bioAffinity Technologies Reports Record Q1 Revenue Driven by Accelerating Growth of CyPath® Lung Sales and Increased Laboratory Volumes
BioAffinity Technologies (Nasdaq: BIAF; BIAFW) reports record Q1 2024 revenue of $2.4 million, driven by CyPath® Lung sales and increased lab volumes. CyPath® Lung orders surged by 547% annualized in the first four months of 2024 over 2023, leading to a 35% increase in the 2024 sales forecast. The number of physician offices ordering the test doubled since January 2024, expanding beyond Texas to states like Pennsylvania and New Jersey. Medicare reimbursement for CyPath® Lung began on January 1, 2024. Precision Pathology Laboratory Services forecasts $9.2-$9.6 million in 2024 revenues, up 23% from 2023. The company reported an increase in R&D and SG&A expenses, resulting in a net loss of $2.1 million for Q1 2024, compared to a net loss of $1.5 million in Q1 2023. BioAffinity closed a $2.5 million funding round to support growth and continued product development in collaboration with the DoD.
- Record Q1 2024 revenue of $2.4 million.
- 547% annualized growth rate for CyPath® Lung orders in the first four months of 2024.
- 35% increase in 2024 CyPath® Lung sales forecast.
- Doubling of physician practices ordering CyPath® Lung since January 2024.
- Medicare reimbursement for CyPath® Lung effective January 1, 2024.
- Expanded market adoption of CyPath® Lung beyond Texas.
- Precision Pathology Laboratory Services forecasts $9.2-$9.6 million in 2024 revenues, up 23% from 2023.
- Successful $2.5 million funding round to support growth.
- Net loss of $2.1 million in Q1 2024, up from $1.5 million in Q1 2023.
- Increased R&D expenses to $394,000 in Q1 2024 from $370,000 in Q1 2023.
- Increased SG&A expenses to $2.2 million in Q1 2024 from $1.1 million in Q1 2023.
- Cash and cash equivalents decreased to $2.5 million as of March 31, 2024, from $2.8 million as of December 31, 2023.
bioAffinity Technologies has shown substantial improvement in its financial performance, reporting
However, the company's net loss widened to
Short-term outlook: While the company is showing strong revenue growth, the increasing operational costs and net loss could be a concern for investors in the short term. The cash position decreased from
Long-term outlook: If bioAffinity can maintain its growth trajectory and manage costs effectively, the long-term prospects are promising, particularly with the potential of CyPath® Lung to capture a larger share of the lung cancer detection market.
The rapid expansion of CyPath® Lung test orders, with a more than
KOL endorsements and the broadening geographic adoption outside Texas are critical indicators of the test's clinical acceptance and effectiveness. With Medicare reimbursement now effective, accessibility and affordability for patients are substantially improved, likely driving further adoption.
From a medical perspective, the promising increase in physician orders and patient referrals indicates a potentially transformative impact on early lung cancer detection. However, the real-world efficacy and long-term patient outcomes will need continuous monitoring to ensure sustained clinical value.
Overall, the growth in adoption and positive reception from the medical community underscore the test's potential but also highlight the need for ongoing validation and support.
bioAffinity Technologies is capitalizing on the growing market demand for early lung cancer detection, a segment projected to be worth
The substantial increase in the number of physician practices ordering CyPath® Lung (up
However, the company faces competition from other diagnostic solutions in the early detection space, which may influence its market share. Moreover, the ability to maintain such high growth rates and expand further into new regions while ensuring high-quality performance will be pivotal.
In summary, bioAffinity is well-positioned to capture significant market share in the lung cancer detection space, but continuous market penetration and competitive differentiation will be key to long-term success.
Expanded, experienced sales team more than doubles number of physician practices ordering CyPath® Lung test year-to-date
More than
KOL referrals and word-of-mouth expanding adoption of CyPath® Lung outside of the beta market launch in
Key Highlights
-
Generated record quarterly revenue of
in the first quarter of 2024.$2.4 million -
Forecasting between
and$9.2 in 2024 revenues for wholly owned subsidiary Precision Pathology Laboratory Services (PPLS), up$9.6 million 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 of21% 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 , andMichigan 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
registered direct offering and concurrent private placement to fund continued growth.$2.5 million
Management Commentary
“We are entering a period of accelerating growth with orders for CyPath® Lung up
“CyPath® Lung is positioned to set a new standard in the early detection of lung cancer – a market projected to reach
First Quarter Financial Results
Revenue for the first quarter of 2024 was
Research and development expenses were
Clinical development expenses were
Selling, general and administrative expenses were
Net loss for the first quarter of 2024 was
Cash and cash equivalents as of March 31, 2024, were
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
bioAffinity Technologies, Inc. Condensed Consolidated Balance Sheets |
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March 31, 2024 |
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December 31, 2023 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
2,453,165 |
|
|
$ |
2,821,570 |
|
Accounts and other receivables, net |
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|
1,123,609 |
|
|
|
811,674 |
|
Inventory |
|
|
9,487 |
|
|
|
18,484 |
|
Prepaid expenses and other current assets |
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|
344,900 |
|
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|
321,017 |
|
Total current assets |
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3,931,161 |
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3,972,745 |
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Non-current assets: |
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Property and equipment, net |
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461,209 |
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|
458,633 |
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Operating lease right-of-use asset, net |
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|
347,860 |
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370,312 |
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Finance lease right-to-use, net |
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1,069,601 |
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1,165,844 |
|
Goodwill |
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|
1,404,486 |
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|
1,404,486 |
|
Intangible assets, net |
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|
818,889 |
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|
833,472 |
|
Other assets |
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|
16,060 |
|
|
|
16,060 |
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|
|
|
|
|
|
|
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Total assets |
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$ |
8,049,266 |
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|
$ |
8,221,552 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
442,485 |
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$ |
604,789 |
|
Accrued expenses |
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|
923,810 |
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|
|
1,149,811 |
|
Unearned revenue |
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|
30,174 |
|
|
|
33,058 |
|
Operating lease liability, current portion |
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|
96,631 |
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|
94,708 |
|
Finance lease liability, current portion |
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|
372,787 |
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|
365,463 |
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Notes payable, current portion |
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|
4,686 |
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|
|
— |
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Total current liabilities |
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|
1,870,573 |
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|
2,247,829 |
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|
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|
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Non-current liabilities: |
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Finance lease liability, net of current portion |
|
|
739,478 |
|
|
|
835,467 |
|
Operating lease liability, net of current portion |
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|
258,110 |
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|
283,001 |
|
Notes payable, net of current portion |
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|
23,037 |
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|
— |
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Total liabilities |
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|
2,891,198 |
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3,366,297 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Preferred stock, par value |
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— |
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— |
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Common stock, par value |
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|
78,515 |
|
|
|
65,762 |
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Additional paid-in capital |
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|
51,744,830 |
|
|
|
49,393,972 |
|
Accumulated deficit |
|
|
(46,665,277 |
) |
|
|
(44,604,479 |
) |
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|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
|
5,158,068 |
|
|
|
4,855,255 |
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|
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|
|
|
|
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Total liabilities and stockholders’ equity |
|
$ |
8,049,266 |
|
|
$ |
8,221,552 |
|
bioAffinity Technologies, Inc. Unaudited Condensed Consolidated Statements of Operations |
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Three Months Ended March 31, |
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2024 |
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2023 |
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(unaudited) |
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Net Revenue |
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$ |
2,406,391 |
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$ |
921 |
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Operating expenses: |
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Direct costs and expenses |
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1,660,007 |
|
|
|
87 |
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Research and development |
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|
393,639 |
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|
369,617 |
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Clinical development |
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|
48,960 |
|
|
|
19,628 |
|
Selling, general and administrative |
|
|
2,196,361 |
|
|
|
1,147,875 |
|
Depreciation and amortization |
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|
149,637 |
|
|
|
21,684 |
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|
|
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Total operating expenses |
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|
4,448,604 |
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|
|
1,558,891 |
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|
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Loss from operations |
|
|
(2,044,213 |
) |
|
|
(1,557,970 |
) |
|
|
|
|
|
|
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Other income (expense): |
|
|
|
|
|
|
|
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Interest income |
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|
6,127 |
|
|
|
38,654 |
|
Interest expense |
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|
(23,550 |
) |
|
|
(1,655 |
) |
Other income |
|
|
— |
|
|
|
— |
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Other expense |
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|
4,510 |
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— |
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Net loss before provision for income taxes |
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|
(2,057,126 |
) |
|
|
(4,919,158 |
) |
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|
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Income tax expense |
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|
(3,672 |
) |
|
|
(11,819 |
) |
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Net loss |
|
$ |
(2,060,798 |
) |
|
$ |
(1,532,790 |
) |
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|
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Net loss per common share, basic and diluted |
|
$ |
(0.21 |
) |
|
$ |
(0.18 |
) |
|
|
|
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Weighted average common shares outstanding, basic
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|
|
9,915,426 |
|
|
|
8,433,689 |
|
View source 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
Source: bioAffinity Technologies, Inc.
FAQ
What was BioAffinity Technologies' Q1 2024 revenue?
How much did CyPath® Lung orders grow in early 2024?
What is BioAffinity Technologies' revenue forecast for Precision Pathology Laboratory Services in 2024?
When did Medicare reimbursement for CyPath® Lung become effective?
What was BioAffinity Technologies' net loss for Q1 2024?
How did BioAffinity Technologies' cash position change by March 31, 2024?