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].

Financial Performance - Net revenue for Q2 2024 was $2,397,652, a significant increase from $19,738 in Q2 2023, representing a growth of approximately 12,100%[11] - Total operating expenses for Q2 2024 were $4,485,450, compared to $1,798,088 in Q2 2023, indicating an increase of about 149%[11] - The net loss for Q2 2024 was $2,110,279, compared to a net loss of $1,740,173 in Q2 2023, reflecting an increase in losses of approximately 21%[11] - For the six months ended June 30, 2024, the net loss was $4,072,094, compared to a net loss of $3,272,963 for the same period in 2023, indicating an increase in losses of approximately 24%[16] - The Company reported total net revenue of $4,804,043 for the six months ended June 30, 2024, compared to $20,659 for the same period in 2023[36] - Total net revenue for the three months ended June 30, 2024, was $2,397,652, compared to $19,738 for the same period in 2023, reflecting a significant increase due to the acquisition of Precision Pathology Laboratories Services, LLC[45] Expenses and Losses - Research and development expenses rose to $402,433 in Q2 2024 from $335,125 in Q2 2023, marking an increase of about 20%[11] - Selling, general, and administrative expenses increased to $2,472,775 in Q2 2024, up from $1,404,917 in Q2 2023, which is an increase of approximately 76%[11] - Stock-based compensation expense for the six months ended June 30, 2024, was $569,907, compared to $327,868 for the same period in 2023, showing an increase of approximately 73.8%[16] - The company recognized advertising expenses of $131,125 for the six months ended June 30, 2024, up from $27,741 for the same period in 2023[29] - The company incurred total lease costs of $148,394 for the three months ended June 30, 2024, compared to $30 for the same period in 2023, indicating a substantial increase[60] Cash Flow and Financial Position - Cash used in operating activities for the six months ended June 30, 2024, was $3,878,400, compared to $2,888,990 for the same period in 2023, representing an increase of about 34.4%[16] - As of June 30, 2024, the company had cash and cash equivalents of $801,311, a decrease from $8,279,182 at the end of the same period in 2023[16] - The total cash balance at June 30, 2024, was $9,875,202, down from $10,911,736 at December 31, 2023[12] - The Company has significant cash balances that regularly exceed the federally insured limit of $250,000, posing a risk to its financial condition[28] - The Company incurred an accumulated deficit of approximately $48.7 million as of June 30, 2024, with cash and cash equivalents of approximately $0.8 million[21] Shareholder Equity and Stock Activity - The company reported a weighted average of 11,389,308 common shares outstanding in Q2 2024, compared to 8,520,714 in Q2 2023, indicating a growth of about 34%[11] - The Company has authorized a total of 100,000,000 shares of Common Stock, increasing from 25,000,000 shares, with 11,752,178 shares issued as of June 30, 2024[66] - The company issued 1,600,000 shares of Common Stock and warrants to purchase an aggregate of 1,600,000 shares in a registered direct offering on March 8, 2024, with an exercise price of $1.64[72] - The company has 8,838,717 warrants outstanding with a weighted average exercise price of $3.53, compared to 4,649,952 warrants as of December 31, 2023, indicating an increase of approximately 90.5%[71] Acquisitions and Subsidiaries - The company acquired substantially all assets of Village Oaks 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[24] - The acquisition resulted in recognized goodwill of $1.404 million, with total net assets acquired amounting to $3.5 million[25] - The company formed a new subsidiary, Precision Pathology Laboratory Services, LLC, on August 14, 2023, to enhance its diagnostic capabilities[18] - The company’s first diagnostic test, CyPathLung, is aimed at the early detection of lung cancer, which is the leading cause of cancer-related deaths[17] Future Outlook and Risks - The cash burn rate and projected financial position are critical factors for future operations, as highlighted in the management's discussion[5] - Future revenue estimates and capital requirements are subject to various risks, including the success of clinical trials and market acceptance of products[5] - The ongoing geopolitical tensions and economic instability may impact the company's operations and financial projections[7] - The company expects to continue incurring losses and negative cash flows for the foreseeable future, raising substantial doubt about its ability to continue as a going concern[21] - The company plans to continue expanding its market presence and developing new products and technologies[9]

Core Points - bioAffinity Technologies, Inc. has entered into warrant exercise agreements with three accredited investors to exercise existing warrants for a total of 1,041,667 shares, generating approximately $1,302,083 in gross cash proceeds [1] - The exercise price of the existing warrants has been reduced from $1.64 to $1.25 per share, and new unregistered warrants have been issued for 1,302,083 shares at an exercise price of $1.50 per share [1] - A securities purchase agreement has been established for the purchase of 360,000 shares in a registered direct offering, along with private warrants for 450,000 shares at a combined purchase price of $1.25 [2] - The gross proceeds from the offering are expected to be around $450,000, excluding potential proceeds from the exercise of the private warrants [3] Company Actions - The closing of the offering is anticipated to occur on or about August 5, 2024, pending customary closing conditions [3] - WallachBeth Capital LLC is acting as the sole placement agent for the registered direct offering and private placement, as well as the financial advisor for the warrant inducement transaction [4] - The common stock will be issued under an effective shelf registration statement previously filed with the SEC, and the private warrants will be offered under an exemption from registration requirements [5]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 July 9, 2024 Date of Report (Date of earliest event reported) Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.007 per share BIAF The Nasdaq Stock Market LLC Tradeable Warrants to purchase Common Stock BIAFW The Nasdaq Stock Market LLC 22211 W Interstate 10 Suite 1206 San Antonio, Texas 78257 (210) 698-5334 (Address of principal executive offices and Registrant's telephone number ...

News Release More than 547% annualized growth rate for CyPath Lung orders in first four months of 2024 over full-year 2023, leading to 35% increase in original 2024 forecast Key Highlights "CyPath Lung is positioned to set a new standard in the early detection of lung cancer – a market projected to reach $4.7 billion by 2030," Zannes continued. "As we continue to scale our operations and enhance our offerings, our focus remains steadfast on improving patient outcomes and delivering shareholder value. With M ...

Segment Information The Company is organized in two operating segments, Diagnostic Research and Development (R&D) and Laboratory Services, whereby its chief operating decision maker ("CODM") assesses the performance of and allocates resources. The CODM is the Chief Executive Officer. Diagnostic R&D includes research and development and clinical development on diagnostic tests. Any revenues assigned to Diagnostic R&D are proceeds received from observational studies. Laboratory services include all the operat ...

CyPathLung has not been tested directly against its competitors' products, but a comparison of the published performance numbers suggests CyPath Lung is among the highest performing tests on the market. Furthermore, CyPath Lung is noninvasive – not even requiring a needle stick – and cost effective, and processing and analysis procedures are easy to perform. 11 Published data and the results of clinical trials allow us to group lung cancer diagnostic tests into three categories: (1) balanced tests;( 2) rule ...