Full Press Release Details
Technologies Reports Second Quarter 2025 Results
Lung revenues up 62% year-over-year in first six months of 2025
ANTONIO, Texas (August 14, 2025) - bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused
on providing noninvasive, accurate detection of early-stage lung cancer and other lung diseases, today reported financial results for
the three months ended June 30, 2025.
second quarter results reflect the continued acceleration of our CyPath Lung commercialization strategy, with testing
revenue up 62% for the first half of the year," Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies
said. "This growth is driven by increasing clinical adoption of our noninvasive lung cancer diagnostic and supported by physician-authored
case studies showing that CyPath Lung has identified early-stage cancers that other tests missed. These real-world results
are validating our test's unique value in guiding clinical decisions and improving patient outcomes.
success of our pilot marketing program in Texas, which has approximately 6% of the total number of U.S. pulmonologists, has demonstrated
that our approach to the medical community is sound and effective. We are prepared to meet increased demand as we implement our strategy
to enter additional key markets, including our expansion in the Mid-Atlantic region and the Veterans Administration healthcare system.
the quarter, we took important steps to strengthen our financial foundation, including a successful $3.25 million public offering and
a strategic price adjustment for CyPath Lung to better reflect its value and align with reimbursement from private payers.
At the same time, our partnership with Cardinal Health OptiFreight Logistics has enhanced our national sample delivery capabilities
to meet growing demand.
are also proud to have expanded our leadership team with the appointment of Dr. Gordon Downie as Chief Medical Officer. His expertise
in pulmonary medicine and lung cancer screening is already shaping our clinical direction, including advancement toward pivotal trials.
intellectual property portfolio continues to grow with newly granted patents in the U.S., China, Canada, and Australia-strengthening
both our diagnostic and therapeutic platforms on a global scale. We also presented breakthrough research at the 2025 RNA Therapeutics
Conference, showcasing our siRNA-based approach to selectively kill cancer cells while sparing healthy tissue, a strategy with broad
potential across multiple tumor types.
ahead, we remain focused on expanding access to CyPath Lung, delivering operational efficiency, and advancing the next
generation of diagnostics and therapeutics," Zannes added. "Every test we deliver is a step toward earlier cancer detection,
better patient care, and stronger value for our shareholders."
Quarter 2025 Financial Results
for the quarter ended June 30, 2025, was $1.3 million, compared with $2.4 million for the second quarter of 2024. The decrease was primarily
attributable to the Company's strategic decision to discontinue unprofitable pathology services and reallocate resources toward
the commercialization of CyPath Lung. CyPath Lung testing revenue for the six months ended June 30, 2025,
increased approximately 62% year-over-year to $323,000, reflecting growth in physician adoption and an increase in total test results
expenses for the second quarter of 2025 were $3.8 million, down 16% from $4.5 million in the second quarter of 2024. The decrease was
primarily due to lower direct costs related to laboratory operations and reduced research and development expenses, partially offset
by increased clinical development spending in support of the Company's pivotal trial strategy.
loss for the quarter ended June 30, 2025, was $4.1 million, or $0.17 per share, compared with a net loss of $2.1 million, or $0.19 per
share, for the second quarter of 2024. The increase in net loss was primarily driven by a $1.5 million increase in non-cash expenses
related to warrant remeasurement and offering costs associated with the Company's May 2025 public offering.
and cash equivalents as of June 30, 2025, were $0.8 million, compared with $1.1 million as of December 31, 2024. bioAffinity Technologies
raised aggregate gross proceeds of $3.25 million through a public offering in May 2025.
bioAffinity Technologies, Inc.
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.
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 strategic actions reducing costs while expanding sales focus on high-margin diagnostics like CyPath Lung; international
patents expanding CyPath Lung's global commercialization potential; the targeted actions accelerating the commercial
growth of CyPath Lung; patient case studies continuing to underscore the diagnostic power of CyPath Lung
in real-world settings; expanding access to CyPath Lung for patients at risk of lung cancer; and advancing new diagnostics
for diseases like COPD and asthma. 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, strategic actions reducing costs while expanding sales focus on high-margin diagnostics like CyPath
Lung; international patents expanding CyPath Lung's global commercialization potential; the targeted actions accelerating
the commercial growth of CyPath Lung; patient case studies continuing to underscore the diagnostic power of CyPath
Lung in real-world settings; expanding access to CyPath Lung for patients at risk of lung cancer; advancing new diagnostics
for diseases like COPD and asthma; and the other factors discussed in the Company's Annual Report on Form 10-K for the year ended
December 31, 2024, 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.
Consolidated Balance Sheets
| June 30, 2025 | December 31, 2024 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 802,835 | $ | 1,105,291 | ||||
| Accounts and other receivables, net | 421,869 | 1,139,204 | ||||||
| Inventory | 43,971 | 27,608 | ||||||
| Prepaid expenses and other current assets | 400,151 | 422,995 | ||||||
| Total current assets | 1,668,826 | 2,695,098 | ||||||
| Non-current assets: | ||||||||
| Property and equipment, net | 351,368 | 375,385 | ||||||
| Operating lease right-of-use asset, net | 399,879 | 463,011 | ||||||
| Finance lease right-of-use asset, net | 167,730 | 780,872 | ||||||
| Goodwill | 1,404,486 | 1,404,486 | ||||||
| Intangible assets, net | 745,972 | 775,139 | ||||||
| Other assets | 12,814 | 19,676 | ||||||
| Total assets | $ | 4,751,075 | $ | 6,513,667 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,169,837 | $ | 987,311 | ||||
| Accrued expenses | 1,048,034 | 1,398,722 | ||||||
| Unearned revenue | 24,404 | 24,404 | ||||||
| Operating lease liability, current portion | 133,239 | 127,498 | ||||||
| Finance lease liability, current portion | 179,844 | 395,301 | ||||||
| Notes payable, current portion | 32,946 | 171,669 | ||||||
| Total current liabilities | 2,588,304 | 3,104,905 | ||||||
| Non-current liabilities: | ||||||||
| Operating lease liability, net of current portion | 274,074 | 342,098 | ||||||
| Finance lease liability, net of current portion | 3,942 | 444,448 | ||||||
| Notes payable, net of current portion | 45,952 | 20,180 | ||||||
| Warrant liability | 3,974,911 | - | ||||||
| Total liabilities | 6,887,183 | 3,911,631 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity (deficit): | ||||||||
| Preferred stock, par value $0.001 per share; 20,000,000 shares authorized; no shares issued or outstanding at June 30, 2025, and December 31, 2024 | - | - | ||||||
| Common stock, par value $0.007 per share; 100,000,000 shares authorized; 28,459,541 and 15,576,674 issued and outstanding at June 30, 2025, and December 31, 2024, respectively | 197,236 | 106,593 | ||||||
| Additional paid-in capital | 58,032,170 | 56,139,753 | ||||||
| Accumulated deficit | (60,365,514 | ) | (53,644,310 | ) | ||||
| Total stockholders' equity (deficit) | (2,136,108 | ) | 2,602,036 | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 4,751,075 | $ | 6,513,667 |
Consolidated Statements of Operations
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net revenue | $ | 1,269,483 | $ | 2,397,652 | $ | 3,123,080 | $ | 4,804,043 | ||||||||
| Operating expenses: | ||||||||||||||||
| Direct costs and expenses | 1,016,602 | 1,407,710 | 2,384,462 | 2,981,151 | ||||||||||||
| Research and development | 311,372 | 402,433 | 678,758 | 796,072 | ||||||||||||
| Clinical development | 129,279 | 51,462 | 267,632 | 100,422 | ||||||||||||
| Selling, general and administrative | 2,214,561 | 2,472,775 | 4,667,110 | 4,658,719 | ||||||||||||
| Depreciation and amortization | 113,229 | 151,070 | 267,817 | 300,707 | ||||||||||||
| Total operating expenses | 3,785,043 | 4,485,450 | 8,265,779 | 8,837,071 | ||||||||||||
| Loss from operations | (2,515,560 | ) | (2,087,798 | ) | (5,142,699 | ) | (4,033,028 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 2,025 | 5,186 | 2,567 | 11,313 | ||||||||||||
| Interest expense | (10,460 | ) | (22,249 | ) | (25,945 | ) | (45,799 | ) | ||||||||
| Other income | 38,053 | 1 | 38,055 | 4,511 | ||||||||||||
| Other expense | (483,043 | ) | - | (492,685 | ) | - | ||||||||||
| Change in fair value of warrants issued | (1,062,818 | ) | - | (1,062,818 | ) | - | ||||||||||
| Total other income (expense), net | (1,516,243 | ) | (17,062 | ) | (1,540,826 | ) | (29,975 | ) | ||||||||
| Net loss before provision for income tax expense | (4,031,803 | ) | (2,104,860 | ) | (6,683,525 | ) | (4,063,003 | ) | ||||||||
| Income tax expense | 28,984 | 5,419 | 37,679 | 9,091 | ||||||||||||
| Net loss | $ | (4,060,787 | ) | $ | (2,110,279 | ) | $ | (6,721,204 | ) | $ | (4,072,094 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.17 | ) | $ | (0.19 | ) | $ | (0.20 | ) | $ | (0.38 | ) | ||||
| Weighted average common shares outstanding | 24,021,546 | 11,389,308 | 20,148,211 | 10,655,483 |