bioAffinity Technologies, Inc. (Nasdaq: BIAF;
BIAFW), a biotechnology company focused on commercializing
noninvasive tests for the detection of early-stage cancer and lung
disease, today reported financial results for the three and 12
months ended December 31, 2023.
Fiscal Year 2023 and Recent Highlights
- Reported fiscal year 2023 revenue of $2.5 million, a
significant increase from $5,000 in 2022, driven by the September
2023 acquisition of Precision Pathology Laboratory Services (PPLS)
and increasing sales of CyPath® Lung, the Company’s noninvasive
test to detect early-stage lung cancer.
- Reported accelerating growth of 350% in CyPath® Lung tests
ordered and processed in Q1 2024 as compared to Q4 2023, exceeding
the Company’s targeted sales forecast for the quarter. The Company
continues with its limited market launch in Texas to refine future
positioning and strategic insight for CyPath® Lung in preparation
for expanding to the national market.
- Achieved a milestone with the Centers for Medicare and Medicaid
Services (CMS) final determination for payment for CyPath® Lung for
the 2024 calendar year, a significant step in the Company’s
strategic plan to accelerate the commercialization of CyPath®
Lung.
- Initiated the sale of CyPath® Lung tests to the Department of
Defense for observational studies and research. This research
expands the test's use and includes the development of a companion
test for bronchoalveolar lavage (BAL) samples to be used in
conjunction with bronchoscopy.
- Announced the appointment of Michael Dougherty, CPA, MBA, as
Chief Financial Officer, bringing extensive experience from his
previous role as CFO of Amazon’s Alexa Commercial Domains.
- Developed marketing materials for CyPath® Lung in collaboration
with leading marketing and advertising firms and began utilizing
them with physicians and patients in January 2024, focusing on the
test’s value as a tool to assist physicians with patient care
decisions.
- Announced the appointment of Dallas Coleman as National
Director of Sales and the ongoing expansion of the sales team. Mr.
Coleman has more than 15 years of experience in medical sales and
marketing, most recently as Executive Account Manager for the
respiratory portfolio of Olympus America’s therapeutic solutions
division.
- Successfully passed the bi-annual College of American
Pathologists (CAP) inspection in January 2024, affirming the high
standards of quality and patient care attained by the Company’s
commercial laboratory, Precision Pathology Laboratory
Services.
- Expanded the Company’s Medical and Scientific Advisory Board
with the appointment of Sandeep Bansal, M.D., Medical Director of
Pennsylvania’s Lung Innovations Network, a patient-centered
practice that offers comprehensive lung care to more than 10,000
patients in central and western Pennsylvania.
- Strengthened the Company’s Board of Directors with the
appointment of Jamie Platt, Ph.D., Managing Director and Chief
Executive Officer of Pictor Limited, where she is leading a
turnaround by restructuring and accelerating product development.
Dr. Platt was instrumental in merger and acquisition exits for two
diagnostic companies with a combined value of approximately $1
billion.
Management Commentary
“As we reflect on the monumental achievements of bioAffinity
Technologies over the past year, I am filled with immense pride and
optimism for the future,” said Maria Zannes, President and Chief
Executive Officer of bioAffinity Technologies. “Our fiscal year
2023 revenue of $2.5 million, up from less than $5,000 in 2022, is
not just a number – it’s a testament to the dedication of our team,
the quality of Precision Pathology’s operations, the trust of our
healthcare partners, and what we believe is the growing recognition
of CyPath® Lung's critical role in the early detection of lung
cancer."
Ms. Zannes continued, "The CMS's final payment determination for
CyPath® Lung for the 2024 calendar year was a major accomplishment
that supports our strategic plan to accelerate commercialization.
This milestone, coupled with our successful acquisition of
Precision Pathology Services and expanding the reach of CyPath®
Lung through partnerships such as with the Department of Defense,
positions us at the forefront of noninvasive lung cancer detection.
Our revenue growth is a beacon of our potential and the impact we
aim to have on millions of lives by providing accessible, accurate,
and noninvasive diagnostic solutions. As we look ahead, we are more
committed than ever to building on this momentum and expanding our
market to fulfill the promise of early cancer detection and
treatment."
Fourth Quarter Financial Results
Revenue for the fourth quarter of 2023 was approximately $2.2
million, up from no revenue for the prior-year period. Revenue was
derived from sales and services of the Company’s commercial
laboratory, Precision Pathology Laboratory Services, including its
sale of CyPath® Lung as a Laboratory Developed Test (LDT).
Research and development expenses were $432,000 for the fourth
quarter of 2023, compared with $429,000 for the comparable period
in 2022. Selling, general and administrative expenses were $2.2
million for the fourth quarter of 2023, compared with $1.2 million
for the comparable period in 2022.
Net loss for the fourth quarter of 2023 was $2.4 million,
compared with a net loss of $1.7 million for the comparable period
in 2022.
Full Year Financial Results
Revenue for 2023 was $2.5 million, up from approximately $5,000
for 2022.
Research and development expenses were $1.5 million in 2023,
compared with $1.4 million in 2022. The increase was primarily
attributable to an increase in compensation costs and benefits as
we added research personnel.
Selling, general and administrative expenses were $6.8 million
in 2023, compared with $2.5 million in 2022. The increase was
primarily attributable to general and administration costs acquired
from PPLS, accounting, legal, and professional fee costs associated
with the acquisition of PPLS, the accounting, legal, and
professional fee costs associated with the SEC filing of a
registration statement on Form S-1, increase in stock-based
compensation, increase in employee compensation as we added sales
and administrative personnel, increase in branding and marketing
collateral, increase in directors and officers insurance, increase
in public company-related expenses as well as an increase related
to board compensation, and other operational expenses.
Additionally, compensation increased due to additional personnel
and support services to support the launch of sales of our
diagnostic test, CyPath® Lung.
Net loss for 2023 was $7.9 million, or $0.91 per share, down
from a net loss for 2022 of $8.1 million, or $1.81 per share.
Cash and cash equivalents as of December 31, 2023, were $2.8
million.
About CyPath® Lung
CyPath® Lung uses advanced flow cytometry and artificial
intelligence (AI) to identify cell populations in patient sputum
that indicate malignancy. Automated data analysis helps determine
if cancer is present or if the patient is cancer-free. CyPath® Lung
incorporates a fluorescent porphyrin, meso-tetra (4-carboxyphenyl)
porphyrin (TCPP), that is preferentially taken up by cancer and
cancer-related cells. Clinical study results demonstrated that
CyPath® Lung had 92% sensitivity, 87% specificity and 88% accuracy
in detecting lung cancer in patients at high risk for the disease
who had small lung nodules less than 20 millimeters. Diagnosing and
treating early-stage cancer can improve outcomes and increase
patient survival.
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 and follow us on LinkedIn, Facebook and X.
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 with the Company’s limited
market launch in Texas to refine future positioning and strategic
insight for CyPath® Lung in preparation for expanding to the
national market, the growing recognition of CyPath® Lung's critical
role in the early detection of lung cancer, being positioned at the
forefront of noninvasive lung cancer detection, the Company’s
revenue growth being a beacon of its potential and the impact it
aims to have on millions of lives by providing accessible,
accurate, and noninvasive diagnostic solutions, being more
committed than ever to building on the Company’s recent momentum
and expanding its market to fulfill the promise of early cancer
detection and treatment. 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 build on its recent momentum and expand its market to fulfill
the promise of early cancer detection and treatment and the other
factors discussed in the Company’s Annual Report on Form 10-K, 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.
bioAffinity Technologies,
Inc.
Consolidated Balance
Sheets
December 31,
2023
2022
ASSETS
Current assets:
Cash and cash equivalents
$
2,821,570
$
11,413,759
Accounts and other receivables, net
811,674
10,489
Inventory
18,484
5,540
Prepaid expenses and other current
assets
321,017
531,899
Total current assets
3,972,745
11,961,687
Non-current assets:
Property and equipment, net
458,633
214,438
Operating lease right-of-use asset,
net
370,312
—
Finance lease right-of-use asset, net
1,165,844
—
Goodwill
1,404,486
—
Intangible assets, net
833,472
—
Other assets
16,060
6,000
Total assets
$
8,221,552
$
12,182,125
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
604,789
$
345,042
Accrued expenses
1,149,811
541,894
Unearned revenue
33,058
—
Operating lease liability, current
portion
94,708
—
Finance lease liability, current
portion
365,463
—
Loan payable
—
251,746
Total current liabilities
2,247,829
1,138,682
Non-current liabilities
Operating lease liability, net of current
portion
283,001
—
Finance lease liability, net of current
portion
835,467
—
Total liabilities
3,366,297
1,138,682
Commitments and contingencies (See Note
10)
-
-
Stockholders’ equity:
Preferred stock, no shares issued or
outstanding at December 31, 2023 and 2022, respectively
—
—
Common stock, par value $0.007 per share;
25,000,000 and 14,285,714 shares authorized; 9,394,610 and
8,381,324 shares issued and outstanding as of December 31, 2023 and
2022, respectively
65,762
58,669
Additional paid-in capital
49,393,972
47,652,242
Accumulated deficit
(44,604,479
)
(36,667,468
)
Total stockholders’ equity
4,855,255
11,043,443
Total liabilities and stockholders’
equity
$
8,221,552
$
12,182,125
bioAffinity Technologies,
Inc.
Consolidated Statements of
Operations
For the Years Ended December
31, 2023 and 2022
2023
2022
Net Revenue
$
2,532,499
$
4,803
Operating expenses:
Direct costs and expenses
1,740,884
467
Research and development
1,467,936
1,378,624
Clinical development
256,661
145,546
Selling, general and administrative
6,790,654
2,481,042
Depreciation and amortization
249,592
10,182
Total operating expenses
10,505,727
4,015,861
Loss from operations
(7,973,228
)
(4,011,058
)
Other income (expense):
Interest income
122,131
46,708
Interest expense
(37,125
)
(2,532,640
)
Other Income
3,325
—
Other Expense
(31,121
)
—
Gain on extinguishment of debt
—
212,258
Fair value adjustments on convertible
notes payable
—
(1,866,922
)
Loss before income taxes
(7,916,018
)
(8,151,654
)
Income tax expense
(20,993
)
(2,459
)
Net loss
$
(7,937,011
)
$
(8,154,113
)
Net loss per common share, basic and
diluted
$
(0.91
)
$
(1.81
)
Weighted average common shares
outstanding
8,747,509
4,498,964
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version on businesswire.com: https://www.businesswire.com/news/home/20240401275172/en/
bioAffinity Technologies Julie Anne Overton Director of
Communications jao@bioaffinitytech.com
Investor Relations Dave Gentry RedChip Companies, Inc.
1-800-733-2447 1-407-491-4498 BIAF@redchip.com
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