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About bioAffinity Technologies, Inc. (NASDAQ: BIAFW)
bioAffinity Technologies, Inc. is a biotechnology company at the forefront of developing innovative solutions to address the critical need for early-stage cancer detection and targeted therapies. The company specializes in creating proprietary noninvasive diagnostic tests and therapeutics that leverage advanced technology to target cancer cells and diseased cell populations with precision. By focusing on improving diagnostic accuracy, bioAffinity aims to enhance patient outcomes, reduce unnecessary medical procedures, and lower healthcare costs.
Core Business and Flagship Product
bioAffinity’s flagship product, CyPath® Lung, is a groundbreaking noninvasive diagnostic test designed for the early detection of lung cancer, one of the leading causes of cancer-related mortality worldwide. Utilizing flow cytometry technology, CyPath Lung identifies cellular changes indicative of cancer, offering a highly accurate and cost-effective alternative to traditional diagnostic methods. The product has been licensed to Precision Pathology Services for further development and commercialization as a laboratory-developed test, underscoring its potential to revolutionize lung cancer diagnostics.
Industry Context and Market Position
bioAffinity operates within the rapidly growing biotechnology sector, specifically targeting the oncology diagnostics and therapeutics market. With the increasing global emphasis on early cancer detection and personalized medicine, the demand for innovative solutions like CyPath Lung is on the rise. The company’s proprietary approach, which focuses on targeting cancer at the cellular level, positions it uniquely in a competitive landscape that includes traditional diagnostic methods and emerging technologies.
Business Model and Revenue Streams
The company generates revenue through strategic licensing agreements and partnerships, such as the licensing of CyPath Lung. This model allows bioAffinity to focus on research and development while leveraging the expertise of commercialization partners to bring its products to market. The approach not only accelerates product adoption but also minimizes operational risks associated with direct commercialization.
Challenges and Competitive Differentiation
While bioAffinity faces challenges typical of the biotechnology industry, including regulatory approvals and demonstrating clinical efficacy, its proprietary technology offers significant competitive advantages. By targeting cancer cells with precision, the company enhances diagnostic accuracy and reduces false positives, setting it apart from competitors. Additionally, its focus on noninvasive diagnostics aligns with the growing preference for patient-friendly medical solutions.
Commitment to Innovation and Patient Care
bioAffinity Technologies is dedicated to advancing healthcare through innovation. By addressing unmet needs in cancer diagnostics and therapeutics, the company not only improves patient outcomes but also contributes to the broader goal of making healthcare more efficient and accessible. Its work exemplifies the potential of biotechnology to transform how diseases are detected and treated, offering hope to millions of patients worldwide.
bioAffinity Technologies (Nasdaq: BIAF) has appointed Dr. William Bauta as Chief Science Officer, succeeding Dr. Vivienne Rebel who retired on Oct. 31, 2024. Dr. Bauta, previously Senior VP of Research and Development since 2016, brings experience from Genzyme and Ilex Products. He has contributed to multiple company inventions and patents, particularly in optimizing CyPath® Lung, their noninvasive early-stage lung cancer detection test. His work has improved test performance, reduced costs, and expanded the company's patent portfolio. Dr. Bauta earned his Ph.D. from the University of Chicago and completed post-doctoral studies at the University of Texas at Austin.
bioAffinity Technologies (Nasdaq: BIAF) has been granted a patent in Japan for its CyPath® Lung diagnostic test method, which predicts lung cancer likelihood. This marks the first patent specifically for CyPath® Lung as a standalone flow cytometry test for lung cancer detection. The patent, titled 'System and Method for Determining the State of Health of the Lungs,' adds to the company's portfolio of 17 awarded patents and 30 pending applications across various regions. The company focuses on developing noninvasive tests for early-stage lung cancer and other lung diseases detection.
WallachBeth Capital announced the closing of bioAffinity Technologies' (Nasdaq: BIAF) $2.6 million registered direct offering and concurrent private placement. The offering included 2,048,294 shares of common stock at $1.30 per share and warrants to purchase up to 2,662,782 shares at $1.50 per share. The warrants will be exercisable upon stockholder approval and expire five years from that date. bioAffinity Technologies plans to use the net proceeds for general corporate purposes and working capital. WallachBeth Capital acted as the sole placement agent for the offering, which was conducted under an effective shelf registration statement. The private placement of warrants was made under exemptions from registration requirements.
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW) has closed a $2.6 million registered direct offering and concurrent private placement. The company sold 2,048,294 shares of common stock at $1.30 per share and issued warrants to purchase up to 2,662,782 shares at an exercise price of $1.50 per share. The warrants will be exercisable upon stockholder approval and expire five years from that date. WallachBeth Capital acted as the sole placement agent. The company plans to use the net proceeds for general corporate purposes and working capital. The offering was made pursuant to an effective shelf registration statement, with a prospectus supplement to be filed with the SEC.
WallachBeth Capital announced that bioAffinity Technologies (Nasdaq: BIAF) has entered into a securities purchase agreement for a $2.66 million registered direct offering and concurrent private placement. The offering includes:
1. 2,048,294 shares of common stock at $1.30 per share in a registered direct offering
2. Common warrants to purchase up to 2,662,782 shares at $1.50 per share in a private placement
The warrants will be exercisable upon stockholder approval and expire five years from approval date. The offering is expected to close around Oct. 21, 2024. WallachBeth Capital is acting as the sole placement agent. The common stock will be issued under an effective shelf registration statement, while the warrants will be issued under a Section 4(a)(2) exemption.
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW) has announced a $2.66 million registered direct offering and concurrent private placement. The company will sell 2,048,294 shares of common stock at $1.30 per share in a registered direct offering. Additionally, in a private placement, it will issue common warrants to purchase up to 2,662,782 shares at an exercise price of $1.50 per share. The warrants will be exercisable upon shareholder approval and expire five years from that date. The offering is expected to close around October 21, 2024, subject to conditions. WallachBeth Capital is acting as the sole placement agent. The common stock will be issued under an effective shelf registration statement, while the warrants will be issued under a Section 4(a)(2) exemption.
bioAffinity Technologies (Nasdaq: BIAF; BIAFW) announced that its VP of Diagnostics, Jennifer Rebeles, Ph.D., contributed to a peer-reviewed paper on flow cytometry guidelines for rare matrix samples. The paper, published in Cytometry Part B: Clinical Cytometry, supports the validation approach used for bioAffinity's CyPath® Lung cancer test.
CyPath® Lung is a noninvasive test for early lung cancer detection, particularly useful for patients with pulmonary nodules. It has shown 92% sensitivity and 87% specificity in detecting lung cancer in nodules 20mm or less. The new guidelines address challenges in validating unique sample types like sputum, which CyPath® Lung uses.
The paper supplements the CLSI Guideline H62 and reflects the increasing use of specialized samples in flow cytometry. It acknowledges the challenges bioAffinity scientists overcame in developing CyPath® Lung, including dealing with high viscosity, inhibitors, and complex cellular mixtures.
bioAffinity Technologies has been awarded a U.S. Federal Supply Schedule contract for its CyPath® Lung test, a noninvasive diagnostic tool for early-stage lung cancer detection. This contract enables the Veterans Health Administration (VHA) and Military Health System to access the test for their patients. The VHA, serving 9.1 million Veterans annually, is the largest integrated healthcare system in the U.S.
Lung cancer is the leading cause of cancer-related death in Veterans, who are 25% more likely to receive a lung cancer diagnosis compared to non-Veterans. The CyPath® Lung test is particularly effective for patients with indeterminate pulmonary nodules detected during low dose computed tomography (LDCT) scans. A recent economic impact study suggests that incorporating CyPath® Lung into the current standard of care could result in significant healthcare cost savings.
bioAffinity Technologies (Nasdaq: BIAF; BIAFW) announced that CFO Michael Dougherty is resigning to accept a position in the Pacific Northwest energy industry. J. Michael Edwards, who served as bioAffinity's consulting CFO from 2014 to 2023 and oversaw the company's IPO in 2022, will return as interim CFO until a permanent replacement is found.
Dougherty will continue in his role until September 15, 2024, assisting with the transition. The company expects a smooth handover due to the strong team and financial processes Dougherty established. Edwards, with over 25 years of experience in corporate finance and accounting, will ensure continuity in the Finance Department.
bioAffinity Technologies, focused on developing noninvasive tests for early-stage cancer detection, will immediately begin searching for a permanent CFO.
bioAffinity Technologies (Nasdaq: BIAF) reported $2.4 million revenue for Q2 2024, driven by growing CyPath® Lung sales. Key highlights include:
- Q2 CyPath® Lung test sales up 217% over Q1 2024
- Expanded sales to 8 states outside Texas
- Raised full-year CyPath® Lung sales forecast by 85%
- Forecasting $9.6 million in 2024 revenues for subsidiary PPLS, up 23% over 2023
- Number of physician offices ordering CyPath® Lung up 144% since Jan. 1, 2024
- Closed a $1.75 million offering to fund growth
The company reported a net loss of $2.1 million for Q2 2024. Cash and equivalents were $0.8 million as of June 30, 2024.
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