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bioAffinity Technologies, Inc. (NASDAQ: BIAF) is a pioneering biotechnology company dedicated to addressing the critical need for the early detection and targeted treatment of cancer and lung diseases. The company develops proprietary, noninvasive diagnostic tests and cancer therapeutics that focus on the cellular level, which has the potential to significantly improve patient outcomes.
One of the company’s leading innovations is the CyPath® Lung test, a noninvasive diagnostic tool designed to detect early-stage lung cancer. This test employs flow cytometry technology to analyze sputum samples, which can dramatically increase diagnostic accuracy, reduce the need for invasive procedures, and lower medical costs while enhancing patient comfort and survival rates. CyPath® Lung has been licensed by Precision Pathology Services for further development and commercial sale as a laboratory-developed test.
Recent company milestones include a securities purchase agreement with institutional investors, announced on March 6, 2024, by WallachBeth Capital LLC. This agreement involves a registered direct offering and a concurrent private placement, expected to raise approximately $2.5 million. The proceeds will support the company's ongoing research, development activities, and potential commercialization efforts.
Financially, bioAffinity Technologies is actively engaging with institutional investors to secure funding necessary for its ambitious projects. The company’s efforts are supported by an effective shelf registration statement filed with the U.S. Securities and Exchange Commission (SEC) and the strategic guidance of WallachBeth Capital, which provides comprehensive capital market and investment banking services tailored to the healthcare sector.
Through its innovative approach and strong industry partnerships, bioAffinity Technologies aims to revolutionize cancer diagnosis and treatment, ultimately improving survival rates and quality of life for patients worldwide.
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.
A peer-reviewed economic study published in the Journal of Health Economics and Outcomes Research has found that incorporating bioAffinity Technologies' CyPath® Lung test into the standard care for Medicare patients with positive lung cancer screenings could lead to significant healthcare savings. The study, conducted by researchers from Brooke Army Medical Center and South Texas Veterans Health Care Systems, estimates potential savings of $2,773 per patient, totaling $379 million in 2022.
The savings are attributed to reduced follow-up diagnostic assessments, expensive procedures, and related complications. For private-payer patients, the potential savings are even higher at $6,460 per patient, with a total estimated savings of $895 million if all screened individuals in 2022 were privately insured. The study highlights CyPath® Lung's potential to improve early lung cancer diagnosis while reducing unnecessary procedures and medical complications.
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.
bioAffinity Technologies (Nasdaq: BIAF, BIAFW) has announced the closing of a registered direct offering and concurrent private placement, along with a warrant inducement, for total gross proceeds of $1.75 million. The company raised approximately $1,302,083 through the exercise of existing warrants by three accredited investors at a reduced price of $1.25 per share. These investors received new unregistered warrants to purchase additional shares. Additionally, bioAffinity closed a securities purchase agreement with an institutional investor, raising about $450,000 through the sale of common stock and warrants. WallachBeth Capital acted as the sole placement agent and financial advisor for these transactions.
WallachBeth Capital announced that bioAffinity Technologies (NASDAQ: BIAF) has entered into warrant exercise agreements and a securities purchase agreement for aggregate gross proceeds of $1.75 million. The transactions include:
1. Exercise of existing warrants by three accredited investors for 1,041,667 shares at $1.25 per share, generating $1,302,083.
2. Issuance of new warrants to purchase 1,302,083 shares at $1.50 per share.
3. A registered direct offering of 360,000 shares and private placement of warrants to purchase 450,000 shares at a combined price of $1.25, generating $450,000.
The transactions are expected to close on August 5, 2024. WallachBeth Capital is acting as the sole placement agent and financial advisor for these transactions.
bioAffinity Technologies (NASDAQ: BIAF) has announced a registered direct offering and concurrent private placement for aggregate gross proceeds of $1.75 million. The company entered into warrant exercise agreements with three existing accredited investors to exercise warrants for 1,041,667 shares at a reduced price of $1.25 per share, raising approximately $1,302,083. In return, investors received new warrants for 1,302,083 shares at $1.50 per share. Additionally, bioAffinity agreed to sell 360,000 shares and warrants for 450,000 shares to an institutional investor at $1.25 per share, expecting to raise about $450,000. The transactions are set to close around August 5, 2024, subject to conditions.
Biotricity (Nasdaq: BTCY) and bioAffinity Technologies (Nasdaq: BIAF) will be featured on the RedChip Small Stocks, Big Money™ show on Bloomberg TV this Saturday, July 13, at 7 p.m. ET. Biotricity's CEO, Dr. Waqaas Al-Siddiq, will discuss their portfolio of cardiac monitoring solutions, including FDA-cleared Bioflux® and Biocore. With 8% market share in cardiology, Biotricity aims for profitability and expects to be EBITDA positive by end of 2024. bioAffinity Technologies' CEO, Maria Zannes, will provide updates on their early-stage cancer diagnostic product, CyPath® Lung. The noninvasive test has shown high sensitivity, specificity, and accuracy, and is part of a pilot program in Texas. The lung cancer screening market is projected to reach $5.7 billion by 2030, and bioAffinity holds substantial patents and insider ownership of 39%, indicating strong growth potential.
bioAffinity Technologies (Nasdaq: BIAF) reported a remarkable 217% increase in second-quarter 2024 sales for CyPath® Lung over the first quarter. The company raised its full-year forecast for CyPath® Lung sales by 85%, significantly surpassing the previous forecast by 75%. CyPath® Lung is positioned as a important noninvasive test for early lung cancer detection, especially beneficial for patients with pulmonary nodules. The lung cancer diagnostics market is expected to reach $4.7 billion by 2030. bioAffinity strategically launched CyPath® Lung in Texas, leveraging Medicare reimbursement and CPT code authorization. The company projects 2024 revenue between $9.2 and $9.6 million from its subsidiary, Precision Pathology Laboratory Services (PPLS), which bills $1,900 per test. Sales are expanding nationally with physicians from eight other states ordering the test. A broader market launch is planned for Q4 2024.
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