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 finetuning our 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.
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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version on businesswire.com: https://www.businesswire.com/news/home/20230814966396/en/
bioAffinity Technologies Julie Anne Overton Director of
Communications jao@bioaffinitytech.com LHA Investor
Relations Tirth T. Patel tpatel@lhai.com
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