S-1/A: bioAffinity Files S-1/A for Resale Amid Delisting Threat

bioAffinity Technologies, Inc. filed an S-1/A registration statement for the resale of up to 32,495,628 shares of common stock by selling stockholders, while facing imminent delisting from Nasdaq and a going concern warning.

Summary

• The company filed an S-1/A registration statement for the resale of up to 32,495,628 shares of common stock by various Selling Stockholders.
• These shares include 4,304,343 from Series B Preferred Stock conversion, 6,714,780 from Private Warrants, 1,430,000 from Inducement Warrants, 19,884,375 from May 2025 Warrants (due to anti-dilution adjustment), and 162,130 from WallachBeth Warrants.
• The company will not receive any proceeds from the sale of these shares by Selling Stockholders, but will receive proceeds from any cash exercise of the Common Warrants and conversion of the Series B Preferred Stock.
• On August 14, 2025, the company completed a private placement, raising approximately $1.2 million in gross proceeds from the issuance of Series B Convertible Preferred Stock and Private Warrants.
• Concurrently, a warrant inducement transaction on August 14, 2025, generated approximately $253,000 in gross proceeds from the cash exercise of existing warrants at a reduced price of $0.23 per share.
• The company's common stock is listed on the Nasdaq Capital Market under the symbol BIAF, with a closing price of $0.256 per share on September 10, 2025.
• bioAffinity Technologies is an Emerging Growth Company (EGC) and a Smaller Reporting Company, utilizing associated exemptions from certain reporting requirements.
• The company is at risk of delisting from Nasdaq Capital Market due to non-compliance with the Minimum Bid Price Requirement ($1.00) and the Continued Listing Equity Requirement ($2.5 million, with the company reporting $1,439,404 as of March 31, 2025).
• A hearing with the Nasdaq Panel was scheduled for September 11, 2025, to address the delisting threat, which would have otherwise occurred on August 18, 2025.

Sentiment

Score: 3

Explanation: The filing details recent capital raises, which provide some liquidity, but the primary focus is on registering a large number of shares for resale, which can create downward pressure. More critically, the company faces imminent delisting from Nasdaq due to severe non-compliance with listing standards (bid price and equity), and its auditor has expressed substantial doubt about its ability to continue as a going concern. These significant financial and operational risks heavily outweigh the recent capital infusion.

Positives

• Successfully completed an August 2025 Private Placement, raising approximately $1.2 million in gross proceeds.
• Successfully completed a Warrant Inducement Private Placement, raising approximately $253,000 in gross proceeds.
• Continues to advance development of its flow cytometry+AI platform for companion diagnostic tests targeting chronic obstructive pulmonary disease (COPD) and asthma.
• Advancing research and development for novel cancer therapeutic approaches, specifically for topical treatment of squamous cell skin cancer.
• The CyPath Lung test has shown potential to detect Stage 1A lung cancer, which could increase overall diagnostic accuracy and potentially improve survival rates.

Negatives

• The common stock closing price was $0.256 per share on September 10, 2025, significantly below Nasdaq's minimum bid price requirement of $1.00.
• Stockholders' equity was $1,439,404 as of March 31, 2025, falling below Nasdaq's minimum requirement of $2,500,000.
• Received written notice from Nasdaq regarding non-compliance with both the Minimum Bid Price Requirement and the Continued Listing Equity Requirement.
• The company was not eligible for a second 180-day compliance period for the Minimum Bid Price Requirement, indicating a severe compliance issue.
• Securities were scheduled for delisting from Nasdaq on August 18, 2025, without a successful appeal.
• The independent registered public accounting firm's report contains an explanatory paragraph describing substantial doubt about the company's ability to continue as a going concern.
• The company has a limited operating history, making it difficult to evaluate its business and future prospects.
• Unable to precisely estimate when significant profit will be generated from its laboratory subsidiary, PPLS.
• The company has limited experience operating a laboratory.
• Does not anticipate paying any cash dividends on its common stock for the foreseeable future.

Risks

• The business plan relies upon the ability to obtain additional sources of capital and financing.
• Must raise additional capital to fund operations in order to continue as a going concern.
• Limited operating history makes it difficult to evaluate the business and future prospects.
• Unable to precisely estimate when significant profit will be generated from PPLS.
• Limited experience operating a laboratory.
• Delays or difficulties in the enrollment of patients could delay or prevent regulatory approvals.
• Clinical trials are expensive, time-consuming, and may not be successful.
• If diagnostic tests do not perform as expected, operating results, reputation, and business will suffer.
• May experience difficulties that delay or prevent development, introduction, or marketing of enhanced or new tests.
• Clinical testing of a particular diagnostic test or therapeutic product candidate may not yield successful results.
• Even if diagnostic tests or therapeutic products receive marketing approval, commercialization may not be successful.
• Currently dependent upon the laboratory subsidiary, PPLS, to offer and perform CyPath Lung.
• If physicians cannot be convinced of the benefits of diagnostic tests or therapeutic products, market acceptance could be delayed.
• Faces substantial competition in the biotechnology and pharmaceutical industries.
• Success depends upon the ability to retain key executives and attract and retain qualified personnel.
• Lack of operating experience may make it difficult to manage growth.
• Will depend on third parties to supply reagents and equipment necessary to perform diagnostic tests and to design trial protocols and monitor clinical trials.
• Exposed to product liability and pre-clinical and clinical liability risks.
• Failure to comply with privacy and security regulations could result in liability or reputational harm.
• Ability to obtain adequate reimbursement for diagnostic tests may impact revenues.
• Employees, consultants, partners, and vendors may engage in misconduct or other improper activities.
• Failure to comply with healthcare laws and regulations could result in substantial penalties.
• The market for proposed tests and products is competitive and rapidly changing.
• Healthcare cost containment initiatives and the growth of managed care may limit returns.
• Disruption of internal information technology systems will adversely affect the business.
• Declining general economic or business conditions may have a negative impact on the business.
• Global climate change and related regulations could negatively affect the business.
• PPLS operations depend upon the relationship of certain pathologists with existing customers.
• PPLS may be unable to maintain equipment or generate revenue when its equipment is not operational.
• If the sole laboratory facility becomes damaged or inoperable, loses its accreditation, or is required to vacate the facility, PPLS's ability to sell its products or provide diagnostic assays and pursue its research and development efforts may be jeopardized.
• Disruption in the commercial courier delivery services used by PPLS to transport sputum samples could harm its business.
• Security breaches, data loss, and other disruptions could compromise sensitive information of PPLS's business.
• If PPLS uses hazardous chemicals in a manner that causes injury, PPLS could be liable for damages.
• If PPLS is unable to successfully scale its operations to support demand, its business could suffer.
• PPLS must dedicate substantial time and resources to its complex billing process to be paid.
• Delays of third-party billing and collection providers and an in-house billing function to transmit claims to payors could have an adverse effect on PPLS.
• If the company fails to comply with obligations imposed by any intellectual property licenses with third parties, it could lose rights important to its business.
• May need to obtain licenses of third-party technology that may not be available or available on reasonable terms.
• Competitive position depends on protection of intellectual property; diagnostic tests and therapeutic products could be subject to infringement claims.
• May become involved in lawsuits to protect or enforce intellectual property.
• If unable to protect trade secrets, business and competitive position could be harmed.
• Changes in patent law could impair ability to protect tests and product candidates.
• Patent protection could be reduced or eliminated for non-compliance with governmental requirements.
• Patent terms may be inadequate to protect diagnostic tests or therapeutic product candidates.
• Issued patents could be found invalid or unenforceable.
• If patent term extension is not obtained, business may be harmed.
• Enjoys only limited geographical protection with respect to certain patents.
• If trademarks and trade names are not adequately protected, may not be able to build name recognition.
• Failure to comply with laws pertaining to laboratory developed tests (LDTs) or in vitro devices (IVDs) could adversely affect the business.
• Third-party licensors of future therapeutic products may be unable to obtain regulatory approval.
• Failure to obtain regulatory approval in foreign jurisdictions would prevent product candidates from being marketed in those jurisdictions that deny approval.
• May never obtain approval or commercialize such products outside of the U.S.
• The impact of changes to healthcare policy and future healthcare reform legislation is unknown.
• Failure to meet the listing requirements of The Nasdaq Capital Market could result in a de-listing of Common Stock.
• Does not expect to pay dividends in the foreseeable future.
• Common Stock market price may never exceed the exercise price of outstanding warrants.
• Holders of warrants have no rights as stockholders until they exercise their warrants.
• The provisions of outstanding warrants could limit a warrant holder's ability to choose the judicial forum for disputes.
• The financial and operational projections that may be made from time to time are subject to inherent risks.
• Stock price has fluctuated in the past, has recently been volatile, and may be volatile in the future.
• Common Stock has often been thinly traded.
• An investment in the company may involve tax implications.
• Ability to use net operating loss carryforwards and certain other tax attributes may be limited.
• The Board can designate classes of Preferred Stock without stockholder approval.
• Provisions in corporate charter documents and under Delaware law could make an acquisition of the company more difficult.
• Provisions in the Charter and Amended and Restated (A&R) Bylaws could make a merger, tender offer, or proxy contest difficult.
• Certain provisions of the Delaware General Corporation Law (DGCL) may have anti-takeover effects.
• The Charter designates Delaware state or federal courts as the exclusive forum for disputes.
• Provisions in the Charter and A&R Bylaws may discourage stockholders from bringing a lawsuit against directors and officers.
• Management collectively owns a substantial percentage of Common Stock.
• If analysts publish unfavorable research, or none at all, about the business, stock price and trading volume could decline.
• Any inability to report and file financial results accurately and timely could harm the business.
• Common Stock could be subject to extreme volatility.
• Future sales and issuances of securities could result in additional dilution of the percentage ownership of stockholders and could cause share price to fall.
• The Nasdaq Capital Market may subsequently delist Common Stock if the company fails to comply with ongoing listing standards.

Future Outlook

The company intends to use the net proceeds from any conversion of Series B Preferred Stock and/or cash exercise of Common Warrants for general corporate purposes, including operating expenses, research and development (clinical and pre-clinical testing of product candidates), working capital, future acquisitions, and general capital expenditures. The company also plans to seek strategic partners to develop its therapeutic discoveries, which could lead to broad-spectrum cancer treatments in the future.

Management Comments

• We intend the forward-looking statements to be covered by the safe harbor provisions of the federal securities laws.
• We agreed to use our reasonable best efforts to obtain such Stockholder Approval, and request that our officers and directors, cast their proxies in favor of such proposal.

Industry Context

bioAffinity Technologies operates in the highly competitive and rapidly evolving biotechnology and medical diagnostics industry. Its focus on noninvasive diagnostics for early-stage lung cancer (CyPath Lung) and development of companion diagnostics for COPD and asthma, utilizing flow cytometry and AI, aligns with the broader industry trend of leveraging advanced technologies for precision medicine. The therapeutic research into novel cancer approaches also places it within the oncology sector. Companies in this space face significant challenges including high R&D costs, lengthy and complex regulatory approval processes, intense competition from established players, and the need for substantial capital to fund operations and clinical trials. Reimbursement policies and healthcare cost containment initiatives also heavily influence market acceptance and revenue generation.

Comparison to Industry Standards

• NA

Management Changes

Corporate Governance

Legal Proceedings

• NA

Related Party Transactions

• WallachBeth Capital LLC acted as financial advisor for the Warrant Inducement Private Placement, receiving a cash fee of 7.5% of total proceeds ($253,000) and warrants for 33,000 shares of Common Stock, plus up to $15,000 in expense reimbursement.
• WallachBeth Capital LLC acted as placement agent for the August 2025 Private Placement, receiving a cash fee of 7.5% of the aggregate purchase price ($1.2 million) and warrants for 129,130 shares of Common Stock, plus up to $65,000 in expense reimbursement.

Stakeholder Impact

• Shareholders face significant potential dilution from the resale of 32.5 million shares and a high risk of delisting from Nasdaq, which would severely impact liquidity and share value. The auditor's going concern warning raises fundamental questions about the company's long-term viability.
• Warrant holders have the ability to exercise warrants for cash, providing a mechanism for liquidity, but exercise is subject to stockholder approval for some warrants and beneficial ownership limitations.
• Investors in the recent private placements provided capital to the company but are now registering their shares for resale, indicating a potential intent to sell, which could add downward pressure on the stock.
• Employees' job security and potential equity value are tied to the company's ability to secure ongoing funding, achieve regulatory compliance, and successfully commercialize its products.
• Customers (physicians and patients) relying on CyPath Lung and future diagnostic/therapeutic products may face uncertainty regarding the company's ability to continue operations and product development due to financial instability.

Next Steps

• Maintain the effectiveness of the registration statement for the resale shares.
• Hold a special meeting of stockholders to obtain approval for the issuance of shares upon exercise of Inducement Warrants and Private Warrants.
• Continue efforts to regain compliance with Nasdaq's Minimum Bid Price Requirement and Continued Listing Equity Requirement.
• Await the decision from the Nasdaq Panel following the September 11, 2025, hearing regarding the delisting appeal.
• Continue advancing the development of the flow cytometry+AI platform for companion diagnostic tests for COPD and asthma.
• Continue advancing research and development for topical treatment of squamous cell skin cancer.
• Seek strategic partners to develop therapeutic discoveries.

Key Dates

Recommendation

The company faces severe financial distress, evidenced by its non-compliance with Nasdaq listing standards (both minimum bid price and stockholders' equity) and the auditor's 'going concern' warning. The imminent threat of delisting from Nasdaq would drastically reduce liquidity and likely lead to a significant decline in share price. While recent capital raises provide some short-term liquidity, they are insufficient to address the fundamental issues, and the registration of over 32 million shares for resale by existing stockholders suggests a lack of confidence and potential for further downward pressure on the stock price. The company's long-term viability is highly questionable given these factors.

Keywords

bioAffinity Technologies, BIAF, SEC filing, S-1/A, common stock resale, private placement, warrants, Series B Preferred Stock, lung cancer diagnostics, CyPath Lung, flow cytometry, AI diagnostics, COPD, asthma, cancer therapeutics, Nasdaq delisting, capital raise, biotechnology, medical diagnostics, going concern