bioAffinity Technologies, Inc.
For the period ended Sep 30, 2025. Filed Nov 14, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 14, 2025
BIAF$2.72+4.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001641172-25-024163
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-14.
0001493152-25-023405
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 115 previous paragraphs and 113 current paragraphs.
70 unchanged; 29 reworded; 14 added; 15 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 8 previous and 8 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (14)
Current report
Financial Results
Current report
On November 5, 2025, the Company announced sales of CyPath® Lung saw consistent month-over-month and quarter-over-quarter growth. Tests processed in October 2025 continue the upward trend with completed tests representing a 111% increase over the monthly average for the first nine months of 2025. Third-quarter sales volume increased 95% over the prior quarter. Medical centers ordering multiple CyPath® Lung tests increased 106% in the third-quarter compared to the prior quarter and increased by 67% in October compared to the 2025 year-to-date monthly average.
Current report
On September 26, 2025, the Company released details of three separate case studies – one in which use of CyPath® Lung led to detecting lung cancer at Stage 1A, its earliest and possibly curative stage, and two where risky invasive procedures were avoided for patients facing difficult healthcare choices.
Current report
On September 9, 2025, the Company released details of a case in which CyPath® Lung identified lung cancer in a patient with difficult-to-diagnose ground-glass pulmonary nodules which shifted the course of care from watchful waiting for up to 5 years to confirmed malignancy and immediate treatment.
Current report
Appointment of New Board Members
Current report
On August 18, 2025, the Company announced the appointment of Roberto Rios, CPA, and John J. Oppenheimer, M.D., to its Board of Directors. Mr. Rios has more than four decades of executive leadership in corporate finance and governance across industries including biotechnology and medical devices, including financial leadership roles at ILEX Oncology, BioMedical Enterprises. Dr. Oppenheimer is the Director of Clinical Research at Pulmonary and Allergy Associates and Clinical Professor of Medicine at Rutgers and a leader in the diagnosis and treatment of asthma and COPD and an advisor to pharmaceutical companies focused on lung health.
Current report
On October 16, 2025, the Company announced it received a notice of allowance from the U.S. Patent Office for its patent application that protects its diagnostic algorithm and test method to detect lung cancer.
Current report
On October 28, 2025, the Company announced that the Australian Patent Office accepted a patent application for the Company’s proprietary platform technology for assessing lung health and predicting the likelihood of multiple lung diseases.
Current report
All share and per-share amounts in the accompanying footnotes have been retroactively adjusted to reflect the Company’s 1-for-30 reverse stock split.
Current report
In October 2025, the Company entered into definitive agreements for the purchase and sale of 720,000 shares of common stock, par value $0.007 per share, at a purchase price of $2.50 per share in a registered direct offering priced at-the-market under Nasdaq rules. The gross proceeds to the Company from the offering were approximately $1.8 million before deducting placement agent fees and other offering expenses payable by the Company.
Current report
On September 29, 2025, the Company consummated a best efforts public offering of an aggregate of (i) 1,047,694 shares of Common Stock and (ii) pre-funded warrants to purchase up to 874,067 shares of Common Stock in lieu of shares of Common Stock. Each share was sold at a public offering price of $2.50. Each pre-funded warrant was sold at a public offering price of $2.493. The total gross proceeds for the transaction were approximately $4.8 million.
Current report
On August 7, 2025, the Company received notice from Nasdaq that it had not regained compliance with Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”) and was not eligible for a second 180-day compliance period as it did not comply with the minimum stockholders’ equity requirement for initial listing on the Nasdaq Capital Market. As a result, unless the Company requested an appeal by August 14, 2025, its securities would be scheduled for delisting from The Nasdaq Capital Market and would be suspended at the opening of business on August 18, 2025. On August 14, 2025, the Company submitted an appeal to Nasdaq which stayed the delisting and suspension of the Company’s securities pending the decision of the panel. On August 14, 2025, the Company received written notice from Nasdaq that its hearing has been scheduled for September 11, 2025. At the hearing, the Company presented its views and its plans to regain compliance with the Minimum Bid Price Rule and Listing Rule 5550(b)(1) (the “Minimum Stockholders’ Equity Rule”) to the panel. On September 18, 2025, Nasdaq granted us an extension until October 2, 2025 to demonstrate compliance with the Minimum Bid Price Rule and the Minimum Stockholders’ Equity Rule. On October 14, 2025, the Company received written notice from The Nasdaq Stock Market LLC stating that the panel has found the Company to be in compliance with the Minimum Bid Price Rule and the Minimum Stockholders’ Equity Rule. The letter also indicated that the Company will be subject to a mandatory panel monitor for a period of one year. If, within that one-year monitoring period, the Company fails to comply with the Minimum Stockholders’ Equity Rule, the Company will not be permitted additional time to regain compliance. However, the Company will have an opportunity to request a new hearing with the Nasdaq Hearings Panel prior to the Company’s securities being delisted from Nasdaq.
Current report
Research and development expenses totaled approximately $331,000 and $275,000 for the three months ended September 30, 2025 and 2024, respectively. The increase of approximately $56,000, or 20%, for the three months ended September 30, 2025, compared to the same period in 2024 was primarily attributable to an increase project costs as we continue to advance development for diagnostic tests targeted at COPD and asthma.
Current report
Nine Months Ended September 30, 2025, Compared to Nine Months Ended September 30, 2024
Removed paragraphs (15)
Previous report
Record CyPath® Lung Sales
Previous report
On August 13, 2025, the Company announced that the number of completed CyPath® Lung tests in July represented a 72% increase over the previous monthly average for the first six months of 2025. The upward trend reflects back-to-back record monthly sales in June and July. The Company reaffirmed its forecast of 3X year-over-year revenues for CyPath® Lung.
Previous report
On July 23, 2025, the Company announced that CyPath® Lung identified a Stage 1A neuroendocrine tumor in the patient’s lung after PET scan, bronchoscopies and a serum tumor marker test suggested the pulmonary nodule was non-cancerous inflammation.
Previous report
On July 9, 2025, the Company released details of a complex clinical case in which CyPath® Lung identified Stage 1A adenocarcinoma lung cancer in a patient whose PET imaging and risk model probability indicated a low risk of malignancy. In each case, use of our test was the determining factor that led to a biopsy and treatment.
Previous report
These most recent case studies follow release on May 8, 2025, of the report “CyPath® Lung in Practice” authored by Gordon Downie, MD, PhD, then Director of the Titus Regional Hospital Lung Nodule Clinic and Interventional Pulmonology, in which he reported on case studies including an 85-year-old patient who averted biopsy after CyPath® Lung was negative for cancer, persuading the patient to wait for three months when a new CT showed the nodules had disappeared. The paper also reported on a patient who was previously treated for lung cancer and had a small nodule in the opposing lung. The CyPath® Lung was positive for cancer and a biopsy confirmed a second primary lung cancer for which the patient is being treated. In a third case study, CyPath® Lung helped identify a hidden recurrence of breast cancer after a routine CT detected a small pulmonary nodule.
Previous report
Appointment of Chief Medical Officer
Previous report
On June 15, 2025, Dr. Gordon Downie was appointed Chief Medical Officer. Dr. Downie brings more than three decades of experience in pulmonary medicine, clinical research, medical innovation, and interventional pulmonology to the role. He has authored more than 30 peer-reviewed publications, many centered on innovation in bronchoscopy, early lung cancer diagnosis and medical device development. He has worked extensively in both academic medicine and private practice, led FDA-approved research programs, and served in national leadership roles with the American College of Chest Physicians in the areas of interventional pulmonology, lung cancer, and medical ethics.
Previous report
On June 24, 2025, the Company announced that the China National Intellectual Property Administration (CNIPA) has issued a notification of patent grant for the company’s novel composition and method for selectively killing cancer by targeting the CD320 and LRP2 receptors on the cell membrane. The Company reported that research and development of this broad-spectrum therapeutic approach will be applied first to topical application for treatment of skin cancers.
Previous report
On July 22, 2025, the Company announced its patent related to a method to detect lung disease through flow cytometry analysis of sputum has been allowed by the Canadian Patent Office. The Canadian patent protects the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in the sputum.
Previous report
On July 15, 2025, the Company announced it received notification of allowance from the China National Intellectual Property Administration (CNIPA) for a patent application related to methods of predicting the likelihood of lung cancer using flow cytometry. The newly allowed Chinese patent protects the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in the sputum.
Previous report
On May 28, 2025, the Company announced the U.S. Patent and Trademark Office (USPTO) issued a new patent covering a novel composition and method for selectively killing cancer by targeting the CD320 and LRP2 receptors on the cell membrane. Company research and development of this broad-spectrum therapeutic approach will be applied first to topical application for treatment of skin cancers.
Previous report
On May 7, 2025, the Company completed a public offering of securities for gross proceeds to the Company of $3.25 million, before deducting agent fees and other estimated expenses payable by the company. The offering consisted of 10,156,250 shares of our Common Stock, of which 2,371,346 were pre-funded warrants, together with warrants to purchase up to 15,234,375 shares of Common Stock, at a combined offering price for each share of common stock (or pre-funded warrant) and accompanying warrant of $0.32 per share. The warrants have an exercise price of $0.352 per share and have certain provisions that allow for additional shares to be issued in the event of a reverse split of the Company’s common stock. Additionally, the warrants include an anti-dilution adjustment which is subject to stockholder approval.
Previous report
As a result of the foregoing transactions on August 13, 2025, the Company will issue approximately 8.0 million additional warrants to the participants in the May 2025 public offering.
Previous report
On August 7, 2025, the Company received notice from Nasdaq noting the Company’s bid price for its common stock closed at less than $1 per share over the previous 30 consecutive business days as of February 7, 2025, and has not regained compliance according to Listing Rule 5550(a)(2). In addition, the Company did not comply with the continued listing requirement of a minimum of $2.5 million in stockholders’ equity set forth in Listing Rule 5550(b)(1). As of August 14, 2025 the Company requested a hearing appeal on the determination. Such request will stay any further action by Nasdaq and will allow the Company’s ordinary shares to continue to trade on Nasdaq under the symbol “BIAF” at least pending the issuance of the Panel’s decision and the expiration of any extension the Panel may grant to the Company following the appeal.
Previous report
Six Months Ended June 30, 2025, Compared to Six Months Ended June 30, 2024
Reworded paragraphs (29)
Previous wording
We continue to advance development our flow cytometry+AI platform for diagnostic tests targeted at Chronic Obstructive Pulmonary Disease (COPD) and asthma. Diagnostics under development are designed to detect specific receptors in sputum that determinethe effectiveness of new and emerging therapies for asthma and COPD that have proved to effectively treat some but not all patients.
Current wording
We continue to advance development of our flow cytometry+AI platform for diagnostic tests targeted at COPD and asthma. Diagnostics under development are designed to detect specific receptors in sputum that determine the effectiveness of new and emerging therapies for asthma and COPD that have proved to effectively treat some but not all patients.
Previous wording
Key financial results for the six months ended June 30, 2025, include:
Current wording
Key financial results for the nine months ended September 30, 2025, include:
Previous wording
Detection at Stage 1A followed by treatment offers a 95% 10-year survival rate as compared to the current overall 5-year survival rate of 26%. and the patient’s prognosis, according to a NEJM study. Physicians have reported numerous patient case studies in which CyPath® Lung was the critical clinical decision maker including instances in which cancer was detected in Stage 1A when existing treatments can be curative. On July 29, 2025, the Company released details of a case study in which Stage 1A invasive mucinous adenocarcinoma was detected by CyPath® Lung after imaging and a competitive serum test were indeterminate.
Current wording
Detection at Stage 1A followed by treatment offers a 95% 10-year survival rate as compared to the current overall 5-year survival rate of 26%, according to a NEJM study. In addition to the three case studies reported in July, 2025, in which CyPath® Lung detected lung cancer at Stage 1A when existing treatments can be curative, the Company released details in September, 2025 of four patient case studies in which CyPath® Lung was the critical factor in clinical decision making, including instances in which cancer was detected at Stage 1A.
Previous wording
On August 13, 2025, the Company entered into a securities purchase agreement with certain institutional and accredited investors, pursuant to which the Company agreed to issue and sell, in a private placement, (i) 990 shares of the Company’s newly designated Series B Convertible Preferred Stock, with a par value $0.001 per share and stated value of $1,000 per share, for gross proceeds to the Company of $990,000, initially convertible into 4,304,343 shares of the Company’s Common Stock, par value $0.007 per share at an initial conversion price of $0.23 per share and (ii) warrants to purchase up to 6,714,780 shares of the Company’s Common Stock at an exercise price of $0.352 per share of Common Stock.
Current wording
On August 13, 2025, the Company entered into a securities purchase agreement with certain institutional and accredited investors, pursuant to which the Company agreed to issue and sell in a private placement (i) 990 shares of the Company’s newly designated Series B Convertible Preferred Stock, with a par value $0.001 per share and stated value of $1,000 per share, for gross proceeds to the Company of $990,000, which were initially convertible into 143,476 shares of the Company’s Common Stock at an initial conversion price of $6.90 per share and (ii) warrants to purchase up to 223,824 shares of the Company’s Common Stock at an exercise price of $10.56 per share of Common Stock.
Previous wording
On August 13, 2025, the Company entered into a warrant inducement agreement with the holder of a warrant to purchase 450,000 shares of Common Stock originally issued on August 5, 2024, with a current exercise price of $1.25 per share and a warrant to purchase 650,000 shares of Common Stock originally issued on October 21, 2024 with a current exercise price of $1.50 per share, pursuant to which the Holder agreed to exercise in cash the Existing Warrants at a reduced exercise price of $0.23 per share, for gross proceeds to the Company of $253,000. As an inducement to such exercise, the Company agreed to issue to the holder unregistered warrants (the “New Warrants”) to purchase up to 1,430,000 shares of the Company’s Common Stock. The New Warrants, which have an exercise price of $0.352 per share and will not become exercisable until the Company’s stockholders approve the issuance of shares of Common Stock.
Current wording
On August 13, 2025, the Company entered into a warrant inducement agreement with the holder of a warrant to purchase 15,000 shares of Common Stock originally issued on August 5, 2024, with a current exercise price of $37.50 per share and a warrant to purchase 21,666 shares of Common Stock originally issued on October 21, 2024, with a current exercise price of $45.00 per share, pursuant to which the Holder agreed to exercise in cash the Existing Warrants at a reduced exercise price of $6.90 per share, for gross proceeds to the Company of $253,000. As an inducement to such exercise, the Company agreed to issue to the holder unregistered warrants (the “New Warrants”) to purchase up to 47,666 shares of the Company’s Common Stock. The New Warrants, which have an exercise price of $10.56 per share and will not become exercisable until the Company’s stockholders approve the issuance of shares of Common Stock.
Previous wording
To date, we have devoted a substantial portion of our efforts and financial resources to the development of our diagnostic test, CyPath®Lung. As a result, since our inception in 2014, we have funded our operations principally through private and public sales of our equity. As of June 30, 2025, we had cash and cash equivalents of $0.8 million. As of August 14, 2025, after the 2025 equity financing, we had cash and cash equivalents of $0.3 million, which we expect will not support our operations through August 2025. We have incurred significant losses and negative cash flows from operations since inception and expect to continue to incur losses and negative cash flows for the foreseeable future. Based on the Company’s current expected level of operating expenditures and the cash and cash equivalents on hand at June 30, 2025, management concludes that there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least twelve (12) months subsequent to the issuance of the accompanying condensed consolidated financial statements.
Current wording
To date, we have devoted a substantial portion of our efforts and financial resources to the development of our diagnostic test, CyPath®Lung. As a result, since our inception in 2014, we have funded our operations principally through private and public sales of our equity. As of September 30, 2025, we had cash and cash equivalents of $7.7 million. As of October 29, 2025, we had cash and cash equivalents of $8.4 million, which we expect will support our operations through May 2026. We have incurred significant losses and negative cash flows from operations since inception and expect to continue to incur losses and negative cash flows for the foreseeable future. Based on the Company’s current expected level of operating expenditures and the cash and cash equivalents on hand at September 30, 2025, management concludes that there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least twelve (12) months subsequent to the issuance of the accompanying condensed consolidated financial statements.
Previous wording
Prior to acquisition of the clinical pathology laboratory by PPLS, Village Oaks, under the trade name Precision Pathology Services, had licensed and developed CyPath® Lung as a laboratory developed test (“LDT”) for sale to physicians. The license agreement provided that revenues from the sale would be split evenly between the Company and Village Oaks. In the second quarter of 2022, prior to the acquisition, we started to recognize revenue as part of a limited beta market testing program of the CyPath®Lung test. We have never been profitable, and as of June 30, 2025, we had a working capital deficit of approximately $0.9 million and an accumulated deficit of approximately $60.4 million. We expect to continue to incur significant operating losses for the foreseeable future as we continue the development of our diagnostic tests and advance our diagnostic tests through clinical trials.
Current wording
Prior to acquisition of the clinical pathology laboratory by PPLS, Village Oaks, under the trade name Precision Pathology Services, had licensed and developed CyPath® Lung as a laboratory developed test (“LDT”) for sale to physicians. The license agreement provided that revenues from the sale would be split evenly between the Company and Village Oaks. In the second quarter of 2022, prior to the acquisition, we started to recognize revenue as part of a limited beta market testing program of the CyPath®Lung test. We have never been profitable, and as of September 30, 2025, we had a working capital of approximately $6.3 million and an accumulated deficit of approximately $65.4 million. We expect to continue to incur significant operating losses for the foreseeable future as we continue the development of our diagnostic tests and advance our diagnostic tests through clinical trials.
Previous wording
Net loss for the three months ended June 30, 2025, was approximately $4.1 million, compared to a net loss of approximately $2.1 million for the three months ended June 30, 2024.
Current wording
Net loss for the three months ended September 30, 2025, was approximately $5.1 million, compared to a net loss of approximately $2.0 million for the three months ended September 30, 2024.
Previous wording
Consolidated revenue decreased approximately $1.7 million, or 35%, to $3.1 million for the six months ended June 30, 2025, as compared to $4.8 million for the three months ended June 30, 2024, primarily as a result of the Company’s targeted strategic actions to discontinue certain unprofitable pathology services, and drive sales growth for CyPath® Lung. CyPath® Lung testing revenue increased approximately $116,000, or 56%, to $323,000 for the six months ended June 30, 2025, compared to $207,000 for the six months ended June 30, 2024, as a result of a total of 390 test results delivered for the three months ended June 30, 2025, compared to 221 tests for the six months ended June 30, 2024
Current wording
Consolidated revenue decreased approximately $0.9 million, or 38%, to $1.5 million for the three months ended September 30, 2025, as compared to $2.4 million for the three months ended September 30, 2024, primarily as a result of the Company’s targeted strategic actions to discontinue certain unprofitable pathology services and drive sales growth for CyPath® Lung. CyPath® Lung testing revenue increased approximately $63,000, or 47%, to $296,000 for the three months ended September 30, 2025, compared to $133,000 for the three months ended September 30, 2024, as a result of a total of 385 test results delivered for the three months ended September 30, 2025, compared to 172 tests for the three months ended September 30, 2024.
Previous wording
Operating expenses totaled approximately $3.8 million and $4.5 million during the three months ended June 30, 2025 and 2024, respectively. The decrease in operating expenses is the result of the following factors:
Current wording
Operating expenses totaled approximately $3.7 million and $4.3 million during the three months ended September 30, 2025 and 2024, respectively. The decrease in operating expenses is the result of the following factors:
Previous wording
Our direct costs and expenses are primarily direct labor for pathology services, laboratory supplies and reagents, laboratory equipment, and allocated shared facilities. Direct costs and expenses totaled $1.0 million and $1.4 million during the three months ended June 30, 2025 and 2024, respectively. The decrease of approximately $0.3 million for 2025 compared to 2024 was primarily attributable to the targeted strategic actions which occurred in March 2025, aimed at streamlining operations and reducing costs related to our lab operations.
Current wording
Our direct costs and expenses are primarily direct labor for pathology services, laboratory supplies and reagents, laboratory equipment, and allocated shared facilities. Direct costs and expenses totaled $0.9 million and $1.4 million during the three months ended September 30, 2025 and 2024, respectively. The decrease of approximately $0.5 million for 2025 compared to 2024 was primarily attributable to the targeted strategic actions which occurred in March 2025, aimed at streamlining operations and reducing costs related to our lab operations.
Previous wording
Clinical development expenses totaled approximately $129,000 and $51,000 for the three months ended June 30, 2025 and 2024, respectively. The increase of approximately $77,000, or 151%, for the three months ended June 30, 2025, compared to the same period in 2024 was primarily attributable to an increase in professional fees in 2025 related to managing our clinical strategy for our pivotal clinical trial.
Current wording
Clinical development expenses totaled approximately $143,000 and $94,000 for the three months ended September 30, 2025 and 2024, respectively. The increase of approximately $49,000, or 53%, for the three months ended September 30, 2025, compared to the same period in 2024 was primarily attributable to an increase in professional fees in 2025 related to managing our clinical strategy for our pivotal clinical trial.
Previous wording
Selling, general and administrative expenses totaled approximately $2.2 million and $2.5 million for the three months ended June 30, 2025 and 2024, respectively. The decrease of approximately $0.3 million, or 10%, for the three months ended June 30, 2025, compared to the same period in 2024 was primarily attributable a decrease in general and administrative costs related to lab operations as a result of our targeted strategic actions which occurred in March 2025, aimed at streamlining operations and reducing costs. These decreases were partially offset by an increase in employee compensation related to the addition of additional personnel and support services to support sales of our diagnostic test, CyPath® Lung.
Current wording
Selling, general and administrative expenses totaled approximately $2.2 million and $2.4 million for the three months ended September 30, 2025 and 2024, respectively. The decrease of approximately $0.2 million, or 7%, for the three months ended September 30, 2025, compared to the same period in 2024 was primarily attributable to a decrease in general and administrative costs related to lab operations as a result of our targeted strategic actions which occurred in March 2025, aimed at streamlining operations and reducing costs. These decreases were partially offset by an increase in employee compensation related to the addition of additional personnel and support services to support sales of our diagnostic test, CyPath® Lung.
Previous wording
Total other income (expense), net totaled ($1.5 million) and approximately $(30,000) for the six months ended June 30, 2025 and 2024, respectively. The increase in the total other expenses of approximately $1.5 million is mostly attributable the remeasurement of warrant liability and offering costs related to the May public offering.
Current wording
Total other income (expense), net totaled ($2.8 million) and approximately ($24,000) for the three months ended September 30, 2025 and 2024, respectively. The increase in the total other expenses of approximately $2.7 million is mostly attributable to the remeasurement of warrant liability, which was reclassified as equity after completion of certain events which prevented for equity classification.
Previous wording
Net loss for the six months ended June 30, 2025, was approximately $6.7 million, compared to a net loss of approximately $4.1 million for the six months ended June 30, 2024.
Current wording
Net loss for the nine months ended September 30, 2025, was approximately $11.8 million, compared to a net loss of approximately $6.0 million for the nine months ended September 30, 2024.
Previous wording
Consolidated revenue decreased approximately $1.1 million, or 35%, to $1.3 million for the three months ended June 30, 2025, as compared to $2.4 million for the three months ended June 30, 2024, primarily as a result of the Company’s targeted strategic actions to discontinue certain unprofitable pathology services, and drive sales growth for CyPath® Lung. CyPath® Lung testing revenue decreased approximately $9,000, or 5%, to $153,000 for the three months ended June 30, 2025, compared to $162,000 for the three months ended June 30, 2024, as a result of a total of 197 test results delivered for the three months ended June 30, 2025, compared to 168 tests for the three months ended June 30, 2024. During the second quarter of the prior year, the Company was estimating CyPath® Lung revenue using limited collection data due to the early stages of collections on the test. However, during the current year the Company is using recent timely collection data to estimate revenue on historical collections. Therefore, the Company recognizes a decrease in revenue compared to the prior year with an increase in tests.
Current wording
Consolidated revenue decreased approximately $2.6 million, or 36%, to $4.6 million for the nine months ended September 30, 2025, as compared to $7.2 million for the nine months ended September 30, 2024, primarily as a result of the Company’s targeted strategic actions to discontinue certain unprofitable pathology services and drive sales growth for CyPath® Lung. CyPath® Lung testing revenue increased approximately $287,000, or 86%, to $619,000 for the nine months ended September 30, 2025, compared to $332,000 for the nine months ended September 30, 2024, as a result of a total of 775 test results delivered for the nine months ended September 30, 2025, compared to 393 tests for the nine months ended September 30, 2024.
Previous wording
Operating expenses totaled approximately $8.3 million and $8.8 million during the six months ended June 30, 2025 and 2024, respectively. The decrease in operating expenses is the result of the following factors:
Current wording
Operating expenses totaled approximately $12.0 million and $13.2 million during the nine months ended September 30, 2025 and 2024, respectively. The decrease in operating expenses is the result of the following factors:
Previous wording
Our direct costs and expenses are primarily direct labor for pathology services, laboratory supplies and reagents, laboratory equipment, and allocated shared facilities. Direct costs and expenses totaled approximately $2.4 million and $3.0 million during the six months ended June 30, 2025 and 2024, respectively. The decrease of approximately $0.6 million for 2025 compared to 2024 was primarily attributable to the targeted strategic actions which occurred in March 2025, aimed at streamlining operations and reducing costs related to our lab operations.
Current wording
Our direct costs and expenses are primarily direct labor for pathology services, laboratory supplies and reagents, laboratory equipment, and allocated shared facilities. Direct costs and expenses totaled approximately $3.3 million and $4.4 million during the nine months ended September 30, 2025 and 2024, respectively. The decrease of approximately $1.1 million for 2025 compared to 2024 was primarily attributable to the targeted strategic actions which occurred in March 2025, aimed at streamlining operations and reducing costs related to our lab operations.
Previous wording
Research and development expenses totaled $0.7 million and $0.8 million for the six months ended June 30, 2025 and 2024, respectively. The decrease of approximately $0.1 million, or 15%, for the six months ended June 30, 2025, compared to the same period in 2024 was primarily attributable to a decrease in compensation costs and benefits and lab supplies.
Current wording
Research and development expenses totaled $1.0 million and $1.1 million for the nine months ended September 30, 2025 and 2024, respectively. The decrease of approximately $0.1 million, or 6%, for the nine months ended September 30, 2025, compared to the same period in 2024 was primarily attributable to a decrease in compensation costs and benefits and lab supplies.
Previous wording
Clinical development expenses totaled approximately $0.3 million and $0.1 million for the six months ended June 30, 2025 and 2024, respectively. The increase of approximately $0.2 million, or 16%, for the six months ended June 30, 2025, compared to the same period in 2024 was primarily attributable to an increase in professional fees in 2025 related to managing our clinical strategy for our pivotal clinical trial.
Current wording
Clinical development expenses totaled approximately $0.4 million and $0.2 million for the nine months ended September 30, 2025 and 2024, respectively. The increase of approximately $0.2 million, or 112%, for the nine months ended September 30, 2025, compared to the same period in 2024 was primarily attributable to an increase in professional fees in 2025 related to managing our clinical strategy for our pivotal clinical trial.
Previous wording
Selling, general and administrative expenses totaled approximately $4.7 million for each of the six months ended June 30, 2025 and 2024, respectively. Our selling, general and administrative costs stayed level as a result of decreases in aimed at streamlining operations and reducing costs in our lab operations, offset by increases in employee compensation related to the addition of additional personnel and support services to support sales of our diagnostic test, CyPath® Lung.
Current wording
Selling, general and administrative expenses totaled approximately $6.9 million and $7.0 million for each of the nine months ended September 30, 2025 and 2024, respectively. Our selling, general and administrative costs stayed level as a result of decreases from targeted strategic actions aimed at streamlining operations and reducing costs in our lab operations, offset by increases in employee compensation related to the addition of personnel and support services to support sales of our diagnostic test, CyPath® Lung.
Previous wording
Depreciation and amortization expenses totaled approximately $268,000 and $300,00 for the six months ended June 30, 2025 and 2024, respectively. The decrease of approximately $33,000, or 11%, for the six months ended June 30, 2025, compared to the same period in 2024 was primarily attributable to the termination of a financing lease in April 2025 due to the Company’s targeted strategic actions announced in March 2025.
Current wording
Depreciation and amortization expenses totaled approximately $381,000 and $452,000 for the nine months ended September 30, 2025 and 2024, respectively. The decrease of approximately $71,000, or 16%, for the nine months ended September 30, 2025, compared to the same period in 2024 was primarily attributable to the termination of a financing lease in April 2025 due to the Company’s targeted strategic actions announced in March 2025.
Previous wording
Total other income (expense), net totaled ($1.5 million) and approximately ($17,000) for the three months ended June 30, 2025 and 2024, respectively. The increase in the total other expenses of approximately $1.5 million is mostly attributable to the remeasurement of warrant liability and offering costs related to the May public offering.
Current wording
Total other income (expense), net totaled ($4.3 million) and approximately $(54,000) for the nine months ended September 30, 2025 and 2024, respectively. The increase in total other expenses of approximately $4.2 million is mostly attributable to the remeasurement of warrant liability and offering costs related to the May public offering, which was further reclassified as equity after the completion of certain events which prevented equity classification.
Previous wording
To date, we have funded our operations primarily through our IPO, exercise of stock options and warrants, and the sale of our securities, resulting in gross proceeds of approximately $46.0 million. We have evaluated whether there are conditions and events that raise substantial doubt about our ability to continue as a going concern for at least one year after the date the condensed consolidated financial statements are issued.
Current wording
To date, we have funded our operations primarily through our IPO, exercise of stock options and warrants, and the sale of our securities, resulting in gross proceeds of approximately $58.2 million. We have evaluated whether there are conditions and events that raise substantial doubt about our ability to continue as a going concern for at least one year after the date the condensed consolidated financial statements are issued.
Previous wording
We have incurred losses since our inception in 2014 as a result of significant expenditures for operations and research and development and, prior to April 2022, the lack of any approved diagnostic test or therapeutic products to generate revenue. For the six months ended June 30, 2025 and 2024, we had net losses of $6.7 million and $4.1 million, respectively, and we expect to incur substantial additional losses in future periods. We have an accumulated deficit of approximately $60.4 million as of June 30, 2025. Despite our recent financing in May 2025 in which we raised gross proceeds of $3.25 million, and our financing in February 2025, in which we raised gross proceeds of approximately $1.4 million, we believe our current cash and anticipated revenue from operations will not be sufficient to support our operations through August 2025. Based on our current expected level of operating expenditures, current expected levels of revenue, and the cash and cash equivalents on hand at June 30, 2025, of $0.8 million, management concludes that there is substantial doubt about our ability to continue as a going concern for a period of at least twelve (12) months subsequent to the issuance of the accompanying unaudited condensed consolidated financial statements contained in this Quarterly Report. We need to raise further capital through the sale of additional equity or debt securities or other debt instruments, strategic relationships or grants, or through exercised outstanding warrants to support our future operations unless our revenue increases significantly. Our business plan includes expansion for our commercialization efforts which will require additional funding. If we are unable to improve our liquidity position, we may not be able to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to generate revenue and raise capital from financing transactions. There can be no assurance that we will be successful in accomplishing these objectives.
Current wording
We have incurred losses since our inception in 2014 as a result of significant expenditures for operations and research and development and, prior to April 2022, the lack of any approved diagnostic test or therapeutic products to generate revenue. For the nine months ended September 30, 2025 and 2024, we had net losses of $11.8 million and $6.1 million, respectively, and we expect to incur substantial additional losses in future periods. We have an accumulated deficit of approximately $65.4 million as of September 30, 2025. Despite our recent financing in the third quarter of 2025 in which we raised gross proceeds of $10.4 million, we believe our current cash and anticipated revenue from operations will be sufficient to support our operations through May 2026. Based on our current expected level of operating expenditures, current expected levels of revenue, and the cash and cash equivalents on hand at September 30, 2025, of $7.7 million, management concludes that there is substantial doubt about our ability to continue as a going concern for a period of at least twelve (12) months subsequent to the issuance of the accompanying unaudited condensed consolidated financial statements contained in this Quarterly Report. We need to raise further capital through the sale of additional equity or debt securities or other debt instruments, strategic relationships or grants, or through exercised outstanding warrants to support our future operations unless our revenue increases significantly. Our business plan includes expansion for our commercialization efforts which will require additional funding. If we are unable to improve our liquidity position, we may not be able to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to generate revenue and raise capital from financing transactions. There can be no assurance that we will be successful in accomplishing these objectives.
Previous wording
Net cash used in operating activities was approximately $4.3 million and $3.9 million for the six months ended June 30, 2025 and 2024, respectively. The increase of approximately $0.4 million in cash used by operations during the six months ended June 30, 2025, compared to the same period in 2024 was primarily attributable to an increase of $2.6 million in our loss from operations, a decrease in accrued expenses by $$0.2 million offset by a decrease in accounts receivable by $1.5 million compared to the prior year, and a fair value adjustment to the warrant liability by $1.1 million related to the May 2025 warrant agreement.
Current wording
Net cash used in operating activities was approximately $6.8 million and $5.6 million for the nine months ended September 30, 2025 and 2024, respectively. The increase of approximately $1.2 million in cash used by operations during the nine months ended September 30, 2025, compared to the same period in 2024 was primarily attributable to an increase of $5.7 million in our loss from operations, a decrease in accounts payable and accrued expenses by $0.4 million offset by a decrease in accounts receivable by $1.2 million compared to the prior year, and a fair value adjustment to the warrant liability by $3.8 million related to the May 2025 warrant agreement.
Previous wording
We used approximately $64,000 for the six months ended June 30, 2025, in investing activities related primarily to purchase of computer and lab equipment, compared to approximately $70,000 used in investing activities for the six months ended June 30, 2024.
Current wording
We used approximately $60,000 for the nine months ended September 30, 2025, in investing activities related primarily to purchase of computer and lab equipment, compared to approximately $80,000 used in investing activities for the nine months ended September 30, 2024.
Previous wording
Cash provided in financing activities was approximately $4.1 million compared to cash provided by financing activities of approximately $1.9 million for the six months ended June 30, 2025 and 2024, respectively. The change in proceeds from prior year was primarily related to net proceeds from the equity transactions of $4.4 million offset by payments for loans and finance leases of $0.3 million, compared to the prior year of equity transactions of $2.1 offset by payments for loans and finance leases of $0.2 million.
Current wording
Cash provided in financing activities was approximately $13.4 million compared to cash provided by financing activities of approximately $3.6 million for the nine months ended September 30, 2025 and 2024, respectively. The change in proceeds from prior year was primarily related to net proceeds from the equity transactions of $13.7 million offset by payments for loans and finance leases of $0.3 million, compared to the prior year of equity transactions of $3.6 million offset by payments for loans and finance leases of approximately $18,000.
Previous wording
We follow accounting considerations of CECL -Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. With the acquisition of PPLS and control of Village Oaks, the Company’s board-certified pathologists provide anatomic and clinical pathology services for patients and other customers. The Company’s other customer types include contract research organizations (“CROs”), hospitals, and independent laboratories. The majority of the Company’s revenues stem from fees for services provided to patients, and thus in those arrangements, the patient is the customer, although the services may be requested by a physician on the patient’s behalf. Furthermore, in addition to its contracts with patients, the Company separately contracts with third-party payors (insurance companies and governmental payors), who are typically responsible for all or the majority of the fees agreed upon for such services provided to patients. Historically, material amounts of gross charges are not collected due to various agreements with insurance companies, capped pricing levels for government payors, and uncollectible balances from individual payors. To estimate these allowances of credit losses, the Company assesses the portfolio risk segments and historical data on collection rates. These estimated allowances offset patient revenues and accounts receivables.
Current wording
We follow accounting considerations of Current Expected Credit Loss (“CECL”) -Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. With the acquisition of PPLS and control of Village Oaks, the Company’s board-certified pathologists provide anatomic and clinical pathology services for patients and other customers. The Company’s other customer types include contract research organizations (“CROs”), hospitals, and independent laboratories. The majority of the Company’s revenues stem from fees for services provided to patients, and thus in those arrangements, the patient is the customer, although the services may be requested by a physician on the patient’s behalf. Furthermore, in addition to its contracts with patients, the Company separately contracts with third-party payors (insurance companies and governmental payors), who are typically responsible for all or the majority of the fees agreed upon for such services provided to patients. Historically, material amounts of gross charges are not collected due to various agreements with insurance companies, capped pricing levels for government payors, and uncollectible balances from individual payors. To estimate these allowances of credit losses, the Company assesses the portfolio risk segments and historical data on collection rates. These estimated allowances offset patient revenues and accounts receivables.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Research and development expenses totaled approximately $311,000 and $402,000 for the three months ended June 30, 2025 and 2024, respectively. The decrease of approximately $91,000, or 23%, for the three months ended June 30, 2025, compared to the same period in 2024 was primarily attributable to a decrease in compensation costs and benefits and lab supplies.