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bioAffinity Technologies, Inc. addresses a critical need to find cancer early and treat cancer specifically. The company develops tests and therapies to detect and treat cancer at the cellular level. Their first product, CyPath® Flow Cytometry for Lung Cancer (CyPath® Lung), has the potential to dramatically increase overall diagnostic accuracy, leading to increased survival, fewer unnecessary invasive procedures, and lower patient anxiety and medical costs.
bioAffinity Technologies Inc. focuses on addressing the need for noninvasive diagnosis of early-stage cancer and diseases of the lung, as well as targeted cancer treatment. They develop proprietary noninvasive diagnostic tests and cancer therapeutics using technology that preferentially targets cancer cells and cell populations indicative of a diseased state. CyPath Lung is their noninvasive test for the detection of early-stage lung cancer.
bioAffinity Technologies (BIAF) reported Q3 2024 revenue of $2.4 million, with CyPath® Lung test orders showing over 1,300% growth in the first nine months of 2024 compared to full-year 2023. The company expanded its physician network by 75% compared to Q2 2024, now receiving orders from 11 states. CyPath® Lung was added to the U.S. Federal Supply Schedule, providing access to 1,380 government healthcare facilities. The company reported a net loss of $2.0 million ($0.16 per share), an improvement from the $2.3 million loss in Q3 2023. Cash position stood at $0.8 million, with an additional $2.7 million raised through an offering in October 2024.
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.
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