Expanded, experienced sales team more than
doubles number of physician practices ordering CyPath® Lung test
year-to-date
More than 547% annualized growth rate for
CyPath® Lung orders in first four months of 2024 over full-year
2023, leading to 35% increase in original 2024 forecast
KOL referrals and word-of-mouth expanding
adoption of CyPath® Lung outside of the beta market launch in
Texas
bioAffinity Technologies, Inc. (Nasdaq: BIAF;
BIAFW), a biotechnology company focused on the need for
noninvasive, accurate tests for the detection of early-stage lung
cancer and other lung diseases, today reported financial results
for the three months ended March 31, 2024.
Key Highlights
- Generated record quarterly revenue of $2.4 million in the first
quarter of 2024.
- Forecasting between $9.2 and $9.6 million in 2024 revenues for
wholly owned subsidiary Precision Pathology Laboratory Services
(PPLS), up 23% over 2023.
- Increased 2024 CyPath® Lung sales forecast 35% from the
original forecast reported in the 2023 Annual Report.
- Number of physician offices ordering CyPath® Lung is up 112%,
more than double, since January 1, 2024.
- Medicare reimbursement for CyPath® Lung became effective on
January 1, 2024.
- More than 547% annualized growth rate for CyPath® Lung orders
in first four months of 2024 over full-year 2023 with April sales
showing a robust increase of 21% over the previous month.
- Referrals and word-of-mouth from physicians, including key
opinion leaders (KOLs), resulting in significant uptake of CyPath®
Lung by physicians in states beyond Texas.
- Physicians in Pennsylvania, New Jersey, North Carolina,
Arizona, and Michigan are ordering CyPath® Lung after hearing about
it from patients and colleagues.
- Medical Director of Lung Innovations Network and The Lung
Center at Penn Highlands Healthcare, Dr. Sandeep Bansal, joined our
Medical and Scientific Advisory Board and incorporated CyPath® Lung
into his medical practice that offers comprehensive lung care to
over 10,000 patients in central and western Pennsylvania.
- Continued to advance new product development initiatives in
collaboration with the U.S Department of Defense’s largest military
health organization, focusing on tests that use our artificial
intelligence and flow cytometry platform for diagnosing COPD and
companion test with bronchoscopy.
- OncoSelect Therapeutics, a subsidiary of bioAffinity, was
awarded a therapeutic patent in India for a novel cancer treatment
method using chemotherapeutic agents conjugated to porphyrins.
- Successfully closed a $2.5 million registered direct offering
and concurrent private placement to fund continued growth.
Management Commentary
“We are entering a period of accelerating growth with orders for
CyPath® Lung up 547% on an annualized basis in the first four
months of the year compared to all of 2023,” bioAffinity President
and Chief Executive Officer Maria Zannes said. “As we continue to
advance our commercial strategy, moving beyond the initial test
market in Texas, the unique and compelling attributes of CyPath®
Lung, including its AI-enhanced data analysis and non-invasive
sample collection, have proven to be key differentiators in the
market and are resonating with physicians and patients alike. This
growing interest is leading to increased adoption by prominent
medical practices and double-digit month-over-month growth in test
orders.”
“CyPath® Lung is positioned to set a new standard in the early
detection of lung cancer – a market projected to reach $4.7 billion
by 2030,” Zannes continued. “As we continue to scale our operations
and enhance our offerings, our focus remains steadfast on improving
patient outcomes and delivering shareholder value. With Medicare
and major private insurers now providing coverage, the pathway for
increased adoption and accelerated growth in usage is clear,
setting the stage for substantial market penetration and revenue
generation in the upcoming quarters.”
First Quarter Financial Results
Revenue for the first quarter of 2024 was $2.4 million, compared
with $921 revenue for the prior-year period. The majority of the
year-over-year increase is through the acquisition of Precision
Pathology Laboratory Services. Revenue is primarily generated from
patient service fees, including billing for CyPath® Lung tests,
with additional revenues generated from histology service fees and
medical director fees.
Research and development expenses were $394,000 for the first
quarter of 2024, compared with $370,000 for the comparable period
in 2023. The increase was primarily due to higher compensation
costs for additional research personnel and higher R&D
laboratory supply costs.
Clinical development expenses were $49,000 for the first quarter
of 2024, compared with $20,000 for the first quarter of 2023. The
increase was primarily due to an increase in compensation costs and
benefits from the addition of new clinical development
personnel.
Selling, general and administrative expenses were $2.2 million
for the first quarter of 2024, compared with $1.1 million for the
comparable period in 2023. The increase was primarily due to
acquired general and administrative costs from PPLS and an increase
in personnel and services to support the launch of CyPath®
Lung.
Net loss for the first quarter of 2024 was $2.1 million, or
$0.21 per share, compared with a net loss of $1.5 million, or $0.18
per share, for the comparable period in 2023.
Cash and cash equivalents as of March 31, 2024, were $2.5
million, compared with $2.8 million as of December 31, 2023.
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.
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 to advance the Company’s
commercial strategy, moving beyond the initial test market in
Texas, positioning CyPath® Lung to set a new standard in the early
detection of lung cancer – a market projected to reach $4.7 billion
by 2030, increased adoption by prominent medical practices and
double-digit month-over-month growth in test orders, revised
forecast of between $9.2 million and $9.6 million in 2024 revenues
for wholly owned subsidiary Precision Pathology Laboratory
Services, up 23% over 2023, and the increased 2024 CyPath® Lung
sales forecast of 35% from the original forecast reported in the
2023 Annual Report. 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
continue to advance the Company’s commercial strategy, moving
beyond the initial test market in Texas, the ability to generate
revenue forecasted and to generate forecasted 2024 CyPath® Lung
sales, and the other factors discussed in the Company’s Annual
Report on Form 10-K for the year ended December 31, 2023, 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.
Condensed Consolidated Balance
Sheets
March 31, 2024
December 31, 2023
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
2,453,165
$
2,821,570
Accounts and other receivables, net
1,123,609
811,674
Inventory
9,487
18,484
Prepaid expenses and other current
assets
344,900
321,017
Total current assets
3,931,161
3,972,745
Non-current assets:
Property and equipment, net
461,209
458,633
Operating lease right-of-use asset,
net
347,860
370,312
Finance lease right-to-use, net
1,069,601
1,165,844
Goodwill
1,404,486
1,404,486
Intangible assets, net
818,889
833,472
Other assets
16,060
16,060
Total assets
$
8,049,266
$
8,221,552
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
442,485
$
604,789
Accrued expenses
923,810
1,149,811
Unearned revenue
30,174
33,058
Operating lease liability, current
portion
96,631
94,708
Finance lease liability, current
portion
372,787
365,463
Notes payable, current portion
4,686
—
Total current liabilities
1,870,573
2,247,829
Non-current liabilities:
Finance lease liability, net of current
portion
739,478
835,467
Operating lease liability, net of current
portion
258,110
283,001
Notes payable, net of current portion
23,037
—
Total liabilities
2,891,198
3,366,297
Commitments and contingencies
Stockholders’ equity:
Preferred stock, par value $0.001 per
share; 20,000,000 shares authorized; no shares issued or
outstanding at March 31, 2024, and December 31, 2023
—
—
Common stock, par value $0.007 per share;
25,000,000 shares authorized; 11,214,502 and 9,394,610 issued and
outstanding at March 31, 2024, and at December 31, 2023,
respectively.
78,515
65,762
Additional paid-in capital
51,744,830
49,393,972
Accumulated deficit
(46,665,277
)
(44,604,479
)
Total stockholders’ equity
5,158,068
4,855,255
Total liabilities and stockholders’
equity
$
8,049,266
$
8,221,552
bioAffinity Technologies,
Inc.
Unaudited Condensed
Consolidated Statements of Operations
Three Months Ended
March 31,
2024
2023
(unaudited)
Net Revenue
$
2,406,391
$
921
Operating expenses:
Direct costs and expenses
1,660,007
87
Research and development
393,639
369,617
Clinical development
48,960
19,628
Selling, general and administrative
2,196,361
1,147,875
Depreciation and amortization
149,637
21,684
Total operating expenses
4,448,604
1,558,891
Loss from operations
(2,044,213
)
(1,557,970
)
Other income (expense):
Interest income
6,127
38,654
Interest expense
(23,550
)
(1,655
)
Other income
—
—
Other expense
4,510
—
Net loss before provision for income
taxes
(2,057,126
)
(4,919,158
)
Income tax expense
(3,672
)
(11,819
)
Net loss
$
(2,060,798
)
$
(1,532,790
)
Net loss per common share, basic and
diluted
$
(0.21
)
$
(0.18
)
Weighted average common shares
outstanding, basic and diluted
9,915,426
8,433,689
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version on businesswire.com: https://www.businesswire.com/news/home/20240514817005/en/
bioAffinity Technologies Julie Anne Overton Director of
Communications jao@bioaffinitytech.com Investor Relations
Dave Gentry RedChip Companies Inc. 1-800-RED-CHIP (733-2447) Or
407-491-4498 BIAF@redchip.com
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