On August 14, 2023 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer and other diseases of the lung, reported financial results for the three and six months ended June 30, 2023, and provided a business update (Press release, BioAffinity Technologies, AUG 14, 2023, View Source [SID1234634406]).

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Highlights from the second quarter of 2023 and subsequent weeks included:

Corporate and Commercial Highlights

The American Medical Association (AMA) issued a Current Procedural Terminology (CPT) code for use with CyPath Lung with an effective date of Oct. 1, 2023. CPT codes provide a uniform system to identify medical services and procedures and seek reimbursement from private payers and public health insurance programs, including Medicare and Medicaid.
The Department of Defense (DOD) purchased CyPath Lung tests for use in an observational study on active military personnel at high risk for developing lung cancer (NCT05870592) and for research on the use of bronchoalveolar lavage fluid to assess cardiopulmonary function and exercise performance in military personnel post COVID-19 infection.
Michael Dougherty joined the management team as Chief Financial Officer. Previously, he served as CFO of Amazon’s Alexa commercial domains with responsibility for financial strategy over Alexa’s multibillion-dollar investments in AI-generated customer experiences.
The Company launched a pilot marketing and sales program in select cities in Texas to provide insights and strategies for the successful product rollout for CyPath Lung.
Research and Development Highlights

Presented advancements in CyPath Lung at the Cleveland Clinic’s invitation-only fourth annual "Advances in Early Lung Cancer Detection" symposium, which focuses on accelerating the development and implementation of new technologies and methods for the early detection of lung cancer.
Presented a poster titled "Development of porphyrin-stained polystyrene compensation beads for use on an automated analysis platform" at CYTO 2023, the annual Congress for the International Society for the Advancement of Cytometry, that demonstrated the suitability of the Company’s proprietary compensation beads for commercial use with flow cytometry, including with CyPath Lung.
Presented a poster titled "Vitamin B12 deprivation does not phenocopy selective cytotoxicity of CD320 and LRP2 silencing" at the University of Massachusetts T.H. Chan Medical School’s fifth annual RNA Therapeutics Symposium demonstrating that deprivation of vitamin B12 does not play a role in the selective cytotoxicity of cancer cells observed after silencing the expression of CD320 and LRP2; this research follows the Company’s discovery that using small interfering RNA (siRNA) to knock down CD320 and LRP2 killed cancer cells in vitro without harming healthy cells.
Management Commentary

"Our sales team is implementing a test market pilot program of CyPath Lung across various target markets in Texas, and we are encouraged with their progress. The pilot program is a tactical program to test various marketing and selling approaches to accelerate the development of a successful regional and then national roll out of the CyPath Lung test. Issuance of a CPT code by the AMA specifically for CyPath Lung is another important milestone that we believe signals the value our diagnostic adds to the clinical care of patients at high risk for developing lung cancer," bioAffinity President and Chief Executive Officer Maria Zannes said.

"We are building brand awareness and finetuning our market positioning at the same time we are showcasing our innovation at prestigious medical and scientific conferences. The result is increased recognition and adoption of CyPath Lung, including interest by the DOD. We expect revenues from CyPath Lung to grow as we expand our geographic reach, add prescribing physicians and focus on larger medical systems," Ms. Zannes added.

Second Quarter Financial Results

Revenue for the second quarter of 2023 was $20,000, compared with $1,000 for the prior-year period. Revenue is generated from royalties from the Company’s licensee, Precision Pathology Services, from sales of CyPath Lung as a laboratory developed test, from clinical flow cytometry services provided to Precision Pathology Services related to CyPath Lung and from CyPath Lung tests purchased by the DOD. Sales to the DOD were $10,000 for the second quarter of 2023.

Research and development expenses were $335,000 for the second quarter of 2023, compared with $248,000 for the comparable period in 2022. The increase was primarily due to higher compensation costs from adding research personnel and higher costs for lab supplies and reagents.

Clinical development expenses were $35,000 for the second quarter of 2023, compared with $28,000 for the second quarter of 2022. The increase was primarily due to higher professional fees related to clinical strategy evaluation as the Company prepares to launch the CyPath Lung pivotal trial.

Selling, general and administrative expenses were $1.4 million for the second quarter of 2023, compared with $409,000 for the comparable period in 2022. The increase was primarily attributed to higher consulting, legal and professional fees related to being a publicly traded company, higher board compensation, and sales and marketing costs for commercialization of CyPath Lung.

Net loss for the second quarter of 2023 was $1.7 million, or $0.20 per share, compared with a net loss of $88,000, or $0.03 per share, for the comparable period in 2022.

Cash and cash equivalents were $8.3 million as of June 30, 2023, compared with $11.4 million as of December 31, 2022. bioAffinity Technologies believes that its available cash will be sufficient to fund planned operations for at least the next 12 months.