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bioAffinity Technologies, Inc. develops and commercializes noninvasive diagnostics for lung cancer and other lung diseases. The company’s first product, CyPath® Lung, is a sputum-based Laboratory Developed Test marketed by Precision Pathology Laboratory Services, a bioAffinity subsidiary, and uses flow cytometry with automated AI-informed analysis to identify cell populations associated with lung malignancy.
Recurring company news centers on CyPath® Lung commercialization, physician adoption, clinical case studies, pulmonary nodule management, lung cancer risk assessment, and post-treatment surveillance. Updates also cover financial results, laboratory-services focus, medical conference and physician-education activity, and research extending the company’s flow cytometry+AI platform toward asthma and COPD diagnostics.
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.
BioVie (Nasdaq:BIVI) and bioAffinity Technologies (Nasdaq:BIAF) will appear on the RedChip Small Stocks, Big Money show on Bloomberg TV on July 6 at 7 p.m. ET. Cuong Do, President and CEO of BioVie, will discuss their late-stage clinical programs for neurodegeneration and liver disease. BioVie's lead asset, bezisterim, has shown promise in treating Parkinson's and Alzheimer's diseases by reducing inflammation, improving motor control, cognition, and brain imaging. BioVie plans to launch a Phase 2b trial for Parkinson's in Fall 2024 and a Phase 3 trial for Alzheimer's in mid-2025.
Maria Zannes, President and CEO of bioAffinity Technologies, will provide a corporate update, highlighting CyPath Lung's success in early-stage lung cancer detection. The test has demonstrated high sensitivity and specificity, with commercialization already underway. The lung cancer screening market is projected to hit $5.7 billion by 2030. bioAffinity's AI-enhanced flow cytometry platform is also being developed for COPD and asthma diagnosis. The company holds extensive patents and is backed by strong insider ownership (39%).
BioAffinity Technologies (Nasdaq: BIAF; BIAFW) has reported a significant 139% growth in the number of pulmonology practices offering its noninvasive CyPath® Lung test for early-stage lung cancer detection since January 1, 2024. Sales outpaced Q1 2024 targets, leading to expansion beyond Texas to eight additional states. The company increased its 2023 sales forecast by 35% in May. This growth is attributed to positive physician-to-physician word of mouth and effective marketing strategies. CyPath® Lung's high sensitivity, specificity, and accuracy have been well-received by the medical community. The lung cancer diagnostics market is projected to reach $4.7 billion by 2030.
BioAffinity Technologies (Nasdaq: BIAF; BIAFW) reports record Q1 2024 revenue of $2.4 million, driven by CyPath® Lung sales and increased lab volumes. CyPath® Lung orders surged by 547% annualized in the first four months of 2024 over 2023, leading to a 35% increase in the 2024 sales forecast. The number of physician offices ordering the test doubled since January 2024, expanding beyond Texas to states like Pennsylvania and New Jersey. Medicare reimbursement for CyPath® Lung began on January 1, 2024. Precision Pathology Laboratory Services forecasts $9.2-$9.6 million in 2024 revenues, up 23% from 2023. The company reported an increase in R&D and SG&A expenses, resulting in a net loss of $2.1 million for Q1 2024, compared to a net loss of $1.5 million in Q1 2023. BioAffinity closed a $2.5 million funding round to support growth and continued product development in collaboration with the DoD.
bioAffinity Technologies, Inc. (Nasdaq: BIAF) reports an increase in sales of CyPath® Lung, their noninvasive diagnostic test for lung cancer detection. April sales were up 21% from March, with new orders from physicians in various states. The company also welcomed new team members to support the CyPath® Lung product launch. Additionally, bioAffinity will present research at the American Thoracic Society's Annual Conference.
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