UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

_______________

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  April 1, 2020

BIOMERICA, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-37863

95-2645573

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

 

 

17571 Von Karman Ave. Irvine, California

92614

 

(Address of Principal Executive Offices)

(Zip Code)

Registrant's telephone number, including area code:  (949) 645-2111

Not Applicable

(Former name or former address if changed since last report)

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:

¨            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))

 

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

 

Title of each class

Trading Symbol

Name of each exchange on which registered

Common Stock, par value $0.08

BMRA

NASDAQ Capital Market

 

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.   ¨

1

Item 1.01              Entry into a Material Definitive Agreement

On April 1, 2020, Biomerica, Inc. (“Biomerica”) entered into two separate non-exclusive license agreements (the “License Agreements”) with the Mount Sinai Icahn School of Medicine in New York (“Mount Sinai”) to license technology from Mount Sinai that Biomerica intends to use to scale up and manufacture a laboratory version serological test for SARS-CoV-2 coronavirus.  This test uses the ELISA microplate format that can run on existing open system equipment found in most hospitals and clinical laboratories in the United States.  The non-exclusive License Agreements provide for royalty payments to Mount Sinai based on a percentage of gross sales of commercial products manufactured and sold by Biomerica that incorporate the Mount Sinai technology licensed under the License Agreements.

 

While Biomerica believes it will be able to utilize the licensed technology to make and sell a commercial product, there can be no assurance Biomerica will be successful at transferring the technology, further developing the technology as needed for commercialization, incorporating the technology into its products, utilizing the technology for Biomerica’s intended purposes, or manufacturing a final product that meets market demands or regulatory requirements.  Biomerica intends to apply for expedited clearance with the FDA under the new Emergency Use Authorization process for this new test format.

 

Forward-Looking Statements

 

The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Certain information included in this Current Report on Form 8-K contains statements that are forward-looking, such as statements relating to Biomerica’s expectations of the use of the technology licensed from Mount Sinai, Biomerica’s commercialization and scaling of its SARS-CoV-2 serological tests, and payments to be made to Mount Sinai related to the License Agreements.  Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: Biomerica’s ability to transfer, further develop, integrate and use the licensed technology; Biomerica’s ability to manufacture and scale its commercial products using the licensed technology; results of studies testing the efficacy of Biomerica’s commercial products; regulatory approvals necessary prior to commercialization of Biomerica’s products; availability of Biomerica’s products; capacity, resource and other constraints on Biomerica’s suppliers; dependence on third party supply chain and manufacturers; dependence on international shipping carriers; governmental import/export regulations; demand for Biomerica’s commercial products; competition from other similar products and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations; and Biomerica’s ability to obtain patent protection and other intellectual property protections on any aspects of its test technologies or commercial products; and Biomerica’s ability to develop and manufacture certain tests it has not yet finalized and has never previously manufactured.   Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Additionally, potential risks and uncertainties include, among others, fluctuations in Biomerica’s operating results due to its business model and expansion plans, downturns in international and or national economies, Biomerica’s ability to raise additional capital, the competitive environment in which Biomerica will be competing, and Biomerica’s dependence on strategic relationships.  Additional risks and uncertainties associated with market conditions and Biomerica are discussed in Biomerica’s filings with the Securities and Exchange Commission, including the “Risk Factors” section of Biomerica’s Annual Report on Form 10-K for the year ended May 31, 2019. Biomerica is under no obligation to update any forward-looking statements after the date of this Form 8-K.

 

Item 7.01              Regulation FD Disclosure

 

On April 2, 2020, Biomerica issued a press release announcing the execution of the two License Agreements. A copy of Biomerica’s press release is furnished hereto as Exhibit 99.1 to this Current Report on Form 8-K and incorporated in this Item 7.01 in its entirety. Both of the License Agreements are non-exclusive and Mount Sinai is making this technology available to other licensees.

 

The information contained in, or incorporated into, this Item 7.01 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference to such filing.

 

Item 9.01              Financial Statements and Exhibits

 

(d)   Exhibits.

 Number

  

Description

 

 

 

99.1

 

Press Release issued April 2, 2020.

2

SIGNATURE

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.

 

BIOMERICA, INC.

Date:  April 3, 2020

By:

 /s/ Zackary S. Irani

Zackary S. Irani

Chief Executive Officer

 

 

3

 Exhibit 99.1

Biomerica Signs Two Definitive Agreements with Mount Sinai Medical School in New York to Scale-up a Laboratory Version Serological Test for COVID-19 That Enables High-Volume Screenings in Labs

  

-         Price point of this high-volume laboratory version test is expected be as low as $10 per patient

 

-         Once developed and scaled-up, Biomerica’s existing production capacity could allow for over 1,000,000 tests per month at its manufacturing facilities in Irvine, California

 

IRVINE, CA--(April 02, 2020) - Biomerica Inc. (NASDAQ: BMRA) today announced it has signed two separate definitive license agreements with Mount Sinai’s Icahn School of Medicine in New York to license technologies   pertaining to a laboratory version serological test for SARS-CoV-2 (“COVID-19”) virus infection which have been developed at Mount Sinai.  This test uses the ELISA microplate format that can run on existing open system equipment found in most hospitals and clinical laboratories in the United States.     

 

Biomerica has extensive serological test development, scale-up and manufacturing capabilities and expertise.   Based on the data received from Mt. Sinai, the Company intends to scale-up commercial manufacturing of the Mt. Sinai licensed technology.   Biomerica has the equipment and capacity to manufacture over 1,000,000 tests in the ELISA microplate format per month at its manufacturing facility in Irvine, California.  While there are unknowns about the transfer and scale-up process, if successful the Company believes it could have commercial sales within weeks.  Biomerica will file for expedited clearance with the FDA under the new EUA process for this new test format.

 

This ELISA microplate format is a serology test that detects antibodies (proteins produced by the immune system in response to infections) in the blood of patients who have been infected with the Covid-19 virus causing the current pandemic.  These antibodies show up in detectable quantities in approximately 8 days following infection, and remain detectable for as long as 3 months or more. Persons who have tested positive for the antibodies and are no longer infectious, can possibly be cleared to return to work as they have a lower likelihood of reinfection and/or spreading the virus.

 

Serology tests are a potentially powerful tool for identifying anyone who has been infected, whether they had symptoms or not. Antibodies to coronaviruses typically remain in humans for up to 90 days or more. Serological testing is important in identifying the total number of people who have been infected with Covid-19 and will allow for further studies that establish whether the immune response protects from future re-infection. Further, this type of testing could be particularly important for the immune surveillance of health care workers, first responders, government workers, and others whose infection risks could be heightened by working with COVID-19 infected individuals.

 

 

 

Zackary Irani, Chairman and Chief Executive Officer, stated, “If person has already been infected with SARS-CoV-2, they  develop antibodies through an immune response that should give them immunity.  The entire Biomerica team is working tirelessly to make our low-cost tests available to the hundreds of requests we have received.   At the same time, we still remaining committed to our strategy of growing our colorectal disease detection product EZ Detect™, and finalizing clinical trials and gaining FDA approval for our HP Detect™H. Pylori test and our InFoods® IBS diagnostic-guided therapy product.”

 

 

About Biomerica (NASDAQ: BMRA)

Biomerica, Inc. (www.biomerica.com) is a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (in home and in physicians' offices) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. The Company's products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica primarily focus is on Gastrointestinal and inflammatory Diseases where the Company has multiple diagnostic and therapeutic products in development.

 

The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release (as well as information included in oral statements or other written statements made or to be made by Biomerica) contains statements that are forward-looking, such as statements relating to the efficacy of the Company’s SARS-CoV-2 (COVID-19) tests, the rapidity of testing results, pricing of the Company’s test kits, demand for  orders, availability of the Company’s COVID-19 test kits, patent protection on  test technology, the Company’s ability to develop and manufacture new products not yet developed or validated, and the efficacy of such undeveloped tests. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation:  results of studies testing the efficacy of the Company’s COVID-19 tests; regulatory approvals necessary prior to commercialization of the Company’s COVID-19 tests; availability of the Company’s COVID-19 tests; capacity, resource and other constraints on our suppliers; dependence on our third party supply chain and manufacturers; dependence on international shipping carriers; governmental import/export regulations; demand for our COVID-19 test; competition from other similar products and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations that make it difficult or impossible for the company to maintain current operations; regulations and the Company’s ability to obtain patent protection on any aspects of its  test technologies, the Company’s ability to develop and manufacture certain tests it has not yet finalized and has never previously manufactured.  Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Additionally, potential risks and uncertainties include, among others, fluctuations in the Company's operating results due to its business model and expansion plans, downturns in international and or national economies, the Company's ability to raise additional capital, the competitive environment in which the Company will be competing, and the Company's dependence on strategic relationships. The Company is under no obligation to update any forward-looking statements after the date of this release.

Contact Information

Company Spokesperson
949-645-2111
www.biomerica.com