0001493152-24-020059.txt : 20240516 0001493152-24-020059.hdr.sgml : 20240516 20240515180752 ACCESSION NUMBER: 0001493152-24-020059 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20240515 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240516 DATE AS OF CHANGE: 20240515 FILER: COMPANY DATA: COMPANY CONFORMED NAME: bioAffinity Technologies, Inc. CENTRAL INDEX KEY: 0001712762 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] ORGANIZATION NAME: 08 Industrial Applications and Services IRS NUMBER: 465211056 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-41463 FILM NUMBER: 24952986 BUSINESS ADDRESS: STREET 1: 22211 WEST INTERSTATE-10 STREET 2: SUITE 1206 CITY: SAN ANTONIO STATE: TX ZIP: 78257 BUSINESS PHONE: 210-698-5334 MAIL ADDRESS: STREET 1: 22211 WEST INTERSTATE-10 STREET 2: SUITE 1206 CITY: SAN ANTONIO STATE: TX ZIP: 78257 8-K 1 form8-k.htm
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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

 

Date of Report (Date of earliest event reported): May 15, 2024

 

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 2.02. Results of Operation and Financial Condition.

 

On May 15, 2024, bioAffinity Technologies, Inc., a Delaware corporation (the “Registrant”), issued a press release that included financial information for its quarter ended March 31, 2024. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

The following exhibit is furnished with this Current Report on Form 8-K:

 

Exhibit   Description
99.1   Press Release issued by bioAffinity Technologies, Inc. dated May 15, 2024
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: May 15, 2024 BIOAFFINITY TECHNOLOGIES, INC.
(Registrant)
     
  By: /s/ Maria Zannes
  Name: Maria Zannes
  Title: President and Chief Executive Officer

 

 

 

 EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

News Release

 

bioAffinity Technologies Reports Record Q1 Revenue Driven by Accelerating Growth of CyPath® Lung Sales and Increased Laboratory Volumes

 

Expanded, experienced sales team more than doubles number of physician practices ordering CyPath® Lung test year-to-date

 

More than 547% annualized growth rate for CyPath® Lung orders in first four months of 2024 over full-year 2023, leading to 35% increase in original 2024 forecast

 

KOL referrals and word-of-mouth expanding adoption of CyPath® Lung outside of the beta market launch in Texas

 

SAN ANTONIO, Texas (May 15, 2024) – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, today reported financial results for the three months ended March 31, 2024.

 

Key Highlights

 

●Generated record quarterly revenue of $2.4 million in the first quarter of 2024.
●Forecasting between $9.2 and $9.6 million in 2024 revenues for wholly owned subsidiary Precision Pathology Laboratory Services (PPLS), up 23% over 2023.
●Increased 2024 CyPath® Lung sales forecast 35% from the original forecast reported in the 2023 Annual Report.
●Number of physician offices ordering CyPath® Lung is up 112%, more than double, since January 1, 2024.
●Medicare reimbursement for CyPath® Lung became effective on January 1, 2024.
●More than 547% annualized growth rate for CyPath® Lung orders in first four months of 2024 over full-year 2023 with April sales showing a robust increase of 21% over the previous month.
●Referrals and word-of-mouth from physicians, including key opinion leaders (KOLs), resulting in significant uptake of CyPath® Lung by physicians in states beyond Texas.
●Physicians in Pennsylvania, New Jersey, North Carolina, Arizona, and Michigan are ordering CyPath® Lung after hearing about it from patients and colleagues.
●Medical Director of Lung Innovations Network and The Lung Center at Penn Highlands Healthcare, Dr. Sandeep Bansal, joined our Medical and Scientific Advisory Board and incorporated CyPath® Lung into his medical practice that offers comprehensive lung care to over 10,000 patients in central and western Pennsylvania.
●Continued to advance new product development initiatives in collaboration with the U.S Department of Defense’s largest military health organization, focusing on tests that use our artificial intelligence and flow cytometry platform for diagnosing COPD and companion test with bronchoscopy.
●OncoSelect Therapeutics, a subsidiary of bioAffinity, was awarded a therapeutic patent in India for a novel cancer treatment method using chemotherapeutic agents conjugated to porphyrins.
●Successfully closed a $2.5 million registered direct offering and concurrent private placement to fund continued growth.

 

 
 

 

Management Commentary

 

“We are entering a period of accelerating growth with orders for CyPath® Lung up 547% on an annualized basis in the first four months of the year compared to all of 2023,” bioAffinity President and Chief Executive Officer Maria Zannes said. “As we continue to advance our commercial strategy, moving beyond the initial test market in Texas, the unique and compelling attributes of CyPath® Lung, including its AI-enhanced data analysis and non-invasive sample collection, have proven to be key differentiators in the market and are resonating with physicians and patients alike. This growing interest is leading to increased adoption by prominent medical practices and double-digit month-over-month growth in test orders.”

 

“CyPath® Lung is positioned to set a new standard in the early detection of lung cancer – a market projected to reach $4.7 billion by 2030,” Zannes continued. “As we continue to scale our operations and enhance our offerings, our focus remains steadfast on improving patient outcomes and delivering shareholder value. With Medicare and major private insurers now providing coverage, the pathway for increased adoption and accelerated growth in usage is clear, setting the stage for substantial market penetration and revenue generation in the upcoming quarters.”

 

First Quarter Financial Results

 

Revenue for the first quarter of 2024 was $2.4 million, compared with $921 revenue for the prior-year period. The majority of the year-over-year increase is through the acquisition of Precision Pathology Laboratory Services. Revenue is primarily generated from patient service fees, including billing for CyPath® Lung tests, with additional revenues generated from histology service fees and medical director fees.

 

Research and development expenses were $394,000 for the first quarter of 2024, compared with $370,000 for the comparable period in 2023. The increase was primarily due to higher compensation costs for additional research personnel and higher R&D laboratory supply costs.

 

Clinical development expenses were $49,000 for the first quarter of 2024, compared with $20,000 for the first quarter of 2023. The increase was primarily due to an increase in compensation costs and benefits from the addition of new clinical development personnel.

 

Selling, general and administrative expenses were $2.2 million for the first quarter of 2024, compared with $1.1 million for the comparable period in 2023. The increase was primarily due to acquired general and administrative costs from PPLS and an increase in personnel and services to support the launch of CyPath® Lung.

 

Net loss for the first quarter of 2024 was $2.1 million, or $0.21 per share, compared with a net loss of $1.5 million, or $0.18 per share, for the comparable period in 2023.

 

Cash and cash equivalents as of March 31, 2024, were $2.5 million, compared with $2.8 million as of December 31, 2023.

 

 
 

 

About bioAffinity Technologies, Inc.

 

bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com.

 

Forward-Looking Statements

 

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding continuing to advance the Company’s commercial strategy, moving beyond the initial test market in Texas, positioning CyPath® Lung to set a new standard in the early detection of lung cancer – a market projected to reach $4.7 billion by 2030, increased adoption by prominent medical practices and double-digit month-over-month growth in test orders, revised forecast of between $9.2 million and $9.6 million in 2024 revenues for wholly owned subsidiary Precision Pathology Laboratory Services, up 23% over 2023, and the increased 2024 CyPath® Lung sales forecast of 35% from the original forecast reported in the 2023 Annual Report. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to continue to advance the Company’s commercial strategy, moving beyond the initial test market in Texas, the ability to generate revenue forecasted and to generate forecasted 2024 CyPath® Lung sales, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. 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. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and 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

 

bioAffinity Technologies

Julie Anne Overton

Director of Communications

jao@bioaffinitytech.com

 

Investor Relations

 

Dave Gentry

RedChip Companies Inc.

1-800-RED-CHIP (733-2447)

Or 407-491-4498

BIAF@redchip.com

 

 
 

 

bioAffinity Technologies, Inc.

Condensed Consolidated Balance Sheets

 

   March 31, 2024   December 31, 2023 
   (unaudited)     
ASSETS          
Current assets:          
Cash and cash equivalents  $2,453,165   $2,821,570 
Accounts and other receivables, net   1,123,609    811,674 
Inventory   9,487    18,484 
Prepaid expenses and other current assets   344,900    321,017 
Total current assets   3,931,161    3,972,745 
           
Non-current assets:          
Property and equipment, net   461,209    458,633 
Operating lease right-of-use asset, net   347,860    370,312 
Finance lease right-to-use, net   1,069,601    1,165,844 
Goodwill   1,404,486    1,404,486 
Intangible assets, net   818,889    833,472 
Other assets   16,060    16,060 
           
Total assets  $8,049,266   $8,221,552 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
           
Current liabilities:          
Accounts payable  $442,485   $604,789 
Accrued expenses   923,810    1,149,811 
Unearned revenue   30,174    33,058 
Operating lease liability, current portion   96,631    94,708 
Finance lease liability, current portion   372,787    365,463 
Notes payable, current portion   4,686    — 
Total current liabilities   1,870,573    2,247,829 
           
Non-current liabilities:          
Finance lease liability, net of current portion   739,478    835,467 
Operating lease liability, net of current portion   258,110    283,001 
Notes payable, net of current portion   23,037    — 
           
Total liabilities   2,891,198    3,366,297 
           
Commitments and contingencies          
           
Stockholders’ equity:          
Preferred stock, par value $0.001 per share; 20,000,000 shares authorized; no shares issued or outstanding at March 31, 2024, and December 31, 2023   —    — 
Common stock, par value $0.007 per share; 25,000,000 shares authorized; 11,214,502 and 9,394,610 issued and outstanding at March 31, 2024, and at December 31, 2023, respectively.   78,515    65,762 
Additional paid-in capital   51,744,830    49,393,972 
Accumulated deficit   (46,665,277)   (44,604,479)
           
Total stockholders’ equity   5,158,068    4,855,255 
           
Total liabilities and stockholders’ equity  $8,049,266   $8,221,552 

 

 
 

 

bioAffinity Technologies, Inc.

Unaudited Condensed Consolidated Statements of Operations

 

   Three Months Ended
March 31,		 
   2024   2023 
   (unaudited) 
Net Revenue  $2,406,391   $921 
           
Operating expenses:          
Direct costs and expenses   1,660,007    87 
Research and development   393,639    369,617 
Clinical development   48,960    19,628 
Selling, general and administrative   2,196,361    1,147,875 
Depreciation and amortization   149,637    21,684 
           
Total operating expenses   4,448,604    1,558,891 
           
Loss from operations   (2,044,213)   (1,557,970)
           
Other income (expense):          
Interest income   6,127    38,654 
Interest expense   (23,550)   (1,655)
Other income   —    — 
Other expense   4,510    — 
           
Net loss before provision for income taxes   (2,057,126)   (4,919,158)
           
Income tax expense   (3,672)   (11,819)
           
Net loss  $(2,060,798)  $(1,532,790)
           
Net loss per common share, basic and diluted  $(0.21)  $(0.18)
           
Weighted average common shares outstanding, basic and diluted   9,915,426    8,433,689 

 

 

 

 

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Cover
May 15, 2024
Document Type 8-K
Amendment Flag false
Document Period End Date May 15, 2024
Entity File Number 001-41463
Entity Registrant Name BIOAFFINITY TECHNOLOGIES, INC.
Entity Central Index Key 0001712762
Entity Tax Identification Number 46-5211056
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 22211 W Interstate 10
Entity Address, Address Line Two Suite 1206
Entity Address, City or Town San Antonio
Entity Address, State or Province TX
Entity Address, Postal Zip Code 78257
City Area Code 210
Local Phone Number 698-5334
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company true
Elected Not To Use the Extended Transition Period false
Common Stock, par value $.007 per share  
Title of 12(b) Security Common Stock, par value $.007 per share
Trading Symbol BIAF
Security Exchange Name NASDAQ
Tradeable Warrants to purchase Common Stock  
Title of 12(b) Security Tradeable Warrants to purchase Common Stock
Trading Symbol BIAFW
Security Exchange Name NASDAQ
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