(Note: This tiny biotech IPO is a unit offering. IPOScoop has NO CALL on unit offerings that are not SPACs.)

(Note: From the S-1/A (prospectus) dated July 28, 2022: “In connection with this Offering, our Board of Directors and stockholders approved a 1-for-7 reverse stock split of our Common Stock, which became effective with the State of Delaware on June 23, 2022. All share and per-share information in this prospectus reflects the 1-for-7 reverse stock split.”)

bioAffinity Technologies, Inc. is a privately held company incorporated in Delaware addressing the need for noninvasive diagnosis of early-stage cancer and diseases of the lung, and targeted cancer treatment. Our Company develops proprietary noninvasive diagnostic tests and cancer therapeutics using technology that preferentially targets cancer cells and cell populations indicative of a diseased state. Research and optimization of our platform technologies are conducted in our laboratories at The University of Texas at San Antonio. We are developing our platform technologies so that, in the future, they will be able to detect and monitor diseases of the lung and other cancers and treat many cancers. 

More than 100 different types of cancers have been identified, all marked by the abnormal and unrestricted proliferation of cells that can eventually kill a patient stricken with the disease. Lung, breast, prostate, and colorectal cancers are the most common, representing more than half of all cancer diagnoses. Lung cancer alone, by far the deadliest, is responsible for an estimated 1.8 million deaths worldwide annually.

 A patient’s overall cancer survivability depends on the type of cancer and the stage at which cancer is treated. The early diagnosis of cancer, before it spreads, is a significant contributor to survival. This is true for lung cancer that is most often detected in later stage when the cancer has spread to other parts of the body. However, if lung cancer is detected and treated early (Stage I), the current overall five-year survival rate of 20.5%² for Stages II-IV can leap to a 10-year survival rate of 92%.³

Current diagnostic protocols include lab tests, various imaging techniques, and biopsy followed by microscopic examination of tissue samples. None of these methods perfectly detects cancer cells, especially in the early stages of the disease. Low-dose computed tomography (LDCT) is recommended for screening patients at high risk for lung cancer. Results of a large clinical trial of more than 53,000 patients showed that screening for lung cancer by LDCT lowered the mortality rate by 20% as compared to x-ray imaging.^4,5 However, the study found that of every 100 people screened for lung cancer who received a positive LDCT result, fewer than four of those individuals truly had the disease. Consequently, there is a great and urgent need for better targeted diagnostic methods that are safe, accurate, rapid, noninvasive, and cost effective for the detection of early-stage lung cancer.

Our first diagnostic test, CyPath^® Lung, addresses the need for early detection of lung cancer, the leading cause of cancer-related deaths. In order to identify patients more confidently who need to undergo more invasive follow-up procedures, physicians will be able to order CyPath^® Lung to assist in the assessment of the potential for the disease. CyPath^® Lung thus serves as another tool in the physician’s decision-making process to distinguish between patients who are likely to have lung cancer and will benefit from timely intervention and those who are likely without disease and should continue their annual screening for lung cancer.

**Note: To date, we have devoted a substantial portion of our efforts and financial resources to the development of the CyPath^® Lung test. As a result, since our inception in 2014, we have generated no revenue from sales of the CyPath^® Lung test and have funded our operations principally through private sales of our equity or debt securities. 

(Note: bioAffinity Technologies, Inc. priced its unit IPO on Aug. 31, 2022, at $6.125 ($6.13) per unit – the mid-point of its $6.00-to-$6.25 price range – and sold 1.28 million units – or 1,282,600 units – slightly less than the 1,285,325 units in the prospectus – to raise $7.86 million. bioAffinity’s stock and tradeable warrants started trading Thursday, Sept. 1, on the NASDAQ. For more details on this IPO’s path to going public, please see the Background note below.)

(Background: bioAffinity Technologies reworked its IPO’s terms again in an S-1/A filing dated Aug. 5, 2022: The number of units was increased to 1.29 million units (1,285,325 units) – up from 1.18 million units – and the assumed IPO price was raised to $6.125 per unit from $6.00. Under the new terms, the IPO’s estimated proceeds are $7.87 million, up from $7.02 million previously. Each unit consists of one share of common stock – proposed symbol “BIAF” – and one tradeable warrant to buy one share of common stock – proposed symbol “BIAFW” – both to be listed on the NASDAQ – and one non-tradeable warrant to buy one share of common stock. Previous SEC filings showed other changes in the number of units and the price range.)