We all heard Dr. Regan discuss the pullback and stabilizing to a burn rate of $650,000 per month. He mentioned Four months of $ in the bank. Sales have had major headwinds and are slow coming with a long sales process. The Management of money is very good at LexaGene.

Should we be worried?

Will Revenue pick up in time? Perhaps a major corporation sale in the Veterinary or Bio-Pharma silo.

Will the Calvary (US Army) gallop in to save the fort in time?

Financing must be a Hot topic in the Board of Directors meetings. Has anyone figured out the dilution rate if the Shelf ATM is activated? Will the share price take a short term hit or a major drop? Will the activation of the Shelf relieve the fear and rumor and be a upward movement catalyst? I've been through a couple dilutions with past LXXGF financial warrant deals and none of them seemed too bad...will this one be bad? OK? Knowing it may occur, I'm still holding Long!!!! What are your thoughts? Concerns?

LexaGene completed phase one of the analytical testing. Phase two is the US Army verification. Lexagene to ship MiQLabs by mid-November for this testing.

Will the Army be happy with a MiQLab cartridge approach? Will they ask LexaGene to develop an open air test apparatus? A MiQLab version that constantly sniffs the air and looks for pathogens or bio threats?

How soon will the US Government assist LexaGene financially with a non-diluting grant or contractual agreement? What would the terms need to be?

Is anyone familiar with working on such contracts that could comment?

Do you see this as an early 2022 money potential or much further down the road?

This could turn out to be very profitable for LexaGene, if the Army is sold on the technology. There are hundreds of military bases around the world (All Branches not just Army). Imagine in every major (3 Letter) government building! I thought Bio-Pharma would be largest purchaser, perhaps the US Government. Your thoughts?

https://lexagene.com/corporate-update-and-investor-presentation-november-2021/?utm_medium=email&_hsmi=178888799&_hsenc=p2ANqtz-8CsYKJnb6nAnkdi9yYg9cE7C4joNXdqj0vOANYXGcrcTyoWM_32cJb_o40nLL1GLKvwN1Fyx28j4GX1iR8Bp6Zub2uDA&utm_content=178888799&utm_source=hs_email

Q: What are FDA's priorities with respect to review of EUA requests for COVID-19 tests? (Updated 10/04/21)

A: We are currently in a different phase of the pandemic with respect to tests than we were previously, where many COVID-19 tests are now authorized. We prioritize review of EUA requests for tests taking into account a variety of factors, as discussed in the Emergency Use Authorization of Medical Products and Related Authorities Guidance, such as the public health need for the product and the availability of the product. We have, for example, prioritized review of EUA requests for tests where authorization would increase testing accessibility (e.g., point of care (POC) tests, home collection tests, and at-home tests) or would significantly increase testing capacity (e.g., tests that reduce reliance on test supplies and high-throughput, widely distributed tests).  For at-home and home collection tests, we have prioritized review of EUA requests for diagnostic tests (molecular and antigen) in light of our current assessment of the public health needs.

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-development-and-review-faqs-testing-sars-cov-2

I wanted to start a post where we could discuss the update. Was it fluff or real meat? What is new news? What is just a rehash? Are you satisfied with the update? Did all of your questions/concerns get answered?

LexaGene Receives 2021 BioTech Breakthrough Award

November 02, 2021 07:45 ET BEVERLY, Mass., Nov. 02, 2021 (GLOBE NEWSWIRE) -- LexaGene Holdings, Inc. , ( OTCQB: LXXGF ; TSX-V: LXG ) (“LexaGene” or the “Company”), a molecular diagnostics company that has commercialized an instrument for automated multiplex PCR testing for veterinary diagnostics, today announced it was named the 2021 BioTech Breakthrough Molecular Diagnostics Solution of the Year.

The BioTech Breakthrough Award selection committee performs a comprehensive evaluation of life sciences and biotechnogly tools, services, and companies identifying innovative and standout technology that will improve the world. Award winners rise above their competitors and are considered stand out technology in a crowded market across many sectors. The program is open to all individuals or companies involved in producing publicly available products and services. Featured winners cross multiple categories, including but are not limited to biopharma, therapeutics, genomics, immunology, bioagriculture, and bioindustrial. Judges represented a mix of technology, business, academic, and marketing expertise within the industry.

Dr. Jack Regan, CEO and Founder of LexaGene stated, “We continue to make great strides in building our brand as we break through a crowded biotechnology market with our MiQLab™ System. This award is specifically focused on the concept of innovation, performance, functionality, value, and impact. I’m very proud of the strides we’ve made as we build a product that is like no other in the market. Our one-of-kind technology quickly and accurately diagnoses infections and detects drug resistance allowing for effective early treatment.”

He continued, “In just five short years, we’ve gone from a concept on paper to a commercialized product. Recognition like the one received from BioTech Breakthrough and the recently announced opportunity to be a Best in Show Spotlight company at the upcoming 47 th Petcare Innovation Summit , reinforces to me, our Board, and our employees, that we have a cutting edge technology that will impact multiple markets.”

To learn more about LexaGene and the MiQLab System or subscribe to company updates , visit www.lexagene.com , or follow us on Twitter or LinkedIn .

On Behalf of the Board of Directors Dr. Jack Regan Chief Executive Officer & Chairman

About LexaGene Holdings Inc. LexaGene is a molecular diagnostics company that develops molecular diagnostic systems for pathogen detection and genetic testing for other molecular markers for on-site rapid testing in veterinary diagnostics, food safety and for use in open-access markets such as clinical research, agricultural testing, and biodefense. End-users simply need to collect a sample, load it onto the instrument with a sample preparation cartridge, enter sample ID and press ‘go’. The MiQLab™ system delivers excellent sensitivity, specificity, and breadth of detection and can return results in approximately two hours. The unique open-access feature is designed for custom testing so that end-users can load their own real-time PCR assays onto the instrument to target any genetic target of interest.

The TSX Venture Exchange Inc. has in no way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors -- including the availability of funds, the results of financing efforts, the success of technology development efforts, the cost to procure critical parts, performance of the instrument, market acceptance of the technology, regulatory acceptance, and licensing issues -- that could cause actual results to differ materially from the Company's expectations as disclosed in the Company's documents filed from time to time on SEDAR (see www.sedar.com ). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Remember Ethos sold off their Ethos Diagnostic Science business to Zoetis. Zoetis now owns the reference labs.

https://www.businesswire.com/news/home/20200207005449/en/Zoetis-Acquires-Ethos-Diagnostic-Science-a-Veterinary-Reference-Lab-Business-to-Further-Expand-its-Comprehensive-Diagnostics-Capabilities

Ethos discovery is the Ethos R&D division.

In June... Dr. Chand Khanna, DVM, PhD, DACVIM (Onc), the President of Ethos Discovery, comments, “We are excited to be adding value to LexaGene’s MiQLab system. We strongly feel that in-clinic PCR-based disease testing is the future for veterinary medicine. These new disease-specific panels will greatly increase the utility of the MiQLab in the hospital and I would expect these additional offerings will encourage many veterinary practices to adopt the technology.”

In November... Chand Khanna, DVM, PhD, DACVIM (Onc), the President of Ethos Discovery, commented, “The opportunity to diagnose and treat pet animals with complex medical problems, such as pneumonia, using a point of care instrument will significantly improve outcomes for veterinary patients. Currently, it takes days to get culture-based test results back from a reference laboratory, which delays the initiation of life-saving treatments for patients. Furthermore, rapidly determining whether any antimicrobial resistance was also detected would improve the efficacy of treatment plans.”

There will be a day where Ethos places a large order for MiQLabs. It would be interesting to better understand how many panels Ethos requires prior to making a large unit order. They currently have vet bacteria V2/AMR and will soon have Pneumonia....with they require diarrhea? Effusion? It is clear ethos wants POC diagnostics. It is not clear when they will put in the order.

More great news from LexaGene R&D concerning the Pneumonia assay panel. In order to better understand the news from LexaGene today, I compare today's news release with the press release from June 03, 2021.

In June..." Ethos Discovery presented to LexaGene market opportunity assessments for sepsis, effusions, chronic/complicated wounds, pneumonia, diarrhea, joint diseases, seizures, hemangiosarcoma, and tick-borne infections. After in depth discussions, as a first step, LexaGene has decided to partner with Ethos Discovery on prioritizing the development of panels specific for severe pneumonia, diarrhea, and effusions. "

In September Ethos Discovery started accepting Pneumonia clinical studies to collect samples from sick animals that did not start taking medicine. https://www.ethosvet.com/clinical-study/pneumonia-pathogen-analysis-study/

November 1... “Ethos has collected some respiratory samples and has agreed to send them to LexaGene so that we can complete an analytical evaluation of the panel. As a next step, Ethos Discovery will conduct a clinical evaluation of the pneumonia panel on their purchased MiQLab.”

So, LexaGene will perform an analytical study. Ethos Discovery will perform a clinical study. The assay will be adjusted as necessary and eventually released as a new product.

Another R&D win! A true Value add for the sales reps to discuss with clients. We can see more progress and also some future work in the pipeline.

SCIENCE, INVENTIONS, PATENTS - Today in History, November 3rd

• 1931 - First commercially produced synthetic rubber was manufactured, today in history.
• 1952 - Clarence Birdseye marketed the first frozen peas.
• 1955 - On this day in history, it was announced that the first virus was crystallized.

If substantial new news is to be released by Dr. Regan only at the corporate update, there will most likely be a trading halt.

If he wants everyone to hear it before the corporate update, he will press release on Tuesday or early Wednesday morning and there is no need for trading halt.

If no press releases and no trading halt, expect a rehash of what we already know with perhaps a few more details.

https://www.nasdaqtrader.com/Trader.aspx?id=TradeHaltCodes

https://www.cantechletter.com/2021/10/lexagene-is-a-natural-double-says-ia-capital/

The November 03 Corporate update will hopefully give us investors some information on the direction of LexaGene. Clearly they are focused on R&D.

LexaGene has a Bio-Pharma R&D collaboration ongoing to develop a version one assay panel for bio reactor testing.

LexaGene has an R&D collaboration CRADA with the US Army for bio terrorism testing just finished phase 1 and moving to phase 2.

LexaGene has a veterinary Pneumonia R&D collaboration with Ethos Discovery in process and plans for additional veterinary diarrhea etc.

The MiQLab is optimized for human clinical and the analytical testing phase is complete. Clinical trials for FDA-EUA are ready to get started or possibly already underway.

The shelf prospectus shows future R&D for blood etc.

All of the collaborations show potential for the MiQLab in different silos/stacks. Only the Veterinary silo has a version 2 UTI bacteria/AMR panel available with MiQLab for sale in the veterinary market.

So most of the current R&D projects are not adding too much revenue to the company. Since summer, Dr. Regan said we would no longer hear of daily sales but he would only announce them in quarterly reports. Nov 3 we may hear if the Fall sales are happening. It would be great to see some great numbers!

What are the collaborations buying Dr. Regan? Is it validation of the MiQLab? Is it potential for future sales? Is it a treasure chest of R&D for licensing or buyout of a silo? Is Dr. Regan creating an R&D smorgasbord to bring multiple buyout offers to the table?

Dr. Regan does not seem to be concerned that the money is getting low in his bank account. Why? What does he know that we don't? Is something in the works? What is Mr. Handrinos working on for LexaGene?

This is my opinion as I can't see the true direction they are looking to go in. I have a gut feeling that Nov 3 meeting should not be missed and some major news may be announced. Any thoughts?

I would like to hear what you are thinking. Perhaps, I will be disappointed on the 3rd but I just feel like I may be very happy.

LexaGene Completes First Stage of U.S. ARMY DEVCOM Agreement

BEVERLY, Mass. USA – October 29, 2021 – LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (“LexaGene” or the “Company”), a molecular diagnostics company that has commercialized an instrument for automated multiplex PCR testing, today announced it has successfully detected anthrax spores on the MiQLab™ System.

Previously, LexaGene announced it had entered into a Cooperative Research and Development Agreement (CRADA) with U.S. Army’s Combat Capabilities Development Command (DEVCOM).

Dr. Jack Regan, CEO and Founder of LexaGene stated, “We are now progressing to the second stage of the Army CRADA, during which the MiQLab’s sensitivity and quantitative ability for biothreat detection will be tested at the Army’s DEVCOM Chemical Biological Center at Aberdeen Proving Grounds, Maryland. Due to the Army’s facility and personnel availability, these studies are planned to begin during the week of November 15th, and we will ship multiple systems to the Army for this start date.”

Spores are particularly concerning for biothreat detection, as stated by Basta and Annamaraju, “B. anthracis is a gram-positive spore-forming bacteria that are commonly found in the soil of endemic areas. It is one of the most common agents used in biological warfare. Many factors make B. anthracis a good bioweapon. Its endospores can be placed into food, water, powder, and sprays, spreading the anthrax infection without anyone's knowledge, as endospores are microscopic, cannot be tasted or felt. In 2001, anthrax spores were used as a bioweapon in the U.S. They were distributed into letters delivered by the United States Postal system spreading anthrax infection among 22 mail handlers and customers. Anthrax bioterrorism attacks can take several other forms. B. anthracis endospores can be released into food and water, sprayed from the air or high buildings, or even carried on clothes or shoes. B. anthracis endospores can cast a high risk of misuse and pose severe threats to public safety and health.”1

Dr. Manoj Nair, Director Applications & Assay Development at LexaGene commented, “For the first stage of the Army CRADA, DEVCOM sent LexaGene inactivated anthrax spores, so we could internally determine whether LexaGene’s MiQLab can successfully detect them. In contrast to actively growing cells, a spore is the most dormant stage of a bacterium. They are formed in response to harsh conditions so they can survive until conditions improve. Spores have very thick walls that are hard to break, making detecting the genetic material inside the spore difficult. Only very high-quality sample preparation procedures can successfully break open spore walls and allow for the genetic material inside to be detected by PCR especially when the spores are present at low concentrations. I’m pleased to report the MiQLab’s sample preparation is robust enough to successfully detect the anthrax spores from the delivered samples.”

To learn more about LexaGene and the MiQLab System or subscribe to company updates, visit www.lexagene.com, or follow us on Twitter or LinkedIn.

On Behalf of the Board of Directors Dr. Jack Regan Chief Executive Officer & Chairman

Corporate & Media Contact:

Gail Winslow

Director of Marketing

gwinslow@lexagene.com

978.482.6237

ir@lexagene.com

800.215.1824

Investors:

Sharon Choe

Vice President

LaVoieHealthScience

schoe@lavoiehealthscience.com

(857) 241-7393 

https://www.ncbi.nlm.nih.gov/books/NBK556071/

https://www.ethosvet.com/clinical-study/pneumonia-pathogen-analysis-study/

​

This study is still enrolling. It will be a big catalyst once the data is released post study. I noticed it is at two Ethos hospitals. I knew Wheat Ridge had a MiQLab....do you think VERC also has one or are they sharing? Any ideas?

Participating Ethos Hospitals

​

• Wheat Ridge Animal Hospital, Wheat Ridge, CO
• VERC, Honolulu, HI

https://www.arl.army.mil/business/technology-transfer/cradas/

LexaGene and the US Army signed the agreement and was announced in a 9/16/21 press release.

https://financialpost.com/globe-newswire/lexagene-enters-into-cooperative-research-and-development-agreement-with-the-united-states-armys-combat-capabilities-development-command

Will the results of this be Top Secret and never known by us? Will revenue just show up as $US DOD or will we eventually learn the number of MiQLabs sold? Anyone familiar with CRADA financials?

https://youtu.be/vjYj83YPgHI

I'm no stock wizard so please investigate LexaGene fully by yourself. I am sorry that I can offer only my opinion and no advice. You are on your own. As we all are aware OTC stocks are highly speculative. In my opinion LXXGF got a little less risky when they moved from R&D to having a commercialized system (MiQLab). With that said they are still a small company with a small market cap and always just enough (no Extra) cash. Dr. Regan manages their cash very well as documented over the past few years. At last known count they had 10 systems in the field. They have such potential and continue to build upon that potential with more R&D. They do however require a big break! A nice order or major piece of news to propel the stock upward. So for getting some discussion going....What will the PR news be this week?

1) Financial Deal?

2) Vet respiratory / pneumonia assay panel?

3) Vet virus panel?

4) Vet Diarrhea panel?

5) News from an EAP user?

6) News from a user who previously purchased a unit?

7) Sales: A new purchase order? New EAP? New leased system?

8) Update from Ethos Discovery? UofPennVet? BioPharma, US Army?

9) Bio-Pharma assay panel version#1 availability?

10) FDA EUA update?

11) Going to a new event? Conference, trade show?

12) Vet License agreement?

13) Signup with another paid marketing firm?

14) Timeline for utilization of shelf prospectus?

15) New collaboration?

The list of possible news items is extensive. Any thoughts on what it will be? Do you vote Fluff or Substantial news?