bioAffinity Technologies Reports $2.4 Million Revenue for Q3 2024
Expanded CyPath® Lung test sales to physicians in
Number of physician offices signed increased
Reaffirmed
Key Highlights
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Generated quarterly revenue of
in the third quarter of 2024.$2.4 million -
More than 1,
300% growth rate for CyPath® Lung orders in first nine months of 2024 over full-year 2023. -
Number of physician offices signed increased by
75% compared to the second quarter of 2024, setting the stage for acceleration of CyPath® Lung sales in the quarters ahead. -
In October 2024, CyPath® Lung was added to the
U.S. Federal Supply Schedule (FSS), a procurement system that provides the Veterans Health Administration and the Military Health System streamlined access to state-of-the-art healthcare products and services. Under the FSS contract, Veterans at high risk for lung cancer will have easy access to CyPath® Lung through 1,380 government health care facilities. Approximately 8,000 Veterans are treated for lung cancer annually, according to the VA. -
Referrals and word-of-mouth from physicians, including key opinion leaders (KOLs), continues to be a key driver for expanding CyPath® Lung in states beyond
Texas ; now receiving CyPath® Lung orders from physicians in 11 states, up from eight in the second quarter of 2024. In addition to previously reported orders fromPennsylvania ,New Jersey ,North Carolina ,Arizona ,Michigan ,California , andOhio , physicians inAlabama ,Louisiana andIllinois have also begun ordering CyPath® Lung tests. -
Added new sales representative to target increasing opportunities in
Texas . -
Continued to advance new product development initiatives in collaboration with Brooke Army Medical Center, the
U.S Department of Defense’s largest military health organization, focusing on tests that use the Company’s artificial intelligence and flow cytometry platform for diagnosing COPD and a companion test with bronchoscopy. -
Economic study published in Journal of Health Economics and Outcomes Research, a peer-reviewed journal, concludes that adding CyPath® Lung to the standard of care for Medicare patients with a positive lung cancer screening could have saved an average of
per patient for total cost savings of$2,773 in 2022.$379 million - Awarded a Certificate of Grant of Patent from the Japan Patent Office for the Company’s unique method using flow cytometry to predict the likelihood of lung disease, including the CyPath® Lung diagnostic test for early-stage lung cancer.
- Appointed William Bauta, Ph.D., as Chief Science Officer following the retirement of Vivienne I. Rebel, M.D., Ph.D. Dr. Bauta joined bioAffinity in 2016 as Senior Vice President. Previously, he was Associate Director of science at Genzyme.
-
Successfully closed a
registered direct offering and concurrent private placement to fund continued growth.$2.7 million
Management Commentary
“We are pleased with the continued progress we achieved in the third quarter, highlighted by a
“Our focus remains on expanding our operations and strengthening our foothold in this rapidly growing market,” Zannes continued. “Our strategic approach in
Third Quarter Financial Results
Revenue for the third quarter of 2024 was
Research and development expenses were
Clinical development expenses were
Selling, general and administrative expenses were
Net loss for the third quarter of 2024 was
Cash and cash equivalents as of September 30, 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 wholly owned 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 accelerating sales growth in the coming quarters; broadening access to CyPath® Lung; expanding the Company’s operations and strengthening its foothold in the rapidly growing market; the Company’s ability to meet rising demand and accelerate its nationwide growth; the Company’s ability to advance its mission to enhance patient outcomes through groundbreaking, noninvasive cancer diagnostics; and the ability of the Company to address the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and broad-spectrum cancer treatments. 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 accelerate sales growth and expand its operations; the Company’s ability to meet rising demand and accelerate its nationwide growth; the Company’s ability to advance its mission to enhance patient outcomes through groundbreaking, noninvasive cancer diagnostics; the ability of the Company to address the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and broad-spectrum cancer treatments, 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.
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September 30, 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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$ |
756,580 |
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$ |
2,821,570 |
|
Accounts and other receivables, net |
|
|
1,327,168 |
|
|
|
811,674 |
|
Inventory |
|
|
25,363 |
|
|
|
18,484 |
|
Prepaid expenses and other current assets |
|
|
440,027 |
|
|
|
321,017 |
|
Total current assets |
|
|
2,549,138 |
|
|
|
3,972,745 |
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Non-current assets: |
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|
|
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|
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Property and equipment, net |
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|
418,190 |
|
|
|
458,633 |
|
Operating lease right-of-use asset, net |
|
|
493,687 |
|
|
|
370,312 |
|
Finance lease right-of-use asset, net |
|
|
877,115 |
|
|
|
1,165,844 |
|
Goodwill |
|
|
1,404,486 |
|
|
|
1,404,486 |
|
Intangible assets, net |
|
|
789,722 |
|
|
|
833,472 |
|
Other assets |
|
|
19,676 |
|
|
|
16,060 |
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|
|
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|
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Total assets |
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$ |
6,552,014 |
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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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$ |
782,937 |
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$ |
604,789 |
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Accrued expenses |
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|
904,252 |
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|
|
1,149,811 |
|
Unearned revenue |
|
|
24,404 |
|
|
|
33,058 |
|
Operating lease liability, current portion |
|
|
124,710 |
|
|
|
94,708 |
|
Finance lease liability, current portion |
|
|
387,780 |
|
|
|
365,463 |
|
Notes payable, current portion |
|
|
267,081 |
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|
|
— |
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Total current liabilities |
|
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2,491,164 |
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|
2,247,829 |
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Non-current liabilities: |
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Finance lease liability, net of current portion |
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|
543,007 |
|
|
|
835,467 |
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Operating lease liability, net of current portion |
|
|
375,139 |
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|
|
283,001 |
|
Notes payable, net of current portion |
|
|
21,679 |
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— |
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Total liabilities |
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3,430,989 |
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3,366,297 |
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Commitments and contingencies |
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- |
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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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|
90,064 |
|
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|
65,762 |
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Additional paid-in capital |
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|
53,708,374 |
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|
49,393,972 |
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Accumulated deficit |
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|
(50,677,413 |
) |
|
|
(44,604,479 |
) |
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|
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Total stockholders’ equity |
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|
3,121,025 |
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|
|
4,855,255 |
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Total liabilities and stockholders’ equity |
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$ |
6,552,014 |
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$ |
8,221,552 |
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bioAffinity Technologies, Inc.
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Net Revenue |
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$ |
2,350,386 |
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$ |
298,484 |
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$ |
7,154,429 |
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$ |
319,143 |
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Operating expenses: |
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Direct costs and expenses |
|
|
1,440,158 |
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|
74,704 |
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|
|
4,421,309 |
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|
76,025 |
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Research and development |
|
|
274,497 |
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|
|
330,376 |
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|
|
1,070,569 |
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|
|
1,035,118 |
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Clinical development |
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|
93,705 |
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|
|
106,422 |
|
|
|
194,127 |
|
|
|
161,310 |
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Selling, general and administrative |
|
|
2,364,592 |
|
|
|
2,023,917 |
|
|
|
7,023,311 |
|
|
|
4,576,708 |
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Depreciation and amortization |
|
|
151,298 |
|
|
|
57,569 |
|
|
|
452,005 |
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|
|
100,805 |
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Total operating expenses |
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|
4,324,250 |
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|
2,592,988 |
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|
|
13,161,321 |
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|
5,949,966 |
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Loss from operations |
|
|
(1,973,864 |
) |
|
|
(2,294,504 |
) |
|
|
(6,006,892 |
) |
|
|
(5,630,823 |
) |
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Other income (expense): |
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Interest income |
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2,228 |
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|
|
27,193 |
|
|
|
13,541 |
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|
|
109,971 |
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Interest expense |
|
|
(21,631 |
) |
|
|
(8,785 |
) |
|
|
(67,430 |
) |
|
|
(11,801 |
) |
Other income |
|
|
9,683 |
|
|
|
4,606 |
|
|
|
9,683 |
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|
|
4,606 |
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Other expense |
|
|
(14,697 |
) |
|
|
(17,100 |
) |
|
|
(10,186 |
) |
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|
(17,100 |
) |
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Total other income (expense) |
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|
(24,417 |
) |
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|
5,914 |
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|
|
(54,392 |
) |
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|
85,676 |
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|
|
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|
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Net loss before provision for income tax expense |
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|
(1,998,281 |
) |
|
|
(2,288,590 |
) |
|
|
(6,061,284 |
) |
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|
(5,545,147 |
) |
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|
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Income tax expense |
|
|
2,559 |
|
|
|
2,294 |
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|
|
11,650 |
|
|
|
18,700 |
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Net loss |
|
$ |
(2,000,840 |
) |
|
$ |
(2,290,884 |
) |
|
$ |
(6,072,934 |
) |
|
$ |
(5,563,847 |
) |
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Net loss per common share, basic and diluted |
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$ |
(0.16 |
) |
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$ |
(0.26 |
) |
|
$ |
(0.54 |
) |
|
$ |
(0.65 |
) |
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|
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Weighted average common shares outstanding |
|
|
12,391,867 |
|
|
|
8,696,554 |
|
|
|
11,237,324 |
|
|
|
8,551,154 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20241114473397/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.