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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): August 14, 2023
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
August 14, 2023, bioAffinity Technologies, Inc., a Delaware corporation (the “Registrant”), issued a press release that included
financial information for its quarter ended June 30, 2023. 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:
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: August 14, 2023 |
BIOAFFINITY TECHNOLOGIES, INC.
(Registrant) |
|
|
|
By: |
/s/
Maria Zannes |
|
Name: |
Maria Zannes |
|
Title: |
President and Chief Executive Officer |
Exhibit
99.1
bioAffinity
Technologies Reports Second Quarter 2023 Financial Results and Provides Business Update
SAN
ANTONIO (Aug. 14, 2023) – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the
need for noninvasive detection of early-stage lung cancer and other diseases of the lung, today reported financial results for the three
and six months ended June 30, 2023, and provided a business update.
Highlights
from the second quarter of 2023 and subsequent weeks included:
Corporate
and Commercial Highlights
| ● | The
American Medical Association (AMA) issued a Current Procedural Terminology (CPT) code for
use with CyPath® Lung with an effective date of Oct. 1, 2023. CPT codes
provide a uniform system to identify medical services and procedures and seek reimbursement
from private payers and public health insurance programs, including Medicare and Medicaid.
|
| ● | The
Department of Defense (DOD) purchased CyPath Lung® tests for use in an observational
study on active military personnel at high risk for developing lung cancer (NCT05870592)
and for research on the use of bronchoalveolar lavage fluid to assess cardiopulmonary function
and exercise performance in military personnel post COVID-19 infection. |
| ● | Michael
Dougherty joined the management team as Chief Financial Officer. Previously, he served as
CFO of Amazon’s Alexa commercial domains with responsibility for financial strategy
over Alexa’s multibillion-dollar investments in AI-generated customer experiences. |
| ● | The
Company launched a pilot marketing and sales program in select cities in Texas to provide
insights and strategies for the successful product rollout for CyPath® Lung. |
Research
and Development Highlights
| ● | Presented
advancements in CyPath® Lung at the Cleveland Clinic’s invitation-only
fourth annual “Advances in Early Lung Cancer Detection” symposium, which
focuses on accelerating the development and implementation of new technologies and methods
for the early detection of lung cancer. |
| ● | Presented
a poster titled “Development of porphyrin-stained polystyrene compensation beads for
use on an automated analysis platform” at CYTO 2023, the annual Congress for the International
Society for the Advancement of Cytometry, that demonstrated the suitability of the Company’s
proprietary compensation beads for commercial use with flow cytometry, including with CyPath®
Lung. |
| ● | Presented
a poster titled “Vitamin B12 deprivation does not phenocopy selective cytotoxicity
of CD320 and LRP2 silencing” at the University of Massachusetts T.H. Chan Medical School’s
fifth annual RNA Therapeutics Symposium demonstrating that deprivation of vitamin B12 does
not play a role in the selective cytotoxicity of cancer cells observed after silencing the
expression of CD320 and LRP2; this research follows the Company’s discovery that using
small interfering RNA (siRNA) to knock down CD320 and LRP2 killed cancer cells in vitro
without harming healthy cells. |
Management
Commentary
“Our
sales team is implementing a test market pilot program of CyPath® Lung across various target markets in Texas, and we
are encouraged with their progress. The pilot program is a tactical program to test various marketing and selling approaches to accelerate
the development of a successful regional and then national roll out of the CyPath® Lung test. Issuance of a CPT code by
the AMA specifically for CyPath® Lung is another important milestone that we believe signals the value our diagnostic
adds to the clinical care of patients at high risk for developing lung cancer,” bioAffinity President and Chief Executive Officer
Maria Zannes said.
“We
are building brand awareness and market positioning at the same time we are showcasing our innovation at prestigious medical and scientific
conferences. The result is increased recognition and adoption of CyPath® Lung, including interest by the DOD. We expect
revenues from CyPath® Lung to grow as we expand our geographic reach, add prescribing physicians and focus on larger medical
systems,” Ms. Zannes added.
Second
Quarter Financial Results
Revenue
for the second quarter of 2023 was $20,000, compared with $1,000 for the prior-year period. Revenue is generated from royalties from
the Company’s licensee, Precision Pathology Services, from sales of CyPath® Lung as a laboratory developed test,
from clinical flow cytometry services provided to Precision Pathology Services related to CyPath® Lung and from CyPath®
Lung tests purchased by the DOD. Sales to the DOD were $10,000 for the second quarter of 2023.
Research
and development expenses were $335,000 for the second quarter of 2023, compared with $248,000 for the comparable period in 2022. The
increase was primarily due to higher compensation costs from adding research personnel and higher costs for lab supplies and reagents.
Clinical
development expenses were $35,000 for the second quarter of 2023, compared with $28,000 for the second quarter of 2022. The increase
was primarily due to higher professional fees related to clinical strategy evaluation as the Company prepares to launch the CyPath®
Lung pivotal trial.
Selling,
general and administrative expenses were $1.4 million for the second quarter of 2023, compared with $409,000 for the comparable period
in 2022. The increase was primarily attributed to higher consulting, legal and professional fees related to being a publicly traded company,
higher board compensation, and sales and marketing costs for commercialization of CyPath® Lung.
Net
loss for the second quarter of 2023 was $1.7 million, or $0.20 per share, compared with a net loss of $88,000, or $0.03 per share, for
the comparable period in 2022.
Cash
and cash equivalents were $8.3 million as of June 30, 2023, compared with $11.4 million as of December 31, 2022. bioAffinity Technologies
believes that its available cash will be sufficient to fund planned operations for at least the next 12 months.
About
bioAffinity Technologies, Inc.
bioAffinity
Technologies, Inc. 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 noninvasive 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. For more information, visit www.bioaffinitytech.com.
Forward-Looking
Statements
This
press release contains certain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These statements are identified by the use of the words “could,” “believe,” “anticipate,”
“intend,” “estimate,” ““expect,” “may,” “continue,” “predict,”
“potential,” “project” and similar expressions that are intended to identify forward-looking statements and include
statements regarding implementing a test market pilot program of CyPath® Lung across various target markets in Texas,
accelerating the development of a successful regional and then national roll out of the CyPath® Lung test, building brand
awareness and market positioning while showcasing the Company at prestigious medical and scientific conferences, and growing revenues
from CyPath® Lung as the Company expands its geographic reach, adds prescribing physicians and focuses on larger medical
systems. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release
and are subject to a number of 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
accelerate the development of a successful regional and then national roll out of the CyPath® Lung test, the Company’s
ability to build brand awareness and market positioning for the CyPath® Lung test, the Company’s ability to grow
revenues from CyPath® Lung by expanding its geographic reach, adding prescribing physicians and focusing on larger medical
systems, and the risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, the Company’s
Quarterly Reports on Form 10-Q, the Company’s Current Reports on Form 8-K and subsequent filings filed with the Securities and
Exchange Commission. The information in this release is provided only as of the date of this release, and the Company undertakes no obligation
to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after
the date on which the statements are made or to reflect the occurrence of unanticipated events, except as required by law.
Contacts:
bioAffinity
Technologies
Julie
Anne Overton
Director
of Communications
jao@bioaffinitytech.com
LHA
Investor Relations
Tirth
T. Patel
tpatel@lhai.com
bioAffinity
Technologies, Inc.
Condensed
Consolidated Balance sheets
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 8,279,182 | | |
$ | 11,413,759 | |
Accounts and other receivables, net | |
| 90,233 | | |
| 10,489 | |
Inventory | |
| 10,101 | | |
| 5,540 | |
Prepaid and other current assets | |
| 279,687 | | |
| 531,899 | |
| |
| | | |
| | |
Total current assets | |
| 8,659,203 | | |
| 11,961,687 | |
| |
| | | |
| | |
Property and equipment, net | |
| 207,377 | | |
| 214,438 | |
Other assets | |
| 6,920 | | |
| 6,000 | |
| |
| | | |
| | |
Total assets | |
$ | 8,873,499 | | |
$ | 12,182,125 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 174,404 | | |
$ | 345,042 | |
Accrued expenses | |
| 515,663 | | |
| 541,894 | |
Unearned revenue | |
| 42,750 | | |
| — | |
Loan payable | |
| 42,334 | | |
| 251,746 | |
| |
| | | |
| | |
Total current liabilities | |
| 775,151 | | |
| 1,138,682 | |
| |
| | | |
| | |
Total liabilities | |
| 775,151 | | |
| 1,138,682 | |
| |
| | | |
| | |
Commitments and contingencies (See Note 9) | |
| | | |
| | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Preferred stock, par value $0.001 per share; 20,000,000 shares authorized; no shares issued or outstanding at June 30, 2023, and December 31, 2022 | |
| — | | |
| — | |
Common stock, par value $0.007 per share; 25,000,000 shares authorized; 8,555,365 issued and outstanding at June 30, 2023; and 8,381,324 shares issued and outstanding at December 31, 2022 | |
| 59,887 | | |
| 58,669 | |
Additional paid-in capital | |
| 47,978,892 | | |
| 47,652,242 | |
Accumulated deficit | |
| (39,940,431 | ) | |
| (36,667,468 | ) |
Total stockholders’ equity | |
| 8,098,348 | | |
| 11,043,443 | |
| |
| | | |
| | |
Total liabilities and stockholders’ equity | |
$ | 8,873,499 | | |
$ | 12,182,125 | |
bioAffinity
Technologies, Inc.
Unaudited
Condensed Consolidated Statements of Operations
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
(Unaudited) | | |
| | |
(Unaudited) | | |
| |
Revenue | |
$ | 19,738 | | |
$ | 1,306 | | |
$ | 20,659 | | |
$ | 1,306 | |
Cost of sales | |
| 1,234 | | |
| 146 | | |
| 1,322 | | |
| 146 | |
Gross profit | |
| 18,504 | | |
| 1,160 | | |
| 19,337 | | |
| 1,160 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 335,125 | | |
| 248,419 | | |
| 704,741 | | |
| 528,267 | |
Clinical development | |
| 35,260 | | |
| 28,240 | | |
| 54,888 | | |
| 80,744 | |
General and administrative | |
| 1,426,469 | | |
| 408,619 | | |
| 2,596,027 | | |
| 803,311 | |
| |
| | | |
| | | |
| | | |
| | |
Total operating expenses | |
| 1,796,854 | | |
| 685,279 | | |
| 3,355,657 | | |
| 1,412,322 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (1,778,350 | ) | |
| (684,119 | ) | |
| (3,336,320 | ) | |
| (1,411,162 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 44,124 | | |
| 276 | | |
| 82,778 | | |
| 847 | |
Interest expense | |
| (1,360 | ) | |
| (399,265 | ) | |
| (3,015 | ) | |
| (1,546,848 | ) |
Gain on extinguishment of debt | |
| — | | |
| 212,258 | | |
| — | | |
| 212,258 | |
Fair value adjustments on convertible notes payable | |
| — | | |
| 782,798 | | |
| — | | |
| 1,186,992 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss before provision for income taxes | |
| (1,735,586 | ) | |
| (88,052 | ) | |
| (3,256,557 | ) | |
| (1,557,913 | ) |
| |
| | | |
| | | |
| | | |
| | |
Income tax expense | |
| 4,587 | | |
| — | | |
| 16,406 | | |
| 2,159 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (1,740,173 | ) | |
$ | (88,052 | ) | |
$ | (3,272,963 | ) | |
$ | (1,560,072 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share, basic and diluted | |
$ | (0.20 | ) | |
$ | (0.03 | ) | |
$ | (0.38 | ) | |
$ | (0.58 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding | |
| 8,520,714 | | |
| 2,693,511 | | |
| 8,477,656 | | |
| 2,687,431 | |
#
# #
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