bioAffinity Technologies, Inc. (BIAF): CyPath® Lung test unit sales double year to date over 2025, with solid gains in physician utilization and recurring orders; testing revenue increases 79%…
bioAffinity Technologies, Inc. (BIAF) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 News Release bioAffinity Technologies Reports Third Quarter 2026 Results and Continued Momentum in CyPath ® Lung Commercialization CyPath ® Lung test unit sales double year to date over 2025, with solid gains in physician utilization and recurring orders; testing rev
How this was made
The 30-second read
Why it matters
The disclosed growth metrics and new distribution partnership provide fresh data for valuation models.
Market read
First‑time disclosure of Q3 results with strong sales momentum, likely to move the stock in the short term.
What to watch
Future cash needs for ongoing trials and the upcoming capital raise could dilute existing shareholders.
Q3 2026 net revenue fell to $1,070,280 from $1,446,066 while net loss widened to $(5,277,023); CyPath Lung testing revenue and physician adoption grew
Testing revenue and ordering-physician growth are reported, but net revenue declined year over year, loss from operations widened from $(2,292,846) to $(3,510,672), and cash was $2,550,034 at September 30, 2026. The company also reports $8.0 million in aggregate gross proceeds from financings in August and October 2026.
Key metrics
as reported| Metric | Value | q/q | y/y |
|---|---|---|---|
| Net revenue, Q3 2026 (three months ended Sept 30)GAAP | $1,070,280 | – | – |
| Net revenue, nine months 2026GAAP | $3,932,386 | – | – |
| Direct costs and expenses, Q3 2026GAAP | $1,114,176 | – | – |
| Direct costs and expenses, nine months 2026GAAP | $3,130,649 | – | – |
| Research and development expenses, Q3 2026GAAP | $389,122 | – | 18% |
| Research and development expenses, nine months 2026GAAP | $1,100,404 | – | – |
| Clinical development expenses, Q3 2026GAAP | $251,043 | – | 75% |
| Clinical development expenses, nine months 2026GAAP | $1,060,968 | – | – |
| Selling, general and administrative expenses, Q3 2026GAAP | $2,759,769 | – | 28% |
| Selling, general and administrative expenses, nine months 2026GAAP | $8,859,961 | – | – |
| Depreciation and amortization, Q3 2026GAAP | $66,842 | – | – |
| Depreciation and amortization, nine months 2026GAAP | $242,916 | – | – |
| Total operating expenses, Q3 2026GAAP | $4,580,952 | – | – |
| Total operating expenses, nine months 2026GAAP | $14,394,898 | – | – |
| Loss from operations, Q3 2026GAAP | $(3,510,672) | – | – |
| Loss from operations, nine months 2026GAAP | $(10,462,512) | – | – |
| Interest expense, Q3 2026GAAP | $(10,713) | – | – |
| Offering costs allocated to warrant liability, Q3 2026GAAP | $(532,209) | – | – |
| Loss on warrant liabilities, Q3 2026GAAP | $(1,218,235) | – | – |
| Loss on warrant liabilities, nine months 2026GAAP | $(1,218,235) | – | – |
| Total other income (expense), net, Q3 2026GAAP | $(1,766,351) | – | – |
| Net loss before provision for income tax, Q3 2026GAAP | $(5,277,023) | – | – |
| Income tax expense, Q3 2026GAAP | — (printed as dash) | – | – |
| Net loss, Q3 2026GAAP | $(5,277,023) | – | – |
| Net loss, nine months 2026GAAP | $(12,273,715) | – | – |
| Net loss per common share, basic and diluted, Q3 2026GAAP | $(5.89) | – | – |
| Net loss per common share, basic and diluted, nine months 2026GAAP | $(23.72) | – | – |
| CyPath Lung testing revenue, first nine months 2026other | approximately $1.1 million | – | 79% |
| CyPath Lung test unit sales, first nine months 2026 vs first nine months 2025other | +100% | – | +100% |
| Ordering physicians, Q3 2026 vs Q3 2025other | +89% | – | +89% |
| Volume from physicians already ordering CyPath Lung, year over yearother | +48% | – | +48% |
| Cash and cash equivalents at Sept 30, 2026GAAP | $2,550,034 | – | – |
| Total assets at Sept 30, 2026GAAP | $7,553,671 | – | – |
| Total stockholders' equity at Sept 30, 2026GAAP | $3,914,561 | – | – |
Capital returns
- No share repurchases or dividends are reported in the filing.
- The company raised an aggregate of $8.0 million in gross proceeds through a private placement offering in August 2026 and a registered direct offering and concurrent private placement in October 2026, for working capital and general corporate purposes.
- Subsequent to quarter-end, the company completed a financing that generated approximately $4.0 million in gross proceeds. The filing does not state whether this financing is part of the $8.0 million aggregate.
What drove it
- The company attributes the Q3 2026 revenue decrease to a decrease in average reimbursement per CyPath Lung test and a slight decline in total cases completed at Precision Pathology Laboratory Services (PPLS), in part due to internal business changes at three PPLS research clients, according to the company's explanation.
- The company states that multiple accounts previously serviced under these three clients have since returned to PPLS and that it is working to restore additional accounts and improve reimbursement levels.
- The company attributes the increase in direct costs to additional personnel to process CyPath Lung commercial tests and tests associated with the longitudinal clinical study.
- The company attributes the increase in research and development expenses to laboratory supplies and costs associated with relocating laboratory facilities in June 2026.
- The company attributes the increase in clinical development expenses to the initiation of clinical trial sites and patient enrollment in the longitudinal clinical study.
- The company attributes the increase in SG&A to additional sales and marketing personnel and support services to expand commercialization of CyPath Lung.
- The company states that the increase in net loss is primarily due to the increase in loss from operations, partially offset by a $1.2 million loss from the change in fair value of warrants, compared with a $2.7 million loss in the prior-year quarter.
- The company states that growth in physician engagement and peer-to-peer education are drivers of CyPath Lung adoption.
- Government channel: the company states that an agreement with AvMEDICAL, a Service-Disabled Veteran-Owned Small Business, expands its distribution network and commercial reach to government agencies, including the Department of Veterans Affairs.
Concerns
- Net revenue was $1,070,280 in Q3 2026 against $1,446,066 in Q3 2025, and $3,932,386 for nine months 2026 against $4,569,146 for nine months 2025.
- Loss from operations was $(3,510,672) in Q3 2026 against $(2,292,846) in Q3 2025, and $(10,462,512) for nine months 2026 against $(7,435,545) for nine months 2025.
- Clinical development expense rose to $251,043 from $143,311 and SG&A rose to $2,759,769 from $2,209,441 in the quarter.
- Cash and cash equivalents were $2,550,034 at Sept 30, 2026, down from $6,449,782 at Dec 31, 2025.
- Net loss per common share was $(5.89) for Q3 2026 against $(71.05) in Q3 2025. The filing does not explain the change in share count in the per-share line beyond the weighted average share figures shown in the statements.
- Stockholders' equity fell to $3,914,561 from $7,277,656 at Dec 31, 2025, and the accumulated deficit grew to $(80,827,779).
What to watch
- Whether restored PPLS accounts and reimbursement improvements reverse the decline in net revenue, as the company states it is working to do.
- Operating expense trajectory for SG&A, clinical development and direct costs, given the company's stated investment in sales personnel and the longitudinal clinical study.
- Progress of the longitudinal clinical trial, where the filing reports 11 active sites as of Sept 30, 2026, including nine VA and military medical centers that had begun enrollment.
- Results of the AvMEDICAL distribution agreement in government healthcare channels.
- The status of the Japan Patent Office Notice of Allowance and the Hong Kong patent grant.
- Cash runway after the $8.0 million aggregate gross proceeds and the subsequent approximately $4.0 million financing, measured against loss from operations of $(3,510,672) in Q3 2026.
- Whether the company reports gross margin, operating cash flow or guidance in future filings, since none is printed in this release.
Balance sheet and cash flow
- Cash and cash equivalents were $2,550,034 at Sept 30, 2026, compared with $6,449,782 at Dec 31, 2025 (balance sheet comparative). The release describes this as approximately $2.6 million and approximately $6.4 million.
- Total assets were $7,553,671 at Sept 30, 2026, compared with $10,960,772 at Dec 31, 2025.
- Total liabilities were $3,639,110 at Sept 30, 2026, compared with $3,683,116 at Dec 31, 2025.
- Total stockholders' equity was $3,914,561 at Sept 30, 2026, compared with $7,277,656 at Dec 31, 2025.
- Accumulated deficit was $(80,827,779) at Sept 30, 2026, compared with $(68,554,064) at Dec 31, 2025.
- Notes payable total $144,715 current and $33,958 non-current at Sept 30, 2026. Finance lease liabilities are $78,926 current and $475,772 non-current. Operating lease liabilities are $168,534 current and $596,086 non-current.
- The filing contains no cash flow statement. Operating cash flow and free cash flow are not reported.
Analysis
bioAffinity reported Q3 2026 net revenue of $1,070,280 against $1,446,066 a year earlier, and $3,932,386 for the nine months against $4,569,146. The company attributes the decline to lower average reimbursement per CyPath Lung test and a slight drop in cases completed at PPLS, linked in part to business changes at three research clients whose accounts it says are returning. The filing reports positive testing metrics: CyPath Lung testing revenue of approximately $1.1 million for the first nine months, up 79%, unit sales up 100% over the first nine months of 2025, ordering physicians up 89% in Q3 and volume from existing ordering physicians up 48%. These demand indicators are printed against a shrinking reported revenue base, and the filing does not reconcile the two.
Cost structure moved against the top line. Total operating expenses rose to $4,580,952 from $3,738,912 in Q3, led by SG&A of $2,759,769 (from $2,209,441), clinical development of $251,043 (from $143,311), and direct costs of $1,114,176 (from $942,211). Loss from operations widened to $(3,510,672) from $(2,292,846). Net loss was $(5,277,023) against $(5,051,084), a smaller gap than operations alone because of a $(1,218,235) loss on warrant liabilities, versus $(2,747,460) a year earlier. The filing also shows $(532,209) of offering costs allocated to the warrant liability in Q3 2026. Net loss per common share was $(5.89) against $(71.05), a change the filing does not explain beyond the reported figures.
The balance sheet shows cash of $2,550,034 at Sept 30, 2026, down from $6,449,782 at Dec 31, 2025, and total stockholders' equity of $3,914,561, down from $7,277,656. The company raised $8.0 million in aggregate gross proceeds through an August private placement and an October registered direct offering with a concurrent private placement, and it reports a subsequent financing of approximately $4.0 million. The filing does not state whether these overlap, and it includes no cash flow statement, so operating and free cash flow cannot be read from the document.
The release provides no financial guidance and no gross margin figure. Management's commentary centers on physician adoption, the longitudinal study (11 active sites, nine of them VA and military medical centers), the AvMEDICAL government distribution agreement, a Hong Kong patent grant, a Japanese Notice of Allowance, and early research in asthma, COPD and topical skin cancer therapeutics. Those items are described as progress, and the filing offers no quantified revenue or margin targets against which to measure them.
The read is mixed. Adoption indicators and nine-month testing revenue growth are reported, but reported net revenue fell in both the quarter and the nine months, operating losses widened, and cash declined to $2,550,034 before the subsequent financings. The figures that most warrant attention are net revenue, loss from operations, and cash at quarter end, with the trajectory of reimbursement per test and PPLS volume as the operating questions the filing leaves open.
Management, verbatim
Our third-quarter results reflect CyPath Lung’s continued momentum in addressing the critical need for early lung cancer detection, driven by both new physicians ordering the test and increased use by existing customers.
Maria Zannes, President of CEO (as printed in the release)
Our priorities remain disciplined execution, expanding commercial adoption and advancing our clinical and research programs.
Maria Zannes, President of CEO (as printed in the release)
Not in the filing
stated, not guessed- Gross margin, gross profit and cost of sales percentage are not reported; cost of revenue is not presented as a separate line.
- Year-over-year percentage change for total net revenue, nine months revenue, total operating expenses, loss from operations and net loss is not printed in the release and has not been calculated.
- Prior-quarter (Q2 2026) figures are not printed, so sequential changes are null.
- Prior-year nine-month percentage changes are not printed for most lines.
- CyPath Lung testing revenue prior-year value is not printed (only the 79% change).
- CyPath Lung test unit sales are given only as a percentage change; no unit count is printed.
- Ordering physician count is given only as a percentage change; no physician count is printed.
- Operating cash flow, investing cash flow, financing cash flow and free cash flow are not reported; no cash flow statement is included.
- Non-GAAP measures, adjusted EBITDA and non-GAAP EPS are not reported.
- Forward guidance for revenue, gross margin, operating expenses or tax rate is not provided.
- Prior-period outlook was not provided, so vs_prior_guidance is empty.
- Segment or product line revenue breakdown beyond total net revenue and the CyPath Lung testing figure is not reported.
- Balance sheet comparatives are at Dec 31, 2025 rather than a prior quarter, so prior_quarter fields for cash, total assets and equity are null.
- Shares outstanding at period end are printed in the balance sheet but excluded from key metrics per the reporting standard.
- Amount of the subsequent approximately $4.0 million financing relative to the $8.0 million aggregate is not stated.
- Interest income, other income and other expense prior-year nine-month comparatives are printed but not captured individually as key metrics.
Written by an AI language model from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure is checked against the filing text, and a metric the filing does not print, or whose value, prior period and change do not add up, is dropped from the metrics. The model can still misread a table, in the metrics or in the text, so check a number in the filing before you rely on it. Consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
The filing is a standard SEC Form 8‑K reporting third‑quarter operating results for bioAffinity Technologies, a Nasdaq‑listed biotech.
Ticker impact
Q3 2026 results show CyPath Lung test unit sales doubled YoY and testing revenue rose 79% to about $1.1 million.
likely upward pressure as the market prices in accelerated sales and new distribution agreements.
Revenue growth and double‑digit unit sales increase are material for a micro‑cap biotech, prompting investors to add to positions.
Market effects
Highlights growing demand for non‑invasive lung diagnostics, potentially benefiting other precision‑medicine firms.
Expands bioAffinity's presence in U.S. government healthcare channels, especially the VA.
New patents in Hong Kong and Japan may bolster the company's international IP portfolio.
Counterpoint
The modest absolute revenue ($1.1 M) may not justify a price rally for a cash‑burning micro‑cap.
Key entities
- companybioAffinity Technologies, Inc.
Developer of CyPath® Lung non‑invasive diagnostic platform.
- partnerAvMEDICAL
Service‑Disabled Veteran‑Owned distributor expanding government channel reach.
