bioAffinity Technologies Reports Second Quarter 2023 Financial Results and Provides Business Update
- The American Medical Association issued a CPT code for use with CyPath Lung
- The Department of Defense purchased CyPath Lung tests for observational study and research
- Michael Dougherty joined as Chief Financial Officer
- The Company launched a pilot marketing and sales program in select cities in Texas for CyPath Lung
- Net loss for Q2 2023 was $1.7 million
- Cash and cash equivalents decreased to $8.3 million as of June 30, 2023
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
“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
Research and development expenses were
Clinical development expenses were
Selling, general and administrative expenses were
Net loss for the second quarter of 2023 was
Cash and cash equivalents were
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and diseases of the lung, and targeted cancer treatment. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity and specificity for the detection of early-stage lung cancer. CyPath® Lung is marketed as a laboratory developed test (LDT) by Precision Pathology Services. OncoSelect® Therapeutics, LLC, a subsidiary of bioAffinity Technologies, is advancing its discoveries shown in vitro to kill cancer cells without harm to normal cells. Research and optimization of the Company’s platform technologies are conducted in its laboratories at The University of
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of the words "could," "believe," "anticipate," "intend," "estimate," "”expect," "may," "continue," "predict," "potential," "project" and similar expressions that are intended to identify forward-looking statements and include statements regarding implementing a test market pilot program of CyPath® Lung across various target markets in
bioAffinity Technologies, Inc. Condensed Consolidated Balance sheets |
||||||||
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2023 |
|
|
2022 |
|
||
|
|
(Unaudited) |
|
|
|
|
||
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
8,279,182 |
|
|
$ |
11,413,759 |
|
Accounts and other receivables, net |
|
|
90,233 |
|
|
10,489 |
|
|
Inventory |
|
|
10,101 |
|
|
|
5,540 |
|
Prepaid and other current assets |
|
|
279,687 |
|
|
|
531,899 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
8,659,203 |
|
|
|
11,961,687 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
207,377 |
|
|
|
214,438 |
|
Other assets |
|
|
6,920 |
|
|
|
6,000 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
8,873,499 |
|
|
$ |
12,182,125 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
174,404 |
|
|
$ |
345,042 |
|
Accrued expenses |
|
|
515,663 |
|
|
|
541,894 |
|
Unearned revenue |
|
|
42,750 |
|
|
|
— |
|
Loan payable |
|
|
42,334 |
|
|
|
251,746 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
775,151 |
|
|
|
1,138,682 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
775,151 |
|
|
|
1,138,682 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies (See Note 9) |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock, par value |
|
|
— |
|
|
|
— |
|
Common stock, par value |
|
|
59,887 |
|
|
|
58,669 |
|
Additional paid-in capital |
|
|
47,978,892 |
|
|
|
47,652,242 |
|
Accumulated deficit |
|
|
(39,940,431 |
) |
|
|
(36,667,468 |
) |
Total stockholders’ equity |
|
|
8,098,348 |
|
|
|
11,043,443 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
$ |
8,873,499 |
$ |
12,182,125 |
bioAffinity Technologies, Inc. Unaudited Condensed Consolidated Statements of Operations |
||||||||||||||||
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
|
|
(Unaudited) |
|
|
|
|
|
(Unaudited) |
|
|
|
|
||||
Revenue |
|
$ |
19,738 |
|
$ |
1,306 |
|
|
$ |
20,659 |
|
|
$ |
1,306 |
|
|
Cost of sales |
|
|
1,234 |
|
|
|
146 |
|
|
|
1,322 |
|
|
|
146 |
|
Gross profit |
|
|
18,504 |
|
|
|
1,160 |
|
|
|
19,337 |
|
|
|
1,160 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
335,125 |
|
|
|
248,419 |
|
|
|
704,741 |
|
|
|
528,267 |
|
Clinical development |
|
|
35,260 |
|
|
|
28,240 |
|
|
|
54,888 |
|
|
|
80,744 |
|
General and administrative |
|
|
1,426,469 |
|
|
|
408,619 |
|
|
|
2,596,027 |
|
|
|
803,311 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
1,796,854 |
|
|
|
685,279 |
|
|
|
3,355,657 |
|
|
|
1,412,322 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(1,778,350 |
) |
|
|
(684,119 |
) |
|
|
(3,336,320 |
) |
|
|
(1,411,162 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
44,124 |
|
|
|
276 |
|
|
|
82,778 |
|
|
|
847 |
|
Interest expense |
|
|
(1,360 |
) |
|
|
(399,265 |
) |
|
|
(3,015 |
) |
|
|
(1,546,848 |
) |
Gain on extinguishment of debt |
|
|
— |
|
|
|
212,258 |
|
|
|
— |
|
|
|
212,258 |
|
Fair value adjustments on convertible notes payable |
|
|
— |
|
|
|
782,798 |
|
|
— |
|
|
1,186,992 |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before provision for income taxes |
|
|
(1,735,586 |
) |
|
|
(88,052 |
) |
|
|
(3,256,557 |
) |
|
|
(1,557,913 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
4,587 |
|
|
|
— |
|
|
|
16,406 |
|
|
|
2,159 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(1,740,173 |
) |
|
$ |
(88,052 |
) |
|
$ |
(3,272,963 |
) |
|
$ |
(1,560,072 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
|
$ |
(0.20 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.58 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding |
|
|
8,520,714 |
|
|
|
2,693,511 |
|
|
|
8,477,656 |
|
|
2,687,431 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20230814966396/en/
bioAffinity Technologies
Julie Anne Overton
Director of Communications
jao@bioaffinitytech.com
LHA Investor Relations
Tirth T. Patel
tpatel@lhai.com
Source: bioAffinity Technologies, Inc.
FAQ
What is the significance of the CPT code issued by the American Medical Association?
What is the Department of Defense using CyPath Lung for?
Who is the new Chief Financial Officer of bioAffinity Technologies?