# EDGAR Filing Document

**Accession Number:** 0001450416
**File Stem:** 0001104659-23-004458
**Filing Date:** 2023-1
**Character Count:** 12916
**Document Hash:** 5333263c47112bcf7699b56c6eeaa105
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-23-004458.hdr.sgml**: 20230118

**ACCESSION NUMBER**: 0001104659-23-004458

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20230118

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230118

**DATE AS OF CHANGE**: 20230118

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** LexaGene Holdings Inc.
- **CENTRAL INDEX KEY:** 0001450416
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** A1
- **FISCAL YEAR END:** 0228

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 000-56456
- **FILM NUMBER:** 23532971

**BUSINESS ADDRESS:**
- **STREET 1:** 500 CUMMINGS CTR., SUITE 4550
- **CITY:** BEVERLY
- **STATE:** MA
- **ZIP:** 01915
- **BUSINESS PHONE:** 800-215-1824

**MAIL ADDRESS:**
- **STREET 1:** 500 CUMMINGS CTR., SUITE 4550
- **CITY:** BEVERLY
- **STATE:** MA
- **ZIP:** 01915

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** STONESHIELD CAPITAL CORP.
- **DATE OF NAME CHANGE:** 20100729

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** STONESHIELD CAPITAL CORP
- **DATE OF NAME CHANGE:** 20081119

?xml version="1.0" encoding="utf-8"?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, D.C. 20549**

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**FORM 8-K**

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**CURRENT REPORT** 

**Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** January 18, 2023

![](tm232561d2_8kimg01.jpg)

**LEXAGENE HOLDINGS INC.**

(Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| &nbsp;&nbsp;**British Columbia** | &nbsp;&nbsp;**000-56456** | &nbsp;&nbsp;**None** |
| &nbsp;&nbsp;(State or other jurisdiction of<br> incorporation or organization) | &nbsp;&nbsp;***Commission File Number:*** | &nbsp;&nbsp;(I.R.S. Employer Identification No.) |
| &nbsp;&nbsp;**500 Cummings Center, Suite 4550,**<br> **Beverly Massachusetts** |  | &nbsp;&nbsp;**01915** |
| &nbsp;&nbsp;*(Address of principal executive offices)* |  | &nbsp;&nbsp;(Zip Code) |

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**(800) 215-1824**

(Registrant's telephone number, including area code)

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

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|:---|
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ⌧

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻

Securities registered pursuant to Section 12(b) of the Act:

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|:---|:---|:---|
| &nbsp;&nbsp;**<u>Title of each class</u>** | &nbsp;&nbsp;**<u>Trading Symbol(s)</u>** | &nbsp;&nbsp;**<u>Name of each exchange on which registered</u>** |
| &nbsp;&nbsp;N/A | &nbsp;&nbsp;**N/A** | &nbsp;&nbsp;N/A |

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**SECTION 7.01 – REGULATION FD**

**Item 7.01 Regulation FD Disclosure**

On January 18, 2023, the Company issued a news release announcing that LexaGene's MiQLab System detects mycoplasma at minute levels, rousing additional interest from biopharma customers. A copy of the news release is furnished as Exhibit 99.1 hereto.

**SECTION 9 – FINANCIAL STATEMENTS AND EXHIBITS**

**Item 9.01 Exhibits.**

(d) Exhibits

104 Cover Page Interactive Data File (embedded within the Inline XBRL Document) <br> [99.1](tm232561d2_ex99-1.htm) [Press Release dated January 18, 2023](tm232561d2_ex99-1.htm)

**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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| | | |
|:---|:---|:---|
|  | **LEXAGENE HOLDINGS INC.** | **LEXAGENE HOLDINGS INC.** |
| Date: January 18, 2023 | By: | /s/ Jeffrey Mitchell |
|  |  | Name: Jeffrey Mitchell |
|  |  | Title: Chief Financial Officer |

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**Exhibit Index**

[99.1](tm232561d2_ex99-1.htm) [Press Release, dated January 18, 2023](tm232561d2_ex99-1.htm) <br> 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

## Exhibit 99.1

#### Exhibit 99.1
![](tm232561d2_ex99-1img01.jpg)

**LexaGene's MiQLab System Detects *Mycoplasma* at Minute Levels, Rousing Additional Interest from BioPharma Customers**

BEVERLY, Mass. USA – Jan 18, 2023 –<u> </u><u>LexaGene Holdings, Inc</u>., (<u>OTCQB: LXXGF</u>; <u>TSX-V: LXG</u>) ("LexaGene" or the "Company"), an innovative, molecular diagnostics company that has commercialized the <u>MiQLab<sup>TM</sup> System</u> for automated, genetic testing, is pleased to announce exciting news regarding the ability of the MiQLab System to detect *Mycoplasma* at minute levels.

Dr. Jack Regan, CEO and Founder of LexaGene commented, "In the process of completing the follow-on feasibility study with one of our biopharma customers, I'm thrilled to report that through this work, we've made an ~500X improvement in sensitivity for *Mycoplasma*. We've communicated this achievement, plus other development milestones, to our biopharma customers, who have in turn expressed great enthusiasm."

*Mycoplasma* contaminates 15 – 80% of U.S. laboratory cell cultures.<sup>1</sup> Confirming a culture or a biopharmaceutical biologic is negative for contaminating *Mycoplasma* takes 28 days by compendial methods.<sup>2</sup> This delay not only shortens the time available to sell the product before expiration, but also puts the biopharma company at more risk during the 4 – 6 weeks of bioreactor growth. At these latter stages, often 10's of millions of dollars' worth of product is at risk should a contamination be detected. Furthermore, it is critical for biopharmaceutical manufacturers to have robust procedures for monitoring and controlling the biosafety of their processes to ensure patient safety and compliance.

The industry is looking to adopt an easy-to-use PCR-based technology that can be operated inside the manufacturing plant which provides extremely sensitive detection in just a few hours. Manufacturers want the ability to detect contaminations in raw materials and across each bioprocessing step, especially the most expensive and value-adding steps. The data generated for this feasibility study demonstrates LexaGene's MiQLab System can be easily configured for extremely sensitive applications such as detecting *Mycoplasma*. This feasibility study adds to the body of data we've already generated that gets us closer to having our technology adopted for the manufacturing stage of producing biologics.

Dr. Regan continued, "Now that we have completed the follow-on feasibility study, we are in the process of discussing next steps with our biopharma customer. I will share updates as they become available."

For more information about LexaGene and the MiQLab System, please visit <u>www.lexagene.com</u> or follow us on <u>Twitter</u> and <u>LinkedIn</u>.

**About LexaGene Holdings Inc.** 

LexaGene is a molecular diagnostics company that has commercialized the MiQLab System for fast and easy detection of biological contaminants, pathogens and other molecular markers. The System is designed for on-site usage and uses real-time PCR chemistry. Our customers include biopharmaceutical companies and veterinary hospitals. The MiQLab System delivers excellent sensitivity, specificity, and breadth of detection.

**Reader Advisory**

*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.*

**LexaGene** \| 500 Cummings Center, Suite 4550, Beverly, Mass., 01915 \| T 800.215.1824 \| info@lexagene.com

![](tm232561d2_ex99-1img01.jpg)

*Except for statements of historical fact, this news release contains certain "forward-looking information" or "forward-looking statements" (collectively, "forward-looking information") within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate" and other similar words, or statements that certain events or conditions "may" or "will" occur and include statements relating to our expectations regarding future results. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.*

*Forward-looking information is based on the opinions and estimates of management at the date the statements are made, including assumptions with respect to American economic growth, demand for the Company's products, the Company's ability to produce and sell its products, sufficiency of our budgeted capital and operating expenditures, the satisfaction by our strategic partners of their obligations under our commercial agreements, our ability to realize upon our business plans and cost control efforts and the impact of COVID-19 on our business, results and financial condition.*

*Our forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work and verification and validation studies; uncertainty as to the timing and results of commercialization efforts; uncertainty as to our ability to supply products in response to customer demand; uncertainty as to the likelihood and timing of any required regulatory approvals, and the availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; intellectual property infringement risks, risks relating to any required regulatory approvals, risks relating to the safety and efficacy of our products, the use of our products, intellectual property protection, risks related to the COVID-19 pandemic and its impact upon our business operations generally, including our ability to develop and commercialize our products, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR at <u>www.sedar.com</u>. Readers are cautioned that this list of risk factors should not be construed as exhaustive.*

*The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.*

[1] <u>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3584481/</u>

[2] <u>https://www.biopharminternational.com/view/usp-mycoplasma-tests-new-regulation-mycoplasma-testing</u>

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**LexaGene** \| 500 Cummings Center, Suite 4550, Beverly, Mass., 01915 \| T 800.215.1824 \| info@lexagene.com