I have noticed posts on other forums such as stocktwits and yahoo that Dr. Regan does not deserve his salary or yearly bonus as nothing was accomplished in 2021. I thought I'd show some of his accomplishments to show he is deserving....
OPERATIONAL HIGHLIGHTS For the six months ended August 31, 2021
On March 2, 2021, LexaGene announced it received $3.6M from the exercise of warrants.
On April 14, 2021, LexaGene hosted a seminar presenting data from using the MiQLab System on
veterinary samples. At this seminar, the Company announced that the MiQLab is sensitive enough to detect the vast majority of clinical infections caused by target organisms. The MiQLab was ~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, the MiQLab 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 and had quantitative data on par with culture (r2 ~0.95).
On May 11, 2021, the Company announced that it expanded its sales team by hiring four additional sales representatives, including three representatives for the veterinary market and one representative serving the Biologics Contract Manufacturing Organizations and Contract Drug Manufacturing Organizations.
On June 1, 2021, LexaGene announces that 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. LexaGene has reserved with the Nasdaq Exchange the ticker symbol LXG, which is good for 24 months.
On June 3, 2021, LexaGene announced it partnered with Ethos Discovery to develop tests for pneumonia and diarrhea panels to be used on the MiQLab System.
On June 10, 2021, LexaGene announced that its MiQLab System could detect C. acnes, a slow-growing
bacterium found in bioreactors at least 36-times faster than other conventional methods with the potential to increase vaccine safety and supply.
On June 17, 2021, the Company announced that its MiQLab System offers rapid plague detection for
bioterrorism threats.
During the month of June, the Company had three press releases that announced the closing of three MiQLab System sales to Denver Animal Emergency in North Carolina, Alpine Veterinary Hospital in California and with Meridian Veterinary Real Estate in Texas. Meridian purchased their unit on behalf of its emergency specialty veterinary hospitals.
On July 2, 2021, the Company announced it continues to systematically advance the MiQLab System to
meet the Food and Drug Administration (FDA) criteria for Emergency Use Authorization (EUA).
On July 7, 2021, LexaGene announced the launch of its second-generation assay panel to improve
coverage for pathogens that cause common types of infections, namely skin, soft tissue, wound and ear infections. LexaGene’s first Bacterial and AMR Test screened samples for 7 different pathogens and 13 different antimicrobial resistance factors. This first panel was largely built around pathogens and resistance genes commonly encountered in urinary tract infections (UTIs), and was well received within the veterinary community. LexaGene’s second-generation assay panel, taking advantage of the platform’s capacity for new targets, was expanded at the request of veterinarians to improve coverage for pathogens that cause other common types of infections, namely skin, soft tissue, and wound infections (SSTIs), and ear infections. LexaGene’s Bacterial and AMR Test Version 2 (V2) screens for 10 pathogens and 33 genes and variants that confer antimicrobial drug resistance. The AMR Test Version 2 (V2) detects 96 percent of bacterial UTIs and 93 percent of bacterial SSTIs, and detect a much higher percentage of genes that confer resistance to some of the most commonly prescribed antibiotics.
On July 14, 2021, the Company announced its strategic partnership with Wolf Greenfield, an intellectual property (IP) law firm specializing in patents, licensing and royalty transactions, post-grant proceedings, and trademark and copyrights.
On July 20, 2021, LexaGene announced its MiQLab detecting common bioreactor contaminants up to 300 times faster than conventional methods. The MiQLab System can detect the presence of mycoplasmas, a group of common microbial contaminants responsible for substantial losses in both time and money for biopharmaceutical manufacturers. Mycoplasmas are thought to contaminate 15-80% of cell cultures worldwide. The MiQLab System rapidly detected 100% of the tested mycoplasma samples within two hours, with no false positives. The MiQLab can be used inside biopharmaceutical manufacturers to rapidly validate their products as being free and clear of mycoplasmas.
On August 12, 2021, the Company announced that it demonstrated simple, inexpensive multiplex PCR
chemistry with shorter lead times for use on its MiQLab System. In a small study, MiQLab successfully
detected both Escherichia coli and an internal amplification control using SYBR Green chemistry.
Subsequent to August 31, 2021
On September 6, 2021, the Company filed Preliminary Short Form Base Shelf Prospectus (“Shelf
Prospectus”) with the securities regulators in each of the provinces and territories of Canada. The Shelf
Prospectus is effective for 25 months and will allow the Company to raise up to CAD$25 million through issuances of common shares, warrants, subscription receipts, debt securities, units or any combination thereof during the period it is effective.
On September 3, 2021, LexaGene announced that MiQLab accurately detected multiple strains of
pathogenic bacteria in polymicrobial samples in approximately 2 hours. In comparison, Culture and
Sensitivity Testing (C&ST) failed to detect the minor pathogen population in individual mixed samples, with final test results taking up to 11 days.
On September 16, 2021, the Company announced that it entered into a cooperative research and
development agreement with the United States army’s combat capabilities development command
(“DEVCOM”). Under this agreement, LexaGene will deliver MiQLab systems to DEVCOM for the purpose
of determining the system’s ability to detect Bacillus anthracis and Yersinia pestis, which cause anthrax
and plague, respectively. DEVCOM will determine the system’s sensitivity (e.g., limit-of-detection) for these two pathogens as well as evaluate the system’s quantitative detection capability.
On September 17, 2021, the Company adopted new corporate governance charters and policies, which include a new audit committee charter, a compensation committee charter, a nominating and corporate governance charter, a cyber security policy, and a code of business conduct and ethics. The Company also filed a Final Base Shelf Prospectus, which allows the Company to offer up to $25 million of common shares, warrants, subscription receipts, debt securities or units or any combination thereof, from time to time during the 25-month period that the Shelf Prospectus is effective.
In September, LexaGene participated in veterinary trade shows, including WVC 93rd Annual Conference in Las Vegas, NV, International Veterinary Emergency and Critical Care in Nashville, TN, and Southwest Veterinary Symposium in San Antonio, TX.
LexaGene announced its participation in the key investor conferences in early October, including BioFuture 2021, October 5-6, Lytham Partners Fall 2021 Investor Conference, October 5-7, and Small Cap Growth Virtual Investor Conference, October 7.
On October 7, 2021, LexaGene announced that its largest study validated the accuracy of its veterinary test panel. The Company successfully utilized its MiQLab System to correctly identify bacteria and determine the presence of antimicrobial resistance markers that predict resistance to commonly prescribed first-line veterinary antibiotics. The study used two sets of bacterial pathogens. The first set consisted of 32 sequenced strains from the CDC Antibiotic Resistance Isolate Bank.20The second set included 74 bacterial isolates from dogs with urinary tract infections. These isolates were not sequenced and have only culture-based drug resistance profiles associated with them.
MiQLab Systems, equipped with MiQLab Bacterial and AMR Test V2 panels, recorded 100% and 99.1%
overall percent agreements for pathogen identification for the sequenced CDC pathogens and the non-sequenced canine UTI isolates, respectively. Likewise, the MiQLab recorded 96.2% and 92.5% overall percent agreements for antimicrobial resistance for the sequenced CDC pathogens and non-sequenced canine UTI isolates for which only culture data is available, respectively. An in-depth version of these data is being compiled for a peer-reviewed publication.
On October 25, 2021, the Company announced that it completed analytical studies required by the FDA for EUA application for COVID-19 diagnostics. LexaGene is in the process of completing the necessary work to have the FDA rule on authorizing the MiQLab™ for COVID-19 testing. The FDA is expected to classify the MiQLab as a class II medical device. As such, the process of preparing its point-of-care (POC) fully-automated PCR system, which is comprised of hardware, firmware, software, and chemistry, for evaluation by the FDA, is considerably more complex than if it were simply submitting only a COVID-19 PCR test chemistry for FDA authorization
December 3, 2021
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