Financial Performance - Consolidated revenue increased approximately 270% to $9.4 million compared to $2.5 million for the year ended December 31, 2023, primarily due to the acquisition of PPLS in September 2023[45] - The company generated revenue of approximately $9.4 million and $2.5 million for the years ended December 31, 2024, and December 31, 2023, respectively[155] - The company generated $2.5 million in revenue from PPLS in 2023 and $9.4 million in 2024, but does not expect to derive immediate profit from these services[169] - For the year 2024, cash used in operations was $7.1 million, and the net loss was $9.0 million[161] - As of December 31, 2024, the company had an accumulated deficit of $53.6 million and only $1.1 million in cash on hand[161] - The company anticipates needing to raise additional capital to support operations and may require further financing through equity or debt securities[166] Product Development and Clinical Trials - A pivotal clinical trial for CyPath Lung is expected to open in the second quarter of 2025, with 3,200 patients participating across multiple collection sites[40] - CyPath Lung achieved an overall 88% specificity and 82% sensitivity in a 150-patient validation trial, correctly detecting 80% of Stage I lung cancers[39] - The test demonstrated 92% sensitivity and 87% specificity for patients with lung nodules 20 millimeters or smaller, with a 99% negative predictive value[39] - The company plans to develop and commercialize its first diagnostic test, CyPath Lung, and aims to secure necessary regulatory approvals[164] - The company is in the preliminary phases of developing diagnostic tests and therapeutic products, which are critical for achieving profitability[156] - The company is conducting research to develop precision diagnostics for asthma and COPD, with patient studies expected to begin in 2026[84] - A pivotal clinical trial for the FDA-cleared FlowPath Lung test is expected to enroll approximately 3,400 patients over 18 months, with the first site opening in Q2 2025[70] Regulatory and Compliance - Medicare reimbursement code 0406U for CyPath Lung became effective on January 1, 2024, following regulatory approvals in 2023[61] - The FDA's final rule on Laboratory Developed Tests (LDTs) will require compliance with premarket review and quality system requirements for LDTs marketed after May 6, 2024[100] - The company has completed its certification as an LDT in accordance with CAP and CLIA regulations in 2023[100] - The FDA may order the temporary or permanent discontinuation of a clinical trial if it believes the trial is not compliant with regulations or poses unacceptable risks[120] - The company must maintain compliance with current good manufacturing practices (cGMP) post-approval to avoid product recalls or regulatory issues[142] - The company may face fines or withdrawal of regulatory approvals if it fails to comply with foreign regulatory requirements[146] Market Potential and Competitive Landscape - The global lung cancer diagnostic market is projected to grow from $15.1 billion in 2023 to $34.8 billion by 2034, with a CAGR of 7.9%[63] - The diagnostics market for COPD was valued at $5.6 billion in 2023 and is projected to reach $8.2 billion by 2029, indicating significant growth potential for the company's future products[84] - The company faces significant competition from larger diagnostic and pharmaceutical companies, which may have greater financial resources and established market presence[196] - The ability to achieve market acceptance for diagnostic tests and therapeutic products is contingent upon factors such as efficacy, safety, pricing, and physician willingness to adopt new tests[191] - The market for diagnostic tests and products is rapidly changing, with technological advancements potentially rendering the company's offerings noncompetitive[218] Financial Risks and Challenges - The company has limited operating history and faces significant risks in establishing its business and expanding its commercialization efforts[162] - The company’s future profitability is uncertain, and failure to generate sufficient revenue could lead to a decline in stockholder value[162] - The company may struggle to obtain adequate reimbursement from third-party payors, which could limit market acceptance and revenue generation[212] - The company relies on third parties for manufacturing and clinical trial management, which may reduce control over timelines and quality[204] - The evolving landscape of privacy regulations poses risks to the company's operations and could result in reputational harm if compliance is not maintained[210] Innovation and Intellectual Property - CyPath Lung is the first cancer diagnostic combining flow cytometry and automated analysis for lung cancer detection from sputum samples[62] - The company achieved a reduction of CD320 and LRP2 protein levels of up to 90% using siRNAs, which inhibited cell growth or killed cancer cells by up to 80%[87] - As of December 31, 2024, the company and its OncoSelect® subsidiary hold a patent estate that includes 17 issued U.S. and foreign counterpart patents, with expiration dates ranging from 2030 to 2039[92] - The diagnostic patent portfolio includes one issued U.S. patent and nine foreign counterpart patents, with applications directed at diagnosing lung health and proprietary compensation beads for flow cytometry[93] - The company plans to rely on regulatory protections such as orphan drug exclusivities and data exclusivities to maintain market position[98] Operational and Management Aspects - The company employs 57 employees, with 21 at bioAffinity and 36 at PPLS, emphasizing recruitment and retention of skilled professionals[147] - The Chief Science Officer has extensive experience in FDA approval processes, having previously worked at Genzyme Corporation and Ilex Products[148] - The loss of key executives could impede the company's ability to achieve its research and commercialization objectives[200] - The company has limited experience in sales and marketing of diagnostic tests, which may hinder its ability to commercialize products effectively[189] Economic and Environmental Factors - Increased inflation rates may result in higher operating costs, impacting demand and pricing for the company's drug candidates[229] - The global macroeconomic environment is affected by geopolitical instability, which could lead to uncertainty in local economies and financial markets[231] - Changes in U.S. trade policies, including tariffs, could adversely impact the company's business and financial condition[227]

Revenue Growth - Record revenue of $9.4 million in 2024, a 270% increase from $2.5 million in 2023[3] - Net revenue for 2024 reached $9,362,022, a significant increase from $2,532,499 in 2023, representing a growth of approximately 269%[21] - Anticipated total revenue for 2025 is projected to be between $6 million to $8 million, including $1 to $2 million from CyPath lung tests[4] Product Adoption - CyPath® Lung orders increased by approximately 1,400% compared to full-year 2023, indicating strong physician adoption[3] - The number of signed physician offices grew by over 300% in 2024, positioning the company for continued growth in 2025[3] Operating Expenses - Operating expenses for 2024 totaled $18.3 million, up from $10.5 million in 2023, reflecting expanded operations and increased marketing efforts[11] - Total operating expenses for 2024 were $18,315,467, up from $10,505,727 in 2023, indicating a rise of about 74%[21] - Selling, general and administrative expenses rose to $9,943,473 in 2024 from $6,790,654 in 2023, marking an increase of approximately 46%[21] Net Loss - Net loss for 2024 was $9.0 million, or $0.75 per share, compared to a net loss of $7.9 million, or $0.91 per share, in 2023[13] - Loss from operations increased to $(8,953,445) in 2024 compared to $(7,973,228) in 2023, reflecting a deterioration of approximately 12%[21] - Net loss for 2024 was $(9,039,831), compared to $(7,937,011) in 2023, which is an increase of about 14%[21] - Net loss per common share improved to $(0.75) in 2024 from $(0.91) in 2023, showing a reduction in loss per share by approximately 17%[21] Cash Position - Cash and cash equivalents decreased to $1.1 million as of December 31, 2024, down from $2.8 million in 2023[14] Research and Development - Research and development expenses remained relatively stable at $1,461,227 in 2024 compared to $1,467,936 in 2023, showing a slight decrease of about 0.5%[21] Clinical Trials and Patents - The FDA pivotal study protocol has been submitted for a clinical trial expected to enroll approximately 3,500 patients in 2025[8] - The company received a patent from the Japan Patent Office for its method using flow cytometry to predict lung disease[7] Economic Impact - The economic validation study indicated potential savings of $379 million for Medicare patients and $895 million for private insurance patients if CyPath® Lung is added to standard care[3] Interest Income and Expense - Interest income decreased to $17,610 in 2024 from $122,131 in 2023, a decline of about 86%[21] - Interest expense increased significantly to $(92,475) in 2024 from $(37,125) in 2023, representing an increase of approximately 149%[21] Shareholder Information - Weighted average common shares outstanding increased to 12,125,029 in 2024 from 8,747,509 in 2023, a rise of about 39%[21]

Group 1 - bioAffinity Technologies, Inc. has closed warrant exercise agreements with four accredited investors, resulting in the exercise of 2,438,473 shares of common stock for gross cash proceeds of approximately $1.4 million [1][2] - In exchange for the immediate exercise of existing warrants, the investors will receive new unregistered warrants to purchase up to 2,926,166 shares of common stock at an exercise price of $0.85 per share, which is 120% of the shares issued from the existing warrants [1] - The exercise price of the existing warrants has been reduced from $1.50 to $0.58 per share as part of this transaction [1] Group 2 - WallachBeth Capital is acting as the sole placement agent for the warrant inducement transaction [2] - The gross proceeds from the warrant inducement are expected to be approximately $1.4 million, excluding any proceeds from the exercise of the new warrants and before deducting placement agent fees and other offering expenses [2]

Group 1 - WallachBeth Capital LLC announced that bioAffinity Technologies, Inc. has entered into warrant exercise agreements with three accredited investors to exercise existing warrants for a total of 2,438,473 shares of common stock, generating approximately $1.4 million in gross cash proceeds [1][2] - In exchange for the immediate exercise of the existing warrants, the investors will receive new unregistered warrants to purchase up to 2,926,168 shares of common stock at an exercise price of $0.85 per share, which is 120% of the shares issued from the existing warrants [1] - The exercise price of the existing warrants has been reduced from $1.50 to $0.58 per share as part of this agreement [1] Group 2 - The closing of the offering is expected to occur on or about February 26, 2025, pending customary closing conditions [2] - WallachBeth Capital is acting as the sole placement agent for this warrant inducement transaction [2]

Core Viewpoint - Zacks Investment Research has initiated coverage of bioAffinity Technologies, Inc. (BIAF) with a "Neutral" recommendation, reflecting a mixed outlook for the company despite its advancements in lung cancer diagnostics [1] Company Overview - bioAffinity Technologies, Inc. is based in San Antonio, TX, and focuses on developing non-invasive diagnostics for early-stage lung cancer and other lung diseases, while also researching potential therapeutic treatments for various cancers [2] Financial Performance - bioAffinity's commercial diagnostic test, CyPath Lung, experienced a 1,300% increase in orders in the first nine months of 2024, leading to third-quarter revenues of $2.4 million, up from $0.3 million in the same period last year [3] - The company has expanded its sales into 11 states and secured inclusion in the Federal Supply Schedule, alongside completing a Texas pilot program, indicating potential for broader adoption in government healthcare systems [3] Growth Drivers - The acceptance of an Australian patent enhances bioAffinity's intellectual property portfolio, providing a competitive edge in non-invasive lung cancer diagnostics [4] - CyPath Lung has shown high sensitivity, specificity, and accuracy in identifying early-stage lung cancer in high-risk patients with nodules smaller than 20 mm, positioning it as a superior diagnostic alternative [4] - A peer-reviewed economic study suggests that CyPath Lung could generate significant savings for healthcare systems [4] Market Positioning - bioAffinity's stock has underperformed compared to industry peers and the broader market over the past year, reflecting investor caution regarding liquidity risks and reliance on CyPath Lung [6] - The company's market capitalization is modest at $12.1 million, indicating a potentially promising but risky investment opportunity [7]

Financial Performance - Net revenue for the three months ended September 30, 2024, was $2,350,386, a significant increase from $298,484 in the same period of 2023, representing a growth of approximately 687%[5] - Total operating expenses for the three months ended September 30, 2024, were $4,324,250, compared to $2,592,988 in the same period of 2023, reflecting an increase of about 67%[5] - The net loss for the three months ended September 30, 2024, was $2,000,840, a decrease from a net loss of $2,290,884 in the same period of 2023, indicating an improvement of approximately 13%[5] - The company reported a net loss of approximately $6.07 million for the nine months ended September 30, 2024, compared to a net loss of $5.56 million for the same period in 2023, indicating an increase in losses of about 9.2%[25] - Total net revenue for the nine months ended September 30, 2024, was $7,154,429, a significant increase from $319,143 in the prior year[49] Assets and Liabilities - Total assets decreased from $8,221,552 to $6,552,014, a reduction of approximately 20.3%[12] - Current liabilities increased from $2,247,829 to $2,491,164, an increase of about 10.8%[13] - Stockholders' equity decreased from $4,855,255 to $3,121,025, a decline of approximately 35.7%[15] - Non-current liabilities increased from $3,366,297 to $3,430,989, an increase of about 1.9%[14] - Cash and cash equivalents at the end of the reporting period were approximately $0.76 million, down from $2.82 million at the beginning of the period[23] Expenses - Research and development expenses for the three months ended September 30, 2024, were $274,497, down from $330,376 in the same period of 2023, showing a reduction of about 17%[5] - Selling, general, and administrative expenses increased to $2,364,592 for the three months ended September 30, 2024, from $2,023,917 in the same period of 2023, marking an increase of approximately 17%[5] - The company incurred approximately $811,000 in acquisition costs related to the Village Oaks acquisition[38] - The company incurred advertising expenses of $232,396 for the nine months ended September 30, 2024, compared to $42,947 for the same period in 2023[42] Shareholder Information - The weighted average common shares outstanding increased to 12,391,867 for the three months ended September 30, 2024, compared to 8,696,554 in the same period of 2023, representing an increase of about 42%[5] - The company has authorized a total of 100,000,000 shares of Common Stock, increasing from 25,000,000 shares following stockholder approval on June 4, 2024[82] - The company issued 1,960,000 common shares during the three months ended September 30, 2024, raising $2,950,000 in additional paid-in capital[17] Acquisitions and Investments - The company completed the acquisition of Village Oaks Pathology Services for a total consideration of $3.5 million, which included $2.5 million in cash and 564,972 shares of common stock valued at $1 million[35] - The acquisition resulted in the recognition of goodwill amounting to $1.4 million, which is not deductible for tax purposes[37] - The company formed a new subsidiary, Precision Pathology Laboratory Services, LLC, to enhance its diagnostic capabilities by acquiring assets from Village Oaks Pathology Services[28] Market and Product Development - The company is focused on developing noninvasive diagnostic tests for early-stage cancer, with its first product, CyPathLung, aimed at lung cancer detection[27] - The company announced that its CyPathLung test will be added to the U.S. Federal Supply Schedule, potentially providing access to 9.1 million Veterans annually[94] - The company received a Japanese patent for the CyPath Lung diagnostic test, adding to its portfolio of 17 awarded patents and 30 pending applications related to its diagnostic platform[97] Financial Risks and Future Outlook - The company faces various risks including funding for operations and regulatory approvals for diagnostic tests[6] - Future operations depend on successful clinical trials and market acceptance of diagnostic tests[6] - The company may need to raise further capital through various means if revenue from operations does not significantly increase[31] - The company has significant cash balances exceeding the federally insured limit of $250,000, which poses a risk to its financial condition[41] Cash Flow and Financing Activities - The company reported a net cash used in operating activities of approximately $5.59 million for the nine months ended September 30, 2024, compared to $4.42 million for the same period in 2023, representing an increase of about 26.5%[25] - The company’s cash flows from financing activities provided a net cash inflow of approximately $3.6 million, primarily from the issuance of common stock and exercised stock options[22] - The company raised $2.3 million in cash through a registered direct offering and concurrent private placement on October 21, 2024, to support its operations[31]

Financial Performance - Generated quarterly revenue of $2.4 million in Q3 2024, a significant increase from $298,000 in the prior-year period [6] - Net loss for Q3 2024 was $2.0 million, improving from a net loss of $2.3 million in Q3 2023 [10] - Net revenue for September 2024 reached $2,350,386, a significant increase from $298,484 in September 2023, representing a growth of approximately 687% [15] - The net loss for September 2024 was $2,000,840, compared to a net loss of $2,290,884 in September 2023, showing an improvement of approximately 13% [15] - The company reported a net loss per common share of $(0.16) for September 2024, an improvement from $(0.26) in September 2023 [15] Growth Metrics - Achieved over 1,300% growth rate for CyPath Lung orders in the first nine months of 2024 compared to the full-year 2023 [2] - Number of physician offices signed increased by 75% over Q2 2024, indicating strong potential for future sales growth [2] - CyPath Lung was added to the U.S. Federal Supply Schedule, providing access to 1,380 government healthcare facilities for high-risk veterans [2] Expenses - Research and development expenses were $274,000 in Q3 2024, a decrease from $330,000 in the same period of 2023 [7] - Selling, general and administrative expenses rose to $2.4 million in Q3 2024, compared to $2.0 million in Q3 2023 [9] - Total operating expenses for the quarter were $4,324,250, up from $2,592,988 in the same quarter last year, indicating an increase of about 67% [15] - Research and development expenses decreased to $274,497 from $330,376 year-over-year, reflecting a reduction of about 17% [15] - Selling, general and administrative expenses rose to $2,364,592, up from $2,023,917, marking an increase of approximately 17% [15] - Clinical development expenses decreased to $93,705 from $106,422, reflecting a reduction of about 12% [15] Cash and Assets - Cash and cash equivalents decreased to $0.8 million as of September 30, 2024, down from $2.8 million at the end of 2023 [11] - Total assets decreased to $6.55 million as of September 30, 2024, from $8.22 million at the end of 2023 [14] Financing Activities - Successfully closed a $2.7 million registered direct offering and concurrent private placement to fund growth initiatives [3] Other Income - Interest income decreased to $2,228 from $27,193 year-over-year, a decline of approximately 92% [15] - Total other income (expense) was $(24,417) compared to $5,914 in the previous year, indicating a negative shift of approximately 514% [15] Shareholder Metrics - The weighted average common shares outstanding increased to 12,391,867 from 8,696,554, representing a growth of about 42% [15]

Core Viewpoint - bioAffinity Technologies, Inc. has successfully closed a registered direct offering and concurrent private placement, raising gross proceeds of $2,662,782 through the sale of common stock and warrants [1][2]. Group 1: Offering Details - The offering included 2,048,294 shares of common stock priced at $1.30 per share and warrants to purchase up to 2,662,782 shares at an exercise price of $1.50 per share [1]. - The warrants will be exercisable upon stockholder approval and will expire five years from the date of such approval [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for general corporate purposes, including working capital [2]. Group 3: Regulatory Compliance - The shares were issued under an effective shelf registration statement filed with the SEC, and a prospectus supplement will be available on the SEC's website [3]. - The private placement of the warrants is made under an exemption from registration, meaning they cannot be offered or sold in the U.S. without an effective registration statement or applicable exemption [3]. Group 4: Company Background - WallachBeth Capital LLC acted as the sole placement agent for the offering, providing a range of capital markets and investment banking services to the healthcare sector [5].

Core Viewpoint - bioAffinity Technologies, Inc. has entered into a securities purchase agreement for a registered direct offering and a concurrent private placement to raise capital for its noninvasive cancer detection tests [1][2]. Group 1: Offering Details - The company will sell 2,048,294 shares of common stock at a price of $1.30 per share [1]. - In addition, the company will issue common warrants to purchase up to 2,662,782 shares at an exercise price of $1.50 per share [1]. - The gross proceeds from the offering are expected to be approximately $2,662,782, excluding any proceeds from the exercise of the warrants [2]. Group 2: Closing and Regulatory Information - The closing of the offering is anticipated to occur on or about October 21, 2024, subject to customary closing conditions [2]. - The shares will be issued under an effective shelf registration statement previously filed with the SEC [3]. - The private placement of the warrants will rely on an exemption from registration under Section 4(a)(2) of the Securities Act [4]. Group 3: Company Background - WallachBeth Capital LLC is acting as the sole placement agent for the offering, providing capital markets and investment banking services to the healthcare sector [5].

As filed with the Securities and Exchange Commission on September 11, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 bioAffinity Technologies, Inc. (Exact name of registrant as specified in its charter) | 8731 | Delaware | 46-5211056 | | --- | --- | --- | | (Primary Standard Industrial | (State or other jurisdiction of | (I.R.S. Employer | | Classification Code Number) | incorporation or org ...