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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

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

 

January 4, 2023

Date of Report (Date of earliest event reported)

 

BIOAFFINITY TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-41463   46-5211056

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(I.R.S. Employer

Identification Number)

 

22211 W Interstate 10

Suite 1206

San Antonio, Texas 78257

(210) 698-5334

(Address of principal executive offices and Registrant’s telephone number, including area code)

 

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):

 

  ☐ 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))

 

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 ☒

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, par value $.007 per share   BIAF   The Nasdaq Stock Market LLC
Tradeable Warrants to purchase Common Stock   BIAFW   The Nasdaq Stock Market LLC

 

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. ☐

 

 

 

 

 

 

Item 8.01. Other Events.

 

Recent Press Release

 

On January 4, 2023, the Company issued a press release announcing the issuance of a Notice of Allowance by the U.S. Patent and Trademark Office for the Company’s patent application. The press release is filed as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

  Exhibit No.   Description
  99.1   Press Release of bioAffinity Technologies, Inc., dated January 4, 2023.
  104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

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.

 

  BIOAFFINITY TECHNOLOGIES, INC.
   
  By: /s/ Maria Zannes
    Maria Zannes
    President and Chief Executive Officer

 

Dated: January 4, 2023

 

 

 

 

 

Exhibit 99.1

 

  News Release

 

For Immediate Release

 

bioAffinity Technologies Announces Notice to Award U.S. Patent Protecting Novel Compounds for Specific Delivery of Cancer Treatments

 

SAN ANTONIO, TX – Jan 4, 2023 – bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW) announced today that the U.S. Patent and Trademark Office (USPTO) has provided a Notice of Allowance for a patent application titled “Porphyrin Compounds and Compositions Useful for Treating Cancer” for the targeted delivery of novel cancer treatments. A Notice of Allowance is issued after the USPTO makes a determination that a patent should be granted for the claimed invention. The U.S. patent will issue to the Company’s wholly owned subsidiary OncoSelect and grant protection to 2037.

 

“A little more than 1.9 million new cancer cases are expected to have been diagnosed in the United States in 2022,” said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. “Not surprisingly, the cost of cancer is staggering. National expenditures for cancer care in the United States in 2018 were $150.8 billion. The larger cost is borne by patients who undergo therapies that often lead to toxic treatment-associated side effects. New treatments delivered by more specific targeting agents like porphyrins are needed to improve survival and a survivor’s quality of life. bioAffinity Technologies is committed to bringing these treatments to market.”

 

Research related to the Company’s non-invasive lung cancer diagnostic CyPath® Lung led to the discoveries being developed to treat cancer including using porphyrins conjugated with oncological drugs for more targeted delivery with fewer unwanted treatment-associated side effects. Porphyrins, such as the synthetic molecule TCPP used in CyPath® Lung, preferentially enter cancer cells and may lead to greater uptake of chemotherapeutics attached to the porphyrin with less impact on healthy cells.

 

“The selectivity of porphyrins that preferentially bind with cancer cells makes them excellent candidates for drug delivery and diagnostic products,” said Dr. William Bauta, bioAffinity Technologies’ Senior Vice President of Therapeutics. “Selective delivery of drugs that kill cancer with little harm to healthy cells helps patients tolerate therapy, leading to more effective treatment that saves lives.”

 

bioAffinity Technologies is advancing its therapeutic assets with the intent to license its products for clinical development. Its subsidiary OncoSelect holds patents to Porphyrin Compounds and Compositions Useful for Treating Cancer in Australia, China and Mexico and pending applications in Canada, the European Patent Office, Hong Kong, India and Japan.

 

 

 

 

About bioAffinity Technologies, Inc.

 

bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW) addresses the need for noninvasive diagnosis of early-stage cancer and diseases of the lung, and targeted cancer treatment. The Company’s first product, CyPath® Lung, is a non-invasive test that has shown high sensitivity and specificity for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Services. OncoSelect Therapeutics, LLC, a subsidiary of bioAffinity Technologies, is advancing its discoveries shown in vitro to kill cancer cells without harm to normal cells. Research and optimization of the Company’s platform technologies are conducted in its laboratories at The University of Texas at San Antonio.

 

Forward-Looking Statements

 

This press release contains forward-looking statements, including statements regarding the anticipated use of proceeds from the Company’s offering of common shares. Forward-looking statements can be identified by words such as “believes,” “expects,” “estimates,” “intends,” “may,” “plans,” “will” and similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.

 

Contacts:

 

Company Contact:

Maria Zannes, President & Chief Executive Officer

mz@bioaffinitytech.com

 

Investor Relations Contact:

Tiberend Strategic Advisors, Inc.

Jonathan Nugent

jnugent@tiberend.com

or

David Irish

dirish@tiberend.com