what went wrong?

[Hncher]

Imagion Biosystems Reports Progress on Regulatory Pathway

MELBOURNE, Australia, April 4, 2018 /PRNewswire/ -- Imagion Biosystems Limited (ASX:IBX), a company dedicated to improving healthcare through the earlier detection of cancer, is pleased to provide an update on recent communications with the U.S Food and Drug Administration (FDA) regarding its plans for clinical development of MagSense™ technology.

Following FDA guidance for medical devices, Imagion filed a Pre-Submission document with the FDA in January 2018 to initiate communications regarding the Company's clinical development plans. Pre-Submissions are optional filings with the FDA but are encouraged, particularly for new technology medical products, to foster open communication and dialog with the agency. The FDA provides written feedback on Pre-Submissions within 3 months, which the Company recently received, confirming key aspects of the Company's development plan:

The Center for Devices and Radiological Health (CDRH) confirmed the Office of Combination Products' opinion that the MagSense system is a combination product and that CDRH is the lead review group;
The CDRH accepted Imagion's general toxicology study plan based on the view that the nanoparticle formulation represents a low safety risk due to prior known safety profiles of the materials incorporated into the formulation;
The CDRH agreed with Imagion's overall clinical study approach of sequential clinical studies starting with the first-in-human Early Feasibility Study and provided clear guidance for the Early Feasibility Study Design.
"We are very happy with the feedback we received and the level of engaged dialog with the FDA in our Pre-Submission process," said Bob Proulx, Executive Chairman of Imagion Biosystems. "This communication gives us confidence that our clinical development plan is on solid ground and in sync with the expected regulatory requirements."

Key next steps in the development process required before first-in-human testing include:

Manufacturing an initial batch of GLP-compliant MagSense nanoparticles;
Undertaking a nanoparticle safety and toxicology study.
About Imagion Biosystems

Imagion Biosystems is at the crossroads of biotechnology and nanotechnology. Its novel bioimaging and nanomagnetic detection systems have been developed specifically to detect cancer earlier and with higher specificity than is currently possible. With MagSense™ technology, the company has the potential to optimize patient care and reduce mortality rates across various cancer indications. Imagion Biosystems listed on the Australian Securities Exchange (ASX) in June 2017. For further information please visit www.imagionbiosystems.com

[ssc]

hncher, I see the ibx 2017 annual report is out. Are you still standing by your statement that "they shouldn't run out of cash!"? Price seems to be saying otherwise, as well as the fact ibx has less than $7 million in cash left, burning $7 million/year and that burn rate doesn't even include what they'll have to pay outside companies for major agreements. From the annual report:

These agreements would include, manufacturing for our formulated nanoparticle, design and prototype production of our instrument, clinical consultants among other things.

Seems like they will be running out of cash in a big way imo.

[ssc]

Proulx bought at .10, current ask .068, are you sure this technology works? Are you sure they have enough cash? Looks like best case is a lot more dilution on the way. jmho

[ssc]

IBX "trailblazing" its way down to .065, leaving those who bought into the ipo with huge losses. Markets at all time highs, war against cancer raging on, yet 8 years in can't even get a trial started for ibx imaging technology. What's wrong with this picture?

[ssc]

Are you excited about this new business strategy? Sounds like since no one wants to buy their nanoparticles, they'll just give them away for free. Now why didn't you think of that?

[Hncher]

Imagion Biosystems Kicks Off “Trailblazer” Nanoparticle Trial Program https://precisionmrx.com/2017/12/21/imagion-biosystems-kicks-off-trailblazer-nanoparticle-trial-program/

[ssc]

From what I heard, they are now focusing on breast cancer as top priority after years of work on ovarian. Also seem to be saying the primary benefit will be to reduce the number of biopsies needed; none of that old 1000's of times better than a mammogram crap spewed by Manny and Marv.

Biggest financial info: $8+ million in cash, burning $1.3 million/quarter, but this does not include all the expense for outsourcing. They are outsourcing nano particle manufacturing, the design of the human product and the building of the human product. Sounds like a lot more cash will be needed to reach their goal of human trials. jmho, curious to see how others paint it.

[Jaybebaybe]

I missed the investor call. Anything interesting discussed?

[Hncher]

Investor Conference Call

ASX Announcement
6 December 2017
Investor conference call
MELBOURNE — 6 December 2017 — Imagion Biosystems Limited (Imagion, ASX:IBX) invites shareholders and other interested parties to join CEO Robert Proulx for an update on the Company’s progress and developments.
Mr Proulx will also address questions from investors as part of the call. Please submit these by email to [e-mail] in advance of the date of the call.
The call is scheduled for Tuesday 12 December 2017 at 12:00pm AEDT (9am AWST / 5pm US Pacific time Monday 11 December).
To connect to the call please use either the following weblink to register or join using one of the dial-in numbers and access code:
WEBLINK: https://attendee.gotowebinar.com/register/6343257790064495618
DIAL-IN: Australia
Long distance [phone]
Toll-free 1 800 071 059
United States
Long distance [phone]
Toll-free 1 877 309 2074
United Kingdom
Long distance [phone]
Toll-free 0 800 169 0433
ACCESS CODE: 168-007-394

[ssc]

Any thoughts on the .09 share price?

[Hncher]

Proulx purchase shares http://www.asx.com.au/asxpdf/20171124/pdf/43pkc6fvjkqqx5.pdf

[ssc]

Interesting. While safety and efficacy are important, the much more significant issue is proving that it works. 7 years testing with mice and still not ready to present a case to the FDA to request approval to even begin a human trial. And the human machine is just now in its design stage. There are reasons ibx has fallen to .10

In light of those facts, and considering how many more years to go before human trial would produce approvable results, I question how you arrived at the conclusion that "they shouldn't run out of cash".

Latest report from ibx states $7 million in cash left, burning $1 million/quarter PLUS costs of outsourcing which will include the large tasks of designing and building a human machine and the manufacturing of nano particles. Then add in the costs of trials to prove the safety and efficacy you mentioned, and the cost of human trials.

Anyone wondering why the ibx price has fallen need only look at the cash requirements to get from here to the end of human trials and it should be clear that the $7 million won't last very long and that further substantial dilution is inevitable.

[Jaybebaybe]

I finally pulled the trigger and grabbed some IBX shares. I’m in it with a long view. It takes time to get going on clinical trials.

[Hncher]

Some interesting thoughts from Australia.

Plenty of blue sky but really is a slow burn.

Ultimately the real value inflection point is proving safety and efficacy in humans and they are some way away from that. In the interim what I would expect;

- StarFish Medical are building the Mag Sense device (outsourcing this device development was the smart approach) and were engaged mid August. No timeline for development was provided but you would expect them to at least have design specs and concepts locked down before the end of the year and clinical prototype manufactured not too long after that.

- Thereafter you would expect them to move to the breast cancer clinical trial design, possibly meeting with the FDA to get what feedback they can on that trial design, and then move to clinical site recruitment and patient recruitment. You'd expect announcements as each of these occur. They said in July this year that they were aiming to kick off this clinical trial within 18 months.

Once that breast cancer trial kicks off, you would expect news flow about prostrate and ovarian cancer diagnosis programs. With the MagSense device already developed, it would then come down to unique Nano formulations for each. Not quite as simple as that but you get the idea of what's possible, with potentially 3 product streams, once much of that earlier heavy lifting is done.

In terms of news flow from out of left field, hard to see what could happen aside from the announcement of any successful non-dilutive grants (hopefully they've applied for some although they shouldn't run out of cash!). Board looks solid, but they maybe they'll appoint a medical advisory board with some heavy hitters if they don't already have one? In terms of TO it is far too early stage for a major to be sniffing around just yet (imo).

I like this space but the listing so far has been disappointing particularly given some of the people behind this and they didn't seem to have any challenge raising the cash. The EV did make it tight and then with the big dumper on day one, coupled with poor market support ... and here it is lingering not far off the pre-IPO seed price.

Disclaimer - I haven't spoken to anyone from the company since pre-IPO so the above are just my guesstimates based on publicly available information, hope this helps.