Conference Call Scheduled for April 3, 2023, at
9:00 a.m. Eastern Time
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 12 months ended
December 31, 2022.
Financial Highlights
- Raised net proceeds of approximately $6.0 million from an
initial public offering (IPO) in September 2022
- Converted nearly $16 million in debt, related accrued interest
and fair value adjustments into shares of common stock in
connection with the IPO
- Raised an additional $7.8 million from the exercise of warrants
and stock options
Corporate and Operational Highlights
- Announced publication in Respiratory Research of an article
titled “Detection of early-stage lung cancer in sputum using
automated flow cytometry and machine learning” detailing results of
bioAffinity Technologies’ clinical validation trial, which showed
CyPath® Lung had 92% sensitivity and 87% specificity in high-risk
patients with nodules smaller than 20 millimeters or no nodules in
the lung, with an area under the ROC curve of 94%
- Selected a contract research organization to manage the pivotal
trial intending to seek U.S. Food and Drug Administration clearance
of CyPath® Lung as a Class II IVD medical device for the detection
of lung cancer; the pivotal trial is expected to recruit 1,800
patients beginning in 2023, with participants followed for at least
one year to determine the presence of lung cancer
- Research continues aimed at the expansion of the Company’s flow
cytometric platform technology for use in detecting additional lung
diseases, including Chronic Obstructive Pulmonary Disease
(COPD)
- Announced publication in the Journal of Visualized Experiments
of an article titled “Porphyrin-Modified Beads for Use as
Compensation Controls in Flow Cytometry” describing the beads
engineered by the Company for use with its CyPath® Lung test
- Received Notice of Allowance for a U.S. patent protecting the
targeted delivery of novel cancer treatments using porphyrin
compounds for bioAffinity Technologies’ wholly owned subsidiary,
OncoSelect® Therapeutics
- Awarded therapeutic patents in China, Mexico and Australia for
compounds comprised of porphyrins conjugated to chemotherapeutic
agents that can provide selective treatment for cancer; the
Company’s global patent portfolio now includes the U.S., Australia,
Canada, China, France, Germany, Hong Kong, Italy, Mexico, Spain,
Sweden and the United Kingdom
- Expanded the Company’s Scientific and Medical Advisory Board
with the appointments of Sheila Habib, M.D., Director of the
Pulmonary Lung Nodule Clinic and the Lung Cancer Screening Program
at South Texas Veterans Health Care, and David Hill, M.D., National
Board Member of the American Lung Association and assistant
clinical professor of medicine at Yale University School of
Medicine
- Strengthened the diagnostics division with the appointment of
Rossella Titone, Ph.D., and Alvaro Souto Padron de Figueiredo,
Ph.D., who bring significant technical expertise in flow cytometry
and clinical research across various cancers
- Appointed Julie Anne Overton, a veteran of print and broadcast
journalism, corporate communications and federal public affairs, as
Director of Communications
- Scheduled to ring the Nasdaq closing bell on April 5 to
commemorate the Company’s 2022 IPO
Management Commentary
“Through the capital raised during and following our IPO, 2022
was a landmark year for bioAffinity Technologies as we executed on
our goal to become a leader in non-invasive early-stage cancer
diagnosis by bringing our first flow cytometry-based diagnostic,
CyPath® Lung, to market. With key research and leadership
appointments, we are engaging clinicians and patients on the value
of early lung cancer screening, lowering healthcare costs and
raising the survival rate for one of the deadliest cancers,” said
Maria Zannes, President and Chief Executive Officer of bioAffinity
Technologies.
Low-dose computed tomography (LDCT) is the standard of care for
screening patients at high risk for lung cancer and can
significantly increase survival by finding early-stage cancer. But
screening’s low positive predictive rate of 3.8% means that only
four people out of 100 who get a positive screening result will
actually have lung cancer. CyPath® Lung assists clinical
decision-making for patients whose screening results are not clear.
Physicians can order bioAffinity’s patient-friendly CyPath® Lung
test to confirm or rule out cancer, reducing the need for biopsy
and other costly invasive procedures, and providing greater clarity
to determine next steps in patient care.
“Our ongoing pilot launch of CyPath® Lung in Texas continues to
provide value by helping us to refine positioning, gather valuable
insights from labs and healthcare providers, and optimize logistics
throughout the care pathway, from ordering the test to reporting
results. By building upon real-world feedback from this test
market, we are enhancing the value proposition of CyPath® Lung and
can achieve more impactful adoption as we prepare for commercial
expansion,” Ms. Zannes said.
Fourth Quarter Financial Results
Revenue for the fourth quarter of 2022 was approximately $2,500,
compared with no revenue for the prior-year period. Revenue was
derived from the sale of CyPath® Lung as a Laboratory Developed
Test (LDT).
Research and development expenses were $429,000 for the fourth
quarter of 2022, compared with $318,000 for the comparable period
in 2021. General and administrative expenses were $1.2 million for
the fourth quarter of 2022, compared with $341,000 for the
comparable period in 2021.
Net loss for the fourth quarter of 2022 was $1.7 million,
compared with a net loss of $5.6 million for the comparable period
in 2021.
Full Year Financial Results
Revenue for 2022 was approximately $5,000, compared with no
revenue for 2021.
Research and development expenses were $1.1 million in 2022,
compared with $1.0 million in 2021. The increase was primarily due
to higher personnel, legal and research costs, partially offset by
lower stock-based compensation expense.
General and administrative expenses were $2.7 million in 2022,
compared with $1.1 million in 2021. The increase was primarily due
to higher consulting, legal and professional fees related to the
Company’s IPO and compliance with public company reporting
requirements. The increase was also attributed to higher
stock-based compensation expense, as well as hiring-related
expenses to support the commercial launch of CyPath® Lung.
Net loss for 2022 was $8.2 million, or $1.81 per share, compared
with a net loss for 2021 of $6.3 million, or $2.36 per share.
Cash and cash equivalents as of December 31, 2022, were $11.4
million. On September 6, 2022, bioAffinity Technologies raised net
proceeds of $6.0 million from an IPO of 1,282,600 units, with each
unit consisting of one share of common stock, one tradeable warrant
to purchase one share of common stock and one non-tradable warrant.
An additional $7.8 million was raised from the exercise of warrants
and options. bioAffinity Technologies believes that its available
cash will be sufficient to fund planned operations for at least the
next 12 months.
Conference Call and Webcast
Management will host a conference call on Monday, April 3, 2023,
at 9:00 a.m. Eastern time to discuss those results and answer
questions.
Date:
Monday, April 3, 2023
Time:
9:00 a.m. Eastern time
Toll Free:
877-270-2148
International:
412-902-6510
Webcast:
Webcast link
A replay of the event will be available for 90 days at the
webcast link above, which can also be found in the Investor
Relations section of bioAffinity Technologies’ website at
ir.bioaffinitytech.com.
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 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.
bioAffinity Technologies,
Inc.
Consolidated Balance
Sheets
December 31,
2022
2021
ASSETS
Current assets:
Cash and cash equivalents
$
11,413,759
$
1,360,638
Accounts and other receivables, net
10,489
1,530
Inventory
5,540
—
Prepaid expenses and other current
assets
531,899
76,065
Total current assets
11,961,687
1,438,233
Deferred offering costs
—
7,942
Property and equipment, net
214,438
4,633
Other assets
6,000
2,500
Total assets
$
12,182,125
$
1,453,308
LIABILITIES, CONVERTIBLE PREFERRED
STOCK, AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable
$
345,042
$
230,407
Accrued expenses
541,894
483,501
Accrued interest
—
1,121,392
Current portion of Paycheck Protection
Program loan
—
52,074
Loan payable
251,746
—
Convertible notes payable at fair
value
—
11,152,151
Total current liabilities
1,138,682
13,039,525
Paycheck Protection Program loan, less
current portion
—
160,184
Total liabilities
1,138,682
13,199,709
Commitments and contingencies
Convertible preferred stock, par value
$0.001 per share; 20,000,000 shares authorized; 0 and 756,558
shares issued and outstanding, aggregate liquidation preference of
$0 and $5,825,648 at December 31, 2022 and 2021, respectively
—
4,044,318
Stockholders’ equity (deficit):
Preferred stock, no shares issued or
outstanding at December 31, 2022 and 2021, respectively
—
—
Common Stock, par value $0.007 per share;
14,285,714 shares authorized; 8,381,324 and 2,677,140 shares issued
and outstanding as of December 31, 2022 and 2021, respectively
58,669
18,740
Additional paid-in capital
47,652,242
12,703,896
Accumulated deficit
(36,667,468
)
(28,513,355
)
Total stockholders’ equity (deficit)
11,043,443
(15,790,719
)
Total liabilities, convertible preferred
stock, and stockholders’ equity (deficit)
$
12,182,125
$
1,453,308
bioAffinity Technologies,
Inc.
Consolidated Statements of
Operations
For the Years Ended December
31, 2022 and 2021
2022
2021
Revenue
$
4,803
$
—
Cost of sales
467
—
Gross profit
4,336
—
Operating expenses:
Research and development
1,142,777
1,007,476
Clinical development
145,546
130,475
Selling, general and administrative
2,727,071
1,068,871
Total operating expenses
4,015,394
2,206,822
Loss from operations
(4,011,058
)
(2,206,822
)
Other income (expense):
Interest income
46,708
424
Interest expense
(2,532,640
)
(1,001,854
)
Gain on extinguishment of debt
212,258
239,200
Fair value of warrants issued
—
(4,080,339
)
Fair value adjustments on convertible
notes payable
(1,866,922
)
724,928
Loss before income taxes
(8,151,654
)
(6,324,463
)
Income tax expense
(2,459
)
(1,950
)
Net loss
$
(8,154,113
)
$
(6,326,413
)
Net loss per common share, basic and
diluted
$
(1.81
)
$
(2.36
)
Weighted average common shares
outstanding
4,498,964
2,675,270
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230331005441/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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