Axim Biotechnologies Inc (PK) (AXIM) 뉴스

It's a beautiful day.

https://www.businesswire.com/news/home/20241016766284/en/Eye-Health-America-and-Vers%C3%A9a-Ophthalmics-Inc.-Enter-Into-a-Preferred-Partnership-to-Support-Management-of-Ocular-Surface-Disease-and-Ocular-Surgery

This is total garbage. Just like the company that owns a majority stake of shares MJNA.

There are shareholders loans that total $484,000. There are no stated terms or conditions for these loans. Is that unusual? Who would loan money with no terms or conditions?

CEO John H in an interview in March 2024 was saying that with two FDA approved DED tests the stock price should be 10 cents. That would imply that AXIM owned the IP for those two tests. Now Tex is saying that insiders own the IP, not the company. What about the cancer tests in development, the Covid antibody level test, the Parkinson’s Disease test. Who owns the IP regarding these tests?

Yep.  Retail investors got crushed.

Verséa Health, Verséa Ophthalmics.   The other companies under that umbrella seem smart, knowledgeable and successful.  

So sorry to hear that. I lost on this one too. Looking like anyone who is still holding will lose now. Sad

Before the Q2 disaster I increased my share count almost 10× based on a false Hope.  After the Q2 disaster I sold out but not before losing 50% in a relatively short amount of time.

Hope is not a good investment strategy. 

The diagnostic test strip market for home use or CLIA waived tests for applications like the market Versea Ophthalmics wants to address seems like a good space. This space can be potentially profitable, but only if the tests have CLIA Waivers.  

Watch from a distance? Meaning you sold your shares and will keep an eye on this or?

Only asking as last I was here you held substantial position.

AXIM Insiders still control the AXIM Intellectual property.  I would be curious to watch from a distance if Verséa Ophthalmics is able to join or merge as part owner.  However it doesn't seem to matter anymore for the retail investor.  The price keeps falling.  Maybe that is the plan.


It probably makes sense for Verséa to let AXIM go bankrupt and then negotiate a deal with the insiders to take the company private.  I will watch from a distance to see what happens.


I have always had a positive impression about Catalina Valencia.  

She must have bought Mr Huemoeller's shares today.  It appears she paid way too much for over a million shares today.
She paid $28,608.22  for 1,086,216 shares which is  0.0263 per share.  She could have bought the same number of shares for $2172.43 today.  The only explanation I can think of is she bought the shares from Mr Huemoeller's family.  


RIP Mr Huemoeller.

Catalina Valencia owned 28.6 million shares in January 2024. She might still have a substantial incentive today to turn things around.

Just some sort of communication with the market might have a positive effect. Bankruptcy would make all those shares worthless.

Tex do you think Catalina becoming CEO matters?

Form 8-KRIP CEO Mr John Huemoeller. 
Catalina Valencia, 75, replaces Mr Huemoeller as CEO.

The market cap is reported as $750,000. The assets are estimated to be $4.2 million. The liabilities are reported to be around $7.3 million. Is the IP (intellectual property ) really worth so little? How much longer can AXIM avoid bankruptcy?

The Q2 results were a disaster. 

Verséa Ophthalmics LinkedIn page is silent about new customers.  No new customers.   No sales.

This basically tells us Q3 results will also be a disaster.  Why would AXIM pay money they don't have to tell us that Q3 was a disaster?  

Tex. Do you think AXIM has any cards left to play? Can they leverage their assets in any kind of meaningful way at this point?

Is Website shut down?

WWW.AXIMEYE.COM

This one still works.
https://aximbiotech.com/

Wonder if we’ll ever hear from AXIM again

Isn't it wonderful

Not seeing posts from AXIM or Versea I checked out the next The American Academy of Optometry meeting scheduled for November 2024.I located the exhibitor map. Versea secured a prime location directly across from Baush and Lomb. Hopefully we start to see some positive posts soon.

Your own statement says it best.

" Investors need to have more detailed information to make sound investment decisions. "


Let me add one more point to your statement.

AXIM needs to show measurable sales improvement across at least 2 quarters before an investor can make a sound investment decision.

If you are currently not invested in AXIM i would suggest waiting until you see at least 2 quarters of growing revenue before investing.

Thanks Tex and mc73.

They never explained why the DED tests number declined in the last quarter. Could it have been a manufacturing issue that limited available supply of tests rather than a steep decline in demand? That would be an important distinction to be able to discern.

I remember seeing in the last 10-Q that the company is projected to achieve break even around the end of 2024. That is 3 1/2 months from now. Is this remotely likely or even possible? And if this is not possible is it legal for AXIM to make a statement to that effect? Did I read that correctly?

The Parkinson’s Disease test could have a large market that is substantially bigger than DED. I was excited to hear about that development. Early diagnosis might be a useful thing for PD patients to perhaps make preventative lifestyle changes early in the course of their disease. Would IR or the CEO be willing to discuss what is going on with this PD test and other tests in development?

Oftentimes a Biotech company will discuss such things to keep investors as optimistic as possible without abusively stretching the truth or pumping.

Can shareholders demand some sort of timely updates? Investors need to have more detailed information to make sound investment decisions.

CLIA waiver efforts are also not clear to me. This is fundamental to the success of the company.

Perhaps there could be an opportunity to double down at a cheap stock price below this stock price or wait a longer time until break even and an end to the massive dilution. Does anybody have any hope left for AXIM?

Q2 results were a total disaster.
Only 1000 tests were sold in Q2 after almost 5000 sold in Q1.

On Page 28 of Q2 10-Q go to the bottom and read the last paragraph.

I really have not focused on the number of shares lately. Since production started I have only focused on revenue.

Last time AXIM management was this quiet they had apparently screwed up manufacturing and after 5 months of silence hired contract manufacturer Auer Precision at the end of December. Q1 sales were very promising. Then the announcement about the Parkinsons disease test. Then absolutely nothing. The Parkinsons disease test was barely mentioned in the Q2 10-Q.

I have no clue what AXIM management has screwed up this time.

Only 1000 tests sold in Q2.

Verséa Ophthalmics new customer announcements on LinkedIn have dropped from one every week to maybe one a month.

When AXIM management is this quiet, my guess is they screwed something up.

At this point, if you own shares...I say take your losses and run. Whether scam or ineffectual company that just can't figure out how to generate operating revenue, let alone profit, this is garbage

On another board, Stock Twits or Yahoo Finance there are posts that there have been sales of stock totaling over 100 million shares in the past few months massively diluting current shareholders. The next thing that they are predicting is that we do a massive reverse split and then continue to dilute shareholders again from there.

Are current shareholders happy about this? Does management suffer at all in this scenario? Am I exaggerating how bad this seems to be for current shareholders? The selling of hundreds of millions of shares under a penny can only put downward pressures on the share price.

I do not see any efforts by management to communicate with shareholders. Is this some sort of nightmare? Is there anything positive that could be said?

Texas, do you think it all comes down to AXIM getting the waiver for the dry eye tests and that catapulting them to meaningful revenue? Do you think this has a happy ending one day if they can stay alive for now and ultimately leverage all of their IP?

New customer from Georgia.

https://www.linkedin.com/posts/vers%C3%A9a-ophthalmics_visionsource-tpoctitans-tpoc-activity-7232355952732127232-Hk3g?utm_source=share&utm_medium=member_android

Dual test for IgE/MMP-9. Will this test replace the existing IgE test?


Cut/Paste from the 2024 Q2 10-Q.

On December 13, 2022, AXIM announced the development of a novel dual IgE/MMP rapid ophthalmological diagnostic test for which the Company filed a provisional patent with the US Patent and Trademark Office. The new product offers clinicians an innovative new rapid ophthalmological diagnostic solution designed to reliably measure both Ocular Immunoglobulin E (IgE) and MMP-9 in a single test. The test is slated for further clinical development in the third quarter of 2024 and, once FDA approved, will be added to AXIM’s expanding catalog of ophthalmological diagnostic tools available to clinicians throughout North America.

The Parkinson’s disease test was mentioned only 5 times in the Q2 10-Q.

1) "We developed a tear based POC PD test"
2) "We released a video interview" where we talked about our POC PD test.
3) lastly Parkinsons was mention 3 times in 1 paragraph talking about, "We filed a patent" for our POC PD test.

10-Q said Q2 revenue fell off a cliff.
How long has it been since Verséa Ophthalmics LinkedIn page shared a post about a new #TPOCTITAN customer?

These results are a total disaster.
Only 1000 tests were sold in Q2.

On Page 28 of Q2 10-Q go to the bottom and read the last paragraph.


Cut/paste:
NOTE 13: COMMITMENT AND CONTINGENCIES (CONTINUED)

On September 15, 2022, the company entered into a license and distribution agreement for its Lactoferrin dry eye test, Ige allergy test for allergic conjunctivitis and quantitative MMp-9 test to identify ocular surface inflammation. The licensee is Versea Ophthalmics, LLC, A Delaware Limited Liability Company.



The agreement will provide Verséa with the exclusive commercial right to AXIM’s proprietary portfolio of point-of-care (POC) lab testing readers and three key biomarker diagnostic tests designed specifically to assist eye-care physicians in detecting and quantifying biomarkers associated with aqueous deficient Dry Eye Disease and non-specific allergic conjunctivitis. The three AXIM’s key biomarker tests – the Ocular Immunoglobulin E (IgE) test, the Lactoferrin test, and the future MMP-9 test – require the collection of 0.5 microliters in tears and provide quantitative results in under 10 minutes, an industry-leading return time.



Verséa plans to launch IgE and Lactoferrin tests at the upcoming 2022 American Academy of Ophthalmology (AAO) and American Academy of Optometry (AAOPT) conferences. The MMP-9 test is anticipated to follow in the next 18-24 months.



In recent months, AXIM has been preparing for the scaling of production of its tests in anticipation of an agreement such as the one reached with Verséa and is now prepared to support new orders associated with the agreement and subsequent launch.



In order to accommodate Versea we have arranged to have IUL a supplier of test readers to supply readers directly to Versea. Axim has no control over readers and receives no income as a result. This is reflected on a net basis on the financials with no profit or loss effect.



Due to the Agreement, the positions of: (i) National Sales Director; and (ii) Chief Medical Officer held by Jeff Busby and Dr. Joseph Tauber, respectively, were no longer necessary for Company operations and, therefore, eliminated.



The Company received an initial license fee of $150,000 and has the right to cancel the agreement if minimum sales targets are not reached. This amount was recorded as deferred revenue and amortized over 5 years beginning September 15, 2022. During the three and six months ended June 30, 2024 and 2023, the Company amortized $7,479, $14,958 and $7,397, $14,876 The carrying balance as of June 30, 2024 and December 31, 2023 was $96,189 and $111,209, respectively.



The Company also received $192,000 towards sale of its IgE and Lactoferrin tests. The tests were not shipped as of December 31, 2023 so the amount was disclosed as deferred revenue as of December 31, 2023. The initial agreement was made between the parties was $12 per test, but subsequently verbally it was agreed for $10 per test by both the parties.



During the quarter ending March 31, 2024 4,550 in tests were shipped at $10 per test resulting in revenue recognition of $45,500 and during the quarter ended June 30, 2024 1,000 tests were shipped resulting in 10,000 revenue recognition; leaving a carrying value of $136,500. There was a verbal agreement to reduce the selling price of the tests from $12- to $10-

Texas, if I recall correctly you said either in the 3rd or 4th quarter sales would increase significantly for AXIM. Do you still believe that?

Revenue has dried up.

Last 3 months: $17,479
Last 6 months: $70,458

Is insurance reimbursement not happening?

10 Q

NOTICE OF LATE FILING
https://www.otcmarkets.com/filing/html?id=17755591&guid=ItO-kKwg3igFB3h

I still own all of my shares and I'm still watching LinkedIn and various websites for updates.

AXIM and Verséa are silent right now.
Nothing to report.
Nothing to talk about.

I'm in the same position on a pharma company, new cancer treatment. Science works but they can't seem to get approval for human clinical trials.

The FDA is, in my opinion, an inept agency full of corruption, so their CEO may just not have the weight of a Pfizer for approval. Could also be that it is our CEO who just can't get the job done. Either way, I could be holding a big bag here soon if I don't monitor constantly.

Good luck to us all

Holding 5 years here. Had to check my account to confirm it has really been that long lol. Stayed in because of the great scientists/research/development approach. But have to say getting discouraged regarding Axim’s wherewithal on the “business” side. Trying to stay positive as I’m invested now success or failure. Enjoy checking in on this board, cheers everyone!

Holding 5 years here. Had to check my account to confirm it has really been that long lol. Stayed in because of the great scientists/research/development approach. But have to say getting discouraged regarding Axim’s wherewithal on the “business” side. Trying to stay positive as I’m invested now success or failure. Enjoy checking in on this board, cheers everyone!

Maybe, in this case, no news is bad news. How long are people holding on here? I know I have been in and out of this once and I think they could really do something but they have to prove it. Taking this long to start generating revenue when they seemed so close to the end game is hurting the share price. All imo

Down 40% late in the day today on high volume. Is there any bad news?

When you find out please let us know.

There are now a number of eye doctors that are CLIA certified. How many doctors is that? How many DED tests are they using per doctor’s office per month and what is the total number of tests used per month? I read this board fairly thoroughly, but I didn’t see this information. I apologize if I missed it and it was posted.

The CLIA waiver is a key objective to increase the use of these DED tests. What is the current status toward achieving this critical objective? Thanks.

I've read articles about the continuous struggle between health providers and insurance providers on what is covered.

Good find. Here is a link to the Verséa Ophthalmics resources page.

https://www.versea.com/divisions/ophthalmics/resources/

Versea website update on 6/4/24 regarding Corcoran Consulting Group and TPOC

https://corcoranccg.com/reimbursement-of-tear-based-point-of-care-tests/

Shared by Verséa Ophthalmics on their LinkedIn page today.


DED TPOC tests mentioned in following article.

https://www.cornealphysician.com/issues/2024/july/detailing-dry-eye-disease-diagnostics/

This ticker managed to get back above 1 cent...still zero revenues? How long can they drag this out?

K934473 - May 1st 2024. Title updated to "Evaluation of Dry Eyes"


https://www.myhealthtoolkit.com/web/public/brands/medicalpolicy/external-policies/evaluation-of-dry-eyes/


History From 2016 Forward

05/01/2024 Annual review, no change to policy intent. Updating rationale and references. Title updated to Evaluation of Dry Eyes.
01/09/2024 Updating review to April. No other changes.
10/31/2023 Moving Review to January. No other changes made.
04/10/2023 Corrected review date from 04/01/2023 to 12/01/2023 to coincide with Avalon review.
04/07/2022

Annual review, no change to policy intent. Updating rationale and references and adding table of terminology.

04/05/2021

Annual review, no change to policy intent. Updating rationale and references.

10/01/2020

Interim review, updating policy with medical necessity criteria: Testing of tear osmolarity in patients suspected of having dry eye IS MEDICALLY NECESSARY to aid in determining the severity of dry eye disease as well as to monitor effectiveness of therapy. Also updating description, rationale and references.

04/14/2020

Annual review, no change to policy intent.

04/03/2019

Annual review, no change to policy intent, but, expanding specificity of tests that are not medically necessary. Also updating coding.

04/17/2017

Interim review, month of review changed, no other changes.

12/04/2017

Interim Review. Updated policy section. No other changes made.

10/19/2017

Annual review, no change to policy.

04/26/2017

Updated category to Laboratory. No other changes.

12/05/2016

New Policy

Repost from 6 months ago.
Wednesday, 01/31/2024 7:57:48 PM

Just trying to keep up with the AXIM owned and FDA cleared 510K tests. Every once in a while I will search for any new information about these tests.


These are our 510K tests.
AXIM bought the rights from
Advanced Tear Diagnostics

==============================
510(k) Number K934473
Device Name
LACTOFERRIN MICROASSAY SYSTEM
Date Received 09/14/1993
Decision Date 12/03/1993

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K934473

==============================
510(k) Number. K991316
Device Name
TOUCH TEAR IGE MICROASSAY KIT
Date Received 04/19/1999
Decision Date 08/09/1999

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K991316

˜===============================

Applicant
TOUCH SCIENTIFIC, INC.
3209 GRESHAM LAKE RD.
SUITE 112
RALEIGH, NC 27615




#AXIMBIOTECH
#AXIMEYE #DryEye
#Parkinsons #TPOC #Diagnostics
#Lactoferrin #510K
510(k) Number K934473
#TotalIgE #510K
510(k) Number. K991316


Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS

Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485

I'm not pressing the bullish button, because this is very low volume AXIM. Obviously there is so much negative history with this company and management that stinks.


However, the 3 month chart does look like a cup and handle.

There are some positive things over the last 8 months. Manufacturing and shipping started in December by cintract manufacturer Auer Precision. New customers were being announced almost weekly for the first 5 months of sales, but seems slower than that recently.

My guess is no progress has been made on the CLIA waiver applications unless Verséa Ophthalmics has agreed to own that process.


This is not investment advice.

New customer.
https://www.linkedin.com/posts/vers%C3%A9a-ophthalmics_tpoctitans-tpoc-ophthalmics-activity-7218947570968989696-Smj4?utm_source=share&utm_medium=member_android