bioAffinity Technologies Reports Fourth Quarter and Full Year 2023 Financial Results
- Significant revenue growth of bioAffinity Technologies in fiscal year 2023, reaching $2.5 million from $5,000 in 2022.
- Acquisition of Precision Pathology Laboratory Services and increased sales of CyPath® Lung drove revenue growth.
- Achieved 350% growth in CyPath® Lung tests ordered in Q1 2024, surpassing sales forecasts.
- Received CMS payment approval for CyPath® Lung for 2024, accelerating commercialization efforts.
- Expanded market reach through sales to the Department of Defense and strengthened the team with key appointments.
- Reported a net loss of $7.9 million for 2023 despite revenue growth.
- High selling, general, and administrative expenses in 2023 compared to 2022.
- Net loss of $7.9 million for 2023, indicating financial challenges despite revenue growth.
Insights
The reported revenue growth for bioAffinity Technologies from $5,000 in 2022 to $2.5 million in 2023 is a substantial increase, indicative of a successful integration of Precision Pathology Laboratory Services and the growing demand for CyPath® Lung. However, the company's net loss widening from $1.7 million in the prior-year period to $2.4 million in the fourth quarter of 2023 raises concerns about the scalability and sustainability of their growth trajectory. The increase in selling, general and administrative expenses suggests significant investment in commercialization efforts, which could be promising if it translates into future revenue growth. The cash position of $2.8 million warrants close monitoring to ensure ongoing operations and further investment in growth initiatives.
The Centers for Medicare and Medicaid Services' final determination for payment for CyPath® Lung is a pivotal development for bioAffinity Technologies. This approval not only adds credibility to the test but also potentially increases its accessibility to a broader patient base. The collaboration with the Department of Defense for observational studies further validates the test's clinical utility and may lead to the development of a companion diagnostic, which could enhance the test's value proposition. However, the long-term impact on the company's financials will depend on the adoption rate of the test and the outcomes of these studies.
The strategic appointments and expansion of the sales team, including the addition of Dallas Coleman as National Director of Sales, demonstrate bioAffinity Technologies' commitment to driving sales and market penetration. The 350% growth in CyPath® Lung tests ordered and processed is an encouraging sign of market acceptance. However, the company's ability to maintain this momentum and successfully expand to the national market will be critical. Marketing efforts initiated in January 2024 will need to be effective in educating physicians and patients about the benefits of early lung cancer detection to support continued revenue growth.
Fiscal Year 2023 and Recent Highlights
-
Reported fiscal year 2023 revenue of
$2.5 million $5,000 -
Reported accelerating growth of
350% in CyPath® Lung tests ordered and processed in Q1 2024 as compared to Q4 2023, exceeding the Company’s targeted sales forecast for the quarter. The Company continues with its limited market launch inTexas to refine future positioning and strategic insight for CyPath® Lung in preparation for expanding to the national market. - Achieved a milestone with the Centers for Medicare and Medicaid Services (CMS) final determination for payment for CyPath® Lung for the 2024 calendar year, a significant step in the Company’s strategic plan to accelerate the commercialization of CyPath® Lung.
- Initiated the sale of CyPath® Lung tests to the Department of Defense for observational studies and research. This research expands the test's use and includes the development of a companion test for bronchoalveolar lavage (BAL) samples to be used in conjunction with bronchoscopy.
- Announced the appointment of Michael Dougherty, CPA, MBA, as Chief Financial Officer, bringing extensive experience from his previous role as CFO of Amazon’s Alexa Commercial Domains.
- Developed marketing materials for CyPath® Lung in collaboration with leading marketing and advertising firms and began utilizing them with physicians and patients in January 2024, focusing on the test’s value as a tool to assist physicians with patient care decisions.
- Announced the appointment of Dallas Coleman as National Director of Sales and the ongoing expansion of the sales team. Mr. Coleman has more than 15 years of experience in medical sales and marketing, most recently as Executive Account Manager for the respiratory portfolio of Olympus America’s therapeutic solutions division.
- Successfully passed the bi-annual College of American Pathologists (CAP) inspection in January 2024, affirming the high standards of quality and patient care attained by the Company’s commercial laboratory, Precision Pathology Laboratory Services.
-
Expanded the Company’s Medical and Scientific Advisory Board with the appointment of Sandeep Bansal, M.D., Medical Director of Pennsylvania’s Lung Innovations Network, a patient-centered practice that offers comprehensive lung care to more than 10,000 patients in central and western
Pennsylvania . -
Strengthened the Company’s Board of Directors with the appointment of Jamie Platt, Ph.D., Managing Director and Chief Executive Officer of Pictor Limited, where she is leading a turnaround by restructuring and accelerating product development. Dr. Platt was instrumental in merger and acquisition exits for two diagnostic companies with a combined value of approximately
$1 billion
Management Commentary
“As we reflect on the monumental achievements of bioAffinity Technologies over the past year, I am filled with immense pride and optimism for the future,” said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. “Our fiscal year 2023 revenue of
Ms. Zannes continued, "The CMS's final payment determination for CyPath® Lung for the 2024 calendar year was a major accomplishment that supports our strategic plan to accelerate commercialization. This milestone, coupled with our successful acquisition of Precision Pathology Services and expanding the reach of CyPath® Lung through partnerships such as with the Department of Defense, positions us at the forefront of noninvasive lung cancer detection. Our revenue growth is a beacon of our potential and the impact we aim to have on millions of lives by providing accessible, accurate, and noninvasive diagnostic solutions. As we look ahead, we are more committed than ever to building on this momentum and expanding our market to fulfill the promise of early cancer detection and treatment."
Fourth Quarter Financial Results
Revenue for the fourth quarter of 2023 was approximately
Research and development expenses were
Net loss for the fourth quarter of 2023 was
Full Year Financial Results
Revenue for 2023 was
Research and development expenses were
Selling, general and administrative expenses were
Net loss for 2023 was
Cash and cash equivalents as of December 31, 2023, were
About CyPath® Lung
CyPath® Lung uses advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath® Lung incorporates a fluorescent porphyrin, meso-tetra (4-carboxyphenyl) porphyrin (TCPP), that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath® Lung had
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 and follow us on LinkedIn, Facebook and X.
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 with the Company’s limited market launch in
bioAffinity Technologies, Inc. Consolidated Balance Sheets |
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December 31, |
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2023 |
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2022 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
|
$ |
2,821,570 |
|
|
$ |
11,413,759 |
|
Accounts and other receivables, net |
|
|
811,674 |
|
|
|
10,489 |
|
Inventory |
|
|
18,484 |
|
|
|
5,540 |
|
Prepaid expenses and other current assets |
|
|
321,017 |
|
|
|
531,899 |
|
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Total current assets |
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3,972,745 |
|
|
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11,961,687 |
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Non-current assets: |
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Property and equipment, net |
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|
458,633 |
|
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|
214,438 |
|
Operating lease right-of-use asset, net |
|
|
370,312 |
|
|
|
— |
|
Finance lease right-of-use asset, net |
|
|
1,165,844 |
|
|
|
— |
|
Goodwill |
|
|
1,404,486 |
|
|
|
— |
|
Intangible assets, net |
|
|
833,472 |
|
|
|
— |
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Other assets |
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|
16,060 |
|
|
|
6,000 |
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Total assets |
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$ |
8,221,552 |
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|
$ |
12,182,125 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
604,789 |
|
|
$ |
345,042 |
|
Accrued expenses |
|
|
1,149,811 |
|
|
|
541,894 |
|
Unearned revenue |
|
|
33,058 |
|
|
|
— |
|
Operating lease liability, current portion |
|
|
94,708 |
|
|
|
— |
|
Finance lease liability, current portion |
|
|
365,463 |
|
|
|
— |
|
Loan payable |
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— |
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251,746 |
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Total current liabilities |
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2,247,829 |
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1,138,682 |
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Non-current liabilities |
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Operating lease liability, net of current portion |
|
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283,001 |
|
|
|
— |
|
Finance lease liability, net of current portion |
|
|
835,467 |
|
|
|
— |
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Total liabilities |
|
|
3,366,297 |
|
|
|
1,138,682 |
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Commitments and contingencies (See Note 10) |
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- |
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- |
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Stockholders’ equity: |
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Preferred stock, no shares issued or outstanding at December 31, 2023 and 2022, respectively |
|
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— |
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— |
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Common stock, par value |
|
|
65,762 |
|
|
|
58,669 |
|
Additional paid-in capital |
|
|
49,393,972 |
|
|
|
47,652,242 |
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Accumulated deficit |
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(44,604,479 |
) |
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|
(36,667,468 |
) |
Total stockholders’ equity |
|
|
4,855,255 |
|
|
|
11,043,443 |
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|
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Total liabilities and stockholders’ equity |
|
$ |
8,221,552 |
|
|
$ |
12,182,125 |
|
|
bioAffinity Technologies, Inc. Consolidated Statements of Operations For the Years Ended December 31, 2023 and 2022 |
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2023 |
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2022 |
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Net Revenue |
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$ |
2,532,499 |
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$ |
4,803 |
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Operating expenses: |
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Direct costs and expenses |
|
|
1,740,884 |
|
|
|
467 |
|
Research and development |
|
|
1,467,936 |
|
|
|
1,378,624 |
|
Clinical development |
|
|
256,661 |
|
|
|
145,546 |
|
Selling, general and administrative |
|
|
6,790,654 |
|
|
|
2,481,042 |
|
Depreciation and amortization |
|
|
249,592 |
|
|
|
10,182 |
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Total operating expenses |
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10,505,727 |
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|
4,015,861 |
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Loss from operations |
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(7,973,228 |
) |
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(4,011,058 |
) |
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Other income (expense): |
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Interest income |
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|
122,131 |
|
|
|
46,708 |
|
Interest expense |
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|
(37,125 |
) |
|
|
(2,532,640 |
) |
Other Income |
|
|
3,325 |
|
|
|
— |
|
Other Expense |
|
|
(31,121 |
) |
|
|
— |
|
Gain on extinguishment of debt |
|
|
— |
|
|
|
212,258 |
|
Fair value adjustments on convertible notes payable |
|
|
— |
|
|
|
(1,866,922 |
) |
|
|
|
|
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Loss before income taxes |
|
|
(7,916,018 |
) |
|
|
(8,151,654 |
) |
|
|
|
|
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Income tax expense |
|
|
(20,993 |
) |
|
|
(2,459 |
) |
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Net loss |
|
$ |
(7,937,011 |
) |
|
$ |
(8,154,113 |
) |
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Net loss per common share, basic and diluted |
|
$ |
(0.91 |
) |
|
$ |
(1.81 |
) |
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Weighted average common shares outstanding |
|
|
8,747,509 |
|
|
|
4,498,964 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20240401275172/en/
bioAffinity Technologies
Julie Anne Overton
Director of Communications
jao@bioaffinitytech.com
Investor Relations
Dave Gentry
RedChip Companies, Inc.
1-800-733-2447
1-407-491-4498
BIAF@redchip.com
Source: bioAffinity Technologies, Inc.
FAQ
What was bioAffinity Technologies' revenue for fiscal year 2023?
What contributed to the revenue growth of bioAffinity Technologies?
What growth percentage did bioAffinity Technologies achieve in CyPath® Lung tests in Q1 2024?
What milestone did bioAffinity Technologies achieve with the Centers for Medicare and Medicaid Services (CMS)?
What was bioAffinity Technologies' net loss for 2023?
What were the cash and cash equivalents for bioAffinity Technologies as of December 31, 2023?
