- Successfully completed $15.6 million IPO,
including the exercise of warrants
- Awarded therapeutic patents in China, Mexico
and Australia
- Company on track to expand marketing outreach
for its initial product, CyPath® Lung, that detects early-stage
lung cancer
bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW), a
biotechnology company addressing the need for noninvasive diagnosis
of early-stage cancer and diseases of the lung, and targeted cancer
treatment, today reported its financial results for the third
quarter of 2022 and provided a business update.
“Since our founding, bioAffinity Technologies has been dedicated
to addressing the urgent need for noninvasive, early-stage cancer
diagnosis and cancer treatment,” said Maria Zannes, President and
Chief Executive Officer of bioAffinity Technologies. “Now that we
have successfully raised the needed funds, we are confident that
the outstanding scientific and commercialization team we have
assembled will demonstrate the clinical value of CyPath® Lung in
the marketplace. We will continue the development of additional
non-invasive diagnostics for early-stage disease. With funds raised
from our recent IPO and the exercise of warrants, bioAffinity
Technologies also will pursue its promising research and
development of broad-spectrum cancer therapeutics.
“We have begun a limited test-market launch in the San Antonio
area and recently have started to recognize revenue from sales of
CyPath® Lung by our licensee, Precision Pathology Services, a
CAP-accredited, CLIA-certified clinical pathology laboratory,”
Zannes said. “The limited launch allows us to evaluate our
marketing program and help ensure each step in the care pathway –
from the initial order by physicians, to sputum collection and
processing, to generating and delivering the patient report – is
efficient and effective. This limited test-market approach allows
us to refine future positioning and develop strategic insight for
our CyPath® Lung test before expanding to a larger national market.
We believe our current efforts will be essential to developing a
strategic and cost-effective plan for a robust national
rollout.”
Corporate Highlights
Award of Therapeutic Patents in China,
Mexico and Australia: In October, the Company was pleased to
announce that its wholly owned subsidiary, OncoSelect®, has been
awarded patents to protect novel porphyrin-conjugated compounds for
selective delivery of cancer treatments by the People’s Republic of
China.
Additionally, bioAffinity Technologies announced that Mexico and
Australia recently awarded the Company therapeutic patents with
claims directed to novel compounds of porphyrin-conjugates for
selective delivery of cancer treatment. The patents grant
protection to 2037.
Presentation at CHEST Conference:
Also in October, bioAffinity Technologies announced that results of
its research into the use of flow cytometry for analyzing the lung
environment to detect diseases of the lung were accepted for
presentation at the American College of Chest Physicians (CHEST)
2022 conference. The data showed how flow cytometry can be used in
development of diagnostics for COPD and asthma – similar to how the
Company successfully uses flow cytometry in the CyPath® Lung test
to detect early-stage lung cancer.
Publication of Peer-Reviewed Results in
PLOS ONE: In September, the Company announced publication of
its research in high-throughput flow cytometry analysis of sputum
in the journal, PLOS ONE. The article, titled Sputum analysis by
flow cytometry; an effective platform to analyze the lung
environment, reports on results of analyzing sputum by flow
cytometry as the basis for high-throughput diagnostic tests to
determine the health of the lung.
Successful Closing of IPO: On
September 6, bioAffinity Technologies announced the successful
closing of its Initial Public Offering (IPO) of 1,282,600 units,
each consisting of one share of common stock, one tradeable warrant
to purchase one share of common stock at an exercise price of $7.35
per share, and one non-tradeable warrant to purchase one share of
common stock at an exercise price of $7.656 per share, for
aggregate gross proceeds of approximately $7.8 million, prior to
deducting underwriting discounts, commissions, and other offering
expenses.
Subsequent to the close of the IPO, the Company announced
receipt of approximately $7.7 million in additional gross proceeds
from the exercise of tradeable and non-tradeable warrants.
Specifically, investors exercised a total of 725,576 tradeable
warrants at a price of $7.35 per share and 310,910 non-tradeable
warrants at a price of $7.656 per share. Combined with the
Company’s underwritten public offering, the Company received an
aggregate of approximately $15.6 million as of September 28, 2022.
In addition, the Company converted almost $11 million in debt and
related accrued interest as a result of the IPO.
Financial Highlights
bioAffinity Technologies reported revenue of about $1,150 for
the three months ended September 30, 2022. There was no revenue to
report the prior year.
bioAffinity Technologies reported a net loss of $4.6 million or
$1.10 per share, for the three months ended September 30, 2022,
compared to a net loss of $1.5 million or $0.57 per share for the
same period in 2021.
Research and development expenses for the three months ended
September 30, 2022, were $319,744 compared to $330,772 for the
third quarter of 2021. The decrease is primarily due to a decrease
in legal costs related to patents and annuities compared to the
prior year.
General and administrative expenses were $596,476 for the third
quarter of 2022, compared to $161,549 for the same period in 2021.
The increase was primarily attributable to an increase in
consulting, legal and professional fees incurred in 2022 compared
to 2021 and costs due to the activities associated with being a
public company.
Cash and cash equivalents totaled $13.5 million at September 30,
2022, compared to $1.4 million at December 31, 2021. In September
2022, the Company completed an Initial Public Offering resulting in
net proceeds to the Company of approximately $15.6 million.
Conference Call and Webcast Details
bioAffinity Technologies will host a conference call and webcast
today at 8:00 a.m. Eastern Time to discuss the Company’s financial
results and provide a general business update. The webcast and
subsequent replay may be accessed by visiting the Company’s website
at https://ir.bioaffinitytech.com/. Please connect to the Company’s
website at least 5 minutes prior to the webcast to ensure adequate
time for any necessary software download. Alternately, please call
1-800-579-2543 (U.S.) or 1-203-518-9856 (international) to listen
to the conference call. The conference ID for the call is BIAFQ322.
Please dial in approximately 10 minutes prior to the call. The
webcast will be available on the Company’s website for
approximately 45 days.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW) 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 non-invasive test that has shown
high sensitivity and specificity for the detection of early-stage
lung cancer. Precision Pathology Services licensed and developed
CyPath® Lung as a Laboratory Developed Test (LDT) and has begun
test marketing in Southeast Texas. 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.
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.
Unaudited Condensed
Consolidated Balance sheets
September 30,
December 31,
2022
2020
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
13,497,938
$
1,360,638
Accounts and other receivables, net
9,930
1,530
Inventory
5,715
—
Prepaid and other current assets
541,323
76,065
Total current assets
14,054,906
1,438,233
Deferred offering costs
—
7,942
Property and equipment, net
1,781
4,633
Other assets
6,000
2,500
Total assets
$
14,062,687
$
1,453,308
LIABILITIES, CONVERTIBLE
PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable
$
149,867
$
230,407
Accrued expenses
474,035
483,501
Accrued interest
25,168
1,121,392
Current portion of Paycheck Protection
Program loan
—
52,074
Loan payable
490,117
—
Convertible notes payable
325,000
11,152,151
Total current liabilities
1,464,187
13,039,525
Paycheck Protection Program loan, less
current portion
—
160,184
Total liabilities
1,464,187
13,199,709
Commitments and contingencies
Convertible preferred stock, par value
$0.001 per share; 20,000,000 shares authorized; 0 and 5,296,044
shares issued and outstanding at September 30, 2022 and December
31, 2021, respectively; aggregate liquidation preference of $0 and
$5,825,648, at September 30, 2022 and December 31, 2021,
respectively
—
4,044,318
Stockholders’ equity (deficit):
Preferred stock, no shares issued or
outstanding at September 30, 2022 and December 31, 2021,
respectively
—
—
Common stock, par value $0.007 per share;
14,285,714 shares authorized; 8,369,750 issued and outstanding at
September 30, 2022; and 2,677,140 shares issued and outstanding at
December 31, 2021, respectively
58,588
18,740
Additional paid-in capital
47,232,797
12,703,896
Accumulated deficit
(34,692,885
)
(28,513,355
)
Total stockholders’ equity (deficit)
12,598,500
(15,790,719
)
Total liabilities, convertible preferred
stock, and stockholders’ equity
$
14,062,687
$
1,453,308
bioAffinity Technologies,
Inc.
Unaudited Condensed
Consolidated Statements of Operations
Three Months Ended September
30,
Nine Months Ended September
30,
2022
2021
2022
2021
Revenue
$
1,150
$
—
$
2,457
$
—
Cost of sales
146
—
292
—
Gross profit
1,005
—
2,165
—
Operating expenses:
Research and development
319,744
330,772
949,388
877,674
Clinical development
60,941
33,972
141,684
78,241
General and administrative
596,476
161,549
1,298,409
591,155
Total operating expenses
977,161
526,293
2,389,481
1,547,070
Loss from operations
(976,156
)
(526,293
)
(2,387,316
)
(1,547,070
)
Other income (expense):
Interest income
3
19
850
24
Interest expense
(589,091
)
(135,359
)
(2,135,941
)
(363,828
)
Gain on extinguishment of debt
—
—
212,258
239,200
Fair value adjustments on convertible
notes payable
(3,053,914
)
(852,161
)
(1,866,922
)
924,099
Net loss before provision for income
taxes
(4,619,158
)
(1,513,794
)
(6,177,071
)
(747,575
)
Income tax expense
(300
)
—
(2,459
)
(1,950
)
Net income (loss)
$
(4,619,458
)
$
(1,513,794
)
$
(6,179,530
)
$
(749,525
)
Net loss per common share, basic and
diluted
$
(1.10
)
$
(0.57
)
$
(1.93
)
$
(0.28
)
Weighted average common shares
outstanding
4,203,781
2,675,054
3,194,765
2,674,924
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221114005386/en/
Company Contact: Maria Zannes, President & Chief Executive
Officer mz@bioaffinitytech.com
Investor Relations Contact: Tiberend Strategic
Advisors, Inc. Jonathan Nugent jnugent@tiberend.com or
David Irish dirish@tiberend.com
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