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Auer Precision was mentioned exactly 1 time.
The Parkinson Disease test was mentioned exactly one time.
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Revenues. $ 39,518
Net loss. $(8,059,682)
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Common stock, $0.0001 par value, 1,000,000,000 shares authorized 245,929,403 and 192,441,917 shares issued and outstanding, respectively.
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The Company has authorized 1,000,000,000 shares of common stock, with a par value of $0.0001 per share. As of December 31, 2023, and 2022, the Company had 245,929,403 and 192,441,917 shares of common stock issued and outstanding, respectively.
2023 Transactions:
The Company converted debt of $380,858 including accrued interest of $30,858 in exchange for 22,207,486 shares.
these shares were issued at $0.031 resulting in extinguishment of debt Beneficial conversion payment of interest ($688,432) and Debt modifications / conversions feature worth ($459,522).
Common stock issued under s-1 23,000,000 shares in exchange for cash $514,931.
Common Stock issued stock purchase agreement 7,280,000 in exchange for equipment valued at $72,800 and recorded a loss on issuance of $80,080.
BTW, the two DED tests are in Production. I seriously doubt the scientists are still making patentable improvements to the two tests in 2024 since they are already in Production.
(Sigh)
John
John
John
Just for grins I cut/pasted the CLIA forward looking statement paragraph from 2023 and 2024. At least John remembered to change the year.
Bottom line. Verséa will have to help with the CLIA Waiver or it will not get done.
AXIM Biotechnologies, Inc. - 10K - Annual Report - April 17, 2023
The FDA allows for a CLIA waiver, and we intend to pursue a waiver for both current tests and all future product offerings. Our scientists have been diligently making patentable improvements to the tests which will simplify use by the clinician and enhance likelihood the CLIA waiver approval. We plan to file for the waiver early in the second quarter of 2023 after conducting a fairly simple comparative clinical study. The objective will be to determine whether the AXIM Eye test system has equal or better simplicity than the other forms of diagnostic testing for DED, which we believe is the case. This study is a key component of the filing process with the FDA for a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver. We believe that the acquisition of these FDA 510k cleared diagnostic products, a waiver and the distribution partnership we have with Versea will allow the business to grow at a rapid pace.
AXIM BIOTECHNOLOGIES, INC.
FORM 10-K
FOR THE YEAR ENDED DECEMBER 31, 2023
TABLE OF CONTENTS
The FDA allows for a CLIA waivers, and we intend to pursue a waiver for both current tests and all future product offerings. Our scientists have been diligently making patentable improvements to the tests which will simplify use by the clinician and enhance likelihood of CLIA waiver approval. We plan to file for the waiver in the second quarter of 2024 after conducting a fairly simple comparative clinical study. The objective will be to determine whether the AXIM Eye test system has equal or better simplicity than the other forms of diagnostic testing for DED, which we believe is the case. This study is a key component of the filing process with the FDA for a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver. We believe that the acquisition of these FDA 510(k) cleared diagnostic products, a waiver and the distribution partnership we have with Versea will allow the business to grow at a rapid pace.
This isnawesome to see!
This is a great point.
There was still an insufficient shares derivative liability entry in the balance sheet. That must be a pretty extreme liability if a billion shares doesn't cover it. I didn't see the AS increase addressed. Did anyone see where that was addressed?
FORM 10K "The FDA allows for a CLIA waivers, and we intend to pursue a waiver for both current tests and all future product offerings. Our scientists have been diligently making patentable improvements to the tests which will simplify use by the clinician and enhance likelihood of CLIA waiver approval. We plan to file for the waiver in the second quarter of 2024 after conducting a fairly simple comparative clinical study. The objective will be to determine whether the AXIM Eye test system has equal or better simplicity than the other forms of diagnostic testing for DED, which we believe is the case. This study is a key component of the filing process with the FDA for a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver. We believe that the acquisition of these FDA 510(k) cleared diagnostic products, a waiver and the distribution partnership we have with Versea will allow the business to grow at a rapid pace."
I've had my comments about MJNA in the past. Is there a risk that MJNA and AXIM BOD and leadership take AXIM private right before sales really take off? Sure that could happen. Axim could also file for bankruptcy and reorganize.
My cost per share is at an acceptable level.
Bottom line for me is we are not even 4 months removed from the Auer Precision manufacturing agreement. Auer Precision is ISO-13485 certified. Verséa Ophthalmics is run by an eye doctor with a dual expertise in diagnostic testing. We have two FDA cleared 510K tests that are in the marketplace right now.
It makes no sense to sell right now.
Obviously a bug on the website. "Please sign in to see pricing" but if you click the cart icon, the price is visible. This is a bug on the website in my opinion. I'm sure you have to create an account to Purchase these tests. The Account setup process should verify and validate the CLIA compliance status of the account location ordering the product.
The website shows $1125 for IgE tests and Lactoferrin Tests. From the following LinkedIn post there is a picture of a box of 50 tests.
$1125 ÷ 50 = $22.5 per test.
https://www.linkedin.com/posts/kyledkluteod_optometry-optometry-optometrists-activity-7182089642018578432-SGx6?utm_source=share&utm_medium=member_android
Why would Verséa Ophthalmics stop posting updates to their LinkedIn page? I don't know but I hope it is not related to the FDA. These tests can only be used by CLIA compliant offices. By extension my guess is that only a CLIA compliant location will be able to order these tests. Unless there is another bug on the website that allows ordering product with a drop ship without an account setup.
Another reason we need CLIA waivers ASAP.
You might want to start thinking of taking your losses and moving on. If not now, when? Another year? 2 years? There has to be a point where you realize nothing will happen here. It might not be to that point yet, but it seems to be getting close imo. I'll watch this for another year and if it is more of the same, I won't even follow on here and iHub any longer.
Hopefully, in the next year, this company produces some results.
It could be a small company with one person wearing many hats. Maybe same person building the website is same person posting to LinkedIn.
Hopefully that same person is not Doctor Sambursky.
At the end of the day, even tho I don't own any shares, it is VERY concerning: the lack of communication.
I've said before - MJNA is a scam company. Hopefully, this ticker is legit but the longer this drags on...
If you click on the Shopping cart the cost per each item is visible. The website appears to not be finished yet and/or the website would probably work better if I was an approved customer.
LFR - Lateral Flow Reader $1950.
I just find it strange how the Verséa Ophthalmics LinkedIn page has gone mostly quiet the last 2 weeks after the page being so active prior to that. Even some recent customer activity has not been posted.
Prior to this two week stretch Verséa Ophthalmics was posting to their LinkedIn page every week.
Maybe someone is on vacation??
It looks good. I'm glad that they went with a very healthy eye optic rather than a sick eye needing treatment. That will attract more eyeballs.
If SAFE banking is passed I'm loading the boat with CVSI. The best CBD brand imo but they need SAFE banking or regulations implemented for them to explode. Just a matter of time
I've been watching in NPTX prior to the name change. I only owned a few shares with planes to build up. When they received a significant grant for research I had high hopes. I still believe with MJNA being a high stake holder we will see growth when safe banking and bills get moved along.
First time I've seen this site. I'm thrilled to see mainly because AXIM is noted on the site. The main web page has a link for partnerships; I've been surprised that AXIM has never been noted.
Does Verséa Ophthalmics have a new website?
I have not noticed this website before. Has anyone else noticed this website before??
https://verseaeyecare.com/
Versea might need a website like this for a couple of reasons.
** Make Re-orders easier for their existing customers already setup as a CLIA compliant office.
** Make ordering easier once CLIA Waivers are submitted and approved. I did not think about an additional website for customers when listing the required steps prior to CLIA Waiver approvals. Just another sign that a plan is being followed.
You seem to be the only person on Ihub following NPTX besides myself. What do you think is happening there? Its part of all of this being a subsidiary of MJNA who holds a big share of AXIM
Could be an interesting week with 4/20 rapidly approaching. I'm not sure if anyone else noticed that Versea a couple months ago took their direct sells page down which sold CBD. Versea and AXIM working together on many fronts has me curious if Versea broke ties with CBD company to work with MJNA / Hemp Meds / Neuropathix in the future. A few comments have been made regarding a potential merger just something else to consider that could be happening behind the scenes. Or, they just got out of the CBD business :)
Agree, good point! If the business is moving in a positive direction, there sure isn't any evidence of it for shareholders. They could be building a massive pathway to revenues and profitability only to take the company out of the public domain
Yes it was.
I found this LinkedIn post from Sean Fetcho CEO of Verséa from just 3 days ago.
https://www.linkedin.com/posts/activity-7183572173842710530-dLJy?utm_source=share&utm_medium=member_android
"Nationwide remote positions available now."
This seems to cast doubt on my speculations that Verséa is needing investment capital.
The Verséa Ophthalmics page just seems to quiet the last 2 weeks.
Nice Close Friday.
I guess the worst-case scenario is Verséa Ophthalmics is insolvent and Verséa Health needs to cut that division.
Without CLIA waiver approvals Verséa Ophthalmics and AXIM are both burning a lot of cash. Adding just one paying customer a week seems like it will take too long to be cash-flow positive.
In that case maybe Mr Huemoeller does change gears and try to market the TPOC Tear-based Point-of-Care Parkinson Disease test.
I guess anything is possible at this point.
I guess we will know soon enough.
Good luck to all.
Not investment advice.
The company is essentially being taken private as the notes are slowly converted. Feels like time for the insiders to make another big grab and tell the world that they are saints for funding the enterprise.
Just a guess but I bet Verséa Health's covid19 test business is shrinking to nothing.
Verséa Ophthalmics is still not generating enough cash-flow. I just think AXIM and Verséa Ophthalmics need an infusion of investment for the next stage of growth.
Maybe the new AS/OS is delayed because of a pending merger??
I don't know.
When there is no news to report I guess I tend to fill the void with opinions.
How is a public company taken private?
What would our shares be worth if AXIM management agreed to a merger to take AXIM private?
I don't know.
I'm asking the questions.
This would probably not be a good thing for retail investors. I guess it could happen if our management wanted it to happen.
It seems like I have noticed a slight change on LinkedIn. Everyone associated with the Ophthalmics division seems to have updated their profiles to "Verséa Health" instead of "Verséa Ophthalmics".
Could be nothing.
Maybe just streamlined messaging for advertising purposes.
Just a curious little change. Plus the Verséa Ophthalmics LinkedIn page has been unusually quiet.
I'm okay to be wrong.
All I expect to learn Monday is the AS and OS. Why do you think the future will be revealed? Why set yourself up for disapointment?
I guess we should know by Monday, 4-15-24 unless there is another extension.
I am starting to believe that it's more than just blue light from screens and lighting that causes DED. I think that the prolification of BT and WiFi may also be related.
There is also the NPTX ticker and the variable AXIM notes that need to be converted when the acumulation phase wraps up.
Blue, why delay the AS/OS information? There has to be a reason.
The only thing I can come up with is a merger.
AXIM and Verséa must be in some type of merger discussions. But my gut is telling me AXIM and Verséa might be in discussions with a third party with a little more financial backing. NOT a Big Pharma. But a third company where AXIM and Verséa still control the consolidated company.
I keep thinking about the delay in shareholder information and this is the only thing that makes sense.
I keep looking at AXIM at different angles to see if I'm being foolish for investing here.
I might be foolish. That is a possibility.
Let me just admit to that.
HOWEVER, if my tiny investment is foolish then multiply that by 100 or 200 or 1000 or whatever the multiple is and that is what Catalina Valencia pulled out of her pocket maybe 15 months ago.
When I see that kind of commitment from Catalina Valencia my thoughts are not "IF" but "WHEN" AXIM is profitable. That was some rock solid commitment from Catalina Valencia.
15 million shares times zero still equals zero.
25 million shares times zero still equals zero.
Just remember that Catalina Valencia made her investment after Doctor Rob Sambursky was brought in as an advisor by the AXIM BOD. Then Dr Sambursky was hired as a VP by Verséa Health and President of Verséa Ophthalmics.
Maybe the plan is taking longer than expected.
Customers and sales are increasing every week.
I am keeping an eye on this ticker. Appreciate all the great DD you post here.
No debate on that point.
It has been a long time.
However I will argue that AXIM is closer now than ever before.
^^ Two FDA cleared 510K Dry Eye disease Diagnostic tests.
^^ Marketing agreement with a very knowledgeable and energetic sales team in Verséa Ophthalmics
^^ Manufacturing agreement with an ISO-13485 certified manufacturer in Auer Precision who seems perfect to help with the AXIM and Verséa Ophthalmics national roll-out.
^^ Sales increasing every month.
^^ Two more Tear-based Point-of-Care tests in the pipeline MMP-9 and Parkinson Disease tests.
What is the old saying?
"Close only counts in horse shoes and hand grenades"
Let's hope for a lucky horse shoe with the CLIA Waiver Application and Approval. Maybe with Verséa Health's experience we don't need luck. But if the FDA doesn't approve a Waiver this will be a slow path.
I've been here since the first beginning with Dr George. It's been a long road.
It's only been what...couple years already?
So that's why some of the employees like Jessica has an address on their business cards that was essentially a mail drop at a shared office in Tampa.
Verséa Health already expanded their office and warehouse space in 2023. Here is that press release from May 8th of last year. I think Kurt Phinney was responsible for helping with the expansion process.
First paragraph:
"plan to add 40 new jobs over the next 2-3 years."
https://www.versea.com/versea-health-inc-expansion-to-a-larger-facility-in-tampa-fl/
I have to believe much of that expansion will be dedicated to supporting the Verséa Ophthalmics division.
I believe AXIM and Verséa Ophthalmics and Auer Precision have all been following a planned roll-out. The CLIA Waivers are maybe the last steps before the flood gates are opened. Hopefully those last steps happen sooner than later.
Wow Tex! You think volume will increase sufficiently that Versea will need to expand their warehouse and accounting infrastructure? That's a lot of readers and tests.
This eye doctor will be announced as a new customer this week or very soon. He seems very excited about getting started with the new TPOC testing system.
https://www.linkedin.com/posts/kyledkluteod_optometry-optometry-optometrists-activity-7182089642018578432-SGx6?utm_source=share&utm_medium=member_android
I started following Kyle Klute on LinkedIn. He seems like a Verséa Ophthalmics sales representative. He is that excited!!
Not investment advice.
Hashtags related to our company and partners.
Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
#Parkinsons #TPOC #Diagnostics
#Lactoferrin #510K
510(k) Number K934473
#TotalIgE #510K
510(k) Number. K991316
Bottom line is Verséa has resources that understand how to interact with the FDA.
Verséa knows how to submit CLIA Waivers and have them approved. It has only been 3+ months since manufacturing started at Auer Precision. At some point Verséa Ophthalmics will have a priority to help AXIM with the CLIA Waiver Application process. Something tells me there is a schedule that needs to be followed.
What needs to happen BEFORE CLIA Waivers are approved??
A few things I can think of are listed:
Auer Precision will need to ramp up manufacturing to meet the explosion of new customers.
AXIM and Verséa Ophthalmics will need hundreds or thousands of the new test readers that are manufactured in Spain.
Verséa Ophthalmics would need to ramp up their support teams. Warehouse, Sales, Accounting, Customer support.
I'm sure there are other considerations.
Blue, thanks for sharing the CLIA Waiver information from Verséa Health!!
AXIM and Verséa Ophthalmics are following a plan. A lot of things need to happen BEFORE turning on the flood of new orders.
At least the FDA is moving faster when CLIA Waivers are submitted.
Not investment advice.
Hashtags related to our company and partners.
Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
#Parkinsons #TPOC #Diagnostics
#Lactoferrin #510K
510(k) Number K934473
#TotalIgE #510K
510(k) Number. K991316
Both of them look the same so it looks like it took just over 2 months for both. One can dream though. I just wish Bigcharts would start working correctly. I wasted so much time this morning trying to get charts to update I didn't give this enough time.
I see the following dates.
My impression is 510K date
Date Received 04/12/2023
Decision Date 06/16/2023
2 months which is still awesome.
Then 1 year later the Waiver approval
Complexity WAIVED
Effective Date 04/04/2024
Versea has a lot of these under their belt. This is something that they clearly know how to get done.
The approval shows
Date received
Date approved
My assumption is that date received is the application date.
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Moderators Blue Skys Squirrel Hunter |
Unlike currently available serological COVID-19 tests that detect an antibody response to the virus, AXIM’s rapid 10-minute test measures a specific subpopulation of antibodies to block binding of the virus to host cell receptors. While there are expensive, time consuming laboratory tests that measure neutralizing antibodies, NeuCovixTM differs in that it is a portable, low cost, rapid point-of-care test with results in 10 minutes.
“We are hopeful our test fills an important need in these uncertain times. While other tests merely show whether someone was infected with coronavirus, we took it a step further by creating a test that stratifies individuals into those who have neutralizing antibodies, which are essential in preventing reinfection, and those who don’t. The test can be deployed for point of care use in convalescent plasma transfusions to severely ill patients and for evaluating efficacy of upcoming vaccines in generating protective antibodies,” said Sergei Svarovsky, PhD, MBA, AXIM’s CSO and co-inventor of NeuCovixTM.
An immediate application of NeuCovixTM, a point-of-care test, is to measure levels of neutralizing antibodies in convalescent plasma so that plasma with the highest levels of neutralizing antibodies can be identified and administered to patients fighting COVID-19. Without this knowledge, many patients could be undertreated with non-neutralizing plasma and may not benefit from this treatment.
Another application of NeuCovixTM is to help ensure that vaccines elicit high levels of neutralizing antibodies. When a vaccine is available, manufacturers can employ the NeuCovixTM rapid, point-of-care test to evaluate protective immune responses in vaccine recipients.
AXIM® Biotech CEO John W. Huemoeller II commented, “Our goal was to make this test, accurate, fast and relatively inexpensive so it could serve as an ‘Immunity Passport port™’ for vaccine developers around the world as they begin larger Phase II and III clinical trials. We are optimistic that NeuCovixTM will be widely used, becoming the gold standard in assessing levels of immunity.”
Doug Lake, Ph.D. and co-inventor of NeuCovixTM commented, “Everybody who recovers from COVID-19 makes antibodies against the virus, but since all antibodies are not created equal, you really want to know if the antibodies you make neutralize the virus. People who recover want to make sure they are protected from re-infection and that they won’t infect others.”
AXIM also announced the filing of a pre-Emergency Use Authorization Application (EUA) and has already initiated dialogue with the FDA in order to finalize its EUA submission. The intellectual property relating to the novel serological test is the subject of Provisional Patent Application No. 63/023,646 “Convalescent Plasma Testing and Treatment” filed on May 12, 2020.
About AXIM® Biotechnologies
Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated oncology company developing rapid diagnostic tests for the early detection of cancer and proprietary small molecules drugs to treat cancer and block metastasis. The Company is also developing novel antibodies for therapeutic and diagnostic uses for oncological therapeutics. For more information, please visit www.AXIMBiotech.com.
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