LexaGene Holdings Inc. (LXG.V) is working to develop genetic analyzers for pathogen detection and 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 LX Analyzer delivers excellent sensitivity, specificity, and breadth of detection and can return results in about 1 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.
We initiated coverage in December 2018 and July 2019. Below is an update.
July 30 - Approved by CDC and FDA Antibiotic Resistance Isolate Bank to Receive Samples to Test for Superbugs.
Recognized by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) Antibiotic Resistance (AR) Isolate Bank as an institution approved to receive samples for testing antibiotic resistance.
LexaGene has access to an enormous repository of fully characterized pathogens, which the Company will use to continually improve the detection capabilities of its LX Analyzer. The CDC has one of the largest collections of pathogens that have been acquired over the years from reference laboratories across the United States. Aug. 8 - To place Beta Unit in Human Clinical Diagnostics Laboratory. Agreement for inclusion of a beta prototype with Assurance Scientific Laboratories (ASL) in Vestavia, Alabama in August 2019. ASL is a certified reference laboratory specializing in providing clinical testing results to physicians nationwide.
The beta test will focus on testing urine samples to detect the presence of pathogens causing urinary tract infections while simultaneously screening these samples for genetic markers for antimicrobial resistance.
Sept 5 - Reports on Beta Results from Cannabis-Focused Testing Laboratory. Announced today that in August it placed a beta unit at CDX Analytics (CDX), an independent testing laboratory in Massachusetts, certified to test cannabis and hemp products for active ingredients as well as contaminants.
The first portion of beta testing is now complete, and when the analyzer was challenged with cannabis samples containing various amounts of cannabinoids – a difficult to handle chemical compound, LexaGene’s instrument reported successful results in all runs where PCR was expected. Sept. 12 - Second Hemp-Cannabis Reference Testing Laboratory as a Beta Test Site. Plans to place its LX Analyzer beta unit into ProVerde Laboratories, Inc. one of three independent laboratories accredited by the state of Massachusetts to test hemp and cannabis products for contaminants such as pesticides and pathogens including bacteria, mold, or other dangerous microorganisms. Current process nominally takes 3 days, and ProVerde is looking for faster solution. Sept. 17 - LexaGene Develops Test for Deadly Mosquito-borne EEE Virus. EEE virus can be transmitted through the bite of an infected mosquito, and has recently caused fatal infections in Michigan, Massachusetts and Rhode Island.
Previously, LexaGene’s technology was only able to detect DNA-based pathogens. The Company has recently modified the analyzer also to detect pathogens that have RNA-based genomes. Examples of pathogens that have RNA-based genomes include EEE and other mosquito-borne viruses such as West Nile, Chikungunya and Zika viruses, as well as other deadly pathogens such as influenza and Ebola. Another benefit of the LX Analyzer is its ability to screen for multiple pathogens at once, which is critical for carrying out successful screening programs of mosquito populations for vector-borne viruses. Sept 19 - Reports on Successful Results from Beta Testing in Human Clinical Diagnostics Laboratory. Completed beta testing with Assurance Scientific Laboratories (ASL) in Vestavia, Alabama. The laboratory processes over 300 urine samples per week for human urinary tract infections – plus hundreds of other sample types.
Sept 25 - Announces Proposed Offering of Units and Filing of Preliminary Prospectus. Oct. 2 - Announces Pricing of Prospectus Offering. The Company will offer a minimum of 6,730,770 units of the Company (each a “Unit”) and a maximum of 19,230,769 Units at the price of $0.52 per Unit for minimum gross proceeds of approximately $3,500,000 and maximum gross proceeds of approximately $10,000,000. Warrant at $0.75 cents
The net proceeds of the Offering will be used for research and development, marketing, general corporate purposes and possibly to support the building of inventory and initial commercial sales.
Oct. 22 - Announces Filing of Final Prospectus. Oct. 29 - Announces Closing of C$6.64 Million Financing. Nov. 13 - Provides Corporate Update. After reporting successful beta test results during the summer and early fall, LexaGene closed a $6.6M CAD financing on October 29, 2019. Management is using these funds to expand the development team in the areas of mechanical, electrical, and software engineering to speed the Company’s ability to evaluate and finalize different components for the commercial design of the LX2™ Genetic Analyzer.
These components will enhance performance, lessen time-to-result, improve manufacturability and serviceability, as well as lower costs for the final commercial build. Once finalized, the Company will begin manufacturing several pre-commercial units. This pilot build serves as a final check before manufacturing a more substantial inventory to meet anticipated market demand.
Dr. Regan comments further, “LexaGene is on a solid pathway to commercialization in 2020. We are excited about the LX Analyzer technology, and as our beta program has shown, there is market readiness and strong demand.” Jan. 21 - Newly-developed Tests Achieve 100% Concordance on Superbug Strains from the CDC. Announced it has expanded its number of validated tests for antibiotic resistance and has completed testing different super-bug isolates provided by the CDC and FDA Antibiotic Resistance (AR) Isolate Bank.
Dr. Regan concludes, “We now have tests that will detect bacterial pathogens that carry antimicrobial resistance and are responsible for the most commonly misdiagnosed infections".
Jan. 27 -Designed to Detect Pathogens such as the Novel Coronavirus. Our genetic analyzer can quickly detect new pathogens in just one hour, on-site. Currently, the traditional process requires that samples from sick individuals must be transported to laboratories for manual processing.
LexaGene is now finalizing the design of its commercial instrument, which it anticipates starting to manufacture in a few months, with the expectation of achieving first commercial sales in Q3 of this year. For implementation in hospitals, clinics, airports, and other locations interested in processing human samples for clinical purposes, the Company will need either Emergency Use Authorization (EUA) or 510(k) clearance from the Food and Drug Administration (FDA).
Feb. 20 - LX Analyzer Successfully Detects Coronavirus RNA. Using LexaGene’s automated LX Analyzer equipped with the adapted CDC Coronavirus Diagnostic Panel, the Company successfully detected the presence of the SARS-CoV-2 N-gene RNA in contrived respiratory samples, whereas the severe acute respiratory syndrome (SARS) coronavirus RNA and Middle East respiratory syndrome (MERS) coronavirus RNA tested negative, as expected.
In addition, on February 19, the board of directors and compensation committee approved 1,285,000 restricted share units (“RSUs”) and 320,000 Options. Each Option is exercisable at a price of $0.72 per Share, for a period of ten years. Mar. 11 - Provides Corporate Update. - In response to the COVID-19 outbreak, the World Health Organization has declared a ‘Public Health Emergency of International Concern’ and the FDA has encouraged CLIA labs and IVD manufacturers to submit applications for Emergency Use Authorization (EUA) to help address the lack of quality diagnostics to fight this disease. To contribute to the solution for this outbreak and make us better prepared for the next outbreak, LexaGene is now aggressively pursuing the clinical diagnostics market. We also have the personnel in place to remain on track to penetrate veterinary diagnostics, food safety and other markets that require open-access testing. Furthermore, the Company has recently contracted an internationally renowned industrial design firm, Ximedica, to accelerate its commercialization efforts. In addition, the Company is in the final stages of hiring key positions in sales, product marketing, quality, regulatory affairs, engineering, and application support.
Mar. 17 - Provides Update on the Exercise of Warrants. LexaGene is pleased to report that over the past 90 days the Company has received CAD $2.8 million through the exercise of 4.3 million warrants. Mar. 24 - Appoints Senior Director of Operations. Steven Armstrong to Senior Director of Operations to oversee the Company’s submission for FDA Emergency Use Authorization of its commercial technology and other regulatory approvals, as well as to institute quality systems for manufacturing. Apr. 1 - Appoints Appoints Director of Product Marketing. Dr. Eleanor Kolossovski to Director of Product Marketing Apr. 16 - Files Patent Application for Expanded Capabilities of Their LX Analyzer. Filing of a provisional patent application to the United States Patent and Trademark Office to protect the expanded testing capabilities of their LX Analyzer technology, as it relates to COVID-19 and other clinical laboratory testing, as well as other high-throughput applications such as food safety testing.
LexaGene plans to launch its multiplex, PCR-based LX Analyzer as its flagship product, targeting decentralized testing facilities in the clinical, veterinary, and food safety markets during Q3 of this year.
Apr. 23 - Proposes to Amend Warrants Terms and Announces a Strategic Marketing Promotional Campaign. Intends to amend the exercise price of the common share purchase warrants (the “Warrants”) issued on March 29, 2019.
4,634,686 Warrants issued with an exercise price of $0.85 per share to $.60 cents; warrant expiry date of June 29 2020.
In addition, the Company is pleased to announce that it has engaged Native Ads, Inc., of New York, New York.
Summary
One of the most stellar accomplishment for the period (Jul. 30) has been the approval by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) Antibiotic Resistance (AR) Isolate Bank of LXG.V as an institution deemed to receive samples for testing antibiotic resistance. This milestone was critical as it enabled LXG.V access to a number of pathogen for which it tested the diagnostic capacities of the LX ANalyzer.
Subsequently, LXG.V reported developing test for Mosquito Borne (EEE) (Sep. 17). The announcement was undersold and noteworthy because the company shared that it moved from detection of DNA-based pathogens to also include RNA-based genomes. This is certainly another major accomplishment that needs to be highlighted.
Previously, LexaGene’s technology was only able to detect DNA-based pathogens. The Company has recently modified the analyzer also to detect pathogens that have RNA-based genomes. Examples of pathogens that have RNA-based genomes include EEE and other mosquito-borne viruses such as West Nile, Chikungunya and Zika viruses, as well as other deadly pathogens such as influenza and Ebola. Another benefit of the LX Analyzer is its ability to screen for multiple pathogens at once, which is critical for carrying out successful screening programs of mosquito populations for vector-borne viruses.
The above developments were instrumental in LXG.V achieving 100% Concordance on Superbug Strains from CDC and FDA Antibiotic Resistance (AR) Isolate Bank. Leveraging this source enabled the company to expand its number of validated tests for antibiotic resistance and completed testing different super-bug isolates (Jan. 21).
LXG.V subsequently reported the ability to detect Corona Virus RNA (Feb. 20) and discriminate it from SARS and MERS virus strains. Those achievements along with emergence of the Coronavirus have enabled LXG.V to submit applications for Emergency Use Authorization (EUA) for COVid -19 Diagnostics as solicited by the FDA (Mar. 11).
LXG.V also stated that it would maintain its focus on both veterinary and food diagnostics, as well as, other markets which require open access testing. To date, the company has placed beta instruments in Human Clinical Diagnostic Laboratory; Assurance Scientific Laboratories (Aug. 8) and reported encouraging results (Sep. 19). It also received positive preliminary results from Cannabis Focus testing lab; CDX Analytics (Sep. 5) & ProVerde Laboratories (Sep. 12).
LXG.V is aiming to launch the LX ANalyzer in Q3 2020. To this end, it has hired Ximedia and ramped up its internal ranks with a Senior Director of Operations and Product Marketing. On April 16, LXG.V filed a Patent regarding its expanded capabilities of the LX ANalyzer relating to Covid-19 and other clinical lab testing including Food Safety. With regards to financing, after filing a vague Preliminary Prospectus (Sep. 25) for which the company did not disclose strike price for 7 days (Oct. 2), it eventually went on to raise $6.3M at $0.52 cents; Warrant $0.75 cents (Oct 29). Given, that the initial targeted amount ranged from $3.5M to $10M, the outcome was moderately positive. Hence, it comes to no surprise that on March 17 LXG.V reported receiving $2.8M from Warrant Exercises. Yesterday afternoon, LXG.V announced its intent to lower the warrant that were set to expire in June 29, 2020 from $0.85 cents to $0.60 cents. As displayed in the above chart, in the last period LXG.V traded between $.435 and $1.00 with an exponential moving average of $0.60 cents; familiar? Evidently, from early March valuation has encountered resistance at $0.70 cents.
No doubt, LXG.V has achieved significant milestones in the past 10 months that makes it a potential acquisition target. However, it still is a pre-revenue capital intensive venture that requires funds and it's something to keep in mind.
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