Axim Biotechnologies Inc (QB) (AXIM) News

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

I have not noticed any posts from Jessica Barr on LinkedIn the last few weeks. She was racking up the frequent flyer miles for Verséa Ophthalmics helping eye doctor offices open up the CLIA compliant #TPOCTITAN locations.

I hope it is nothing. Maybe it is a transition to "train the sales staff" to help. Maybe it is a focus by Verséa Ophthalmics to help AXIM with the CLIA Waiver Application process? I don't know what it means. If anything.

#Ophthalmic #Surgical #Instruments

Abdul Hanan and Company made following post yesterday on LinkedIn and copied Verséa Ophthalmics. Apparently Verséa Ophthalmics will market #Ophthalmic #Surgical #Instruments as well as their diagnostic and therapeutic solutions. A complete Ophthalmic supply company. No posts yet from Verséa Ophthalmics.



https://www.linkedin.com/posts/abdul-hanan-%26-company_lid-retractors-ophthalmic-activity-7216000138144583681-h4tX?utm_source=share&utm_medium=member_android

I know this has to have a damn small SS and even smaller float if 141,000 shares moved it a half penny

New customer from Nebraska. There might be a few more from Nebraska waiting to be announced. Nice bump in share price. Low volume.


https://www.linkedin.com/posts/vers%C3%A9a-ophthalmics_tpoctitans-tpoc-ded-activity-7213511813043236865-gqkj?utm_source=share&utm_medium=member_android

Of course...only 130k shares traded

Does someone know something???

Another new office....
Good Life Eyecare i

We are up 50% in the first hour of trading happy Monday

This technology with a little gift of medicine astronomy would be superior above all curing everything imo

Blue you asked for my thoughts on Incannex

https://www.prnewswire.com/news-releases/incannex-to-acquire-apirx-pharmaceuticals-usa-llc-301509597.html

It was only a quick read and only a thumbnail opinion.

Appendix A of this Incannex Healthcare report shows most of the intellectual property is Preclinical or Phase-1. Verséa Health might be a good fit for Incannex, but it looks like a lot of work to bring products to market.

Verséa does have both short-term and long-term projects but they definitely seems to want FDA cleared products that can be sold through their growing national sales force. Price would be a factor for a deal to be successful.

AXIM is a great fit for Verséa. Already two FDA cleared products as a foundation. At least 2 more products in the Dry Eye pipeline. Many other patents.

However in my opinion, sales are not growing fast enough for AXIM to survive much longer. On the other hand AXIM Insiders control the company. I think a stock merger makes the most sense for both Verséa and for AXIM.

With a stock merger no cash or very little cash would be needed. Existing Insiders would keep their shares and hope for a better future. Retail would also keep their shares. Insider ownership would expand to include Verséa and Insiders remain in control of the combined company.

Verséa can hopefully bring in new investment to expand the business and get CLIA Waivers submitted and approved for the AXIM products.

Just a gut feeling. I'm guessing Mr Huemoeller would need to retire his salary and become a board member for a merger to happen. Catalina Valencia may also need to retire her salary for a deal to work.

New Customer from Omaha, Nebraska.

https://www.linkedin.com/posts/vers%C3%A9a-ophthalmics_tpoctitans-tpoc-osd-activity-7209163202037714945-XALW?utm_source=share&utm_medium=member_android

Totally agree.
I think Verséa Ophthalmics will be successful, but put the pom poms away because AXIM is destroying the retail investors. Nothing to cheer about right now.

Obviously the share price is in the toilet for the insiders as well. But at least they hopefully already know what the plans are for the next few quarters.

A Billion shares multiplied by half a penny is only $5 million. The AXIM market cap is way less than $5 million right now. A billion shares can't even fund AXIM for more than 2 quarters with the rate of spend seen in 2023.

1,000,000,000×0.005= $5 million.

My hands are cut to pieces trying to grad this falling knife. It's about time we get some inside help to hold this thing up. Done bottom fishing here.

I was hoping reading the lyrics to keeping the faith by Billy Joel would give me a sense of calm... So far that hasn't worked. Wishing I had some disposable cash right now to through at this stock and hope for the best but I'm tapped out for the moment. Here's hoping that AXIM follows through with second quarter submission.

Seems like something nasty is going on behind the curtains. Shareholders are in the dark and no revenues....

Have I mentioned how much John W. Huemoeller II "SUCKS" at watching over AXIM's share value?

Next week is another week with very little wifi for me. Good luck to all.

Its always a good sign when management shows such great interest in acquiring equity.

The AXIM stock price is still tanking hard even below 1 penny. Yes. That is correct.

The AXIM stock price has dropped maybe 75% over the last year when it was announced in July 2023 that AXIM was manufacturing and shipping their FDA cleared 510-K tests to paying customers.

Then FIVE MONTHS OF SILENCE.

The AXIM stock price has dropped maybe 50% over the last 5 months since sales and shipments started in December 2023 after Auer Precision was announced as contract manufacturer.


Why should I feel so positive right now?
Why create continuous posts about a Company bleeding cash that they are obviously borrowing from someone else? What is my point?

We are not able to see all of the positive developments happening right now with our merchandising partner Verséa Ophthalmics.

Think about it. Those three posts by Doctor Kyle Klute are from one doctor from one regional location near Omaha Nebraska. At least 3 other eye doctors are mentioned in the posts or made comments to the posts. Verséa Ophthalmics just completed a successful #TPOC implementation training in Omaha Nebraska. Omaha Nebraska is just one regional location where Verséa Ophthalmics has hired sales people.


Verséa Ophthalmics has announced #TPOCTITANS from many different regional locations across the USA. In my opinion, Verséa Ophthalmics has a serious backlog of customers waiting to be announced as #TPOCTITANS across maybe 10 or 15 regional locations. Right now we only see the announcements on LinkedIn. There are a lot more new customers waiting in line.

Should I allow myself to feel this positive?

In my opinion, we are literally just one or two quarters away from very explosive growth in sales and revenue.

In the previous post I shared a link from Verséa Health that stated Verséa Ophthalmics "Hosted a successful T-POC Implementation training in Omaha Nebraska".

In this post I want to string together three posts over the last 2 months by a new customer Doctor Kyle Klute, who to date still has not been announced as a #TPOCTITAN by Verséa Ophthalmics. That announcement should be coming soon. Notice the above training was in Omaha Nebraska. At least 2 of the 4 eye doctors mentioned in these posts are based out of Omaha Nebraska. It will be interesting to watch if Verséa Ophthalmics adds more of these regional #TPOC Implementation training courses across the country. This is another way to better utilize existing resources to add more locations within a compressed amount of time.

First post by Dr Klute from 2 months ago has a picture of the AXIM tests branded by Verséa Ophthalmics. (TWO MONTHS AGO!!!) Verséa Ophthalmics has a serious backlog of new customers waiting to be announced as #TPOCTITANS (This is great news. Demand for the AXIM tests is strong.)

https://www.linkedin.com/posts/kyledkluteod_optometry-optometry-optometrists-activity-7182089642018578432-SGx6?utm_source=share&utm_medium=member_android

Second post mentions Verséa Ophthalmics and the post references a peer reviewed article from August 2023 that I believe was a first attempt by Verséa Ophthalmics to lay the groundwork for CLIA waiver approvals. However in my opinion this attempt may have been nullified by AXIMs failures to manufacture the tests within their lab. (NOTE: This was 5 months prior to Auer Precision being announced as the contract manufacturer in December 2023.)

https://www.linkedin.com/posts/kyledkluteod_dryeye-optometry-eyecare-activity-7183116415497895937-S66r?utm_source=share&utm_medium=member_android


The third post is from 1 month ago and calls out thanks to Kerry Robbers and Rahim Hirji for getting them trained and running. In the comments another eye doctor mentions she is taking the CLIA lab director certification course so her office can implement the Verséa Ophthalmics testing platform.


https://www.linkedin.com/posts/kyledkluteod_optometrists-dryeye-eyecare-activity-7193277260458594304-UOAG?utm_source=share&utm_medium=member_android

I my opinion. AXIM would already be bankrupt if not for deep pockets from insiders and MJNA and Verséa.

The AXIM (Sapphire Biotech) science team have produced some very unique and marketable quantitative Point-of-Care Diagnostic tests.

Verséa Ophthalmics is lead by a very knowledgeable Eye Doctor who also has founded three prior Diagnostic companies. Verséa Ophthalmics is building a team of very qualified professionals. Verséa Health is apparently investing very heavily into the success of the Ophthalmics division.

People should read the last few quarterly reports and make up their own mind about investing in AXIM. If Verséa Ophthalmics helps AXIM with CLIA Waivers comparison studies and documentation to the FDA AXIM can be cash-flow positive sooner.

The only reason I increased my position recently
is a gut feeling that there could be some type of merger between AXIM and Verséa Ophthalmics.
Maybe that is wishful thinking on my part.

Good luck.

Tex do you think the true worth of AXIM and its portfolio of present and future tests, IP, and patents is very under valued by this sub penny share price?

Verséa Ophthalmics is mentioned in this Verséa Health LinkedIn post.

Verséa Ophthalmics:
"Hosted a successful T-POC Implementation training in Omaha Nebraska".

This is good news. Hopefully the backlog of new customers starts to come online faster.


https://www.linkedin.com/posts/verseaholdings_verseahealth-healthcareinnovation-activity-7204857792128544768-ATjw?utm_source=share&utm_medium=member_android

That was a disappoint when this happened. I use to buy the gum and seemed to have interesting approaches.

I would think it might be related to CLIA waiver. Maybe they need ISO certification before they can obtain the CLIA. Just a thought