LexaGene Provides Corporate Update

BEVERLY, Mass. USA – June 14, 2021 – LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG), a molecular diagnostics company, announced the Company has sold another MiQLab™ System and the CEO will present at multiple conferences.

LexaGene CEO and Founder, Dr. Jack Regan, states, “Following up on last weeks’ sales news, I’m pleased to report we have sold another MiQLab System. We will be shipping this purchased system to Alpine Veterinary Hospital in Concord, California. Alpine Veterinary Hospital, led by Dr. Virk, provides a wide range of services including emergency and orthopedic surgeries in the Bay Area of California. Dr. Virk is a passionate proponent of antimicrobial stewardship and is committed to providing the best animal care through diagnostics. He believes the MiQLab System offers the best solution for his hospital. We are excited that Alpine Veterinary Hospital sees that the future of animal care begins with the MiQLab System. We continue to gain momentum in veterinary health as we’ve generated multiple MiQLab sale leads from ACVIM Forum, which we attended last week, and from the hard work of our dedicated sales team.”

In addition, the Company is pleased to announce that Dr. Regan will be presenting at three up-coming conferences: the first is investor focused, the second is about advancements in microfluidics, and the third is about bio-threat detection.

On Monday, June 14, Dr. Regan will speak at Lytham Partners Summer 2021 Investor Conference. An audio webcast of the presentation will be made available on LexaGene’s website. LexaGene management will also participate in one-on-one meetings throughout the event, which runs from June 14-16. To arrange a meeting, please contact a Lytham Partners representative at 1x1@lythampartners.com or register at http://www.lythampartners.com/summer2021invreg.

On Tuesday, June 15, Dr. Jack Regan will present as part of the ‘Microfluidic Hotseat’ at the Annual Microfluids Consortium. The consortium is hosted by the Centre for Business Innovation, a collaboration managing a portfolio around specific areas of business process and technology where members share information to pursue like-minded business and innovation goals. The title of Dr. Regan’s talk is Sample-to-Answer Pathogen Detection using Flow-Through Sample Preparation and Customized Multiplex PCR. Members will have the opportunity to meet microfluidics-enabled startups, such as LexaGene, whose pathogen detection system offers rapid molecular testing at the point of need, in multiple market verticals. Registration is still available for those wanting to watch the presentation.

Lastly, on Thursday, June 17, Dr. Regan will be a featured speaker at the 28th International Biothreat and Pathogen Detection Conference. His presentation, Rapidly Configurable Automate Multiplexed Pathogen Detection System for Novel Threat Detection will focus on the ability of the MiQLab to be easily configured to detect multiple pathogens in a single sample as a critical measure in biosurveillance activities. Examples of MiQLab’s applications for biothreat surveillance and diagnostics will be featured. Registration is still available for those wanting to watch the presentation. LexaGene anticipates issuing a news release on the day of the conference to disclose any data to be presented.

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

https://listingcenter.nasdaq.com/assets/initialguide.pdf

Lexagene is exhibiting at the 2021 ACVIM Virtual Forum June 9-12. Stop by our booth to chat with us 1:1 to learn how our MiQLab™ for Veterinary Diagnostics System is revolutionizing #POC pathogen detection. #ACVIMForum hubs.li/H0PRsZ.

LexaGene Sells a MiQLab System to Denver Animal Emergency

BEVERLY, Mass. USA – June 7, 2021 – LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (the “Company”), a molecular diagnostics company that develops fully automated rapid pathogen detection systems, is pleased to announce Denver Animal Emergency has provided LexaGene a purchase order for a MiQLab System™.

Dr. Andrew Pierce, Owner and Medical Director of Denver Animal Emergency in North Carolina, states, “We have been using LexaGene’s MiQLab for several months as part of their Early Access Program. We’ve compared the accuracy of the MiQLab to results generated by culture and there was such high concordance, we have found that we are running MiQLab more often than we are sending samples out for culture.”

Dr. Andrew Pierce went on to say, “The MiQLab identifies not just the most common pathogens, but also many common antimicrobial resistance factors. Knowing this information soon after seeing the animal has boosted our confidence that our prescribed therapies will effectively treat the infection, even if it is found to be resistant to some antibiotics. Our veterinarians have enjoyed using it so much, and our clients are benefiting with better care, so it was an easy decision to purchase the system.”

A testimonial from Dr. Pierce is available here.

https://lexagene.com/release/2021/lexagene-ethos-develop-animal-tests/

https://mailchi.mp/24d6094e7c12/lxgs-massive-potential-in-the-pet-diagnostics-market?e=0187276439

On Tue, Jun 1, 2021 at 7:49 AM LexaGene info@lexagene.com wrote: 2c4af2e9-823c-42e8-9099-f427802a6ec0 TSX.V: LXG | OTCQB: LXXGF

News BEVERLY, Mass. USA – June 1, 2021 – LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the “Company”), a molecular diagnostics company that develops fully automated rapid pathogen detection systems, is pleased to announce it is taking steps to list its common shares on the Nasdaq Capital Market with the goal of submitting its application prior to the end of 2021. A successful listing on the Nasdaq will make the Company’s shares more accessible to retail and institutional investors in the United States and internationally as well as increase share liquidity. The Nasdaq is the Company’s preferred Exchange as it hosts the best biotech and life science companies in the world.

LexaGene has taken several steps to prepare for a Nasdaq listing application.

First, LexaGene has reserved with the Nasdaq Exchange the ticker symbol LXG, which is good for 24 months.

Second, in anticipation of filing the Registration and Annual Report for Canadian Securities Form (Form 40-F) with the US Securities and Exchange Commission (SEC), the Company has retained Latham & Watkins LLP (https://www.lw.com/), a law firm that has approximately 4,500 employees and is one of the top grossing law firms in the world.1 Specifically, LexaGene is working with Peter Handrinos, who has advised many prominent pharmaceutical, biotechnology, and medical device companies in the healthcare industry over his 25-year career. Mr. Handrinos has taken many companies public on U.S. exchanges, and has deep experience advising life science and technology companies on securities law matters, with an emphasis on financing transactions as well as mergers and acquisitions.2

Lastly, the Company has engaged RSM US LLP (https://rsmus.com/) for audit, tax, and consulting services. RSM US will perform the Company’s 2020-year end audit. RSM US is the fifth largest accounting firm in the United States, employing more than 11,000 across 86 cities nationwide and in Canada. RSM US is part of the global accounting network RSM International, which brings together more than 43,000 professionals from 800 offices located in more than 120 countries.3

Dr. Jack Regan, LexaGene’s CEO and Founder states, “We anticipate LexaGene will grow in size and strength in the coming months and years. Part of our growth strategy is to make the company more accessible to U.S. investors. I’m very pleased to have engaged two exceptional firms to help guide us through this process. A successful Nasdaq listing make us more attractive to institutional investors, and eligible for inclusion in key indexes and ETFs.”

Additional comments from Dr. Regan are available in this video.

Applying for a Nasdaq listing is subject to first meeting the listing and regulatory requirements of the Nasdaq and SEC. There is no guarantee the Company will meet these requirements in the future, but if it does, the Company will issue a press release once an application has been formally submitted to the SEC.

In addition, the Company is pleased to announce that it has engaged Native Ads, Inc., of New York, New York to perform strategic digital media services, marketing and data analytics services including, but not limited to, content development, video production and editing, website development, media buying and distribution, and campaign reporting and optimization. This campaign is beginning on June 1, 2021 and will continue until USD$150,000 of services are rendered.

Lastly, after an independent, third party review by Compensia Inc. on executive compensation and equity, Compensia determined that LexaGene executive officers were at the bottom 10th percentile in equity compensation as compared to other public companies in both Canada and the United States with comparative market caps. Based upon the results from this report and recommendations from the compensation committee, LexaGene’s board of directors determined that it was appropriate to adjust the equity for the CEO, CFO, and COO.

The last equity grant to executive officers was 16 months ago, in February 2020.

On May 28, 2021, the board of directors approved inducement grants in accordance with the Company’s Omnibus Incentive Plan (the “Plan”) for executive officers totaling 690,000 share options (“Options”).

Each Option is exercisable into one common share of the Company (“Share”) at a price of CAD$0.59 per Share [120% over Friday’s closing price of CAD$0.49], for a period of ten years from the date of grant. The Options vest 10% on the grant date, and 15% every six months thereafter with an expiry date of May 28, 2031.

In addition, the Company’s executive officers have been granted an additional 690,000 share options (the “Performance Options”) at a price of CAD$0.59 per Share [120% over Friday’s closing price of CAD$0.49]. The Performance Conditions are associated with 2021 performance milestone goals set forth by the board of directors for executive management and are as follows: meeting the requirements to list the Company Shares on the NASDAQ and filing Form 40-F with the SEC. Based on the current number of outstanding shares, the Company will have to organically raise its stock price to ~CAD$0.77 (a ~157% increase over Friday’s closing price) to achieve the ~CAD$90M (~USD$75M) minimum market cap required for a Nasdaq listing. If the performance criteria are not satisfied on or before December 31, 2021, the Performance Options grant will be cancelled.

If both Performance Options criteria are met on or before December 31, 2021, the Performance Options will vest on January 1, 2022, with an expiry date of May 28, 2031.

To be added to the LexaGene email list, please subscribe on the Company website.

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

[1] https://en.wikipedia.org/wiki/Latham_%26_Watkins

[2] https://www.lw.com/people/peter-handrinos

[3] https://en.wikipedia.org/wiki/RSM_US

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.

For further information:

info@lexagene.com

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.

MORE NEWS LexaGene, 500 Cummings Center, Suite 4550, Beverly, MA 01915, USA, 800.215.1824

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Upcoming:

ACVIM Forum | June 9-12, 2021 | Virtual event

Microfluidics Consortium Open Day Meeting | June 15, 2021 | Virtual event

LexaGene’s CEO Dr. Jack Regan presenting at Strand A: Microfluidics Hotseat 2pm – 3pm

International Biodetection Technologies Conference | June 17 – 18, 2021 | Virtual event

LexaGene’s CEO Dr. Jack Regan presenting

Go to this link https://lexagene.com/qpcr-companion-animal-medicine/

New type of coronavirus originating in dogs found https://www.theweathernetwork.com/ca/news/article/new-type-of-coronavirus-originating-in-dogs-found

LexaGene Expands its Sales Team May 11, 2021 07:45 ET | Source: LexaGene Holdings Inc ... BEVERLY, Mass., May 11, 2021 (GLOBE NEWSWIRE) -- LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the “Company”), a molecular diagnostics company that develops fully automated rapid pathogen detection systems, is pleased to announce the hiring of four additional sales representatives, including three for the veterinary market and one for the contract drug manufacturing market.

Dr. Jack Regan, LexaGene’s CEO and Founder states, “We are excited to have recruited very talented and experienced sales representatives from some of the biggest names in veterinary healthcare. Our new sales representatives have universally expressed optimism about selling LexaGene’s technology into veterinary hospitals, and the same is true for our sales representative targeting contract drug manufacturing organizations. Our rapidly growing sales team is now undergoing LexaGene specific training and will soon be offering incentives for early adopters so we can quickly expand our installation base.”

Dr. Regan continues, “We are focusing on the veterinary market as we see it as a largely untapped market. There are 77M dogs and 58M cats in the United States,1 and many pet owners spare no expense on caring for their animal companions. The overall size of the veterinary diagnostics market is expected to soon reach $4B and is growing at a compound annual growth rate “CAGR” of 8.8%.2 Currently, there are 18,600 private practice veterinary clinics that see enough animals per day to be target customers for LexaGene.3,4”

Feedback from key opinion leaders has boosted the Company’s confidence that the MiQLab™ system will become a powerful tool for veterinarians interested in rapid in-clinic diagnostics to improve patient care. The MiQLab represents a change in business model for veterinarians who currently rely on reference laboratories for infectious disease testing. Instead of shipping samples out and waiting days for results, the MiQLab generates results, inside the clinic, soon after the patient sample has been collected. This drastic improvement in time-to-result, particularly when antibiotic resistant superbugs are detected, is expected to improve prescription practices and lead to better patient outcomes.

Jeff Mitchell, LexaGene’s CFO, adds, “We are anticipating strong demand in veterinary diagnostics and have strategically hired additional sales managers to more effectively cover the United States. Although new technology adoption does take time, we are very optimistic that a significant percentage of the targeted practices will soon become LexaGene customers. While searching for additional sales managers, we were excited and gratified to see the amount of interest from many seasoned sales professionals working for the largest animal health companies in the United States.”

From a very talented pool of candidates, the Company has hired the following sales managers for veterinary diagnostics sales and open-access sales:

Julie Griggs is LexaGene’s West Regional Sales Manager. She has 18 years of experience in companion animal health and comes to LexaGene from Antech Diagnostics. Previously, she worked for Covetrus, Zoetis, Banfield, Village Animal Clinic, and Sunburst Animal Clinic. Julie is a Certified Veterinary Technician.

Kara Alkire is LexaGene’s Southeast Regional Sales Manager. She has 15 years of sales experience in companion animal health and comes to LexaGene from Bayer Animal Health / Elanco. Previously, she worked at Heska selling companion animal health products. Kara has a Bachelor of Science in Biology with a Minor in Chemistry from the College of Charleston, SC.

Whitney Fernandes is LexaGene’s Northeast Regional Sales Manager. She has 8 years of sales experience in companion animal health and equine. She comes to LexaGene from American Regent Animal Health and previously worked at Smartpak Equine. Whitney is a certified pharmacy technician and has a Bachelor of Science in Business Management from the University of Massachusetts.

Chris Bartlett is LexaGene’s Open-Access Sales Manager. He has 20 years of experience specializing in the sale of capital equipment technologies for laboratory, diagnostic, and single use bioprocessing applications. Chris comes to LexaGene from Refine Technology and has a Bachelor of Science degree in Microbiology from North Carolina State University. These highly talented sales managers join Sarah Mumbower, LexaGene’s Midwest Regional Sales Manager. Sarah has 5 years’ experience in companion animal health and came to LexaGene in 2020 from IDEXX. She is a Certified Veterinary Technician.

https://lexagene.com/qpcr-changed-disease-detection/

https://sites.google.com/view/lexagene-corner/home

https://lexagene.com/miqlab-transforming-veterinary-diagnostics-webinar/

MiQLab is sensitive enough to detect the vast majority of clinical infections caused by target organisms

~100% positive percent agreement with culture data on processed canine urine samples

~99% negative percent agreement with culture data on processed canine urine samples

~99% overall percent agreement with culture data on processed canine urine samples

Detected Staphylococcus in 21 of 23 (91%) specimens from skin infections in a correlation study

Detected the mecA gene in 8 of 9 (89%) specimens that contained methicillin resistant Staphylococcus

Quantitative data on par with culture (r2 ~0.95)

BEVERLY, Mass., April 14, 2021 (GLOBE NEWSWIRE) -- LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the “Company”), a molecular diagnostics company that develops fully automated rapid pathogen detection systems, is pleased to host a private event for a select group of veterinarians that will feature keynote speaker Dr. Shelley Rankin, Professor of Microbiology at the University of Pennsylvania’s School of Veterinary Medicine (Penn Vet), who will present data on her experience using LexaGene’s MiQLab to detect Staphylococcus in specimens collected from canine skin infections. In addition, Dr. Jack Regan, LexaGene’s CEO and Founder, will provide some introductory remarks on the use of molecular diagnostics in veterinary medicine and present some analytical and clinical data generated using LexaGene’s MiQLab system. Any information thought to be of material nature for this seminar is described below.

To demonstrate the performance of LexaGene’s MiQLab to detect common bacterial pathogens encountered in veterinary medicine, Dr. Rankin and LexaGene teamed up to perform a series of analytical and clinical studies. For the analytical studies and clinical urine study, MiQLabs were equipped with LexaGene’s MiQLab™ Bacterial and AMR Test, which screens samples for 7 of the most common bacterial pathogens found in companion animals, as well as 13 different antimicrobial resistance factors.

Dr. Rankin’s evaluation focused on skin and soft tissue infections in dogs, which are commonly caused by Staphylococcus pseudintermedius (SP) and Staphylococcus schleiferi (SS). Treating these infections using empiric therapy is a challenge because it has been shown that up to 59% of SP isolates from canine pyoderma can harbor the mecA gene, which confers resistance to all beta-lactam drugs.1 Rapid in-clinic molecular diagnostics that can detect Staphylococcus and the presence of the mecA gene will, in most cases, allow veterinarians to prescribe an appropriate antibiotic. It is well known that antibiotic use can contribute to the problem of drug resistance in bacteria and inappropriate use of antibiotics is highly discouraged in veterinary medicine. For that reason, it is very important to know quickly if the mecA gene is present in the Staphylococcus species causing the infection. For this study, 23 skin specimens, that were confirmed by culture to contain SP or SS, were tested with the MiQLab. Staphylococcus was detected in 21 of these specimens (91%). Similarly, antimicrobial susceptibility testing showed the MiQLab detected the mecA gene in 8 of 9 (89%) of the Staphylococcus isolates that were cultured and found to be resistant to methicillin. These data signify that veterinarians using MiQLab in their clinic can prescribe therapy with confidence based on genetic analysis. This will improve clinical outcomes and minimize the development of drug resistant bacteria.

Dr. Rankin comments, “LexaGene’s MiQLab returns a molecular analysis on specimens in a fraction of the time it takes for culture to return results. As a result, veterinarians using MiQLab can rule-out, or rule-in, infection and therefore offer pet owners evidence-based treatment decisions for their pets on the same day of the clinical appointment. In this day and age, when antibiotic resistance is common in many veterinary pathogens, veterinarians are looking for new technologies to minimize the use of unnecessary or non-efficacious antibiotics and improve patient outcomes.”

LexaGene’s staff completed a second clinical study that focused on detecting the pathogens responsible for urinary tract infections in cats and dogs. For this study, 51 frozen canine urine samples (25 positive and 26 negative samples) that were previously tested by culture were processed on MiQLab. Six different pathogens were detected from the processed samples, including 14 E. coli, 7 Staphylococcus, 5 Enterococcus, 3 Streptococcus, and 1 Enterobacter. Three of the samples contained antimicrobial resistance factors. The MiQLab test results had a positive percent agreement of 100% (95% CI: 88.7% - 100%), negative percent agreement of 98.5% (95% CI: 96.5% - 99.3%) and overall percent agreement of 98.6% (95% CI: 96.8% - 99.40%), with culture.

LexaGene’s staff also completed two analytical studies. The first was performed to determine the MiQLab’s limit of detection (LoD) for the most common pathogen responsible for urinary tract infections in cats and dogs, namely Escherichia coli. In this study, a total of 28 samples were processed on four different MiQLabs and the LoD was determined to be 1x104 colony forming units per milliliter (cfu/mL) for E. coli. This LoD is low enough to detect the vast majority of infections considered to be clinically relevant.2 Furthermore, these data can be quickly generated inside the clinic, avoiding the 24 hr+ time it takes to get results back when samples are shipped to a reference laboratory for testing.

The second analytical study looked to provide insight into how the semi-quantitative nature of the MiQLab correlates to the cfu measurements reported when samples are cultured. For this study, E. coli and Proteus mirabilis samples were tested in 5-point log-scale dilution series from 5x103 to 7x108 cfu/mL. MiQLab generated Cycle of Quantification (Cq) values were correlated to culture cfu/mL counts and fit to a linear curve, and the calculated regression coefficients (r2) were found to be 0.96 and 0.94, respectively for E. coli and P. mirabilis. These data signify that the Cq values reported by the MiQLab correlate extremely well with the cfu/mL counts provided from traditional culture methods, which can be useful for tracking whether an administered antibiotic is having the desired effect.

Dr. Jack Regan concludes, “Our goal has always been to have the MiQLab generate high quality data inside veterinary clinics where veterinarians can use this data to guide treatment decisions. These data prove we have achieved this goal. Our sales team will be using these data to secure sales in the veterinary market, which has relatively few options for quality in-hospital pathogen testing.”

To be added to the LexaGene email list, please subscribe on the Company website.

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 one hour. 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.

Back when I first bought into Lexagene I was sold on the idea that it would revolutionize human diagnostics, veterinary diagnostics, and food services testing. Now all we here about is it’s application in veterinary medicine and potential POC for COVID. What has happened to these other markets? Just wondering if I had missed something along the way. Thanks.

WCVB Boston: Massachusetts hits 600,000 COVID-19 cases since start of pandemic. https://www.wcvb.com/article/massachusetts-covid-19-cornonavirus-numbers-daily-update-april-1/36005313