S-1/A: bioAffinity Technologies Seeks $4M in Public Offering

bioAffinity Technologies, Inc. is offering up to 729,927 shares of common stock and pre-funded warrants in a best efforts public offering to raise approximately $3.4 million, while facing Nasdaq delisting threats.

Summary

• Offering up to 729,927 shares of Common Stock and up to 729,927 Pre-Funded Warrants at an assumed public offering price of $5.48 per share, adjusted for a 1-for-30 reverse stock split.
• The offering is a 'best efforts' endeavor with no minimum amount required to be sold, leading to uncertainty in raising the targeted capital.
• Net proceeds are estimated at approximately $3.4 million, assuming gross proceeds of $4.0 million, after deducting Placement Agent fees and estimated offering expenses.
• Proceeds will be allocated to working capital and general corporate purposes.
• The company develops noninvasive diagnostics for early-stage lung cancer (CyPath Lung) and other lung diseases (COPD, asthma) utilizing flow cytometry and AI.
• Research into novel cancer therapeutic approaches, including topical treatment for squamous cell skin cancer, is ongoing through its subsidiary, OncoSelect Therapeutics, LLC.
• Facing Nasdaq delisting due to non-compliance with the Minimum Bid Price Requirement ($1.00) and the Continued Listing Equity Requirement ($2,500,000 stockholders' equity).
• A 1-for-30 reverse stock split became effective on September 18, 2025, to address the minimum bid price requirement.
• Nasdaq granted an extension until October 2, 2025, to demonstrate compliance with both listing requirements.
• A private placement on August 14, 2025, raised approximately $1.2 million gross proceeds from Series B Convertible Preferred Stock and warrants.
• A warrant inducement transaction on August 14, 2025, generated approximately $253,000 gross proceeds from the exercise of 36,666 warrants.
• The Floor Price for August 2025 and May 2025 Warrants was increased from $3.00 to $4.50 per share, effective August 12, 2025.

Sentiment

Score: 3

Explanation: The company is in a precarious financial position, evidenced by Nasdaq delisting threats and a going concern warning from auditors. While it has promising diagnostic and therapeutic development, the current capital raise is a 'best efforts' offering, highlighting significant uncertainty in securing necessary funding. The reverse stock split and recent capital raises are reactive measures to immediate challenges rather than indicators of strong underlying performance.

Positives

• Development of CyPath Lung, a noninvasive diagnostic for early-stage lung cancer, with potential to increase diagnostic accuracy, improve survival, reduce unnecessary procedures, and lower costs.
• Advancing development of flow cytometry+AI platform for companion diagnostic tests for COPD and asthma.
• Discoveries and advancement of novel cancer therapeutic approaches through OncoSelect Therapeutics, LLC, with ongoing research for topical treatment of squamous cell skin cancer.
• Successful completion of a private placement raising approximately $1.2 million and a warrant inducement transaction raising approximately $253,000 in August 2025.
• Nasdaq granted an extension until October 2, 2025, to regain compliance with listing requirements, providing a temporary reprieve.

Negatives

• Facing Nasdaq delisting threats due to non-compliance with the Minimum Bid Price Requirement ($1.00) and the Continued Listing Equity Requirement ($2,500,000).
• The offering is a 'best efforts' offering with no minimum amount, meaning the company may not raise sufficient capital to fund its business plans.
• Immediate and substantial dilution of $4.72 per share for new investors purchasing common stock in this offering.
• Limited operating history makes it difficult to evaluate the business and future prospects.
• Uncertainty regarding when significant profit will be generated from Precision Pathology Laboratory Services (PPLS).
• The company has limited experience operating a laboratory.
• The trading price of common stock has been, and may continue to be, subject to wide price fluctuations and volatility.
• The company has an accumulated deficit of $(60,365,514) as of June 30, 2025.
• The independent registered public accounting firm's report contains an explanatory paragraph describing conditions that raise substantial doubt about the company's ability to continue as a going concern.

Risks

• Business plan relies on obtaining additional sources of capital and financing.
• Must raise additional capital to fund operations to continue as a going concern.
• Limited operating history makes it difficult to evaluate 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 patient enrollment could delay or prevent regulatory approvals.
• Clinical trials are expensive, time-consuming, and may not be successful.
• If tests do not perform as expected, operating results, reputation, and business will suffer.
• May experience difficulties delaying or preventing 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 PPLS to offer and perform CyPath Lung.
• Market acceptance could be delayed if physicians are not convinced of the benefits of diagnostic tests or therapeutic products.
• Faces substantial competition in biotechnology and pharmaceutical industries.
• Success depends on ability to retain key executives and attract and retain qualified personnel.
• Lack of operating experience may make it difficult to manage growth.
• Dependence on third parties to manufacture and market diagnostic tests and design/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.
• 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 business.
• Declining general economic or business conditions may have a negative impact on business.
• Global climate change and related regulations could negatively affect 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 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.
• Failure to comply with intellectual property licenses could lead to loss of important rights.
• May need to obtain licenses of third-party technology that may not be available or available on reasonable terms.
• Competitive position depends on intellectual property protection; diagnostic tests and therapeutic products could be subject to infringement claims.
• May become involved in lawsuits to protect or enforce intellectual property.
• Inability to protect trade secrets could harm business and competitive position.
• 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 LDTs or IVDs could adversely affect 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.
• Financial and operational projections 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 may involve tax implications.
• Ability to use net operating loss carryforwards and certain other tax attributes may be limited.
• 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 Charter and Amended and Restated (A&R) Bylaws could make a merger, tender offer, or proxy contest difficult.
• Certain provisions of Delaware's General Corporation Law (DGCL) may have anti-takeover effects.
• Charter designates Delaware state or federal courts as the exclusive forum for disputes.
• Provisions in 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 business, stock price and trading volume could decline.
• Any inability to report and file financial results accurately and timely could harm business.
• This is a best efforts offering, no minimum amount of securities is required to be sold, and may not raise the amount of capital believed to be required for business plans, including near-term business plans.
• 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.
• Nasdaq Capital Market may subsequently delist Common Stock if ongoing listing standards are not met.

Future Outlook

The company intends to use the net proceeds from this offering for working capital and general corporate purposes. It expects to present findings from its therapeutic discoveries at conferences and publish research in peer-reviewed journals in the near future. It intends to seek strategic partners for therapeutic discoveries. There can be no assurance that the company will regain Nasdaq compliance or successfully commercialize its products.

Management Comments

• At the hearing, the company presented its views and its plans to regain compliance with the Minimum Bid Price Requirement and the Continued Listing Equity Requirement to the Panel.

Industry Context

The company operates in the biotechnology and pharmaceutical industries, specifically focusing on noninvasive diagnostics for lung cancer and other lung diseases, and novel cancer therapeutics. This is a highly competitive and rapidly changing market, subject to significant regulatory oversight, healthcare cost containment initiatives, and the growth of managed care. The company's diagnostic platform uses flow cytometry and AI, aligning with trends in precision medicine and AI-driven diagnostics.

Management Changes

Corporate Governance

Stakeholder Impact

• Shareholders: Existing shareholders face significant dilution from the offering and potential further dilution from future capital raises. They also face the risk of delisting from Nasdaq, which could reduce liquidity and share value. New investors face immediate dilution.
• Employees: The company's ability to continue as a going concern and fund operations will impact job security and potential equity incentives.
• Customers/Physicians: Continued development and commercialization of diagnostic tests like CyPath Lung depend on the company's financial stability.
• Creditors: The 'going concern' warning and need for capital raise indicate increased risk for creditors.

Next Steps

• Demonstrate compliance with Nasdaq's Minimum Bid Price Requirement and Continued Listing Equity Requirement by October 2, 2025.
• Present findings from therapeutic discoveries at conferences and publish research in peer-reviewed journals.
• Seek strategic partners to develop therapeutic discoveries.
• Complete the current 'best efforts' public offering by October 31, 2025, or earlier.

Key Dates

Recommendation

The company faces severe financial distress, including an auditor's 'going concern' warning and imminent Nasdaq delisting threats. While the public offering and reverse stock split are attempts to address these issues, the 'best efforts' nature of the offering provides no guarantee of sufficient capital. New investors face immediate and substantial dilution. The high degree of risk, coupled with a volatile stock price and uncertain future funding, makes this a high-risk investment with significant downside potential.

Keywords

bioAffinity Technologies, BIAF, CyPath Lung, lung cancer, diagnostics, noninvasive, flow cytometry, AI, artificial intelligence, COPD, asthma, cancer therapeutics, OncoSelect Therapeutics, SEC filing, S-1/A, public offering, common stock, pre-funded warrants, Nasdaq delisting, reverse stock split, capital raise, biotech, medical devices, pharmaceutical