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 months
ended March 31, 2023.
Highlights from the first quarter of 2023 and subsequent weeks
included:
Corporate and Commercial Highlights
- Appointed Michael Dougherty as Chief Financial Officer. Mr.
Dougherty most recently served as CFO of Amazon’s Alexa commercial
domains, where he was responsible for financial strategy over
Alexa’s multibillion-dollar investments in AI-generated customer
experiences.
- Engaged Havas Health & You and Trinity Life Sciences to
create the branding and marketing strategy for CyPath® Lung.
- Continued with the initial rollout of CyPath® Lung to select
test markets in Texas with encouraging user feedback and survey
responses.
- Management rang the Nasdaq Stock Market closing bell on April 5
to commemorate the Company’s IPO in September 2022.
Research and Development Highlights
- Received Notice of Allowance from the U.S. Patent and Trademark
Office for a patent titled “Porphyrin Compounds and Compositions
Useful for Treating Cancer” for the targeted delivery of novel
cancer treatments. This patent is owned by the Company’s wholly
owned subsidiary OncoSelect® Therapeutics and grants protection
through 2037.
- Expanded geographic coverage for this OncoSelect® Therapeutics
patent to include issuance in Hong Kong, which joins the U.S.,
Australia, China and Mexico, with patent applications pending in
Canada, the European Union, India and Japan.
- CyPath® Lung clinical validation study results were published
in Respiratory Research and demonstrated 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%.
- The article “Porphyrin-Modified Beads for Use as Compensation
Controls in Flow Cytometry” was published in the peer-reviewed
Journal of Visualized Experiments (JoVE) and describes the protocol
for preparing porphyrin-labeled compensation beads to optimize the
ability of CyPath® Lung to detect early-stage lung cancer.
- Presented advancements in CyPath® Lung at the Cleveland
Clinic’s invitation-only fourth annual “Advances in Early Lung
Cancer Detection” Symposium, which brings together global leaders
in the field of lung cancer, including physicians, advocates and
industry, to accelerate the development and implementation of new
technologies and methods for early lung cancer detection.
Management Commentary
“Our first quarter results reflect our focus on positioning
bioAffinity Technologies both financially and organizationally to
achieve our most important near-term objective: expanding the
commercial launch of CyPath® Lung into additional markets to
optimize our rollout for maximum success. Preliminary commercial
results are encouraging, and with constructive initial feedback
from physicians, we’re fine-tuning the CyPath® Lung branding and
marketing strategy. A survey of pulmonologists, internists and
primary care physicians shows that they understand the need for a
noninvasive, accurate lung cancer diagnostic and are receptive to
including the test as part of their clinical decision-making for
high-risk patients,” bioAffinity President and Chief Executive
Officer Maria Zannes said.
“CyPath® Lung is currently commercially available as a
laboratory developed test through our licensee, Precision Pathology
Services. The launch of our pivotal clinical trial later this year
is a critical step toward securing FDA clearance as a Class II in
vitro diagnostic, which would enable us to market directly to U.S.
physicians and their patients and facilitate dialogues with
payers,” Ms. Zannes added.
First Quarter Financial Results
Revenue for the first quarter of 2023 was $1,000, compared with
no revenue for the prior-year period. Revenue is currently
generated exclusively from royalties from the Company’s licensee,
Precision Pathology Services, from sales of CyPath® Lung as a
laboratory developed test.
Research and development expenses were $370,000 for the first
quarter of 2023, compared with $280,000 for the comparable period
in 2022. The increase was primarily due to higher compensation
costs from adding research personnel and higher R&D equipment
costs.
Clinical development expenses were $20,000 for the first quarter
of 2023, compared with $53,000 for the first quarter of 2022. The
decline was primarily attributed to lower professional fees related
to clinical strategy evaluation as the Company prepares to launch
the CyPath® Lung pivotal trial.
Selling, general and administrative expenses were $1.2 million
for the first quarter of 2023, compared with $395,000 for the
comparable period in 2022. The increase was primarily attributed to
higher consulting, legal and professional fees incurred to comply
with public company reporting requirements.
Net loss for the first quarter of 2023 was $1.5 million, or
$0.18 per share, compared with a net loss of $1.5 million, or $0.55
per share, for the comparable period in 2022.
Cash and cash equivalents as of March 31, 2023, were $9.8
million, 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 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.
Condensed Consolidated Balance
Sheets
March 31,
December 31,
2023
2022
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
9,769,088
$
11,413,759
Accounts and other receivables, net
11,027
10,489
Inventory
11,335
5,540
Prepaid and other current assets
441,132
531,899
Total current assets
10,232,582
11,961,687
Property and equipment, net
225,067
214,438
Other assets
6,920
6,000
Total assets
$
10,464,569
$
12,182,125
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
146,537
$
345,042
Accrued expenses
481,336
541,894
Loan payable
168,430
251,746
Total current liabilities
796,303
1,138,682
Total liabilities
796,303
1,138,682
Commitments and contingencies (See Note
8)
-
-
Stockholders’ equity:
Preferred stock, par value $0.001 per
share; 20,000,000 shares authorized; no shares issued or
outstanding at March 31, 2023, and December 31, 2022
—
—
Common stock, par value $0.007 per share;
14,285,714 shares authorized; 8,463,052 issued and outstanding at
March 31, 2023; and 8,381,324 shares issued and outstanding at
December 31, 2022
59,241
58,669
Additional paid-in capital
47,809,283
47,652,242
Accumulated deficit
(38,200,258
)
(36,667,468
)
Total stockholders’ equity
9,668,266
11,043,443
Total liabilities and stockholders’
equity
$
10,464,569
$
12,182,125
bioAffinity Technologies,
Inc.
Unaudited Condensed
Consolidated Statements of Operations
Three Months Ended March 31,
2023
2022
Revenue
$
921
$
—
Cost of sales
87
—
Gross profit
834
—
Operating expenses:
Research and development
369,617
279,848
Clinical development
19,628
52,503
Selling, general and administrative
1,169,559
394,692
Total operating expenses
1,558,804
727,043
Loss from operations
(1,557,970
)
(727,043
)
Other income (expense):
Interest income (expense), net
36,999
(1,147,012
)
Fair value adjustments on convertible
notes payable
—
404,194
Loss before income taxes
(1,520,971
)
(1,469,861
)
Income tax expense
11,819
2,159
Net loss
$
(1,532,790
)
$
(1,472,020
)
Net loss per common share, basic and
diluted
$
(0.18
)
$
(0.55
)
Weighted average common shares
outstanding
8,433,689
2,681,221
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230515005205/en/
bioAffinity Technologies Julie Anne Overton Director of
Communications jao@bioaffinitytech.com
LHA Investor Relations Tirth T. Patel tpatel@lhai.com
bioAffinity Technologies (NASDAQ:BIAF)
Historical Stock Chart
From Jun 2024 to Jul 2024
bioAffinity Technologies (NASDAQ:BIAF)
Historical Stock Chart
From Jul 2023 to Jul 2024